Import Alert 17-04: Detention without physical examination bulk shipments of high-risk bovine tissue from BSE-countries--bovine spongiform encephalopathy
As of October 26, 2026, FDA Import Alert 17-04 (Bulk shipments of high-risk bovine tissue from BSE-countries) has no foreign food firms listed in SupplierRadar's records; it covers bulk shipments of high-risk bovine tissues and tissue-derived ingredients.
Data from FDA public records, last checked . Request a correction
- 0
- foreign food firms listed
- 0
- added in the last 90 days
- 0
- removed in the last 90 days
What changed in the last 90 days
Removed from Import Alert 17-04
SupplierRadar has recorded no removals from Import Alert 17-04 in the last 90 days, as of October 26, 2026. A removal is shown at the top of this page, and on the firm's own page, the day it is found.
Added to Import Alert 17-04
No firm was added to Import Alert 17-04 in the last 90 days, as of October 26, 2026.
What the alert covers and why FDA issued it
- Official title
- Detention Without Physical Examination Bulk Shipments of High-Risk Bovine Tissue from BSE-Countries--Bovine Spongiform Encephalopathy
- Product scope
- Bulk shipments of high-risk bovine tissues and tissue-derived ingredients (see Attachment A for a list of affected products). Adrenal gland; Bone marrow; Brain; Brain extract; Cerebellum; Cerebrospinal fluid; Cranial nerves; Colon (proximal and distal); Dura mater; Eye; Hypothalamus; Ileum; Lymph nodes; Nasal mucosa; Olfactory bulb or gland;;Pineal gland; Pituitary gland; Placenta; Spinal cord; Spleen; Suprarenal gland; Tonsil
- Last published
BSE has been identified in more than 100,000 cattle in the United Kingdom and, to a much lesser extent, in several other countries. This neurological disease is a transmissible spongiform encephalopathy (TSE) and is similar to other TSEs such as scrapie in sheep and Creutzfeldt-Jakob Disease (CJD) in humans. The spongiform encephalopathies are uniformly fatal and no rapid diagnostic test for infection in living animals or humans is presently available. Current scientific information indicates that the causative agent is extremely resistant to activation by normal disinfection or sterilization procedures. A range of research projects into the exact nature of both the BSE agent and other TSE agents, host range, patterns of pathogenicity, and development of rapid ante mortem diagnostic tests is ongoing.
Since 1991, USDA has prohibited the importation into the U.S. of certain tissues and organs from ruminants from countries where BSE exists. (refer to 9 CFR 94.18). On January 6, 1998, USDA issued an interim rule listing other countries because of import requirements less restrictive than those that would be acceptable for importation into the U.S. and/or because of inadequate surveillance, which would present a significant risk. USDA's regulations are intended to protect livestock in the United States from contracting TSEs and address known or strongly suspected modes of transmission. The USDA regulations permit, under certain conditions, the importation of some cosmetic ingredients (i.e., collagen, collagen products, amniotic liquids or extracts, placental liquids or extracts, serum albumin, and serocolostrum) derived from ruminants from BSE-countries (see 9 CFR 95.4).
Read the rest of the reason
The USDA regulations do not apply to imports of:
o cosmetic products that are packaged and ready for sale;
o bovine-derived materials intended for human consumption as either finished dietary supplement products or for use as ingredients in dietary supplements; or
o human food (except meat, i.e., skeletal muscle).
In March 1996, the Spongiform Encephalopathy Advisory Committee of the UK reported that 10 cases of CJD in the UK are likely linked to exposure BSE before the UK ban in 1989.
The FDA has recommended that manufacturers who use bovine by-products voluntarily investigate the geographic source(s) of any bovine or bovine material used in their products (generally neural or glandular tissue or tissue extracts). The Agency also suggested that each manufacturer develop a plan "to assure, with a high degree of certainty," that such materials are not from BSE-countries, as identified by USDA's APHIS, or from scrapie-infected sheep flocks, either foreign or domestic.
FDA considers further protective steps to be reasonable and, in an August 17, 1994, letter (Attachment B), recommended that manufacturers and importers of dietary supplements, cosmetic products, and raw materials for these finished product develop plans for ensuring, with a high degree of certainty, that specific bovine-derived materials from BSE-countries are not being used.
Attachment A is an expanded list of those tissues presenting the highest known risk of infectivity, e.g., high-risk tissue, which are the subject of this import alert. Additional tissues may be added to this list as studies warrant and this import alert will be revised accordingly.
FDA will be gathering information on the development of BSE plans for all bovine - derived tissues and documenting the use of high-risk tissue from BSE-countries during domestic inspections under both the cosmetics and dietary supplements compliance programs. Due to the difficulty in verifying the presence of high-risk tissues in finished dietary supplements or cosmetic products, this import alert is limited to bulk lots of these tissues from BSE-affected or at risk countries listed above. However, if during wharf examinations or label reviews high-risk bovine tissues are noted in the ingredients statement, districts should follow the procedure in the Guidance section of this alert to notify CFSAN.
The United States Department of Agriculture issued an interim rule on January 6, 1998. The interim rule restricts the importation of ruminants, meat and meat products from ruminants, and certain ruminant products and byproducts not only from countries and other regions in which BSE is known to exist, but also from countries and other regions which, because of import requirements less restrictive than those that would be acceptable for import into the United States and/or because of inadequate surveillance, present a significant risk.
Listing on an import alert is FDA's notice to the firm and a fact an importer must consider in its supplier evaluation under 21 CFR 1.505. What the red, green and yellow lists mean.
Questions about Import Alert 17-04
- What is Import Alert 17-04?
- Import Alert 17-04, “Detention without physical examination bulk shipments of high-risk bovine tissue from BSE-countries--bovine spongiform encephalopathy”, is an FDA import alert; FDA last published the alert on December 10, 2020.
- How do firms get off Import Alert 17-04?
- A firm asks FDA to remove it by submitting evidence that the cause of the listing has been corrected. The Guidance section of the alert on FDA's website gives the procedure and the contact for 17-04; our guide explains the steps and the evidence FDA usually asks for.
Built for the person who signs the FSVP file
Look before you order.
Check up to five suppliers against every FDA record in one paste, no account needed. Watch the ones you buy from and get the source the day a record changes.
SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.