BASF Plant Science LP; Availability of Plant Pest Risk Assessment and Environmental Assessment for Determination of Nonregulated Status of Soybean Genetically Engineered for Herbicide Resistance, 66892-66893 [2013-26701]
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Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / Notices
period on the draft EA and 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
Monsanto’s MON 87712 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 MON 87712 soybean).
Determination
Based on APHIS’ analysis of field and
laboratory data submitted by Monsanto,
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 Monsanto’s
MON 87712 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.
tkelley on DSK3SPTVN1PROD with NOTICES
Done in Washington, DC, this 1st day of
November 2013.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2013–26703 Filed 11–6–13; 8:45 am]
BILLING CODE 3410–34–P
VerDate Mar<15>2010
18:27 Nov 06, 2013
Jkt 232001
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2012–0028]
BASF Plant Science LP; Availability of
Plant Pest Risk Assessment and
Environmental Assessment for
Determination of Nonregulated Status
of Soybean Genetically Engineered for
Herbicide Resistance
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public
that the Animal and Plant Health
Inspection Service is making available
for public comment our plant pest risk
assessment and our draft environmental
assessment regarding a request from
BASF Plant Science LP seeking a
determination of nonregulated status of
soybean designated as event BPS–
CV127–9, which has been genetically
engineered for resistance to herbicides
in the imidazolinone family. We are
soliciting comments on whether this
genetically engineered soybean is likely
to pose a plant pest risk.
DATES: We will consider all comments
that we receive on or before December
9, 2013.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2012-0028.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2012–0028, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238.
Supporting documents and any
comments we receive on this docket
may be viewed at https://
www.regulations.gov/
#!docketDetail;D=APHIS-2012-0028 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 Web site at
https://www.aphis.usda.gov/
biotechnology/petitions_table_
pending.shtml under APHIS Petition
Number 09–015–01p.
FOR FURTHER INFORMATION CONTACT: Dr.
Rebecca Stankiewicz Gabel, Chief,
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
Biotechnology Environmental Analysis
Branch, Environmental Risk Analysis
Programs, Biotechnology Regulatory
Services, APHIS, 4700 River Road Unit
147, Riverdale, MD 20737–1236; (301)
851–3927, email: rebecca.l.stankiewiczgabel@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:
Background
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 § 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 has received a petition (APHIS
Petition Number 09–015–01p) from
BASF Plant Science LP (BASF) of
Research Triangle Park, NC, seeking a
determination of nonregulated status of
soybean (Glycine max) designated as
event BPS–CV127–9, which has been
genetically engineered for resistance to
herbicides in the imidazolinone family.
The petition states that this soybean is
unlikely to pose a plant pest risk 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
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://
E:\FR\FM\07NON1.SGM
07NON1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / Notices
the Federal Register on July 13, 2012,
(77 FR 41363–41364, Docket No.
APHIS–2012–0028), APHIS announced
the availability of the BASF petition for
public comment. APHIS solicited
comments on the petition for 60 days
ending on September 11, 2012, 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 75 comments on the
petition. Several of these comments
included electronic attachments
consisting of a consolidated document
of many identical or nearly identical
letters, for a total of 4,676 comments.
Issues raised during the comment
period include the nature of agronomic
inputs, such as fertilizer and pesticide
applications, associated with this new
trait; effects of herbicide use, including
potential impacts to plants from offtarget herbicide drift, management of
herbicide-resistant weeds, and human
health considerations from exposure to
herbicides; and domestic and
international economic impacts
associated with the development and
marketing of a new herbicide-resistant
product. APHIS has evaluated the issues
raised during the comment period and,
where appropriate, has provided a
discussion of these issues in our
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 EA,
preliminary finding of no significant
impact (FONSI), and its 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.
www.regulations.gov/#!docketDetail;D=APHIS2012-0028.
VerDate Mar<15>2010
16:24 Nov 06, 2013
Jkt 232001
Alternatively, 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 substantive new issues, APHIS
will follow Approach 2. Under
Approach 2, APHIS first solicits written
comments from the public on a draft EA
and 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 PPRA and other
information, APHIS will revise the
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).
For this petition, we are using Approach
2.
APHIS has prepared a PPRA to
determine if soybean event BPS–
CV127–9 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
BASF, 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 soybean event BPS–
CV127–9 and it would continue to be a
regulated article, or (2) make a
determination of nonregulated status of
soybean event BPS–CV127–9.
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).
In accordance with our process for
soliciting public input when
considering petitions for determinations
of nonregulated status for GE organisms,
we are publishing this notice to inform
the public that APHIS will accept
written comments on our PPRA and
PO 00000
Frm 00004
Fmt 4703
Sfmt 4703
66893
draft EA regarding the petition for a
determination of nonregulated status
from interested or affected persons for a
period of 30 days from the date of this
notice. Copies of the PPRA and draft
EA, as well as the previously published
petition, are available as indicated in
the ADDRESSES and FOR FURTHER
INFORMATION CONTACT sections of this
notice.
As indicated previously, after the
comment period closes, APHIS will
review all written comments received
during the comment period and any
other relevant information. After
reviewing and evaluating the comments
on the draft EA and PPRA and other
information, APHIS will revise the
PPRA as necessary and prepare a final
EA. Based on the final EA, APHIS will
prepare a NEPA decision document
(either a FONSI or a notice of intent to
prepare an environmental impact
statement). If a FONSI is reached,
APHIS will furnish a response to the
petitioner, either approving or denying
the petition. APHIS will also publish 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.
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
November 2013.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2013–26701 Filed 11–6–13; 8:45 am]
BILLING CODE 3410–34–P
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ACTION: Notice of Business Meeting.
AGENCY:
Friday, November 15,
2013; 9:30 a.m. EST.
PLACE: 1331 Pennsylvania Ave NW.,
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DATE AND TIME:
Meeting Agenda
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II. Office of General Counsel Ethics
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III. Program Planning
• Review and Vote on the Proposed
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E:\FR\FM\07NON1.SGM
07NON1
]]>Agencies
[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Pages 66892-66893]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26701]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2012-0028]
BASF Plant Science LP; Availability of Plant Pest Risk Assessment
and Environmental Assessment for Determination of Nonregulated Status
of Soybean Genetically Engineered for Herbicide 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 is making available for public comment our plant
pest risk assessment and our draft environmental assessment regarding a
request from BASF Plant Science LP seeking a determination of
nonregulated status of soybean designated as event BPS-CV127-9, which
has been genetically engineered for resistance to herbicides in the
imidazolinone family. We are soliciting comments on whether this
genetically engineered soybean is likely to pose a plant pest risk.
DATES: We will consider all comments that we receive on or before
December 9, 2013.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2012-0028.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2012-0028, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at https://www.regulations.gov/#!docketDetail;D=APHIS-2012-
0028 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 Web site at
https://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml
under APHIS Petition Number 09-015-01p.
FOR FURTHER INFORMATION CONTACT: Dr. Rebecca Stankiewicz Gabel, Chief,
Biotechnology Environmental Analysis Branch, Environmental Risk
Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River
Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3927, email:
rebecca.l.stankiewicz-gabel@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:
Background
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 has received a petition (APHIS Petition
Number 09-015-01p) from BASF Plant Science LP (BASF) of Research
Triangle Park, NC, seeking a determination of nonregulated status of
soybean (Glycine max) designated as event BPS-CV127-9, which has been
genetically engineered for resistance to herbicides in the
imidazolinone family. The petition states that this soybean is unlikely
to pose a plant pest risk 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
[[Page 66893]]
the Federal Register on July 13, 2012, (77 FR 41363-41364, Docket No.
APHIS-2012-0028), APHIS announced the availability of the BASF petition
for public comment. APHIS solicited comments on the petition for 60
days ending on September 11, 2012, 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, 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-
2012-0028.
---------------------------------------------------------------------------
APHIS received 75 comments on the petition. Several of these
comments included electronic attachments consisting of a consolidated
document of many identical or nearly identical letters, for a total of
4,676 comments. Issues raised during the comment period include the
nature of agronomic inputs, such as fertilizer and pesticide
applications, associated with this new trait; effects of herbicide use,
including potential impacts to plants from off-target herbicide drift,
management of herbicide-resistant weeds, and human health
considerations from exposure to herbicides; and domestic and
international economic impacts associated with the development and
marketing of a new herbicide-resistant product. APHIS has evaluated the
issues raised during the comment period and, where appropriate, has
provided a discussion of these issues in our 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 EA, preliminary finding of no significant
impact (FONSI), and its 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.
Alternatively, 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 substantive new issues, APHIS will
follow Approach 2. Under Approach 2, APHIS first solicits written
comments from the public on a draft EA and 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 PPRA
and other information, APHIS will revise the 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). For this
petition, we are using Approach 2.
APHIS has prepared a PPRA to determine if soybean event BPS-CV127-9
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 BASF, 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 soybean event BPS-CV127-9 and it would
continue to be a regulated article, or (2) make a determination of
nonregulated status of soybean event BPS-CV127-9.
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).
In accordance with our process for soliciting public input when
considering petitions for determinations of nonregulated status for GE
organisms, we are publishing this notice to inform the public that
APHIS will accept written comments on our PPRA and draft EA regarding
the petition for a determination of nonregulated status from interested
or affected persons for a period of 30 days from the date of this
notice. Copies of the PPRA and draft EA, as well as the previously
published petition, are available as indicated in the ADDRESSES and FOR
FURTHER INFORMATION CONTACT sections of this notice.
As indicated previously, after the comment period closes, APHIS
will review all written comments received during the comment period and
any other relevant information. After reviewing and evaluating the
comments on the draft EA and PPRA and other information, APHIS will
revise the PPRA as necessary and prepare a final EA. Based on the final
EA, APHIS will prepare a NEPA decision document (either a FONSI or a
notice of intent to prepare an environmental impact statement). If a
FONSI is reached, APHIS will furnish a response to the petitioner,
either approving or denying the petition. APHIS will also publish 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.
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 November 2013.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-26701 Filed 11-6-13; 8:45 am]
BILLING CODE 3410-34-P
