Pioneer Hi-Bred International, Inc.; 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, 32231-32233 [2013-12687]
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tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Notices
intended to protect other States that
would be endangered by the
introduction of a quarantine pest
established elsewhere in the United
States.
APHIS is aware that individual States
enforce phytosanitary regulations and
procedures within their borders to
address pests of concern, and that those
pests are not always also the subject of
an APHIS response program or activity.
To strengthen APHIS’ safeguarding
system to protect agriculture and to
facilitate agriculture trade through
effective management of phytosanitary
measures, APHIS initiated the Federally
Recognized State Managed
Phytosanitary (FRSMP) Program, which
establishes an administrative process for
granting Federal recognition to certain
State-managed official control programs
for plant pest eradication or
containment and State-managed pest
exclusion programs. (The FRSMP
Program was previously referred to as
the Official Control Program.) Federal
recognition of a State’s pest control
activities will justify actions by Federal
inspectors at ports of entry to help
exclude pests that are under a
phytosanitary program in a destination
State. This process involves the use of
information collection activities,
including the submission by States of a
protocol for quarantine pests of concern
and a protocol for regulated nonquarantine pests.
These information collection
activities were previously approved by
the Office of Management and Budget
(OMB) with an estimated total annual
burden on respondents of 106,000
hours. However, we overestimated the
number of respondents, and we have
adjusted the estimated total annual
burden on respondents to 1,399 hours.
We are asking OMB to approve these
information collection activities for an
additional 3 years.
The purpose of this notice is to solicit
comments from the public (as well as
affected agencies) concerning our
information collection. These comments
will help us:
(1) Evaluate whether the collection of
information is necessary for the proper
performance of the functions of the
Agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our
estimate of the burden of the collection
of information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, through use, as
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appropriate, of automated, electronic,
mechanical, and other collection
technologies; e.g., permitting electronic
submission of responses.
Estimate of burden: The public
reporting burden for this collection of
information is estimated to average 82
hours per response.
Respondents: State Plant Health
Regulatory Officials.
Estimated annual number of
respondents: 53.
Estimated annual number of
responses per respondent: 0.33.
Estimated annual number of
responses: 17.
Estimated total annual burden on
respondents: 1,399 hours. (Due to
averaging, the total annual burden hours
may not equal the product of the annual
number of responses multiplied by the
reporting burden per response.)
All responses to this notice will be
summarized and included in the request
for OMB approval. All comments will
also become a matter of public record.
32231
AGENCY:
preliminary determination of
nonregulated status.
DATES: We will consider any
information that we receive on or before
June 28, 2013.
ADDRESSES: You may submit any
information by either of the following
methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/#!document
Detail;D=APHIS-2012-0031.
• Postal Mail/Commercial Delivery:
Send any information to Docket No.
APHIS–2012–0031, 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-2012-0031 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 11–063–01p.
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 Pioneer Hi-Bred
International, Inc., seeking a
determination of nonregulated status of
canola designated as DP–073496–4,
which has been genetically engineered
for resistance to the herbicide
glyphosate. We are also making
available for public review our plant
pest risk assessment, environmental
assessment, and preliminary finding of
no significant impact for the
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)
Done in Washington, DC, this 22nd day of
May 2013.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2013–12697 Filed 5–28–13; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2012–0031]
Pioneer Hi-Bred International, Inc.;
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.
SUMMARY:
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32232
Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
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 11–063–01p) from
Pioneer Hi-Bred International, Inc., of
Johnston, IA, seeking a determination of
nonregulated status of canola (Brassica
napus) designated as event DP–073496–
4, which has been genetically
engineered for tolerance to the herbicide
glyphosate. 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 41364–41366, Docket No.
APHIS–2012–0031), APHIS announced
the availability of the Pioneer 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 4,686 comments on
the petition. Issues raised during the
comment period include outcrossing
and cross-pollination concerns and
effects of herbicide use, such as the
development of herbicide-resistant
weeds and effects on non-target
organisms. 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
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=APHIS2012-0031.
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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 DP–
073496–4 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
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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
Pioneer, 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 DP–
073496–4 and it would continue to be
a regulated article, or (2) make a
determination of nonregulated status of
canola event DP–073496–4.
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 Pioneer,
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 DP–073496–4 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 DP–073496–4, whereby
canola event DP–073496–4 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
DP–073496–4, 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 DP–073496–4, as well as the
Pioneer 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.
E:\FR\FM\29MYN1.SGM
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Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Notices
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 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 22nd day of
May 2013.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2013–12687 Filed 5–28–13; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2013–0036]
Notice of Request for Extension of
Approval of an Information Collection;
Importation of Artificially Dwarfed
Plants
Animal and Plant Health
Inspection Service, USDA.
ACTION: Extension of approval of an
information collection; comment
request.
tkelley on DSK3SPTVN1PROD with NOTICES
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995, this
notice announces the Animal and Plant
Health Inspection Service’s intention to
request an extension of approval of an
information collection associated with
the regulations for the importation of
artificially dwarfed plants.
SUMMARY:
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18:07 May 28, 2013
Jkt 229001
We will consider all comments
that we receive on or before July 29,
2013.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2013-00360001.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2013–0036, 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-2013-0036 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.
FOR FURTHER INFORMATION CONTACT: For
information on the regulations for the
importation of artificially dwarfed
plants, contact Mr. Dave Farmer,
National Operations Manager, PEQ
Coordinator, PPQ, APHIS, Venture IV,
Suite 200, 920 Main Campus Drive,
Raleigh, NC 27606; (919) 855–7366. For
copies of more detailed information on
the information collection, contact Mrs.
Celeste Sickles, APHIS’ Information
Collection Coordinator, at (301) 851–
2908.
SUPPLEMENTARY INFORMATION: Title:
Importation of Artificially Dwarfed
Plants.
OMB Number: 0579–0176.
Type of Request: Extension of
approval of an information collection.
Abstract: Under the Plant Protection
Act (7 U.S.C. 7701 et seq.), the Secretary
of Agriculture is authorized to prohibit
or restrict the importation, entry, or
interstate movement of plants, plant
products, and other articles to prevent
the introduction of plant pests into the
United States or their dissemination
within the United States. This authority
has been delegated to the Animal and
Plant Health Inspection Service.
The regulations contained in
‘‘Subpart–Plants for Planting’’ (7 CFR
319.37 through 319.37–14) prohibit or
restrict the importation of living plants,
plant parts, and seeds for propagation.
Among other things, § 319.37–5(q)
requires artificially dwarfed plants that
are imported into the United States,
except for plants that are less than 2
DATES:
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32233
years old, to be accompanied by a
phytosanitary certificate issued by the
government of the country of origin.
This phytosanitary certificate must
contain declarations that the plants
were:
• Grown for at least 2 years in a
greenhouse or screenhouse in a nursery
registered with the government of the
country where the plants were grown;
• Grown in a greenhouse or
screenhouse that has screening with
openings of not more than 1.6
millimeters on all vents and openings,
and all entryways equipped with
automatic closing doors;
• Grown in pots containing only
sterile growing media during the 2-year
period when they were grown in a
greenhouse or screenhouse in a
registered nursery;
• Grown on benches at least 50
centimeters above the ground during the
2-year period when they were grown in
a greenhouse or screenhouse in a
registered nursery; and
• Inspected (along with the
greenhouse or screenhouse and nursery)
for any evidence of pests and found free
of pests of quarantine significance to the
United States at least once every 12
months by the plant protection service
of the country where the plants are
grown.
The phytosanitary certificate and
declarations help APHIS verify that
imported artificially dwarfed plants do
not pose a risk for the introduction of
longhorned beetles and other pests into
the United States.
We are asking the Office of
Management and Budget (OMB) to
approve our use of this information
collection activity for an additional 3
years.
The purpose of this notice is to solicit
comments from the public (as well as
affected agencies) concerning our
information collection. These comments
will help us:
(1) Evaluate whether the collection of
information is necessary for the proper
performance of the functions of the
Agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our
estimate of the burden of the collection
of information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, through use, as
appropriate, of automated, electronic,
mechanical, and other collection
technologies; e.g., permitting electronic
submission of responses.
E:\FR\FM\29MYN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 103 (Wednesday, May 29, 2013)]
[Notices]
[Pages 32231-32233]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12687]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2012-0031]
Pioneer Hi-Bred International, Inc.; 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 Pioneer Hi-Bred International, Inc., seeking a
determination of nonregulated status of canola designated as DP-073496-
4, which has been genetically engineered for resistance to the
herbicide glyphosate. 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
June 28, 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-2012-0031.
Postal Mail/Commercial Delivery: Send any information to
Docket No. APHIS-2012-0031, 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-2012-0031 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 11-063-01p.
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)
[[Page 32232]]
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
11-063-01p) from Pioneer Hi-Bred International, Inc., of Johnston, IA,
seeking a determination of nonregulated status of canola (Brassica
napus) designated as event DP-073496-4, which has been genetically
engineered for tolerance to the herbicide glyphosate. 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 41364-41366, Docket No. APHIS-2012-
0031), APHIS announced the availability of the Pioneer 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-
2012-0031.
---------------------------------------------------------------------------
APHIS received 4,686 comments on the petition. Issues raised during
the comment period include outcrossing and cross-pollination concerns
and effects of herbicide use, such as the development of herbicide-
resistant weeds and effects on non-target organisms. 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 DP-
073496-4 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 Pioneer, 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 DP-073496-4 and it would continue to
be a regulated article, or (2) make a determination of nonregulated
status of canola event DP-073496-4.
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
Pioneer, 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 DP-073496-4 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
DP-073496-4, whereby canola event DP-073496-4 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 DP-073496-4, 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 DP-073496-4, as well
as the Pioneer 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.
[[Page 32233]]
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 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 22nd day of May 2013.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-12687 Filed 5-28-13; 8:45 am]
BILLING CODE 3410-34-P
