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

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Asgrow Seed Co.; Availability of Determination of Nonregulat



[Federal Register: June 27, 1996 (Volume 61, Number 125)]
[Notices]               

[Page 33484-33485]

>From the Federal Register Online via GPO Access [wais.access.gpo.gov]






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.






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: mkpeterson@aphis.usda.gov.



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]
BILLING CODE 3410-34-P

 
 

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