August 16, 2013
Authored by: Brandon Neuschafer
FDA announced today that it will conduct an environmental impact statement (EIS) on the draft Produce Safety Rule proposed in January 2013. An EIS is required under the National Environmental Policy Act for certain government agency actions that may significantly affect the quality of the human environment. The EIS is a tool used by the agency to tailor the specific action, such as rulemaking, to address environmental concerns. FDA indicated that it is conducting the EIS “because it has received information through comments and its own analysis that an environmental analysis is needed.” FDA is also commencing a scoping process to determine the scope of the environmental review. Comments on the scope of review FDA should undertake are due November 15, 2013, the same day that comments on the substantive provisions of the draft Produce Safety Rule are due. FDA has indicated that the EIS process is not anticipated to result in further delay of finalization of the Produce Safety Rule.