Cornell University and University of Hawaii; Receipt of Petition for Determination of Nonregulated Status for Papaya Lines Genetically Engineered for Virus Resistance

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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