FSMA 204, Rule 204, BT Act of 2002, Proposed FDA Traceability Rule, the Final Rule, Subpart S, Subpart J, FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods.

These many names refer to just two FDA traceability rules, officially named:

Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (also called Subpart J or BT Act) and Requirements for Additional Traceability Records for Certain Foods (also called Food Traceability Final Rule or FSMA 204)

Why are there so many different names for these regulations and how do we make sense of them all? It’s helpful to look at a brief history of the rules and the federal rulemaking process itself.

свернуть