Bioterrorism Preparedness and Response - Recordkeeping

The U.S. Food and Drug Administration (FDA) promulgated a final regulation requiring establishment and maintenance of records by persons who manufacture, process, transport, distribute, hold, or import food in the United States. The rule comes into effect on February 5, 2005, except for small businesses where the effective date is June 9, 2005, except for very small businesses where the effective date is December 11, 2006. This is a lengthy (95 page) and complex rulemaking, but it appears that maritime carriers transporting food into the United States as cargo either may directly comply with its recordkeeping provisions or may enter into an agreement with the nontransporter immediate subsequent recipient located in the United States to establish and maintain the required records. Under either option, life is about to get more complex for carriers and port facilities that handle food products. 69 Fed. Reg. 71561 (December 9, 2004). The FDA issued a Notice stating that it will conduct a series of public meetings to discuss these new regulations. Meetings will be held in College Park, MD (January 13); Chicago (January 25); Seattle (January 25); San Francisco (January 27); Orlando (January 27); Philadelphia (February 1); and Boston (February 1). 69 Fed. Reg. 71655 (December 9, 2004). The FDA has also released Draft Guidance to clarify the circumstances under which the FDA may access and copy records required to be maintained under the Bioterrorism Act. (HK Law).