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  1. Domestic MOUs

MOU 225-19-031

Memorandum of Understanding Between the Agricultural Marketing Service, United States Department of Agriculture; and the Food and Drug Administration, Department of Health and Human Services

I. Purpose    

The purpose of the Memorandum of Understanding (MOU) between the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) and the Food and Drug Administration (FDA) identifies each agency’s area of expertise and operation in inspecting, sampling, and testing raw peanuts, Brazil nuts, and pistachio nuts for aflatoxins.  This MOU also establishes procedures for the exchange of information and coordination of activities.

II. Legal Authority

The Agricultural Marketing Act of 1946 (7 U.S.C. 1621-1627), Agricultural Marketing Agreement Act of 1937, as amended (7 U.S. C. 601-674), the Farm Security and Rural Investment Act of 2002 (7 U.S.C. 7958), and the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301, et seq.).

III. Background on Aflatoxins

Aflatoxins are toxic metabolites produced by the molds Aspergillus flavus, Aspergillus nomius, and Aspergillus parasiticus.  Aflatoxins, if present in sufficient amounts, may cause acute toxicity and are known to be carcinogenic.  Peanuts, tree nuts, corn, and small grains are susceptible to aflatoxin contamination.  

IV. Substance of Agreement

A. With Respect to Mandatory Aflatoxin Testing of Domestic and Imported Raw Peanuts (In Shell and Shelled)

FDA is responsible for the regulation of foods, including peanuts, in interstate commerce under the provisions of the FD&C Act.  Strategies used by the FDA to minimize aflatoxins in the U.S. food supply include establishing regulatory levels, monitoring susceptible commodities, taking appropriate enforcement action, providing guidance to the food industry, and working with other agencies on food safety.  

AMS administers the Minimum Quality and Handling Standards for Domestic and Imported Peanuts Marketed in the United States (7 CFR Part 996) to monitor levels of aflatoxins in raw peanuts and to ensure the wholesomeness of raw peanuts moving into channels for human consumption. USDA is responsible for sampling, inspecting, and testing each lot of raw peanuts for total aflatoxins and issuing an analysis certificate for each lot.  The USDA limit for domestic edible raw peanuts is 15 parts per billion (ppb) total aflatoxins or less as specified in 7 CFR Part 996, Section 996.11.  Imported raw peanuts must meet the same requirement as domestic raw peanuts.  Each lot of domestic and imported raw peanuts must be sampled and certified by a USDA Federal or Federal-State inspector and tested for aflatoxin by a USDA or USDA-approved laboratory before introduction into U.S. commerce.  All domestic and imported raw peanuts intended for human consumption must be certified as “negative” (i.e., 15 ppb or less) for aflatoxins.

a. AMS Responsibilities:

  1. Continue to administer the USDA Laboratory Approval Program for Analysis of Aflatoxins (LAP-Aflatoxin) for the testing of total aflatoxins in raw peanuts.
  2. Draw samples in accordance with 7 CFR Part 996 and the current AMS (Specialty Crops Inspection Division) sampling instructions in the applicable Inspection Instructions.  Refer to the AMS website for Inspection Instructions.  
  3. Inspect and certify the total aflatoxins of all domestic and imported raw peanuts intended for human consumption as specified in 7 CFR Part 996.  
  4. Perform aflatoxin assays using only the official methods of analysis permitted by USDA, AMS, Science and Technology Program, Laboratory Approval and Testing Division in accordance with 7 CFR Part 996.  Currently, the methods permitted are (1) immunoaffinity column (IAC) cleanup with direct fluorometry method (AOAC Official Method 991.31, A-G); (2) IAC cleanup with high performance liquid chromatography (HPLC) method (AOAC Official Method 991.31, A-F, H); and (3) water slurry with thin-layer chromatography (TLC) method (AOAC Official Method 998.03).  In the future, other methods may be permitted by AMS. AMS will notify FDA when additional methods are added.  For the most up-to-date list of permitted methods, refer to the AMS website.   

    Analysis is to be performed by USDA, AMS, National Science Laboratories (Blakely, GA) or USDA, AMS-approved laboratories (various locations; see the AMS website for the official listing).
  5. Issue analysis certificates for each lot.  Issue analysis certificates per the LAP-Aflatoxin as: (1) “negative” if the level of total aflatoxins is 15 ppb or less; or (2) enter the result of total aflatoxins on the certificate if the level is over 15 ppb.
  6. Provide FDA Office of Food Safety (OFS) headquarters staff with a quarterly summary of the total number of lots sampled, range of levels of total aflatoxins found, and a list of the applicants for each lot containing total aflatoxins above 15 ppb.  Details on individual lots will be made available to FDA upon request.
  7. Provide the appropriate FDA Office the results/certificates of shipped lots that fail to meet 7 CFR Part 996 as timely as possible.  If requested, AMS will communicate all actions taken on a given lot.  With approval from USDA Office of the General Counsel, AMS would make staff available to testify on sample collection and analysis if FDA acts based on the AMS results.  

b.    FDA Responsibilities:

  1. Notify AMS of the criteria and levels of total aflatoxins that may be subject to action by FDA under the FD&C Act. 
  2. Provide AMS with FDA Office contact information.
  3. Notify AMS after FDA takes the following actions—issuance of a warning letter, seizure, injunction, or prosecution—on a domestic handler or importer of raw peanuts for issues relating to raw peanuts if FDA sharing such information is permitted by law.
  4. Acknowledge that AMS has a comprehensive program for raw peanuts (domestic or imported).  FDA follow-up may be appropriate, including when lots of raw peanuts are reported by AMS as exceeding 20 ppb aflatoxins, and when such peanuts have not been brought into compliance through reconditioning or have not been destroyed.  
  5. Notify AMS of any changes to FDA Compliance Policy Guides (CPGs) or any guidance that may impact the MOU.

B. With Respect to Voluntary Aflatoxin Testing of Imported Brazil Nuts (In-Shell and Shelled)

FDA is responsible for the regulation of foods, including Brazil nuts, in interstate commerce under the provisions of the FD&C Act. Strategies used by the FDA to minimize aflatoxins in the U.S. food supply include establishing regulatory levels, monitoring susceptible commodities, taking appropriate enforcement action, providing guidance to the food industry, and working with other agencies on food safety.  

FDA and AMS have cooperated with U.S. importers in a program for sampling and testing of imported Brazil nuts for total aflatoxins.  Neither AMS nor FDA has a formal agreement with the Brazil nut importers.  Under a voluntary USDA program, importers of Brazil nuts may offer lots to USDA for inspection prior to introduction into U.S. commerce.  USDA is responsible for sampling and testing each offered lot for total aflatoxins and for issuing an analysis certificate for each lot tested.
 
a. AMS Responsibilities (if requested by importer to sample and test):

  1. Draw samples in accordance with the FDA Investigations Operations Manual, Sample Schedule 6, Aflatoxin Sample Sizes.
  2. Perform all aflatoxin assays using only the official methods of analysis permitted by USDA, AMS, Science and Technology Program, Laboratory Approval and Testing Division.  The method(s) will be the same as those permitted under the LAP-Aflatoxin (see section IV.A.a.4 above).  Analysis is to be performed by USDA, AMS, National Science Laboratories (Blakely, GA).
    1. In-shell (Shell and Kernel) Analysis
      The entire sample of shells and kernels will be ground in a vertical cutter mixer and a well-mixed portion of the ground sample will be chemically assayed.  The level of total aflatoxins will be calculated using one-half the weight of the in-shell nut test sample. 
    2. Shelled Kernel Analysis
      The entire sample is individually shelled and ground.  A well-mixed portion of the ground sample will be chemically assayed.
  3. Issue analysis certificates for each lot.
  4. Inform appropriate FDA Office of Brazil nut shipments that are being tested. 
  5. Provide appropriate FDA Office the results/certificate(s) of analysis for lots that may be subject to action under the FD&C Act.  With approval from USDA Office of the General Counsel, AMS would make staff available to testify on sample collection and analysis if FDA acts based on the AMS results.

b. FDA Responsibilities:

  1. Notify AMS of the criteria and levels of total aflatoxins that may be subject to action by FDA under the FD&C Act.
  2. Provide AMS with FDA Office contact information.
  3. Notify AMS after FDA takes the following actions—issuance of a warning letter, seizure, injunction, or prosecution—on an importer of Brazil nuts that is being inspected, sampled, and tested by AMS if FDA sharing such information is permitted by law.
  4. Acknowledge that AMS has sampling and testing services in which lots of imported Brazil nuts have been sampled by AMS.  FDA follow-up may be appropriate, including when lots of Brazil nuts are reported by AMS as exceeding 20 ppb, and when such Brazil nuts have not been brought into compliance through reconditioning or have not been destroyed.
  5. Notify AMS of any changes to CPGs or any guidance that may impact the MOU.

C. With respect to Mandatory Aflatoxin Testing of Domestic and Imported Pistachio Nuts (In-Shell and Shelled) 

FDA is responsible for the regulation of foods, including pistachios, in interstate commerce under the provisions of the FD&C Act.  Strategies used by FDA to minimize aflatoxins in the U.S. food supply include establishing regulatory levels, monitoring susceptible commodities, taking appropriate enforcement action, providing guidance to the food industry and working with other agencies on food safety. 

AMS administers domestic aflatoxin requirements for pistachio nuts under Pistachios Grown in California, Arizona, and New Mexico (7 CFR Part 983), and administers mandatory import requirements for pistachio nuts under Specialty Crops; Import Regulations (7 CFR Part 999, Section 600).  AMS is responsible for sampling and testing each lot for total aflatoxins and for issuing an analysis certificate for each lot tested.  All domestic and imported shipments of pistachio nuts intended for human consumption must be covered by an aflatoxin certificate.  The import regulations require importers of pistachio nuts to offer each lot of the product to a USDA or a USDA-approved laboratory for aflatoxin testing and certification prior to importation.  Domestic handlers that produce 5,000 pounds or less of dried pistachio nuts during the production year are exempt and importers that bring in 5,000 pounds or less of dried pistachio nuts between September 1 and August 31 of each year are exempt.

a. AMS Responsibilities:

  1. Continue to administer the USDA LAP-Aflatoxin for the testing of total aflatoxins in domestic and imported pistachio nuts.
  2. Draw samples in accordance with 7 CFR Part 983 and Part 999, Section 600 and the current AMS (Specialty Crops Inspection Division) sampling instructions in the applicable Inspection Instructions.
  3. Perform all aflatoxin assays using only the official methods of analysis permitted by USDA, AMS, Science and Technology Program, Laboratory Approval and Testing Division in accordance with 7 CFR Part 983 and Part 999, Section 600. 

    Currently, the permitted methods are (1) IAC cleanup with direct fluorometry method (AOAC Official Method 991.31, A-G) and (2) IAC cleanup with HPLC method (AOAC Official Method 991.31, A-F, H). In the future, other methods may be permitted by AMS. AMS will notify FDA when additional methods are added.  For the most up-to-date list of permitted methods, refer to the AMS website.

    Analysis is to be performed by USDA, AMS, National Science Laboratories (Blakely, GA) or USDA, AMS-approved laboratories (various locations; see the AMS website for the official listing).

    If imported pistachio nuts are analyzed (1) using IAC cleanup with HPLC method (AOAC Official Method 991.31, A-F, H) and (2) by USDA, AMS, National Science Laboratories (Blakely, GA), FDA will acknowledge that AMS has a comprehensive sampling and testing program for pistachios.
    1. In-shell (Shell and Kernel) Analysis 
      The entire sample of shells and kernels will be dry ground in a vertical cutter mixer or water-slurried using a high shear mixer.  A well-mixed portion of the ground sample will be chemically assayed.  The domestic and import regulations require the total aflatoxins level in pistachio nuts to be calculated on a kernel weight basis (7 CFR Part 983, Section 150). The level of total aflatoxins will be calculated using one-half the weight of the in-shell nut test sample. 
    2. Shelled Kernel Analysis
      The entire sample is individually shelled, and shelled kernels are ground. A well-mixed portion of the ground sample will be chemically assayed.
  4. Issue analysis certificates for each lot.  Issue analysis certificates as “negative” if the level of total aflatoxins is at or below 15 ppb.  Failed lots are reported as specified under 7 CFR Part 983 and 7 CFR Part 999, Section 600.  The lots may be re-worked and resubmitted for testing by USDA or a USDA-approved laboratory.  Any lot or portion thereof that fails to meet the import requirements prior to or after reconditioning may be exported, sold for non-human consumption, or disposed of under the supervision of Customs and Border Protection and, if necessary for verification purposes, the Federal or Federal-State Inspection Programs, with the costs of certifying the disposal of such lot paid by the importer (7 CFR 999, Section 600).
  5. Provide FDA OFS headquarters staff with a quarterly summary of the total number of failed lots analyzed, range of levels of total aflatoxins found, and a list of the applicants for each lot containing aflatoxins above 15 ppb.  Details on individual lots will be made available to FDA upon request.
  6. Provide appropriate FDA Office the results/certificates of failed lots as timely as possible and communicate follow-up actions regarding product reconditioning or disposition.  With approval from USDA Office of the General Counsel, AMS would make staff available to testify on sample collection and analysis if FDA acts based on the AMS results.

b. FDA Responsibilities:

  1. Notify AMS of the criteria and levels of total aflatoxins that may be subject to action by FDA under the FD&C Act.
  2. Review results of aflatoxin analyses for lots provided by AMS to determine whether they may be subject to action under the FD&C Act.
  3. Provide AMS with FDA Office contact information.
  4. Notify AMS after FDA takes the following actions—issuance of a warning letter, seizure, injunction, or prosecution—on domestic handlers or importers of pistachios if FDA sharing such information is permitted by law.
  5.  Acknowledge that AMS has a comprehensive sampling and testing program for pistachios (domestic or imported).  FDA follow-up may be appropriate, including when lots of raw pistachios are reported by AMS as exceeding 20 ppb, and when such pistachios have not been brought into compliance through reconditioning or have not been destroyed.  
  6. Notify AMS of any changes to CPGs or any guidance that may impact the MOU.

V.    AMS and FDA Mutually Agree To:

A. Designate liaison officers to serve as a central contact to handle matters and questions related to this agreement.

For the Food and Drug Administration:

Director, Division of Plant Products and Beverages
HFS-315
Office of Food Safety
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park, MD 20740-3835
Telephone: 240-402-1700

For the Agricultural Marketing Service:

For aflatoxin testing:
Director, Laboratory Approval and Testing Division
Science and Technology Program
Agricultural Marketing Service
U.S. Department of Agriculture
1400 Independence Avenue SW, Room 3533-S
Washington, DC 20250-0272
Telephone: 202-690-4089

For inspection services:
Director, Specialty Crops Inspection Division
Specialty Crops Program
Agricultural Marketing Service
U.S. Department of Agriculture
1400 Independence Avenue SW, Room 1536-S
Washington, DC 20250-0240
Telephone: 202-720-5870

For marketing orders and agreements:
Director, Marketing Order and Agreement Division
Specialty Crops Program
Agricultural Marketing Service
U.S. Department of Agriculture
1400 Independence Avenue SW, Room 1406-S
Washington, DC 20250-0237
Telephone: 202-720-2491

B. Maintain close working relations with each other, both in headquarters as well as in the field.

C. Work together toward greater efficiency for improvement of the testing program.

VI.    Revision

This revision of the Memorandum of Understanding (MOU) between AMS and FDA supersedes agreement no. 225-11-0008.

VII.    Names and Addresses of Participating Agencies

A. Agricultural Marketing Service,
U.S. Department of Agriculture
14th Street and Independence Avenue, SW
Washington, DC 20250

B. Food and Drug Administration,
Department of Health and Human Services
10903 New Hampshire Avenue
Silver Spring, MD 20993

VIII. Resource Obligations

This MOU represents the broad outline of AMS’s and FDA’s intent to collaborate in areas of mutual interest related to raw peanuts, Brazil nuts, and pistachio nuts. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. This MOU does not create binding, enforceable obligations for either AMS or FDA. This MOU and all associated agreements are subject to the applicable policies, rules, regulations, and statutes under which AMS and FDA operate.

IX.    Period of Agreement

This MOU will become effective from the date of signature by the later participant to sign it.  This MOU may be modified or terminated by written mutual consent of both AMS and FDA. It may be terminated by either party upon 30 days’ notice in writing to the other party.
                                                              
Approved and Accepted for the Agricultural Marketing Service
/s/
Bruce Summers
Administrator
Agricultural Marketing Service
Date: 8/29/19

Approved and Accepted for the Food and Drug Administration
/s/
Susan T. Mayne, Ph.D.
Director
Center for Food Safety and Applied Nutrition
Date: 9/5/19