BASF Plant Science, LP; Determination of Nonregulated Status of Canola Genetically Engineered for Altered Oil Profile and Resistance to an Imidazolinone Herbicide, 38588-38589 [2019-16921]
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38588
Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Notices
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, draft PPRA, and the
supplemental information provided by
Verdeca from March 13, 2019, to April
12, 2019.3 APHIS solicited comments on
those documents and whether the
subject soybean is likely to pose a plant
pest risk. APHIS received three
comments on the petition and
supporting documents, all of which
opposed a decision of nonregulated
status for HB4 soybean. Those
comments are addressed in our final EA.
jspears on DSK3GMQ082PROD with NOTICES
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
HB4 soybean. 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
HB4 soybean).
Determination
Based on APHIS’ analysis of field and
laboratory data submitted by Verdeca,
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’
3 84
FR 9077–9078.
VerDate Sep<11>2014
16:49 Aug 06, 2019
Jkt 247001
response to those public comments,
APHIS has determined that HB4
soybean 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 1st day of
August 2019.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2019–16920 Filed 8–6–19; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2018–0014]
BASF Plant Science, LP; Determination
of Nonregulated Status of Canola
Genetically Engineered for Altered Oil
Profile and Resistance to an
Imidazolinone Herbicide
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public of
our determination that canola
designated as event LBFLFK, which has
been genetically engineered to allow for
the synthesis of long chain omega-3
polyunsaturated fatty acids, including
eicosapentaenoic acid and
docosahexaenoic acid, from oleic acid
in canola seed, 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 BASF
Plant Science, LP, 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.
SUMMARY:
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
This change in regulatory status
will be recognized August 7, 2019.
ADDRESSES: You may read the
documents referenced in this notice and
the comments we received at https://
www.regulations.gov/
#!docketDetail;D=APHIS-2018-0014 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 are also
available on the APHIS website at
https://www.aphis.usda.gov/
biotechnology/petitions_table_
pending.shtml under APHIS Petition
17–321–01p.
FOR FURTHER INFORMATION CONTACT: Dr.
Subray Hegde, Director, Biotechnology
Risk Analysis Programs, Biotechnology
Regulatory Services, APHIS, 4700 River
Road, Unit 147, Riverdale, MD 20737–
1236; (301) 851–3901; email:
subray.hegde@usda.gov. To obtain
copies of the supporting documents for
this petition, contact Ms. Cindy Eck at
(301) 851–3892, email: cynthia.a.eck@
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
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 17–321–01p) from
BASF Plant Science, LP, of Florham
Park, NJ (BASF), seeking a
determination of nonregulated status of
canola (Brassica napus L.) designated as
event LBFLFK, which has been
genetically engineered to allow for the
synthesis of long chain omega-3
polyunsaturated fatty acids (LC–
PUFAs), including eicosapentaenoic
acid (EPA) and docosahexaenoic acid
DATES:
E:\FR\FM\07AUN1.SGM
07AUN1
Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Notices
jspears on DSK3GMQ082PROD with NOTICES
(DHA), from oleic acid in canola seed.
The canola has also been genetically
engineered for resistance to an
imidazolinone herbicide. The BASF
petition states that information collected
during field trials and laboratory
analyses indicates that LBFLFK canola
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 March 30, 2018
(83 FR 13722–13723, Docket No.
APHIS–2018–0014), APHIS announced
the availability of the BASF petition for
public comment. APHIS solicited
comments on the petition for 60 days
ending on May 29, 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 eight comments on
the petition. Three of the comments
were from individuals, three were from
the canola industry, one was from a
public interest group, and one was from
a State government. APHIS evaluated
the issues raised during the comment
period and, where appropriate,
provided a discussion of those issues in
our draft environmental assessment
(EA).
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 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
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=APHIS2018-0014.
VerDate Sep<11>2014
16:49 Aug 06, 2019
Jkt 247001
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 draft PPRA from April 4,
2019, to May 6, 2019.3 APHIS solicited
comments on those documents and
whether the subject canola is likely to
pose a plant pest risk. APHIS received
three comments on the petition and
supporting documents, one of which
opposed and two of which supported a
decision of nonregulated status for
LBFLFK canola. Those comments are
addressed in our final EA.
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
LBFLFK canola. 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 LBFLFK canola).
Determination
Based on APHIS’ analysis of field and
laboratory data submitted by BASF,
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’
3 84
PO 00000
FR 13243–13244.
Frm 00003
Fmt 4703
Sfmt 4703
38589
response to those public comments,
APHIS has determined that LBFLFK
canola 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 1st day of
August 2019.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2019–16921 Filed 8–6–19; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2018–0095]
Addition of Scotland to the List of
Regions Classified as Having
Controlled Risk for Bovine Spongiform
Encephalopathy
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public
that we have added Scotland, a region
within the United Kingdom, to our list
of regions classified as having
controlled risk for bovine spongiform
encephalopathy (BSE) and have
removed Scotland from our list of
regions considered negligible risk for
BSE. We are taking this action because
of the confirmation of classical C-type
BSE in an indigenous cow in Scotland.
DATES: The case of BSE in Scotland was
confirmed on October 18, 2018.
FOR FURTHER INFORMATION CONTACT: Dr.
Rebecca Gordon, Import Risk Analyst,
Strategy and Policy, VS, APHIS, 920
Main Campus Drive, Suite 200, Raleigh,
NC 27606; (919) 855–7741; email:
Rebecca.K.Gordon@usda.gov.
SUPPLEMENTARY INFORMATION:
The regulations in 9 CFR part 92
subpart B, ‘‘Importation of Animals and
Animal Products; Procedures for
Requesting BSE Risk Status
Classification With Regard To Bovines’’
(referred to below as the regulations), set
forth the process by which the Animal
SUMMARY:
E:\FR\FM\07AUN1.SGM
07AUN1
]]>Agencies
[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Notices]
[Pages 38588-38589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16921]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2018-0014]
BASF Plant Science, LP; Determination of Nonregulated Status of
Canola Genetically Engineered for Altered Oil Profile and Resistance to
an Imidazolinone Herbicide
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public of our determination that canola
designated as event LBFLFK, which has been genetically engineered to
allow for the synthesis of long chain omega-3 polyunsaturated fatty
acids, including eicosapentaenoic acid and docosahexaenoic acid, from
oleic acid in canola seed, 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 BASF Plant Science, LP, 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 August 7,
2019.
ADDRESSES: You may read the documents referenced in this notice and the
comments we received at https://www.regulations.gov/#!docketDetail;D=APHIS-2018-0014 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 are also available on the APHIS website at
https://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml
under APHIS Petition 17-321-01p.
FOR FURTHER INFORMATION CONTACT: Dr. Subray Hegde, Director,
Biotechnology Risk Analysis Programs, Biotechnology Regulatory
Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236;
(301) 851-3901; 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 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
17-321-01p) from BASF Plant Science, LP, of Florham Park, NJ (BASF),
seeking a determination of nonregulated status of canola (Brassica
napus L.) designated as event LBFLFK, which has been genetically
engineered to allow for the synthesis of long chain omega-3
polyunsaturated fatty acids (LC-PUFAs), including eicosapentaenoic acid
(EPA) and docosahexaenoic acid
[[Page 38589]]
(DHA), from oleic acid in canola seed. The canola has also been
genetically engineered for resistance to an imidazolinone herbicide.
The BASF petition states that information collected during field trials
and laboratory analyses indicates that LBFLFK canola 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 March 30, 2018 (83 FR 13722-13723, Docket No. APHIS-2018-
0014), APHIS announced the availability of the BASF petition for public
comment. APHIS solicited comments on the petition for 60 days ending on
May 29, 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-
2018-0014.
---------------------------------------------------------------------------
APHIS received eight comments on the petition. Three of the
comments were from individuals, three were from the canola industry,
one was from a public interest group, and one was from a State
government. APHIS evaluated the issues raised during the comment period
and, where appropriate, provided a discussion of those issues in our
draft environmental assessment (EA).
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 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 draft PPRA from April
4, 2019, to May 6, 2019.\3\ APHIS solicited comments on those documents
and whether the subject canola is likely to pose a plant pest risk.
APHIS received three comments on the petition and supporting documents,
one of which opposed and two of which supported a decision of
nonregulated status for LBFLFK canola. Those comments are addressed in
our final EA.
---------------------------------------------------------------------------
\3\ 84 FR 13243-13244.
---------------------------------------------------------------------------
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 LBFLFK canola. 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 LBFLFK canola).
Determination
Based on APHIS' analysis of field and laboratory data submitted by
BASF, 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 LBFLFK canola 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 1st day of August 2019.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-16921 Filed 8-6-19; 8:45 am]
BILLING CODE 3410-34-P
