Monsanto Co.; Availability of Determination of Nonregulated Status for Tomato Genetically Engineered for Insect Resistance

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 97-114-2]

Monsanto Co.; Availability of Determination of Nonregulated

Status for Tomato Genetically Engineered for Insect 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 the

Monsanto Company's tomato line designated as 5345, which has been

genetically engineered for resistance to certain lepidopteran insect

pests, 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 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: March 26, 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 asked to call

in advance of visiting at (202) 690-2817 to facilitate entry into the

reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Sivramiah Shantharam,

Biotechnology and Biological Analysis, PPQ, APHIS, 4700 River Road Unit

147, Riverdale, MD 20737-1236; (301) 734-4882. 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 October 14, 1997, the Animal and Plant Health Inspection Service

(APHIS) received a petition (APHIS Petition No. 97-287-01p) from

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

that a tomato line designated as 5345, which has been genetically

engineered for resistance to certain lepidopteran insect pests, does

not present a plant pest risk and, therefore, is not a regulated

article under APHIS' regulations in 7 CFR part 340.

On November 28, 1997, APHIS published a notice in the Federal

Register (62 FR 63312-63313, Docket No. 97-114-1) 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 (EPA), and the Food and Drug Administration in

regulating the subject tomato line and food products derived from it.

In that notice, APHIS solicited written comments from the public as to

whether this tomato line posed a plant pest risk. The comments were to

have been received by APHIS on or before January 27, 1998. During the

designated 60-day comment period, APHIS received two negative comments

on the subject petition, both of which were from consumer policy

organizations. The commenters argue that APHIS should deny the subject

petition because the petitioner's insect pest resistance management

strategies are inadequate based on recently published information in

scientific journals. However, APHIS regulatory authority is based on an

assessment of plant pest risk. EPA is the lead agency dealing with pest

resistance management strategies for transgenic insect resistant

plants, and EPA has established a pest resistance management working

group to deal with pest resistance management issues. APHIS is working

with EPA to examine the issues surrounding the development of pest

resistance, and scientific consultations in public forums are being

pursued in conjunction with the registration process under the Federal

Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7

U.S.C. 136 et seq.). While APHIS has carefully considered the comments

submitted, our determination has not been affected by the points made

by the commenters because they extend to authority exercised by EPA

under FIFRA.

Analysis

Tomato line 5345 has been genetically engineered to express a

CryIA(c) insect control protein derived from the common soil bacterium

Bacillus thuringiensis subsp. kurstaki HD-73 (Btk). The subject tomato

line also expresses the nptII gene, which codes for the enzyme neomycin

phosphotransferase (NPTII) and has been used as a selectable marker in

the development of the transgenic tomato plants. While tomato line 5345

contains the aad gene, tests indicate that the AAD protein is not

expressed in the subject tomato plants. Expression of the added genes

is controlled in part by noncoding DNA sequences derived from the plant

pathogens Agrobacterium tumefaciens and cauliflower mosaic virus. The

Agrobacterium transformation method was used to transfer the added

genes into the UC82B parental tomato plants.

The subject tomato 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 this tomato line conducted under APHIS

notifications since 1995 indicates that there were no deleterious

effects on plants, nontarget organisms, or the environment as a result

of the environmental release of tomato line 5345.

Determination

Based on its analysis of the data submitted by Monsanto and a

review of other scientific data and field tests of the subject tomato

line, as well as comments submitted by the public regarding the subject

petition, APHIS has determined that tomato line 5345:

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(1) Exhibits no plant pathogenic properties; (2) is no more likely to

become a weed than tomato 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; and (5)

will not harm threatened or endangered species or other organisms, such

as bees, that are beneficial to agriculture. Therefore, APHIS has

concluded that the subject tomato line and any progeny derived from

hybrid crosses with other nontransformed tomato varieties will be as

safe to grow as tomato in traditional breeding programs that are not

subject to regulation under 7 CFR part 340.

The effect of this determination is that Monsanto's tomato line

5345 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

tomato line or its progeny. However, importation of tomato line 5345 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, 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 tomato line 5345 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 3rd day of April 1998.

Craig A. Reed,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 98-9376 Filed 4-8-98; 8:45 am]

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