Ventria Bioscience; Availability of Environmental Assessment and Finding of No Significant Impact for Field Tests of Genetically Engineered Rice Expressing Lysozyme, 37077-37079 [E5-3350]
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Federal Register / Vol. 70, No. 123 / Tuesday, June 28, 2005 / Notices
is necessary for the proper performance
of the functions of the agency, including
whether the information will have
practical utility; (2) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on those who are to respond, including
through the use of appropriate
automated, electronic, mechanical, or
other technological collection
techniques or other forms of information
technology.
Upon OMB approval, this information
collection will be merged into the
information collection currently
approved under OMB No. 0581–0178,
Vegetable and Specialty Crop Marketing
Orders.
Comments should reference OMB No.
0581–0211 and the California Dried
Prune Marketing Order No. 993, and be
mailed to Docket Clerk, Fruit and
Vegetable Programs, AMS, USDA, 1400
Independence Avenue, SW Stop 0237,
Washington, DC 20250–0237; Tel: (202)
720–2491, Fax: (202) 720–8938; Fax:
(202) 720–8938; or E-mail:
moab.docketclerk@usda.gov. All
comments received will be available for
public inspection during regular
business hours at the same address.
All responses to this notice will be
summarized and included in the request
for OMB approval. All comments will
also become a matter of public record.
Dated: June 23, 2005.
Kenneth C. Clayton,
Acting Administrator, Agricultural Marketing
Service.
[FR Doc. 05–12698 Filed 6–27–05; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. 02–088–6]
RIN 0579-AB47
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
In accordance with the
Paperwork Reduction Act, this notice
announces the Office of Management
and Budget’s approval of a collection of
information contained in the Animal
VerDate jul<14>2003
17:51 Jun 27, 2005
Jkt 205001
Mrs.
Celeste Sickles, APHIS’ Information
Collection Coordinator, MRPBS, APHIS,
4700 River Road Unit 123, Riverdale,
MD 20737–1238; (301) 734–7477.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Background
In an interim rule published in the
Federal Register on December 13, 2002
(67 FR 76908–76938, Docket No. 02–
088–1) and effective on February 11,
2003, the Animal and Plant Health
Inspection Service (APHIS) established
regulations in 7 CFR part 331 and 9 CFR
part 121 governing the possession, use,
and transfer of biological agents and
toxins that have been determined to
have the potential to pose a severe
threat to public health and safety, to
animal health, to plant health, or to
animal or plant products (i.e., select
agents and toxins).
On March 18, 2005, we published in
the Federal Register (70 FR 13242–
13292, Docket No. 02–088–4) a final
rule that adopts, with changes, the
December 2002 interim rule. The final
rule includes certain regulatory
provisions that differ from those
included in the December 2002 interim
rule. Some of those provisions involve
changes from the information collection
requirements set out in the December
2002 interim rule, which were approved
by the Office of Management and
Budget (OMB) under OMB control
number 0579–0213.
In accordance with section 3507(j) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et. seq.), the information
collection and recordkeeping
requirements included in the final rule
were submitted for emergency approval
to OMB. OMB approved the collection
of information requirements with
respect to the final rule under OMB
control number 0579–0213 (expires
October 31, 2005).
Done in Washington, DC, this 22nd day of
June 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E5–3351 Filed 6–27–05; 8:45 am]
Agency Information Collection
Activities; OMB Approval Received
SUMMARY:
and Plant Health Inspection Service’s
final rule regarding the possession, use,
and transfer of select agents and toxins.
BILLING CODE 3410–34–P
PO 00000
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37077
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
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
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
https://www.aphis.usda.gov/ppd/rad/
webrepor.html.
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 https://
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\28JNN1.SGM
28JNN1
37078
Federal Register / Vol. 70, No. 123 / Tuesday, June 28, 2005 / Notices
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
VerDate jul<14>2003
16:46 Jun 27, 2005
Jkt 205001
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-
PO 00000
Frm 00004
Fmt 4703
Sfmt 4703
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 selffertilizing, has short pollen viability,
and the sites are several miles from
commercial rice crops. Therefore, it is
extremely unlikely that crosspollination could occur with
commercial rice.
3. The nos sequence is from the soilinhabiting 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
E:\FR\FM\28JNN1.SGM
28JNN1
Federal Register / Vol. 70, No. 123 / Tuesday, June 28, 2005 / Notices
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]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
[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
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
SUMMARY: We are advising the public
that the Animal and Plant Health
16:46 Jun 27, 2005
Jkt 205001
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
ingrid.e.berlanger@aphis.usda.gov. The
environmental assessment and finding
of no significant impact are also
available on the Internet at https://
www.aphis.usda.gov/brs/aphisdocs/05
_11701r_ea.pdf.
FOR FURTHER INFORMATION CONTACT:
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
SUPPLEMENTARY INFORMATION:
Animal and Plant Health Inspection
Service
VerDate jul<14>2003
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
https://www.aphis.usda.gov/ppd/rad/
webrepor.html.
PO 00000
Frm 00005
Fmt 4703
Sfmt 4703
37079
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.
E:\FR\FM\28JNN1.SGM
28JNN1
]]>Agencies
[Federal Register Volume 70, Number 123 (Tuesday, June 28, 2005)]
[Notices]
[Pages 37077-37079]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-3350]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
https://
[[Page 37078]]
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]
BILLING CODE 3410-34-P
