30204 Federal Register / Vol. 61, No. 116 / Friday, June 14, 1996 / Proposed Rules

§ 180.1001 Exemptions from the

requirement of a tolerance.

* * * * *

(c) * * *

Inert Ingredient Limits Uses

* * * * * * *

Vinyl pyrrolidone-acrylic acid copolymer

(CAS Reg. No. 28062–44–4), minimum

number average molecular weight (in

amu) 6,000.

Adhesive, dispersion

stabilizer and coating for sustained

release granules.

* * * * * * *

* * * * * (e) * * *

Inert Ingredient Limits Uses

* * * * * * *

Vinyl pyrrolidone-acrylic acid copolymer

(CAS Reg. No. 28062–44–4), minimum

number average molecular weight (in

amu) 6,000.

Adhesive, dispersion

stabilizer and coating for sustained

release granules.

* * * * * * *

[FR Doc. 96–15197 Filed 6–13–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Parts 180 and 186

[PP5F4545, FAP6H5737/P663; FRL–5375–5]

Quizalofop-P Ethyl Ester; Pesticide

Tolerance and Maximum Residue Level

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish a

tolerance for the residues of the

herbicide quizalofop (2-[4-(6-

chloroquinoxalin-2-yl)oxy)phenoxy])-

propanoic acid], and quizalofop ethyl

[ethyl-(2-[4-(6-chloroquinoxalin-2-yl)

oxy)phenoxy)propanoate), all expressed

as quizalofop ethyl in or on the raw

agricultural commodity canola seed at

1.0 part per million (ppm) and to

establish a maximum residue limit for

quizalofop ethyl on canola meal at 1.5

ppm. E.I. DuPont de Nemours Company

submitted petitions pursuant to the

Federal Food, Drug, and Cosmetic Act

(FFDCA) requesting these regulations to

establish certain maximum permissible

residue levels for residues of the

herbicide.

DATES: Comments, identified by the

docket control number [PP PP5F4545,

FAP6H5737/P663], must be received on

or before July 15, 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 Hwy., Arlington, VA

22202. Comments and data may also be

submitted to OPP 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 Word Perfect 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket number

[PP 5F4545, FAP 6H5737/P663].

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). 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

notice. All written comments will be

available for public inspection in Rm.

1132 at the Virginia address given

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

through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail, Robert J. Taylor, Product Manager

(PM-25), Registration Division (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location, telephone number, and

e-mail address: Rm. 241, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA

22202, (703)-305-6027; e-mail:

taylor.robert@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued notices published in the Federal

Register of February 1, 1996 (61 FR

3696) (FRL-4994-3), which announced

that E.I. Du Pont de Nemours Company,

Agricultural Products, Walkers Mill,

Barley Mill Plaza, P.O. Box 80038,

Wilmington, DE 19880-0038, had

submitted pesticide petition (PP)

5F4545 to EPA proposing to amend 40

CFR 180.441 by establishing tolerances

for residues of the herbicide quizalof [2-

4-(6-chloroquinoxalin-2-

yl)oxylphenoxy)propanic acid] and

quizalofop ethyl(ethyl-2-[4,(6-

chloroxyunoxalin-2-

yl)oxy)phenoxy]propanonate), all

expressed as quizalofop ethyl in or on

foliage of legume vegetables (except

soybean) at 3.0 ppm and on canola seed

at 2.0 ppm. DuPont also submitted a
Federal Register / Vol. 61, No. 116 / Friday, June 14, 1996 / Proposed Rules 30205

feed/food additive petition (FAP)

6F5737 proposing to amend 40 CFR

185.5250 by establishing tolerances for

the combined residues of the herbicide

quizalof [2-[4-(6-chloroquinoxalin-2-

yl)oxylphenyl)propanic acide] and

quizalofopethyl(ethyl-2-

[4,(6chloroxyunoxalin-2-

yl)oxy)phenoxy]propanonate), all

expressed as quizalofop ethyl in or on

the food commodities canola, meal at

3.0 ppm and canola, oil at 0.1 ppm and

to amend 40 CFR 186.5250 by

establishing tolerances for the combined

residues of the herbicide quizalof [2-[4-

(6-chloroquinoxalin-2-

yl)oxylphenyl)propanic acide] and

quizalofop ethyl(ethyl-2-[4,(6-

choroxyunoxalin-2-

yl)oxy)phenoxy]propanonate), all

expressed as quizalofop ethyl in or on

the feed commodity canola, meal at 3.0

ppm.

There were no comments or requests

for referral to an advisory committee

received in response to these notices of

filing.

During the course of the review of the

PP 5F4545, the Agency determined that

the filing notice had several errors in the

chemical name, that the proposed

listing for foliage of legume vegetables

(except soybeans) was not necessary

since it duplicated a listing under PP

3F4268 (final rule published elsewhere

in today’s Federal Register) and should

be deleted from PP 5F4545. The Agency

also determined that the proposed

tolerance for canola, seed at 2.0 was

higher than necessary. The petitioner

subsequently submitted a revised

section F deleting the listing for foliage

of legume vegetables, and proposing the

establishment of a tolerance for the

combined residues of the herbicide

quizalofop ethyl 2-[4-(6-

chloroquinoxalin-2-

yl)oxy)phenoxy)propanoic acid), and

quizalofop ethyl (ethyl-2-[4-(6-

chloroquinoxalin-2-yl)oxy)phenoxy]

propanoate, all expressed as quizalofop

ethyl in on the raw agricultural

commodity canola, seed at 1.0 ppm.

During the course of the review of

FAP 6H5767, the Agency noted that

there were several errors in the filing

notice, including the designation of the

petition number, the filing notice

should have read 6H5737 instead of

6F5737. The Agency also determined

that food additive tolerances were not

necessary for canola, oil or canola, meal

and that a section 701 maximum residue

level (MRL) instead of a section 409 feed

additive tolerance was needed for

canola meal. The petitioner

subsequently submitted a revised

section F proposing the establishment of

a maximum residue limit (MRL) for the

combined residues of the herbicide

quizalofop ethyl 2-[4-(6-

chloroquinoxalin-2-yl)oxy)phenoxy)

propanoic acid), and quizalofop ethyl

(ethyl-2-[6-chloroquinoxalin-2-

yl)oxy)phenoxy]propanoate, all

expressed as quizalofop ethyl in or on

canola meal at 1.5 ppm.

In the Federal Register of June 14,

1995 (60 FR 31300) (FRL-4944-2), EPA

issued a revised policy concerning

when section 409 food and feed additive

tolerances were needed to prevent the

adulteration of foods and animal feeds.

Under EPA’s revised policy, a section

409 tolerance is necessary for pesticide

residues in processed food when it is

likely that the level of some residues of

the pesticide will exceed the section 408

tolerance level in ‘‘ready to eat’’

processed food. Of particular relevance

to the quizalofop ethyl feed additive

tolerance is EPA‘s decision to interpret

the term ‘‘ready to eat’’ processed food

as food ready for consumption ‘‘as is’’

without further preparation. For foods

that are found to be not ‘‘ready to eat,’’

EPA takes into account the dilution of

residues that occurs in preparing a

‘‘ready to eat’’ food.

EPA has determined that canola meal

is not a ‘‘ready to eat’’ animal feed. EPA

has found no evidence that canola meal

is feed to livestock as a stand-alone

feedstock. Rather, canola meal is used as

an ingredient in animal feeds. The

section 408 tolerance for quizalofop

ethyl on canola seed is 1.0 ppm. The

highest average field trial (HAFT)

residue found in canola was 0.65 ppm.

A processing study showed that the

concentration factor for canola meal was

2.3X. Thus, given this information, it is

likely that quizalofop ethyl residues of

1.5 ppm (0.65 x 2.3) could occur in

canola meal. However, to project what

residues are likely in ‘‘ready to eat’’

animal feed containing canola meal the

1.5 ppm level must be divided by 4 to

allow for dilution occurring when

canola meal is added to other feedstuffs.

Once this dilution is taken into account,

the maximum residue level of

quizalofop ethyl in animal feed would

be 0.375 (1.5 ppm/4=0.375 ppm). Since

this is below the section 408 tolerance

level, animal feed containing such

residue levels would not be adulterated,

and no section 409 feed additive

tolerance is needed.

To aid in the efficient enforcement of

the Act, EPA is proposing to establish a

maximum residue limit (MRL) for

quizalofop ethyl residues in canola

meal. The MRL will reflect the

maximum residue of quizalofop ethyl in

processed foods consistent with a legal

level of such residues being present in

canola and the use of good

manufacturing practices. See 21 U.S.C.

542(a)(2)(c) and rules published

December 6, 1995 (60 FR 62366) (FRL4971-7), and February 29, 1996 (61 FR

7734) (FRL-4996-2), regarding

imidacloprid. Processed food not in

compliance with an applicable MRL

will be deemed adulterated under

section 402. Taking into account the

degree to which quizalofop ethyl may

concentrate during processing using

good manufacturing processes (2.3) and

the level of residues expected in canola

(0.65 ppm), EPA proposes a MRL of 1.5

ppm for canola meal. For purposes of

enforcement of the MRL, the same

analytical method used for enforcement

of the section 408 regulations, should be

used.

The data submitted in the petition

and other relevant material have been

evaluated. The toxicology data

submitted in support of these petitions

is discussed under a final rule regarding

PP 3F4268 and FAP 5H5720, published

elsewhere in today’s issue of the

Federal Register.

Based on the NOEL of 0.9 mg/kg/bwt/

day in the 2-year rat feeding study, and

using a hundredfold uncertainty factor,

the reference dose (RfD) for quazalofop

ethyl is calculated to be 0.009 mg/kg/

bwt/day. The theoretical maximum

residue contribution (TMRC) is

0.000478 mg/kg/bwt/day for existing

tolerances for the overall U.S.

population. The current action will

increase the TMRC by less than

0.000077 mg/kg/bwt/day. These

tolerances and previously established

tolerances utilize a total of 6.8 % of the

RfD for the overall U.S. populations,

with all exposure coming from

published uses. For U.S. subgroup

populations, non-nursing infants and

children aged 1 to 6 years, the current

action and previously established

tolerances utilize, respectively a total of

18.842 percent and 11.98 percent of the

RfD, with all exposure coming from

previously established tolerances,

assuming that residue levels are at the

established tolerances and that 100

percent of the crop is tested.

There are no desirable data lacking for

this petition.

The nature of the residue in plant and

livestock is adequately understood. An

adequate amount of geographically

representative crop field trial residue

data were presented which show that

the proposed tolerances should not be

exceeded when quizalofop ethyl is

formulated into ASSURE and used as

directed. An adequate analytical

methodology (high-pressure liquid

chromatography using either ultraviolet

or fluorescence detection) is available

for enforcement purposes in Vol. II of
30206 Federal Register / Vol. 61, No. 116 / Friday, June 14, 1996 / Proposed Rules

the Food and Drug Administration

Pesticide Analytical Method (PAM II,

Method I). There are currently no

actions pending against the registration

of this chemical. Any secondary

residues expected to occur in eggs, milk,

meat, fat, and meat byproducts of cattle,

goats, hogs, horses, sheep, and poultry

from this use will be covered by existing

tolerances.

Based on the information cited above,

the Agency has determined that when

used in accordance with good

agricultural practice, this ingredient is

useful and that the tolerance established

by amending 40 CFR part 180 will

protect the public health, and the

establishment of the maximum residue

level by amending 40 CFR part 186 is

consistent with residue levels

permissible in processed foods under 21

U.S.C. 342(a)(2)(C). It is proposed,

therefore, that the tolerances be

established as set forth below.

Any person who has registered or

submitted an application for registration

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 document in the

Federal Register that this rulemaking

proposal be referred to an Advisory

Committee in accordance with section

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

Cosmetic Act.

Interested persons are invited to

submit written comments on the

proposed regulation. Comments must

bear a notation indicating the document

control number [PP 5F4545, FAP

6H5720/P663]. 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 4:30

p.m., Monday through Friday, except

legal holidays.

A record has been established for this

rulemaking under docket number [PP

5F4545, FAP 6H5737/P663](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

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 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 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

final 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.

Under Executive Order 12866 (58 FR

51735, October 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 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.

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 a specified by

Executive Order 12875 (58 FR 58093,

October 28, 1993), entitled Enhancing

the Intergovernmental Partnership, or

special consideration as required by

Executive Order 12898 (59 FR 7629,

February 26, 1994).

Pursuant to the terms of this

Executive Order, EPA has determined

that this proposed rule is not

‘‘significant’’ and therefore not subject

to OMB review.

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 food additive regulations

or raising tolerance levels or food

additive regulations or establishing

exemptions from tolerance requirements

do not have a significant economic

impact on a substantial number of small

entities. A certification statement

containing the factual basis for this

conclusion was published in the

Federal Register of May 4, 1981 (46 FR

24950). Because MRLs function

similarly to tolerances and food additive

regulations, the establishment of a MRL

also does not have a significant effect on

a small number of small entities.

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

List of Subjects in 40 CFR Part 186

Environmental protection, Animal

feeds, Pesticides and pests.

Dated: May 26, 1996.

James Tompkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, it is proposed that 40 CFR

chapter I be amended as follows:

PART 180 [AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

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

b. In 180.441, by revising paragraph

(a) to read as follows:

§ 180.441 Quizalofop ethyl; tolerances for

residues.

(a) Tolerances are established for the

combined residues of the herbicide

quizalofop 2-[4-(6-chloroquinoxalin-2-

yl)oxy)phenoxy)propanic acid], and

quizalofop ethyl (ethyl 2-(4-((6-

chloroquinoxalin-2-

yl)oxy)phenoxy)propanoate, all

expressed as quizalofop ethyl, in or on

the raw agricultural commodities:

Commodities Part per million

soybeans ................... 0.05

canola, seed .............. 1.0

* * * * *

PART 186—[AMENDED]

2. In part 186:

a. The authority citation for part 186

continues to read as follows:

Authority: 21 U.S.C. 342, 348, and 701.
Federal Register / Vol. 61, No. 116 / Friday, June 14, 1996 / Proposed Rules 30207

b. In 186.5250, by adding paragraph

(c) to read as follows:

§ 186.5250 Quizalofop ethyl.

* * * * *

(c) A maximum residue level

regulation is established permitting

residues of quizalofop (2-(4-(6-

chloroquinoxalin-2-yl)oxy)phenoxy)

propanoic acid) and quizalofop ethyl

(ethyl 2-[4-(6-chloroquinoxalin-2-

yl)oxy)phenoxy)-12-propanoate, in or on

the following feed resulting from

application of the herbicide to canola.

Feed Parts per million

canola, meal .............. 1.5

This regulation reflects the maximum

level of residues in canola meal

consistent with the use of quizalofop

ethyl on canola in conformity with

180.441 of this chapter and with the use

of good manufacturing practices.

[FR Doc. 96–15200 Filed 6–13–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 300

[FRL–5519–3]

National Oil and Hazardous

Substances Pollution Contingency

Plan; National Priorities List

AGENCY: Environmental Protection

Agency.

ACTION: Notice of Intent to Delete the

Leetown Pesticides Site in Leetown,

Jefferson County, West Virginia, from

the National Priorities List; Request for

Comments.

SUMMARY: The Environmental Protection

Agency (EPA) Region III announces its

intent to delete the Leetown Pesticides

Site (Site) from the National Priorities

List (NPL) and requests public comment

on this proposed action. The NPL

constitutes Appendix B to 40 CFR part

300. Part 300 comprises the National Oil

and Hazardous Substances Pollution

Contingency Plan (NCP), which EPA

promulgated pursuant to Section 105 of

the Comprehensive Environmental

Response, Compensation, and Liability

Act (CERCLA) of 1980, as amended.

EPA and the West Virginia Division of

Environmental Protection have

determined that all appropriate CERCLA

actions have been implemented and that

the Site poses no significant threat to

public health or the environment.

Therefore, further remedial measures

pursuant to CERCLA are not needed.

DATES: Comments concerning the

proposed deletion of the Site from the

NPL may be submitted on or before July

15, 1996.

ADDRESSES: Comments may be

submitted to EPA’s Remedial Project

Manager for the Leetown Pesticides Site:

Melissa Whittington (3HW23), U.S. EPA

Region III, 841 Chestnut Building,

Philadelphia, Pennsylvania 19107,

(whittington.melissa@epamail.epa.gov)

Comprehensive information on this

Site is available for viewing at the Site

information repositories at the following

locations:

U.S. EPA Region III, 9th Floor Library,

841 Chestnut Building, Philadelphia,

Pennsylvania 19107

Old Charles Town Public Library, 200

East Washington Street, Charles

Town, West Virginia 25414

FOR FURTHER INFORMATION CONTACT:

Melissa Whittington, Remedial Project

Manager, at the address above or by

telephone at (215) 566–3235.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction

II. NPL Deletion Criteria

III. Deletion Procedures

IV. Basis For Intended Site Deletion

I. Introduction

The Environmental Protection Agency

(EPA) Region III announces its intent to

delete the Leetown Pesticides Site,

which is located in Leetown, West

Virginia, from the National Priorities

List (NPL), Appendix B to 40 CFR part

300, the National Oil and Hazardous

Substances Pollution Contingency Plan

(NCP), and requests comments on this

decision. EPA identifies sites that

appear to present a significant risk to

public health or the environment and

maintains the NPL as the list of those

sites. As discussed in the NCP at 40 CFR

300.425(e)(3), a site deleted from the

NPL remains eligible for remedial action

in the unlikely event that conditions at

the site warrant such action in the

future.

EPA will accept comments on the

proposal to delete this Site from the

NPL for thirty calendar days after

publication of this notice in the Federal

Register.

Section II of this notice explains the

criteria for deleting sites from the NPL.

Section III discusses the procedures that

EPA is using for this action. Section IV

discusses the Leetown Pesticides Site

and explains how the Site meets the

deletion criteria.

II. NPL Deletion Criteria

The NCP at 40 CFR 300.425(e)

provides that sites may be deleted from

or recategorized on the NPL where no

further response is appropriate.

Specifically, this section of the NCP

provides that, in making a

determination to delete a site from the

NPL, EPA shall consider, in

consultation with the State, whether any

of the following criteria have been met:

(i) Responsible parties or other

persons have implemented all

appropriate response actions required;

(ii) All appropriate Fund-financed

response under CERCLA has been

implemented, and no further action by

responsible parties is appropriate; or

(iii) The remedial investigation has

shown that the release poses no

significant threat to public health or the

environment and, therefore, taking of

remedial measures is not appropriate.

The NCP at 40 CFR 300.425(e) further

provides that sites may not be deleted

from the NPL until the State in which

the site is located has concurred on the

proposed deletion. All sites deleted

from the NPL are eligible for further

Fund-financed remedial actions should

future conditions warrant such action.

Whenever there is a significant release

from a site deleted from the NPL, the

site shall be restored to the NPL without

application of the Hazard Ranking

System.

Deletion of a site from the NPL does

not itself create, alter, or revoke any

individual’s rights or obligations. The

NPL is designed primarily for

informational purposes and to assist

Agency management.

III. Deletion Procedures

The procedures required to ensure

public involvement during a proposal to

delete a site from the NPL are

enumerated at 40 CFR 300.425(e)(4).

Pursuant to that section, EPA has

published this Notice of Intent to Delete,

together with concurrent notices in the

local newspapers in the vicinity of the

Site, to announce the initiation of a 30-

day public comment period. The public

is asked to comment on EPA’s intention

to delete the Site from the NPL. All

documents supporting EPA’s intention

to delete the Site from the NPL are

available for inspection by the public at

the information repositories located at

the addresses listed above.

EPA will accept and evaluate public

comments on this Notice of Intent to

Delete before making a final decision on

the deletion. If EPA receives any

significant comments during the public

comment period, the Agency will

prepare a Responsiveness Summary to

address those comments.

A deletion occurs when the Regional

Administrator places a final deletion

notice in the Federal Register. Once this