Monsanto Co.; Availability of Petition for Determination of Nonregulated Status of Canola Genetically Engineered for Herbicide Tolerance, 41357-41358 [2012-17132]

Download as PDF Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 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 9th day of July 2012. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2012–17129 Filed 7–12–12; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2012–0035] Monsanto Co.; Availability of Petition for Determination of Nonregulated Status of Canola Genetically Engineered for Herbicide Tolerance Animal and Plant Health Inspection Service, USDA. ACTION: Notice. srobinson on DSK4SPTVN1PROD with NOTICES AGENCY: We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from the Monsanto Company (Monsanto) seeking a determination of nonregulated status of canola designated as MON 88302, which has been SUMMARY: VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 genetically engineered for tolerance to the herbicide glyphosate with more flexibility in the timing of herbicide application. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the Monsanto 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 September 11, 2012. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!documentDetail;D=APHIS-2012-00350001. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2012–0035, 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-2012-0035 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/ 11_18801p.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 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 PO 00000 Frm 00008 Fmt 4703 Sfmt 4703 41357 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. 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 11–188–01p) from the Monsanto Company of St. Louis, MO, seeking a determination of nonregulated status of canola (Brassica napus) designated as event MON 88302, which has been genetically engineered for tolerance to the herbicide glyphosate with more flexibility in the timing of herbicide application, stating that this canola 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 petition, canola event MON 88302 has been genetically engineered for tolerance to the herbicide glyphosate via the incorporation of a cp4 epsps coding sequence, producing the same 5-enolpyruvylshikimate-3phosphate synthase (CP4 EPSPS) protein that is produced in commercial Roundup Ready® crop products. MON 88302 utilizes an improved promoter sequence to enhance CP4 EPSPS expression in male reproductive tissues (i.e., pollen). Enhanced CP4 EPSPS expression in the male reproductive tissues of MON 88302 allows the greater flexibility of glyphosate herbicide applications as MON 88302 plants can be sprayed with higher rates of glyphosate and at later stages of development with no detectable impact to male fertility. Canola event MON 88302 is currently regulated under 7 CFR part 340. Interstate movements and field tests of canola event MON 88302 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 E:\FR\FM\13JYN1.SGM 13JYN1 srobinson on DSK4SPTVN1PROD with NOTICES 41358 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 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 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 canola 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. 1 To view the notice, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2011-0129. VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 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 9th day of July 2012. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2012–17132 Filed 7–12–12; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2012–0029] Bayer CropScience LP; Availability of Petition, Plant Pest Risk Assessment, and Environmental Assessment for Determination of Nonregulated Status of Soybean Genetically Engineered for Herbicide Tolerance 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 Bayer CropScience LP seeking a determination of nonregulated status of soybean designated as event FG72, which has been genetically engineered for resistance to the herbicides glyphosate and isoxaflutole. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and SUMMARY: PO 00000 Frm 00009 Fmt 4703 Sfmt 4703 products. We are soliciting comments on whether this genetically engineered soybean is likely to pose a plant pest risk. We are making available for public comment the Bayer petition, our plant pest risk assessment, and our draft environmental assessment for the proposed determination of nonregulated status. DATES: We will consider all comments that we receive on or before September 11, 2012. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https:// www.regulations.gov/#!documentDetail; D=APHIS-2012-0029-0001. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2012–0029, 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-2012-0029 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, 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_32801p.pdf, https://www.aphis.usda.gov/brs/ aphisdocs/09_32801p_dea.pdf, and https://www.aphis.usda.gov/brs/ aphisdocs/09_32801p_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 petition, draft environmental assessment, or plant pest risk assessment, 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 E:\FR\FM\13JYN1.SGM 13JYN1

Agencies

[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41357-41358]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17132]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0035]


Monsanto Co.; Availability of Petition for Determination of 
Nonregulated Status of Canola Genetically Engineered for Herbicide 
Tolerance

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 Monsanto 
Company (Monsanto) seeking a determination of nonregulated status of 
canola designated as MON 88302, which has been genetically engineered 
for tolerance to the herbicide glyphosate with more flexibility in the 
timing of herbicide application. The petition has been submitted in 
accordance with our regulations concerning the introduction of certain 
genetically engineered organisms and products. We are making the 
Monsanto 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 
September 11, 2012.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2012-0035-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2012-0035, 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-
0035 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/11_18801p.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 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 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 11-188-01p) 
from the Monsanto Company of St. Louis, MO, seeking a determination of 
nonregulated status of canola (Brassica napus) designated as event MON 
88302, which has been genetically engineered for tolerance to the 
herbicide glyphosate with more flexibility in the timing of herbicide 
application, stating that this canola 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 petition, canola event MON 88302 has been 
genetically engineered for tolerance to the herbicide glyphosate via 
the incorporation of a cp4 epsps coding sequence, producing the same 5-
enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) protein that is 
produced in commercial Roundup Ready[supreg] crop products. MON 88302 
utilizes an improved promoter sequence to enhance CP4 EPSPS expression 
in male reproductive tissues (i.e., pollen). Enhanced CP4 EPSPS 
expression in the male reproductive tissues of MON 88302 allows the 
greater flexibility of glyphosate herbicide applications as MON 88302 
plants can be sprayed with higher rates of glyphosate and at later 
stages of development with no detectable impact to male fertility. 
Canola event MON 88302 is currently regulated under 7 CFR part 340. 
Interstate movements and field tests of canola event MON 88302 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

[[Page 41358]]

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 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 canola 
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 9th day of July 2012.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2012-17132 Filed 7-12-12; 8:45 am]
BILLING CODE 3410-34-P
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