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MOU 225-72-2001

Memorandum of Understanding

Between
The Agricultural Marketing Service
United States Department of Agriculture 

and

The Food and Drug Administration
United States Department of Health and Human Services

 

COMPLIANCE POLICY GUIDE 7155a.05
225-72-2001

 

SUBJECT: MOU with USDA, Agricultural Marketing Service, Regarding Imported Dates and Date Material (FDA 225-72-2001, Revised November 19, 1985)

 

I. PURPOSE

This agreement sets forth the working arrangements being followed or adopted to enable the Agricultural Marketing Service (AMS) and the Food and Drug Administration (FDA) to discharge, as effectively as possible, their responsibilities relating to the inspection, sampling, and examination of imported dates and date material.

 

II. STATUTES RELATING TO THE AGREEMENT

A. FDA is charged with the enforcement of the Federal Food, Drug, and Cosmetic Act. FDA inspects, samples, and examines imported dates and date products intended for processing to determine whether they are in compliance with 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. AMS is responsible for certifying that imported retail packages of dates or bulk dates intended for packaging meet the minimum grade and condition standards as set forth in section 608e of the Agricultural Marketing Agreement of 1937, as amended. These requirements recognize insect infestation, filth, and decomposition in dates as defects which may prohibit importation.

Nothing in this agreement shall lessen the responsibilities of AMS under the Agricultural Marketing Agreement Act of 1937; nor of FDA under the Federal Food, Drug, and Cosmetic Act, as amended.

 

III. BACKGROUND

So that the responsibilities of both agencies could be efficiently carried out, an agreement concerning the inspection, sampling, and examination of whole dates, packaged or intended for packaging, was executed May 29, 1953. The agreement was subsequently amended October 7, 1963, September 27, 1971, November 21, 1977, and March 28, 1983. This agreement replaces the Memorandum of Understanding as amended on March 28, 1983.

 

VI. SUBSTANCE OF AGREEMENT

A. In addition to evaluating dates for the grade condition requirements, AMS will:

1. Sample and examine, at the time and place of entry, all lots (except those of 70 pounds or less, or lots that are so denatured as to render them unfit for human consumption) of imported packaged dates or bulk dates that are declared for packaging. Samples will be collected in accordance with the sample collection criteria in Attachment A of this agreement. For those of this agreement, a "lot" shall be considered that portion of an offering for import bearing a single identifying number or mark.

2. Examine the dates for insect infestation, filth, decomposition, and (if pitted) for pits or pit fragments in accordance with the revised method of analysis for dried fruit found in FDA Technical Bulletin Number 5, Macroanalytical Procedures Manual, pages V-53 through V-58.

3. Accept or reject lots of dates according to guidelines covering filth, decomposition, or insect infestation using the sequential analysis plan which appears as attachment B of this agreement.

4. Upon completion of the examination, promptly notify the appropriate FDA district office of:

a. Any lots found not meet minimum acceptance criteria of this agreement because of pits or pit fragments, insect infestation, filth, or decomposition, and:

b. Any cases about which there is any question regarding the laboratory examination results.

5. Upon request, provide FDA with a copy of each examination report which will contain information such as that called for in the findings chart on page V-58 of FDA Technical Bulletin 5, Macroanalytical Procedures Manual.

6. Inform the Division of Microbiology, Center for Food Safety and Applied Nutrition, FDA, of any requests for the reclassification of dates and date material and any action taken on those requests.

B. FDA will

1. Sample and examine lots of dates or date material that are declared for use in processing and lots of dates of 70 pounds or less that are packaged or declared for packaging. Samples will be collected in accordance with the sample collection criteria in attachment A of this agreement.

2. Unless AMS is notified to the contrary:

a. Accept the findings of AMS on any lot of dates sampled and inspected by them.

b. Cause detention of any lot of dates rejected by AMS because it contains excess pits, or pit fragments, insect infestation, filth, and/or decomposed dates if offered for reentry by the importer for processing.

c. Permit entry as dates for processing without resampling any lot of whole dates certified by AMS as failing to meet the minimum grade and condition requirements as outlined in Section 608e of the Agricultural Marketing Agreement Act of 1937, as amended. This will be done only for those lots which have not been rejected according to guidelines covering filth, decomposition, or insect infestation using the sequential analysis plan which appears as attachment B of this agreement, and which are not otherwise in violation with the Federal Food, Drug, and Cosmetic Act.

3. Inform the appropriate AMS field office of any detentions of dates that might be offered for reentry for other than processing purposes.

 

V. NAMES AND ADDRESSES OF PARTICIPATING AGENCIES

A. Agricultural Marketing Service

U.S. Department of Agriculture
14th and Independence Avenue, S.W.
Washington, D.C. 20250

B. Food and Drug Administration

Department of Health and Human Services
5600 Fishers Lane
Rockville, MD 20857

 

VI. LIAISON OFFICERS

A. For the Agricultural Marketing Service:

Head, Grading Section
Processed Products Branch
Fruit and Vegetable Division
Agricultural Marketing Service
U.S. Department of Agriculture
14th and Independence Avenue, S.W.
Washington, D.C. 20250

202-447-5021

 

B. For the Food and Drug Administration

Chief, Microanalytical Branch (HFF-237)
(currently Paris M. Brickey, Jr.)
Division of Microbiology
Center for Food Safety and Applied Nutrition (HFF-237)
Food and Drug Administration
200 C Street, S.W.
Washington, D.C. 20204

202-245-1223

 

VII. PERIOD OF AGREEMENT

This agreement when accepted by both parties, will be effective indefinitely. It may be modified by mutual written consent or terminated by either party upon 30 day written notice to the other.

 

ATTACHMENT A

SAMPLE COLLECTION CRITERIA

 

A. Random sample all lots

B. Determine number of subsamples to collect on the basis of lot size from the following chart:

 

NUMBER OF CONTAINERS IN THE LOT
Number of Containers
In the Lot

Number of Subsamples Required

Whole Dates

Date Material
100 or Less 3 4
101-600 8 6
601-1200 14 8
1201-2000 26 10
2001- 2800 36 12
2801- 6000 44 14
6001- 9600 56 16
9601- 15000 68 18
Over 15000 82 22

 

C. Each subsample should consist of 300 400 dates or a 3-pound chunk Bag subs separately and identify.

Note: Chart is based upon unit containers weighing between 20 pounds and 100 pounds. Should containers exceed 100 pounds, consider as 2 or more containers. For example, a 150-pound container would be 2 containers and a 300-pound container, 3 containers

 

ATTACHMENT B

SEQUENTIAL ANALYSIS PLAN FOR DATES
Number of dates
Examined*
Number of Defective Dates
Accept at or below
Continue Analysis
Reject at or above
100 1 2-7 8
200 5 6-12 13
300 10 11-17 18
400 14 15-21 22
500 16 19-25 26
600 23 24-30 31
700 27 28-34 35
800 34 - 35

*Product is to be selected at random and as nearly equal in number as practical from each subsample in the sample.

Approved and Accepted
for [outside party]

Signed by:

Date:

 

Approved and Accepted
for the Food and Drug Administration

Signed by:

Date: