FDA Publishes Guidance Document for Bioterrorism Act

September 14, 2005 — 

In the September 12 Federal Register, the US Food and Drug Administration (FDA) announced publication of information designed to provide guidance on the recordkeeping requirements associated with the Bioterrorism Act of 2002 and subsequent FDA Final Rule published in December, 2004. This Act requires persons that "manufacture, process, pack, transport, distribute, receive, hold, or import food," register their establishment and maintain records allowing "for the identification of the immediate previous sources and the immediate subsequent recipients of food." "Food" as defined by the Act includes animal feed. This Guidance Document should help clarify the requirements and reinforce the list of exempt entities.

[Ed. Although the Act specifically exempts farms from these requirements, there have been a number of instances involving FDA inspectors attempting to cite farms manufacturing animal feed for non-compliance.]

Sources:
Guidance Document: http://www.cfsan.fda.gov/%7Edms/recguid.html
Bioterrorism Act (FDA Final Rule): http://www.cfsan.fda.gov/~dms/frrecord.html