[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
________________________________________________________________________
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. 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.
-----------------------------------------------------------------------
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]
BILLING CODE 3410-34-P
