[Federal Register Volume 61, Number 180 (Monday, September 16, 1996)]
[Notices]
[Pages 48663-48664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23663]


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 Notices
                                                 Federal Register
 ________________________________________________________________________
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
 appearing in this section.
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  Federal Register / Vol. 61, No. 180 / Monday, September 16, 1996 / 
Notices  

[[Page 48663]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 96-024-2]


Cornell University and University of Hawaii; Availability of 
Determination of Nonregulated Status for Papaya Lines 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 certain 
papaya lines developed by Cornell University and the University of 
Hawaii that have been genetically engineered for virus resistance 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 Cornell 
University and the University of Hawaii in their 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 Cornell University 
and University of Hawaii 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: September 5, 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. David Heron, 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 February 20, 1996, the Animal and Plant Health Inspection 
Service (APHIS) received a petition (APHIS Petition No. 96-051-01p) 
from Cornell University, Geneva, NY, and the University of Hawaii, 
Honolulu, HI, (Cornell/Hawaii) seeking a determination that papaya 
lines designated as 55-1 and 63-1 that have been genetically engineered 
to contain genes that confer virus resistance do not present a plant 
pest risk and, therefore, are not regulated articles under APHIS' 
regulations in 7 CFR part 340.
    On May 3, 1996, APHIS published a notice in the Federal Register 
(61 FR 19904-19905, Docket No. 96-024-1) announcing that the Cornell/
Hawaii 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 papaya lines and food products 
derived from them. In the notice, APHIS solicited written comments from 
the public as to whether these papaya lines pose a plant pest risk. The 
comments were to have been received by APHIS on or before July 2, 1996. 
During the designated 60-day comment period, APHIS received 18 comments 
on the subject petition from universities; papaya growers, processors, 
and shippers; a State agricultural experiment station; a papaya 
industry association; an office of the cooperative extension service; 
and a State department of agriculture. All of the comments were 
favorable to the petition.

Analysis

    Papaya lines 55-1 and 63-1 have been genetically engineered to 
express the coat protein gene from papaya ringspot virus (PRV), strain 
HA 5-1, which confers resistance to PRV. Both the subject papaya lines 
contain the nptII selectable marker gene, and line 55-1 also contains 
the gus selectable marker gene. Expression of the added genes is 
controlled by the nopaline synthase promoter from Agrobacterium 
tumefaciens and by the 35S promoter and terminator from the plant 
pathogen cauliflower mosaic virus. The genes used to develop lines 55-1 
and 63-1 were transferred into the parental cultivar Sunset through use 
of the microprojectile process.
    The subject papaya lines have been considered regulated articles 
under APHIS' regulations in 7 CFR part 340 because they contain gene 
sequences derived from plant pathogens. However, contained field trials 
of papaya lines 55-1 and 63-1 conducted under APHIS permits indicate 
that there were no deleterious effects on plants, nontarget organisms, 
or the environment as a result of the field testing of these papaya 
lines.

Determination

    Based on its analysis of the data submitted by Cornell/Hawaii and a 
review of other scientific data, comments received, and field tests of 
the subject papaya lines, APHIS has determined that papaya lines 55-1 
and 63-1: (1) Exhibit no plant pathogenic properties; (2) will not 
increase the likelihood of the emergence of new plant viruses; (3) are 
no more likely to become weeds than papaya developed by traditional 
breeding techniques; (4) will not increase the weediness potential for 
any other cultivated or wild species with which they can interbreed; 
(5) will not harm threatened or endangered species or other organisms, 
such as bees, that are beneficial to agriculture; and (6) will not 
cause damage to processed agricultural commodities. Therefore, APHIS 
has concluded that the subject papaya lines and any progeny derived 
from hybrid crosses with other nontransformed papaya varieties will be 
as safe to grow as papaya in traditional breeding programs that are not 
subject to regulation under 7 CFR part 340.
    The effect of this determination is that Cornell/Hawaii's papaya 
lines 55-1 and 63-1 are no longer considered regulated articles under 
APHIS' regulations in 7 CFR part 340. Therefore, the requirements 
pertaining to regulated

[[Page 48664]]

articles under those regulations no longer apply to the field testing, 
importation, or interstate movement of the subject papaya lines or 
their progeny. However, importation of the subject papaya lines 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, as amended (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 Cornell/Hawaii's papaya lines 55-1 and 63-1 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 11th day of September 1996.
A. Strating,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-23663 Filed 9-13-96; 8:45 am]
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