[Federal Register Volume 59, Number 231 (Friday, December 2, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29713]
[[Page Unknown]]
[Federal Register: December 2, 1994]
VOL. 59, NO. 231
Friday, December 2, 1994
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 94-121-1]
Receipt of Petition for Determination of Nonregulated Status for
Genetically Engineered Potato Lines
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from the Monsanto Company
seeking a determination of nonregulated status for certain potato lines
genetically engineered for resistance to the Colorado potato beetle.
The petition has been submitted in accordance with our regulations
concerning the introduction of certain genetically engineered organisms
and products. In accordance with those regulations, we are soliciting
public comments on whether these potato lines present a plant pest
risk.
DATES: Written comments must be received on or before January 31, 1995.
ADDRESSES: Please send an original and three copies of your comments to
Chief, Regulatory Analysis and Development, PPD, APHIS, USDA, P.O.
Drawer 810, Riverdale, MD 20738. Please state that your comments refer
to Docket No. 94-121-1. A copy of the petition and any comments
received 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
access to that room to inspect the petition or comments are asked to
call in advance of visiting at (202) 690-2817.
FOR FURTHER INFORMATION CONTACT: Dr. Susan Koehler, Biotechnologist,
Biotechnology Permits, BBEP, APHIS, USDA, P.O. Drawer 810, Riverdale,
MD 20738. The telephone number for the agency contact will change when
agency offices in Hyattsville, MD, move to Riverdale, MD, during
January. Telephone: (301) 436-7612 (Hyattsville); (301) 734-7612
(Riverdale). To obtain a copy of the petition, contact Ms. Kay Peterson
at (301) 436-7601 (Hyattsville) or (301) 734-7601 (Riverdale).
SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340,
``Introduction of Organisms and Products Altered or Produced Through
Genetic Engineering Which Are Plant Pests or Which There Is Reason to
Believe Are Plant Pests,'' regulate, among other things, the
introduction (importation, interstate movement, or release into the
environment) of organisms and products altered or produced through
genetic engineering that are plant pests or that there is reason to
believe are plant pests. Such genetically engineered organisms and
products are considered ``regulated articles.''
The regulations in Sec. 340.6(a) provide that any person may submit
a petition to the Animal and Plant Health Inspection Service (APHIS)
seeking a determination that an article should not be regulated under 7
CFR part 340. Paragraphs (b) and (c) of Sec. 340.6 describe the form
that a petition for determination of nonregulated status must take and
the information that must be included in the petition.
On September 14, 1994, APHIS received a petition (APHIS Petition
No. 94-257-01p) from the Monsanto Company (Monsanto) of St. Louis, MO,
requesting a determination of nonregulated status under 7 CFR part 340
for seven Russet Burbank potato lines (BT6, BT10, BT12, BT16, BT17,
BT18, and BT23) genetically engineered with the plasmid vector PV-
STBT02, which confers resistance to the Colorado potato beetle (CPB)
(Leptinotarsa decemlineata). The Monsanto petition states that the
subject potato lines should not be regulated by APHIS because they do
not present a plant pest risk.
As described in the petition, the subject potato lines were
genetically engineered to produce an insect control protein derived
from the common soil bacterium Bacillus thuringiensis subsp.
tenebrionis (Btt). This insect control protein is identical in amino
acid sequence to one of the proteins (band 3 protein encoded by the
cryIIIA gene) naturally produced by Btt and found in commercial
microbial Btt formulations registered as pesticides with the
Environmental Protection Agency (EPA). According to Monsanto, the
protein is highly selective in controlling CPB and is expressed at a
consistently effective level in the potato foliage throughout the
growing season. The expression of this insect control protein in the
subject 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. The subject potato lines also
express an nptII gene derived from the prokaryotic transposon Tn5
encoding the enzyme neomycin phosphotransferase II. The expression of
this gene in the subject potato lines is regulated by the 35S promoter
(as described above) and the nontranslated 3' region of the nopaline
synthase gene derived from the plant pathogen Agrobacterium. The
expression of neomycin phosphotransferase II in the subject potato
lines allows for selective growth of transgenic plant cells on the
antibiotic kanamycin during plant tissue culture. These genes were
stably transferred into the genome of potato plants through an
Agrobacterium tumefaciens-mediated transformation utilizing a binary,
double-border plant expression vector, PV-STBT02.
Monsanto's subject CPB-resistant potato lines are currently
considered regulated articles under the regulations in 7 CFR part 340
because they contain gene sequences (vectors, promoters, and
terminators) derived from plant pathogenic sources. The subject potato
lines were evaluated at a total of 34 locations under nine APHIS
permits issued between 1991 and 1993. In the process of reviewing
Monsanto's permit applications for field trials of the subject potato
lines, APHIS determined that the vectors and other elements were
disarmed and that the trials, which were conducted under conditions of
reproductive and physical containment or isolation, would not present a
risk of plant pest introduction or dissemination.
In the Federal Plant Pest Act, as amended (7 U.S.C. 150aa et seq.),
``plant pest'' is defined as ``any living stage of: Any insects, mites,
nematodes, slugs, snails, protozoa, or other invertebrate animals,
bacteria, fungi, other parasitic plants or reproductive parts thereof,
viruses, or any organisms similar to or allied with any of the
foregoing, or any infectious substances, which can directly or
indirectly injure or cause disease or damage in any plants or parts
thereof, or any processed, manufactured or other products of plants.''
APHIS views this definition very broadly. The definition covers direct
or indirect injury, disease or damage not just to agricultural crops,
but also to plants in general, for example, native species, as well as
to organisms that may be beneficial to plants, for example, honeybees,
rhizobia, etc.
These genetically engineered potato lines are also currently
subject to regulation by other agencies. The EPA is responsible for the
regulation of pesticides under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA
requires that all pesticides, including insecticides, be registered
prior to distribution or sale, unless exempt by EPA regulation.
Accordingly, Monsanto has submitted to EPA an application to register
this plant-pesticide, i.e. the Btt CPB control protein as produced by
the cryIIIA gene and its controlling sequences in these genetically
engineered potato lines. On December 8, 1993, EPA announced receipt of
this application (EPA File Symbol 524-UTU) in the Federal Register (58
FR 64582-64583). This is the first application for registration of a
transgenic plant pesticide under section 3(c) of FIFRA, as amended, in
which a plant has been genetically altered to produce a pesticide.
Under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.), pesticides added to raw agricultural commodities generally are
considered to be unsafe unless a tolerance or exemption from tolerance
has been established. Foods containing unsafe pesticides are deemed to
be adulterated. Residue tolerances for pesticides are established by
EPA under the Federal Food, Drug, and Cosmetic Act; the Food and Drug
Administration (FDA) enforces the tolerances set by the EPA. Monsanto
has also submitted to the EPA a pesticide petition (PP 3F4273)
proposing to amend 40 CFR part 180 to establish a tolerance exemption
for residues of the plant pesticide active ingredient Btt CPB control
protein as expressed in plant cells. On December 8, 1993, EPA announced
receipt of this petition [58 FR 64583-64584]. Consistent with the
``Coordinated Framework for Regulation of Biotechnology'' (51 FR 23302-
23350, June 26, 1986), APHIS and the EPA are coordinating their review
of these genetically engineered potato lines to avoid duplication and
assure that all relevant issues are addressed.
FDA's policy statement concerning regulation of plants derived from
new plant varieties was published in the Federal Register on May 29,
1992, and appears at 57 FR 22984-23005. Monsanto has notified the FDA
that they have completed their food safety and nutritional assessment
as required under this FDA policy statement.
In accordance with Sec. 340.6(d) of the regulations, we are
publishing this notice to inform the public that APHIS will accept
written comments regarding the Petition for Determination of
Nonregulated Status from any interested person for a period of 60 days
from the date of this notice. The petition and any comments received
are available for public review, and copies of the petition may be
ordered (see the ADDRESSES section of this notice).
After the comment period closes, APHIS will review the data
submitted by the petitioner, all written comments received during the
comment period, and any other relevant information. Based on the
available information, APHIS will furnish a response to the petitioner,
either approving the petition in whole or in part, or denying the
petition. APHIS will then publish a notice in the Federal Register
announcing the regulatory status of Monsanto's CPB-resistant potato
lines BT6, BT10, BT12, BT16, BT17, BT18, and BT23 and the availability
of APHIS' written decision.
Authority: 7 U.S.C. 150aa-150jj, 151-167, 1622n; 31 U.S.C. 9701;
7 CFR 2.17, 2.51, and 371.2(c).
Done in Washington, DC, this 25th day of November 1994.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 94-29713 Filed 12-1-94; 8:45 am]
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