Tougher U.S. Food Import Controls Aimed at Bioterrorists

WASHINGTON, DC, August 25, 2003 (ENS) - To protect Americans from the possibility of eating food contaminated by bioterrorists, businesses and individuals who produce, import or distribute food will have to meet four new requirements imposed by the U.S. Food and Drug Administration, the agency announced on Friday.

One rule holds that foreign and domestic facilities that manufacture, process, pack or hold food to be consumed by humans or animals in the United States be required to register with the agency.

The Food and Drug Administration (FDA) also wants to be given prior notice before food is imported or offered for import into the United States.

Another rule would require specific records about a food's "immediate previous sources and immediate subsequent recipients" to be kept and retained. Retail food operations are exempted from maintaining records on immediate subsequent recipients when food is sold directly to consumers.

A fourth rule would identify procedures the secretary of Health and Human Services, through the FDA, would take to stop foods "that present a serious health threat to humans or animals" from entering the U.S. food system.

Kathy Wilson inspect labels on foods at the Montgomery County Food and Nutrition Service Center Warehouse in Montgomery County, Maryland. (Photo by Ken Hammond courtesy USDA)

Imported food from foreign facilities that are required to register but have not done so will be held at the port of entry until the facility is registered. In addition, the agency warned, it is a prohibited act to fail to register if required to do so, which could subject the owner, operator, or agent-in-charge of the facility to criminal or civil penalties.

The new requirement would apply to all affected facilities for all foods and animal feed products regulated by the FDA, including dietary supplements, infant formula, beverages - including alcoholic beverages - and food additives.

Some facilities would be exempt from the new rules - farms, restaurants, certain pet food entities, retail food establishments, non-profit establishments that prepare or serve food, fishing vessels not engaged in processing, and facilities regulated exclusively by the U.S. Department of Agriculture.

Foreign facilities would be exempt "if the food from the facility undergoes significant further processing or packaging by another facility outside of the United States," the FDA said.

Businesses with 500 employees or more would have six months to comply with the final regulations after publication in the Federal Register, the agency said. Smaller businesses would have 12 or 18 months to comply, depending on their size.

The agency said it expects the final registration requirements will be published by mid-October to allow the food industry time to understand the new requirements and comply by December 12, the date specified by Congress.

In response to the terrorist strikes of September 11, 2001, President George W. Bush signed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 into law on June 12, 2002.

The act includes a large number of provisions to help ensure the safety of the United States from bioterrorism, including new authority for the Secretary of Health and Human Services to take action to protect the nation's food supply against the threat of intentional contamination. The Food and Drug Administration, as the food regulatory arm of the Department of Health and Human Services, is responsible for developing and implementing these food safety provisions.