E7-12098. SemBioSys Genetics, Inc.; Availability of an Environmental Assessment for a Field Release of Safflower Genetically Engineered To Produce Human Proinsulin

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public that we have prepared an environmental assessment for a proposed field release involving a transgenic safflower line that has been genetically engineered to express, within the seeds, human proinsulin fused to an Arabidopsis oleosin molecule. The purpose of this field release is to obtain seed material for development of downstream insulin purification techniques. The environmental assessment is available to the public for review and comment.

DATES:

We will consider all comments received on or before July 23, 2007.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov,, select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click “Submit.” In the Docket ID column, select APHIS-2007-0023 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instruction for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link.
• Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2007-0023, Regulatory Analysis and Development, PPD APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2007-0023.

Reading Room: You may read the environmental assessment (EA) and any comments we receive 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 is available on the Internet at http://www.aphis.usda.gov/​brs/​aphisdocs/​06_​363103r_​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 environmental assessment, 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 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 seed from these safflower plants will be ground and used for the development of proinsulin purification technology 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 utilizing a recombinant DNA technique that uses a vector derived from Agrobacterium tumefaciens.

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 the transgenic safflower, we have 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. 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).

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 the individual listed under FOR FURTHER INFORMATION CONTACT.

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 18th day of June 2007.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.