[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]
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Notices
Federal Register
________________________________________________________________________
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]
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