[Federal Register Volume 70, Number 123 (Tuesday, June 28, 2005)]
[Notices]
[Pages 37079-37080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-3353]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 05-006-3]


Ventria Bioscience; Availability of Environmental Assessment and 
Finding of No Significant Impact for Field Tests of Genetically 
Engineered Rice Expressing Lactoferrin

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 and reached 
a finding of no significant impact for confined field tests of rice 
plants genetically engineered to express the protein lactoferrin. The 
environmental assessment provides a basis for our conclusion that these 
field tests will not present a risk of introducing or disseminating a 
plant pest and 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 
tests.

DATES: Effective Date: June 21, 2005.

ADDRESSES: You may read the environmental assessment, the finding of no 
significant impact, and any comments that we received on Docket No. 05-
006-1 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.
    You may view APHIS documents published in the Federal Register and 
related information on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Levis Handley, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-5721. To obtain copies of the environmental 
assessment, contact Ms. Ingrid Berlanger, at (301) 734-4885; email 
[email protected]. The environmental assessment and 
finding of no significant impact are also available on the Internet at 
http://www.aphis.usda.gov/brs/aphisdocs/05 05 --11701r--ea.pdf.

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 into the environment of a regulated 
article.
    On October 28, 2004, the Animal and Plant Health Inspection Service 
(APHIS) received a permit application (APHIS permit number 04-302-01r) 
from Ventria Bioscience, Sacramento, CA, for a permit for a confined 
field planting of rice (Oryza sativa) plants genetically engineered to 
express a gene coding for the protein lactoferrin, rice line LF164-12. 
The application was for a field trial in Scott County, MO. On February 
23, 2005, APHIS published a notice in the Federal Register (70 FR 8763, 
Docket No. 05-006-1) announcing the availability of an environmental 
assessment (EA) for this confined field planting. The 30-day comment 
period ended on March 25, 2005.
    On April 27, 2005, while APHIS was evaluating these comments, we 
received a request from Ventria Bioscience to plant rice line LF164-12 
in a second site in Washington County, NC (APHIS permit number 05-117-
01r). Because many of the issues are similar for the two field tests, 
APHIS chose to extend the comment period to gather additional comments 
that specifically address any new issues that may exist for the North 
Carolina location. On May 13, 2005, APHIS published a second Federal 
Register notice (70 FR 25521-25522, Docket No. 05-006-2) extending the 
comment period on Docket No. 05-006-1 for a period of 20 days.
    APHIS has considered the comments from both comment periods and the 
comments received during the intervening period. APHIS received 676 
comments. Comments were received from rice growers, rice marketing and 
processing groups, agricultural support businesses, consumer groups, 
university professionals, private individuals, industry trade 
organizations, large rice purchasers, Federal, State and local 
government representatives, and growers of crops other than rice. Five 
hundred eighty-six respondents did not support the issuance of a permit 
for a field trial of rice expressing lactoferrin. Forty-eight 
commenters did support granting a permit for a field trial for rice 
that expresses lactoferrin. Two commenters provided information only 
and conveyed no opinion on the proposed field trial. The remaining 40 
comments were duplications of submitted comments.

[[Page 37080]]

    The majority of the commenters expressed concern that rice from 
this field trial may inadvertently become mixed with rice intended for 
food or feed use. Commenters were concerned that birds, mammals, water, 
or human error might move small amounts of rice from the permitted 
field into commercially grown rice or rice products. Commenters also 
suggested that hybridization may occur with weedy rice types and allow 
the lactoferrin gene to persist in the environment. Commenters also 
focused on potential market loss for commercial rice if genetically 
engineered rice were to be grown in the same geographic area. Several 
of these commenters also expressed concern for food safety if this rice 
were incorporated in general commodity rice. Supporters of the field 
trial commented on the safety of the trial, the closed production 
design for the field trial, and the economic and health benefits that 
could result from the production of rice that expresses lactoferrin.
    APHIS evaluated the impacts on the human environment in the EA, and 
we have responded to comments in an attachment to the finding of no 
significant impact (FONSI), which is available as indicated under the 
heading, FOR FURTHER INFORMATION CONTACT. Between the close of the 
previous comment period and the publication of this notice, Ventria 
Bioscience has withdrawn its application to conduct a field test in 
Scott County, MO. However, because many of the issues in Missouri are 
similar to those in North Carolina and the public expressed a great 
deal of interest in the Missouri test site, APHIS has addressed the 
comments from both Federal Register notices in an attachment to the 
FONSI.

Background

    The subject rice plants have been genetically engineered, using 
micro-projectile bombardment, to express human lactoferrin protein. 
Expression of the gene is controlled by the rice glutelin1 promoter, 
the rice glutelin 1 signal peptide, and the NOS (nopaline synthase) 
terminator sequence from Agrobacterium tumefaciens. The gene is 
expressed only in the endosperm. In addition, the plants contain the 
coding sequence for the gene hygromycin phosphotransferase (hpt), an 
enzyme which confers tolerance to the antibiotic hygromycin. This gene 
is a selectable marker that is only expressed during plant cell culture 
and is not expressed in any tissues of the mature plant. Expression of 
the gene is controlled by the rice glucanase 9 (Gns 9) promoter and the 
Rice Alpha Amylase 1A (RAmy1A) terminator.
    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 purposes of the field tests 
are for pure seed production and for the extraction of lactoferrin for 
a variety of research and commercial products. The planting will be 
conducted using multiple measures to ensure strict confinement. In 
addition, the experimental protocols and field plot design, as well as 
the procedures for termination of the field tests, are designed to 
ensure that none of the subject rice plants persist in the environment 
beyond the termination of the experiments.
    Pursuant to its regulations in 7 CFR 340, promulgated under the 
Plant Protection Act of 2000, APHIS has determined that this field 
trial will not pose a risk of the introduction or dissemination of a 
plant pest for the following reasons:
    1. The field trial is confined. Regulated articles are not likely 
to be removed from the field site through transport by water or 
animals. Accidental transport of regulated articles from the site by 
humans is minimized by strict standard operating procedures and permit 
conditions.
    2. Rice is predominately self-fertilizing, has short pollen 
viability, and the sites are several miles from commercial rice crops. 
Therefore, it is extremely unlikely that cross-pollination could occur 
with commercial rice.
    3. The nos sequence is from the soil-inhabiting bacterial plant 
pathogen, Agrobacterium sp. and does not encode a protein. It does not 
cause plant disease and has a history of safe use in a number of 
genetically engineered plants (e.g., rice, corn, cotton and soybean 
varieties). The regulatory sequences from rice are the Gns9 promoter, 
Gt1 promoter, gt1 signal peptide, and the RAmyl 1A terminator. None of 
the DNA regulatory sequences can cause plant disease by themselves or 
in conjunction with the genes that were introduced into the transgenic 
rice lines.
    4. Lactoferrin is expressed predominantly in seed. Levels of 
expression in the remainder of the plant are not detectable.
    5. Given the history of safe use of lactoferrin supplements in food 
and oral hygiene products and as nutritional supplements, APHIS 
concludes that humans are unlikely to be significantly affected by 
incidental contact with this rice that may occur during this field 
trial.
    6. Based on the lack of toxicity of the proteins that will be 
produced and the prescribed permit conditions to minimize any seed 
remaining on the soil surface, APHIS concludes that there will be no 
significant effect on any native floral or faunal species in Scott 
County, MO, or Washington County, NC.
    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). Copies of the EA 
and FONSI are available as indicated under the heading, FOR FURTHER 
INFORMATION CONTACT.

    Done in Washington, DC, this 22nd day of June 2005.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E5-3353 Filed 6-27-05; 8:45 am]
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