[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]
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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.
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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]
BILLING CODE 3410-34-M
