Texas A&M AgriLife Research; Determination of Nonregulated Status of Cotton Genetically Engineered for Ultra-low Gossypol Levels in the Cottonseed, 52377-52378 [2018-22545]
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VerDate Sep<11>2014
19:46 Oct 16, 2018
Jkt 247001
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[FR Doc. 2018–22149 Filed 10–16–18; 8:45 am]
BILLING CODE 3410–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2017–0097]
Texas A&M AgriLife Research;
Determination of Nonregulated Status
of Cotton Genetically Engineered for
Ultra-low Gossypol Levels in the
Cottonseed
Animal and Plant Health
Inspection Service, USDA.
AGENCY:
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
ACTION:
52377
Notice.
We are advising the public of
our determination that cotton
designated as event TAM66274, which
has been genetically engineered for
ultra-low gossypol levels in the
cottonseed, 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 Texas
A&M AgriLife Research 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: This change in regulatory status
will be recognized October 17, 2018.
ADDRESSES: You may read the
documents referenced in this notice and
the comments we received at https://
www.regulations.gov/#!docketDetail;D=
APHIS-2017-0097 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.
Supporting documents are also
available on the APHIS website at
https://www.aphis.usda.gov/
biotechnology/petitions_table_
pending.shtml under APHIS Petition
17–292–01p.
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.
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
SUMMARY:
E:\FR\FM\17OCN1.SGM
17OCN1
52378
Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
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 17–292–01p) from
Texas A&M AgriLife Research of College
Station, TX (Texas A&M), seeking a
determination of nonregulated status of
cotton (Gossypium hirsutum) designated
as event TAM66274, which has been
genetically engineered for ultra-low
gossypol levels in the cottonseed. The
Texas A&M petition states that
information collected during field trials
and laboratory analyses indicates that
TAM66274 cotton 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
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 December 5,
2017 (82 FR 57426–57427, Docket No.
APHIS–2017–0097), APHIS announced
the availability of the Texas A&M
petition for public comment. APHIS
solicited comments on the petition for
60 days ending on February 5, 2018, 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 47 comments on the
petition. Of those, 44 were supportive,
two opposed, and one was not related
to the petition.
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
1 On March 6, 2012, we published in the Federal
Register (77 FR 13258–13260, Docket No. APHIS–
2011–0129) a notice describing our process for
soliciting public comments and information when
considering petitions for determinations of
nonregulated status for GE organisms (see https://
www.regulations.gov/#!docketDetail;D=APHIS2011-0129).
2 To view the notice, the petition, and the
comments we received, go to https://
www.regulations.gov/#!docketDetail;D=APHIS2017-0097.
VerDate Sep<11>2014
19:46 Oct 16, 2018
Jkt 247001
involves a GE organism that raises
substantive new issues. According to
our public review process for such
petitions (see footnote 1), APHIS is
following Approach 2, where we first
solicit written comments from the
public on a draft environmental
assessment (EA) and a draft 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 draft
PPRA and other information, APHIS
revises the draft PPRA as necessary and
prepares a final EA and, based on the
final EA, a National Environmental
Policy Act (NEPA) finding 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.
APHIS sought public comment on a
draft EA and a draft PPRA from August
1, 2018, to August 31, 2018.3 APHIS
solicited comments on the draft EA, the
draft PPRA, and whether the subject
cotton is likely to pose a plant pest risk.
APHIS received two comments on the
petition, both of which supported a
decision of nonregulated status for event
TAM66274 cotton.
National Environmental Policy Act
After reviewing and evaluating the
comments received during the comment
period on the draft EA and draft PPRA
and other information, APHIS has
prepared a final EA. The EA has been
prepared to provide the public with
documentation of APHIS’ review and
analysis of any potential environmental
impacts associated with the
determination of nonregulated status of
cotton designated as event TAM66274.
The EA was 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). Based on our EA, the response to
public comments, and other pertinent
scientific data, APHIS has reached a
FONSI with regard to the preferred
alternative identified in the EA (to make
3 83
PO 00000
Fmt 4703
Determination
Based on APHIS’ analysis of field and
laboratory data submitted by Texas
A&M, references provided in the
petition, peer-reviewed publications,
information analyzed in the EA, the
PPRA, comments provided by the
public, and information provided in
APHIS’ response to those public
comments, APHIS has determined that
cotton designated as event TAM66274 is
unlikely to pose a plant pest risk and
therefore is no longer subject to our
regulations governing the introduction
of certain GE organisms.
Copies of the signed determination
document, PPRA, final EA, FONSI, and
response to comments, as well as the
previously published petition and
supporting documents, 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 10th day of
October 2018.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2018–22545 Filed 10–16–18; 8:45 am]
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Announcement of meeting.
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FR 37459–37460.
Frm 00003
a determination of nonregulated status
of cotton designated as event
TAM66274).
Sfmt 4703
E:\FR\FM\17OCN1.SGM
17OCN1
Agencies
[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52377-52378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22545]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2017-0097]
Texas A&M AgriLife Research; Determination of Nonregulated Status
of Cotton Genetically Engineered for Ultra-low Gossypol Levels in the
Cottonseed
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public of our determination that cotton
designated as event TAM66274, which has been genetically engineered for
ultra-low gossypol levels in the cottonseed, 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 Texas A&M AgriLife Research 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: This change in regulatory status will be recognized October 17,
2018.
ADDRESSES: You may read the documents referenced in this notice and the
comments we received at https://www.regulations.gov/#!docketDetail;D=APHIS-2017-0097 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.
Supporting documents are also available on the APHIS website at
https://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml
under APHIS Petition 17-292-01p.
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: [email protected]. To obtain copies
of the supporting documents for this petition, 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
[[Page 52378]]
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. APHIS received a petition (APHIS Petition Number
17-292-01p) from Texas A&M AgriLife Research of College Station, TX
(Texas A&M), seeking a determination of nonregulated status of cotton
(Gossypium hirsutum) designated as event TAM66274, which has been
genetically engineered for ultra-low gossypol levels in the cottonseed.
The Texas A&M petition states that information collected during field
trials and laboratory analyses indicates that TAM66274 cotton 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
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 December 5, 2017 (82 FR 57426-57427, Docket No. APHIS-2017-
0097), APHIS announced the availability of the Texas A&M petition for
public comment. APHIS solicited comments on the petition for 60 days
ending on February 5, 2018, 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.
---------------------------------------------------------------------------
\1\ On March 6, 2012, we published in the Federal Register (77
FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing our
process for soliciting public comments and information when
considering petitions for determinations of nonregulated status for
GE organisms (see https://www.regulations.gov/#!docketDetail;D=APHIS-
2011-0129).
\2\ To view the notice, the petition, and the comments we
received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-
2017-0097.
---------------------------------------------------------------------------
APHIS received 47 comments on the petition. Of those, 44 were
supportive, two opposed, and one was not related to the petition.
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 is following
Approach 2, where we first solicit written comments from the public on
a draft environmental assessment (EA) and a draft 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 draft PPRA and other information,
APHIS revises the draft PPRA as necessary and prepares a final EA and,
based on the final EA, a National Environmental Policy Act (NEPA)
finding 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.
APHIS sought public comment on a draft EA and a draft PPRA from
August 1, 2018, to August 31, 2018.\3\ APHIS solicited comments on the
draft EA, the draft PPRA, and whether the subject cotton is likely to
pose a plant pest risk. APHIS received two comments on the petition,
both of which supported a decision of nonregulated status for event
TAM66274 cotton.
---------------------------------------------------------------------------
\3\ 83 FR 37459-37460.
---------------------------------------------------------------------------
National Environmental Policy Act
After reviewing and evaluating the comments received during the
comment period on the draft EA and draft PPRA and other information,
APHIS has prepared a final EA. The EA has been prepared to provide the
public with documentation of APHIS' review and analysis of any
potential environmental impacts associated with the determination of
nonregulated status of cotton designated as event TAM66274. The EA was
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). Based on our EA,
the response to public comments, and other pertinent scientific data,
APHIS has reached a FONSI with regard to the preferred alternative
identified in the EA (to make a determination of nonregulated status of
cotton designated as event TAM66274).
Determination
Based on APHIS' analysis of field and laboratory data submitted by
Texas A&M, references provided in the petition, peer-reviewed
publications, information analyzed in the EA, the PPRA, comments
provided by the public, and information provided in APHIS' response to
those public comments, APHIS has determined that cotton designated as
event TAM66274 is unlikely to pose a plant pest risk and therefore is
no longer subject to our regulations governing the introduction of
certain GE organisms.
Copies of the signed determination document, PPRA, final EA, FONSI,
and response to comments, as well as the previously published petition
and supporting documents, 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 10th day of October 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-22545 Filed 10-16-18; 8:45 am]
BILLING CODE 3410-34-P