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, 25942-25943 [2013-10504]

Download as PDF 25942 Federal Register / Vol. 78, No. 86 / Friday, May 3, 2013 / Notices nonregulated status of Roundup Ready® corn line GA21 to maize line HCEM485, whereby maize line HCEM485 is no longer subject to our regulations governing the introduction of certain genetically engineered organisms. Copies of the signed determination document, as well as copies of the extension request, PPRA, EA, and FONSI and response to comments, are available as indicated in the ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice. National Environmental Policy Act To provide the public with documentation of APHIS’ review and analysis of any potential environmental impacts associated with the determination of nonregulated status of maize line HCEM485, an EA has been prepared. The 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). 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. erowe on DSK2VPTVN1PROD with NOTICES a regulated article under APHIS’ regulations in 7 CFR part 340. On February 27, 2013, APHIS published a notice 2 in the Federal Register (78 FR 13303–13304, Docket No. APHIS–2012–0033) announcing the availability of a draft environmental assessment (EA) and plant pest risk assessment (PPRA) for public comment for the Stine Seed extension request. The extension request and APHIS’ preliminary decision were also published with that notice. APHIS received three comments on the subject EA and PPRA during the designated 30day public comment period, which ended March 29, 2013. Issues raised during the comment period included effects of glyphosate, pollen drift, crop diversity, and human health concerns. APHIS has addressed the issues raised during the comment period and has provided responses to these comments as an attachment to the finding of no significant impact (FONSI). DEPARTMENT OF AGRICULTURE Determination Based on APHIS’ analysis of field and laboratory data submitted by Stine Seed, references provided in the extension request, peer-reviewed publications, information analyzed in the EA, the similarity of maize line HCEM485 to the antecedent organism, Roundup Ready® corn line GA21, comments provided by the public, and information provided in APHIS’ response to those public comments, APHIS has determined that maize line HCEM485 is unlikely to pose a plant pest risk. We are therefore extending the determination of 2 To view the notice, petition, draft EA, the PPRA, and the comments we received, go to https:// www.regulations.gov/#!docketDetail;D=APHIS– 2012–0033. VerDate Mar<15>2010 14:52 May 02, 2013 Jkt 229001 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. 2013–10510 Filed 5–2–13; 8:45 am] BILLING CODE 3410–34–P 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 Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: 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 InnateTM 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. PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 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 https://www.regulations.gov/ #!documentDetail;D=APHIS-2012-00670001. • 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 https:// 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 https:// 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: rebecca.l.stankiewiczgabel@aphis.usda.gov. To obtain copies of the petition, contact Ms. Cindy Eck at (301) 851–3892, email: cynthia.a.eck@aphis.usda.gov. SUPPLEMENTARY INFORMATION: DATES: 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 § 340.6(a) provide that any person may submit a petition E:\FR\FM\03MYN1.SGM 03MYN1 erowe on DSK2VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 86 / Friday, May 3, 2013 / Notices 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 § 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 InnateTM 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, InnateTM 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 InnateTM technologies. Simplot’s InnateTM 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. InnateTM potatoes are currently regulated under 7 CFR part 340. Interstate movements and field tests of InnateTM 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 § 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 VerDate Mar<15>2010 14:52 May 02, 2013 Jkt 229001 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. In accordance with § 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 1 To view the notice, go to https:// www.regulations.gov/#!docketDetail;D=APHIS– 2011-0129. PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 25943 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 DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2012–0023] Changes to Scrapie Flock Certification Program Animal and Plant Health Inspection Service, USDA. ACTION: Notice and request for comments. AGENCY: SUMMARY: We are giving notice of changes to the Scrapie Flock Certification Program (SFCP), a voluntary program for sheep and goat flock owners who wish to reduce and/ or eliminate the risk of introducing classical scrapie into their flocks. In order to refocus the program’s risk reduction strategy on animal sampling, we plan to eliminate the Complete Monitored category of the SFCP. This will affect all ‘‘Complete Monitored’’ and ‘‘Certified’’ flocks. Flock owners who are currently enrolled in the Complete Monitored or Certified category who wish to remain in the SFCP will be allowed to enroll in either the Select category or the Export category. This change will allow us to apply limited agency resources to areas that most effectively contribute to scrapie eradication, such as nationwide surveillance activities for the disease in sheep and goats. E:\FR\FM\03MYN1.SGM 03MYN1

Agencies

[Federal Register Volume 78, Number 86 (Friday, May 3, 2013)]
[Notices]
[Pages 25942-25943]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 https://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 https://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 https://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: 
rebecca.l.stankiewicz-gabel@aphis.usda.gov. To obtain copies of the 
petition, contact Ms. Cindy Eck at (301) 851-3892, email: 
cynthia.a.eck@aphis.usda.gov.

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.
---------------------------------------------------------------------------

    \1\ To view the notice, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
---------------------------------------------------------------------------

    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
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