Nationwide Assignment to Collect and Analyze Samples of Direct-Human-Contact Feeds for Salmonella

Date: October 16, 2008

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

Subject: Nationwide Assignment to Collect and Analyze Samples of Direct-Human-Contact Feeds for Salmonella

To: All FDA District Directors, FDA Regional and District Laboratory Directors, FDA District Investigations Branch Directors, and FDA District Compliance Branch Directors

Objectives:

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

Background:

FDA’s Center for Veterinary Medicine (CVM) is concerned about the potential for animal feeds to serve as vehicles for transmitting pathogenic and antibiotic-resistant bacteria to humans and other animals and is particularly concerned about the potential for direct-human-contact feeds to directly transmit Salmonella to human.

Direct-human-contact feeds are animal feeds that are intended for use in feeding animals in homes, pet stores, petting zoos, zoos, fairs, or festivals. The feeds are likely to be directly handled or ingested by individuals, including certain vulnerable populations such as children, the elderly, and persons with compromised immune systems. Direct-human-contact feeds include, but are not limited to the following:

• Pet treats, chews, or snacks.
• Pet foods.
• Vitamins, minerals, or mixtures of vitamins, minerals, and other feed ingredients that are intended for dogs, cats, and other pets. These products are manufactured in various forms (pills, boluses, solutions, powders, etc)
• Feed ingredients or mixtures of feed ingredients intended to be given as food or treats to animals in pet stores, petting zoos, zoos, fairs, or festivals.

There are numerous reports of human salmonellosis infections in the United States (US) in which the illnesses were linked to human contact with various pets at homes, pet stores, petting zoos, zoos, fairs, and festivals. Pets implicated in these cases or outbreaks include dogs, chicks, ducklings, rabbits, livestock (cattle, sheep, and goats), reptiles (bearded dragons, iguanas, lizards, snakes), turtles, and rodents. Rodents have also been implicated when they were used as snake food.

In most of these reports, the authors did not determine if feeds fed to the animals were implicated in the outbreaks/cases or played a role in the illnesses. However, in one of the reports on pet turtle-associated with human salmonellosis, the authors found the causative Salmonella in the turtle’s drinking water. Also, in one of the reports in which outbreaks of human salmonellosis infections were associated with frozen vacuum-packed rodents used to feed snakes, the authors found the causative Salmonella in the organs of the rodents. In addition, there are published reports of three recent outbreaks of human salmonellosis in Canada and the US that were linked to Salmonella contained in pig ears and other pet treats fed to dogs. These three outbreaks occurred between 1999 and 2005, and two of the outbreaks were associated with pet treats manufactured in Texas and Washington.

For these reasons, CVM considers it prudent to keep Salmonella-contaminated direct-human-contact feeds out of interstate commerce.

Assignment:

1. Overview of Samples to Collect

   Resources have been allocated under the fiscal year (FY) 2009 work plan to collect and analyze 300 official samples of feed under PAC code 71003E, and to collect 300 investigational samples of feed under PAC code 71R800. Resources have also been allocated under the fiscal year (FY) 2009 work plan to collect and analyze 160 samples of imported feeds at ports of entry in the US, but this assignment does not cover these 160 import samples. This assignment only covers feeds that are already in commerce in the US, i.e. the 300 domestic official samples allocated under 71003E and the 300 domestic investigational samples allocated under 71R800. FDA districts will collect all of the 300 official and 300 investigational samples in the work plan under this assignment, but will analyze only the 300 official feed samples. The 300 investigational samples will be sent to the FDA’s Center for Veterinary Medicine/Office of Research (CVM-OR) for research purposes only, i.e., to provide information on the presence of other microbes in animal feeds.

   The time spent collecting and analyzing the 300 official samples should be reported under PAC code 71003E. To be consistent with the Feed Contaminants Program, the time spent collecting the 300 investigational samples should be reported under PAC code 71R800.

   All of the 600 samples (300 official and 300 investigational) of direct-human-contact feeds should be collected between October 2008 and September 2009. The samples can be collected at the manufacturer, distributor, wholesaler, or retailer (including pet stores, petting zoos, zoos, 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 in determining nationwide prevalence. This assignment does not cover canned direct-human-contact pet foods.;

   Each of the 19 FDA district offices (excluding SWID) should plan on initially collecting 12 official and 12 investigational samples (for a total of 228 official and 228 investigational samples). The remaining 72 official and 72 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.

   Firms that manufacture pet foods, pet treats, and other direct-human-contact feeds are numerous and include those that manufacture products for sale locally, as well as those that manufacture products for sale regionally or nationwide. Examples include, but are not limited to, the Del Monte Corporation, Nestle Purina PetCare Company, Hill’s Pet Nutrition, Iams Company, Kraft Foods North America, Kent Feeds, Texas Farm Products Company, and Bil-Jac Foods. 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 US sell foods and treats for pets. In addition, all 50 states hold annual fairs and festivals and have pet food vendors and/or petting zoos. CVM does not anticipate that districts will have difficulty in locating direct-human-contact feeds or in collecting samples of these feeds as manufactured, sold, or fed. 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.

   Due to reports of seasonal variations in the prevalence of Salmonella in feeds, districts are encouraged to spread out their sample collection throughout the fiscal year, e. g., collect one quarter of assigned samples during the fall (October, November, and December 2008), one quarter during the winter (January, February, and March 2009), one quarter during the spring (April, May, and June 2009), and one quarter during the summer (July, August, and September 2009). If this is not feasible, districts should try to collect half of the assigned samples during the spring and the other half during the summer. If a district is only able to collect assigned samples during one season of the year, we recommend that samples be collected during summer.

2. Sample Collection

   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. and that interstate commerce is documented. In addition, collect labels and labeling materials from these feeds and try to provide the address and contact information about the feed manufacturers/distributors/retailers on the sample collection report (C/R). If it is determined that the feed is of foreign origin, try to collect import documentation or, at a minimum, attempt to relate the shipment back to an entry number.

   During the surveillance portion of this assignment, each district should aseptically collect three official samples and three investigational samples from each of the four categories of direct-human-contact feeds 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 or wet 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.
   • Vitamins, minerals, or mixtures of vitamins, minerals, and other feed ingredients in the form of pills, boluses, solutions, or powders intended for dogs, cats, and other household pets.
   • Feed ingredients, or mixtures of feed ingredients, intended to be given as food or treats to animals in pet stores, petting zoos, zoos, or at local/regional/state/national fairs and festivals. The preferred samples to collect in this category, during the initial visits by districts, are pellets, crumbles, boluses, or seeds 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 ten sub-samples with each weighing approximately 200 g (7.1 oz) while each investigational sample consists of only one sub-sample weighing approximately 300 g (10.6 oz). 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 ten intact packages and aseptically place each into a separate, appropriately sized, sterile Whirl-Pak® bag or sterile, capped plastic bottle. 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 ten sub-samples. The proper controls to collect in this case include opened and unopened Whirl-Pak® bags or plastic bottles and unopened gloves.
     • For each investigational sample, aseptically collect one or more intact packages and place in a sterile Whirl-Pak® bag or capped plastic bottle 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), aseptically open four randomly selected intact packages and collect two or three sub-samples at random from different sections of each package for a total of ten sub-samples. Each of the ten 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 unopened Whirl-Pak® bags or plastic bottles, unopened scoops or spoons, and unopened gloves.
     • 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), aseptically open three randomly selected intact packages and collect three or four sub-samples from different sections of each package for a total of ten sub-samples. Each of the ten 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 unopened Whirl-Pak® bags or plastic bottles, unopened scoops or spoons, and unopened gloves.
     • 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 five sub-samples from different sections of each of two randomly selected bulk containers for a total of ten sub-samples. If all of the feed is in one bulk container, collect all ten sub-samples from different sections of the container. Each of the ten 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 unopened Whirl-Pak® bags or plastic bottles, unopened scoops or spoons, and unopened gloves.
     • 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 at petting zoos:

     • For each official sample from feeds that are already dispensed into small bags for use by the public at zoos and petting farms, 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 ten 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 unopened Whirl-Pak® bags or plastic bottles and unopened gloves.
     • For each official sample from feeds that are already placed in coin-operated feed dispensers for use by the public at zoos and petting farms, consider each serving (if 200 g or larger) or an appropriate combination of servings (if each is less than 200 g) as one sub-sample. Randomly select ten sub-samples and aseptically dispense each sub-sample in a sterile Whirl-Pak® bags or sterile, capped plastic bottles. The proper controls to collect in this case include opened and unopened Whirl-Pak® bags or plastic bottles and unopened gloves.
     • For each investigational sample, aseptically collect one sample of approximately 300 g (10.6 oz) and dispense in a sterile Whirl-Pak® bag or sterile, capped plastic bottle.

   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.

   • Official samples: Each FDA district, except SWID and other import districts, should aseptically collect a total of twelve (12) official samples (three from each of the four types of direct-human-contact feed) during initial visits to pertinent establishment under this assignment, and aseptically collect additional official samples as needed during follow-up investigation(s) of official samples that were found to be positive for Salmonella or other microorganisms of concern. Each official sample should consist of ten sub-samples with each weighing approximately 200 g (7.1 oz). Each of these ten sub-samples already includes the 702(b) portions so there is no need to collect additional 702(b) portions.
   • Investigational samples: Each FDA district, except SWID and other import districts, should aseptically collect a total of twelve (12) investigational samples (three from each of the four types of direct-human-contact feed) during its initial visits to pertinent establishments under this assignment, and aseptically collect additional investigational samples as needed during follow-up investigation(s) of official samples that were found to be positive for Salmonella or other microorganisms of concern. 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, or to document interstate commerce, for the investigational samples since they will be used for research purposes only and are not considered to be official samples.

3. Sample Handling and Shipment

   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 mail 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 Sampling:  Preparation, Handling, Shipping, or contact Dr. Xin Li (Phone: 240-453-6863; Email: Xin.li@fda.hhs.gov) for guidance on handling and shipment.

   Official samples: Each official sample, consisting of ten sub-samples (~ 200 g or ~ 7.1 oz per sub-sample), may be used for regulatory purposes. The districts should ship the samples collected under this assignment to the National Sample Distributor (NSD)-designated laboratory for analyses of Salmonella. Report time used in collecting, submitting, preparing, and analyzing the official samples under PAC 71003E.

   Investigational samples: Each investigational sample (~ 300 g or ~ 10.6 oz) will be used for research purposes only, should be sent 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; Email: kristin.cameron@fda.hhs.gov), and should be labeled “Investigational Sample for Research Purposes Only.” The investigational sample should be identified with the FACTS sample number, the collector’s name, the date of collection, the state (Oklahoma, New Jersey, etc.) in which the sample was collected, and a description of the sample and its intended use. Report time used in collecting and submitting the investigational samples under PAC 71R800.

4. Sample Analysis

   Official samples: Analyze each official sample of direct-human-contact feeds for Salmonella. Use the method described in Chapter 5 of the Bacteriological Analytical Manual (BAM) Online.

   Aseptically weigh approximately 37.5 g (~ 1.3 oz) from each of the ten 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.

   For samples that are found positive for Salmonella, the servicing lab should send each Salmonella isolate to the NSD-designated laboratory for serotyping (ARL or DEN-LAB), and retain the duplicate Salmonella isolate in the laboratory. Upon receiving the notice of disposal, the servicing laboratory should 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; Email: kristin.cameron@fda.hhs.gov), and should be labeled "For Research Purposes Only." All serotyped Salmonella isolates should be sent to DEN-LAB for antimicrobial-susceptibility testing.

   In addition, each servicing laboratory should conduct a pulsed-field gel electrophoresis (PFGE) to determine the genetic fingerprint of each Salmonella isolate found in samples of direct-human-contact feeds from this assignment. The servicing lab should send the PFGE image(s) from the animal feed isolates to Mr. Jason Abbott at 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]. Include the FACTS sample number when electronically sending each PFGE image to CVM-OR. The CVM-OR is responsible for downloading PFGE image(s) of animal feed isolates into the CDC PulseNet database. The CVM-OR may request servicing laboratories to conduct a second restriction enzyme digest for the PFGE analysis.

   Investigational samples: CVM-OR will not analyze any of the investigational samples collected under PAC 71R800 in this assignment for Salmonella. The purpose of these samples is to provide surveillance information on microbes other than Salmonella in direct-human-contact feeds that may present a safety concern.

5. Primary Contact

   The primary contact for this assignment is Dr. Xin Li (Phone: 240-453-6863; Email: xin.li@fda.hhs.gov). Please contact her if you have any questions about sample collection, sample handling and shipment, and sample analysis.

   Regulatory/Administrative Follow-up:

   The Center for Veterinary Medicine (CVM) intends to support regulatory action against Salmonella-contaminated direct-human-contact feeds, and their manufacturers, for which interstate commerce can be documented under this assignment.

   For each direct-human-contact feed sample found to contain Salmonella, districts should initiate procedures to remove the contaminated feed from interstate commerce, inform the responsible firm of the need to initiate corrective action to prevent future contamination, and recommend the issuance of a Warning Letter. In addition, within 90 days or less after districts have been informed by the laboratory of the finding of Salmonella in a feed sample, districts should conduct follow-up investigations of the facility or facilities where the violative sample was manufactured to review manufacturing and handling procedures, document what corrections, if any, were made and collect follow-up samples.

   Although this assignment is for domestic feeds, if it can be clearly demonstrated that the feed is of foreign origin, districts should submit a recommendation to the Division of Import Operations (DIOP) for DIOP to consider placing the feed, and its foreign manufacturer/shipper on Detention Without Physical Examination (DWPE) under IA 72-03, or IA 71-04, as applicable. DIOP may follow up on the recommendation by directing FDA Import Districts to collect and analyze samples from such feed as needed. DIOP will forward all recommendations for placement or removal from DWPE to CVM for concurrence.

   CVM will evaluate the information provided in a district's recommendation for regulatory action. Please contact Mr. Jack Geltman if general assistance is necessary in regards to regulatory action (Phone: 240-276-9203; Email jack.geltman@fda.hhs.gov). For recommendations about recalls, please contact Ms. Kathy Hemming Thompson (Phone: 240-276-9216; Email: kathy.hemming@fda.hhs.gov). For assistance with recommendations for DWPE, please contact Ms. Judy Baron (Phone: 301-594-3875; Email: judy.baron@fda.hhs.gov) at DIOP.

   Priority/Timeframe/Resources:

   This assignment has a routine priority and the concurrence of ORA. The assignment is a part of the Feed Contaminants Program and resources have been allocated to it under the FY 2009 Work Plan. Report time for the collection, submission, preparation, and analysis of each official sample (10 sub-samples, each weighing ~ 200 g) under PAC 71003E. Report time for the collection and submission of each investigational sample (one ~ 300 g sample) under PAC 71R800. The average collection time is estimated to be 4.2 hours per sample in the FY 2009 workplan.

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