[Federal Register Volume 60, Number 15 (Tuesday, January 24, 1995)]
[Notices]
[Pages 4588-4589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1622]



 ========================================================================
 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. 60, No. 15 / Tuesday, January 24, 1995 / 
Notices  
[[Page 4588]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 94-092-2]


Availability of Determination of Nonregulated Status for 
Genetically Engineered Tomato Line

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

SUMMARY: We are advising the public of our determination that a DNA 
Plant Technology Corporation delayed-ripening tomato line, designated 
as line 1345-4, is no longer considered a regulated article under our 
regulations governing the introduction of certain genetically 
engineered organisms. The determination is based on our analysis of a 
petition submitted by DNA Plant Technology Corporation for a 
determination of nonregulated status, and our review of scientific data 
and comments received from the public in response to a previous notice 
announcing receipt of the DNA Plant Technology Corporation'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: January 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, 
USDA, room 850, Federal Building, 6505 Belcrest Road, Hyattsville, MD 
20782, (301) 436-7612. The telephone number for the agency will change 
when agency offices in Hyattsville, MD, move to Riverdale, MD, during 
February. Telephone: (301) 436-7612 (Hyattsville); (301) 734-7612 
(Riverdale). To obtain a copy of the determination or the environmental 
assessment and finding of no significant impact, contact Ms. Kay 
Peterson at (301) 436-7601 (Hyattsville); (301) 734-7601 (Riverdale).

SUPPLEMENTARY INFORMATION:

Background

    On August 16, 1994, the Animal and Plant Health Inspection Service 
(APHIS) received a petition from DNA Plant Technology Corporation 
(DNAP) of Oakland, CA, seeking a determination that its delayed-
ripening tomato line 1345-4 (tomato line 1345-4) and any progeny 
derived from hybrid crosses between that line and other non-transformed 
tomato varieties do not present a plant pest risk and, therefore, are 
not regulated articles under APHIS' regulations in 7 CFR part 340.
    On September 26, 1994, APHIS published a notice in the Federal 
Register (59 FR 49055-49056, Docket No. 94-092-1) announcing receipt of 
the DNAP petition and stating that the petition was available for 
public review. The notice also discussed the role of APHIS and the Food 
and Drug Administration in regulating tomato line 1345-4 and food 
products derived from it. In the notice, APHIS solicited written 
comments from the public as to whether tomato line 1345-4 posed a plant 
pest risk. The comments were to have been received by APHIS on or 
before November 25, 1994.
    APHIS received seven comments on the DNAP petition submitted by 
universities, State officials, and a tomato grower. One comment 
concerned the information provided in the notice of receipt of the 
petition; the remainder of the comments were in favor of the petition. 
APHIS has provided a summary of the comments in the determination 
document, which is available upon request from the individual listed 
under FOR FURTHER INFORMATION CONTACT.

Analysis

    Tomato line 1345-4, as described by its developer, DNAP, contains a 
gene that delays ripening. Using TranswitchTM gene suppression 
technology, DNAP introduced a truncated version of the tomato 
aminocyclopropane carboxylate (ACC) synthase gene into the tomato 
genome in the ``sense'' or normal orientation, resulting in tomato 
plants that exhibit significantly reduced levels of ACC synthase. ACC 
synthase is the rate-limiting enzyme that coverts s-adenosylmethionine 
to 1-aminocyclopropane-1-carboxylic acid, the immediate precursor to 
ethylene. Tomato line 1345-4 contains a gene which is derived from the 
tomato ACC synthase gene, but which does not encode a functional ACC 
synthase enzyme. Though the fruit of these plants exhibits delayed-
ripening, they ripen as usual when exogenous ethylene is applied. 
Tomato line 1345-4 has also been transformed with the nptII gene from 
E. coli that encodes the enzyme neomycin phosphotransferase II and 
serves as a selectable marker enabling identification of the 
transformed plant cells. This gene is fused to a nos promoter sequence 
and octopine synthase termination sequence from A. tumefaciens, a known 
plant pest.
    Tomato line 1345-4 has been considered a regulated article under 
APHIS' regulations in 7 CFR part 340 because the line has been 
engineered using noncoding regulatory sequences derived from the plant 
pathogens A. tumefaciens and cauliflower mosaic virus. However, field 
tests of tomato line 1345-4 have been conducted at tomato growing 
regions in the United States since 1992 under permits issued by APHIS, 
and the field reports from those tests indicate that there were no 
deleterious effects on plants, nontarget organisms, or the environment 
as a result of this testing.

Determination

    Based on its analysis of data submitted by DNAP, a review of other 
scientific data and comments received from the public, APHIS has 
determined that tomato line 1345-4: (1) Exhibits no plant pathogenic 
properties; (2) is no more likely to become a weed than the 
nonengineered parental variety; (3) is unlikely to increase the 
weediness potential of any other cultivated plant or 
[[Page 4589]] native wild species with which the organism can 
interbreed; (4) is unlikely to harm other organisms, such as bees, that 
are beneficial to agriculture; and (5) will not cause damage to 
processed agricultural commodities. APHIS has also concluded that there 
is a reasonable certainty that new progeny varieties bred from tomato 
line 1345-4 will not exhibit new plant pest properties, i.e., 
properties substantially different from any observed in the field-
tested tomato line, or those observed in traditional tomato breeding 
programs.
    The effect of this determination is that tomato line 1345-4 and all 
other lines bred from this line by sexual or asexual reproduction 
involving Mendelian inheritance, 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 line or its 
progeny. However, the importation of the tomato line and any nursery 
stock 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 (NEPA) of 1969 (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 Guidelines 
Implementing NEPA (44 FR 50381-50384, August 28, 1979, and 44 FR 51272-
51274, August 31, 1979). Based on that EA, APHIS has reached a finding 
of no significant impact (FONSI) with regard to its determination that 
the tomato line designated as 1345-4 and other lines bred from the line 
by sexual or asexual reproduction involving Mendelian inheritance, 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 17th day of January 1995.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-1622 Filed 1-23-95; 8:45 am]
BILLING CODE 3410-34-M