[Federal Register Volume 71, Number 232 (Monday, December 4, 2006)]
[Notices]
[Pages 70360-70362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20516]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2006-0140]


Bayer CropScience; Extension of Determination of Nonregulated 
Status to Rice Genetically Engineered for Glufosinate Herbicide 
Tolerance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our decision to extend a 
determination of nonregulated status to a rice line developed by Bayer 
CropScience, which has been genetically engineered to be tolerant to 
the herbicide glufosinate. Therefore, APHIS no longer considers the 
rice line to be a regulated article under Agency regulations governing 
the introduction of certain genetically engineered organisms. Our 
decision is based on our evaluation of data submitted by Bayer 
CropScience in its request for an extension of a determination of 
nonregulated status, an analysis of other scientific data, and comments 
received from the public in response to a previous notice and 
preliminary determination. This notice also announces the availability 
of our written determination, final environmental assessment, and our 
finding of no significant impact.

EFFECTIVE DATE: November 24, 2006.

ADDRESSES: You may read the extension request, the final environmental 
assessment, finding of no significant impact, the comments we received 
on our previous notice, and our responses to those comments in our 
reading room or on the Internet. 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

[[Page 70361]]

coming. To view those documents on the Internet, go to http://www.regulations.gov, click on the ``Advanced Search'' tab, and select 
``Docket Search.'' In the Docket ID field, enter APHIS-2006-0140, then 
click ``Submit.'' Clicking on the Docket ID link in the search results 
page will produce a list of all documents in the docket.

FOR FURTHER INFORMATION CONTACT: Dr. Neil Hoffman, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-6331, [email protected]. To obtain 
copies of the extension request or the environmental assessment (EA) 
and finding of no significant impact (FONSI), contact Mr. Steve Bennett 
at (301) 734-5672; e-mail: [email protected]. The 
extension request, final EA, response to comments, and FONSI are also 
available on the Internet at http://www.aphis.usda.gov/brs/
aphisdocs/06--23401p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/06_23401p_ea.pdf.

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.''
    The regulations in Sec.  340.6(a) provide that any person may 
submit a petition to the Animal and Plant Health Inspection Service 
(APHIS) seeking a determination that an article should not be regulated 
under 7 CFR part 340. Further, the regulations in Sec.  340.6(e)(2) 
provide that a person may request that APHIS extend a determination of 
nonregulated status to other organisms. Such a request must include 
information to establish the similarity of the antecedent organism and 
the regulated article in question.

Background

    On August 18, 2006, APHIS received a request for an extension of a 
determination of nonregulated status (APHIS No. 06-234-01p) from Bayer 
CropScience (Bayer) of Research Triangle Park, NC, for rice (Oryza 
sativa L.) designated as Liberty Link[supreg] Transformation Event 
LLRICE601, which has been genetically engineered for tolerance to the 
herbicide glufosinate. Bayer requested an extension of a determination 
of nonregulated status issued in response to APHIS petition number 98-
329-01p for glufosinate-tolerant rice transformation events LLRICE06 
and LLRICE62, the antecedent organisms (See 64 FR 22595, published 
April 27, 1999, Docket No. 98-126-2). Based on the similarity of the 
antecedent rice lines LLRICE06 and LLRICE62 and rice line LLRICE601, 
Bayer CropScience requested a determination that rice line LLRICE601 
does not present a plant pest risk and, therefore, is not a regulated 
article under APHIS' regulations in 7 CFR part 340.
    On July 31, 2006, Bayer CropScience notified APHIS that trace 
levels of LLRICE601 were detected in long grain commercial rice. 
Subsequently, Bayer CropScience supplied APHIS and the Food and Drug 
Administration (FDA) with information about the molecular 
characterization and agronomic performance of LLRICE601. APHIS 
completed a preliminary risk assessment and determined that LLRICE601 
did not pose any plant pest or environmental concerns. This risk 
assessment is attached as appendix I to the final environmental 
assessment (EA).
    On September 8, 2006, APHIS published a notice in the Federal 
Register (71 FR 53076-53077, Docket No. APHIS-2006-0140) announcing 
that an EA and a preliminary decision for the Bayer extension request 
had been prepared and was available for public comment. The analysis 
upon which APHIS based its preliminary decision was also published 
within that notice. APHIS received 15,871 comments on the subject EA 
and preliminary decision during the designated 30-day public comment 
period, which ended October 10, 2006. Of the 15,871 comments, 15,517 
opposed the extension request. Respondents opposing the extension 
request were 12 public interest groups, academic professionals, organic 
food producers, and individuals. Of these comments, 10,500 nearly 
identical comments were submitted by members of 1 public interest group 
and 4,796 nearly identical comments were submitted by members of 
another public interest group. There were 354 comments supporting the 
extension of nonregulated status to LLRICE601. Respondents supporting 
the petition were rice growers, millers (or from related industries), 
rice industry groups, academia, a commodity company, a State government 
agency, and individuals. APHIS has addressed the issues raised during 
the comment period and has provided responses to these comments as 
attachments to the finding of no significant impact (FONSI).

Decision

    Based on an analysis of the data submitted by Bayer and a review of 
other scientific data, APHIS has determined that rice transformation 
event LLRICE601 is very similar to the antecedent organisms in APHIS 
petition number 98-329-01p and poses no more potential for plant pest 
risk than the antecedent organisms. Therefore, APHIS has concluded that 
rice line LLRICE601 and any progeny derived from crosses with other 
rice varieties will be as safe to grow as rice that is not subject to 
regulation under 7 CFR part 340.
    Because APHIS has determined that the subject rice line does not 
present a plant pest risk based on its similarity to the antecedent 
organisms, Bayer rice line LLRICE601 will no longer be considered a 
regulated article under APHIS' regulations in 7 CFR part 340. 
Therefore, the requirements pertaining to regulated articles under 
those regulations no longer apply to the field testing, importation, or 
interstate movement of LLRICE601 or its progeny.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
extension of a determination of nonregulated status for LLRICE601, an 
EA was prepared. The 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). Based on that EA, 
APHIS has reached a FONSI with regard to the determination that Bayer 
rice line LLRICE601 and lines developed from it are no longer regulated 
articles under its regulations in 7 CFR part 340. Copies of the EA and 
FONSI are available as indicated in the FOR FURTHER INFORMATION CONTACT 
section of this notice.


[[Page 70362]]


    Done in Washington, DC, this 29th day of November 2006.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E6-20516 Filed 12-1-06; 8:45 am]
BILLING CODE 3410-34-P