[Federal Register Volume 61, Number 87 (Friday, May 3, 1996)]
[Notices]
[Pages 19904-19905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11016]



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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 96-024-1]


Cornell University and University of Hawaii; Receipt of Petition 
for 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 that the Animal and Plant Health 
Inspection Service has received a petition from Cornell University and 
the University of Hawaii seeking a determination of nonregulated status 
for papaya lines designated as 55-1 and 63-1 that have 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 these papaya 
lines present a plant pest risk.

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

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 96-024-1, 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. 96-024-1. 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. Keith Reding, 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; e-mail: 
[email protected].

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 February 20, 1996, APHIS received a petition (APHIS Petition No. 
96-051-01p) from Cornell University, Geneva, NY, and the University of 
Hawaii, Honolulu, HI (Cornell/Hawaii), requesting a determination of

[[Page 19905]]

nonregulated status under 7 CFR part 340 for papaya lines designated as 
55-1 and 63-1 that have been genetically engineered to contain genes 
that confer virus resistance. The Cornell/Hawaii petition states that 
papaya lines 55-1 and 63-1 should not be regulated by APHIS because 
they do not present a plant pest risk.
    As described in the petition, papaya (Carica papaya) lines 55-1 and 
63-1 have been genetically engineered to express the coat protein gene 
of papaya ringspot virus (PRV), strain HA5-1, which confers resistance 
to PRV. Both the subject papaya lines also contain the selectable 
marker gene nptII, and line 55-1 contains the gus selectable marker 
gene, in addition. Expression of the added genes is controlled by the 
untranslated 3' region of the nopaline synthase gene from Agrobacterium 
tumefaciens and the 35S promoter and 35S terminator from the plant 
pathogen cauliflower mosaic virus (CAMV). In developing lines 55-1 and 
63-1, the microprojectile process was used to transfer the introduced 
gene sequences into the gynodioecious cultivar Sunset. The Sunset 
cultivar is of commercial importance in Hawaii, where PRV is a serious 
plant pest of papaya.
    The subject papaya lines have been considered regulated articles 
under the regulations in 7 CFR part 340 because they contain gene 
sequences from the plant pathogens mentioned above. The subject papaya 
lines have been evaluated in field trials conducted under APHIS 
permits. In the process of reviewing the applications for field trials 
of lines 55-1 and 63-1, 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.
    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 the Cornell/Hawaii papaya lines 55-
1 and 63-1 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 29th day of April 1996.
Lonnie J. King,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-11016 Filed 5-2-96; 8:45 am]
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