FDA Releases Final Environmental Impact Statement on Produce Rule

Constituent Update

November 13, 2015

The U.S. Food and Drug Administration (FDA) has released the Final Environmental Impact Statement (EIS) for the produce safety rule—entitled Standards for Growing, Harvesting, Packing, and Holding Produce for Human Consumption. The rule, which establishes science-based standards, is now final.

The EIS places the produce safety rule in the context of its likely impact on the environment, including human health and socioeconomic effects.

The EIS evaluates the impact of the rule as originally proposed in January 2013 and as amended in a September 2014 supplemental proposal, in addition to alternative provisions. It focuses on four areas in the rule that could significantly affect the environment: the scope of the rule, water quality standards, the use of raw manure and compost, and provisions affecting domesticated and wild animals, and considers the combined impacts of all the provisions that comprise the rule.

A significant beneficial impact on public health is expected due to the anticipated decrease in the number of illnesses tied to produce contamination. Only the water quality standards were found to potentially have a significant adverse environmental impact. As in the Draft EIS, the Final EIS notes that any produce regulation that causes a farmer to use ground water instead of surface water could exacerbate existing groundwater shortages, although added flexibility in the water provisions make such a management decision unlikely.

The FDA considered public comments submitted in response to the Draft EIS, published in January 2015, in drafting the final version. The agency then considered the findings of the Final EIS in finalizing the produce rule.

The agency is also required to prepare a public document, called the Record of Decision (ROD), to state FDA’s decision with respect to the provisions of the final rule. In the ROD, the agency explains how the provisions in the final rule best meet FDA’s public health goals while minimizing environmental impacts as much as possible.

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Page Last Updated: 11/13/2015
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