January 15, 2005

 

 FDA biosecurity record-keeping rule becomes effective; meetings planned - January 15, 2005

Posted on January 1, 2005
 

A new Food and Drug Administration regulation requires the establishment and maintenance of records by persons in the United States who manufacture, process, pack, transport, distribute, receive, hold, or import food, including pet food and other animal food. Some veterinary clinics that sell pet food and other animal feed may be affected by the rule. Several public meetings are planned for January and February to facilitate discussion of the regulation.

The final rule, which becomes effective Feb. 7, 2005, implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The requirement is intended to improve the FDA's ability to respond to and contain health threats to humans or animals caused by accidental or deliberate food contamination.

"These records will be crucial for FDA to deal effectively with food-related emergencies, such as deliberate contamination of food by terrorists," said Dr. Lester M. Crawford, acting FDA commissioner. "The ability to trace back will enable us to get to the source of contamination. The records also enable FDA to trace forward to remove adulterated food that poses a significant health threat in the food supply."

The compliance date is Dec. 9, 2005 for large businesses. For small businesses employing fewer than 500 but more than 10 full-time equivalent employees, the compliance date is June 9, 2006. For very small businesses with 10 or fewer full-time equivalent employees, the compliance date is Dec. 11, 2006.

Public meetings are planned for Jan. 13 in Maryland, Jan. 25 in Illinois and Washington state, Jan. 27 in California and Florida, and Feb. 1 in Philadelphia and Boston. A complete schedule of meetings and information on how to register to attend one of these meetings is available at www.cfsan.fda.gov/~dms/fsbtac24.html.

More information on the regulation is available at www.fda.gov/bbs/topics/news/2004/NEW01143.html, or by contacting Nega Beru, by mail at the Center for Food Safety and Applied Nutrition (HFS-305), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740; or by phone at (301) 436-1400.