On Monday, August 19, the Food and Drug Administration (FDA) will publish a notice of intent (NOI) to prepare an environmental impact statement (EIS) to evaluate potential the environmental effects of the proposed rule for new produce safety standards. The proposed rule, Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption, was published on March 20, 2013. The proposed rule sets out to establish science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables that are grown for human consumption aimed at minimizing the risk of serious adverse health consequences or death to reduce the incidence of foodborne illness associated with produce. The rule comes as a result of the FDA Food Safety Modernization Act (FSMA) and the standards established by the rule will not apply to produce that is consumed raw, produce that is for personal or on-farm consumption, or produce that is not a raw agricultural commodity. Also, produce that is commercially processed to adequately reduce the presence of microogranisms of public health significance could be exempt under the rule.
While FDA originally published the proposed rule claiming a categorical exclusion from needing to conduct an environmental assessment, later comments it received and further FDA analysis have suggested that the proposed standards could “significantly affect” the environment. The notice begins the process of soliciting public comment and identifying issues to be analyzed in an EIS. For example, the FDA has already identified the use of ground water for irrigation as something that has to be considered that could affect the quality of the human environment due to recent concerns of ground water depletion. In addition, comments from stakeholders also suggested that finalization of the proposed standards could lead to greater use of synthetic fertilizers due to the proposed stringent requirements for the application of biological soil amendments of animal origin. The comment period on the proposed rule is open through November 15, 2013. FDA has encouraged additional stakeholder input on “the issues, alternatives, mitigation measures, or other information FDA should include for further analysis in the EIS for the produce safety rule.” The public comments will be considered by the Agency as they make their determination on whether or not to hold any public scoping meetings before preparing a draft EIS. Growers and stakeholders interested in helping inform or shape FDA’s assessment of the irrigation and pesticide issues identified, to date, as well as any other issues impacting adherence to the proposed safety standards should carefully consider the impacts of finalization of the proposed rule on their current business operations.