Receipt of Petition for Determination of Nonregulated Status for Genetically Engineered Corn

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 a corn line

designated as MON 80100 that has been genetically engineered for insect

resistance. 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 this corn

line presents a plant pest risk.

DATES: Written comments must be received on or before August 7, 1995.

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

Docket No. 95-041-1, Regulatory Analysis and Development, PPD, APHIS,

Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1237. Please

state that your comments refer to Docket No. 95-041-1. 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. Ved Malik, Biotechnologist, 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) 734-7601.

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 April 3, 1995, APHIS received a petition (APHIS Petition No. 95-

093-01p) from the Monsanto Company (Monsanto) of St. Louis, MO,

requesting a determination of nonregulated status under 7 CFR part 340

for an insect-resistant corn line designated as MON 80100. The Monsanto

petition states that the subject corn line should not be regulated by

APHIS because it does not present a plant pest risk.

As described in the petition, corn line MON 80100 has been

genetically engineered with the cryIA(b) gene that encodes for a

CryIA(b) insect control protein derived from the common soil bacterium

Bacillus thuringiensis subsp. kurstaki (Btk). This protein is a member

of a class of insecticidal proteins, also known as delta-endotoxins,

that are produced as parasporal crystals by B. thuringiensis in nature,

and are known to be quite selective in their toxicity to specific

organisms, while nontoxic to all other organisms. Btk proteins are

effective against certain lepidopteran insects, including European corn

borer (ECB). ECB is a major corn pest that reduces yield by disrupting

normal plant physiology and causing damage to the leaves, stalks, and

ears. Results of field tests conducted by Monsanto under permits and

notifications granted by APHIS and under an experimental use permit

obtained from the Environmental Protection Agency (EPA) indicate that

corn plants producing the CryIA(b) protein were protected throughout

the growing season from leaf and stalk feeding damage caused by ECB. In

addition to expressing the CryIA(b) protein, the plants also express

the selectable marker enzyme 5-enolpyruvylshikimate-3-phosphate

synthase (CP4 EPSPS). The cryIA(b) gene and the CP4 EPSPS marker gene

were introduced into the subject corn line by a particle acceleration

method and their expression is under the control of the enhanced 35S

promoter derived from the plant pathogen cauliflower mosaic virus.

Monsanto's MON 80100 corn line is currently considered a regulated

article under the regulations in 7 CFR part 340 because it contains

gene sequences derived from plant pathogenic sources. The subject corn

line was evaluated in field trials conducted under APHIS permits or

notifications from 1992 through 1994. In the process of reviewing the

applications for field trials of the subject corn, 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

[[Page 30062]] well as to organisms that may be beneficial to plants,

for example, honeybees, rhizobia, etc.

This genetically engineered corn line is 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 exempted by EPA regulation. Accordingly, Monsanto has

submitted to the EPA an application to register the transgenic plant

pesticide Btk CryIA(b) insect control protein as produced in corn.

Under the Federal Food, Drug, and Cosmetic Act (FFDCA) (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 the EPA under the FFDCA; the Food and Drug

Administration (FDA) enforces the tolerances set by the EPA. Monsanto

has also submitted to the EPA a pesticide petition (PP 5F4473)

proposing to amend 40 CFR part 180 to establish a tolerance exemption

for residues of the plant pesticide active ingredient B. thuringiensis

delta-endotoxin as produced in corn by a cryIA(b) gene and its

controlling sequences.

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 this genetically engineered corn line

to avoid duplication and ensure that all relevant issues are addressed.

The 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 the FDA

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.

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 MON 80100 corn line 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 2.17, 2.51, and 371.2(c).

Done in Washington, DC, this 1st day of June 1995.

Lonnie J. King,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 95-13919 Filed 6-6-95; 8:45 am]

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