Animal & Veterinary

FY 2012 Nationwide Assignment to Collect and Analyze Samples of Pet Foods, Pet Treats, and Supplements for Pets from Interstate Commerce in the United States for Salmonella

MEMORANDUM

Date: October 24, 2011

OBJECTIVE

  1. To determine the prevalence of Salmonella in samples collected from a limited number of pet foods, pet treats, and supplements for pets;
  2. To determine the serotype, genetic fingerprint, and antimicrobial susceptibilities of each Salmonella found in samples collected from pet foods, pet treats, and supplements for pets under this assignment;
  3. To ensure that Salmonella-contaminated pet foods, pet treats, and supplements for pets are removed from interstate commerce; and,
  4. To collect investigational samples for research purposes and for providing surveillance information on microbes other than Salmonella in pet foods, pet treats, and supplements for pets.

BACKGROUND

FDA’s Center for Veterinary Medicine (CVM) is concerned about animal feeds serving as vehicles for transmitting pathogenic and antibiotic-resistant bacteria to humans and other animals and is particularly concerned about Salmonella being transmitted to humans through pet foods, pet treats, and supplements for pets that are intended to be fed to animals in homes, where they are likely to be directly handled or ingested by humans. In this document, “animal feed” is used to mean “food”, as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act (the Act), for animals.

The association between human outbreaks of salmonellosis and contact with Salmonella-contaminated pet foods and pet treats is well established. Notably, Health Canada informed FDA of Canadian outbreaks of human salmonellosis that were linked to Salmonella Infantis in pig-ear dog treats that were manufactured in Canada in 1999 and to Salmonella Newport in beefsteak-patty dog treats that were manufactured in Texas in 2002. In addition, human outbreaks of salmonellosis in Canada and the United States in 2005 were linked to pet treats contaminated with Salmonella Thompson. Moreover, the Centers for Disease Control and Prevention (CDC) reported that, between January 2006 and December 2007, seventy human cases of salmonellosis were linked to Salmonella Schwarzengrund in dry dog foods that were manufactured by a company in the United States.

Salmonella-contaminated pet foods, pet treats and supplements for pets pose a significant health risk to humans. Certain vulnerable populations such as children, the elderly, and individuals with compromised immune systems, are particularly susceptible to Salmonella infection from such animal feeds. For these reasons, CVM considers it prudent to keep Salmonella-contaminated pet foods, pet treats and supplements for pets out of interstate commerce.

OVERVIEW OF THE ASSIGNMENT

All samples under this nationwide assignment will be collected from domestic products of pet foods, pet treats and supplements for pets in the United States. This assignment does not cover imported products in either import status or domestic imports.

SAMPLE COLLECTION

The samples can be collected at the manufacturer, distributor, wholesaler, or retailer in which pet foods, pet treats, and supplements for pets are offered for sale or for consumption. If possible, a variety of products from different manufacturers and sources should be selected to support efforts to determine nationwide prevalence. This assignment, however, does not cover canned pet food.

A large number of firms manufacture pet foods, pet treats, and supplements for pets for local, regional, or nationwide sale. Firms that distribute pet foods, pet treats, supplements for pets are also numerous and have outlets all over the country. Such distributors include, but are not limited to, major chains such as PetSmart, PetCo, WalMart, Costco, Sam’s Club, and Target. Major grocery store chains in the United States sell pet foods, pet treats, and supplements for pets. CVM does not anticipate that districts will have difficulty in finding and sampling pet foods, pet treats, and supplements for pets. However, districts that have difficulty in identifying appropriate feed manufacturers, distributors, wholesalers, or retailers from which to collect samples should contact Dr. Xin Li (Phone: 240-453-6863; Email: xin.li@fda.hhs.gov) at CVM for assistance.

For both official and investigational samples, follow the sample collection procedures as described in the FDA Investigators Operations Manual (IOM), Subchapter 4.3, Collection Techniques) and the aseptic sample collection procedures as described in the IOM, Subchapter 4.3.6, Aseptic Sample. For official samples, ensure that the proper controls are collected as outlined in IOM 4.3.6; interstate commerce is documented; labels and labeling materials are collected and try to provide the address and contact information about the feed manufacturers/distributors/retailers on the sample collection report (C/R). For investigational samples, there is no need to document interstate commerce, for the investigational samples will be used for research purposes only.

Each of the nineteen FDA’s districts (excluding SWID) will plan on initially collecting fourteen (14) official and fourteen (14) investigational samples. There will be a total of 266 official (14x19) and 266 investigational samples (14x19) for the nineteen districts involved in the surveillance portion of this assignment. The remaining 34 official and 34 investigational samples should be reserved for collection at all FDA districts when a district, on its own initiative or in response to requests from other districts or CVM, conducts follow-up investigations of official samples that were found to be positive for Salmonella or other microorganisms of concern.

During the surveillance portion of this assignment, each district will collect:

  1. Six (6) official samples and six (6) investigational samples from non-canned pet foods. Examples include, but are not limited to, non-canned foods for puppies, dogs, kittens, cats, rabbits, reptiles (e. g., turtles, snakes, lizards, and iguanas), rodents (e. g., gerbils, hamsters, guinea pigs, rats, and mice), birds, aquarium fish, and raw meat and poultry formulations for pets;
  2. Five (5) official samples and five (5) investigational samples from pet treats. Examples include, but are not limited to rawhide bones, pig ears, dog biscuits, salmon treats, and shrimp snacks; and,
  3. Three (3) official samples and three (3) investigational samples from vitamins, minerals, and other supplements for pets in the form of pills, boluses, solutions or powders.

For this assignment, each official sample should consist of 10 sub-samples with each weighing approximately 200 g (7.1 oz). Each of these 10 sub-samples already includes the 702(b) portions. Therefore, there is no need to collect additional 702(b) portions per 21 CFR 2.10 (b)(3).

Each investigational sample should consist of one sub-sample weighing approximately 300 g (10.6 oz). There is no need to collect 702(b) portions and control samples for the investigational samples since they will be used for research purposes only.

Official and investigational samples can be collected on the same day and from the same lot of feed, but should be assigned different FACTS sample numbers.

Please use the following guidelines when collecting samples:

  • Packages with a net weight of less than 0.91 kg (2 lbs):
    • For each official sample from packages with a net weight of less than 0.91 kg (2 lbs) but greater than or equal to 200 g (7.1 oz), randomly select 10 intact packages. If the net weight of a package is less than 200 g (7.1 oz), combine intact packages as needed to achieve approximately 200 g (7.1 oz) of each sub-samples for a total of 10 sub-samples.
    • For each investigational sample, collect one or more intact packages for a total sample weight of approximately 300 g (10.6 oz).
  • Packages with a net weight of 0.91 – 4.54 kg (2 - 10 lbs):
    • For each official sample from packages with a net weight of 0.91 to 4.54 kg (2 to 10 lbs), randomly select 4 intact packages, and aseptically open and collect 2 or 3 sub-samples from different sections of each of the 4 packages for a total of 10 sub-samples. Each of the 10 sub-samples should weigh approximately 200 g (7.1 oz) and be placed into a sterile Whirl-Pak® bag or sterile, capped plastic bottle. The proper controls to collect in this case include opened and then closed empty Whirl-Pak® bags or plastic bottles, unopened Whirl-Pak® bags or plastic bottles, unopened scoops or spoons, and unopened gloves (if used).
    • For each investigational sample, aseptically collect one sample of approximately 300 g (10.6 oz), and place in a sterile Whirl-Pak® bag or sterile, capped plastic bottle.
  • Packages with a net weight of 4.54 kg – 9.08 kg (10 - 20 lbs):
    • For each official sample from packages with a net weight of 4.54 to 9.08 kg (10 to 20 lbs), randomly select 3 intact packages, and aseptically open and collect 3 or 4 sub-samples from different sections of each of the 3 packages for a total of 10 sub-samples. Each of the 10 sub-samples should weigh approximately 200 g (7.1 oz) and be placed in a sterile Whirl-Pak® bag or sterile, capped plastic bottle. The proper controls to collect in this case include opened and then closed empty Whirl-Pak® bags or plastic bottles, unopened Whirl-Pak® bags or plastic bottles, unopened scoops or spoons, and unopened gloves (if used).
    • For each investigational sample, aseptically collect one sample of approximately 300 g (10.6 oz), and place in a sterile Whirl-Pak® bag or sterile, capped plastic bottle.
  • Packages with a net weight of greater than 20 lbs:
    • For each official sample from packages with a net weight of greater than 9.08 kg (20 lbs), randomly select 2 intact packages, and aseptically open and collect 5 sub-samples from different sections of each of the 2 packages for a total of 10 sub-samples. If only one package is available, aseptically collect all 10 sub-samples from different sections the package. Each of the 10 sub-samples should weigh approximately 200 g (7.1 oz) and be placed in a sterile Whirl-Pak® bag or sterile, capped plastic bottle. The proper controls to collect in this case include opened and then closed empty Whirl-Pak® bags or plastic bottles, unopened Whirl-Pak® bags or plastic bottles, unopened scoops or spoons, and unopened gloves (if used).
    • For each investigational sample, aseptically collect one sample of approximately 300 g (10.6 oz), and place in a sterile Whirl-Pak® bag or sterile, capped plastic bottle.

SAMPLE HANDLING

Handle, identify, package and ship samples in ways to ensure sample integrity. Please refer to IOM, Subchapter 4.5, for details about sample preparation, handling, and shipping. Samples collected under this assignment will, in general, not require refrigeration, and should be shipped by overnight to the laboratory as soon as possible after collection. In those occasional instances where refrigeration may be indicated (e. g., moist feed), investigators should refer to the IOM or contact Dr. Xin Li (Phone: 240-453-6863; Email: xin.li@fda.hhs.gov) at CVM for assistance.

ANALYTICAL

Official samples: FDA’s servicing laboratories will analyze the official samples of pet foods, pet treats, and supplements for pets for Salmonella. Use the method described in Chapter 5, Salmonella of the Bacteriological Analytical Manual (BAM) Online. Screening method for this assignment is VIDAS SLM AOAC 2004.03

Aseptically weigh approximately 37.5 g (~ 1.3 oz) from each of the 10 sub-samples to form a 375 g (13.2 oz) composite sample for Salmonella analysis. Prepare pet treats and chews for Salmonella analysis using the procedures outlined in BAM, chapter 5, section C (Preparation of foods for isolation of Salmonella), sub-section 20 (Pig ears and other types of dog chew pieces).

Reserve approximately 75 grams (~ 2.6 oz) or more from each of the 10 sub-samples for use as the 702(b) portion. Each of these 10 sub-samples already includes the 702(b) portions so there is no need to collect additional 702(b) portions per 21 CFR 2.10 (b)(3).

If sample is positive for Salmonella, the servicing lab will send each Salmonella isolate to ARL or DEN-LAB for serotyping, and retain the duplicate Salmonella isolate in the laboratory. All serotyped Salmonella isolates will be sent to DEN-LAB for antimicrobial-susceptibility testing.

In addition, each servicing laboratory will conduct a pulsed-field gel electrophoresis (PFGE) for each Salmonella isolate under this assignment. The servicing lab will email the PFGE image(s) with FACTS sample numbers to Mr. Jason Abbott at CVM Office of Research (CVM-OR) [MOD II, Room 1501, HFV-530, 8401 Muirkirk Road, Laurel, MD 20708; Phone: (301) 210-4185; E-mail Address: jason.abbott@fda.hhs.gov]. Mr. Jason Abbott at CVM-OR is responsible for downloading the PFGE image(s) of direct-human-contact feed Salmonella isolates into the CDC PulseNet database. Mr. Jason Abbott may request servicing laboratories to conduct a second restriction enzyme digest for the PFGE analysis.

Upon receiving the notice of disposal, the servicing laboratory will send the Salmonella isolate to Ms. Kristin Cooley at CVM Office of Research (CVM-OR) (MOD II, Room 1517, HFV-530, 8401 Muirkirk Road, Laurel, MD 20708; Phone: 301-210-4350; Email: kristin.cooley@fda.hhs.gov), and should be labeled “For Research Purposes Only.”

Investigational samples: CVM-OR will analyze the investigational samples collected under this assignment for microbes (primary for Enterococcus spp. and generic Escherichia coli) that may present a safety concern to provide surveillance information on direct-human-contact feed for research purpose only.

PRIMARY CONTACT

Dr. Xin Li at CVM (HFV-220, 7519 Standish Place, Rockville, MD 20855; Phone: 240-453-6863; Email: xin.li@fda.hhs.gov). Please contact her if you have any questions regarding sample collection, sample handling and shipment, and sample analysis.

REGULATORY/ADMINSTRATIVE FOLLOW-UP

The Center for Veterinary Medicine (CVM) intends to support advisory/regulatory action against Salmonella-contaminated pet foods, pet treats, and supplements for pets, and their manufacturers, for which interstate commerce can be documented under this assignment.

START/COMPLETION DATES

All samples will be collected between October 2011 and September 2012. Due to reports of seasonal variations in the prevalence of Salmonella in feeds, sampling districts are encouraged to spread their sample collection over the entire fiscal year. If it is not feasible, we recommend all samples be collected prior to the 4th quarter of the fiscal year.

/signed/
Daniel G. McChesney, Ph.D.
Director, Office of Surveillance and Compliance

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