Oregon State University; Availability of an Environmental Assessment and Finding of No Significant Impact for a Controlled Release of Genetically Engineered Populus Species and Hybrids, 8846-8847 [E8-2909]
Download as PDF
<![CDATA[
8846
Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices
The draft guideline may be viewed on
the Regulations.gov Web site or in our
reading room (see ADDRESSES above for
instructions for accessing
Regulations.gov and information on the
location and hours of the reading room).
You may request paper copies of the
draft guideline by calling or writing to
the person listed under FOR FURTHER
INFORMATION CONTACT.
Authority: 21 U.S.C. 151 et seq.
Done in Washington, DC, this 11th day of
February 2008.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E8–2913 Filed 2–14–08; 8:45 am]
decision notice, and our response to the
comments we received on the EA 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) 690–2817 before
coming. The EA, FONSI and decision
notice, and our response to public
comments are also available on the
Internet at https://www.aphis.usda.gov/
brs/aphisdocs/06_25001r_ea.pdf.
FOR FURTHER INFORMATION CONTACT:
Animal and Plant Health Inspection
Service
Biotechnology Regulatory Services,
APHIS, 4700 River Road Unit 147,
Riverdale, MD 20737–1236; (301) 734–
7324. To obtain copies of the
environmental assessment, contact Ms.
Cynthia Eck, Document Control Officer,
at (301) 734–0667; e-mail:
cynthia.a.eck@aphis.usda.gov.
[Docket No. APHIS–2007–0018]
SUPPLEMENTARY INFORMATION:
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Oregon State University; Availability of
an Environmental Assessment and
Finding of No Significant Impact for a
Controlled Release of Genetically
Engineered Populus Species and
Hybrids
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
rwilkins on PROD1PC63 with NOTICES
AGENCY:
SUMMARY: We are advising the public
that an environmental assessment has
been prepared for a proposed controlled
field release of genetically engineered
(transgenic) clones of Populus species
and hybrids. The purpose of this
controlled field release is to examine the
effects of the genetic constructs on the
intended traits of reproductive sterility,
reduced stature, reduced light response,
and modified lignin content. After
assessing the application, reviewing
pertinent scientific information, and
considering public comments, we have
concluded that this field release will not
present a plant pest risk, nor will it have
a significant impact on the quality of the
human environment. Based on the
environmental analysis that there are no
significant impacts associated with this
controlled field release, the Animal and
Plant Health Inspection Service has
determined that a finding of no
significant impact is appropriate and
therefore an environmental impact
statement need not be prepared for this
field release.
EFFECTIVE DATE: February 15, 2008.
ADDRESSES: You may read the
environmental assessment (EA), finding
of no significant impact (FONSI) and
VerDate Aug<31>2005
15:58 Feb 14, 2008
Jkt 214001
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 organisms and
products are considered ‘‘regulated
articles.’’ A permit must be obtained or
a notification acknowledged before a
regulated article may be introduced. The
regulations set forth the permit
application requirements and the
notification procedures for the
importation, interstate movement, or
release in the environment of a
regulated article.
On September 7, 2006, the Animal
and Plant Health Inspection Service
(APHIS) received a permit application
(APHIS No. 06–250–01r) from Oregon
State University, in Corvallis, OR, for a
controlled field release of genetically
engineered Populus alba and Populus
hybrids. A previous environmental
assessment (EA) was prepared for a
subset of trees in this release under
Permit 95–031–01R. Under that permit,
trees engineered with sterility
constructs were allowed to flower. Since
the researcher intends to add more trees
to the permit and allow these additional
trees to flower, this new EA has been
prepared which updates the previous
EA.
PO 00000
Frm 00003
Fmt 4703
Sfmt 4703
Permit application 06–250–01r
describes 95 genetic constructs that can
be categorized into reproductive sterility
genes, genes affecting stature or light
response, genes aimed to modify tree
chemistry, and activation tagging
mutants aimed at the development of
‘‘experimental domesticates.’’ These
DNA sequences were introduced into
Populus plants using disarmed
Agrobacterium tumefaciens and also
contain regulatory sequences from the
plant pests cauliflower mosaic virus,
tobacco mosaic virus, Aspergillus
nidulans, and Agrobacterium
tumefaciens. The subject Populus plants
are considered regulated articles under
the regulations in 7 CFR part 340
because they were created using donor
sequences from plant pests.
On July 18, 2007, APHIS published a
notice 1 in the Federal Register (72 FR
39378–39379, Docket No. APHIS–2007–
0018) announcing the availability of an
EA for controlled release of genetically
engineered Populus species and
hybrids. During the 30-day comment
period, which ended on August 17,
2007, APHIS received five comments.
Comments opposing the granting of the
permit were submitted by two
individuals and a public interest group.
Comments supporting the granting of
the permit were submitted by the permit
applicant and a limited liability
company. APHIS has addressed the
issues raised during the comment
period and has provided responses as an
attachment to the finding of no
significant impact (FONSI).
Pursuant to the regulations in 7 CFR
part 340 promulgated under the Plant
Protection Act, APHIS has determined
that this field release will not pose a risk
of introducing or disseminating a plant
pest. Additionally, based upon analysis
described in the EA, APHIS has
determined that the action proposed in
Alternative C of the EA, to issue the
permit with supplemental permit
conditions, will not have a significant
impact on the quality of the human
environment. You may read the FONSI
and decision notice on the Internet or in
the APHIS reading room (see ADDRESSES
above). Copies may also be obtained
from the person listed under FOR
FURTHER INFORMATION CONTACT.
The EA and FONSI were prepared in
accordance with (1) The National
Environmental Policy Act of 1969
(NEPA), as amended (42 U.S.C. 4321 et
seq.), (2) regulations of the Council on
Environmental Quality for
1 To view the notice, the EA, and the comments
we received, go to https://www.regulations.gov/
fdmspublic/component/main?main=DocketDetail&
d=APHIS–2007–0018.
E:\FR\FM\15FEN1.SGM
15FEN1
Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices
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).
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 11th day of
February 2008.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E8–2909 Filed 2–14–08; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2007–0023]
SemBioSys Genetics, Inc.; Availability
of an Environmental Assessment and
Finding of No Significant Impact for a
Proposed Field Release of Genetically
Engineered Safflower
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
rwilkins on PROD1PC63 with NOTICES
AGENCY:
SUMMARY: We are advising the public
that an environmental assessment has
been prepared for a proposed field
release of a safflower line genetically
engineered to express, within its seeds,
human proinsulin fused to an
Arabidopsis oleosin molecule. After our
assessment of the application, review of
pertinent scientific information, and
consideration of comments provided by
the public, we have concluded that this
field release will not present a risk of
introducing or disseminating a plant
pest, nor will it have a significant
impact on the quality of the human
environment. Based on its finding of no
significant impact, the Animal and Plant
Health Inspection Service has
determined that an environmental
impact statement need not be prepared
for these field releases.
EFFECTIVE DATE: February 15, 2008.
ADDRESSES: You may read the
environmental assessment (EA), finding
of no significant impact (FONSI), and
any comments we received on this
docket in our reading room. The reading
room 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,
VerDate Aug<31>2005
15:58 Feb 14, 2008
Jkt 214001
please call (202) 690–2817 before
coming. The EA, FONSI and decision
notice, and responses to comments are
available on the Internet at: https://
www.aphis.usda.gov/brs/aphisdocs/
06_363103r_ea.pdf.
FOR FURTHER INFORMATION CONTACT: Dr.
Patricia Beetham, Biotechnology
Regulatory Services, APHIS, 4700 River
Road Unit 147, Riverdale, MD 20737–
1236; (301) 734–0664. To obtain copies
of the EA, FONSI and decision notice,
and response to comments, contact Ms.
Cynthia Eck at (301) 734–0667; e-mail:
cynthia.a.eck@aphis.usda.gov.
SUPPLEMENTARY INFORMATION: 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 organisms and
products are considered ‘‘regulated
articles.’’ A permit must be obtained or
a notification acknowledged before a
regulated article may be introduced. The
regulations set forth the permit
application requirements and the
notification procedures for the
importation, interstate movement, or
release in the environment of a
regulated article.
On December 18, 2006, the Animal
and Plant Health Inspection Service
(APHIS) received a permit application
(APHIS No. 06–363–103r) from
SemBioSys Genetics, Inc. of West
Sacramento, CA, for a field trial using a
line of transgenic safflower. Permit
application 06–363–103r describes a
transgenic safflower (Carthamus
tinctorius) cultivar that has been
genetically engineered to express a
fusion protein consisting of oleosin from
Arabidopsis thaliana and human
proinsulin exclusively within its seeds.
Expression of this fusion protein is
controlled by the phaseolin promoter
and terminator sequences from
Phaseolus vulgaris L. (common bean).
Constructs were inserted into the
recipient organisms via a disarmed
Agrobacterium tumefaciens vector
system. The seeds from these safflower
plants will be ground up and used for
the development of proinsulin
purification technology and are not for
commercial production.
The subject safflower is considered a
regulated article under the regulations
PO 00000
Frm 00004
Fmt 4703
Sfmt 4703
8847
in 7 CFR part 340 because it has been
genetically engineered utilizing a
recombinant DNA technique that uses a
vector derived from Agrobacterium
tumefaciens.
On June 22, 2007, APHIS published a
notice 1 in the Federal Register (72 FR
34426–34427, Docket No. APHIS–2007–
0023) announcing the availability of an
environmental assessment (EA) for the
proposed field release. During the 30day comment period, APHIS received
seven comments. There was one
individual who was opposed to the use
of biotechnology in food crops in
general, but did not cite specific plant
pest risk issues associated with this EA.
Another commenter raised specific
issues regarding the EA that mirrored
the concerns of one of the five public
interest groups that also sent in
comments on the EA. In total, five
public interest groups wrote letters in
opposition to allowing the planting of
this GE safflower. APHIS has responded
to these comments in an attachment to
the finding of no significant impact
(FONSI).
Pursuant to the regulations in 7 CFR
part 340 promulgated under the Plant
Protection Act, APHIS has determined
that this field release will not pose a risk
of introducing or disseminating a plant
pest. Additionally, based upon analysis
described in the EA, APHIS has
determined that the action proposed in
Alternative B of the EA (the preferred
alternative), to issue the permit with
supplemental permit conditions, will
not have a significant impact on the
quality of the human environment.
Therefore, APHIS has determined that a
FONSI is appropriate for this proposed
action. You may read the FONSI and
decision notice on the Internet or in the
APHIS reading room (see ADDRESSES
above). Copies of the EA are also
available from the individual listed
under FOR FURTHER INFORMATION
CONTACT.
The EA and FONSI were prepared in
accordance with (1) The National
Environmental Policy Act of 1969
(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).
1 To view the notice, the EA, and the comments
we received, go to https://www.regulations.gov/
fdmspublic/component/
main?main=DocketDetail&d=APHIS–2007–0023.
E:\FR\FM\15FEN1.SGM
15FEN1
]]>Agencies
[Federal Register Volume 73, Number 32 (Friday, February 15, 2008)]
[Notices]
[Pages 8846-8847]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2909]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2007-0018]
Oregon State University; Availability of an Environmental
Assessment and Finding of No Significant Impact for a Controlled
Release of Genetically Engineered Populus Species and Hybrids
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that an environmental assessment
has been prepared for a proposed controlled field release of
genetically engineered (transgenic) clones of Populus species and
hybrids. The purpose of this controlled field release is to examine the
effects of the genetic constructs on the intended traits of
reproductive sterility, reduced stature, reduced light response, and
modified lignin content. After assessing the application, reviewing
pertinent scientific information, and considering public comments, we
have concluded that this field release will not present a plant pest
risk, nor will it have a significant impact on the quality of the human
environment. Based on the environmental analysis that there are no
significant impacts associated with this controlled field release, the
Animal and Plant Health Inspection Service has determined that a
finding of no significant impact is appropriate and therefore an
environmental impact statement need not be prepared for this field
release.
Effective Date: February 15, 2008.
ADDRESSES: You may read the environmental assessment (EA), finding of
no significant impact (FONSI) and decision notice, and our response to
the comments we received on the EA 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) 690-2817 before coming.
The EA, FONSI and decision notice, and our response to public comments
are also available on the Internet at https://www.aphis.usda.gov/brs/
aphisdocs/06_25001r_ea.pdf.
FOR FURTHER INFORMATION CONTACT: Biotechnology Regulatory Services,
APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-
7324. To obtain copies of the environmental assessment, contact Ms.
Cynthia Eck, Document Control Officer, at (301) 734-0667; e-mail:
cynthia.a.eck@aphis.usda.gov.
SUPPLEMENTARY INFORMATION: 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 organisms and
products are considered ``regulated articles.'' A permit must be
obtained or a notification acknowledged before a regulated article may
be introduced. The regulations set forth the permit application
requirements and the notification procedures for the importation,
interstate movement, or release in the environment of a regulated
article.
On September 7, 2006, the Animal and Plant Health Inspection
Service (APHIS) received a permit application (APHIS No. 06-250-01r)
from Oregon State University, in Corvallis, OR, for a controlled field
release of genetically engineered Populus alba and Populus hybrids. A
previous environmental assessment (EA) was prepared for a subset of
trees in this release under Permit 95-031-01R. Under that permit, trees
engineered with sterility constructs were allowed to flower. Since the
researcher intends to add more trees to the permit and allow these
additional trees to flower, this new EA has been prepared which updates
the previous EA.
Permit application 06-250-01r describes 95 genetic constructs that
can be categorized into reproductive sterility genes, genes affecting
stature or light response, genes aimed to modify tree chemistry, and
activation tagging mutants aimed at the development of ``experimental
domesticates.'' These DNA sequences were introduced into Populus plants
using disarmed Agrobacterium tumefaciens and also contain regulatory
sequences from the plant pests cauliflower mosaic virus, tobacco mosaic
virus, Aspergillus nidulans, and Agrobacterium tumefaciens. The subject
Populus plants are considered regulated articles under the regulations
in 7 CFR part 340 because they were created using donor sequences from
plant pests.
On July 18, 2007, APHIS published a notice \1\ in the Federal
Register (72 FR 39378-39379, Docket No. APHIS-2007-0018) announcing the
availability of an EA for controlled release of genetically engineered
Populus species and hybrids. During the 30-day comment period, which
ended on August 17, 2007, APHIS received five comments. Comments
opposing the granting of the permit were submitted by two individuals
and a public interest group. Comments supporting the granting of the
permit were submitted by the permit applicant and a limited liability
company. APHIS has addressed the issues raised during the comment
period and has provided responses as an attachment to the finding of no
significant impact (FONSI).
---------------------------------------------------------------------------
\1\ To view the notice, the EA, and the comments we received, go
to https://www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2007-0018.
---------------------------------------------------------------------------
Pursuant to the regulations in 7 CFR part 340 promulgated under the
Plant Protection Act, APHIS has determined that this field release will
not pose a risk of introducing or disseminating a plant pest.
Additionally, based upon analysis described in the EA, APHIS has
determined that the action proposed in Alternative C of the EA, to
issue the permit with supplemental permit conditions, will not have a
significant impact on the quality of the human environment. You may
read the FONSI and decision notice on the Internet or in the APHIS
reading room (see ADDRESSES above). Copies may also be obtained from
the person listed under FOR FURTHER INFORMATION CONTACT.
The EA and FONSI were prepared in accordance with (1) The National
Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et
seq.), (2) regulations of the Council on Environmental Quality for
[[Page 8847]]
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).
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 11th day of February 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service. 4
[FR Doc. E8-2909 Filed 2-14-08; 8:45 am]
BILLING CODE 3410-34-P
