[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Notices]
[Pages 68321-68322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27985]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2007-0044]
Forage Genetics International; Supplemental Request for Partial
Deregulation of Roundup Ready Alfalfa
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: The Animal and Plant Inspection Service has received a
supplemental request for ``partial deregulation'' from Forage Genetics
International for the planting, harvesting, and movement interstate of
Roundup Ready[reg] alfalfa under measures designed to ensure any risks
posed by cultivation are mitigated. This notice seeks to inform
interested or affected persons of the availability of the documents
submitted to the Agency from Forage Genetics International requesting a
``partial deregulation.''
ADDRESSES: You may view the request for ``partial deregulation'' on the
Regulations.gov Web site (see http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0044) or on the APHIS Web
site (see http://www.aphis.usda.gov/brs/aphisdocs/04_11001p_pea2.pdf). Copies may also be obtained from the person listed under FOR
FURTHER INFORMATION CONTACT.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Mr. Rick Coker, Biotechnology
Regulatory Services, APHIS, 4700 River Road, Unit 146, Riverdale, MD
20737-1236; (301) 734-5720. To obtain copies of the supplemental
request for ``partial deregulation,'' contact Ms. Cindy Eck at (301)
734-0667, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: 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.''
On November 24, 2004, APHIS published a notice in the Federal
Register (69 FR 68300-68301, Docket No. 04-085-1) announcing receipt of
a petition from the Monsanto Company (Monsanto) and Forage Genetics
International (FGI) requesting a determination of nonregulated status
under 7 CFR part 340 for alfalfa (Medicago sativa L.) designated as
[[Page 68322]]
events J101 and J163, which have been genetically engineered for
tolerance to the herbicide glyphosate. The petition stated that this
article should not be regulated by APHIS because it is unlikely to pose
a plant pest risk. APHIS also announced in that notice the availability
of a draft environmental assessment (EA) examining the potential
environmental impacts of the proposed action in accordance with
National Environmental Policy Act requirements for the proposed
determination of nonregulated status. Following review of public
comments and completion of the EA, we published another notice in the
Federal Register on June 27, 2005 (70 FR 36917-36919, Docket No. 04-
085-3), advising the public of our determination, effective June 14,
2005, that the Monsanto/FGI alfalfa events J101 and J163 were no longer
considered regulated articles under APHIS regulations in 7 CFR part
340.
On February 13, 2007, the U.S. District Court for the Northern
District of California issued a ruling in a lawsuit filed by the Center
for Food Safety--along with several other nonprofit organizations and
alfalfa growers--challenging our decision to deregulate alfalfa events
J101 and J163 (referred to in the lawsuit as Roundup Ready[reg]
alfalfa, or ``RRA''), pursuant to the Plant Protection Act (PPA), as
amended, and in compliance with the Administrative Procedure Act and
the National Environmental Policy Act (NEPA) of 1969, as amended (42
U.S.C. 4321 et seq.). Under the provisions of NEPA, agencies must
examine the potential environmental impacts of proposed major Federal
actions, and the District Court ruled that APHIS' EA failed to consider
certain environmental and interrelated economic impacts. As a result,
the Court ruled that APHIS is required to prepare an environmental
impact statement (EIS).
On March 12, 2007, the Court vacated the deregulation
determination, returning RRA to regulated status under 7 CFR part 340,
and issued an injunction which enjoined the Agency from taking any
further action related to RRA until an EIS was completed by APHIS.
Accordingly, APHIS published a notice \1\ of intent to prepare an EIS
in the Federal Register on January 7, 2008 (73 FR 1198-1200, Docket No.
APHIS-2007-0044) soliciting comments on the scope and nature of issues
the Agency should consider in preparing the EIS. After reviewing the
comments, we published (see footnote 1) a notice of availability of a
draft EIS in the Federal Register on January 12, 2010 (75 FR 1585-1586,
Docket No. APHIS-2007-0044) soliciting comments on the draft EIS.
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\1\ The notice, as well as comments received and supporting and
related materials, can be viewed at http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0044.
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Subsequently, on June 21, 2010, the U.S. Supreme Court reversed the
decision of the lower court which had mandated an injunction of any
further planting of RRA or any other regulatory action by APHIS related
to RRA until completion of an EIS. The U.S. Supreme Court remanded the
case back to the 9th Circuit Court of Appeals which further remanded
the case back to the U.S. District Court for the Northern District of
California.
Following the U.S. Supreme Court decision, FGI submitted a
supplemental request for ``partial deregulation'' or similar
administrative action for RRA, along with an accompanying
``Environmental Report,'' to allow the future planting, harvesting, and
interstate movement of RRA crops under conditions designed to ensure
any risks posed by the introduction of RRA into the environment are
thoroughly mitigated.
APHIS is evaluating this supplemental request and will be making a
decision on it in the future. Meanwhile, the Agency is working to
complete and publish the final EIS and record of decision for RRA.
APHIS is notifying the public that its receipt of this supplemental
request for ``partial deregulation'' and this notice to the public
regarding it in no way indicates that the Agency agrees with the
petitioners' description, application, or implementation of a ``partial
deregulation.'' Such matters and related issues are solely determined
by APHIS pursuant to its PPA statutory authority and its biotechnology
regulations in 7 CFR part 340.
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, November 1, 2010.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-27985 Filed 11-4-10; 8:45 am]
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