69876 Federal Register / Vol. 65, No. 225 / Tuesday, November 21, 2000 / Rules and Regulations

regulations is authorized under 33 CFR

117.35.

Dated: November 8, 2000.

Gerald M. Davis,

Captain, U.S. Coast Guard, Acting

Commander, First Coast Guard District.

[FR Doc. 00–29804 Filed 11–20–00; 8:45 am]

BILLING CODE 4910–15–U

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301075; FRL–6752–4]

RIN 2070–AB78

Fenhexamid; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

fenhexamid in or on pears. This action

is in response to EPA’s granting of an

emergency exemption under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on pears. This regulation

establishes a maximum permissible

level for residues of fenhexamid in this

food commodity. The tolerance will

expire and is revoked on December 31,

2002.

DATES: This regulation is effective

November 21, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301075,

must be received by EPA on or before

January 22, 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–301075 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Barbara Madden, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 305–6463; and e-mail

address: madden.barbara@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by

this action if you are an agricultural

producer, food manufacturer, or

pesticide manufacturer. Potentially

affected categories and entities may

include, but are not limited to:

Categories NAICS

codes

Examples of potentially affected

entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of This

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘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/. To access the

OPPTS Harmonized Guidelines

referenced in this document, go directly

to the guidelines at http://www.epa.gov/

opptsfrs/home/guidelin.htm.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301075. 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.

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 residues of

the fungicide fenhexamid, (N-2,3-

dichloro-4-hydroxyphenyl)-1-methyl

cyclohexanecarboxamide), in or on

pears at 15 parts per million (ppm). This

tolerance will expire and is 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

Federal Register / Vol. 65, No. 225 / Tuesday, November 21, 2000 / Rules and Regulations 69877

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA)

authorizes EPA to exempt any Federal

or State agency from any provision of

FIFRA, if EPA determines that

‘‘emergency conditions exist which

require such exemption.’’ This

provision was not amended by the Food

Quality Protection Act (FQPA). EPA has

established regulations governing such

emergency exemptions in 40 CFR part

166.

III. Emergency Exemption for

Fenhexamid on Pears and FFDCA

Tolerances

According to the Applicant,

development of thiabenzadole

resistance in California Botrytis

populations has left packing houses

without an effective tool to control the

disease. Registered alternatives include

thiabenzadole, captan, Bio-Save

Pseudomonas syringae, Aspire Candida

oleophila, chlorine and ozone. Testing

in the laboratory and in the field

suggests that thiabenzadole resistance

may be developing above historic levels.

Captan is not considered a viable

alternative because several countries

have banned the import of captantreated fruit. The Applicant additionally

claims that the unpredictable efficacy

and results of biological controls have

kept the pear industry from adopting

this technology, and chlorine and ozone

are claimed to burn the fruit. While the

Agency does not fully agree with all of

the arguments presented by the

Applicant, EPA concurs that emergency

conditions could exist for some packing

houses in this State. On September 21,

2000, the Applicant availed of itself the

authority to declare a crisis exemption

under section 18 of FIFRA for the

postharvest use of fenhexamid on pears

to control gray mold.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

fenhexamid in or on pears. In doing so,

EPA considered the safety standard in

FFDCA section 408(b)(2), and EPA

decided that the necessary tolerance

under FFDCA section 408(l)(6) would be

consistent with the safety standard and

with FIFRA section 18. Consistent with

the need to move quickly on the

emergency exemption in order to

address an urgent non-routine situation

and to ensure that the resulting food is

safe and lawful, EPA is issuing this

tolerance without notice and

opportunity for public comment as

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

this tolerance will expire and is revoked

on December 31, 2002, under FFDCA

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

pesticide not in excess of the amounts

specified in the tolerance remaining in

or on pears after that date will not be

unlawful, provided the pesticide is

applied in a manner that was lawful

under FIFRA, and the residues do not

exceed a level that was authorized by

this tolerance at the time of that

application. EPA will take action to

revoke this tolerance earlier if any

experience with, scientific data on, or

other relevant information on this

pesticide indicate that the residues are

not safe.

Because this tolerance is being

approved under emergency conditions,

EPA has not made any decisions about

whether fenhexamid meets EPA’s

registration requirements for use on

pears or whether a permanent tolerance

for this use would be appropriate.

Under these circumstances, EPA does

not believe that this tolerance serves as

a basis for registration of fenhexamid by

a State for special local needs under

FIFRA section 24(c). Nor does this

tolerance serve as the basis for any State

other than California to use this

pesticide on this crop under section 18

of FIFRA without following all

provisions of EPA’s regulations

implementing section 18 as identified in

40 CFR part 166. For additional

information regarding the emergency

exemption for fenhexamid, 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 fenhexamid and to make a

determination on aggregate exposure,

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

time-limited tolerance for residues of

fenhexamid in or on pears at 15 ppm.

EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerance follows.

A. Toxicological Endpoints

The dose at which no observed

adverse effect level (NOAEL) from the

toxicology study identified as

appropriate for use in risk assessment is

used to estimate the toxicological

endpoint. However, the lowest dose at

which lowest observed adverse effect

level (LOAEL) of concern are identified

is sometimes used for risk assessment if

no NOAEL was achieved in the

toxicology study selected. An

uncertainty factor (UF) is applied to

reflect uncertainties inherent in the

extrapolation from laboratory animal

data to humans and in the variations in

sensitivity among members of the

human population as well as other

unknowns. An UF of 100 is routinely

used, 10X to account for interspecies

differences and 10X for intraspecies

differences.

For dietary risk assessment (other

than cancer) the Agency uses the UF to

calculate an acute or chronic reference

dose (acute RfD or chronic RfD) where

the RfD is equal to the NOAEL divided

by the appropriate UF (RfD = NOAEL/

UF). Where an additional safety factor is

retained due to concerns unique to the

FQPA, this additional factor is applied

to the RfD by dividing the RfD by such

additional factor. The acute or chronic

Population Adjusted Dose (aPAD or

cPAD) is a modification of the RfD to

accommodate this type of FQPA Safety

Factor.

For non-dietary risk assessments

(other than cancer) the UF is used to

determine the level of concern (LOC).

For example, when 100 is the

appropriate UF (10X to account for

interspecies differences and 10X for

intraspecies differences) the LOC is 100.

To estimate risk, a ratio of the NOAEL

to exposures (margin of exposure (MOE)

= NOAEL/exposure) is calculated and

compared to the LOC.

The linear default risk methodology

(Q*) is the primary method currently

used by the Agency to quantify

carcinogenic risk. The Q* approach

assumes that any amount of exposure

will lead to some degree of cancer risk.

A Q* is calculated and used to estimate

risk which represents a probability of

occurrence of additional cancer cases

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

in a million). Under certain specific

circumstances, MOE calculations will

be used for the carcinogenic risk

assessment. In this non-linear approach,

a ‘‘point of departure’’ is identified

below which carcinogenic effects are

69878 Federal Register / Vol. 65, No. 225 / Tuesday, November 21, 2000 / Rules and Regulations

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 (MOE cancer =

point of departure/exposures) is

calculated. A summary of the

toxicological endpoints for fenhexamid

used for human risk assessment is

shown in the following Table 1:

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

ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, UF

FQPA SF* and Level of

Concern for Risk AssessmentStudy and Toxicological Effects

Acute Dietary females 13–50

years of age

None None None

Acute Dietary general population including infants and

children

None None None

Chronic Dietary all populations NOAEL = 17 mg/kg/day UF

= 100 Chronic RfD =

0.17 mg/kg/day

FQPA SF = 3 cPAD =

chronic RfD ÷ FQPA SF

= 0.057 mg/kg/day

1–Year Feeding Study in Dogs LOAEL = 124/

133 mg/kg/day in males/females, based on

decreased RBC counts, hemoglobin and

hematocrit and increased Heinz bodies in

RBC. Also, in females, increased absolute

and relative adrenal weights correlated with

histopathological observations of increases in

incidence and severity of intracytoplasmic

vacuoles in the adrenal cortex.

Short-Term Dermal (1 to 7 days)

(Residential)

Dermal NOAEL = 1,000

mg/kg/day (limit dose)

(dermal absorption rate =

20%)

LOC for MOE = 300 (Residential)21–Day Dermal Study - Rabbits No rabbits

died during this study. No skin irritation was

observed in any treated animals. There were

no compound related effects on clinical

signs, body weight, food consumption, hematology, clinical chemistry, organ weights, or

gross and histologic pathology. Dermal administration of fenhexamid was well tolerated

by both sexes for 21–days at the limit dose

of 1,000 mg/kg/day.

Intermediate-Term Dermal (1

week to several months)

(Residential)

Dermal NOAEL = 1,000

mg/kg/day (limit dose)

(dermal absorption rate =

20%

LOC for MOE = 300 (Residential)21–Day Dermal Study - Rabbits No rabbits

died during this study. No skin irritation was

observed in any treated animals. There were

no compound related effects on clinical

signs, body weight, food consumption, hematology, clinical chemistry, organ weights, or

gross and histologic pathology. Dermal administration of fenhexamid was well tolerated

by both sexes for 21–days at the limit dose

of 1,000 mg/kg/day.

Long-Term Dermal (several

months to lifetime) (Residential)

None None None

Short-Term Inhalation (1 to 7

days) (Residential)

None None None

Intermediate-Term Inhalation (1

week to several months)

(Residential)

None None None

Long-Term Inhalation (several

months to lifetime) (Residential)

None None None

Cancer (oral, dermal, inhalation) None None The Agency has classified Fenhexamid as a

‘‘not likely’’ carcinogen. This classification is

based on the lack of evidence of carcinogenicity in male and female rats as well as in

male and female mice and on the lack of

genotoxicity in an acceptable battery of mutagenicity studies.

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

Federal Register / Vol. 65, No. 225 / Tuesday, November 21, 2000 / Rules and Regulations 69879

B. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.553) for the

residues of fenhexamid, in or on a

variety of raw agricultural commodities

including grapes, raisins and

strawberries. Risk assessments were

conducted by EPA to assess dietary

exposures from fenhexamid 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. No acute dietary

endpoint has been identified. Therefore,

no assessment was conducted for acute

dietary exposures.

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: use

of tolerance level residues and 100% of

the crop was treated.

iii. Cancer. The Agency has classified

fenhexamid as a ‘‘not likely’’

carcinogen. Therefore, no exposure

assessment was conducted to assess

cancer concerns.

2. Dietary exposure from drinking

water. The use pattern associated with

the emergency exemption (use of

fenhexamid as a postharvest treatment

on pears) is not expected to impact

water resources. However, the Agency is

required to perform an aggregate risk

assessment which includes all

registered uses of fenhexamid that

would lead to exposure to humans

through drinking water. Therefore, the

Agency estimated environmental

concentrates in drinking water from the

use of fenhexamid on strawberries to

determine the aggregate risk assessment.

The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

fenhexamid 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

fenhexamid.

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 ground water. In

general, EPA will use GENEEC (a tier 1

model) before using PRZM/EXAMS (a

tier 2 model) for a screening-level

assessment for surface water. The

GENEEC model is a subset of the PRZM/

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

GENEEC incorporates a farm pond

scenario, while PRZM/EXAMS

incorporate an index reservoir

environment in place of the previous

pond scenario. The PRZM/EXAMS

model includes a percent crop area

factor as an adjustment to account for

the maximum percent crop coverage

within a watershed or drainage basin.

None of these models include

consideration of the impact processing

(mixing, dilution, or treatment) of raw

water for distribution as drinking water

would likely have on the removal of

pesticides from the source water. The

primary use of these models by the

Agency at this stage is to provide a

coarse screen for sorting out pesticides

for which it is highly unlikely that

drinking water concentrations would

ever exceed human health levels of

concern.

Since the models used are considered

to be screening tools in the risk

assessment process, the Agency does

not use estimated environmental

concentrations (EECs) from these

models to quantify drinking water

exposure and risk as a % RfD or % PAD.

Instead drinking water levels of

comparison (DWLOCs) are calculated

and used as a point of comparison

against the model estimates of a

pesticide’s concentration in water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food, and from

residential uses. Since DWLOCs address

total aggregate exposure to fenhexamid

they are further discussed in the

aggregate risk sections below.

Based on the GENEEC and SCI-GROW

models the estimated environmental

concentrations (EECs) of fenhexamid for

chronic exposures are estimated to be

4.8 parts per billion (ppb) for surface

water and 0.0007 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).

Fenhexamid 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

fenhexamid 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,

fenhexamid 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 fenhexamid has a common

mechanism of toxicity with other

substances. For information regarding

EPA’s efforts to determine which

chemicals have a common mechanism

of toxicity and to evaluate the

cumulative effects of such chemicals,

see the final rule for Bifenthrin Pesticide

Tolerances (62 FR 62961, November 26,

1997).

C. Safety Factor for Infants and Children

1. Safety factor for infants and

children—i. In general. FFDCA section

408 provides that EPA shall apply an

additional tenfold margin of safety for

infants and children in the case of

threshold effects to account for prenatal

and postnatal toxicity and the

completeness of the data base on

toxicity and exposure unless EPA

determines that a different margin of

safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans.

ii. Developmental toxicity studies. In

a developmental toxicity study in rats,

maternal toxicity (marginally decreased

body weight gain and decreased food

consumption during the treatment

period only) was observed at the LOAEL

of 1,044 milligrams/kilograms/day (mg/

kg/day) (only dose level tested). The

NOAEL for maternal toxicity was <1,044

mg/kg/day. At the same dose level of

1,044 mg/kg/day, no treatment-related

signs of developmental toxicity were

observed in the fetuses. The NOAEL for

developmental toxicity was 1,044 mg/

69880 Federal Register / Vol. 65, No. 225 / Tuesday, November 21, 2000 / Rules and Regulations

kg/day and the LOAEL was not

established (>1,044 mg/kg/day).

Although a NOAEL was not determined

for maternal toxicity in this study, the

study need not be repeated because the

effects at the LOAEL were only marginal

and of minimal toxicological concern.

In a developmental toxicity study in

rabbits, the NOAEL for maternal toxicity

was 100 mg/kg/day and the LOAEL was

300 mg/kg/day, based on alterations of

excretory products (discolored urine,

scant feces, small scybala), decreased

body weight gain and decreased food

consumption (especially during the first

week of dosing) and decreased placental

weight. At the next higher dose level of

1,000 mg/kg/day, the maternal effects

were increased in severity. A decreased

gestation index, based on a slightly

increased incidence of abortions and

total litter resorptions, was not

considered to be treatment-related

because the incidences of abortions and

resorptions fell within the historical

control range submitted with the study.

The NOAEL for developmental toxicity

was 300 mg/kg/day and the LOAEL was

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

decreased fetal body weights (<5%) in

males only and increased delayed

ossification in several bones (especially

the 5th sternal segments and the 15th

caudal vertebrae).

iii. Reproductive toxicity study. In a

2–generation (1 litter/generation)

reproduction study in rats, there were

no treatment-related effects on

mortality, clinical signs, behavior or

reproductive parameters for adult

(parent) animals. The NOAEL for

reproductive toxicity was 1,814/2,043

mg/kg/day (M/F) (HDT). The NOAEL for

parental toxicity was 38/45 mg/kg/day

(M/F) and the LOAEL was 406/477 mg/

kg/day (M/F). In males at the LOAEL of

406 mg/kg/day, increased serum

creatinine levels and decreased kidney

weights indicated mild kidney damage

and increased serum alkaline

phosphatase levels and decreased liver

weights indicated mild liver damage. In

females at the LOAEL of 477 mg/kg/day,

increased serum alkaline phosphatase

levels and very slightly increased serum

GGT levels suggested mild liver damage.

At the next higher dose level of 1,814/

2,043 mg/kg/day (M/F)(HDT), the effects

observed at the LOAEL in both males

and females were slightly increased in

severity. In addition, decreased body

weight, increased food consumption,

and increased serum GGT levels were

observed in males and decreased body

weights, increased food consumption,

increased serum urea nitrogen levels,

increased serum creatinine levels and

decreased kidney weights were

observed in females. The NOAEL for

neonatal toxicity was 38/45 mg/kg/day

(M/F) and the LOAEL was 406/477 mg/

kg/day (M/F). At the LOAEL of 406/477

mg/kg/day, treatment-related decreased

pup body weights were observed in F1

pups on postnatal days 14 and 21 and

in F2 pups on postnatal days 7, 14 and

21. At the next higher dose level of

1,814/2,043 mg/kg/day (M/F) (HDT), the

decreased pup body weights were

increased in severity. In addition, an

increased mortality was observed among

the post weaning F1 pups selected to be

F1 parents (possibly due to the small

size of the pups at weaning, which was

30% less than controls).

The results in this reproduction study

are equivocal with respect to evaluating

the possibility of increased

susceptibility of pups, as compared to

adults, to fenhexamid. On the basis of

NOAELs/LOAELs, no increased

susceptibility of pups to fenhexamid

was demonstrated in this study.

However, the severity of the effects

observed in the pups may have been

greater than that observed in the adults

at the same dose levels. In addition,

several other toxicological

considerations, including possibly

increased intake of test material in pups

resulting from intake in both milk and

diet during the lactation period and

possibly decreased levels of UDPglucuronyltransferase enzyme in pups (a

normally occurring phenomenon in rat

pups) resulting in decreased metabolism

or ‘‘detoxification’’ of test material,

contributed to the uncertainty of the

determination.

iv. Prenatal and postnatal sensitivity.

The available Agency Guideline studies

indicate no increased susceptibility of

rat or rabbit fetuses to in utero exposure

to fenhexamid. In the prenatal

developmental toxicity study in rats, no

evidence of developmental toxicity was

seen even at the highest dose tested. In

the prenatal developmental toxicity

study in rabbits, developmental toxicity

was seen only in the presence of

maternal toxicity.

In the 2–generation reproduction

study in rats, quantitatively (i.e., based

on NOAELs/LOAELs in parental

animals versus offspring), there was no

evidence of increased susceptibility of

the pups. Qualitatively, however, there

was evidence of increased susceptibility

based on the comparative severity of

effects at the LOAEL (406 mg/kg/day):

Parental toxicity was characterized as

alterations in clinical chemistry

parameters and decreased organ weights

without collaborative histopathology;

while offspring toxicity was manifested

as significantly decreased pup body

weights in both generations during the

lactation period (on lactation days 7, 14,

and 21 in the F2 generation and

lactation days 14 and 21 in the F1

generation offspring)

v. Conclusion. The Agency has

determined that a safety factor is

required for fenhexamid because

qualitatively, there was evidence of

increased susceptibility based on the

comparative severity of effects in the 2–

generation reproduction study in rats.

The effects on pups were of concern

because:

1. Significant pup body weight

decreases were observed in both the F1

and the F2 generations.

2. The pup body weight decreases in

the F2 generation were observed during

early lactation (lactation day 7 through

day 21) when the pups are exposed to

the test material primarily through the

mother’s milk.

3. The pup body weight decreases in

the F1 generation were observed during

late lactation (lactation days 14 through

21) when the pups are exposed to the

test material through the mother’s milk

and through the feed.

4. In the metabolism study on

fenhexamid, glucuronidation of

fenhexamid was clearly demonstrated to

be the single major route of metabolism,

detoxification and excretion of

fenhexamid in adult male and female

Wistar rats. The demonstrated poor

glucuronidation capacity of rat pups

between days 7 and 21 (in a referenced

study) indicates a possibly increased

sensitivity of pups and serves to support

a concern for neonatal toxicity.

However, the Agency has reduced the

FQPA safety factor to 3x because:

1. The toxicology data base is

complete for the assessment of the

effects of fenhexamid following in utero

and/or postnatal exposure.

2. There is no indication of increased

susceptibility of rat or rabbit fetuses to

in utero exposure in the prenatal

developmental toxicity studies with

fenhexamid.

3. The increased susceptibility

demonstrated in the 2–generation

reproduction study was only qualitative

(not quantitative) evidence and was

observed only in the presence of

parental toxicity.

4. The qualitative offspring effect was

limited to decreased body weight and

no other adverse effects (e.g., decreased

pup survival, behavioral alterations, etc)

were observed.

5. Adequate data are available or

conservative modeling assumptions are

used to assess dietary food and drinking

water exposure.

6. There are currently no residential

uses for fenhexamid.

Federal Register / Vol. 65, No. 225 / Tuesday, November 21, 2000 / Rules and Regulations 69881

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 U.S. EPA Office of Water

are used to calculate DWLOCs: 2

Liter(L)/70 kilogram (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

ground water are less than the

calculated DWLOCs, OPP concludes

with reasonable certainty that exposures

to fenhexamid 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 fenhexamid on drinking

water as a part of the aggregate risk

assessment process.

1. Acute risk. 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. No acute dietary

endpoint has been identified. Therefore,

no risk assessment was conducted for

acute dietary exposures.

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to fenhexamid from food

will utilize 7% of the cPAD for the U.S.

population, 65% of the cPAD for all

infants, less than 1 year old and 16% of

the cPAD for children, 1–6 years old,

the subpopulation of children at greatest

exposure. There are no residential uses

for fenhexamid that result in chronic

residential exposure to fenhexamid. In

addition, despite the potential for

chronic dietary exposure to fenhexamid

in drinking water, after calculating

DWLOCs and comparing them to

conservative model estimated

environmental concentrations of

fenhexamid in surface and ground

water, EPA does not expect the

aggregate exposure to exceed 100% of

the cPAD, as shown in the following

Table 2:

TABLE 2. — AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO FENHEXAMID

Population Subgroup cPAD mg/kg/

day % cPAD (Food) Surface WaterEEC (ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. Population 0.057 7 4.8 0.0007 1,900

Children, 1–6 years 0.057 16 4.8 0.0007 480

All infants, < 1 year 0.057 65 4.8 0.0007 190

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).

Fenhexamid 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.

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).

Fenhexamid 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. The Agency has classified

Fenhexamid as a ‘‘not likely’’

carcinogen. Therefore, no risk

assessment was conducted to assess

cancer concerns.

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 fenhexamid

residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Bayer AG Method 00362, a high

performance liquid chromatography

method with electrochemical detection,

is the enforcement method for

fenhexamid residues in plant

commodities. A copy of the method has

been sent to FDA for publication in the

Pesticide Analytical Manual (PAM),

Volume II, as a Roman numeral method.

In the interim, it 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 Codex or Mexican MRL

tolerances established for fenhexamid

and no Canadian MRL on pears..

VI. Conclusion

Therefore, the tolerance is established

for residues of fenhexamid, (N-2,3-

dichloro-4-hydroxyphenyl)-1-methyl

cyclohexanecarboxamide), in or on

pears at 15 ppm.

69882 Federal Register / Vol. 65, No. 225 / Tuesday, November 21, 2000 / Rules and Regulations

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–301075 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 22, 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–301075, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

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

person or by courier, bring a copy to the

location of the PIRIB described in Unit

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

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

file format and avoid the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 6.1/8.0 file

format or ASCII file format. Do not

include any CBI in your electronic copy.

You may also submit an electronic copy

of your request at many Federal

Depository Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

VIII. Regulatory Assessment

Requirements

This final rule establishes a time

limited tolerance under FFDCA section

408. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Public

Law 104–4). Nor does it require any

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or require OMB review or any

Agency action under Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23,

1997). This action does not involve any

technical standards that would require

Agency consideration of voluntary

consensus standards pursuant to section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104–113, section

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

tolerances and exemptions that are

established on the basis of a FIFRA

section 18 exemption under FFDCA

section 408, such as the tolerance in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

Federal Register / Vol. 65, No. 225 / Tuesday, November 21, 2000 / Rules and Regulations 69883

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: November 8, 2000.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

371.

2. Section 180.553 is amended by

revising paragraph (b) to read as follows:

§ 180.553 Fenhexamid; tolerances for

residues.

* * * * *

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for the residues of the fungicide

fenhexamid, (N-2,3-dichloro-4-

hydroxyphenyl)-1-methyl

cyclohexanecarboxamide), in

connection with use of the pesticide

under section 18 emergency exemptions

granted by EPA. The tolerances will

expire on the dates specified in the

following table:

Commodity Parts per

million

Expiration/

Revocation

Date

Pears 15 .............. 12/31/02

* * * * *

[FR Doc 00–29770 Filed 11–20–00; 8:45 a.m.]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 300

[FRL–6903–9]

National Oil and Hazardous

Substances Pollution Contingency

Plan; National Priorities List

AGENCY: Environmental Protection

Agency.

ACTION: Notice of deletion of the Tenth

Street Dump/Junkyard Superfund Site

from the National Priorities List (NPL).

SUMMARY: The Environmental Protection

Agency (EPA) Region 6 announces the

deletion of the Tenth Street Dump/

Junkyard Superfund Site (Site) located

in Oklahoma City, Oklahoma from the

National Priorities List (NPL). The NPL,

promulgated pursuant to Section 105 of

the Comprehensive Environmental

Response, Compensation, and Liability

Act (CERCLA) of 1980, as amended, is

codified at Appendix B to the National

Oil and Hazardous Substances Pollution

Contingency Plan (NCP), 40 CFR Part

300. The EPA and the State of

Oklahoma, through the Oklahoma

Department of Environmental Quality

(ODEQ), have determined that the Site

poses no significant threat to public

health or the environment and,

therefore, no further response actions

are appropriate. (Neither CERCLArequired five-year reviews nor operation

and maintenance are considered further

response action for the purpose of

deletion.)

EFFECTIVE DATE: November 21, 2000.

FOR FURTHER INFORMATION CONTACT: Ms.

Camille D. Hueni, Remedial Project

Manager, 214–665–2231, United States

Environmental Protection Agency,

Region 6, 6SF–AP, 1445 Ross Avenue,

Suite 1200, Dallas, Texas, 75202–2733.

Information on the Site is available at

the local information repository located

at the Ralph Ellison Library, 2000 N.E.

23rd Street, Oklahoma City, Oklahoma

73111. Requests for comprehensive

copies of documents should be formally

directed to Mr. Donn Walters, Regional

Superfund Information Management

Team, EPA Region 6, SF–PO, 1445 Ross

Avenue, Suite 1200, Dallas, Texas,

75202–2733.

SUPPLEMENTARY INFORMATION: The Site

being deleted from the NPL is the Tenth

Street Dump/Junkyard Superfund Site

located in Oklahoma City, Oklahoma. A

Notice of Intent to Delete for the Site

was published on May 1, 2000 (65 FR

25292). The closing date for comments

on the Notice of Intent to Delete was

May 31, 2000. EPA received no

comments and therefore no

Responsiveness Summary was prepared.

The EPA identifies sites which appear

to present a significant risk to public

health, welfare, or the environment and

maintains the NPL as the list of those

sites. Deletion of a site from the NPL

does not affect responsible party

liability or impede EPA efforts to

recover costs associated with response

actions. Section 300.425(e)(3) of the

NCP, 40 CFR 300.425(e)(3), states that

Fund-financed actions may be taken at

sites deleted from the NPL in the event

that future conditions at the site warrant

such action. Pursuant to CERCLA

Section 105 and 40 CFR 300.425(e), the

Site is hereby deleted from the NPL.

List of Subjects in 40 CFR Part 300

Environment protection, Air pollution

control, Chemicals, Hazardous

substances, Hazardous waste,

Intergovernmental regulations,

Penalties, Reporting and recordkeeping

requirements, Superfund, Water

pollution control, Water supply.