[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41362-41363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17144]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0025]


Okanagan Specialty Fruits, Inc.; Availability of Petition for 
Determination of Nonregulated Status of Apples Genetically Engineered 
To Resist Browning

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 (APHIS) has received a petition from Okanagan 
Specialty Fruits, Inc., seeking a determination of nonregulated status 
of apple events designated as events GD743 and GS784, which have been 
genetically engineered to resist browning. The petition has been 
submitted in accordance with our regulations concerning the 
introduction of certain genetically engineered organisms and products. 
We are making the Okanagan Specialty Fruits, Inc., petition available 
for review and comment to help us identify potential environmental and 
interrelated economic issues and impacts that APHIS may determine 
should be considered in our evaluation of the petition.

DATES: We will consider all comments that we receive on or before 
September 11, 2012.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2012-0025-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2012-0025, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-
0025 or in our reading room, which 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) 7997039 before coming.
    The petition is also available on the APHIS Web site at http://www.aphis.usda.gov/brs/aphisdocs/10_16101p.pdf.

FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, 
Environmental Risk Analysis Programs, Biotechnology Regulatory 
Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; 
(301) 851-3954, email: [email protected]. To obtain copies 
of the petition, contact Ms. Cindy Eck at (301) 851-3892, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    Under the authority of the plant pest provisions of the Plant 
Protection Act (7 U.S.C. 7701 et seq.), 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 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 10-161-01p) 
from Okanagan Specialty Fruits, Inc., of British Columbia, Canada, 
seeking a determination of nonregulated status of apples (Malus x 
domestica) designated as events GD743 and GS784, which have been 
genetically engineered to

[[Page 41363]]

resist browning, stating that these apples are unlikely to pose a plant 
pest risk and, therefore, should not be a regulated article under 
APHIS' regulations in 7 CFR part 340.
    As described in the petition, apple events GD743 and GS784 have 
been genetically engineered to resist enzymatic browning through the 
insertion of a polyphenol oxidase suppression sequence derived from 
apple. Apple events GD743 and GS784 are currently regulated under 7 CFR 
part 340. Interstate movements and field tests of apple events GD743 
and GS784 have been conducted under permits issued or notifications 
acknowledged by APHIS.
    Field tests conducted under APHIS oversight allowed for evaluation 
in a natural agricultural setting while imposing measures to minimize 
the risk of persistence in the environment after completion of the 
test. Data are gathered on multiple parameters and used by the 
applicant to evaluate agronomic characteristics and product 
performance. These and other data are used by APHIS to determine if the 
new variety poses a plant pest risk.
    Paragraph (d) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register providing 60 days for public comment for 
petitions for a determination of nonregulated status. On March 6, 2012, 
we published in the Federal Register (77 FR 13258-13260, Docket No. 
APHIS-2011-0129) a notice \1\ describing our process for soliciting 
public comment when considering petitions for determinations of 
nonregulated status for GE organisms. In that notice we indicated that 
APHIS would accept written comments regarding a petition once APHIS 
deemed it complete.
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    \1\ To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
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    In accordance with Sec.  340.6(d) of the regulations and our 
process for soliciting public input when considering petitions for 
determinations of nonregulated status for GE organisms, 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. The petition is available for 
public review, and copies are available as indicated under ADDRESSES 
and FOR FURTHER INFORMATION CONTACT above.
    We are interested in receiving comments regarding potential 
environmental and interrelated economic issues and impacts that APHIS 
may determine should be considered in our evaluation of the petition. 
We are particularly interested in receiving comments regarding 
biological, cultural, or ecological issues, and we encourage the 
submission of scientific data, studies, or research to support your 
comments. We also request that, when possible, commenters provide 
relevant information regarding specific localities or regions as apple 
growth, crop management, and crop utilization may vary considerably by 
geographic region.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information; any substantive issues identified by APHIS based on our 
review of the petition and our evaluation and analysis of comments will 
be considered in the development of our decisionmaking documents.
    As part of our decisionmaking process regarding a GE organism's 
regulatory status, APHIS prepares a plant pest risk assessment to 
assess its plant pest risk and the appropriate environmental 
documentation--either an environmental assessment (EA) or an 
environmental impact statement (EIS)--in accordance with the National 
Environmental Policy Act (NEPA), to provide the Agency with a review 
and analysis of any potential environmental impacts associated with the 
petition request. For petitions for which APHIS prepares an EA, APHIS 
will follow our published process for soliciting public comment (see 
footnote 1) and publish a separate notice in the Federal Register 
announcing the availability of APHIS' EA and plant pest risk 
assessment. Should APHIS determine that an EIS is necessary, APHIS will 
complete the NEPA EIS process in accordance with Council on 
Environmental Quality regulations (40 CFR part 1500-1508) and APHIS' 
NEPA implementing regulations (7 CFR part 372).

    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 9th day of July 2012.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2012-17144 Filed 7-12-12; 8:45 am]
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