Earlier this month, the US Food and Drug Administration (FDA) released a draft Environmental Impact Statement (EIS) for its proposed rule on produce safety. The proposed produce safety rule was promulgated under the Food Safety Modernization Act (FSMA) and provides standards for growing, harvesting, packing, and holding of produce for human consumption. The FDA estimates that this rule, if implemented as proposed, would prevent 1.57 million foodborne illnesses each year.

The draft EIS assesses the environmental (including human) and related socioeconomic impact of “potentially significant provisions,” or those provisions of the proposed rule that FDA has determined may significantly affect the quality of the human environment. According to the agency, it also assesses the No Action Alternative, “which is made up of baseline agricultural practices, regulations, and industry programs, as well as background environmental conditions.”

The EIS for the product safety rule considered four potentially significant provisions: the definition of which farms are covered by the rule (covered farms), water quality standards, the use of raw manure and compost, and provisions affecting domesticated and wild animals. Of these, only the water standards provision was found to potentially have a significant adverse environmental impact. The proposed produce safety rule would require that agricultural water not exceed a defined statistical threshold value of generic E. coli. In order to meet this standard, some covered farms would potentially have had to switch their water source from surface water to groundwater, or to treat their surface water with chemicals.

The agency released a Constituent Update that stated “there are critical groundwater shortages in certain parts of the country that would exist even if this proposed rule were not enacted, [and] actions that may lead to increases in groundwater drawdown in parts of the country experiencing severe shortages would be considered a significant environmental impact.”

However, the agency’s EIS ultimately concluded that most covered farms would not need to switch from surface water to groundwater or to chemically treat their water. This is because certain proposed supplemental changes to the rule would allow time for potentially dangerous microbes in agricultural water to die off prior to measuring the E. coli content of the water. This change was identified in the EIS as the most environmentally preferred option, as this proposed change would mean that most covered farms would not need to change their water source or treat their water with chemicals.

The commenting period for the Draft EIS ends March 13, 2015. FDA will also hold a public meeting on the EIS on Tuesday, Feb. 10 in College Park, MD.

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