Federal Register / Vol. 66, No. 247 / Wednesday, December 26, 2001 / Rules and Regulations 66325

mutually acceptable amendments to the

terms described in the direct final rule.

* * * * *

[FR Doc. 01–31485 Filed 12–21–01; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301198; FRL–6816–2]

RIN 2070–AB78

Imazapic; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for combined residues of

imazapic, (±)-2-[4,5-dihydro-4-methyl-4-

(1-methylethyl)-5-oxo-1H-imidazol-2-

yl]-5-methyl-3-pyridinecarboxylic acid

and its metabolite (±)-2-[4,5-dihydro-4-

methyl-4-(1-methylethyl)-5-oxo-1Himidazol-2-yl]-5-hydroxymethyl-3-

pyridinecarboxylic acid, both free CL

263284 and conjugated CL 189215) in or

on grass, forage and grass, hay and the

combined residues of imazapic and its

metabolite CL 263284 in or on milk; fat,

meat, and meat byproducts (except

kidney) of cattle, goats, horses, and

sheep; and kidney of cattle, goats,

horses, and sheep. BASF requested this

tolerance under the Federal Food, Drug,

and Cosmetic Act, as amended by the

Food Quality Protection Act of 1996.

DATES: This regulation is effective

December 26, 2001. Objections and

requests for hearings, identified by

docket control number OPP–301198,

must be received by EPA on or before

February 25, 2002.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301198 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: James A. Tompkins, Product

Manager (PM) 25, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW.,Washington,

DC 20460; telephone number: (703)

305–5697; and e-mail address:

tompkins.jim@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

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/. A frequently

updated electronic version of 40 CFR

part 180 is available at http://

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

cfrhtml_00/Title_40/40cfr180_00.html, a

beta site currently under development.

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–301198. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

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

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

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

In the Federal Register of August 24,

2000 (65 FR 51608) (FRL–6598–6), 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 9F5092) for tolerance by

American Cyanamid Company, P.O. Box

400, Princeton, NJ 08543–0400. This

notice included a summary of the

petition prepared by American

Cyanamid, the registrant at the time of

filing. The current registrant for the

chemical is BASF, at the same address.

There were no comments received in

response to the notice of filing.

The petition requested that 40 CFR

180.490(a) be amended by establishing a

tolerance for combined residues of the

herbicide imazapic and its

hydroxymethyl metabolite, both free (CL

263284) and conjugated (CL 189215) in

or on the raw agricultural commodities

grass, forage at 35 ppm, and grass, hay

at 15 parts per million (ppm).

Tolerances were also proposed for the

combined residues of imazapic and its

free hydroxymethyl metabolite in or on

milk at 0.1 ppm; fat, meat, and meat

byproducts (except kidney) of cattle,

goats, horses, and sheep at 0.1 ppm; and

kidney of cattle, goats, horses, and

sheep at 2.0 ppm.

Section 408(b)(2)(A)(i) of the FFDCA

allows EPA to establish a tolerance (the

legal limit for a pesticide chemical

residue in or on a food) only if EPA

determines that the tolerance is ‘‘safe.’’

Section 408(b)(2)(A)(ii) defines ‘‘safe’’ to

mean that ‘‘there is a reasonable

certainty that no harm will result from

66326 Federal Register / Vol. 66, No. 247 / Wednesday, December 26, 2001 / Rules and Regulations

aggregate exposure to the pesticide

chemical residue, including all

anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

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

combined residues of imazapic and its

metabolite, both free CL 263284 and

conjugated CL 189215, in or on grass,

forage at 30 ppm, and grass, hay at 15

ppm; and for the combined residues of

imazapic and its free hydroxymethyl

metabolite in milk at 0.1 ppm; fat, meat,

and meat byproducts (except kidney) of

cattle, goats, horses, and sheep at 0.1

ppm; and kidney of cattle, goats, horses,

and sheep at 1.0 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 imazapic 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.—IMAZAPIC TECHNICAL SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type (All Studies Acceptable) Results

870.3100 90-Day oral toxicity rodents-rat NOAEL = 1,552 mg/kg/day in males, 1,728

mg/kg/day in females (HDT)

LOAEL = not established

870.3200 21-Day dermal toxicity-rabbit NOAEL = 1,000 mg/kg/day (males and females)

LOAEL = not established

870.3700 Prenatal developmental in rodents-rat Maternal NOAEL = 1,000 mg/kg/day (HDT)

LOAEL = not established

Developmental NOAEL = 1,000 mg/kg/day

LOAEL = not established

870.3700 Prenatal developmental in nonrodents-rabbit Maternal NOAEL = 350 mg/kg/day

LOAEL = 500 mg/kg/day based on decreased body weight gain and food consumption. At 700 mg/kg/day (HDT), there

was excessive mortality resulting in a total

of only 7 surviving litters

Developmental NOAEL = 500 mg/kg/day

LOAEL = not established. Due to excessive

mortality at 700 mg/kg/day, only 47 fetuses

were available for examination which precluded a meaningful evaluation of developmental findings at this dose level

870.3800 Reproduction and fertility effects-rat Parental/Systemic NOAEL = 1,205 mg/kg/day

in males, 1,484 mg/kg/day in females

(HDT)

LOAEL = not established

Reproductive NOAEL = 1,205 mg/kg/day in

males, 1,484 mg/kg/day in females

LOAEL = not established

Offspring NOAEL = 1,205 mg/kg/day in

males, 1,484 mg/kg/day in females

LOAEL = not established

Federal Register / Vol. 66, No. 247 / Wednesday, December 26, 2001 / Rules and Regulations 66327

TABLE 1.—IMAZAPIC TECHNICAL SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued

Guideline No. Study Type (All Studies Acceptable) Results

870.4100 Chronic toxicity dogs NOAEL = not established

LOAEL = 137 mg/kg/day in males, 180 mg/

kg/day in females based on increased incidence of minimal degeneration and/or necrosis and lymphocyte and/or macrophage

infiltration in skeletal muscle in both males

and females and slightly decreased blood

creatinine levels in females (LDT)

870.4100/870.4200 Chronic/carcinogenicity rats NOAEL = 1,029 mg/kg/day in males, 1,237

mg/kg/day in females (HDT)

LOAEL = not established

No evidence of carcinogenicity

870.4300 Carcinogenicity mice NOAEL = 1,134 mg/kg/day in males, 1,422

mg/kg/day in females (HDT)

LOAEL = not established

No evidence of carcinogenicity

870.5265 Gene mutation Non-mutagenic when tested up to 5,000 μg/

plate, in presence and absence of activation, in S. typhimurium strains TA98,

TA100, TA1535 and TA1537 and E.coli

strain WP2uvra.

870.5300 Gene mutation Non-mutagenic at the HGPRT locus in Chinese hamster ovary (CHO) cells tested up

to cytotoxic concentrations or limit of solubility, in presence and absence of activation.

870.5375 Chromosome aberration Did not induce structural chromosome aberration in CHO cell cultures in the presence

and absence of activation.

870.5385 Chromosomal aberration Non-mutagenic in rat bone marrow chromosomal aberrations assay up to 5,000 mg/

kg.

870.7485 Metabolism and pharmacokinetics - rat Total recovery of the administered dose was

98–106% at 7 days. Urinary excretion was

the major route of elimination (94–102% of

the dose), with only unchanged parent detected. There was no evidence of bioaccumulation in the tissues. There were no

sex- or dose-related differences following

oral or intravenous administration.

B. Toxicological Endpoints

The dose at which no adverse effects

are observed (the NOAEL) from the

toxicology study identified as

appropriate for use in risk assessment is

used to estimate the toxicological level

of concern (LOC). However, the lowest

dose at which adverse effects of concern

are identified (the LOAEL) is sometimes

used for risk assessment if no NOAEL

was achieved in the toxicology study

selected. An uncertainty factor (UF) is

applied to reflect uncertainties inherent

in the extrapolation from laboratory

animal data to humans and in the

variations in sensitivity among members

of the human population as well as

other unknowns. An UF of 100 is

routinely used, 10X to account for

interspecies differences and 10X for

intraspecies differences. Because a

developmental neurotoxicity study is

not needed, there are currently no

residential uses, dietary exposure

assessments will not underestimate the

potential exposures for infants and

children, and the toxicology database is

complete, no additional FQPA Safety

Factor (FQPA SF) is required.

For dietary risk assessment (other

than cancer) the Agency uses the UF to

calculate an acute or chronic reference

dose (acute RfD or chronic RfD) where

the RfD is equal to the NOAEL divided

by the appropriate UF (RfD = NOAEL/

UF). Where an additional safety factor is

retained due to concerns unique to the

FQPA, this additional factor is applied

to the RfD by dividing the RfD by such

additional factor. The acute or chronic

Population Adjusted Dose (aPAD or

cPAD) is a modification of the RfD to

accommodate this type of FQPA Safety

Factor.

For non-dietary risk assessments

(other than cancer) the UF is used to

determine the LOC. For example, when

100 is the appropriate UF (10X to

account for interspecies differences and

10X for intraspecies differences) the

LOC is 100. To estimate risk, a ratio of

the NOAEL to exposures (margin of

exposure (MOE) = NOAEL/exposure) is

calculated and compared to the LOC.

The linear default risk methodology

(Q*) is the primary method currently

used by the Agency to quantify

carcinogenic risk. The Q* approach

assumes that any amount of exposure

will lead to some degree of cancer risk.

66328 Federal Register / Vol. 66, No. 247 / Wednesday, December 26, 2001 / Rules and Regulations

A Q* is calculated and used to estimate

risk which represents a probability of

occurrence of additional cancer cases

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

in a million). Under certain specific

circumstances, MOE calculations will

be used for the carcinogenic risk

assessment. In this non-linear approach,

a ‘‘point of departure’’ is identified

below which carcinogenic effects are

not expected. The point of departure is

typically a NOAEL based on an

endpoint related to cancer effects

though it may be a different value

derived from the dose response curve.

To estimate risk, a ratio of the point of

departure to exposure (MOEcancer = point

of departure/exposures) is calculated. A

summary of the toxicological endpoints

for imazapic used for human risk

assessment is shown in the following

Table 2:

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR IMAZAPIC FOR USE IN HUMAN RISK ASSESSMENT

Exposure Scenario Dose Used in Risk

Assessment, UF

FQPA SF and Level of

Concern for Risk

Assessment

Study and Toxicological Effects

Acute dietary (general population and females 13-50

years old)

None An acute dietary endpoint

was not selected based

on the absence of an appropriate endpoint attributed to a single dose

None

Chronic dietary (all populations) LOAEL= 137 mg/kg/day

UF = 300

Chronic RfD = 0.5 mg/kg/

day

FQPA SF = 1X

cPAD = cRfD/FQPA

SF = 0.5 mg/kg/day

LOAEL = 137 mg/kg/day based on increased

incidence of minimal degeneration and/or necrosis of skeletal muscle in 1 year dog feeding study

Incidental oral, short-term (1-7

days)

Oral NOAEL = 350 mg/kg/

day

LOC = 100 LOAEL = 500 mg/kg/day based on decreased

body weight and food consumption during

the dosing period in rabbit developmental

study

Incidental oral, intermediateterm (7 days-several months)Oral NOAEL = 350 mg/kg/

day

LOC = 100 LOAEL = 500 mg/kg/day based on decreased

body weight and food consumption during

the dosing period in rabbit developmental

study

Short- and intermediate-term

dermal (1-7 days and 1 weekseveral months)

(Occupational)

None No systemic toxicity was

seen following repeated

dermal application at

1,000 mg/kg/day over a

3-week period. Since no

hazard was identified,

quantification is not required.

None

Long-term dermal (several

months-lifetime)

(Occupational)

Oral LOAEL = 137 mg/kg/

day (dermal absorption

rate = 50%)

LOC for MOE = 300 LOAEL = 137 mg/kg/day based on increased

incidence of minimal degeneration and/or necrosis of skeletal muscle in 1 year dog feeding study

Short- and intermediate-term inhalation (1-7 days and 1

week-several months)

(Occupational)

Oral study NOAEL= 350

mg/kg/day (inhalation absorption rate = 100%)

LOC for MOE = 100 LOAEL = 500 mg/kg/day based on decreased

body weight and food consumption during

dosing in rabbit developmental study

Long-term inhalation (several

months-lifetime)

(Occupational)

Oral study LOAEL= 137

mg/kg/day (inhalation absorption rate = 100%)

LOC for MOE = 300 LOAEL = 137 mg/kg/day based on increased

incidence of minimal degeneration and/or necrosis of skeletal muscle in 1 year dog feeding study

Cancer (oral, dermal, inhalation) Cancer classification

(‘‘Group E’’)

Risk assessment not requiredNo evidence of carcinogenicity

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.490(a) for the

combined residues of imazapic and its

metabolites CL 263284 and CL 189215,

in or on peanut, nutmeat at 0.1 ppm.

Time-limited tolerances set to expire

December 31, 2001 are established

under (40 CFR 180.490(b) in connection

with section 18 emergency exemptions

(99NE0009) for residues of imazapic and

its metabolites CL 263284 and CL

189215 for grass, forage at 30 ppm;

grass, hay at 15 ppm; milk at 0.10 ppm;

fat, meat, and meat byproducts (except

kidney) of cattle, goats, hogs, horses,

and sheep at 0.10 ppm; and kidney of

cattle, goats, hogs, horses, and sheep at

1.0 ppm. The present analyses included

the published peanut values together

with re-evaluated tolerance levels for

livestock-derived commodities, based

on the new grass use proposed. Risk

assessments were conducted by EPA to

assess dietary exposures from imazapic

in food as follows:

i. Acute exposure. Acute dietary risk

assessments are performed for a foodVerDate 11<MAY>2000 19:32 Dec 21, 2001 Jkt 197001 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 E:\FR\FM\26DER1.SGM pfrm07 PsN: 26DER1
Federal Register / Vol. 66, No. 247 / Wednesday, December 26, 2001 / Rules and Regulations 66329

use pesticide if a toxicological study has

indicated the possibility of an effect of

concern occurring as a result of a 1 day

or single exposure. An acute exposure

assessment is not applicable based on

the absence of an appropriate effect of

concern.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment the

Dietary Exposure Evaluation Model

(DEEMTM version 7.73) 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: Residues present

at tolerance levels, 100% of each crop

is treated, and the use of default

processing concentration factors (Tier 1

analysis).

iii. Cancer. A cancer risk assessment

was not conducted, since imazapic has

been classified as a ‘‘Group E’’ chemical

(evidence of non-carcinogenicity for

humans) based upon lack of evidence of

carcinogenicity in two adequate studies

(rats and mice).

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

imazapic 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 imazapic.

The Agency uses the First Index

Reservoir Screening Tool (FIRST) or the

Pesticide Root Zone/Exposure Analysis

Modeling System (PRZM/EXAMS), to

produce estimates of pesticide

concentrations in an index reservoir.

The Screening Concentrations in

Ground Water (SCI-GROW) model is

used to predict pesticide concentrations

in shallow ground water. For a

screening-level assessment for surface

water EPA will use FIRST (a tier 1

model) before using PRZM/EXAMS (a

tier 2 model). The FIRST model is a

subset of the PRZM/EXAMS model that

uses a specific high-end runoff scenario

for pesticides. While both FIRST and

PRZM/EXAMS incorporate an index

reservoir environment, 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 imazapic

they are further discussed in the

aggregate risk sections below.

Based on the FIRST and SCI-GROW

models, the EECs of imazapic for acute

exposures are estimated to be 17 parts

per billion (ppb) for surface water and

14 ppb for ground water. The EECs for

chronic exposures are estimated to be

1.5 ppb for surface water and 14 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).

Imazapic 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

imazapic 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,

imazapic 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 imazapic has a common

mechanism of toxicity with other

substances. For information regarding

EPA’s efforts to determine which

chemicals have a common mechanism

of toxicity and to evaluate the

cumulative effects of such chemicals,

see the final rule for Bifenthrin Pesticide

Tolerances (62 FR 62961, November 26,

1997).

D. Safety Factor for Infants and

Children

1. In general. FFDCA section 408

provides that EPA shall apply an

additional tenfold margin of safety for

infants and children in the case of

threshold effects to account for prenatal

and postnatal toxicity and the

completeness of the 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. Prenatal and postnatal sensitivity.

Based on the available data, no evidence

of increased susceptibility was seen in

the rat and rabbit prenatal toxicity

studies or following prenatal/postnatal

exposure in the 2-generation

reproduction study.

3. Conclusion. There is a complete

toxicity data base for imazapic and

exposure data are complete or are

estimated based on data that reasonably

account for potential exposures. EPA

determined that the 10X safety factor to

protect infants and children should be

removed. The FQPA factor is removed

because: A developmental neurotoxicity

study is not needed; there are currently

no residential uses; and dietary

exposure assessments will not

underestimate the potential exposures

for infants and children.

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

66330 Federal Register / Vol. 66, No. 247 / Wednesday, December 26, 2001 / Rules and Regulations

Agency determines how much of the

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

available for exposure through drinking

water e.g., allowable chronic water

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

food + residential exposure). This

allowable exposure through drinking

water is used to calculate a DWLOC.

A DWLOC will vary depending on the

toxic endpoint, drinking water

consumption, and body weights. Default

body weights and consumption values

as used by the USEPA Office of Water

are used to calculate DWLOCs: 2L/70 kg

(adult male), 2L/60 kg (adult female),

and 1L/10 kg (child). Default body

weights and drinking water

consumption values vary on an

individual basis. This variation will be

taken into account in more refined

screening-level and quantitative

drinking water exposure assessments.

Different populations will have different

DWLOCs. Generally, a DWLOC is

calculated for each type of risk

assessment used: Acute, short-term,

intermediate-term, chronic, and cancer.

When EECs for surface water and

ground water are less than the

calculated DWLOCs, OPP concludes

with reasonable certainty that exposures

to the pesticide in drinking water (when

considered along with other sources of

exposure for which OPP has reliable

data) would not result in unacceptable

levels of aggregate human health risk at

this time. Because OPP considers the

aggregate risk resulting from multiple

exposure pathways associated with a

pesticide’s uses, levels of comparison in

drinking water may vary as those uses

change. If new uses are added in the

future, OPP will reassess the potential

impacts of residues of the pesticide in

drinking water as a part of the aggregate

risk assessment process.

1. Acute risk. Imazapic is not

expected to pose an acute risk because

no acute endpoint of concern was

identified in the toxicity test.

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to imazapic from food

will utilize 0.1% of the cPADs for the

U.S. population, all infants, and

children 1-6 years old. There are no

residential uses for imazapic that result

in chronic residential exposure to

imazapic. In addition, there is potential

for chronic dietary exposure to imazapic

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 IMAZAPIC RESIDUES

Population Subgroup cPAD mg/

kg/day

%cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. population 0.5 0.000269 1.5 14 17,000

All infants (< 1 year old) 0.5 0.000505 1.5 14 5,000

Children (1-6 years old) 0.5 0.000684 1.5 14 5,000

3. Short- or intermediate-term risk.

Since there are no registered uses for

imazapic which would result in nondietary, non-occupational exposure,

contributions to the aggregate risk from

both short- and intermediate-term nondietary exposures are not expected.

4. Aggregate cancer risk for U.S.

population. Imazapic has been classified

as a ‘‘Group E’’ chemical (evidence of

non-carcinogenicity for humans);

therefore imazapic is not expected to

pose a cancer risk.

5. 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 imazapic

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate independent method

validation (ILV) studies have been

submitted in support of all methods. A

method which is similar to the peanut

enforcement method has been submitted

for the determination of residues of

imazapic and its metabolites CL 263284

and CL 189215 in/on grass forage and

hay, and methods for the enforcement of

tolerances of imazapic and CL 263284 in

milk and livestock tissues and an HPLC/

MS method for the enforcement of

tolerances in fat have been submitted.

B. International Residue Limits

There are no CODEX, Canadian, or

Mexican maximum residue limits

(MRLs) for imazapic residues.

C. Conditions

The registrant has committed to

conduct four side-by-side grass field

trials using the maximum rate WDG

acid formulation. The registrant has also

agreed to conduct four additional grass

field trials reflecting a single

postemergence application of the 2 lb

acid equivalence (ae)/gal ammonium

salt SC formulation at 0.1875 lb ae/A;

these trials will be conducted in Regions

7 and 8. The registrant also is required

to conduct a 28–day inhalation toxicity

study, using the protocol for the existing

90–day inhalation toxicity study. The

results of this study will provide a basis

from which to determine more reliable

route-specific Margins of Exposure

(MOEs) for worker inhalation risks

rather than the less reliable route-toroute MOE calculations currently being

used.

V. Conclusion

Therefore, the tolerance is established

for combined residues of the herbicide

imazapic and its hydroxymethyl

metabolite, both free (CL 263284) and

conjugated (CL 189215) in or on the raw

agricultural commodities grass, forage at

30 ppm, and grass, hay at 15 ppm.

Tolerances are also established for the

combined residues of imazapic and its

free hydroxymethyl metabolite in or on

milk at 0.1 ppm; fat, meat, and meat

byproducts (except kidney) of cattle,

goats, horses, and sheep at 0.1 ppm; and

kidney of cattle, goats, horses, and

sheep at 1.0 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations which govern the

submission of objections and requests

for hearings appear in 40 CFR part 178.

Although the procedures in those

regulations require some modification to

reflect the amendments made to the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

Federal Register / Vol. 66, No. 247 / Wednesday, December 26, 2001 / Rules and Regulations 66331

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–301198 in the subject line

on the first page of your submission. All

requests must be in writing, and must be

mailed or delivered to the Hearing Clerk

on or before February 25, 2002.

1. Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(s) on which a hearing

is requested, the requestor’s contentions

on such issues, and a summary of any

evidence relied upon by the objector (40

CFR 178.27). Information submitted in

connection with an objection or hearing

request may be claimed confidential by

marking any part or all of that

information as CBI. Information so

marked will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the

information that does not contain CBI

must be submitted for inclusion in the

public record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, 1200 Pennsylvania

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

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. The Office of

the Hearing Clerk is open from 8 a.m.

to 4 p.m., Monday through Friday,

excluding legal holidays. The telephone

number for the Office of the Hearing

Clerk is (202) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

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

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

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

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by docket control

number OPP–301198, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

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

person or by courier, bring a copy to the

location of the PIRIB described in Unit

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

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

file format and avoid the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 6.1/8.0 or

ASCII file format. Do not include any

CBI in your electronic copy. You may

also submit an electronic copy of your

request at many Federal Depository

Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

VII. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). Because this rule has

been exempted from review under

Executive Order 12866 due to its lack of

significance, this rule is not subject to

Executive Order 13211, Actions

Concerning Regulations That

Significantly Affect Energy Supply,

Distribution, or Use (66 FR 28355, May

22, 2001). This final rule does not

contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Public

Law 104–4). Nor does it require any

special considerations under Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or OMB review or any Agency

action under Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

This action does not involve any

technical standards that would require

Agency consideration of voluntary

consensus standards pursuant to section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104–113, section

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

tolerances and exemptions that are

established on the basis of a petition

under FFDCA section 408(d), such as

the tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

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

seq.) do not apply. In addition, the

Agency has determined that this action

will not have a substantial direct effect

on States, on the relationship between

the national government and the States,

or on the distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

66332 Federal Register / Vol. 66, No. 247 / Wednesday, December 26, 2001 / Rules and Regulations

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

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

For these same reasons, the Agency has

determined that this rule does not have

any ‘‘tribal implications’’ as described

in Executive Order 13175, entitled

Consultation and Coordination with

Indian Tribal Governments (65 FR

67249, November 6, 2000). Executive

Order 13175, requires EPA to develop

an accountable process to ensure

‘‘meaningful and timely input by tribal

officials in the development of

regulatory policies that have tribal

implications.’’ ‘‘Policies that have tribal

implications’’ is defined in the

Executive Order to include regulations

that have ‘‘substantial direct effects on

one or more Indian tribes, on the

relationship between the Federal

government and the Indian tribes, or on

the distribution of power and

responsibilities between the Federal

government and Indian tribes.’’ This

rule will not have substantial direct

effects on tribal governments, on the

relationship between the Federal

government and Indian tribes, or on the

distribution of power and

responsibilities between the Federal

government and Indian tribes, as

specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.

VIII. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

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

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of this final

rule in the Federal Register. This final

rule is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: December 11, 2001.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

371.

2. Section 180.490 is amended by

revising paragraph (a) and removing and

reserving the text of paragraph (b) to

read as follows:

§ 180.490 Imazapic-ammonium; tolerances

for residues.

(a) General. (1) Tolerances are

established for combined residues of the

herbicide imazapic, (±)-2-[4,5-dihydro4-methyl-4-(1-methylethyl)-5-oxo-1Himidazol-2-yl]-5-methyl-3-

pyridinecarboxylic acid and its

metabolite (±)-2-[4,5-dihydro-4-methyl4-(1-methylethyl)-5-oxo-1H-imidazol-2-

yl]-5-hydroxymethyl-3-

pyridinecarboxylic acid, both free and

conjugated, in or on the following food

commodities:

Commodity Parts per million

Grass, forage ............................................................................................................................... 15

Grass, hay ................................................................................................................................... 30

Peanut nutmeat ........................................................................................................................... 0.1

(2) Tolerances are also established for

the combined residues of the herbicide

imazapic, (±)-2-[4,5-dihydro-4-methyl-4-

(1-methylethyl)-5-oxo-1H-imidazol-2-

yl]-5-methyl-3-pyridinecarboxylic acid

and its free metabolite (±)-2-[4,5-

dihydro-4-methyl-4-(1-methylethyl)-5-

oxo-1H-imidazol-2-yl]-5-

hydroxymethyl-3-pyridinecarboxylic

acid, in or on the following food

commodities:

Commodity Parts per million

Cattle, fat ..................................................................................................................................... 0.10

Cattle, kidney ............................................................................................................................... 1.0

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

Cattle, meat ................................................................................................................................. 0.1

Goats, fat ..................................................................................................................................... 0.1

Goats, kidney ............................................................................................................................... 1.0

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

Goats, meat ................................................................................................................................. 0.1

Horses, fat ................................................................................................................................... 0.1

Horses, kidney ............................................................................................................................. 1.0

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

Horses, meat ............................................................................................................................... 0.1

Milk ............................................................................................................................................... 0.1

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

Commodity Parts per million

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

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

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

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

(b) Section 18 emergency exemptions.

[Reserved]

* * * * *

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

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301200; FRL–6816–8]

RIN 2070–AB78

Halosulfuron-methyl; Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

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

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996.

DATES: This regulation is effective

December 26, 2001. Objections and

requests for hearings, identified by

docket control number OPP–301200,

must be received by EPA on or before

February 25, 2002.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301200 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Shaja R. Brothers, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave.,

NW.,Washington, DC 20460; telephone

number: (703) 308–3194; and e-mail

address: brothers.shaja@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’, ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301200. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

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

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

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

In the Federal Register of August 31,

2001 (66 FR 45993) (FRL–6796–1), EPA

issued a notice pursuant to section 408

of the Federal Food, Drug, and Cosmetic

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

amended by the Food Quality Protection

Act of 1996 (FQPA) (Public Law 104–

170) announcing the filing of a pesticide

petition (PP) for tolerance by the

Interregional Research Project Number 4

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

Brunswick, NJ 08902–3390. This notice

included a summary of the petition

prepared by Gowan Company, the

registrant. There were no comments

received in response to the notice of

filing.

The petition requested that 40 CFR

180.479 be amended by establishing a

tolerance for residues of the herbicide

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

dimethoxy-2-pyrimidinyl)

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

or on the melon subgroup-crop group

9A (includes citron melon, muskmelon,

and watermelon) at 0.1 part per million

(ppm).

Section 408(b)(2)(A)(i) of the FFDCA

allows EPA to establish a tolerance (the

legal limit for a pesticide chemical

residue in or on a food) only if EPA

determines that the tolerance is ‘‘safe.’’

Section 408(b)(2)(A)(ii) defines ‘‘safe’’ to

mean that ‘‘there is a reasonable

certainty that no harm will result from

aggregate exposure to the pesticide