[Federal Register Volume 65, Number 169 (Wednesday, August 30, 2000)]
[Notices]
[Pages 52693-52694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22097]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 00-026-2]


Monsanto Co.; 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 of our 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. Our decision is based on our 
evaluation of data submitted by Monsanto Company in its request for an 
extension of a determination of nonregulated status, an analysis of 
other scientific data, and comments received from the public in 
response to a previous notice. This notice also announces the 
availability of our finding of no significant impact.

EFFECTIVE DATE: September 29, 2000.

ADDRESSES: You may read the extension request, the environmental 
assessment and finding of no significant impact, and all comments 
received in our reading room. The reading room is located in room 1141 
of the USDA South Building, 14th Street and Independence Avenue, SW., 
Washington, DC. Normal reading room hours are 8 a.m. to 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 and finding of no significant impact, contact Ms. Kay 
Peterson at (301) 734-4885; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340,

[[Page 52694]]

``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. 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. 00-011-01p) 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. Monsanto requested an extension of a determination of 
nonregulated status issued previously for Roundup Ready corn line GA21 
(GA21), 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 requested 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.
    On June 21, 2000, APHIS published a notice in the Federal Register 
(65 FR 38494-38495, Docket No. 00-026-1) announcing that an 
environmental assessment (EA) for Monsanto's extension request had been 
prepared and was available for public comment. During the designated 
30-day public comment period, APHIS received a total of two comments, 
both of which were from university colleges of agriculture, and both of 
which were in support of the subject extension request. The two 
commenters supporting nonregulated status for corn line NK603 stressed, 
among other things, its agronomic suitability, the low probability of 
introgression of the herbicide tolerance trait due to the absence of 
sexually compatible wild relatives, and the environmental benefits of 
glyphosate use in no-till and minimum tillage systems. The EA and the 
finding of no significant impact (FONSI) are available from the person 
listed under FOR FURTHER INFORMATION CONTACT.

Analysis

    Like the antecedent organism, corn line NK603 has been genetically 
engineered to express an enzyme, 5-enolpyruvylshikimate-3-phosphate 
synthase (EPSPS), that imparts tolerance to the herbicide glyphosate. 
Corn was the source of the EPSPS enzyme in the antecedent organism, 
while a functionally equivalent 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 Agrobacterium tumefaciens.
    Corn line NK603 and the antecedent organism were genetically 
engineered using the same transformation method and contain a 
functionally equivalent enzyme which makes the plants tolerant to the 
herbicide glyphosate. Accordingly, we have determined that NK603 is 
similar to the antecedent organism GA21 in APHIS petition 97-099-01p 
and, therefore, 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 a plant pathogen. 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.

Determination

    Based on an analysis of the data submitted by Monsanto, a review of 
other scientific data, and field tests of the subject corn line, APHIS 
has determined that corn line NK603: (1) Exhibits no plant pathogenic 
properties; (2) is no more likely to become a weed than herbicide-
tolerant corn varieties developed by traditional breeding techniques; 
(3) is unlikely to increase the weediness potential for any other 
cultivated or wild species with which it can interbreed; (4) will not 
cause damage to raw or processed agricultural commodities; and (5) will 
not harm threatened or endangered species or other organisms, such as 
bees, that are beneficial to agriculture. Therefore, APHIS has 
concluded that corn line NK603 and any progeny derived from crosses 
with other corn varieties will be as safe to grow as corn that is not 
subject to regulation under 7 CFR part 340.
    Because APHIS has determined that the subject corn line does not 
present a plant pest risk based on its similarity to the antecedent 
organism, Monsanto's corn line NK603 will 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 no longer apply to the field testing, importation, or 
interstate movement of the subject corn line or its progeny. However, 
importation of corn line NK603 and seeds capable of propagation are 
still subject to the restrictions found in APHIS' foreign quarantine 
notices in 7 CFR part 319. National Environmental Policy Act.
    An EA was prepared to examine the potential environmental impacts 
associated with this determination. 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). Based on that EA, APHIS has reached a FONSI with regard to 
its determination that Monsanto's corn line NK603 and lines developed 
from it are no longer regulated articles under its regulations in 7 CFR 
part 340. Copies of the EA and the FONSI are available upon request 
from the individual listed under FOR FURTHER INFORMATION CONTACT.

    Done in Washington, DC, this 24th day of August 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-22097 Filed 8-29-00; 8:45 am]
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