Bayer CropScience LP; Availability of a Preliminary Plant Pest Risk Assessment, Draft Environmental Assessment, Preliminary Finding of No Significant Impact, and Preliminary Determination of Nonregulated Status for Cotton Genetically Engineered For Resistance to HPPD-Inhibitor Herbicides (e.g., Isoxaflutole) and Glyphosate, 26410-26412 [2018-12187]
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<![CDATA[
26410
Notices
Federal Register
Vol. 83, No. 110
Thursday, June 7, 2018
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–2017–0098]
Notice of a Determination Regarding
the Classical Swine Fever and Swine
Vesicular Disease Status of Japan
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public of
our determination that Japan is free of
classical swine fever (CSF) and swine
vesicular disease (SVD). Based on an
evaluation of the CSF and SVD status of
Japan, which we made available to the
public for review and comment through
a previous notice, the Administrator has
determined that CSF and SVD are not
present in Japan and that live swine,
pork, and pork products may safely be
imported into the United States from
Japan subject to conditions in the
regulations.
SUMMARY:
This change in Japan’s CSF and
SVD status will be recognized on July 9,
2018.
FOR FURTHER INFORMATION CONTACT: Dr.
Kelly Rhodes, Senior Staff Veterinarian,
Regionalization Evaluation Services,
National Import Export Services, VS,
APHIS, USDA, 4700 River Road Unit 38,
Riverdale, MD 20737–1231; email:
Kelly.Rhodes@aphis.usda.gov; (301)
851–3315.
SUPPLEMENTARY INFORMATION:
The regulations in 9 CFR part 94
(referred to below as the regulations)
govern the importation of certain
animals and animal products into the
United States in order to prevent the
introduction of various animal diseases,
including classical swine fever (CSF)
and swine vesicular disease (SVD).
These are dangerous and communicable
diseases of swine.
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DATES:
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Within part 94, § 94.9 contains
requirements governing the importation
of pork and pork products from regions
where CSF exists. Section 94.10
contains importation requirements for
swine from regions where CSF is
considered to exist. Section 94.12
contains requirements governing the
importation of pork or pork products
from regions where SVD exists. Section
94.14 prohibits the importation of
domestic swine which are moved from
or transit any region in which SVD is
known to exist.
In accordance with §§ 94.9(a)(1) and
94.10(a)(1), the Animal and Plant Health
Inspection Service (APHIS) maintains a
web-based list of regions which the
Agency considers free of CSF. Sections
94.9(a)(2) and 94.10(a)(2) state that
APHIS will add a region to this list after
it conducts an evaluation of the region
and finds that CSF is not present.
Similarly, in accordance with
§ 94.12(a)(1), APHIS maintains a webbased list of regions which the Agency
considers free of SVD. Paragraph (a)(2)
of this section states that APHIS will
add a region to this list after it conducts
an evaluation of the region and finds
that SVD is not present.
The regulations in § 92.2 contain
requirements for requesting the
recognition of the animal health status
of a region (as well as for the approval
of the export of a particular type of
animal or animal product to the United
States from a foreign region). If, after
review and evaluation of the
information submitted in support of the
request, APHIS believes the request can
be safely granted, APHIS will make its
evaluation available for public comment
through a document published in the
Federal Register. Following the close of
the comment period, APHIS will review
all comments received and will make a
final determination regarding the
request that will be detailed in another
document published in the Federal
Register.
In accordance with that process, Japan
requested that APHIS evaluate the CSF
and SVD disease status of the country.
Based on our evaluation, we determined
that Japan is free of both CSF and SVD
and that the surveillance, prevention,
and control measures implemented by
Japan are sufficient to minimize the
likelihood of introducing CSF and SVD
into the United States via imports of
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species or products susceptible to these
diseases.
On February 20, 2018, we published
in the Federal Register (83 FR 7138,
Docket No. APHIS–2017–0098) a
notice 1 in which we announced the
availability for review and comment of
our evaluation of the CSF and SVD
status of Japan. We solicited comments
on the notice for 30 days ending on
March 22, 2018. We received no
comments on our evaluation.
Therefore, based on the findings of
our evaluation and the absence of
comments that would lead us to
reconsider those findings, we are
announcing our determination to add
Japan to the list of regions declared free
of CSF and the list of regions declared
free of SVD. These lists are available on
the APHIS website at https://
www.aphis.usda.gov/aphis/ourfocus/
animalhealth/animal-and-animalproduct-import-information/ct_animal_
disease_status.
Authority: 7 U.S.C. 450, 7701–7772, 7781–
7786, and 8301–8317; 21 U.S.C. 136 and
136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
371.4.
Done in Washington, DC, this 1st day of
June 2018.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2018–12186 Filed 6–6–18; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2017–0073]
Bayer CropScience LP; Availability of
a Preliminary Plant Pest Risk
Assessment, Draft Environmental
Assessment, Preliminary Finding of No
Significant Impact, and Preliminary
Determination of Nonregulated Status
for Cotton Genetically Engineered For
Resistance to HPPD-Inhibitor
Herbicides (e.g., Isoxaflutole) and
Glyphosate
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
1 To view the notice and the supporting
documents, go to https://www.regulations.gov/
docket?D=APHIS20170098.
E:\FR\FM\07JNN1.SGM
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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
We are advising the public
that the Animal and Plant Health
Inspection Service has prepared a
preliminary determination regarding a
request from Bayer CropScience LP
seeking a determination of nonregulated
status for cotton designated as event
GHB811, which has been genetically
engineered for dual resistance to HPPDinhibitor herbicides (e.g., isoxaflutole)
and the herbicide glyphosate. We are
also making available for public review
and comment our preliminary plant pest
risk assessment, draft environmental
assessment, and preliminary finding of
no significant impact for the
preliminary determination of
nonregulated status.
DATES: We will consider all comments
that we receive on or before July 9,
2018.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/#!docket
Detail;D=APHIS-2017-0073.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2017–0073, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238.
The draft environmental assessment,
preliminary regulatory determination,
preliminary finding of no significant
impact, preliminary plant pest risk
assessment, and any comments we
receive on this docket may be viewed at
https://www.regulations.gov/#!docket
Detail;D=APHIS-2017-0073 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 for this
petition are also available on the APHIS
website at https://www.aphis.usda.gov/
biotechnology/petitions_table_
pending.shtml under APHIS Petition
Number 17–138–01p.
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 petition, contact Ms. Cindy
Eck at (301) 851–3892, email:
cynthia.a.eck@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Under the authority of the plant pest
provisions of the Plant Protection Act (7
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SUMMARY:
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17:19 Jun 06, 2018
Jkt 244001
U.S.C. 7701 et seq.), the regulations in
7 CFR part 340, ‘‘Introduction of
Organisms and Products Altered or
Produced Through Genetic Engineering
Which Are Plant Pests or Which There
Is Reason to Believe Are Plant Pests,’’
regulate, among other things, the
introduction (importation, interstate
movement, or release into the
environment) of organisms and products
altered or produced through genetic
engineering that are plant pests or that
there is reason to believe are plant pests.
Such genetically engineered (GE)
organisms and products are considered
‘‘regulated articles.’’
The regulations in § 340.6(a) provide
that any person may submit a petition
to the Animal and Plant Health
Inspection Service (APHIS) seeking a
determination that an article should not
be regulated under 7 CFR part 340.
APHIS received a petition (APHIS
Petition Number 17–138–01p) from
Bayer CropScience LP (Bayer) of
Research Triangle Park, NC, seeking a
determination of nonregulated status of
cotton (Gossypium spp.) designated as
event GHB811, which has been
genetically engineered for dual
resistance to HPPD-inhibitor herbicides
(e.g., isoxaflutole) and the herbicide
glyphosate. The Bayer petition states
that information collected during field
trials and laboratory analyses indicates
that GHB811 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 October 27,
2017 (82 FR 49782–49783, Docket No.
APHIS–2017–0073), APHIS announced
the availability of the Bayer petition for
public comment. APHIS solicited
comments on the petition for 60 days
ending on December 26, 2017, in order
to help identify potential environmental
and interrelated economic issues and
impacts that APHIS may determine
should be considered in our evaluation
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://
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=APHIS2017-0073.
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26411
of the petition. APHIS received eight
comments on the petition. One
submission was in favor of the GHB811
cotton determination. Seven of the
comments expressed a general
disapproval of the planting and use of
GE crops. Of the seven comments in
opposition, two submissions contained
attached comments by organizations.
APHIS has evaluated the issues raised
during the comment period and, where
appropriate, has provided a discussion
of these issues in our draft
environmental assessment (EA).
After public comments are received
on a completed petition, APHIS
evaluates those comments and then
provides a second opportunity for
public involvement in our
decisionmaking process. According to
our public review process (see footnote
1), the second opportunity for public
involvement follows one of two
approaches, as described below.
If APHIS decides, based on its review
of the petition and its evaluation and
analysis of comments received during
the 60-day public comment period on
the petition, that the petition involves a
GE organism that raises no substantive
new issues, APHIS will follow
Approach 1 for public involvement.
Under Approach 1, APHIS announces in
the Federal Register the availability of
APHIS’ preliminary regulatory
determination along with its draft EA,
preliminary finding of no significant
impact (FONSI), and its preliminary
plant pest risk assessment (PPRA) for a
30-day public review period. APHIS
will evaluate any information received
related to the petition and its supporting
documents during the 30-day public
review period. For this petition, we are
using Approach 1.
Had APHIS decided, based on its
review of the petition and its evaluation
and analysis of comments received
during the 60-day public comment
period on the petition, that the petition
involves a GE organism that raises
substantive new issues, APHIS would
follow Approach 2. Under Approach 2,
APHIS first solicits written comments
from the public on a draft EA and
preliminary 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 preliminary PPRA
and other information, APHIS would
revise the preliminary PPRA as
necessary and prepare a final EA and,
based on the final EA, a National
Environmental Policy Act (NEPA)
decision document (either a FONSI or a
notice of intent to prepare an
environmental impact statement).
E:\FR\FM\07JNN1.SGM
07JNN1
sradovich on DSK3GMQ082PROD with NOTICES
26412
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
As part of our decisionmaking process
regarding a GE organism’s regulatory
status, APHIS prepares a PPRA to assess
the plant pest risk of the article. APHIS
also prepares the appropriate
environmental documentation—either
an EA or an environmental impact
statement—in accordance with NEPA,
to provide the Agency and the public
with a review and analysis of any
potential environmental impacts that
may result if the petition request is
approved.
APHIS has prepared a preliminary
PPRA and has concluded that cotton
designated as event GHB811, which has
been genetically engineered for dual
herbicides resistance, is unlikely to pose
a plant pest risk. In section 403 of the
Plant Protection Act, ‘‘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 or 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 has also prepared a draft EA in
which we present two alternatives based
on our analysis of data submitted by
Bayer, a review of other scientific data,
field tests conducted under APHIS
oversight, and comments received on
the petition. APHIS is considering the
following alternatives: (1) Take no
action, i.e., APHIS would not change the
regulatory status of cotton designated as
event GHB811, or (2) make a
determination of nonregulated status of
cotton designated as event GHB811.
The draft 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 draft EA and other pertinent
scientific data, APHIS has prepared a
preliminary FONSI with regard to the
preferred alternative identified in the
draft EA.
Based on APHIS’ analysis of field and
laboratory data submitted by Bayer,
references provided in the petition,
peer-reviewed publications, information
analyzed in the draft EA, the
preliminary PPRA, comments provided
by the public on the petition, and
discussion of issues in the draft EA,
APHIS has determined that cotton
designated as event GHB811 is unlikely
to pose a plant pest risk. We have
therefore reached a decision to make a
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17:19 Jun 06, 2018
Jkt 244001
preliminary determination of
nonregulated status of cotton designated
as event GHB811, whereby cotton
designated as event GHB811 would no
longer be subject to our regulations
governing the introduction of certain GE
organisms.
We are making available for a 30-day
review period APHIS’ preliminary
regulatory determination of cotton
designated as event GHB811, along with
our preliminary PPRA, draft EA, and
preliminary FONSI for the preliminary
determination of nonregulated status.
The draft EA, preliminary FONSI,
preliminary PPRA, and our preliminary
determination for cotton designated as
event GHB811, as well as the Bayer
petition and the comments received on
the petition, are available as indicated
under ADDRESSES and FOR FURTHER
INFORMATION CONTACT above. Copies of
these documents may also be obtained
from the person listed under FOR
FURTHER INFORMATION CONTACT.
After the 30-day review period closes,
APHIS will review and evaluate any
information received during the 30-day
review period. If, after evaluating the
information received, APHIS determines
that we have not received substantive
new information that would warrant
APHIS altering our preliminary
regulatory determination or preliminary
FONSI, substantially changing the
proposed action identified in the draft
EA, or substantially changing the
analysis of impacts in the draft EA,
APHIS will notify the public through an
announcement on our website of our
final regulatory determination. If,
however, APHIS determines that we
have received substantive new
information that would warrant APHIS
altering our preliminary regulatory
determination or preliminary FONSI,
substantially changing the proposed
action identified in the draft EA, or
substantially changing the analysis of
impacts in the draft EA, then APHIS
will conduct the additional analysis and
prepare an amended EA, a new FONSI,
and/or a revised PPRA, which would be
made available for public review in a
subsequent notice in the Federal
Register, similar to an Approach 2
petition. APHIS will also notify the
petitioner.
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 1st day of
June 2018.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2018–12187 Filed 6–6–18; 8:45 am]
BILLING CODE 3410–34–P
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COMMISSION ON CIVIL RIGHTS
Notice of Public Meeting of the Idaho
Advisory Committee
U.S. Commission on Civil
Rights.
ACTION: Announcement of meeting.
AGENCY:
Notice is hereby given,
pursuant to the provisions of the rules
and regulations of the U.S. Commission
on Civil Rights (Commission) and the
Federal Advisory Committee Act
(FACA) that a meeting of the Idaho
Advisory Committee (Committee) to the
Commission will be held at 1:00 p.m.
(Mountain Time) Wednesday, June 20,
2018, for the purpose of discussing
potential civil rights topics of study.
DATES: The meeting will be held on
Wednesday, June 20, 2018, at 1:00 p.m.
MT.
Public Call Information:
Dial: 877–675–4751.
Conference ID: 5522721.
FOR FURTHER INFORMATION CONTACT:
Angelica Trevino at atrevino@usccr.gov
or (213) 894–3437.
SUPPLEMENTARY INFORMATION: This
meeting is available to the public
through the following toll-free call-in
number: 877–675–4751, conference ID
number: 5522721. Any interested
member of the public may call this
number and listen to the meeting.
Callers can expect to incur charges for
calls they initiate over wireless lines,
and the Commission will not refund any
incurred charges. Callers will incur no
charge for calls they initiate over landline connections to the toll-free
telephone number. Persons with hearing
impairments may also follow the
proceedings by first calling the Federal
Relay Service at 1–800–877–8339 and
providing the Service with the
conference call number and conference
ID number.
Members of the public are entitled to
make comments during the open period
at the end of the meeting. Members of
the public may also submit written
comments; the comments must be
received in the Regional Programs Unit
within 30 days following the meeting.
Written comments may be mailed to the
Western Regional Office, U.S.
Commission on Civil Rights, 300 North
Los Angeles Street, Suite 2010, Los
Angeles, CA 90012. They may be faxed
to the Commission at (213) 894–0508, or
emailed Angelica Trevino at atrevino@
usccr.gov. Persons who desire
additional information may contact the
Regional Programs Unit at (213) 894–
3437.
Records and documents discussed
during the meeting will be available for
SUMMARY:
E:\FR\FM\07JNN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26410-26412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12187]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2017-0073]
Bayer CropScience LP; Availability of a Preliminary Plant Pest
Risk Assessment, Draft Environmental Assessment, Preliminary Finding of
No Significant Impact, and Preliminary Determination of Nonregulated
Status for Cotton Genetically Engineered For Resistance to HPPD-
Inhibitor Herbicides (e.g., Isoxaflutole) and Glyphosate
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 26411]]
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has prepared a preliminary determination regarding a
request from Bayer CropScience LP seeking a determination of
nonregulated status for cotton designated as event GHB811, which has
been genetically engineered for dual resistance to HPPD-inhibitor
herbicides (e.g., isoxaflutole) and the herbicide glyphosate. We are
also making available for public review and comment our preliminary
plant pest risk assessment, draft environmental assessment, and
preliminary finding of no significant impact for the preliminary
determination of nonregulated status.
DATES: We will consider all comments that we receive on or before July
9, 2018.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2017-0073.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2017-0073, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
The draft environmental assessment, preliminary regulatory
determination, preliminary finding of no significant impact,
preliminary plant pest risk assessment, and any comments we receive on
this docket may be viewed at https://www.regulations.gov/#!docketDetail;D=APHIS-2017-0073 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 for this petition are also available on the
APHIS website at https://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under APHIS Petition Number 17-138-01p.
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 petition, contact Ms. Cindy Eck at (301) 851-3892, email:
[email protected].
SUPPLEMENTARY INFORMATION:
Under the authority of the plant pest provisions of the Plant
Protection Act (7 U.S.C. 7701 et seq.), the regulations in 7 CFR part
340, ``Introduction of Organisms and Products Altered or Produced
Through Genetic Engineering Which Are Plant Pests or Which There Is
Reason to Believe Are Plant Pests,'' regulate, among other things, the
introduction (importation, interstate movement, or release into the
environment) of organisms and products altered or produced through
genetic engineering that are plant pests or that there is reason to
believe are plant pests. Such genetically engineered (GE) organisms and
products are considered ``regulated articles.''
The regulations in Sec. 340.6(a) provide that any person may
submit a petition to the Animal and Plant Health Inspection Service
(APHIS) seeking a determination that an article should not be regulated
under 7 CFR part 340. APHIS received a petition (APHIS Petition Number
17-138-01p) from Bayer CropScience LP (Bayer) of Research Triangle
Park, NC, seeking a determination of nonregulated status of cotton
(Gossypium spp.) designated as event GHB811, which has been genetically
engineered for dual resistance to HPPD-inhibitor herbicides (e.g.,
isoxaflutole) and the herbicide glyphosate. The Bayer petition states
that information collected during field trials and laboratory analyses
indicates that GHB811 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 October 27, 2017 (82 FR 49782-49783, Docket No. APHIS-2017-
0073), APHIS announced the availability of the Bayer petition for
public comment. APHIS solicited comments on the petition for 60 days
ending on December 26, 2017, 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 eight comments on the petition. One submission was in
favor of the GHB811 cotton determination. Seven of the comments
expressed a general disapproval of the planting and use of GE crops. Of
the seven comments in opposition, two submissions contained attached
comments by organizations. APHIS has evaluated the issues raised during
the comment period and, where appropriate, has provided a discussion of
these issues in our draft environmental assessment (EA).
---------------------------------------------------------------------------
\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://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-
2017-0073.
---------------------------------------------------------------------------
After public comments are received on a completed petition, APHIS
evaluates those comments and then provides a second opportunity for
public involvement in our decisionmaking process. According to our
public review process (see footnote 1), the second opportunity for
public involvement follows one of two approaches, as described below.
If APHIS decides, based on its review of the petition and its
evaluation and analysis of comments received during the 60-day public
comment period on the petition, that the petition involves a GE
organism that raises no substantive new issues, APHIS will follow
Approach 1 for public involvement. Under Approach 1, APHIS announces in
the Federal Register the availability of APHIS' preliminary regulatory
determination along with its draft EA, preliminary finding of no
significant impact (FONSI), and its preliminary plant pest risk
assessment (PPRA) for a 30-day public review period. APHIS will
evaluate any information received related to the petition and its
supporting documents during the 30-day public review period. For this
petition, we are using Approach 1.
Had APHIS decided, based on its review of the petition and its
evaluation and analysis of comments received during the 60-day public
comment period on the petition, that the petition involves a GE
organism that raises substantive new issues, APHIS would follow
Approach 2. Under Approach 2, APHIS first solicits written comments
from the public on a draft EA and preliminary 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
preliminary PPRA and other information, APHIS would revise the
preliminary PPRA as necessary and prepare a final EA and, based on the
final EA, a National Environmental Policy Act (NEPA) decision document
(either a FONSI or a notice of intent to prepare an environmental
impact statement).
[[Page 26412]]
As part of our decisionmaking process regarding a GE organism's
regulatory status, APHIS prepares a PPRA to assess the plant pest risk
of the article. APHIS also prepares the appropriate environmental
documentation--either an EA or an environmental impact statement--in
accordance with NEPA, to provide the Agency and the public with a
review and analysis of any potential environmental impacts that may
result if the petition request is approved.
APHIS has prepared a preliminary PPRA and has concluded that cotton
designated as event GHB811, which has been genetically engineered for
dual herbicides resistance, is unlikely to pose a plant pest risk. In
section 403 of the Plant Protection Act, ``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 or
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 has also prepared a draft EA in which we present two
alternatives based on our analysis of data submitted by Bayer, a review
of other scientific data, field tests conducted under APHIS oversight,
and comments received on the petition. APHIS is considering the
following alternatives: (1) Take no action, i.e., APHIS would not
change the regulatory status of cotton designated as event GHB811, or
(2) make a determination of nonregulated status of cotton designated as
event GHB811.
The draft 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 draft EA and other pertinent scientific data,
APHIS has prepared a preliminary FONSI with regard to the preferred
alternative identified in the draft EA.
Based on APHIS' analysis of field and laboratory data submitted by
Bayer, references provided in the petition, peer-reviewed publications,
information analyzed in the draft EA, the preliminary PPRA, comments
provided by the public on the petition, and discussion of issues in the
draft EA, APHIS has determined that cotton designated as event GHB811
is unlikely to pose a plant pest risk. We have therefore reached a
decision to make a preliminary determination of nonregulated status of
cotton designated as event GHB811, whereby cotton designated as event
GHB811 would no longer be subject to our regulations governing the
introduction of certain GE organisms.
We are making available for a 30-day review period APHIS'
preliminary regulatory determination of cotton designated as event
GHB811, along with our preliminary PPRA, draft EA, and preliminary
FONSI for the preliminary determination of nonregulated status. The
draft EA, preliminary FONSI, preliminary PPRA, and our preliminary
determination for cotton designated as event GHB811, as well as the
Bayer petition and the comments received on the petition, are available
as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
Copies of these documents may also be obtained from the person listed
under FOR FURTHER INFORMATION CONTACT.
After the 30-day review period closes, APHIS will review and
evaluate any information received during the 30-day review period. If,
after evaluating the information received, APHIS determines that we
have not received substantive new information that would warrant APHIS
altering our preliminary regulatory determination or preliminary FONSI,
substantially changing the proposed action identified in the draft EA,
or substantially changing the analysis of impacts in the draft EA,
APHIS will notify the public through an announcement on our website of
our final regulatory determination. If, however, APHIS determines that
we have received substantive new information that would warrant APHIS
altering our preliminary regulatory determination or preliminary FONSI,
substantially changing the proposed action identified in the draft EA,
or substantially changing the analysis of impacts in the draft EA, then
APHIS will conduct the additional analysis and prepare an amended EA, a
new FONSI, and/or a revised PPRA, which would be made available for
public review in a subsequent notice in the Federal Register, similar
to an Approach 2 petition. APHIS will also notify the petitioner.
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 1st day of June 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-12187 Filed 6-6-18; 8:45 am]
BILLING CODE 3410-34-P
