Environmental statements; availability, etc.: Rice plants genetically engineered to express lactoferrin; confined field tests and consideration for additional test site,


[Federal Register: May 13, 2005 (Volume 70, Number 92)]


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From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Animal and Plant Health Inspection Service

[Docket No. 05-007-2]

Ventria Bioscience; Availability of Revised Environmental Assessment, With Consideration for an Additional Test Site in North Carolina, for Field Tests of Genetically Engineered Rice Expressing Lysozyme

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 revised an environmental assessment for confined

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field tests of rice plants genetically engineered to express the protein lysozyme and has included information on an additional field test site. This environmental assessment is available for public review and comment.

DATES: We will consider all comments that we receive on or before June 2, 2005.

ADDRESSES: You may submit comments by either of the following methods:

EDOCKET: Go to http://www.epa.gov/feddocket to submit or

view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once you have entered EDOCKET, click on the ``View Open APHIS Dockets'' link to locate this document.

Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. 05-007-2, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 05-007-2.

Reading Room: You may read the environmental assessment and any comments that we receive 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: Dr. Levis Handley, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-5721. To obtain copies of the environmental assessment, contact Ms. Ingrid Berlanger, at (301) 734-4885; e-mail ingrid.e.berlanger@aphis.usda.gov. The environmental assessment is also

available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/05_11702r_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 into the United States. The regulations set forth the permit application requirements and the notification procedures for the importation, interstate movement, and release into the environment of a regulated article.

On October 28, 2004, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS permit number 04-309-01r) from Ventria Bioscience, Sacramento, CA, for a permit for a confined field test of rice (Oryza sativa) plants genetically engineered to express a gene coding for the protein lysozyme, rice line LZ159-53. According to the permit application, the field test would be conducted in Scott County, MO. On February 23, 2005, APHIS published a notice in the Federal Register (70 FR 8762-8763, Docket No. 05-007-1), announcing the availability of an environmental assessment (EA) for the proposed field test and soliciting public comments for 30 days. This 30-day comment period closed on March 25, 2005. During the 30-day comment period, APHIS received 243 comments. Comments were received from rice growers, rice marketing and processing groups, agricultural support businesses, consumer groups, university professionals, private individuals, industry trade organizations, large rice purchasers, growers of crops other than rice, and Federal, State and local government representatives.

On April 27, 2005, while APHIS was evaluating these comments, we received a request from Ventria Biosciences to plant rice line LF164-12 in a second site in Washington County, NC (APHIS permit number 05-117- 02r). At this time, Ventria Biosciences has not withdrawn its application to conduct a field test in Scott County, MO. However, it is likely that conducting a field test for this growing season is not feasible due to climatic factors in this location. Because APHIS has not yet considered all of the comments associated with the earlier EA and the issues raised in North Carolina are similar to those in Missouri, APHIS has amended the EA to evaluate the issues in North Carolina as well as Missouri. These are covered in Appendices V and VI. In addition to evaluating site-specific issues presented by the North Carolina application, this revised EA also corrects errors in the original EA. These changes are described in the summary of the EA.

APHIS is seeking comments on the additional information provided in this revised EA. We are particularly interested in comments related to Appendices V and VI that address issues in North Carolina. APHIS will consider all comments received during the previous comment period (70 FR 8762-8763, Docket No. 05-007-1) as well as any new comments received during this comment period (see DATES above). The expanded EA will be open for public comment for an additional 20 days.

The subject rice plants have been genetically engineered, using micro-projectile bombardment, to express human lysozyme protein. Expression of the gene is controlled by the rice glutelin 1 promoter, the rice glutelin 1 signal peptide, and the nos (nopaline synthase) terminator sequence from Agrobacterium tumefaciens. The gene is expressed only in the endosperm. In addition, the plants contain the coding sequence for the gene hygromycin phosphotransferase (hpt), an enzyme which confers tolerance to the antibiotic hygromycin. This gene is a selectable marker that is only expressed during plant cell culture and is not expressed in any tissues of the mature plant. Expression of the gene is controlled by the rice glucanase 9 (Gns 9) promoter and the Rice Alpha Amylase 1A (RAmy1A) terminator. The genetically engineered rice plants are considered regulated articles under the regulations in 7 CFR part 340 because they contain gene sequences from plant pathogens.

The purpose of the field planting is for pure seed production and for the extraction of lysozyme for a variety of research and commercial products. The planting will be conducted using physical confinement measures. In addition, the experimental protocols and field plot design, as well as the procedures for termination of the field planting, are designed to ensure that none of the subject rice plants persist in the environment beyond the termination of the experiments.

To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts and plant pest risk associated with the proposed confined field planting of the subject rice plants, an environment assessment (EA) has been prepared. The EA was prepared in accordance with (1) The National

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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 from the individual listed under FOR FURTHER INFORMATION CONTACT.

Done in Washington, DC, this 9th day of May 2005. Elizabeth E. Gaston, Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 05-9607 Filed 5-12-05; 8:45 am]