[ATTACHMENT B]

U.S. DEPARTMENT OF AGRICULTURE-AGRICULTURAL MARKETING SERVICE,

GRAIN DIVISION

Subject: Confirmation of Telephonic Report of Low Quality Grain, Rice, or Pulses.

To: FDA District Office (Address and Telephone Number).

This will confirm our telephonic report of (Date) about the following inferior quality (commodity):

Item and remarks

Commodity:

Certificate No.:

Carrier Identification:

Other Identification (if any):

Sampling Date (if known):

Plant or Elevator:

Location at time of sampling:

Approximately amount of commodity:

Destination (if known):

Actionable Conditions:

Cc:

Chief Grain Inspector, Official Inspection Agency, (When applicable) Field Office Supervisor, Field Office, Grain Division.

Applicant (Note to applicant: Please promptly contact the above FDA District Office and discuss with them FDA interest in the commodity and proposed further handling of the commodity.)

Grain Division Field Office.

GR Notice 1519
June 10, 1974

U.S. DEPARTMENT OF AGRICULTURE, AGRICULTURAL MARKETING SERVICE, GRAIN DIVISION, HYATTSVILLE, MD.

Information for : Regional Directors and Field Office Supervisors.

DIRECTORY OF CHIEF INSPECTORS, INVESTIGATIONS BRANCH, FOOD AND DRUG

ADMINISTRATION

This Notice supplements GR Notice 1453.

The Chief Inspector of the appropriate Investigations Branch, Food and Drug Administration, is the person to contact when reporting sanitation problems in accordance with the AMS-FDA Agreement and GR Instruction 910-5. The attached Directory shows the location and telephone number of the appropriate Chief Inspector to contact for specific geographic areas. Please retain this list, and attach it to GR Instruction 910-5.

New York (remaining counties) --- 599 Delaware Ave., Buffalo, N.Y. 14202.

Region VII: Iowa, Kansas, Missouri, 1009 Cherry St., Kansas City, Mo.

U.S. DEPARTMENT OF AGRICULTURE-AGRICULTURAL MARKETING SERVICE, GRAIN

DIVISION, HYATTSVILLE, MD.

Information for: Chief Grain Inspectors, Interested Parties in the Grain Industry, State Departments of Agriculture, Regional Directors, and Field Office Supervisors.

This Notice transmits GR Instruction 910-6, "AMS-FDA Agreement for Graded Commodities," concerning the AMS-FDA agreement on grain under the U.S. Grain Standards Act, and rice, beans, peas, and lentils under the Part 68 regulations of the Agricultural Marketing Act of 1946.

The revised agreement became effective on May 29, 1974, and supersedes the February 19, 1942, agreement which concerned adulteration of grain: and the September 1, 1949, agreement that concerned deceptive loading of grain.

A letter (copy attached) explaining the principal changes in the revised agreement is being sent by this office to interested parties in the grain, pulse, and rice industries.

Attachment.

GEORGE T. LIPSCOMB,

Chief, Commodity Inspection Branch.
J. L. O'BRATE,

Acting Chief, Grain Inspection Branch.

GR Instruction 910-6
June 5, 1974

U.S. DEPARTMENT OF AGRICULTURE-AGRICULTURAL MARKETING SERVICE,
GRAIN DIVISION, HYATTSVILLE, MD.

Action by: Regional Directors and Field Office Supervisors.

AMS-FDA AGREEMENT FOR GRADED COMMODITIES

I. Background

The Food and Drug Administration (FDA) and the Agricultural Marketing Service (AMS) have certain related objectives in carrying out their respective regulatory and service functions. In order to assure the most effective possible discharge of their responsibilities, and that their activities be fully responsive to the public interest, the two agencies have revised and reissued a Memorandum of Agreement concerning inspection and grading of grain under the U.S. Grain Standards Act, and rice, beans, peas, and lentils under the Part 68 regulations under the Agricultural Marketing Act of 1946.

II. Purpose

This Instruction assigns responsibility to the Regional Directors and Field Office Supervisors for certain activities with respect to the revised agreement between the AMS and the FDA.

III. Assigned responsibilities

Regional Directors shall determine that this Instruction and the agreement (Exhibit A attached) are fully understood and implemented in their regions and that actions required of the Field Office Supervisors, A (1), (2), (3), (4), and (6) of the agreement are carried out.

The report by the Field Office Supervisor to the appropriate FDA Field Office, required by item A(4) of Exhibit A, shall be made by telephone within 24 hours of the receipt of information by the Field Office that a specific lot may be actionable by reason of failing to comply with FDA requirements. The verbal notification shall be followed immediately by written notification to the FDA Field Office in the format of Exhibit B attached. A copy of the written notification shall be sent to the appropriate Reigonal Office.

IV. Effective date

This agreement became effective on May 29, 1974.

V. Questions

Questions concerning the agreement, this Instruction, or the location of FDA Field Offices shall be directed to the appropriate Regional Office.

Attachments.

GEORGE I. LIPSCOMB,

Chief, Commodity Inspection Branch.
J. L. O'BRATE,

Acting Chief, Grain Inspection Branch.
U.S. DEPARTMENT OF AGRICULTURE,
AGRICULTURAL MARKETING SERVICE,
Hyattsville, Md., June 5, 1974.

DEAR SIRS: The Food and Drug Administration (FDA), an agency of the Department of Health, Education and Welfare, and the Agricultural Marketing Service (AMS), an agency of the Department of Agriculture, have certain related objectives in carrying out their respective regulatory and service functions. In order to assure the most effective possible discharge of their responsibilities, and that the activities be fully responsive to the public interest, the two agencies have revised and reissued a Memorandum of Agreement (see Exhibit A attached) concerning inspection and grading of grain, rice, and pulses.

Under the new agreement, AMS will:

Immediately inform the appropriate FDA Field Office of the identity of plants where withdrawal or suspension of inspection and grading services by AMS has occurred or is in process because of sanitation or other current good manufacturing practice deficiencies;

Investigate any report from FDA to the effect that a processor, packer, or shipper obtaining inspections from AMS has not corrected objectionable conditions found to exist by FDA and take such corrective action in accordance with AMS authority;

Provide in the standards for grain, rice, and pulses the limit of allowances of deleterious substances and adulterants in the numerical grades to levels which do not exceed those permitted by FDA for food and feed;

Make examinations during inspection and grading to determine the presence of these deleterious substances and adulterants; and

Report to FDA information concerning the location and identification of a lot which, upon inspection and grading by AMS graders or licensed inspectors, is found to contain deleterious substances or adulterants in excess of that permitted by the FDA for food and feed.

The FDA and AMS will mutually exchange data and cooperate in the development of sampling plans, methodology and guidelines for determining natural and unavoidable defects common to products inspected and graded by AMS.

Other modifications to the agreement consist largely of changing the point of exchange of information from Washington headquarters to appropriate field office levels, in order to effect more timely cooperation between the two agencies. We believe that this action will make our inspection service more valuable to both those who use it and to the public. The action now taken confirms the interests of AMS and FDA in providing assurance to the public that illegal or unwholesome products will not enter trade channels.

We look forward to continuing to serve you. We are confident that the revised agreement will improve the posture of both industry and government in carrying

out our food inspection responsibilities and to the benefit of both the food industry and the public.

This agreement supersedes the February 19, 1942, agreement which concerned adulteration of grain; and the September 1, 1949, agreement that concerned deceptive loading of grain.

If you have any questions concerning this letter, please contact the Grain Inspection Branch or the Commodity Inspection Branch, Grain Division, Agricultural Marketing Service, USDA, 6525 Belcrest Road, Hyattsville, Maryland 20782, telephone (301) 436-8827 or 436-8847.

Sincerely,

Attachment.

HOWARD WOODWORTH,
Director, Grain Division.

[EXHIBIT A]

[From the Federal Register, May 29, 1974]

INSPECTION AND GRADING OF GRAIN, RICE, AND PULSES

AGREEMENT WITH THE AGRICULTURAL MARKETING SERVICE

The Agricultural Marketing Service and the Food and Drug Administration have drawn up an agreement concerning certain related objectives in carrying out their responsibilities under the Agricultural Marketing Act of 1946 and the Federal Food, Drug, and Cosmetic Act respectively. The agreement sets forth the working arrangements being followed or adopted in the interest of the public so that each agency will discharge as effectively as possible its inspection and standardization activities for grain, rice, and pulses. It reads as follows: MEMORANDUM OF AGREEMENT BETWEEN THE AGRICULTURAL MARKETING SERVICE AND THE FOOD AND DRUG ADMINISTRATION CONCERNING THE INSPECTION AND GRADING OF GRAIN, RICE, AND PULSES

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's activities are directed toward the protection of the public health of the nation by insuring that foods and feeds are safe and wholesome. This is accomplished in part by inspecting the processing and distribution of grain, rice, and pulses (beans, peas, and lentils) and examining samples thereof to assure compliance with the Act.

The Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture, under the authority of (1) the Agricultural Marketing Act of 1946 and regulations thereunder (7 CFR Part 68) and (2) the U.S. Grain Standards Act, and regulations thereunder (7 CFR Part 26) carries out, in cooperation with official inspection agencies, certain inspection and grading functions designed to aid in the efficient marketing of grain, rice, and pulses. These include the development of commercial grade standards and furnishing inspection and grading services, including the issuance of certificates of quality and/or condition, to producers, shippers, merchandisers, processors, or other interested parties. The major purpose is to provide objective information concerning the grade, quality, or condition of grain, rice, and pulses which will be of maximum assistance to all interested parties engaged in marketing functions.

The two agencies have certain related objectives in carrying out their respective regulatory and service activities. Therefore, it is believed desirable from the standpoint of public interest to set forth in this Memorandum of Agreement the working arrangements which are being following or adopted in the interest of each agency discharging as effectively as possible its responsibilities related to regulatory and service activities for grain, rice, and pulses.

A. The Agricultural Marketing Service will:

(1) Immediately inform the appropriate FDA field office of the identity of plants where withdrawal or suspension of inspection and grading services by AMS has occurred or is in process because of sanitation or other deficiencies in food handling practices.

(2) Investigate any report from FDA to the effect that a processor, packer, or shipper obtaining inspections from AMS has not corrected objectionable conditions found to exist by FDA, and take such corrective action as is in accordance