Two regs of particular interest to distributors deal with establishing and maintaining records and detention of foods that may pose a risk to the public.
The record-keeping proposal aims to help FDA track foods implicated in future emergencies, such as terrorism-related contamination. Manufacturers, processors, packers, distributors, etc., would be required to keep records identifying the immediate source from which they received the food, as well as the immediate subsequent recipient. This requirement would apply to almost all foreign and domestic food sources and almost all recipients in the U.S.
To minimize the economic burden, FDA's proposals would allow companies to keep the required information in any form they prefer and in any format, including paper or electronic, provided that the records contain all required information. Existing records can be used provided that they include the required information.
Such information, required for each food item, includes: firm's name and responsible individual who was immediate previous source and subsequent recipient; address, phone and fax numbers, e-mail address of that person; type of food, including brand name and specific variety; date received or released; lot number or other identifier; quantity and type of packaging; name, address, phone number, fax number and e-mail address of transporter.
Transporters would be required to keep similar documentation, including information about all means of transportation used.
Restaurants and other food preparers for food served directly to consumers and firms regulated exclusively by the U.S. Department of Agriculture (USDA) would be exempt from the new record-keeping requirements.
FDA's administrative detention authority is self-executing and currently in effect. It includes expedited procedures for instituting certain enforcement actions against perishable foods. The rule also includes procedures describing how FDA will detain a food item and the process for appealing a detention order. The detention order would provide the following information: detention order number; hour and date of the order; identification of the detained item; detention period; a statement that the food identified in the order is detained for the period shown; brief, general statement of the reasons for the detention; address and location where the article of food is to be detained and the appropriate storage and transportation conditions.
A comment period of 60 days is provided. Submit written comments to FDA at: Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Proposals can be accessed electronically at the FDA web page on the Bioterrorism Act.
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