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FDA | FDA Centennial
MOU number: 225-76-2001
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. In fulfilling its responsibilities under the Act, FDA directs its activities toward the protection of the public health of the Nation by ensuring that foods are safe and wholesome and that products are honestly and informatively labeled. This is accomplished by inspecting the processing and distribution of foods and examining samples thereof to assure compliance with the Act. FDA also promulgates under the Act mandatory standards of identity, quality, and fill of container for food products after appropriate notices and public procedures.
The National Marine Fisheries Service (NMFS) of the National Oceanic and Atmospheric Administration, Department of Commerce, under authorities established by the Agriculture Marketing Act and the Fish and Wildlife Act, is responsible for:
(1) the development and advancement of commercial grade standards for fishery products and better health and sanitation standards in the industry, and
(2) furnishing inspection, analytical, and grading services and issuing certificates to producers, processors, shippers, receivers, or interested parties.
The major purpose is to encourage and assist the industry in improving the quality and safety of its products, and to provide objective information by means of inspection and official certification concerning the class, quality, quantity, identity, or condition of products which will be of maximum assistance to interested parties engaged in the production, processing, and marketing of fish and fishery products.
The two agencies have certain common or related objectives in carrying out their respective regulatory and service activities. This Memorandum of Understanding sets forth the working arrangements which are being followed or adopted to enable each agency to discharge, as effectively as possible, its responsibilities related to the inspection and standardization activities for fishery products. The Memorandum of Understanding recognizes that plants under NMFS voluntary inspection service contracts are subjected to inspection to ensure their compliance with good manufacturing practices and other applicable provisions of pertinent laws.
SERVICES TO BE FURNISHED
A. The National Marine Fisheries Service will:
1. Supply FDA headquarters with a complete list of all processing and packing establishments which are operating under NMFS inplant inspection on a contract basis. This list will set forth the type of service provided and the food products involved. NMFS will immediately advise the appropriate FDA field office of those plants subject to withdrawal or suspension of service, termination of contract, or denial of inspection services because of sanitation or other current good manufacturing practice deficiencies.
2. Assign a grade or Government legend only to products which meet all requirements for such a grade or legend. Whenever the product has not been inspected for all factors required to ensure compliance with a grade and/or legend, the certificate shall state the specified factors to which the inspection or grading was limited.
3. Apply to plants and products under voluntary inspection appropriate FDA requirements pertaining to good manufacturing practices, labeling, food additives, tolerances, standards of identity, minimum quality, and fill of container as are established by FDA regulations, and which are applied by FDA in its enforcement of the Federal Food, Drug, and Cosmetic Act.
4. Furnish the appropriate FDA field office, on request, with any pertinent information concerning specific lots of products inspected or graded by NMFS that have been proceeded against or are being considered for action by FDA.
5. Decline to inspect, grade, certify, or permit the use of official grade marks or other approved identification, except Retained Tags, on a food product which is considered adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act, of such type and/or in such amounts so as to result in the food product being subject to regulatory action by FDA. NMFS will make such examinations and test as are reasonably feasible for those materials and substances that would be likely to contaminate the product.
6. Report to the appropriate FDA field office information concerning any product that has been placed under official retention by NMFS because it is suspected, or known to be adulterated, or misbranded under the Federal Food, Drug, and Cosmetic Act, of such type and/or in such amounts so as to result in the food product being subject to regulatory action by FDA, unless such product is so reconditioned as to comply with FDA requirements or is segregated and disposed of for non-food use or otherwise lawfully shipped or sold.
7. Decline to inspect or grade samples of products which are the subject of seizure, prosecution, injunction, or import detention action. This does not preclude reinspection of samples legally collected for that purpose by NMFS, if the FDA seizures or other actions involve products which have previously been inspected or graded by NMFS.
8. Participate in a cooperative effort in investigations of food poisoning, product recalls, and problems concerning food contamination caused by disasters or other phenomena involving foods where both agencies have mutual obligations.
9. Inform FDA headquarters whenever it has information that an employee or U.S. Department of Commerce licensed inspector is to be, or has been, called as a witness at judicial proceedings involving FDA action, and advise FDA of the nature of his proposed testimony.
10. Investigate any report from FDA to the effect that a processor operating under contract with NMFS has not corrected objectionable conditions found to exist and take action in accordance with the Agriculture Marketing Act and the Fish and Wildlife Act.
B. The Food and Drug Administration will:
1. Recognize that the NMFS service provided in connection with the voluntary contract inspection of fishery processing establishments contributes to protection of consumers and aids FDA in enforcement of pertinent statutes. The NMFS inspection service will not diminish FDA's authority to inspect but should minimize FDA inspections in establishments under NMFS contract inspection. In this regard, NMFS inspectors shall routinely notify contract establishments of pertinent FDA requirements, advise them on how to comply and verify compliance. NMFS inspectors may not act as FDA inspectors but their inspections and consultations with FDA should reduce the necessity for FDA inspections.
2. Request from the appropriate NMFS field office any pertinent information concerning the grade or quality determinations relative to specific lot of products that have been proceeded against or are being considered for action by FDA and are known or believed to have been inspected by NMFS. FDA will take into consideration the NMFS inspection certificates and other available data in its review of the case.
3. Provide timely notification to appropriate NMFS field personnel of all official seizure actions taken by FDA of fishery products processed or packed in NMFS inspection plants. This would include the name of product(s), processing or packing plant(s) involved, and basis for seizure action.
4. Whenever possible mark the claimant's samples of seized products in the following manner:
"Lot sampled by the Food and Drug Administration," sample number, lot number, and name and location of the FDA employee taking sample.
5. On request, review labels, legends, stamps, and other official marks for products packed under the various inspection services of NMFS, and give an advisory opinion as to whether they do or do not conflict with the misbranding provisions of the Federal Food, Drug, and Cosmetic Act.
6. Inform and continue to keep the NMFS informed of the criteria used by FDA to establish action levels for food products and processing establishments considered to be in violation of the Federal Food, Drug, and Cosmetic Act, in order to provide maximum assurance that NMFS does not classify a food establishment, label, processing practice, or other situations as acceptable which FDA would consider actionable under the Federal Food, Drug, and Cosmetic Act.
7. Provide NMFS with current applicable administrative guidelines, tolerances, etc., that are routinely applied to fish and fishery products by FDA.
8. Invite the NMFS inspector assigned to a processing plant which is operating under NMFS contract inspection to participate with the FDA inspector during his inspection of such plant. The FDA and NMFS inspectors shall discuss any conditions noted which may result I violations of law.
C. It is mutually agreed that:
1. Where either agency believes that a particular violation is occurring in serveral fish processing plants in the industry, it may request a meeting with the other agency to consider steps to investigate the situation immediately and, where necessary, to take mutually agreeable remedial action, recognizing that in the event that remedial action cannot be mutually agreed on promptly, FDA must proceed in accordance with its responsibilities, obligations, and programs under the Federal Food, Drug, and Cosmetic Act.
2. Both agencies will participate in periodic joint meetings, and with industry as appropriate, to promote better communication and understanding of regulations, policy, and statutory responsibilities, to improve sanitation and food-handling practices in processing establishments, and to serve as clearinghouse for questions and problems as may arise.
3. Each agency will keep its customary records and make those related to the operation of this Memorandum of Understanding available to the other agency as mutually agreed upon.
4. Both agencies will exchange data and cooperate in the development of sampling plans, methodology, and guidelines for determining unavoidable natural and environmental defects common to fish and fishery products.
5. When either agency is unable to carry out any or all of its responsibilities under this Memorandum of Understanding, immediate notification should be provided to the other agency.
6. Formal training courses sponsored by either agency will be available whenever possible for the other's personnel.
7. Both agencies will maintain close working relations with each other, both in headquarters as well as in the field. Appropriate NMFS and FDA personnel will meet periodically for purposes of program planning, coordination, evaluation, and review concerning inspectional matters of mutual interest.
8. Proposed regulations by either agency establishing any type of standard for fishery products will be referred to the other agency for review and comments prior to issuance, except amendments to voluntary grade standards which do not modify any of the minimum quality factors contained in standards previously referred to FDA for its review and recommendations.
9. Each agency will designate to the other a central contact point to which communications dealing with this agreement or matters affected thereby may be first referred for attention.
10. Nothing in this Memorandum of Understanding modifies other existing agreements or memoranda of understanding, nor does it preclude entering into separate agreements setting forth procedures for special programs which can be handled more efficiently and expeditiously by such other arrangements.
11. The provisions of this Memorandum of Understanding may be modified at any time by mutual agreement.
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Approved and Accepted Signed by: Date: September 25, 1974 |
Approved and Accepted Signed by: Alexander M. Schmidt, M.D. Date: October 10, 1974 |