[Federal Register Volume 70, Number 194 (Friday, October 7, 2005)]
[Notices]
[Pages 58664-58665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-20195]


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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.

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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. 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: 
[email protected]. 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: 
[email protected]. The EA and FONSI are 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 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]
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