[Federal Register Volume 75, Number 195 (Friday, October 8, 2010)]
[Notices]
[Pages 62365-62366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25387]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2010-0047]
Monsanto Company and KWS SAAT AG; Supplemental Request for
Partial Deregulation of Roundup Ready Sugar Beet
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: The Animal and Plant Health Inspection Service has received a
supplemental request for ``partial deregulation'' or similar
administrative action from the Monsanto Company and KWS SAAT AG for the
planting, harvesting, and interstate movement of Roundup Ready[supreg]
sugar beets under measures designed to ensure any risks posed by
cultivation are mitigated. This notice is to inform the public of the
availability of the documents submitted to the Agency from Monsanto
Company and KWS SAAT AG 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-2010-0047) or on the APHIS Web
site (see http://www.aphis.usda.gov/brs/aphisdocs2/03_32301p_a1.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 October 19, 2004, APHIS published a notice in the Federal
Register (69 FR 61466-61467, Docket No. 04-075-1) announcing receipt of
a petition from the Monsanto Company (Monsanto) and KWS SAAT AG (KWS)
requesting a determination of nonregulated status under 7 CFR part 340
for sugar beet (Beta vulgaris ssp. vulgaris) designated as event H7-1,
which has 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 March
17, 2005 (70 FR 13007-13008, Docket No. 04-075-2), advising the public
of our determination, effective March 4, 2005, that the Monsanto/KWS
sugar beet event H7-1 was no longer considered a regulated article
under APHIS regulations in 7 CFR part 340.
On September 21, 2009, the U.S. District Court for the Northern
District of California issued a ruling in a lawsuit filed by two
organic seed groups and two nonprofit organizations challenging our
decision to deregulate sugar beet event H7-1 (referred to in the
lawsuit as Roundup Ready[reg] sugar beet, or ``RRSB''), pursuant to the
Plant Protection Act (PPA) 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 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). Accordingly, APHIS is preparing
an EIS, for which we published a notice \1\ in the Federal Register (75
FR 29969-29972, Docket No. APHIS-2010-0047) on May 28, 2010, to solicit
[[Page 62366]]
comments on the proposed scope of the EIS. The EIS process is ongoing.
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\1\ The notice can be viewed at http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2010-0047.
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On August 13, 2010, the Court vacated the deregulation
determination, remanding the issue back to APHIS. RRSB is therefore
once again a regulated article under 7 CFR part 340, and Monsanto and
KWS have submitted a supplemental request for ``partial deregulation''
or similar administrative action for RRSB, along with an accompanying
``Environmental Report,'' to allow the future planting, harvesting, and
interstate movement of RRSB crops (both seed and root) under conditions
designed to ensure any risks posed by the introduction of these sugar
beets into the environment are thoroughly mitigated.
APHIS is evaluating this supplemental request and developing
appropriate environmental analyses to inform its decisionmaking in
reference to any APHIS decision or decisions to authorize future seed
and root crop plantings under a combination of permits, administrative
orders, or other regulatory options and measures. APHIS is considering
regulatory options and measures that would include mitigating measures
consistent with those it had proposed to the Court as interim measures
while APHIS completes the EIS for the petition for determination of
non-regulated status for RRSB. APHIS anticipates making a decision on
the supplemental petition for ``partial deregulation'' and on other
appropriate interim regulatory actions related to RRSB by the end of
the year. There will be an opportunity for public comment on any
environmental analyses developed for such decision or decisions. 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.
Done in Washington, DC, this 4th day of October 2010.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-25387 Filed 10-7-10; 8:45 am]
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