80_FR_48645 80 FR 48489 - Monsanto Company; Availability of Petition for Determination of Nonregulated Status for Maize Genetically Engineered for Resistance to Dicamba and Glufosinate

80 FR 48489 - Monsanto Company; Availability of Petition for Determination of Nonregulated Status for Maize Genetically Engineered for Resistance to Dicamba and Glufosinate

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 156 (August 13, 2015)

Page Range48489-48490
FR Document2015-19925

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 for maize designated as MON 87419, which has been genetically engineered for resistance to the herbicides dicamba and glufosinate. 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 issues and impacts that APHIS should be considering in our evaluation of the petition.

Federal Register, Volume 80 Issue 156 (Thursday, August 13, 2015) 
[Federal Register Volume 80, Number 156 (Thursday, August 13, 2015)]
[Notices]
[Pages 48489-48490]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19925]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2015-0048]


Monsanto Company; Availability of Petition for Determination of 
Nonregulated Status for Maize Genetically Engineered for Resistance to 
Dicamba and Glufosinate

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service (APHIS) has received a petition from the Monsanto 
Company (Monsanto) seeking a determination of nonregulated status for 
maize designated as MON 87419, which has been genetically engineered 
for resistance to the herbicides dicamba and glufosinate. 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 issues and impacts that APHIS should be 
considering in our evaluation of the petition.

DATES: We will consider all comments that we receive on or before 
October 13, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0048.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0048, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    The petition and any comments we receive on this docket may be 
viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0048 
or in our reading room, which is located in room 1141 of the USDA South 
Building, 14th Street and Independence Avenue SW., Washington, DC. 
Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.
    The petition is also available on the APHIS Web site at: http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under 
APHIS petition number 15-113-01p, or by contacting Ms. Cindy Eck at 
(301) 851-3892; email: cynthia.a.eck@aphis.usda.gov.

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.

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. 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 15-113-01p) 
from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a 
determination of nonregulated status for maize (Zea mays) designated as 
event MON 87419 which has been genetically engineered for resistance to 
the herbicides dicamba and glufosinate. The Monsanto petition states 
that information collected during field trials and laboratory analyses 
indicates that MON 87419 maize is unlikely to pose a plant pest risk 
and, therefore, should not be a regulated article under APHIS' 
regulations in 7 CFR part 340.
    MON 87419 maize is currently regulated under 7 CFR part 340. 
Interstate movements and field tests of MON 87419 maize have been 
authorized by APHIS. Field tests conducted under APHIS oversight 
allowed for evaluation in a natural agricultural setting while imposing 
measures to minimize the risk of persistence in the environment after 
completion of the tests. Data are gathered on multiple parameters and 
used by the applicant to evaluate agronomic characteristics and product 
performance. These and other data are used by APHIS to determine if the 
new variety poses a plant pest risk.
    Paragraph (d) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register providing 60 days for public comment for 
petitions for a determination of nonregulated status. On March 6, 2012, 
we published in the Federal Register (77 FR 13258-13260, Docket No. 
APHIS-2011-0129) a notice \1\ describing our process for soliciting 
public comment when considering petitions for determinations of 
nonregulated status for GE organisms. In that notice we indicated that 
APHIS would accept written comments regarding a petition once APHIS 
deemed it complete.
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    \1\ To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
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    In accordance with Sec.  340.6(d) of the regulations and our 
process for soliciting public input when considering petitions for 
determinations of nonregulated status for GE organisms, we are 
publishing this notice to inform the public that APHIS will accept 
written comments regarding the petition for a determination of 
nonregulated status from interested or affected persons for a period of 
60 days from the date of this notice. The petition is available for 
public review and comment, and copies are available as indicated under 
ADDRESSES 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 maize 
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.

[[Page 48490]]

    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 parts 1500 through 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 10th day of August 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-19925 Filed 8-12-15; 8:45 am]
BILLING CODE 3410-34-P

Federal Register / Vol. 80, No. 156 / Thursday, August 13, 2015 / Notices 48489 Colorado 80225 www.aphis.usda.gov/biotechnology/ completion of the tests. Data are [FR Doc. 2015–19854 Filed 8–12–15; 8:45 am] petitions_table_pending.shtml under gathered on multiple parameters and BILLING CODE 3410–23–P APHIS petition number 15–113–01p, or used by the applicant to evaluate by contacting Ms. Cindy Eck at (301) agronomic characteristics and product 851–3892; email: cynthia.a.eck@ performance. These and other data are DEPARTMENT OF AGRICULTURE aphis.usda.gov. used by APHIS to determine if the new FOR FURTHER INFORMATION CONTACT: Dr. variety poses a plant pest risk. Animal and Plant Health Inspection Paragraph (d) of § 340.6 provides that John Turner, Director, Environmental Service APHIS will publish a notice in the Risk Analysis Programs, Biotechnology [Docket No. APHIS–2015–0048] Federal Register providing 60 days for Regulatory Services, APHIS, 4700 River public comment for petitions for a Road Unit 147, Riverdale, MD 20737– Monsanto Company; Availability of determination of nonregulated status. 1236; (301) 851–3954, email: Petition for Determination of On March 6, 2012, we published in the john.t.turner@aphis.usda.gov. Nonregulated Status for Maize Federal Register (77 FR 13258–13260, SUPPLEMENTARY INFORMATION: Under the Docket No. APHIS–2011–0129) a Genetically Engineered for Resistance authority of the plant pest provisions of to Dicamba and Glufosinate notice 1 describing our process for the Plant Protection Act (7 U.S.C. 7701 soliciting public comment when AGENCY: Animal and Plant Health et seq.), the regulations in 7 CFR part considering petitions for determinations Inspection Service, USDA. 340, ‘‘Introduction of Organisms and of nonregulated status for GE organisms. ACTION: Notice. Products Altered or Produced Through In that notice we indicated that APHIS Genetic Engineering Which Are Plant would accept written comments SUMMARY: We are advising the public Pests or Which There Is Reason to regarding a petition once APHIS that the Animal and Plant Health Believe Are Plant Pests,’’ regulate, deemed it complete. Inspection Service (APHIS) has received among other things, the introduction In accordance with § 340.6(d) of the a petition from the Monsanto Company (importation, interstate movement, or regulations and our process for (Monsanto) seeking a determination of release into the environment) of soliciting public input when nonregulated status for maize organisms and products altered or considering petitions for determinations designated as MON 87419, which has produced through genetic engineering of nonregulated status for GE organisms, been genetically engineered for that are plant pests or that there is we are publishing this notice to inform resistance to the herbicides dicamba and reason to believe are plant pests. Such the public that APHIS will accept glufosinate. The petition has been genetically engineered (GE) organisms written comments regarding the petition submitted in accordance with our and products are considered ‘‘regulated for a determination of nonregulated regulations concerning the introduction articles.’’ status from interested or affected of certain genetically engineered The regulations in § 340.6(a) provide persons for a period of 60 days from the organisms and products. We are making that any person may submit a petition date of this notice. The petition is the Monsanto petition available for to the Animal and Plant Health available for public review and review and comment to help us identify Inspection Service (APHIS) seeking a comment, and copies are available as potential issues and impacts that APHIS determination that an article should not indicated under ADDRESSES above. We should be considering in our evaluation be regulated under 7 CFR part 340. are interested in receiving comments of the petition. Paragraphs (b) and (c) of § 340.6 regarding potential environmental and DATES: We will consider all comments describe the form that a petition for a interrelated economic issues and that we receive on or before October 13, determination of nonregulated status impacts that APHIS may determine 2015. must take and the information that must should be considered in our evaluation ADDRESSES: You may submit comments be included in the petition. of the petition. We are particularly by either of the following methods: APHIS has received a petition (APHIS interested in receiving comments • Federal eRulemaking Portal: Go to Petition Number 15–113–01p) from the regarding biological, cultural, or http://www.regulations.gov/ Monsanto Company (Monsanto) of St. ecological issues, and we encourage the #!docketDetail;D=APHIS-2015-0048. Louis, MO, seeking a determination of submission of scientific data, studies, or • Postal Mail/Commercial Delivery: nonregulated status for maize (Zea research to support your comments. We Send your comment to Docket No. mays) designated as event MON 87419 also request that, when possible, APHIS–2015–0048, Regulatory Analysis which has been genetically engineered commenters provide relevant and Development, PPD, APHIS, Station for resistance to the herbicides dicamba information regarding specific localities 3A–03.8, 4700 River Road Unit 118, and glufosinate. The Monsanto petition or regions as maize growth, crop Riverdale, MD 20737–1238. states that information collected during management, and crop utilization may The petition and any comments we field trials and laboratory analyses vary considerably by geographic region. receive on this docket may be viewed at indicates that MON 87419 maize is After the comment period closes, http://www.regulations.gov/ unlikely to pose a plant pest risk and, APHIS will review all written comments #!docketDetail;D=APHIS-2015-0048 or therefore, should not be a regulated received during the comment period in our reading room, which is located in article under APHIS’ regulations in 7 and any other relevant information. Any room 1141 of the USDA South Building, CFR part 340. substantive issues identified by APHIS 14th Street and Independence Avenue MON 87419 maize is currently based on our review of the petition and SW., Washington, DC. Normal reading regulated under 7 CFR part 340. our evaluation and analysis of tkelley on DSK3SPTVN1PROD with NOTICES room hours are 8 a.m. to 4:30 p.m., Interstate movements and field tests of comments will be considered in the Monday through Friday, except MON 87419 maize have been authorized development of our decisionmaking holidays. To be sure someone is there to by APHIS. Field tests conducted under documents. help you, please call (202) 799–7039 APHIS oversight allowed for evaluation before coming. in a natural agricultural setting while 1 To view the notice, go to http:// The petition is also available on the imposing measures to minimize the risk www.regulations.gov/#!docketDetail;D=APHIS- APHIS Web site at: http:// of persistence in the environment after 2011-0129. VerDate Sep<11>2014 16:56 Aug 12, 2015 Jkt 235001 PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 E:\FR\FM\13AUN1.SGM 13AUN1

48490 Federal Register / Vol. 80, No. 156 / Thursday, August 13, 2015 / Notices As part of our decisionmaking process DATES: The meeting will be held on or other reasonable accommodation for regarding a GE organism’s regulatory September 25, 2015 from 9 a.m. to 5 access to the facility or proceedings by status, APHIS prepares a plant pest risk p.m. contacting the person listed in the assessment to assess its plant pest risk All RAC meetings are subject to section titled FOR FURTHER INFORMATION and the appropriate environmental cancellation. For status of meeting prior CONTACT. All reasonable documentation—either an to attendance, please contact the person accommodation requests are managed environmental assessment (EA) or an listed under FOR FURTHER INFORMATION on a case by case basis. environmental impact statement (EIS)— CONTACT. Dated: August 4, 2015. in accordance with the National ADDRESSES: The meeting will be held at Jeremiah C. Ingersoll, Environmental Policy Act (NEPA), to the Corvallis Forestry Sciences Lab and Forest Supervisor. provide the Agency with a review and Siuslaw National Forest Supervisor’s [FR Doc. 2015–19663 Filed 8–12–15; 8:45 am] analysis of any potential environmental Office at 3200 SW. Jefferson Way, impacts associated with the petition BILLING CODE 3411–15–M Corvallis, OR 97331. Members of the request. For petitions for which APHIS public may attend in person or join by prepares an EA, APHIS will follow our video-teleconference from Forest published process for soliciting public DEPARTMENT OF COMMERCE Service facilities in Hebo, Waldport, or comment (see footnote 1) and publish a Reedsport, Oregon. separate notice in the Federal Register Submission for OMB Review; Written comments may be submitted Comment Request announcing the availability of APHIS’ as described under SUPPLEMENTARY EA and plant pest risk assessment. INFORMATION. All comments, including On behalf of the Committee for the Should APHIS determine that an EIS is names and addresses when provided, Implementation of Textile Agreements necessary, APHIS will complete the are placed in the record and are (CITA), the Department of Commerce NEPA EIS process in accordance with available for public inspection and will submit to the Office of Management Council on Environmental Quality copying. The public may inspect and Budget (OMB) for clearance the regulations (40 CFR parts 1500 through comments received at the Siuslaw following proposal for collection of 1508) and APHIS’ NEPA implementing National Forest Supervisor’s Office in information under the provisions of the regulations (7 CFR part 372). Corvallis, Oregon. Please call ahead to Paperwork Reduction Act (44 U.S.C. Authority: 7 U.S.C. 7701–7772 and 7781– facilitate entry into the building. Chapter 35). 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and FOR FURTHER INFORMATION CONTACT: Lisa Agency: International Trade 371.3. Romano, Public Affairs Staff Officer, by Administration. Done in Washington, DC, this 10th day of phone at 541–750–7075 or via email at Title: Interim Procedures for August 2015. lmromano@fs.fed.us. Considering Requests under the Kevin Shea, Individuals who use Commercial Availability Provision of Administrator, Animal and Plant Health telecommunication devices for the deaf the United States–Colombia Trade Inspection Service. (TDD) may call the Federal Information Promotion Agreement. [FR Doc. 2015–19925 Filed 8–12–15; 8:45 am] Relay Service (FIRS) at 1–800–877–8339 Form Number(s): N/A. BILLING CODE 3410–34–P between 8:00 a.m. and 8:00 p.m., OMB Control Number: 0625–0272. Eastern Standard Time, Monday Type of Request: Regular submission. through Friday. Burden Hours: 89. DEPARTMENT OF AGRICULTURE SUPPLEMENTARY INFORMATION: The Number of Respondents: 16 (10 for purpose of the meeting is: Requests; 3 for Responses; 3 for Forest Service 1. To conduct RAC business, elect a Rebuttals). RAC chairperson, set the 2015 fiscal Average Hours per Response: 8 hours Siuslaw Resource Advisory Committee year overhead rate, share information, per Request; 2 hours per Response; and Meeting provide a public forum, and review and 1 hour per Rebuttal. select Secure Rural Schools Title II Needs and Uses: Title II, Section AGENCY: Forest Service, USDA. 203(o) of the United States-Colombia projects for funding. ACTION: Notice of meeting. The meeting is open to the public. Trade Promotion Agreement The agenda will include time for people Implementation Act (the ‘‘Act’’) [Public SUMMARY: The Siuslaw Resource to make oral statements of three minutes Law 112–42] implements the Advisory Committee (RAC) will meet in or less. Individuals wishing to make an commercial availability provision Corvallis, Oregon. The committee is oral statement should request to do so provided for in Article 3.3 of the United authorized under the Secure Rural in writing by September 5, 2015, to be States-Colombia Trade Promotion Schools and Community Self- scheduled on the agenda. Anyone who Agreement (the ‘‘Agreement’’). The Determination Act (the Act) and would like to bring related matters to Agreement entered into force on May operates in compliance with the Federal the attention of the committee may file 15, 2012. Subject to the rules of origin Advisory Committee Act. The purpose written statements with the committee in Annex 4.1 of the Agreement, and of the committee is to improve staff before or after the meeting. Written pursuant to the textile provisions of the collaborative relationships and to comments and requests for time for oral Agreement, a fabric, yarn, or fiber provide advice and recommendations to comments must be sent to Lisa Romano, produced in Colombia or the United the Forest Service concerning projects Public Affairs Staff Officer, 3200 SW States and traded between the two tkelley on DSK3SPTVN1PROD with NOTICES and funding consistent with Title II of Jefferson Way, Corvallis, OR 97331; or countries is entitled to duty-free tariff the Act. Additional RAC information, by email to lmromano@fs.fed.us. treatment. Annex 3–B of the Agreement including the meeting agenda and the Meeting Accommodations: If you are also lists specific fabrics, yarns, and meeting summary/minutes can be found a person requiring reasonable fibers that the two countries agreed are at the following Web site: http:// accommodation, please make requests not available in commercial quantities www.fs.usda.gov/main/siuslaw/ in advance for sign language in a timely manner from producers in workingtogether/advisorycommittees. interpreting, assistive listening devices Colombia or the United States. The VerDate Sep<11>2014 16:56 Aug 12, 2015 Jkt 235001 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 E:\FR\FM\13AUN1.SGM 13AUN1


Document Created: 2018-02-23 10:57:03
Document Modified: 2018-02-23 10:57:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesWe will consider all comments that we receive on or before October 13, 2015.
ContactDr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3954, email: [email protected]
FR Citation80 FR 48489 
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