[Federal Register Volume 72, Number 120 (Friday, June 22, 2007)]
[Notices]
[Pages 34426-34427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12098]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2007-0023]


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.

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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 (202) 690-2817 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; (301) 734-0664. To obtain copies of the environmental 
assessment, contact Ms. Cynthia Eck at (301) 734-0667; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340,

[[Page 34427]]

``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.
[FR Doc. E7-12098 Filed 6-21-07; 8:45 am]
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