Monsanto Co.; Availability of Determination of Nonregulated Status for Potato Genetically Engineered for Insect and Virus Resistance

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 97-094-2]

Monsanto Co.; Availability of Determination of Nonregulated

Status for Potato Genetically Engineered for Insect and Virus

Resistance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that certain

potato lines developed by the Monsanto Company, which have been

genetically engineered for insect and virus resistance, 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's 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: December 3, 1998.

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 requested to

call before visiting on (202) 690-2817 to facilitate entry into the

reading room.

FOR FURTHER INFORMATION CONTACT: Dr. James White, Biotechnology and

Biological Analysis, PPQ, APHIS, 4700 River Road Unit 147, Riverdale,

MD 20737-1236; (301) 734-5940. 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 July 23, 1997, the Animal and Plant Health Inspection Service

(APHIS) received a petition (APHIS Petition No. 97-204-01p) from the

Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination

that seven NewLeaf Plus Russet Burbank potato lines, which

have been genetically engineered for resistance to the Colorado potato

beetle (CPB) and potato leaf roll virus (PLRV), do not present a plant

pest risk and, therefore, are not regulated articles under APHIS'

regulations in 7 CFR part 340. Subsequently, Monsanto requested that

all but two (RBMT21-129 and RBMT21-350) of the NewLeaf Plus

Russet Burbank potato lines be withdrawn from consideration in the

subject petition.

On November 20, 1997, APHIS published a notice in the Federal

Register (62 FR 61961-61962, Docket No. 97-094-1) 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 potato lines and food products derived from them. In the

notice, APHIS solicited written comments from the public as to whether

these potato lines posed a plant pest risk. The comments were to have

been received by APHIS on or before January 20, 1998. During the

designated 60-day comment period, APHIS received 14 comments from the

following: Potato farmers and processors; State and national trade

associations; a State congressional delegation; the U.S. Department of

Agriculture's Agricultural Research Service; a research entomologist

from a university agricultural research center; and a European crop

research institute. All of the comments were in support of the subject

petition.

Analysis

Russet Burbank potato lines RBMT21-129 and RBMT21-350 have been

genetically engineered to contain the cryIIIA gene derived from

Bacillus thuringiensis subsp. tenebrionis (Btt), which encodes an

insecticidal protein that is effective against CPB, and the orf1/orf2

gene derived from PLRV, which imparts resistance to PLRV. In addition

to the cryIIIA gene and the orf1/orf2 gene, these potato lines contain

the nptII gene, which encodes the NPTII protein used as a selectable

marker in the initial stages of plant transformation. The subject

potato lines were developed through use of the Agrobacterium

tumefaciens transformation method, and expression of the added genes is

controlled in part by gene sequences derived from the plant pathogens

A. tumefaciens and figwort mosaic virus.

The subject potato lines have been considered regulated articles

under APHIS' regulations in 7 CFR part 340 because they contain gene

sequences derived from plant pathogens. However, evaluation of field

data reports from field tests of these potato lines conducted under

APHIS permits and notifications since 1994 indicates that there were no

deleterious effects on plants, nontarget organisms, or the environment

as a result of the environmental release of the subject potato plants.

Determination

Based on its analysis of the data submitted by Monsanto, a review

of other scientific data and field tests of the subject potato lines,

and an analysis of comments from the public on the subject petition,

APHIS has determined that Russet Burbank potato lines RBMT21-129 and

RBMT21-350:

(1) Exhibit no plant pathogenic properties; (2) are no more likely

to become a weed than pest-resistant potato lines 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 cause damage to raw or processed

agricultural commodities; and (5) will not harm threatened or

endangered species or other organisms, such as bees, that are

beneficial to agriculture, or have an adverse impact on the ability to

control nontarget insect pests.

[[Page 69611]]

Therefore, APHIS has concluded that the subject Russet Burbank potato

lines and any progeny derived from crosses with other potato varieties

will be as safe to grow as potatoes that are not subject to regulation

under 7 CFR part 340.

The effect of this determination is that Monsanto's Russet Burbank

potato lines RBMT21-129 and RBMT21-350 are no longer considered

regulated articles 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 potato lines or their progeny.

However, importation of the subject potato lines or seeds capable of

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 Russet Burbank potato lines RBMT21-129

and RBMT21-350 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 December 1998.

Joan M. Arnoldi,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 98-33435 Filed 12-16-98; 8:45 am]

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