[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
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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 
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 delegations of authority, filing of petitions and applications and agency 
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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