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

SUMMARY: We are advising the public that the Animal and Plant Health

Inspection Service has received a petition from the Asgrow Seed Company

seeking a determination of nonregulated status for a squash line

designated as CZW-3 that has been genetically engineered for virus

resistance. The petition has been submitted in accordance with our

regulations concerning the introduction of certain genetically

engineered organisms and products. In accordance with those

regulations, we are soliciting public comments on whether this squash

line presents a plant pest risk.

DATES: Written comments must be received on or before April 2, 1996.

ADDRESSES: Please send an original and three copies of your comments to

Docket No. 96-002-1, Regulatory Analysis and Development, PPD, APHIS,

Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please

state that your comments refer to Docket No. 96-002-1. A copy of the

petition and any comments received 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 access to that room to inspect the petition

or comments are asked to call in advance of visiting at (202) 690-2817.

FOR FURTHER INFORMATION CONTACT: Dr. James White, Biotechnology

Permits, BBEP, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale,

MD 20737-1237; (301) 734-7612. To obtain a copy of the petition,

contact Ms. Kay Peterson at (301) 734-7612.

SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340,

``Introduction of Organisms and Products Altered or Produced Through

Genetic Engineering Which Are Plant Pests or Which There Is Reason to

Believe Are Plant Pests,'' regulate, among other things, the

introduction (importation, interstate movement, or release into the

environment) of organisms and products altered or produced through

genetic engineering that are plant pests or that there is reason to

believe are plant pests. Such genetically engineered organisms and

products are considered ``regulated articles.''

The regulations in Sec. 340.6(a) provide that any person may submit

a petition to the Animal and Plant Health Inspection Service (APHIS)

seeking a determination that an article should not be regulated under 7

CFR part 340. Paragraphs (b) and (c) of Sec. 340.6 describe the form

that a petition for determination of nonregulated status must take and

the information that must be included in the petition.

On December 18, 1995, APHIS received a petition (APHIS Petition No.

95-352-01p) from the Asgrow Seed Company (Asgrow) of Kalamazoo, MI,

requesting a determination of nonregulated status under 7 CFR part 340

for a yellow crookneck squash line designated as CZW-3 (line CZW-3)

that has been genetically engineered to contain genes that confer virus

resistance. The Asgrow petition states that squash line CZW-3 should

not be regulated by APHIS because it does not present a plant pest

risk.

As described in the petition, 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 three 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 by 35S promoters and terminators from the plant pathogen

cauliflower mosaic virus. The Agrobacterium tumefaciens vector system

was used to transfer the plasmid containing the DNA elements described

above into the yellow crookneck squash parental line.

Line CZW-3 has been considered a regulated article under the

regulations in 7 CFR part 340 because it contains gene sequences from

plant pathogens. The subject squash line has been evaluated in field

trials conducted in 1993 and 1994 under APHIS permits. In the process

of reviewing the applications for field trials of line CZW-3, APHIS

determined that the vectors and other elements were disarmed and that

the trials, which were conducted under conditions of reproductive and

physical containment or isolation, would not present a risk of plant

pest introduction or dissemination.

In the Federal Plant Pest Act, as amended (7 U.S.C. 150aa et seq.),

``plant pest'' is defined as ``any living stage of: Any insects, mites,

nematodes, slugs, snails, protozoa, or other invertebrate animals,

bacteria, fungi, other parasitic plants or reproductive parts thereof,

viruses, or any organisms similar to or allied with any of the

foregoing, or any infectious substances, which can directly or

indirectly injure or cause disease or damage in any plants or parts

thereof, or any processed, manufactured or other products of plants.''

APHIS views this definition very broadly. The definition covers direct

or indirect injury, disease, or damage not just to agricultural crops,

but also to plants in general, for example, native species, as well as

to organisms that may be beneficial to plants, for example, honeybees,

rhizobia, etc.

The Food and Drug Administration (FDA) published a statement of

policy on foods derived from new plant varieties in the Federal

Register on May 29, 1992 (57 FR 22984-23005). The FDA statement of

policy includes a discussion of FDA's authority for ensuring food

safety under the Federal Food, Drug, and Cosmetic Act, and provides

guidance to industry on the scientific considerations associated with

the development of foods derived from new plant varieties, including

those plants developed through the techniques of genetic engineering.

[[Page 3900]]

In accordance with Sec. 340.6(d) of the regulations, we are

publishing this notice to inform the public that APHIS will accept

written comments regarding the Petition for Determination of

Nonregulated Status from any interested person for a period of 60 days

from the date of this notice. The petition and any comments received

are available for public review, and copies of the petition may be

ordered (see the ADDRESSES section of this notice).

After the comment period closes, APHIS will review the data

submitted by the petitioner, all written comments received during the

comment period, and any other relevant information. Based on the

available information, APHIS will furnish a response to the petitioner,

either approving the petition in whole or in part, or denying the

petition. APHIS will then publish a notice in the Federal Register

announcing the regulatory status of Asgrow's yellow crookneck squash

line CZW-3 and the availability of APHIS' written decision.

Authority: 7 U.S.C. 150aa-150jj, 151-167, and 1622n; 31 U.S.C.

9701; 7 CFR 2.22, 2.80, and 371.2(c).

Done in Washington, DC, this 30th day of January 1996.

Terry L. Medley,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 96-2259 Filed 2-1-96; 8:45 am]

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