67272 Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Rules and Regulations

(6) * * *

(i) Calculation of rolling averages

initially. The carbon monoxide or

hydrocarbon CEMS must begin

recording one-minute average values by

12:01 a.m. and hourly rolling average

values by 1:01 a.m., when 60 oneminute values will be available for

calculating the initial hourly rolling

average for those sources that come into

compliance on the regulatory

compliance date. Sources that elect to

come into compliance before the

regulatory compliance date must begin

recording one-minute and hourly rolling

average values within 60 seconds and

60 minutes (when 60 one-minute values

will be available for calculating the

initial hourly rolling average),

respectively, from the time at which

compliance begins.

* * * * *

(b) * * *

(5) * * *

(i) Calculation of rolling averages

initially. Continuous monitoring

systems must begin recording oneminute average values by 12:01 a.m.,

hourly rolling average values by 1:01

a.m.(e.g., when 60 one-minute values

will be available for calculating the

initial hourly rolling average), and

twelve-hour rolling averages by 12:01

p.m.(e.g., when 720 one-minute

averages are available to calculate a 12-

hour rolling average), for those sources

that come into compliance on the

regulatory compliance date. Sources

that elect to come into compliance

before the regulatory compliance date

must begin recording one-minute,

hourly rolling average, and 12-hour

rolling average values within 60

seconds, 60 minutes (when 60 oneminute values will be available for

calculating the initial hourly rolling

average), and 720 minutes (when 720

one-minute values will be available for

calculating the initial 12-hour hourly

rolling average) respectively, from the

time at which compliance begins.

* * * * *

[FR Doc. 00–28710 Filed 11–8–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301074; FRL–6751–7]

RIN 2070–AB78

Sulfentrazone; Pesticide Tolerances

for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for combined

residues of sulfentrazone N-[2,4-

dichloro-5-[4-(difluoromethyl)-4,5-

dihydro-3-methyl-5-oxo-1H-1,2,4-

triazol-1-yl]phenyl]methanesulfonamide

and its major metabolite 3-

hydroxymethyl sulfentrazone N-[2,4-

dichloro-5-[4-(difluoromethyl)-4,5-

dihydro-3-hydroxymethyl-5-oxo-1H1,2,4-triazol-1-

yl]phenyl]methanesulfonamide in or on

horseradish and sugarcane. This action

is in response to EPA’s granting of

emergency exemptions under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on horseradish and

sugarcane. This regulation establishes a

maximum permissible level for

combined residues of sulfentrazone in

these food commodities. The tolerances

will expire and are revoked on

December 31, 2002.

DATES: This regulation is effective

November 9, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301074,

must be received by EPA on or before

January 8, 2001.

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–301074 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Meredith Laws, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: 703 305–9366; and e-mail

address: laws.meredith@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:

Categories NAICS

codes

Examples of potentially affected

entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

Categories NAICS

codes

Examples of potentially affected

entities

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–301074. 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, 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.

Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Rules and Regulations 67273

II. Background and Statutory Findings

EPA, on its own initiative, in

accordance with sections 408(e) and 408

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

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

is establishing a tolerance for combined

residues of the herbicide sulfentrazone,

in or on horseradish and sugarcane at

0.1 and 0.05 part per million (ppm)

respectively. These tolerances will

expire and are revoked on December 31,

2002. 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(e) of the

FFDCA allows EPA to establish a

tolerance or an exemption from the

requirement of a tolerance on its own

initiative, i.e., without having received

any petition from an outside party.

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 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 Exemptions for

Sulfentrazone on Horseradish and

Sugarcane and FFDCA Tolerances

Illinois submitted a section 18 request

for the emergency use of sulfentrazone

on horseradish to control annual

broadleaf weeds. EPA reviewed the

request and concluded that the situation

was urgent and nonroutine because

heavy rains, urbanization, and drainage

canal problems led to flooding of fields

during the spring of 1999 resulting in

significant problems with yellow

nutsedge and broadleaf weeds.

Louisiana submitted a section 18

request for the emergency use of

sulfentrazone to control morning glories

infesting sugarcane fields. EPA agrees

that morning glory infestations may

create emergency conditions for growers

since the registered alternative herbicide

is ineffective against late season

infestations when used on a higher

yielding sugarcane variety. Due to this

variety’s earlier lay-by, late season

applications of soil herbicides are not

possible. Additionally, morning glory

vines can cause indirect economic costs

to growers by disabling combine-type

harvesters.

EPA has authorized under FIFRA

section 18 the use of sulfentrazone on

horseradish and sugarcane for control of

annual broadleaf weeds in Illinois and

morning glories in Louisiana,

respectively. After having reviewed the

submissions, EPA concurs that

emergency conditions exist for these

States.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by the

combined residues of sulfentrazone in

or on horseradish and sugarcane. In

doing so, EPA considered the safety

standard in FFDCA section 408(b)(2),

and EPA decided that the necessary

tolerances 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 exemptions in

order to address an urgent non-routine

situation and to ensure that the resulting

food is safe and lawful, EPA is issuing

these tolerances without notice and

opportunity for public comment as

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

these tolerances will expire and are

revoked on December 31, 2002, under

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

pesticide not in excess of the amounts

specified in the tolerances remaining in

or on horseradish and sugarcane 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 these tolerances at the

time of that application. EPA will take

action to revoke these tolerances earlier

if any experience with, scientific data

on, or other relevant information on this

pesticide indicate that the residues are

not safe.

Because these tolerances are being

approved under emergency conditions,

EPA has not made any decisions about

whether sulfentrazone meets EPA’s

registration requirements for use on

horseradish or on sugarcane or whether

permanent tolerances for these uses

would be appropriate. Under these

circumstances, EPA does not believe

that these tolerances serve as a basis for

registration of sulfentrazone by a State

for special local needs under FIFRA

section 24(c). Nor do these tolerances

serve as the basis for any State other

than Illinois and Louisiana to use this

pesticide on these crops 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

exemptions for sulfentrazone, 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 sulfentrazone and to make a

determination on aggregate exposure,

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

time-limited tolerances for combined

residues of sulfentrazone in or on

horseradish and sugarcane at 0.1 and

0.05 ppm, respectively. EPA’s

assessment of the dietary exposures and

risks associated with establishing these

tolerances follows.

A. 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

67274 Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Rules and Regulations

used to estimate the toxicological

endpoint. 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 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 x10-6 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 sulfentrazone used for human risk

assessment is shown in the following

Table 1:

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SULFENTRAZONE 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 = 10.0 mg/kg/day

UF = 100 Acute RfD =

0.10 mg/kg/day

FQPA SF = 10 aPAD = acute RfD/FQPA SF =

0.01 mg/kg/day

Rat Developmental LOAEL =

25 mg/kg/day based on

decreased fetal weight

and retarded skeletal development as evidenced

by an increased number of

litters with any variation

and by decreased numbers of caudal vertebral

and metacarpal ossification sites.

Acute Dietary general population including infants and

children

NOAEL = 250 mg/kg/day UF

= 100 Acute RfD = 2.5

mg/kg/day

FQPA SF = 10 aPAD = acute RfD/FQPA SF =

0.25 mg/kg/day

Acute Neurotoxicity Study in

Rats LOAEL = 750 mg/kg/

day based on increased

incidences of clinical signs

abdominal gripping,

abdominogenital staining,

and/or reddish- brown

staining under the cage,

FOB findings, and decreased motor activity

which was reversed by

Day 14 postdose. There

was no evidence of

neuropathology at the

highest dose tested (2,000

mg/kg/day).

Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Rules and Regulations 67275

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SULFENTRAZONE 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

Chronic Dietary all populationsNOAEL= 14.0 mg/kg/day UF

= 100 Chronic RfD = 0.14

mg/kg/day

FQPA SF = 10 cPAD = chronic RfD/FQPA SF =

0.014 mg/kg/day

2-Gen. Repro. Study in Rats

LOAEL = 33/44 mg/kg/day

in males and females, respectively based on 1) decreased maternal body

weight and/or body weight

gain during gestation in

both P and F1 generations, 2) reduced

premating body weight

gains in the second generation (F1 adults), 3) increased duration of gestation in both F1 and F2

dams, 4) reduced prenatal

viability (fetal and litter), 5)

reduced litter size, 6) increased number of stillborn pups, 7) reduced pup

and litter postnatal survival, and 8) decreased

pup body weights throughout gestation. In males, effects included decreased

fertility in F1 generation

and/or atrophy of the germinal epithelium of the

testes, oligospermia and

intratubular degeneration

of the seminal product in

the epididymis.

*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 180.498) for the

combined residues of sulfentrazone, in

or on a variety of raw agricultural

commodities. A permanent tolerance

has been established for soybean, seed

at 0.05 ppm. Time-limited tolerances

have been established for cowpeas, lima

beans, and sunflowers, with an

expiration date of 12/30/00. Risk

assessments were conducted by EPA to

assess dietary exposures from

sulfentrazone 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: Two acute doses

and endpoints were selected, one for the

females 13+ years old population

subgroup and another for the U.S.

population and other subgroups

(excluding females 13+ years old).

Therefore, acute dietary exposure

analyses were performed using two

separate endpoints. Tolerance level

residues and 100% crop treated were

used for all commodities (Tier 1). As the

acute analyses were Tier 1 assessments,

acute risk estimates are shown at the

95th percentile.

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:

Tolerance level residues and 100% crop

treated information were used for all

commodities (Tier 1).

iii. Cancer. Sulfentrazone has been

classified as a ‘‘Group E’’ chemical (not

likely to be carcinogenic to humans via

relevant routes of exposure). Therefore,

no cancer dietary exposure risk analysis

was performed.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

sulfentrazone 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

sulfentrazone.

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.

67276 Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Rules and Regulations

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 sulfentrazone

they are further discussed in the

aggregate risk sections below.

Based on the GENEEC and SCI-GROW

models the EECs of sulfentrazone for

acute exposures are estimated to be 12.5

parts per billion (ppb) for surface water

and 21.8 ppb for ground water. The

EECs for chronic exposures are

estimated to be 12.0 ppb for surface

water and 10.2 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).

Sulfentrazone 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

sulfentrazone 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,

sulfentrazone 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 sulfentrazone 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 ten–fold 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 margin

of exposure (MOE) analysis or through

using uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans.

ii. Developmental toxicity studies— a.

Rats. In the oral developmental study in

rats, the maternal (systemic) NOAEL

was 25 mg/kg/day, based on increased

spleen weights and splenic

extramedullary hematopoiesis at the

LOAEL of 50 mg/kg/day. The

developmental (fetal) NOAEL was 10

mg/kg/day, based on decreased mean

fetal weight and retardation in skeletal

development as evidenced by increased

numbers of litters with any variation

and by decreased numbers of caudal

vertebral and metacarpal ossification

sites at the LOAEL of 25 mg/kg/day.

In the dermal developmental study in

rats, the maternal (systemic) NOAEL

was ≥250 mg/kg/day and a LOAEL was

not determined. The developmental

(fetal) NOAEL was 100 mg/kg/day,

based on decreased fetal weight and

increased fetal variations (hypoplastic

or wavy ribs, incompletely ossified

lumbar vertebral arches, incompletely

ossified ischia or pubes, and reduced

numbers of thoracic vertebral and rib

ossification sites) at the LOAEL of 250

mg/kg/day.

b. Rabbits. In the oral developmental

toxicity study in rabbits, the maternal

(systemic) NOAEL was 100 mg/kg/day,

based on increased abortions, clinical

signs (decreased feces and hematuria),

and reduced body weight gain during

gestation at the LOAEL of 250 mg/kg/

day. The developmental (pup) NOAEL

was 100 mg/kg/day, based on increased

resorptions, decreased live fetuses per

litter, and decreased fetal weight at the

LOAEL of 250 mg/kg/day.

iii. Reproductive toxicity study—

Rats. In the 2-generation reproductive

toxicity study in rats, the maternal

(systemic) NOAEL was 14/16 mg/kg/day

in males and females, respectively,

based on decreased maternal body

weight and/or body weight gain during

gestation in both P and F1 generations,

and reduced premating body weight

gains in the second generation (F1

adults) at the LOAEL of 33/44 mg/kg/

day for males and females, respectively.

The developmental (pup) NOAEL was

14/16 mg/kg/day based on 1) reduced

prenatal viability (fetal and litter), 2)

reduced litter size, 3) increased number

of stillborn pups, 4) reduced pup and

litter postnatal survival, and 5)

decreased pup body weights throughout

lactation at the LOAEL of 33/44 mg/kg/

day. The reproductive NOAEL was 14/

16 mg/kg/day, based on 1) increased

duration of gestation in both F1 and F2

dams, 2) decreased fertility in F1

generation (males), and/or 3) atrophy of

the germinal epithelium of the testes,

oligospermia and intratubular

degeneration of the seminal product in

the epididymis at the LOAEL of 33/44

mg/kg/day.

iv. Prenatal and postnatal sensitivity.

The toxicological data base for

evaluating prenatal and postnatal

toxicity for sulfentrazone is complete

with respect to current data

requirements. Based on the

developmental and reproductive

toxicity studies discussed above for

sulfentrazone there appears to be

prenatal and postnatal sensitivity.

v. Conclusion. There is a complete

toxicity data base for sulfentrazone 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

retained. For acute dietary analysis, the

FQPA SF was retained and is applicable

to the U.S. population and all subgroups

due to the increased susceptibility

observed in the prenatal developmental

studies. For chronic dietary analysis, the

Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Rules and Regulations 67277

FQPA safety factor was retained and is

applicable for all populations due to the

qualitative increased susceptibility

observed in the 2-generation

reproduction study.

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

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,

non-occupational 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

sulfentrazone 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 sulfentrazone on 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 sulfentrazone

will occupy <1% of the aPAD for the

U.S. population, 6% of the aPAD for

females 13 years and older, <1% of the

aPAD for all infants (<1 year old) and

<1% of the aPAD for children (1-6 years

old). In addition, despite the potential

for acute dietary exposure to

sulfentrazone in drinking water, after

calculating DWLOCs and comparing

them to conservative model estimated

environmental concentrations of

sulfentrazone in 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 SULFENTRAZONE

Population Subgroup aPAD (mg/kg) % aPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Acute

DWLOC

(ppb)

Females, 13-50 years old 0.01 6 12.5 21.8 284

U.S. population (including infants and children) 0.25 <1 12.5 21.8 8,700

Children (1-6 years old) and all infants (1 year old) 0.25 <1 12.5 21.8 2484

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to sulfentrazone from food

will utilize 2% of the cPAD for the U.S.

population, 4% of the cPAD for all

infants (< 1 year old) and 6 % of the

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

are no residential uses for sulfentrazone

that result in chronic residential

exposure to sulfentrazone. In addition,

despite the potential for chronic dietary

exposure to sulfentrazone in drinking

water, after calculating DWLOCs and

comparing them to conservative model

estimated environmental concentrations

of sulfentrazone in 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 SULFENTRAZONE

Population Subgroup cPAD (mg/kg) % cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S Population 0.014 2 4.0 10.2 478

Children (1-6 years old) 0.014 6 4.0 10.2 132

Children (Females 13-50 years old) 0.014 2 4.0 10.2 412

Males (13-19 years old) 0.014 3 4.0 10.2 477

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).

Sulfentrazone is not registered for use

on any sites that would result in

residential exposure. Therefore, the

aggregate risk is the sum of the risk from

food and water, which were previously

addressed.

67278 Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Rules and Regulations

4. Intermediate-term risk.

Intermediate-term aggregate exposure

takes into account non-dietary, nonoccupational exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Sulfentrazone is not registered for use

on any sites that would result in

residential exposure. 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. Because sulfentrazone is not

a carcinogen, a cancer aggregate risk

assessment was not conducted.

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

sulfentrazone residues.

V. Other Considerations

A. Analytical Enforcement Methodology

An analytical methodology for the

determination of sulfentrazone, 3-

desmethyl sulfentrazone, and 3-

hydroxymethyl sulfentrazone residues

in/on various matrices was submitted

with a petition for a sulfentrazone

tolerance on soybeans. A petition

method validation (PMV) was

successfully completed by the Agency’s

Analytical Chemistry Laboratory. The

Limit of Quantitation (LOQ) and

Minimum Detection Limit (MDL) were

determined to be 0.05 ppm and 0.005-

0.025 ppm, respectively. EPA concluded

that the method is suitable for

enforcement purposes.

Adequate enforcement methodology

(example - gas chromotography) is

available to enforce the tolerance

expression. The method may be

requested from: Calvin Furlow, PIRIB,

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 Codex, Canandian or

Mexican residue limits for sulfentrazone

on horseradish and sugarcane.

Therefore, no compatibility problems

exist for the proposed tolerances.

C. Conditions

Rotational field trial data for wheat,

corn, rice and sorghum were submitted

in support of a petition for a

sulfentrazone tolerance on soybeans.

Permanent tolerances have been

established on cereal grains (excluding

sweet corn) when planted in rotation

with the primary crop soybeans. The

suggested rotational crop restrictions on

the Section 18 labels pertaining to these

emergencies are the same as those on

the label for soybeans. Therefore,

additional rotational crop data are not

necessary for this action.

VI. Conclusion

Therefore, the tolerances are

established for combined residues of

sulfentrazone, in or on horseradish and

sugarcane at 0.1 and 0.05 ppm,

respectively.

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,

you must identify docket control

number OPP–301074 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 January 8, 2001.

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–301074, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Rules and Regulations 67279

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 timelimited 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/

exemption 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).

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: October 25, 2000.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180— [AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 321(q), (346a) and

371.

2. Section 180.498 is amended by

alphabetically adding the commodities

to the table in paragraph (b) to read as

follows:

§ 180.498 Sulfentrazone; tolerances for

residues.

* * * * *

(b)* * *

Commodity Parts per million Expiration/Revocation Date

*******

Horseradish, Roots .................................................................................................................. 0.1 12/31/02

*******

Sugarcane ................................................................................................................................ 0.05 12/31/02

*******

67280 Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Rules and Regulations

* * * * *

[FR Doc. 00–28714 Filed 11–8–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 300

[FRL–6898–2]

National Oil and Hazardous

Substances Pollution Contingency

Plan; National Priorities List

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Direct final deletion of the

Superfund Site from the National

Priorities List (NPL).

SUMMARY: EPA Region 5 announces the

deletion of the Ilada Energy Company

Site (Site) from the National Priorities

List (NPL) and requests public comment

on this action. The NPL constitutes

appendix B of 40 CFR part 300 which

is the National Oil and Hazardous

Substance Pollution Continency Plan

(NCP), which EPA promulgated

pursuant to section 105 of the

Comprehensive Environmental

Response, Compensation and Liability

Act of 1980, as amended, (CERCLA).

EPA and the Illinois Environmental

Protection Agency (IEPA) have

determined that the Site poses no

significant threat to public health or the

environment and, therefore, further

remedial measures pursuant to CERCLA

are not appropriate.

DATES: This ‘‘direct final’’ action will be

effective January 8, 2001, unless EPA

receives dissenting comments by

December 11, 2000. If written dissenting

comments are received, EPA will

publish a timely withdrawal of the rule

in the Federal Register informing the

public that the rule will not take effect.

ADDRESSES: Comments may be mailed to

Jon Peterson, Remedial Project Manager,

or Gladys Beard, Associate Remedial

Project Manager, U.S. Environmental

Protection Agency, Superfund Division,

U.S. EPA, Region 5, 77 W. Jackson

Blvd., (SR–6J), Chicago, IL 60604.

Requests for comprehensive information

on this Site is available through the

public docket which is available for

viewing at the Site Information

Repositories at the following locations:

U.S. EPA Region 5, Administrative

Records, 77 W. Jackson Blvd., Chicago,

IL 60604, Illinois Environmental

Protection Agency, 1021 North Grand

Avenue East, Springfield, Illinois 62794

and Cape Girardeau Public Library, 711

N. Clark, Cape Girardeau, MO 63701.

FOR FURTHER INFORMATION CONTACT: Jon

Peterson at (312) 353–1264, email

peterson.jon@epa.gov or Gladys Beard

(SR–6J), U.S. Environmental Protection

Agency, 77 W. Jackson, Chicago, II,

(312) 886–7253, FAX (312) 886–4071, email beard.gladys@epa.gov

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction

II. NPL Deletion Criteria

III. Deletion Procedures

IV. Basis of Intended Site Deletion

V. Action

I. Introduction

The Environmental Protection Agency

(EPA) Region 5 announces the deletion

of the Ilada Energy Company Site, East

Girardeau, Illinois from the National

Priorities List (NPL), appendix B of the

National Oil and Hazardous Substances

Pollution Contingency Plan (NCP), 40

CFR part 300. EPA identifies sites that

appear to present a significant risk to

public health, welfare, or the

environment and maintains the NPL as

the list of these sites. EPA and the State

of Illinois have determined that the

remedial action for the Site has been

successfully executed. EPA will accept

comments on this action for thirty days

after publication of this action in the

Federal Register.

Section II of this notice explains the

criteria for deleting sites from the NPL.

Section III discusses the procedures that

EPA is using for this action. Section IV

discusses the history of the Ilada Energy

Company Site and explains how the Site

meets the deletion criteria. Section V

states EPA’s action to delete the Site

from the NPL unless dissenting

comments are received during the

comment period.

II. NPL Deletion Criteria

Section 300.425(e) of the NCP

provides that Sites may be deleted from,

or recategorized on the NPL where no

further response is appropriate. In

making a determination to delete a Site

from the NPL, EPA shall consider, in

consultation with the state, whether any

of the following criteria has been met:

(i) Responsible parties or other

persons have implemented all

appropriate response actions required;

(ii) All appropriate Fund-financed

response under CERCLA has been

implemented, and no further response

action by responsible parties is

appropriate; or

(iii) The remedial investigation has

shown that the release poses no

significant threat to public health or the

environment and, therefore, taking of

remedial measures is not appropriate.

Even if the Site is deleted from the

NPL, where hazardous substances,

pollutants, or contaminants remain at

the Site above levels that allow for

unlimited use and unrestricted

exposure, EPA’s policy is that a

subsequent review of the Site will be

conducted at least every five years after

the initiation of the remedial action at

the Site to ensure that the Site remains

protective of public health and the

environment. In the case of this Site,

EPA will conduct a Five-Year Review in

the year of 2005. As explained below,

the Site meets the NCP’s deletion

criteria (i) listed above. If new

information becomes available which

indicates a need for further action, EPA

may initiate remedial actions. Whenever

there is a significant release from a site

deleted from the NPL, the site shall be

restored to the NPL without the

application of the Hazard Ranking

System (HRS).

III. Deletion Procedures

The following procedures were used

for the intended deletion of the Site:

(1) All appropriate responses under

CERCLA have been implemented and

no further action by EPA is appropriate;

(2) The State has concurred with the

proposed deletion decision; (3) A notice

has been published in the local

newspaper and has been distributed to

appropriate federal, state, and local

officials and other interested parties

announcing the commencement of a 30-

day dissenting public comment period

on EPA’s Direct Final Action to Delete;

and, (4) All relevant documents have

been made available for public review

in the local Site information

repositories. EPA is requesting only

dissenting comments on the Direct Final

Action to Delete.

For deletion of the Site, EPA’s

Regional Office will accept and evaluate

public comments on EPA’s Final Notice

before making a final decision to delete.

If necessary, the Agency will prepare a

Responsiveness Summary, responding

to each significant comment submitted

during the public comment period.

Deletion of the Site from the NPL does

not itself create, alter, or revoke any

individual’s rights or obligations. The

NPL is designed primarily for

informational purposes and to assist

Agency management. As mentioned in

section II of this document,

§ 300.425(e)(3) of the NCP states that the

deletion of a Site from the NPL does not

preclude eligibility for future response

actions.