21784 Federal Register / Vol. 60, No. 85 / Wednesday, May 3, 1995 / Proposed Rules

40 CFR Part 180

[OPP–300383; FRL–4945–6]

RIN 2070–AB78

Poly(phenylhexylurea), Cross-Linked;

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 poly(phenylhexylurea), cross-linked,

when used as an inert ingredient

(encapsulating agent) in pesticide

formulations applied to growing crops

only under 40 CFR 180.1001(d) to

replace the existing exemption from the

requirement of a tolerance for residues

of cross-linked polyurea-type

encapsulating polymer under 40 CFR

180.1082. The Monsanto Co. requested

this proposed regulation.

DATES: Written comments, identified by

the document control number, [OPP–

300383], must be received on or before

June 2, 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,

deliver 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.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect in 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket number

[OPP–300383]. No Confidential

Business Information (CBI) should be

submitted through e-mail. Electronic

comments on this proposed rule may be

filed online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

below in this document.

FOR FURTHER INFORMATION CONTACT: By

mail: Mary Waller, 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-

8811; e-mail:

Waller.Mary@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: The

Monsanto Co., Suite 1100, 700 14th St.,

NW., Washington, DC 20005, submitted

pesticide petition (PP) 4E04408 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 part 180 by replacing the

existing exemption from the

requirement of a tolerance for residues

of cross-linked polyurea-type

encapsulating polymer listed under 40

CFR 180.1082 with an exemption from

the requirement of a tolerance for

residues of poly(phenylhexylurea),

cross-linked, when used as an inert

ingredient (encapsulating agent) 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

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

inert ingredient. The Agency has

decided that no data, in addition to that

described below, for

poly(phenylhexylurea), cross-linked,

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.

Poly(phenylhexylurea), cross-linked,

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

poly(phenylhexylurea), cross-linked, is

36,000. 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. Poly(phenylhexylurea), crosslinked, is not a cationic polymer, nor is

it reasonably expected to become a

cationic polymer in a natural aquatic

environment.

3. Poly(phenylhexylurea), crosslinked, does not contain less than 32.0

percent by weight of the atomic element

carbon.

4. Poly(phenylhexylurea), crosslinked, contains as an integral part of its

composition the atomic elements

carbon, hydrogen, nitrogen, and oxygen.

5. Poly(phenylhexylurea), crosslinked, 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).
Federal Register / Vol. 60, No. 85 / Wednesday, May 3, 1995 / Proposed Rules 21785

6. Poly(phenylhexylurea), crosslinked, is not a biopolymer, a synthetic

equivalent of a biopolymer, or a

derivative or modification of a

biopolymer that is substantially intact.

7. Poly(phenylhexylurea), crosslinked, is not manufactured from

reactants containing, other than

impurities, halogen atoms or cyano

groups.

8. Poly(phenylhexylurea), crosslinked, does not contain a reactive

functional group that is intended or

reasonably expected to undergo further

reaction.

9. Poly(phenylhexylurea), crosslinked, is neither designed nor

reasonably expected to substantially

degrade, decompose, or depolymerize.

The establishment of an exemption

from the requirement of a tolerance for

residues of poly(phenylhexylurea),

cross-linked, when used as an inert

ingredient (encapsulating agent) in

pesticide formulations applied to

growing crops only under 40 CFR

180.1001 will obviate the need to

maintain an exemption of polyurea-type

encapsulating polymer as listed under

40 CFR 180.1082. The polymer listed in

40 CFR 180.1082 is described as being

‘‘formed by the reaction of

polymethylene polyphenylisocyanate

and hexamethylene diamine.’’ The

resultant polymer can best be described

as poly(phenylhexylurea), cross-linked,

the subject of this proposed regulation.

In addition, based on the polymer’s

conformance to the set of criteria that

are used to identify low-risk polymers,

the additional use restrictions described

in 40 CFR 180.1082 (i.e., use as an

encapsulating material for formulations

of alachlor (2-chloro-N-(2,6-

diethylphenyl)-N-(methoxymethyl)

acetamide) for use on dry beans, lima

beans, peas, potatoes and soybeans,

when applied to the soil before edible

portions of the crops form are no longer

applicable.

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-300383]. 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.

A record has been established for this

rulemaking under docket number [OPP300383] (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 a.m. to

4:30 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in Room 1132 of the

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

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.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer all comments received

electronically into printed, paper form

as they are received and will place the

paper copies in the official rulemaking

record which will also include all

comments submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ‘‘ADDRESSES’’ at the beginning of

this document.

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: April 20, 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 ingredients Limits Uses

* * * * * * *

Poly(phenylhexylurea), cross-linked; minimum average molecular weight 36,000............................................... Encapsulating agent.

* * * * * * *
21786 Federal Register / Vol. 60, No. 85 / Wednesday, May 3, 1995 / Proposed Rules

* * * * *

§ 180.1082 [Removed]

3. By removing § 180.1082 Crosslinked polyurea-type encapsulating

polymer (Alachlor); exemption from the

requirement of a tolerance.

[FR Doc. 95–10867 Filed 5–2–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 185

[OPP–300260A; FRL–4951–8]

RIN 2070–AC18

Acephate, Triadimefon, Iprodione, and

Imazalil; Revocation of Food Additive

Regulations; Reopening and Extension

of Comment Period

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule; Reopening and

extension of comment period.

SUMMARY: EPA is reopening and

extending until June 2, 1995, the

comment period for a proposed rule that

was published in the Federal Register of

January 18, 1995 (60 FR 3607) that

proposed the revocation of certain

section 409 food additive regulations

established under the Federal Food,

Drug and Cosmetic Act (FFDCA) for four

chemicals: acephate, triadimefon,

iprodione, and imazalil. The original

comment period on the proposal

extended until April 18, 1995, but

because of the unavailability of certain

documents in the docket, the comment

period is being extended.

DATES: Written comments, identified by

the document control number [OPP300360A], must be received on or before

June 2, 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.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect in 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket

number, [OPP-300360A]. No CBI should

be submitted through e-mail. Electronic

comments on this proposed rule may be

filed online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

below in this document.

FOR FURTHER INFORMATION CONTACT: By

mail: Niloufar Nazmi, Special Review

and Reregistration Division (7508W),

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. WF32C5, Crystal Station #1, 2800

Crystal Drive, Arlington, VA 22202,

(703)-308-8028; e-mail:

nazmi.niloufar@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: A record

has been established for this rulemaking

under docket number [OPP-300360A]

(including any 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 a.m. to

4 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in Rm. 1132 of the

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Hwy., Arlington, VA.

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.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer all comments received

electronically into printed, paper form

as they are received and will place the

paper copies in the official rulemaking

record which will also include all

comments submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ‘‘ADDRESSES’’ at the beginning of

this document.

List of Subjects in 40 CFR Part 185

Administrative practice and

procedure, Agricultural commodities,

Food additives, Pesticides and pests,

Processed foods, Reporting and

recordkeeping requirements.

Dated: April 25, 1995.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

[FR Doc. 95–10869 Filed 5–2–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 300

[FRL–5197–1]

National Oil and Hazardous

Substances Pollution Contingency

Plan; National Priorities List

AGENCY: Environmental Protection

Agency.

ACTION: Notice of intent to delete Alpha

Chemical Corporation Site from the

National Priorities List: request for

comments.

SUMMARY: The Environmental Protection

Agency (EPA) Region IV announces its

intent to delete the Alpha Chemical

Corporation Site from the National

Priorities List (NPL) and requests public

comment on this proposed action. The

NPL is codified as Appendix B of the

National Oil and Hazardous Substances

Pollution Contingency Plan (NCP), 40

CFR part 300, which EPA promulgated

pursuant to section 105 of the

Comprehensive Environmental

Response, Compensation, and Liability

Act (CERCLA) of 1980, as amended.

EPA and the State of Florida

Department of Environmental Protection

(FDEP) have determined that the Site

poses no significant threat to public

health or the environment and therefore,

no further response pursuant to

CERCLA is appropriate.

DATES: Comments concerning this Site

may be submitted on or before: June 2,

1995.

ADDRESSES: Comments may be mailed

to: Joe Franzmathes, Director, Waste

Management Division, U.S.

Environmental Protection Agency, 345

Courtland Street, N.E., Atlanta, Georgia

30365.

Comprehensive information on this

Site is available through the Region IV