FDA implements new regulations for maintaining records relating to food.

To shore up food supply security and protect against terrorist threats, the U.S. Food and Drug Administration on December 6 issued final rules for the establishment and maintenance of records relating to food. Under Section 306 of the 2002 Bioterrorism Act, the secretary of the Department of Health and Human Services was charged with issuing regulations requiring persons who manufacture, process, pack, transport, distribute, receive, hold, or import food to establish and maintain records. The records must identify the immediate previous source of all food received, and the immediate subsequent recipient of all food released, FDA said.

Food covered by the regulation includes dietary supplements; infant formula; beverages (including alcoholic beverages and bottled water); fruits and vegetables; fish and seafood; dairy products and shell eggs; bakery foods; and candy, including chewing gum.

Restaurants are excluded from the regulation. A combination restaurant/retail facility is excluded if sales of the food it sells to consumers for immediate consumption account for over 90 percent of its total food sales.

Food companies, importers, and distributors must keep records including the source of food and the firm's telephone and e-mail address if available, date received, quantity and type of packaging, and the name of the transportation company that made the food delivery.

Depending on the shelf life of the food, records on human foods must be retained from six months to two years. Records for animal food must be kept for one year. Transporters of all types of food face a maximum record retention requirement of one year, FDA said in the news release. Companies may keep the required information in either paper or electronic format, FDA said.

The Grocery Manufacturers of America welcomed the final rule. "FDA has addressed GMA's concerns about the workability of recordkeeping as well as industry questions about what specific information must be maintained. Additionally, the agency's changes to its rule for records access will give companies the needed flexibility to respond to FDA requests for access to company records in a timely fashion," GMA said in a press statement.

Also commenting on the rules, Tim Hammonds, president and chief executive officer of the Food Marketing Institute, said that the final rules "recognize the industry's proven food safety systems and emphasize action" to protect the public instead of paperwork. "Food retailers and wholesalers applaud the agency for relying on existing records and technologies--proven systems that have worked time and again in product recalls," Hammonds said in a press statement. "The industry does not need to create new or duplicative records, an unneeded waste of time and resources," he added.