Federal Register / Vol. 61, No. 119 / Wednesday, June 19, 1996 / Proposed Rules 31079

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: June 4, 1996.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR part 180 is

amended as follows:

1. The authority citation for part 180

continues to read as follows:

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

2. Section 180.471 is revised to read

as follows:

§ 180.471 3-Dichloroacetyl-5-(2-furanyl)-2,2-

dimethyloxazolidine; tolerances for

residues.

Time-limited tolerances are

established for residues of 3-

dichloroacetyl-5-(2-furanyl)-2,2-

dimethyloxazolidine (CAS Reg. No.

121776–33–8) when used as an inert

ingredient (safener) in pesticide

formulations in or on the following

agricultural commodities:

Commodity Parts per

million Expiration date

Corn, fodder (field) ....................................................................................................................................... 0.01 June 30, 1998

Corn, forage (field) ....................................................................................................................................... 0.01 June 30, 1998

Corn, grain (field) ......................................................................................................................................... 0.01 June 30, 1998

[FR Doc.96–15584 Filed 6–18–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 6E4652/P664; FRL–5377–1]

RIN 2070–AC18

Quizalofop ethyl; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish

tolerances for the combined residues of

the herbicide quizalofop-p ethyl ester,

its acid metabolite quizalofop-p, and the

S enantiomers of both the ester and the

acid, all expressed as quizalofop-p-ethyl

ester, in or on the raw agricultural

commodities peppermint tops and

spearmint tops. The proposed regulation

to establish maximum permissible

levels for residues of the herbicide was

requested in a petition submitted by the

Interregional Research Project No. 4 (IR4).

DATES: Comments, identified by the

docket number [PP 6E4652/P664], must

be received on or before July 19, 1996.

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 to OPP by sending electronic

mail (e-mail) to:

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. Comments 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 [PP 6E4652/P664].

Electronic comments on this proposed

rule may be filed online at many Federal

Depository Libraries. Additional

information on electronic submissions

can be found in the

‘‘SUPPLEMENTARY INFORMATION’’

section of this document.

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 a .m. to 4:30 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Hoyt L. Jamerson, Registration

Division (7505W), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St. SW., Washington, DC

20460. Office location and telephone

number: Sixth Floor, Crystal Station #1,

2800 Jefferson Davis Highway,

Arlington, VA 22202, (703) 308-8783; email: jamerson.hoyt@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: The

Interregional Research Project No. 4 (IR4), New Jersey Agricultural Experiment

Station, P.O. Box 231, Rutgers

University, New Brunswick, NJ 08903,

has submitted pesticide petition (PP)

6E4652 to EPA on behalf of the Oregon

Agricultural Experiment Station.

This petition requests that the

Administrator, pursuant to section

408(e) of the Federal Food, Drug, and

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

346a(e), amend 40 CFR 180.441 by

establishing tolerances for the combined

residues of the herbicide quizalofop-p

ethyl ester [ethyl (R)-(2-[4-((6-

chloroquinoxalin- 2-yl)oxy)phenoxyl]

propionate], its acid metabolite

quizalofop-p [R-(2-[4-((6-

chloroquinoxalin-2-yl)oxy)phenoxy])

propanoic acid], and the S enantiomers

of both the ester and the acid, all

expressed as quizalofop-p-ethyl ester, in

or on the raw agricultural commodities

peppermint tops and spearmint tops at

2 parts per million (ppm).

The scientific data submitted in the

petition and other relevant material

have been evaluated. The toxicological

data considered in support of the

proposed tolerances include:

1. Several acute toxicology studies

placing technical-grade quizalofop ethyl

in toxicity Category III.

2. An 18–month carcinogenicity study

with CD-1 mice fed diets containing 0,

2, 10, 80 and 320 ppm (equivalent to 0,

0.2, 1.5, 12, and 48 mg/kg/day) with no

carcinogenic effects observed under the

conditions of the study at levels up to

and including 80 ppm. There was an

elevated incidence of hepatocellular

adenomas and carcinomas combined in

CD-1 male mice at the 320 ppm dose

level, which exceeded the maximum

tolerated dose (MTD).

3. A 2–year chronic toxicity/

carcinogenicity study in rats fed diets

containing 0, 25, 100 and 400 ppm

(equivalent to 0, 0.9, 3.7, and 15.5 mg/

kg/day for males and 0, 1.1, 4.6, and

18.6 mg/kg/day for females) with no

carcinogenic effects observed under the

conditions of the study. The NOEL for

systemic toxicity is established at 25
31080 Federal Register / Vol. 61, No. 119 / Wednesday, June 19, 1996 / Proposed Rules

ppm (0.9 mg/kg/day) based on red blood

cell destruction in males, and slight/

minimal centrilobular enlargement of

the liver in females at the 100 ppm dose

level.

4. A 1–year feeding study in dogs fed

diets containing 0, 0.625, 2.5, and 10

mg/kg/day with a NOEL of 10 mg/kg/

day (HDT).

5. A developmental toxicity study in

rats fed dosage levels of 0, 30, 100, and

300 mg/kg/day, with no developmental

effects observed under the conditions of

the study. The NOEL for maternal

toxicity is established at 30 mg/kg/day.

6. A developmental toxicity study in

rabbits fed dosage levels of 0, 7, 20, and

60 mg/kg/day with no developmental

effects observed under the conditions of

the study. The NOEL for maternal

toxicity is established at 20 mg/kg/day

based on decreases in food consumption

and body weight gain at 60 mg/kg/day

(HDT).

7. A two-generation reproduction

study in rats fed diets containing 0, 25,

100 and 400 ppm (equivalent to 0, 1.25,

5, and 20 mg/kg/day) with a NOEL for

developmental toxicity at 25 ppm based

on an increase in liver weight and an

increase in the incidence of

eosinophillic changes in the liver at 100

ppm. The NOEL for parental toxicity is

established at 100 ppm based on

decreased body weight and premating

weight gain in males at the 400 ppm

dose level.

8. Mutagenicity data included gene

mutation assays with E. coli and S.

typhimurium (negative); DNA damage

assays with B. subtilis (negative); and a

chromosomal aberration test in Chinese

hamster cells (negative).

OPP’s Health Effects Division,

Carcinogenicity Peer Review Committee

(CPRC) has evaluated the rat and mouse

cancer studies for quizalofop ethyl along

with other relevant short-term toxicity

studies, mutagenicity studies, and

structure-activity relationships. The

CPRC has classified quizalofop ethyl as

a Group D carcinogen (not classifiable as

to human cancer potential). The Group

D classification is based on an

approximate doubling in the incidence

of male mice liver tumors between

controls and the high dose. This finding

was not considered strong enough to

warrant the classification of a Category

C (possible human carcinogen); the

increase was of marginal statistical

significance, occurred at a high dose

which exceeded the predicted MTD,

and occurred in a study in which the

concurrent control for liver tumors was

somewhat low as compared to the

historical controls, while the high dose

control group was at the upper end of

previous historical control groups. No

new cancer studies are required for

quizalofop ethyl at this time.

The Reference Dose (RfD) for

quizalofop ethyl is calculated at 0.009

mg/kg of body weight/day. The RfD is

based on the NOEL of 0.9 mg/kg/day

from the 2-year rat feeding study, and an

uncertainty factor of 100. The

theoretical maximum residue

contribution (TMRC) from existing

tolerances and the proposed tolerance

for mint tops utilizes 5 percent of the

RfD for the overall U.S. population and

18.5 percent of the RfD for non-nursing

infants (the population subgroup most

highly exposed). EPA generally has no

concern for dietary exposures below 100

percent of the RfD.

The nature of the residue in plants is

adequately understood. An adequate

analytical method (HPLC-UV) is

available for enforcement purposes.

Prior to its publication in the Pesticide

Analytical Manual, Volume II (PAM II),

the enforcement method is being made

available in the interim to anyone who

is interested in pesticide residue

enforcement from: By mail, Calvin

Furlow, Public Response and Program

Resources Branch, Field Operations

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location and telephone

number: Crystal Mall #2, Rm 1128, 1921

Jefferson Davis Hwy., Arlington, VA

22202 (703)305–5805.

There is no reasonable expectation

that secondary residues will occur in

milk, eggs, or meat of livestock and

poultry since there are no significant

livestock feed commodities associated

with this action. Data submitted with

the petition demonstrate that residues of

quizalofop ethyl do not concentrate in

mint oil. The proposed tolerances for

peppermint and spearmint tops is

adequate to cover residues in mint oil.

There are presently no actions

pending against the continued

registration of this chemical. The

pesticide is considered useful for the

purpose for which the tolerance is

sought.

Based on the information and data

considered, the Agency has determined

that the tolerance established by

amending 40 CFR part 180 would

protect the public health. Therefore, it is

proposed that the 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, which

contains any of the ingredients listed

herein, may request within 30 days after

publication of this notice 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 docket

number [PP 6E4652/P664].

A record has been established for this

rulemaking under docket number [PP

6E4652/P664] (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 Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

Under Executive Order 12866 (58 FR

51735, Oct. 4, 1993), the Agency must

determine whether the regulatory action

is ‘‘significant’’ and therefore subject to

all the requirements of the Executive

Order (i.e., Regulatory Impact Analysis,

review by the Office of Management and

Budget (OMB)). Under section 3(f), the

order defines ‘‘significant’’ as those

actions likely to lead to a rule (1) having

an annual effect on the economy of $100

million or more, or adversely and

materially affecting a sector of the

economy, productivity, competition,

jobs, the environment, public health or

safety, or State, local or tribal

governments or communities (also

known as ‘‘economically significant’’);

(2) creating serious inconsistency or
Federal Register / Vol. 61, No. 119 / Wednesday, June 19, 1996 / Proposed Rules 31081

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.

This action does not impose any

enforceable duty, or contain any

‘‘unfunded mandates’’ as described in

Title II of the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104–4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28, 1993), entitled Enhancing

the Intergovernmental Partnership

Partnership, or special consideration as

required by Executive Order 12898 (59

FR 7629, February 16, 1994).

Pursuant to the requirements of the

Regulatory Flexibility Act (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 explaining the

factual basis for this determination 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: June 10, 1996.

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 § 180.441, by revising paragraph

(c) to read as follows:

§ 180.441 Quizalofop ethyl; tolerances for

residues.

* * * *

*

(c) Tolerances are established for the

combined residues of the herbicide

quizalofop-p ethyl ester [ethyl (R)-(2-[4-

((6-chloroquinoxalin-2-yl)oxy)phenoxyl]

propionate], its acid metabolite

quizalofop-p [R-(2-[4-((6-

chloroquinoxalin-2-yl)oxy)phenoxy])

propanoic acid], and the S enantiomers

of both the ester and the acid, all

expressed as quizalofop-p-ethyl ester, in

or on the following raw agricultural

commodities:

Commodity Parts per

million

Cottonseed ................................ 0.05

Peppermint, tops ....................... 2

Spearmint, tops ......................... 2

[FR Doc. 96–15595 Filed 6–18–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Parts 180 and 185

[OPP–300431; FRL–5379–7]

RIN 2070–AC18

Triadimefon; Revocation of Pesticide

Tolerances and a Food Additive

Regulation

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to revoke

the pesticide tolerances for triadimefon

on barley grain, green forage and straw

and the food additive regulation for

triadimefon on milled fractions of barley

(except flour) because there are no

longer registered uses of triadimefon on

barley. EPA is proposing that the

revocation of the tolerance become

effective as of May 23, 1997.

DATES: Written comments, identified by

the docket number OPP–300431, must

be received on or before July 19, 1996.

This revocation is proposed to become

effective on May 23, 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 Hwy., Arlington, VA.

Information submitted and any

comment(s) concerning this notice 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(s) 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 to the submitter.

Information on the proposed action and

any written comments will be available

for public inspection in Rm. 1132 at the

Virginia address given above, from 8

a.m. to 4:30 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 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket number

[OPP–300431]. 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, Lisa Nisenson, Special Review

Branch (7508W), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location and telephone

number: 3rd floor, Crystal Station, 2800

Crystal Drive, Arlington, VA 22202,

(703) 308–8031; e-mail:

nisenson.lisa@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

A. Statutory Background

The Federal Food, Drug, and Cosmetic

Act (FFDCA), 21 U.S.C. 301 et seq.,

authorizes the establishment by

regulation of maximum permissible

levels of pesticides in foods. Such

regulations are commonly referred to as

‘‘tolerances.’’ Without such a tolerance

or an exemption from the requirement

of a tolerance, a food containing a

pesticide residue is ‘‘adulterated’’ under

section 402 of the FFDCA and may not

be legally moved in interstate

commerce. 21 U.S.C. 331, 342.

The FFDCA has separate provisions

for tolerances for pesticide residues on

raw agricultural commodities (RACs)

and tolerances on processed food. For

pesticide residues in or on RACs, EPA

establishes tolerances, or exemptions

from tolerances when appropriate,

under section 408. 21 U.S.C. 346a. EPA

regulates pesticide residues in

processed foods under section 409,

which pertains to ‘‘food additives.’’ 21

U.S.C. 348. Maximum residue