Monsanto Co.; Receipt of Petition for Determination of Nonregulated Status for Potato Lines Genetically Engineered for Insect Resistance

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 March 22, 1996.

ADDRESSES: Please send an original and three copies of your comments to

Docket No. 95-090-1, Regulatory Analysis and Development, PPD, APHIS,

Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please

state that your comments refer to Docket No. 95-090-1. 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. James Lackey, Biotechnology

Permits, BBEP, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale,

MD 20737-1237; (301) 734-7612. To obtain a copy of the petition,

contact Ms. Kay Peterson at (301) 734-7612.

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 December 4, 1995, APHIS received a petition (APHIS Petition No.

95-338-01p) from the Monsanto Company (Monsanto) of St. Louis, MO,

requesting a determination of nonregulated status under 7 CFR part 340

for two Superior potato lines (SPBT02-5 and SPBT02-7) which have been

transformed with plasmid vector PV-STBT02. On December 15, 1995, APHIS

received Monsanto's amendment to its petition to include five Atlantic

potato lines (ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31 and ATBT04-36)

transformed with plasmid vector PV-STBT04. Plasmid vectors PV-STBT02

and PV-STBT04 confer resistance to the Colorado potato beetle (CPB).

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 two Superior potato lines

transformed with plasmid vector PV-STBT02 and the five Atlantic potato

lines transformed with plasmid vector PV-STBT04 have been genetically

engineered to contain the cryIIIA gene from the common soil bacterium

Bacillus thuringiensis subsp. tenebrionis (Btt), which encodes a delta-

endotoxin insect control protein that is effective against CPB. The

components of the two plasmid vectors, PV-STBT02 and PV-STBT04, are

identical with the exception of the promoter for the cryIIIA gene. In

the two Superior potato lines transformed with plasmid vector PV-

STBT02, expression of the cryIIIA gene is controlled by the enhanced

cauliflower mosaic virus (CaMV) 35S promoter and the nontranslated

region of the pea small subunit of ribulose-1,5-bisphosphate

carboxylase. In the five Atlantic potato lines transformed with plasmid

vector PV-STBT04, the second chimeric gene consists of the Arabidopsis

thaliana ribulose-1,5-bisphosphate carboxylase small subunit ats1A

promoter.

The subject potato lines also contain the nptII gene from the

prokaryotic transposon Tn5 which encodes the enzyme neomycin

phosphotransferase II and is used as a selectable marker for

transformation. Expression of the nptII gene in the two Superior and

five Atlantic potato lines is controlled by the CaMV 35S promoter and

the 3' region of the nopaline synthase gene. The genes used to develop

the subject potato lines were stably transferred into the genome of

potato plants through the use of an Agrobacterium tumefaciens

transformation system.

Plasmid vector PV-STBT02 is the same vector used to transform the

seven Russet Burbank potato lines for which APHIS issued a

determination of nonregulated status on March 2, 1995 (60 FR 13108-

13109, March 10, 1995). However, unlike the Russet Burbank potato

variety, which is male sterile, Superior and Atlantic potato varieties

are male fertile.

The subject Superior and Atlantic potato lines have been considered

regulated articles under the regulations in 7 CFR part 340 because they

contain gene sequences derived from plant pathogens. The subject potato

lines have been evaluated in field trials conducted since 1992 under

APHIS permits or notifications. In the process of reviewing the

applications for field trials of these 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

[[Page 1558]]

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.

The U.S. Environmental Protection Agency (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. Residue

tolerances for pesticides are established by EPA under the Federal

Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 201 et seq.), and the

Food and Drug Administration (FDA) enforces tolerances set by EPA under

the FFDCA. EPA announced issuance of a conditional registration to

Monsanto on May 5, 1995, for full commercialization of the plant

pesticide Btt CryIII(A) delta endotoxin and the genetic material

necessary for its production in potato. In addition to the

registration, EPA also issued an exemption from the requirement of a

tolerance for residues of the subject plant pesticide in potatoes on

May 3, 1995 (60 FR 21725-21728), as requested by Monsanto.

FDA published a statement of policy on foods derived from new plant

varieties in the Federal Register on May 29, 1992 (57 FR 22984-23005).

The FDA statement of policy includes a discussion of FDA's authority

for ensuring food safety under the FFDCA, and provides guidance to

industry on the scientific considerations associated with the

development of foods derived from new plant varieties, including those

plants developed through the techniques of genetic engineering.

Monsanto completed its consultations with FDA for Russet Burbank potato

lines containing the Btt cryIII(A) gene and has initiated consultations

with FDA for the Superior and Atlantic potato lines that are the

subject of this notice.

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 Superior potato lines SPBT02-5 and SPBT02-7 and Atlantic

potato lines ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31, and ATBT04-36,

and the availability of APHIS' written decision.

Authority: 7 U.S.C. 150aa-150jj, 151-167, and 1622n; 31 U.S.C.

9701; 7 CFR 2.22, 2.80, and 371.2(c).

Done in Washington, DC, this 11th day of January 1996.

Terry L. Medley,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 96-661 Filed 1-19-96; 8:45 am]

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