FDA proposes rules for advance notice of food imports

Jan 30, 2003 (CIDRAP News) – Starting next December, importers will have to start notifying the Food and Drug Administration (FDA) at least a day in advance of every food shipment coming into the United States.

That requirement is likely to generate an average of about 20,000 shipment notices daily, the FDA said in announcing proposed regulations to implement it. The requirement is part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

The requirement will "allow FDA to target inspections more effectively and to help ensure the safety of imported food products before they enter domestic commerce," the agency said in a news release yesterday.

"The more we know about the source of the food we eat the better prepared we'll be to monitor its safety," Secretary of Health and Human Services (HHS) Tommy Thompson said in the news release.

The FDA also proposed rules for implementing a requirement that food manufacturing and processing facilities register with the agency. That requirement is also part of the 2002 bioterrorism law and will take effect Dec 12 of this year. Farms, restaurants, retail food stores, nonprofit food services, and facilities (such as slaughterhouses) that are regulated exclusively by the US Department of Agriculture (USDA) are exempt from the requirement.

Regarding food imports, the FDA proposes to require notification by noon of the day before the food will arrive at the border crossing or port of entry. Notices would be submitted through an FDA Internet-based system that would operate at all times, the agency said.

The new law says that "food imported or offered for import without adequate prior notice will be refused admission and held at the port of entry until adequate prior notice is received, unless FDA directs its removal to a secure facility," the FDA said.

The proposed rule does not apply to meat, poultry, and egg products that are exclusively regulated by the USDA, nor does it cover food that individuals carry in their baggage for their personal use.

The FDA said it will take public comments for 60 days on both sets of regulations. The agency plans to issue a final rule on both by Oct 12, 2003.