2002 Bioterrirism Act imposes mandates on business, and a compliance industry emerges

The Bioterrorism Act of 2002 affects small, medium, and large companies alike. The required dates of compliance may vary by company size, but the requirements themselves stay the same. Moreover, compliance is not an option. It is a mandate. Formulated by the Food and Drug Administration (FDA) in 2002, the Bioterrorism Act of 2002 requires FDA-regulated companies to adhere to a specific set of requirements for the establishment and maintenance of records. The scope of the regulation includes requirements for the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food. The regulation dictates that companies be able to produce records within four hours pertaining to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of food products.

We have noted that the need to comply with Sarbanes-Oxley has created a cottage industry of compliance solutions, and now we see a similar trend on the bioterror act compliance area. One example is an ERP from Toledo, Ohio-based TGI.

-read more about TGI compliance solutions at company Web site