24 July 2003

FDA moves on bioterror regs

The following article is excerpted from the 23 July 2003 edition of “The Journal of Commerce”.

Importers are assured that they will have a single point of entry for data that's required under the Bioterrorism Act of 2002, Food and Drug Administration officials said Wednesday.

Officials of the Center for Food Safety and Applied Nutrition said that the FDA will collect its data from the Automated Commercial System (ACS), the entry system operated by the Bureau of Customs and Border Protection.

They said that rules covering import requirements under the bioterrorism law will be published before Oct. 12, but they declined to give further details.

However, the FDA heard "loud and clear" the message from importers that the timing of prior notice was too long. The agency had proposed a deadline of noon of the day before the shipment is due to arrive at a U.S. port or border. The trade said was too far in advance, especially for shipments arriving from countries near the U.S.

The FDA proposed its rules for advance notice July 18. Importers would have been required to use an FDA online system to report advance information on food shipments.

The idea raised a storm of protest among importers, leading to behind-the-scenes negotiations between FDA and Customs to work out better method.

The FDA will use ACS to meet the December deadline established by Congress in the bioterrorism act, but it will also continue to use the Administrative System for Import Support (OASIS) to determine admissibility of import commodities.

In two years, when Customs transfers to the ACS successor, the Automated Commercial Environment (ACE), the agency will collect its data through the International Trade Data System (ITDS).

Compliance with the bioterrorism law was one of a 10-point "progress report" that FDA presented Wednesday to Secretary for Health and Human Services Tommy Thompson.

FDA officials also said that it has hired 655 new field personnel to carry out its inspection efforts, ….

Inspectors now cover 90 ports and border crossings, compared with 40 in 2001.

But as volumes continue to stretch resources, officials said the FDA is beginning to use risk-management tools to prioritize inspections….