FOOD INDUSTRY BIOTERRORISM ACT GUIDE
Authored by Olsson, Frank & Weeda, P.C.
The Food Industry Bioterrorism Act Guide is designed to serve
as a convenient reference source and guide to the Bioterrorism Act and federal
regulations and policies implementing the Bioterrorism Act. The Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism
Act) is the greatest expansion in the Food and Drug Administration’s (FDA) food
enforcement authorities since passage of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) in 1938.
The Food Industry Bioterrorism Act Guide provides a comprehensive
examination of the Bioterrorism Act, FDA’s implementing regulations, guidances,
and similar documents. It is designed to assist U.S. and foreign food industry
users in understanding not only the strict legal requirements, but also FDA’s
findings, conclusions, and views as set forth in rulemaking preambles and other
documents.
Because the Food and Drug Administration regulations and guidance
documents implementing the Bioterrorism Act are being issued over an extended
period of time, the Guide will be published in two phases. The first phase of
publication (over 220 pages) covers the Bioterrorism Act and all implementing
regulations and guidances through February 1, 2004. The second phase of publication
will cover future implementing regulations and guidances. Readers are reminded
that regulatory requirements and policies change over time. The regulations
and guidance documents implementing the Bioterrorism Act may undergo further
changes after publication of the Guide is complete. (257 pages, Published 2004)


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