[Federal Register Volume 64, Number 206 (Tuesday, October 26, 1999)]
[Notices]
[Page 57625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27920]
========================================================================
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.
========================================================================
Federal Register / Vol. 64, No. 206 / Tuesday, October 26, 1999 /
Notices
[[Page 57625]]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: kay.peterson@usda.gov.
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]
BILLING CODE 3410-34-P
