41594 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Rules and Regulations

§ 52.2423 [Amended]

3. In § 52.2423(f), the citation

‘‘Section 120–04–02.A.3.’’ is revised to

read ‘‘Section 9 VAC 5–40–20.A.3.’’

[FR Doc. 00–16366 Filed 7–5–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 63

[AD–FRL–6730–6]

RIN 2060–AE86

National Emission Standards for

Hazardous Air Pollutants for Polyether

Polyols Production; Synthetic Organic

Chemical Manufacturing Industry;

Epoxy Resins Production and NonNylon Polyamides Production; and

Petroleum Refineries

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Withdrawal of amendment in

direct final rule.

SUMMARY: Due to an adverse comment,

the EPA is withdrawing an amendment

from the May 8, 2000 direct final rule

for National Emission Standards for

Hazardous Air Pollutants (NESHAP) for

Polyether Polyols Production; Synthetic

Organic Chemical Manufacturing

Industry; Epoxy Resins Production and

Non-Nylon Polyamides Production; and

Petroleum Refineries. The amendment

being withdrawn deals with the

definition of equipment leak in the

Petroleum Refineries NESHAP. The

withdrawal of the amendment from the

direct final rule will only affect sources

subject to the Petroleum Refineries

NESHAP.

DATES: Amendment 6 in the direct final

rule, which amends § 63.641, published

on May 8, 2000 (65 FR 26491), is

withdrawn as of July 6, 2000. The

remaining amendments will be effective

July 7, 2000, as stated in the May 8 rule.

ADDRESSES: Docket numbers A–90–20

(Hazardous Organic NESHAP); A–92–37

(Epoxy Resins Production and NonNylon Polyamides Production); A–93–

48 (Petroleum Refineries); and A–96–38

(Polyether Polyols Production) contain

supporting information used in

developing the standards. The dockets

are located at the U.S. Environmental

Protection Agency, 401 M Street SW,

Washington, DC 20460, in room M–

1500, Waterside Mall (ground floor),

and may be inspected from 8:30 a.m. to

5:30 p.m., Monday through Friday,

excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Mr.

Robert E. Rosensteel at (919) 541–5608,

Emission Standards Division (MD–13),

Environmental Protection Agency,

Research Triangle Park, North Carolina

27711, electronic mail address

‘‘rosensteel.bob@epa.gov’’.

SUPPLEMENTARY INFORMATION: On May 8,

2000, the EPA published a direct final

rule (65 FR 26491) and a parallel

proposal (65 FR 26544) to amend

portions of the NESHAP for Polyether

Polyols Production; Synthetic Organic

Chemical Manufacturing Industry;

Epoxy Resins Production and NonNylon Polyamides Production; and

Petroleum Refineries. The EPA stated in

the direct final rule that if relevant,

adverse comments were received by

June 7, 2000, the EPA would publish a

document to withdraw the affected

portions of the direct final rule before its

effective date of July 7, 2000. The EPA

received an adverse comment on

Amendment 6 in the direct final rule

and, therefore, is withdrawing

Amendment 6. This withdrawal of

Amendment 6 only affects sources

subject to the Petroleum Refineries

NESHAP (40 CFR part 63, subpart CC).

Amendment 6 would have changed the

definition of equipment leak to add the

term ‘‘connectors’’ to the equipment

leak provisions in the NESHAP.

The adverse comment stated that the

EPA’s rationale for adding connectors to

the list of equipment in the definition of

equipment leak was not supported by

the record of the rulemaking for the

Petroleum Refineries NESHAP. It

indicated that meetings with, and

correspondence from, EPA and Congress

supported flexibility and the New

Source Performance Standard (NSPS)

option without connectors. Therefore,

the EPA is withdrawing this amendment

and will decide the appropriate

response to this comment. The 19

amendments for which we did not

receive adverse comments will become

effective on July 7, 2000, as provided in

the May 8, 2000 direct final rule (65 FR

26491).

Dated: June 30, 2000.

Robert Brenner,

Acting, Assistant Administrator for Air and

Radiation.

[FR Doc. 00–17068 Filed 7–5–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301008; FRL–6590–1]

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 (benzoic acid, 3,5-

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

ethylbenzoyl)hydrazide) in or on grapes.

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

grapes. This regulation establishes a

maximum permissible level for residues

of tebufenozide in this food commodity.

The tolerance will expire and is revoked

on December 31, 2001.

DATES: This regulation is effective July

6, 2000. Objections and requests for

hearings, identified by docket control

number OPP–301008, must be received

by EPA on or before September 5, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VII. of the

‘‘SUPPLEMENTARY INFORMATION.’’

To ensure proper receipt by EPA, your

objections and hearing requests must

identify docket control number OPP–

301008 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Barbara Madden, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number, 703–305–6463; e-mail address:

madden.barbara@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by

this action if you are an agricultural

producer, food manufacturer, or

pesticide manufacturer. Potentially

affected categories and entities may

include, but are not limited to:

Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Rules and Regulations 41595

CategoriesNAICS

codes

Examples of potentially affected entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under ‘‘ FOR FURTHER

INFORMATION CONTACT.’’

B. How Can I Get Additional

Information, Including Copies of This

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’ and then look

up the entry for this document under

the ‘‘Federal Register-Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301008. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA, from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

EPA, on its own initiative, in

accordance with sections 408 (l)(6) of

the Federal Food, Drug, and Cosmetic

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

establishing a tolerance for residues of

the insecticide tebufenozide, in or on

grapes at 3 parts per million (ppm). This

tolerance will expire and is revoked on

December 31, 2001. EPA will publish a

document in the Federal Register to

remove the revoked tolerance from the

Code of Federal Regulations.

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. EPA does not intend for its

actions on section 18 related tolerances

to set binding precedents for the

application of section 408 and the new

safety standard to other tolerances and

exemptions.

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 the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA)

authorizes EPA to exempt any Federal

or State agency from any provision of

FIFRA, if EPA determines that

‘‘emergency conditions exist which

require such exemption.’’ This

provision was not amended by the Food

Quality Protection Act (FQPA). EPA has

established regulations governing such

emergency exemptions in 40 CFR part

166.

III. Emergency Exemption for

Tebufenozide on Grapes and FFDCA

Tolerances

Grapes are California’s number one

ranked crop in dollar value, accounting

for over 90% of the grapes grown in the

United States. The European export

market for California wines accounts for

well over $250 million. The Grape Leaf

folder causes injury in the larval stages

by rolling and feeding on the leaves,

reducing photosynthetic function. The

Omnivorous leaf roller directly reduces

grape yields by injuring the flowers and

developing berries it feeds on. The

Omnivorous leaf roller also allows entry

of bunch rot organisms that damage

entire clusters which may result in

rejection at the winery.

Cryolite is the registered alternative

most often used to control both Grape

Leaf folders and Omnivorous leaf

rollers. However, for the 2000 crop year,

nearly all major California wineries with

export markets have advised their

growers that they will not accept grapes

which have been treated with cryolite or

any other product which would affect

the level of fluorides in wine. The

European Community recently

established strict tolerance levels of 1

ppm with respect to fluoride residues.

There is a direct correlation between

even limited use of cryolite on wine

grapes which can result in fluoride

levels in wine above 3 ppm. Therefore,

the State claims that there is no feasible

registered alternative available to wine

growers to control these pests. EPA has

authorized under FIFRA section 18 the

use of tebufenozide on grapes for

control of Omnivorous leaf roller and

Grape leaf folder in California. After

having reviewed the submission, EPA

concurs that emergency conditions exist

for wine grapes for the State. However,

the Agency does not believe that an

urgent and non-routine finding can be

made for table grapes since growers can

still use cryolite.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

tebufenozide in or on grapes. In doing

so, EPA considered the 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 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 as

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

41596 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Rules and Regulations

this tolerance will expire and is revoked

on December 31, 2001, under FFDCA

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

pesticide not in excess of the amounts

specified in the tolerance remaining in

or on grapes 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

grapes 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 California to use

this pesticide on this crop under section

18 of FIFRA without following all

provisions of EPA’s regulations

implementing 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 under FOR FURTHER

INFORMATION CONTACT.

IV. Aggregate Risk Assessment and

Determination of Safety

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. For

further discussion of the regulatory

requirements of section 408 and a

complete description of the risk

assessment process, see the final rule on

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997) (FRL–5754–

7).

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 in or on grapes at 3 ppm.

EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerance follows.

A. Toxicological Endpoints

The dose at which no observed

adverse effect level (NOAEL) from the

toxicology study identified as

appropriate for use in risk assessment is

used to estimate the toxicological

endpoint. However, the dose at which

the lowest observed adverse effect level

(LOAEL) of concern are identified is

sometimes used for risk assessment if no

NOAEL was achieved in the toxicology

study selected. An uncertainty factor

(UF) is applied to reflect uncertainties

inherent in the extrapolation from

laboratory animal data to humans and in

the variations in sensitivity among

members of the human population as

well as other unknowns. An UF of 100

is routinely used, 10X to account for

interspecies differences and 10X for

intraspecies differences.

For dietary risk assessment (other

than cancer) the Agency uses the UF to

calculate an acute or chronic reference

dose (acute RfD or chronic RfD) where

the RfD is equal to the NOAEL divided

by the appropriate UF (RfD = NOAEL/

UF). Where an additional safety factor is

retained due to concerns unique to the

FQPA, this additional factor is applied

to the RfD by dividing the RfD by such

additional factor. The acute or chronic

Population Adjusted Dose (aPAD or

cPAD) is a modification of the RfD to

accommodate this type of FQPA safety

factor.

For non-dietary risk assessments

(other than cancer) the UF is used to

determine the level of concern (LOC).

For example, when 100 is the

appropriate UF (10X to account for

interspecies differences and 10X for

intraspecies differences) the LOC is 100.

To estimate risk, a ratio of the NOAEL

to exposures (margin of exposure (MOE)

= NOAEL/exposure) is calculated and

compared to the LOC.

The linear default risk methodology

(Q*) is the primary method currently

used by the Agency to quantify

carcinogenic risk. The Q* approach

assumes that any amount of exposure

will lead to some degree of cancer risk.

A Q* is calculated and used to estimate

risk which represents a probability of

occurrence of additional cancer cases

(e.g., risk is expressed as 1 x 10-6 or one

in a million). Under certain specific

circumstances, MOE calculations will

be used for the carcinogenic risk

assessment. In this non-linear approach,

a ‘‘point of departure’’ is identified

below which carcinogenic effects are

not expected. The point of departure is

typically a NOAEL based on an

endpoint related to cancer effects

though it may be a different value

derived from the dose response curve.

To estimate risk, a ratio of the point of

departure to exposure (MOEcancer = point

of departure/exposures) is calculated.

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR TEBUFENOZIDE FOR USE IN HUMAN RISK

ASSESSMENT

Exposure Scenario Dose Used in Risk

Assessment, UF

FQPA SF* and Level of

Concern for Risk

Assessment

Study and Toxicological Effects

Acute dietary females 13–50 years of

age

None Not applicable Not applicable

Acute dietary general population including infants and childrenNone Not applicable Not applicable

Chronic dietary all populations NOAEL = 1.8 milligram/

kilogram/day (mg/kg/day)

UF = 100 Chronic RfD =

0.018 mg/kg/day

FQPA SF = 1 cPAD =

chronic RfD ÷ FQPA SF

= 0.018 mg/kg/day

Chronic toxicity study in dogs LOAEL = 8.7

mg/kg/day based on growth retardation, alterations in hematology parameters,

changes in organ weights, and

histopathological lesions in the bone,

spleen and liver.

Short-term dermal (1 to 7 days) (residential)None Not applicable Not applicable

Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Rules and Regulations 41597

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR TEBUFENOZIDE FOR USE IN HUMAN RISK

ASSESSMENT—Continued

Exposure Scenario Dose Used in Risk

Assessment, UF

FQPA SF* and Level of

Concern for Risk

Assessment

Study and Toxicological Effects

Intermediate-term dermal (1 week to

several months) (residential)

None Not applicable Not applicable

Long-term dermal (several months to

lifetime) (residential)

None Not applicable Not applicable

Short-term inhalation (1 to 7 days)

(residential)

None Not applicable Not applicable

Intermediate-term inhalation (1 week

to several months) (residential)

None Not applicable Not applicable

Long-term inhalation (several months

to lifetime) (residential)

None Not applicable Not applicable

Cancer (oral, dermal, inhalation) Tebufenozide is classified

as Group E (no evidence

of carcinogenicity in humans).

Not applicable Not applicable

*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

B. Exposure Assessment

1. Dietary exposure 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.

Tolerances, listed under 40 CFR

180.482, currently exist for residues of

tebufenozide on apples, berries, brassica

crop group, canola, cotton, cranberries,

pome fruits, pecans, mint, sugarcane,

turnips, fruiting vegetables, leafy green

vegetables, and walnuts. Additionally,

time-limited tolerances for eggs, milk,

pears, peanuts, peppers, rice, sugarcane,

sweet potatoes, and livestock

commodities of cattle, goats, hogs,

horses, poultry and sheep have been

established. Risk assessments were

conducted by EPA to assess dietary

exposures from tebufenozide in food as

follows:

i. Acute exposure. Acute dietary risk

assessments are performed for a fooduse pesticide if a toxicological study has

indicated the possibility of an effect of

concern occurring as a result of a 1 day

or single exposure. Toxicity observed in

oral toxicity studies were not

attributable to a single dose or 1 day

exposure. Therefore, no toxicological

endpoint was identified for acute

toxicity and no acute dietary risk

assessment is needed.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment the

Dietary Exposure Evaluation Model

(DEEM) analysis evaluated the

individual food consumption as

reported by respondents in the USDA

1989–1992 nationwide Continuing

Surveys of Food Intake by Individuals

(CSFII) and accumulated exposure to

the chemical for each commodity. The

following assumptions were made for

the chronic exposure assessments.

Data included in the application

indicate no tebufenozide concentration

in grape juice or raisins. For the chronic

analysis, tolerance level residues and

some percent crop treated (PCT) and

some market share assumptions were

used. Where market share information

was available, it was used in preference

over PCT data since it is the larger, more

conservative number and therefore more

protective of human health.

iii. Cancer. Tebufenozide is classified

as Group E (no evidence of

carcinogenicity in humans).

iv. Anticipated residue and PCT

information. Section 408(b)(2)(F) states

that the Agency may use data on the

actual percent of food treated for

assessing chronic dietary risk only if the

Agency can make the following

findings: Condition 1, that the data used

are reliable and provide a valid basis to

show what percentage of the food

derived from such crop is likely to

contain such pesticide residue;

Condition 2, that the exposure estimate

does not under estimate exposure for

any significant subpopulation group;

and Condition 3, if data are available on

pesticide use and food consumption in

a particular area, the exposure estimate

does not understate exposure for the

population in such area. In addition, the

Agency must provide for periodic

evaluation of any estimates used. To

provide for the periodic evaluation of

the estimate of PCT as required by

section 408(b)(2)(F), EPA may require

registrants to submit data on PCT.

The Agency used PCT information as

follows: < 1% almonds, 2% apples, 1%

dry beans/peas, 3% fresh cabbage, 2%

cole crops, 4% cotton, 3% fresh

spinach, 29% processed spinach, 5%

sugarcane and 16% walnuts.

The Agency used Percent Market

Share information as follows: 10%

pome fruit, 19% cotton, 82% sugarcane,

10% fruiting vegetables, 14% leafy

vegetables, 18% cole crop vegetables,

and 25% blueberries.

The Agency believes that the three

conditions listed above have been met.

With respect to Condition 1, PCT

estimates are derived from Federal and

private market survey data, which are

reliable and have a valid basis. EPA uses

a weighted average PCT for chronic

dietary exposure estimates. This

weighted average PCT figure is derived

by averaging State-level data for a

period of up to 10 years, and weighting

for the more robust and recent data. A

weighted average of the PCT reasonably

represents a person’s dietary exposure

over a lifetime, and is unlikely to under

estimate exposure to an individual

because of the fact that pesticide use

patterns (both regionally and nationally)

tend to change continuously over time,

such that an individual is unlikely to be

exposed to more than the average PCT

over a lifetime. The Agency is

reasonably certain that the percentage of

the food treated is not likely to be an

under estimation. As to Conditions 2

and 3, regional consumption

information and consumption

information for significant

41598 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Rules and Regulations

subpopulations is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups. Use of this

consumption information in EPA’s risk

assessment process ensures that EPA’s

exposure estimate does not understate

exposure for any significant

subpopulation group and allows the

Agency to be reasonably certain that no

regional population is exposed to

residue levels higher than those

estimated by the Agency. Other than the

data available through national food

consumption surveys, EPA does not

have available information on the

regional consumption of food to which

tebufenozide may be applied in a

particular area.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

tebufenozide in drinking water. Because

the Agency does not have

comprehensive monitoring data,

drinking water concentration estimates

are made by reliance on simulation or

modeling taking into account data on

the physical characteristics of

tebufenozide.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System

(PRZM/EXAMS) to estimate pesticide

concentrations in surface water and

screening concentration in ground water

(SCI-GROW), which predicts pesticide

concentrations in ground water. In

general, EPA will use GENEEC (a tier 1

model) before using PRZM/EXAMS (a

tier 2 model) for a screening-level

assessment for surface water. The

GENEEC model is a subset of the PRZM/

EXAMS model that uses a specific highend runoff scenario for pesticides.

GENEEC incorporates a farm pond

scenario, while PRZM/EXAMS

incorporate an index reservoir

environment in place of the previous

pond scenario. The PRZM/EXAMS

model includes a percent crop area

factor as an adjustment to account for

the maximum percent crop coverage

within a watershed or drainage basin.

None of these models include

consideration of the impact processing

(mixing, dilution, or treatment) of raw

water for distribution as drinking water

would likely have on the removal of

pesticides from the source water. The

primary use of these models by the

Agency at this stage is to provide a

coarse screen for sorting out pesticides

for which it is highly unlikely that

drinking water concentrations would

ever exceed human health levels of

concern.

Since the models used are considered

to be screening tools in the risk

assessment process, the Agency does

not use estimated environmental

concentrations (EECs) from these

models to quantify drinking water

exposure and risk as a %RfD or %PAD.

Instead, drinking water levels of

comparison (DWLOCs) are calculated

and used as a point of comparison

against the model estimates of a

pesticide’s concentration in water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food, and from

residential uses. Since DWLOCs address

total aggregate exposure to tebufenozide

they are further discussed in the

aggregate risk sections below.

Based on the GENEEC and SCI-GROW

models the estimated environmental

concentrations (EECs) of tebufenozide

for chronic exposures are estimated to

be 17 parts per billion (ppb) for surface

water and 1 ppb for ground water.

3. From non-dietary exposure. The

term ‘‘residential exposure’’ is used in

this document to refer to nonoccupational, non-dietary exposure

(e.g., for lawn and garden pest control,

indoor pest control, termiticides, and

flea and tick control on pets).

Tebufenozide is not registered for use

on any sites that would result in

residential exposure.

4. Cumulative exposure to substances

with a 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.’’

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. For information

regarding EPA’s efforts to determine

which chemicals have a common

mechanism of toxicity and to evaluate

the cumulative effects of such

chemicals, see the final rule for

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997).

C. Safety factor for infants and children

1. Safety factor for infants and

children—i. In general. 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 prenatal

and postnatal toxicity and the

completeness of the data base on

toxicity and exposure 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.

ii. Developmental toxicity studies. In

prenatal developmental toxicity studies

in rats and rabbits, there was no

evidence of maternal or developmental

toxicity; the maternal and

developmental NOAELS were 1,000 mg/

kg/day (highest dose tested).

iii. Reproductive toxicity study. In 2-

generation reproduction studies in rats,

toxicity to the fetuses/offspring, when

observed, occurred at equivalent or

higher doses than in the maternal/

parental animals.

iv. Prenatal and postnatal sensitivity.

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 2-generation

reproduction studies in rats, effects

occurred at the same or lower treatment

levels in the adults as in the offspring.

v. Conclusion. There is a complete

toxicity data base for tebufenozide and

exposure data is complete or is

estimated based on data that reasonably

accounts for potential exposures. Data

provided no indication of increased

sensitivity of rats or rabbits to in utero

and/or postnatal exposure to

tebufenozide. Based on this, EPA

concludes that reliable data support the

use of the standard 100-fold uncertainty

factor, and that the 10X safety factor to

protect infants and children should be

removed.

D. Aggregate Risks and Determination of

Safety

To estimate total aggregate exposure

to a pesticide from food, drinking water,

and residential uses, the Agency

calculates DWLOCs which are used as a

point of comparison against the model

Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Rules and Regulations 41599

estimates of a pesticide’s concentration

in water (EECs). DWLOC values are not

regulatory standards for drinking water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food and residential

uses. In calculating a DWLOC, the

Agency determines how much of the

acceptable exposure (i.e., the PAD) is

available for exposure through drinking

water (e.g., allowable chronic water

exposure (mg/kg/day) = cPAD—(average

food + chronic non-dietary, nonoccupational exposure)). This allowable

exposure through drinking water is used

to calculate a DWLOC.

A DWLOC will vary depending on the

toxic endpoint, drinking water

consumption, and body weights. Default

body weights and consumption values

as used by EPA to calculate DWLOCs:

2 Liter/70 kilograms (adult male), 2L/60

kg (adult female), and 1L/10 kg (child).

Default body weights and drinking

water consumption values vary on an

individual basis. This variation will be

taken into account in more refined

screening-level and quantitative

drinking water exposure assessments.

Different populations will have different

DWLOCs. Generally, a DWLOC is

calculated for each type of risk

assessment used: acute, short-term,

intermediate-term, chronic, and cancer.

When EECs for surface water and

groundwater are less than the calculated

DWLOCs, EPA concludes with

reasonable certainty that exposures to

tebufenozide in drinking water (when

considered along with other sources of

exposure for which EPA has reliable

data) would not result in unacceptable

levels of aggregate human health risk at

this time. Because EPA considers the

aggregate risk resulting from multiple

exposure pathways associated with a

pesticide’s uses, levels of comparison in

drinking water may vary as those uses

change. If new uses are added in the

future, EPA will reassess the potential

impacts of tebufenozide on drinking

water as a part of the aggregate risk

assessment process.

1. Acute risk. No toxicological

endpoint was identified for acute

toxicity. Therefore, no acute aggregate

risk assessment is needed.

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to tebufenozide from food

will utilize 20% of the cPAD for the

U.S. population, 75% of the cPAD for

non-nursing infants and 51% of the

cPAD for children (1–6 years old). There

are no residential uses for tebufenozide

that result in chronic residential

exposure to tebufenozide. In addition,

despite the potential for chronic dietary

exposure to tebufenozide in drinking

water, after calculating the DWLOCs

and comparing them to conservative

model estimated environmental

concentrations of tebufenozide in

surface and ground water. EPA does not

expect the aggregate exposure to exceed

100% of the cPAD.

Population Subgroup cPAD mg/

kg/day

% cPAD

(food)

Surface

water EEC

(ppb)

Ground

water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. population ........................................................................................ 0.018 20% 17 1 500

Non-nursing infants (<1 year old) ............................................................ 0.018 75% 17 1 50

Females (13+, nursing) ............................................................................ 0.018 23% 17 1 400

3. Short-term and intermediate-term

risk. Short-term and Intermediate-term

aggregate exposure takes into account

residential exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Tebufenozide is not registered for use

on any sites that would result in

residential exposure. Additionally, no

toxicological effects have been

identified for short-term and

intermediate-term toxicity. Therefore,

the aggregate risk is the sum of the risk

from food and water, which were

previously addressed.

5. Aggregate cancer risk for U.S.

population. Tebufenozide is classified

as Group E (no evidence of

carcinogenicity in humans).

6. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to the general

population, and to infants and children

from aggregate exposure to tebufenozide

residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology

(example—gas chromotography) is

available to enforce the tolerance

expression. The method may be

requested from: Calvin Furlow, PRRIB,

IRSD (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW,

Washington, DC 20460; telephone

number: (703) 305–5229; e-mail address:

furlow.calvin@epa.gov.

B. International Residue Limits

There are no Mexican Maximum

Residue Limits (MRL) for tebufenozide

in or on grapes. Codex has a 1.0 ppm

MRL on grapes for fat soluble

tebufenozide. Canada has a

tebufenozide MRL on grapes at 0.5 ppm.

International harmonization is not

feasible for this action.

C. Conditions

Grapes are not rotated; therefore, a

discussion of rotational crop

requirements is not germane to this

action.

VI. Conclusion

Therefore, the tolerance is established

for residues of benzoic acid, 3,5-

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

ethylbenzoyl)hydrazide, tebufenozide,

in or on grapes at 3 ppm.

VII. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations which govern the

submission of objections and requests

for hearings appear in 40 CFR part 178.

Although the procedures in those

regulations require some modification to

reflect the amendments made to the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) provides

essentially the same process for persons

to ‘‘object’’ to a regulation for an

exemption from the requirement of a

tolerance issued by EPA under new

section 408(d), as was provided in the

old FFDCA sections 408 and 409.

However, the period for filing objections

is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an

Objection or Request a Hearing?

You must file your objection or

request a hearing on this regulation in

accordance with the instructions

provided in this unit and in 40 CFR part

178. To ensure proper receipt by EPA,

41600 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Rules and Regulations

you must identify docket control

number OPP–301008 in the subject line

on the first page of your submission. All

requests must be in writing, and must be

mailed or delivered to the Hearing Clerk

on or before September 5, 2000.

1. Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(s) on which a hearing

is requested, the requestor’s contentions

on such issues, and a summary of any

evidence relied upon by the objector (40

CFR 178.27). 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.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. You

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. The Office of

the Hearing Clerk is open from 8 a.m.

to 4 p.m., Monday through Friday,

excluding legal holidays. The telephone

number for the Office of the Hearing

Clerk is (202) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

tompkins.jim@epa.gov, or by mailing a

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

Unit VII.A., you should also send a copy

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by the docket control

number OPP–301008, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. In

person or by courier, bring a copy to the

location of the PIRIB described in Unit

I.B.2. You may also send an electronic

copy of your request via e-mail to: oppdocket@epa.gov. Please use an ASCII

file format and avoid the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 6.1/8.0 file

format or ASCII file format. Do not

include any CBI in your electronic copy.

You may also submit an electronic copy

of your request at many Federal

Depository Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

VIII. Regulatory Assessment

Requirements

This final rule establishes a time

limited tolerance under FFDCA section

408. 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) (Public

Law 104–4). Nor does it require any

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); 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 or any

Agency action under Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23,

1997). This action does not involve any

technical standards that would require

Agency consideration of voluntary

consensus standards pursuant to section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104–113, section

12(d) (15 U.S.C. 272 note). Since

tolerances and exemptions that are

established on the basis of a FIFRA

section 18 petition under FFDCA

section 408, 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. In

addition, the Agency has determined

that this action will not have a

substantial direct effect on States, on the

relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Rules and Regulations 41601

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

IX. 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 final

rule in the Federal Register. This final

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 6, 2000.

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. 321(q), (346a) and

371.

2. In §180.482, by alphabetically

adding ‘‘Grapes’’ to the table in

paragraph (b) to read as follows:

§ 180.482 Tebufenozide; tolerances for

residues

*****

(b)Section 18 emergency exemptions.

***

Commodity

Parts

per

million

Expiration/

Revocation

Date

*****

Grapes .......................... 3.0 12/31/01

*****

*****

[FR Doc. 00–17043 Filed 6–30–00; 3:20 pm]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301007; FRL–6590–3]

RIN 2070–AB

Fludioxonil; Extension of Tolerance for

Emergency Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation extends a

time-limited tolerance for residues of

the fungicide fludioxonil in or on

strawberries at 2 parts per million (ppm)

for an additional 1-year period. This

tolerance will expire and is revoked on

May 31, 2001. 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 strawberries. Section

408(l)(6) of the Federal Food, Drug, and

Cosmetic Act 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 the Federal

Insecticide, Fungicide, and Rodenticide

Act.

DATES: This regulation is effective July

6, 2000. Objections and requests for

hearings, identified by docket control

number OPP–301007, must be received

by EPA on or before September 5, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit III. of the

‘‘SUPPLEMENTARY INFORMATION.’’

To ensure proper receipt by EPA, your

objections and hearing requests must

identify docket control number OPP–

301007 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Stephen Schaible, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: 703 308–9362; and e-mail

address: schaible.stephen@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

CategoriesNAICS

codes

Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically.You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’ and then look

up the entry for this document under

the ‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301007. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA, from 8:30