[Federal Register Volume 78, Number 86 (Friday, May 3, 2013)]
[Notices]
[Pages 25942-25943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10504]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0067]


J.R. Simplot Co.; Availability of Petition for Determination of 
Nonregulated Status of Potato Genetically Engineered for Low Acrylamide 
Potential and Reduced Black Spot Bruise

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 the J.R. 
Simplot Company (Simplot) seeking a determination of nonregulated 
status of potatoes designated as Innate\TM\ potatoes (events E12, E24, 
F10, F37, J3, J55, J78, G11, H37, and H50), which have been genetically 
engineered for low acrylamide potential (acrylamide is a human 
neurotoxicant and potential carcinogen that may form in potatoes and 
other starchy foods under certain cooking conditions) and reduced black 
spot bruise. The petition has been submitted in accordance with our 
regulations concerning the introduction of certain genetically 
engineered organisms and products. We are making the Simplot 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 July 
2, 2013.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2012-0067-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2012-0067, 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-
0067 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.
    The petition is also available on the APHIS Web site at http://www.aphis.usda.gov/brs/aphisdocs/13_02201p.pdf.

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 
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

[[Page 25943]]

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 13-022-01p) 
from the J.R. Simplot Company (Simplot) of Boise, ID, seeking a 
determination of nonregulated status of potatoes (Solanum tuberosum) 
designated as Innate\TM\ potatoes (events E12, E24, F10, F37, J3, J55, 
J78, G11, H37, and H50), which have been genetically engineered for low 
acrylamide potential and reduced black spot bruise. Acrylamide is a 
human neurotoxicant and potential carcinogen that may form in potatoes 
and other starchy foods under certain cooking conditions. The petition 
states that these potatoes 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, Innate\TM\ potatoes have been 
genetically engineered through the insertion of genetic elements from 
potato or wild potato (a group of related plant species that are 
sexually compatible with potato) using Simplot's Innate\TM\ 
technologies. Simplot's Innate\TM\ technologies allow researchers to 
isolate genetic elements from any plant genome, rearrange them, or link 
them together in desired permutations, and introduce them back into the 
genome, without incorporating anything other than plant DNA. Innate\TM\ 
potatoes are currently regulated under 7 CFR part 340. Interstate 
movements and field tests of Innate\TM\ potatoes have been conducted 
under 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 
tests. 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 information regarding the extent of true potato 
seed use for planting in the United States as compared to the use of 
asexually propagated fragments of potato tubers. We are also 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 potato 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 29th day of April 2013.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-10504 Filed 5-2-13; 8:45 am]
BILLING CODE 3410-34-P