82_FR_5536 82 FR 5525 - The Scotts Co. and Monsanto Co.; Determination of Nonregulated Status of Creeping Bentgrass Genetically Engineered for Resistance to Glyphosate

82 FR 5525 - The Scotts Co. and Monsanto Co.; Determination of Nonregulated Status of Creeping Bentgrass Genetically Engineered for Resistance to Glyphosate

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 82, Issue 11 (January 18, 2017)

Page Range5525-5526
FR Document2017-01077

We are advising the public of our determination that creeping bentgrass designated as event ASR368, which has been genetically engineered for resistance to the herbicide glyphosate by the Scotts Company and Monsanto Company 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 the Scotts Company and Monsanto Company in its petition for a determination of nonregulated status, our analysis of publically available scientific data, and comments received from the public on the petition for nonregulated status and its associated environmental impact statement and plant pest risk assessment. This notice also announces the availability of our written determination and record of decision.

Federal Register, Volume 82 Issue 11 (Wednesday, January 18, 2017) 
[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)]
[Notices]
[Pages 5525-5526]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-01077]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2015-0096]


The Scotts Co. and Monsanto Co.; Determination of Nonregulated 
Status of Creeping Bentgrass Genetically Engineered for Resistance to 
Glyphosate

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that creeping 
bentgrass designated as event ASR368, which has been genetically 
engineered for resistance to the herbicide glyphosate by the Scotts 
Company and Monsanto Company 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 the Scotts Company and Monsanto Company 
in its petition for a determination of nonregulated status, our 
analysis of publically available scientific data, and comments received 
from the public on the petition for nonregulated status and its 
associated environmental impact statement and plant pest risk 
assessment. This notice also announces the availability of our written 
determination and record of decision.

DATES: Effective January 18, 2017.

ADDRESSES: You may read the documents referenced in this notice and any 
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 http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under 
APHIS Petition Number 15-300-01p and are posted with the comments we 
received on the Regulations.gov Web site at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0096.

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: [email protected]. To obtain copies 
of the documents referenced in this notice, contact Ms. Cindy Eck at 
(301) 851-3892, email: [email protected].

SUPPLEMENTARY INFORMATION: 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 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 from the Scotts Company of Marysville, 
OH, and Monsanto Company of St. Louis, MO (Scotts/Monsanto), seeking a 
determination of nonregulated status of creeping bentgrass (Agrostis 
stolonifera L.) designated as event ASR368, which has been genetically 
engineered for resistance to the herbicide glyphosate. The Scotts/
Monsanto petition states that information collected during field trials

[[Page 5526]]

and laboratory analyses indicates that ASR368 bentgrass is not likely 
to be a plant pest 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 January 8, 
2016 (81 FR 902-903, Docket No. APHIS-2015-0096), APHIS announced the 
availability of the Scotts/Monsanto petition for public comment. APHIS 
solicited comments on the petition for 60 days ending on March 8, 2016. 
The notice also announced that APHIS would prepare either an 
environmental assessment or an environmental impact statement (EIS) in 
accordance with the National Environmental Policy Act of 1969, as 
amended (42 U.S.C. 4321 et seq., NEPA) to provide the Agency with a 
review and analysis of any potential environmental impacts associated 
with the petition request.
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    \1\ To view the notice, the petition, the comments we received, 
and other supporting documents, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0096.
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    Following review of public comments, we published another notice 
\2\ in the Federal Register on August 3, 2016 (81 FR 51174-51176, 
Docket No. APHIS-2015-0096), advising the public of our intent to 
prepare an EIS for the potential determination of nonregulated status 
requested by the petition. APHIS decided to prepare an EIS in order to 
perform a comprehensive environmental analysis of the potential 
environmental impacts that may occur as a result of granting 
determinations of nonregulated status for this event.
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    \2\ To view the draft EIS, final EIS, supporting documents, and 
the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0096.
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National Environmental Policy Act and Record of Decision

    To provide the public with documentation of APHIS' review and 
analysis of the potential environmental impacts associated with a 
determination of nonregulated status of ASR368 bentgrass, an EIS has 
been prepared in accordance with: (1) NEPA, as amended (42 U.S.C. 4321 
et seq.); (2) regulations of the Council on Environmental Quality for 
implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508); (3) USDA regulations implementing NEPA (7 CFR part 1b); and (4) 
APHIS' NEPA Implementing Procedures (7 CFR part 372).
    A notice of availability regarding the draft EIS prepared by APHIS 
was published by the Environmental Protection Agency (EPA) in the 
Federal Register on September 30, 2016 (81 FR 67348-67349, Docket No. 
ER-FRL-9029-3). Along with the draft EIS, APHIS also made available the 
plant pest risk assessment (PPRA) for the petition. APHIS reviewed and 
evaluated all of the public comments received on the draft EIS and 
prepared formal responses to them as part of the final EIS.
    A notice of availability regarding the final EIS prepared by APHIS 
was published by EPA in the Federal Register on December 9, 2016 (81 FR 
89095-89096, Docket No. ER-FRL-9030-6). The NEPA implementing 
regulations in 40 CFR 1506.10 require a minimum 30-day review period 
between the time the notice of availability of a final EIS is published 
and the time an agency makes a decision on an action covered by the 
EIS. APHIS has reviewed and evaluated the comments received during the 
30-day review period and has concluded that it has fully and 
appropriately analyzed the relevant environmental issues covered by the 
final EIS and those comments. Based on our final EIS, the response to 
public comments, and other pertinent scientific data, APHIS has 
prepared a record of decision for the final EIS.

Determination of Nonregulated Status

    Based on APHIS' analysis of field and laboratory data submitted by 
Scotts/Monsanto, references provided in the petitions, peer-reviewed 
publications, information analyzed in the EIS, the PPRA, comments 
provided by the public, and APHIS' evaluation of and response to those 
comments, APHIS has determined that is unlikely to pose a plant pest 
risk. Accordingly, the petition requesting a determination of 
nonregulated status is approved and ASR368 bentgrass is no longer 
subject to our regulations governing the introduction of certain 
genetically engineered organisms and to the plant pest provisions of 
the Plant Protection Act.
    Copies of the signed determination document and the signed record 
of decision, as well as copies of the final EIS and the PPRA 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 12th day of January 2017.
Michael C. Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-01077 Filed 1-17-17; 8:45 am]
 BILLING CODE 3410-34-P

Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Notices 5525 Title: Interstate Movement of Fruit Estimated annual number of any comments we received in our From Hawaii. respondents: 110. reading room. The reading room is OMB Control Number: 0579–0331. Estimated annual number of located in room 1141 of the USDA Type of Request: Extension of responses per respondent: 25. South Building, 14th Street and approval of an information collection. Estimated annual number of Independence Avenue SW., Abstract: The Plant Protection Act (7 responses: 2,782. Washington, DC. Normal reading room U.S.C. 7701 et seq.) authorizes the Estimated total annual burden on hours are 8 a.m. to 4:30 p.m., Monday Secretary of Agriculture to restrict the respondents: 618 hours. (Due to through Friday, except holidays. To be importation, entry, or interstate averaging, the total annual burden hours sure someone is there to help you, movement of plants, plant products, and may not equal the product of the annual please call (202) 799–7039 before other articles to prevent the number of responses multiplied by the coming. Those documents are also introduction of plant pests into the reporting burden per response.) available on the Internet at http://www. United States or their dissemination All responses to this notice will be aphis.usda.gov/biotechnology/petitions_ within the United States. The summarized and included in the request table_pending.shtml under APHIS regulations in 7 CFR part 318, State of for OMB approval. All comments will Petition Number 15–300–01p and are Hawaii and Territories Quarantine also become a matter of public record. posted with the comments we received Notices, prohibit or restrict the Done in Washington, DC, this 11th day of on the Regulations.gov Web site at interstate movement of fruits, January 2017. http://www.regulations.gov/#!docket vegetables, and other products from Kevin Shea, Detail;D=APHIS-2015-0096. Hawaii, Puerto Rico, the U.S. Virgin FOR FURTHER INFORMATION CONTACT: Dr. Administrator, Animal and Plant Health Islands, and Guam to the continental Inspection Service. John Turner, Director, Environmental United States to prevent the spread of Risk Analysis Programs, Biotechnology [FR Doc. 2017–01009 Filed 1–17–17; 8:45 am] plant pests or noxious weeds. Regulatory Services, APHIS, 4700 River BILLING CODE 3410–34–P In accordance with the regulations in Road, Unit 147, Riverdale, MD 20737– § 318.13–26, breadfruit, jackfruit, fresh 1236; (301) 851–3954, email: pods of cowpea and its relatives, dragon john.t.turner@aphis.usda.gov. To obtain DEPARTMENT OF AGRICULTURE fruit, mangosteen, moringa pods, and copies of the documents referenced in melon must meet certain conditions for Animal and Plant Health Inspection this notice, contact Ms. Cindy Eck at interstate movement from Hawaii into Service (301) 851–3892, email: cynthia.a.eck@ the continental United States. These aphis.usda.gov. conditions involve information [Docket No. APHIS–2015–0096] collection activities, such as compliance SUPPLEMENTARY INFORMATION: The The Scotts Co. and Monsanto Co.; regulations in 7 CFR part 340, agreements, certificates and limited Determination of Nonregulated Status ‘‘Introduction of Organisms and permits, among other things. We are asking the Office of of Creeping Bentgrass Genetically Products Altered or Produced Through Management and Budget (OMB) to Engineered for Resistance to Genetic Engineering Which Are Plant approve our use of these information Glyphosate Pests or Which There Is Reason to collection activities for an additional 3 AGENCY: Animal and Plant Health Believe Are Plant Pests,’’ regulate, years. Inspection Service, USDA. among other things, the introduction The purpose of this notice is to solicit (importation, interstate movement, or ACTION: Notice. comments from the public (as well as release into the environment) of affected agencies) concerning our SUMMARY: We are advising the public of organisms and products altered or information collection. These comments our determination that creeping produced through genetic engineering will help us: bentgrass designated as event ASR368, that are plant pests or that there is (1) Evaluate whether the collection of which has been genetically engineered reason to believe are plant pests. Such information is necessary for the proper for resistance to the herbicide genetically engineered (GE) organisms performance of the functions of the glyphosate by the Scotts Company and and products are considered ‘‘regulated Agency, including whether the Monsanto Company is no longer articles.’’ information will have practical utility; considered a regulated article under our The regulations in § 340.6(a) provide (2) Evaluate the accuracy of our regulations governing the introduction that any person may submit a petition estimate of the burden of the collection of certain genetically engineered to APHIS seeking a determination that of information, including the validity of organisms. Our determination is based an article should not be regulated under the methodology and assumptions used; on our evaluation of data submitted by 7 CFR part 340. Paragraphs (b) and (c) (3) Enhance the quality, utility, and the Scotts Company and Monsanto of § 340.6 describe the form that a clarity of the information to be Company in its petition for a petition for a determination of collected; and determination of nonregulated status, nonregulated status must take and the (4) Minimize the burden of the our analysis of publically available information that must be included in collection of information on those who scientific data, and comments received the petition. are to respond, through use, as APHIS received a petition from the from the public on the petition for appropriate, of automated, electronic, Scotts Company of Marysville, OH, and nonregulated status and its associated mechanical, and other collection Monsanto Company of St. Louis, MO environmental impact statement and (Scotts/Monsanto), seeking a mstockstill on DSK3G9T082PROD with NOTICES technologies; e.g., permitting electronic plant pest risk assessment. This notice submission of responses. determination of nonregulated status of also announces the availability of our Estimate of burden: The public creeping bentgrass (Agrostis stolonifera written determination and record of reporting burden for this collection of L.) designated as event ASR368, which decision. information is estimated to average 0.22 has been genetically engineered for hours per response. Effective January 18, 2017. DATES: resistance to the herbicide glyphosate. Respondents: Importers of fruit from ADDRESSES: You may read the The Scotts/Monsanto petition states that Hawaii. documents referenced in this notice and information collected during field trials VerDate Sep<11>2014 17:41 Jan 17, 2017 Jkt 241001 PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 E:\FR\FM\18JAN1.SGM 18JAN1

5526 Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Notices and laboratory analyses indicates that 67348–67349, Docket No. ER–FRL– Done in Washington, DC, this 12th day of ASR368 bentgrass is not likely to be a 9029–3). Along with the draft EIS, January 2017. plant pest and therefore should not be APHIS also made available the plant Michael C. Gregoire, a regulated article under APHIS’ pest risk assessment (PPRA) for the Acting Administrator, Animal and Plant regulations in 7 CFR part 340. petition. APHIS reviewed and evaluated Health Inspection Service. In a notice 1 published in the Federal all of the public comments received on [FR Doc. 2017–01077 Filed 1–17–17; 8:45 am] Register on January 8, 2016 (81 FR 902– the draft EIS and prepared formal BILLING CODE 3410–34–P 903, Docket No. APHIS–2015–0096), responses to them as part of the final APHIS announced the availability of the EIS. Scotts/Monsanto petition for public DEPARTMENT OF AGRICULTURE comment. APHIS solicited comments on A notice of availability regarding the the petition for 60 days ending on final EIS prepared by APHIS was Animal and Plant Health Inspection March 8, 2016. The notice also published by EPA in the Federal Service announced that APHIS would prepare Register on December 9, 2016 (81 FR [Docket No. APHIS–2016–0107] either an environmental assessment or 89095–89096, Docket No. ER–FRL– an environmental impact statement 9030–6). The NEPA implementing Notice of Request for Extension of (EIS) in accordance with the National regulations in 40 CFR 1506.10 require a Approval of an Information Collection; Environmental Policy Act of 1969, as minimum 30-day review period Importation of Emerald Ash Borer Host amended (42 U.S.C. 4321 et seq., NEPA) between the time the notice of Material From Canada to provide the Agency with a review availability of a final EIS is published and analysis of any potential AGENCY: Animal and Plant Health and the time an agency makes a environmental impacts associated with Inspection Service, USDA. decision on an action covered by the the petition request. ACTION: Extension of approval of an EIS. APHIS has reviewed and evaluated Following review of public the comments received during the 30- information collection; comment comments, we published another request. day review period and has concluded notice 2 in the Federal Register on that it has fully and appropriately August 3, 2016 (81 FR 51174–51176, SUMMARY: In accordance with the analyzed the relevant environmental Paperwork Reduction Act of 1995, this Docket No. APHIS–2015–0096), issues covered by the final EIS and notice announces the Animal and Plant advising the public of our intent to those comments. Based on our final EIS, Health Inspection Service’s intention to prepare an EIS for the potential determination of nonregulated status the response to public comments, and request an extension of approval of an requested by the petition. APHIS other pertinent scientific data, APHIS information collection associated with decided to prepare an EIS in order to has prepared a record of decision for the the regulations for the importation of perform a comprehensive final EIS. emerald ash borer host material from environmental analysis of the potential Canada to prevent the introduction and Determination of Nonregulated Status spread of emerald ash borer in the environmental impacts that may occur as a result of granting determinations of Based on APHIS’ analysis of field and United States. nonregulated status for this event. laboratory data submitted by Scotts/ DATES: We will consider all comments Monsanto, references provided in the that we receive on or before March 20, National Environmental Policy Act and 2017. Record of Decision petitions, peer-reviewed publications, information analyzed in the EIS, the ADDRESSES: You may submit comments To provide the public with PPRA, comments provided by the by either of the following methods: documentation of APHIS’ review and public, and APHIS’ evaluation of and • Federal eRulemaking Portal: Go to analysis of the potential environmental http://www.regulations.gov/#!docket response to those comments, APHIS has impacts associated with a determination Detail;D=APHIS-2016-0107. determined that is unlikely to pose a of nonregulated status of ASR368 plant pest risk. Accordingly, the petition • Postal Mail/Commercial Delivery: bentgrass, an EIS has been prepared in Send your comment to Docket No. accordance with: (1) NEPA, as amended requesting a determination of APHIS–2016–0107, Regulatory Analysis (42 U.S.C. 4321 et seq.); (2) regulations nonregulated status is approved and and Development, PPD, APHIS, Station of the Council on Environmental ASR368 bentgrass is no longer subject to 3A–03.8, 4700 River Road Unit 118, Quality for implementing the our regulations governing the Riverdale, MD 20737–1238. procedural provisions of NEPA (40 CFR introduction of certain genetically Supporting documents and any parts 1500–1508); (3) USDA regulations engineered organisms and to the plant comments we receive on this docket implementing NEPA (7 CFR part 1b); pest provisions of the Plant Protection may be viewed at http://www. and (4) APHIS’ NEPA Implementing Act. regulations.gov/#!docketDetail;D= Procedures (7 CFR part 372). Copies of the signed determination APHIS-2016-0107 or in our reading A notice of availability regarding the document and the signed record of room, which is located in room 1141 of draft EIS prepared by APHIS was decision, as well as copies of the final the USDA South Building, 14th Street published by the Environmental EIS and the PPRA are available as and Independence Avenue SW., Protection Agency (EPA) in the Federal indicated in the ADDRESSES and FOR Washington, DC. Normal reading room Register on September 30, 2016 (81 FR hours are 8 a.m. to 4:30 p.m., Monday FURTHER INFORMATION CONTACT sections mstockstill on DSK3G9T082PROD with NOTICES of this notice. through Friday, except holidays. To be 1 To view the notice, the petition, the comments sure someone is there to help you, we received, and other supporting documents, go to Authority: 7 U.S.C. 7701–7772 and 7781– http://www.regulations.gov/#!docketDetail;D= please call (202) 799–7039 before 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and coming. APHIS-2015-0096. 2 To view the draft EIS, final EIS, supporting 371.3. documents, and the comments we received, go to FOR FURTHER INFORMATION CONTACT: For http://www.regulations.gov/#!docketDetail;D= information on the regulations for the APHIS-2015-0096. importation of emerald ash borer host VerDate Sep<11>2014 17:41 Jan 17, 2017 Jkt 241001 PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 E:\FR\FM\18JAN1.SGM 18JAN1


Document Created: 2018-02-01 15:19:22
Document Modified: 2018-02-01 15:19:22
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.
DatesEffective January 18, 2017.
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] To obtain copies of the documents referenced in this notice, contact Ms. Cindy Eck at (301) 851-3892, email: [email protected]
FR Citation82 FR 5525 
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