Federal Register / Vol. 66, No. 247 / Wednesday, December 26, 2001 / Rules and Regulations 66333

Commodity Parts per million

Sheep, fat .................................................................................................................................... 0.1

Sheep, kidney .............................................................................................................................. 1.0

Sheep, mbyp (except kidney) ...................................................................................................... 0.1

Sheep, meat ................................................................................................................................ 0.1

(b) Section 18 emergency exemptions.

[Reserved]

* * * * *

[FR Doc. 01–31493 Filed 12–21–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301200; FRL–6816–8]

RIN 2070–AB78

Halosulfuron-methyl; Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for residues of halosulfuronmethyl in or on the melon subgroup. IR4 requested this tolerance under the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996.

DATES: This regulation is effective

December 26, 2001. Objections and

requests for hearings, identified by

docket control number OPP–301200,

must be received by EPA on or before

February 25, 2002.

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 VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301200 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Shaja R. Brothers, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave.,

NW.,Washington, DC 20460; telephone

number: (703) 308–3194; and e-mail

address: brothers.shaja@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:

Categories NAICS 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’’, ‘‘Regulations

and Proposed Rules,’’ 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–301200. 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

In the Federal Register of August 31,

2001 (66 FR 45993) (FRL–6796–1), EPA

issued a notice pursuant to section 408

of the Federal Food, Drug, and Cosmetic

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

amended by the Food Quality Protection

Act of 1996 (FQPA) (Public Law 104–

170) announcing the filing of a pesticide

petition (PP) for tolerance by the

Interregional Research Project Number 4

(IR-4), 681 U.S. Highway 1 South, North

Brunswick, NJ 08902–3390. This notice

included a summary of the petition

prepared by Gowan Company, the

registrant. There were no comments

received in response to the notice of

filing.

The petition requested that 40 CFR

180.479 be amended by establishing a

tolerance for residues of the herbicide

halosulfuron-methyl, methyl 5-[(4,6-

dimethoxy-2-pyrimidinyl)

aminocarbonylamino] sulfonyl-3-chloro1-methyl-1H-pyrazole-4-carboxylate, in

or on the melon subgroup-crop group

9A (includes citron melon, muskmelon,

and watermelon) at 0.1 part per million

(ppm).

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

66334 Federal Register / Vol. 66, No. 247 / Wednesday, December 26, 2001 / Rules and Regulations

chemical residue, including all

anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue....’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. 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).

III. 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 and to make a determination

on aggregate exposure, consistent with

section 408(b)(2), for a tolerance for

residues of halosulfuron-methyl on the

melon subgroup at 0.1 ppm. EPA’s

assessment of 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 halosulfuronmethyl are discussed in Unit II.A. of the

final rule on halosulfuron-methyl

pesticide tolerances published in the

Federal Register for September 29, 2000

(65 FR 58424) (FRL–6746–2).

B. Toxicological Endpoints

The dose at which no adverse effects

are observed (the NOAEL) from the

toxicology study identified as

appropriate for use in risk assessment is

used to estimate the toxicological level

of concern (LOC). However, the lowest

dose at which adverse effects of concern

are identified (the LOAEL) 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

intra species 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 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. A

summary of the toxicological endpoints

for halosulfuron-methyl used for human

risk assessment is shown in the

following Table 1:

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR HALOSULFURON-METHYL 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

NOAEL = 50 mg/kg/day; UF

= 100; Acute RfD = 0.5

mg/kg/day

FQPA SF = 1X; aPAD =

acute RfD/FQPA SF = 0.5

mg/kg/day

Developmental- Rabbit; LOAEL = 150 mg/kg/

day based on decreased mean litter size and

increases in resorptions and post implantation

loss.

Chronic Dietary all populations NOAEL= 10 mg/kg/day; UF

= 100; Chronic RfD = 0.1

mg/kg/day

FQPA SF = 1X; cPAD =

chronic RfD/FQPA SF =

0.1 mg/kg/day

Chronic Toxicity-Dog; LOAEL 40 mg/kg/day decrease in body weight gain and alterations in

hematology and clinical chemistry parameters.

Short-Term Dermal (1 to 7 days)

(Residential)

dermal (or oral) study

NOAEL= 50 mg/kg/day

(dermal absorption rate =

75%)

LOC for MOE = 100 (Residential)Developmental- Rabbit; LOAEL = 150 mg/kg/

day based on decreased mean litter size and

increases in resorptions and post implantation

loss.

Federal Register / Vol. 66, No. 247 / Wednesday, December 26, 2001 / Rules and Regulations 66335

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR HALOSULFURON-METHYL 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) to

Long - Term (several months

to lifetime) (Residential)

dermal (or oral) study

NOAEL = 10 mg/kg/day

(dermal absorption rate =

75%

LOC for MOE = 100 (Residential)Chronic Toxicity-Dog; LOAEL 40 mg/kg/day decrease in body weight gain and alterations in

hematology and clinical chemistry parameters.

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

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.479) for

residues of halosulfuron-methyl, in or

on the following raw agricultural

commodities: squash/cucumber (crop

subgroup 9-B); tree nuts (crop group14),

pistachio nutmeat; almond hulls; sugar

cane; corn (sweet, kernel+cob with

husks removed; field grain, fodder and

forage; and pop grain and fodder); rice

(grain and straw); and cotton (gin byproducts and undelinted seed) at the

range of 0.05 to 0.8 ppm. Additionally,

tolerances for residues of halosulfuronmethyl and its metabolites determined

as 3-chloro-1-methyl-5-

sulfamoylpyrazole-4-carboxylic acid

(CSA, expressed as parent equivalents)

are established at 0.1 ppm on meat byproducts including cattle, goats, hogs,

horses and sheep. Risk assessments

were conducted by EPA to assess

dietary exposures from halosulfuronmethyl 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 one

day or single exposure. 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 acute

exposure assessments: The Acute

DEEM analysis was performed

assuming tolerance level residues and

100% crop treated (CT) for commodities

for which halosulfuron-methyl is

registered and 0.1 ppm (the

recommended tolerance) and 100% CT

for the melon subgroup (crop group 9–

A). No reduction factors of any kind

were used in the analysis. This analysis

is considered highly conservative.

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 CSFII and

accumulated exposure to the chemical

for each commodity. The following

assumptions were made for the chronic

exposure assessments: The chronic

DEEM analysis was performed

assuming tolerance level residues and

100% crop treated (CT) for commodities

for which halosulfuron-methyl is

registered and a proposed tolerance 0.1

ppm and 100% CT for the melon

subgroup (crop group 9–A). No

reduction factors of any kind were used

in the analysis. This analysis is

considered highly conservative.

iii. Cancer. Halosulfuron-methyl is

classified as a ‘‘not likely’’ human

carcinogen based on a lack of evidence

of carcinogenicity in male and female

mice and rats. Accordingly, a cancer

risk assessment was not conducted.

2. Dietary exposure from drinking

water. The available data on

halosulfuron-methyl (parent) shows that

the compound is mobile in soil and is

persistent at phytotoxically significant

levels for months to years at some sites.

Halosulfuron-methyl has the potential

to leach to groundwater, and also

presents concerns for transport to

surface water by runoff.

The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

halosulfuron-methyl 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

halosulfuron-methyl.

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 SCIGROW, which predicts pesticide

concentrations in groundwater. 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 halosulfuronmethyl they are further discussed in the

aggregate risk sections below.

Based on the GENEEC model the

acute and chronic estimated

environmental concentrations (EECs) of

halosulfuron-methyl for surface water

are estimated to be 8.3 μg/L and 1.7 μg/

L, respectively. Based on the SCI-GROW

model the estimated EECs of

66336 Federal Register / Vol. 66, No. 247 / Wednesday, December 26, 2001 / Rules and Regulations

halosulfuron-methyl for groundwater is

estimated to be 0.065 μg/L.

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).

Halosulfuron-methyl is currently

registered for use on the following

residential non-dietary sites:

commercial and residential turf and on

other non-crop sites including airports,

cemeteries, fallow areas, golf courses,

landscaped areas, public recreation

areas, residential property, road sides,

school grounds, sod or turf seed farms,

sports fields, landscaped areas with

established woody ornamentals and

other similar use sites. The risk

assessment was conducted as follows:

For short-term exposure and risk for

residential lawn applicators (handlers),

the resulting dermal exposure for female

handlers is 0.000043 mg/kg/day

resulting in an MOE of 1,200,000. This

MOE does not exceed EPA’s level of

concern for residential handlers.

Chronic- and intermediate-term handler

assessments were not conducted

because lawn application of

halosulfuron-methyl is not expected to

be made continuously over the duration

of the chronic- or intermediate-term

exposure scenarios.

For residential postapplication

exposure and risk calculations for

adults, short- and intermediate-term

exposures result in MOEs that range

from 1,800 to 5,200. These MOEs do not

exceed EPA’s level of concern for

adults.

For children’s residential

postapplication exposure and risk

calculations, dermal exposure was

combined with incidental oral hand-tomouth and object-to-mouth exposures

(because all exposures are compared to

the same endpoint) to represent a worstcase scenario. The short-term risk

estimate results in an MOE of 2,900 and

the intermediate-term risk results in an

MOE of 1,100. These risks do not exceed

EPA’s level of concern.

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

halosulfuron-methyl 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, halosulfuronmethyl 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 halosulfuron-methyl 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).

D. Safety Factor for Infants and

Children

1 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 database 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 margin of exposure (MOE) analysis

or through using uncertainty (safety)

factors in calculating a dose level that

poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity.

There was no indication of increased

susceptibility of rats or rabbits to in

utero and/or postnatal exposure to

halosulfuron-methyl. In the prenatal

developmental toxicity studies in rats

and rabbits and the two-generation

reproduction study in rats, effects in the

offspring were observed only at or above

treatment levels which resulted in

evidence of parental toxicity.

3. Conclusion. There is a complete

toxicity database for halosulfuronmethyl and exposure data are complete

or are estimated based on data that

reasonably accounts for potential

exposures. EPA determined that the 10X

safety factor to protect infants and

children should be removed. The FQPA

factor is removed because there was no

indication of increased susceptibility of

rats or rabbits in utero and/or postnatal

exposure to halosulfuran methyl, and

although a developmental neurotoxicity

study was required, an additional safety

factor was not warranted.

E. 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

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 + residential 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 the USEPA Office of Water

are used to calculate DWLOCs: 2L/70 kg

(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, OPP concludes with

reasonable certainty that exposures to

the pesticide in drinking water (when

considered along with other sources of

exposure for which OPP has reliable

data) would not result in unacceptable

levels of aggregate human health risk at

this time. Because OPP 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, OPP will reassess the potential

impacts of residues of the pesticide in

drinking water as a part of the aggregate

risk assessment process.

1. Acute risk. Using the exposure

assumptions discussed in this unit for

acute exposure, the acute dietary

exposure from food to halosulfuronmethyl will occupy <1% of the aPAD for

females (13 years and older), infants,

and children (1–6 years old). In

Federal Register / Vol. 66, No. 247 / Wednesday, December 26, 2001 / Rules and Regulations 66337

addition, there is potential for acute

dietary exposure to halosulfuron-methyl

in drinking water. After calculating

DWLOCs and comparing them to the

EECs for surface and ground water, EPA

does not expect the aggregate exposure

to exceed 100% of the aPAD, as shown

in the following Table 2:

TABLE 2.— AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO HALOSULFURON-METHYL

Population Subgroup aPAD (mg/

kg)

% aPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Acute

DWLOC

(ppb)

All infants 0.5 0.00070 8.3 0.065 5,000

Children (1–6 years) 0.5 0.00097 8.3 0.065 5,000

Females (13–50 years 0.5 0.00058 8.3 0.065 15,000

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to halosulfuron-methyl

from food will utilize <1% of the cPAD

for the U.S. population, infants (<1 year

old), children (1–6 years old), and

females (13–50 years old). Based on the

use pattern, chronic residential

exposure to residues of halosulfuronmethyl is not expected. In addition,

there is potential for chronic dietary

exposure to halosulfuron-methyl in

drinking water. After calculating

DWLOCs and comparing them to the

EECs for surface and ground water, EPA

does not expect the aggregate exposure

to exceed 100% of the cPAD, as shown

in the following Table 3:

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO HALOSULFURON-METHYL

Population Subgroup cPAD mg/

kg/day

% cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. Population 0.10 0.00020 1.7 0.065 3,500

All infants (<1 year) 0.10 0.00059 1.7 0.065 1,000

Children (1–6 years) 0.10 0.00035 1.7 0.065 1,000

Females (13–50 years) 0.10 0.00016 1.7 0.065 3,000

3. Short-term risk. Short-term

aggregate exposure takes into account

residential exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Halosulfuron-methyl is currently

registered for use that could result in

short-term residential exposure and the

Agency has determined that it is

appropriate to aggregate chronic food

and water and short-term exposures for

halosulfuron-methyl.

Using the exposure assumptions

described in this unit for short-term

exposures, EPA has concluded that food

and residential exposures aggregated

result in aggregate MOEs of 4,500 for

females 13–50 years and older, and

2,800 for infants (<1 year old). A shortterm risk assessment is required for

adults because there is a residential

exposure scenario (handler and

postapplication). In addition, a shortterm risk assessment is required for

infants and children because there are

residential post-application dermal and

oral exposure scenarios. The risk

calculations for adult females is

expected to result in a higher risk than

adult males because a lower body

weight is used (60 kg), therefore adult

females will represent the U.S.

population. These aggregate MOEs do

not exceed the Agency’s level of

concern for aggregate exposure to food

and residential uses. In addition, shortterm DWLOCs were calculated and

compared to the EECs for chronic

exposure of halosulfuron-methyl in

ground and surface water. After

calculating DWLOCs and comparing

them to the EECs for surface and ground

water, EPA does not expect short-term

aggregate exposure to exceed the

Agency’s level of concern, as shown in

the following Table 4:

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO HALOSULFURON-METHYL

Population Subgroup

Aggregate

MOE (Food

+ Residential)

Aggregate

Level of

Concern

(LOC)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Short-Term

DWLOC

(ppb)

U.S. Population 4,500 100 1.7 0.065 17,000

Infants (<1 year old) 2,800 100 1.7 0.065 4,800

Females (13–50 years old) 4,500 100 1.7 0.065 15,000

66338 Federal Register / Vol. 66, No. 247 / Wednesday, December 26, 2001 / Rules and Regulations

4. Intermediate-term risk.

Intermediate-term aggregate exposure

takes into account residential exposure

plus chronic exposure to food and water

(considered to be a background

exposure level).

Halosulfuron-methyl is currently

registered for use(s) that could result in

intermediate-term residential exposure

and the Agency has determined that it

is appropriate to aggregate chronic food

and water and intermediate-term

exposures for halosulfuron-methyl.

Using the exposure assumptions

described in this unit for intermediateterm exposures, EPA has concluded that

food and residential exposures

aggregated result in aggregate MOEs of

1,700 females 13–50 years old, and

1,100 for infants (<1 year old). An

intermediate-term risk assessment is

required for adults because there is a

residential exposure scenario (handler

and postapplication). In addition, an

intermediate-term risk assessment is

required for infants and children

because there are residential postapplication dermal and oral exposure

scenarios. The risk calculations for adult

females is expected to result in a higher

risk than adult males because a lower

body weight is used (60 kg), therefore

adult females will represent the U.S.

population. These aggregate MOEs do

not exceed the Agency’s level of

concern for aggregate exposure to food

and residential uses. In addition,

intermediate-term DWLOCs were

calculated and compared to the EECs for

chronic exposure of halosulfuronmethyl in ground and surface water.

After calculating DWLOCs and

comparing them to the EECs for surface

and ground water, EPA does not expect

intermediate-term aggregate exposure to

exceed the Agency’s level of concern, as

shown in the following Table 5:

TABLE 5.— AGGREGATE AGGREGATE RISK ASSESSMENT FOR INTERMEDIATE-TERM EXPOSURE TO HALOSULFURON-METHYL

Population Subgroup

Aggregate

MOE (Food

+ Residential)

Aggregate

Level of

Concern

(LOC)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Intermediate-Term

DWLOC (ppb)

U.S. Population 1,700 100 1.7 0.065 3,300

Infants (<1 year old) 1,100 100 1.7 0.065 910

Females (13–50 years old) 1,700 100 1.7 0.065 2,800

5. Aggregate cancer risk for U.S.

population. Halosulfuron-methyl is

classified as a not likely human

carcinogen based on a lack of evidence

of carcinogenicity in male and female

mice and rats, and thus no cancer risk

is expected from exposure to

halosulfuron methyl.

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

halosulfuron-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

EPA now requires measurement of

parent halosulfuron only using the

revised enforcement method, Analytical

Method for the Determination of MON

12000 in Raw Agricultural Commodities

and Processed Fractions. The method

was accepted by EPA as an enforcement

method and sent to FDA to be included

in PAM II.

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 established Codex,

Canadian, or Mexican maximum residue

limits (MRLs) or tolerances for residues

of halosulfuron-methyl in/on the melon

subgroup.

V. Conclusion

Therefore, the tolerance is established

for residues of halosulfuron-methyl,

methyl 5-[(4,6-dimethoxy-2-

pyrimidinyl) amino]

carbonylaminosulfonyl-3-chloro-1-

methyl-1H-pyrazole-4-carboxylate, in or

on melon subgroup at 0.1 ppm.

VI. 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,

you must identify docket control

number OPP–301200 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 February 25, 2002.

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

Federal Register / Vol. 66, No. 247 / Wednesday, December 26, 2001 / Rules and Regulations 66339

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 VI.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 docket control

number OPP–301200, 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 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).

VII. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). Because this rule has

been exempted from review under

Executive Order 12866 due to its lack of

significance, this rule is not subject to

Executive Order 13211, Actions

Concerning Regulations That

Significantly Affect Energy Supply,

Distribution, or Use (66 FR 28355, May

22, 2001). 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

special considerations under Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or 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 petition

under FFDCA section 408(d), 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

by Congress in the preemption

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

For these same reasons, the Agency has

determined that this rule does not have

any ‘‘tribal implications’’ as described

in Executive Order 13175, entitled

Consultation and Coordination with

Indian Tribal Governments (65 FR

67249, November 6, 2000). Executive

Order 13175, requires EPA to develop

an accountable process to ensure

‘‘meaningful and timely input by tribal

officials in the development of

regulatory policies that have tribal

implications.’’ ‘‘Policies that have tribal

implications’’ is defined in the

Executive Order to include regulations

that have ‘‘substantial direct effects on

one or more Indian tribes, on the

relationship between the Federal

government and the Indian tribes, or on

the distribution of power and

responsibilities between the Federal

government and Indian tribes.’’ This

rule will not have substantial direct

effects on tribal governments, on the

relationship between the Federal

government and Indian tribes, or on the

distribution of power and

responsibilities between the Federal

66340 Federal Register / Vol. 66, No. 247 / Wednesday, December 26, 2001 / Rules and Regulations

government and Indian tribes, as

specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.

VIII. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

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

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of 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: December 13, 2001.

Peter Caulkins,

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), 346(a) and

371.

2. Section 180.479 is amended by

alphabetically adding the following

commodity to the table in paragraph

(a)(2) to read as follows:

§ 180.479 Halosulfuron-methyl; tolerances

for residues.

(a) * * *

(2) * * *

Commodity Parts per million

*****

Melon Subgroup ............. 0.1

*****

* * * * *

[FR Doc. 01–31639 Filed 12–21–01; 8:45 am

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 271

[FRL–7120–8]

Kentucky: Final Authorization of State

Hazardous Waste Management

Program Revision

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Immediate final rule.

SUMMARY: Kentucky has applied to EPA

for Final authorization of the changes to

its hazardous waste program under the

Resource Conservation and Recovery

Act (RCRA). EPA has determined that

these changes satisfy all requirements

needed to qualify for Final

authorization, and is authorizing the

State’s changes through this immediate

final action. EPA is publishing this rule

to authorize the changes without a prior

proposal because we believe this action

is not controversial and do not expect

comments that oppose it. Unless we get

written comments which oppose this

authorization during the comment

period, the decision to authorize

Kentucky’s changes to their hazardous

waste program will take effect as

provided below. If we get comments

that oppose this action, we will publish

a document in the Federal Register

withdrawing this rule before it takes

effect and a separate document in the

proposed rules section of this Federal

Register will serve as a proposal to

authorize the changes.

DATES: This Final authorization will

become effective on February 25, 2002

unless EPA receives adverse written

comment by January 25, 2002. If EPA

receives such comment, it will publish

a timely withdrawal of this immediate

final rule in the Federal Register and

inform the public that this authorization

will not take effect.

ADDRESSES: Send written comments to

Narindar Kumar, Chief, RCRA Programs

Branch, Waste Management Division,

U.S. Environmental Protection Agency,

The Sam Nunn Atlanta Federal Center,

61 Forsyth Street, SW., Atlanta, GA,

30303–3104; (404) 562–8440. You can

view and copy Kentucky’s application

from 8 a.m. to 4:30 p.m. at the following

addresses: Kentucky Department for

Environmental Protection, Division of

Waste Management, Fort Boone Plaza,

Building 2, 18 Reilly Road, Frankfort,

Kentucky 40601, (502) 564–6716; U.S.

EPA, Region 4, Library, 61 Forsyth

Street, SW., Atlanta, Georgia 30303–

3104; (404) 562–8190.

FOR FURTHER INFORMATION CONTACT:

Narindar Kumar, Chief RCRA Programs

Branch, Waste Management Division,

U.S. Environmental Protection Agency,

The Sam Nunn Atlanta Federal Center,

61 Forsyth Street, SW., Atlanta, GA,

30303–3104; (404) 562–8440.

SUPPLEMENTARY INFORMATION:

A. Why Are Revisions to State

Programs Necessary?

States which have received final

authorization from EPA under RCRA

section 3006(b), 42 U.S.C. 6926(b), must

maintain a hazardous waste program

that is equivalent to, consistent with,

and no less stringent than the Federal

program. As the Federal program

changes, States must change their

programs and ask EPA to authorize the

changes. Changes to State programs may

be necessary when Federal or State

statutory or regulatory authority is

modified or when certain other changes

occur. Most commonly, States must

change their programs because of

changes to EPA’s regulations in 40 Code

of Federal Regulations (CFR) parts 124,

260 through 266, 268, 270, 273 and 279.

B. What Decisions Have We Made in

This Rule?

We conclude that Kentucky’s

application for the Omnibus Provision

meets all of the statutory and regulatory

requirements established by RCRA.

Therefore, we grant Kentucky Final

authorization to operate its hazardous

waste program with the Omnibus

Provision changes described in the

authorization application. Kentucky has

responsibility for permitting Treatment,

Storage, and Disposal Facilities (TSDFs)

within its borders (except in Indian

Country) and for carrying out the

aspects of the RCRA program described

in its revised program application,

subject to the limitations of the

Hazardous and Solid Waste

Amendments of 1984 (HSWA). New

Federal requirements and prohibitions

imposed by Federal regulations that

EPA promulgates under the authority of

HSWA take effect in authorized States

before they are authorized for the

requirements. Thus, EPA will

implement those requirements and

prohibitions in Kentucky, including

issuing permits, until the State is

granted authorization to do so.

C. What Is the Effect of Today’s

Authorization Decision?

The effect of this decision is that a

facility in Kentucky subject to RCRA

will now have to comply with the

authorized State requirements instead of

the equivalent Federal requirements in

order to comply with RCRA. Kentucky

has enforcement responsibilities under

its state hazardous waste program for