[Federal Register Volume 63, Number 94 (Friday, May 15, 1998)]
[Notices]
[Pages 27041-27042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13006]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 97-119-2]


AgrEvo USA Co.; Availability of Determination of Nonregulated 
Status for Corn Genetically Engineered for Insect Resistance and 
Glufosinate Herbicide Tolerance

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 
AgrEvo USA Company's corn line designated as Transformation Event CBH-
351, which has been genetically engineered for insect resistance and 
glufosinate herbicide tolerance, 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's 
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: May 8, 1998.

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,

[[Page 27042]]

except holidays. Persons wishing to inspect those documents are 
requested to call before visiting on (202) 690-2817 to facilitate entry 
into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Susan Koehler, Biotechnology and 
Biological Analysis, PPQ, APHIS, 4700 River Road Unit 147, Riverdale, 
MD 20737-1236; (301) 734-4886. To obtain a copy of the determination or 
the environmental assessment and finding of no significant impact, 
contact Ms. Kay Peterson at (301) 734-4885; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    On September 22, 1997, the Animal and Plant Health Inspection 
Service (APHIS) received a petition (APHIS Petition No. 97-265-01p) 
from AgrEvo USA Company (AgrEvo) of Wilmington, DE, seeking a 
determination that a corn line designated as Transformation Event CBH-
351 (event CBH-351), which has been genetically engineered for insect 
resistance and glufosinate herbicide tolerance, does not present a 
plant pest risk and, therefore, is not a regulated article under APHIS' 
regulations in 7 CFR part 340.
    On February 23, 1998, APHIS published a notice in the Federal 
Register (63 FR 8897-8898, Docket No. 97-119-1) 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 line and food products derived from it. In the notice, 
APHIS solicited written comments from the public as to whether this 
corn line posed a plant pest risk. The comments were to have been 
received by APHIS on or before April 24, 1998. During the designated 
60-day comment period, APHIS received 2,271 form letters from farmers 
expressing support for the subject petition, and a comment letter from 
a research entomologist at a research unit of the U.S. Department of 
Agriculture's Agricultural Research Service providing data and 
information that event CBH-351 corn effectively controls European corn 
borer (ECB) during all corn developmental stages.

Analysis

    Corn event CBH-351 has been genetically engineered to express a 
Cry9C insect control protein derived from the common soil bacterium 
Bacillus thuringiensis subsp. tolworthi (Bt tolworthi). The petitioner 
stated that the Cry9C protein is effective in protecting the subject 
corn line from damage caused by ECB larvae throughout the growing 
season. The subject corn line also expresses the bar gene derived from 
the bacterium Streptomyces hygroscopicus. The bar gene encodes the 
phosphinothricin acetyltransferase (PAT) enzyme, which, when introduced 
into the plant cell, confers tolerance to the herbicide glufosinate. 
The particle bombardment method was used to transfer the added genes 
into the recipient inbred corn line (PA91 x H99) x H99, and their 
expression is controlled in part by gene sequences derived from the 
plant pathogens Agrobacterium tumefaciens and cauliflower mosaic virus. 
While the subject corn line contains the bla selectable marker gene, 
which is normally expressed in bacteria, tests indicate that this gene 
is not expressed in the plant.
    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 plant pathogens. However, evaluation of field data reports 
from field tests of the corn conducted under APHIS notifications since 
1995 indicates that there were no deleterious effects on plants, 
nontarget organisms, or the environment as a result of the 
environmental release of corn event CBH-351.

Determination

    Based on its analysis of the data submitted by AgrEvo, a review of 
other scientific data and field tests of the subject corn line, and an 
analysis of comments from the public on the subject petition, APHIS has 
determined that corn event CBH-351: (1) Exhibits no plant pathogenic 
properties; (2) is no more likely to become a weed than corn lines 
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; (5) will not harm threatened or 
endangered species or other organisms, such as bees, that are 
beneficial to agriculture; and (6) should not reduce the ability to 
control insects and weeds in corn or other crops when cultivated. 
Therefore, APHIS has concluded that the subject corn line 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.
    The effect of this determination is that AgrEvo's corn event CBH-
351 is no longer 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 or its progeny. 
However, importation of corn event CBH-351 or 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 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, as amended (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 AgrEvo's corn event CBH-351 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 11th day of May 1998.
Charles P. Schwalbe,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-13006 Filed 5-14-98; 8:45 am]
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