[Federal Register Volume 60, Number 195 (Tuesday, October 10, 1995)]
[Notices]
[Pages 52642-52643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25015]



 ========================================================================
 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. 60, No. 195 / Tuesday, October 10, 1995 / 
Notices  

[[Page 52642]]


DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 95-042-2]


Availability of Determination of Nonregulated Status for 
Genetically Engineered Tomato Line of Monsanto Company

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that a tomato 
line developed by the Monsanto Company designated as 8338 that has been 
genetically engineered for delayed ripening 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 the Monsanto Company in its 
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 
Monsanto Company 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: September 27, 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. Susan Koehler, 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 22, 1995, the Animal and Plant Health Inspection 
Service (APHIS) received a petition (APHIS Petition No. 95-053-01p) 
from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a 
determination that a tomato line designated as 8338 that has been 
genetically engineered for delayed ripening does not present a plant 
pest risk and, therefore, is not a regulated article under APHIS' 
regulations in 7 CFR part 340.
    On June 13, 1995, APHIS published a notice in the Federal Register 
(60 FR 31139-31140, Docket No. 95-042-1) announcing that the Monsanto 
petition had been received and was available for public review. The 
notice also discussed the role of APHIS and the Food and Drug 
Administration in regulating the subject tomato line and food products 
derived from it. In the notice, APHIS solicited written comments from 
the public as to whether the subject tomato line posed a plant pest 
risk. The comments were to have been received by APHIS on or before 
August 14, 1995.
    APHIS received two comments on the subject petition, both from 
State departments of agriculture. Both of the comments were in support 
of nonregulated status for tomato line 8338.

Analysis

    Tomato line 8338 has been genetically engineered to express the 
enzyme 1-aminocyclopropane-1-carboxylic acid deaminase (ACCd), which 
catalyzes deamination of ACC, an essential precursor for ethylene 
biosynthesis. Levels of ethylene control the rate of fruit ripening. 
Removal of ACC in the subject tomato line reduces ethylene production 
and delays ripening. Tomato line 8338 also contains the neomycin 
phosphotransferase (nptII) selectable marker gene, which encodes the 
enzyme NPTII. Expression of the accd gene and the nptII gene is driven 
by constitutive 35S promoters derived from the plant pathogenic 
caulimoviruses, figwort mosaic virus and cauliflower mosaic virus, 
respectively. The subject tomato line was transformed through the use 
of disarmed vectors from a common soil-borne bacterium, the plant 
pathogen Agrobacterium tumefaciens.
    Tomato line 8338 has been considered a regulated article under 
APHIS' regulations in 7 CFR part 340 because it contains the 35S 
promoters and 3' regulatory gene sequences derived from the plant 
pathogens mentioned above, and because A. tumefaciens was used as the 
plant transformation vector. However, evaluation of field data reports 
from field tests of the subject tomato line conducted under APHIS 
permits or notifications since 1992 indicates 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 Monsanto and a 
review of other scientific data, comments received, and field tests of 
the subject tomato line, APHIS has determined that tomato line 8338: 
(1) Exhibits no plant pathogenic properties; (2) is no more likely to 
become a weed than other tomatoes 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 harm other organisms, such as bees, that are beneficial to 
agriculture; and (5) should not cause damage to raw or processed 
agricultural commodities. Therefore, APHIS has concluded that tomato 
line 8338 and any progeny derived from hybrid crosses with other 
nontransformed tomato varieties will be just as safe to grow as 
traditionally bred tomato lines that are not regulated under 7 CFR part 
340.
    The effect of this determination is that a tomato line designated 
as 8338 is no longer considered a regulated article under APHIS' 
regulations in 7 CFR part 340. Therefore, the notification requirements 
pertaining to regulated articles under those regulations no longer 
apply to the field testing, importation, or interstate movement of 
tomato line 8338 or its progeny. However, the importation of the 
subject 

[[Page 52643]]
tomato line or seeds capable of propagation is 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)(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; 60 FR 6000-6005, February 1, 1995). Based 
on that EA, APHIS has reached a finding of no significant impact 
(FONSI) with regard to its determination that tomato line 8338 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 2nd day of October 1995.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-25015 Filed 10-6-95; 8:45 am]
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