PMEP Home Page --> Pesticide Active Ingredient Information --> Herbicides and Growth Regulators --> fatty alcohol to monuron (Telvar) --> glufosinate-ammonium (Rely, Finale) --> glufosinate-ammonium (Rely, Finale) Availability of Determination of Nonregulated Status 4/98

glufosinate-ammonium (Rely, Finale) Availability of Determination of Nonregulated Status 4/98

[Federal Register: May 7, 1998 (Volume 63, Number 88)]
[Notices]               
[Page 25194-25195]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07my98-29]

-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 97-130-2]

 
AgrEvo USA Co.; Availability of Determination of Nonregulated 
Status for Sugar Beet 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 AgrEvo 
USA Company's sugar beet designated as Transformation Event T120-7, 
which 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 and an analysis of other 
scientific data. 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 28, 1998.

ADDRESSES: The determination, an environmental assessment and finding 
of no significant impact, and 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. Ved Malik, Biotechnology and 
Biological Analysis, PPQ, APHIS, 4700 River Road Unit 147, Riverdale, 
MD 20737-1236; (301) 734-6774. 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: 
mkpeterson@aphis.usda.gov.

SUPPLEMENTARY INFORMATION:

Background

    On December 2, 1997, the Animal and Plant Health Inspection Service 
(APHIS) received a petition (APHIS Petition No. 97-336-01p) from AgrEvo 
USA Company (AgrEvo) of Wilmington, DE, seeking a determination that 
sugar beet

[[Page 25195]]

(Beta vulgaris L.) designated as Transformation Event T120-7 (event 
T120-7), which 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 6, 1998, APHIS published a notice in the Federal 
Register (63 FR 6148-6149, Docket No. 97-130-1) 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 sugar beet and food products derived from it. In the 
notice, APHIS solicited written comments from the public as to whether 
this sugar beet posed a plant pest risk. The comments were to have been 
received by APHIS on or before April 7, 1998. APHIS received no 
comments on the subject petition during the designated 60-day comment 
period. Analysis
    Event T120-7 sugar beet has been genetically engineered to contain 
a synthetic version of the pat gene derived from Streptomyces 
viridochromogenes. The pat gene encodes the enzyme phosphinothricin-N-
acetyltransferase (PAT), which confers tolerance to the herbicide 
glufosinate. Expression of the pat gene is controlled by 35S promoter 
and terminator sequences derived from the plant pathogen cauliflower 
mosaic virus. Event T120-7 sugar beet also contains the aph(3')II or 
nptII marker gene used in plant transformation.
    Expression of the nptII gene is controlled by gene sequences 
derived from Agrobacterium tumefaciens, and analysis indicates that the 
NPTII protein is expressed in certain parts of the subject sugar beet 
plants. The A. tumefaciens method was used to transfer the added genes 
into the parental sugar beet line.
    The subject sugar beet 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 this sugar beet conducted under APHIS 
permits since 1994 indicates that there were no deleterious effects on 
plants, nontarget organisms, or the environment as a result of the 
environmental release of event T120-7 sugar beet.

Determination

    Based on its analysis of the data submitted by AgrEvo, and a review 
of other scientific data and field tests of the subject sugar beet, 
APHIS has determined that event T120-7: (1) Exhibits no plant 
pathogenic properties; (2) is no more likely to become a weed than 
sugar beet 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; and (5) will not harm 
threatened or endangered species or other organisms, such as bees, that 
are beneficial to agriculture. Therefore, APHIS has concluded that the 
subject sugar beet and any progeny derived from crosses with other 
sugar beet varieties will be as safe to grow as sugar beet in 
traditional breeding programs that are not subject to regulation under 
7 CFR part 340.
    The effect of this determination is that AgrEvo's event T120-7 
sugar beet 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 
subject sugar beet or its progeny. However, importation of event T120-7 
sugar beet 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 event T120-7 sugar beet 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 30th day of April, 1998.
Craig A. Reed,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-12125 Filed 5-6-98; 8:45 am]
BILLING CODE 3410-34-P