Memorandum of Understanding
Between The Interstate Shellfish Sanitation Conference
and The Food and Drug Administration
SUBJECT: MOU with Interstate Shellfish Sanitation Conference to Improve the Sanitation and Quality of Shellfish by Delineating Responsibilities
This agreement will establish a basis upon which to foster and improve the sanitation and quality of shellfish in this country by stating the responsibilities of the Food and Drug Administration (FDA) and the Interstate Shellfish Sanitation Conference (ISSC) and the establishment of the Interstate Shellfish Sanitation Program (ISSP) and the ISSC Procedures (Procedures).
A. "Conference Meetings" means the duly called meetings of the ISSC.
B. "ISSC' means the Interstate Shellfish Sanitation Conference. The ISSC consists of agencies from shellfish producing and receiving States, FDA, the shellfish industry, and the National Marine Fisheries Service of the U.S. Department of Commerce.
C. "ISSP" means the Interstate Shellfish Sanitation Program adopted by the ISSC. The ISSP is a set of guidelines for sanitary control of shellfish that is adequate to insure that the shellfish produced in States that comply with these guidelines will be safe and sanitary.
D. "NSSP" means the National Shellfish Sanitation Program. The NSSP consists of agencies from shellfish producing States, FDA, and the shellfish industry. Under international agreements with FDA, foreign government also participate in the NSSP.
E. "Procedures" means the formally adopted methods of accomplishing ISSC business not otherwise established in the constitution or bylaws of the ISSC. The Procedures will establish methods for uniform application of the ISSP and will guide the activities and relationships of ISSC participants.
F. "Shellfish" means all edible species of molluscan bivalves, the most common of which are the fresh frozen oyster, clam, and mussel. All scallop species from the family Pectinidae are excluded from this definition.
G. "State shellfish regulatory officials" means those officials that have responsibility for any one of the following regulatory activities: Classification of shellfish growing waters; patrol of shellfish growing waters; sanitation of shellfish processing, storage or distribution facilities, or laboratory analysis of shellfish samples.
FDA is the Federal Agency responsible for enforcing the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 301 et. seq., the Fair Packaging and Labeling Act, 15 U.S.C. 1451 et. seq., and certain portions of the Public Health Service Act, including 42 U.S.C. 241, 242, 243, and 264. These laws require that all foods shipped in interstate commerce, including shellfish, be prepared, packed, and held at all times under sanitary conditions; that they be honestly and informatively labeled; and that the food itself be safe, clean, and sanitary. FDA is authorized to accept assistance from State and local authorities in the enforcement of laws to prevent and to suppress the spread of communicable disease, 42 U.S.C. 243 and 21 U.S.C. 372.
This latter authority gave rise to the NSSP, which was initiated in 1925 and has continued, to date, as a voluntary FDA, State, and shellfish industry program. The NSSP Manual of Operations, last published in 1965, sets forth the standards and procedures that govern the NSSP, including the recommended sanitary control practices for regulating the production and shipment of shellfish in interstate commerce.
The ISSC was formed September 21, 1982, at a meeting held in Annapolis, MD. Participants at the meeting included regulatory officials from 22 States, FDA, the National Marine Fisheries Service of the U.S. Department of Commerce, and members of the shellfish industry. At this meeting, the State officials ratified a constitution, bylaws, and minimum procedures for the formation of the ISSC.
The purpose of the ISSC is to provide a formal structure wherein State regulatory authorities can establish updated guidelines, and procedures for the uniform application of those guidelines, for sanitary control of the shellfish industry. The ISSC is a voluntary organization and is open to all persons interested in fostering controls that will assure sources of safe and sanitary shellfish.
IV. SUBSTANCE OF AGREEMENT
A. FDA agrees to:
1. Recognize the ISSC as the primary voluntary national organization of State shellfish regulatory officials that will provide guidance and counsel on matters for the sanitary control of shellfish.
2. Evaluate State shellfish sanitary control programs using the guidelines of the ISSP, the Procedures, and other appropriate criteria including applicable Federal laws and regulations.
3. Provide the ISSC with information on any State shellfish sanitation control program that FDA finds not to be in substantial compliance with the criteria referenced in IV.A.2.
4. Promote the maintain shellfish sanitation Memorandums of Understanding (MOUs) with foreign countries that have agreed to follow the NSSP Manual of Operations. FDA will inform the ISSC of the agency's evaluation of these foreign shellfish sanitation control programs. FDA will take appropriate steps to assure that references to the NSSP in existing MOUs are changed to the ISSP as the MOUs are revised or updated.
5. Coordinate Federal interagency affairs on matters of concern to the ISSC, including classification of shellfish growing waters under Federal jurisdiction.
6. Support or provide shellfish sanitation training, seminars, technical assistance, and scientific research as resources permit. FDA will make every effort to maintain a current scientific basis of the ISSP guidelines and standards.
7. In a manner consistent with paragraph IV.C.2. of this agreement, publish revisions to the ISSP and issue interpretations of the ISSP.
8. Publish and distribute monthly a current listing of all State certified interstate shippers as furnished to FDA on Form FD-3038b, SHELLFISH CERTIFICATION, by each State.
9. Participate to the fullest extent possible in the ISSC meetings, committees, and other deliberative groups that are necessary for the ISSC and the
ISSP to function effectively.
B. ISSC agrees to:
1. Adopt the NSSP Manual of Operations, Part I and II, and the amendments adopted at Workshops as the ISSP. The ISSC further agrees that the Procedures and any future revisions and documents adopted by the ISSC will be used as the set of guidelines for sanitary control of shellfish.
2. Furnish FDA with any pertinent information that indicates that a member State's program may not be in substantial compliance with the ISSP and assist FDA with whatever means available to secure necessary corrective measures.
3. Notify FDA of any interstate shipments or shellfish that may not be in compliance with the ISSP or that may be adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act.
4. Furnish FDA with copies of all revisions or changes to the ISSP or Procedures for review for consistency with existing laws, regulations, and policies of FDA.
5. Review evaluation reports of State shellfish sanitation control programs submitted by FDA in accordance with paragraph IV.A.3. of this agreement and request appropriate reviews among ISSC members. The ISSC will inform FDA of the recommendations or actions taken in response to the information furnished.
6. Allow representatives of foreign governments that have effective agreements with FDA concerning sanitary control of shellfish to attend the Conference meetings.
C. ISSC and FDA mutually agree to:
1. Exchange information concerning the Procedures, the ISSP, and the matters that arise from the Conference meetings in a timely manner.
2. Resolve problems of interpretations and policy that involved the Procedures, the ISSP, and the ISSC.
3. Recognize that the ISSP and the ISSC Procedures contain the principal standards and procedures for the sanitary control of shellfish.
V. NAME AND ADDRESS OF PARTICIPATING ORGANIZATIONS
A. Food and Drug Administration
5600 Fisher Lane
Rockville, MD 20857
B. Interstate Shellfish Sanitation Conference
2111 Kenbridge Drive
Austin, TX 78758
VI. Liaison Officers
The liaison officer for each party will be responsible for facilitating exchanges of information and expeditiously informing other interested parties within each respective organization on matters requiring prompt attention. Each party agrees to provide notification of any changes in liaison officer appointments. Such notification shall constitute an amendment to and not require a revision of this agreement.
A. For Food and Drug Administration:
FDA member of ISSC Executive Board
(currently Mr. J. David Clem)
Chief, Shellfish Sanitation Branch, HFF-344
Bureau of Foods
Food and Drug Administration
200 C St. SW.
Washington, D.C. 20204
B. For Interstate Shellfish Sanitation Conference:
ISSC Chairman of Board
(currently Mr. Neil B. Travis)
2111 Kenbridge Drive
Austin, TX 78758
VII. PERIOD OF AGREEMENT
This agreement will become effective upon acceptance by both parties and shall continue until terminated. The agreement may be revised by mutual consent, or terminated by either party upon a 30-day advance written notice to the other party.
Approved and Accepted for the Interstate Shellfish Sanitation Conference
Signed by: Neil B. Travis
ISSC Chariman of the Board
Date: March 14, 1984
Approved and Accepted for the Food and Drug Administration
Signed by: Mark Novitch
Acting Commissioner of Food and Drugs
Date: March 14, 1984
1. U.S. Department of Health and Human Services, Public Health Service (PHS). National Shellfish Sanitation Program, Manual of Operations: Part I, Sanitation of Shellfish Growing Areas, 1965 Revision; and Part II, Sanitation of the Harvesting and Processing of Shellfish, 1965 Revision.
2. National Shellfish Sanitation Program Policies and Interpretations, issued by the Public Health Service and Food and Drug Administration with respect to the National Shellfish Sanitation Program. A bound volume of these documents is maintained in the offices of the Shellfish Sanitation Branch, HFF-344, Food and Drug Administration, 200 C St. SW., Washington, DC 20204.
3. Official Methods of Analysis, 13th ed., 1980, Association of Official Analytical Chemists (AOAC), Box 540, Benjamin Franklin Station, Washington, DC 20044.
4. Food and Drug Administration, "Interstate Certified Shellfish Shippers List," published monthly and distributed to food control officials and other interested persons by FDA, Bureau of Foods, Shellfish Sanitation Branch, HFF-344, 200 C St. SW., Washington, DC 20204.
5. Federal Food, Drug and Cosmetic Act, U.S. Code, Title 21.
6. Fair Packaging and Labeling Act, Pub. L. 89-755, approved November 3, 1966.
7. Public Health Service Act with respect to research and investigation, 42 U.S.C. 241F; international cooperation, 42 U.S.C. 242F; Federal—State cooperation, 42 U.S.C. 243; and control of communicable diseases, 42 U.S.C. 264.
8. American Public Health Association "Recommended Procedures for the Examination of Seawater and Shellfish," 4th ed., 1970. APHA, Inc., 1015 18th St. NW., Washington, DC 20036.
9. Food and Drug Administration, "Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding Human Food" regulations, 21 CFR Part 110.
10. Food and Drug Administration Definitions and Standards for Food, "Fish and Shellfish" regulations, 21 CFR Part 161.
11. Control of communicable diseases regulations, specific provision for shellfish, 21 CFR 1240.60
12. Interstate Conveyance Sanitation regulation concerning food service sanitation on land and air conveyances, and vessels. Special food requirements, 21 CFR 1250.26
13. Interstate Shellfish Sanitation Conference Constitution, Bylaws and Procedures adopted September 21, 1982, Annapolis, MD. A certified copy is on file with the Shellfish Sanitation Branch, HFF-344, Food and Drug Administration, 200 C St. SW., Washington, DC 20204.