• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Animal & Veterinary

  • Print
  • Share
  • E-mail

FY 2011 Nationwide Assignment to Collect and Analyze Samples of Direct-Human-Contact Feed from Interstate Commerce in the United States for Salmonella

Date: October 21, 2010

From: Director, Office of Surveillance and Compliance (HFV-200)

Subject Nationwide Assignment to Collect and Analyze Samples of Direct-Human-Contact Feed from Interstate Commerce in the United States for Salmonella

To: DDs, DIBs, DCBs, Laboratory Directors

Info: RFDDs


Routine Priority
ORA Concurrence # 2010101301
FACTS Assignment Code #1228632


OBJECTIVE

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

BACKGROUND

FDA’s Center for Veterinary Medicine (CVM) is concerned about animal feed 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 direct-human-contact feed. Direct-human-contact feed includes animal feed, pet food, and pet treats that are intended to be fed to animals in homes, petting zoos, agricultural fairs, and similar venues 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. This includes, but is not limited to, “animal feed” as defined in section 201(w) of the Act.

The association between human outbreaks of salmonellosis and contact with Salmonella-contaminated direct-human-contact feed 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. More recently, the Centers for Disease Control and Prevention (CDC) reported that, between January 1, 2006 and December 11, 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 direct-human-contact feed poses 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 feed. For these reasons, CVM considers it prudent to keep Salmonella-contaminated direct-human-contact feed out of interstate commerce.

SAMPLE COLLECTION

The samples can be collected at the manufacturer, distributor, wholesaler, or retailer (including pet stores, petting zoos, zoos, agricultural fairs, and festivals) in the forms (bulk or packaged) in which the feeds are offered for sale or for consumption. If possible, a variety of products and sources should be selected to support efforts to determine nationwide prevalence. This assignment, however, does not cover canned pet foods.

A large number of firms manufacture direct-human-contact feed for local, regional, or nationwide sale. Firms that distribute direct-human-contact feeds 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. Most major grocery store chains in the U.S. sell foods and treats for pets. In addition, all 50 states hold annual agricultural fairs and festivals where pet food vendors and/or petting zoos can be found. CVM does not anticipate that districts will have difficulty in finding and sampling direct-human-contact feeds. 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 (http://www.fda.gov/ICECI/Inspections/IOM/ucm122525.htm) 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). If the feed collected for official sample is of foreign origin, try to collect import documentation, or at a minimum, attempt to relate the shipment back to an entry number. For investigational samples, there is no need to document interstate commerce, for the investigational samples will be used for research purposes only.

During the surveillance portion of this assignment, each district will collect 3 official samples and 3 investigational samples from each of the four categories of direct-human-contact feed identified in the four bulleted paragraphs below:

  • Pet treats, chews, or snacks. Examples include, but are not limited to, rawhide bones, pig ears, dog biscuits, salmon treats, and shrimp snacks.
  • Non-canned pet foods. Examples include, but are not limited to, dry pet foods, and other 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, and aquarium fish.
  • Supplements. Example include, but are not limited to, vitamins, minerals, or mixtures of vitamins and minerals in the form of pills, boluses, or powders intended for dogs, cats, and other household pets.
  • Feeds. Examples include, but are not limited to, feeds intended to be given to animals in pet stores, petting zoos, zoos, or at local/regional/state/national agricultural fairs and festivals. The preferred samples to collect in this category are pellets, crumbles, boluses, or seeds/grains that are already dispensed into small bags for purchase and use by the public, or loosely obtained from coin-operated feed dispensers.

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 of the feed 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 greater than 4.54 kg (10 lbs):
    • For each official sample from packages with a net weight of greater than 4.54 kg (10 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.
  • Bulk feeds:
    • For each official sample from feeds that are available in bulk, aseptically collect 5 sub-samples from different sections of each of 2 randomly selected containers or storage units of the bulk feed for a total of 10 sub-samples. If all of the bulk feed is in one container or storage unit, aseptically collect all 10 sub-samples from different sections of the container or storage unit. 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.
  • Feeds in pet stores, petting zoos, zoos, or at agricultural fairs and festivals:
    • For each official sample from feeds that are already dispensed into small bags for use by the public, consider each bag [if 200 g (7.1 oz) or larger] or an appropriate combination of bags [if each bag is less than 200 g (7.1 oz)] as one sub-sample. Randomly select 10 sub-samples, and aseptically place each sub-sample 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, 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 UPS 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 at http://www.fda.gov/ICECI/Inspections/IOM/ucm122527.htm, 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 direct-human-contact feed for Salmonella. Use the method described in Chapter 5 of the Bacteriological Analytical Manual (BAM) Online at http://www.fda.gov/Food/ScienceResearch/ LaboratoryMethods/BacteriologicalAnalyticalManualBAM/UCM070149.

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, chews and snacks, 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: 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 Cameron at CVM Office of Research (CVM-OR) (MOD II, Room 1517, HFV-530, 8401 Muirkirk Road, Laurel, MD 20708; Phone: 301-210-4350; e-mail: kristin.cameron@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 direct-human-contact feeds, and their manufacturers, for which interstate commerce can be documented under this assignment.

Contacts: CVM 

Contacts: ORA 

Scientific and Technical Questions:

Scientific and Technical Questions:

Dr. Xin Li
FDA/CVM/OSC/DAF/HFV-222
Phone: 240-453-6863
e-mail: xin.li@fda.hhs.gov
 

Ms. Peggy J. Carter
FDA/ORA/ORO/DFS/SCRRB/HFC-141
Phone: 301-827-1472
e-mail: peggy.carter@fda.hhs.gov 
 

Compliance:

Investigations:

Mr. Jack Geltman
FDA/CVM/OSC/DC/HFV-232
Phone: 240-276-9203
e-mail: jack.geltman@fda.hhs.gov
 

Mr. James L. Dunnie Jr.
FDA/ORA/ORO/DDFI/DB/HFC-132
Phone: 301-827-5652
e-mail: james.dunnie@fda.hhs.gov
 

 

 Recommendation for DWPE:

Ms. Kathy Hemming Thompson
FDA/CVM/OSC/DC/HFV-232
Phone: 240-276-9216
e-mail: kathy.hemming@fda.hhs.gov
 

Mr. Marty Muckenfuss
FDA/ORA//ORO/DIOP/OPB/HFC-170
Phone: 301-594-3874
e-mail: martin.muchenfuss@fda.hhs.gov
 

Investigational Samples:

 

Mailing address: CVM Office of Research
                      MOD II Bldg A DAFM
                      8401 Muirkirk Road
                      Laurel, MD 20708
 

 

Ms. Kristin Cameron – INV Samples
FDA/CVM/OR/DAFM/HFV-530
Phone: 301-210-4350 Room 1517
e-mail: kristin.cameron@fda.hhs.gov
 

 

Mr. Jason Abbott – PFGE Images
FDA/CVM/OR/DAFM/HFV-530
Phone: (301) 210-4185 Room 1501
e-mail: jason.abbott@fda.hhs.gov
 

 


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