[Federal Register Volume 67, Number 226 (Friday, November 22, 2002)]
[Notices]
[Pages 70391-70392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-29752]


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 Notices
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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 delegations of authority, filing of petitions and applications and agency 
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  Federal Register / Vol. 67, No. 226 / Friday, November 22, 2002 / 
Notices  

[[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: 
[email protected].

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