22930 Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301122; FRL–6781–4]

RIN 2070–AB78

Forchlorfenuron; Time-Limited

Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance forresidues of

Forchlorfenuron; N-(2-chloro-4-

pyridinyl)-N ′-phenylurea in or on

almond, apple, blueberry, cranberry, fig,

grapes, kiwifruit, olive, pear, and plums

(fresh). Siemer & Associates

Incorporated, agent for KIM-C1, LLC

requested this tolerance under the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerance

will expire on April 1, 2004.

DATES: This regulation is effective May

7, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301122 must be received

by EPA on or before July 6, 2001.

ADDRESSES: Written objections and

hearing requests may besubmitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301122 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Cynthia Giles-Parker, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: 703–305–7740; and e-mail

address: giles-parker.cynthia@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

Categories NAICS 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

‘‘FederalRegister—Environmental

Documents.’’ You can also godirectly 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. A

frequently updated electronic version of

40 CFR part 180 is available at http://

www.access.gpo.gov/nara/cfr/

cfrhtml_180/Title_40/40cfr180_00.html,

a beta site currently under development.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301122. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

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

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

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

In the Federal Register of July 28,

1998 (63 FR 40273)(FRL–5799–3), EPA

issued a notice pursuant to section 408

of the Federal Food, Drug, and Cosmetic

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

amended by the Food Quality Protection

Act of 1996 (FQPA) (Public Law 104–

170) announcing the filing of a pesticide

petition (PP 7G4906) for tolerance by

KIM-C1, LLC, 6333 East Liberty Avenue,

Fresno, California 93727. This notice

included a summary of the petition

prepared by KIM-C1, the registrant.

The petition requested that 40 CFR

part 180 be amended by establishing a

time-limited tolerance for residues of

the plant growth regulator N-(2-chloro4-pyridinyl)-N ′-phenylurea, in or on

almond, apple, blueberry, cranberry, fig,

grapes, kiwifruit, olive, pear, and plums

(fresh) at 0.01 part per million (ppm).

The tolerance will expire on April 1,

2004.

One comment was received in

response to the Notice of Filing. The

comment was received on December 7,

2000 as a letter dated December 1, 2000

from Mr. Robert Bianco, Desert Grape

Growers League of California. The

League requested that the Agency

reduce the number of table grape acres,

investigate allegations regarding taste,

and that the Experimental Use Permit be

crop destruct. In response to the first

issue, it is noted that the registrant has

subsequently submitted a revised testing

program that incorporates a reduced

number of table grape acres. Regarding

the issue of requiring a crop destruct

condition on the grapes treated in the

Experimental Use Permit due to a

difference in taste of the harvested

grapes, the Agency has determined that

requiring a crop destruct condition may

be imposed only in response to

concerns relating to human health.

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

Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Rules and Regulations 22931

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue....’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. For

further discussion of the regulatory

requirements of section 408 and a

complete description of the risk

assessment process, see the final rule on

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997) (FRL–5754–

7).

III. Aggregate Risk Assessment and

Determination of Safety

Consistent with section 408(b)(2)(D),

EPA has reviewed the available

scientific data and other relevant

information in support of this action.

EPA has sufficient data to assess the

hazards of and to make a determination

on aggregate exposure, consistent with

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

residues of N-(2-chloro-4-pyridinyl)-N ′-

phenylurea on almond, apple,

blueberry, cranberry, fig, grapes,

kiwifruit, olive, pear, and plums (fresh)

at 0.01 ppm. EPA’s assessment of

exposures and risks associated with

establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by N-(2-chloro-4-

pyridinyl)-N ′-phenylurea are discussed

in the following Table 1 as well as the

no observed adverse effect level

(NOAEL) and the lowest observed

adverse effect level (LOAEL) from the

toxicity studies reviewed.

TABLE 1.— SUBCHRONIC, CHRONIC, AND OTHERTOXICITY

Guideline

No. Study Type Results

870.3100 90–Day oral toxicity rodents NOAEL = M*≥400; F*=84 mg/kg/day; LOAEL = M*=not determined, F=428 mg/kg/day based on

decrease BW*, BW gain & food efficiency.

870.3150 90–Day oral toxicity in nonrodentsNOAEL = M=1608; F=19.1 mg/kg/day; LOAEL = M=162.4; F=188.7 mg/kg/day based on decreases (≥10%) in BW gain, FC & food efficiency.

870.3700a Prenatal developmental in rodentsMaternal NOAEL = 200 mg/kg/day; LOAEL = 400 mg/kg/day based on increased incidence of alopecia; decrease in BW & BW gains. Developmental NOAEL = 200 mg/kg/day; LOAEL = 400

mg/kg/day based on decreased mean fetalBW.

870.3700b Prenatal developmental in

nonrodents

Maternal NOAEL = ≥100 mg/kg/day; LOAEL = not determined. Developmental NOAEL = ≥100

mg/kg/day; LOAEL = not determined.

870.3800 Reproduction and fertility effectsParental/Systemic NOAEL = M=11/13;F=13/15 mg/kg/day; LOAEL = 144–202 mg/kg/day based

on decreasedFC F0 & F1; clinical signs of toxicity & lower BW in F1M& F and growth retardation in F1 & F2 pups. Reproductive NOAEL = M144/168; F=169/202 mg/kg/day; LOAEL = 544–

926 mg/kg/day based on increased pup mortality (F1a, F1b and F2a), emaciation in F1b,

anddecrease in F1 pups litter.

870.4300 Carcinogenicity mice NOAEL = M=7; F=9 mg/kg/day; LOAEL = M=93; F=122 mg/kg/day based on reduced BW & BW

gain & FC; kidney toxicity (M=suppurative inflammation, F = non-suppurative interstitial nephritis. no evidence of carcinogenicity.

*

M=Male; F=Female; BW=Body Weight; FC=Food Consumption

B. Toxicological Endpoints

The dose at which no adverse effects

are observed (the NOAEL) from

thetoxicology study identified as

appropriate for use in risk assessment is

used to estimate the toxicological level

of concern (LOC). However, the lowest

dose at which adverse effects of concern

are identified (the LOAEL) is sometimes

used for risk assessment if no NOAEL

was achieved in the toxicology study

selected. An uncertainty factor (UF) is

applied to reflect uncertainties inherent

in the extrapolation from laboratory

animal data to humans and in the

variations in sensitivity among members

of the human population as well as

other unknowns. An UF of 100 is

routinely used, 10X to account for

interspecies differences and 10X for

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

todetermine the LOC. For example,

when 100 is the appropriate UF (10X to

account for interspecies differences and

10X for intraspecies differences) the

LOC is 100. To estimate risk, a ratio of

the NOAEL to exposures (margin of

exposure (MOE) = NOAEL/exposure) is

calculated and compared to the LOC.

The linear default risk methodology

(Q*) is the primary method currently

used by the Agency to quantify

carcinogenic risk. The Q* approach

assumes that any amount of exposure

will lead to some degree of cancer risk.

A Q* is calculated and used to estimate

risk which represents a probability of

occurrence of additional cancer cases

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

in a million). Under certain specific

circumstances, MOE calculations will

be used for the carcinogenic risk

22932 Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Rules and Regulations

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 N-(2-chloro-4-pyridinyl)-N ′-

phenylurea used for human risk

assessment is shown in the following

Table 2:

TABLE 2.— SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR N-(2-CHLORO-4-PYRIDINYL)-N’-PHENYLUREA FOR

USE IN HUMAN RISK ASSESSMENT

Exposure Scenario

Dose Used in Risk

Assessment, UF

(mg/kg/day)

FQPA SF* and Level of

Concern for Risk

Assessment

Study and Toxicological Effects

Acute Dietary ..................................... ............................................... None ..........................................

Chronic Dietary .................................. NOAEL = 7.0 ............................ Decreases in body weight, body

weight gain and food consumption as well as effects

on the kidney at the LOAEL

of 93 and 122 mg/kg/day for

males and females, respectively. The risk assessment is

required..

2–year rat feeding study

....................................................... UF = 100; FQPA = 10X ............ Chronic RfD=0.07 mg/kg/day

cPAD=0.007 mg/kg/day Apply

to all population subgroups.

Short-Term Dermal ............................ NOAEL=200 .............................. Decreases in maternal body

weights and body weight

gains as well as decrease in

mean fetal body weights..

developmental rat study

Intermediate-Term Dermal ................ NOAEL=17 ................................ Based on decreases in body

weight gain and food consumption..

90–day feeding study in dogs

Long-Term Dermal ............................ ............................................... None .......................................... ....................

Short-Term Inhalation ........................ NOAEL=200 .............................. Same as short-term dermal. ..... developmental rat study

Intermediate-Term Inhalation ............ NOAEL=17 ................................ Same as intermediate-term dermal..90–day feeding study in dogs

Long-Term Inhalation ........................ ............................................... None ..........................................

Cancer ............................................... ............................................... Not yet classified .......................

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

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. Risk assessments were

conducted by EPA to assess dietary

exposures from N-(2-chloro-4-

pyridinyl)-N ′-phenylurea 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. An acute

exposure assessment is unnecessary

because no toxicological endpoint was

selected.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment the

Dietary Exposure Evaluation Model

(DEEM) analysisevaluated 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: This

chronic dietary DEEM analysis was a

Tier 1 (assumptions: time-limited

tolerance level residues of the subject

commodities and 100% crop treated).

The DEEM default concentration

factors were used for the processed

commodities of all the subject crops.

The resulting dietary food exposures

occupy 1.5% of the cPAD for the most

highly exposed population subgroup,

non-nursing infants. These results

should be viewed as conservative

(health protective) risk estimates.

Refinements such as the use of percent

crop-treated information (this is a

limited acreage EUP use) and/or

anticipated residue values would yield

lower estimates of chronic dietary

exposure.

iii. Cancer. No concern for cancer

risks were identified. Data from

available studies do not indicate a

treatment-related tumor problem and

cancer risk endpoints have not been

identified.

2. Dietary exposure from drinking

water. The Agency lackssufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for N-(2-

chloro-4-pyridinyl)-N ′-phenylurea 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

Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Rules and Regulations 22933

characteristics of N-(2-chloro-4-

pyridinyl)-N ′-phenylurea.

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 SCI-GROW, 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 high-end 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 N-(2-chloro4-pyridinyl)-N ′-phenylurea they are

further discussed in the aggregate risk

sections below.

Based on the GENEEC and SCI-GROW

models the EECs of N-(2-chloro-4-

pyridinyl)-N ′-phenylurea for acute and

chronic exposures are estimated to be

4.7 parts per billion (ppb) (peak and 56–

day average) for surface water and 26

ppb (acute and chronic) 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).

N-(2-Chloro-4-pyridinyl)-N ′-

phenylurea is not registered for use on

any sites that would result in residential

exposure.

4. Cumulative exposure to substances

with a common mechanismof 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 N-

(2-chloro-4-pyridinyl)-N ′-phenylurea

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, N-(2-chloro-4-

pyridinyl)-N ′-phenylurea 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 N-

(2-chloro-4-pyridinyl)-N ′-phenylurea

has a common mechanism of toxicity

with other substances. For information

regarding EPA’s efforts to determine

which chemicals have a common

mechanism of toxicity and to evaluate

the cumulative effects of such

chemicals, see the final rule for

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997).

D. Safety Factor for Infants and

Children

1. Safety factor for infants and

children—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 margin

of exposure (MOE) analysis or through

using uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans.

2. Conclusion. There is an adequate

toxicity databasefor N-(2-chloropyridinyl)-N ′-phenylurea for this EUP

and exposure data are complete or are

estimated based on data that reasonably

accounts for potential exposures. For

the purposes of the experimental use

permit only, the FQPA safety factor will

be retained (10X) and applied to all

groups for assessing chronic dietary

risk.

E. Aggregate Risks and Determination of

Safety

To estimate total aggregate exposure

to a pesticide from food, drinking water,

and residential uses, the Agency

calculates DWLOCs which are used as a

point of comparison against the model

estimates of a pesticide’s concentration

in water (EECs). DWLOC values are not

regulatory standards for drinking water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food and residential

uses. In calculating a DWLOC, the

Agency determines how much of the

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

available for exposure through drinking

water e.g., allowable chronic water

exposure (mg/kg/day) = cPAD - (average

food + residential exposure). This

allowable exposure through drinking

water is used to calculate a DWLOC.

A DWLOC will vary depending on the

toxic endpoint, drinking

waterconsumption, 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, the Office of Pesticide

Programs (OPP) concludes with

reasonable certainty that exposures to

the pesticide in drinking water (when

considered along with other sources of

exposure for which OPP has reliable

data) would not result in unacceptable

levels of aggregate human health risk at

this time. Because OPP considers the

aggregate risk resulting from multiple

exposure pathways associated with a

pesticide’s uses, levels of comparison in

drinking water may vary as those uses

change. If new uses are added in the

future, OPP will reassess the potential

22934 Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Rules and Regulations

impacts of residues of the pesticide in

drinking water as a part of the aggregate

risk assessment process.

1. Acute risk. Not applicable; no acute

dietary endpointwas identified.

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to N-(2-chloro-4-

pyridinyl)-N ′-phenylurea from food will

utilize 0.3% of the cPAD for the U.S.

population, 1.5% of the cPAD for nonnursing infants and 1.0% of the cPAD

for children (1–6 years). There are no

residential uses for N-(2-chloro-4-

pyridinyl)-N ′-phenylurea that result in

chronic residential exposure to N-(2-

chloro-4-pyridinyl)-N ′-phenylurea. In

addition, there is potential for chronic

dietary exposure to N-(2-chloro-4-

pyridinyl)-N ′-phenylurea in drinking

water. After calculating DWLOCs and

comparing them to the EECs for surface

and ground water, EPA does not expect

the aggregate exposure to exceed 100%

of the cPAD, as shown in the following

Table 3:

TABLE 3.— AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO N-(2-CHLORO-4-PYRIDINYL)-N ′-

PHENYLUREA

Population Subgroup cPAD mg/

kg/day

% cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. Population (total) 0.007 0.3 4.7 26 240

Females (13–50 years) 0.007 0.1 4.7 26 210

Infants/Children 0.007 0.4-1.5 4.7 26 70

Other 0.007 0.3 4.7 26 240

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).

N-(2-Chloro-4-pyridinyl)-N ′-

phenylurea 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 do not exceed the

Agency’s level of concern.

4. Intermediate-term risk.

Intermediate-termaggregate exposure

takes into account residential exposure

plus chronic exposure to food and water

(considered to be a background

exposure level).

N-(2-Chloro-4-pyridinyl)-N ′-

phenylurea 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 do not exceed the

Agency’s level of concern.

5. Aggregate cancer risk for U.S.

population. No concern for cancer risks

were identified. Data from available

studies do not indicate a treatmentrelated tumor problem and cancer risk

endpoints have not been identified.

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 N-(2-chloro4-pyridinyl)-N ′-phenylurea residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

1. Plants. The proposed enforcement

method is a high performance liquid

chromatography using ultraviolet

detection (HPLC/UV) procedure which

measures parent N-(2-chloro-4-

pyridinyl)-N ′-phenylurea. For the

purpose of the Experimental Use Permit,

the method has been adequately

validated. The limit of quantitation

(LOQ) is 0.01 ppm and the limit of

detection is 0.003 ppm.

2. Animals. Depending on the results

of a ruminant metabolism study, an

enforcement method for the regulated

residue in animal commodities may be

required to support a Section 3

registration with permanent tolerances.

Adequate enforcement methodology

is available to enforce the

toleranceexpression. 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, Canadian, or

Mexican IRLs for N-(2-chloro-4-

pyridinyl)-N ′-phenylurea.

C. Conditions

There are no conditions for the

registration.

V. Conclusion

Therefore, the time-limited tolerance

is established for residues of N-(2-

chloro-4-pyridinyl)-N ′-phenylurea in or

on almond, apple, blueberry, cranberry,

fig, grapes, kiwifruit, olive, pear, and

plums (fresh) at 0.01 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any personmay

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–301122 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 July 6, 2001.

1. Filing the request. Your objection

must specify thespecific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Rules and Regulations 22935

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 orrequest 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 inthe judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

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

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

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

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by docket control

number OPP–301122, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

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

person or by courier, bring a copy to the

location of the PIRIB described in Unit

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

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

file format and avoid the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 6.1/8.0 or

ASCII file format. Do not include any

CBI in your electronic copy. You may

also submit an electronic copy of your

request at many Federal Depository

Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

VII. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(d) inresponse

to a petition submitted to the Agency.

The Office of Management and Budget

(OMB) has exempted these types of

actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Public

Law 104–4).Nor does it require any

special considerations under Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or OMB review or any Agency

action under Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

This action does not involve any

technical standards that would require

Agency consideration of voluntary

consensus standards pursuant to section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104–113, section

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

tolerances and exemptions that are

established on the basis of a petition

under FFDCA section 408(d), such as

the tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.) do not apply. In addition, the

Agency has determined that this action

will not have a substantial direct effect

on States, on the relationship between

the national government and the States,

or on the distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

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

For these same reasons, the Agency

has determined that this rule does not

have any ‘‘tribal implications’’ as

described in Executive Order 13175,

entitled Consultation and Coordination

with Indian Tribal Governments (65 FR

67249, November 6, 2000). Executive

Order 13175, requires EPA to develop

an accountable process to ensure

‘‘meaningful and timely input by tribal

officials in the development of

regulatory policies that have tribal

implications.’’ ‘‘Policies that have tribal

implications’’ is defined in the

Executive Order to include regulations

22936 Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Rules and Regulations

that have ‘‘substantial direct effects on

one or more Indian tribes, on the

relationship between the Federal

government and the Indian tribes, or on

the distribution of power and

responsibilities between the Federal

government and Indian tribes.’’ This

rule will not have substantial direct

effects on tribal governments, on the

relationship between the Federal

government and Indian tribes, or on the

distribution of power and

responsibilities between the Federal

government and Indian tribes, as

specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.’’

VIII. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., asadded 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

recordkeepingrequirements.

Dated: April 30, 2001.

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), 346(a) and

371.

2. Section 180.569 is added to read as

follows:

§ 180.569 Forchlorfenuron; tolerances for

residues.

(a) General. Time-limited tolerances

are established forresidues of the plant

growth regulator forchlorfenuron; N-(2-

chloro-4-pyridinyl)-N ′-phenylurea in or

on the food commodities:

Commodity Parts per million

Expiration/

Revocation

Date

Almond ...... 0.01 4/1/04

Apple ......... 0.01 4/1/04

Blueberry .. 0.01 4/1/04

Cranberry .. 0.01 4/1/04

Fig ............. 0.01 4/1/04

Grape ........ 0.01 4/1/04

Kiwifruit ..... 0.01 4/1/04

Olive .......... 0.01 4/1/04

Pear .......... 0.01 4/1/04

Plum

(fresh).

0.01 4/1/04

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

restrictions. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 01–11414 Filed 5–4–01; 8:45 am]

BILLING CODE 6560–50–S

FEDERAL EMERGENCY

MANAGEMENT AGENCY

44 CFR Part 64

[Docket No. FEMA–7761]

Suspension of Community Eligibility

AGENCY: Federal Emergency

Management Agency, FEMA.

ACTION: Final rule.

SUMMARY: This rule identifies

communities, where the sale of flood

insurance has been authorized under

the National Flood Insurance Program

(NFIP), that are suspended on the

effective dates listed within this rule

because of noncompliance with the

floodplain management requirements of

the program. If the Federal Emergency

Management Agency (FEMA) receives

documentation that the community has

adopted the required floodplain

management measures prior to the

effective suspension date given in this

rule, the suspension will be withdrawn

by publication in the Federal Register.

EFFECTIVE DATES: The effective date of

each community’s suspension is the

third date (‘‘Susp.’’) listed in the third

column of the following tables.

ADDRESSES: If you wish to determine

whether a particular community was

suspended on the suspension date,

contact the appropriate FEMA Regional

Office or the NFIP servicing contractor.

FOR FURTHER INFORMATION CONTACT:

Donna M. Dannels, Division Director,

Policy and Assessment Division,

Mitigation Directorate, 500 C Street,

S.W., Room 411, Washington, D.C.

20472, (202) 646–3098.

SUPPLEMENTARY INFORMATION: The NFIP

enables property owners to purchase

flood insurance which is generally not

otherwise available. In return,

communities agree to adopt and

administer local floodplain management

aimed at protecting lives and new

construction from future flooding.

Section 1315 of the National Flood

Insurance Act of 1968, as amended, 42

U.S.C. 4022, prohibits flood insurance

coverage as authorized under the

National Flood Insurance Program, 42

U.S.C. 4001 et seq., unless an

appropriate public body adopts

adequate floodplain management

measures with effective enforcement

measures. The communities listed in

this document no longer meet that

statutory requirement for compliance

with program regulations, 44 CFR part

59 et seq. Accordingly, the communities

will be suspended on the effective date

in the third column. As of that date,

flood insurance will no longer be

available in the community. However,

some of these communities may adopt

and submit the required documentation

of legally enforceable floodplain

management measures after this rule is

published but prior to the actual

suspension date. These communities

will not be suspended and will continue

their eligibility for the sale of insurance.

A notice withdrawing the suspension of

the communities will be published in

the Federal Register.

In addition, the Federal Emergency

Management Agency has identified the

special flood hazard areas in these

communities by publishing a Flood

Insurance Rate Map (FIRM). The date of

the FIRM if one has been published, is

indicated in the fourth column of the

table. No direct Federal financial

assistance (except assistance pursuant to

the Robert T. Stafford Disaster Relief

and Emergency Assistance Act not in

connection with a flood) may legally be

provided for construction or acquisition

of buildings in the identified special

flood hazard area of communities not

participating in the NFIP and identified

for more than a year, on the Federal

Emergency Management Agency’s

initial flood insurance map of the

community as having flood-prone areas

(section 202(a) of the Flood Disaster

Protection Act of 1973, 42 U.S.C.

4106(a), as amended). This prohibition

against certain types of Federal

assistance becomes effective for the

communities listed on the date shown

in the last column. The Associate

Director finds that notice and public

comment under 5 U.S.C. 553(b) are

impracticable and unnecessary because