[Federal Register Volume 73, Number 32 (Friday, February 15, 2008)]
[Notices]
[Pages 8847-8848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2910]


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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 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.

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SUMMARY: 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.

EFFECTIVE DATE: February 15, 2008.

ADDRESSES: 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: http://www.aphis.usda.gov/brs/aphisdocs/06_363103r_ea.pdf.

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 EA, FONSI and 
decision notice, and response to comments, contact Ms. Cynthia Eck at 
(301) 734-0667; e-mail: [email protected].

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 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).
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    \1\ To view the notice, the EA, and the comments we received, go 
to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0023.
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    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).


[[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.

    Done in Washington, DC, this 11th day of February 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E8-2910 Filed 2-14-08; 8:45 am]
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