17812 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices

after a Council meeting. Written

statements received prior to the meeting

will be distributed to all members of the

Council before any final discussion or

vote is completed. Any statements

received after the meeting will become

part of the permanent meeting file and

will be forwarded to the Council

members for their information.

Members of the public that would like

to attend the meeting, present an oral

statement, or submit a written

statement, should contact Ms. Charlene

Shaw, Designated Federal Officer,

National Drinking Water Advisory

Council, U.S. EPA, Office of Ground

Water and Drinking Water (4601), 401 M

Street SW., Washington, D.C. 20460.

The telephone number is Area Code

(202) 260–2285 or E-Mail

shaw.charlene@epamail.epa.gov.

Dated: April 7, 1997.

Cynthia C. Dougherty,

Director, Office of Ground Water and Drinking

Water.

[FR Doc. 97–9384 Filed 4–10–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[PF–729; FRL–5597–6]

W. Neudorff GmbH KG; Pesticide

Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of a

regulation for an exemption from the

requirement of a tolerance for residues

of low erucic acid (less than 2%)

rapeseed oil, i.e., canola oil, when used

in accordance with good agricultural

practice as an active ingredient in

pesticide formulations applied to

growing crops. The summary of the

petition published in this notice was

prepared by the petitioner.

DATES: Comments, identified by the

docket number [PF–729], must be

received on or before, May 12, 1997.

ADDRESSES: By mail, submit written

comments to Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide 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

22202.

Comments and data may also be

submitted electronically by following

the instructions under

‘‘SUPPLEMENTARY INFORMATION’’

of this document. No Confidential

Business Information (CBI) should be

submitted through e-mail.

Information submitted as comments

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). 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: By

mail: Sheryl Reilly, Regulatory Action

Leader (PM 90), Biopesticides and

Pollution Prevention Division, Office of

Pesticide Programs, U.S. Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location,

telephone number, and e-mail address:

5th floor, CS 1-5W29, 2800 Crystal

Drive, Arlington, VA, Telephone No.

703–308–8265, e-mail:

reilly.sheryl@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition (PP

6F4747) from W. Neudorff GmbH KG

(‘‘Neudorff’’), c/o Walter Telarek, 1008

Riva Ridge Drive, Great Falls, VA 22066,

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 an exemption

from the requirement of a tolerance for

residues of the insecticide, canola oil,

on growing crops. EPA has determined

that the petition contains 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.

As required by section 408(d) of the

FFDCA, as recently amended by the

Food Quality Protection Act, W.

Neudorff GmbH KG included in the

petition a summary of the petition and

authorization for the summary to be

published in the Federal Register in a

notice of receipt of the petition. The

summary represents the views of W.

Neudorff GmbH KG; EPA, as mentioned

above, is in the process of evaluating the

petition. As required by section

408(d)(3) EPA is including the summary

as a part of this notice of filing. EPA

may have made minor edits to the

summary for the purpose of clarity.

EPA invites interested persons to

submit comments on this notice of

filing. Comments must bear a

notification indicating the document

control number [PF–729].

The official record for this

rulemaking, as well as the public

version, has been established for this

rulemaking under docket number ‘‘PF–

729’’ (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

rulemaking record is located at the

Virginia 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 file format or ASCII file

format. All comments and data in

electronic form must be identified by

the docket number PF–729; FRL–5597–

–6. Electronic comments on this

proposed rule may be filed online at

many Federal Depository Libraries.

List of Subjects

Environmental Protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: March 28, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

Below is a summary of the pesticide

petition. The summary of the petition

was prepared by the petitioner. 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.
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices 17813

W. Neudorff GmbH KG

PP 6F4747

A. Proposed Use Practices

1. Recommended application method

and rate(s), frequency of application,

and timing of application. Spray tanks

and sprinkler irrigation systems may be

used. The rate of application is 3.84 to

7.68 gallons of active ingredient per

acre. The frequency and timing of

application vary widely according to the

crop being treated. For example: for fruit

and nut trees, the product is applied

during the dormant and pre-bloom

stages and during the summer; for sugar

beets, the product is applied as needed;

and for cotton, the product is applied

when insects appear, and thereafter,

weekly as needed.

B. Product Identity/Chemistry

1. Identity of the pesticide and

corresponding residues. The active

ingredient is low erucic acid (less than

2%) rapeseed oil, i.e., canola oil. Canola

oil is the full refined edible oil obtained

from certain varieties of plants, i.e.,

Brassica napus or B. campestris of the

family Cruciferae. The organic

substance is rapidly degraded in the

environment to organic constituents by

normal biological, physical and

chemical processes that can be

reasonably expected to exist where the

pesticide is applied.

2. Magnitude of residue anticipated at

the time of harvest and method used to

determine the residue. Neudorff has

requested waivers for these data

requirements. The waiver requests were

based on canola oil’s known low

toxicity and risks, natural occurrence

and abundance in the environment,

widespread use as an edible fat and oil

in foods, FDA generally recognized as

safe (GRAS) status (21 CFR 184.1555(c)),

non-toxic mode of action, anticipated

low volume use in pesticide products,

and the data available in the open

literature. Further, EPA has already

promulgated an exemption from the

requirement for a tolerance for canola

oil when it is used as a surfactant or

related adjuvant of a surfactant in

pesticide formulations applied to

growing crops (40 CFR 180.1001(d)). In

addition, EPA has expressly waived

these data requirements for soybean oil,

which is a vegetable oil whose fatty acid

profile is very similar to that of canola

oil.

3. Statement of why an analytical

method for detecting and measuring the

levels of the pesticide residue are not

needed. Neudorff has not proposed an

analytical method, because canola oil

levels harmful to plants and animals are

highly unlikely to occur when it’s

formulated canola oil product is applied

according to label instructions.

Moreover, it is an organic compound

known to be rapidly degraded in the

environment to organic constituents by

normal biological, physical and

chemical processes that can be

reasonably expected to exist where the

pesticide is applied. Furthermore, the

oils, or triglycerides, within canola oil

already exist as normal constituents of

the plants being treated. Last, there is no

information indicating that this

substance, its metabolites, and

degradates either are absorbed by or

cannot be metabolized by plants.

C. Mammalian Toxicological Profile

1. Acute toxicity. Available literature

indicates that this substance has low

acute toxicities. In addition, FDA has

promulgated a regulation granting GRAS

status to this substance (21 CFR

184.1555(c)).

2. Genotoxicity, reproductive and

developmental toxicity, subchronic

toxicity, and chronic toxicity. Canola oil

is a food that is readily metabolized by

humans. There is adequate information

available from literature sources to

characterize the toxicity of canola oil.

These studies indicate that canola oil’s

nutritional and toxicological profile is

similar to those of other vegetable oils

(50 FR 3745, 3752, January 28, 1985).

Moreover, the available literature

indicates that the use of this substance

as a component of food is safe (50 FR

3745, 3753).

D. Aggregate Exposure

1. Dietary exposure—a. Food. Canola

oil is used as a fat and oil in food

consumed by humans. FDA has

promulgated a regulation listing canola

oil as GRAS when used as a direct food

additive (21 CFR 184.1555(c)).

Moreover, FDA has stated that the upper

level of canola oil likely to be ingested

by a U.S. consumer is safe (50 FR 3745).

b. Drinking water. There is unlikely to

be any exposure to this substance via

drinking water. Even though the

chemical can be washed off treated

plants by rain and during processing of

crops by water, it is an organic

compound known to be rapidly

degraded in the environment into

organic constituents by normal

biological, physical, and chemical

processes.

2. Non-dietary exposure. The only

non-dietary exposure expected is to

applicators. However, exposure to this

chemical resulting from its application

according to label directions is not

expected to present any risk of adverse

health effects.

E. Cumulative Exposure

This substance has been designated

by FDA as a GRAS food substance. It is

a vegetable oil that has been used as a

cooking oil and in margarine for many

years. Because of these facts, and the

fact that canola oil has a higher ratio of

unsaturated fats to saturated fats than

other vegetable oils, no cumulative

adverse health effects are expected from

long-term exposure to this chemical.

1. Exposure through other pesticides

and substances with the common mode

of toxicity as this pesticide. Canola oil

is an insect repellant which belongs to

a class of structurally related

compounds known as vegetable oils.

This class includes corn, cottonseed,

sesame and soybean oils. Of these, only

soybean oil is a currently registered

pesticide. Vegetable oils have a nontoxic

mode of action; it has been theorized

that they (a) alter the cuticle structure of

the leaf surface, thus repelling the

insects, or (b) act as irritants to insects.

Consequently, the nontoxic mode of

action for vegetable oils appears to be as

functional blockades to the metabolic

abilities or feeding abilities of insects.

These compounds are approved for food

uses in the United States and are

recognized by the Food and Drug

Administration as safe. Vegetable oils

could be considered in an aggregate

exposure assessment; however, there is

no information showing that these

compounds cause significant adverse

effects to mammals or that the use of

soybean oil and canola oil as

insecticides will result in significant

additional exposure. Moreover,

Neudorff has no information indicating

or suggesting that canola oil has toxic

effects on animals that would be

cumulative with those of any other

compound.

F. Safety Determination

1. U.S. population. Canola oil is a

direct food additive that is considered

GRAS by FDA (21 CFR 184.1555(c)). It

is commonly used as a human food, i.e.,

as a fat or oil in food. Moreover, EPA

has promulgated an exemption from the

requirements for a tolerance for canola

oil when it is used in accordance with

good agricultural practice as a surfactant

or related adjuvants of surfactants in

pesticide formulations applied to

growing crops (40 CFR 180.1001(d)).

Canola oil is widely distributed in

commerce and available to the general

public throughout the United States for

non-pesticidal uses. Canola oil has a

non-toxic mode of action for the target

pests. It is an organic compound known

to be rapidly degraded in the

environment to organic constituents by
17814 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices

normal biological, physical and

chemical processes that can be

reasonably expected to exist where the

pesticide is applied. Use of canola oil as

an active ingredient in the products

sought to be registered is expected to be

low, and is not likely to result in

adverse human health effects, based

upon available reports and information.

Since people are exposed to this

substance from food or other sources,

the incremental exposure from its use in

pesticide products is expected to be

negligible.

2. Infants and children. FDA’s GRAS

determination applies equally to adults

and infants and children, with the

exception of the chemical’s use in infant

formulas. This exception is due to FDA

not evaluating the use, however.

Moreover, the fatty acid profile for

canola oil is similar to the fatty acid

profiles for other vegetable oils. All

vegetable oils are metabolized the same;

and human metabolic pathways are

well-established. In essence, vegetable

oils are broken down in the digestive

tract into useful components that are

either burned as fuel or stored as fat for

later use by the body. Furthermore,

there is nothing about the chemistry of

this substance or the anticipated levels

of it that will be consumed by infants

and children to indicate that their

normal homeostatic mechanisms will

not be protective.

G. Existing Tolerances

1. Existing tolerances or tolerance

exemptions. EPA has promulgated an

exemption from the requirement for a

tolerance for canola oil (low erucic acid

rapeseed oil conforming to 21 CFR

184.1555(c)) when it is used in

accordance with good agricultural

practice as a surfactant or related

adjuvants of surfactants in pesticide

formulations applied to growing crops

(40 CFR 180.1001(d)).

2. International tolerances or

tolerance exemptions. No maximum

residue level has been established for

this substance by the Codex

Alimentarius Commission.

[FR Doc. 97–9386 Filed 4–10–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–181042; FRL 5598–5]

Emamectin Benzoate; Receipt of

Application for Emergency Exemption,

Solicitation of Public Comment

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: EPA has received a specific

exemption request from the Hawaii

Department of Agriculture (hereafter

referred to as the ‘‘Applicant’’) to use

the pesticide emamectin benzoate (CAS

137512–74–4) (formulated as ‘‘Proclaim

5SG’’) to control the diamondback moth

on up to 1,000 acres of head and

Chinese Napa cabbage in Hawaii. The

Applicant proposes the use of a ‘‘new’’

chemical (an active ingredient not

currently found in any registered

product). In accordance with 40 CFR

166.24, EPA is soliciting public

comment before making the decision

whether or not to grant the exemption.

DATES: Comments must be received on

or before April 15, 1997.

ADDRESSES: Three copies of written

comments, bearing the identification

notation ‘‘OPP–181042,’’ should be

submitted by mail to: Public Response

and Program Resource Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

comments to: Rm. 1132, Crystal Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA.

Comments and data may also be

submitted electronically by following

the instructions under

‘‘SUPPLEMENTARY INFORMATION’’

of this document. No Confidential

Business Information (CBI) should be

submitted through e-mail.

Information submitted in any

comment concerning this notice may be

claimed confidential by marking any

part or all of that information as CBI.

Information so marked 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 provided by the

submitter for inclusion in the public

record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice. All written

comments filed pursuant to this notice

will be available for public inspection in

Rm. 1132, Crystal Mall #2, 1921

Jefferson Davis Highway, Arlington, VA,

from 8:30 a.m. to 4 p.m., Monday

through Friday, except legal holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Olga Odiott, Registration Division

(7505W), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location, telephone number and

e-mail: Sixth floor, Crystal Station #1,

2800 Jefferson Davis Highway,

Arlington, VA, (703) 308–6418; e-mail:

odiott.olga@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Pursuant

to section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA)

(7 U.S.C. 136p), the Administrator may,

at her discretion, exempt a state agency

from any registration provision of

FIFRA if she determines that emergency

conditions exist which require such

exemption. The Applicant has requested

the Administrator to issue a specific

exemption for the use of emamectin

benzoate on head and Chinese Napa

cabbage to control the diamondback

moth. Information in accordance with

40 CFR part 166 was submitted as part

of this request.

The Applicant states that the

diamondback moth has become resistant

to registered materials, which were

formerly effective at providing control.

Growers using these products have

experienced significant yield reductions

due to feeding damage by the

diamondback moth, when it was not

adequately controlled through use of

registered materials. The Applicant

states that although several alternative

control practices have been adopted by

many cabbage growers, these

alternatives are only partially effective,

and that without an effective control

such as emamectin benzoate, cabbage

growers in Hawaii will likely suffer

severe economic losses.

The Applicant proposes to apply

emamectin benzoate at a rate of 0.0075

lbs. active ingredient (a.i.) per acre with

a maximum of six applications per crop

season, but no more than 0.045 lbs., a.i.

applied per acre per crop season. The

proposed use is for up to 1,000 acres of

head and Chinese Napa cabbage.

Therefore, use under this exemption

could potentially amount to a maximum

total of 45 lbs. of the active ingredient,

emamectin benzoate. This is the second

time an exemption request for this use

has been requested.

This notice does not constitute a

decision by EPA on the application

itself. The regulations governing section

18 require publication of a notice of

receipt in the Federal Register for an

application for a specific exemption

proposing the use of a new

(unregistered) chemical. Such notice

provides for opportunity for public

comment on the application.

The official record for this notice, as

well as the public version, has been

established for this notice under docket

number [OPP–181042] (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.,