[Federal Register Volume 64, Number 80 (Tuesday, April 27, 1999)]
[Notices]
[Pages 22595-22596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10510]


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 Notices
                                                 Federal Register
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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 
 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 
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  Federal Register / Vol. 64, No. 80 / Tuesday, April 27, 1999 / 
Notices  

[[Page 22595]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 98-126-2]


AgrEvo USA Co.; Availability of Determination of Nonregulated 
Status for Rice Genetically Engineered for 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 certain 
rice transformation events developed by AgrEvo USA Company, which have 
been genetically engineered for tolerance to the herbicide glufosinate, 
are no longer considered regulated articles 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, our 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: April 15, 1999.

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 to facilitate entry into the 
reading room.

FOR FURTHER INFORMATION CONTACT: Dr. David Heron, Biotechnology and 
Biological Analysis, PPQ, APHIS, 4700 River Road Unit 147, Riverdale, 
MD 20737-1236; (301) 734-5141. 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 November 25, 1998, the Animal and Plant Health Inspection 
Service (APHIS) received a petition (APHIS Petition No. 98-329-01p) 
from AgrEvo USA Company (AgrEvo) of Wilmington, DE, seeking a 
determination that rice (Oryza sativa L.) designated as Liberty 
Link Rice Transformation Events LLRICE06 and LLRICE62 (rice 
transformation events LLRICE06 and LLRICE62), which have been 
genetically engineered for tolerance to the herbicide glufosinate, do 
not present a plant pest risk and, therefore, are not regulated 
articles under APHIS' regulations in 7 CFR part 340.
    On January 26, 1999, APHIS published a notice in the Federal 
Register (64 FR 3924-3925, Docket No. 98-126-1) 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 rice transformation events and food products derived from 
them. In the notice, APHIS solicited written comments from the public 
as to whether rice transformation events LLRICE06 and LLRICE62 posed a 
plant pest risk. The comments were to have been received by APHIS on or 
before March 29, 1999. APHIS received four comments on the subject 
petition during the designated 60-day comment period from the 
following: a farmers rice cooperative; a State rice growers 
association; a State rice research board; and a State university rice 
research station. All of the comments were in support of the subject 
petition.

Analysis

    Rice transformation events LLRICE06 and LLRICE62 have been 
genetically engineered to contain a bar gene derived from Streptomyces 
hygroscopicus strain HP632. The bar gene encodes the enzyme 
phosphinothricin-N-acetyltransferase (PAT), which confers tolerance to 
the herbicide glufosinate. Expression of the bar gene is controlled by 
35S promoter and terminator sequences derived from the plant pathogen 
cauliflower mosaic virus. The direct gene transfer method was used to 
transfer the added genes into the parental rice varieties M202 
(LLRICE06) and Bengal (LLRICE62).
    The subject rice transformation events have been considered 
regulated articles under APHIS' regulations in 7 CFR part 340 because 
they contain gene sequences derived from a plant pathogen. However, 
evaluation of field data reports from field tests of these rice 
transformation events conducted under APHIS notifications since 1997 
indicates that there were no deleterious effects on plants, nontarget 
organisms, or the environment as a result of the environmental release 
of rice transformation events LLRICE06 and LLRICE62.

Determination

    Based on its analysis of the data submitted by AgrEvo, and a review 
of other scientific data and field tests of the subject rice 
transformation events, APHIS has determined that rice transformation 
events LLRICE06 and LLRICE62: (1) Exhibit no plant pathogenic 
properties; (2) are no more likely to become weeds than rice varieties 
developed by traditional plant breeding; (3) are unlikely to increase 
the weediness potential for any other cultivated or wild species with 
which they can interbreed; (4) will not harm threatened or endangered 
species or organisms that are recognized as beneficial to agriculture; 
and (5) will not cause damage to raw or processed agricultural 
commodities. Therefore, APHIS has concluded that the subject rice 
transformation events and any progeny derived from hybrid crosses with 
other rice varieties will be as safe to grow as rice in traditional 
breeding programs that are not subject to regulation under 7 CFR part 
340.
    The effect of this determination is that AgrEvo's rice 
transformation events LLRICE06 and LLRICE62 are no longer considered 
regulated articles under APHIS' regulations in 7 CFR part 340.

[[Page 22596]]

Therefore, the requirements pertaining to regulated articles under 
those regulations no longer apply to the subject rice transformation 
events or their progeny. However, importation of the subject rice 
transformation events 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 (NEPA), as amended (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 rice transformation events LLRICE06 and 
LLRICE62 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 20th day of April 1999.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-10510 Filed 4-26-99; 8:45 am]
BILLING CODE 3410-34-P