This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

public. Notices of hearings and investigations,

committee meetings, agency decisions and

rulings, delegations of authority, filing of

petitions and applications and agency

statements of organization and functions are

examples of documents appearing in this

section.

Notices Federal Register

7746

Vol. 60, No. 27

Thursday, February 9, 1995

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 94–139–1]

Receipt of Petition for Determination of

Nonregulated Status for Genetically

Engineered Cotton

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice.

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 cotton lines 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 these genetically

engineered cotton lines present a plant

pest risk.

DATES: Written comments must be

received on or before April 10, 1995.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 94–139–1, Animal and Plant

Health Inspection Service, Policy and

Program Development, Regulatory

Analysis and Development, 4700 River

Road Unit 118, Riverdale, MD 20737–

1238. Please state that your comments

refer to Docket No. 94–139–1. 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. Keith Reding, Biotechnologist,

Animal and Plant Health Inspection

Service, Biotechnology, Biologics, and

Environmental Protection,

Biotechnology Permits, 4700 River Road

Unit 147, Riverdale, MD 20737–1237.

The telephone number for the agency

contract will change when agency

offices in Hyattsville, MD, move to

Riverdale, MD, during February.

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 regulation in § 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 § 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 November 4, 1994, APHIS

received a petition (APHIS Petition No.

94–308–01p) from the Monsanto

Company of St. Louis, MO, requesting a

determination of nonregulated status

under 7 CFR part 340 for a cotton line

designated as 531, genetically

engineered to produce an insecticidal

protein for resistance to lepidopteran

insect pests. On January 10, 1995,

Monsanto amended the petition to add

two additional lines designated as 757

and 1076. The three cotton lines, 531,

757, and 1076, are trademarked by

Monsanto as Bollagard TM Cotton Lines.

The Monsanto petition states that the

subject cotton lines 531, 757, and 1076,

should not be regulated by APHIS

because they do not present a plant pest

risk.

As described in the petition, the

subject cotton lines were developed to

produce an insect control protein

derived from the common soil

bacterium Bacillus thuringiensis subsp.

kurstaki (Btk). This genetically

engineered insect control protein is

nearly identical (differing in only 6 of

1,178 nonessential amino acids) to one

of the proteins encoded by the cryIA(c)

gene. This protein is naturally produced

by Btk and found in commercial

microbial Btk formulations registered as

pesticides with the Environmental

Protection Agency (EPA). According to

Monsanto, the protein is highly

selective in controlling such

lepidopteran cotton pests as cotton

bollworm, tobacco budworm, and pink

bollworm, and is expressed at a

consistent level in the cotton plant

throughout the growing season. The

expression of this insect control protein

is regulated by a promoter and

terminating sequence. The promotors

were either the 35S sequence derived

from the cauliflower mosaic virus or a

promoter from an alternate source.

Terminating sequences used were either

the 7S 3′ non-translated region of the

soybean alpha subunit of the betaconglycinin gene or the E9 3′ sequence

from the pea ribulose-1,5,-bisphosphate

carboxylase, small subunit (rbcS).

The subject cotton lines also contain

the nptII gene from the prokaryotic

transposon Tn5 which encodes the

enzyme neomycin phosphotransfease II.

The expression of this gene in the

subject cotton 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

tumefaciens. The expression of this

enzyme in the subject cotton 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 cotton plants using A. tumefaciensmediated transformation utilizing a

binary, single-border plant expression

vector.

Monsanto’s cotton lines 531, 757, and

1076 are currently considered regulated

articles under the regulations in 7 CFR

part 340 because they contain gene

sequences (vectors, promoters, and
Federal Register / Vol. 60, No. 27 / Thursday, February 9, 1995 / Notices 7747

terminators) derived from plant

pathogenic sources. In cotton growing

locations throughout the United States,

cotton line 531 was evaluated under 5

APHIS permits issued between 1991

and 1993, and cotton lines 757 and 1076

were tested under 6 APHIS permits or

notifications in 1993 and 1994. After

reviewing Monsanto’s permit

applications for field trials of cotton

lines 531, 757, and 1076, 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 cotton

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 for a conditional registration

for a transgenic plant pesticide

containing the new active ingredient Btk

delta endotoxin protein as produced by

the cryIA(c) gene and its controlling

sequences. On September 29, 1994, EPA

announced receipt of this application

(EPA File Symbol 524–UTI) in the

Federal Register (59 FR 49663, OPP–

30373; FRL–4913–5).

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 4F4331)

proposing to amend 40 CFR part 180 to

establish a tolerance exemption for

residues of the plant pesticide active

ingredient Btk delta endotoxin protein

as produced by the cryIA(c) gene and its

controlling sequences. On September

14, 1994, EPA announced receipt of this

petition in the Federal Register (59 FR

47136–47137, PF–605; FRL–4904–7).

Consistent with the ‘‘Coordinated

Framework for Regulation of

Biotechnology’’ (51 FR 23302–23350,

June 26, 1986), APHIS and the EPA are

coordinating their reviews of these

genetically engineered cotton lines to

avoid duplication and assure 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 Federal

Food, Drug, and Cosmetic Act, 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 § 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 genetically engineered

cotton lines 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 3rd day of

February 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–3290 Filed 2–8–95; 8:45 am]

BILLING CODE 3410–34–M

[Docket 94–119–3]

Boll Weevil Control Program; Change

of Public Hearing Site

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice.

SUMMARY: We are advising the public

that the Animal and Plant Health

Inspection Service has changed the

location and time of one of two public

hearings scheduled to be held regarding

an environmental assessment and

preliminary finding of no significant

impact for a proposed program to

eradicate the boll weevil in the Lower

Rio Grande Valley, Texas. The hearings

were announced in a notice published

in the Federal Register on January 30,

1995. We have changed the site and

time of the second hearing in response

to requests from the public.

DATES: Two public hearings will be held

on February 16, 1995, in Weslaco, TX;

one from 1 p.m. to 5:30 p.m., the other

from 7:30 p.m. to 10:30 p.m. Pre-hearing

registration for oral participation at a

hearing may be made by mail

(postmarked on or before February 8,

1995), or at the hearing site on the date

of the hearings, beginning one hour

prior to each hearing.

ADDRESSES: The first public hearing (1

p.m. to 5:30 p.m.) will be held in the

Hoblitzelle Auditorium, Texas

Agriculture Experiment Station, 2415

East Highway 83, Weslaco, TX. The

second public hearing (7:30 p.m. to

10:30 p.m.) will be held at the Best

Western Palm Air Motor Inn, 415 South

International Boulevard (Highway

1015), Weslaco, TX. Registration for oral

participation at either hearing may be

mailed to Vicki Wickheiser,

Environmental Analysis and

Documentation, BBEP, APHIS, USDA,

Room 543, Federal Building, 6505

Belcrest Road, Hyattsville, MD 20782.

FOR FURTHER INFORMATION CONTACT:

Vicki Wickheiser at the address listed

above or by telephone at (301) 436–

8963.

SUPPLEMENTARY INFORMATION: On

January 30, 1995, the Animal and Plant

Health Inspection Service published in

the Federal Register (60 FR 5617–5618,

Docket No. 94–119–2) a notice that, in

part, announced that two public