Asgrow Seed Co.; Availability of Determination of Nonregulated Status for Squash Line Genetically Engineered for Virus Resistance

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 96-002-2]

Asgrow Seed Co.; Availability of Determination of Nonregulated

Status for Squash Line Genetically Engineered for 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 the

Asgrow Seed Company's squash line designed as CZW-3 that has been

genetically engineered for virus resistance 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 the Asgrow Seed 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

Asgrow Seed 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: June 14, 1996.

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.

FOR FURTHER INFORMATION CONTACT: Dr. James White, Biotechnology

Permits, BBEP, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-

1237; (301) 734-7612. To obtain a copy of the determination or the

environmental assessment and finding of no significant impact, contact

Ms. Kay Peterson at (301) 734-7612; e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

On December 18, 1995, the Animal and Plant Health Inspection

Service (APHIS) received a petition (APHIS Petition No. 95-352-01p)

from the Asgrow Seed Company (Asgrow) of Kalamazoo, MI, seeking a

determination that a yellow crookneck squash line designated as CZW-3

(line CZW-3) that has been genetically engineered to contain genes that

confer virus resistance does not present a plant pest risk and,

therefore, is not a regulated article under APHIS' regulations in 7 CFR

part 340.

On February 2, 1996, APHIS published a notice in the Federal

Register (61 FR 3899-3900, Docket No. 96-002-1) announcing that the

Asgrow petition had been received and was available for public review.

The notice also discussed the role of APHIS and the Food and Drug

Administration in regulating the subject squash line and food products

derived from it. In the notice, APHIS solicited written comments from

the public as to whether this squash line posed a plant pest risk. The

comments were to have been received by APHIS on or before April 2,

1996. During the designated 60-day comment period, APHIS received four

comments on the subject petition from universities, an office of the

cooperative extension service, and an agricultural consultant. All of

the comments were favorable to the petition.

Analysis

Line CZW-3 has been genetically engineered to contain the coat

protein genes from cucumber mosaic virus, watermelon mosaic virus 2,

and zucchini yellow mosaic virus for resistance to these viruses. The

subject squash line also contains the nptII gene from the prokaryotic

transposon Tn5, which encodes the enzyme neomycin phosphotransferase II

and is used as a selectable marker for transformation. Expression of

the added genes is controlled in part by 35S promoters and terminators

from the plant pathogen cauliflower mosaic virus. The genes used to

develop line CZW-3 were stably transferred into the genome of the

yellow crookneck squash parental line through the use of the

Agrobacterium tumefaciens transformation system.

The subject squash 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 line CZW-3 conducted in 1993 and 1994

under APHIS permits indicates that there were no deleterious effects on

plants, nontarget organisms, or the environment as a result of the

environmental release of this squash line.

[[Page 33485]]

Determination

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

of other scientific data, comments received, and field tests of the

subject squash line, APHIS has determined that line CZW-3: (1) Exhibits

no plant pathogenic properties; (2) is no more likely to become a weed

than virus resistant squash 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; (5) will

not increase the likelihood of the emergence of new plant viruses; and

(6) 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 squash line and any progeny derived from

hybrid crosses with other nontransformed squash varieties will be as

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

subject to regulation under 7 CFR part 340.

The effect of this determination is that Asgrow's yellow crookneck

squash line CZW-3 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 squash line or its progeny. However, importation of the subject

squash line 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 (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 Asgrow's yellow crookneck squash line CZW-3 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 21st day of June 1996.

Bobby R. Acord,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 96-16465 Filed 6-26-96; 8:45 am]

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