CORTEZ News Article



New FDA Rule Proposed
		Published 20030205
		Mark.Schmittling@CORTEZteam.com

A new regulation, proposed by the Food and Drug Administration (FDA), would require import data for food shipments to be electronically submitted to FDA one day prior to arriving into the United States. This proposed rule would take effect on December 12, 2003. This new rule is designed to safeguard against importations of terrorist products or products that could be used for terrorist activities. As the Notice published in The Federal Register on February 3, 2003 states the new rule "would enhance FDA's ability to inspect imported food when it arrives in the U.S." Purchasers or agents of imported food who maintain a place of business in the United States would be responsible for electronically submitting this information. "The FDA Prior Notice System will be designed to provide an automatic electronic acknowledgment of receipt of a complete prior notice submission, with a time and date stamp." The import data submitted to FDA will be the following: the name of the company submitting the information the entry number or other U.S. Customs identification number associated with the import the location where it is being held the complete FDA product code the common or usual name or market name or the trade or brand name, if different from the common or usual name or market name the quantity described from smallest package size to largest container the lot or code numbers or other identifier of the food if applicable the name of the manufacturer the product's country of origin the shipper and country from which the article of food was shipped the importer, owner, and consignee the carrier This data must be submitted one day prior to the arrival of the merchandise at a U.S. border. Amendments to this information "must be submitted no later than 2 hours prior to arrival." This prior notice requirement will apply to all food brought across a U.S. border, whether it is intended for consumption or not. In other words, food products put in a Foreign Trade Zone or sent in bond through the United States are also subject to prior notification to FDA. There are, however, the following exceptions: the prior notice rule does not apply to food that travelers bring into the United States in their personal baggage for personal use. Exemptions also apply to foods under the USDA's exclusive jurisdiction and include: the Federal Meat Inspection Act the Poultry Products Inspection Act the Egg Products Inspection Act The full text of this new ruling can be consulted in the Federal Register: February 3, 2003 Volume 68, Number 22. Comments on this new rule can be electronically submitted by April 4, 2003. Send them to: http://www.fda.gov/dockets/ecomment Written comments can be sent to: The Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, ATTN: Stuart Shapiro, Desk Officer for FDA. We will keep you posted on any development of this new rule. Again, it is expected to take effect in December of this year.

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