The U.S. Food and Drug Administration (FDA) on August 16 announced its intent to prepare an Environmental Impact Statement (EIS) that will assess 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 officials said the Agency is conducting the EIS because its own analysis and information received information through comments suggested that such an evaluation is needed. FDA is already assessing the issues that may give rise to significant impacts related to the environment, the practicality of the rules, and alternative ways to achieve the food safety goal. Because FDA is paralleling its own assessment of the issues with the EIS process, the Agency does not anticipate that the EIS will delay final rule deliberations but will help by generating additional data and analysis and providing opportunity for stakeholder engagement.

The Agency said it will carry out the EIS through a public process and will actively engage various stakeholders, including other federal and state agencies as well as tribal leaders.

The public may 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, address them to:

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.