Syngenta Biotechnology, Inc.; Determination of Nonregulated Status of Corn Genetically Engineered for Insect Resistance, 13302-13303 [2013-04517]

Download as PDF 13302 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices Done in Washington, DC, this 20th day of February 2013. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2013–04496 Filed 2–26–13; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2012–0024] Syngenta Biotechnology, Inc.; Determination of Nonregulated Status of Corn Genetically Engineered for Insect Resistance Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: SUMMARY: We are advising the public of our determination that a corn line developed by the Syngenta Biotechnology, Inc., designated as event SYN–05307–1, which has been genetically engineered for resistance to corn rootworm, an insect pest of corn, is 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 Syngenta Biotechnology, 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 notice 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 Date: February 27, 2013. You may read the documents referenced in this notice and the comments we received in our reading room. The reading room 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. Those documents are also available on the Internet at https:// www.aphis.usda.gov/biotechnology/ not_reg.html and are posted with the erowe on DSK2VPTVN1PROD with NOTICES ADDRESSES: VerDate Mar<15>2010 15:18 Feb 26, 2013 Jkt 229001 previous notice and the comments we received on the Regulations.gov Web site at https://www.regulations.gov/ #!docketDetail;D=APHIS–2012–0024. 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 documents referenced in this notice, contact Ms. Cindy Eck at (301) 851–3892, email: cynthia.a.eck@aphis.usda.gov. 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 § 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. 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 received a petition (APHIS Petition Number 10–336–01p) from Syngenta Biotechnology, Inc., (Syngenta) of Research Triangle Park, NC, seeking a determination of nonregulated status of corn (Zea mays L.) designated as event SYN–05307–1, which has been genetically engineered for resistance to corn rootworm, an insect pest of corn. The petition states that this corn is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS’ regulations in 7 CFR part 340. In a notice 1 published in the Federal Register on July 13, 2012 (77 FR 41366– 41367, Docket No. APHIS–2012–0024), APHIS announced the availability of the Syngenta petition, a plant pest risk 1 To view the notice, petition, draft EA, the PPRA, and the comments we received, go to https:// www.regulations.gov/#!docketDetail;D=APHIS– 2012–0024. PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 assessment (PPRA), and a draft environmental assessment (EA) for public comment. APHIS solicited comments on the petition, whether the subject corn is likely to pose a plant pest risk, the draft EA, and the PPRA for 60 days ending on September 11, 2012. APHIS received 86 comments during the comment period, with 14 commenters expressing support of the EA’s preferred alternative to make a determination of nonregulated status and the remaining 72 commenters expressing opposition. One of the comments opposing a determination of nonregulated status included submitted electronic attachments that consisted of many signed letters containing identical material (4,601 letters). Issues raised during the comment period included adequacy of the EA, effects on nontarget organisms, and potential effects on human and animal health. 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. 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 Syngenta’s corn event SYN–05307–1, 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 finding of no significant impact with regard to the preferred alternative identified in the EA. Determination Based on APHIS’ analysis of field and laboratory data submitted by Syngenta, 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 Syngenta’s corn event SYN–05307–1 is unlikely to pose a plant pest risk and therefore is no longer subject to our regulations governing the introduction of certain genetically engineered organisms. E:\FR\FM\27FEN1.SGM 27FEN1 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices Copies of the signed determination document, as well as copies of the petition, PPRA, EA, finding of no significant impact, and response to comments 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 22nd day of February 2013. Michael Gregoire, Deputy Administrator, Biotechnology Regulatory Services, Animal and Plant Health Inspection Service. [FR Doc. 2013–04517 Filed 2–26–13; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2012–0033] Stine Seed Farm, Inc.; Availability of Plant Pest Risk Assessment, Environmental Assessment, and Preliminary Decision for an Extension of a Determination of Nonregulated Status of Corn Genetically Engineered for Herbicide Tolerance Animal and Plant Health Inspection Service, USDA. ACTION: Notice. erowe on DSK2VPTVN1PROD with NOTICES AGENCY: SUMMARY: We are advising the public that the Animal and Plant Health Inspection Service has prepared a preliminary decision regarding a request from Stine Seed Farm, Inc., to extend to maize line HCEM485, which has been genetically engineered to be tolerant to the herbicide glyphosate, our determination of nonregulated status of Roundup Ready® corn line GA21. We are seeking comment on whether this genetically engineered corn is likely to pose a plant pest risk. We are making available for public comment our plant pest risk assessment and draft environmental assessment for the proposed determination of nonregulated status. DATES: We will consider all comments that we receive on or before March 29, 2013. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!documentDetail;D=APHIS-2012-00330001. • Postal Mail/Commercial Delivery: Send your comment to Docket No. VerDate Mar<15>2010 15:18 Feb 26, 2013 Jkt 229001 APHIS–2012–0033, 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-2012-033 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 extension request, draft environmental assessment, and plant pest risk assessment are also available on the APHIS web site at https:// www.aphis.usda.gov/brs/aphisdocs/ 09_06301p.pdf, https:// www.aphis.usda.gov/brs/aphisdocs/ 09_06301p_dea.pdf, and https:// www.aphis.usda.gov/brs/aphisdocs/ 09_06301p_dpra.pdf. 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 supporting documents, contact Ms. Cindy Eck at (301) 851– 3885, email: cynthia.a.eck@aphis.usda.gov. SUPPLEMENTARY INFORMATION: Background Under the authority of the plant pest provisions of the Plant Protection Act (PPA) (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 organisms (GE) 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. Further, the regulations in § 340.6(e)(2) PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 13303 provide that a person may request that APHIS extend a determination of nonregulated status to other organisms. Such a request must include information to establish the similarity of the antecedent organism and the regulated article in question. In a notice published in the Federal Register on December 5, 1997 (62 FR 64350–64351, Docket No. 97–052–2), APHIS announced our determination of nonregulated status of Roundup Ready® corn line GA21. APHIS has received a request for an extension of a determination of nonregulated status (APHIS Number 09–063–01p) of Roundup Ready® corn line GA21 to maize line HCEM485 1 from Stine Seed Farm, Inc., (Stine Seed) of Research Triangle Park, NC. Stine Seed seeks a determination of nonregulated status of corn designated as maize line HCEM485, which has been genetically engineered to be glyphosate tolerant. In its request, Stine Seed stated that this corn is similar to Roundup Ready® corn line GA21 and, based on the similarity to the antecedent organism, is 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 extension request, maize line HCEM485 has been genetically engineered by a 6.0 kb corn genomic fragment, originally isolated from a bacterial chromosome library derived from the corn inbred line B73, containing a modified form of the endogenous Zea mays EPSPS encoding gene. The antecedent organism, Roundup Ready® corn line GA21, was made with a 1.3kb restriction fragment of the corn EPSPS gene. Both corn lines were produced with the same mutations responsible for conferring glyphosate herbicide tolerance. Maize line HCEM485 is currently regulated under 7 CFR part 340. Interstate movements and field tests of maize line HCEM485 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 test. 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 whether the new variety poses a plant pest risk. 1 The terms ‘‘corn’’ and ‘‘maize’’ both refer to Zea mays. In this notice, we refer to ‘‘maize line HCEM485’’ as this is the name used by Stine Seed in its extension request to identify its GE corn. Otherwise, we use the more common term ‘‘corn’’ when referring to Zea mays. E:\FR\FM\27FEN1.SGM 27FEN1

Agencies

[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13302-13303]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04517]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0024]


Syngenta Biotechnology, Inc.; Determination of Nonregulated 
Status of Corn Genetically Engineered for Insect Resistance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that a corn 
line developed by the Syngenta Biotechnology, Inc., designated as event 
SYN-05307-1, which has been genetically engineered for resistance to 
corn rootworm, an insect pest of corn, is 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 Syngenta Biotechnology, 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 notice 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 Date: February 27, 2013.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received in our reading room. The reading room 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. Those 
documents are also available on the Internet at https://www.aphis.usda.gov/biotechnology/not_reg.html and are posted with the 
previous notice and the comments we received on the Regulations.gov Web 
site at https://www.regulations.gov/#!docketDetail;D=APHIS-2012-0024.

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 documents referenced in this notice, contact Ms. Cindy Eck at 
(301) 851-3892, email: cynthia.a.eck@aphis.usda.gov.

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. 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 received a petition (APHIS Petition Number 10-336-01p) from 
Syngenta Biotechnology, Inc., (Syngenta) of Research Triangle Park, NC, 
seeking a determination of nonregulated status of corn (Zea mays L.) 
designated as event SYN-05307-1, which has been genetically engineered 
for resistance to corn rootworm, an insect pest of corn. The petition 
states that this corn is unlikely to pose a plant pest risk and, 
therefore, should not be a regulated article under APHIS' regulations 
in 7 CFR part 340.
    In a notice \1\ published in the Federal Register on July 13, 2012 
(77 FR 41366-41367, Docket No. APHIS-2012-0024), APHIS announced the 
availability of the Syngenta petition, a plant pest risk assessment 
(PPRA), and a draft environmental assessment (EA) for public comment. 
APHIS solicited comments on the petition, whether the subject corn is 
likely to pose a plant pest risk, the draft EA, and the PPRA for 60 
days ending on September 11, 2012.
---------------------------------------------------------------------------

    \1\ To view the notice, petition, draft EA, the PPRA, and the 
comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2012-0024.
---------------------------------------------------------------------------

    APHIS received 86 comments during the comment period, with 14 
commenters expressing support of the EA's preferred alternative to make 
a determination of nonregulated status and the remaining 72 commenters 
expressing opposition. One of the comments opposing a determination of 
nonregulated status included submitted electronic attachments that 
consisted of many signed letters containing identical material (4,601 
letters). Issues raised during the comment period included adequacy of 
the EA, effects on nontarget organisms, and potential effects on human 
and animal health. 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.

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 Syngenta's corn event SYN-
05307-1, 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 finding of no 
significant impact with regard to the preferred alternative identified 
in the EA.

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Syngenta, 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 Syngenta's corn event 
SYN-05307-1 is unlikely to pose a plant pest risk and therefore is no 
longer subject to our regulations governing the introduction of certain 
genetically engineered organisms.

[[Page 13303]]

    Copies of the signed determination document, as well as copies of 
the petition, PPRA, EA, finding of no significant impact, and response 
to comments 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 22nd day of February 2013.
Michael Gregoire,
Deputy Administrator, Biotechnology Regulatory Services, Animal and 
Plant Health Inspection Service.
[FR Doc. 2013-04517 Filed 2-26-13; 8:45 am]
BILLING CODE 3410-34-P