E7-12532. ArborGen, LLC; Availability of an Environmental Assessment and Finding of No Significant Impact for a Controlled Release of Genetically Engineered Eucalyptus

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 prepared an environmental assessment for a proposed controlled field release of genetically engineered clones of Eucalyptus hybrids. The purpose of this release is to continue research on two constructs that confer cold tolerance from a previously approved notification and test the efficacy of a third, claimed as confidential business information. After assessing the application, reviewing pertinent scientific information, and considering comments provided by the public, we have concluded that this field release will not present a plant pest risk, nor will it 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 this field release.

DATES:

Effective Date: June 28, 2007.

ADDRESSES:

You may read the environmental assessment (EA), finding of no significant impact (FONSI), and any comments we received on the EA 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 [phone] before coming. The EA, FONSI and decision notice, and responses to comments are available on the Internet at http://www.aphis.usda.gov/​brs/​aphisdocs/​06_​325111r_​ea.pdf.

FOR FURTHER INFORMATION CONTACT:

Dr. Levis Handley, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone]. To obtain copies of the EA, FONSI, and response to comments, contact Ms. Cynthia Eck at [phone]; e-mail: [e-mail].

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 November 21, 2006, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS No. 06-325-111r) from ArborGen, LLC, in Summerville, SC, for a controlled field release of genetically engineered Eucalyptus hybrids. Under this permit, trees planted under a previously approved notification (05-256-03n) would be allowed to flower.

Permit application 06-325-111r describes Eucalyptus trees engineered with three constructs. Two of these constructs are intended to confer cold tolerance and the third genetic construct is claimed as confidential business information (CBI). In addition, the trees have been engineered with a selectable marker gene, also claimed as CBI. These DNA sequences were introduced into Eucalyptus trees using disarmed Agrobacterium tumefaciens. The subject Eucalyptus trees are considered regulated articles under the regulations in 7 CFR part 340 because they were created using donor sequences from plant pests.

On April 20, 2007, APHIS published a notice ^[1] in the Federal Register (72 FR 19876-19877, Docket No. APHIS 2007-0027) announcing the availability of an environmental assessment (EA) for a controlled release of genetically engineered Eucalyptus hybrids. During the 30-day comment period, which ended May 21, 2007, APHIS received 270 comments. There were 153 comments supporting APHIS granting permit 06-325-111r, the majority of which were nearly identical form letters. Respondents supporting the approval of the permit were foresters, paper and packaging companies, or from related industries, academia, agricultural biotech companies, and individuals. There were 67 respondents who submitted 102 comments opposed to APHIS granting the permit. One opposing comment came in the form of a petition bearing 5,495 signatories. Respondents opposing APHIS granting this permit were primarily from 13 public interest groups; other respondents included academia and individuals. APHIS has addressed the issues raised during the comment period and has provided responses to these comments as an attachment to the finding of no significant impact (FONSI).

Pursuant to the regulations promulgated under the Plant Protection Act, APHIS has determined that this field release will not pose a risk of introducing or disseminating a plant pest. Additionally, based upon analysis described in the EA, APHIS has determined that the action proposed in Alternative C of the EA, issue the permit with supplemental permit conditions, will not have a significant impact on the quality of the human environment. You may read the FONSI and decision notice on the Internet or in the APHIS reading room (see ADDRESSES above). Copies may also be obtained from the person listed under the FOR FURTHER INFORMATION CONTACT section of this notice.

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 of these Eucalyptus trees, an EA and FONSI have been prepared. The EA and 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).

Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

Done in Washington, DC, this 25th day of June 2007.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  To view the notice and the comments we received go to http://www.regulations.gov,, click on the “Advanced Search” tab, and select “Docket Search.” In the Docket ID field, enter APHIS-2007-0027, then click “Submit.” Clicking on the Docket ID link in the search results page will produce a list of all documents in the docket.