[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Notices]
[Pages 67100-67101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26792]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0025]


Okanagan Specialty Fruits, Inc.; Availability of Plant Pest Risk 
Assessment and Environmental Assessment 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 is making available for public comment our plant 
pest risk assessment and our draft environmental assessment regarding a 
request 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. We 
are soliciting comments on whether these genetically engineered apples 
are likely to pose a plant pest risk.

DATES: We will consider all comments that we receive on or before 
December 9, 2013.

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.
     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) 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. Rebecca Stankiewicz Gabel, Chief, 
Biotechnology Environmental Analysis Branch, Environmental Risk 
Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River 
Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3927, 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

    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. APHIS has 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 stated 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 GE 
organisms, APHIS accepts written comments regarding a petition once 
APHIS deems it complete. In a notice \2\ published in

[[Page 67101]]

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, and the comments we 
received, 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 a consolidated 
document of many identical or nearly identical letters, for a total of 
72,745 comments. Issues raised during the comment period include 
concerns regarding marketing and economic impacts; cross-pollination; 
and health, nutrition, and food safety. APHIS has evaluated the issues 
raised during the comment period and, where appropriate, has provided a 
discussion of these issues in our environmental assessment (EA).
    After public comments are received on a completed petition, APHIS 
evaluates those comments and then provides a second opportunity for 
public involvement in our decisionmaking process. According to our 
public review process (see footnote 1), the second opportunity for 
public involvement follows one of two approaches, as described below.
    If APHIS decides, based on its review of the petition and its 
evaluation and analysis of comments received during the 60-day public 
comment period on the petition, that the petition involves a GE 
organism that raises no substantive new issues, APHIS will follow 
Approach 1 for public involvement. Under Approach 1, APHIS announces in 
the Federal Register the availability of APHIS' preliminary regulatory 
determination along with its EA, preliminary finding of no significant 
impact (FONSI), and its plant pest risk assessment (PPRA) for a 30-day 
public review period. APHIS will evaluate any information received 
related to the petition and its supporting documents during the 30-day 
public review period.
    Alternatively, if APHIS decides, based on its review of the 
petition and its evaluation and analysis of comments received during 
the 60-day public comment period on the petition, that the petition 
involves a GE organism that raises substantive new issues, APHIS will 
follow Approach 2. Under Approach 2, APHIS first solicits written 
comments from the public on a draft EA and 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 PPRA 
and other information, APHIS will revise the PPRA as necessary and 
prepare a final EA and, based on the final EA, a National Environmental 
Policy Act (NEPA) decision document (either a FONSI or a notice of 
intent to prepare an environmental impact statement). For this 
petition, we are using Approach 2.
    APHIS has prepared a PPRA to determine if apple events GD743 and 
GS784 are unlikely to pose a plant pest risk. In section 403 of the 
Plant Protection Act, ``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 agent or other pathogen, or any article similar 
to or allied with any of the foregoing.
    APHIS has also prepared a draft EA in which we present two 
alternatives based on our analysis of data submitted by Okanagan, a 
review of other scientific data, field tests conducted under APHIS 
oversight, and comments received on the petition. APHIS is considering 
the following alternatives: (1) Take no action, i.e., APHIS would not 
change the regulatory status of apple events GD743 and GS784 and they 
would continue to be regulated articles, or (2) make a determination of 
nonregulated status of 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).
    In accordance with 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 on our PPRA and draft EA regarding 
the petition for a determination of nonregulated status from interested 
or affected persons for a period of 30 days from the date of this 
notice. Copies of the PPRA and draft EA, as well as the previously 
published petition, are available as indicated in the ADDRESSES and FOR 
FURTHER INFORMATION CONTACT sections of this notice.
    As noted previously, after the comment period closes, APHIS will 
review all written comments received during the comment period and any 
other relevant information. After reviewing and evaluating the comments 
on the draft EA and PPRA and other information, APHIS will revise the 
PPRA as necessary and prepare a final EA. Based on the final EA, APHIS 
will prepare a NEPA decision document (either a FONSI or a notice of 
intent to prepare an environmental impact statement).
    If a FONSI is reached, APHIS will furnish a response to the 
petitioner, either approving or denying the petition. APHIS will also 
publish 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.

    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 4th day of November 2013.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-26792 Filed 11-7-13; 8:45 am]
BILLING CODE 3410-34-P