[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20623-20624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8775]


 ========================================================================
 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 
 appearing in this section.
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  Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / 
Notices  

[[Page 20623]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2010-0040]


Florigene Pty., Ltd.; Availability of Petition and Environmental 
Assessment for 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 that the Animal and Plant Health 
Inspection Service has received a petition from Florigene Pty., Ltd., 
seeking a determination of nonregulated status for roses 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 has been 
submitted in accordance with our regulations concerning the 
introduction of certain genetically engineered organisms and products. 
In accordance with those regulations, we are soliciting comments on 
whether these genetically engineered roses are likely to pose a plant 
pest risk. We are also making available for public comment an 
environmental assessment for the proposed determination of nonregulated 
status.

DATES: We will consider all comments that we receive on or before June 
13, 2011.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2010-0040 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-2010-0040, 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-2010-0040.
    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.
    Availability of Documents: The petition, draft environmental 
assessment, and plant pest risk assessment are on available on the 
Regulations.gov Web site (see link above) or on the APHIS Web site at 
http://www.aphis.usda.gov/brs/aphisdocs/08_31501p.pdf, http://www.aphis.usda.gov/brs/aphisdocs/08_31501p_ea.pdf, and http://www.aphis.usda.gov/brs/aphisdocs/08_31501p_pra.pdf.

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 petition, draft 
environmental assessment, or plant pest risk assessment, contact Ms. 
Cindy Eck at (301) 734-0667, e-mail: [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 has received a petition (APHIS Petition Number 08-315-01p) 
from Florigene Pty., Ltd. 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, stating 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.
    As described in the petition, the addition of genes from pansy and 
wishbone flower produces blue pigments in the rose lines, altering the 
flower color. Hybrid rose lines IFD-524[Oslash]1-4 and IFD-
529[Oslash]1-9 are currently regulated under 7 CFR part 340. 
Importation and testing of hybrid rose lines IFD-524[Oslash]1-4 and 
IFD-529[Oslash]1-9 have been conducted under permits issued or 
notifications acknowledged by APHIS.
    Trials conducted under APHIS oversight allowed for evaluation in a 
typical horticultural setting while imposing measures to minimize the 
risk of persistence in the environment after completion of the test. 
Data were gathered on multiple parameters and used by the applicant to 
evaluate phenotypic characteristics and product performance. These data 
are used by APHIS to determine if the new variety poses a plant pest 
risk. Florigene has petitioned APHIS to make a determination that 
hybrid rose lines IFD-524-1-4 and IFD-529-1-9 shall no longer be 
considered regulated articles under 7 CFR part 340.
    In section 403 of the Plant Protection Act (7 U.S.C. 7701 et seq.), 
``plant pest'' is defined as any living stage of any of the following 
that can directly or indirectly injure, cause damage to, or cause 
disease in any plant or plant product: A protozoan, a nonhuman animal, 
a parasitic plant, a bacterium, a fungus, a virus or viroid, an 
infectious

[[Page 20624]]

agent or other pathogen, or any article similar to or allied with any 
of the foregoing. APHIS has prepared a plant pest risk assessment to 
determine if hybrid rose lines IFD-524[Oslash]1-4 and IFD-529[Oslash]1-
9 are unlikely to pose a plant pest risk.
    APHIS has also prepared a draft environmental assessment (EA) in 
which it presents two alternatives based on its analyses of data 
submitted by Florigene, a review of other scientific data, and field 
tests conducted under APHIS oversight. APHIS is considering the 
following alternatives: (1) Take no action, i.e., APHIS would not 
change the regulatory status of hybrid rose lines IFD-524[Oslash]1-4 
and IFD-529[Oslash]1-9 and they would continue to be regulated 
articles, or (2) grant nonregulated status to hybrid rose lines IFD-
524[Oslash]1-4 and IFD-529[Oslash]1-9 in whole.
    The draft EA has been prepared to provide the APHIS decisionmaker 
with a review and analysis of any potential environmental impacts 
associated with the proposed determination of nonregulated status for 
hybrid rose lines IFD-524[Oslash]1-4 and IFD-529[Oslash]1-9. 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).
    In accordance with Sec.  340.6(d) of the regulations, we are 
publishing this notice to inform the public that APHIS will accept 
written comments regarding the petition for a determination of 
nonregulated status from interested or affected persons for a period of 
60 days from the date of this notice. We are also soliciting written 
comments from interested or affected persons on the draft EA prepared 
to examine any potential environmental impacts of the proposed 
determination for the deregulation of the subject hybrid rose lines, 
and the plant pest risk assessment. The petition, draft EA, and plant 
pest risk assessment are available for public review, and copies of the 
petition, draft EA, and plant pest risk assessment are available as 
indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. All comments received regarding the petition, draft EA, 
and plant pest risk assessment will be available for public review. 
After reviewing and evaluating the comments on the petition, the draft 
EA, plant pest risk assessment, and other data, APHIS will furnish a 
response to the petitioner, either approving or denying the petition. 
APHIS will then publish a notice in the Federal Register announcing the 
regulatory status of hybrid rose lines IFD-524[Oslash]1-4 and IFD-
529[Oslash]1-9 and the availability of APHIS' written environmental 
decision and regulatory determination.

    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 7th day of April 2011.
Gregory L. Parham,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-8775 Filed 4-12-11; 8:45 am]
BILLING CODE 3410-34-P