This proposed rule proposes to amend FDA’s regulation for registration of food facilities that requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA. The proposed rule would codify the already effective, self-implementing requirements in section 102 of the FDA Food Safety Modernization Act ("FSMA"), which amends section 415 of the Federal Food, Drug & Cosmetic Act ("FD&C Act") regarding requirements for food facility registration. In addition, the proposed rule would implement other requirements of section 102 of FSMA, including mandatory electronic registration submissions beginning in 2016 and amendments to the retail food establishment definition. Further, the proposed rule would implement other changes to improve the utility of the food facility registration database.
Regulatory Impact Analysis
Federal Register: 80 FR 19159, April 9, 2015