To help prevent the food supply from becoming a tool of terrorists, the U.S. Food and Drug Administration last month published proposed regulations that would require prior notice to FDA before food is imported or offered for import into the United States. The proposal implements a major element of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. By obtaining advance notice of imported food shipments, FDA can target inspections more effectively, the agency said.
Under the proposal, FDA must be notified by noon of the calendar day before the day the imported food will arrive at the U.S. border crossing or at the port of entry. The proposed rule would require the prior notice to be submitted electronically through an FDA Internet-based system that would be operational 24/7. FDA expects an average of about 20,000 prior notices concerning imported food to be submitted daily. The proposed rule does not apply to meat, poultry or egg products that are exclusively regulated by the U.S. Department of Agriculture at the time of importation.
The proposed rule would require that notices contain the following information for each imported food entry:
- Identification of the submitter, including name and firm information;
- Entry type and U.S. Customs System (ACS) entry number, or other U.S. Customs identification number for the import;
- Location for any imported food products held at the port of entry for failure to submit an adequate prior notice;
- Identification of the articles of food, including complete FDA product code, the common or usual name or market name, the trade or brand name (if different from the common or market name), the quantity described from the smallest package size to the largest container, and the lot or code numbers or other identifier (if applicable);
- Identification of the manufacturer;
- Identification of the grower, if known;
- Originating country;
- Identification of the shipper;
- Country from which the article of food was shipped;
- Anticipated arrival information: location, date, and time;
- Customs entry process information;
- Identification of the importer, owner, and consignee; and
- Identification of the carrier.
Another FDA proposal, also required by the bioterrorism law, would require domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA by Dec. 12. In the event of an outbreak of food-borne illness, such information will help FDA and other authorities determine the source and case, the agency said.
Affected organizations have said the new rules will disrupt the freight flow. Gary Petty, president of the National Private Truck Council, said the proposals would be problematic to both companies shipping food into the United States and trucking companies.
“There’s been a substantial increase in food, particularly fish and fruit, coming into this country,” Petty says. “You have to wonder, with 20,000 shipments a day coming into this country, if a terrorist is going to give prior notice.”
The proposal would be “onerous to administer,” Petty says. “It will take a lot to work. It’s a long way from becoming reality.”
The plan is not practical, said Susan Stout, spokeswoman for the Grocery Manufacturers of America. The U.S. food supply chain is dependent on just-in-time delivery and around-the-clock food processing facilities and transportation systems.
Comments on both FDA proposals are due April 4. Copies of the documents are available on FDA’s Bioterrorism Act website (www.fda.gov/oc/bioterrorism/ bioact.html). Comments may be submitted electronically at www.fda.gov/ dockets/ecomments. Cite Docket No. 02N-0278 for the prior notice rule and Docket No. 02N-0276 for the registration rule.
Whether FDA completes the rulemaking or not, prior notice and registration will begin this year. The bioterrorism law orders FDA to implement both by Dec. 12 whether or not it has issued final regulations.