[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]
========================================================================
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.
========================================================================
Federal Register / Vol. 64, No. 80 / Tuesday, April 27, 1999 /
Notices
[[Page 22595]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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