[Federal Register Volume 65, Number 120 (Wednesday, June 21, 2000)]
[Notices]
[Pages 38494-38495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15622]


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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: 
[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,

[[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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