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[Federal Register Volume 76, Number 26 (Tuesday, February 8, 2011)]
[Notices]
[Pages 6759-6761]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2878]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2010-0047]

Monsanto Company and KWS SAAT AG; Decision With Respect to the 
Petition for Partial Deregulation of Genetically Engineered Roundup 
Ready Sugar Beets

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our decision to ``partially 
deregulate'' Roundup Ready[supreg] sugar beets developed by the 
Monsanto Company (Monsanto) and KWS SAAT AG (KWS), designated as event 
H7-1, in response to a supplemental Monsanto/KWS petition requesting 
partial deregulation of event H7-1. APHIS has determined that it will, 
for an interim period of time, grant the petition in part. APHIS will 
grant a partial deregulation for event H7-1 sugar beet root crop 
production activities when conducted under certain mandatory 
conditions. APHIS has decided not to grant partial deregulation for 
event H7-1 sugar beet seed crop production. Rather, APHIS has decided 
that event H7-1 sugar beet seed production shall remain regulated under 
APHIS' regulations governing the introduction of certain genetically 
engineered organisms. Our decision granting the petition in part on an 
interim basis is based on our evaluation of data submitted by Monsanto 
and KWS in its supplemental petition for a determination of ``partial 
deregulation,'' our analysis of other scientific data, and comments 
received from the public in response to our previous notice announcing 
the availability of the environmental assessment (EA) associated with 
the supplemental petition for partial deregulation. This notice also 
announces the availability of our written decision, final EA, and 
finding of no significant impact.

DATES: Effective Date: February 8, 2011.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received 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.
    Documents referenced in this notice are also available on the 
Internet at http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2010-0047.
    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. David Reinhold, Assistant 
Director, Environmental Risk Analysis Programs, BRS, APHIS, 4700 River 
Road Unit 146, Riverdale, MD 20737-1238; (301) 734-0660.

[[Page 6760]]

    To enter into a compliance agreement to introduce event H7-1 sugar 
beet root crop, contact APHIS' Regulatory Operations Programs at (301) 
734-5301. To obtain copies of the documents referenced in this notice, 
contact Ms. Cindy Eck at (301) 734-0667, e-mail: 
cynthia.a.eck@aphis.usda.gov.

SUPPLEMENTARY INFORMATION: 

Background

    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 4, 2010, the Animal and Plant Health Inspection Service 
(APHIS) published a notice \1\ in the Federal Register (75 FR 67945-
67946, Docket No. APHIS-2010-0047) announcing the availability of an 
environmental assessment for a supplemental petition from the Monsanto 
Company (Monsanto) and KWS SAAT AG (KWS) requesting ``partial 
deregulation'' or similar administrative action under 7 CFR part 340 
(referred to below as the regulations) for sugar beets (Beta vulgaris 
ssp. vulgaris) designated as event H7-1. These sugar beets have been 
genetically engineered for tolerance to the herbicide glyphosate and 
are considered regulated articles under the regulations in 7 CFR part 
340. The supplemental petition seeks action by APHIS that would 
authorize the continued cultivation of H7-1 sugar beets, subject to 
carefully tailored interim measures.
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    \1\ To review the notice and the supporting and related 
material, go to http://www.regulations.gov;fdmspublic/component/
main?main=Docket Detail&d=APHIS-2010-0047.
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    APHIS received 3,722 comments during the comment period. There were 
3,058 comments from groups or individuals who supported the ``partial 
deregulation'' and 633 from those who opposed the ``partial 
deregulation.'' APHIS has addressed the issues raised during the 
comment period and has provided responses to these comments as an 
attachment to the finding of no significant impact.
    The supplemental petition is related to a petition submitted by 
Monsanto and KWS to APHIS 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 environmental assessment (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 fully deregulated and no longer considered a regulated 
article under the regulations. 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, finding that APHIS should have completed an environmental impact 
statement (EIS) prior to granting full deregulation of H7-1 sugar 
beets. Later, on August 13, 2010, the Court vacated APHIS' decision to 
deregulate event H7-1 sugar beets until APHIS prepares a full EIS prior 
to a further decision on the petition for full deregulation and 
remanded the matter to APHIS. Accordingly, event H7-1 sugar beets once 
again became a regulated article subject to APHIS' regulatory oversight 
under 7 CFR part 340 and the Plant Protection Act.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with 
Monsanto/KWS' petition for ``partial deregulation'' for event H7-1 
sugar beets, an 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 considered and evaluated a range of alternatives. 
APHIS' preferred alternative is an interim partial deregulation--a 
combination of alternatives 2 and 3. The preferred alternative 
incorporates specific aspects of both alternatives 2 and 3. Under this 
preferred alternative, pursuant to Sec.  340.6 of the regulations, 
APHIS will partially deregulate the event H7-1 sugar beet root crop. 
APHIS has determined that they will not be subject to requirements of 7 
CFR part 340 if they are grown under the mandatory conditions 
established by APHIS. Event H7-1 sugar beet root crop production 
activities conducted under these mandatory conditions will not be 
considered regulated under 7 CFR part 340. Event H7-1 sugar beet seed 
crop will remain regulated subject to requirements of 7 CFR part 340, 
requiring a permit or notification for movement and environmental 
release.
    Under the partial, conditional deregulation, APHIS will require 
compliance with mandatory conditions for the root crop that will 
restrict its movement and environmental release via APHIS compliance 
agreements authorized under the Plant Protection Act. Any person who 
wants to enter into a compliance agreement must first contact APHIS' 
Regulatory Operations Programs by calling the phone number listed under 
FOR FURTHER INFORMATION CONTACT to enter into a compliance agreement in 
advance of the introduction.
    This preferred alternative, including a conditional, partial 
deregulation, is an interim action that is limited in scope and 
duration and will neither result in significant impacts to the human 
environment nor prejudice any decision to be analyzed in the 
forthcoming EIS for a determination regarding full deregulation of 
event H7-1 sugar beets. APHIS has determined that the mandatory 
conditions imposed pursuant to the partial deregulation of event H7-1 
sugar beet root crop, as well as permitting of the seed crop under 7 
CFR part 340, ensures that the implementation of this interim 
regulatory action will not result in any environmental impacts which 
may significantly affect the quality of the human environment. The 
mandatory conditions will also effectively ensure that no potentially 
harmful economic or marketing impacts will occur in the interim while 
APHIS completes its EIS prior to making a determination on whether or 
not to grant full nonregulated status to event H7-1 sugar beets.

Determination

    Based on APHIS' analysis of data submitted by Monsanto and KWS, 
references provided in the petition, information analyzed in the plant 
pest risk assessment and the EA, comments provided by the public, and 
information provided in APHIS' response to those public comments, APHIS 
has determined that event H7-1 sugar beet root crop grown under 
mandatory conditions is unlikely to pose a plant

[[Page 6761]]

pest risk and should not be subject to the requirements of 7 CFR part 
340. APHIS has reached this determination based on its plant pest risk 
assessment. APHIS has determined that event H7-1 sugar beet root crop 
production does not pose a plant pest risk and should not be subject to 
the requirements of our regulations in 7 CFR part 340 if grown under 
the mandatory conditions established by APHIS. Further, APHIS has 
concluded that granting partial deregulation of the H7-1 sugar beet 
root crop under certain conditions and allowing the seed crop to be 
planted under the requirements of 7 CFR part 340 will have no 
significant environmental effect on the human environment.
    This granting of a partial deregulation for root crop production is 
an interim partial deregulation for the root crop with required 
conditions until an EIS is completed regarding the Monsanto/KWS 
petition for a full deregulation of event H7-1. APHIS expects to 
complete the EIS by May 2012, but unforeseen conditions may affect the 
specific completion date of the EIS. This interim partial deregulation 
of event H7-1 root crop and root production activities, along with the 
interim permitting of event H7-1 seed crop under 7 CFR part 340, will 
remain in effect through December 31, 2012, to allow the harvesting and 
processing of the 2012 commercial root crop and seed crop unless APHIS 
issues a final EIS, record of decision, and a determination decision 
for a full deregulation of event H7-1 sugar beets before those harvests 
are completed in 2012.
    Copies of the signed determination document, as well as copies of 
the petition, pest risk assessment, EA, finding of no significant 
impact, and response to comments are available as indicated in the 
ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.

    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 4th day of February 2011.
Cindy J. Smith,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-2878 Filed 2-7-11; 8:45 am]
BILLING CODE 3410-34-P
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