[Federal Register Volume 72, Number 94 (Wednesday, May 16, 2007)]
[Notices]
[Pages 27539-27540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9432]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2007-0006]


Availability of an Environmental Assessment and Finding of No 
Significant Impact for a Proposed Field Release of Rice Genetically 
Engineered To Express Lactoferrin, Lysozyme, or Serum Albumin

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has prepared an environmental assessment for 
confined field release of rice plants genetically engineered to express 
the human proteins lactoferrin, lysozyme, or serum albumin. 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 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.

EFFECTIVE DATE: May 16, 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 (202) 690-2817 before coming. The EA, FONSI and 
decision notice, and responses to comments are available on the 
Internet at the following links:
 http://www.aphis.usda.gov/brs/aphisdocs/06_27801r_ea.pdf
 http://www.aphis.usda.gov/brs/aphisdocs/06_27802r_ea.pdf
 http://www.aphis.usda.gov/brs/aphisdocs/06_28502r_ea.pdf

FOR FURTHER INFORMATION CONTACT: Mr. John Cordts, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-5531. 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

[[Page 27540]]

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 October 5, 2006, the Animal and Plant Health Inspection Service 
(APHIS) received two permit applications (06-278-01r and 06-278-02r) 
followed by a third permit application (06-285-02r) received on October 
12, 2006, from Ventria Bioscience, Sacramento, CA, for confined field 
release of rice (Oryza sativa) plants genetically engineered to express 
genes coding for the proteins lactoferrin, lysozyme, or serum albumin, 
respectively. The proposed field releases are to be conducted in Geary 
County, KS. The subject plants have been genetically engineered, using 
techniques of micro-projectile bombardment or disarmed Agrobacterium-
mediated transformation, to express proteins for recombinant human 
lactoferrin, lysozyme, or serum albumin. Expression of the genes is 
controlled by the rice glutelin 1 promoter (GT1), the rice glutelin 1 
signal peptide (gt1), and the nopaline synthase (NOS) terminator 
sequence from Agrobacterium tumefaciens. The genes are expressed only 
in the seed. In addition, the plants may contain either or both of the 
coding sequences for the genes hygromycin phosphotransferase (hpt) or 
phosphinothricin acetyltransferase (pat), which are marker genes that 
allow for the selection of transgenic tissues in the laboratory using 
the antibiotic hygromycin and/or the herbicide bialaphos. Neither 
selectable marker gene is expressed in mature rice tissues, nor do they 
have any inherent plant pest characteristics or enhance gene transfer 
from plants to other organisms. The genetically engineered rice plants 
are considered regulated articles under the regulations in 7 CFR part 
340 because they contain gene sequences from plant pathogens.
    The purpose of these field releases is for pure seed production and 
for the extraction of lactoferrin, lysozyme, and serum albumin for a 
variety of research and commercial products. There is currently no 
commercial rice production in Geary County or in any other location in 
the State of Kansas. The planting will be conducted using physical 
confinement measures. In addition, the protocols and field plot design, 
as well as the procedures for termination of the field plantings, are 
designed to ensure that none of the subject rice plants persist in the 
environment after the crop is harvested.
    On February 28, 2007, APHIS published a notice \1\ in the Federal 
Register (72 FR 8959-8960, Docket No. APHIS-2007-0006) announcing the 
availability of an environmental assessment (EA) for the proposed field 
release of rice genetically engineered to express lactoferrin, 
lysozyme, or serum albumin. During the designated 30-day comment 
period, which ended March 30, 2007, APHIS received 20,034 comments. Of 
the 20,034 comments received, 20,005 were opposed to APHIS' approval of 
these permits. Respondents opposing APHIS' approval of these permits 
were four public interest groups, academic professionals, organic food 
producers, rice growers, millers (or from related industries), and 
individuals. One public interest group submitted 13,289 nearly 
identical comments, and 5,621 nearly identical comments were submitted 
by another public interest group. There were 29 comments supporting 
APHIS' approval of these permits. Respondents supporting the approval 
of these permits were from academia, a farm bureau, a corn and grain 
sorghum growers association, a corporation, a State government agency, 
and individuals. APHIS has addressed the issues raised during the 
comment period and has provided responses to these comments as 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 these field releases 
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 3 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.
    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 9th day of May, 2007.
W. Ron DeHaven,
Administrator, Animal and Plant Health Inspection Service.
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    \1\ To view the notice, EA, and the comments we received, go to 
http://www.regulations.gov, click on the ``Advanced Search'' tab, 
and select ``Docket Search.'' In the Docket ID field, enter APHIS-
2007-0006, then click on ``Submit.'' Clicking on the Docket ID link 
in the search results page will produce a list of all documents in 
the docket.
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 [FR Doc. E7-9432 Filed 5-15-07; 8:45 am]
BILLING CODE 3410-34-P