[Federal Register Volume 75, Number 213 (Thursday, November 4, 2010)]
[Notices]
[Pages 67945-67946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27970]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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 delegations of authority, filing of petitions and applications and agency 
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  Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / 
Notices  

[[Page 67945]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2010-0047]


Monsanto Company and KWS SAAT AG; Availability of an 
Environmental Assessment for Supplemental Request for Partial 
Deregulation of Sugar Beets Genetically Engineered To Be Tolerant to 
the Herbicide Glyphosate

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service (APHIS) has prepared a draft environmental 
assessment as part of its decisionmaking process to address a 
supplemental request for partial deregulation of sugar beets 
genetically engineered (GE) for tolerance to the herbicide glyphosate, 
or for similar administrative action to authorize the continued 
cultivation of the GE sugar beets subject to carefully tailored interim 
measures proposed by APHIS. This environmental assessment will be 
available for public comment for 30 days. Comments received by the end 
of the 30-day period will be analyzed and used to inform APHIS' 
decision on whether to grant the supplemental request for ``partial 
deregulation'' of the GE sugar beets or to grant some similar 
administrative action to authorize the continued cultivation of the GE 
sugar beets subject to carefully tailored interim measures proposed by 
APHIS.

DATES: We will consider all comments that we receive on or before 
December 6, 2010.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2010-0047 to submit 
or view comments and to view supporting and related materials available 
electronically.
     Postal Mail/Commercial Delivery: Please send one copy of 
your comment to Docket No. APHIS-2010-0047, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. APHIS-2010-0047.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room is located in room 1141 of 
the USDA South Building, 14th Street and Independence Avenue, SW., 
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., 
Monday through Friday, except holidays. To be sure someone is there to 
help you, please call (202) 690-2817 before coming.
    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 147, Riverdale, MD 
20737-1236; (301) 734-5720. To obtain copies of the environmental 
assessment, contact Ms. Cynthia 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 8, 2010, the Animal and Plant Health Inspection Service 
(APHIS) published a notice \1\ in the Federal Register (75 FR 62365-
62366, Docket No. APHIS-2010-0047) announcing receipt of a supplemental 
petition from the Monsanto Company (Monsanto) and KWS SAAT AG (KWS) 
requesting ``partial deregulation'' or some similar administrative 
action under 7 CFR part 340 for sugar beets (Beta vulgaris ssp. 
vulgaris) designated as event H7-1 to authorize its continued 
cultivation subject to carefully tailored interim measures proposed by 
APHIS. APHIS has prepared a draft environmental assessment (EA) for 
event H7-1 sugar beets, which have been genetically engineered for 
tolerance to the herbicide glyphosate and are considered regulated 
articles under the regulations in 7 CFR part 340.
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    \1\ To review the notice and the supplemental petition, go to 
http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2010-0047.
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    The supplemental petition is related to a petition submitted by 
Monsanto and KWS on November 19, 2003, seeking a determination of 
nonregulated status for event H7-1 sugar beets (Petition 03-323-01). On 
October 19, 2004, APHIS published a notice in the Federal Register (69 
FR 61466-61467, Docket No. 04-075-1) announcing that the Monsanto/KWS 
petition and an EA were available for public review. On March 17, 2005, 
we published a notice in the Federal Register (70 FR 13007-13008, 
Docket No. 04-075-2) advising the public of our determination, 
effective March 4, 2005, that event H7-1 sugar beets were 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 challenging APHIS' 
decision to deregulate event H7-1 sugar beets. The Court's September 
21, 2009, ruling invalidated APHIS' decision to grant nonregulated 
status to event H7-1 sugar beets until APHIS prepares a full 
environmental impact statement (EIS) supporting its decision. 
Accordingly, event H7-1 sugar beets are once again a regulated article 
and subject to APHIS' regulatory oversight under 7 CFR part 340.
    The draft EA analyzes the alternatives available to APHIS for its 
decision regarding this supplemental request for ``partial 
deregulation'' or for similar administrative action to authorize the 
cultivation of event H7-1 sugar beets subject to carefully tailored 
interim measures proposed by APHIS. Based on the scope of the draft EA, 
the specific decisions to be made are:

[[Page 67946]]

     Should APHIS grant the supplemental request for ``partial 
deregulation'' or similar administrative action to authorize the 
continued cultivation of event H7-1 sugar beets subject to the interim 
measures proposed by APHIS in Federal District Court?
     Should APHIS continue to regulate the environmental 
release and movement of event H7-1 sugar beets under 7 CFR part 340?
     What conditions (interim regulatory measures) should be 
imposed to prevent any potential plant pest risk from planted event H7-
1 sugar beets that remain under regulation, to minimize disruptions to 
U.S. sugar beet production, and to minimize the likelihood of impacts 
of concern to the Court until APHIS can complete an EIS before making a 
determination on whether or not to grant nonregulated status to event 
H7-1 sugar beets?
     Would the preferred alternative, if selected (see 
alternative 2 below), have significant impacts on the quality of the 
human environment requiring preparation of an EIS?
    The draft EA has been prepared to analyze the alternatives 
available to APHIS for responding to this supplemental request and to 
provide the public with documentation of APHIS' review and analysis of 
any potential individual and cumulative environmental impacts 
associated with the ``partial deregulation'' or for similar 
administrative action to authorize the cultivation of event H7-1 sugar 
beets subject to carefully tailored interim measures proposed by APHIS.
    The draft EA considers and evaluates three reasonable alternatives. 
The alternatives analyzed in the draft EA include:
     Alternative 1--APHIS Denies Petition Request for Partial 
Deregulation/No Further Actions To Authorize Cultivation of Event H7-1 
Sugar Beets (No Action). This alternative would deny the request for 
``partial deregulation'' or any similar administrative action under 7 
CFR part 340 for the cultivation of event H7-1 sugar beets, thereby 
halting any consideration of authorizing commercial production until 
the completion of the EIS.
     Alternative 2--Event H7-1 Sugar Beet Production (Seed/
Root) Under APHIS 7 CFR Part 340 (Preferred Alternative). APHIS' 
preferred alternative is to authorize the commercial production of 
event H7-1 sugar beets under APHIS permits, in accordance with 7 CFR 
part 340, subject to mandatory conditions to prevent any potential 
plant pest risks from such cultivation. These conditions are intended 
both to minimize any potential for the escape and dissemination of 
plant pests and the likelihood of impacts of concern raised by the 
Court in the lawsuit challenging APHIS' decision to deregulate event 
H7-1 sugar beets.
     Alternative 3--Partial Deregulation of Event H7-1 Sugar 
Beets (Seed/Root). This alternative would grant the petition request 
for partial deregulation to allow the commercial production of event 
H7-1 sugar beets. The supplemental request that APHIS received from 
Monsanto/KWS did not clearly explain what the petitioners mean or 
envision by a ``partial deregulation.'' The petitioner did not identify 
any specific mechanism(s) that would be used to impose the conditions 
to prevent any potential plant pest risks, which parties would be 
subject to the conditions, or how compliance with the conditions would 
be ensured. APHIS has interpreted this petition to mean that Monsanto/
KWS is requesting that event H7-1 sugar beets would no longer be 
regulated under 7 CFR part 340 provided that they are cultivated under 
the conditions and interim measures that APHIS proposed to the Court. 
APHIS further interprets the request to mean that Monsanto/KWS would be 
the responsible party for overseeing implementation and monitoring of 
conditions for cultivation of event H7-1 sugar beets. Under this 
alternative, APHIS would grant the petition for partial deregulation; 
APHIS would no longer regulate event H7-1sugar beets under 7CFR Part 
340; and the cultivation of event H7-1 sugar beets would be allowed 
under conditions imposed by Monsanto/KWS through technology stewardship 
agreements, contracts, or other legal instruments.
    Alternatives considered but rejected in the draft EA include: (1) 
Deregulating root production under conditions imposed by APHIS while 
prohibiting seed production, (2) deregulating root production under 
conditions imposed by APHIS while authorizing continued seed production 
under APHIS permits or notification, (3) deregulating seed production 
under conditions imposed by APHIS while prohibiting root production, 
and (4) deregulating seed production under conditions imposed by APHIS 
while authorizing continued root production under APHIS permits or 
notification.
    The draft EA was prepared in accordance with (1) The National 
Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et 
seq.), (2) regulations of the Council on Environmental Quality for 
implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) 
APHIS' NEPA Implementing Procedures (7 CFR part 372).
    The draft EA may be viewed on the Regulations.gov Web site or in 
our reading room. (Instructions for accessing Regulations.gov and 
information on the location and hours of the reading room are provided 
under the heading ADDRESSES at the beginning of this notice.) In 
addition, copies may be obtained by calling or writing to the 
individual listed under FOR FURTHER INFORMATION CONTACT.

    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 November 2010.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-27970 Filed 11-2-10; 11:15 am]
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