[Federal Register Volume 60, Number 134 (Thursday, July 13, 1995)]
[Notices]
[Pages 36096-36097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17080]



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DEPARTMENT OF AGRICULTURE
[Docket No. 94-139-2]


Availability of Determination of Nonregulated Status for 
Genetically Engineered Cotton

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's genetically engineered, insect-resistant cotton 
lines designated as 531, 757, and 1076 are no longer considered 
regulated articles under our regulations governing the introduction of 
certain genetically engineered organisms. Our determination is based on 
our evaluation of data submitted by the Monsanto Company in its 
petition for a determination of nonregulated status, an analysis of 
other scientific data, and our review of comments received from the 
public in response to a previous notice announcing our receipt of the 
Monsanto Company petition. This notice also announces the availability 
of our written determination document and its associated environmental 
assessment and finding of no significant impact.

EFFECTIVE DATE: June 22, 1995.

ADDRESSES: The determination, an environmental assessment and finding 
of no significant impact, the petition, and all written comments 
received regarding the petition may be inspected at USDA, room 1141, 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except 
holidays. Persons wishing to inspect those documents are asked to call 
in advance of visiting at (202) 690-2817.

FOR FURTHER INFORMATION CONTACT: Dr. Keith Reding, Biotechnologist, 
Biotechnology Permits, BBEP, APHIS, 4700 River Road Unit 147, 
Riverdale, MD 20737-1237; (301) 734-7612. To obtain a copy of the 
determination or the environmental assessment and finding of no 
significant impact, contact Ms. Kay Peterson at (301) 734-7612.

SUPPLEMENTARY INFORMATION:

Background

    On November 4, 1994, the Animal and Plant Health Inspection Service 
(APHIS) received a petition (APHIS Petition No. 94-308-01p) from the 
Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination 
that cotton lines designated as 531, 757, and 1076 that have been 
genetically engineered for insect resistance do not present a plant 
pest risk and, therefore, are not regulated articles under APHIS' 
regulations in 7 CFR part 340.
    On February 9, 1995, APHIS published a notice in the Federal 
Register (60 FR 7746-7747, Docket No. 94-139-1) announcing that the 
Monsanto petition had been received and was available for public 
review. The notice also discussed the role of APHIS, the Environmental 
Protection Agency, and the Food and Drug Administration in regulating 
the subject cotton lines and food products derived from them. In the 
notice, APHIS solicited written comments from the public as to whether 
the subject cotton lines posed a plant pest risk. The comments were to 
have been received by APHIS on or before April 10, 1995.
    APHIS received 69 comments on the Monsanto petition, from cotton 
farmers, individuals, universities, agricultural experiment stations, 
cooperative extension service offices, a bank, a chemical company, a 
cotton researcher, a cotton cooperative association, a gas and oil 
supplier, and a worker's compensation trust. Sixty-eight commenters 
either provided information supporting nonregulated status for the 
subject cotton lines or urged expedited approval to allow commercial 
planting of the insect-resistant cotton. One commenter cited several 
issues for further consideration, without recommending approval or 
denial of the petition. APHIS has provided a summary and discussion of 
the comments in the determination document, which is available upon 
request from the individual listed under FOR FURTHER INFORMATION 
CONTACT.

Analysis

    Monsanto's cotton lines 531, 757, and 1076 have been genetically 
engineered to express an insect control protein encoded by the cryIA(c) 
gene that occurs naturally in Bacillus thuringiensis subsp. kurstaki 
(Btk), a common soil bacterium. This protein is effective against such 
lepidopteran insect pests as cotton bollworm, tobacco budworm, and pink 
bollworm, and is expressed at a consistent level in the cotton plant 
throughout the growing season. The subject cotton lines also contain 
the nptII gene which encodes the enzyme neomycin phosphotransferase II. 
Presence of the NPTII protein confers tolerance to the antibiotic 
kanamycin and allows selection of the transformed cells in the presence 
of kanamycin. These genes were stably transferred into the genome of 
cotton plants using Agrobacterium tumefaciens-mediated transformation.
    The subject cotton lines have been considered regulated articles 
under APHIS' regulations in 7 CFR part 340 because they contain gene 
sequences (vectors, promoters, and terminators) derived from plant-
pathogenic sources. However, evaluation of field data reports from 
field tests of the subject cotton lines conducted since 1992 under 
APHIS permits or notifications indicates that there were no deleterious 
effects on plants, nontarget organisms, or the environment as a result 
of the subject cotton plants' release into the environment.

Determination

    Based on its analysis of the data submitted by Monsanto and a 
review of other scientific data, comments received from the public, and 
field tests of the subject cotton lines, APHIS has determined that 
cotton lines 531, 757, and 1076: (1) Exhibit no plant pathogenic 
properties; (2) are no more likely to become weeds than their 
nonengineered parental varieties; (3) are not likely to increase the 
weediness potential of any other cultivated plant or native wild 
species with which they can interbreed; (4) will not cause damage to 
raw or processed agricultural 

[[Page 36097]]
commodities; (5) and are not likely to harm other organisms, such as 
bees, that are beneficial to agriculture. APHIS has also concluded that 
there is a reasonable certainty that new lepidopteran-resistant cotton 
varieties bred from these lines will not exhibit new plant pest 
properties, i.e., properties substantially different from any observed 
for the lepidopteran-resistant cotton lines already field tested or 
those observed for cotton in traditional breeding programs.
    The effect of this determination is that insect-resistant cotton 
lines designated as 531, 757, and 1076 are no longer considered 
regulated articles under APHIS' regulations in 7 CFR part 340. 
Therefore, the permit and notification requirements pertaining to 
regulated articles under those regulations no longer apply to the field 
testing, importation, or interstate movement of the subject cotton 
lines or their progeny. However, the importation of the subject cotton 
lines or seeds capable of propagation is still subject to the 
restrictions found in APHIS' foreign quarantine notices in 7 CFR part 
319.

National Environmental Policy Act

    An environmental assessment (EA) has been prepared to examine the 
potential environmental impacts associated with this determination. The 
EA was prepared in accordance with: (1) The National Environmental 
Policy Act of 1969 (NEPA)(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 
finding of no significant impact (FONSI) with regard to its 
determination that the subject cotton lines and lines developed from 
them are no longer regulated articles under its regulations in 7 CFR 
part 340. Copies of the EA and the FONSI are available upon request 
from the individual listed under FOR FURTHER INFORMATION CONTACT.

    Done in Washington, DC, this 6th day of July 1995.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-17080 Filed 7-12-95; 8:45 am]
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