[Federal Register: November 22, 2002 (Volume 67, Number 226)]
[Notices]
[Page 70391-70392]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22no02-32]
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Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
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[[Page 70391]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 01-025-2]
Monsanto Co.; Availability of 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 the
Monsanto Company cotton designated as Event 15985, 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 Monsanto Company 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: November 5, 2002.
ADDRESSES: You may read a copy of the determination, an environmental
assessment and finding of no significant impact, the petition for a
determination of nonregulated status submitted by Monsanto Company, and
all comments received on the petition and the environmental assessment
in our reading room. The reading room is located in room 1141, 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 that someone is available to help
you, please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. David Heron, Biotechnology
Regulatory Services, APHIS, Suite 5B05, 4700 River Road Unit 147,
Riverdale, MD 20737-1236; (301) 734-5141. To obtain a copy of the
determination or environmental assessment and finding of no significant
impact, contact Ms. Kay Peterson at (301) 734-4885; e-mail:
Kay.Peterson@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
On December 7, 2000, the Animal and Plant Health Inspection Service
(APHIS) received a petition (APHIS Petition No. 00-342-01p) from
Monsanto Company (Monsanto) of St. Louis, MO, requesting a
determination of nonregulated status under 7 CFR part 340 for cotton
(Gossypium hirsutum L.) designated as Bollgard II Cotton Event 15985
(event 15985), which has been genetically engineered for resistance to
certain lepidopteran insect pests. The Monsanto petition states that
the subject cotton should not be regulated by APHIS because it does not
present a plant pest risk.
On March 18, 2002, APHIS published a notice in the Federal Register
(67 FR 11973-11974, Docket No. 01-025-1) announcing that the Monsanto
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. APHIS received
seven comments on the petition and the EA during the 60-day comment
period, which ended May 17, 2002. The comments were received from
university entomologists and extension specialists, an agricultural
services company, and a consumer advocacy group. Six comments were in
support of the subject petition, and one comment was critical of the EA
prepared for the proposed determination of nonregulated status. The
commenters supporting nonregulated status for the subject cotton
emphasized its effectiveness in insect control and the related
reductions in insecticide applications, the importance of the two
Bacillus thuringiensis (Bt) toxins in high dose insect resistance
management strategies, its usefulness in integrated pest management,
the absence of the risk of development of a new plant pest, and the
similarities in the environmental effects of event 15985 cotton to
traditionally-bred varieties. One commenter stated that the EA prepared
for the petition was inadequate and the preparation of an environmental
impact statement was necessary because allowing large-scale
commercialization of this cotton constituted a major Federal action
that would significantly impact the environment. The alleged
inadequacies in the EA included failures to address the cumulative
effects of gene stacking, the concerns of organic farmers, and the
environmental impacts of the approval of a so-called illegal grant of
the genetic resource of insect susceptibility to Bt from the public
trust into the possession of commercial entities. We have provided a
response to these comments as an attachment to our finding of no
significant impact (FONSI), which is available from the person listed
under FOR FURTHER INFORMATION CONTACT.
Cotton event 15985 has been genetically engineered to express a
Cry2Ab insecticidal protein derived from the common soil bacterium B.
thuringiensis subsp. kurstaki (Btk). The petitioner states that the
Cry2Ab protein is effective in providing protection from the feeding of
lepidopteran insect pests such as tobacco budworm, pink bollworm, and
cotton bollworm. The subject cotton event also expresses the [beta]-D-
glucuronidase (GUS) protein used as a selectable marker. Expression of
the added genes is controlled in part by gene sequences from the plant
pathogens cauliflower mosaic virus and Agrobacterium tumefaciens.
Particle acceleration technology was used to transfer the added genes
into the recipient Delta and Pine Land Company variety 50B (DP50B).
Cotton cultivar DP50B expresses a Btk Cry1Ac insecticidal protein and a
NPTII selectable marker protein, and was developed from cotton event
531, which was deregulated by APHIS in 1995 (APHIS No. 94-308-01p).
[[Page 70392]]
Cotton event 15985 has been considered a regulated article under
the regulations in 7 CFR part 340 because it contains gene sequences
from plant pathogens. This cotton has been field tested since 1998 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 vectors and other elements were disarmed and
that the trials, which were conducted under conditions of reproductive
and physical containment or isolation, would not present a risk of
plant pest introduction or dissemination.
Determination
Based on its analysis of the data submitted by Monsanto, a review
of other scientific data, field tests of the subject cotton, and
comments submitted by the public, APHIS has determined that cotton
event 15985: (1) Exhibits no plant pathogenic properties; (2) is no
more likely to become a weed than cotton developed by traditional
breeding techniques; (3) is unlikely to increase the weediness
potential for any other cultivated or wild species with which it can
interbreed; (4) will not cause damage to raw or processed agricultural
commodities; and (5) will not harm threatened or endangered species or
organisms, such as bees, that are beneficial to agriculture. Therefore,
APHIS has concluded that the subject cotton and any progeny derived
from hybrid crosses with other nontransformed cotton varieties will be
as safe to grow as cotton in traditional breeding programs that is not
subject to regulation under 7 CFR part 340.
The effect of this determination is that Monsanto's cotton event
15985 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 cotton event
15985 and seeds capable of propagation are still subject to the
restrictions found in APHIS' foreign quarantine notices in 7 CFR part
319.
National Environmental Policy Act
An EA was prepared to examine the potential environmental impacts
associated with a determination of nonregulated status for Monsanto's
cotton event 15985. 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 its determination that cotton
event 15985 and lines developed from it are no longer regulated
articles under its regulations in 7 CFR part 340. Copies of the EA and
FONSI are available from the individual listed under FOR FURTHER
INFORMATION CONTACT.
Done in Washington, DC, this 19th day of November 2002.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-29752 Filed 11-21-02; 8:45 am]
BILLING CODE 3410-34-P