From Field to Fork: FDA Bioterrorism Rules Issued

Oct. 17, 2003
"By requiring advance notice for imported food shipments and registering domestic and foreign food facilities, we are providing critical new tools for

"By requiring advance notice for imported food shipments and registering domestic and foreign food facilities, we are providing critical new tools for the Food and Drug Administration (FDA) to identify potentially dangerous foods and better keep our food supply safe and secure," said Health and Human Services Secretary Tommy G. Thompson. FDA issued two new regulations on Oct. 9th, 2003 to implement key provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Advance notification parallels rules issued under the Container Security Initiative (CSI), but with some specific differences.

Prior notice of imported foods must be received and confirmed electronically by FDA no more than five days before its arrival in the U.S.

Minimum notification requirements do not exactly match CSI requirements:

  • FDA is requiring notification two hours prior to arrival by land via road. (CSI requires 1 hour for non-FAST shipments and 30 minutes for FAST shipments. FAST is the Free and Secure Trade process implemented by U.S. and Canadian Customs.)
  • Shipments arriving by air or by land via rail require four hours' advance notification (CSI requires four hours by air and two hours before arrival at the U.S. port of entry via rail.)
  • Ocean shipments require notification eight hours before arrival via water (CSI requires notice 24 hours before lading at the foreign port of export).
  • The food must also be accompanied by confirmation of receipt for FDA review.
  • Advance notice can be submitted electronically in most circumstances using Customs' existing ABI/ACS system. FDA will also operate a new Prior Notice System Interface that can receive such notifications.

Additional requirements also go into effect for facilities registration. Registration is required for domestic facilities whether or not food from the facility enters interstate commerce. The registration requirements apply to all facilities that manufacture, process, pack or hold food regulated by FDA, including animal feed, dietary supplements, infant formula, beverages (including alcoholic beverages) and food additives. Private residences of individuals and certain food transport vehicles and facilities that manufacture food contact substances and pesticides can be exempted. In addition, farms, restaurants, other retail food establishments, non-profit food establishments in which food is prepared for or served directly to the consumer, non-processing fishing vessels and facilities such as meat and poultry slaughterhouses that are regulated exclusively by the U.S. Dept. of Agriculture may be exempted. Foreign facilities can be exempted if the food from the facility is to undergo further processing or packaging by another facility before it is exported to the U.S.

Facility registrations may be submitted electronically via the Internet or by paper via surface mail or by facsimile. FDA began accepting registrations Oct. 16. Registering facilities will receive confirmation and a registration number.

These rules take effect Dec. 12, 2003.
For information,