Monsanto Company; Availability of Petition for Determination of Nonregulated Status of Cotton Genetically Engineered for Insect Resistance, 50818-50819 [2019-20961]

Download as PDF 50818 Federal Register / Vol. 84, No. 187 / Thursday, September 26, 2019 / Notices khammond on DSKJM1Z7X2PROD with NOTICES displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. National Institute of Food and Agriculture Title: Veterinary Medicine Loan Repayment Program (VMLRP). OMB Control Number: 0524–0050. Summary of Collection: In January 2003, the National Veterinary Medical Service Act (NVMSA) was passed into law adding section 1415A to the National Agricultural Research, Extension, and Teaching Policy Act of 1997. This law established a new Veterinary Medicine Loan Repayment Program (VMLRP) (7 U.S.C. 3151a) authorizing the Secretary of Agriculture to carry out a program of entering into agreements with veterinarians under which they agree to provide veterinary services in veterinarian shortage situations. The purpose of the program is to assure an adequate supply of trained food animal veterinarians in shortage situations and provide USDA with a pool of veterinary specialists to assist in the control and eradication of animal disease outbreaks. The National Institute of Food and Agriculture (NIFA) will designate geographic and practice areas that have a shortage of food supply veterinarians in order to carry out the VMLRP goals of strengthening the nation’s animal health infrastructure and supplementing the Federal response during animal health emergencies. NIFA will carry out NVMSA by entering into educational loan repayment agreements with veterinarians who agree to provide veterinary services in veterinarian shortage situation for a determined period of time. NIFA will collect information using the Shortage Situation Nomination Form, Application Form, Records and Reports, and Surveys Need and Use of the Information: The information collected allows the National Institute of Food and Agriculture to request from VMLRP applicants’ information related to eligibility, qualification, career interests, and recommendations necessary to evaluate their applications for repayment of educational indebtedness in return for agreeing to provide veterinary services in veterinarian shortage situations. The information will also be used to determine an applicant’s eligibility for participation in the program. The information also allows the VMLRP to assess program VerDate Sep<11>2014 16:48 Sep 25, 2019 Jkt 247001 processes and impact, make program improvements based on process feedback, and provide feedback to State Animal Health Officials on veterinarian shortage situations, which can aide them during the nomination process. Description of Respondents: Individuals or households; Business or other for-profit. Number of Respondents: 1,090. Frequency of Responses: Reporting: Biennially. Total Burden Hours: 11,658. Ruth Brown, Departmental Information Collection Clearance Officer. [FR Doc. 2019–20866 Filed 9–25–19; 8:45 am] BILLING CODE 3410–09–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2019–0050] Monsanto Company; Availability of Petition for Determination of Nonregulated Status of Cotton Genetically Engineered for Insect Resistance Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from Monsanto Company seeking a determination of nonregulated status for cotton designated as MON 88702, which has been genetically engineered for resistance to certain insects, primarily Lygus spp. 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. SUMMARY: We will consider all comments that we receive on or before November 25, 2019. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!docketDetail;D=APHIS-2019-0050. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2019–0050, Regulatory Analysis DATES: PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 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 https://www.regulations.gov/#! docketDetail;D=APHIS-2019-0050 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 website at: https:// www.aphis.usda.gov/biotechnology/ petitions_table_pending.shtml under APHIS petition 19–091–01p. FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737–1236; (301) 851–3892, email: cynthia.a.eck@ 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. Paragraphs (b) and (c) of § 340.6 describe the submission procedures, format, and the information that must be included in the petition. APHIS has received a petition (APHIS Petition Number 19–091–01p) from Monsanto Company (Monsanto) seeking a determination of nonregulated status for cotton designated as MON 88702, which has been genetically engineered for resistance to certain insects. The Monsanto petition states that this cotton is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS’ regulations in 7 CFR part 340. E:\FR\FM\26SEN1.SGM 26SEN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 84, No. 187 / Thursday, September 26, 2019 / Notices As described in the petition, MON 88702 cotton was generated using Agrobacterium-mediated transformation with plasmid PV–GHIR508523 containing the mCry51Aa2 expression cassette. The coding sequence mCry51Aa2 produces a modified Cry51Aa2 insecticidal crystal (Cry) protein derived from Bacillus thuringiensis (Bt) that protects cotton against feeding damage caused by targeted hemipteran (Lygus hesperus and Lygus lineolaris) and thysanopteran (Frankliniella spp.) insect pests. MON 88702 cotton has been field tested in the continental United States and Puerto Rico over 8 years as authorized under APHIS permits and notifications. Field tests conducted under APHIS oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize the likelihood 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 1 To view the notice, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2011-0129. VerDate Sep<11>2014 16:48 Sep 25, 2019 Jkt 247001 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. 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 decision making documents. As part of our decision making 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 20th day of September 2019. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2019–20961 Filed 9–25–19; 8:45 am] BILLING CODE 3410–34–P COMMODITY FUTURES TRADING COMMISSION Agency Information Collection Activities Under OMB Review Commodity Futures Trading Commission. ACTION: Notice. AGENCY: PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 50819 In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collection and its expected costs and burden. DATES: Comments must be submitted on or before October 28, 2019. ADDRESSES: Comments regarding the burden estimate or any other aspect of the information collection, including suggestions for reducing the burden, may be submitted directly to the Office of Information and Regulatory Affairs (OIRA) in OMB within 30 days of this notice’s publication by either of the following methods. Please identify the comments by ‘‘OMB Control No. 3038– 0099.’’ • By email addressed to: OIRAsubmissions@omb.eop.gov or • By mail addressed to: the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention Desk Officer for the Commodity Futures Trading Commission, 725 17th Street NW, Washington DC 20503. A copy of all comments submitted to OIRA should be sent to the Commodity Futures Trading Commission (the ‘‘Commission’’) by either of the following methods. The copies should refer to ‘‘OMB Control No. 3038–0099.’’ • By mail addressed to: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581; • By Hand Delivery/Courier to the same address; or • Through the Commission’s website at https://comments.cftc.gov. Please follow the instructions for submitting comments through the website. A copy of the supporting statement for the collection of information discussed herein may be obtained by visiting https://RegInfo.gov. All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to https:// www.cftc.gov. You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 SUMMARY: E:\FR\FM\26SEN1.SGM 26SEN1

Agencies

[Federal Register Volume 84, Number 187 (Thursday, September 26, 2019)]
[Notices]
[Pages 50818-50819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20961]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2019-0050]


Monsanto Company; Availability of Petition for Determination of 
Nonregulated Status of Cotton Genetically Engineered for Insect 
Resistance

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 Monsanto 
Company seeking a determination of nonregulated status for cotton 
designated as MON 88702, which has been genetically engineered for 
resistance to certain insects, primarily Lygus spp. 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 
November 25, 2019.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2019-0050.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2019-0050, 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 https://www.regulations.gov/#!docketDetail;D=APHIS-2019-0050 
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 website at: https://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under 
APHIS petition 19-091-01p.

FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Biotechnology 
Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 
20737-1236; (301) 851-3892, email: [email protected].

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 submission procedures, format, and the information that must be 
included in the petition.
    APHIS has received a petition (APHIS Petition Number 19-091-01p) 
from Monsanto Company (Monsanto) seeking a determination of 
nonregulated status for cotton designated as MON 88702, which has been 
genetically engineered for resistance to certain insects. The Monsanto 
petition states that this cotton is unlikely to pose a plant pest risk 
and, therefore, should not be a regulated article under APHIS' 
regulations in 7 CFR part 340.

[[Page 50819]]

    As described in the petition, MON 88702 cotton was generated using 
Agrobacterium-mediated transformation with plasmid PV-GHIR508523 
containing the mCry51Aa2 expression cassette. The coding sequence 
mCry51Aa2 produces a modified Cry51Aa2 insecticidal crystal (Cry) 
protein derived from Bacillus thuringiensis (Bt) that protects cotton 
against feeding damage caused by targeted hemipteran (Lygus hesperus 
and Lygus lineolaris) and thysanopteran (Frankliniella spp.) insect 
pests. MON 88702 cotton has been field tested in the continental United 
States and Puerto Rico over 8 years as authorized under APHIS permits 
and notifications. Field tests conducted under APHIS oversight allowed 
for evaluation in a natural agricultural setting while imposing 
measures to minimize the likelihood of persistence in the environment 
after completion of the tests. Data are gathered on multiple parameters 
and used by the applicant to evaluate agronomic characteristics and 
product performance. These and other data are used by APHIS to 
determine if the new variety poses a plant pest risk.
    Paragraph (d) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register providing 60 days for public comment for 
petitions for a determination of nonregulated status. On March 6, 2012, 
we published in the Federal Register (77 FR 13258-13260, Docket No. 
APHIS-2011-0129) a notice \1\ describing our process for soliciting 
public comment when considering petitions for determinations of 
nonregulated status for GE organisms. In that notice we indicated that 
APHIS would accept written comments regarding a petition once APHIS 
deemed it complete.
---------------------------------------------------------------------------

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

    In accordance with Sec.  340.6(d) of the regulations and our 
process for soliciting public input when considering petitions for 
determinations of nonregulated status for GE organisms, we are 
publishing this notice to inform the public that APHIS will accept 
written comments regarding the petition for a determination of 
nonregulated status from interested or affected persons for a period of 
60 days from the date of this notice. The petition is available for 
public review and 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.
    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 decision making documents. As 
part of our decision making 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 20th day of September 2019.
 Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-20961 Filed 9-25-19; 8:45 am]
 BILLING CODE 3410-34-P
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