U. S. Department of Health and Human Services
U. S. Food and Drug Administration
Office of Regulatory Affairs
May 20, 2003

Summary of ORA BSE Import Bulletin 99B-14

The Food and Drug Administration (FDA) has alerted its import field offices to the potential importation of human food products and nutritional supplements containing ruminant material from BSE-affected or at-risk countries as determined by United States Department of Agriculture (USDA)/Animal, Plant Health and Inspection Service (APHIS). The current action is a followup to an earlier FDA alert issued in January 2000 regarding bulk shipments of high risk bovine tissues from these same countries. An expanded list of products at issue and a list of the current BSE-affected countries is set out below.

USDA/APHIS has prohibited the importation into the United States of all edible ruminant products from Europe, Oman, and other BSE-affected countries. The Import Bulletin will facilitate FDA's careful review of all imports of FDA-regulated products to ensure coordination with APHIS on the prohibitions. FDA's review will include evaluation of product ingredient lists to determine whether the products offered for import contain certain ruminant materials. Products that appear to contain ruminant material from the identified countries will be referred to APHIS for disposition.

PRODUCTS

• Cheese products containing meat of ruminant origin
• Ruminant meat products
• Poultry products containing or processed with ruminant products
• Rennet from ruminant animals
• Pie fillings containing or processed with ruminant products
• Multiple ingredient food products (soups, stews, sandwiches, mixed dinners, etc.) containing or processed with ruminant products
• Baby foods, geriatric foods, and dietary foods containing or processed with ruminant products
• Vitamins, minerals, proteins, and other dietary supplements that contain or have been processed with ruminant material
• Food additives (emulsifiers, enzymes, flavor enhancers, etc.) containing or processed with ruminant materials
• Botanicals containing or processed with ruminant materials
• Animal by-products and extracts for human use

BSE-AFFECTED OR AT-RISK COUNTRIES

This document was issued on May 20, 2003.
For more recent information on Bovine Spongiform Encephalopathy (BSE)
See http://www.fda.gov/oc/opacom/hottopics/bse.html