Import Alert 71-04

"Detention Without Physical Examination Of Animal Feeds, Other Than Pet Treats, Due To The Presence Of Salmonella"

In March, 2003, the Southwest Import District collected a sample of ovine (sheep) meat and bone meal from an Australian manufacturer in domestic status. Subsequently, the sample was analyzed and found to be contaminated with Salmonella. Although traced back to an imported shipment, it was difficult to assess whether the source of adulteration had occurred at the foreign manufacturer or at the domestic manufacturer. Subsequently, samples of feeds from other foreign manufacturers collected at entry by SWID have been found positive for Salmonella.

This import alert provides for manufacturers and shippers, from multiple countries, to be placed on detention without physical examination for animal feeds, other than pet treats, found to contain Salmonella. Pet treats are covered by Import Alert #72-03.

Districts may detain, without physical examination, products offered for importation from manufacturers and shippers identified in the Red List to this alert.

Report animal feed samples found positive for Salmonella to CVM, Division of Compliance, HFV-232. Refer to Compliance Program 71003, Feed Contaminants Program, for further guidance. Recommendations for detention without physical examination 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.

To enable the agency to assess whether the firm has identified the source of the problem, and has taken the appropriate steps to correct and prevent future occurrences, FDA recommends that the firm provide the following information:

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

b. Documentation showing corrective action(s), such as:

i. a description of the process(es) being used
ii. verification that the process is adequate
iii. measures that have been taken to prevent recontamination

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

FDA personnel should assess the adequacy of the firm¿s corrective process by reviewing third party analytical results for five (5) consecutive shipments, where the removal request relates to a single product, or twelve (12) consecutive shipments, where the removal request relates to multiple products.

All requests for removal from DWPE should be forwarded to DIOP
Food Drug Administration
12420 Parklawn Dr.
ELEM - 3109
Rockville Md 20857

Animal feeeds (see attachment)

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain Salmonella, a poisonous or deleterious substance, which may render it injurious to health, [Adulteration, Section 402(a)(1)]"

OASIS Charge code - SALMONELLA