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SemBioSys Genetics, Inc.; Availability of an Environmental Assessment and Finding of No Significant Impact for a Proposed Field Release of Genetically Engineered Safflower

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Information about this document as published in the Federal Register.

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Animal and Plant Health Inspection Service, USDA.




We are advising the public that an environmental assessment has been prepared for a proposed field release of a safflower line genetically engineered to express, within its seeds, human proinsulin fused to an Arabidopsis oleosin molecule. After our assessment of the application, review of pertinent scientific information, and consideration of comments provided by the public, we have concluded that this field release will not present a risk of introducing or disseminating a plant pest, 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 these field releases.


February 15, 2008.


You may read the environmental assessment (EA), 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 (202) 690-2817 before coming. The EA, FONSI and decision notice, and responses to comments are available on the Internet at:​brs/​aphisdocs/​06_​363103r_​ea.pdf.

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Dr. Patricia Beetham, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-0664. To obtain copies of the EA, FONSI and decision notice, and response to comments, contact Ms. Cynthia Eck at (301) 734-0667; e-mail:

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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 December 18, 2006, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS No. 06-363-103r) from SemBioSys Genetics, Inc. of West Sacramento, CA, for a field trial using a line of transgenic safflower. Permit application 06-363-103r describes a transgenic safflower (Carthamus tinctorius) cultivar that has been genetically engineered to express a fusion protein consisting of oleosin from Arabidopsis thaliana and human proinsulin 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 seeds from these safflower plants will be ground up and used for the development of proinsulin purification technology and are 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 utilizing a recombinant DNA technique that uses a vector derived from Agrobacterium tumefaciens.

On June 22, 2007, APHIS published a notice [1] in the Federal Register (72 FR 34426-34427, Docket No. APHIS-2007-0023) announcing the availability of an environmental assessment (EA) for the proposed field release. During the 30-day comment period, APHIS received seven comments. There was one individual who was opposed to the use of biotechnology in food crops in general, but did not cite specific plant pest risk issues associated with this EA. Another commenter raised specific issues regarding the EA that mirrored the concerns of one of the five public interest groups that also sent in comments on the EA. In total, five public interest groups wrote letters in opposition to allowing the planting of this GE safflower. APHIS has responded to these comments in an attachment to the finding of no significant impact (FONSI).

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 introducing or disseminating a plant pest. Additionally, based upon analysis described in the EA, APHIS has determined that the action proposed in Alternative B of the EA (the preferred alternative), to issue the permit with supplemental permit conditions, will not have a significant impact on the quality of the human environment. Therefore, APHIS has determined that a FONSI is appropriate for this proposed action. You may read the FONSI and decision notice on the Internet or in the APHIS reading room (see ADDRESSES above). Copies of the EA are also available from the individual listed under FOR FURTHER INFORMATION CONTACT.

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).

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Start Printed Page 8848 Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

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Done in Washington, DC, this 11th day of February 2008.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

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[FR Doc. E8-2910 Filed 2-14-08; 8:45 am]