[Federal Register Volume 60, Number 141 (Monday, July 24, 1995)]
[Notices]
[Pages 37870-37871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18071]



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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 
 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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  Federal Register / Vol. 60, No. 141 / Monday, July 24, 1995 / 
Notices  


[[Page 37870]]


DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 95-023-2]


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 cotton lines designated as 1445 and 1698 that have 
been genetically engineered for tolerance to the herbicide glyphosate 
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: July 11, 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. Sivramiah Shantharam, 
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 February 14, 1995, the Animal and Plant Health Inspection 
Service (APHIS) received a petition (APHIS Petition No. 95-045-01p) 
from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a 
determination that cotton lines designated as 1445 and 1698 that have 
been genetically engineered for tolerance to the herbicide glyphosate 
do not present a plant pest risk and, therefore, are not regulated 
articles under APHIS' regulations in 7 CFR part 340.
    On March 30, 1995, APHIS published a notice in the Federal Register 
(60 FR 16428-16430, Docket No. 95-023-1) 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 May 30, 1995.
    APHIS received a total of 10 comments on the Monsanto petition, 
from universities, cooperative extension service offices, agricultural 
experiment stations, a council representing cotton interests, and a 
State department of agriculture. All the commenters supported the 
Monsanto petition for nonregulated status for the subject cotton lines.
Analysis
    Cotton lines 1445 and 1698 contain the gene for CP4 EPSPS (5-
enolpyruvylshikimate-3-phosphate synthase) isolated from Agrobacterium 
sp. strain CP4, which encodes an enzyme conferring tolerance to 
glyphosate, the active ingredient in Roundup herbicide. The 
subject cotton lines also contain the nptII gene, which encodes the 
selectable marker neomycin phosphotransferase II. Cotton lines 1445 and 
1698 were produced through the use of Agrobacterium tumefaciens 
transformation.
    The subject cotton lines were considered regulated articles because 
they contain certain gene sequences (vectors, vector agents, promoters, 
and terminators) derived from plant pathogens. However, evaluation of 
field data reports from field tests of the subject cotton lines 
conducted under APHIS permits or notifications since 1992 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 1445 and 1698: (1) Exhibit no plant pathogenic properties; 
(2) are no more likely to become weeds than cotton developed by 
traditional breeding techniques; (3) are unlikely to increase the 
weediness potential for any other cultivated or wild species with which 
they can interbreed; (4) will not harm other organisms, such as bees, 
that are beneficial to agriculture; and (5) should not cause damage to 
processed agricultural commodities. APHIS has also concluded that there 
is no reason to believe that new progeny cotton varieties derived from 
cotton lines 1445 and 1698 will exhibit new plant pest properties, 
i.e., properties substantially different from any observed for the 
cotton lines 1445 and 1698 already field tested, or those observed for 
cotton in traditional breeding programs.
    The effect of this determination is that cotton lines designated as 
1445 and 1698 are no longer considered regulated articles under APHIS' 
regulations in 7 CFR part 340. Therefore, the notification requirements 
pertaining to regulated articles under those regulations no longer 
apply to the field testing, importation, or interstate movement of 
cotton lines 1445 and 1698 or their progeny. However, the importation 
of the subject cotton lines or seeds capable of propagation is still 
subject to the 

[[Page 37871]]
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 cotton lines 1445 and 1698 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 14th day of July 1995.
Lonnie J. King,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-18071 Filed 7-21-95; 8:45 am]
BILLING CODE 3410-34-P