FDA Update August 16, 2013 : Biogenesis Analytical Blog

FDA Update August 16, 2013

by Nancy McDonald on 08/22/14

The U.S. Food and Drug Administration (FDA) is announcing 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,” which is 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 because it has received information through comments and its own analysis that an environmental analysis is needed. The agency is already assessing the 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. Because FDA is paralleling its own assessment of the issues with the EIS process, the Agency doesn’t anticipate that the EIS will delay final rule deliberations but will help by generating additional data and analysis and providing 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.

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