GENECTIVE SA; Availability of Plant Pest Risk Assessment, Environmental Assessment, Preliminary Finding of No Significant Impact, and Preliminary Determination of Nonregulated Status of Maize Genetically Engineered for Herbicide Resistance, 45169-45171 [2013-17937]
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45169
Notices
Federal Register
Vol. 78, No. 144
Friday, July 26, 2013
This section of the FEDERAL REGISTER
contains documents other than rules or
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public. Notices of hearings and investigations,
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DEPARTMENT OF AGRICULTURE
Submission for OMB Review;
Comment Request
tkelley on DSK3SPTVN1PROD with NOTICES
July 22, 2013.
The Department of Agriculture has
submitted the following information
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Public Law 104–13. Comments
regarding (a) 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;
(b) the accuracy of the agency’s estimate
of burden including the validity of the
methodology and assumptions used; (c)
ways to enhance the quality, utility and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on those who are to respond, including
through the use of appropriate
automated, electronic, mechanical, or
other technological collection
techniques or other forms of information
technology.
Comments regarding this information
collection received by August 26, 2013
will be considered. Written comments
should be addressed to: Desk Officer for
Agriculture, Office of Information and
Regulatory Affairs, Office of
Management and Budget (OMB), New
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Commenters are encouraged to submit
their comments to OMB via email to:
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Clearance Office, USDA, OCIO, Mail
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An agency may not conduct or
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18:54 Jul 25, 2013
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potential persons who are to respond to
the collection of information that such
persons are not required to respond to
the collection of information unless it
displays a currently valid OMB control
number.
Animal and Plant Health Inspection
Service
Title: Animal Disease Traceability
Information Systems, Agreements, and
Reports (formerly: National Animal
Identification System).
OMB Control Number: 0579–0259.
Summary of Collection: The Animal
and Plant Health Inspection Service
(APHIS) has the authority to issue
orders and promulgate regulations to
prevent the introduction into the United
States and the dissemination within the
United States of any pest or disease of
livestock. APHIS’ regulations govern
cooperative programs to control and
eradicate communicable diseases of
livestock. The regulations also establish
requirements for the interstate
movement of livestock to prevent the
dissemination of diseases of livestock
within the United States. Knowing
where diseased and at-risk animals are,
where they have been, and when, is
indispensable in emergency response
and in ongoing disease control and
eradication programs. To provide a
system that could provide for animal
traceability, APHIS developed the
Animal Disease Traceability (ADT)
framework and ADT information
systems. The basic data APHIS acquires
through the ADT information systems
will help APHIS obtain timely
information on animal movement
tracebacks and trace forwards when
responding to an animal disease of
concern.
Need and Use of the Information:
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consistent, and efficient system which
will allow traces of animals to be
completed in a timely manner, detection
of disease, and ensure rapid
containment of disease. The ADT
information systems involve reporting
and recordkeeping activities, including
animal identification; premises
registration; nonproducer participant
registration; updates submitted by
animal identification number
manufacturers and managers;
cooperative agreements; cooperative
agreement applications; cooperator
(State/Tribe) quarterly accomplishment
reports; an identification number
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management system; and records
associated with animal movement
activities. Failing to collect the needed
information would make it impossible
for APHIS to conduct a timely traceback
or trace forward of animals potentially
exposed to disease.
Description of Respondents: Business
or other for-profit; State, Local, or Tribal
Government.
Number of Respondents: 60,315.
Frequency of Responses:
Recordkeeping; Reporting: On occasion.
Total Burden Hours: 47,054.
Ruth Brown,
Departmental Information Collection
Clearance Officer.
[FR Doc. 2013–17925 Filed 7–25–13; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2012–0046]
GENECTIVE SA; Availability of Plant
Pest Risk Assessment, Environmental
Assessment, Preliminary Finding of No
Significant Impact, and Preliminary
Determination of Nonregulated Status
of Maize 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 GENECTIVE SA, seeking a
determination of nonregulated status of
maize designated as VCO–01981–5,
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
August 26, 2013.
ADDRESSES: You may submit any
information by either of the following
methods:
SUMMARY:
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45170
Federal Register / Vol. 78, No. 144 / Friday, July 26, 2013 / Notices
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2012-0046.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2012–0046, 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-2012-0046 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) 7997039
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 11–342–01p.
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:
tkelley on DSK3SPTVN1PROD with NOTICES
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.
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18:54 Jul 25, 2013
Jkt 229001
APHIS received a petition (APHIS
Petition Number 11–342–01p) from
GENECTIVE SA of Chappes, France,
seeking a determination of nonregulated
status of maize (Zea mays L.) designated
as event VCO–01981–5, which has been
genetically engineered for resistance to
the herbicide glyphosate. 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 41353–41354, Docket No.
APHIS–2012–0046), APHIS announced
the availability of the GENECTIVE SA
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 79 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 4,693 comments.
Issues raised during the comment
period include outcrossing and crosspollination 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
1 On March 6, 2012, APHIS published in the
Federal Register (77 FR 13258–13260, Docket No.
APHIS–2011–0129) a notice describing our process
for soliciting public comment 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-;0046.
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Fmt 4703
Sfmt 4703
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 with a review
and analysis of any potential
environmental impacts associated with
the petition request.
APHIS has prepared a PPRA and has
concluded that maize event VCO–
01981–5 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
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26JYN1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 144 / Friday, July 26, 2013 / Notices
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
GENECTIVE SA, 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
maize event VCO–01981–5 and it would
continue to be a regulated article, or (2)
make a determination of nonregulated
status of maize event VCO–01981–5.
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
GENECTIVE SA, references provided in
the petition, peer-reviewed
publications, information analyzed in
the EA, the PPRA, comments provided
by the public, and discussion of issues
in the EA in response to those public
comments, APHIS has determined that
maize event VCO–01981–5 is unlikely
to pose a plant pest risk. We have
therefore reached a preliminary decision
to make a determination of nonregulated
status of maize event VCO–01981–5,
whereby maize event VCO–01981–5
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 maize event
VCO–01981–5, 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 maize
event VCO–01981–5, as well as the
GENECTIVE SA 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
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18:54 Jul 25, 2013
Jkt 229001
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 19th day of
July, 2013.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2013–17937 Filed 7–25–13; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Food and Nutrition Service
Agency Information Collection
Activities: Proposed Collection;
Comment Request–WIC Nutrition
Services and Administration (NSA)
Cost Study
Food and Nutrition Service
(FNS), USDA.
ACTION: Notice.
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995, this
notice invites the general public and
other public agencies to comment on
this proposed information collection.
This collection is a new collection to
obtain data on how State and local WIC
agencies calculate NSA costs; how
recent Program changes have impacted
NSA costs; and how administrative
costs and policies compare to those of
Supplemental Nutrition Assistance
Program (SNAP) and Temporary
Assistance for Needy Families (TANF).
SUMMARY:
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45171
Written comments must be
received on or before September 24,
2013.
DATES:
Comments are invited on (a)
whether the proposed data collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall 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 assumptions that
were used; (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
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Written comments may be sent to: Dr.
Melissa Abelev, Food and Nutrition
Service, U.S. Department of Agriculture,
3101 Park Center Drive, Room 1014,
Alexandria, VA 22302. Comments may
also be submitted via fax to the attention
of Dr. Melissa Abelev at 703–305–2209
or via email to
Melissa.Abelev@fns.usda.gov.
Comments will also be accepted through
the Federal eRulemaking Portal. Go to
https://www.regulations.gov, and follow
the online instructions for submitting
comments electronically.
All written comments will be open for
public inspection at the office of the
Food and Nutrition Service during
regular business hours (8:30 a.m. to 5:00
p.m., Monday through Friday) at 3101
Park Center Drive, Room 1014,
Alexandria, Virginia 22302.
All responses to this notice will be
summarized and included in the request
for Office of Management and Budget
approval. All comments will be a matter
of public record.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
copies of this information collection
should be directed to Dr. Melissa Abelev
at 703–305–2209.
SUPPLEMENTARY INFORMATION:
Title: WIC Nutrition Services and
Administration (NSA) Cost Study.
Form Number: N/A.
OMB Number: Not yet assigned.
Expiration Date: Not yet determined.
Type of Request: New collection.
Abstract: The Special Supplemental
Nutrition Program for Women, Infants,
and Children (WIC), (Pub. L. 109–85), is
administered at the Federal level by the
Food and Nutrition Service (FNS) of the
U.S. Department of Agriculture.
Through Federal grants to States, WIC
ADDRESSES:
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]]>Agencies
[Federal Register Volume 78, Number 144 (Friday, July 26, 2013)]
[Notices]
[Pages 45169-45171]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17937]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2012-0046]
GENECTIVE SA; Availability of Plant Pest Risk Assessment,
Environmental Assessment, Preliminary Finding of No Significant Impact,
and Preliminary Determination of Nonregulated Status of Maize
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 GENECTIVE SA, seeking a determination of nonregulated
status of maize designated as VCO-01981-5, 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
August 26, 2013.
ADDRESSES: You may submit any information by either of the following
methods:
[[Page 45170]]
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2012-0046.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2012-0046, 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-
0046 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) 7997039 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 11-342-01p.
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
11-342-01p) from GENECTIVE SA of Chappes, France, seeking a
determination of nonregulated status of maize (Zea mays L.) designated
as event VCO-01981-5, which has been genetically engineered for
resistance to the herbicide glyphosate. 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 41353-41354, Docket No. APHIS-2012-
0046), APHIS announced the availability of the GENECTIVE SA 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 process for soliciting public comment 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-;0046.
---------------------------------------------------------------------------
APHIS received 79 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
4,693 comments. 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 with a review and analysis
of any potential environmental impacts associated with the petition
request.
APHIS has prepared a PPRA and has concluded that maize event VCO-
01981-5 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
[[Page 45171]]
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 GENECTIVE SA, 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 maize event VCO-01981-5 and it would continue to
be a regulated article, or (2) make a determination of nonregulated
status of maize event VCO-01981-5.
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
GENECTIVE SA, references provided in the petition, peer-reviewed
publications, information analyzed in the EA, the PPRA, comments
provided by the public, and discussion of issues in the EA in response
to those public comments, APHIS has determined that maize event VCO-
01981-5 is unlikely to pose a plant pest risk. We have therefore
reached a preliminary decision to make a determination of nonregulated
status of maize event VCO-01981-5, whereby maize event VCO-01981-5
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 maize event VCO-01981-5, 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 maize event VCO-01981-5, as well
as the GENECTIVE SA petition and the comments received on the petition,
are available as indicated under ADDRESSES and FOR FURTHER INFORMATION
CONTACT above. Copies of these documents may also be obtained from the
person listed under FOR FURTHER INFORMATION CONTACT.
After the 30-day review period closes, APHIS will review and
evaluate any information received during the 30-day review period. If,
after evaluating the information received, APHIS determines that we
have not received substantive new information that would warrant APHIS
altering our preliminary regulatory determination or 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. 2013-17937 Filed 7-25-13; 8:45 am]
BILLING CODE 3410-34-P
