Contains Nonbinding Recommendations 
Guidance for Industry 
Testing for Salmonella Species in Human 
Foods and Direct-Human-Contact Animal 
Foods 
Note: The title page of this document was corrected on April 30, 2012 to provide information 
on how to obtain additional copies from the Center for Veterinary Medicine.  
Additional copies are available from:  
Office of Food Safety  
Division of Plant and Dairy Food Safety, HFS-317 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD  20740 
(Tel) 240-402-2367  
http://www.fda.gov/FoodGuidances 
or 
Communications Staff (HFV-12) 
Center for Veterinary Medicine 
Food and Drug Administration 
7519 Standish Place 
Rockville, MD 20855 
(Tel) 240-453-6848 
http://www.fda/gov/AnimalVeterinary/GuidanceComplianceEnforcement/Guidanceforindustry/ 
default.htm 
You may submit either electronic or written comments regarding this guidance at any time.  
Submit electronic comments to http://www.regulations.gov.  Submit written comments on 
the guidance to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  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 Food Safety and Applied Nutrition  
March 2012  Contains Nonbinding Recommendations 
Table of Contents  
 
 
 
I.    Introduction  
 
 
II.    Background 
 
 
III.   Discussion 
 
 
IV.   References
 
 
  
 
 
 
  2 Contains Nonbinding Recommendations 
Guidance for Industry1 
 
Testing for Salmonella Species in Human Foods and Direct-Human-
2
Contact Animal Foods  
 
 
This guidance represents the Food and Drug Administration's (FDA's) 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, call the telephone number listed on the title page of this 
guidance. 
 
 
 
 
I.  Introduction    
 
This guidance is intended for firms that manufacture, process, pack or hold human foods or 
direct-human-contact animal foods intended for distribution to consumers, institutions, or food 
processors.  This guidance does not apply to egg producers and other persons who are covered 
by FDAs final rule Prevention of Salmonella Enteritidis in Shell Eggs During Production, 
Storage, and Transportation (July 9, 2009, 74 FR 33030).  FDA has issued two separate 
guidances that in part, address environmental and egg testing for Salmonella Enteritidis as 
required by this final rule.  These guidances are entitled Guidance for Industry: Prevention of 
Salmonella Enteritidis in Shell Eggs During Production, Storage and Transportation, (Ref. 1) 
issued in December 2011, which provides guidance to egg producers on how to comply with 
certain provisions contained in the final rule, including provisions for environmental and egg 
testing for Salmonella Enteritidis; and Draft Guidance for Industry: Questions and Answers 
Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, 
Storage, and Transportation, (Ref. 2) issued in July 2011, which responds to questions FDA has 
received on the final rule since its publication and includes guidance on environmental and egg 
testing for Salmonella Enteritidis.   
The purpose of this guidance is to address testing procedures for Salmonella species (Salmonella 
spp.) in human foods and direct-human-contact animal foods, and the interpretation of test 
results, when the presence of Salmonella spp. in the food may render the food injurious to human 
                                                 
1 This guidance has been prepared by the Division of Plant and Dairy Food Safety in the Center for Food Safety and 
Applied Nutrition and the Center for Veterinary Medicine at the U.S. Food and Drug Administration. 
2 Direct-human-contact foods are animal foods that are intended for use in feeding animals in homes, petting zoos, 
agricultural fairs, and similar venues where they are likely to be directly handled or ingested by humans.  Contains Nonbinding Recommendations 
health.3  Under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C.  342(a)(1)), a food is deemed to be adulterated if it bears or contains any poisonous or 
deleterious substance which may render it injurious to health.  FDA may take enforcement action 
where food has tested positive for Salmonella spp. (Refs. 3, 4 and 5).  Prohibitions applicable to 
adulterated food are contained in section 301 (21 U.S.C.  331) of the FD&C Act.  
Consequences for violations of the FD&C Act may include seizure, injunction, and criminal 
prosecution (See, e.g., sections 302, 303 and 304 of the FD&C Act (21 U.S.C.  332, 333 and 
334)).  
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's 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 Agency guidances means that something is suggested or 
recommended, but not required.  
 
II.  Background  
 
Salmonella spp. can cause serious and sometimes fatal infections in young children, frail or 
elderly people, and others with weakened immune systems.  Healthy persons infected with 
Salmonella spp. often experience fever, diarrhea (which may be bloody), nausea, vomiting, and 
abdominal pain.  In rare circumstances, infection with Salmonella spp. can result in the organism 
getting into the blood stream and producing more severe illnesses such as arterial infections (i.e., 
infected aneurysms), endocarditis, and arthritis.  In addition, direct-human-contact animal foods 
contaminated with Salmonella spp. pose a significant health risk to humans who have direct 
contact with the foods at homes, petting zoos, agricultural fairs, or similar venues.   
 
III.  Discussion 
 
 
Many firms that manufacture, process, pack or hold human foods or direct-human-contact animal 
foods test the food for the presence of Salmonella spp.  Where the presence of Salmonella spp. in 
the food may render the food injurious to human health, FDA recommends that firms that test 
their food for the presence of Salmonella spp.: 
 
  Maintain control of a food that is being tested for the presence of Salmonella spp., 
pending the final outcome of that testing, to ensure that the food could be reconditioned, 
destroyed, or diverted (e.g., to a use in which the food will not be consumed by humans 
but is fed to animals (as long as such diversion would not adulterate the animal food, and 
such diversion is not to direct-human-contact animal foods)).  For the purposes of this 
guidance, FDA considers that a firm maintains control of a food if the food has not been 
transferred to another person (Ref. 6). 
 
                                                 
3 This guidance does not address how to obtain a representative sample from a designated lot of food.  Readers 
should refer to the discussion of sampling plans in Chapter 1 of Reference 7 for guidance about sampling 
procedures. 
  Contains Nonbinding Recommendations 
  Use the cultural method in FDAs Bacteriological Analytical Manual (BAM) (Ref. 7), or 
a similarly validated (Ref. 9) non-BAM method, to conduct tests for Salmonella spp. in a 
sample of a food, including safeguards to ensure that the sample is properly taken and 
handled.   
 
  Be aware that testing for Salmonella spp. in food using the cultural method in the BAM 
(or similarly validated method) can yield one of three results: 
o  A presumptive positive result, which is a preliminary result that may or may not 
ultimately yield a confirmed positive result (i.e., it may yield a negative result).  
You may perform additional testing, using biochemical and serological methods 
described in the BAM or similarly validated (Ref. 9) non-BAM methods, on a 
cultural isolate from any presumed positive sample to obtain a final result.  
However, you should not have to perform another test or obtain a cultural isolate 
from a presumed positive sample if you choose to not ship the food based on the 
presumptive positive result (Ref. 9); 
o  A confirmed positive result, which can only be obtained if a presumptive positive 
result, in the first test stage, is followed by additional testing as described above 
that results in a confirmed Salmonella spp. cultural isolate; or  
o  A negative result, which can be obtained if either: 
  The first test stage does not yield a presumptive positive result; or 
  Additional testing, as described above, after a presumptive positive result 
does not result in confirmation of the presence of Salmonella spp.   
 
  Consider any confirmed positive result to be valid (even if subsequent tests on the 
original sample or other samples from the food are negative), absent other circumstances 
clearly demonstrating the inaccuracy of the first test result. 4  There are a number of 
explanations why a food that is contaminated with Salmonella spp. may initially yield a 
confirmed positive result for Salmonella spp. in one test and subsequently yield a 
negative result for Salmonella spp. in one or more additional tests. For example, the 
distribution of Salmonella spp. in the food may not be homogeneous.   
 
  Validate any treatment or process used to adequately reduce5 Salmonella spp. in a food.   
 
FDA may take enforcement action if we sample a lot of food and one or more composite unit(s) 
is positive for Salmonella spp. (Refs. 3, 4 and 5), even when the manufacturer has previously 
tested the food and obtained negative results. 
 
                                                 
4 Examples of such circumstances include clear evidence of contamination during sampling (Ref. 8) and clear 
evidence of laboratory error (such as a test result obtained when a negative control used during the test is positive 
for Salmonella spp.). 
5 In this document, we use the phrase adequately reduce to mean reducing the presence of Salmonella spp. to an 
extent sufficient to prevent illness. The extent of reduction sufficient to prevent illness is usually determined by the 
estimated extent to which Salmonella spp. may be present in the food combined with a safety factor to account for 
uncertainty in that estimate.  For example, if it is estimated that there would be no more than 1000 (i.e., 3 logs) 
Salmonella organisms per gram of food, and a safety factor of 100 (i.e., 2 logs) is employed, a process adequate to 
reduce Salmonella spp. would be a process capable of reducing Salmonella spp. by 5 logs per gram of food. 
 
  Contains Nonbinding Recommendations 
 
IV. References  
We have placed the following references on display in the Division of Dockets Management, 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may 
see them at that location between 9 a.m. and 4 p.m., Monday through Friday.    
1.  FDA.  2011. Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs 
During Production, Storage and Transportation. 
2.  FDA. 2011. Draft Guidance for Industry: Questions and Answers Regarding the Final 
Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and 
Transportation.  
3.  FDA. 2005. Compliance Policy Guide Sec. 527.300, Dairy Products - Microbial 
Contaminants and Alkaline Phosphatase Activity.   
4.  FDA. 1995. Compliance Policy Guide Sec 555.300, Foods, Except Dairy Products - 
Adulteration with Salmonella (CPG 7120.20). 
5.  FDA. 1995.  Compliance Policy Guide Sec. 690.700, Salmonella Contamination of Dry 
Dog Food (CPG 7126.17).  
6.  FDA. 2010. Draft Guidance for Industry: Questions and Answers Regarding the 
Reportable Food Registry as Established by the Food and Drug Administration 
Amendments Act of 2007 (Edition 2). 
7.  FDA. 2011. Bacteriological Analytical Manual, November 2011 Version, Chapter 5. 
8.  ICMSF (International Commission on Microbiological Specifications for Foods) (2002) 
Microorganisms in Foods 7. Microbiological Testing in Food Safety Management, 
Springer Science + Business Media, LLC, pp. 191-197.  
9.  FDA.  2011.  Guidelines for the Validation of Analytical Methods for the Detection of 
Microbial Pathogens in Foods.