Agritope, Inc.; Availability of Environmental Assessment for Determination of Nonregulated Status

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 99-003-2]

Agritope, Inc.; Availability of Environmental Assessment for

Determination of Nonregulated Status

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that an environmental assessment

has been prepared for a proposed determination that certain cantaloupe

lines developed by Agritope, Inc., which have been genetically

engineered for altered fruit ripening, would no longer be considered

regulated articles under our regulations governing the introduction of

certain genetically engineered organisms. We are making this

environmental assessment available to the public for review and

comment.

DATES: We will consider all comments that we receive by November 26,

1999.

ADDRESSES: Please send an original and three copies of your comments

to: Docket No. 99-003-2, Regulatory Analysis and Development, PPD,

APHIS Suite 3C03, 4700 River Road, Unit 118, Riverdale, MD 20737-1238.

Please state that your comment refers to Docket No. 99-003-2.

You may read the petition for a determination of nonregulated

status submitted by Agritope, Inc., the environmental assessment, and

any comments we receive on this notice of availability 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. To be sure someone is there to help you, please call

(202) 690-2817 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Sivramiah Shantharam,

Biotechnology and Biological Analysis, PPQ, APHIS, 4700 River Road Unit

133, Suite 4B03, Riverdale, MD 20737-1236; (301) 734-4882. To obtain a

copy of the environmental assessment, contact Ms. Kay Peterson at (301)

734-4885; e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

On December 6, 1998, the Animal and Plant Health Inspection Service

(APHIS) received a petition (APHIS Petition No. 98-350-01p) from

Agritope, Inc. (Agritope), of Portland, OR, seeking a determination

that cantaloupe (Cucumis melo L.) lines designated as A and B, which

have been genetically engineered for delayed fruit ripening, do not

present a plant pest risk and, therefore, are not regulated articles

under APHIS' regulations in 7 CFR part 340.

On March 16, 1999, APHIS published a notice in the Federal Register

(64 FR 12926-12927, Docket No. 99-003-1) announcing that the Agritope

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 cantaloupe lines and food

products derived from them. In the notice, APHIS solicited written

comments from the public as to whether cantaloupe lines A and B posed a

plant pest risk. The comments were to have been received by APHIS on or

before May 17, 1999. APHIS received no comments on the subject petition

during the designated 60-day comment period.

Cantaloupe lines A and B have been genetically engineered to

contain a modified SAMase (sam-k) gene derived from Escherichia coli

bacteriophage T3. The sam-k gene encodes an S-adenosylmethionine

hydrolase enzyme capable of degrading and thus reducing S-

adenosylmethionine (SAM). Reduction of SAM results in lowered ethylene

production during fruit ripening in cantaloupe lines A and B and a

corresponding increase in the uniformity of ripening in the field. The

subject cantaloupe lines also contain and express the neomycin

phosphotransferase II (nptII) gene derived from E. coli. The nptII gene

was used as a selectable marker during the plant transformation

process. Expression of the added genes is controlled in part by gene

sequences from the plant pathogen Agrobacterium tumefaciens, and the A.

tumefaciens method was used to transfer the added genes into the

parental inbred cantaloupe lines.

Cantaloupe lines A and B are considered regulated articles under

APHIS' regulations in 7 CFR part 340 because they contain gene

sequences derived from a plant pathogen. Field tests of the subject

cantaloupe lines have been conducted under APHIS permits and

notifications since 1997 under confined conditions. If Agritope's

petition for a determination of nonregulated status were approved,

Agritope's cantaloupe lines A and B would no longer be considered

regulated articles under APHIS' regulations in 7 CFR part 340 and the

requirements pertaining to regulated articles under those regulations

would no longer apply to the subject cantaloupe lines or their progeny.

To provide the public with documentation of APHIS' review and

analysis of the environmental impacts and plant pest risk associated

with a determination of nonregulated status for Agritope's cantaloupe

lines A and B, an environmental assessment (EA) has been prepared. The

EA was prepared in accordance with: (1) The National Environmental

Policy Act of 1969 (NEPA), as amended (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).

Done in Washington, DC, this 20th day of October, 1999.

Bobby R. Acord,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 99-27920 Filed 10-25-99; 8:45 am]

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