[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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