[Federal Register Volume 60, Number 121 (Friday, June 23, 1995)]
[Notices]
[Pages 32650-32651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15379]



 ========================================================================
 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 
 appearing in this section.
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  Federal Register / Vol. 60, No. 121 / Friday, June 23, 1995 / 
Notices  

[[Page 32650]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 95-016-2]


Availability of Determination of Nonregulated Status for 
Genetically Engineered Tomato Lines

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that tomato 
lines developed by Zeneca Plant Science and Petoseed Company, Inc., 
designated as B, Da, and F that have been genetically engineered for 
suppressed polygalacturonase enzyme activity 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 Zeneca Plant Science and Petoseed 
Company, Inc., in their 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 Zeneca Plant Science and Petoseed, Inc., 
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: June 6, 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. Subhash Gupta, 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 February 7, 1995, the Animal and Plant Health Inspection Service 
(APHIS) received a petition (APHIS Petition No. 94-290-01p) from Zeneca 
Plant Science of Wilmington, DE, and Petoseed Company, Inc., of 
Woodland, CA, (Zeneca/Petoseed) seeking a determination that tomato 
lines designated as B, Da, and F that have been genetically engineered 
for suppressed polygalacturonase (PG) enzyme activity do not present a 
plant pest risk and, therefore, are not regulated articles under APHIS' 
regulations in 7 CFR part 340.
    On March 17, 1995, APHIS published a notice in the Federal Register 
(60 FR 14413-14414, Docket No. 95-016-1) announcing receipt of the 
Zeneca/Petoseed petition and announcing that the petition was available 
for public review. The notice also discussed the role of APHIS and the 
Food and Drug Administration in regulating the subject tomato lines and 
food products derived from them. In the notice, APHIS solicited written 
comments from the public as to whether the subject tomato lines posed a 
plant pest risk. The comments were to have been received by APHIS on or 
before May 16, 1995.
    APHIS received five comments on the Zeneca/Petoseed petition, from 
a food company, a seed company, and State departments of agriculture. 
All the commenters supported the Zeneca/Petoseed petition for 
nonregulated status for the subject tomato lines.

Analysis

    Zeneca/Petoseed's tomato lines B, Da, and F have been developed 
from an unmodified proprietary inbred tomato line coded as T7, that has 
been genetically engineered to contain a fragment of the tomato PG gene 
in the sense or antisense orientation. Inhibition of the PG enzyme 
resulting from the transcription of the PG gene fragment results in an 
increased thickness of the tomato, which is a desired characteristic in 
processing tomatoes. The subject tomato lines also contain the 
bacterial neomycin phosphotransferase (nptII) gene that is used as a 
selectable marker. Tomato lines B, Da, and F were transformed through 
the use of disarmed vectors from a common soil-borne bacterium, the 
plant pathogen Agrobacterium tumafaciens. The subject tomato lines have 
been considered regulated articles under APHIS' regulations in 7 CFR 
part 340 because they contain certain gene sequences derived from 
plant-pathogenic sources. However, evaluation of field data reports 
from field tests of the subject tomato lines conducted under APHIS 
permits or notifications since 1991 indicate that there were no 
deleterious effects on plants, nontarget organisms, or the environment 
as a result of the subject tomato plants' release into the environment.

Determination

    Based on its analysis of the data submitted by Zeneca/Petoseed and 
a review of other scientific data, comments received from the public, 
and field tests of the subject tomato lines, APHIS has determined that 
tomato lines B, Da, and F: (1) Exhibit no plant pathogenic properties; 
(2) are no more likely to become a weed than tomatoes with suppressed 
PG activity developed by traditional breeding techniques; (3) are 
unlikely to increase the weediness potential of any other cultivated 
plant or wild species with which they can interbreed; (4) are unlikely 
to harm other organisms, such as bees, which are beneficial to 
agriculture; and (5) should not cause damage to processed agricultural 
commodities.
    The effect of this determination is that tomato lines designated as 
B, Da, and F are no longer considered regulated articles 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 tomato lines or their progeny. However, the 
importation of the subject tomato lines or seeds capable of propagation 
is still subject to [[Page 32651]] 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 tomato lines 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 15th day of June 1995.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-15379 Filed 6-22-95; 8:45 am]
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