[Federal Register: July 20, 2005 (Volume 70, Number 138)]
[Notices]
[Page 41679-41681]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jy05-34]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-051-2]
Syngenta Seeds, Inc.; Determination of Nonregulated Status for
Cotton Genetically Engineered for Insect Resistance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our determination that cotton
designated as transformation Event COT102, which has been genetically
engineered for insect resistance, is no longer considered a regulated
article under our regulations governing the introduction of certain
genetically engineered organisms. Our determination is based on our
evaluation of data submitted by Syngenta Seeds, Inc., in its petition
for a determination of nonregulated status, our analysis of other
scientific data, and comments received from the public in response to a
previous notice. This notice also announces the availability of our
written determination and our finding of no significant impact.
EFFECTIVE DATE: July 6, 2005.
ADDRESSES: You may read a copy of the determination, the environmental
assessment and finding of no significant impact, the petition for a
determination of nonregulated status submitted by Syngenta Seeds, Inc.,
and all comments received on the petition and the environmental
assessment 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.
Other Information: 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. Margaret Jones, Biotechnology
Regulatory Services, APHIS, 4700 River
[[Page 41680]]
Road Unit 147, Riverdale, MD 20737; (301) 734-4880. To obtain copies of
the determination, the environmental assessment (EA) and finding of no
significant impact (FONSI), and the petition, contact Ms. Ingrid
Berlanger at (301) 734-5715; e-mail: ingrid.e.berlanger@aphis.usda.gov.
The petition and the EA, including the FONSI and determination, are
also available on the Internet at: http://www.aphis.usda.gov/brs/aphisdocs/03_15501p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/03_15501p_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.''
The regulations in Sec. 340.6(a) provide that any person may
submit a petition to the Animal and Plant Health Inspection Service
(APHIS) seeking a determination that an article should not be regulated
under 7 CFR part 340. Paragraphs (b) and (c) of Sec. 340.6 describe
the form that a petition for a determination of nonregulated status
must take and the information that must be included in the petition.
On June 4, 2003, APHIS received a petition (APHIS Petition Number
03-155-01p) from Syngenta Seeds, Inc. (Syngenta) of Research Triangle
Park, NC, requesting a determination of nonregulated status under 7 CFR
part 340 for cotton (Gossypium hirsutum L.) designated as
transformation event COT102, which has been genetically engineered for
selective lepidopteran insect resistance. The Syngenta petition states
that the subject cotton should not be regulated by APHIS because it
does not present a plant pest risk.
On January 28, 2005, APHIS published a notice in the Federal
Register (70 FR 4085-4086, Docket No. 04-051-1) announcing that the
Syngenta petition and an environmental assessment (EA) were available
for public review. That notice also discussed the role of APHIS, the
Environmental Protection Agency, and the Food and Drug Administration
in regulating the subject cotton and food products developed from it.
We solicited comments concerning the petition and EA for 60 days
ending March 29, 2005. We received nine comments by that date,
submitted by seven individuals (one commenter submitted three copies of
the same comment). The comments were from a university professor, three
private individuals, and three anonymous commenters. Two of the
commenters discussed field trials of genetically modified rice, and a
third commenter discussed field trials of Syngenta cotton but did not
address the petition for nonregulated status. None of the four
remaining commenters supported granting nonregulated status to
Syngenta's insect-resistant cotton event COT102. The issues raised in
the comments are addressed in an attachment to the finding of no
significant impact (FONSI).
Background
As described in the petition, Event COT102 cotton has been
genetically engineered to contain an insecticidal Vip3A(a) gene derived
from Bacillus thuringiensis (Bt) strain AB88 under the control of the
actin-2 promoter derived from Arabidopsis thaliana, which confers
expression of the VIP3A(a) protein throughout the plant with the
exception of the fiber and nectar. Event COT102 cotton also contains
the selectable marker gene aph4 derived from Escherichia coli. The aph4
gene encodes the enzyme hygromycinB phosphotransferase and its
expression is controlled by the ubiquitin-3 promoter from A. thaliana.
Agrobacterium-mediated gene transfer was used to transfer the added
genes into the recipient Coker 312 cotton variety. The petitioner
states that while the VIP3A protein shares no homology with known Cry
proteins, testing has shown that VIP3A is similarly specific in
toxicity only to the larvae of certain lepidopteran species. However,
the VIP3A apparently targets a different receptor than the Cry1
proteins in sensitive species and therefore may be useful in the
management of pest resistance.
Event COT102 has been considered a regulated article under the
regulations in 7 CFR part 340 because it contains gene sequences from
the plant pathogen Agrobacterium tumefaciens. This cotton event has
been field tested since 2000 in the United States under APHIS
notifications. In the process of reviewing the notifications for field
trials of the subject cotton, APHIS determined that the vector was
disarmed and that the trials, which were conducted under conditions of
reproductive and physical confinement or isolation, would not present a
risk of plant pest introduction or dissemination.
Determination
Based on its analysis of the data submitted by Syngenta Seeds,
Inc., a review of other scientific data, field tests of the subject
cotton, and comments submitted by the public, APHIS has determined that
COT102 cotton: (1) Exhibits no plant pathogenic properties; (2) is no
more likely to become weedy than the nontransgenic parental line or
other cultivated cotton; (3) is unlikely to increase the weediness
potential of any other cultivated or wild species with which it can
interbreed; (4) will not cause damage to raw or processed agricultural
commodities; (5) will not harm threatened or endangered species or
organisms that are beneficial to agriculture; and (6) should not reduce
the ability to control pests and weeds in cotton or other crops.
Therefore, APHIS has concluded that the subject cotton and any progeny
derived from hybrid crosses with other non-transformed cotton varieties
will be as safe to grow as cotton in traditional breeding programs that
are not subject to regulation under 7 CFR part 340. The effect of this
determination is that Syngenta's COT102 cotton is no longer considered
a regulated article under APHIS' regulations in 7 CFR part 340.
Therefore, the requirements pertaining to regulated articles under
those regulations no longer apply to the subject cotton or its progeny.
However, importation of COT102 cotton and seeds capable of propagation
are still subject to the restrictions found in APHIS' foreign
quarantine notices in 7 CFR part 319 and imported seed regulations in 7
CFR part 361.
National Environmental Policy Act
An EA was prepared to examine any potential environmental impacts
associated with the proposed determination of nonregulated status for
the subject cotton. The EA was 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). Based on that EA,
APHIS has reached a FONSI with regard to the determination that
Syngenta's COT102 cotton and lines developed from it are
[[Page 41681]]
no longer regulated articles under its regulations in 7 CFR part 340.
Copies of the EA and FONSI are available as indicated in the FOR
FURTHER INFORMATION CONTACT section of this notice.
Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.3.
Done in Washington, DC, this 14th day of July 2005.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-14263 Filed 7-19-05; 8:45 am]
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