FDA outlines two new regulations for food import safety
The U.S. Food and Drug Administration announced the release of two regulations to increase safety of food imports during a press conference Thursday in Washington.
The new regulations involve the requirement of a prior notice filed to the FDA for all food shipments entering the country, in addition to the registration of all domestic and overseas processors with activities in the U.S. market. FDA was mandated by Congress to develop the regulations under the 2002 Public Health Security and Bioterrorism Preparedness and Response Act.
“These new requirements represent the latest steps in our ongoing efforts to respond to new threats and improve the safety of all the foods that we eat in this country,” said Health and Human Services Secretary Tommy G. Thompson in a statement.
The advance notice for food imports will take effect Dec. 12. This will allow the FDA to know in advance when specific food shipments are arriving in the U.S. port of entry. The agency expects to receive about 25,000 notifications a day.
FDA Commissioner Mark B. McClellan said the agency took into account the numerous comments and concerns from law enforcement, national security and industry officials in the development of the prior notice regulation.
For example, the proposed rule issued earlier this year would have required importers to provide prior notice by noon the day before arrival of a food shipment in the United States by all transport modes, including land and road.
Under the final regulation, FDA must receive prior notices no more than five days before arrival and no fewer than:
* Two hours before before arrival by truck.
* Four hours before arrival by air or rail.
* Eight hours before arrival by vessel.
In addition, for international mail shipments, notifications must be made before the shipment is mailed. When an individual carries or transports foods subject to the new requirement, advance notice of two, four or eight hours is required according to the mode of transport, FDA said.
The prior notice may be electronically submitted to FDA in most cases using the Bureau of Customs and Border Protection’s Automated Broker Interface system. FDA will also operate a new prior notice system interface that shippers can use.
McClellan said the FDA will continue to work closely with Customs on the implementation of the prior notice regulation.
“Using the electronic data required under these regulations and a sophisticated automated targeting system, CBP and the FDA will be working side-by-side to make joint decisions about food shipments that could pose a potential threat to the United States,” said Customs Commissioner Robert C. Bonner in a statement.
The second regulation requires all owners, operators or agents in charge of domestic or foreign food facilities to register with the FDA. This information will include name and address of each facility and information about the categories of food processed by these operations. For a foreign facility, the registration must include the name of the U.S. agent for the facility.
FDA said the registration is required for domestic facilities whether or not food from the facility enters interstate commerce. Domestic facilities must also provide emergency contact information and any changes to registrations must be reported to within 60 days, the agency said.
Certain food transport vehicles, pesticide manufacturers, farms, restaurants and other retail establishments are exempt from the FDA registration. Also exempt are slaughterhouses for meat and poultry because they’re already regulated by the U.S. Department of Agriculture.
FDA said food processing facility registrations may be submitted electronically via the Internet or on paper forms through the mail or fax. Registrations may also be submitted on CD-ROM by mail. The agency will be able to accept registrations from anywhere in the world 24 hours a day starting Oct. 16. “Filling out registration online should take about 15 minutes if a facility has its paperwork ready,” FDA said.
FDA plans to “exercise broad enforcement discretion” for the prior notice rule for the first four months after its implementation.
“During this time, FDA and CBP will educate importers about how they can comply with the regulations, and will work with trade associations and foreign governments to make sure all importers are well informed of the new requirements,” the agency said. “Thereafter, FDA will phase in full implementation of the prior notice requirements.”