JMT helped the U.S. FDA satisfy the National Environmental Policy Act (NEPA) as the agency generated its first-ever Environmental Impact Statement (EIS) for a Proposed Rule for the growing, harvesting, packing, and holding of produce.
Over the span of nearly two years, JMT provided National Environmental Policy Act (NEPA) compliance services for the U.S. Food and Drug Administration (FDA) that culminated in the publication of the agency’s first-ever Environmental Impact Statement (EIS). In addition to providing FDA with assistance and support on this high-profile, historic NEPA document, JMT also provided communications support for the project’s associated public involvement requirements.
As part of its obligations under NEPA, FDA determined that an EIS was necessary to assess the environmental impacts of provisions in its proposed rule entitled Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (also known as the Produce Safety Proposed Rule or the Proposed Rule for short). The Proposed Rule was designed to minimize foodborne illnesses from pathogens such as Salmonella and E. coli, and was one of seven rules that FDA proposed to implement a new fully-integrated food safety system, as authorized by Congress under the Food Safety Modernization Act of 2011.
JMT assisted the FDA with assessing the environmental (including human) and related socioeconomic impacts for provisions of the Proposed Rule that may significantly impact the environment. Specifically, the EIS for the Proposed Rule analyzed potential impacts to the following eight resource areas: human health and safety; water resources; biological and ecological resources; waste generation, disposal, and resource use; air quality and greenhouse gases; soils; cultural resources; and socioeconomics and environmental justice.
During the NEPA process leading up to the publication of the final EIS, JMT planned and coordinated public meetings with a nationwide webinar that allowed participants from across the country and U.S. territories to view a presentation and provide public comment on the Proposed Rule, as well as exchange questions with a panel of FDA subject matter experts. In addition, FDA received in excess of 17,000 comments on the Proposed Rule and the scope of the EIS. JMT supported FDA in categorizing and summarizing these comments in order to provide FDA with recommendations regarding the scope of the EIS. The draft EIS was released in January 2015; the final EIS and Record of Decision (ROD), along with the Produce Safety Final Rule, were released in fall 2015.
Throughout the project, JMT directly supported consultation with the Council on Environmental Quality (CEQ) on the scale of the EIS, the U.S. Department of Agriculture as a cooperating agency, the National Association of State Departments of Agriculture, and the U.S. Fish and Wildlife Service on potential impacts to threatened and endangered species.
Cultural Resources: In addition to conducting an impact analysis and public involvement activities for scoping and the draft EIS, JMT aided FDA with efforts to consult with all 566 federally-recognized Native American tribes across the country to solicit their participation in the EIS. It was indicated early on that some tribes had concerns about how the proposed rule would impact agricultural growers on reservations and Native American sovereign surface and groundwater rights. The tribes’ concerns were incorporated and addressed in the EIS.
Information Technology & GIS: JMT Technology Group provided GIS and cartographic assistance in support of the EIS process. Cartographic displays were used to help depict geographic areas affected by the Proposed Rule. This task required pulling data from a variety of federal agencies such as the U.S. Department of Agriculture, U.S. Environmental Protection Agency, U.S. Geological Survey, and others to create effective displays that depicted the implications of the rule. The Technology Group also provided a technology solution for the tailoring and development of Microsoft SharePoint in building an online, client-accessible administrative record that was compliant with the Administrative Procedure Act and met FDA’s requirements for NEPA administrative records.
Graphics: JMT’s Graphics department prepared a branding scheme that was accepted for all interim, draft, and final deliverables on this contract. The Graphics team played an integral role in document formatting and visual presentation throughout the project.
Planning: JMT’s Planning group conducted an initial analysis of potential land use implications through the proposed rulemaking.