Import Alert 72-03

"Detention Without Physical Examination and Intensified Coverage of Pig Ears And Other Pet Treats Due To The Presence Of Salmonella"

In September 1999, FDA learned that 30 cases of Salmonella infantis in Canada were strongly associated with pig ear dog treats. All affected individuals are dog owners. Many of the cases have been children. Rollover Brand pig ear dog treats, manufactured by Farm Meats Canada, Ltd., High River, Alberta, Canada had been determined to be the most likely source of contamination. An inspection was conducted at Farm Meats Canada, Ltd. by Canadian health authorities. Multiple positive samples were found in the plant.

Analysis also identified a PFGE (Pulsed Field Gel Electrophoresis) match to an opened box in a home of a dog owner (1 band difference) with samples taken at the plant. Additional product from other homes, phage type matches.

Farm Meats Canada, Ltd., has recalled the product from the Canadian marketplace. A safety alert issued by the Canadian Food Inspection Agency (CFIA) on September 24, 1999, advised that the elderly, children and persons with weakened immune systems should avoid handling the pig ear dog treats.

Further, other Canadian companies have been under investigation by the Canadian Food Inspection Agency (CFIA). Samples from Euro Can Manufacturing Inc. (Pet Products), collected on September 13, 1999, and analyzed by Health Canada, have been found positive for Salmonella. Euro Can Manufacturing and Farm Meats have recalled their pig ear dog treats in Canada. On September 25, 1999 the CFIA issued a safety alert on Euro Can pet chews.

Review of OASIS data indicates that both firms have routinely shipped products to the U.S.

FDA and CDC are not aware of any cases of Salmonella in the U.S. that have been linked to pig ear dog treats; however, CDC has notified state health departments so they can ask about possible exposure to pig ear dog treats.

Districts may detain, without physical examination, the identified pet treat products from the manufacturers named in the attachmnet to this import alert.

Intensified coverage of pet treats from other Canadian manufacturers or manufacturers in other countries appears warranted. Entries identified as pet treats, chews, etc. should be examined to determine if they are in fact pig ear dog treats or other products subject to detention without physical examination.

Samples collected and found positive for Salmonella should be reported to Division of Compliance, HFV-232. Recommendations for detention without physical examination for firms not listed on the attachment should be forwarded to DIOP.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.

In order to fully evaluate whether the problem of Salmonella in pet treats has been corrected, CVM is requiring the following information from those firms requesting removal from detention without physical examination:

1. The firm must provide evidence that the it has identified the source of the problem and has taken appropriate steps to prevent future occurrences. This should be documented by:

a. Results of the firm's investigation(s) into the problem of Salmonella contamination

b. Documentation showing corrective action(s). This should include at a minimum:

1) a description of the current process(es) being used;
2) verification that the process is adequate;
and
3) measures that have been taken to prevent
recontamination.

c. Copies of three (3) production records showing at a minimum, the process, quantities processed, lot numbers and dates of processing,

AND

2. For requests for removal of a single product, using the current process, documentation showing that a minimum of five (5) consecutive, non-violative shipments have been released based on private laboratory analyses. Requests to remove multiple products from a manufacturer will require a minimum of twelve (12) non-violative shipments representative of products covered by detention without physical examination.

All requests for removal from DWPE should be forwarded to DIOP (HFC-170) which in turn will forward the requests to CVM for evaluation. For questions regarding, or clarification of the requirements for, removal from DWPE, CVM, Division of Compliance, HFV-232.

Pig ear dog chews or pet treats

"The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to contain a poisonous and deleterious substance, namely Salmonella, which may render it injurious to health [Adulteration, 402(a)(1)]."

OASIS charge code - SALMONELLA