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

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

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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]

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