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. 98-067-2]

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.

-----------------------------------------------------------------------

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

potato lines developed by Monsanto Company, which have been genetically

engineered for resistance to the Colorado potato beetle and potato

virus Y, 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 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: February 25, 1999.

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,

[[Page 11435]]

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. David Heron, Biotechnology and

Biological Analysis, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147,

Riverdale, MD 20737-1236; (301) 734-5141. 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:

Kay.P[email protected].

SUPPLEMENTARY INFORMATION:

Background

On December 5, 1997, the Animal and Plant Health Inspection Service

(APHIS) received a petition (APHIS Petition No. 97-339-01p) from

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

that four NewLeaf Y potato lines, which have been

genetically engineered for resistance to the Colorado potato beetle

(CPB) and potato virus Y (PVY) 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 one of the four

NewLeaf Y potato lines, Hilite line HLMT15-46, be withdrawn

from consideration in the subject petition.

On July 20, 1998, APHIS published a notice in the Federal Register

(63 FR 38805-38806, Docket No. 98-067-1) 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 September 18, 1998. During the designated 60-day

comment period, APHIS received 6 comments from potato growers and State

and national trade associations. All of the comments were in support of

the subject petition.

The subject three NewLeaf Y potato lines include one

line of Russet Burbank (RBMT15-101) and two lines of Shepody (SEMT15-02

and SEMT15-15). These three potato lines have been genetically

engineered to contain the cry3A gene derived from Bacillus

thuringiensis subsp. tenebrionis (BTT), which encodes a protein that is

insecticidal to CPB, and the PVY coat protein gene (PVYcp), which

imparts resistance to PVY. In addition to the cry3A gene and the PVYcp

gene, the subject potato lines contain and express the nptII gene,

which is used as a selectable marker in the early stages of plant

selection. While the two Shepody lines (SEMT15-02 and SEMT15-15) also

contain the aad marker gene, tests indicate that this gene is not

expressed in the potato plants. 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.

Russet Burbank potato line RBMT15-101 and Shepody potato lines

SEMT15-02 and SEMT15-15 have been considered regulated articles under

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

sequences derived from plant pathogens. These potato lines have been

evaluated in field trials conducted since 1993 under APHIS

notifications. In reviewing the notifications, APHIS determined that

these field trials, which were conducted under reproductive and

physical containment, would not present a risk of plant pest

introduction or dissemination.

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 line RBMT15-101 and

Shepody potato lines SEMT15-02 and SEMT15-15: (1) Exhibit no plant

pathogenic properties and will not pose an increased plant pest risk

from the appearance of new plant viruses; (2) are no more likely to

become weeds than pest-resistant potato lines developed by traditional

plant breeding; (3) are unlikely to increase the weediness potential

for any other cultivated or wild species with which they can

interbreed; (4) will not harm threatened or endangered species or other

organisms, such as bees, that are beneficial to agriculture; and (5)

will not cause damage to raw or processed agricultural commodities.

Therefore, APHIS has concluded that the subject 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 line RBMT15-101 and Shepody potato lines SEMT15-02 and SEMT15-15

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 Russet Burbank potato line

RBMT15-101 and Shepody potato lines SEMT15-02 and SEMT15-15 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 (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 Monsanto's Russet Burbank potato line RBMT15-101 and

Shepody potato lines SEMT15-02 and SEMT15-15 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 3rd day of March, 1999.

Joan M. Arnoldi,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 99-5780 Filed 3-8-99; 8:45 am]

BILLING CODE 3410-34-P