[Federal Register Volume 60, Number 134 (Thursday, July 13, 1995)]
[Notices]
[Pages 36095-36096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17079]
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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.
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Federal Register / Vol. 60, No. 134 / Thursday, July 13, 1995 /
Notices
[[Page 36095]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 95-011-2]
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 corn
developed by AgrEvo USA Company designated as Glufosinate Resistant
Corn Transformation Events T14 and T25 that has been genetically
engineered for tolerance to the herbicide glufosinate 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 AgrEvo
USA 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 AgrEvo USA 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: June 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. David Heron, 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 December 23, 1994, the Animal and Plant Health Inspection
Service (APHIS) received a petition (APHIS Petition No. 94-357-01p)
from AgrEvo USA Company (AgrEvo) of Wilmington, DE, seeking a
determination that corn designated as Glufosinate Resistant Corn (GRC)
Transformation Events T14 and T25 (GRC Events T14 and T25) that has
been genetically engineered for tolerance to the herbicide glufosinate
does not present a plant pest risk and, therefore, is not a regulated
article under APHIS' regulations in 7 CFR part 340.
On February 27, 1995, APHIS published a notice in the Federal
Register (60 FR 10537-10538, Docket No. 95-011-1) announcing that the
AgrEvo petition had been received and was available for public review.
The notice also discussed the role of APHIS, the Environmental
Protection Agency, and the Food and Drug Administration in regulating
the subject corn and food products derived from it. In the notice,
APHIS solicited written comments from the public as to whether the
subject corn posed a plant pest risk. The comments were to have been
received by APHIS on or before April 28, 1995.
APHIS received nine comments on the AgrEvo petition. Comments were
received from associations, universities, seed companies, and a State
department of agriculture. All the commenters supported the AgrEvo
petition for nonregulated status for the subject corn.
Analysis
GRC Events T14 and T25 contain a gene that encodes the enzyme
phosphinothricin-N-acetyltransferase (PAT). The PAT enzyme catalyzes
the conversion of L-phosphinothricin, the active ingredient in
glufosinate-ammonium, to an inactive form, thereby conferring
resistance to herbicides in the phosphinothricin class. The pat gene in
GRC Events T14 and T25 is a synthetic version of the gene isolated from
the bacterium Streptomyces viridochromogenes. Expression of the pat
gene is regulated by the 35S promoter and the 35S terminator derived
from the plant pathogen cauliflower mosaic virus. The subject corn has
been considered a regulated article under APHIS' regulations in 7 CFR
part 340 because it contains certain gene sequences derived from a
plant pathogen. However, evaluation of field data reports from field
tests of the subject corn conducted under APHIS permits or
notifications since 1992 indicate 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 AgrEvo and a review
of other scientific data, comments received from the public, and field
tests of the subject corn, APHIS has determined that GRC Events T14 and
T25: (1) Exhibit no plant pathogenic properties; (2) are no more likely
to become weeds than other corn developed by traditional breeding
techniques; (3) are unlikely to increase the weediness potential for
any other cultivated or wild species with which they can interbreed;
(4) will not harm other organisms, such as bees, that are beneficial to
agriculture; and (5) should not cause damage to processed agricultural
commodities. APHIS has also concluded that there is no reason to
believe that new progeny corn varieties derived from GRC Events T14 and
T25 will exhibit new plant pest properties, i.e., properties
substantially different from any observed for the GRC Events T14 and
T25 already field tested or those observed for corn in traditional
breeding programs.
The effect of this determination is that corn designated as GRC
Events T14 and T25 is no longer considered a regulated article under
APHIS' regulations in 7 CFR part 340. Therefore, the permit and
notification requirements pertaining to regulated articles under those
regulations no longer apply to the field testing, importation, or
interstate movement of GRC Events T14 and T25 or their progeny.
However, the importation of the subject corn or seeds
[[Page 36096]]
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). Based on that EA, APHIS has reached a
finding of no significant impact (FONSI) with regard to its
determination that GRC Events T14 and T25 and lines developed from them
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 6th day of July 1995.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-17079 Filed 7-13-95; 8:45 am]
BILLING CODE 3410-34-P
