Animal and Plant Health Inspection Service, USDA.
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.
We will consider all comments we receive on or before September 12, 2005.
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. Start Printed Page 47170Please 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.Start Further Info
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: email@example.com. The EA is also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/05_15201r_ea.pdf.End Further Info End Preamble Start Supplemental 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.Start Signature
Done in Washington, DC, this 8th day of August 2005.
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E5-4381 Filed 8-11-05; 8:45 am]
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