34310 Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 /Rules and Regulations

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since these tolerances and

exemptions that are established under

FFDCA section 408 (l)(6), such as the

tolerances in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

Agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit 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 United

States prior to publication of this rule in

the Federal Register. This rule is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

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 8, 1998.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I 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 § 180.516, by adding text to

paragraph (b) to read as follows:

§ 180.516 Fludioxonil; tolerances for

residues.

* * * * *

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for residues of the fungicide fludioxonil

(4-(2,2-difluoro-1,3-benzodioxol-4-yl)-

1H-pyrrole-3-carbonitrile) in connection

with use of the pesticide under section

18 emergency exemptions granted by

EPA. The tolerances will expire and are

revoked on the dates specified in the

following table:

Commodity Parts per million Expiration/revocation date

Apricots ................................................................................................ 5.0 12/31/99

Nectarines ............................................................................................ 5.0 12/31/99

Peaches ............................................................................................... 5.0 12/31/99

Plums ................................................................................................... 5.0 12/31/99

* * * * *

[FR Doc. 98–16677 Filed 6–23–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300675; FRL 5796–9]

RIN 2070–AB78

Tebufenozide; Benzoic Acid, 3,5-

dimethyl-1-(1,1-dimethylethyl)-2-(4-

ethylbenzoyl) hydrazide

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for residues of tebufenozide

in or on pecans and grapes, wine and a

time-limited tolerance for residues of

tebufenozide in or on pears. The timelimited tolerance for pears is being

established to allow the use of

tebufenozide on pears under an

Experimental Use Permit. Rohm and

Haas Company requested these

tolerances under the Federal Food,

Drug, and Cosmetic Act (FFDCA), as

amended by the Food Quality Protection

Act of 1996 (Pub. L. 104–170).

DATES: This regulation is effective June

24, 1998. Objections and requests for

hearings must be received by EPA on or

before August 24, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300675],

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–

300675], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), 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. 119, CM #2, 1921

Jefferson Davis Hwy., 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 5.1/6.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300675]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this
Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 /Rules and Regulations 34311

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Joseph M. Tavano, 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: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 305–6411, e-mail:

tavano.joseph@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 28, 1998 (63

FR 4252) [FRL 5763–6]; March 6, 1998

(63 FR 11240) [FRL 5777–5] and March

27, 1998 (63 FR 14926) [5577–6]. EPA,

issued notices pursuant to section 408

of the Federal Food, Drug, and Cosmetic

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

announcing the filing of pesticide

petitions (PP) for tolerance by Rohm and

Haas Company, 100 Independence mall

west, Philadelphia, PA 19106–2399.

These notices included a summary of

the petitions prepared by Rohm and

Haas Company, the registrant. There

were no comments received in response

to these notices of filing.

The petition requested that 40 CFR

180.482 be amended by establishing a

tolerance for residues of the insecticide,

tebufenozide, in or on pecans, grapes,

wine and pears at 0.01, 0.5, and 1.0 part

per million (ppm) respectively.

I. Risk Assessment and Statutory

Findings

New section 408(b)(2)(A)(i) of the

FFDCA 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 and in

residential settings, 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. . . .’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

pesticide through the diet (e.g., food and

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

(sometimes called a ‘‘safety factor’’) of

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100% or

less of the RfD) is generally considered

acceptable by EPA. EPA generally uses

the RfD to evaluate the chronic risks

posed by pesticide exposure. For shorter

term risks, EPA calculates a margin of

exposure (MOE) by dividing the

estimated human exposure into the

NOEL from the appropriate animal

study. Commonly, EPA finds MOEs

lower than 100 to be unacceptable. This

100-fold MOE is based on the same

rationale as the 100-fold uncertainty

factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

‘‘acute,’’ ‘‘short-term,’’ ‘‘intermediate

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1–day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

to the pesticide for a period of 1–7 days,

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources (e.g. frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization. Since

the toxicological endpoint considered in
34312 Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 /Rules and Regulations

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

children. The TMRC is a ‘‘worst case’’

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

was not regionally based.

II. Aggregate Risk Assessment and

Determination of Safety

Consistent with section 408(b)(2)(D),

EPA has reviewed the available

scientific data and other relevant

information in support of this action,

EPA has sufficient data to assess the

hazards of tebufenozide, benzoic acid,

3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-

ethylbenzoyl) hydrazide and to make a

determination on aggregate exposure,

consistent with section 408(b)(2), for

tolerances for residues of tebufenozide

on pecans, grapes, wine and pears at

0.01, 0.5, and 1.0 ppm respectively.

EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by tebufenozide,

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

dimethylethyl)-2-(4-ethylbenzoyl)

hydrazide are discussed below.

1. Acute toxicity studies with

technical grade: Oral LD50 in the rat is

> 5 grams for males and females -

Toxicity Category IV; dermal LD50 in the

rat is = 5,000 milligram/kilogram (mg/

kg) for males and females - Toxicity

Category III; inhalation LC50 in the rat is

> 4.5 mg/l - Toxicity Category III;

primary eye irritation study in the rabbit

is a non-irritant; primary skin irritation

in the rabbit > 5mg - Toxicity Category

IV. Tebufenozide is not a sentizer.

2. In a 21–day dermal toxicity study,

Crl: CD rats (6/sex/dose) received

repeated dermal administration of either

the technical 96.1% product RH-75,992

at 1,000 mg/kg/day Limit-Dose or the

formulation 23.1% a.i. product RH755,992 2F at 0, 62.5, 250, or 1,000 mg/

kg/day, 6 hours/day, 5 days/week for 21

days. Under conditions of this study,

RH-75,992 Technical or RH-75,992 2F

demonstrated no systemic toxicity or

dermal irritation at the highest dose

tested 1,000 mg/kg/ during the 21–day

study. Based on these results, the NOEL

for systemic toxicity and dermal

irritation in both sexes is 1,000 mg/kg/

day highest dose tested (HDT). A

lowest-observable-effect level (LOEL) for

systemic toxicity and dermal irritation

was not established.

3. A 1–year dog feeding study with a

(LOEL) of 250 ppm, 9 mg/kg/day for

male and female dogs based on

decreases in RBC, HCT, and HGB,

increases in Heinz bodies,

methemoglobin, MCV, MCH,

reticulocytes, platelets, plasma total

bilirubin, spleen weight, and spleen/

body weight ratio, and liver/body

weight ratio. Hematopoiesis and

sinusoidal engorgement occurred in the

spleen, and hyperplasia occurred in the

marrow of the femur and sternum. The

liver showed an increased pigment in

the Kupffer cells. The no-observed effect

level (NOEL) for systemic toxicity in

both sexes is 50 ppm (1.9 mg/kg/day).

4. An 18–month mouse

carcinogenicity study with no

carcinogenicity observed at dosage

levels up to and including 1,000 ppm.

5. A 2–year rat carcinogenicity with

no carcinogenicity observed at dosage

levels up to and including 2,000 ppm

(97 mg/kg/day and 125 mg/kg/day for

males and females, respectively).

6. In a prenatal developmental

toxicity study in Sprague-Dawley rats

25/group Tebufenozide was

administered on gestation days 6–15 by

gavage in aqueous methyl cellulose at

dose levels of 50, 250, or 1,000 mg/kg/

day and a dose volume of 10 ml/kg.

There was no evidence of maternal or

developmental toxicity; the maternal

and developmental toxicity NOEL was

1,000 mg/kg/day.

7. In a prenatal developmental

toxicity study conducted in New

Zealand white rabbits 20/group

Tebufenozide was administered in 5 ml/

kg of aqueous methyl cellulose at gavage

doses of 50, 250, or 1,000 mg/kg/day on

gestation days 7–19. No evidence of

maternal or developmental toxicity was

observed; the maternal and

developmental toxicity NOEL was 1,000

mg/kg/day.
Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 /Rules and Regulations 34313

8. In a 1993 two-generation

reproduction study in Sprague-Dawley

rats tebufenozide was administered at

dietary concentrations of 0, 10, 150, or

1,000 ppm (0, 0.8, 11.5, or 154.8 mg/kg/

day for males and 0, 0.9, 12.8, or 171.1

mg/kg/day for females). The parental

systemic NOEL was 10 ppm (0.8/0.9

mg/kg/day for males and females,

respectively) and the LOEL was 150

ppm (11.5/12.8 mg/kg/day for males and

females, respectively) based on

decreased body weight, body weight

gain, and food consumption in males,

and increased incidence and/or severity

of splenic pigmentation. In addition,

there was an increased incidence and

severity of extramedullary

hematopoiesis at 2,000 ppm. The

reproductive NOEL was 150 ppm. (11.5/

12.8 mg/kg/day for males and females,

respectively) and the LOEL was 2,000

ppm (154.8/171.1 mg/kg/day for males

and females, respectively) based on an

increase in the number of pregnant

females with increased gestation

duration and dystocia. Effects in the

offspring consisted of decreased number

of pups per litter on postnatal days 0

and/or 4 at 2,000 ppm (154.8/171.1 mg/

kg/day for males and females,

respectively) with a NOEL of 150 ppm

(11.5/12.8 mg/kg/day for males and

females, respectively).

9. In a 1995 two-generation

reproduction study in rats Tebufenozide

was administered at dietary

concentrations of 0, 25, 200, or 2,000

ppm (0, 1.6, 12.6, or 126.0 mg/kg/day

for males and 0, 1.8, 14.6, or 143.2 mg/

kg/day for females). For parental

systemic toxicity, the NOEL was 25 ppm

(1.6/1.8 mg/kg/day in males and

females, respectively), and the LOEL

was 200 ppm (12.6/14.6 mg/kg/day in

males and females), based on

histopathological findings (congestion

and extramedullary hematopoiesis) in

the spleen. Additionally, at 2,000 ppm

(126.0/143.2 mg/kg/day in M/F),

treatment-related findings included

reduced parental body weight gain and

increased incidence of hemosiderinladen cells in the spleen. Columnar

changes in the vaginal squamous

epithelium and reduced uterine and

ovarian weights were also observed at

2,000 ppm, but the toxicological

significance was unknown. For

offspring, the systemic NOEL was 200

ppm. (12.6/14.6 mg/kg/day in males and

females), and the LOEL was 2,000 ppm

(126.0/143.2 mg/kg/day in M/F) based

on decreased body weight on postnatal

days 14 and 21.

10. Several mutagenicity tests which

were all negative. These include an

Ames assay with and without metabolic

activation, an in vivo cytogenetic assay

in rat bone marrow cells, and in vitro

chromosome aberration assay in CHO

cells, a CHO/HGPRT assay, a reverse

mutation assay with E. Coli, and an

unscheduled DNA synthesis assay

(UDS) in rat hepatocytes.

11. The pharmacokinetics and

metabolism of tebufenozide were

studied in female Sprague-Dawley rats

(3–6/sex/group) receiving a single oral

dose of 3 or 250 mg/kg of RH-5992,14C

labeled in one of three positions (A-ring,

B-ring or N-butylcarbon). The extent of

absorption was not established. The

majority of the radiolabeled material

was eliminated or excreted in the feces

within 48 hours within 48 hours; small

amounts (1 to 7% of the administered

dose) were excreted in the urine and

only traces were excreted in expired air

or remained in the tissues. There was no

tendency for bioacculmulation.

Absorption and excretion were rapid.

A total of 11 metabolites, in addition

to the parent compound, were identified

in the feces; the parent compound

accounted for 96 to 99% of the

administered radioactivity in the high

dose group and 35 to 43% in the low

dose group. No parent compound was

found in the urine; urinary metabolites

were not characterized. The identity of

several fecal metabolites was confirmed

by mass spectral analysis and other fecal

metabolites were tentatively identified

by cochromatography with synthetic

standards. A pathway of metabolism

was proposed based on these data.

Metabolism proceeded primarily by

oxidation of the three benzyl carbons,

two methyl groups on the B-ring and an

ethyl group on the A-ring to alcohols,

aldehydes or acids. The type of

metabolite produced varies depending

on the position oxidized and extent of

oxidation. The butyl group on the

quaternary nitrogen also can be leaved

(minor), but there was no fragmentation

of the molecule between the benzyl

rings.

No qualitative differences in

metabolism were observed between

sexes, when high or low dose groups

were compared or when different

labeled versions of the molecule were

compared.

12. The absorption and metabolism of

tebufenozide were studied in a group of

male and female bile-duct cannulated

rats. Over a 72 hour period, biliary

excretion accounted for 30%[M] to

34%[F] of the administered dose while

urinary excretion accounted for ≈ 5% of

the administered dose and the carcass

accounted for < 0.5% of the

administered dose for both males and

females. Thus systemic absorption

(percent of dose recovered in the bile,

urine and carcass] was 35%[M] to

39%[F]. The majority of the

radioactivity in the bile (20% [M] to

24% [F]) of the administered dose] was

excreted within the first 6 hours

postdosing indicating rapid absorption.

Furthermore, urinary excretion of the

metabolites was essentially complete

within 24 hours postdosing. A large

amount [67%(F) to 70% (M)] of the

administered dose was unabsorbed and

excreted in the feces by 72 hours. Total

recovery of radioactivity was 105% of

the administered dose.

A total of 13 metabolites were

identified in the bile; the parent

compound was not identified i.e.

unabsorbed compound nor were the

primary oxidation products seen in the

feces in the pharmacokinetics study.

The proposed metabolic pathway

proceeded primary by oxidation of the

benzylic carbons to alcohols, aldehydes

or acids. Bile contained most of the

other highly oxidized products found in

the feces. The most significant

individual bile metabolites accounted

for 5% to 18% of the total radioactivity

(F and/or M). Bile also contained the

previously undetected (in the

pharmacokinetics study] ‘‘A’’ Ring

ketone and the ‘‘B’’ Ring diol. The other

major components were characterized as

high molecular weight conjugates. No

individual bile metabolite accounted for

> 5% of the total administered dose.

Total bile radioactivity accounted for ≈

17% of the total administered dose.

No major qualitative differences in

biliary metabolites were observed

between sexes. The metabolic profile in

the bile was similar to the metabolic

profile in the feces and urine.

B. Toxicological Endpoints

1. Acute toxicity. Toxicity observed in

oral toxicity studies were not

attributable to a single dose (exposure).

No neuro or systemic toxicity was

observed in rats given a single oral

administration of Tebufenozide at 0,

500, 1,000, or 2,000 mg/kg. No maternal

or developmental toxicity was observed

following oral administration of

tebufenozide at 1,000 mg/kg/day (LimitDose) during gestation to pregnant rats

or rabbits. Thus the risk from acute

exposure is considered negligible.

2. Short - and intermediate - term

toxicity. No dermal or systemic toxicity

was seen in rats receiving 15 repeated

dermal applications of the technical

(97.2%) product at 1,000 mg/kg/day

(Limit- Dose) as well as a formulated

(23% a.i) product at 0, 62.5, 250, or

1,000 mg/kg/day over a 21–day period

(MRID 42991507). The HIARC noted

that in spite of the hematological effects

seen in the dog study, similar effects

were not seen in the rats receiving the
34314 Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 /Rules and Regulations

compound via the dermal route

indicating poor dermal absorption. Also,

no developmental endpoints of concern

were evident due to the lack of

developmental toxicity in either rat or

rabbit studies. This risk is considered to

be negligable.

3. Chronic toxicity. EPA has

established the RfD for tebufenozide,

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

dimethylethyl)-2-(4-ethylbenzoyl)

hydrazide at 0.018 mg/kg/day. This RfD

is based on a NOEL of 1.8 mg/kg/day

and an uncertainty factor (UF) of 100.

The NOEL was established from the

chronic toxicity study in dogs where the

NOEL was 1.8 mg/kg/day based on

growth retardation, alterations in

hematology parameters, changes in

organ weights, and histopathological

lesions in the bone, spleen and liver at

8.7 mg/kg/day. EPA determined that the

10 x factor to protect children and

infants as required by FQPA should be

removed. Therefore, the RfD remains the

same at: 0.018 mg/kg/day. An UF of 100

is supported by the following factors.

(i) Developmental toxicity studies

showed no increased sensitivity in

fetuses when compared to maternal

animals following in utero exposures in

rats and rabbits.

(ii) Multi-generation reproduction

toxicity studies in rats showed no

increased sensitivity in pups as

compared to adults and offspring.

(iii) There are no data gaps.

4. Carcinogenicity. Tebufenozide has

been classified as a Group E, ‘‘no

evidence of carcinogenicity for

humans,’’ chemical by EPA.

C. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.482) for the residues of

tebufenozide, in or on walnuts at 0.1

ppm and apples at 1.0 ppm. Numerous

section 18 tolerances have been

established at levels ranging from 0.3

ppm in sugar beet roots to 5.0 ppm in

turnip tops. Risk assessments were

conducted by EPA to assess dietary

exposures and risks from tebufenozide,

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

dimethylethyl)-2-(4-ethylbenzoyl)

hydrazide as follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a one day or single exposure. Toxicity

observed in oral toxicity studies were

not attributable to a single dose

(exposure). No Neuro or systemic

toxicity was observed in rats given a

single oral administration of

tebufenozide at 0, 500, 1,000 or 2,000

mg/kg. No maternal or developmental

toxicity was observed following oral

administration of tebufenozide at 1,000

mg/kg/day (Limit-Dose) during gestation

to pregnant rats or rabbits. This risk is

considered to be negligable.

ii. Chronic exposure and risk. The RfD

used for the chronic dietary analysis is

0.018 mg/kg/day. In conducting this

exposure assessment, EPA has made

very conservative assumptions 100% of

pecans and wine and sherry and and

pears and all other commodities having

tebufenozide tolerances will contain

tebufenozide residues and those

residues would be at the level of the

tolerance which result in an

overestimate of human dietary

exposure. Thus, in making a safety

determination for this tolerance, HED is

taking into account this conservative

exposure assessment. The existing

tebufenozide tolerances published,

pending, and including the necessary

section 18 tolerance(s) resulted in a

Theoretical Maximum Residue

Contribution (TMRC) that is equivalent

to the following percentages of the RfD:

U.S. Population (31% of RfD); Nursing

Infants (<1 year old) (41% of RfD); NonNursing Infants (<1 year old) (80% of

Rfd); Children (1–6 years old) (60% of

RfD); Children (7–12 years old) (43% of

Rfd); Females (13 + years old, nursing)

(31% of RfD); Males (13–19 years old)

(28% of RfD); Non-Hispanic Blacks

(34% of RfD); Non Hispanic Others

(42% of RfD) Western Region (35% of

RfD). The subgroups listed above are: (1)

the U.S. population (48 States); (2) those

for infants and children; and, (3) the

other subgroups for which the

percentage of the RfD occupied is

greater than that occupied by the

subgroup U.S. population (48 States).

2. From drinking water— i. Acute

exposure and risk. Because no acute

dietary endpoint was determined, the

Agency concludes that there is a

reasonable certainty of no harm from

acute exposure from drinking water.

ii. Chronic exposure and risk.

Submitted environmental fate studies

suggest that tebufenozide is moderately

persistent to persistent and

mobile.Under certain conditions

tebufenozide appears to have the

potential to contaminate ground and

surface water through runoff and

leaching; subsequently potentially

contaminating drinking water.There are

no established Maximum Contaminant

Levels (MCL) for residues of

tebufenozide in drinking water and no

Health Advisories (HA) have been

issued for tebufenozide therefore these

could not be used as comparative values

for risk assessment. Therefore, potential

residue levels for drinking water

exposure were calculated using

GENEEC (surface water) and SCIGROW

(ground water) for human health risk

assessment. Because of the wide range

of half-life values (66–729 days)

reported for the aerobic soil metabolism

input parameter a range of potential

exposure values were calculated. In

each case the worst case upper bound

exposure limits were then compared to

appropriate chronic drinking water level

of concern (DWLOC). In each case the

calculated exposures based on model

data were below the DWLOC.

3. From non-dietary exposure.

Tebufenozide is not currently registered

for use on any residential non-food

sites. Therefore there is no chronic,

short- or intermediate-term exposure

scenario.

4. 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 scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex 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

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common
Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 /Rules and Regulations 34315

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether

tebufenozide, benzoic acid, 3,5-

dimethyl-1-(1,1-dimethylethyl)-2-(4-

ethylbenzoyl) hydrazide has a common

mechanism of toxicity with other

substances or how to include this

pesticide in a cumulative risk

assessment. Unlike other pesticides for

which EPA has followed a cumulative

risk approach based on a common

mechanism of toxicity, tebufenozide,

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

dimethylethyl)-2-(4-ethylbenzoyl)

hydrazide does not appear to produce a

toxic metabolite produced by other

substances. For the purposes of this

tolerance action, therefore, EPA has not

assumed that tebufenozide, benzoic

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

dimethylethyl)-2-(4-ethylbenzoyl)

hydrazide has a common mechanism of

toxicity with other substances.

D. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. Since no acute

toxicological endpoints were

established, no acute aggregate risk

exists.

2. Chronic risk. Using the

conservative exposure assumptions

described above, and taking into

account the completeness and reliability

of the toxicity data, EPA has concluded

that dietary (food only) exposure to

tebufenozide will utilize 31% of the RfD

for the U.S. population. Submitted

environmental fate studies suggest that

tebufenozide is moderately persistent to

persistent and mobile; thus,

tebufenozide could potentially leach to

ground water and runoff to surface

water under certain environmental

conditions. The modeling data for

tebufenozide indicate levels less than

OPP’s DWLOC. EPA generally has no

concern for exposures below 100% of

the RfD because the RfD represents the

level at or below which daily aggregate

dietary exposure over a lifetime will not

pose appreciable risks to human health.

There are no registered residential uses

of tebufenozide. Since there is no

potential for exposure to tebufenozide

from residential uses, EPA does not

expect the aggregate exposure to exceed

100% of the RfD.

3. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential

exposure. Since there are currently no

registered indoor or outdoor residential

non-dietary uses of tebufenozide and no

short- or intermediate-term toxic

endpoints, short- or intermediate-term

aggregate risk does not exist.

E. Aggregate Cancer Risk for U.S.

Population

Since, tebufenozide has been

classified as a Group E, ‘‘no evidence of

carcinogenicity for humans,’’ this risk

does not exist.

F. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children— i. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

tebufenozide, benzoic acid, 3,5-

dimethyl-1-(1,1-dimethylethyl)-2-(4-

ethylbenzoyl) hydrazide, EPA

considered data from developmental

toxicity studies in the rat and rabbit and

a two-generation reproduction study in

the rat. The developmental toxicity

studies are designed to evaluate adverse

effects on the developing organism

resulting from maternal pesticide

exposure gestation. Reproduction

studies provide information relating to

effects from exposure to the pesticide on

the reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard uncertainty

factor (usually 100 for combined interand intra-species variability)) and not

the additional tenfold MOE/uncertainty

factor when EPA has a complete data

base under existing guidelines 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 standard MOE/safety factor.

ii. Developmental toxicity studies—a.

Rats. In a developmental toxicity study

in rats, the maternal (systemic) NOEL

was 250 mg/kg/day. The LOEL was

1,000 mg/kg/day, based on decreased

body weight and food consumption. The

developmental (pup) NOEL was ≤ 1,000

mg/kg/day (HGT)

b. Rabbits. In a developmental

toxicity study in rabbits, the maternal

and developmental NOELs were ≤ 1,000

mg/kg/day (HDT).

iii. Reproductive toxicity study. In a

1993 two-generation reproduction study

in Sprague-Dawley rats, tebufenozide

was administered at dietary

concentrations of 0, 10, 150, or 1,000

ppm (0, 0.8, 11.5, or 154.8 mg/kg/day

for males and 0, 0.9, 12.8, or 171.1 mg/

kg/day for females). The parental

systemic NOEL was 10 ppm (0.8/0.9

mg/kg/day for males and females,

respectively) and the LOEL was 150

ppm (11.5/12.8 mg/kg/day for males and

females, respectively) based on

decreased body weight, body weight

gain, and food consumption in males,

and increased incidence and/or severity

of splenic pigmentation. In addition,

there was an increased incidence and

severity of extramedullary

hematopoiesis at 2,000 ppm. The

reproductive NOEL was 150 ppm. (11.5/

12.8 mg/kg/day for males and females,

respectively) and the LOEL was 2,000

ppm (154.8/171.1 mg/kg/day for males

and females, respectively) based on an

increase in the number of pregnant

females with increased gestation

duration and dystocia. Effects in the

offspring consisted of decreased number

of pups per litter on postnatal days 0

and/or 4 at 2,000 ppm (154.8/171.1 mg/

kg/day for males and females,

respectively) with a NOEL of 150 ppm

(11.5/12.8 mg/kg/day for males and

females, respectively)

In a 1995 two-generation reproduction

study in rats, tebufenozide was

administered at dietary concentrations

of 0, 25, 200, or 2,000 ppm (0, 1.6, 12.6,

or 126.0 mg/kg/day for males and 0, 1.8,

14.6, or 143.2 mg/kg/day for females).

For parental systemic toxicity, the

NOEL was 25 ppm (1.6/1.8 mg/kg/day

in males and females, respectively), and

the LOEL was 200 ppm (12.6/14.6 mg/

kg/day in males and females), based on

histopathological findings (congestion

and extramedullary hematopoiesis) in

the spleen. Additionally, at 2,000 ppm

(126.0/143.2 mg/kg/day in M/F),

treatment-related findings included

reduced parental body weight gain and

increased incidence of hemosiderinladen cells in the spleen. Columnar

changes in the vaginal squamous
34316 Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 /Rules and Regulations

epithelium and reduced uterine and

ovarian weights were also observed at

2,000 ppm, but the toxicological

significance was unknown. For

offspring, the systemic NOEL was 200

ppm. (12.6/14.6 mg/kg/day in males and

females), and the LOEL was 2,000 ppm

(126.0/143.2 mg/kg/day in M/F) based

on decreased body weight on postnatal

days 14 and 21.

iv. Pre- and post-natal sensitivity. The

toxicology data base for tebufenozide is

complete and includes acceptable

developmental toxicity studies in both

rats and rabbits as well as a two twogeneration reproductive toxicity studies

in rats.

The EPA determined that the data

provided no indication of increased

sensitivity of rats or rabbits to in utero

and/or postnatal exposure to

tebufenozide. No maternal or

developmental findings were observed

in the prenatal developmental toxicity

studies at doses up to 1,000 mg/kg/day

in rats and rabbits. In the two twogeneration reproduction studies in rats,

effects occurred at the same or lower

treatment levels in the adults as in the

offspring.

2. Acute risk. Since no acute

toxicological endpoints were

established, no acute aggregate risk

exists.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to tebufenozide,

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

dimethylethyl)-2-(4-ethylbenzoyl)

hydrazide from food will utilize from

31% of the RfD for the U.S. population

to 80% of the RfD for non-nursing

infants less than 1 year old. The

potential for exposure to tebufenozide

in drinking water does not exceed EPA’s

level of concern. There are currently no

tebufenozide residential or non-dietary

exposure scenarios. EPA generally has

no concern for exposures below 100%

of the RfD because the RfD represents

the level at or below which daily

aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. EPA does not expect

the aggregate exposure to exceed 100%

of the RfD. EPA concludes that there is

a reasonable certainty that no harm will

result to infants and children from

aggregate exposure to tebufenozide,

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

dimethylethyl)-2-(4-ethylbenzoyl)

hydrazide residues.

4. Short- or intermediate-term risk.

Since no short- and intermediate-term

toxicological endpoints were

established by EPA, no acute aggregate

risk exists.

III. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residues of

tebufenozide in/on plants is adequately

understood. The residue of concern for

both regulatory (tolerance expression)

and risk assessment purposes is the

parent compound, tebufenozide per se.

There are no animal feed items

associated with pecans. According to

information supplied by the petitioner,

wine grapes and wine grape processing

commodities are not items of animal

feed in Europe. Therefore, a discussion

of potential transfer of secondary

residues to animal commodities is not

germane to these actions.

B. Analytical Enforcement Methodology

A HPLC/UV analytical method,

Enforcement Residue Analytical Method

for RH-5992 in Pecans with HPLC-MS

Confirmation is adequate for

enforcement purposes in pecans. A

successful Agency validation for an

analytical method to detect residues of

tebufenozide per se has been conducted

by ACL/BEAD.

The method used in the analysis of

the total residue of concern in the

European field residue trials in wine,

Method AL 013/92–0, was developed by

Rohm and Haas and independently

validated. In the validation of this

method, at levels from 0.01 to 0.5 ppm

in wine recoveries ranged from 84 to

109%; in grapes at levels of 0.02 to 1.0

ppm recoveries ranged from 77 to 128%.

The limit of quantitation was given as

0.02 ppm for grapes and 0.01 ppm for

wine. The method is different from

those validated for domestic

commodities but was determined to be

adequate for data collection.

C. Magnitude of Residues

Adequate residue data were provided

to support tolerances of 0.01 ppm for

pecans and 0.5 ppm for grapes, wine

and a time-limited tolerance for pears.

There are no pecan or pear processed

comodities of regulatory concern. In

those instances when treated grapes

were vinified, residues of tebufenozide

in the aged wine were a third to a half

of those in the treated grapes. The

maximum residue found in the wine

treated at label rates was 0.3 ppm;

therefore, a tolerance for wine grapes

would suffice for the wine made from

them.

Since there are no pecan or pear

animal feed items and according to

information supplied by the petitioner,

wine grapes and wine grape processing

commodities are not items of animal

feed in Europe, no secondary residues

in animals are expected.

D. International Residue Limits

There are currently no CODEX,

Canadian, or Mexican listings for

tebufenozide residues in or on pecans or

pears, therefore there are no

harmonization issues for these crops.

Maximum residue levels (MRL) of 0.5

ppm have been established for wine

grapes in France, Italy, and Germany.

The tolerance of 0.5 ppm in or on wine

grapes is in harmony with these MRLs.

E. Rotational Crop Restrictions

Since pecans, grapes, and pears are

not rotated to other crops, a discussion

of tebufenozide accumulation in

rotational crops is not germane to this

action.

IV. Conclusion

Therefore, the tolerance is established

for residues of tebufenozide in pecans,

grapes, wine, and pears at 0.01, 0.5, and

1.0 ppm respectively.

V. 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 new

section 408(e) and (l)(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 govern 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 August 24, 1998,

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

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 issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if
Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 /Rules and Regulations 34317

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

issues 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 so marked 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.

VI. Public Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300675] (including any

comments and data submitted

electronically). 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 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Room 119 of the Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at: oppdocket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer 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 Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

VII. Regulatory Assessment

Requirements

This final rule establishes tolerances

under FFDCA section 408(d) in

response to a petitions submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

U.S.C. 3501 et seq., or impose any

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Pub. L.

104–4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since these tolerances and

exemptions that are established on the

basis of petitions under FFDCA section

408(d), such as the tolerances in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply.

Nevertheless, the Agency has previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950) and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

VIII. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit 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 United

States prior to publication of the rule in

the Federal Register. This rule is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

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 12, 1998.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I 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 §180.482, by alphabetically

adding the following commodities to the

table in paragraph (b) to read as follows:

§180.482 Tebufenozide; tolerances for

residues.

* * * * *

(b)* * *

Commodity Parts per million Expiration/Revocation Date

* * * * * * *

Grapes, wine 1 ..................................................................................... 0.5 NA

Pears ................................................................................................... 1.0 2001

Pecans ................................................................................................. 0.01 NA
34318 Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 /Rules and Regulations

Commodity Parts per million Expiration/Revocation Date

* * * * * * *

1 There are no U.S. registrations on grapes as of June 24, 1998.

[FR Doc. 98–16822 Filed 6–23–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185, and 186

[OPP–300627; FRL–5777–7]

RIN 2070–AB78

Recodification of Certain Tolerance

Regulations

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: The Environmental Protection

Agency is issuing this technical

amendment to consolidate parts 185 and

186 pesticide tolerance regulations into

part 180. This recodification is

consistent with the Food Quality

Protection Act which places all

pesticide tolerances under section 408

of the Federal Food, Drug, and Cosmetic

Act, thus eliminating the distinction

between pesticide tolerances for raw

and processed foods.

DATES: This regulation becomes effective

June 24, 1998.

FOR FURTHER INFORMATION CONTACT: By

mail, Joseph Nevola, Special Review

Branch (7508W), Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location, telephone

number and e-mail address: 3rd Floor,

Crystal Station, 2800 Crystal Drive,

Arlington, VA 22202, (703) 308-8037; email: nevola.joseph@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Pesticide

tolerance regulations promulgated

under sections 408 and 409 of the

Federal Food, Drug, and Costmetic Act

(FFDCA), 21 U.S.C. 346a and 348,

appear in parts 180, 185 and 186 of title

40 of the Code of Federal Regulations.

Part 180 contains pesticide tolerance

regulations for pesticide chemical

residues in raw agricultural

commodities. Such regulations were

promulgated under FFDCA section 408.

Parts 185 and 186 contain food additive

regulations for pesticide chemical

residues in processed food. These

regulations were promulgated under

FFDCA section 409.

The Food Quality Protection Act

(FQPA) was signed into law in August

of 1996. Under section 408(j) of the

FFDCA, as amended by the FQPA, all

pesticide tolerances established under

FFDCA section 409 were deemed to be

tolerances under FFDCA section 408.

Since there is no longer a statutory

reason for the separation of these

tolerances into different parts of the

CFR, as a part of the routine process of

issuing new and revised tolerances, EPA

is consolidating certain sections of the

regulations in parts 185 and 186 into 40

CFR part 180. Although the tolerances

are being restructured to fit into part

180, no substantive changes are being

made. The tolerance regulations in parts

185 and 186 are being redesignated as

follows:

Old CFR section New CFR

section

185.425 ......................................... 180.519

185.2900 ....................................... 180.520

185.3475 ....................................... 180.521

185.3480 ....................................... 180.522

185.4025 ....................................... 180.523

185.4200 ....................................... 180.524

185.5300 ....................................... 180.525

186.5400 ....................................... 185.526

This action is being taken pursuant to

EPA’s authority under FFDCA section

408(e)(1)(C) to issue regulations

implementing the requirements of

section 408. Because this regulation

involves a technical change to existing

regulations and has no substantive

impact, EPA for good cause finds that it

would be in the public interest to

promulgate this regulations without

issuing a notice of proposed rulemaking

under section 408(e)(2).

I. Regulatory Assessment Requirements

This final rule does not impose any

requirements. It only implements

technical amendments to the Code of

Federal Regulations (CFR), by

recodifying certain tolerances that have

already been established under FFDCA

section 408. Basically, this notice

simply consolidates the tolerances,

which currently appear in two separate

parts of the CFR (i.e., 40 CFR parts 185

and 186), into a single part (i.e., 40 CFR

part 180). As such, this action does not

require review by the Office of

Management and Budget (OMB) under

Executive Order 12866, entitled

Regulatory Planning and Review (58 FR

51735, October 4, 1993), the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq., or Executive Order 13045, entitled

Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997). For

the same reason, it does not require any

action under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Pub. L. 104–4), Executive Order 12875,

entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994). In addition, since this type of

action does not require any proposal, no

action is needed under the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.).

II. Submission to Congress and the

General Accounting Office

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

Agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and the Comptroller General of

the United States. EPA will submit 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 United

States prior to publication of the rule in

the Federal Register. This rule is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

List of Subjects

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

40 CFR Part 185

Environmental protection, Food

additives, Pesticides and pests.

40 CFR Part 186

Environmental protection, Animal

feeds, Pesticides and pests.