[Federal Register Volume 75, Number 195 (Friday, October 8, 2010)]
[Pages 62365-62366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25387]



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.


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 
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at http://www.aphis.usda.gov.

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.

    \1\ The notice can be viewed at http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2010-0047.

    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]