ArborGen, LLC; Availability of an Environmental Assessment for Controlled Release of a Genetically Engineered Eucalyptus Hybrid

Summary:

We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment for a proposed controlled field release of a genetically engineered clone of a Eucalyptus hybrid. The purpose of the field release is to assess the effectiveness of gene constructs intended to confer cold tolerance, to test the efficacy of genes introduced to alter lignin biosynthesis, to test the efficacy of genes designed to alter growth, and to test the efficacy of genes designed to alter flowering. We are making the environmental assessment available to the public for review and comment.

Dates:

We will consider all comments that we receive on or before March 12, 2012.

Addresses:

You may submit comments by either of the following methods:

Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2011-0130-0001.

Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2011-0130, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0130 or in our reading room, which 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.

For further information contact:

Mr. Evan Chestnut, Policy Analyst, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-0942. To obtain copies of the environmental assessment, contact Ms. Cynthia Eck at (301) 734-0667; email:cynthia.a.eck@aphis.usda.gov.

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 in the environment of a regulated article.

On February 21, 2011, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS No. 11-052-101rm) from ArborGen, LLC, in Summerville, SC, for a controlled field release of genetically engineered Eucalyptus hybrids in six locations encompassing a total of 14.7 acres in the States of Alabama, Florida, Mississippi, and South Carolina. Five of these locations currently have active APHIS permits (08-011-106rm, 08-014-101rm, 09-070-10rm, 10-112-101r, and 11-041-101rm) for environmental release of genetically engineered Eucalyptus hybrids in Alabama, Florida, Mississippi, and South Carolina. The sixth site in South Carolina has been listed as a holding site for genetically engineered trees in previous APHIS permits and notifications and is a new location for the release of genetically engineered Eucalyptus. ArborGen is requesting that trees be allowed to flower at four locations in Alabama, Florida and Mississippi. At two locations in South Carolina, ArborGen has requested to release trees in containers and have indicated they will not allow these trees to flower at these locations.

Permit application 11-052-101rm describes Eucalyptus trees derived from a hybrid of Eucalyptus grandis×Eucalyptus urophylla. The purpose of the field tests is to assess the effectiveness of gene constructs intended to confer cold tolerance; to test the efficacy of genes introduced to alter lignin biosynthesis; to test the efficacy of genes designed to alter growth; and to test the efficacy of genes designed to alter flowering. In addition, the trees have been engineered with a selectable marker that confers resistance to the antibiotic kanamycin. These DNA sequences were introduced into Eucalyptus trees using disarmed Agrobacterium tumefaciens.

The subject Eucalyptus trees are considered regulated articles under 7 CFR part 340 because they were created using donor sequences from plant pests.

To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts and plant pest risks associated with the proposed release under permit of these genetically engineered Eucalyptus trees, APHIS has prepared an environmental assessment (EA). The EA was prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321et 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).

The EA may be viewed on the Regulations.gov Web site or in our reading room. (Instructions for accessing Regulations.gov and information on the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this notice.) In addition, copies may be obtained by calling or writing to theindividual listed under FOR FURTHER INFORMATION CONTACT.

Done in Washington, DC, this 6th day of February 2012. Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

References

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