26986 Federal Register / Vol. 63, No. 94 / Friday, May 15, 1998 /Rules and Regulations

with.’’ Any such use of methyl bromide

would subject the resulting product to

the labeling rule. Similarly, any product

‘‘containing’’ methyl bromide, as that

phrase is defined by the labeling rule, is

subject to the rule.

III. Submission to Congress and the

General Accounting Office

The Congressional Review Act

(‘‘Act’’), 5 U.S.C. section 801 et seq., as

added by the Small Business Regulatory

Enforcement Fairness Act of 1996, does

not apply because this action is not a

rule.

IV. Additional Information

For more information on methyl

bromide, please contact the

Stratospheric Protection Hotline at 1–

800–296–1996, Monday–Friday,

between the hours of 10:00 a.m. and

4:00 p.m. (EST). Federal Register

publications can be ordered from the

Government Printing Office Order Desk

(202) 783–3238; the citation is the date

of publication. Each of the final rules

referred to in this Notice may also be

retrieved from EPA’s Ozone Depletion

World Wide Web site, at http://

www.epa.gov/docs/ozone/ .

List of Subjects in 40 CFR Part 82

Environmental protection,

Administrative practice and procedure,

Air pollution control, Reporting and

recordkeeping requirements.

Dated: May 8, 1998.

Richard D. Wilson,

Acting Assistant Administrator for Air and

Radiation.

[FR Doc. 98–12851 Filed 5–14–98; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300640; FRL–5784–8]

RIN 2070–AB78

Tebufenozide; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

tebufenozide in or on peppers (bell and

non-bell) . This action is in response to

EPA’s granting of an emergency

exemption under section 18 of the

Federal Insecticide, Fungicide, and

Rodenticide Act authorizing use of the

pesticide on peppers (bell and non-bell).

This regulation establishes a maximum

permissible level for residues of

tebufenozide in this food commodity

pursuant to section 408(l)(6) of the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerance

will expire and is revoked on September

30, 1999.

DATES: This regulation is effective May

15, 1998. Objections and requests for

hearings must be received by EPA on or

before July 14, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300640],

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–

300640], 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–

300640]. 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: Andrew Ertman, 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) 308–9367, e-mail:

ertman.andrew@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, 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, in or on

peppers (bell and non-bell) at 0.5 part

per million (ppm). This tolerance will

expire and is revoked on September 30,

1999. EPA will publish a document in

the Federal Register to remove the

revoked tolerance from the Code of

Federal Regulations.

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 Federal Food, Drug,

and Cosmetic Act (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 are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum published in the Federal

Register of November 13, 1996 (61 FR

58135) (FRL–5572–9).

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. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions
Federal Register / Vol. 63, No. 94 / Friday, May 15, 1998 /Rules and Regulations 26987

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) of the FFDCA

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. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for

Tebufenozide on Peppers (Bell and

Non-bell) and FFDCA Tolerances

The applicant indicates that

emergency conditions exist because beet

armyworm (BAW) populations have

demonstrated resistance to registered

insecticides. The survival rate of the

pest has been furhter compounded by a

mild winter and unusually dry, hot

weather which has increased. Naturally

occurring epizootics require cool, wet

conditions to have their greatest impact

on this pest. The applicant also notes

that there are unusually large numbers

of BAW and damage due to BAW in

peppers could result in a 50% yield loss

without the use of an effective pesticide.

EPA has authorized under FIFRA

section 18 the use of tebufenozide on

peppers (bell and non-bell) for control

of beet armyworm in Texas. After

having reviewed the submission, EPA

concurs that emergency conditions exist

for this State.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

tebufenozide in or on peppers (bell and

non-bell). In doing so, EPA considered

the new safety standard in FFDCA

section 408(b)(2), and EPA decided that

the necessary tolerance under FFDCA

section 408(l)(6) would be consistent

with the new safety standard and with

FIFRA section 18. Consistent with the

need to move quickly on the emergency

exemption in order to address an urgent

non-routine situation and to ensure that

the resulting food is safe and lawful,

EPA is issuing this tolerance without

notice and opportunity for public

comment under section 408(e), as

provided in section 408(l)(6). Although

this tolerance will expire and is revoked

on September 30, 1999, under FFDCA

section 408(l)(5), residues of the

pesticide not in excess of the amounts

specified in the tolerance remaining in

or on peppers (bell and non-bell) after

that date will not be unlawful, provided

the pesticide is applied in a manner that

was lawful under FIFRA, and the

residues do not exceed a level that was

authorized by this tolerance at the time

of that application. EPA will take action

to revoke this tolerance earlier if any

experience with, scientific data on, or

other relevant information on this

pesticide indicate that the residues are

not safe.

Because this tolerance is being

approved under emergency conditions

EPA has not made any decisions about

whether tebufenozide meets EPA’s

registration requirements for use on

peppers (bell and non-bell) or whether

a permanent tolerance for this use

would be appropriate. Under these

circumstances, EPA does not believe

that this tolerance serves as a basis for

registration of tebufenozide by a State

for special local needs under FIFRA

section 24(c). Nor does this tolerance

serve as the basis for any State other

than Texas to use this pesticide on this

crop under section 18 of FIFRA without

following all provisions of section 18 as

identified in 40 CFR part 166. For

additional information regarding the

emergency exemption for tebufenozide,

contact the Agency’s Registration

Division at the address provided above.

III. Risk Assessment and Statutory

Findings

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
26988 Federal Register / Vol. 63, No. 94 / Friday, May 15, 1998 /Rules and Regulations

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

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

(non-nursing infants (<1 year old)) was

not regionally based.

IV. 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 and to make a

determination on aggregate exposure,

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

time-limited tolerance for residues of

tebufenozide on peppers (bell and nonbell) at 0.5 ppm. 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 are

discussed below.

1. Acute toxicity. No acute dietary risk

endpoint was identified by the Agency,

therefore this risk assessment is not

required.

2. Short - and intermediate - term

toxicity— i. Short-term. NOEL = 1,000

milligrams/kilogram/day (mg/kg/day).

Concerning short-term dermal toxicity,

the Agency noted that in a 21–day

dermal toxicity study in rats there was

no systemic toxicity observed at 1,000

mg/kg/day, the highest dose tested

(HDT). This risk assessment is not

required.

ii. Intermediate-term. The Agency did

not identify an intermediate-term

toxicology endpoint. Additionally,

because there is no intermediate

exposure scenario with this section 18

request, an intermediate-term risk

assessment is not required.

3. Chronic toxicity. EPA has

established the RfD for tebufenozide at

0.018 mg/kg/day. This RfD is based on

a 1–year feeding study in dogs with a

NOEL of 1.8 mg/kg/day. An uncertainty

factor of 100 was used to account for

both the interspecies extrapolation and

intraspecies variability. The lowesteffect-level (LEL) of 8.7 mg/kg/day was

based on hematopoietic findings

(decreased red blood cells, hematocrit,

hemoglobin levels, and increased heinz

bodies, MCV, MCH, reticulocytes, and

platelets).
Federal Register / Vol. 63, No. 94 / Friday, May 15, 1998 /Rules and Regulations 26989

4. Carcinogenicity. Tebufenozide has

been classified as a Group E, ‘‘no

evidence of carcinogenicity for

humans,’’ chemical by the Agency.

B. 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 a variety of raw

agricultural commodities. A permanent

tolerance has been established for the

residues of tebufenozide in/on walnuts

at 0.1 ppm. A permanent tolerance at

1.0 ppm has also previously been

established for imported apples. Time

limited tolerances have been established

on apples and on associated animal

commodities, cottonseed at 0.2 ppm,

leafy vegetables (except brassica) at 5.0

ppm, brassica (cole) leafy vegetables at

5.0 ppm, sugar beets at 0.3 ppm,

sugarcane at 0.03 ppm, and turnip tops

at 5.0 ppm. A time limited tolerance for

peppers (bell and non-bell) had been

established at 0.5 ppm, however this

tolerance expired on February 28, 1998.

Risk assessments were conducted by

EPA to assess dietary exposures and

risks from tebufenozide 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. Since an

acute dietary endpoint has not been

identified in the toxicology database, an

assessment of acute dietary risk was not

conducted for this section 18 request.

ii. Chronic exposure and risk. In

conducting this exposure assessment,

EPA has made very conservative

assumptions -- 100% of sugarcane 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, EPA is

taking into account this conservative

exposure assessment. The existing

tebufenozide tolerances (published,

pending, and including the necessary

section 18 tolerances) result in a

Theoretical Maximum Residue

Contribution (TMRC) that is equivalent

to the following percentages of the RfD:

Population Subgroup TMRC food (mg/kg/day) %RfD

U.S. Population - 48 States ................................................................................. 0.005516 31%

Nursing Infants (<1 year old) ............................................................................... 0.007384 41%

Non-Nursing Infants (<1 year old) ....................................................................... 0.014348 80%

Children (1–6 years old) ...................................................................................... 0.010646 59%

Children (7–12 years old) .................................................................................... 0.007595 42%

Non-Hispanic Blacks ............................................................................................ 0.006063 34%

Non-Hispanic Others ............................................................................................ 0.007358 41%

Western Region ................................................................................................... 0.006033 34%

The subgroups listed above are: (a) the

U.S. population (48 States); (b) those for

infants and children; and, (c) the other

subgroups for which the percentage of

the RfD occupied is greater than that

occupied by the subgroup U.S.

population (48 States).

For chronic dietary risk to

tebufenozide, the population subgroup

with the largest percentage of the RfD

occupied is non-nursing infants (<1 year

old) at 80% of the RfD.

2. From drinking water. 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. There is no established

Maximum Contaminant Level (MCL) for

residues of tebufenozide in drinking

water. No drinking water Health

Advisories have been issued for

tebufenozide. There is no entry for

tebufenozide in the ‘‘Pesticides in

Groundwater Database’’ (EPA 734–12–

92–001, September 1992).

Chronic exposure and risk. Because

the Agency lacks sufficient waterrelated exposure data to complete a

comprehensive drinking water risk

assessment for many 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 contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

exposure from contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause tebufenozide to exceed the

RfD if the tolerance being considered in

this document were granted. The

Agency has therefore concluded that the

potential exposures associated with

tebufenozide in water, even at the

higher levels the Agency is considering

as a conservative upper bound, would

not prevent the Agency from

determining that there is a reasonable

certainty of no harm if the tolerance is

granted.

3. From non-dietary exposure.

Tebufenozide is not currently registered

for any indoor or outdoor residential

uses; therefore, no non-dietary

residential exposure is anticipated.

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
26990 Federal Register / Vol. 63, No. 94 / Friday, May 15, 1998 /Rules and Regulations

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

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 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 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 has a

common mechanism of toxicity with

other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. Since no acute endpoint

was identified for tebufenozide, no

acute risk assessment is required.

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. The Agency

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. Despite the potential

for exposure to tebufenozide in drinking

water, EPA does not expect the

aggregate exposure (food and water) to

exceed 100% of the RfD. Since there are

no non-dietary non-occupational

exposure scenarios for tebufenozide,

there are no additional exposure from

those routes. The Agency concludes that

there is a reasonable certainty that no

harm will result from aggregate chronic

exposure to tebufenozide residues.

3. Short- and intermediate-term risk.

Since there were no toxicity endpoints

identified by the Agency for

tebufenozide and no indoor/outdoor

residential uses, no short- or

intermediate-term risk assessment was

required.

D. Aggregate Cancer Risk for U.S.

Population

Since tebufenozide has been classified

as a Group E chemical, ‘‘no evidence of

carcinogenicity for humans,’’ no cancer

risk assessment was required.

E. 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, 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 during

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 MOE and

uncertainty factor (usually 100 for

combined inter- and 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 (HDT).

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—

Rats. In a multigeneration reproductive

toxicity study in rats, the parental

(systemic) NOEL was 0.85 mg/kg/day.

Splenic pigmentation changes and

extramedullary hematopoiesis occurred

at the LOEL of 12.1 mg/kg/day (Female,

Male; F0, F1). In addition to these

effects, decreased body weight gain and

food consumption occurred at 171.1 mg/

kg/day. The reproductive (pup) NOEL

was 125 mg/kg/day. The reproductive

LOEL of 171.1 mg/kg/day, based on a

slight increase in the number of

pregnant females that either did not

deliver or had difficulty and had to be

sacrificed (F1). Additionally at the

LOEL, in F1 dams, the length of

gestation increased and implantation

sites decreased significantly. Finally,

the number of pups per litter decreased

on Lactation Day (LD) 4 to 90% of the

controls for the F1 and on LD’s 0 and 4

to 80% for the second generation.

iv. Pre- and post-natal sensitivity— a.

Pre-natal sensitivity. The developmental

NOELs of >1,000 mg/kg/day (HDT) from

the developmental toxicity studies in

rats and rabbits demonstrate that there

is no developmental (prenatal) toxicity

present for tebufenozide. Additionally,

these developmental NOELs are greater

than 500–fold higher than the NOEL of

1.8 mg/kg/day from the 1–year feeding

study in dogs which was the basis of the

RfD.

b. Post-natal sensitivity. In the

reproductive toxicity study in rats, the

reproductive NOEL (12.1 mg/kg/day) is

14–fold higher than the parental NOEL

(0.85 mg/kg/day) and indicates that

post-natal toxicity in the reproductive

studies occurs only in the presence of

significant parental toxicity. These

developmental and reproductive studies

indicate that tebufenozide does not have

additional post-natal sensitivity for

infants and children in comparison to

other exposed groups.

2. Acute risk. Since no acute endpoint

was identified for tebufenozide, no

acute risk assessment is required.

3. Chronic risk. Using the

conservative exposure assumptions

described above, HED has concluded

that the percentage of the RfD that will

be utilized by dietary (food only)

exposure to residues of tebufenozide

ranges from 41% for nursing infants (<

1 year old) up to 80% for non-nursing
Federal Register / Vol. 63, No. 94 / Friday, May 15, 1998 /Rules and Regulations 26991

infants (< 1 year old). Despite the

potential for exposure to tebufenozide

in drinking water, HED does not expect

the aggregate exposure (food and water)

to exceed 100% of the RfD. Taking into

account the completeness and reliability

of the toxicity data and the conservative

exposure assessment, HED concludes

that there is a reasonable certainty that

no harm will result to infants and

children from aggregate exposure to

tebufenozide residues.

V. Other Considerations

A. Metabolism In Plants

The metabolism of tebufenozide in/on

plants is adequately understood. The

residue of concern is the parent

compound, tebufenozide per se, as

specified in 40 CFR 180.482.

B. Analytical Enforcement Methodology

The Rohm and Haas Analytical

Method TR 34–93–119 (HPLC/UV),

should be adequate to determine

residues of tebufenozide per se in/on

peppers.

C. Magnitude of Residues

Residues of tebufenozide per se are

not expected to exceed 0.5 ppm in or on

peppers as a result of this section 18

use.

D. International Residue Limits

There are currently no CODEX,

Canadian, or Mexican listings for

tebufenozide residues, therefore there

are no harmonization issues for this

action.

VI. Conclusion

Therefore, the tolerance is established

for residues of tebufenozide in peppers

(bell and non-bell) at 0.5 ppm.

VII. 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 July 14, 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

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

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.

VIII. Public Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300640] (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

Rm. 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:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer 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.

IX. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(l)(6). 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 under

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

tolerance 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
26992 Federal Register / Vol. 63, No. 94 / Friday, May 15, 1998 /Rules and Regulations

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

acations 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

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has 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 this rule in today’s Federal Register.

This 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: May 5, 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, in paragraph (b) by

revising the entry for ‘‘Peppers’’ in the

table to read as follows:

§180.482 Tebufenozide; tolerances for

residues.

* * * * *

(b) * * *

Commodity Parts per million Expiration/revocation date

* * * * * * *

Peppers ............................................................................................... 0.5 9/30/99

* * * * * * *

* * * * *

[FR Doc. 98–12718 Filed 5–14–98; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 1

[FCC 97–218]

Forfeiture Proceedings; Correction

AGENCY: Federal Communications

Commission.

ACTION: Correcting amendments.

SUMMARY: This document contains

corrections to the final regulations (47

CFR Part 1), which were published in

the Federal Register of August 14, 1997,

(62 FR 43474). The regulations related

to Practice and Procedure for Guidelines

for Assessing Forfeitures.

DATES: Effective on May 15, 1998.

FOR FURTHER INFORMATION CONTACT:

Deborah Hannah, Compliance and

Information Bureau, (202) 418–1168,

email dhannah@fcc.gov.

SUPPLEMENTARY INFORMATION:

Background

The final rule regulations that are the

subject of this correction amended the

Commission’s rules to incorporate a

note to the rule the Commission’s policy

statement regarding forfeitures.

Need for Correction

As published, the final regulations

contain an error which may prove to be

misleading and need to be clarified.

List of Subjects in 47 CFR Part 1

Penalties.

Accordingly, 47 CFR Part 1 is

corrected by making the following

correcting amendment:

PART 1—PRACTICE AND

PROCEDURE

1. The authority citation for part 1

continues to read as follows:

Authority: 47 U.S.C. 151, 154, 303, and

309(j); unless otherwise noted.

§ 1.80 [Corrected]

2. In § 1.80, in note to paragraph

(b)(4), page 112, the first column, line

27, remove the figure ‘‘$27,500’’ and

add, in its place, ‘‘$275,000’’.

Federal Communications Commission.

Pamera D. Hairston,

Chief, Compliance Division.

[FR Doc. 98–12904 Filed 5–14–98; 8:45 am]

BILLING CODE 6712–01–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 73

[MM Docket No. 98–16; RM–9213]

Radio Broadcasting Services; Three

Rivers, TX

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: This document dismisses a

petition filed by Live Oak Broadcasting

proposing the allotment of Channel

265A to Three Rivers, Texas. See 63 FR

07360, February 13, 1998. Petitioner

failed to filed comments indicating its

continuing interest in applying for

Channel 265A at Three Rivers, Texas, if

allotted. Therefore, we have dismissed

the petition for rule making by Live Oak

Broadcasting. With this action, this

proceeding is terminated.

EFFECTIVE DATE: June 15, 1998.

FOR FURTHER INFORMATION CONTACT: Pam

Blumenthal, Mass Media Bureau, (202)

418–2180.

SUPPLEMENTARY INFORMATION: This is a

synopsis of the Commission’s Report

and Order, MM Docket No. 98–16,

adopted April 22, 1998, and released

May 1, 1998. The full text of this

Commission decision is available for

inspection and copying during normal

business hours in the FCC Reference

Center (Room 239), 1919 M Street, NW,

Washington, DC. The complete text of