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Glyphosate - Availability of Determination of Nonregulated Status 11/97

[Federal Register: December 5, 1997 (Volume 62, Number 234)]
[Notices]
[Page 64350-64351]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de97-35]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 97-052-2]
Monsanto Co. and Dekalb Genetics Corp.; Availability of
Determination of Nonregulated Status for Genetically Engineered Corn
Line
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our determination that a corn
line developed by Monsanto Company and Dekalb Genetics Corporation
designated as GA21, which has been genetically engineered for tolerance
to the herbicide glyphosate, 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 and Dekalb Genetics
Corporation in their petition for a determination of nonregulated
status and an analysis of other scientific data. This notice also
announces the availability of our written determination document and
its associated environmental assessment and finding of no significant
impact.

EFFECTIVE DATE: November 18, 1997.

ADDRESSES: The determination, an environmental assessment and finding
of no significant impact, the petition, and any 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 to facilitate entry into the
reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Ray Dobert, Biotechnology
Evaluation, BSS, PPQ, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-8365. To obtain a copy of the determination or
the environmental assessment and finding of no significant impact,
contact Ms. Kay Peterson at (301) 734-4885; e-mail:
mkpeterson@aphis.usda.gov.

SUPPLEMENTARY INFORMATION:

Background

    On April 9, 1997, the Animal and Plant Health Inspection Service
(APHIS) received a petition (APHIS Petition No. 97-099-01p) from
Monsanto Company of St. Louis, MO, and Dekalb Genetics Corporation of
Mystic, CT (Monsanto/Dekalb), seeking a determination that a corn line
designated as GA21, which has been genetically engineered for tolerance
to the herbicide glyphosate, does not present a plant pest risk and,
therefore, is not a regulated article under APHIS' regulations in 7 CFR
part 340.
    On August 13, 1997, APHIS published a notice in the Federal
Register (62 FR 43311-43312, Docket No. 97-052-1) announcing that the
Monsanto/Dekalb 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 corn line and food products derived from it. In the notice,
APHIS solicited written comments from the public as to whether the
subject corn line posed a plant pest risk. The comments were to have
been received by APHIS on or before October 14, 1997. APHIS received no
comments on the subject petition during the designated 60-day comment
period.

Analysis

    Corn line GA21 has been genetically engineered to contain a
modified corn 5-enolpyruvylshikimate-3-phosphate-synthase (EPSPS) gene,
which, when expressed in the plant, confers tolerance to the herbicide
glyphosate. The modified corn EPSPS gene was introduced into the
parental inbred corn line AT by the particle acceleration method, and
its expression is controlled in part by the rice actin promoter and
intron and the NOS 3' termination sequence derived from the plant
pathogen Agrobacterium tumefaciens.
    Corn line GA21 has been considered a regulated article under APHIS'
regulations in 7 CFR part 340 because it contains gene sequences
derived from a plant pathogen. However, evaluation of field data
reports from field tests of the subject corn line conducted under APHIS
notifications since 1994 indicates that there were no deleterious
effects on plants, nontarget organisms, or the environment as a result
of the subject corn plants' release into the environment.

Determination

    Based on its analysis of the data submitted by Monsanto/Dekalb, and
a review of other scientific data and field tests of the subject corn
line, APHIS has determined that corn line GA21: (1) Exhibits no plant
pathogenic properties; (2) is no more likely to become a weed than corn
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 harm other
organisms, including agriculturally beneficial organisms and threatened
and endangered species; and (5) should not cause damage to raw or
processed agricultural commodities. Therefore, APHIS has concluded that
corn line GA21 and any progeny derived from hybrid crosses with
nontransformed corn varieties will be just as safe to grow as
traditionally bred corn lines that are not regulated under 7 CFR part
340.
    The effect of this determination is that the Monsanto/Dekalb corn
line designated as GA21 is no longer considered a regulated article
under APHIS' regulations in 7 CFR part 340.

[[Page 64351]]

Therefore, the requirements pertaining to regulated articles under
those regulations no longer apply to the field testing, importation, or
interstate movement of corn line GA21 or its progeny. However,
importation of the subject corn line 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), 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 finding of no significant impact (FONSI) with regard to its
determination that the Monsanto/Dekalb corn line GA21 and lines
developed from it 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 28th day of November 1997.
Craig A. Reed,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-31901 Filed 12-4-97; 8:45 am]
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