United States’ Bioterrorism Act Regulations

Updated: August 13, 2004

Summary:

On October 9, 2003, the United States (US) Food and Drug Administration (FDA) announced interim final regulations to implement the United States’ Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). The regulations came into effect on December 12, 2003. The FDA has announced a transitional compliance policy, which defines a phase-in period for the prior notice rules until August 12, 2003. Full enforcement is effective August 13, 2004.

Background:

• On October 9, 2003, the United States Food and Drug Administration (FDA) announced interim final regulations to implement the United States’ Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). The rules became effective on December 12, 2003.

• The interim final regulations represent a revision to the proposed interim regulations on Prior Notice of Imported Food Shipments and Registration of Food Facilities announced in February 2003.

• British Columbia’s agriculture, fisheries and food industries had significant concerns with the initial interim regulations, particularly the proposed timelines for prior notice of imports and the requirement that only a United States’ importer could make the notification. These threatened to interrupt “just in time” deliveries of fresh BC agriculture, food and fisheries products to US destinations. The Ministry responded to these concerns by providing formal technical comments to the US FDA on April 3, 2003. These can be found here.

• Further information on the interim final rules announced on October 9th can be found on the US FDA’s website  (http://www.cfsan.fda.gov/~dms/fsbtact.html). Of particular note, the requirements on prior notice have been revised. The interim final rules now provide that prior notice must be received and confirmed electronically by the FDA no more than five days before arrival and no fewer than:
   

  1. Two hours before arrival by road
  2. Four hours before arrival by air or by rail
  3. Eight hours before arrival by water

The interim final rules also provide that any individual with knowledge of the required information can make the prior notice.

• The Ministry's comments to the interim final rules can be found here.

• Starting on December 12, 2003, the FDA and US Customs and Border Protection (Customs) expected a “good faith” effort at compliance. During the first eight months (until August 12, 2004) agencies were primarily educating the affected firms and individuals.

• Full enforcement is effective August 13, 2004. Non-compliance with the regulations will result in fines and/or refusal of shipments at the border.

• The Government of Canada is monitoring the situation closely and will continue to make representations to US officials should problems arise at the border due to full enforcement.

• Agriculture & Agri-Food Canada has updated their website to include questions and answers, and provides contact details should there be problems reported at the border. The website address is: http://ats.agr.gc.ca/us/bioterrorism_e.htm. This website is very comprehensive and thus should be able to provide you with all of the information needed.

Last update: August 13, 2004

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