Monsanto Co.; Availability of Plant Pest Risk Assessment, Environmental Assessment, Preliminary Finding of No Significant Impact, and Preliminary Determination of Nonregulated Status of Canola Genetically Engineered for Herbicide Resistance, 44924-44926 [2013-17933]
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44924
Federal Register / Vol. 78, No. 143 / Thursday, July 25, 2013 / Notices
Comments on this notice must be
received by September 23, 2013 to be
assured of consideration.
ADDRESSES: Address all comments
concerning this notice to Tara Smith,
USDA, Agriculture Research Service,
National Agricultural Library, 10301
Baltimore Avenue, Room 108–B,
Beltsville, Maryland 20705. Comments
may be sent by fax to (301) 504–6409,
or by email to tara.smith@ars.usda.gov.
FOR FURTHER INFORMATION CONTACT: Tara
Smith, telephone (301) 504–5515.
SUPPLEMENTARY INFORMATION:
Title: Food Safety Education and
Training Materials Sharing Form
DATES:
ehiers on DSK2VPTVN1PROD with NOTICES
BILLING CODE 3410–03–P
OMB Number: OMB control number
is 0518–0046.
Expiration Date: Three years from the
date of approval.
Type of Request: Approval for data
collection from individuals working in
the areas of food safety education and
training.
Abstract: The Food Safety Education
and Training Materials Sharing form
contains three sections and is used to
collect information about materials
developed to support food safety
education (e.g. DVDs, posters,
curriculum, kits) for inclusion in NAL’s
Food Safety Education and Training
Materials Database. The questionnaire
collects the name and email address of
the person submitting the form,
information on the resource/education
material developed (e.g. title, target
audience focus, a description,
publisher/distributor information and
information on the author) to determine
if a readability formula was used or if
the project is associated with a grant or
other funded mechanism.
Estimate of Burden: Public reporting
burden for this collection of information
is estimated to average 15 minutes per
respondent.
Respondents: Individuals working in
the areas of food safety education and
training.
Estimated Number of Respondents: 35
per year.
Estimated Total Annual Burden on
Respondents: 525 minutes or 8.75
hours.
Comments are invited on (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the Agency,
including whether the information will
have practical utility; (b) the accuracy of
the Agency’s estimate of the burden of
the proposed collection of information,
including the validity of the
methodology and the assumptions used;
13:49 Jul 24, 2013
Jkt 229001
Dated: July 16, 2013.
Caird E. Rexroad, Jr.,
Associate Administrator, ARS.
[FR Doc. 2013–17887 Filed 7–24–13; 8:45 am]
Authority: Pub. L. 104–13; 5 CFR Part
1320 (60 FR 44978, August 29, 1995)
VerDate Mar<15>2010
(c) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on those who respond, including the
use of appropriate automated,
electronic, mechanical, or other
technology. Comments should be sent to
the address in the preamble. All
responses to this notice will be
summarized and included in the request
for OMB approval. All comments will
become a matter of public record.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2012–0035]
Monsanto Co.; Availability of Plant
Pest Risk Assessment, Environmental
Assessment, Preliminary Finding of No
Significant Impact, and Preliminary
Determination of Nonregulated Status
of Canola 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 has prepared a
preliminary determination regarding a
request from the Monsanto Company
seeking a determination of nonregulated
status of canola designated as MON
88302, which has been genetically
engineered for resistance to the
herbicide glyphosate with more
flexibility in the timing of herbicide
application. We are also making
available for public review our plant
pest risk assessment, environmental
assessment, and preliminary finding of
no significant impact for the
preliminary determination of
nonregulated status.
DATES: We will consider any
information that we receive on or before
August 26, 2013.
ADDRESSES: You may submit any
information by either of the following
methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2012-0035.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2012–0035, Regulatory Analysis
SUMMARY:
PO 00000
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Sfmt 4703
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238.
Supporting documents for this
petition and any other information we
receive on this docket may be viewed at
https://www.regulations.gov/
#!docketDetail;D=APHIS-2012-0035 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
Web site at https://www.aphis.usda.gov/
biotechnology/
petitions_table_pending.shtml under
APHIS Petition Number 11–188–01p.
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.stankiewiczgabel@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:
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 received a petition (APHIS
Petition Number 11–188–01p) from the
Monsanto Company (Monsanto) of St.
Louis, MO, seeking a determination of
nonregulated status of canola (Brassica
napus) designated as event MON 88302,
E:\FR\FM\25JYN1.SGM
25JYN1
Federal Register / Vol. 78, No. 143 / Thursday, July 25, 2013 / Notices
ehiers on DSK2VPTVN1PROD with NOTICES
which has been genetically engineered
for resistance to the herbicide
glyphosate with more flexibility in the
timing of herbicide application. The
petition stated that this canola 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
the Federal Register on July 13, 2012,
(77 FR 41357–41358, Docket No.
APHIS–2012–0035), APHIS announced
the availability of the Monsanto 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 67 comments on the
petition. Several of these comments
included electronic attachments
consisting of a document of identical or
nearly identical letters, for a total of
4,670 comments on the petition. Issues
raised during the comment period
include effects of herbicide use, such as
the development of herbicide-resistant
weeds and effects on non-target
organisms, gene flow, and effects on
organic crop production. 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
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=APHIS2012-0035.
VerDate Mar<15>2010
13:49 Jul 24, 2013
Jkt 229001
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.
For this petition, we are using Approach
1.
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).
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 PPRA and has
concluded that canola event MON
88302 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.
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44925
APHIS has prepared an EA in which
we present two alternatives based on
our analysis of data submitted by
Monsanto, 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 canola event MON
88302 and it would continue to be a
regulated article, or (2) make a
determination of nonregulated status of
canola event MON 88302.
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 and other
pertinent scientific data, APHIS has
reached a preliminary FONSI with
regard to the preferred alternative
identified in the EA.
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 on the
petition, and discussion of issues in the
EA, APHIS has determined that canola
event MON 88302 is unlikely to pose a
plant pest risk. We have therefore
reached a preliminary decision to make
a determination of nonregulated status
of canola event MON 88302, whereby
canola event MON 88302 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 canola event
MON 88302, along with our PPRA, EA,
and preliminary FONSI for the
preliminary determination of
nonregulated status. The EA,
preliminary FONSI, PPRA, and our
preliminary determination for canola
event MON 88302, as well as the
Monsanto 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
E:\FR\FM\25JYN1.SGM
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44926
Federal Register / Vol. 78, No. 143 / Thursday, July 25, 2013 / Notices
AGENCY:
public review our plant pest risk
assessment, environmental assessment,
and preliminary finding of no
significant impact for the preliminary
determination of nonregulated status.
DATES: We will consider any
information that we receive on or before
August 26, 2013.
ADDRESSES: You may submit any
information by either of the following
methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2012-0027.
• Postal Mail/Commercial Delivery:
Send your information to Docket No.
APHIS–2012–0027, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238.
Supporting documents for this
petition and any other information we
receive on this docket may be viewed at
https://www.regulations.gov/
#!docketDetail;D=APHIS-2012-0027 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
Web site at https://www.aphis.usda.gov/
biotechnology/
petitions_table_pending.shtml under
APHIS Petition Number 10–281–01p.
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.stankiewiczgabel@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:
We are advising the public
that the Animal and Plant Health
Inspection Service has prepared a
preliminary determination regarding a
request from the Monsanto Company
seeking a determination of nonregulated
status of maize designated as MON
87427, which has been genetically
engineered with tissue-selective
resistance to glyphosate in order to
facilitate the production of hybrid maize
seed. We are also making available for
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
APHIS altering our preliminary
regulatory determination or FONSI,
substantially changing the proposed
action identified in the EA, or
substantially changing the analysis of
impacts in the EA, APHIS will notify
the public through an announcement on
our Web site 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 FONSI,
substantially changing the proposed
action identified in the EA, or
substantially changing the analysis of
impacts in the EA, then APHIS will
notify the public of our intent to
conduct additional analysis and to
prepare an amended EA, a new FONSI,
and/or a revised PPRA, which would be
made available for public review
through the publication of a notice of
availability in the Federal Register.
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 19th day of
July 2013.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2013–17933 Filed 7–24–13; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2012–0027]
Monsanto Co.; Availability of Plant
Pest Risk Assessment, Environmental
Assessment, Preliminary Finding of No
Significant Impact, and Preliminary
Determination of Nonregulated Status
of Maize Genetically Engineered With
Tissue-Selective Glyphosate
Resistance Facilitating the Production
of Hybrid Maize Seed
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
ehiers on DSK2VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
13:49 Jul 24, 2013
Jkt 229001
PO 00000
Frm 00005
Fmt 4703
Sfmt 4703
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 10–281–01p) from the
Monsanto Company (Monsanto) of St.
Louis, MO, seeking a determination of
nonregulated status of maize (Zea mays
L.) designated as event MON 87427,
which has been genetically engineered
for tissue-selective resistance to
glyphosate in order to facilitate the
production of hybrid maize seed. The
petition stated that this maize 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
the Federal Register on July 13, 2012,
(77 FR 41359–41361, Docket No.
APHIS–2012–0027), APHIS announced
the availability of the Monsanto 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 82 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 23,698 comments.
Issues raised during the comment
period include effects of herbicide use,
such as the development of herbicideresistant weeds and effects on non-target
organisms, gene flow, effects on organic
corn production, and health concerns.
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=APHIS2012-0027.
E:\FR\FM\25JYN1.SGM
25JYN1
]]>Agencies
[Federal Register Volume 78, Number 143 (Thursday, July 25, 2013)]
[Notices]
[Pages 44924-44926]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17933]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2012-0035]
Monsanto Co.; Availability of Plant Pest Risk Assessment,
Environmental Assessment, Preliminary Finding of No Significant Impact,
and Preliminary Determination of Nonregulated Status of Canola
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 has prepared a preliminary determination regarding a
request from the Monsanto Company seeking a determination of
nonregulated status of canola designated as MON 88302, which has been
genetically engineered for resistance to the herbicide glyphosate with
more flexibility in the timing of herbicide application. We are also
making available for public review our plant pest risk assessment,
environmental assessment, and preliminary finding of no significant
impact for the preliminary determination of nonregulated status.
DATES: We will consider any information that we receive on or before
August 26, 2013.
ADDRESSES: You may submit any information by either of the following
methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2012-0035.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2012-0035, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
Supporting documents for this petition and any other information we
receive on this docket may be viewed at https://www.regulations.gov/#!docketDetail;D=APHIS-2012-0035 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 Web site at https://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under APHIS Petition Number 11-188-01p.
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
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 received a petition (APHIS Petition Number
11-188-01p) from the Monsanto Company (Monsanto) of St. Louis, MO,
seeking a determination of nonregulated status of canola (Brassica
napus) designated as event MON 88302,
[[Page 44925]]
which has been genetically engineered for resistance to the herbicide
glyphosate with more flexibility in the timing of herbicide
application. The petition stated that this canola 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 the Federal
Register on July 13, 2012, (77 FR 41357-41358, Docket No. APHIS-2012-
0035), APHIS announced the availability of the Monsanto 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-
2012-0035.
---------------------------------------------------------------------------
APHIS received 67 comments on the petition. Several of these
comments included electronic attachments consisting of a document of
identical or nearly identical letters, for a total of 4,670 comments on
the petition. Issues raised during the comment period include effects
of herbicide use, such as the development of herbicide-resistant weeds
and effects on non-target organisms, gene flow, and effects on organic
crop production. 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. For this petition, we are using Approach 1.
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).
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 PPRA and has concluded that canola event MON
88302 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 prepared an EA in which we present two alternatives based
on our analysis of data submitted by Monsanto, 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 canola event MON 88302 and it would continue to be
a regulated article, or (2) make a determination of nonregulated status
of canola event MON 88302.
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 and other pertinent scientific data, APHIS has reached
a preliminary FONSI with regard to the preferred alternative identified
in the EA.
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 on the petition, and discussion of issues in the
EA, APHIS has determined that canola event MON 88302 is unlikely to
pose a plant pest risk. We have therefore reached a preliminary
decision to make a determination of nonregulated status of canola event
MON 88302, whereby canola event MON 88302 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 canola event MON 88302, along
with our PPRA, EA, and preliminary FONSI for the preliminary
determination of nonregulated status. The EA, preliminary FONSI, PPRA,
and our preliminary determination for canola event MON 88302, as well
as the Monsanto 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
[[Page 44926]]
APHIS altering our preliminary regulatory determination or FONSI,
substantially changing the proposed action identified in the EA, or
substantially changing the analysis of impacts in the EA, APHIS will
notify the public through an announcement on our Web site 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 FONSI, substantially
changing the proposed action identified in the EA, or substantially
changing the analysis of impacts in the EA, then APHIS will notify the
public of our intent to conduct additional analysis and to prepare an
amended EA, a new FONSI, and/or a revised PPRA, which would be made
available for public review through the publication of a notice of
availability in the Federal Register. 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 19th day of July 2013.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-17933 Filed 7-24-13; 8:45 am]
BILLING CODE 3410-34-P
