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Solicitation of Letters of Interest To Participate in National Environmental Policy Act Pilot Project

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Animal and Plant Health Inspection Service, USDA.




The Animal and Plant Health Inspection Service is soliciting letters of interest from entities subject to the regulations governing the introduction of genetically engineered (GE) organisms in 7 CFR part 340 to participate in a National Environmental Policy Act (NEPA) Pilot Project. The NEPA Pilot Project will test new approaches to developing environmental analyses and documents required under NEPA to determine the extent to which these approaches improve the quality, timeliness, and cost effectiveness of such analyses and documents. The pilot project will focus only on NEPA analyses and documents associated with petitions for nonregulated status for GE organisms.


Letters of interest may be submitted through April 8, 2013 to the person listed under FOR FURTHER INFORMATION CONTACT.

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Mr. David Reinhold, Assistant Director, Environmental Risk Analysis Programs, BRS, APHIS, 4700 River Road Unit 146, Riverdale, MD 20737-1238; (301) 734-0660; e-mail:

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The regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered organisms and products are considered “regulated articles.” The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340, also referred to as a request to grant nonregulated status or to deregulate an article.

Before APHIS determines whether an article can be deregulated, APHIS prepares a plant pest risk assessment (PPRA) to assess the plant pest risk of the article. In accordance with The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), APHIS also prepares an environmental assessment (EA) or an environmental impact statement (EIS) to examine potential environmental impacts that may result from an Agency determination of nonregulated status.

The regulations in § 340.6(c)(1) through (c)(5) require the petitioner to submit specific information to meet regulatory requirements and inform APHIS' evaluation of the petition. While petitioners may submit much of the necessary information, APHIS retains primary responsibility for researching and analyzing all the data necessary to prepare the environmental documents. APHIS also evaluates all comments received on the environmental documents. APHIS has, on occasion, used consultants and contractors to perform some of these functions under APHIS guidance and oversight. In APHIS' experience, the cost of a draft EA generally ranges from $60,000-$80,000, and the cost of a complete EIS can exceed $1,000,000.

To explore ways to enhance APHIS' NEPA compliance, APHIS is implementing a NEPA Pilot Project that will involve working with petitioners and outside experts to develop high-quality environmental analyses and documents in a timelier manner. This pilot project is part of a larger effort to improve the petition evaluation process and is one of the strategies identified in USDA's High Priority Performance Goal for biotechnology regulation in the President's Performance Agenda.[1]

The pilot project will explore two voluntary mechanisms: (1) A petitioner-submitted environmental report based upon which APHIS would develop an EA or an EIS; and (2) an EA or EIS prepared by a contractor, funded by a cooperative services agreement between the petitioner and APHIS.[2] This project is consistent with the Council on Environmental Quality's (CEQ) regulations for implementing NEPA (40 CFR parts 1500-1508), which allow Federal agencies to obtain relevant information from applicants for the purpose of conducting a NEPA analysis and to contract for services by an independent contractor (chosen and directed by the Agency) to prepare environmental analyses and documents that are paid for by the petitioners.

The petitioner-submitted environmental reports should contain information necessary to develop a draft EA or EIS, including, for example, a description of the geographic area that will be affected and potential impacts on the environment, such as effects on water quality and sensitive wildlife species.

Under the contractor-prepared EA or EIS alternative, petitioners will provide funds for the environmental analyses and documents, while APHIS will select and direct the contractor. In addition, with this alternative, analyses and documents may be prepared for the entire NEPA process or only part of the process, i.e., for the draft EA or EIS, for the evaluation of comments, and/or for the final EA or EIS.

APHIS will independently evaluate all information and references in the environmental documents, supplement the information and analysis in the environmental reports as necessary, and make its own evaluation of the environmental issues and the adequacy of the analyses of those issues to ensure that the scope and content of the environmental analyses meet all requirements of CEQ's regulations and APHIS' NEPA implementing regulations (7 CFR part 372).

NEPA compliance is an important Agency responsibility, and the pilot project is designed and intended to Start Printed Page 19310assist APHIS in developing more effective methods for the NEPA process. APHIS intends to create mechanisms for early and frequent interactions between APHIS' Biotechnology Regulatory Services program staff and participants in the pilot project to identify and thoroughly evaluate the potential environmental impacts pertinent to the Agency's NEPA analysis. This pilot will also include mechanisms to identify NEPA-related issues early in the process involving both the petitioners and interested partners. APHIS also intends to use the pilot project to develop guidance for all petitioners that clearly identifies the information needed to initiate and complete the required NEPA analysis.

APHIS will evaluate the overall results of the pilot project, including the effectiveness of using environmental analyses and documents prepared by petitioners (environmental reports) as compared to environmental analyses and documents prepared using an independent contractor (EAs and EISs), and a cost analysis of the two approaches in relationship to the quality and timeliness of the final product.

APHIS is soliciting letters of interest from regulated entities interested in participating in the NEPA Pilot Project; no limit has been set on the number of participants. APHIS anticipates that the pilot project will run for 2 years. However, APHIS is interested in advancing the pilot project in the next few months and therefore encourages interested entities to submit letters of interest as soon as possible. Interested entities may submit letters of interest by mail or e-mail through April 8, 2013 to the person listed under FOR FURTHER INFORMATION CONTACT. APHIS will promptly contact all entities that submit letters of interest to discuss their participation in the NEPA Pilot Project.

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Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

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Done in Washington, DC, this 1st day of April 2011.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

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1.  To learn more about the President's Performance Agenda, visit​.

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2.  APHIS will continue to conduct environmenanalyses and prepare environmental documents for regulated entities that are unable or choose not to participate in the pilot project.

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[FR Doc. 2011-8329 Filed 4-6-11; 8:45 am]