[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Pages 60447-60448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25090]


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 Notices
                                                 Federal Register
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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 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
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  Federal Register / Vol. 76, No. 189 / Thursday, September 29, 2011 / 
Notices  

[[Page 60447]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2010-0040]


Florigene Pty., Ltd.; Determination of Nonregulated Status for 
Altered Color Roses

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that two 
hybrid rose lines developed by Florigene Pty., Ltd., designated as IFD-
524[Oslash]1-4 and IFD-529[Oslash]1-9, which have been genetically 
engineered to produce novel flower color, are 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 Florigene Pty., Ltd., in its 
petition for a determination of nonregulated status, our analysis of 
available scientific data, and comments received from the public in 
response to our previous notice announcing the availability of the 
petition for nonregulated status and its associated environmental 
assessment and plant pest risk assessment. This notice also announces 
the availability of our written determination and finding of no 
significant impact.

DATES: Effective Date: September 29, 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. Those 
documents are also available on the Internet at http://www.aphis.usda.gov/biotechnology/not_reg.html and are posted with the 
previous notice and the comments we received on the Regulations.gov Web 
site at http://www.regulations.gov/#!docketDetail;D=APHIS-2010-0040.

FOR FURTHER INFORMATION CONTACT: Mr. Evan Chestnut, Policy Analyst, 
Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, 
Riverdale, MD 20737-1236; (301) 734-0942, e-mail: 
[email protected]. To obtain copies of the documents 
referenced in this notice, contact Ms. Cindy Eck at (301) 734-0667, 
email: [email protected].

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.''
    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. 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.
    APHIS received a petition (APHIS Petition Number 08-315-01p) from 
Florigene Pty., Ltd. (Florigene) of Victoria, Australia, seeking a 
determination of nonregulated status for two hybrid rose lines 
designated as IFD-524[Oslash]1-4 and IFD-529[Oslash]1-9, which have 
been genetically engineered to produce novel flower color. The petition 
stated that these rose lines are unlikely to pose a plant pest risk 
and, therefore, should not be regulated articles under APHIS' 
regulations in 7 CFR part 340.
    In a notice \1\ published in the Federal Register on April 13, 2011 
(76 FR 20623-20624, Docket No. APHIS-2010-0040), APHIS announced the 
availability of the Florigene petition, a plant pest risk assessment, 
and a draft environmental assessment (EA) for public comment. APHIS 
solicited comments on the petition, whether the subject roses are 
likely to pose a plant pest risk, the draft EA, and the plant pest risk 
assessment for 60 days ending on June 13, 2011.
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    \1\ To view the notice, petition, draft EA, the plant pest risk 
assessment, and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2010-0040.
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    APHIS received two comments during the comment period, with one 
commenter expressing support of the EA's preferred alternative and one 
commenter expressing opposition. The commenter opposing a determination 
of nonregulated status cited scientific concerns related to the plant 
pest determination. APHIS has addressed the issues raised by this 
commenter in an attachment to the finding of no significant impact.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
determination of nonregulated status for Florigene's rose lines IFD-
524[Oslash]1-4 and IFD-529[Oslash]1-9, an EA has been 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 our EA, the response 
to public comments, and other pertinent scientific data, APHIS has 
reached a finding of no significant impact with regard to the preferred 
alternative identified in the EA.

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Florigene, references provided in the petition,

[[Page 60448]]

peer-reviewed publications, information analyzed in the EA, the plant 
pest risk assessment, comments provided by the public, and information 
provided in APHIS' response to those public comments, APHIS has 
determined that Florigene's rose lines IFD-524[Oslash]1-4 and IFD-
529[Oslash]1-9 are unlikely to pose a plant pest risk and therefore are 
no longer subject to our regulations governing the introduction of 
certain genetically engineered organisms.
    Copies of the signed determination document, as well as copies of 
the petition, plant 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 23rd day of September 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-25090 Filed 9-28-11; 8:45 am]
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