[Federal Register Volume 60, Number 119 (Wednesday, June 21, 1995)]
[Notices]
[Pages 32299-32300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15112]



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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 95-007-2]


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 Ciba 
Seeds' corn designated as Event 176 Corn 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 Ciba Seeds 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 Ciba Seeds 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 17, 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 November 15, 1994, the Animal and Plant Health Inspection 
Service (APHIS) received a petition (APHIS Petition No. 94-319-01p) 
from Ciba Seeds of Research Triangle Park, NC, seeking a determination 
that corn designated as Event 176 Corn 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 February 21, 1995, APHIS published a notice in the Federal 
Register (60 FR 9656-9657, Docket No. 95-007-1) announcing receipt of 
the Ciba Seeds petition and announcing that the petition 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 24, 1995.
    APHIS received 37 comments on the Ciba Seeds petition. Comments 
were received from farm-related businesses, universities, national and 
State associations, farmers cooperatives, farmers, individuals, a 
cooperative extension research center, and a member of the U.S. House 
of Representatives. Thirty-five commenters either expressed support for 
the Event [[Page 32300]] 176 Corn petition for nonregulated status or 
endorsed the concept of an insect-resistant corn variety without 
specific reference to the petition. Two of the 37 commenters expressed 
reservations about a determination in favor of the subject petition 
based on their concerns about resistance management. APHIS has provided 
a summary and discussion of the comments in the determination document, 
which is available upon request from the individual listed under FOR 
FURTHER INFORMATION CONTACT.

Analysis

    Ciba Seeds' Event 176 Corn has been genetically engineered to 
express an insect control protein representing a truncated form of the 
CryIA(b) protein that occurs naturally in Bacillus thuringiensis subsp. 
kurstaki (Btk), a common gram-positive soil bacterium. Btk proteins are 
very effective against certain lepidopteran insects, including European 
corn borer (ECB). Event 176 Corn has been modified to produce the 
CryIA(b) protein in green tissues and pollen cells. During field tests 
of Event 176 Corn, ECB infestations were significantly reduced as 
compared to the nontransgenic control plants.
    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 plant-pathogenic sources. However, evaluation of 
field data reports from field tests of the subject corn 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 Ciba Seeds and a 
review of other scientific data, comments received from the public, and 
field tests of the subject corn, APHIS has determined that Event 176 
Corn: (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 Event 176 Corn will not 
exhibit new plant pest properties, i.e., properties substantially 
different from any observed in the field tested Event 176 Corn, or 
those observed in corn in traditional breeding programs.
    The effect of this determination is that insect-resistant corn 
designated as Event 176 Corn 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 the subject corn or its progeny. 
However, the importation of the subject corn or seeds 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 the subject corn 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 13th day of June 1995.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-15112 Filed 6-20-95; 8:45 am]
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