Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Rules and Regulations 9979

40 CFR Part 180

[OPP–300457; FRL–5592–2]

RIN 2070–AB78

Clofencet; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes

tolerances for the residues of the plant

growth regulator (hybridizing agent)

clofencet, [2-(4-chlorophenyl)-3-ethyl2,5-dihydro-5-oxo-4-

pyridazinecarboxylic acid, potassium

salt] expressed as the free acid, active

ingredient code 128726, CAS No.

82697–71–0 in or on the raw

agricultural commodities wheat as a

primary application; in or on the cereal

grains group (except rice, wild rice,

sweet corn and wheat) and soybeans as

rotational crops; and in animal

products. Monsanto Co. submitted a

petition to EPA under the Federal Food,

Drug and Cosmetic Act as amended by

the Food Quality Protection Act of 1996

requesting the tolerances.

EFFECTIVE DATE: This rule becomes

effective March 5, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [OPP–

300457], may be submitted to: Hearing

Clerk (1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. A copy of any

objections and hearing requests filed

with the Hearing Clerk should 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 copy of objections and

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

1921 Jefferson Davis Hwy., Arlington,

VA 22202. Fees accompanying

objections and hearing requests shall be

labeled ‘‘Tolerance Petition Fees’’ and

forwarded to: EPA Headquarters

Accounting Operations Branch, OPP

(Tolerance Fees), P.O. Box 360277M,

Pittsburgh, PA 15251.

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. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect in 5.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket number [OPP–300457]. 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 submissions can be found

below in this document.

FOR FURTHER INFORMATION CONTACT: By

mail: Philip V. Errico, 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 Highway., Arlington, VA

22202, (703) 305–6027; e-mail:

errico.philip@epamail. epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 7, 1996 (61

FR 41153), (PF–667; FRL–5388–7), EPA

issued a notice announcing that

Monsanto Company, 700 14th St., NW.,

Suite 1100, Washington, DC 20005, had

submitted pesticide petition 4F4346 to

EPA which requested that the

Administrator, pursuant to section 408

of the Federal Food, Drug and Cosmetic

Act (FFDCA), amend 40 CFR part 180 to

establish tolerances for residues of

clofencet, [2-(4-chlorophenyl)-3-ethyl2,5-dihydro-5-oxo-4-

pyridazinecarboxylic acid, potassium

salt] expressed as the free acid, in or on

the raw agricultural commodities: wheat

grain at 250 parts per million (ppm),

wheat hay at 40 ppm, wheat straw at 50

ppm and wheat forage at 10 ppm; in the

animal product commodities of cattle,

goats, hogs, horses and sheep: fat at 0.04

ppm, kidney at 10 ppm, meat at 0.15

ppm, meat by-products (except kidney)

at 0.5 ppm and milk at 0.02 ppm; in

animal product commodities of poultry:

eggs at 1 ppm, fat at 0.04 ppm, meat at

0.15 ppm and meat by-products at 0.20

ppm; and rotational crop tolerances in

the raw agricultural commodities:

soybeans at 30 ppm, soybean hay at 10

ppm and soybean forage at 10 ppm;

cereal grains group (except rice, wild

rice, sweet corn and wheat): grain at 20

ppm, straw at 4 ppm, forage at 4 ppm,

stover (fodder) at 1 ppm and hay at 15

ppm.

In the Federal Register of December

12, 1996 (61 FR 65392), (PF–678; FRL–

5576–2), EPA issued a second notice to

bring the Notice into conformity with

the Food Quality Protection Act (FQPA)

of 1996. The notice contained a

summary of the petition prepared by the

petitioner, Monsanto Co., including

information and arguments to support

its conclusion that the petition

complied with FQPA. It was stated in

the notice that the conclusions and

arguments were not of the EPA.

There were no comments received in

response to the notices of filing.

The data submitted in the petition

and other relevant material have been

evaluated. The toxicological data listed

below were considered in support of

these tolerances.

I. Toxicology Profile

1. A battery of acute toxicity studies

placing technical clofencet in toxicity

category II for eye irritation, category III

for oral LD50, category IV for inhalation

LC50 and dermal irritation and category

V for dermal LC50.

2. A 90–day rat neurotoxicity study at

doses of 0, 200, 2,000 or 20,000 ppm

(males = 0, 12.3, 124.5 or 1,232

milligrams per kilogram per day (mg/kg/

day); females = 0, 15.2, 149.8 or 1,537.2

mg/kg/day) with a No Observed Effect

Level (NOEL) of 2,000 ppm in females

based on decreased body weight gain in

females and 20,000 ppm in males. At

the 20,000 ppm (Highest Dose Tested

(HDT)), no neurotoxicity was observed

in either male or female rats.

3. A 21–day rat dermal toxicity study

at doses of 0, 100, 300 or 1,000 mg/kg/

day which showed no significant toxic

effects at any dose tested with a

systemic and dermal NOEL of 1,000 mg/

kg/day.

4. A 90–day dog feeding study at

doses of 0, 10, 50, 200 or 500 mg/kg/day

with a NOEL of 50 mg/kg/day based on

histological findings in the thymus and

testes.

5. A 90–day rat feeding study at doses

of 0, 200, 1,000, 5,000 or 20,000 ppm

(males = 0, 12, 60, 311 or 1,207 mg/kg/

day; females = 0, 15, 75, 373 or 1,477

mg/kg/day) with a NOEL of 5,000 ppm

in the diet based on decreased

cumulative weight gain and slightly

increased kidney weights in females.

6. A rat developmental toxicity study

at doses of 0, 100, 300 or 1,000 mg/kg/

day with a maternal and developmental

NOEL of 1,000 mg/kg/day HDT. There

was no developmental toxicity

considered to be the result of clofencet

administration.

7. A rabbit developmental toxicity

study at doses of 0, 50, 150 or 500 mg/

kg/day) with a maternal and

developmental NOEL of 150 mg/kg/day

based on mortality, increased abortions

and decreased body weight gain,

decreased food consumption, lower fetal

body weights, increased incidence of

fetal hydrocephalus and an increase in
9980 Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Rules and Regulations

the number of fetuses/litters with

unossified bones.

8. A rat two-generation reproduction

study at dietary concentrations of 0,

500, 5,000 or 20,000 ppm (males = 0, 38,

393 or 1,602 mg/kg/day; females = 0, 52,

529 or 2,044 mg/kg/day) with a maternal

NOEL of 5,000 ppm based on suggestive

increase in mortality, decrease in body

weight/weight gains and lung

pathology. The reproductive NOEL is

500 ppm based on an increase in pup

mortality in F1a and F1b during

lactation days 1 to 4 and decreased body

weights during lactation.

9. A 1–year dog chronic toxicity study

at doses of 0, 5, 30 or 200 mg/kg/day.

The NOEL was 5 mg/kg/day based on

liver and epididymal/testicular effects.

10. An 18–month mouse

carcinogenicity study at doses of 0, 70,

300, 3,000 or 7,000 ppm (males = 0,

11.45, 50.31, 501.20 or 1,228.22 mg/kg/

day; females = 0, 16.92, 70.67, 710.79 or

1,608.46 mg/kg/day) with a systemic

NOEL of 3,000 ppm based on decreased

survival as well as bone marrow

myeloid hyperplasia, lung congestion

and skin fibrosis in males and an

increased incidence of histiocytic

sarcomas in females at 7,000 ppm

(HDT).

11. A 2–year rat chronic/

carcinogenicity study at dietary doses of

0, 100, 1,000, 10,000 or 20,000 ppm

(males = 0, 4.7, 47, 470 or 989

milligrams per kilogram of body weight

per day (mg/kg bwt/day)); females = 0,

5.9, 58, 607 or 1,288 mg/kg bwt/day)

with a systemic NOEL of 1,000 ppm

based on hematuria, white/gray lung

foci and kidney lesions. Clofencet at

20,000 ppm (HDT) may cause an

increase in the number of animals with

hepatocellular carcinomas and

adenomas/carcinomas in males and an

increase in thyroid C-cell adenomas in

males and females.

12. A metabolism study in rats

indicated that clofencet was rapidly

absorbed and excreted by 7 days postdosing, with the majority of the

administered 14C-label (>78%)

eliminated in the urine within 24 hours.

Analysis of the excreta indicated that

14C MON 21200 was eliminated mostly

unmetabolized in the urine (87.9 to

92.1% of the administered dose) and in

the feces (4.5 to 9.1% of the

administered dose). Less than 1% was

of the administered 14C-label was

eliminated as expired CO2. Less than

1% was retained in the tissue at 7 days

post-dosing, indicating low

bioaccumulation. There were no

apparent sex- or dose-related differences

in the absorption, distribution,

metabolism or elimination.

13. Acceptable studies on gene

mutation and other genotoxic effects:

Ames Salmonella Assay; CHO/HGPRT

Point Mutation Assay; In Vitro

Cytogenetics Assay in Human

Lymphocytes; Mouse Micronucleus

Assay; and In Vivo/In Vitro Hepatocyte

DNA Repair Assay yielded negative

results.

II. Dose Response Assessment

Reference dose (RfD). The RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. The RfD is determined

by using the toxicological end-point or

the NOEL for the most sensitive

mammalian toxicological study. To

assure the adequacy of the RfD, the

Agency uses an uncertainty factor in

deriving it. The factor is usually 100 to

acount for both interspecies

extrapolation and intraspecies

variability represented by the

toxicological data. The EPA has

determined a RfD of 0.05 mg/kg/day

with an uncertainty factor of 100 for this

risk assessment, based on a NOEL of 5.0

mg/kg/day from a 1–year feeding study

in dogs which demonstrated the effect

of epididymitis, tubular degeneration

and absence of spermatozoa as endpoint

effects.

Carcinogenicity classification. Using

the Guidelines for Carcinogenic Risk

Assessment published September 24,

1986 (51 FR 33992), the EPA has

classified clofencet as Group ‘‘C’’ for

carcinogenicity (possible human

carcinogen) based on the increase in

histiocytic sarcomas (malignant) by both

pair-wise and trend analyses in female

mice. The thyroid C-cell tumors in male

rats (mainly benign) were considered to

have occurred only at an excessive dose.

There were no apparent genotoxicity

concerns and little additional support

for carcinogenicity based on structureactivity relationship (SAR) with a

related wheat hybridizing agent,

fenridazon; therefore, the EPA’s

Carcinogenicity Peer Review Committee

recommended that for the purpose of

risk characterization, the RfD approach

be used for quantitation of human risk.

III. Residential Exposure Assessment

The toxicological endpoint of concern

for residential exposure is systemic

toxicity resulting from chronic

exposure. There are no proposed

residential uses for clofencet and it is

not likely to be applied in or near

residential areas; therefore, there are no

residential risk concerns.

IV. Dietary Exposure Assessment

Use of a pesticide results or may

reasonably be expected to result,

directly or indirectly, in pesticide

residues in food. Primary residues or

indirect/inadvertent residues in

agricultural commodities are

determined by chemical analysis. To

account for the diversity of growing

conditions, cultural practices, soil types,

climatic conditions, crop varieties and

methods of application of the pesticide,

data from studies that represent the

commodities are collected and

evaluated to determine an appropriate

level of residue that would not be

exceeded if the pesticide is used as

represented in the studies.

1. Plant/animal metabolism and

magnitude of the residue. The nature of

the residue (metabolism) of clofencet in

plants and animals is adequately

understood for the purposes of these

tolerances. There are no Codex

maximum residue levels established for

residues of clofencet on wheat or the

rotational crops. The residue of concern

to be regulated is the parent, clofencet.

2. Residue analytical methods. The

analytical method proposed for

detecting and measuring levels of

clofencet in or on the commodities with

a limit of detection that allows

monitoring of food with residues at or

above the levels set in the tolerance for

primary and rotational crops includes

derivatization of clofencet to its methyl

ester followed by analysis via gas

chromatography with electron capture

detection, however, for rotational crops,

it is necessary to first hydrolyze

clofencet-sugar conjugates to clofencet

before proceeding with derivatization.

The method for animal tissues includes

derivatization of clofencet to its methyl

ester followed by analysis via HPLC

with UV detection. For milk and eggs,

analysis is achieved by extraction,

concentration and direct analysis via

HPLC with UV detection. EPA will

provide information on this method to

the Food and Drug Administration

(FDA). Because of the long lead time

from establishing these tolerances to

publication, the enforcement

methodology is being made available in

the interim to anyone interested in

pesticide enforcement when requested

by mail from: 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:

Rm. 1130A, CM #2, 1921 Jefferson-Davis

Highway, Arlington, VA 22202, (703)

305–5937.
Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Rules and Regulations 9981

The presence of the pesticide or

degradates of the pesticide in potable

water may also be a source of dietary

exposure that must be considered in

establishing a tolerance level for an

agricultural commodity.

V. Aggregate Exposures Assessment

In examining aggregate exposure,

FQPA directs EPA to consider available

information concerning exposures from

the pesticide residue in food, including

water, and all other non-occupational

exposures. The aggregate sources of

exposure the Agency looks at include

food, drinking water or groundwater,

and exposure through pesticide use in

gardens, lawns, or buildings (residential

and other indoor uses).

1. Acute dietary. There is no concern

for acute effects due to dietary exposure

to clofencet.

2. Chronic dietary. Tolerances in this

petition are based on residues from field

trial data. Using the Dietary Risk

Evaluation System (DRES), a routine

chronic exposure analysis was based on

0.1% crop treated and on tolerance

values for wheat and rotational crops

listed in this petition. Although percent

crop treated were used, the estimate is

conservative, since it is assumed that

100% of the fields treated with clofencet

in the United States are rotated to cereal

grains group crops (except rice, wild

rice, sweet corn and wheat) and

soybeans at the same time. At this time,

there is no concern for chronic effects

due to exposure of clofencet in the diet.

3. Drinking water. Because the Agency

lacks specific water- related exposure

data for most pesticides, EPA has

commenced and nearly completed a

process to identify a reasonable yet

conservative bounding figure for the

potential contribution of water related

exposure to the aggregate risk posed by

a pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. The Agency

then applied the estimated residue

levels, in conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOEL’s) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of water containing that

pesticide. This analysis is included in

the docket for this rulemaking. While

EPA has not yet pinpointed the

appropriate bounding figure for

consumption of water containing

pesticides, the ranges the Agency is

continuing to examine are all well

below the level that would cause

clofencet to exceed the RfD by granting

the tolerances being considered in this

document. The Agency has therefore

concluded that the potential exposures

associated with clofencet in water, even

at the higher levels the Agency is

considering as a conservative upper

bound, will not prevent the Agency

from determining that there is a

reasonable certainty of no harm.

4. Non-occupational non-dietary.

Since the proposed use does not involve

residential use and since clofencet is not

likely to be used in or near residential

areas, non-occupational non-dietary

exposure is not expected.

5. Cumulative exposure to substances

with common mechanism of toxicity.

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also policies and

methodologies for conducting

cumulative risk assessments. While the

Agency has some information in its files

that may be helpful in determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodology to resolve the

scientific issues concerning common

mechanism of toxicity in a meaningful

way. EPA has begun a pilot process to

study this issue further through the

examination of particular classes of

pesticides. The Agency hopes that the

results of this pilot process will enable

it to develop and apply policies for

evaluating the cumulative effects of

chemicals having a common mechanism

of toxicity. At present, however, the

Agency does not know how to apply the

information in its files concerning

common mechanism issues to most risk

assessments.

In making individual tolerance

decisions, the Agency will determine

whether: (1) It has sufficient information

to determine that a pesticide does not

appear to share a common mechanism

of toxicity with other substances; or (2)

it is unable to conclude that a pesticide

does not share a common mechanism of

toxicity with other substances.

For pesticides falling into the first

category, the Agency will explain its

determination and factor the

determination into the tolerance

decision. For pesticides falling into the

second category, the Agency will

conclude that it does not have sufficient

available information concerning

common mechanism of toxicity to

scientifically apply that information to

the tolerance decision, the tolerance

decision will be reached based upon the

best available and useful information for

the individual chemical, and a risk

assessment will be performed for the

tolerance action assuming that no

common mechanism of toxicity exists.

However, tolerance decisions falling

into the second category will be

reexamined by the Agency after EPA

establishes methodologies and

procedures for integrating information

concerning common mechanism into its

risk assessments. In such circumstances,

related registration actions may be

conditioned upon the provision of such

data as may be necessary to evaluate

common mechanism of toxicity issues

in a risk assessment.

In the case of clofencet, EPA has not

yet determined whether or how to

include this chemical in a cumulative

risk assessment. This tolerance

determination therefore does not take

into account common mechanism

issues. After EPA develops a

methodology for applying common

mechanism of toxicity issues to risk

assessments, the Agency will develop a

process (either as part of the periodic

review of pesticides or otherwise) to

reexamine those tolerance decisions

made earlier. The registrant must

submit, upon EPA’s request and

according to a schedule determined by

the Agency, such information as the

Agency directs to be submitted in order

to evaluate issues related to whether

clofencet share(s) a common mechanism

of toxicity with any other substance

and, if so, whether any tolerances for

clofencet needs to be modified or

revoked.

VI. Determination of Safety for the U.S.

Population and Non-nursing Infants

Using the Dietary Risk Evaluation

System (DRES), a routine chronic

dietary exposure analysis was based on

use of 0.1% of the wheat crop treated,

and 0.1% of the cereal grains group

crops (except rice, wild rice, sweet corn

and wheat) and soybeans as rotated

crops in fields previously containing

wheat treated with clofencet, and

tolerance levels established in this

document. Percent crop treated of 0.1%

is based on the petitioner’s expectations

that up to 33,000 acres of wheat grown

for seed will be treated in the year 2000.

This 33,000 acres is 0.05% of the

approximate 70,000,000 acres of wheat

which is grown for grain in the United

States. Pursuant to section 408(b)(2)(F)

of FFDCA as amended, the Agency may,

when assessing chronic dietary risk,

consider available data and information

on the percent of food actually treated
9982 Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Rules and Regulations

with the pesticide chemical, and finds

that the data are reliable and provides

a valid basis to show what percentage of

the food derived from such crop is

likely to contain such pesticide

chemical residue, finds that the

exposure estimate does not understate

exposure for any significant

subpopulation group, finds that, if data

are available on pesticide use and

consumption of food in a particular

area, the population in such area is not

dietarily exposed to residues above

those estimated by the Agency, and

provides for the periodic reevaluation of

the estimate of anticipated dietary

exposure.

The Agency believes the above

conditions have been met for the

conditions stated above. Based on the

available information and the use of this

conservative risk assessment, EPA finds

the exposure estimate does not

understate exposure for any significant

subpopulation group. Also, EPA has no

data that show clofencet use on wheat

grown for seed, and consumption of

food in a particular area differ

significantly from that used in the

conservative risk assessment stated

herein. Registration of end-use

product(s) containing clofencet

conditioned on production of no more

clofencet than necessary to treat no

more than 35,000 acres per year. The

additional 2,000 acres was requested by

the registrant, and does not significantly

effect the results of this risk

determination. Before the petitioner can

increase production of product for

treatment of greater than 35,000 acres

per year, permission from the Agency

must be obtained. The petitioner must

also provide annual reports on

production of end-use products

containing clofencet, number of acres

treated, and a best estimate of which

crops and how many acres were planted

as rotational crops on fields previously

planted to wheat treated with clofencet.

The registrant must also provide field

residue data on wheat grain, forage, hay

and straw from commercially treated

crop beginning 18 months after wheat

grain is first harvested. Field residue

trials on the rotated crops listed in this

document may also be required. The

Agency will provide for periodic

reevaluation of the dietary exposure, if

warranted, with percent crop treated,

acres of wheat treated, end-use product

production information provided by the

petitioner and other available sources,

and submitted field residue data. The

reason for using 0.1% instead of 0.05%

crop treated is to allow expansion of use

if other conditions of registration are

satisfied. Before expansion beyond 0.1%

is allowed, reevaluation of the dietary

exposure may be performed using all

available information as necessary.

Based on the conservative dietary

assessment presented above, the

proposed use of clofencet uses 0.73% of

the RfD for the U.S. population and for

the most highly exposed subgroups,

0.6% for non-nursing infants (<1 year

old), 1.6% for children (1 to 6 years old)

and 1.2% for children (7 to 12 years

old). The risk estimate from combined

food and water sources is expected to be

below 25% of the RfD even with the

addition of a reasonable bounding figure

for the contribution from drinking

water. EPA concluded there is a

reasonable certainty that no harm will

occur from aggregate exposure to

clofencet for this directed use on wheat

and the subsequent rotational crops

[cereal grains group (except rice, wild

rice, sweet corn and wheat) and

soybeans].

VII. Determination of Safety for Infants

and Children

Risk to infants and children was

determined by the use of the two

developmental toxicity studies in rats

and rabbits and the two-generation

reproduction study in rats noted above.

The developmental toxicity studies

evaluates the potential for adverse

effects on the developing organism

resulting from exposure during prenatal

development to the female parent. The

reproduction study provides

information relating to effects from

exposure to the chemical on the

reproductive capability of both (mating)

parents and on systemic toxicity.

FFDCA section 408 provides that the

EPA shall apply an additional safety

factor of 10 in the case of threshold

effects for infants and children to

account for pre- and post-natal toxicity

and the completeness of the database

unless EPA determines, based on

reliable data, that a different safety

factor would be appropriate. EPA

believes that reliable data support using

a different safety factor (usually 100X

(100 times)) and not the additional

safety factor when EPA has a complete

data base and when the severity of the

effect in infants or children or the

potency or unusual toxic properties of a

compound do not raise concerns

regarding the adequacy of the traditional

safety factors. The Agency believes that

an additional safety factor for infants

and children is not warranted here.

First, a complete set of developmental

and reproductive studies have been

submitted and EPA has found them to

be acceptable. Second, since the NOELs

from the developmental and

reproductive studies are 7.6X to 200X

(7.6 times to 200 times) higher than the

NOEL used for the RfD, the Agency does

not believe the effects seen in these

studies are of such concern to require an

additional safety factor. Accordingly,

the Agency believes the RfD has an

adequate margin of protection for

infants and children. The percent of the

RfD that would be utilized by the

aggregate exposure to clofencet will

range from 0.6% for non-nursing infants

to 1.6% for children 1 to 6 years old.

EPA concluded that there is reasonable

certainty that no harm will occur to

infants and children from aggregate

exposure to clofencet.

VIII. Other Considerations

Endocrine effects. No specific tests

have been conducted with clofencet to

determine whether the chemical may

have an effect in humans that is similar

to an effect produced by a naturally

occuring estrogen or other endocrine

effects. However, there were no

significant findings in other relative

toxicity studies, i.e., teratology and

multi-generation reproductive studies,

which would suggest that clofencet

produces these kinds of effects.

IX. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under the new

section 408(e) and (1)(6) as was

provided in the old section 408 and in

section 409. However, the period for

filing objections is 60 days, rather than

30 days. EPA currently has procedural

regulations which governs the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by May 5, 1997 file

written objections to any aspect of this

regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

below (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
Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Rules and Regulations 9983

which a hearing is requested, the

requestor’s contentions on such issues,

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 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 of such 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).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

‘‘Confidential Business Information’’

(CBI). Information marked as CBI will

not be disclosed except in accordance

with procedures set forth in 40 CFR part

2. A copy of the information 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.

X. Public Docket

A record has been established for this

rulemaking and all written comments

for this rule under docket number

[OPP–300457]. A public version of this

record, which does not include any

information claimed as CBI, is available

for inspection from 8:30 a.m. to 4 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. EPA has also established

a special record for post-FQPA

tolerances which contains documents of

general applicability. This record can be

found in the same location.

Electronic comments may 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, is kept in

paper form. Accordingly, in the event

there are objections and hearing

requests, EPA will transfer any copies of

objections and hearing requests received

electronically into printed, paper form

as they are received and will place

paper copies in the official rulemaking

record.

XI. Regulatory Assessment

Requirements

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this action is

not a ‘‘significant regulatory action’’

and, since this action does not impose

any information collection requirements

subject to approval under the Paperwork

Reduction Act, 44 U.S.C. 3501 et seq.,

it is not subject to review by the Office

of Management and Budget. In addition,

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), or special

considerations as required by Executive

Order 12898 (59 FR 7629, February 16,

1994).

Because tolerances established on the

basis of a petition under section 408(d)

of FFDCA do not require issuance of a

proposed rule, the regulatory flexibility

analysis requirements of the Regulatory

Flexibility Act (RFA), 5 U.S.C. 604(a),

do not apply. Prior to the recent

amendment of the FFDCA, EPA had

treated such rulemakings as subject to

the RFA; however, the amendments to

the FFDCA clarify that no proposal is

required for such rulemakings and

hence that the RFA is inapplicable.

Under 5 U.S.C. 801(a)(1)(A) of the

Administrative Procedure Act (APA) as

amended by the Small Business

Regulatory Enforcement Fairness Act of

1996 (Title II of Pub. L. 104–121, 110

Stat. 847), EPA submitted a report

containing this rule and other required

information to the U.S. Senate, the U.S.

House of Representatives and the

Comptroller General of the General

Accounting Office prior to publication

of the rule in today’s Federal Register.

This rule is not a ‘‘major rule’’ as

defined by 5 U.S.C. 804(2) of the APA

as amended.

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: February 24, 1997.

Daniel M. Barolo,

Director, 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. By adding § 180.497, to read as

follows:

§ 180.497 Clofencet; tolerances for

residues.

(a) Tolerances--general. Tolerances

are established for the plant growth

regulator (hybridizing agent) clofencet,

[2-(4-chlorophenyl)-3-ethyl-2,5 dihydro5-oxo-4-pyridazinecarboxylic acid,

potassium salt] expressed as the free

acid in or on the following raw

agricultural commodities:

Commodities Parts per

million

Cattle, fat .................................. 0.04

Cattle, kidney ............................ 10.0

Cattle, mbyp (except kidney) .... 0.5

Cattle, meat .............................. 0.15

Eggs .......................................... 1.0

Goats, fat .................................. 0.04

Goats, kidney ............................ 10.0

Goats, mbyp (except kidney) .... 0.5

Goats, meat .............................. 0.15

Hogs, fat ................................... 0.04

Hogs, kidney ............................. 10.0

Hogs, mbyp (except kidney) ..... 0.5

Hogs, meat ............................... 0.15

Horses, fat ................................ 0.04

Horses, kidney .......................... 10.0

Horses, mbyp (except kidney) .. 0.5

Horses, meat ............................ 0.15

Milk ............................................ 0.02

Poultry, fat ................................. 0.04

Poultry, mbyp ............................ 0.20

Poultry, meat ............................. 0.15

Sheep, fat ................................. 0.04

Sheep, kidney ........................... 10.0

Sheep, mbyp (except kidney) ... 0.5

Sheep, meat ............................. 0.15

Wheat, forage ........................... 10.0

Wheat, grain ............................. 250.0

Wheat, hay ................................ 40.0

Wheat, straw ............................. 50.0

(b) Tolerances for Indirect or

inadvertent residues. Tolerances are

established for indirect or inadvertent

residues of the plant growth regulator

(hybridizing agent) clofencet, [2-(4-

chlorophenyl)-3-ethyl-2,5-dihydro-5-

oxo-4-pyridazinecarboxylic acid,

potassium salt] expressed as the free

acid in or on the following raw

agricultural commodities when present

therein as a result of the application of

clofencet to the growing crops in

paragraph (a) of this section:

Commodities Parts per

million

Cereal grains group (except

rice, wild rice, sweet corn

and wheat), forage ................ 4.0
9984 Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Rules and Regulations

Commodities Parts per

million

Cereal grains group (except

rice, wild rice, sweet corn

and wheat, grain ................... 20.0

Cereal grains group (except

rice, wild rice, sweet corn

and wheat), hay .................... 15.0

Cereal grains group (except

rice, wild rice, sweet corn

and wheat), stover (fodder) ... 1.0

Cereal grains group (except

rice, wild rice, sweet corn

and wheat), straw .................. 4.0

Soybeans .................................. 30.0

Soybean, forage ....................... 10.0

Soybean, hay ............................ 10.0

[FR Doc. 97–5415 Filed 3–4–97; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[OPP–300456; FRL–5591–7]

RIN 2070–AC78

Tebufenozide; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for combined

residues of the insecticide tebufenozide

in or on the raw agricultural

commodities peppers, non-brassica

leafy vegetables (Crop Group 4 - celery,

lettuce, spinach, swiss chard), turnips

grown for foliage tops only, and brassica

(cole) leafy vegetables (Crop Group 5 -

broccoli, cabbage, cauliflower, collards,

kale, kohlrabi, and mustard greens) in

connection with EPA’s granting of

emergency exemptions under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

tebufenozide on peppers, leafy

vegetables (except brassica), turnips

grown for foliage tops only and brassica

leafy vegetables in Texas; and lettuce,

broccoli, cauliflower, cabbage and

spinach in Arizona. This regulation

establishes maximum permissible levels

for residues of tebufenozide in these

foods. These tolerances will expire on

February 28, 1998.

DATES: This regulation becomes

effective March 5, 1997. This regulation

expires on February 28, 1998.

Objections and requests for hearings

must be received by EPA on May 5,

1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300456],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

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

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300456], should be 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 Highway.,

Arlington, VA. 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.

Copies of objections and hearing

requests will also be accepted on disks

in WordPerfect 5.1 file format or ASCII

file format. All copies of objections and

hearing requests in electronic form must

be identified by the docket number

[OPP–300456]. 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.

FOR FURTHER INFORMATION CONTACT: By

mail: Pat Cimino, Registration Division

(7505W), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location, telephone number, and

e-mail address: Sixth Floor, Crystal

Station #1, 2800 Jefferson Davis

Highway, Arlington, VA 22202. (703)

308–8328, e-mail:

cimino.pat@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA,

pursuant to section 408(e) and (l)(6) of

the Federal Food, Drug, and Cosmetic

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

(l)(6), is establishing a tolerance for

residues of the insecticide tebufenozide

(benzoic acid, 3,5-dimethyl-1-(1,1-

dimethylethyl)-2-(4-

ethylbenzoyl)hydrazide) in or on

peppers at 0.5 part per million (ppm),

leafy vegetables (except brassica) at 5.0

ppm, turnip tops at 5.0 ppm, and

brassica (cole) leafy vegetables at 5.0

ppm. These tolerances will expire on

February 28, 1998.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the FFDCA, 21 U.S.C. 301

et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq. The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities were discussed in detail

in the final rule establishing the timelimited tolerance for an emergency

exemption for use of propiconazole on

sorghum (61 CFR 58135, November 13,

1996)(FRL–5572–9).

New section 408(b)(2)(A)(i) allows

EPA to establish a tolerance (the legal

limit for a pesticide chemical residue in

or on a food) only if EPA determines

that the tolerance is ‘‘safe.’’ Section

408(b)(2)(A)(ii) defines ‘‘safe’’ to mean

that ‘‘there is a reasonable certainty that

no harm will result from aggregate

exposure to the pesticide chemical

residue, including all anticipated

dietary exposures and all other

exposures for which there is reliable

information.’’ This includes exposure

through drinking water, but does not

include occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue....’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State Agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) requires EPA to

establish a time-limited tolerance or

exemption from the requirement for a

tolerance for pesticide chemical

residues in food that will result from the

use of a pesticide under an emergency

exemption granted by EPA under

section 18 of FIFRA. Section 408(l)(6)

also requires EPA to promulgate

regulations by August 3, 1997,

governing the establishment of

tolerances and exemptions under

section 408(l)(6) and requires that the