[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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