[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19309-19310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8329]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2010-0117]


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

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: 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.

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

FOR FURTHER INFORMATION CONTACT: 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: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Background

    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 Sec.  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 Sec.  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\
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    \1\ To learn more about the President's Performance Agenda, 
visit http://www.performance.gov/.
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    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.
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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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    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

[[Page 19310]]

assist 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.

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

    Done in Washington, DC, this 1st day of April 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-8329 Filed 4-6-11; 8:45 am]
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