[Federal Register Volume 63, Number 68 (Thursday, April 9, 1998)]
[Notices]
[Pages 17354-17355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9376]


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 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 
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  Federal Register / Vol. 63, No. 68 / Thursday, April 9, 1998 / 
Notices  

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 97-114-2]


Monsanto Co.; Availability of Determination of Nonregulated 
Status for Tomato Genetically Engineered for Insect Resistance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that the 
Monsanto Company's tomato line designated as 5345, which has been 
genetically engineered for resistance to certain lepidopteran insect 
pests, 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 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'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: March 26, 1998.

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. Sivramiah Shantharam, 
Biotechnology and Biological Analysis, PPQ, APHIS, 4700 River Road Unit 
147, Riverdale, MD 20737-1236; (301) 734-4882. 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 October 14, 1997, the Animal and Plant Health Inspection Service 
(APHIS) received a petition (APHIS Petition No. 97-287-01p) from 
Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination 
that a tomato line designated as 5345, which has been genetically 
engineered for resistance to certain lepidopteran insect pests, does 
not present a plant pest risk and, therefore, is not a regulated 
article under APHIS' regulations in 7 CFR part 340.
    On November 28, 1997, APHIS published a notice in the Federal 
Register (62 FR 63312-63313, Docket No. 97-114-1) announcing that the 
Monsanto petition had been received and was available for public 
review. The notice also discussed the role of APHIS, the Environmental 
Protection Agency (EPA), and the Food and Drug Administration in 
regulating the subject tomato line and food products derived from it. 
In that notice, APHIS solicited written comments from the public as to 
whether this tomato line posed a plant pest risk. The comments were to 
have been received by APHIS on or before January 27, 1998. During the 
designated 60-day comment period, APHIS received two negative comments 
on the subject petition, both of which were from consumer policy 
organizations. The commenters argue that APHIS should deny the subject 
petition because the petitioner's insect pest resistance management 
strategies are inadequate based on recently published information in 
scientific journals. However, APHIS regulatory authority is based on an 
assessment of plant pest risk. EPA is the lead agency dealing with pest 
resistance management strategies for transgenic insect resistant 
plants, and EPA has established a pest resistance management working 
group to deal with pest resistance management issues. APHIS is working 
with EPA to examine the issues surrounding the development of pest 
resistance, and scientific consultations in public forums are being 
pursued in conjunction with the registration process under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 
U.S.C. 136 et seq.). While APHIS has carefully considered the comments 
submitted, our determination has not been affected by the points made 
by the commenters because they extend to authority exercised by EPA 
under FIFRA.

Analysis

    Tomato line 5345 has been genetically engineered to express a 
CryIA(c) insect control protein derived from the common soil bacterium 
Bacillus thuringiensis subsp. kurstaki HD-73 (Btk). The subject tomato 
line also expresses the nptII gene, which codes for the enzyme neomycin 
phosphotransferase (NPTII) and has been used as a selectable marker in 
the development of the transgenic tomato plants. While tomato line 5345 
contains the aad gene, tests indicate that the AAD protein is not 
expressed in the subject tomato plants. Expression of the added genes 
is controlled in part by noncoding DNA sequences derived from the plant 
pathogens Agrobacterium tumefaciens and cauliflower mosaic virus. The 
Agrobacterium transformation method was used to transfer the added 
genes into the UC82B parental tomato plants.
    The subject tomato line 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 tomato line conducted under APHIS 
notifications since 1995 indicates that there were no deleterious 
effects on plants, nontarget organisms, or the environment as a result 
of the environmental release of tomato line 5345.

Determination

    Based on its analysis of the data submitted by Monsanto and a 
review of other scientific data and field tests of the subject tomato 
line, as well as comments submitted by the public regarding the subject 
petition, APHIS has determined that tomato line 5345:

[[Page 17355]]

(1) Exhibits no plant pathogenic properties; (2) is no more likely to 
become a weed than tomato lines 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 tomato line and any progeny derived from 
hybrid crosses with other nontransformed tomato varieties will be as 
safe to grow as tomato in traditional breeding programs that are not 
subject to regulation under 7 CFR part 340.
    The effect of this determination is that Monsanto's tomato line 
5345 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 
field testing, importation, or interstate movement of the subject 
tomato line or its progeny. However, importation of tomato line 5345 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, as amended (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 Monsanto's tomato line 5345 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 3rd day of April 1998.
Craig A. Reed,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-9376 Filed 4-8-98; 8:45 am]
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