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FOOD INDUSTRY BIOTERRORISM ACT GUIDE

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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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