Bioterrorism Preparedness and Response - Recordkeeping

Thursday, December 09, 2004
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 The FDA has also released Draft Guidance to clarify the circumstances under which the FDA may access and copy records required to be maintained under the Bioterrorism Act.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).

Maritime Safety

Indian Cargo Ship Sinks Off Oman

An Indian cargo ship loaded with vehicles and food supplies destined for Yemen sank on Saturday off the coast of Oman but without loss of life, Oman’s ONA state news agency reported.

Danish Maritime Authority Supports Maritime Cultural Days

The Danish Maritime Authority's buoy tender ’POUL LØWENØRN’ will be alongside in Korsør in connection with the Maritime Cultural Days. The vessel will be open to visitors throughout Saturday,

ABS Makes it Safer to ‘Walk to Work’

ABS announced the publication of The ABS Guide for Certification of Offshore Access Gangways. The new Guide addresses certification for safety systems used for “walk to work” (W2W) crew transfers.

 
 
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