About BRS' NEPA Pilot Project
The USDA, Animal and Plant Health Inspection Service (APHIS), Biotechnology Regulatory Services (BRS) announced a NEPA pilot program on April 7, 2011. This 2-year, voluntary pilot project will evaluate the quality, time, and cost of NEPA analyses developed using two different tools. The two tools are petitioner-submitted environmental reports (ERs), and cooperative service agreements (CSAs) between APHIS and the petitioner to fund APHIS-selected contractors to prepare environmental assessments (EAs) or environmental impact statements (EISs).
ERs are petitioner-prepared technical documents that aid the agency in preparing NEPA analyses. ERs provide information about a specific genetically engineered (GE) organism and can accompany a petition for nonregulated status (submitted under the regulations at 7 CFR 340.6), but are not a required component of the submission. An ER presents data beyond that required for a plant pest risk determination. It provides the background information necessary to analyze impacts on different resource areas from the action proposed in the petition. ERs are not NEPA documents. The agency will use the information in the ER to prepare a NEPA analysis in-house or by a qualified contractor. As required by the CEQ regulations, the agency is responsible for ensuring that the analyses in the NEPA documents (EAs and EISs) are balanced, address relevant issues, and take a hard look at the potential environmental impacts. As is the agency’s current practice, all draft EAs will be available for public comment before the document is finalized and a decision document is prepared. EISs will follow the CEQ-defined public involvement requirements.
Petitioner-funded NEPA documents will be prepared through a CSA between the petitioner and APHIS. The CSA will outline the timeline for completion of the project, set a schedule for milestone reports, and stipulate how cost accounts will be reported to the petitioner. In accordance with the CSA, APHIS will use the money provided by the petitioner to pay for services to prepare an EA or EIS. APHIS will select and enter directly into a contract with the qualified environmental service provider. The petitioner will not be a party to this contract. All services will be reviewed and approved by APHIS only.
As part of this pilot project, APHIS will provide guidance to petitioners who wish to prepare ERs and use feedback from participants and observed issues to refine that guidance throughout the pilot program. APHIS will independently evaluate each ER and document the ways in which the report contributed to the final NEPA analysis. The agency will also track the time required to review and evaluate a report.
In the past, APHIS has prepared the majority of its environmental analyses in-house. However, more recently, APHIS has contracted for the preparation of some EAs and EISs. This pilot program seeks to gather data to assess the impact of these practices on the overall quality, and the time for NEPA analyses to be conducted prior to making decisions on petitions for nonregulated status, as well as the cost to the agency. The pilot project will document agency resources needed to manage and review contractor-prepared analyses. The agency will compare resources used for contracted analyses to those prepared in-house. As part of the pilot project, APHIS will provide participants with information on contract mechanisms for funding the preparation of a NEPA documents by contractors through use of CSAs.
In addition to providing general guidance to participants, APHIS will meet with participants to discuss their specific petition for nonregulated status and provide guidance on the specific types of data or analyses needed for that product.
- Provide a transparent web-based mechanism for the public and interested parties to easily access information regarding the NEPA Pilot, including relevant environmental documents and guidance for NEPA Pilot processes and procedures.
- Provide the public with quarterly updates on the number of pilot project petitions and a catalog of the stages of these petitions.
- Workshop on ERs and CSAs.
- Provide guidance to participants on ERs and CSAs.
- Updated guidance based on feedback from participants and identified issues.
- Final report evaluating the effectiveness of the tools used in this pilot to reduce cost and time of preparation of NEPA analyses related to petitions for nonregulated status and the impacts of these tools on the quality of the analyses.
July 7, 2011