[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
________________________________________________________________________
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
