80 FR 8589 - Okanagan Specialty Fruits, Inc.; Determination of Nonregulated Status of Apples Genetically Engineered To Resist Browning

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 32 (February 18, 2015)

We are advising the public of our determination that apple events developed by Okanagan Specialty Fruits, Inc., designated as events GD743 and GS784, which have been genetically engineered to resist browning, 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 Okanagan Specialty Fruits, Inc., 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 notices 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.

[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Notices]
[Pages 8589-8590]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03272]


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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. 80, No. 32 / Wednesday, February 18, 2015 / 
Notices

[[Page 8589]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0025]


Okanagan Specialty Fruits, Inc.; 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 of our determination that apple 
events developed by Okanagan Specialty Fruits, Inc., designated as 
events GD743 and GS784, which have been genetically engineered to 
resist browning, 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 Okanagan Specialty Fruits, Inc., 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 notices 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 February 18, 2015.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received 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) 799-7039 before coming.
    Supporting documents are also available on the APHIS Web site at 
http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml 
under APHIS Petition Number 10-161-01p.

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 supporting documents for this petition, contact Ms. Cindy Eck at 
(301) 851-3892, 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. APHIS received a petition (APHIS Petition Number 
10-161-01p) from Okanagan Specialty Fruits, Inc., (Okanagan) 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 resist browning. The petition 
states 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.
    According to our process \1\ for soliciting public comment when 
considering petitions for determinations of nonregulated status of 
genetically engineered (GE) organisms, APHIS accepts written comments 
regarding a petition once APHIS deems it complete. In a notice \2\ 
published in the Federal Register on July 13, 2012 (77 FR 41362-41363, 
Docket No. APHIS-2012-0025), APHIS announced the availability of the 
Okanagan petition for public comment. APHIS solicited comments on the 
petition for 60 days ending on September 11, 2012, in order to help 
identify potential environmental and interrelated economic issues and 
impacts that APHIS may determine should be considered in our evaluation 
of the petition.
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    \1\ On March 6, 2012, APHIS published in the Federal Register 
(77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing 
our public review process for soliciting public comments and 
information when considering petitions for determinations of 
nonregulated status for GE organisms. To view the notice, go to 
http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
    \2\ To view the notice, the petition, the comments we received, 
and other supporting documents, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0025.
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    APHIS received 1,939 comments on the petition. Several of these 
comments included electronic attachments consisting of consolidated 
documents of many identical or nearly identical letters, for a total of 
72,745 comments. Issues raised during the comment period included 
concerns regarding marketing and economic impacts; cross-pollination; 
and health, nutrition, and food safety. APHIS decided, based on its 
review of the petition and its evaluation and analysis of the comments 
received during the 60-day public comment period on the petition, that 
the petition involves a GE organism that involves a new crop trait or 
raises substantive new issues. According to our public review process 
for such petitions (see footnote 1), APHIS first solicits written 
comments from the public on a draft environmental assessment (EA) and a 
plant pest risk assessment (PPRA) for a 30-day comment period through 
the publication of a Federal Register notice. Then, after reviewing and 
evaluating the comments on the draft EA and the PPRA and other 
information, APHIS revises the PPRA as necessary and prepares a final 
EA and, based on the final EA, a National Environmental Policy Act

[[Page 8590]]

(NEPA) decision document (either a finding of no significant impact 
(FONSI) or a notice of intent to prepare an environmental impact 
statement). If a FONSI is reached, APHIS furnishes a response to the 
petitioner, either approving or denying the petition. APHIS also 
publishes a notice in the Federal Register announcing the regulatory 
status of the GE organism and the availability of APHIS' final EA, 
PPRA, FONSI, and our regulatory determination.
    APHIS sought public comment on a draft EA and a PPRA from November 
8, 2013, to January 30, 2014.\3\ APHIS solicited comments on the draft 
EA, the PPRA, and whether the subject apples are likely to pose a plant 
pest risk. APHIS received 105,971 comments during the comment period, 
of which 100,976 were form letters. The majority of the comments 
expressed general opposition to APHIS making a determination of 
nonregulated status of GE organisms. Issues raised during the comment 
period included concerns regarding potential effects on human and 
animal health and nontarget organisms and economic impacts on apple 
growers. APHIS has addressed the issues raised during the comment 
period and has provided responses to comments as an attachment to the 
FONSI.
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    \3\ In a notice (see footnote 2) published in the Federal 
Register on November 8, 2013, (78 FR 67100-67101, Docket No. APHIS-
2012-0025), APHIS announced the availability of a draft EA and a 
PPRA for public comment for 30 days, ending December 9, 2013. In a 
notice published in Federal Register on December 31, 2013, (78 FR 
79568-79569, Docket No. APHIS-2012-0025), APHIS reopened the comment 
period on the draft EA and the PPRA for an additional 30 days, 
ending January 30, 2014. We also indicated in that notice that we 
would consider all comments received between December 10, 2013 (the 
day after the close of the original comment period) and the date of 
the notice.
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National Environmental Policy Act

    After reviewing and evaluating the comments received during the 
comment period on the draft EA and the PPRA and other information, 
APHIS has prepared a final EA. The EA has been prepared to provide the 
public with documentation of APHIS' review and analysis of any 
potential environmental impacts associated with the determination of 
nonregulated status of Okanagan's apple events GD743 and GS784. The EA 
was prepared in accordance with: (1) 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 FONSI with regard to the preferred alternative 
identified in the EA (to make a determination of nonregulated status of 
apple events GD743 and GS784).

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Okanagan, references provided in the petition, peer-reviewed 
publications, information analyzed in the EA, the PPRA, comments 
provided by the public, and information provided in APHIS' response to 
those public comments, APHIS has determined that Okanagan's apple 
events GD743 and GS784 are unlikely to pose a plant pest risk and 
therefore are no longer subject to our regulations governing the 
introduction of certain GE organisms.
    Copies of the signed determination document, PPRA, final EA, FONSI, 
and response to comments, as well as the previously published petition 
and supporting documents, 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 12th day of February 2015.
Michael C. Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-03272 Filed 2-17-15; 8:45 am]
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