Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules 15111

otherwise interfering with an action

taken or planned by another agency; (3)

materially altering the budgetary

impacts of entitlement, grants, user fees,

or loan programs; or (4) raising novel

legal or policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in this Executive

Order.

Pursuant to the terms of this

Executive Order, EPA has determined

that this rule is not ‘‘significant’’ and is

therefore not subject to OMB review.

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96–

354, 94 Stat. 1164, 5 U.S.C. 601–612),

the Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemptions from tolerance

requirements do not have a significant

economic impact on a substantial

number of small entities. A certification

statement to this effect was published in

the Federal Register of May 4, 1981 (46

FR 24950).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: March 8, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, it is proposed that 40 CFR

part 180 be amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

2. In § 180.447, by adding new

paragraph (d), to read as follows:

§ 180.447 Imazethapyr, ammonium salt;

tolerance for residues.

* * * * *

(d) Tolerances with regional

registration, as defined in § 180.1(n) of

this chapter, are established for the sum

of residues of the herbicide

imazethapyr, 2-[4,5-dihydro-4-methyl-4-

(1-methylethyl)-5-oxo-1H-imidazol-2-

yl]-5-ethyl-3-pyridine carboxylic acid,

as its ammonium salt, and its

metabolite, 2-[4,5-dihydro-4-methyl-4-

(1-methylethyl)-5-oxo-1H-imidazol-2-

yl]-5-(1-hydroxyethyl)-3-pyridine

carboxylic acid, both free and

conjugated, in or on the following raw

agricultural commodities:

Commodity Parts per

million

Endive (escarole) ...................... 0.1

Lettuce (head and leaf) ............ 0.1

[FR Doc. 95–6932 Filed 3–21–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[OPP–300380; FRL–4936–4]

RIN 2070–AC18

Acetic Acid Ethenyl Ester, Polymer

with Ethenol and (α)-2-Propenyl-(ω)-

Hydroxypoly(Oxy-1,2-Ethanediyl);

Tolerance Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes to

establish an exemption from the

requirement of a tolerance for residues

of acetic acid ethenyl ester, polymer

with ethenol and (α)-2-propenyl-(ω)-

hydroxypoly(oxy-1,2-ethanediyl) (CAS

Reg. No. 137091–12–4), when used as

an inert ingredient (component of watersoluble film) in pesticide formulations

applied to growing crops only under 40

CFR 180.1001(d). Japan Technical

Information Center, Inc., requested this

proposed regulation on behalf of

Nippon Gohsei (U.S.A.) Co., Ltd.

DATES: Written comments, identified by

the document control number, [OPP–

300380], must be received on or before

April 21, 1995.

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 Hwy., Arlington, VA

22202. 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).

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 submitted for

inclusion in the public record.

Information not marked confidential

will be included in the public docket by

EPA without prior notice. All written

comments will be available for public

inspection in Rm. 1132 at the address

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

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT:

Kerry Leifer, Registration Support

Branch, Registration Division (7505W),

Environmental Protection Agency, 401

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

Office location and telephone number:

2800 Crystal Drive, North Tower, 6th

Floor, Arlington, VA 22202, (703) 308–

8323.

SUPPLEMENTARY INFORMATION: Japan

Information Center, Inc., 775 South 23rd

St., Arlington, VA 22202, on behalf of

Nippon Gohsei (U.S.A.) Co., Ltd.,

submitted pesticide petition (PP)

4EO4403 to EPA requesting that the

Administrator, pursuant to section

408(e) of the Federal Food Drug, and

Cosmetic Act (FFDCA) (21 U.S.C.

346a(e)), propose to amend 40 CFR

180.1001(d) by establishing an

exemption from the requirement of a

tolerance for residues of acetic acid

ethenyl ester, polymer with ethenol and

(α)-2-propenyl-(ω)-hydroxypoly(oxy-1,2-

ethanediyl) (CAS Reg. No. 137091–12–

4), when used as an inert ingredient

(component of water-soluble film) in

pesticide formulations applied to

growing crops only under 40 CFR

180.1001(d).

Inert ingredients are all ingredients

that are not active ingredients as defined

in 40 CFR 153.125, and include, but are

not limited to, the following types of

ingredients (except when they have a

pesticidal efficacy of their own):

solvents such as alcohols and

hydrocarbons; surfactants such as

polyoxyethylene polymers and fatty

acids; carriers such as clay and

diatomaceous earth; thickeners such as

carrageenan and modified cellulose;

wetting, spreading, and dispersing

agents; propellants in aerosol

dispensers; microencapsulating agents;

and emulsifiers. The term ‘‘inert’’ is not

intended to imply nontoxicity; the

ingredient may or may not be

chemically active.

The data submitted in the petition

and other relevant material have been

evaluated. As part of the EPA policy

statement on inert ingredients published

in the Federal Register of April 22, 1987

(52 FR 13305), the Agency set forth a list

of studies which would generally be

used to evaluate the risks posed by the

presence of an inert ingredient in a

pesticide formulation. However, where

it can be determined without that data

that the inert ingredient will present

minimal or no risk, the Agency

generally does not require some or all of

the listed studies to rule on the

proposed tolerance or exemption from

the requirement of a tolerance for an
15112 Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules

inert ingredient. The Agency has

decided that no data, in addition to that

described below, for acetic acid ethenyl

ester, polymer with ethenol and (α)-2-

propenyl-(ω)-hydroxypoly(oxy-1,2-

ethanediyl) will need to be submitted.

The rationale for this decision is

described below.

In the case of certain chemical

substances that are defined as

‘‘polymers,’’ the Agency has established

a set of criteria which identify categories

of polymers that present low risk. These

criteria (described in 40 CFR 723.250)

identify polymers that are relatively

unreactive and stable compared to other

chemical substances as well as polymers

that typically are not readily absorbed.

These properties generally limit a

polymer’s ability to cause adverse

effects. In addition, these criteria

exclude polymers about which little is

known. The Agency believes that

polymers meeting the criteria noted

above will present minimal or no risk.

Acetic acid ethenyl ester, polymer with

ethenol and (α)-2-propenyl-(ω)-

hydroxypoly(oxy-1,2-ethanediyl)

conforms to the definition of a polymer

given in 40 CFR 723.250(b)(11) and

meets the following criteria that are

used to identify low-risk polymers.

1. The minimum number-average

molecular weight of acetic acid ethenyl

ester, polymer with ethenol and (α)-2-

propenyl-(ω)-hydroxypoly(oxy-1,2-

ethanediyl) is 15,000. Substances with

molecular weights greater than 400

generally are not absorbed through the

intact skin, and substances with

molecular weights greater than 1,000

generally are not absorbed through the

intact gastrointestinal tract. Chemicals

not absorbed through skin or GI tract

generally are incapable of eliciting a

toxic response.

2. Acetic acid ethenyl ester, polymer

with ethenol and (α)-2-propenyl-(ω)-

hydroxypoly(oxy-1,2-ethanediyl) is not

a cationic polymer, nor is it reasonably

expected to become a cationic polymer

in a natural aquatic environment.

3. Acetic acid ethenyl ester, polymer

with ethenol and (α)-2-propenyl-(ω)-

hydroxypoly(oxy-1,2-ethanediyl) does

not contain less than 32.0 percent by

weight of the atomic element carbon.

4. Acetic acid ethenyl ester, polymer

with ethenol and (α)-2-propenyl-(ω)-

hydroxypoly(oxy-1,2-ethanediyl)

contains as an integral part of its

composition the atomic elements

carbon, hydrogen, nitrogen, and oxygen.

5. Acetic acid ethenyl ester, polymer

with ethenol and (α)-2-propenyl-(ω)-

hydroxypoly(oxy-1,2-ethanediyl) does

not contain as an integral part of its

composition, except as impurities, any

elements other than those listed in 40

CFR 723.250(d)(3)(ii).

6. Acetic acid ethenyl ester, polymer

with ethenol and (α)-2-propenyl-(ω)-

hydroxypoly(oxy-1,2-ethanediyl) is not

a biopolymer, a synthetic equivalent of

a biopolymer, or a derivative or

modification of a biopolymer that is

substantially intact.

7. Acetic acid ethenyl ester, polymer

with ethenol and (α)-2-propenyl-(ω)-

hydroxypoly(oxy-1,2-ethanediyl) is not

manufactured from reactants containing,

other than impurities, halogen atoms or

cyano groups.

8. Acetic acid ethenyl ester, polymer

with ethenol and (α)-2-propenyl-(ω)-

hydroxypoly(oxy-1,2-ethanediyl) does

not contain a reactive functional group

that is intended or reasonably expected

to undergo further reaction.

9. Acetic acid ethenyl ester, polymer

with ethenol and (α)-2-propenyl-(ω)-

hydroxypoly(oxy-1,2-ethanediyl) is

neither designed nor reasonably

expected to substantiaully degrade,

decompose, or depolymerize.

Based on the information above and

review of its use, EPA has found that,

when used in accordance with good

agricultural practice, this ingredient is

useful, and a tolerance is not necessary

to protect the public health. Therefore,

EPA proposes that the exemption from

the requirement of a tolerance be

established as set forth below.

Any person who has registered or

submitted an application for registration

of a pesticide, under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA) as amended, that contains

any of the ingredients listed herein, may

request within 30 days after the

publication of this document in the

Federal Register that this rulemaking

proposal be referred to an Advisory

Committee in accordance with section

408(e) of the FFDCA.

Interested persons are invited to

submit written comments on the

proposed regulation. Comments must

bear a notation indicating the document

control number, [OPP–300380]. All

written comments filed in response to

this petition will be available in the

Public Response and Program Resources

Branch, at the address given above, from

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

Friday, except legal holidays.

The Office of Management and Budget

has exempted this rule from the

requirements of section 2 of Executive

Order 12866.

Pursuant to the requirement of the

Regulatory Flexibility Act (Pub. L. 96–

354, 94 Stat. 1164, 5 U.S.C. 601–612),

the Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemptions from tolerance

requirements do not have an economic

impact on a substantial number of small

entities. A certification statement to this

effect was published in the Federal

Register of May 4, 1981 (46 FR 24950).

List of Subject in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: March 8, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, it is proposed that 40 CFR

part 180 be amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

2. Section 180.1001(d) is amended in

the table therein by adding and

alphabetically inserting the inert

ingredient, to read as follows:

§ 180.1001 Exemptions from the

requirement of a tolerance.

* * * * *

(d) * * *

Inert ingredient Limits Uses

* * * * * * *

Acetic acid ethenyl ester, polymer with ethenol and

(α)-2-propenyl-(ω)-hydroxypoly(oxy-1,2-ethanediyl)

(CAS Reg. No. 137091–12–4); minimum number

average molecular weight 15,000.

.............................................. Component of water-soluble film.

* * * * * * *
Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules 15113

* * * * *

[FR Doc. 95–6933 Filed 3–21–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Parts 180, 185, and 186

[FAP 4H5683/P600; FRL–4935–1]

RIN 2070–AC18

Hexazinone; Pesticide Tolerances and

Food/Feed Additive Regulations

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes to

amend the current tolerance for residues

of the herbicide hexazinone (3-

cyclohexyl-6-(dimethylamino)-1-

methyl-1,3,5-triazine-2,4(1H,3H)-dione

and its metabolites (calculated as

hexazinone) in or on sugarcane at 0.2

part per million (ppm) by revoking the

current tolerance and reestablishing the

same tolerance with regional

registration and tolerance as described

by 40 CFR 180.1(n). EPA also proposes

to establish food and feed additive

regulations for residues of hexazinone

and its metabolites (calculated as

hexazinone) in sugarcane molasses at

0.5 ppm. E. I. du Pont de Nemours &

Co., Inc., requested these proposed

regulations.

DATES: Written comments, identified by

the document control number [FAP

4H5683/P600], must be received on or

before April 21, 1995.

ADDRESSES: By mail, submit written

comments to: Public Response Section,

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 Hwy.,

Arlington, VA 22202.

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). 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 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 Virginia

address given above, from 8 a.m. to 4

p.m., Monday through Friday, excluding

legal holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Joanne I. Miller, Product Manager

(PM) 23, Registration Division (7505C),

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 237, CM #2, 1921 Jefferson Davis

Hwy., Arlington, VA 22202, (703–305–

7830).

SUPPLEMENTARY INFORMATION: E.I. du

Pont de Nemours & Co., Inc., has

requested a regional registration for the

use of hexazinone end-use pesticide

products for the use site, sugarcane. The

company proposed that the use-site

exclude the State of Florida, because the

product is not efficacious in muck soils

at dosages that would be economically

viable to growers. The company has

stated that the rate needed for weed

control in the typically high organic soil

of Florida used for the culture of

sugarcane would exceed the maximum

labelled dosage. In addition, the

company also stated that the high rates

would not be economically viable

considering other less expensive, lower

application rate products. Based on the

information submitted, the company has

proposed a geographically limited

registration for use of hexazinone in

sugarcane. In this case, the company

contends that there is little likelihood

for the use of hexazinone in the State of

Florida and that its residue data are

representative of all sugarcane-growing

areas of the United States.

Published information on acres of

sugarcane grown in the State of Florida

on other than organic soils (Spodosols,

Entisols, Mollisols) was 11.1% of a total

of 464,191 acres in 1993 (Sugar Y

Azucar 89:(1): 39–44). EPA has no data

on potential residues of hexazinone

when used in the culture of sugarcane

commodities from studies with

sugarcane cultured in the State of

Florida. Residue chemistry data from a

Florida study are required to allow the

unrestricted use of hexazinone in the

culture of sugarcane.

EPA issued a notice, published in the

Federal Register of July 13, 1994 (59 FR

35179), which announced that E.I. Du

Pont de Nemours & Co., Inc., had

submitted food additive petition (FAP)

4H5683 to EPA requesting that the

Administrator, pursuant to section 409

of the Federal Food, Drug and Cosmetic

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

40 CFR parts 185 and 186 by

establishing tolerances for residues of

the herbicide hexazinone (3-cyclohexyl6-dimethylamino)-1-methyl-1,3,5-

triazine-2,4-(1H,3H)-dione) in or on

sugarcane molasses at 5.0 ppm and

sugarcane bagasse at 0.5 ppm.

Sugarcane bagasse is not currently

considered a food or a feed commodity

by EPA; therefore, the requested

tolerance is not proposed to be

established in this document.

There were no comments received in

response to the notice of filing. The

scientific data submitted with the

petition and other relevant material

have been evaluated. The toxicological

and residue chemistry data considered

in support of the proposed actions

include the following:

1. Plant and animal metabolism

studies.

2. Enforcement methodology for

determining residues.

3. A 90-day feeding study with rats,

with a NOEL of 50 mg/kg/day and an

LEL of 150 mg/kg/day with the effect

being decreased body weights in both

sexes.

4. A 90-day feeding study with dogs,

with a NOEL of 25 mg/kg/day, increase

alkaline phosphatase, decreased

albumin/globulin, and increased

absolute and relative liver weights in

both sexes.

5. A 21-day dermal study in rabbits,

with a NOEL of 1,000 mg/kg/day, the

highest dose tested (HDT).

6. A 12-month chronic feeding study

with dogs, with a NOEL of 5.0 mg/kg/

day and a lowest effect level (LEL) of

37.5 mg/kg/day with thinness in one

male dog, increased alkaline

phosphatase in males, decrease albumin

and increased golbulin in males, pale

kidneys in one female, and increased

incidence of hepatocellular vacuolation

in males, and cytoplasmic inclusions

and pigmented Kupffer cells in the

livers of females.

7. A 24-month carcinogenicity study

in mice that was equivocal for

adenomas/carcinomas, with no

statistical significance in pair-wise

comparison between control and dosed

animals; systemic NOEL of 30 mg/kg/

day and systemic LEL of 375 mg/kg/day.

8. A developmental toxicity study

with rats, with a maternal NOEL of 100

mg/kg/day and maternal LEL of 400 mg/

kg/day; a developmental NOEL of 100

mg/kg/day and developmental LEL of

400 mg/kg/day (decreased fetal body

weight, increased incidence of fetuses

with no kidney papilla, and increased

incidence of fetus with unossified

sternebrae).

9. A developmental toxicity study in

rabbits, with a maternal NOEL of 50 mg/

kg/day and a maternal LEL of 125 mg/

kg/day (decreased body weight gains,

increased resorptions and increased

clinical signs); and with a

developmental NOEL of 50 mg/kg/day

and a developmental LEL of 125 mg/kg/

day (decreased body weight and delayed

ossifications of extremities).