[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
________________________________________________________________________
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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