Many of the provisions within the law apply to facilities required to register with FDA under the Bioterrorism Act
of 2002. Under the Bioterrorism Act, facilities – both domestic and foreign – that manufacture, process, pack or
hold (store) food are required to register.
Importantly, the law covers “food,” as defined in the federal Food, Drug and Cosmetic Act, as products intended
for consumption by humans or animals in the United States. It also applies to such products regardless of whether
they are shipped in interstate or intrastate commerce.
Thus, under this broad umbrella, the law applies to, among others, grain elevators, feed and feed ingredient and
pet food manufacturers, grain processors, biofuels producers manufacturing co-products like distillers dried grains
for use as feed ingredients, and exporters of grains, feed and feed ingredients, and processed commodities.
In addition, some of the new regulations mandated by FSMA will affect facilities and entities that are not required
to register with FDA as a food facility. For example, FDA’s rules for foreign supplier verification programs and
sanitary transportation of food/feed will apply to entities regardless of whether they are required to register as a
food facility.