MOU 225-26-004

This memorandum supersedes MOU 225-19-031, dated September 5, 2019.

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) is to identify each agency’s roles and responsibilities in inspecting, sampling, and testing raw peanuts, Brazil nuts, pistachio nuts, and almonds 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, a class of mycotoxins, 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

The FDA is responsible for the regulation of foods 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.

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

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 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. Administer the USDA Laboratory Approval Program for Analysis of Mycotoxins (LAP-Mycotoxins) for the testing of total aflatoxins in raw peanuts.
2. Draw samples in accordance with 7 CFR 996.11 and the currenvt 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 996.11.
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 996.11  
   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-Mycotoxins 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 the FDA’s Office of Post-Market Assessment (OPMA) 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 the 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 the 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 the FDA Office contact information.
3. Notify AMS after the 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 the FDA sharing such information is permitted by law.
4. Acknowledge that AMS has a comprehensive program for raw peanuts (domestic or imported). The  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’s Compliance Policy Guides (CPGs) or any guidance that may impact raw peanuts.

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

The 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 the 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, Chapter 4 – Sampling, Sample Schedule Chart 6, Mycotoxin 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-Mycotoxins (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 the 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 the FDA under the FD&C Act.
2. Provide AMS with FDA Office contact information.
3. Notify AMS after the 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 the 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. The 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 Brazil nuts.

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

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 999.600).  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 AMS-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. Administer the USDA LAP-Mycotoxins for the testing of total aflatoxins in domestic and imported pistachio nuts.
2. Draw samples in accordance with 7 CFR Part 983 and 7 CFR 999.600, 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 7 CFR 999.600.
   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 the 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).
   Imported pistachio nuts are analyzed (1) using the permitted methods and (2) by USDA, AMS, National Science Laboratories (Blakely, GA) or USDA, AMS-approved laboratories (various locations; see the AMS website for the official listing).
   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 983.150). 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 999.600.  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 999.600).
5. Provide the FDA’s Office of Post-Market Assessment (OPMA) 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 the 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 the 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 the 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 the 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). The 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 pistachio nuts.

D. With respect to Voluntary Testing of Imported Almonds (In-Shell and Shelled)

AMS administers a voluntary aflatoxin testing program for American Goods Returned commonly referred to as United States Goods Returned (USGR) almonds.  Under this voluntary program, upon request, lots of USGR almonds are sampled following approved methods and analyzed for aflatoxin utilizing USDA or USDA-AMS approved laboratories. The FDA is responsible for final admissibility determinations for USGR almonds.

a. AMS Responsibilities (when requested):

1. Administer the total aflatoxins testing of USGR almonds in coordination with the FDA.
2. Draw samples in accordance with Sample Schedule Chart 6 (Mycotoxin Sample Sizes) of the FDA’s Investigations Operations Manual utilizing the current AMS Specialty Crops Inspection Division (SCID) sampling instructions in the applicable Inspection Instructions.  Refer to the AMS website for Inspection Instructions.
3. Verify that aflatoxin analyses are performed using only the official methods of analysis that are equivalent to FDA methods and permitted by USDA, AMS, Science and Technology Program, Laboratory Approval and Testing Division in accordance with published LAP-Mycotoxins requirements.
   Currently, the permitted methods are (1) IAC with HPLC/UPLC-FLD, Iodine (AOAC 991.31, A-F, H); (2) IAC with HPLC/UPLC-FLD, PHRED (AOAC 991.31, A-F, H; AOAC 2005.08), or (3) IAC with HPLC/UPLC-FLD, Kobra Cell (AOAC 991.31, A-F, H; AOAC 999.07).  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 (see the AMS website for the official listing).
   Almonds are analyzed (1) using the permitted methods and (2) by USDA, AMS, National Science Laboratories (Blakely, GA) or USDA, AMS-approved laboratories.
   1. In-shell (Shell and Kernel) Analysis 
      The entire sample of shells and kernels will be dry ground in a vertical cutter mixer.  A well-mixed portion of the ground sample will be chemically assayed.  The total aflatoxins level in almonds needs to be calculated on a kernel weight basis.
   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. Provide the FDA with the testing results for indicated lot(s) electronically in a timely manner.
5. Provide the FDA with AMS local office contact information.

b. FDA Responsibilities:

1. Continue to make admissibility decisions on USGR lots of almonds.
2. Review results of aflatoxin analyses for lots provided by AMS to make admissibility decision(s).
3. Acknowledge that AMS has a comprehensive sampling and testing program for almonds. The FDA may conduct follow-up testing as appropriate.
4. Notify AMS of changes to any guidance that may impact almonds.
5. Provide AMS with FDA local office contact information.

V. Disclosure of Information

The Parties will not, as a part of the activities covered by this MOU, share any non-public information, including “confidential commercial or financial information” (21 C.F.R. § 20.61) or trade secret information (18 U.S.C. § 1839(3)) obtained by or provided directly to FDA from a third party.  Access to non-public information shall be governed by separate Confidentiality Disclosure Agreements, in accordance with 21 C.F.R. § 20.85. Any information sharing under this MOU and all associated agreements are subject to the applicable policies, rules, regulations, and statutes under which AMS and the FDA operate.

VI. AMS and FDA Mutually Agree To:

A. Maintain close working relations with each other, both in headquarters as well as in the field.
B. Work together toward greater efficiency for improvement of the testing program.
C. 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 Chemical Contaminants
Office of Post-Market Assessment
Office of Food Chemical Safety, Dietary Supplements, and Innovation
Human Foods Program
5001 Campus Drive
College Park, MD 20740-3835
Telephone: 240-402-1200

For the Agricultural Marketing Service:

For Mycotoxin testing:
Director, Laboratory Approval and Testing Division
Science and Technology Program
Agricultural Marketing Service
U.S. Department of Agriculture
1400 Independence Avenue SW, Room 2912-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, Market Development Division
Specialty Crops Program
Agricultural Marketing Service
U.S. Department of Agriculture
1400 Independence Avenue SW, Room 1406-S
Washington, DC 20250-0237
Telephone: 202-720-8085

VII. Revision

This MOU between AMS and the FDA revises and supersedes FDA MOU 225-19-031.

VIII.    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

IX. Resource Obligations

This MOU represents the broad outline of AMS’s and the FDA’s intent to collaborate in areas of mutual interest related to raw peanuts, Brazil nuts, pistachio nuts, and almonds. 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 the FDA. This MOU and all associated agreements are subject to the applicable policies, rules, regulations, and statutes under which AMS and the FDA operate.

X. 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 the 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/          
Erin Morris
Administrator
Agricultural Marketing Service
Date: 03/11/2026

Approved and Accepted for the Food & Drug Administration      

/s/
Kyle Diamantas
Deputy Commissioner for Human Foods
Date: 03/11/2026