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Are registration requirements under the Food Safety Modernization Act (FSM) the same as that under The Bioterrorism Act, or is FDA going to have a second registration process?
Under FSMA the registration is the same as under the Bioterrorism Act however it has changed in the sense that it must be renewed. When the BT Act was passed, registration was originally a one-time requirement. FSMA amends that provision and requires facilities to re-register every 2 years. The statute specifies that the re-registration period is between October 1 - December 31 every other year. We expect that the re-registration obligations will begin in 2012, but FDA hasn’t announced specifics yet. If a company registered under the BT Act, they will need to re-register every 2 years going forward. FSMA’s language modifies FFDCA section 415(a) (the Bioterrorism Act registration provision.