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 
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, FDAs guidance documents, including this CPG, do not establish legally enforceable 
responsibilities.  Instead, they describe the Agencys 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 1960s, 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 
FDAs analytical capability and the agencys aim of limiting aflatoxin exposure to the 
lowest possible level. 
 
Animal feeding studies conducted in the 1970s and 1980s, 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. 
 
2  Contains Nonbinding Recommendations 
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: 
 
Animal Food and 
Intended Use  Action Level 
Animal Food Ingredient 
finishing (i.e., feedlot) beef cattle  corn and peanut products  300 ppb 
beef cattle, swine, or poultry (regardless 
cottonseed meal  300 ppb 
of age or breeding status) 
finishing swine of 100 pounds or greater  corn and peanut products  200 ppb 
breeding beef cattle, breeding swine, or 
corn and peanut products  100 ppb 
mature poultry 
corn, peanut products, and other 
animal food and food 
immature animals1  20 ppb 
ingredients, but excluding 
cottonseed meal 
corn, peanut products, 
cottonseed meal, and other food 
pets (dogs, cats, rabbits, etc.) of all ages  20 ppb 
ingredients and complete pet 
food 
dairy animals and other animal species 
corn, peanut products, 
(including wildlife), or other uses not 
cottonseed meal, and other  20 ppb 
specified in this table; or, when the 
animal food and food ingredients 
intended use is not known 
                                                 
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. 
3  Contains Nonbinding Recommendations 
 
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 agencys 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 
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