Posted August 20, 2013

Evidenced by recent posts on this blog, the pace of action and news involving regulatory activity under the Food Safety Modernization (FSMA) is picking up speed.  For information on these other developments, be sure to check previous posts to this blog.  Updates are also available on the National Agricultural Law Center Facebook page and via twitter at @nataglaw. 

Another recent FSMA update is that the FDA has announced its intent to prepare an Environmental Impact Statement (EIS) to evaluate the potential environmental effects of the proposed rule “Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption” and the beginning of a “scoping process” designed to determine relevant issues influencing the scope of the environmental analysis. 

According to the FDA’s Center for Food Safety and Applied Nutrition Constituent Update, available here, the FDA will conduct the EIS “because it has received information through comments and its own analysis that an environmental analysis is needed.”  FDA “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.”  The agency does not anticipate a delay of the final rule. 

According to the Notice, available here, the EIS is necessary for the final rule because the “proposed action may significantly affect the quality of the human environment.”  Public comment has indicated that irrigation practices in some regions “use water that is unlikely to meet the proposed microbial standards for much, if not all of the growing season.”

The proposed rule “Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption” is part of the FDA’s implementation of the Food Safety Modernization Act (FSMA).  According to the Federal Register summary of the proposed rule, the purpose of the rule is to minimize the risk of illness from consumption of contaminated produce by establishing “science-based minimum” safety standards for fruits and vegetables grown for human consumption.  The proposed rule is available here. 

The comment period for the proposed rule was recently extended to Nov.  15, 2013.  A recent post on this blog on the extension is available here. 

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