CPG Sec. 683.100 Action Levels for Aflatoxins in Animal Feeds

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

Sec. 683.100 Action Levels for
Aflatoxins in Animal Food
Compliance Policy Guide
Guidance for FDA Staff
This version of the Compliance Policy Guide replaces the version made available August 1994.
The document has been revised to current CPG formatting standards, update contact
information, and clarify existing language.
Additional copies are available from:
Policy and Regulations Staff (HFV-6)
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855
https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm
Submit either electronic or written comments on this compliance policy guide (CPG) 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 docket number FDA-1989-
D-0239.
For further information regarding this document, contact AskCVM@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Office of Regulatory Affairs
and
Center for Veterinary Medicine
March 2019

Contains Nonbinding Recommendations
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Sec. 683.100 Action Levels for Aflatoxins in Animal Food
Compliance Policy Guide
Guidance for FDA Staff
This compliance policy guide represents the current thinking of the Food and Drug Administration (FDA)
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 the approach satisfies the requirements of the applicable statutes
and regulations. To discuss an alternative approach, contact the FDA office responsible for this
guidance as listed on the title page.
I. 	Introduction
The purpose of this compliance policy guide (CPG) is to provide guidance for FDA staff on
action levels for aflatoxins in animal food and animal food ingredients.
In general, FDA’s guidance documents, including this CPG, do not establish legally enforceable
responsibilities. Instead, they describe the Agency’s current thinking on various topics and
should be viewed only as recommendations, unless specific regulatory or statutory requirements
are cited. The use of the word should in Agency guidances means that something is suggested or
recommended, but not required.
II. 	Background
Aflatoxins (i.e., aflatoxin B1, B2, G1 and G2) are toxic by-products of mold growth on
certain agricultural commodities. Since their discovery in the early 1960’s, aflatoxins have
been shown to be carcinogenic to laboratory test animals. In 1969, FDA set an action level
for aflatoxins at 20 parts per billion (ppb) for all foods, including animal food, based on
FDA’s analytical capability and the agency’s aim of limiting aflatoxin exposure to the
lowest possible level.
Animal feeding studies conducted in the 1970’s and 1980’s, however, demonstrated that
levels of aflatoxins above 20 ppb could be fed to certain food-producing animals without
presenting a danger to the health of these animals or posing a risk to consumers of food
derived from the exposed animals. Based on these scientific studies, the agency revised its
action levels for aflatoxins in animal food and animal food ingredients for beef cattle, swine,
and poultry.
Aflatoxins can be present in dog and cat food as well. In 1998, 2005, 2011, and 2013 aflatoxin
contamination of dog and cat food resulted in illness, dog mortalities, and extensive recalls of
affected dog and cat food.

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Action levels are not binding on the courts, the regulated industry, or the agency (see 55
Federal Register 20782, May 21, 1990). There may be situations where circumstances
warrant enforcement action at levels below an action level or where enforcement action is not
warranted even though an action level is exceeded.
III. 	Regulatory Action Guidance
To take regulatory action, FDA must (1) confirm the intended use of the animal food and
animal food ingredient, and (2) show that the levels of aflatoxins in the animal food and
animal food ingredient will support a charge of adulteration under section 402(a)(1) of the
Federal Food, Drug, and Cosmetic Act.
When samples are analyzed in accordance with applicable methods of the current Official
Methods of Analysis of the Association of Official Analytical Chemists (AOAC), contact the
CVM Post-Market Compliance Animal Food Team (HFV-236) if both of the following
conditions are met:
1. 	The original and check analyses confirm the level of total aflatoxins (B1, B2, G1 and
G2) in the animal food or animal food ingredient is above the following action levels:
Intended Use Animal Food and
Animal Food Ingredient Action Level
finishing (i.e., feedlot) beef cattle 	corn and peanut products 	300 ppb
beef cattle, swine, or poultry (regardless
of age or breeding status) cottonseed meal 	300 ppb
finishing swine of 100 pounds or greater 	corn and peanut products 	200 ppb
breeding beef cattle, breeding swine, or
mature poultry corn and peanut products 	100 ppb
immature animals1
corn, peanut products, and other
animal food and food
ingredients, but excluding
cottonseed meal
20 ppb
pets (dogs, cats, rabbits, etc.) of all ages
corn, peanut products,
cottonseed meal, and other food
ingredients and complete pet
food
20 ppb
dairy animals and other animal species
(including wildlife), or other uses not
specified in this table; or, when the
intended use is not known
corn, peanut products,
cottonseed meal, and other
animal food and food ingredients
20 ppb
1 For example, chickens and ducks less than 8 weeks of age; turkeys less than 12 weeks of age; goats, sheep, and
pigs less than 4 month of age; cattle and equine less than 6 months of age.

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2. 	The identity of any aflatoxin present (i.e., aflatoxin B1, B2, G1 and G2) is confirmed by
chemical derivative formation.
Before consulting with HFV-236, determine, if possible, the intended use of the food or
food ingredient (animal species, class, age, etc.) as well as the proportion of the ingredient
in the mixed food (number of pounds per ton). If information concerning the intended use
is not available, consult with the CVM Post-Market Compliance Animal Food Team when
the presence of aflatoxins has been confirmed at levels above 20 ppb.
In considering enforcement action for aflatoxin levels below an action level, consideration
must be given to the agency’s ability to support the adulteration charge. Discussions of
possible enforcement actions at levels below an action level should include consideration of
all compelling reasons for pursuing the action. Similar consideration is required if a field
office believes that enforcement action at levels above an action is not warranted.
Issued: 11/21/79
Reissued: 10/01/80
Last Revised: 5/18/89, 8/28/94, 3/12/19