E7-11798. Availability of an Environmental Assessment and Finding of No Significant Impact for a Proposed Field Release of Genetically Engineered Safflower

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public that an environmental assessment has been prepared for a proposed field release involving a transgenic safflower line that has been genetically engineered to express, within the seeds, a carp growth hormone fused to an Arabidopsis oleosin. The purpose of this field release is to obtain a seed increase for future use as a supplement in aquaculture meal. After assessment of the application, review of pertinent scientific information, and consideration of comments provided by the public, we have concluded that these field releases will not present a risk of introducing or disseminating a plant pest. We have completed the environmental assessment and have concluded that this field release 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 releases.

DATES:

Effective Date: June 7, 2007.

ADDRESSES:

You may read the environmental assessment (EA), the finding of no significant impact (FONSI), and any comments we received 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 [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_​25002r_​ea.pdf.

Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT:

Dr. Patricia Beetham, 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 September 5, 2006, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS No. 06-250-02r) from SemBioSys Genetics, Inc. of West Sacramento, CA, for a field trial using a line of transgenic safflower. Permit application 06-250-02r describes a transgenic safflower (Carthamus tinctorius) cultivar that has been genetically engineered to express a fusion protein consisting of oleosin from Arabidopsis thaliana and carp growth hormone (somatotropin) from Cyprinus carpio exclusively within its seeds. Expression of this fusion protein is controlled by the phaseolin promoter and terminator sequences from Phaseolus vulgaris L. (common bean). Constructs were inserted into the recipient organisms via a disarmed Agrobacterium tumefaciens vector system. The seed from these safflower plants will be ground and incorporated into aquaculture feed to be used in experimental fish feeding studies by SemBioSys and is not for commercial production.

The subject safflower is considered a regulated article under the regulations in 7 CFR part 340 because it has been genetically engineered using the recombinant DNA technique using a vector derived from Agrobacterium tumefaciens.

On February 5, 2007, APHIS published a notice in the Federal Register (72 FR 5263-5264, Docket No. APHIS-2006-0190) announcing the availability of an environmental assessment (EA) for the proposed field release. During the 30-day comment period, APHIS received 33 comments. Two comments were from individuals who supported the planting of genetically engineered crops in general, but did not raise any specific points regarding the EA. Conversely, 23 comments were from individuals who were opposed to the use of biotechnology in food crops in general, but did not cite specific plant pest risk issues associated with this particular EA. One public interest group submitted 20,360 nearly identical letters from individuals opposing pharmacological proteins produced in food crops in general without addressing specific issues within the EA. Another public interest group submitted a letter bearing 25 signatures of representatives of various organizations that oppose pharmacological proteins in food crops and addressed specific issues within the EA. In total, eight public interest groups wrote letters in opposition to allowing the planting of the transgenic safflower. APHIS' responses to these comments are provided as an attachment to the finding of no significant impact (FONSI) and decision notice.

Pursuant to the regulations in 7 CFR part 340 promulgated under the Plant Protection Act, APHIS has determined that this field release will not pose a risk of the introduction or dissemination of a plant pest. Additionally, based upon analysis described in the EA, APHIS has determined that the action proposed in Alternative B 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 FOR FURTHER INFORMATION CONTACT.

To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts and plant pest risks associated with proposed release of the transgenic safflower, 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 13th day of June 2007.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.