WASHINGTON, D.C. — The U.S. Food and Drug Administration has published two new FDA regulations affecting the cross-border trucking industry.
The first regulation requires food importers to provide the FDA with advance notice of human and animal food shipments imported or offered for import on or after December 12, 2003. This will allow FDA to know, in advance, when specific food shipments will be arriving at U.S. ports of entry and what those shipments will contain.
This advance information will allow the FDA, working with U.S. Customs and Border Protection (CBP), to more effectively target inspections and ensure the safety of imported foods. The FDA expects to receive about 25,000 notifications about incoming shipments each day.
When must prior notice be submitted? Prior notice must be received and confirmed electronically by FDA no more than five days before arrival and, as specified by the mode of transportation below, no fewer than:
1. two hours before arrival by land by road; 2. four hours before arrival by air or by land by rail; 3. eight hours before arrival by water.
The second regulation requires domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the United States to register with the agency by Dec. 12, 2003. As a result, FDA will have for the first time a complete roster of foreign and domestic food facilities. The requirements will enable the FDA to quickly identify and locate affected food processors and other establishments in the event of deliberate or accidental contamination of food. The FDA expects about 420,000 facilities to register under this requirement.
Most of the prior notice information required by the interim final rule is data usually provided by importers or brokers to the Bureau of Customs and Border Protection (CBP) when foods arrive in the United States. Now, the new rules will require that this information also be provided to FDA in advance of an imported food’s arrival to the United States. FDA will use this information in advance of the arrival to review, evaluate, and assess the information, and determine whether to inspect the imported food.
FDA and CBP have collaborated on the implementation of the prior notice interim final rule. Nearly all of the current imported food shipments can comply by using CBP’s Automated Broker Interface of the Automated Commercial System (ABI/ACS). Prior notice can be submitted either through ABI/ACS or FDA’s Prior Notice (PN) System Interface beginning December 12, 2003.
For additional information on the new FDA regulations please refer to the following links:
Registration of Food Facilities Fact Sheet: http://www.cfsan.fda.gov/~dms/fsbtac12.html
Full Text of New Rules: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/pdf/03-25849.pdf
Prior Notice of Imported Food Shipment Fact Sheet: http://www.cfsan.fda.gov/~dms/fsbtac13.html
Full Text of New Rules: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/pdf/03-25877.pdf
Please note the FDA is hosting a number of teleconferences in New York and Michigan on Tuesday, October 28, 2003 where carriers can attend free of charge to obtain more information on the new regulations. Carriers must pre-register for the event and space is limited at each location so carriers are encouraged to register as soon as possible. OTA will notify the carrier community should any additional viewing locations for the FDA teleconference become available.
Please refer to the following link for more information on the teleconference locations and registration information:
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