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

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 98-067-1]

Monsanto Co.; Receipt of Petition for Determination of

Nonregulated Status for Potato Lines Genetically Engineered for Insect

and Virus Resistance

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 Monsanto Company

seeking a determination of nonregulated status for certain potato lines

genetically engineered for resistance to the Colorado potato beetle and

potato virus Y. 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 September 18,

1998.

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

Docket No. 98-067-1, 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. 98-067-1. 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

to facilitate entry into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr. David Heron, Biotechnology and

Biological Analysis, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147,

Riverdale, MD 20737-1236; (301) 734-5141. To obtain a copy of the

petition, contact Ms. Kay Peterson at (301) 734-4885; e-mail:

Kay.P[email protected].

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 5, 1997, APHIS received a petition (APHIS Petition No.

97-339-01p) from Monsanto Company (Monsanto) of St. Louis, MO,

requesting a determination of nonregulated status under 7 CFR part 340

for certain NewLeaf Y potato lines. The subject potato lines

include one line of Russet Burbank (RBMT15-101), two lines of Shepody

(SEMT15-02 and SEMT15-15), and one line of HiLite (HLMT15-46), which

have been genetically engineered for resistance to the Colorado potato

beetle (CPB) and potato virus Y (PVY). 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, all four of the subject

NewLeaf Y potato lines have been genetically engineered to

contain the cry3A gene from Bacillus thuringiensis subsp. tenebrionis

(Btt), which encodes a protein that is insecticidal to CPB, and the PVY

coat protein gene (PVYcp), which imparts resistance to PVY. In addition

to the cry3A gene and the PVYcp gene, these potato lines contain and

express the nptII selectable marker gene, which is used in the initial

stages of plant selection. While the two Shepody lines (SEMT15-02 and

SEMT15-15) and the HiLite line (HLMT15-46) also contain the aad marker

gene, tests indicate that this gene is not expressed in these potato

plants. The subject potato lines were developed through the use of the

Agrobacterium tumefaciens transformation system, and expression of the

introduced genes is controlled in part by gene sequences derived from

the plant pathogens A. tumefaciens and figwort mosaic virus.

The subject potato lines have been considered regulated articles

under the regulations in 7 CFR part 340 because they contain gene

sequences derived from plant pathogens. These potato lines have been

evaluated in field trials conducted since 1995 under APHIS

notifications. In the process of reviewing the notifications for field

trials of the subject potato lines, APHIS determined 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.

The U.S. Environmental Protection Agency (EPA) is responsible for

the

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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. In this

regard, EPA has issued a registration to Monsanto for full

commercialization of the plant pesticide Btt CRY3A delta endotoxin and

the genetic material necessary for its production in potato. Residue

tolerances for pesticides are established by EPA under the Federal

Food, Drug and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301 et

seq.), and the Food and Drug Administration (FDA) enforces tolerances

set by EPA under the FFDCA. In addition to the registration, EPA has

issued exemptions from the requirement of a tolerance for residues of

the subject plant pesticide CRY3A in potatoes, for the NPTII protein as

a plant pesticide inert ingredient in all plants, and for the PVY coat

protein in or on all plants and raw agricultural commodities.

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 has completed consultation with FDA on the subject potato

lines.

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 NewLeaf Y

potato lines RBMT15-101, SEMT15-02, SEMT15-15, and HLMT15-46 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 14th day of July, 1998.

Craig A. Reed,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 98-19228 Filed 7-17-98; 8:45 am]

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