[Federal Register Volume 60, Number 47 (Friday, March 10, 1995)]
[Notices]
[Pages 13108-13109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5993]



 ========================================================================
 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. 47 / Friday, March 10, 1995 / 
Notices  
[[Page 13108]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 94-121-2]


Availability of Determination of Nonregulated Status for 
Gentically Engineered Potato 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 certain 
potato lines genetically engineered for resistance to the Colorado 
potato beetle by the Monsanto Company 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 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: March 2, 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, 
Animal and Plant Health Inspection Service, Biotechnology, Biologics, 
and Environmental Protection, Biotechnology Permits, 4700 River Road 
Unit 147, Riverdale, MD 20737-1228; (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 September 14, 1994, the Animal and Plant Health Inspection 
Service (APHIS) received a petition from the Monsanto Company 
(Monsanto) of St. Louis, MO, seeking a determination that seven Russet 
Burbank potato lines designed at BT6, BT10, BT12, BT16, BT17, BT18, and 
BT23, that have been genetically engineered for resistance to the 
Colorado potato (CPB) (hereinafter CPB-resistant potato lines) do not 
present a plant pest risk and, therefore, are not regulated articles 
under APHIS' regulations in 7 CFR part 340.
    On December 2, 1994, APHIS published a notice in the Federal 
Register (59 FR 61866-61867, Docket No. 94-121-1) announcing receipt of 
the Monsanto petition and announcing that the petition 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 potato lines and food products derived from 
them. In the notice, APHIS solicted written comments from the public as 
to whether the subject potato lines posed a plant pest risk. The 
comments were to have been received by APHIS on or before January 31, 
1995.
    APHIS received a total of 61 comments on the Monsanto petition. 
Comments were received from the following categories of respondents, 
with the categories containing the larger number of respondents listed 
first: potato farmers; universities; registered dietitians; regional 
and national potato growers' association, councils, and boards; 
cooperative extension service offices; State departments of 
agriculture; high school educators; individuals; potato marketing 
services; a potato research company; an agricultural experiment 
station; the department of agriculture of a foreign government; a food 
company; an international technology transfer agency; a potato 
processor; and a member of the U.S. House of Representatives. Fifty-
eight of the commenters urged approval of the petition or provided 
information in support of nonregulated status for the subject potato 
lines. Three of the 61 commenters did not directly or indirectly 
support approval of the petition: one of the three did not address the 
APHIS approval process; another endorsed the concept of the development 
of a CPB-resistant patato but expressed certain concerns; and one 
commenter asked that APHIS deny the petition. APHIS has provided a 
summary and discussion of the comments in the determination document, 
which is available upon request from the individual listed under FOR 
FURTHER INFORMATION CONTACT.

Analysis

    The Monsanto CPB-resistant potato lines have been genetically 
engineered to express a gene from the common soil bacterium Bacillus 
thuringiensis subsp. tenebrionis (Btt) the encodes a highly selective 
insecticidal delta-endotoxin crystalline protein, CryIIIA. This insect 
control protein is identical in amino acid sequence to one of the 
proteins naturally produced by Btt and found in commercial microbial 
Btt formulations. According to Monsanto, the protein is highly 
selective in controlling CPB and is expressed at an effective level in 
the potato foliage throughout the growing season. The expression of the 
insect control protein in the subject potato lines is regulated by an 
enhanced 35S promoter derived from the plant pathogen cauliflower 
mosaic virus and by the nontranslated region of the small subunit of 
ribulose-1,5-bisphosphate carboxylase referred to as E9 3' derived from 
pea plants. The CPB-resistant patato lines also express a selectable 
marker gene derived from the prokaryotic transposon Tn5 encoding the 
enzyme neomycin phosphotransferase II (nptII). The expression of the 
nptII gene in the subject potato lines is regulated by the 35S promoter 
and the nontranslated 3' region of the nopaline synthase gene derived 
from the plant pathogen Agrobacterium tumefaciens. The expression of 
nptII in the subject potato lines allows for selective growth of 
transgenic plant cells on the antibiotic [[Page 13109]] kanamycin 
during plant tissue culture. These genes were stably transferred into 
the genome of potato plants through an A. tumefaciens-mediated 
transformation.
    The subject potato lines have been considered ``regulated 
articles'' under APHIS' regulations in 7 CFR part 340 because their 
noncoding regulatory sequences were derived from the plant pathogens A. 
tumefaciens and cauliflower mosaic virus. However, evaluation of field 
data reports from field tests of the subject potato lines conducted 
since 1991 in the major potato-growing areas of the country indicate 
that there were no deleterious effects on plants, nontarget organisms, 
or the environment as a result of the subject patato lines' release 
into the environment.

Determination

    Based on its analysis of the data submitted by Monsanto, a review 
of other scientific data, the comments received from the public, and a 
review of field tests of the subject potato lines, APHIS has determined 
that the subject patio lines: (1) Exhibit no plant pathogenic 
properties; (2) are no more likely to become weeds than CPB-resistant 
potato lines that could potentially be developed by traditional 
breading techniques; (3) are unlikely to increase the weediness 
potential of any other cultivated plant or native wild species with 
which the organisms can interbreed; (4) will not cause damage to 
processed agricultural commodities; (5) are unlikely to harm other 
organisms, such as bees or earthworms, that are beneficial to 
agriculture; and (6) should pose no greater threat to the ability to 
control CPB in potatoes and other crops than that posed by the widely-
practiced method of applying insecticides to control CPB on potatoes. 
APHIS has also concluded that there is a reasonable certainty that new 
varieties developed from the subject potato lines will not exhibit new 
plant pest properties, i.e., properties substantially different from 
any observed in the field-tested potato lines, or those observed in 
standard potatoes in traditional breeding programs.
    The effect of this determination is that the seven Russet Burbank 
potato lines designated as BT6, BT10, BT12, BT16, BT17, BT18, and BT23 
and all other lines developed from them 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 potato 
lines or their progeny. However, the importation of the subject potato 
lines and any potato nursery stock or seeds capable of propagation is 
still subject to the restrictions from 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 NEPA Procedures. Based 
on that EA, APHIS has reached a finding of no significant impact 
(FONSI) with regard to its determination that the subject potato lines 
and other lines developed from those lines 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 6th day of March 1995.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-5993 Filed 3-9-95; 8:45 am]
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