Syngenta Seeds Inc.; Availability of Preliminary Finding of No Significant Impact and Preliminary Decision for an Extension of a Determination of Nonregulated Status of Corn Genetically Engineered for Glyphosate and Glufosinate-Ammonium Resistance, 65687-65689 [2015-27296]
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65687
Notices
Federal Register
Vol. 80, No. 207
Tuesday, October 27, 2015
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.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2015–0080]
Syngenta Seeds Inc.; Availability of
Preliminary Finding of No Significant
Impact and Preliminary Decision for an
Extension of a Determination of
Nonregulated Status of Corn
Genetically Engineered for Glyphosate
and Glufosinate-Ammonium
Resistance
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public
that the Animal and Plant Health
Inspection Service has reached a
preliminary decision to extend our
determination of nonregulated status of
corn events Bayer/Genective S.A.VCO–
01981–5 (hereinafter Genective VCO–
01981–5 corn) and Pioneer’s DP–
004114–3 (hereinafter Pioneer 4114
corn) to Syngenta’s corn event
MZHG0JG in response to a request from
Syngenta Seeds Inc. MZHG0JG corn has
been genetically engineered for
resistance to the herbicide glyphosate
using the same mechanism of action as
Genective VCO–01981–5 and also to be
resistant to the herbicide glufosinate
using the same mechanism of action as
Pioneer 4114. We are making available
for public comment our preliminary
finding of no significant impact for the
proposed determination of nonregulated
status.
DATES: We will consider all comments
that we receive on or before November
27, 2015.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!docketDetail;D=APHIS-2015-0080.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
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SUMMARY:
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Jkt 238001
APHIS–2015–0080, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737–1238.
The Syngenta Seeds Inc. extension
request, our preliminary finding of no
significant impact, our preliminary
determination, and any comments we
receive on this docket may be viewed at
https://www.regulations.gov/
#!docketDetail;D=APHIS-2015-0080 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.
Supporting documents and any
comments we received regarding our
determination of nonregulated status of
the antecedent organisms, Genective
VCO–01981–5 corn and Pioneer 4114
corn, can be found at https://
www.regulations.gov/
#!docketDetail;D=APHIS-2012-0046 and
https://www.regulations.gov/
#!docketDetail;D=APHIS-2012-0026.
Supporting documents may also be
found on the APHIS Web site for
MZHG0JG corn (the organism under
evaluation) under APHIS Petition
Number 15–124–01p, and the
antecedent organisms Genective VCO–
01981–5 corn and Pioneer 4114 corn
under APHIS Petition Numbers 11–342–
01p and 11–244–01p.
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 supporting documents,
contact Ms. Cindy Eck at (301) 851–
3885, email: cynthia.a.eck@
aphis.usda.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of the plant pest provisions of
the Plant Protection Act (PPA) (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
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Fmt 4703
Sfmt 4703
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 organisms
(GE) 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.
Further, the regulations in § 340.6(e)(2)
provide that a person may request that
APHIS extend a determination of
nonregulated status to other organisms.
Such a request must include
information to establish the similarity of
the antecedent organism and the
regulated article in question.
On September 25, 2013,1 APHIS
announced its determination of
nonregulated status of corn (Zea mays)
designated as event VCO–01981–5
(hereinafter Genective VCO–01981–5
corn), which was genetically engineered
for resistance to the herbicide
glyphosate. On June 20, 2013,2 APHIS
announced its determination of
nonregulated status of corn designated
as event DP–004114–3 (hereinafter
Pioneer 4114 corn), which was
genetically engineered for resistance to
the herbicide glufosinate-ammonium.
APHIS has received a request for an
extension of a determination of
nonregulated status of Genective VCO–
01981–5 corn and Pioneer 4114 corn to
corn designated as event MZHG0JG
(APHIS Petition Number 15–124–01p)
from Syngenta Seeds Inc. (Syngenta) of
Research Triangle Park, NC. MZHG0JG
corn expresses resistance to both
glyphosate and glufosinate-ammonium.
In its request, Syngenta stated that this
corn is similar to the antecedent
organisms, Genective VCO–01981–5
corn and Pioneer 4114 corn and, based
on the similarity to these antecedent
organisms, 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 extension request,
MZHG0JG corn was developed through
agrobacterium-mediated transformation
to stably incorporate the transgenes
1 https://www.aphis.usda.gov/brs/aphisdocs/11_
34201p_det.pdf.
2 https://www.aphis.usda.gov/brs/aphisdocs/11_
24401p_det.pdf.
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Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices
mepsps-02 and pat-09 into the
MZHG0JG corn genome. The gene
mepsps-02 encodes the enzyme
modified 5-enol pyruvylshikimate-3phosphate synthase (mEPSPS), a variant
of the native EPSPS enzyme from corn,
which contains two amino acid
substitutions that were introduced
specifically to confer resistance to
herbicides containing glyphosate. The
gene pat-09 encodes the enzyme
phosphinothricin acetyltransferase
(PAT) derived from the soil bacterium
Streptomyces viridochromogenes. PAT
acetylates glufosinate-ammonium, thus
inactivating it and conferring resistance
to glufosinate-ammonium in herbicide
products. The antecedent organisms,
Genective VCO–01981–5 corn and
Pioneer 4114 corn, were similarly
genetically engineered to produce
proteins which catalyze the same
reactions as do the proteins produced in
MZHG0JG corn. Based on the
information in the request, we have
concluded that MZHG0JG corn is
similar to Genective VCO–01981–5 corn
and Pioneer 4114 corn. MZHG0JG corn
is currently regulated under 7 CFR part
340.
As part of our decisionmaking process
regarding a GE organism’s regulatory
status, APHIS evaluates the plant pest
risk of the article. In section 403 of the
PPA, ‘‘plant pest’’ is defined as any
living stage of any of the following that
can directly or indirectly injure, cause
damage to, or cause disease in any plant
product: A protozoan, a nonhuman
animal, a parasitic plant, a bacterium, a
fungus, a virus or viroid, an infectious
agent or other pathogen, or any article
similar to or allied with any of the
foregoing.
APHIS completed plant pest risk
assessments (PPRA) on the antecedent
organisms in which we concluded that
Genective VCO–01981–5 corn and
Pioneer 4114 corn are unlikely to
present plant pest risks. APHIS also
prepared a plant pest risk similarity
assessment (PPRSA) to compare
MZHG0JG to the antecedents. As
described in the PPRSA, the proteins
expressed in MZHG0JG corn are similar
to those expressed in Genective VCO–
01981–5 corn and Pioneer 4114 corn,
and APHIS has concluded that the
proteins expressed in Genective VCO–
01981–5 corn and Pioneer 4114 corn are
unlikely to affect the plant pest risk of
Genective VCO–01981–5 corn and
Pioneer 4114 corn. Furthermore, the
Environmental Protection Agency
reviewed the safety of the proteins
expressed in MZHG0JG corn and
concluded that adverse effects will not
occur to nontarget organisms. Therefore,
based on our PPRAs for Genective VCO–
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19:58 Oct 26, 2015
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01981–5 corn and Pioneer 4114 corn
and the similarity between Genective
VCO–01981–5 corn, Pioneer 4114 corn,
and MZHG0JG corn as described in the
PPRSA, APHIS has concluded that the
proteins expressed in MZHG0JG corn
are unlikely to pose a plant pest risk and
that MZHG0JG corn is unlikely to pose
a different plant pest risk than
Genective VCO–01981–5 corn and
Pioneer 4114 corn.
APHIS also prepared an
environmental assessment (EA) for
MZHG0JG corn based on our analysis of
data submitted by Syngenta, a review of
other scientific data, and field tests
conducted under APHIS oversight. The
EA was prepared to provide the APHIS
decisionmaker with a review and
analysis of any potential environmental
impacts associated with the
determination of nonregulated status for
MZHG0JG corn. The EA was prepared
in accordance with: (1) The National
Environmental Policy Act of 1969
(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).
In addition, APHIS has carefully
examined the existing NEPA
documentation completed for Genective
VCO–01981–5 corn and Pioneer 4114
corn and has concluded that Syngenta’s
request to extend a determination of
nonregulated status to MZHG0JG corn
encompasses the same scope of
environmental analysis as Genective
VCO–01981–5 corn and Pioneer 4114
corn. Therefore, based on the similarity
of MZHG0JG corn to Genective VCO–
01981–5 corn and Pioneer 4114 corn,
APHIS has prepared a preliminary
finding of no significant impact (FONSI)
on MZHG0JG corn. APHIS is
considering the following alternatives:
(1) Take no action, i.e., APHIS would
not change the regulatory status of
MZHG0JG corn and it would continue
to be a regulated article, or (2) make a
determination of nonregulated status of
MZHG0JG corn. APHIS’ preferred
alternative is to make a determination of
nonregulated status of MZHG0JG corn.
APHIS has analyzed information
submitted by Syngenta, references
provided in the extension request, peerreviewed publications, and information
in the EAs of the antecedent organisms.
APHIS has also analyzed information in
the PPRAs for the antecedent organisms,
and other information. Based on APHIS’
analysis of this information, the
similarity of MZHG0JG corn to the
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Fmt 4703
Sfmt 4703
antecedent organisms, our conclusion
that the proteins expressed in MZHG0JG
corn are unlikely to pose a plant pest
risk, and our conclusion that MZHG0JG
corn is unlikely to pose a different plant
pest risk than Genective VCO–01981–5
corn and Pioneer 4114 corn, APHIS has
determined that MZHG0JG corn is
unlikely to pose a plant pest risk. We
have therefore reached a preliminary
decision to approve the request to
extend the determination of
nonregulated status of Genective VCO–
01981–5 corn and Pioneer 4114 corn to
MZHG0JG corn, whereby MZHG0JG
corn would no longer be subject to our
regulations governing the introduction
of certain genetically engineered
organisms.
Paragraph (e) of § 340.6 provides that
APHIS will publish a notice in the
Federal Register announcing all
preliminary decisions to extend
determinations of nonregulated status
for 30 days before the decisions become
final and effective. In accordance with
§ 340.6(e) of the regulations, we are
publishing this notice to inform the
public of our preliminary decision to
extend the determination of
nonregulated status of Genective VCO–
01981–5 corn and Pioneer 4114 corn to
MZHG0JG corn.
APHIS will accept written comments
on the preliminary FONSI regarding a
determination of nonregulated status of
MZHG0JG corn for a period of 30 days
from the date this notice is published in
the Federal Register. The preliminary
FONSI, as well as the extension request,
supporting documents, and our
preliminary determination with
appended PPRSA for MZHG0JG corn,
are available for public review as
indicated under ADDRESSES and FOR
FURTHER INFORMATION CONTACT above.
Copies of these documents may also be
obtained by contacting the person listed
under FOR FURTHER INFORMATION
CONTACT.
After the comment period closes,
APHIS will review all written comments
received during the comment period
and any other relevant information. All
comments will be available for public
review. After reviewing and evaluating
the comments, if APHIS determines that
no substantive information has been
received that would warrant APHIS
altering its preliminary regulatory
determination or FONSI, our
preliminary regulatory determination
will become final and effective upon
notification of the public through an
announcement on our Web site at
https://www.aphis.usda.gov/
biotechnology/petitions_table_
pending.shtml. APHIS will also furnish
a response to the petitioner regarding
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Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices
our final regulatory determination. No
further Federal Register notice will be
published announcing the final
regulatory determination regarding
MZHG0JG corn.
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 22nd day of
October.
Michael C. Gregoire,
Associate Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2015–27296 Filed 10–26–15; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
Monsanto Co.; Determination of
Nonregulated Status of Maize
Genetically Engineered For Protection
Against Corn Rootworm and
Resistance to Glyphosate
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public of
our determination that maize designated
as event MON 87411, which has been
genetically engineered for protection
against corn rootworm and resistance to
the herbicide glyphosate, 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
Monsanto Company in its petition for a
determination of nonregulated status,
our analysis of available scientific data,
and comments received from the public
in response to our previous notices
announcing the availability of the
petition for nonregulated status and its
associated environmental assessment
and plant pest risk assessment. This
notice also announces the availability of
our written determination and finding
of no significant impact.
DATES: Effective October 27, 2015.
ADDRESSES: You may read the
documents referenced in this notice and
the comments we received at https://
www.regulations.gov/
#!docketDetail;D=APHIS-2014-0007 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
tkelley on DSK3SPTVN1PROD with NOTICES
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Jkt 238001
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.
APHIS received a petition (APHIS
Petition Number 13–290–01p) from
Monsanto Company (Monsanto) of St.
Louis, MO, seeking a determination of
nonregulated status of maize (Zea mays)
designated as event MON 87411, which
has been genetically engineered for
protection against corn rootworm and
resistance to the herbicide glyphosate.
The Monsanto petition states that
information collected during field trials
and laboratory analyses indicates that
MON 87411 maize is not likely to be a
plant pest and therefore should not be
a regulated article under APHIS’
regulations in 7 CFR part 340.
According to our process 1 for
soliciting public comment when
SUPPLEMENTARY INFORMATION:
[Docket No. APHIS–2014–0007]
SUMMARY:
holidays. To be sure someone is there to
help you, please call (202) 799–7039
before coming.
Supporting documents are also
available on the APHIS Web site at
https://www.aphis.usda.gov/
biotechnology/petitions_table_
pending.shtml under APHIS Petition
Number 13–290–01p.
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 supporting documents for
this petition, contact Ms. Cindy Eck at
(301) 851–3892, email: cynthia.a.eck@
aphis.usda.gov.
1 On March 6, 2012, APHIS published in the
Federal Register (77 FR 13258–13260, Docket No.
APHIS–2011–0129) a notice describing our public
review process for soliciting public comments and
information when considering petitions for
determinations of nonregulated status for GE
organisms. To view the notice, go to https://
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65689
considering petitions for determinations
of nonregulated status of GE organisms,
APHIS accepts written comments
regarding a petition once APHIS deems
it complete. In a notice 2 published in
the Federal Register on March 7, 2014
(79 FR 13035–13036, Docket No.
APHIS–2014–0007), APHIS announced
the availability of the Monsanto petition
for public comment. APHIS solicited
comments on the petition for 60 days
ending on May 6, 2014, in order to help
identify potential environmental and
interrelated economic issues and
impacts that APHIS may determine
should be considered in our evaluation
of the petition.
APHIS received 423 comments on the
petition. Issues raised during the
comment period include the
contamination of conventional crop
production, the potential for disruption
of trade due to the presence of
unwanted genetically engineered
commodities in exports, the potential
for negative impacts to plant fitness and
the environment, and health concerns.
APHIS decided, based on its review of
the petition and its evaluation and
analysis of the comments received
during the 60-day public comment
period on the petition, that the petition
involves a GE organism that raises
substantive new issues. According to
our public review process for such
petitions (see footnote 1), APHIS first
solicits written comments from the
public on a draft environmental
assessment (EA) and a preliminary plant
pest risk assessment (PPRA) for a 30-day
comment period through the
publication of a Federal Register notice.
Then, after reviewing and evaluating the
comments on the draft EA and the
preliminary PPRA and other
information, APHIS revises the
preliminary PPRA as necessary and
prepares a final EA and, based on the
final EA, a National Environmental
Policy Act (NEPA) decision document
(either a finding of no significant impact
(FONSI) or a notice of intent to prepare
an environmental impact statement). If
a FONSI is reached, APHIS furnishes a
response to the petitioner, either
approving or denying the petition.
APHIS also publishes a notice in the
Federal Register announcing the
regulatory status of the GE organism and
the availability of APHIS’ final EA,
PPRA, FONSI, and our regulatory
determination.
www.regulations.gov/#!docketDetail;D=APHIS2011-0129.
2 To view the notice, the petition, other
supporting documents, and the comments we
received, go to https://www.regulations.gov/
#!docketDetail;D=APHIS-2014-0007.
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]]>Agencies
[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Pages 65687-65689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27296]
========================================================================
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.
========================================================================
Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 /
Notices
[[Page 65687]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2015-0080]
Syngenta Seeds Inc.; Availability of Preliminary Finding of No
Significant Impact and Preliminary Decision for an Extension of a
Determination of Nonregulated Status of Corn Genetically Engineered for
Glyphosate and Glufosinate-Ammonium 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 has reached a preliminary decision to extend our
determination of nonregulated status of corn events Bayer/Genective
S.A.VCO-01981-5 (hereinafter Genective VCO-01981-5 corn) and Pioneer's
DP-004114-3 (hereinafter Pioneer 4114 corn) to Syngenta's corn event
MZHG0JG in response to a request from Syngenta Seeds Inc. MZHG0JG corn
has been genetically engineered for resistance to the herbicide
glyphosate using the same mechanism of action as Genective VCO-01981-5
and also to be resistant to the herbicide glufosinate using the same
mechanism of action as Pioneer 4114. We are making available for public
comment our preliminary finding of no significant impact for the
proposed determination of nonregulated status.
DATES: We will consider all comments that we receive on or before
November 27, 2015.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2015-0080.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2015-0080, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
The Syngenta Seeds Inc. extension request, our preliminary finding
of no significant impact, our preliminary determination, and any
comments we receive on this docket may be viewed at https://www.regulations.gov/#!docketDetail;D=APHIS-2015-0080 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.
Supporting documents and any comments we received regarding our
determination of nonregulated status of the antecedent organisms,
Genective VCO-01981-5 corn and Pioneer 4114 corn, can be found at
https://www.regulations.gov/#!docketDetail;D=APHIS-2012-0046 and https://www.regulations.gov/#!docketDetail;D=APHIS-2012-0026. Supporting
documents may also be found on the APHIS Web site for MZHG0JG corn (the
organism under evaluation) under APHIS Petition Number 15-124-01p, and
the antecedent organisms Genective VCO-01981-5 corn and Pioneer 4114
corn under APHIS Petition Numbers 11-342-01p and 11-244-01p.
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 supporting documents, contact Ms. Cindy Eck at (301) 851-3885,
email: cynthia.a.eck@aphis.usda.gov.
SUPPLEMENTARY INFORMATION: Under the authority of the plant pest
provisions of the Plant Protection Act (PPA) (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 organisms (GE) 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. Further, the regulations in Sec. 340.6(e)(2)
provide that a person may request that APHIS extend a determination of
nonregulated status to other organisms. Such a request must include
information to establish the similarity of the antecedent organism and
the regulated article in question.
On September 25, 2013,\1\ APHIS announced its determination of
nonregulated status of corn (Zea mays) designated as event VCO-01981-5
(hereinafter Genective VCO-01981-5 corn), which was genetically
engineered for resistance to the herbicide glyphosate. On June 20,
2013,\2\ APHIS announced its determination of nonregulated status of
corn designated as event DP-004114-3 (hereinafter Pioneer 4114 corn),
which was genetically engineered for resistance to the herbicide
glufosinate-ammonium. APHIS has received a request for an extension of
a determination of nonregulated status of Genective VCO-01981-5 corn
and Pioneer 4114 corn to corn designated as event MZHG0JG (APHIS
Petition Number 15-124-01p) from Syngenta Seeds Inc. (Syngenta) of
Research Triangle Park, NC. MZHG0JG corn expresses resistance to both
glyphosate and glufosinate-ammonium. In its request, Syngenta stated
that this corn is similar to the antecedent organisms, Genective VCO-
01981-5 corn and Pioneer 4114 corn and, based on the similarity to
these antecedent organisms, is unlikely to pose a plant pest risk and,
therefore, should not be a regulated article under APHIS' regulations
in 7 CFR part 340.
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\1\ https://www.aphis.usda.gov/brs/aphisdocs/11_34201p_det.pdf.
\2\ https://www.aphis.usda.gov/brs/aphisdocs/11_24401p_det.pdf.
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As described in the extension request, MZHG0JG corn was developed
through agrobacterium-mediated transformation to stably incorporate the
transgenes
[[Page 65688]]
mepsps-02 and pat-09 into the MZHG0JG corn genome. The gene mepsps-02
encodes the enzyme modified 5-enol pyruvylshikimate-3-phosphate
synthase (mEPSPS), a variant of the native EPSPS enzyme from corn,
which contains two amino acid substitutions that were introduced
specifically to confer resistance to herbicides containing glyphosate.
The gene pat-09 encodes the enzyme phosphinothricin acetyltransferase
(PAT) derived from the soil bacterium Streptomyces viridochromogenes.
PAT acetylates glufosinate-ammonium, thus inactivating it and
conferring resistance to glufosinate-ammonium in herbicide products.
The antecedent organisms, Genective VCO-01981-5 corn and Pioneer 4114
corn, were similarly genetically engineered to produce proteins which
catalyze the same reactions as do the proteins produced in MZHG0JG
corn. Based on the information in the request, we have concluded that
MZHG0JG corn is similar to Genective VCO-01981-5 corn and Pioneer 4114
corn. MZHG0JG corn is currently regulated under 7 CFR part 340.
As part of our decisionmaking process regarding a GE organism's
regulatory status, APHIS evaluates the plant pest risk of the article.
In section 403 of the PPA, ``plant pest'' is defined as any living
stage of any of the following that can directly or indirectly injure,
cause damage to, or cause disease in any plant product: A protozoan, a
nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or
viroid, an infectious agent or other pathogen, or any article similar
to or allied with any of the foregoing.
APHIS completed plant pest risk assessments (PPRA) on the
antecedent organisms in which we concluded that Genective VCO-01981-5
corn and Pioneer 4114 corn are unlikely to present plant pest risks.
APHIS also prepared a plant pest risk similarity assessment (PPRSA) to
compare MZHG0JG to the antecedents. As described in the PPRSA, the
proteins expressed in MZHG0JG corn are similar to those expressed in
Genective VCO-01981-5 corn and Pioneer 4114 corn, and APHIS has
concluded that the proteins expressed in Genective VCO-01981-5 corn and
Pioneer 4114 corn are unlikely to affect the plant pest risk of
Genective VCO-01981-5 corn and Pioneer 4114 corn. Furthermore, the
Environmental Protection Agency reviewed the safety of the proteins
expressed in MZHG0JG corn and concluded that adverse effects will not
occur to nontarget organisms. Therefore, based on our PPRAs for
Genective VCO-01981-5 corn and Pioneer 4114 corn and the similarity
between Genective VCO-01981-5 corn, Pioneer 4114 corn, and MZHG0JG corn
as described in the PPRSA, APHIS has concluded that the proteins
expressed in MZHG0JG corn are unlikely to pose a plant pest risk and
that MZHG0JG corn is unlikely to pose a different plant pest risk than
Genective VCO-01981-5 corn and Pioneer 4114 corn.
APHIS also prepared an environmental assessment (EA) for MZHG0JG
corn based on our analysis of data submitted by Syngenta, a review of
other scientific data, and field tests conducted under APHIS oversight.
The EA was prepared to provide the APHIS decisionmaker with a review
and analysis of any potential environmental impacts associated with the
determination of nonregulated status for MZHG0JG corn. The EA was
prepared in accordance with: (1) The National Environmental Policy Act
of 1969 (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).
In addition, APHIS has carefully examined the existing NEPA
documentation completed for Genective VCO-01981-5 corn and Pioneer 4114
corn and has concluded that Syngenta's request to extend a
determination of nonregulated status to MZHG0JG corn encompasses the
same scope of environmental analysis as Genective VCO-01981-5 corn and
Pioneer 4114 corn. Therefore, based on the similarity of MZHG0JG corn
to Genective VCO-01981-5 corn and Pioneer 4114 corn, APHIS has prepared
a preliminary finding of no significant impact (FONSI) on MZHG0JG corn.
APHIS is considering the following alternatives: (1) Take no action,
i.e., APHIS would not change the regulatory status of MZHG0JG corn and
it would continue to be a regulated article, or (2) make a
determination of nonregulated status of MZHG0JG corn. APHIS' preferred
alternative is to make a determination of nonregulated status of
MZHG0JG corn.
APHIS has analyzed information submitted by Syngenta, references
provided in the extension request, peer-reviewed publications, and
information in the EAs of the antecedent organisms. APHIS has also
analyzed information in the PPRAs for the antecedent organisms, and
other information. Based on APHIS' analysis of this information, the
similarity of MZHG0JG corn to the antecedent organisms, our conclusion
that the proteins expressed in MZHG0JG corn are unlikely to pose a
plant pest risk, and our conclusion that MZHG0JG corn is unlikely to
pose a different plant pest risk than Genective VCO-01981-5 corn and
Pioneer 4114 corn, APHIS has determined that MZHG0JG corn is unlikely
to pose a plant pest risk. We have therefore reached a preliminary
decision to approve the request to extend the determination of
nonregulated status of Genective VCO-01981-5 corn and Pioneer 4114 corn
to MZHG0JG corn, whereby MZHG0JG corn would no longer be subject to our
regulations governing the introduction of certain genetically
engineered organisms.
Paragraph (e) of Sec. 340.6 provides that APHIS will publish a
notice in the Federal Register announcing all preliminary decisions to
extend determinations of nonregulated status for 30 days before the
decisions become final and effective. In accordance with Sec. 340.6(e)
of the regulations, we are publishing this notice to inform the public
of our preliminary decision to extend the determination of nonregulated
status of Genective VCO-01981-5 corn and Pioneer 4114 corn to MZHG0JG
corn.
APHIS will accept written comments on the preliminary FONSI
regarding a determination of nonregulated status of MZHG0JG corn for a
period of 30 days from the date this notice is published in the Federal
Register. The preliminary FONSI, as well as the extension request,
supporting documents, and our preliminary determination with appended
PPRSA for MZHG0JG corn, are available for public review as indicated
under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. Copies of
these documents may also be obtained by contacting the person listed
under FOR FURTHER INFORMATION CONTACT.
After the comment period closes, APHIS will review all written
comments received during the comment period and any other relevant
information. All comments will be available for public review. After
reviewing and evaluating the comments, if APHIS determines that no
substantive information has been received that would warrant APHIS
altering its preliminary regulatory determination or FONSI, our
preliminary regulatory determination will become final and effective
upon notification of the public through an announcement on our Web site
at https://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml. APHIS will also furnish a response to
the petitioner regarding
[[Page 65689]]
our final regulatory determination. No further Federal Register notice
will be published announcing the final regulatory determination
regarding MZHG0JG corn.
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 22nd day of October.
Michael C. Gregoire,
Associate Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-27296 Filed 10-26-15; 8:45 am]
BILLING CODE 3410-34-P
