[Federal Register Volume 62, Number 109 (Friday, June 6, 1997)]
[Notices]
[Pages 31062-31063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14876]


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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 
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 delegations of authority, filing of petitions and applications and agency 
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  Federal Register / Vol. 62, No. 109 / Friday, June 6, 1997 / 
Notices  

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 96-095-2]


Monsanto Co.; Availability of Determination of Nonregulated 
Status for Genetically Engineered Corn

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 corn line designated as MON 802, which has been 
genetically engineered for insect resistance and glyphosate herbicide 
tolerance, 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 the Monsanto Company in its 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: May 27, 1997.

ADDRESSES: The determination, an environmental assessment and finding 
of no significant impact, and 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 
requested to call before visiting on (202) 690-2817 to facilitate entry 
into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr. James Lackey, BSS, PPQ, APHIS, 
4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-8713. 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 November 12, 1996, the Animal and Plant Health Inspection 
Service (APHIS) received a petition (APHIS Petition No. 96-317-01p) 
from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a 
determination that a corn line designated as MON 802, which has been 
genetically engineered for insect resistance and glyphosate herbicide 
tolerance, does not present a plant pest risk and, therefore, is not a 
regulated article under APHIS' regulations in 7 CFR part 340.
    On December 18, 1996, APHIS published a notice in the Federal 
Register (61 FR 66650-66651, Docket No. 96-095-1) 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 corn line and food products derived from it. In the notice, 
APHIS solicited written comments from the public as to whether this 
corn line posed a plant pest risk. The comments were to have been 
received by APHIS on or before February 18, 1997. APHIS received no 
comments on the subject petition during the designated 60-day comment 
period.

Analysis

    Corn line MON 802 has been genetically engineered to express a 
CryIA(b) insect control protein derived from the common soil bacterium 
Bacillus thuringiensis subsp. kurstaki (Bt). The petitioner stated that 
the Bt delta-endotoxin protein is effective in protecting the subject 
corn line from damage caused by the European corn borer throughout the 
growing season. The subject corn line also expresses the CP4 EPSPS 
protein isolated from Agrobacterium sp. strain CP4 and the GOX protein 
cloned from Achromobacter sp. strain LBAA, which, when introduced into 
the plant cell, confer tolerance to the herbicide glyphosate. The 
particle acceleration method was used to transfer the added genes into 
the parental corn line, and their expression is controlled in part by 
the intron from the corn hsp70 gene and by gene sequences from the 
plant pathogens Agrobacterium tumefaciens and cauliflower mosaic virus. 
The nptII selectable marker gene is present in the subject corn line 
under the control of a bacterial promoter, but is not expressed in the 
plant.
    The subject corn line has been considered a regulated article under 
APHIS' regulations in 7 CFR part 340 because it contains gene sequences 
derived from plant pathogens. However, evaluation of field data reports 
from field tests of the corn line conducted under APHIS notifications 
since 1993 indicates that there were no deleterious effects on plants, 
nontarget organisms, or the environment as a result of the 
environmental release of corn line MON 802.

Determination

    Based on its analysis of the data submitted by Monsanto, a review 
of other scientific data, and field tests of the subject corn line, 
APHIS has determined that corn line MON 802: (1) Exhibits no plant 
pathogenic properties; (2) is no more likely to become a weed than corn 
lines 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 cause damage to raw 
or processed agricultural commodities; (5) will not harm threatened or 
endangered species or other organisms, such as bees, that are 
beneficial to agriculture; and (6) should not reduce the ability to 
control insects in corn or other crops when cultivated. Therefore, 
APHIS has concluded that the subject corn line and any progeny derived 
from hybrid crosses with other nontransformed corn varieties will be as 
safe to grow as corn in traditional breeding programs that are not 
subject to regulation under 7 CFR part 340.
    The effect of this determination is that Monsanto's corn line MON 
802 is no longer considered a regulated article under APHIS' 
regulations in 7 CFR part 340. Therefore, the requirements pertaining 
to regulated articles under those regulations no longer apply to the 
field testing, importation, or interstate movement of the subject corn 
line or its progeny. However, importation of corn line MON 802 or seeds 
capable of

[[Page 31063]]

propagation are 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, as amended (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 Monsanto's corn line MON 802 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 30th day of May 1997.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-14876 Filed 6-5-97; 8:45 am]
BILLING CODE 3410-34-P