University of Kentucky; Availability of an Environmental Assessment and a Finding of No Significant Impact for Field Tests of Genetically Engineered Neotyphodium, 58664-58665 [05-20195]
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Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices
corn, these plants are not infected by
this organism, nor do they contain
genetic material from this pathogen that
can cause plant disease; (2) it exhibits
no characteristics that would cause it to
be more weedy than the non-transgenic
parent corn line or other cultivated
corn; (3) gene introgression from DAS–
59122–7 corn into wild relatives in the
United States and its territories is
extremely unlikely and is not likely to
increase the weediness potential of any
resulting progeny nor adversely affect
genetic diversity of related plants any
more than would introgression from
traditional corn hybrids; (4) disease and
insect susceptibility and compositional
profiles of the kernel is similar to nontransgenic corn and should have no
adverse impact on raw or processed
agricultural commodities; (5) it exhibits
no potential to have significant adverse
impact on organisms beneficial to
agriculture; (6) compared to current
agricultural practices, cultivation of
DAS–59122–7 should not reduce the
ability to control pests and weeds in
corn or other crops. In addition to our
finding of no plant pest risk, there will
be no effect on threatened or
endangered species resulting from a
determination of non-regulated status
for DAS–59122–7 and its progeny.
Therefore, APHIS has concluded that
the subject corn and any progeny
derived from hybrid crosses with other
non-transformed corn varieties will be
as safe to grow as corn varieties in
traditional breeding programs that are
not subject to regulation under 7 CFR
part 340. The effect of this
determination is that Dow
AgroSciences/Pioneer corn line DAS–
59122–7 is no longer considered a
regulated article under APHIS’
regulations in 7 CFR part 340.
Therefore, the requirements
pertaining to regulated articles under
those regulations no longer apply to the
subject corn or its progeny. However,
importation of corn line DAS–59122–7
and seeds capable of propagation are
still subject to the restrictions found in
APHIS’ foreign quarantine notices in 7
CFR part 319 and imported seed
regulations in 7 CFR part 361.
National Environmental Policy Act
An EA was prepared to examine any
potential environmental impacts and
plant pest risk associated with the
determination of nonregulated status for
the Dow AgroSciences/Pioneer corn line
DAS–59122–7. The EA was 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
VerDate Aug<31>2005
18:27 Oct 06, 2005
Jkt 208001
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 that EA, APHIS has reached
a FONSI with regard to the
determination that Dow AgroSciences/
Pioneer corn line DAS–59122–7 and
lines developed from it are no longer
regulated articles under its regulations
in 7 CFR part 340. Copies of the EA and
FONSI are available from the individual
listed in the FOR FURTHER INFORMATION
CONTACT section of this notice.
Authority: 7 U.S.C. 1622n and 7701–7772;
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 3rd day of
October 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 05–20194 Filed 10–6–05; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. 05–062–2]
University of Kentucky; Availability of
an Environmental Assessment and a
Finding of No Significant Impact for
Field Tests of Genetically Engineered
Neotyphodium
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
SUMMARY: We are advising the public
that the Animal and Plant Health
Inspection Service has prepared an
environmental assessment for a field
trial of genetically engineered strains of
an endophytic fungus of perennial
ryegrass, Neotyphodium sp. isolate Lp1.
The fungi have been genetically
engineered to disrupt the ergovaline
synthesis pathway. The environmental
assessment provides a basis for our
conclusion that these field tests will not
present a risk of introducing or
disseminating a plant pest and will not
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 tests.
DATES: A permit may be issued on or
after October 7, 2005.
FOR FURTHER INFORMATION CONTACT: Mr.
Michael Blanchette, Biotechnology
PO 00000
Frm 00003
Fmt 4703
Sfmt 4703
Regulatory Services, APHIS, 4700 River
Road, Unit 147, Riverdale, MD 20737–
1236; (301) 734–5141; e-mail:
michael.p.blanchette@aphis.usda.gov.
To obtain copies of the petition, the
environmental assessment (EA), or the
finding of no significant impact
(FONSI), contact Ms. Ingrid Berlanger at
(301) 734–4885; e-mail:
ingrid.e.berlanger@aphis.usda.gov. The
EA and FONSI are also available on the
Internet at: https://www.aphis.usda.gov/
brs/aphisdocs/05_15201r_ea.pdf.
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 into the environment of a
regulated article.
On June 1, 2005, the Animal and
Plant Health Inspection Service (APHIS)
received a permit application (APHIS
No. 05–152–01r) from the University of
Kentucky, Department of Plant
Pathology, for a confined field release of
two mutant strains of Neotyphodium sp
isolate Lp1, which is an endophytic
fungus of Lolium perenne (perennial
ryegrass). These two mutants were
generated by inserting a gene construct
containing a hygromycin
phosphotransferase gene (hph) into
specific genes in the ergovaline
synthesis pathway. The literature is
obscure regarding the specific donor of
the hph gene to the plasmid that was
used to create this construct. The
identical hph gene has been identified
in three bacterial species, Klebsiella sp.,
Streptomyces hygroscopicus, and
Escherichia coli. Expression of the hph
gene is regulated by the Neurospora
crassa cross-pathway control gene (cpc1) promoter and a transcription
termination sequence from the trpC
gene of Aspergillus nidulans.
Strain Lp1–4175 results from an
insertion of the hph construct in the
dimethylallyltryptophan synthase
E:\FR\FM\07OCN1.SGM
07OCN1
Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices
(dmaW) gene. This strain does not
produce ergot alkaloids or clavine
mycotoxins that are believed to cause
toxicoses to grazing livestock and
wildlife. Strain Lp1–981 was generated
by an insertion of the hph construct in
lysergyl peptide synthetase subunit 1
(lpsA). This line lacks the ability to
produce ergovaline and other amides of
lysergic acid, but retains the ability to
produce clavines and lysergic acid.
Perennial ryegrass plants that have
been inoculated with either mutant
strain will be planted in the trial for the
purpose of increasing seed. The
endophyte is only transmitted vertically
through seed. Therefore this trial will
result in an increase in inoculated seed
for future experiments.
On August 12, 2005, we published in
the Federal Register (70 FR 47169–
47170, Docket No. 05–062–1) a notice
announcing the availability, for review
and comment, of an environmental
assessment (EA) for a field trial of the
genetically engineered strains of
Neotyphodium sp. isolate Lp1. We
solicited comments on the EA for 30
days ending on September 12, 2005. We
received eight comments by that date,
from an academic professional, a public
interest group, and private individuals.
All eight commenters expressed
concerns about the field trial. Some of
the comments criticized the treatment of
horizontal gene transfer and acute
toxicity in the EA. Others suggested that
these types of experiments should only
be conducted in a contained facility.
APHIS has responded to these
comments in an attachment to the
finding of no significant impact
(FONSI).
Pursuant to its regulations (7 CFR part
340) promulgated under the Plant
Protection Act, APHIS has determined
that this field trial will not pose a risk
of the introduction or dissemination of
a plant pest for the following reasons:
1. The test fungi Neotyphodium sp.
Lp1 strains Lp1-981 and Lp1-4175 are
identical to the untransformed
endophyte except for their inability to
produce toxic ergot alkaloids.
2. Neotyphodium species are not
known as animal or human pathogens,
and both it and its sexually transmitted
¨
form of the species (Epichloee sp.) are
only found in grasses.
3. Dissemination of Neotyphodium sp.
Lp1 strains Lp1-981 and Lp1-4175 will
be prevented through physical methods,
normal site security, small size of the
trials, and cleaning of equipment.
4. The host range of Neotyphodium
sp. Lp1 strains Lp1-981 and Lp1-4175
and mode of transmission has not
changed.
VerDate Aug<31>2005
18:27 Oct 06, 2005
Jkt 208001
5. The Neotyphodium sp. Lp1 strains
Lp1-981 and Lp1-4175 are expected to
be less toxic to herbivores than the
untransformed endophyte and therefore
should not pose any new dietary threat.
6. The Neotyphodium species has
never been associated with animal or
human disease and therefore will not
pose a risk to human health.
7. Hygromycin B phosphotransferase
(from the marker gene) does not confer
any plant pest characteristics to
Neotyphodium species.
8. Threatened and endangered species
in the area are not hosts of
Neotyphodium sp. nor do they feed on
hosts of these fungi, and therefore will
not be affected by the trials.
The EA and the 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). Copies of the EA and FONSI are
available from the individual listed
under FOR FURTHER INFORMATION
CONTACT.
Done in Washington, DC, this 3rd day of
October 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 05–20195 Filed 10–6–05; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Food and Nutrition Service
Agency Information Collection
Activities: Proposed Collection;
Comment Request—School Lunch and
Breakfast Cost Study-II
Food and Nutrition Service,
USDA.
ACTION: Notice.
AGENCY:
SUMMARY: In accordance with the
Paperwork Reduction Act of 1995, this
notice invites the general public and
other public agencies to comment on the
proposed collection of data for the
School Lunch and Breakfast Cost StudyII in order to assess the adequacy of the
Federal meal reimbursement rates.
DATES: Written comments must be
received on or before December 6, 2005.
ADDRESSES: Comments are invited on:
(a) Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
PO 00000
Frm 00004
Fmt 4703
Sfmt 4703
58665
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 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
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Comments may be sent to Alberta
Frost, Director, Office of Analysis,
Nutrition and Evaluation, 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 Alberta Frost at
703–305–2576 or via e-mail to
Alberta.Frost@fns.usda.gov.
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
p.m., Monday through Friday) at Room
1014, 3101 Park Center Drive,
Alexandria, Virginia 22302.
All responses to this notice will be
summarized and included in the request
for OMB 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 Alberta Frost at
703–305–2017.
SUPPLEMENTARY INFORMATION:
Title: School Lunch and Breakfast
Cost Study-II.
OMB Number: Not yet assigned.
Form Number: N/A.
Expiration Date: Not yet determined.
Type of Request: New Collection of
Information.
Abstract: The School Lunch and
Breakfast Cost Study-II will collect and
analyze data from a nationally
representative sample of public schools
participating in the National School
Lunch Program (NSLP). Data will be
collected so as to provide sufficient
information on school meal production
costs to assess the adequacy of Federal
meal reimbursement rates. The
information will be used to determine
the national average reported and full
costs to produce NSLP and School
Breakfast Program (SBP) reimbursable
meals, the extent to which indirect costs
are charged to School Food Authority
(SFA) accounts for food service
operations, the value of administrative
costs used to produce reimbursable
E:\FR\FM\07OCN1.SGM
07OCN1
]]>Agencies
[Federal Register Volume 70, Number 194 (Friday, October 7, 2005)]
[Notices]
[Pages 58664-58665]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20195]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 05-062-2]
University of Kentucky; Availability of an Environmental
Assessment and a Finding of No Significant Impact for Field Tests of
Genetically Engineered Neotyphodium
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 an environmental assessment for a field
trial of genetically engineered strains of an endophytic fungus of
perennial ryegrass, Neotyphodium sp. isolate Lp1. The fungi have been
genetically engineered to disrupt the ergovaline synthesis pathway. The
environmental assessment provides a basis for our conclusion that these
field tests will not present a risk of introducing or disseminating a
plant pest and will not 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
tests.
DATES: A permit may be issued on or after October 7, 2005.
FOR FURTHER INFORMATION CONTACT: Mr. Michael Blanchette, Biotechnology
Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD
20737-1236; (301) 734-5141; e-mail:
michael.p.blanchette@aphis.usda.gov. To obtain copies of the petition,
the environmental assessment (EA), or the finding of no significant
impact (FONSI), contact Ms. Ingrid Berlanger at (301) 734-4885; e-mail:
ingrid.e.berlanger@aphis.usda.gov. The EA and FONSI are also available
on the Internet at: https://www.aphis.usda.gov/brs/aphisdocs/05_
15201r_ea.pdf.
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 into the environment of a regulated
article.
On June 1, 2005, the Animal and Plant Health Inspection Service
(APHIS) received a permit application (APHIS No. 05-152-01r) from the
University of Kentucky, Department of Plant Pathology, for a confined
field release of two mutant strains of Neotyphodium sp isolate Lp1,
which is an endophytic fungus of Lolium perenne (perennial ryegrass).
These two mutants were generated by inserting a gene construct
containing a hygromycin phosphotransferase gene (hph) into specific
genes in the ergovaline synthesis pathway. The literature is obscure
regarding the specific donor of the hph gene to the plasmid that was
used to create this construct. The identical hph gene has been
identified in three bacterial species, Klebsiella sp., Streptomyces
hygroscopicus, and Escherichia coli. Expression of the hph gene is
regulated by the Neurospora crassa cross-pathway control gene (cpc-1)
promoter and a transcription termination sequence from the trpC gene of
Aspergillus nidulans.
Strain Lp1-4175 results from an insertion of the hph construct in
the dimethylallyltryptophan synthase
[[Page 58665]]
(dmaW) gene. This strain does not produce ergot alkaloids or clavine
mycotoxins that are believed to cause toxicoses to grazing livestock
and wildlife. Strain Lp1-981 was generated by an insertion of the hph
construct in lysergyl peptide synthetase subunit 1 (lpsA). This line
lacks the ability to produce ergovaline and other amides of lysergic
acid, but retains the ability to produce clavines and lysergic acid.
Perennial ryegrass plants that have been inoculated with either
mutant strain will be planted in the trial for the purpose of
increasing seed. The endophyte is only transmitted vertically through
seed. Therefore this trial will result in an increase in inoculated
seed for future experiments.
On August 12, 2005, we published in the Federal Register (70 FR
47169-47170, Docket No. 05-062-1) a notice announcing the availability,
for review and comment, of an environmental assessment (EA) for a field
trial of the genetically engineered strains of Neotyphodium sp. isolate
Lp1. We solicited comments on the EA for 30 days ending on September
12, 2005. We received eight comments by that date, from an academic
professional, a public interest group, and private individuals. All
eight commenters expressed concerns about the field trial. Some of the
comments criticized the treatment of horizontal gene transfer and acute
toxicity in the EA. Others suggested that these types of experiments
should only be conducted in a contained facility. APHIS has responded
to these comments in an attachment to the finding of no significant
impact (FONSI).
Pursuant to its regulations (7 CFR part 340) promulgated under the
Plant Protection Act, APHIS has determined that this field trial will
not pose a risk of the introduction or dissemination of a plant pest
for the following reasons:
1. The test fungi Neotyphodium sp. Lp1 strains Lp1-981 and Lp1-4175
are identical to the untransformed endophyte except for their inability
to produce toxic ergot alkaloids.
2. Neotyphodium species are not known as animal or human pathogens,
and both it and its sexually transmitted form of the species
(Epichloe[euml] sp.) are only found in grasses.
3. Dissemination of Neotyphodium sp. Lp1 strains Lp1-981 and Lp1-
4175 will be prevented through physical methods, normal site security,
small size of the trials, and cleaning of equipment.
4. The host range of Neotyphodium sp. Lp1 strains Lp1-981 and Lp1-
4175 and mode of transmission has not changed.
5. The Neotyphodium sp. Lp1 strains Lp1-981 and Lp1-4175 are
expected to be less toxic to herbivores than the untransformed
endophyte and therefore should not pose any new dietary threat.
6. The Neotyphodium species has never been associated with animal
or human disease and therefore will not pose a risk to human health.
7. Hygromycin B phosphotransferase (from the marker gene) does not
confer any plant pest characteristics to Neotyphodium species.
8. Threatened and endangered species in the area are not hosts of
Neotyphodium sp. nor do they feed on hosts of these fungi, and
therefore will not be affected by the trials.
The EA and the 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). Copies of the EA
and FONSI are available from the individual listed under FOR FURTHER
INFORMATION CONTACT.
Done in Washington, DC, this 3rd day of October 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-20195 Filed 10-6-05; 8:45 am]
BILLING CODE 3410-34-P
