[Federal Register Volume 62, Number 234 (Friday, December 5, 1997)]
[Notices]
[Pages 64350-64351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31901]


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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: 
[email protected].

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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