AgrEvo USA Co.; Availability of Determination of Nonregulated Status for Canola Genetically Engineered for Male Sterility, Fertility Restoration, and Glufosinate Herbicide Tolerance

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 98-114-2]

AgrEvo USA Co.; Availability of Determination of Nonregulated

Status for Canola Genetically Engineered for Male Sterility, Fertility

Restoration, and 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

canola transformation events developed by AgrEvo USA Company, which

have been genetically engineered for male sterility, fertility

restoration, and 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

and on our 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: March 22, 1999.

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 asked

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

into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Susan Koehler, Biotechnology and

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

Riverdale, MD 20737-1236; (301) 734-4886. To obtain a copy of the

determination or the environmental assessment and finding of no

significant impact, contact Ms. Kay Peterson at

[[Page 15338]]

(301) 734-4885; e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

On October 5, 1998, the Animal and Plant Health Inspection Service

(APHIS) received a petition (APHIS Petition No. 98-278-01p) from AgrEvo

USA Company (AgrEvo) of Wilmington, DE, seeking a determination that

canola (Brassica napus L.) designated as In Vigor Hybrid

Canola Transformation Events MS8 and RF3 (transformation events), which

have been genetically engineered for male sterility (MS8), fertility

restoration (RF3), and tolerance to the herbicide glufosinate (both MS8

and RF3), do not present a plant pest risk and, therefore, are not

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

On December 8, 1998, APHIS published a notice in the Federal

Register (63 FR 67643-67644, Docket No. 98-114-1) 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 canola transformation events and food products derived from

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

as to whether these canola transformation events posed a plant pest

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

February 8, 1999. APHIS received no comments on the subject petition

during the designated 60-day comment period.

Analysis

The subject transformation events have been genetically engineered

to contain a barnase gene (MS8) for male sterility or a barstar gene

(RF3) for fertility restoration. The barnase gene expresses a

ribonuclease that blocks pollen development and results in a male

sterile plant, and the barstar gene encodes a specific inhibitor of

this ribonuclease and restores fertility. The barnase and barstar genes

were derived from Bacillus amyloliquefaciens, and are linked in the

subject transformation events to the bar gene derived from Streptomyces

hygroscopicus. The bar gene encodes the enzyme phosphinothricin-N-

acetyltransferase (PAT), which confers tolerance to the herbicide

glufosinate. The herbicide tolerance trait allows for selection of

plants carrying the linked genes for pollination control during

breeding and for tolerance to the herbicide during commercial

cultivation. Expression of the added genes is controlled in part by

gene sequences derived from Arabidopsis thaliana, Nicotiana tabacum,

and the plant pathogen Agrobacterium tumefaciens. The A. tumefaciens

method was used to transfer the added genes into the parental canola

variety, Drakkar.

Canola transformation events MS8, RF3, and their hybrid combination

MS8/RF3 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 canola transformation events

conducted under APHIS permits and 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 the

subject canola transformation events.

Determination

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

of other scientific data and field tests of the subject canola, APHIS

has determined that canola transformation events MS8, RF3, and their

hybrid combination MS8/RF3: (1) Exhibit no plant pathogenic properties;

(2) are no more likely to become weeds than canola developed by

traditional breeding techniques and are unlikely to increase the

weediness potential for any other cultivated or wild species with which

they can interbreed; (3) will not cause damage to raw or processed

agricultural commodities; (4) will not harm threatened or endangered

species or other organisms, such as bees, that are beneficial to

agriculture; and (5) are unlikely to have any significant adverse

impact on agricultural practices. Therefore, APHIS has concluded that

the subject canola transformation events and any progeny derived from

hybrid crosses with other canola varieties will be as safe to grow as

canola in breeding programs that are not subject to regulation under 7

CFR part 340.

The effect of this determination is that AgrEvo's canola

transformation events MS8, RF3, and their hybrid combination MS8/RF3

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 subject canola

transformation events or their progeny. However, importation of these

canola 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 canola transformation events MS8, RF3, and

their hybrid combination MS8/RF3 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 24th day of March 1999.

Craig A. Reed,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 99-7803 Filed 3-30-99; 8:45 am]

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