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Bioterrorism Act Compliance

Bioterrorism Act of 2002
Establishment & Maintenance of Records (69 FR 71561)

Persons who manufacture, process, pack, distribute, receive, hold, or import food in the United States must establish and maintain the following records to identify the immediate previous sources and immediate sub-sequent recipients for all food they receive and release, unless otherwise excluded from the requirements of subpart J of this final rule:

• Name, address, telephone number and, if available, fax number, and e-mail address of the immediate previous source and subsequent recipient;
• Adequate description;
• Date received or released;
• The lot or code number or other identifier;
• Quantity and how the food is packaged; and
• Name, address, telephone number and, if available, fax number, and e-mail address of the transporter who transported the food to and from you.
• Records must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request.
• Failure to establish or maintain records or refusal to permit access to or verification or copying of any record is a prohibited act under section 301 of the FD&C Act.
• The compliance date for the records establishment and maintenance requirements is December 9, 2005, except that the compliance date for small businesses employing fewer that 500, but more than 10 full-time equivalent employees is June 9, 2005, and the compliance date for very small businesses that employ 10 or fewer full-time equivalent employees is December 11, 2006.




B/T 2002 Summary
• Register premises with FDA
• Mandatory One-up, One-Down traceability
• Maintain records for 1 to 2 years
• Produce records in less than 24 hours
• Failure to do so is a felony
• Compliance is determined during an outbreak (e.g. the spinach growers)

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