Countdown to bioterrorism rules

Chaos is soon likely to set in with only one month to go until tough laws on bioterrorism enter into force in the US. At least 90 per cent of foreign and domestic facilities have yet to register with the FDA.

Since September 11 the Bush administration has poured billions of dollars into measures to crank up food security. The action plan devised by the Food and Drug Administration (FDA) seeks to address the potential threat to the domestic and imported food supply.

Last year Congress enacted the Public Health Security and Bioterrorism Prevention and Response Act, clearing the way for new rules that require domestic and foreign food plants to register with the agency and requiring food importers to give FDA advance notice before shipments arrive at ports or border crossings.

The rules were slightly amended last month, instead of requiring importers to notify the FDA by noon on the day before a food shipment arrives, the agency will ask for eight hours notice before shipments arrive by sea, four hours notice if by air or rail, and two hours if shipments arrive by land. A move criticised at the time by the Center for Science in the Public Interest (CSPI​).

"These regulations are critically needed to protect the food supply, but we're concerned that the agency is requiring less advance notice for imported food shipments,"​ said CSPI food safety director Caroline Smith DeWaal.

The second regulation finalised by FDA requires food domestic and overseas food manufacturers to register with the government. Requiring registration​ of food importers is a sensible means of letting the FDA know exactly whom it is regulating, said the CSPI.

All very well if the food manufacturers actually register, but with only 37 000 clocked up out of an estimated 400,000 facilities - both domestic and foreign - panic could well set in on 12 December next month, the day the law kicks off.

According to the American Herbal Products Association, in a communication this week the FDA noted that 'the number and rate of food facility registrations is much lower than we had expected.' The agency went on to say that this 'may foreshadow a 'huge' influx on or near December 12, 2003 [and may create] volume problems with the registration IT system.'

All facilities that manufacture, process, pack or hold food for consumption in the United States must be registered with the FDA. Since dietary supplements are defined as foods in the US registration is also relevant to manufacturers, processors, packers and holders of dietary supplements and their ingredients.