Memorandum of Understanding
The Department of Health, Education, and Welfare
Food and Drug Administration
The Animal and Plant Health Inspection Service
The Animal and Plant Health Inspection Service of the Department of Agriculture and the Food and Drug Administration have entered into an agreement concerning related objectives in carrying out their respective responsibilities under the Federal Meat Inspection Act and the Poultry Products Inspection Act, and the Federal Food, Drug, and Cosmetic Act. The agreement, which sets forth the working arrangements to be followed or adopted in order to enable each agency to discharge its responsibilities when an FDA Class I or Class II is initiated, reads as follows:
Concerning the Recall and Disposition of Class I and
Class II Recalled Products for Human Consumption
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.
When illegal products are encountered, FDA will move expeditiously with one of several procedures to assure the removal of the product from the market. Recall is one of the most frequently used procedures for removing illegal products from consumer channels. It has assumed a new dimension of importance in FDA's enforcement scheme.
The Animal and Plant Health Inspection Service (APHIS) of the Department of Agriculture (USDA) was established by the Secretary of Agriculture on April 2, 1972, pursuant to authority contained in 5 U.S.C. 301 and Reorganization Plan 2 of 1953.
APHIS was created to conduct regulatory and control programs to protect the wholesomeness of meat and poultry products for human consumption and to protect and improve animal and plant health for the benefit of man and his environment. In cooperation with state governments, APHIS administers federal laws and regulations pertaining to animal and plant health and quarantine, meat and poultry inspection, humane treatment of animals, and control and eradication of pests and diseases. Federal inspection is made of all meat, poultry, and related products processed by plants shipping in interstate and foreign commerce as required by law. The work includes inspection of poultry and animals at the time of slaughter and inspection of processed products during various stages of production and handling to assure wholesomeness of products and truthfulness in labeling.
During the recall of a product processed in accordance with the Federal Meat Inspection Act and/or the Poultry Products Inspection Act, which name recalled ingredients subject to FDA jurisdiction, both agencies have common or related objectives in carrying out their respective regulatory and service activities. This Memorandum of Understanding sets forth the working arrangement which are being followed or adopted to enable each agency to discharge as effectively as possibly its responsibilities when an FDA Class I or Class II recall is initiated. A Class I recall is initiated in an emergency situation which is life threatening and in which the hazardous product is the direct cause of the threat. A Class II recall is initiated in a priority situation which may be immediate or long range and potentially life threatening or otherwise hazardous to health, and in which the hazardous product is either indirectly or directly the cause of the threat.
SERVICES TO BE FURNISHED
A. Food and Drug Administration will:
1. Expeditiously furnish APHIS Meat and Poultry Inspection Program, compliance staff, the rationale on which the recall is based and the identity of USDA inspected firms known by FDA to have received the products being recalled. This information will relate to ingredients under the exclusive jurisdiction of FDA that were subsequently used in meat and poultry products in a USDA inspected plant.
2. Assist USDA (when requested) in its investigation and evaluation to determine the need for the secondary recall of a meat and/or poultry product processed in a USDA inspected plant.
3. Furnish the APHIS compliance staff pertinent evident to support a USDA request to a U.S. attorney for seizure (if necessary) under section 403(a) of the Federal Meat Inspection Act (21 U.S.C. 673) and section 20 of the Poultry Products Inspection Act (21 U.S.C 469(b)).
B. The Animal and Plant Health Inspection Service will:
1. Evaluate processing procedures in consultation with FDA to determine the need for the secondary recall or USDA meat and poultry inspected products.
2. Initiate a secondary recall of meat and poultry products, when necessary, and monitor and determine the effectiveness of the recall.
3. Issue appropriate press releases after consultation with FDA and affected firms.
4. Provide FDA with identity and amounts of USDA inspected meat and poultry products containing ingredients under recall.
5. Advise FDA of product disposition, if other than destruction, before disposition occurs.
C. It is mutually agreed that:
1. 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.
2. Both agencies will collaborate in furnishing reports of the progress of the work and such other reports as may be mutually agreed upon from time to time between the cooperating parties.
3. Primary liaison for operational matters will be maintained between the following units:
For USDA: Compliance Staff, FO, MPI, APHIS (202) 447-3317).
For FDA: Field Compliance Branch, FOD, EDRO (1866) 300-4374) or (301)-796-8240.
4. Secondary liaison for technical matters will be maintained between the following units:
For USDA: Toxicology and Epidemiology Staff, SS, MPI, APHIS (301-344-2003).
For FDA: Recall Office, Division of Regulatory Guidance, Bureau of Foods (202-245-1251).
Secondary liaison will include early transmissions to USDA of hazard notices involving FDA regulated products which are potential ingredients in USDA inspected meat or poultry products.
5. This agreement, when accepted by both parties, may be modified by mutual consent or terminated by either party upon thirty (30) days advance written notice.
Approved and Accepted
Signed by: F.J. Mulhern
Date: June 3, 1975
Approved and Accepted
Signed by: Sam D. Fine
Date: May 20, 1975