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Compliance with FDA Bioterrorism Act

RF Pathways WMS provides product traceability to assist industry with the critical FDA Bioterrorism Act of 2002.


The Bioterrorism Act of 2002

SUMMARY: The Food and Drug Administration (FDA) is issuing a final
regulation that requires the establishment and maintenance of records
by persons who manufacture, process, pack, transport, distribute,
receive, hold, or import food in the United States. Such records are to
allow for the identification of the immediate previous sources and
immediate subsequent recipients of food. The final rule implements the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (the Bioterrorism Act), and is necessary to help address
credible threats of serious adverse health consequences or death to
humans or animals. The requirement to establish and maintain records is
one of several tools that will help improve FDA's ability to respond
to, and further contain, threats of serious adverse health consequences
or death to humans or animals from accidental or deliberate
contamination of food. In the event of an outbreak of foodborne
illness, such information will help FDA and other authorities determine
the source and cause of the event. In addition, the information will
improve FDA's ability to quickly notify the consumers and/or facilities
that might be affected by the outbreak.

DATES: Effective Date: This final rule is effective February 7, 2005.
Compliance Dates: The compliance date is December 9, 2005; except
that for small businesses employing fewer than 500, but more than 10
full-time equivalent employees, the compliance date is June 9, 2005;
and except that for very small businesses that employ 10 or fewer full-
time equivalent employees, the compliance date is December 11, 2006.

FOR FURTHER INFORMATION CONTACT: Nega Beru, Center for Food Safety and
Applied Nutrition (HFS-305), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, 301-436-1400.

http://www.fda.gov/oc/bioterrorism/bioact.html

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