[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
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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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