CPG Sec 570.375 Aflatoxins in Peanuts and Peanut Products

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

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Compliance Policy Guide
Sec. 570.375 Aflatoxins in Peanuts and
Peanut Products:
Guidance for FDA Staff
You may submit either electronic or written comments regarding this guidance at any time.
Submit electronic comments to https://www.regulations.gov. Submit written comments to the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-
2018-D-0721 listed in the notice of availability published in the Federal Register.
For questions regarding this document, contact the Center for Food Safety and Applied Nutrition
(CFSAN), Office of Compliance at CFSANCompliancePolicy@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
and
Office of Regulatory Affairs
June 2021

Contains Nonbinding Recommendations
Table of Contents
I. 	Introduction
II. 	Background
III. 	Policy
IV. 	Regulatory Action Guidance
V. 	Specimen Charges

Contains Nonbinding Recommendations
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Compliance Policy Guide
Sec. 570.375 Aflatoxins in Peanuts and
Peanut Products:
Guidance for FDA Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or we)
on this topic. It does not establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the requirements of the applicable
statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible
for this guidance at the phone number listed on the title page.
*I. 	Introduction
The purpose of this document is to provide guidance for FDA staff on aflatoxins in peanuts and
peanut products. We revised this document to update the format and to include revisions for
clarity, references to other aflatoxin Compliance Policy Guides (CPGs), and a reference to the
Memorandum of Understanding between the Agricultural Marketing Service (AMS) of the
United States Department of Agriculture (USDA) and FDA.
The contents of this document do not have the force and effect of law and are not meant to bind
the public in any way, unless specifically incorporated into a contract. This document is
intended only to provide clarity to the public regarding existing requirements under the law.
FDA guidance documents, including this guidance, should be viewed only as recommendations,
unless specific regulatory or statutory requirements are cited. The use of the word should in
FDA guidance means that something is suggested or recommended, but not required.
II. 	Background
Aflatoxins (B1, B2, G1, and G2) are toxic metabolites produced by the molds Aspergillus flavus,
Aspergillus nomius, and Aspergillus parasiticus. Toxicological manifestations of aflatoxins
include teratogenicity, mutagenicity, and carcinogenicity in susceptible animal species.
Consumption of food with high levels of aflatoxins is associated with liver cancer in humans.
Aflatoxins may occur in food as a result of mold growth in susceptible raw agricultural
commodities. The growth of molds that produce aflatoxins is influenced by environmental
factors such as temperature, humidity, and extent of rainfall during the pre-harvesting,

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harvesting, or post-harvesting periods. Foods most susceptible to molds that produce aflatoxins
include: peanuts, corn, some tree nuts including Brazil nuts and pistachios, and some small
grains such as rice. Because aflatoxins are known carcinogens to humans, the presence of
aflatoxins in foods should be reduced to the lowest levels attainable using modern agricultural
and processing techniques.
III. 	Policy
Aflatoxins are poisonous or deleterious substances, which may render a food injurious to health.
FDA may consider peanuts and peanut products containing total aflatoxins greater than 20
micrograms per kilogram (mcg/kg) or parts per billion (ppb), except raw peanuts that will be
further processed to remove moldy and otherwise defective nuts, to be adulterated within the
meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 342(a)(1)).
IV. 	Regulatory Action Guidance
The following represents the criteria for submitting a recommendation for seizure or a
recommendation that the article is subject to import refusal to CFSAN, Office of Compliance,
Division of Enforcement (HFS-605), for aflatoxins in processed peanuts and peanut products:
• 	Both original and check analyses show total aflatoxins (i.e., aflatoxins B1, B2, G1, G2)
greater than 20 ppb, and
• 	Identity of any aflatoxin present (i.e., aflatoxins B1, B2, G1, G2) is confirmed.
The following represents the criteria for submitting a recommendation for seizure or a
recommendation that the article is subject to import refusal to CFSAN, Office of Compliance,
Division of Enforcement (HFS-605), for aflatoxins in raw peanuts:
• 	USDA’s certificate of analysis of the raw peanuts indicates total aflatoxins of greater than
20 ppb, and
• 	The raw peanuts are being shipped to or are at a processor that does not have facilities
and procedures that will remove moldy or otherwise defective nuts.
Divisions should include a detention without physical examination (DWPE) request, if
applicable, in the recommendation that the article is subject to import refusal.
CFSAN will evaluate such requests and recommendations on a case-by-case basis, based on the
information specific to each regulatory package.
See the following CPGs for guidance on aflatoxins in human food, Brazil nuts, and pistachio
nuts:
• 	CPG Sec. 555.400 Aflatoxins in Human Food

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• 	CPG Sec. 570.200 Aflatoxins in Brazil Nuts
• 	CPG Sec. 570.500 Aflatoxins in Pistachio Nuts
Coordination with USDA/AMS
See the Memorandum of Understanding (MOU-225-19-031) between USDA/AMS and FDA for
information regarding working arrangements for sampling and analyzing raw peanuts, Brazil
nuts, and pistachio nuts for aflatoxins.
V. Specimen Charges
Domestic Seizure
The article of food was adulterated when introduced into, and while in interstate commerce, and
is adulterated while held for sale after shipment in interstate commerce, within the meaning of 21
U.S.C. 342(a)(1), in that it bears and contains a poisonous or deleterious substance, namely
aflatoxins, which may render it injurious to health.
Import Refusal
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C
Act in that it appears to be adulterated within the meaning of section 402(a)(1) of the FD&C Act
in that it bears and contains a poisonous or deleterious substance, namely aflatoxins, which may
render it injurious to health.*
*Material between asterisks is new or revised*
Issued: 10/1/80
Revised: 3/95, 5/05, 11/29/05, 06/01/2021
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