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If the Grain Division, AMS, USDA, applicant is located in the State of

Region II:

New York (Bronx, Kings, Nassau,
New York, Queens, Richmond,
Rockland, Suffolk, and West-
chester Counties).

The location and telephone number of the
Chief Inspector, Investigations Branch
FDA, to contact is-

850 3d Ave., Brooklyn, N.Y. 11232. Commercial: 212-788-3000, ext. 1309. FTS: 212-788-1309.

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

New Jersey

Puerto Rico

Region III:

Pennsylvania and Delaware_______

Commercial: 716-842-6915. FTS:
Same.

970 Broad St., room $31. Newark, N.J.
07102. Commercial: 201-645-6230.
FTS: 201-645-6231.

Post Office and Courthouse Bldg., room 107, P.O. Box 4421, Old San Juan Station, San Juan, P.R. 00905, Commercial: 809-723-6136. FTS: 202967-1221 and ask for 809-C22-0443.

1204 U.S. Customhouse. 2d and Chestnut Sts., Philadelphia, Pa. 19106. Commercial: 215-597-4390. FTS: Same.

Maryland, Virginia, and West Vir- 900 Madison Ave., Baltimore, Md., ginia, 21201. Commercial: 301-962-4099. FTS: Same.

Region IV:

Alabama, Georgia, North Carolina 880 West Peachtree St. NW., Atlanta, and South Carolina. Ga. 30309. Commercial: 404-5263218. FTS: Same.

Kentucky, Mississippi, and Tennes- 297 Plus Park Blvd., Nashville, Tenn.,

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Minnesota and Wisconsin_________ 240 Hennepin Ave., Minneapolis, Minn. 55401. Commercial: 612-725–2126. engeimagnet de MFTS: Same.

Region VI:

New Mexico, Oklahoma, and Texas_3032 Bryan St., Dallas, Tex. 75204.

Arkansas and Louisiana____.

Commercial: 214-749-2174. FTS:
Same.

222 U.S. Customhouse. 423 Canal St.,
New Orleans, La. 70130. Commer-
cial: 504-527-6345. FTS: Same.

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

and Nebraska.

64106. Commercial: 816-374-5623. FTS: Same.

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Region X: Alaska, Idaho, Oregon, and Federal Office Bldg., 901 1st Ave.,
Washington.
Seattle, Wash. 98104. Commercial:
206-442-5319. FTS: Same.

GR Notice 1516
June 5, 1974

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.

T. 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

with AMS authority. Where AMS authority is inadequate to effect needed corrective action, AMS will so inform FDA.

(3) In developing standards for all grades of grain, rice, and pulses, take into account criteria such as tolerances and action levels and not set standards inconsistent with such criteria. During the inspection and grading of these commodities, make such examinations to determine compliance with these criteria as are feasible considering the circumstances under which such services are performed.

(4) Report to the appropriate FDA field office information intended to permit location and identification of any lot of grain, rice, or pulses which, upon inspection and grading by AMS graders or licensed inspectors, is found to meet the FDA criteria for classifying grain, rice, or pulses as actionable under the Federal Food, Drug, and Cosmetic Act.

(5) Furnish FDA headquarters, on request, any pertinent information in AMS possession concerning inspections and gradings of specific lots of grain, rice, and pulses by AMS graders or licensed inspectors that have been proceeded against or are being considered for action by FDA.

(6) Require that inspection certificates issued by official inspection personnel include codemarkinges or other identifications to identify the inspected and graded grain, rice, or pulses.

(7) Inform FDA headquarters whenever AMS has information that an AMS grader or licensed inspector is to be or has been subpoenaed as a witness at judicial proceedings involving FDA action on grain, rice, or pulses and inform FDA of the nature of the proposed testimony.

B. The Food and Drug Administration will:

(1) Invite the AMS grader or licensed inspector stationed at a plant which is obtaining inspection by AMS to accompany the FDA inspector during his inspection of such plant. The FDA inspector will point out or discuss with the AMS grader, or licensed inspector, any conditions noted which may result in violations of the Federal Food, Drug, and Cosmetic Act.

(2) Request from AMS headquarters any needed information concerning the inspection and grading of specific lots of grain, rice, or pulses that have been proceeded against, or are being considered for action by FDA, and are known or believed to have been inspected and graded by an AMS grader or licensed inspector.

(3) Immediately notify the appropriate AMS field office concerning the details of serious, objectionable sanitation conditions or handling practices or the presence of contaminated, adulterated, or otherwise unsafe or unwholesome food or feed products whenever they are found by FDA in processing, packing or shipping plants where AMS graders or licensed inspectors are currently conducting inspections and gradings of grain, rice, or pulses when FDA believes such information would be of value to AMS or the official inspection agencies in their inspection and grading activities. On receipt of the information, AMS will initiate such corrective action as is feasible including withdrawal or suspension of inspection and grading services.

(4) Provide timely notification and sufficient detail to the appropriate AMS field office concerning FDA initiated seizure actions against any lots of grain, rice, or pulses to facilitate the identity of such lots by AMS graders or licensed inspectors.

(5) Inform AMS headquarters of the criteria which are used by FDA in determining whether grain, rice, or pulses would be considered actionable under the Federal Food, Drug, and Cosmetic Act, so that AMS may use the criteria in AMS standards and in performing inspection and grading activities.

(6) On request of AMS, review labels, legends, stamps, and other official marks for grain, rice, and pulses from the standpoint of possible conflict with the misbranding provisions of the Federal Food, Drug, and Cosmetic Act.

C. It is mutually agreed that:

(1) Both agencies will maintain close working relations with each other, both in headquarters as well as in the field.

(2) Regulations proposed by either agency affecting AMS grain, rice, or pulse standards will be referred to the other agency for review and comments prior to issuance.

(3) Both agencies will cooperate jointly and with the grain, rice, and pulse industries in the improvement of sanitation and food handling practices in grain, rice, and pulse handling and processing plants. Both agencies will mutually exchange data and cooperate in the development of sampling plans, methodology,

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