Federal Register / Vol. 61, No. 116 / Friday, June 14, 1996 / Rules and Regulations 30171

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 any copies of objections and

hearing requests 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.

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.

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, 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 of 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 3, 1996.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR part 180 is

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 § 180.377, the table to paragraph

(a) is amended by adding alphabetically

the entry for artichokes, to read as

follows:

§ 180.377 Diflubenzuron; tolerance for

residues.

(a) * * *

Commodity Parts per

million

Artichokes ................................. 6.0

* * * * *

[FR Doc. 96–15191 Filed 6–13–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Parts 180 and 186

[PP3F4268, FAP5720/R2247; FRL–5375-6]

Quizalofop-P Ethyl Ester; Pesticide

Tolerance and Feed Additive

Regulation

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document increases the

current tolerance for cotton seeds to 0.1

part per million (ppm) for the combined

residues of the herbicide quizalofop-pethyl ester [ethyl (R)-2[4-((6-

chloroquinoxalin-2-

yl)oxy)phenoxyl]propanoate], and 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;

establishes time limited tolerances with

an expiration date for quizalofop-p-ethyl

ester in or on the raw agricultural

commodities legume vegetables

(succulent or dried) group at 0.25 ppm,

foliage of legume vegetables (except

soybeans) at 3.0 ppm, sugarbeet root at

0.1 ppm, sugarbeet top at 0.5 ppm; and

establishes a time limited feed additive

tolerance with an expiration date for

quizalofop-p-ethyl ester for sugarbeet

molasses at 0.2 ppm. Because there has

been insufficient time since the

imposition of the additional data

requirements for specific geographical

representation for sugarbeet and bean

field trials to generate the necessary

residue data and additional time is

necessary to further refine a revised

analytical method and complete the

tolerance method validation (TMV), the

Agency is granting the tolerances for

legume vegetables (succulent and dried)

group, foliage of legume vegetables

(except soybeans), sugarbeet top and

sugarbeet root with a 3–year expiration

date]. E.I. du Pont de Nemours Co.,

requested these tolerances and feed

additive regulations in petitions

submitted to the EPA pursuant to the

Federal Food, Drug, and Cosmetic Act

(FFDCA).

EFFECTIVE DATE: These regulations

become effective June 14, 1996.

ADDRESSES: Written objection and

hearing requests, identified by the

document control number, [PP3F4268,

FAP5H5720/R2247], may be submitted

to: Hearing Clerk (1900), Environmental

Protection Agency, Rm. 3708, 401 M St.,

SW., Washington DC 20460. Fees

accompanying objections shall be

labeled ‘‘Tolerance Fees’’ and forwarded

to: EPA Headquarters Accounting

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing request

filed with the Hearing Clerk may also be

identified by the document control

number and submitted 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 a copy of objections and

hearing requests to: Rm. 1132, CM #2,

1921 Jefferson Davis Hwy., Arlington,

VA 22202. A copy of objections and

hearing requests filed with the Hearing

Clerk may also be submitted

electronically by sending electronic

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

Copies of objections and hearing

requests must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.
30172 Federal Register / Vol. 61, No. 116 / Friday, June 14, 1996 / Rules and Regulations

copies of objections and hearing

requests will also be acceptable on disks

in Word Perfect 5.1 file format or ASCII

file format. All copies of objections and

hearing requests electronic form must be

identified by the docket number

[PP3F4268, FAP5H5720/R2247]. No

Confidential Business Information (CBI)

should be submitted through e-mail.

Electronic copies of objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries. Additional information on

electronic submission can be found

below in this document.

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

703-305-6027; e-mail:

taylor.robert@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register August 17, 1995 (60 FR

42884) (FRL-4963-7), which announced

that the E.I. du Pont de Nemours Co.,

Inc., Walkers Mill Bldg, Barley Mill

Plaza, Wilmington, DE 19880, had

submitted pesticide petition (PP)

3F4268 to EPA proposing that 40 CFR

part 180 be amended by establishing a

regulation to permit the combined

residues of the herbicide quizalofop-pethyl ester (ethyl R-2-(4-(6-

chloroquinoxalin-2-

yl)oxy)phenoxy)propanoic acid) and the

S enantiomers of the ester and acid, all

expressed as quizolofop-p-ethyl ester, in

or on the raw agricultural commodities

legume vegetable (succulent or dried)

group at 0.3 ppm, foilage of legume

vegetables (except soybeans and bean

hay) at 0.7 ppm; sugar beet root at 0.1

ppm; sugar beet top at 0.5 ppm and

cottonseed at 0.1 ppm. Dupont also

submitted feed additive petition (FAP)

5H5720 proposing to amend 40 CFR

part 186 by establishing a regulation to

permit residues of the herbicide

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

((6-chloroquinoxalin-2-

yl)oxy)phenoxy)propanoic acid, and the

senantiomers of the ester and the acid

all expressed as quizalofop-p-ethyl

ester, in or on the animal feed sugar beet

molasses at 0.2 ppm.

No comments or requests for referral

to an advisory committee were received

in response to these notices of filing.

Subsequently, the petitioner amended

these petitions by submitting revised

section Fs. Amended filing notices were

published in the Federal Register of

September 13, 1995 (60 FR 47577) (FRL4975-3), proposing these changes.

PP 3F4268. DuPont amended this

petition by proposing a regulation to

permit the combined residues of the

herbicide quizalofop-p-ethyl ester and

its acid metabolite, quizalofop-p-[R-(4-

((6-chloroquinoxalin-2-

yl)oxy)phenoxy)propanoic acid), and

the S enantiomers of the ester and the

acid all expressed as quizalofop-p-ethyl

ester in or on the following raw

agricultural commodities (RACs): cotton

seed at 0.1 ppm, legume vegetable

(succulent or dried) group at 0.3 ppm;

foliage of legume vegetable (except

soybeans and bean hay) at 0.7 ppm;

sugar beet root at 0.1 ppm; and sugar

beet top at 0.5 ppm.

FAP 5H5720. DuPont amended this

petition by proposing that 40 CFR part

186 be amended by establishing a

regulation to permit the combined

residues of the herbicide quizalofop-pethyl ester and its acid metabolite

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

chloroquinoxalin-2-

yl)oxy)phenoxy)propanoic acid and the

S-enantiomers of the ester and the acid,

all expressed as quizalofop-p-ethyl

ester, in or on the feed commodity sugar

beet molasses at 0.5 ppm.

The Agency received one comment

opposing the tolerances stated in the

amended filing notices published

September 13, 1995. The commenter’s

opposition to the tolerances was based

upon toxicological concerns including

the concept of ‘‘NOEL’’ (no observed

effect level); the use of animal testing to

represent human reaction to potentially

toxic substances (pesticides); the

indications of a link between pesticide

exposure and Parkinson’s Disease (PD).

The Agency has reviewed the

comment and decided to proceed with

these tolerances. The Agency, made the

decision that a wide variety of

toxicological studies would serve as the

basis for determining if a pesticide

could be requested and used without an

reasonable risk. It is true that animal

models do not and cannot predict every

human reaction to pesticides, but the

general consensus is that they offer the

best information as to what a pesticide

might do to humans. Usually, the

Agency requires and reviews long-term

studies in rodents and non-rodents to

determine a dose which causes no

observed adverse effects. The NOEL is

divided by an uncertainty factor-often at

least 100-to arrive at doses or exposures

that should not cause harmful effects on

humans. This is a long established

procedure and EPA believes is

protective of public health.

The Agency understands that the

testing of one pesticide does not predict

all the possible adverse interactions

with other pesticides—or for that matter

other drugs or environmental pollutants.

The Agency is exploring ways of testing

the interactions of pesticides having a

similar toxicity endpoint, but progress

in that area is slow. The commenter

presented no evidence showing

quizalofop-p-ethyl ester would interact

with other pesticides.

With reference to the indications of a

link between pesticide exposure and

Parkinson’s disease, the Agency is

aware that many researchers are

investigating the potential reaction of

pesticide exposures to chronic

neurological diseases including

Parkinson‘s Disease, and additional

research is need to study this important

area. Available studies in humans or

animals have not yet established any

relationship between pesticide

exposures and Parkinson’s Disease.

During the course of the review of

these petitions, the Agency determined

that the tolerances proposed for

cottonseed, legume vegetables

(succulent of dried), foliage of legume

vegetables (except soybean and bean

hay), and the proposed feed additive

regulation for sugarbeet molasses need

revisions. The petitioner subsequently

submitted a revised section F proposing

that tolerances be established for the

combined residues of the herbicide

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

((6-chloroquinoxalin-2-

yl)oxy)phenoxy)propanoate], and its

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

chloroquinoxalin-2-

yl)oxy)phenoxy)propanoic acid), and

the acid, all expressed as quizalofop-pethyl ester in or on the following raw

agricultural commodities: cottonseed at

0.1 ppm; legume vegetable (succulent or

dried) group at 0.25 ppm; foliage of

legume vegetables (except soybeans) at

3.0 ppm; sugar beet root at 0.1 ppm; and

sugar beet top at 0.5 ppm. A revised

section F was submitted for FAP

5H5720 proposing the establishment of

a feed additive tolerance for the

combined residues of the herbicide

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

((6-chloroquinoxalin-2-

yl)oxy)phenoxy)propanoate], and its

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

chloroquinoxalin-2-

yl)oxy)phenoxy)propanoic acid), and

the S enantioners of the ester and the

acid, all expressed as quizalofop-p-ethyl

ester be established on sugarbeet

molasses at 0.2 ppm. The 3.0 ppm

tolerance for foliage of legume

vegetables was previously proposed

under PP 5F4545 on February 1, 1996

(61 FR 3696) (FRL-4994-3). The

proposed tolerance for sugarbeet

molasses was previously proposed.
Federal Register / Vol. 61, No. 116 / Friday, June 14, 1996 / Rules and Regulations 30173

The data submitted in the petition

and other relevant material have been

evaluated. The toxicology data listed

below considered in support of this

tolerance.

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 dosages of 0, 0.3,

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 12 mg/kg/day and a

marginal increase in the incidence of

hepatocellular tumors at 48 mg/kg/day

HDT (highest dose tested) which

exceeded the maximum tolerated dose

(MTD). (Please see the discussion by the

HED Carcinogenicity Peer Review

Committee.)

3. A 2-year chronic toxicity/

carcinogenicity study in rats fed dosages

of 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 at levels up to and including

18.6 g/kg/day (HDT) and a systemic

NOEL of 0.9 mg/kg/day based on altered

red cell parameters and slight/minimal

centrilobular enlargement of the liver at

3.7 mg/kg/day.

4. A 1-year feeding study in dogs fed

dosages of 0. 0.625, 2.5, and 10 mg/kg/

day with 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 (HDT), with a maternal

toxicity NOEL of 30 mg/kg/day and a

developmental toxicity NOEL of greater

than 300 mg/kg/day (HDT).

6. A developmental toxicity study in

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

60 mg/kg/day with no developmental

effects noted at 60 mg/kg/day (HDT),

and a maternal toxicity NOEL of 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 dosages of 1, 1.25, 5,

and 20 mg/kg/day with a reproductive

(developmental) NOEL of 1.25 mg/kg/

day based on an increase in liver weight

and increase in the incidence of

eosinophilic changes in the liver at 5.0

mg/kg/day and a parental NOEL of 5.0

mg/kg/day based on decreased body

weight and premating weight gain in

males at 20 mg/kg/day (HDT).

8. Mutagenicity data included gene

mutation assays with E. coli and S.

typhimurium (negative); DNA damage

assays with B. subtillis (negative) and a

chromosomal aberration test in Chinese

hamster cells (negative).

The Carcinogenicity Peer Review

Committee (CPRC) of HED has evaluated

the rat and mouse cancer studies on

quizalofop along with other relevant

short-term toxicity studies, mutagenicity

studies, and structure activity

relationships. The CPRC concluded,

after three meetings and an evaluation

by the OPP Science Advisory Panel, that

the classification should be a Category

D (not classifiable as to human cancer

potential). No new cancer studies were

required.

The first CPRC review tentatively

concluded that quizalofop should be

classified as a Category B2 (probable

human carcinogen). That classification

was based on liver tumors in female

rats, ovarian tumors in female mice, and

liver tumors in male mice. This

classification was downgraded to a

Category C (possible human carcinogen)

at a second CPRC review. The change in

classification was due to a

reexamination of the liver tumors in

female rats and ovarian tumors in

female mice. The first peer review had

found a statistically significant positive

trend for liver carcinomas in female rats.

Subsequent to this conclusion the tumor

data was reevaluated, and the

reevaluation showed a reduced number

of carcinomas. Although there remained

a statistically significant positive trend

for carcinomas in the study, the CPRC

concluded that the carcinomas were not

biologically significant given the few

carcinomas identified (one at the middose and two at the high dose). Noting

that this level of carcinomas was within

historical levels, the CPRC concluded

that administration of quizalofop did

not appear to be associated with the

liver carcinomas.

As to the ovarian tumors in female

mice, the CPRC had first attached

importance to the fact that these tumors

were statistically significant at the high

dose as compared to historical control

values although statistically significant

when compared to concurrent controls.

However, review of further historical

control data showed that the level of

ovarian tumors in the quizalofop study

was similar to the background rate in

several other studies. Given this

information and that the quizalofop

study showed no hyperplasia of the

ovary, no signs of endocrine activity

related to ovarian function, and no dose

response relationship, the CPRC

concluded that the ovarian tumors were

probably not compound-related.

The findings of the second CPRC

review were presented to EPA’s

Scientific Advisory Panel (SAP). The

SAP concurred with the CPRC

conclusion that the liver tumors in

female rats and the ovary tumors in

female mice showed no evidence of

carcinogenicity. However, the SAP

disagreed with CPRC’s classification of

quizalofop as a Category C based on the

liver tumors in male mice. The SAP

concluded that the mouse liver tumors

did support such a classification

because the tumors occurred at a dose

above the maximum-tolerated dose

(MTD) and because they were not

statistically significant if a ‘‘p’’ value of

less than .01 was used instead of a ‘‘p’’

value of less than .05. The SAP believed

that such greater statistical rigor was

appropriate for variable tumor

endpoints such as male mouse liver

tumors.

Following the SAP review, the CPRC

changed the classification for quizalofop

to Category D. The Category 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 finding of a Category C

(possible human carcinogen) since 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.

EPA has found the evidence on the

carcinogenicity of quizalofop-p-ethyl

ester in animals to be equivocal and

therefore concludes that quizalofop-pethyl ester does not induce cancer in

animals within the meaning of the

Delaney clause. Important to this

conclusion was the following evidence:

(1) The only statistically significant

tumor response that appears compoundrelated was seen at a single dose in a

single sex in a single species; (2) the

response was only marginally

statistically significant; (3) the response

was only significant when benign and

malignant tumors were combined; (4)

the tumors were in the male mouse

liver; (5) the tumors were within

historical controls; and (6) the

mutagenicity studies were negative.

Although in some circumstances a

finding of animal carcinogenicity could

be made despite any one, or even

several, of the six factors noted, the

combination of all of these factors here

cast sufficient doubt on the

reproducibility of the response in the

high dose male mouse that EPA

concludes the evidence on

carcinogenicity is equivocal.

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

day in the 2-year rat feeding study, and

using a hundred-fold uncertainty factor,

the reference dose (RFD) for quiazalofop

ethyl is calculated to be 0.009 mg/kg/
30174 Federal Register / Vol. 61, No. 116 / Friday, June 14, 1996 / Rules and Regulations

bwt/day. The theoretical maximum

residue contribution (TMRC) is

0.000218 mg/kg/bwt/day for existing

tolerances for the overall U.S.

population. The current action will

increase the TMRC by less than

0.000260 mg/kg/bwt/day. These

tolerances and previously established

tolerances utilize a total of 5.3 percent

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

18.8 percent and 11.9 percent of the

RfD, assuming that residue levels are at

the established tolerances and that 100

percent of the crop is tested.

Data desirable but lacking for this

chemical include additional sugarbeet

and bean residue field trials and

completion of a tolerance method

validation (TMV) for a revised analytical

method. The additional residue data are

needed in response to a recent change

in EPA guidelines. The Agency is

granting the tolerances for legume

vegetables (succulent or dried) group,

foliage of legume vegetables (except

soybeans), sugarbeet root and sugarbeet

top with a 3-year expiration date to

allow the petitioner, E.I. duPont de

Nemours and Company to gather

additional residue data and to further

refine the analytical method and allow

the Agency to complete the TMV.

The nature of the residue in plants

and livestock is adequately understood.

An adequate amount of geographically

represenative crop field reidue data

were presented which show that the

proposed tolerances should not be

exceeded when quizalofop-p ethyl ester

is formulated into ASSURE II and used

as directed. An adequate analytical

method (high-pressure liquid

chromatography using either ultraviolet

or fluorescence detection) is available

for enforcement purposes in Vol. II of

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 milk, eggs,

and meat, fat, and meat byproducts of

cattle, goats, hogs, horses, sheep, and

poultry will be covered by existing

tolerances.

The pesticide is considered useful for

the purpose for which the regulation is

sought and is capable of achieving the

intended physical or technical effect.

Based on the information cited above,

the Agency has determined that the

establishment of tolerances by

amending 40 CFR part 180 will protect

the public health, and the establishment

of feed additive regulations by

amending 40 CFR part 186 will be safe.

Therefore, EPA is establishing the

tolerances and feed additive regulation

as set forth below.

Any person adversely affected by this

regulation may, within 30 days after

publication of this document in the

Federal Register, file written objections

with the Hearing Clerk, at the address

given above, 40 CFR 178.20. A copy of

the objections and/or hearing requests

filed with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections. 40 CFR

178.25. Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33 (i). If a hearing is

requested, the objections must include a

statement of the factual issue(s) on

which the hearing is requested, the

requestor‘s contentions on each such

issue, and a summary of any evidence

relied upon by the objector. 40 CFR

178.27. A request for a hearing will be

granted if the Administrator determines

that the material submitted shows the

following: There is a genuine and

substantial issue of fact; there is a

reasonable possibility that available

evidence identified by the requestor

would, if established, resolve one or

more issues in favor of the requestor,

taking into account uncontested claims

or facts to the contrary; and resolution

of the factual issue(s) in the manner

sought by the requestor would be

adequate to justify the action requested.

40 CFR 178.32.

A record has been established for this

rulemaking under docket number

[PP3F4268, FAP5H5720/R2247]

(including objections and hearing

requests 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.

Written objections and hearing

requests, identified by the document

control number [PP3F4268,

FAP5H5720/R2247] may be submitted

to the Hearing Clerk (1900),

Environmental Protection Agency, Rm.

3708, 401 M St., SW., Washington, DC

20460. A copy of electronic objections

and hearing requests filed with the

Hearing Clerk can be sent directly to

EPA at: opp-docket@epamail.epa.gov.

A copy of electronic objections and

hearing requests filed with the Hearing

Clerk 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 any objections and hearing

requests 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 objections and hearing

requests 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 review by the Office of

Management and Budget (OMB) and the

requirements of the Executive Order.

Under Section 3(f), the order defines a

‘‘significant regulatory action’’ as an

action that is likely to result in 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,

completion, jobs, the environment,

public health or safety, or State, local,

or tribal governments or communities

(also referred to 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 the

rights and obligation of recipients

thereof; 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

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; or

special consideration as required by
Federal Register / Vol. 61, No. 116 / Friday, June 14, 1996 / Rules and Regulations 30175

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.

List of Subjects in 40 CFR Part 186

Environmental protection, Animals

feeds, Pesticides and pests.

Dated: May 29, 1996.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

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

(c) and adding paragraph (d) 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)phenoxy)propanoate], and its

acid metabolite quizalofop-p [R-(2-(4-

((6-quinoxalin-2-

yl)oxy)phenoxy)propanoic acid], and

the S enantiomers of both the ester and

the acid, all expressed as quizalofop-pethyl ester, in or on the following raw

agricultural commodities;

Commodity Parts per million

cottonseed ................. 0.1

lentils ......................... 0.05

(d) Time limited tolerances to expire

on June 14, 1999 are established for the

combined residues of the herbicide

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

((6-chloroquinoxalin-2-

yl)oxy)phenoxy)propanoate) and it 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-pethyl ester in or on the following raw

agricultural commodities:

Commodities Parts per million

foliage of legume

vegetables (except

soybeans).

3.0

legume vegetables

(succulent or dried)

group.

0.25

sugarbeet, root .......... 0.1

sugarbeet, top ........... 0.5

PART 186—[AMENDED]

2. In part 186:

a. The authority for part 186

continues to read as follows:

Authority: 21 U.S.C. 342, 348, and 701.

b. In 186.5250, by redesignating the

existing paragraph and table as

paragraph (a) and adding paragraph (b)

to read as follows:

§ 186.5250 Quizalofop ethyl.

* * * * *

(b) A feed additive regulation to

expire (insert date 3 years from date of

publication in the Federal Register) is

established to permit the combined

residues of the herbicide quizalofop-pethyl ester [ethyl] (R)-2-[4-((6-

chloroquinoxalin-2-

yl)oxy)phenoxy)propanoate], and its

acid metabolite quizalofop-p [R-(2-(4-

((6-chloroquinoxalin-2-

yl)oxy)phenoxy)propanoic acid), and

the S enantiomers of the ester and the

acid, all expressed as quizalofop-p-ethyl

ester in or on sugar beet molasses at 0.2

part per million (ppm)

[FR Doc. 96–15040 Filed 6–13–96; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF TRANSPORTATION

Research and Special Programs

Administration

49 CFR Part 106

[Docket No. RSP–1, Amdt. No. 106–11]

RIN 2137–ACXX

Direct Final Rule Procedure; Petitions

for Rulemaking

AGENCY: Research and Special Programs

Administration (RSPA), DOT.

ACTION: Final rule.

SUMMARY: To further the goals of

Executive Order 12866 on Regulatory

Planning and Review, and in response

to the recommendations of the National

Performance Review (NPR) and the

former Administrative Conference of the

United States, RSPA is implementing a

new and more efficient procedure for

adopting noncontroversial rules. This

‘‘direct final rule’’ procedure involves

issuing a final rule providing notice and

an opportunity to comment and stating

that the rule will become effective on a

specified date without further

publication of the text of the rule if

RSPA does not receive an adverse

comment or notice of intent to file an

adverse comment. If no adverse

comment or notice of intent to file an

adverse comment were received, RSPA

would issue a subsequent notice in the

Federal Register to confirm that fact and

reiterate the effective date. If an adverse

comment or notice of intent to file an

adverse comment were received, RSPA

would issue a subsequent notice in the

Federal Register to confirm that fact and

withdraw the direct final rule before it

goes into effect.

RSPA is also amending its rulemaking

procedures to specify in more detail the

required contents of a petition for

rulemaking and provide that petitions

for rulemaking and petitions for

reconsideration will be reviewed and

acted upon by the appropriate Associate

Administrator or the Chief Counsel and

that decisions of the Associate

Administrator may be appealed to the

Administrator.

EFFECTIVE DATE: July 15, 1996.

FOR FURTHER INFORMATION CONTACT:

Nancy E. Machado, Office of the Chief

Counsel, RSPA, Department of

Transportation, 400 Seventh Street,

SW., Washington, DC 20590–0001;

Telephone (202) 366–4400.

SUPPLEMENTARY INFORMATION:

I. Background

In Executive Order 12866,

‘‘Regulatory Planning and Review’’ (58

FR 51735; October 4, 1993), the

President set forth the Administration’s

regulatory philosophy and principles.

The Executive Order contemplates an

efficient and effective rulemaking

process, including the conservation of

limited government resources for

carrying out its regulatory functions.

Furthermore, ‘‘Improving Regulatory

Systems,’’ an Accompanying Report of

the National Performance Review,

recognized the need to streamline the

regulatory process and recommended

the use of ‘‘direct final’’ rulemaking