J.R. Simplot Co.; Availability of Petition for Determination of Nonregulated Status of Potato Genetically Engineered for Late Blight Resistance, Low Acrylamide Potential, Reduced Black Spot Bruising, and Lowered Reducing Sugars, 66689-66690 [2014-26598]

Download as PDF Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices nonregulated status of GE organisms. Issues raised during the comment period included concerns regarding the potential transfer of genes from GE to non-GE potatoes and potential health and environmental impacts. APHIS has addressed the issues raised during the comment period and has provided responses to comments as an attachment to the FONSI. APHIS received additional information from Simplot on the molecular characterization of one of the events, J3, after publication of the petition, PPRA, and draft EA. The new information indicates rearranged repeated sequences of the inserted genetic material at the right border. APHIS has reviewed the revised structure and concluded the revision does not change the analyses or conclusions in either the PPRA or the EA because there are no new sequences present that were not previously described, no new insertion site(s), and no expected change in functionality. The updated characterization of J3 has been appended to the petition as Appendix 11. asabaliauskas on DSK5VPTVN1PROD with NOTICES National Environmental Policy Act After reviewing and evaluating the comments received during the comment period on the draft EA and 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 Simplot’s InnateTM potatoes. 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 InnateTM potatoes). Determination Based on APHIS’ analysis of field and laboratory data submitted by Simplot, 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 Simplot’s VerDate Sep<11>2014 18:25 Nov 07, 2014 Jkt 235001 InnateTM potatoes 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 3rd day of November 2014. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2014–26593 Filed 11–7–14; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2014–0076] J.R. Simplot Co.; Availability of Petition for Determination of Nonregulated Status of Potato Genetically Engineered for Late Blight Resistance, Low Acrylamide Potential, Reduced Black Spot Bruising, and Lowered Reducing Sugars Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public that the Animal and Plant Health Inspection Service has received a petition from the J.R. Simplot Company seeking a determination of nonregulated status for InnateTM Potato designated as Russet Burbank event W8, which has been genetically engineered for late blight resistance, low acrylamide potential, reduced black spot bruising, and lowered reducing sugars. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the J.R. Simplot Company petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that the Animal and Plant Health Inspection Service may determine should be considered in our evaluation of the petition. SUMMARY: PO 00000 Frm 00007 Fmt 4703 Sfmt 4703 66689 We will consider all comments that we receive on or before January 9, 2015. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to http://www.regulations.gov/ #!docketDetail;D=APHIS-2014-0076. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2014–0076, 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-2014-0076 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/biotechnology/ petitions_table_pending.shtml under APHIS petition number 14–093–01p. 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: john.t.turner@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: 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 to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. DATES: E:\FR\FM\10NON1.SGM 10NON1 asabaliauskas on DSK5VPTVN1PROD with NOTICES 66690 Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices 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 14–093–01p) from the J.R. Simplot Company seeking a determination of nonregulated status for InnateTM Potato designated as Russet Burbank event W8, which has been genetically engineered for late blight resistance, low acrylamide potential, reduced black spot bruising, and lowered reducing sugars. The J.R. Simplot petition states that information collected during field trials and laboratory analyses indicates that InnateTM Potato is not likely to be a plant pest and therefore should not be a regulated article under APHIS’ regulations in 7 CFR part 340. InnateTM Potato is currently regulated under 7 CFR part 340. Interstate movements and field tests of InnateTM Potato 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 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 comment, 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 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 involvement (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 parts 1500–1508) and APHIS’ NEPA implementing regulations (7 CFR part 372). 1 To view the notice, go to http:// www.regulations.gov/#!docketDetail;D=APHIS2011-0129. Authority: 7 U.S.C. 7701–7772 and 7781– 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. VerDate Sep<11>2014 18:25 Nov 07, 2014 Jkt 235001 PO 00000 Frm 00008 Fmt 4703 Sfmt 4703 Done in Washington, DC, this 3rd day of November 2014. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2014–26598 Filed 11–7–14; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Rural Utilities Service Information Collection Activity; Comment Request Rural Utilities Service, USDA. Notice and request for comments. AGENCY: ACTION: In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended), the Rural Utilities Service (RUS) invites comments on this information collection for which RUS intends to request approval from the Office of Management and Budget (OMB). DATES: Comments on this notice must be received by January 9, 2015. FOR FURTHER INFORMATION CONTACT: Michele L. Brooks, Director, Program Development and Regulatory Analysis, Rural Utilities Service, USDA, 1400 Independence Avenue SW., STOP 1522, Room 5162—South Building, Washington, DC 20250–1522. Telephone: (202) 690–1078. Fax: (202) 720–8435 or email Michele.Brooks@ wdc.usda.gov. SUPPLEMENTARY INFORMATION: The Office of Management and Budget’s (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104–13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that RUS is submitting to OMB for extension. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency’s estimate of the burden of the collection including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or SUMMARY: E:\FR\FM\10NON1.SGM 10NON1

Agencies

[Federal Register Volume 79, Number 217 (Monday, November 10, 2014)]
[Notices]
[Pages 66689-66690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26598]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2014-0076]


J.R. Simplot Co.; Availability of Petition for Determination of 
Nonregulated Status of Potato Genetically Engineered for Late Blight 
Resistance, Low Acrylamide Potential, Reduced Black Spot Bruising, and 
Lowered Reducing Sugars

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has received a petition from the J.R. Simplot 
Company seeking a determination of nonregulated status for Innate\TM\ 
Potato designated as Russet Burbank event W8, which has been 
genetically engineered for late blight resistance, low acrylamide 
potential, reduced black spot bruising, and lowered reducing sugars. 
The petition has been submitted in accordance with our regulations 
concerning the introduction of certain genetically engineered organisms 
and products. We are making the J.R. Simplot Company petition available 
for review and comment to help us identify potential environmental and 
interrelated economic issues and impacts that the Animal and Plant 
Health Inspection Service may determine should be considered in our 
evaluation of the petition.

DATES: We will consider all comments that we receive on or before 
January 9, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0076.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2014-0076, 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-2014-
0076 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/biotechnology/petitions_table_pending.shtml under 
APHIS petition number 14-093-01p.

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: john.t.turner@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: 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.

[[Page 66690]]

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 14-093-01p) 
from the J.R. Simplot Company seeking a determination of nonregulated 
status for Innate\TM\ Potato designated as Russet Burbank event W8, 
which has been genetically engineered for late blight resistance, low 
acrylamide potential, reduced black spot bruising, and lowered reducing 
sugars. The J.R. Simplot petition states that information collected 
during field trials and laboratory analyses indicates that Innate\TM\ 
Potato is not likely to be a plant pest and therefore should not be a 
regulated article under APHIS' regulations in 7 CFR part 340.
    Innate\TM\ Potato is currently regulated under 7 CFR part 340. 
Interstate movements and field tests of Innate\TM\ Potato 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 http://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 comment, 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 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 involvement 
(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 parts 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 3rd day of November 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-26598 Filed 11-7-14; 8:45 am]
BILLING CODE 3410-34-P