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MOU 225-75-4002

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

 

I. PURPOSE

This agreement with the Agricultural Marketing Service (AMS) and the Food and Drug Administration (FDA) establishes the procedures for the exchange of information and the coordination of activities so as to avoid duplication of effort in inspecting and sampling dry milk product plants to determine whether products manufactured at one plant may be contaminated with salmonella microorganisms. This agreement supersedes the agreement on this subject which became effective on February 19, 1975.

 

II. BACKGROUND

A. The United States Department of Agriculture (USDA) has two types of voluntary inspection programs: (1) Plant Inspection Program (PIP) for USDA Approval for Grading Services and (2) Resident Inspection and Grading Program.

1. Plant Inspection Program (PIP) for USDA Approval for Grading Services. Under the Plant Inspection Program (PIP), dry milk plants are surveyed for approval every three months. The surveys include a salmonella surveillance of the plant's product and environmental material. Official inspection and grading of the product is provided on request and assignment basis under this program. Dry milk products produced under this program are not eligible to be packed under the USDA shield.

An approved plant is one or more adjacent buildings, or parts thereof, comprising a processing facility at one location in which the facilities and methods of operation therein have been surveyed and approved by the administrator as suitable and adequate for inspection or grading service (7 CFR Part 58, Subpart B—General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service).

2. Resident Inspection and Grading Program. Under this program the processing operation of a dry milk plant and all finished products are subject to continuous inspection. Dry milk products produced under the Resident Inspection and Grading Program are eligible to packaged under the USDA shield.

B. The Food and Drug Administration (FDA) has the authority to prevent the shipment of adulterated or misbranded products in interstate commerce. For enforcement purposes, FDA may inspect establishments where food is manufactured, processed, or packed, or held and may sample food and/or food products at such establishments.

 

III. SUBSTANCE OF AGREEMENT

A. The following procedures will apply to plants and products under the PIP program:

1. AMS will:

(a) Supply FDA with copies of its quarterly publication "Dairy Plants Surveyed and Approved for USDA Grading Service."

(b) Promptly notify FDA in writing when a plant or product is no longer under its Salmonella Surveillance Program or when a plant or product comes under the program.

(c) Report to FDA by telephone, confirm by written report, positive product samples on commercial production when quarterly surveillance reveals two or more positive product tests.

(d) Report to FDA any single positive product sample.

(e) Report all results, both positive and negative, of follow-up tests on positive product samples.

(f) Report positive environmental samples whenever the positive tests are repetitive.

(g) Report any conclusion as to whether the positive product test result was an isolated finding, or if not, whether the apparent source of contamination was detected and corrected.

(h) After notification from FDA regarding any information relating to the plant or product noncompliance involving salmonella, take necessary corrective action, and if necessary to achieve prompt correction, supplement its power with coordinated FDA authority and support.

2. FDA will:

(a) Not inspect dry milk product plants for salmonella in dry milk products provided the plant is operating under the PIP. FDA may inspect a dry milk product plant, however, when AMS reports positive salmonella samples on two or more production lots from plants engaged in commercial distribution or where routine sampling by FDA of lots in commercial distribution reveals positive salmonella findings. Nothing in this agreement precludes FDA from (1) inspecting any plant for problems other than salmonella, whether or not such plant produces dry milk products under the PIP and (2) sampling dry milk products for problems other than salmonella.

(b) Sample commercially distributed dry milk products when two or more production lots are identified to be salmonella positive. FDA will not duplicate USDA efforts by resampling the same stocks for salmonella at the same location previously examined by USDA.

(c) Notify AMS of any information it obtains relating to plant or product noncompliance involving salmonella.

(d) On request from AMS, report data and results on its salmonella surveillance of dry milk plants that are not approved under the AMS program, or on those in the USDA Salmonella Surveillance Program.

(e) Give advance notice to AMS if FDA determines that in the interest of the public health it is necessary to take regulatory actions on firms under the USDA voluntary programs.

B. The following additional procedures shall apply for plants and products under the USDA Resident Inspection and Grading Program:

3. AMS will:

(a) Furnish to FDA the names and locations of plants operating under the program.

(b) Promptly notify FDA in writing when a plant is no longer under the program.

(c) Report salmonella test results in accordance with the provisions in Section III(A)(1)(c) through (g) of this agreement.

4. FDA will:

Rely upon the AMS Salmonella Surveillance Program on plants operating under the program, and will not sample for salmonella the finished dry milk products after shipment from such plants. This agreement does not preclude FDA from sampling drug milk or dry milk products at manufacturing plants using these products as an ingredient when sampling is conducted as a followup to consumer complaints, or as a result of information that the dry milk or dry milk products may have become contaminated or adulterated after leaving dry milk manufacturer's control. This agreement also does not preclude FDA from inspecting any plant for problems other than salmonella whether or not such plant produces dry milk products under salmonella inspection program nor does it preclude the sampling of their products, including dry milk products, for problems other than salmonella.

 

IV. NAME AND ADDRESS OF PARTICIPATING AGENCIES

A. Agricultural Marketing Service
Department of Agriculture
P.O. Box 96456
Washington, D.C. 20090-6456

 

B. Food and Drug Administration
Department of Health and Human Services
5600 Fishers Lane
Rockville, MD 20857

 

V. LIAISON OFFICERS

A. For the Agricultural Marketing Service:

Chief, Dairy Grading and Standardization Branch
Agricultural Marketing Service
(Currently Mr. Richard W. Webber)
P.O. Box 96456
Washington, D.C. 20090-6456

202-447-3171

 

B. For the Food and Drug Administration

Director, Division of Emergency and Epidemiological
Operations, Office of Regulatory Affairs
(Currently Mr. Richard C. Swanson)
5600 Fishers Lane (HFC-160)
Rockville, MD 20857
301-443-4567

 

VI. PERIOD OF AGREEMENT

This agreement becomes effective upon acceptance by both parties and will remain in effect indefinitely. It may be revised by mutual written consent or terminated by either party upon a 30-day advance written notice to the other.

Approved and Accepted
for the Department of Agriculture

Signed by: J. Patrick Byle, Administrator
Agriculture Marketing Service

Date: October 23, 1987

Approved and Accepted
for the Food and Drug Administration

Signed by: John M. Taylor, Associate Commissioner for Regulatory Affairs

Date: November 18, 1987