Memorandum of Understanding
Between The Agricultural Marketing Service and
The Food and Drug Administration
The Agricultural Marketing Service (AMS) of the United States Department of Agriculture and the Food and Drug Administration (FDA) of the Department of Health, Education, and Welfare, hereby jointly agree to the following terms and conditions as described herein.
Purpose: To outline the authority or basis for cooperative efforts between these two agencies regarding the inspection, sampling, and examination of imported raisins. (Imported Raisins under Section 8.e. of the Agricultural Marketing Agreement Act of 1937).
I. STATUTES RELATING TO THE AGREEMENT
A. The Food and Drug Administration of the Department of Health, Education and Welfare is charged with the enforcement of the Federal Food, Drug, and Cosmetic Act. The Food and Drug Administration inspects samples, and examines imported raisins for the purpose of determining their status under the statute. One provision of the Act deems a food to be adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance.
B. As a result of the 1971 Amendment to the Agricultural Marketing Agreement Act of 1937, the Fruit and Vegetable Division of the Agricultural Marketing Service is responsible for certifying that imported raisins meet the minimum grade and condition standards as outlined in Raisin 8.e. Import Regulation. These requirements recognize insect infestation, filthy, and decomposed raisins as defects which prohibit importation.
C. So that the responsibilities of both agencies can be efficiently carried out, an agreement concerning the inspection, sampling, and examination of raisins is hereby executed as a supplement to the May 11, 1972 agreement between the Agricultural Marketing Service and the Food and Drug Administration and any subsequent revision thereof.
D. Nothing in this agreement shall lessen the responsibilities of the Department of Agriculture under the Agricultural Marketing Agreement of 1937, nor of the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act. Results of any year's raisin crop may be appraised at the termination of any shipping season relative to the tolerance of insect infested, filthy, and decomposed raisins.
II. SERVICES TO BE PERFORMED
A. In addition to evaluating the raisins for grade condition requirements, the Agricultural Marketing Service will:
1. Sample and examine at time and place of entry all lots (except those of 100 pounds or less) of imported raisins. For the purpose of the Program, a "lot" shall be considered that portion of an offering for import bearing a single identifying number or mark. The sampling rate will be 3 sub samples per 100 or less primary containers (less than 100 pounds each); 6 subs/101-600 containers; 13 subs/601-1200 containers; 21 subs/1201-2000 containers; and 29 sub samples/2001-2800 primary containers; etc. Each sub shall consist of approximately 20 ounces.
2. Examine the raisins for insect infestation, filth, decomposition, mold, and sand or grit by the official FDA method. The individual subs will be examined visually and a composite sample will be subjected to the F & D micro analytical method. (One composite will be made per 3-6 subs; 2 per 13 subs; 3 per 21 subs; and 4 composites per 29 subs).
3. Accept or reject the lots of raisins according to the USDA Administrative Guides for filth, decomposition, mold, and insect infestation and according to the FDA Administrative Guidelines (40 mg. sand/grit per 100 grams raisins) for sand or grit.
4. Upon completion of the examination, promptly notify the appropriate Food and Drug District Office:
(a) of any lots found not to meet minimum acceptance criteria because of insect infestation, filth, or decomposed raisins, and,
(b) any cases about which there is question regarding the laboratory examination results.
5. At the end of the season, provide the FDA a copy of each examination report.
B. The FDA will:
Unless the USDA is notified to the contrary:
1. Accept the findings of USDA on any lots of raisins sampled and inspected by them.
2. Cause detention of any lots of raisins rejected by USDA because they contain insect infestation and/or filthy and decomposed raisins.
3. Permit diversion, after suitable denaturing, of the lots for non-human food use; i.e., alcohol manufacture.
III. NAME AND ADDRESS OF PARTICIPATING AGENCY
Agricultural Marketing Service
U.S. Department of Agriculture
IV. LIAISON OFFICERS
A. Mr. John B. Wegener
Head, Technical Services Section
Processed Products Standardization and Inspection Branch
Agricultural Marketing Service, USDA
South Agriculture Building, Room 0739
Washington, D.C. 20250
B. Mr. Richard Klug
Assistant for Import Operations
Field Operations Branch, RO-110
Division of Field Operations, EDRO
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20852
V. PERIOD OF AGREEMENT
This agreement, when accepted by both parties, covers an indefinite period of time and may be modified by mutual consent of both parties or terminated by either party upon thirty (30) days advance written notice.
VI. Nothing in this agreement modifies previously existing agreements nor does it preclude entering into separate agreements setting forth procedures for special programs which can be handled more efficiently and expeditiously by such special agreement.
VII. This agreement is entered into under the authority of the Economy Act approved June 30, 1932, as amended 31 USC 686.
Approved and Accepted
for the U.S. Department of Agriculture
Signed by: Administrator, Agriculture Marketing Service
Date: May 7, 1973
Approved and Accepted
for the Food and Drug Administration
Signed by: Sam D. Fine, Associate Commissioner for Compliance
Date: April 18, 1973