[Federal Register: June 21, 2000 (Volume 65, Number 120)]
[Notices]
[Page 38494-38495]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jn00-28]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 00-026-1]
Monsanto Co.; Availability of Environmental Assessment for
Extension of Determination of Nonregulated Status for Corn Genetically
Engineered for Glyphosate Herbicide Tolerance
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 decision to extend to one additional
corn line our determination that a corn line developed by Monsanto
Company, which has been genetically engineered for tolerance to the
herbicide glyphosate, is no longer considered a regulated article 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 July 21, 2000.
ADDRESSES: Please send your comment and three copies to: Docket No. 00-
026-1, 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. 00-026-
1.
You may read the extension request and the environmental assessment
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. John Turner, Biotechnology
Assessments Section, Permits and Risk Assessments, PPQ, APHIS, Suite
5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-
8365. To obtain a copy of the extension request or the environmental
assessment, contact Ms. Kay Peterson at (301) 734-4885; e-mail:
kay.peterson@usda.gov.
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,
[[Page 38495]]
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. Further, the regulations in Sec. 340.6(e)(2) provide that
a person may request that APHIS extend a determination of nonregulated
status to other organisms. Such a request must include information to
establish the similarity of the antecedent organism and the regulated
article in question.
Background
On January 11, 2000, APHIS received a request for an extension of a
determination of nonregulated status (APHIS No. 00-11-01p) from
Monsanto Company (Monsanto) of St. Louis, MO, for a corn line
designated as Roundup Ready corn line NK603 (NK603), which
has been genetically engineered for tolerance to the herbicide
glyphosate. The Monsanto request seeks an extension of a determination
of nonregulated status issued for Roundup Ready corn line
GA21 (GA21) in response to APHIS petition number 97-099-01p (62 FR
64350-64351, December 5, 1997, Docket No. 97-052-2). Based on the
similarity of NK603 to GA21, the antecedent organism, Monsanto requests
a determination that glyphosate-tolerant corn line NK603 does not
present a plant pest risk and, therefore, is not a regulated article
under APHIS' regulations in 7 CFR part 340.
Analysis
Like the antecedent organism, corn line NK603 has been genetically
engineered to contain an enzyme, 5-enolpyruvylshikimate-3-phosphate
synthase (EPSPS), that imparts tolerance to the herbicide glyphosate.
However, corn was the source of the EPSPS enzyme in the antecedent
organism, while the EPSPS enzyme in NK603 was derived from
Agrobacterium sp. strain CP4. The subject corn line and the antecedent
organism were developed through use of the particle acceleration
method, and expression of the added genes in NK603 and the antecedent
organism is controlled in part by gene sequences derived from the plant
pathogen A. tumefaciens.
Corn line NK603 and the antecedent organism were genetically
engineered using the same transformation method and contain a
functionally equivalent enzyme that makes the plants tolerant to the
herbicide glyphosate. Accordingly, we have determined that corn line
NK603 is similar to the antecedent organism in APHIS petition number
97-099-01p, and we are proposing that this line should no longer be
regulated under the regulations in 7 CFR part 340.
The subject corn line has been considered a regulated article under
APHIS' regulations in 7 CFR part 340 because it contains gene sequences
derived from plant pathogens. However, evaluation of field data reports
from field tests of NK603 conducted under APHIS notifications since
1997 indicates that there were no deleterious effects on plants,
nontarget organisms, or the environment as a result of its
environmental release.
Should APHIS approve Monsanto's request for an extension of a
determination of nonregulated status, corn line NK603 would no longer
be considered a regulated article under APHIS' regulations in 7 CFR
part 340. Therefore, the requirements pertaining to regulated articles
under those regulations would no longer apply to the field testing,
importation, or interstate movement of the subject corn line or its
progeny.
National Environmental Policy Act
An environmental assessment (EA) has been prepared to examine any
potential environmental impacts associated with this proposed extension
of a determination of nonregulated status. 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). Copies of Monsanto's extension request and
the EA are available upon request from the individual listed under FOR
FURTHER INFORMATION CONTACT.
Done in Washington, DC, this 15th day of June 2000.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-15622 Filed 6-20-00; 8:45 am]
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