Contains Nonbinding  Recommendations  
 
Guidance for FDA Staff 

 
Compliance Policy Guide 

Sec. 690.800 Salmonella in Food for 

Animals 

 
 
 
Additional copies are available from: 
Food and Feed Policy Staff 
Office of Policy and Risk Management 
Office of Regulatory Affairs 
Food and Drug Administration 
12420 Parklawn Drive 
Rockville, MD 20857 
http://www.fda.gov/ora/compliance_ref/cpg/default.htm  
 
Submit comments on this guidance at any time.  Submit written comments to the   
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Room 1061, Rockville, MD 20852.  Submit electronic comments to 
http://www.regulations.gov. All comments should be identified with the docket number 
listed in the notice of availability that publishes in the Federal Register. 
  
U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Veterinary Medicine 

Office of Regulatory Affairs  

 
July 2013  
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 Contains Nonbinding  Recommendations  
 
Table of Contents 
 
 
      I. Introduction  
 
              II. Background 
 
         III. Policy 
 
               IV. Regulatory Action Guidance 
 
           V. Specimen Charges 
 
 
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 Contains Nonbinding  Recommendations  
 
Guidance for FDA Staff 

 
Compliance Policy Guide 

Sec. 690.800 Salmonella in Food for Animals
  
 
This guidance represents the Food and Drug Administration's (FDAs) current thinking 
on this topic. It does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. You can use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations.  If you want to 
discuss an alternative approach, contact the FDA staff responsible for implementing this 
guidance. If you cannot identify the appropriate FDA staff, contact the Office of 
Regulatory Affairs at the address listed on the title page of this guidance. 
 
I. Introduction: 
 
The purpose of this document is to provide guidance for FDA staff on the presence of 
Salmonella in food for animals. This document supersedes CPG Sec. 690.700 Salmonella 
Contamination of Dry Dog Food. 
 
Food is defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act). In keeping with this statutory definition, the term food for animals is used 
in this document to mean: (1) articles used for food or drink for animals other than 
humans; and (2) articles used for ingredients of any such articles.  In this document, 
animal feed is used to mean food for animals other than pet food.  Furthermore, for 
purposes of this document, pet food is used to mean food for pets and includes treats and 
chews for pets. The policies in this guidance apply to finished animal feed and pet food 
and the ingredients used to manufacture these products.   
 
This guidance document does not address Salmonella in human food. Contact the Center 
for Food Safety and Applied Nutrition (CFSAN) when Salmonella contamination is 
associated with human food.  
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe FDAs current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in FDA guidances means that 
something is suggested or recommended, but not required. 
 
 
 
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 Contains Nonbinding  Recommendations  
 
II. Background: 

 
Salmonella is a rod-shaped, nonspore-forming, gram-negative microorganism consisting 
of over 2,500 different serotypes (serovars).   Salmonella has widespread occurrence in 
animals, especially in poultry and swine. Environmental sources of Salmonella include 
water, soil, insects, factory surfaces, kitchen surfaces, animal feces, raw meats, raw 
poultry, and raw seafood. 
 
When consumed by humans, Salmonella can cause salmonellosis.  The symptoms of 
salmonellosis include nausea, vomiting, abdominal cramps, minimal diarrhea, fever, and 
headache. Additional information about Salmonella can be found in the FDA Bad Bug 
Book, located on the FDAs website at: 
http://www.fda.gov/Food/FoodSafety/FoodborneIllness/FoodborneIllnessFoodbornePath 
ogensNaturalToxins/BadBugBook/ucm069966.htm. 
 
Certain food for animals, such as pet food, poses a significant risk to human health when 
contaminated with Salmonella, because humans come in direct contact with these foods. 
Salmonella from such pet food may be ingested directly by humans from their hands or 
utensils that are contaminated when they feed their pets.  Certain vulnerable populations, 
such as children, the elderly, and individuals with compromised immune systems, are 
particularly susceptible to acquiring salmonellosis from pet food and may experience 
more severe symptoms.  Additionally, animals may become infected, either 
asymptomatically or clinically, with Salmonella from the pet food, thus increasing the 
potential human exposure. 
 
The association between human outbreaks of salmonellosis and Salmonella-contaminated 
pet foods is well established. The Centers for Disease Control and Prevention reported 
that from January 1, 2006 to October 31, 2008, 79 human cases of salmonellosis were 
linked to Salmonella Schwarzengrund in dry dog food manufactured by a company in the 
United States. Health Canada reported that in 2005, cases of salmonellosis in Canada and 
the United States caused by Salmonella Thompson were linked to pet treats contaminated 
with Salmonella Thompson.  In addition, Health Canada informed FDA of Canadian 
outbreaks of human salmonellosis that were linked to Salmonella Newport in beefsteak-
patty dog treats that were manufactured in Texas in 2002 and to Salmonella Infantis in 
pig-ear dog treats that were manufactured in Canada in 1999.  
 
Salmonella-contaminated animal feed can cause illness in animals that consume the feed.  
Whether  Salmonella causes illness in an animal depends on the serotype.  Different 
animal species typically develop disease in response to different serotypes. Salmonella  
serotypes that cause disease in a particular species are referred to as pathogenic for that 
animal species.  
 
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 Contains Nonbinding  Recommendations  
 
III. Policy: 

 
FDA considers an animal feed or pet food that may be injurious to health because it is 
contaminated with Salmonella to be adulterated under section 402(a)(1) of the FD&C Act 
(21 U.S.C. 342(a)(1)). Given the variability in the potential risk that such contamination 
may pose to human and animal health, FDAs policy for prioritizing regulatory action 
takes into account certain risk-based criteria, including the type of food for animals that is 
involved. 
 
FDA believes regulatory action is warranted in cases involving pet foods contaminated 
with any Salmonella serotype, due to the heightened human health risk given the high 
likelihood of direct human contact with such food.   
 
FDA believes the likelihood of direct human contact with animal feed is substantially 
lower than for pet foods.  Therefore, in cases of animal feed contaminated with  
Salmonella, FDA believes regulatory action is warranted when such cases involve 
Salmonella serotypes that are known to cause disease in the animal species for which the 
feed is intended. Cases of contamination involving other Salmonella serotypes should be 
considered on a case-by-case basis.  
 
A. Salmonella-Contaminated Pet Food  All Serotypes  
 
FDA considers a pet food to be adulterated under section 402(a)(1) of the FD&C Act (21 
U.S.C. 342(a)(1)) when it is contaminated with Salmonella and will not subsequently 
undergo a commercial heat step or other commercial process that will kill the Salmonella. 
 
The following are some examples of pet food:  
   Dog and cat food, aquarium fish food, raw meat and raw poultry formulations for 
pets 
   Pet treats or chews (e.g., dog biscuits, rawhide, pig ears) 
   Vitamins, minerals, and other nutritional supplements intended for dogs, cats, and 
other pets 
   Pet food ingredients such as animal products, plant protein products, grain 
products, vitamin and mineral products. 
 
B. Salmonella-Contaminated Animal Feed  Serotypes Pathogenic to 
Animals 
 
FDA considers an animal feed to be adulterated under section 402(a)(1) of the FD&C Act 
when it is contaminated with a Salmonella serotype that is considered pathogenic to the 
animal intended to consume the animal feed and the animal feed will not subsequently 
undergo a commercial heat step or other commercial process that will kill the Salmonella. 
FDA should evaluate cases involving contamination of animal feed with other 
Salmonella serotypes on a case-by-case basis. 
 
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 Contains Nonbinding  Recommendations  
 
The following are some examples of animal feeds and the pathogenic Salmonella  
serotypes that have been associated with disease in the particular animal species 
consuming these feeds: 
   Poultry feed with Salmonella Pullorum, Salmonella Gallinarum, or Salmonella  
Enteritidis  
 	  Swine feed with Salmonella Choleraesuis 
 	  Sheep feed with Salmonella Abortusovis 
 	  Horse feed with Salmonella Abortusequi 
 	  Dairy and beef feed(s) with Salmonella Newport or Salmonella Dublin 
 
IV. Regulatory Action Guidance:  
 
The Districts should consider the following risk-based criteria in deciding whether to 
recommend seizure or import refusal of a pet food, animal feed, or their ingredients to the 
Center for Veterinary Medicine (CVM), Office of Compliance and Surveillance, Division 
of Compliance (HFV-230): 
 
A. 	 Pet Food 
 
1. 	  Salmonella is present in one or more subsamples of the pet food or pet food 
ingredient; and 
2. 	  The pet food or pet food ingredient will not be, or information is not available to 
determine whether the pet food or pet food ingredient will be, further processed 
with a heat treatment or other method during the commercial manufacturing or 
processing to eliminate the Salmonella. 
3. 	  The Salmonella is of any serotype. 
 
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 Contains Nonbinding  Recommendations  
 
B. 	 Animal Feed  
 
1. 	  Salmonella is present in one or more subsamples of the animal feed or feed 
ingredient; and 
2. 	  The animal feed or feed ingredient will not be, or information is not available to 
determine whether the animal feed or animal feed ingredient will be, further 
processed with a heat treatment or other method during the commercial 
manufacturing or processing to eliminate the Salmonella; and 
3. 	  The Salmonella is of a serotype that is pathogenic to the animal species for which 
the animal feed or feed ingredient is intended (see section III.B. of this 
document).      
 
Contact CVMs Division of Compliance in cases involving animal feed that are positive 
for Salmonella serotypes that are not listed in section III.B. of this document before 
pursuing further action.  
 
V. Specimen Charges: 
 
A. Domestic Seizure 
 
The article of food was adulterated when introduced into and while in interstate 
commerce or adulterated while held for sale after shipment in interstate commerce, 
within the meaning of the Act, 21 U.S.C. 342(a)(1), in that it bears and contains a 
poisonous or deleterious substance, namely Salmonella, which may render it injurious to 
health.  
 
B. 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 appears to bear and contain a poisonous or deleterious substance, 
namely Salmonella, which may render it injurious to health. 
 
Issued: July 12, 2013 
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