82 FR 35172 - Bayer CropScience LP: Determination of Nonregulated Status of Canola Genetically Engineered for Male Sterility and Glufosinate-Ammonium Resistance

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 82, Issue 144 (July 28, 2017)

Page Range		35172-35172
FR Document		2017-15949

We are advising the public of our determination to extend the nonregulated status of InVigor[supreg] MS8 canola (hereinafter MS8 canola) to Bayer CropSciences LP's (Bayer) canola event MS11 which has been genetically engineered for male sterility and resistance to the herbicide glufosinate-ammonium using the same mechanism of action as Bayer's MS8 canola. Our determination is based on our evaluation of data submitted by Bayer 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 assessment and plant pest risk similarity assessment. This notice also announces the availability of our written determination and finding of no significant impact.

Federal Register, Volume 82 Issue 144 (Friday, July 28, 2017)

[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Notices]
[Page 35172]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-15949]


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Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

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Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / 
Notices

[[Page 35172]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2017-0015]


Bayer CropScience LP: Determination of Nonregulated Status of 
Canola Genetically Engineered for Male Sterility and Glufosinate-
Ammonium Resistance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination to extend the 
nonregulated status of InVigor[supreg] MS8 canola (hereinafter MS8 
canola) to Bayer CropSciences LP's (Bayer) canola event MS11 which has 
been genetically engineered for male sterility and resistance to the 
herbicide glufosinate-ammonium using the same mechanism of action as 
Bayer's MS8 canola. Our determination is based on our evaluation of 
data submitted by Bayer 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 assessment and 
plant pest risk similarity assessment. This notice also announces the 
availability of our written determination and finding of no significant 
impact.

DATES: Effective July 28, 2017.

FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Document Control 
Officer/Team Leader, Policy Coordination Programs, Biotechnology 
Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 
20737-1236; (301) 851-3954, email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 7 CFR part 340, ``Introduction of Organisms and 
Products Altered or Produced Through Genetic Engineering Which Are 
Plant Pests or Which There Is Reason to Believe Are Plant Pests,'' 
regulate, among other things, the introduction (importation, interstate 
movement, or release into the environment) of organisms and products 
altered or produced through genetic engineering that are plant pests or 
that there is reason to believe are plant pests. Such genetically 
engineered (GE) organisms and products are considered ``regulated 
articles.''
    The regulations in Sec.  [thinsp]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.  [thinsp]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 request for an extension of the determination of 
nonregulated status of MS8 canola to canola designated as canola event 
MS11 (APHIS Petition Number 16-235-01p) from Bayer CropScience LP 
(Bayer) of Research Triangle Park, NC. MS11 canola expresses male 
sterility and resistance to the herbicide glufosinate-ammonium. In its 
request, Bayer stated that this canola is similar to the antecedent 
organism MS8 canola and, based on the similarity to the antecedent 
organism, is unlikely to pose a plant pest risk and, therefore, should 
not be a regulated article under APHIS' regulations in 7 CFR part 340.
    In a notice \1\ published in the Federal Register on April 12, 2017 
(82 FR 17625-17626, Docket No. APHIS-2017-0015), APHIS announced the 
availability of the Bayer's petition, draft environmental assessment, 
preliminary finding of no significant impact, draft plant pest risk 
similarity assessment, and preliminary determination for nonregulated 
status for public comment. We solicited comments on the notice for 30 
days ending May 12, 2017. We extended the deadline for comments until 
May 30, 2017, in a document published in the Federal Register on May 
10, 2017 (82 FR 21790-21791, Docket No. APHIS-2017-0015). We received 5 
comments by that date. The comments are discussed in the finding of no 
significant impact (FONSI) that accompanies this notice.
---------------------------------------------------------------------------

    \1\ To view the notice, the petition, the comments we received, 
and other supporting documents, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0015.
---------------------------------------------------------------------------

Determination of Nonregulated Status

    Based on APHIS' analysis of field and laboratory data submitted by 
Bayer, references provided in the petitions, peer-reviewed 
publications, information analyzed in the environmental assessment, the 
plant pest risk similarity assessment (PPRSA), comments provided by the 
public, and APHIS' evaluation of and response to those comments, APHIS 
has determined that MS11 canola is unlikely to pose a plant pest risk. 
Accordingly, the petition requesting a determination of nonregulated 
status is approved and MS11 canola 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 environmental assessment, 
FONSI, and the PPRSA 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 25th day of July 2017.
Christine Zakarka,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-15949 Filed 7-27-17; 8:45 am]
 BILLING CODE 3410-34-P

35172

Notices Federal Register
Vol. 82, No. 144

Friday, July 28, 2017

This section of the FEDERAL REGISTER Background until May 30, 2017, in a document
contains documents other than rules or published in the Federal Register on
The regulations in 7 CFR part 340,
proposed rules that are applicable to the May 10, 2017 (82 FR 21790–21791,
public. Notices of hearings and investigations, ‘‘Introduction of Organisms and
Products Altered or Produced Through Docket No. APHIS–2017–0015). We
committee meetings, agency decisions and
rulings, delegations of authority, filing of Genetic Engineering Which Are Plant received 5 comments by that date. The
petitions and applications and agency Pests or Which There Is Reason to comments are discussed in the finding
statements of organization and functions are Believe Are Plant Pests,’’ regulate, of no significant impact (FONSI) that
examples of documents appearing in this among other things, the introduction accompanies this notice.
section. (importation, interstate movement, or
release into the environment) of Determination of Nonregulated Status
organisms and products altered or Based on APHIS’ analysis of field and
DEPARTMENT OF AGRICULTURE produced through genetic engineering laboratory data submitted by Bayer,
that are plant pests or that there is
Animal and Plant Health Inspection references provided in the petitions,
reason to believe are plant pests. Such
Service peer-reviewed publications, information
genetically engineered (GE) organisms
and products are considered ‘‘regulated analyzed in the environmental
[Docket No. APHIS–2017–0015] articles.’’ assessment, the plant pest risk similarity
The regulations in § 340.6(a) provide assessment (PPRSA), comments
Bayer CropScience LP: Determination that any person may submit a petition provided by the public, and APHIS’
of Nonregulated Status of Canola to the Animal and Plant Health evaluation of and response to those
Genetically Engineered for Male Inspection Service (APHIS) seeking a comments, APHIS has determined that
Sterility and Glufosinate-Ammonium determination that an article should not MS11 canola is unlikely to pose a plant
Resistance be regulated under 7 CFR part 340. pest risk. Accordingly, the petition
Paragraphs (b) and (c) of § 340.6 requesting a determination of
AGENCY: Animal and Plant Health describe the form that a petition for a nonregulated status is approved and
Inspection Service, USDA. determination of nonregulated status MS11 canola is no longer subject to our
ACTION: Notice. must take and the information that must regulations governing the introduction
be included in the petition. of certain genetically engineered
SUMMARY: We are advising the public of APHIS received a request for an organisms and to the plant pest
our determination to extend the extension of the determination of provisions of the Plant Protection Act.
nonregulated status of InVigor® MS8 nonregulated status of MS8 canola to
canola (hereinafter MS8 canola) to Bayer canola designated as canola event MS11 Copies of the signed determination
CropSciences LP’s (Bayer) canola event (APHIS Petition Number 16–235–01p) document and the signed record of
MS11 which has been genetically from Bayer CropScience LP (Bayer) of decision, as well as copies of the final
engineered for male sterility and Research Triangle Park, NC. MS11 environmental assessment, FONSI, and
resistance to the herbicide glufosinate- canola expresses male sterility and the PPRSA are available as indicated in
ammonium using the same mechanism resistance to the herbicide glufosinate- the ADDRESSES and FOR FURTHER
of action as Bayer’s MS8 canola. Our ammonium. In its request, Bayer stated INFORMATION CONTACT sections of this
determination is based on our that this canola is similar to the notice.
evaluation of data submitted by Bayer in antecedent organism MS8 canola and,
Authority: 7 U.S.C. 7701–7772 and 7781–
its petition for a determination of based on the similarity to the antecedent
7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
nonregulated status, our analysis of organism, is unlikely to pose a plant
371.3.
publically available scientific data, and pest risk and, therefore, should not be
comments received from the public on a regulated article under APHIS’ Done in Washington, DC, this 25th day of
the petition for nonregulated status and regulations in 7 CFR part 340. July 2017.
its associated environmental assessment In a notice 1 published in the Federal Christine Zakarka,
and plant pest risk similarity Register on April 12, 2017 (82 FR Acting Administrator, Animal and Plant
assessment. This notice also announces 17625–17626, Docket No. APHIS–2017– Health Inspection Service.
the availability of our written 0015), APHIS announced the [FR Doc. 2017–15949 Filed 7–27–17; 8:45 am]
determination and finding of no availability of the Bayer’s petition, draft
BILLING CODE 3410–34–P
significant impact. environmental assessment, preliminary
finding of no significant impact, draft
DATES: Effective July 28, 2017.
plant pest risk similarity assessment,
FOR FURTHER INFORMATION CONTACT: Ms. and preliminary determination for
asabaliauskas on DSKBBXCHB2PROD with NOTICES

Cindy Eck, Document Control Officer/ nonregulated status for public comment.
Team Leader, Policy Coordination We solicited comments on the notice for
Programs, Biotechnology Regulatory 30 days ending May 12, 2017. We
Services, APHIS, 4700 River Road, Unit extended the deadline for comments
147, Riverdale, MD 20737–1236; (301)
851–3954, email: cynthia.a.eck@ 1 To view the notice, the petition, the comments

aphis.usda.gov. we received, and other supporting documents, go to
http://www.regulations.gov/
SUPPLEMENTARY INFORMATION: #!docketDetail;D=APHIS-2017-0015.

VerDate Sep<11>2014 18:50 Jul 27, 2017 Jkt 241001 PO 00000 Frm 00001 Fmt 4703 Sfmt 9990 E:\FR\FM\28JYN1.SGM 28JYN1

Document Created: 2017-07-28 03:10:02
Document Modified: 2017-07-28 03:10:02

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Effective July 28, 2017.
Contact		Ms. Cindy Eck, Document Control Officer/Team Leader, Policy Coordination Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236; (301) 851-3954, email: [email protected]
FR Citation		82 FR 35172

82 FR 35172 - Bayer CropScience LP: Determination of Nonregulated Status of Canola Genetically Engineered for Male Sterility and Glufosinate-Ammonium Resistance

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 82, Issue 144 (July 28, 2017)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service