J.R. Simplot Co.; Availability of Plant Pest Risk Assessment and Environmental Assessment for Determination of Nonregulated Status of Potato Genetically Engineered for Low Acrylamide Potential and Reduced Black Spot Bruise, 31080-31082 [2014-12555]
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31080
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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.
Alternatively, if APHIS decides, based
on its review of the petition and its
evaluation and analysis of comments
received during the 60-day public
comment period on the petition, that the
petition involves a new crop-trait GE
organism or 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 a PPRA for a 30-day
comment period through the
publication of a Federal Register notice.
Then, after reviewing and evaluating the
comments on the draft EA and the 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 soybean event
SYHTOH2 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
Syngenta/BCS, a review of other
scientific data, field tests conducted
under APHIS oversight, and comments
received on the petition. APHIS is
considering the following alternatives:
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Jkt 232001
(1) Take no action, i.e., APHIS would
not change the regulatory status of
soybean event SYHTOH2 and it would
continue to be a regulated article, or (2)
make a determination of nonregulated
status of soybean event SYHTOH2.
APHIS’ preferred alternative is to make
a determination of nonregulated status
of soybean event SYHTOH2.
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 Syngenta/
BCS, 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 soybean event SYHTOH2 is
unlikely to pose a plant pest risk. We
have therefore reached a preliminary
decision to make a determination of
nonregulated status of soybean event
SYHTOH2, whereby soybean event
SYHTOH2 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 soybean
event SYHTOH2, along with our PPRA,
EA, and preliminary FONSI for the
preliminary determination of
nonregulated status. The PPRA, EA,
preliminary FONSI, and our preliminary
determination for soybean event
SYHTOH2, as well as the Syngenta/BCS
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
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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 23rd day of
May 2014.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2014–12554 Filed 5–29–14; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2012–0067]
J.R. Simplot Co.; Availability of Plant
Pest Risk Assessment and
Environmental Assessment for
Determination of Nonregulated Status
of Potato Genetically Engineered for
Low Acrylamide Potential and
Reduced Black Spot Bruise
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public
that the Animal and Plant Health
Inspection Service is making available
for public comment our plant pest risk
assessment and our draft environmental
assessment regarding a request from the
J.R. Simplot Company seeking a
determination of nonregulated status of
potatoes designated as InnateTM
potatoes (events E12, E24, F10, F37, J3,
J55, J78, G11, H37, and H50), which
have been genetically engineered for
low acrylamide potential (acrylamide is
a human neurotoxicant and potential
carcinogen that may form in potatoes
and other starchy foods under certain
cooking conditions) and reduced black
spot bruise. We are soliciting comments
SUMMARY:
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on whether this genetically engineered
potato is likely to pose a plant pest risk.
DATES: We will consider any
information that we receive on or before
June 30, 2014.
ADDRESSES: You may submit any
information by either of the following
methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!docketDetail;D=APHIS-2012-0067.
• Postal Mail/Commercial Delivery:
Send your information to Docket No.
APHIS–2012–0067, 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-2012-0067 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 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 13–022–01p.
FOR FURTHER INFORMATION CONTACT: Dr.
John Turner, Director, Environmental
Risk Analysis Programs, Biotechnology
Regulatory Services, APHIS, 4700 River
Road, Unit 147, Riverdale, MD 20737–
1236; (301) 851–3954, email:
john.t.turner@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: 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
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18:23 May 29, 2014
Jkt 232001
to the Animal and Plant Health
Inspection Service (APHIS) seeking a
determination that an article should not
be regulated under 7 CFR part 340.
APHIS has received a petition (APHIS
Petition Number 13–022–01p) from the
J.R. Simplot Company (Simplot) of
Boise, ID, seeking a determination of
nonregulated status of potatoes
(Solanum tuberosum) designated as
InnateTM potatoes (events E12, E24, F10,
F37, J3, J55, J78, G11, H37, and H50),
which have been genetically engineered
for low acrylamide potential and
reduced black spot bruise. Acrylamide
is a human neurotoxicant and potential
carcinogen that may form in potatoes
and other starchy foods under certain
cooking conditions. The petition states
that these potatoes are 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 input 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 May 3, 2013 (78
FR 25942–25943, Docket No. APHIS–
2012–0067), APHIS announced the
availability of the Simplot petition for
public comment. APHIS solicited
comments on the petition for 60 days
ending on July 2, 2013, 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 308 comments on the
petition; one of these comments
included electronic attachments
consisting of a consolidated document
of many identical or nearly identical
letters, for a total of 41,475 comments.
Some comments expressed support of a
determination of nonregulated status
because of potential health benefits and
improvements to the potato industry.
Issues raised during the comment
period include concerns regarding
effects on conventional potato
production, export markets, and plant
fitness. APHIS has evaluated the issues
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=APHIS2012-0067.
PO 00000
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31081
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 input 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.
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
new crop-trait GE organism or 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 a
PPRA for a 30-day comment period
through the publication of a Federal
Register notice. Then, after reviewing
and evaluating the comments on the
draft EA and the PPRA and other
information, APHIS will revise the
PPRA as necessary and prepare a final
EA and, based on the final EA, a
National Environmental Policy Act
(NEPA) decision document (either a
FONSI or a notice of intent to prepare
an environmental impact statement).
For this petition, we are using Approach
2.
APHIS has prepared a PPRA to
determine if InnateTM potatoes are
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
E:\FR\FM\30MYN1.SGM
30MYN1
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31082
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any article similar to or allied with any
of the foregoing.
APHIS has also prepared a draft EA in
which we present two alternatives based
on our analysis of data submitted by
Simplot, 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 InnateTM potatoes
and they would continue to be a
regulated article, or (2) make a
determination of nonregulated status of
InnateTM potatoes. APHIS’ preferred
alternative is to make a determination of
nonregulated status of InnateTM
potatoes.
The EA was prepared in accordance
with (1) NEPA, as amended (42 U.S.C.
4321 et seq.), (2) regulations of the
Council on Environmental Quality for
implementing the procedural provisions
of NEPA (40 CFR parts 1500–1508), (3)
USDA regulations implementing NEPA
(7 CFR part 1b), and (4) APHIS’ NEPA
Implementing Procedures (7 CFR part
372).
In accordance with our process for
soliciting public input when
considering petitions for determinations
of nonregulated status for GE organisms,
we are publishing this notice to inform
the public that APHIS will accept
written comments on our draft EA and
our PPRA regarding the petition for a
determination of nonregulated status
from interested or affected persons for a
period of 30 days from the date of this
notice. Copies of the draft EA and the
PPRA, as well as the previously
published petition, are available as
indicated under ADDRESSES and FOR
FURTHER INFORMATION CONTACT above.
After the comment period closes,
APHIS will review all written comments
received during the comment period
and any other relevant information.
After reviewing and evaluating the
comments on the draft EA and the PPRA
and other information, APHIS will
revise the PPRA as necessary and
prepare a final EA. Based on the final
EA, APHIS will prepare a NEPA
decision document (either a FONSI or a
notice of intent to prepare an
environmental impact statement). If a
FONSI is reached, APHIS will furnish a
response to the petitioner, either
approving or denying the petition.
APHIS will also publish a notice in the
Federal Register announcing the
regulatory status of the GE organism and
the availability of APHIS’ final EA,
PPRA, FONSI, and our regulatory
determination.
VerDate Mar<15>2010
18:23 May 29, 2014
Jkt 232001
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 23rd day of
May 2014.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2014–12555 Filed 5–29–14; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2013–0013]
Monsanto Company and Forage
Genetics International; Availability of a
Plant Pest Risk Assessment and
Environmental Assessment for
Determination of Nonregulated Status
of Genetically Engineered Alfalfa
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public
that the Animal and Plant Health
Inspection Service is making available
for public comment our plant pest risk
assessment and our draft environmental
assessment regarding a request from the
Monsanto Company and Forage
Genetics International seeking a
determination of nonregulated status of
alfalfa designated as event KK179,
which has been genetically engineered
to express reduced levels of guaiacyl
lignin. We are soliciting comments on
whether this genetically engineered
alfalfa is likely to pose a plant pest risk.
DATES: We will consider all comments
that we receive on or before June 30,
2014.
SUMMARY:
You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!docketDetail;D=APHIS-2013-0013.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2013–0013, 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-2013-0013 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
ADDRESSES:
PO 00000
Frm 00005
Fmt 4703
Sfmt 4703
p.m., Monday through Friday, except
holidays. To be sure someone is there to
help you, please call (202) 799–7039
before coming.
Supporting documents are also
available on the APHIS Web site at
https://www.aphis.usda.gov/
biotechnology/petitions_table_
pending.shtml under APHIS Petition
Number 12–321–01p.
FOR FURTHER INFORMATION CONTACT: Dr.
John Turner, Director, Environmental
Risk Analysis Programs, Biotechnology
Regulatory Services, APHIS, 4700 River
Road, Unit 147, Riverdale, MD 20737–
1236; (301) 851–3954, email:
john.t.turner@aphis.usda.gov. To obtain
copies of the supporting documents for
this petition, contact Ms. Cindy Eck at
(301) 851–3892, email: cynthia.a.eck@
aphis.usda.gov.
Under the
authority of the plant pest provisions of
the Plant Protection Act (7 U.S.C. 7701
et seq.), the regulations in 7 CFR part
340, ‘‘Introduction of Organisms and
Products Altered or Produced Through
Genetic Engineering Which Are Plant
Pests or Which There Is Reason to
Believe Are Plant Pests,’’ regulate,
among other things, the introduction
(importation, interstate movement, or
release into the environment) of
organisms and products altered or
produced through genetic engineering
that are plant pests or that there is
reason to believe are plant pests. Such
genetically engineered (GE) organisms
and products are considered ‘‘regulated
articles.’’
The regulations in § 340.6(a) provide
that any person may submit a petition
to the Animal and Plant Health
Inspection Service (APHIS) seeking a
determination that an article should not
be regulated under 7 CFR part 340.
APHIS has received a petition (APHIS
Petition Number 12–321–01p) from the
Monsanto Company and Forage
Genetics International seeking a
determination of nonregulated status of
alfalfa designated as event KK179,
which has been genetically engineered
to express reduced levels of guaiacyl
lignin, a major subunit component of
total lignin that slows the digestion of
cellulose in livestock, as compared to
conventional alfalfa at the same stage of
growth. The petition states that this
alfalfa event 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 input when
SUPPLEMENTARY INFORMATION:
1 On March 6, 2012, APHIS published in the
Federal Register (77 FR 13258–13260, Docket No.
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30MYN1
Agencies
[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Notices]
[Pages 31080-31082]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12555]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2012-0067]
J.R. Simplot Co.; Availability of Plant Pest Risk Assessment and
Environmental Assessment for Determination of Nonregulated Status of
Potato Genetically Engineered for Low Acrylamide Potential and Reduced
Black Spot Bruise
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service is making available for public comment our plant
pest risk assessment and our draft environmental assessment regarding a
request from the J.R. Simplot Company seeking a determination of
nonregulated status of potatoes designated as InnateTM
potatoes (events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50),
which have been genetically engineered for low acrylamide potential
(acrylamide is a human neurotoxicant and potential carcinogen that may
form in potatoes and other starchy foods under certain cooking
conditions) and reduced black spot bruise. We are soliciting comments
[[Page 31081]]
on whether this genetically engineered potato is likely to pose a plant
pest risk.
DATES: We will consider any information that we receive on or before
June 30, 2014.
ADDRESSES: You may submit any information by either of the following
methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2012-0067.
Postal Mail/Commercial Delivery: Send your information to
Docket No. APHIS-2012-0067, 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-2012-0067 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 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 13-022-01p.
FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director,
Environmental Risk Analysis Programs, Biotechnology Regulatory
Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236;
(301) 851-3954, email: john.t.turner@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: Under the authority of the plant pest
provisions of the Plant Protection Act (7 U.S.C. 7701 et seq.), the
regulations in 7 CFR part 340, ``Introduction of Organisms and Products
Altered or Produced Through Genetic Engineering Which Are Plant Pests
or Which There Is Reason to Believe Are Plant Pests,'' regulate, among
other things, the introduction (importation, interstate movement, or
release into the environment) of organisms and products altered or
produced through genetic engineering that are plant pests or that there
is reason to believe are plant pests. Such genetically engineered (GE)
organisms and products are considered ``regulated articles.''
The regulations in Sec. 340.6(a) provide that any person may
submit a petition to the Animal and Plant Health Inspection Service
(APHIS) seeking a determination that an article should not be regulated
under 7 CFR part 340. APHIS has received a petition (APHIS Petition
Number 13-022-01p) from the J.R. Simplot Company (Simplot) of Boise,
ID, seeking a determination of nonregulated status of potatoes (Solanum
tuberosum) designated as InnateTM potatoes (events E12, E24,
F10, F37, J3, J55, J78, G11, H37, and H50), which have been genetically
engineered for low acrylamide potential and reduced black spot bruise.
Acrylamide is a human neurotoxicant and potential carcinogen that may
form in potatoes and other starchy foods under certain cooking
conditions. The petition states that these potatoes are 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 input 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 May 3, 2013 (78 FR 25942-25943, Docket No. APHIS-2012-
0067), APHIS announced the availability of the Simplot petition for
public comment. APHIS solicited comments on the petition for 60 days
ending on July 2, 2013, 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-
2012-0067.
---------------------------------------------------------------------------
APHIS received 308 comments on the petition; one of these comments
included electronic attachments consisting of a consolidated document
of many identical or nearly identical letters, for a total of 41,475
comments. Some comments expressed support of a determination of
nonregulated status because of potential health benefits and
improvements to the potato industry. Issues raised during the comment
period include concerns regarding effects on conventional potato
production, export markets, and plant fitness. 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 input 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.
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 new crop-
trait GE organism or 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 a PPRA for a 30-day comment period
through the publication of a Federal Register notice. Then, after
reviewing and evaluating the comments on the draft EA and the PPRA and
other information, APHIS will revise the PPRA as necessary and prepare
a final EA and, based on the final EA, a National Environmental Policy
Act (NEPA) decision document (either a FONSI or a notice of intent to
prepare an environmental impact statement). For this petition, we are
using Approach 2.
APHIS has prepared a PPRA to determine if InnateTM
potatoes are 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
[[Page 31082]]
any article similar to or allied with any of the foregoing.
APHIS has also prepared a draft EA in which we present two
alternatives based on our analysis of data submitted by Simplot, 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 InnateTM potatoes and they
would continue to be a regulated article, or (2) make a determination
of nonregulated status of InnateTM potatoes. APHIS'
preferred alternative is to make a determination of nonregulated status
of InnateTM potatoes.
The EA was prepared in accordance with (1) NEPA, as amended (42
U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental
Quality for implementing the procedural provisions of NEPA (40 CFR
parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part
1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).
In accordance with our process for soliciting public input when
considering petitions for determinations of nonregulated status for GE
organisms, we are publishing this notice to inform the public that
APHIS will accept written comments on our draft EA and our PPRA
regarding the petition for a determination of nonregulated status from
interested or affected persons for a period of 30 days from the date of
this notice. Copies of the draft EA and the PPRA, as well as the
previously published petition, are available as indicated under
ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
After the comment period closes, APHIS will review all written
comments received during the comment period and any other relevant
information. After reviewing and evaluating the comments on the draft
EA and the PPRA and other information, APHIS will revise the PPRA as
necessary and prepare a final EA. Based on the final EA, APHIS will
prepare a NEPA decision document (either a FONSI or a notice of intent
to prepare an environmental impact statement). If a FONSI is reached,
APHIS will furnish a response to the petitioner, either approving or
denying the petition. APHIS will also publish a notice in the Federal
Register announcing the regulatory status of the GE organism and the
availability of APHIS' final EA, PPRA, FONSI, and our regulatory
determination.
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 23rd day of May 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-12555 Filed 5-29-14; 8:45 am]
BILLING CODE 3410-34-P