[Federal Register: June 28, 2005 (Volume 70, Number 123)]
[Notices]
[Page 37077-37079]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jn05-40]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 05-007-3]
Ventria Bioscience; Availability of Environmental Assessment and
Finding of No Significant Impact for Field Tests of Genetically
Engineered Rice Expressing Lysozyme
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 lysozyme. 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-
007-1 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; e-mail
ingrid.e.berlanger@aphis.usda.gov. The environmental assessment and
finding of no significant impact are also available on the Internet at
[[Page 37078]]
http://www.aphis.usda.gov/brs/aphisdocs/05_11702r_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 04-309-01r)
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 lysozyme, rice line LZ159-53. 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 8762-
8763, Docket No. 05-007-1) 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 LZ159-53
in a second site in Washington County, NC (APHIS permit number 05-117-
02r). 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 25522-25524, Docket No. 05-007-2) extending the
comment period on Docket No. 05-007-1 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 607
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 fifty respondents did not support the issuance of a permit for
a field trial of rice expressing lysozyme. Forty-nine commenters did
support granting a permit for a field trial for rice that expresses
lysozyme. Two commenters provided information only and conveyed no
opinion on the proposed field trial. The remaining six comments were
duplications of submitted comments.
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 lysozyme 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 lysozyme.
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 lysozyme protein.
Expression of the gene is controlled by the rice glutelin 1 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 lysozyme 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 Part 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
[[Page 37079]]
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. Lysozyme 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 lysozyme 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. E5-3350 Filed 6-27-05; 8:45 am]
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