Receipt of Petition for Determination of Nonregulated Status for Genetically Engineered Potato Lines

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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