63168 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Notices

F. International Tolerances

No international tolerances have been

established under CODEX. Therefore

there is no need to ensure consistency.

[FR Doc. 97–30813 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–776; FRL–5753–3]

Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of pesticide petitions

proposing the establishment of

regulations for residues of certain

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by the

docket control number PF–776, must be

received on or before December 26,

1997.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch (7502C),

Information Resources and Services

Division, Office of Pesticides Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460. In

person bring comments to: Rm. 1132,

CM #2, 1921 Jefferson Davis Highway,

Arlington, VA.

Comments and data may also be

submitted electronically to: oppdocket@epamail.epa.gov. Follow the

instructions under ‘‘SUPPLEMENTARY

INFORMATION.’’ No confidential

business information should be

submitted through e-mail.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

that does not contain CBI must be

submitted for inclusion in the public

record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: The

Regulatory Action Leader listed in the

table below:

Regulatory Action

Leader Telephone Number/E-mail Address Office Location/Address

Driss Benmhend .... 703–308–9525, e-mail: benmhend.driss@epamail.epa.gov. 5th floor CS#1, 2800 Crystal Drive, Arlington, VA 22202

Michael

Mendelsohn.

703–308–8715, e-mail: mendelsohn.mike@epamail.epa.gov. Do.

SUPPLEMENTARY INFORMATION: EPA has

received pesticide petitions as follows

proposing the establishment and/or

amendment of regulations for residues

of certain pesticide chemicals in or on

various food commodities under section

408 of the Federal Food, Drug, and

Comestic Act (FFDCA), 21 U.S.C. 346a.

EPA has determined that these petitions

contain data or information regarding

the elements set forth in section

408(d)(2); however, EPA has not fully

evaluated the sufficiency of the

submitted data at this time or whether

the data supports granting of the

petition. Additional data may be needed

before EPA rules on the petition.

The official record for this notice of

filing, as well as the public version, has

been established for this notice of filing

under docket control number [PF–776]

(including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The official

record is located at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Comment and data will

also be accepted on disks in

Wordperfect 5.1/6.1 or ASCII file

format. All comments and data in

electronic form must be identified by

the docket control number [PF–776] and

appropriate petition number. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries.

List of Subjects

Environmental protection,

Agricultural commodities, Food

additives, Feed additives, Pesticides and

pests, Reporting and recordkeeping

requirements.

Dated: November 18, 1997.

Janet Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

Summaries of Petitions

Petitioner summaries of the pesticide

petitions are printed below as required

by section 408(d)(3) of the FFDCA. The

summaries of the petitions were

prepared by the petitioners and

represent the views of the petitioners.

EPA is publishing the petition

summaries verbatim without editing

them in any way. The petition summary

announces the availability of a

description of the analytical methods

available to EPA for the detection and

measurement of the pesticide chemical

residues or an explanation of why no

such method is needed.

1. Engelhard Corporation

PP 7E4908

EPA has received a pesticide petition

(PP 7E4908) from Engelhard

Corporation, 101 Wood Avenue, Iselin,

NJ 08830, proposing pursuant to section

408(d) of the Federal Food, Drug and

Cosmetic Act, 21 U.S.C. 346a, to amend

40 CFR part 180 by establishing an

exemption from the requirement of a

tolerance for residues of kaolin in or on

all food commodities. Pursuant to the

section 408(d)(2)(A)(i) of the FFDCA, as

amended, Engelhard Corporation has

submitted the following summary of

information, data, and arguments in

support of their pesticide petition.

A. Proposed Use Practices

Kaolin is to be used as an aid in

control of damage to plants from insects,

mites, fungi, and bacteria. Kaolin is

used at the rates of 6.25 to 12.4 lbs/acre

for row crop vegetables, 25 to 175 lbs/

acre for tree fruit crops, and 12.5 to 37.5

lbs/acre for small fruit crops. Treatment

is made prior to leaf or plant emergence

and applied to crops at 7 to 10 day
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Notices 63169

intervals depending on the pest to be

controlled. Dosage rates are applied

with standard spray equipment.

B. Product Identity/Chemistry

Kaolin is a white, nonporous,

nonswelling, natural occuring

aluminosilicate mineral with the

chemical formula Al4Si4O10(OH)8.

Kaolin is one of the most highly divided

and highly refined naturally occurring

minerals. Median particle size of

commercial products vary between 0.1 –

10 microns. Kaolin is nonreative. Its

hydrophilic surface allows kaolin to be

easily dispersed in water at neutral pH

values of 6–8. Common physical

properties of kaolin are: platy shape,

high brightness (80–95), specific gravity

2.58–2.63, refractive index 1.56–1.62,

and Mohs hardness 2–3.

C. Toxicological Profile

Acute toxicity. An acute oral toxicity

limit test, acute dermal toxicity test on

the active ingredient and an acute oral

toxicity test, a primary skin irritation

test, and primary eye irritation test on

the end use product have been

submitted. The acute oral limit dose test

on the active ingredient showed that the

single dose Acute Oral LD50 is greater

than 5,000 mg/kg of bodyweight of rats.

The acute dermal toxicity limit test on

the active ingredient showed that the

single dose Acute Dermal LD50 is greater

than 5,000 mg/kg of bodyweight. The

primary skin irritation study on the end

use product showed that the test

substance is classified as slightly

irritating to the skin. The primary eye

irritation study on the end use product

showed that the test substance is

classified as minimally irritating and

non-irritating to the unrinsed and rinsed

eye respectively.

Kaolin is used as an indirect food

additive for paper/paper board dry food

contact, adhesives, polymeric coatings,

rubber articles, and cellophane. Kaolin

is used in pharmaceuticals, tablet

diluents, poultices, and surgical dusting

powders. Kaolin is used as a cosmetic

in face powders, face masks, and face

packs. Kaolin is used in health products

and toiletries, toothpaste, and

antiperspirants. Kaolin can be used

directly in foods as an anti-caking agent

(up to 2.5%). Kaolin has GRAS

(Generally Recognized as Safe) status

under 21 CFR 186.1256 and is generally

recognized as safe ‘‘As an indirect

human food ingredient with no

limitation other than current good

manufacturing practice.’’

D. Aggregate Exposure

1. Dietary exposure. Dietary exposure

of kaolin via food or water is difficult

to estimate due to the use of kaolin in

thousands of products. Kaolin is an

inert mineral naturally occuring in the

environment, and has no known

toxicological effects.

2. Non-dietary exposure, nonoccupational exposure. Increased nondietary exposure of kaolin via lawn care,

topical insect repellents, etc., is not

applicable to this application.

E. Cumulative Exposure

Kaolin has no mode of toxicity and

therefore cumulative exposure is not

applicable. Kaolin is used in thousands

of products as well as being a naturally

occurring part of the environment.

Cumulative exposure is not possible to

calculate nor is it necessary due to the

non-toxic nature of kaolin.

F. Endocrine Disruptors

Engelhard Corporation has no

information to suggest that kaolin will

adversely affect the immune or

endocrine systems.

G. Safety Considerations

The lack of toxicity of kaolin is

demonstrated by the above summary.

Based on this information, the aggregate

exposure to kaolin over a lifetime

should not pose appreciable risks to

human health. There is a reasonable

certainty that no harm will result from

aggregate exposure to kaolin residues.

Exempting kaolin from the requirement

of a tolerance should be considered safe

and pose insignificant risk.

H. Analytical Method

An analytical method for residues is

not needed as this petition requests an

exemption from the requirement of a

tolerance.

I. Existing Tolerances

Kaolin is exempted from the

requirement of a tolerance ‘‘when used

as an inert ingredient in pesticide

formulations applied to growing crops

or to raw agricultural commodities after

harvest.’’ (40 CFR 180.1001).

The registrant does not know if

international tolerance exemptions

exist. (Driss Benmhend).

2. Plant Genetic Systems (America) Inc.

PP 7G4921

EPA has received pesticide petition

(PP 7G4921) from Plant Genetic Systems

(America), Inc., 7200 Hickman Road,

Suite 202, Des Moines, IA 50322,

proposing pursuant to section 408(d) of

the Federal Food, Drug and Cosmetic

Act, 21 U.S.C. 346a(d), to amend 40 CFR

part 180 by establishing a temporary

exemption from the requirement of a

tolerance for residues of the plantpesticide Bacillus thuringiensis subsp.

tolworthi Cry9C and the genetic material

necessary for the production of this

protein in corn for feed use only. The

summary of the petition published in

this notice was proposed by the

petitioner. This request proposes to

amend Experimental Use Permit,

70218–EUP–1, issued to Plant Genetic

Systems (America), Inc. on February 5,

1997, issued under crop destruct

conditions.

Pursuant to the section 408(d)(2)(A)(i)

of the FFDCA, as amended, Plant

Genetic Systems (America) has

submitted the following summary of

information, data and arguments in

support of their pesticide petition. This

summary was prepared by Plant Genetic

Systems (America) and EPA has not

fully evaluated the merits of the

petition. The summary may have been

edited by EPA if the terminology used

was unclear, the summary contained

extraneous material, or the summary

was not clear that it reflected the

conclusion of the petitioner and not

necessarily EPA.

A. Bacillus thuringiensis subsp.

tolworthi Cry9C Protein Uses

Corn plants have been protected from

lepidopteran insect pests such as

European corn borer Ostrinia nubilalis

(Huber), by expressing a Cry9C protein.

The Cry9C protein expressed by the

corn plants corresponds to the

insecticidal moiety of the Cry9C crystal

protein of a Bacillus thuringiensis

subsp. tolworthi strain. Transgenic corn

plants, expressing Cry9C protein,

represents an excellent addition to

growers’ options for insect control that

reduces or eliminates the need for

chemical inputs and fits well within an

integrated pest management program.

B. Product Identity/Chemistry

The cry9C gene, was isolated from the

Bacillus thuringiensis tolworthi strain,

truncated and modified before it was

stably inserted into corn plants. The

tryptic core of the microbially produced

Cry9C delta-endotoxin is similar to the

Cry9C protein found in event CBH351.

The Cry9C protein was produced and

purified from a bacterial host, for the

purposes of mammalian toxicity studies.

Product analysis that compared the

Cry9C protein from the two sources

included: SDS-PAGE, Western blots, Nterminal amino acid sequencing,

glycosylation tests (for possible posttranslational modifications) and insect

bioassays.

No analytical method is included

since this petition requests a temporary

exemption from the requirement of a

tolerance.
63170 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Notices

C. Mammalian Toxicological Profile

Bacillus thuringiensis proteins have

been used commercially for more than

30 years without any evidence for

adverse health effects. Bacillus

thuringiensis mode-of-action can be

divided into a series of critical steps:

ingestion by the insect, specific binding

to brush border membrane receptors,

membrane insertion, and pore formation

thus destroying the midgut lining and

causing death of the insect. Bacillus

thuringiensis proteins do not bind or

cause these types of effects to

mammalian gut membranes. The

extensive mammalian toxicity studies

performed to support the safety of

Bacillus thuringiensis - containing

pesticides clearly demonstrate that the

tested isolates are not toxic or

pathogenic (McClintock, et al., 1995,

Pestic. Sci. 45:95–105). Although

Bacillus thuringiensis strains have been

used for decades as sprayable microbial

products, no confirmed cases of allergic

reactions have been documented,

despite dermal, oral and inhalation

exposures. A reference to this is made

by the EPA in a Federal Register notice,

dated August 16, 1995 (60 FR 42443)

(FRL–4971–3).

The Cry9C protein insecticidal modeof-action is apparently similar to that of

the well known Cry1A proteins. In

addition to the safe history of Bacillus

thuringiensis proteins outlined above,

several other studies were performed to

evaluate mammalian safety of the Cry9C

protein. An acute toxicological study

was performed with mice, which

demonstrated that the Cry9C protein

had an LD50 >6,500 mg/kg. A test for in

vitro digestibility under simulated

gastric conditions showed that the

Cry9C protein found in bacteria and the

protein produced in plants was stable

for 4 hours when exposed to simulated

gastric juice. However, an amino acid

sequence homology search performed

using three different data banks (against

135,867 sequences) only found

homology to other related Bacillus

thuringiensis proteins. To determine

possible short stretch homology, an 8-

amino acid homology search was also

performed. Except with the Bacillus

thuringiensis proteins, no identical 8-

amino acid peptide sequences could be

detected in the searches. Therefore, it is

unlikely that Cry9C protein would have

significant allergenic potential.

The Cry9C protein or metabolites of

the protein are not expected to interact

with the immune or endocrine system,

since the protein sequence does not

match any known allergens or

hormones. Since proteins, in general,

are not known to be carcinogenic it is

unlikely that the Cry9C protein would

have carcinogenic properties.

All living organisms contain DNA and

there are no examples of nucleic acids

causing any toxicological effects from

dietary consumption. The genetic

material necessary for the production of

the Cry9C protein in plants includes the

genetic construct that encodes the

Cry9C protein and all other necessary

genetic elements for it’s expression.

These elements include: a promotor,

polylinker sequences, leader sequences

and terminators and none of which are

expected to cause any toxicological

effects.

Taken together, the data supports the

lack of mammalian toxicological effects

for the plant-pesticide Bacillus

thuringiensis subsp. tolworthi Cry9C

protein and the genetic material

necessary for the production of this

protein in corn for feed use only.

D. Aggregate Exposure

Since the Cry9C protein is expressed

in plant tissues, dermal or inhalation

will be negligible to non-existent.

Drinking water is unlikely to be

contaminated with Cry9C protein due to

the rapid degradation of plant materials

in the soil. Furthermore, no direct

human dietary exposure to Cry9C

protein will occur since this request is

for animal feed use only.

E. Cumulative Effects

The unique mode-of-action of Bt

proteins in general, coupled with the

lack of mammalian toxicity for the

Cry9C protein provides no basis for the

expectation of cumulative effects with

other compounds.

F. Safety Determination

Bt microbial pesticides containing Cry

proteins have been applied for more

than 30 years to food and feed crops

consumed by the US population. There

have been no human safety problems

attributed to Cry proteins. The extensive

mammalian toxicity studies performed

to support the safety of Bacillus

thuringiensis - containing pesticides

clearly demonstrate that the tested

isolates are not toxic or pathogenic

(McClintock, et al., 1995, Pestic. Sci.

45:95–105). The lack of mammalian

toxicity of the Cry9C protein provides

support for our request of a temporary

exemption from the requirement of a

tolerance set forth in this petition. Nondietary exposure of infants, children or

the US population in general, to the

Cry9C protein expressed in corn plant

materials, are not expected due to the

uses of this product for animal feed use

only.

G. Existing Tolerances

No tolerances or tolerance exemptions

have been granted for the Bacillus

thuringiensis subsp. tolworthi Cry9C

and the genetic material necessary for

the production of this protein in corn

for feed use only. (Michael

Mendelsohn)

[FR Doc. 97–31131 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–779; FRL–5755–6]

Notice of Filing of Pesticide Petition

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of pesticide petitions

proposing the establishment of

regulations for residues of certain

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by the

docket control number PF–779, must be

received on or before December 26,

1997.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticides Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460. In

person bring comments to: Rm. 1132,

CM #2, 1921 Jefferson Davis Highway,

Arlington, VA.

Comments and data may also be

submitted electronically to: oppdocket@epamail.epa.gov. Follow the

instructions under ‘‘SUPPLEMENTARY

INFORMATION.’’ No confidential

business information should be

submitted through e-mail.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

that does not contain CBI must be

submitted for inclusion in the public

record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8:30 a.m. to 4 p.m.,