AgrEvo USA Co.; Availability of Determination of Nonregulated Status for Rice Genetically Engineered for Glufosinate Herbicide Tolerance

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 98-126-2]

AgrEvo USA Co.; Availability of Determination of Nonregulated

Status for Rice Genetically Engineered for Glufosinate Herbicide

Tolerance

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

rice transformation events developed by AgrEvo USA Company, which have

been genetically engineered for tolerance to the herbicide glufosinate,

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

AgrEvo USA Company in its petition for a determination of nonregulated

status, our 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 AgrEvo USA 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: April 15, 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, 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. David Heron, Biotechnology and

Biological Analysis, PPQ, APHIS, 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:

[email protected].

SUPPLEMENTARY INFORMATION:

Background

On November 25, 1998, the Animal and Plant Health Inspection

Service (APHIS) received a petition (APHIS Petition No. 98-329-01p)

from AgrEvo USA Company (AgrEvo) of Wilmington, DE, seeking a

determination that rice (Oryza sativa L.) designated as Liberty

Link Rice Transformation Events LLRICE06 and LLRICE62 (rice

transformation events LLRICE06 and LLRICE62), which have been

genetically engineered for tolerance to the herbicide glufosinate, do

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

articles under APHIS' regulations in 7 CFR part 340.

On January 26, 1999, APHIS published a notice in the Federal

Register (64 FR 3924-3925, Docket No. 98-126-1) announcing that the

AgrEvo 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 rice transformation events and food products derived from

them. In the notice, APHIS solicited written comments from the public

as to whether rice transformation events LLRICE06 and LLRICE62 posed a

plant pest risk. The comments were to have been received by APHIS on or

before March 29, 1999. APHIS received four comments on the subject

petition during the designated 60-day comment period from the

following: a farmers rice cooperative; a State rice growers

association; a State rice research board; and a State university rice

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

petition.

Analysis

Rice transformation events LLRICE06 and LLRICE62 have been

genetically engineered to contain a bar gene derived from Streptomyces

hygroscopicus strain HP632. The bar gene encodes the enzyme

phosphinothricin-N-acetyltransferase (PAT), which confers tolerance to

the herbicide glufosinate. Expression of the bar gene is controlled by

35S promoter and terminator sequences derived from the plant pathogen

cauliflower mosaic virus. The direct gene transfer method was used to

transfer the added genes into the parental rice varieties M202

(LLRICE06) and Bengal (LLRICE62).

The subject rice transformation events have been considered

regulated articles under APHIS' regulations in 7 CFR part 340 because

they contain gene sequences derived from a plant pathogen. However,

evaluation of field data reports from field tests of these rice

transformation events conducted under APHIS notifications since 1997

indicates that there were no deleterious effects on plants, nontarget

organisms, or the environment as a result of the environmental release

of rice transformation events LLRICE06 and LLRICE62.

Determination

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

of other scientific data and field tests of the subject rice

transformation events, APHIS has determined that rice transformation

events LLRICE06 and LLRICE62: (1) Exhibit no plant pathogenic

properties; (2) are no more likely to become weeds than rice varieties

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 organisms that are recognized as beneficial to agriculture;

and (5) will not cause damage to raw or processed agricultural

commodities. Therefore, APHIS has concluded that the subject rice

transformation events and any progeny derived from hybrid crosses with

other rice varieties will be as safe to grow as rice in traditional

breeding programs that are not subject to regulation under 7 CFR part

340.

The effect of this determination is that AgrEvo's rice

transformation events LLRICE06 and LLRICE62 are no longer considered

regulated articles under APHIS' regulations in 7 CFR part 340.

[[Page 22596]]

Therefore, the requirements pertaining to regulated articles under

those regulations no longer apply to the subject rice transformation

events or their progeny. However, importation of the subject rice

transformation events 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 AgrEvo's rice transformation events LLRICE06 and

LLRICE62 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 20th day of April 1999.

Craig A. Reed,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 99-10510 Filed 4-26-99; 8:45 am]

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