August 16, 2013

FDA to Prepare Environmental Impact Statement on Proposed Produce Rule

Today, the U.S. Food and Drug Administration (FDA) has announced its intent to prepare an Environmental Impact Statement (EIS) that will evaluate the potential environmental effects of the proposed rule, “Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption.”

FDA is also announcing the beginning of a “scoping process,” designed to determine relevant issues that will influence the scope of the environmental analysis.

Comments are due by November 15, 2013, to coincide with the closing of the recently extended comment period for the proposed produce safety rule.

FDA is conducting the EIS in response to comments and its own analysis that an environmental analysis is needed. The agency is already assessing issues that may give rise to significant impacts from the standpoint of the environment and the practicality of the rules and alternative ways to achieve the food safety goal.

FDA is paralleling its own assessment of the issues with the EIS process, thus the Agency doesn’t anticipate that the EIS will delay final rule deliberations, but rather will generate additional data and analysis and provide the opportunity for stakeholder engagement.

FDA will carry out the EIS through a public process and actively engage various stakeholders, including other Federal agencies, State agencies and Tribal leaders.

Submit comments electronically starting August 19, 2013 on http://www.regulations.gov, using the docket number FDA-2011-N-0921.

To submit comments by mail, send to FDA at:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All submissions must include the agency name and docket number, FDA-2011-N-0921.