FDA issues final two proposed food safety regulations

WASHINGTON, D.C. (May 13, 2003) — The Food and Drug Administration has announced publication of the final two food safety proposed regulations required by the Bioterrorism Preparedness and Response Act of 2002.

The proposals are the last two of four proposed regulations that the Act calls upon FDA to develop regarding domestic and in-bound food. The first two, published in January, require companies that make, process, pack, or warehouse food for export to notify the FDA by noon the day before their goods arrive at the U.S. border. Carriers that do not “hold” food are not part of the pre-notification requirement. However, they must still register with the FDA before Dec. 12, and will be responsible for preparing loads and operating within the new time frames.

Under the new proposals, manufacturers, processors, packers, distributors, receivers, holders and importers of food would be required to keep records identifying the immediate source from which they received the food, as well as the subsequent recipient. Records may be kept in any format, paper or electronic, provided they contain all the required information, including: The source and recipient’s name, address, telephone and fax numbers, and e-mail address; description of type of food, including brand name and specific variety; the date received or released; the lot number or other identifier number; the quantity and type of packaging; and the name, address, telephone number of the carrier.

Carriers would also be required to keep similar documentation, including information about all the means of transportation used. Records would have to be kept between one and two years, depending on the type of food.

If the FDA deems a food shipment to be suspect, it will detain it. A copy of the detention order would be given to the owner, operator, and/or agent in charge of the place where the food is located. For perishable food, the proposed rule would require an appeal to be filed within two calendar days of the detention order, while non-perishable food requires an appeal within four days. FDA is required to issue a decision within five calendar days after an appeal is filed.

A comment period of 60 days will be provided on these proposals. The FDA is required to publish a final rule regarding all the proposals no later than December 12, 2003.

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