Import Alert 71-02

"Detention Without Physical Examination Of Animal Feeds And Feed Ingredients That May Contain Ingredients Of Animal Origin"

The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) regulates the importation of animals and animal-derived materials. More specifically, under 9 CFR 95.4, the USDA does not allow the importation of animal feeds or feed ingredients that contain or consist of processed animal protein (e.g. meat and bone meal) and other animal waste and by product materials that have been derived from animals that have been in specified BSE-affected and BSE-at-risk countries. The USDA may, however, allow for the importation of specific non-ruminant animal-derived products, provided the product is the subject of a valid USDA import permit (VS Form 16-6).

BSE is the bovine form of a group of uniformly fatal Neurological diseases known as TSEs (Transmissible Spongiform Encephalopathies). BSE appears to be spread in part through feeding of infected material to cattle. At this time, the causative agent is unknown and there is no test for the presence of the agent in animal derived products. There appears to be a link between the bovine TSE, BSE, and a human form of TSE known as vCJD (new variant Creutzfeldt-Jakob Disease).

In support of the USDA/APHIS import prohibitions, the FDA instituted Import Alert #99-25, "Detention Without Physical Examination of Animal Feed, Animal Feed Ingredients and Other Products For Animal Use Consisting or Containing Ingredients of Animal Origin and NOT the subject of a valid USDA permit."

To ensure compliance with Import Alert #99-25, the FDA has a sampling program to conduct random sampling and analysis of feed and feed ingredients for the presence of animal tissues offered for entry into the U.S. The firms listed in the Attachment of this Import Alert #71-02 have offered feed and/or feed ingredients into the U.S. that have been found to contain animal protein upon sampling and analysis.

Districts may detain without physical examination products offered for import from those firms that are identified in the attachment to this alert. In order to fully evaluate whether such products contain ingredients of animal origin subject to detention under Import Alert #99-25 and, if so, whether this problem has been corrected, FDA recommends that firms provide the following information:

1. Evidence that the firm has determined that the products it is importing are no longer subject to detention under Import Alert 99-25, because it has taken appropriate steps to prevent the presence of animal material in feed and feed ingredients.
This should be documented by:

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

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

1) a description of the current processes being used to prevent contamination and

2) verification that the processes are adequate

c. Documentation, based on current feed microscopy analytical methodology, that a minimum of five (5) consecutive import entries have been released by FDA based on private laboratory analyses that show the shipments contain no material of animal origin. Requests to remove from the DWPE list multiple products from a manufacturer should include a minimum of twelve (12) import entries representative of products covered by detention without physical examination.

OR

2. Evidence that the product is the subject of a valid USDA import permit (VS Form 16-6).

All requests for removal from DWPE should be forwarded to the address below. Requests will be forwarded to CVM for evaluation.

Food And Drug Administration
Division, Import Operations and Policy
12420 Parklawn Drive
ELEM-3109
Rockville, MD 20857

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.

Animal feeds and feed ingredients

"The article is subject to refusal of admission pursuant to Section 801(a)(1)in that it appears that such article has been manufactured, processed, or packed under insanitary conditions."

OASIS Charge Code: MFR INSAN