[Federal Register Volume 77, Number 140 (Friday, July 20, 2012)]
[Notices]
[Pages 42693-42694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17819]



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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2010-0047]


Monsanto Company and KWS SAAT AG; Determination of Nonregulated 
Status of Sugar Beet Genetically Engineered for Tolerance to the 
Herbicide Glyphosate

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that sugar 
beet genetically engineered for tolerance to the herbicide glyphosate, 
designated as H7-1, is no longer considered a regulated article under 
our regulations governing the introduction of certain genetically 
engineered organisms. Our determination is based on our evaluation of 
data submitted by the Monsanto Company and KWS SAAT AG in its petition 
for a determination of nonregulated status, our analysis of publically 
available scientific data, and comments received from the public on the 
petition for nonregulated status and its associated environmental 
impact statement and plant pest risk assessment. This notice also 
announces the availability of our written determination and record of 
decision.

DATES: Effective Date: July 20, 2012.

ADDRESSES: You may read the documents referenced in this notice and any 
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) 799-7039 before coming. Those 
documents are also available on the Internet at http://www.aphis.usda.gov/biotechnology/not_reg.html and are posted with the 
comments we received on the Regulations.gov Web site at http://www.regulations.gov/#!docketDetail;D=APHIS-2010-0047.

FOR FURTHER INFORMATION CONTACT: Dr. Rebecca L. Stankiewicz Gabel, 
Senior Environmental Protection Specialist, Environmental Risk Analysis 
Programs, BRS, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-
1238; (301) 851-3927. To obtain copies of the documents referenced in 
this notice, contact Ms. Cindy Eck at (301) 851-3892, email: 
[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 (GE) organisms and 
products are considered ``regulated articles.''
    The regulations in Sec.  340.6(a) provide that any person may 
submit a petition to APHIS seeking a determination that an article 
should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of 
Sec.  340.6 describe the form that a petition for a determination of 
nonregulated status must take and the information that must be included 
in the petition.
    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 
of 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 does not present a plant pest risk. APHIS 
also announced in that notice the availability of a draft environmental 
assessment (EA) 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 challenging APHIS' 
determination of nonregulated status of sugar beet event H7-1, finding 
that APHIS should have completed an environmental impact statement 
(EIS) prior to making a determination of nonregulated status of sugar 
beet event H7-1. On May 28, 2010 (75 FR 29969-29972, Docket No. APHIS-
2010-0047), we subsequently published a notice of intent to prepare an 
EIS and proposed scope of study.

National Environmental Policy Act and Record of Decision

    To provide the public with documentation of APHIS' review and 
analysis of the potential environmental impacts of sugar beet event H7-
1 and interrelated socioeconomic impacts associated with a 
determination of nonregulated status of sugar beet event H7-1, an EIS 
has been 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).
    A notice of availability regarding the draft EIS was published by 
the Environmental Protection Agency (EPA) in the Federal Register on 
October 14, 2011 (76 FR 63922, Docket No. ER-FRL-8999-5), and a notice 
of availability regarding the final EIS was published by EPA in the 
Federal Register on June 8, 2012 (77 FR 34041-34042, Docket No. ER-FRL-
9003-4). The NEPA implementing regulations in 40 CFR 1506.10 require a 
minimum 30-day waiting period between the time the notice of 
availability of a final EIS is published and the time an agency makes a 
decision on an action covered by the EIS. APHIS has reviewed the final 
EIS and evaluated the comments received during the 30-day waiting 
period and has concluded that it has fully and appropriately analyzed 
the issues covered by the final EIS and those comments. Based on our 
final EIS, the response to public comments, and other pertinent 
scientific data, APHIS has prepared a record of decision for the final 
EIS.

Determination of Nonregulated Status

    Based on APHIS' analysis of field and laboratory data submitted by 
Monsanto/KWS, references provided in the petition, peer-reviewed 
publications, information analyzed in the EIS, the plant pest risk 
assessment, comments provided by the public, and APHIS' evaluation of 
and response to those comments, APHIS has determined that sugar beet 
event H7-1 is unlikely to pose a plant pest risk and, in fact, is not a 
plant pest. Accordingly, the petition requesting a determination of 
nonregulated status is approved, and sugar beet event H7-1 is no longer 
subject to our regulations governing the

[[Page 42694]]

introduction of certain genetically engineered organisms and to the 
plant pest provisions of the Plant Protection Act.
    Copies of the determination of nonregulated status document and the 
record of decision, as well as copies of the final plant pest risk 
assessment and final EIS upon which the determination and record of 
decision were based, are available as indicated in the ADDRESSES and 
FOR FURTHER INFORMATION CONTACT sections of this notice.

    Done in Washington, DC, this 18th day of July 2012.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service. 
Notice
[FR Doc. 2012-17819 Filed 7-19-12; 8:45 am]
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