CVM Issues Assignment to Collect Official Samples of Raw Foods for Dogs or Cats in Interstate Commerce in the United States and Analyze them for Salmonella, Listeria monocytogenes, Escherichia coli O157:H7 and Non O157:H7 Shiga Toxin-Producing Escherichia coli (STEC)
Date: June 3, 2015
- To investigate the occurrence of Salmonella, Listeria monocytogenes, E. coli O157:H7 and non O157:H7 STEC in the surveillance samples of raw foods for dogs or cats,
- To determine the serotype, genetic fingerprint, and antimicrobial susceptibilities of each isolate of Salmonella; to determine the serotype, and genetic fingerprint of Listeria monocytogenes, and E. coli O157:H7 found in samples collected from the survey of raw foods for dogs or cats.
In recent years, an increasing number of dog and cat owners have begun feeding their pets various foods that are labeled or advertised as raw with/without minimal processing. The FDA has not yet defined raw or minimally processed foods for dogs or cats. Based on information gathered to date, it appears they can range from animal products brought home by hunters and fed to dogs or cats, to complete and balanced foods for dogs or cats available at retail stores that may or may not have undergone traditional pasteurization processes. The samples collected under this assignment will include any dog or cat foods labeled or advertised as raw and sold at retail stores.
Peer-reviewed articles reported raw pet foods contained bacterial pathogens including Salmonella, L. monocytogenes, Escherichia coli O157:H7 and non O157:H7 STEC. For example, Joffe (2002)1 reported that Salmonella was found in 80% of the samples of raw chicken dog food diets and in 30% of the stool samples from dogs fed the diets. The FDA/Center for Veterinary Medicine/ Veterinary Laboratory Investigation and Response Network (CVM Vet-LIRN) in collaboration with the Food Emergency Response Network (FERN) conducted a research study and found that among the 196 samples of raw dog and cat food purchased from online stores, 15 were positive for Salmonella (7.7%), 32 were positive for L. monocytogenes (16.3%), none were positive for E. coli O157:H7 and 10 were positive for non O157:H7 STEC (CVM, 2014).2 Finley (2007)3 reported that, 50% of dogs fed Salmonella-contaminated raw food diets shed Salmonella in their feces, while none of the control dogs fed Salmonella-negative diets shed Salmonella. In addition, dogs fed Salmonella-contaminated raw food diets shed the same Salmonella serotypes as found in their food. There are published reports of transmission of Salmonella from household dogs or cats with salmonellosis to people that became ill.4, 5, 6 STEC (E. coli O157:H7 is a sub-set of STEC) and L. monocytogenes were found among clinical isolates from dogs.7, 8
Thus, the scientific literature indicates that feeding raw foods to household pets such as dogs or cats carries a risk to human and animal health. Even if the pets do not appear to be sick after consuming raw pet foods containing pathogens such as Salmonella and Listeria monocytogenes, they can become carriers of such pathogens and transfer the pathogens to the environment. Humans can be infected by contacting pathogens in the contaminated environment. Raw pet foods containing pathogens can also contaminate food contact surfaces and human hands that increase the risk of human exposure.
The FDA CVM makes the following statement on FDA’s website: “FDA does not believe raw meat foods for animals are consistent with the goal of protecting the public from significant health risks, particularly when such products are brought into the home and/or used to feed domestic pets; however, we understand that some people prefer to feed these types of diets to their pets.”
All the samples under this assignment will be collected at retail stores from raw foods for only dogs or cats. These dog or cat foods should be labeled or advertised as raw. In addition, the label on the package should state Made or Manufactured in the United States. The types of raw foods are frozen raw food (e.g., mixes or grinds in forms of bites, medallions, or patties), freeze-dried raw food, or dehydrated raw food that will be customarily consumed by dogs or cats without cooking by the consumer.
Note: This assignment does not cover canned foods or raw milk for dogs or cats.
All samples shall be collected in accordance with IOM Chapter 4.3. Investigators shall make every reasonable effort to collect the following information for the FACTS Collection Report:
- Complete labeling (product label, case label (if available) and
- Manufacturer, distributor, and shipper
All Districts are to collect a 702(b) portion in accordance with IOM 22.214.171.124 and regulation 21 CFR 2.10(b).
Each official sample shall consist of 10 sub-samples with each sub-sample weighing approximately 200 g (7.1 oz) (or as identified below for frozen, freeze-dried, or dehydrated raw foods) randomly collected. Collect an additional 10 sub-samples of equal weight for the 702(b) portion (10 subs for analysis + 10 subs for reserve sample storage for a total of 20 subs/sample). Investigators should collect all sub-samples from the same lot. All sub-samples are considered as the same lot if there is no lot information on the product.
Handle, identify, package and ship samples in ways to ensure sample integrity. Deliver samples to the laboratory promptly with the original storage conditions. Please refer to IOM, Subchapter 4.5, for details about sample preparation, handling, and shipping. Samples collected under this assignment will, in general, require refrigeration or need to be kept frozen, and should be shipped by overnight service to the laboratory as soon as possible after collection. Keep in mind that frozen raw foods for dogs or cats will need to be shipped and received frozen. Therefore, arrangement for dry ice or any other equipment required to keep the product frozen as per IOM instructions will need to be made ahead of time.
Ship official samples to the identified servicing laboratories on the (FY) 2015 work plan for your specific District for analyses of Salmonella, Listeria monocytogenes, E. coli O157:H7 and non O157:H7 STEC.
AOAC Official Method 2004.03 [Determination of Salmonella in Foods by VIDAS (SLM) Immunoassay], an enzyme-linked immuno-fluorescent assay, or 2011.03 VIDAS SLM EASY, is to be used as the screening methods for this assignment. Refer to procedures outlined in the FDA’s Bacteriological Analytical Manual (BAM) on line, Feb. 2011, chapter 5, Salmonella for the confirmatory method to use in this assignment.
Aseptically weigh 37.5 g from each of the 10 sub-samples to form a 375 g composite for Salmonella analysis.
LISTERIA MONOCYTOGENES ANALYSIS
RAPID SCREENING METHODS
Listeria AOAC Official Method 999.06 Listeria in Foods, Enzyme-Linked Immunofluoescent Assay (ELFA) VIDAS LIS Assay Screening Method. Official Methods of Analysis of AOAC International, current edition.
Listeria AOAC Official Method 2004.06. Modified Vidas. Official Methods of Analysis of AOAC International, current edition.
Aseptically weigh 50.0 g from each of the 10 sub-samples to form 2 composites (5 sub-samples per composite) for Listeria monocytogenes analysis.
Use Bacteriological Analytical Manual (BAM) on line, Feb. 2011, chapter 10, Detection and Enumeration of Listeria monocytogenes in Foods.
Chapter 10 requires that all Listeria monocytogenes positive samples be enumerated using reserve sample (Section J)
Chapter 11, Serodiagnosis of Listeria monocytogenes.
E. COLI ANALYSIS
Use Bacteriological Analytical Manual (BAM) on line, Feb. 2011, chapter 4A, Section K qPCR Screening Method for E. coli serotype O157:H7 from foods.
Aseptically weigh 25 g from each sub-sample, and analyze sub-sample individually.
If the qPCR assay detects a non O157:H7 STEC, follow the procedure in Chapter 4A, Section R of the BAM to isolate the STEC from the enrichment sample.
REGULATORY & ADMINISTRATIVE FOLLOW-UP
The raw foods for dogs or cats product is adulterated under section 402(a)(1) of the Act (21 U.S.C. 342(a)(1) in that it bears or contains a poisonous or deleterious substance, namely Salmonella, Listeria monocytogenes, or E. coli O157:H7.
Refer to the July 2013 Compliance Policy Guide Sec. 690.800 Salmonella in Food for Animals for the latest policy on Salmonella.
Positive findings of Salmonella, Listeria monocytogenes, E. coli O157:H7 in a sample of raw foods for dogs or cats product collected from a retail store may result in a Class I recall, press release, and Reportable Food Registry (RFR) submission.
Start Date: June 1, 2015
Completion Date: August 31, 2015
Daniel G. McChesney, Ph.D.
Director, Office of Surveillance and Compliance
1Joffe DJ and others. Preliminary assessment of the risk of Salmonella infection in dogs fed raw chicken diets. Can Vet J 2002; 43:441–442.
2Nemser SM and others. Investigation of Listeria, Salmonella, and Toxigenic Escherichia coli in Various Pet Foods. Foodborne Pathogens and Disease 2014; 11:706-709.
3Finley R and others. The risk of salmonellae shedding by dogs fed Salmonella-contaminated commercial raw food diets. Can Vet J. 2007; 48:69–75.
4Sato Y and others. Salmonella virchow infection in an infant transmitted by household dogs. J Vet Med Sci 2000; 62:767-769.
5Morse EV and others. Canine salmonellosis: a review and report of dog to child transmission of Salmonellla enteritidis. American Journal of Public Health 1976; 66:82-84.
6Hoelzer K and others. Animal contact as a source of human non-typhoidal salmonellosis. Veterinary Research 2011; 42:34-60.
7Läikkö and others. Canine tonsillitis associated with Listeria monocytogenes. Veterinary Record 2004; 154:732.
8Beutin L. Escherichia coli a pathogen in dogs and cats. Veterinary Research 1999; 30:285-298.