The Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (PL 107-188)
(commonly known as the Bioterrorism Act), among other things,
contains a section (Title III) that requires the U.S. Food and
Drug Administration to develop four sets of regulations for food
facilities. The act adopts the definition of food used in the
Federal Food, Drug and Cosmetic Act, namely as food for humans
or animals. In this way, the law encompasses grain handling, grain
processing, feed, feed ingredient and pet food establishments,
among others. The law expressly exempts farms, retail food stores,
restaurants and fishing vessels from the provisions governing
facility animal feeding operations.
The law specifically requires that
FDA issue regulations requiring such establishment to:
- Register facilities with FDA.
- Provide prior notice of food, feed, feed ingredients
and other agricultural commodities intended for import and use
in the United States.
- Maintain records to be made available to FDA if the agency
has a “reasonable belief” that the agricultural
products are adulterated and pose a “threat of serious
adverse health consequences or death” to humans or animals.
The law also provides FDA with
“administrative detention” authority. This enables
the agency to detain a product if it has a “reasonable belief”
that the agricultural product is adulterated and poses a “threat
of serious adverse health consequences or death” to humans
or animals.
Click
here to access the Bioterrorism Act. This PDF file is extremely
large (200-plus pages) and will take some time to load.
