[Federal Register Volume 60, Number 171 (Tuesday, September 5, 1995)]
[Notices]
[Pages 46107-46108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21847]



 ========================================================================
 Notices
                                                 Federal Register
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 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.
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  Federal Register / Vol. 60, No. 171 / Tuesday, September 5, 1995 / 
Notices  


[[Page 46107]]


DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 95-041-2]


Availability of Determination of Nonregulated Status for 
Genetically Engineered Corn

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that the 
Monsanto Company's corn line designated as MON 80100 that has been 
genetically engineered for insect resistance is no longer considered a 
regulated article under our regulations governing the introduction of 
certain genetically engineered organisms. Our determination is based on 
our evaluation of data submitted by the Monsanto Company in its 
petition for a determination of nonregulated status, an analysis of 
other scientific data, and our review of comments received from the 
public in response to a previous notice announcing our receipt of the 
Monsanto Company petition. This notice also announces the availability 
of our written determination document and its associated environmental 
assessment and finding of no significant impact.

EFFECTIVE DATE: August 22, 1995.

ADDRESSES: The determination, an environmental assessment and finding 
of no significant impact, the petition, and all written comments 
received regarding the petition may be inspected 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. Persons wishing to inspect those documents are asked to call 
in advance of visiting at (202) 690-2817.

FOR FURTHER INFORMATION CONTACT: Dr. Ved Malik, Biotechnologist, 
Biotechnology Permits, BBEP, APHIS, 4700 River Road Unit 147, 
Riverdale, MD 20737-1237; (301) 734-7612. To obtain a copy of the 
determination or the environmental assessment and finding of no 
significant impact, contact Ms. Kay Peterson at (301) 734-7612.

SUPPLEMENTARY INFORMATION:

Background

    On April 3, 1995, the Animal and Plant Health Inspection Service 
(APHIS) received a petition (APHIS Petition No. 95-093-01p) from the 
Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination 
that corn designated as MON 80100 that has been genetically engineered 
for insect resistance does not present a plant pest risk and, 
therefore, is not a regulated article under APHIS' regulations in 7 CFR 
part 340.
    On June 7, 1995, APHIS published a notice in the Federal Register 
(60 FR 30061-30062, Docket No. 95-041-1) announcing that the Monsanto 
petition had been received and was available for public review. The 
notice also discussed the role of APHIS, the Environmental Protection 
Agency (EPA), and the Food and Drug Administration in regulating the 
subject corn line and food products derived from it. In the notice, 
APHIS solicited written comments from the public as to whether corn 
line MON 80100 posed a plant pest risk. The comments were to have been 
received by APHIS on or before August 7, 1995.
    APHIS received nine comments on the Monsanto petition, from 
farmers, industry, universities, a growers association, and a State 
department of agriculture. All the commenters expressed support for the 
subject petition.
Analysis

    Monsanto's corn line MON 80100 has been genetically engineered to 
express a CryCIA(b) insect control protein derived from the common soil 
bacterium Bacillus thuringiensis subsp. kurstaki (Btk). Btk proteins 
are effective against certain lepidopteran insects, including European 
corn borer (ECB), a major corn pest. Results of field tests conducted 
by Monsanto under permits and notifications granted by APHIS and under 
an experimental use permit obtained from EPA indicate that corn plants 
producing the CryCIA(b) protein were protected throughout the growing 
season from leaf and stalk feeding damage caused by ECB. In addition to 
expressing the CryCIA(b) protein, the plants also express the 
selectable marker enzyme 5-enolpyruvylshikimate-3-phosphate synthase 
(CP4 EPSPS). The cryIA(b) gene and the CP4 EPSPS marker gene were 
introduced into the subject corn line by a particle acceleration method 
and their expression is under the control of the enhanced 35S promoter 
derived from the plant pathogen cauliflower mosaic virus.
    The subject corn line has been considered a regulated article under 
APHIS' regulations in 7 CFR part 340 because it contains certain gene 
sequences derived from plant-pathogenic sources. However, evaluation of 
field data reports from field tests of corn line MON 80100 conducted 
since 1992 indicates that there were no deleterious effects on plants, 
nontarget organisms, or the environment as a result of the subject corn 
plants' release into the environment.

Determination

    Based on its analysis of the data submitted by Monsanto and a 
review of other scientific data, comments received from the public, and 
field tests of the subject corn, APHIS has determined that corn line 
MON 80100: (1) Exhibits no plant pathogenic properties; (2) is no more 
likely to become a weed than lepidopteran-insect-resistant corn 
developed through traditional breeding techniques; (3) is unlikely to 
increase the weediness potential of any other cultivated plant or 
native wild species with which it can interbreed; (4) should not cause 
damage to raw or processed agricultural commodities; (5) is unlikely to 
harm organisms beneficial to the agricultural ecosystem; and (6) when 
cultivated, should not reduce the ability to control insects in corn 
and other crops. APHIS has also concluded that there is a reasonable 
certainty that new varieties developed from corn line MON 80100 will 
not exhibit new plant pest properties, i.e., properties substantially 
different from any observed in the field tested corn line MON 80100, or 
those observed in corn in traditional breeding programs. 

[[Page 46108]]

    The effect of this determination is that an insect-resistant corn 
line designated as MON 80100 is no longer considered a regulated 
article under APHIS' regulations in 7 CFR part 340. Therefore, the 
notification requirements pertaining to regulated articles under those 
regulations no longer apply to the field testing, importation, or 
interstate movement of corn line MON 80100 or its progeny. However, the 
importation of the subject corn line or seed capable of propagation is 
still subject to the restrictions found in APHIS' foreign quarantine 
notices in 7 CFR part 319.

National Environmental Policy Act

    An environmental assessment (EA) has been 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)(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; 60 FR 6000-6005). Based on that EA, APHIS 
has reached a finding of no significant impact (FONSI) with regard to 
its determination that the subject corn line 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 28th day of August 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 95-21847 Filed 9-1-95; 8:45 am]
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