[Federal Register: August 12, 2005 (Volume 70, Number 155)]
[Notices]
[Page 47169-47170]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au05-38]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 05-062-1]
University of Kentucky; Availability of Environmental Assessment
for Field Tests of Genetically Engineered Neotyphodium
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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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.
This environmental assessment is available for public review and
comment.
DATES: We will consider all comments we receive on or before September
12, 2005.
ADDRESSES: You may submit comments by either of the following methods:
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. 05-062-1,
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700
River Road Unit 118, Riverdale, MD 20737-1238.
[[Page 47170]]
Please state that your comment refers to Docket No. 05-062-1.
EDOCKET: Go to http://www.epa.gov/feddocket to submit or
view public comments. Once you have entered EDOCKET, click on the
``View Open APHIS Dockets'' link to locate Docket No. 05-062-1.
Reading Room: You may read the environmental assessment, and any
comments that we receive 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, please call (202) 690-2817
before coming.
Other Information: You may view APHIS documents published in the
Federal Register and related information on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html
.
FOR FURTHER INFORMATION CONTACT: Mr. Michael Blanchette, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-5141. To obtain copies of the petition or the
environmental assessment (EA), contact Ms. Ingrid Berlanger at (301)
734-4885; e-mail: ingrid.e.berlanger@aphis.usda.gov. The EA is also
available on the Internet at http://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 permit number 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 (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.
The genetically engineered Neotyphodium are considered regulated
articles under the regulations in 7 CFR part 340 because they may be
plant pests. To provide the public with documentation of APHIS' review
and analysis of any potential environmental impacts and plant pest risk
associated with the proposed field trial of theses strains of
genetically engineered Neotyphodium, an environmental assessment (EA)
has been prepared. 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 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
are available as indicated in the FOR FURTHER INFORMATION CONTACT
section of this notice.
Done in Washington, DC, this 8th day of August 2005.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E5-4381 Filed 8-11-05; 8:45 am]
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