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  1. Domestic MOUs

MOU 225-72-2009

Memorandum of Understanding
between the Agricultural Marketing Service
andthe Food and Drug Administration
Concerning Information Sharing and Other Activities Related to the Auditing, Inspection, and Grading of Food Products [1]

1. Purpose

Cooperation and information sharing in the inspection of food products and establishments.1

2. Background

The Food and Drug Administration (FDA) of the Department of Health and Human Services is charged with the enforcement of the Federal Food, Drug, and Cosmetic Act (FFDCA) and other laws. In fulfilling its responsibilities under the FFDCA, FDA's activities are directed toward protecting the public health by ensuring that foods are safe and wholesome and truthfully and informatively labeled. This is accomplished, in part, by inspecting the production, processing, and distribution of foods and examining samples thereof to ensure compliance with applicable requirements. FDA also promulgates under the FFDCA mandatory standards of identity, quality, and fill of containers for food products after appropriate notices and hearings.

The Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture, under the authority of the Agricultural Marketing Act of 1946, carries out certain voluntary service functions designed to aid in the efficient marketing of agricultural products. These include developing commercial grade standards and specifications for foods, furnishing auditing, inspection and grading services (including the issuance of certificates of quality and/or condition) and auditing reports to producers, processors, shippers, buyers, or other interested parties. The major purpose is to assist producers in preparing quality wholesome products that meet users’ requirements and to provide objective information concerning the grade, quality, or condition of a product, which will assist interested parties engaged in marketing functions. In addition to inspection and grading services for products, AMS offers voluntary audit, survey, and verification services at product locations and facilities. AMS’ regulatory authority facilitates fair trade practices among the industry through education, mediation, arbitration, licensing and enforcement of the Perishable Agricultural Commodities Act of 1930.

The two agencies have certain related objectives in carrying out their respective regulatory and service activities. Therefore, the agencies believe it is desirable from the standpoint of public health protection to set forth in this Memorandum of Understanding (MOU) the working arrangements that are being followed or adopted in the interest of each agency discharging as effectively as possible its responsibilities related to inspection/grading and standardization activities for food products. The MOU recognizes that AMS’ audit, survey, and verification services contribute to the protection of consumers by helping agricultural producers fulfill their responsibility to ensure that their products are safe and meet applicable FDA requirements. The MOU also recognizes that FDA may take into consideration information resulting from AMS services in making risk-based determinations, such as in establishing inspection priorities. In addition, the MOU recognizes that FDA is the competent authority in the United States for the safety of these food products, and that determinations made by AMS do not change or diminish FDA's authority under the FFDCA. Nothing in this MOU, or any determination made by AMS, would restrict FDA from conducting its own inspection or taking regulatory action, nor would it affect the legal responsibilities of establishments under the FFDCA.

3. Substance of the Agreement

A. The Agricultural Marketing Service will:
  1. supply to FDA-designated offices, upon request, complete lists of all farms, packing plants, handlers, and food processors that are operating under AMS continuous or other resident or temporary inspection or grading contracts or contractual audit services. This list will include the type of service provided and the food products involved;
  2. immediately advise the appropriate FDA office of those plants subject to withdrawal or suspension of service, termination of contract, or denial of inspection services because of sanitation or other current good manufacturing practice or good agricultural practice deficiencies. AMS will notify the appropriate FDA office of those facilities that appear not to conform to agricultural best practices that relate to food safety or to FDA’s current Good Manufacturing Practice regulation under 21 CFR part 110;
  3. investigate any report from FDA that a grower, packer, or processor operating under contract with AMS has not corrected objectionable conditions found to exist by FDA, and take action in accordance with AMS regulations and contracts;
  4. decline to inspect, grade, or audit samples of products that are known to have been seized by FDA, or that are known to be involved in FDA enforcement actions. This does not preclude reinspection of legally authorized samples by AMS if the FDA seizure or other enforcement action involved products that had previously been inspected or graded by AMS;
  5. decline to assign a U.S. grade or permit the use of Government official marks or other approved identification on a food product (1) that is known or believed by AMS to be adulterated under the FFDCA or other applicable federal statute, or (2) that AMS has otherwise found not to be suitable for grade assignment because of possible adulteration, contamination, or food safety risk;
  6. decline to provide auditing, inspection, and grading services to a facility (1) that is known or believed by AMS to have significant violations of the FFDCA, or other applicable statute, that are uncorrected or reoccurring, or (2) for which FDA has provided notification to AMS that FDA has found unsanitary conditions;
  7. notify the appropriate FDA office with information on any lot of product which, upon inspection, is known or believed to fail to comply with FDA requirements, unless AMS verifies, in coordination with FDA, that such product is appropriately reconditioned or relabeled to comply with FDA requirements or is segregated and disposed of for nonfood use or otherwise lawfully shipped or sold;
  8. furnish to FDA upon request, any pertinent information concerning the grade or quality determination relative to specific lots of products inspected or graded by AMS that have been proceeded against or are being considered for any action by FDA;
  9. record on the audit, inspection or grading report any pertinent codes or other marks that will serve to identify the specific goods, which are audited, inspected, or graded;
  10. when requested by FDA, provide assistance necessary to facilitate investigations required to ensure public health;
  11. for product areas where FDA has provided the appropriate training to AMS, routinely advise contract establishments of pertinent FDA requirements and provide information on compliance and points of contact at FDA;
  12. upon FDA request, sample and analyze specific lots of agricultural commodities for investigations involving potential regulatory violations; provide feedback to FDA on results of sampling and analysis, if requested; provide support for associated requests for testimony in related court actions; and follow FDA protocols related to chain of custody, sampling, and analysis for lots when samples and analysis are performed for FDA, or obtain approval from FDA for using alternative methodologies;
  13. notify the appropriate FDA office immediately of any presumptive or confirmed positive findings of human pathogens of public health significance or residues of pesticide and/or environmental contaminants in products inspected by AMS that exceed tolerances, action levels, or otherwise adulterate the food;
  14. furnish to FDA upon request any pertinent reports AMS generates that include general information on deficiencies in current good manufacturing practice or good agricultural practice;
  15. notify the appropriate FDA office of those facilities that fail to conform to current good manufacturing practices or good agricultural practices related to food safety;
  16. cooperate with FDA in responding to food safety emergencies involving food products, within resource constraints;
  17. notify FDA in writing whenever an employee or AMS inspector has been asked to testify in a case in which FDA is a party. Decline to testify for a private entity unless that entity has complied with AMS’ "Touhy" regulations including issuance of a subpoena (7 CFR §1.214 & §1.215 et seq.); and
  18. inform FDA about firms that have repeated violations of AMS requirements.
B. The Food and Drug Administration will:
  1. maintain guidance documents on its website or otherwise provide these documents to AMS upon request, which AMS can use in providing audit services for industry;
  2. as appropriate, invite the AMS inspector/grader present at a plant operating under contract with AMS to accompany the FDA investigator during his or her inspection of such plant. The FDA investigator may point out or discuss with the AMS inspector/grader the conditions noted which may be violations of the FFDCA;
  3. request from the AMS contact designated in this document any information related to grade, quality or food safety for a specific firms or lot(s) of product(s) against which FDA is taking action or is considering taking action and that is/are known or believed to have been inspected or audited by AMS.FDA may take into consideration the results of AMS inspection certificates and other available data;
  4. request from the AMS contact designated in this document, for specific facilities under FDA investigation or action, any pertinent information concerning AMS audits related to identity preservation, food safety, or food defense;
  5. immediately notify the AMS contact designated in this document concerning the details of objectionable conditions whenever such conditions are found to exist in processing or packing plants or primary production locations where AMS is conducting inspections of products or conducting audits of facilities and/or best practices, or in other food plants, when FDA believes such information would be of value to AMS in its auditing, survey, or verification services, or its inspection and grading activities;
  6. whenever possible, mark the claimant's samples of seized products in such a manner that AMS inspectors will recognize such post-seizure samples;
  7. provide AMS with access to documented protocols for sampling, analysis, and chain of custody for lots when samples and analyses are performed at FDA’s request;
  8. provide to the AMS contact designated in this MOU to keep AMS informed of the criteria used by FDA to assist AMS in understanding which conditions FDA would consider actionable under the FFDCA and other statutes.FDA will also discuss and identify FDA training information and material that could be beneficial to AMS;
  9. on request of AMS, review labels, legends, stamps, and other official marks and claims for products packed under the various audit, grading, and/or inspection services of AMS from the standpoint of possible conflict with the misbranding provisions of the FFDCA;
  10. notify AMS when FDA has sent a warning letter to a facility covered under AMS’ inspection and auditing services.Notify AMS when FDA intends to take or is taking regulatory action against a food product or facility, except where it may be inappropriate in the context of criminal action; and
  11. notify AMS in writing whenever an employee or FDA inspector has been asked to testify in a case in which AMS is a party. Decline to testify for a private entity unless that entity has complied with FDA's "Touhy" regulations, including issuance of a subpoena. (21 CFR 20.1and 20.2).
C. AMS and FDA mutually agree that each agency will:
  1. maintain close working relations with each other, both in headquarters as well as in the field. Appropriate AMS and FDA personnel will meet periodically, as resources permit, for purposes of program planning, coordination, evaluation, and review concerning inspectional matters of mutual interest and to serve as a clearinghouse for questions and problems as may arise.Provide a list of regional office contacts;
  2. participate in meetings with industry, as resources permit, to promote better communication and understanding of regulations, policy, and statutory responsibilities, and to improve sanitation and food-handling practices;
  3. cooperate in the development of the other's regulations, guidance and programs related to relevant products, as appropriate;
  4. make formal training courses available to the other's personnel, as resources permit;
  5. take advantage of the inspectional capabilities of the other to achieve the maximum utilization of resources, when appropriate and as resources permit;
  6. exchange data and cooperate in the development of sampling plans, methodology, and guidelines for determining natural and unavoidable defects common to products audited, inspected, and graded by AMS;
  7. work with industry toward greater efficiency in connection with improvement in coding and traceability methods;
  8. cooperate in the handling of those cases of misbranding which also come under the provisions of the Perishable Agricultural Commodities Act of 1930, as amended; and
  9. develop procedures that include proper safeguards against unauthorized use and disclosure of the non-public information exchanged under this MOU.

4. Information Sharing

The procedures established under Section 3.C. must include proper safeguards against unauthorized use and disclosure of the non-public information exchanged under this MOU. Proper safeguards shall include the adoption of policies and procedures to ensure that the information shared under this MOU shall be shared and used consistent with the Trade Secrets Act [18 U.S.C. § 1905], the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], the Privacy Act of 1974, as amended [5 U.S.C. § 552a], the Freedom of Information Act [5 U.S.C. § 552], any other applicable Federal law and regulations implementing it. Pursuant to FFDCA section 301(j) [21 U.S.C. 331(j)], FDA will not reveal to AMS any method or process which is entitled to protection as a trade secret. Any Federal partner may decide not to share information or expertise in response to a particular request for information, or to limit the scope of information and expertise sharing in response to a particular request. See Process for Information Sharing under Appendix A.

Access to the non-public information shared under this MOU shall be restricted to authorized FDA and AMS employees, agents, and officials who require access to perform their official duties in accordance with the uses of the information as authorized in this MOU, unless authorized in writing by the agency that provided the information or otherwise required by law. Such personnel shall be advised of (1) the confidential nature of the information; (2) safeguards against unauthorized disclosure of confidential information; and (3) the administrative, civil and criminal penalties contained in applicable Federal laws for the unauthorized disclosure of confidential information.

If an agency that has received information under this MOU receives a Freedom of Information Act (FOIA) request for which there are responsive records that originated with the other agency, to the extent practicable, it will refer that request to the other agency for it to respond directly to the requestor regarding the releasability of the information. In such cases, the agency making the referral will notify the requestor that a referral has been made and that a response will issue directly from the other agency.

5. Limitations

This MOU represents the broad outline of the Parties' present intent to collaborate in areas of mutual interest to FDA and AMS. It does not create binding, enforceable obligations against either Agency. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. With the exception of MOU number: 225-72-2009 (dated June 25, 1975), this MOU does not affect or supersede any existing agreements or arrangements between the Parties and does not affect the ability of the Parties to enter into other agreements or arrangements related to this MOU. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and AMS operate. Nothing in this MOU shall obligate FDA and AMS to any current expenditure or future expenditure of resources in advance of the availability of appropriations from Congress.

6. Liaison Officers

To facilitate the activities carried out under this MOU, each agency will establish a single agency liaison. The initial liaisons will be:

For FDA:

Martha Myrick
Office of Regulatory Affairs
Phone: 240-402-5840
Email:martha.myrick@fda.hhs.gov

For AMS:

Erin Morris
Deputy Associate Administrator
1400 Independence Ave, SW,
Room 3077-S, Mail Stop 0201
Washington, DC 20250-1300
Phone:202-690-4024
Email:Erin.Morris@ams.usda.gov

Each agency may designate a new liaison at any time by notifying the other in writing. If at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the agency will name a new liaison and notify the other agency through the designated liaison.

7. Effective Date, Terms, Termination and Modification

This agreement will become effective when signed by both parties and it will continue in effect unless modified by mutual written consent at any time or terminated by either party upon a 60 day advance written notice to the other. The parties agree that they will review this agreement every three years to determine whether it should be modified or terminated. This MOU supersedes the Memorandum of Understanding (MOU number: 225-72-2009) dated June 25, 1975.

Approved and Accepted
for the United State Department of Agriculture’s Agricultural Marketing Service
Signed by: Rayne Pegg
Administrator, Agricultural Marketing Service
Date: February 11, 2011

Approved and Accepted
for the Food and Drug Administration
Signed by: Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Date: March 4, 2011

APPENDIX A

Process for Information Sharing

Pursuant to Section 4 of the Memorandum of Understanding (MOU) entered into by the Food and Drug Administration (FDA) and the Agricultural Marketing Service (AMS) any Federal partner “may decide not to share information or expertise in response to a particular request for information, or to limit the scope of information and expertise sharing in response to a particular request.” Nothing in the process described below changes Section 4.

When, under the current MOU, staff at the FDA or AMS request from the other agency information that may contain confidential material, the request should be in writing, which includes an informal email, and need only identify the subject for which information is requested. Although a more specific description of the information asked for may be helpful, it would not be required for purposes of making a request. However, the following language should be included in the request:

"Information that is shared under this request will be under the FDA-AMS Memorandum of Understanding. We agree not to disclose any shared information in any manner without your written permission or as required by law with advance notice to the originating agency." With the inclusion of this statement, requestors would not have to use a particular format or include other pre-specified text.

A response to a request should also be in writing, but it, too, can be an informal email that acknowledges transmission of information in response to the request. Although identifying each piece of information/document provided may be helpful, it would not be required for purposes of responding to a request. However, the following language should be included in the response:

"Pursuant to the FDA-AMS Memorandum of Understanding, this communication may contain privileged and/or confidential information exempt from public disclosure. It may not be disclosed or shared in any manner without our express written consent or as required by law with advance notice to the originating agency." With the inclusion of this statement, responders would not have to use a particular format or include other pre-specified text.

[1] This agreement does not apply to egg products, inspection of which is covered by the Egg Products Inspection Act; to meat or poultry products, inspection of which are covered by the Meat Inspection Act and the Poultry Products Inspection Act (USDA Food Safety and Inspection Service); nor to grains, including rice, dry beans, peas, or lentils, inspection of which are covered by the U.S. Grain Standards Act (USDA Grain Inspection, Packers and Stockyards Administration).

 
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