66778 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations

Commodity Parts per million

Canola, seed ........................ 0.05

Vegetable, legume, group .... 0.05

(2) Tolerances are established for the

combined residues of the herbicide

imazamox, and its metabolite AC263284

[(±)2-[4,5-dihydro-4-methyl-4-(1-

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

(hydroxymethyl)-3-pyridinecarboxylic

acid in or on the raw agricultural

commodities:

Commodity Parts per million

Wheat, grain ......................... 0.30

Wheat, forage ....................... 0.30

Wheat, hay ........................... 0.30

Wheat, straw ......................... 0.20

Wheat, bran .......................... 1.0

Wheat, shorts ....................... 0.80

Wheat, germ ......................... 0.60

(3) Tolerances are established for the

combined residues of the herbicide

imazamox, and its metabolite AC263284

(free and conjugated), and AC312622,

[(±)-2-[4,5-dihydro-4-methyl-4-(1-

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

3,5-pyridinecarboxylic acid in or on the

raw agricultural commodities:

Commodity Parts per million

Alfalfa, seed .......................... 0.40

Alfalfa, forage ....................... 2.0

Alfalfa, hay ............................ 4.0

* * * * *

[FR Doc. 01–31799 Filed 12–26–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301197; FRL–6816–1]

RIN 2070–AB78

Halosulfuron-methyl; Pesticide

Tolerances for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

Halosulfuron-methyl in or on asparagus.

This action is in response to EPA’s

granting of an emergency exemption

under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA) authorizing use of the

pesticide on asparagus. This regulation

establishes a maximum permissible

level for residues of halosulfuronmethyl in this food commodity. The

tolerance will expire and is revoked on

December 31, 2003.

DATES: This regulation is effective

December 27, 2001. Objections and

requests for hearings, identified by

docket control number OPP–301197,

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 VII. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301197 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Meredith Laws, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–9366; and e-mail

address: laws.meredith@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by

this action if you are an agricultural

producer, food manufacturer, or

pesticide manufacturer. Potentially

affected categories and entities may

include, but are not limited to:

Categories NAICS

Codes

Examples of Potentially Affected

Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

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_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–301197. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Mall #2, 1921 Jefferson Davis

Hwy., Arlington, VA, from 8:30 a.m. to

4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

EPA, on its own initiative, in

accordance with sections 408(e) and

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

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

is establishing a tolerance for residues of

the herbicide halosulfuron-methyl,

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

pyrimidinyl)

amino]carbonylaminosulfonyl-3-chloro1-methyl-1H-pyrazole-4-carboxylate, in

or on asparagus at 2.0 parts per million

(ppm). This tolerance will expire and is

revoked on 12/31/03. EPA will publish

a document in the Federal Register to

remove the revoked tolerance from the

Code of Federal Regulations (CFR).

Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations 66779

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment. EPA does not intend for its

actions on section 18 related tolerances

to set binding precedents for the

application of section 408 and the new

safety standard to other tolerances and

exemptions. Section 408(e) of the

FFDCA allows EPA to establish a

tolerance or an exemption from the

requirement of a tolerance on its own

initiative, i.e., without having received

any petition from an outside party.

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

allows EPA to establish a tolerance (the

legal limit for a pesticide chemical

residue in or on a food) only if EPA

determines that the tolerance is ‘‘safe.’’

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

mean that ‘‘there is a reasonable

certainty that no harm will result from

aggregate exposure to the pesticide

chemical residue, including all

anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by the

Food Quality Protection Act (FQPA).

EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

III. Emergency Exemption for

Halosulfuron-methyl on Asparagus and

FFDCA Tolerances

Washington, Idaho and Oregon

requested the use of halosulfuronmethyl to control nutsedge infesting

asparagus fields. Michigan requested the

use of halosulfuron-methyl to control

nutsedge and pigweed infesting

asparagus fields. In the Pacific

Northwest nutsedge has spread

throughout the asparagus growing

region and has been declared a Class B

noxious weed in Washington.

Asparagus growers are especially

vulnerable to nutsedge because of the

difficulty in controlling a perennial

monocot weed in a perennial monocot

crop. The information provided by the

four applicant states indicates that

nutsedge is reducing asparagus yields

and reducing the life span of the crop.

EPA agrees that heavily infested fields

can have severe yield losses.

Additionally, EPA expects that yield

reductions in Michigan due to redroot

pigweed could be quite high due to

coverage of the crop during the harvest

period. EPA has authorized under

FIFRA section 18 the use of

halosulfuron-methyl on asparagus for

control of nutsedge in Washington,

Idaho, Oregon and Michigan and also

for control of pigweed in Michigan.

After having reviewed the submissions,

EPA concurs that emergency conditions

exist for these States.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

halosulfuron-methyl in or on asparagus.

In doing so, EPA considered the safety

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

and EPA decided that the necessary

tolerance under FFDCA section 408(l)(6)

would be consistent with the safety

standard and with FIFRA section 18.

Consistent with the need to move

quickly on the emergency exemption in

order to address an urgent non-routine

situation and to ensure that the resulting

food is safe and lawful, EPA is issuing

this tolerance without notice and

opportunity for public comment as

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

this tolerance will expire and is revoked

on December 31, 2003, under FFDCA

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

pesticide not in excess of the amounts

specified in the tolerance remaining in

or on asparagus after that date will not

be unlawful, provided the pesticide is

applied in a manner that was lawful

under FIFRA, and the residues do not

exceed a level that was authorized by

this tolerance at the time of that

application. EPA will take action to

revoke this tolerance earlier if any

experience with, scientific data on, or

other relevant information on this

pesticide indicate that the residues are

not safe.

Because this tolerance is being

approved under emergency conditions,

EPA has not made any decisions about

whether halosulfuron-methyl meets

EPA’s registration requirements for use

on asparagus or whether a permanent

tolerance for this use would be

appropriate. Under these circumstances,

EPA does not believe that this tolerance

serves as a basis for registration of

halosulfuron-methyl by a State for

special local needs under FIFRA section

24(c). Nor does this tolerance serve as

the basis for any State other than

Washington, Idaho, Oregon and

Michigan to use this pesticide on this

crop under section 18 of FIFRA without

following all provisions of EPA’s

regulations implementing section 18 as

identified in 40 CFR part 166. For

additional information regarding the

emergency exemption for halosulfuronmethyl, contact the Agency’s

Registration Division at the address

provided under FOR FURTHER

INFORMATION CONTACT.

IV. Aggregate Risk Assessment and

Determination of Safety

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. For

further discussion of the regulatory

requirements of section 408 and a

complete description of the risk

assessment process, see the final rule on

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997) (FRL–5754–

7).

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

EPA has reviewed the available

scientific data and other relevant

information in support of this action.

EPA has sufficient data to assess the

hazards of halosulfuron-methyl and to

make a determination on aggregate

exposure, consistent with section

408(b)(2), for a time-limited tolerance

for residues of halosulfuron-methyl in

or on asparagus at 2.0 ppm. EPA’s

assessment of the dietary exposures and

risks associated with establishing the

tolerance follows.

A. Toxicological Endpoints

The dose at which no adverse effects

are observed (the NOAEL) from the

toxicology study identified as

appropriate for use in risk assessment is

used to estimate the toxicological

endpoint. However, the lowest dose at

which adverse effects of concern are

identified (the LOAEL) is sometimes

used for risk assessment if no NOAEL

was achieved in the toxicology study

selected. An uncertainty factor (UF) is

applied to reflect uncertainties inherent

in the extrapolation from laboratory

animal data to humans and in the

variations in sensitivity among members

of the human population as well as

other unknowns. An UF of 100 is

routinely used, 10X to account for

interspecies differences and 10X for

intraspecies differences.

For dietary risk assessment (other

than cancer) the Agency uses the UF to

calculate an acute or chronic reference

66780 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations

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 facto is

retained due to concerns unique to the

FQPA, this additional factor is applied

to the RfD by dividing the RfD by such

additional factor. The acute or chronic

Population Adjusted Dose (aPAD or

cPAD) is a modification of the RfD to

accommodate this type of FQPA Safety

Factor.

For non-dietary risk assessments

(other than cancer) the UF is used to

determine the level of concern (LOC).

For example, when 100 is the

appropriate UF (10X to account for

interspecies differences and 10X for

intraspecies differences) the LOC is 100.

To estimate risk, a ratio of the NOAEL

to exposures (margin of exposure (MOE)

= NOAEL/exposure) is calculated and

compared to the LOC.

The linear default risk methodology

(Q*) is the primary method currently

used by the Agency to quantify

carcinogenic risk. The Q* approach

assumes that any amount of exposure

will lead to some degree of cancer risk.

A Q* is calculated and used to estimate

risk which represents a probability of

occurrence of additional cancer cases

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

in a million). Under certain specific

circumstances, MOE calculations will

be used for the carcinogenic risk

assessment. In this non-linear approach,

a ‘‘point of departure’’ is identified

below which carcinogenic effects are

not expected. The point of departure is

typically a NOAEL based on an

endpoint related to cancer effects

though it may be a different value

derived from the dose response curve.

To estimate risk, a ratio of the point of

departure to exposure (MOEcancer = point

of departure/exposures) is calculated. A

summary of the toxicological endpoints

for halosulfuron-methyl used for human

risk assessment is shown in the

following Table 1:

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR HALOSULFURON-METHYL FOR USE IN HUMAN RISK

ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, UF

FQPA SF* and Level of

Concern for Risk AssessmentStudy and Toxicological Effects

Acute dietary

(Females 13+, Infants and Children)

NOAEL = 50 mg/kg/day

UF = 100

Acute RfD = 0.5 mg/kg/

day

FQPA SF = 1x

aPAD = acute RfD ÷

FQPA SF

= 0.5 mg/kg/day

Developmental - rabbit

LOAEL = 150 mg/kg/day based on decreased

mean litter size, increased resorptions, and increased postimplantation loss.

Acute dietary

(Adult male)

None No appropriate endpoint

was selected

A dose and endpoint was not identified for this

subpopulation since there were no toxicological effects applicable to adult males and

attributable to a single exposure (dose) observed in oral toxicity studies including the developmental toxicity studies in rats and rabbits.

Chronic dietary

all populations

NOAEL= 10 mg/kg/day

UF = 100

Chronic RfD =

0.1 mg/kg/day

FQPA SF = 1x

cPAD =

chronic RfD ÷ FQPA SF

= 0.1 mg/kg/day

Chronic toxicity - dog

LOAEL = 40 mg/kg/day based on decrease in

body weight gain and alterations in hematology and clinical chemistry parameters

Short-term dermal (1 to 7 days)

(Residential)

Oral study NOAEL=

50 mg/kg/day (dermal

absorption rate =

75%)

LOC for MOE =

100 (Residential)

Developmental - rabbit

LOAEL = 150 mg/kg/day based on decreased

mean litter size, increased resorptions, and increased postimplantation loss

Intermediate-term dermal (1 week to

several months)

(Residential)

Oral study NOAEL=

10 mg/kg/day (dermal

absorption rate = 75%

LOC for MOE =

100 (Residential)

Chronic toxicity - dog

LOAEL = 40 mg/kg/day based on decrease in

body weight gain during weeks 0–13

Long-term dermal (several months to

lifetime)

(Residential)

Oral study NOAEL=

10 mg/kg/day (dermal

absorption rate = 75%

when appropriate)

LOC for MOE =

100 (Residential)

Chronic toxicity - dog

LOAEL = 40 mg/kg/day based on decrease in

body weight gain and alterations inhematology

and clinical chemistry parameters

Inhalation (any time period)

(Residential)

None - Low toxicity and use pattern do not indicate a

need for risk assessment for this route.

Cancer (oral, dermal, inhalation) - - Classified as a ‘‘Not-likely’’ human carcinogen

based on the lack of evidence of carcinogenicity in male and female mice and rats.

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

B. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.479) for the

residues of halosulfuron-methyl, in or

on a variety of raw agricultural

commodities. The established tolerances

include tree nuts (crop group 14);

sugarcane; corn rice and cotton, and

their associated commodities.

Additionally, tolerances are established

for residues of halosulfuron-methyl and

its metabolites determined as 3-chloro1-methyl-5-sulfamoylpyrazole-4-

carboxylic acid (also referred to as CSA,

expressed as parent equivalents) in/on

meat by-products of cattle, goats, hogs,

horses and sheep. Risk assessments

were conducted by EPA to assess

dietary exposures from halosulfuronmethyl in food as follows:

Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations 66781

i. Acute exposure. Acute dietary risk

assessments are performed for a fooduse pesticide if a toxicological study has

indicated the possibility of an effect of

concern occurring as a result of a one

day or single exposure. The Dietary

Exposure Evaluation Model (DEEM)

analysis evaluated the individual food

consumption as reported by

respondents in the USDA 1989–1992

nationwide Continuing Surveys of Food

Intake by Individuals (CSFII) and

accumulated exposure to the chemical

for each commodity. The following

assumptions were made for the acute

exposure assessments: A Tier 1 acute

dietary exposure analysis was

conducted. The assumptions of the Tier

1 analysis were tolerance level residues

and 100 percent crop-treated for all

commodities for which halosulfuronmethyl tolerances are established and

for the section 18 subject crop

(asparagus). Percent crop treated and

anticipated residues were not used.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment the

DEEM analysis evaluated the

individual food consumption as

reported by respondents in the USDA

1989–1992 nationwide CSFII and

accumulated exposure to the chemical

for each commodity. The following

assumptions were made for the chronic

exposure assessments: A Tier 1 chronic

dietary exposure analysis was

conducted. The assumptions of this Tier

1 analysis were tolerance level residues

and 100 percent crop-treated for all

commodities for which halosulfuronmethyl tolerances are established and

for the subject section 18 crop

(asparagus). Percent crop treated and

anticipated residues were not used.

iii. Cancer. There is no evidence of

carcinogenicity for halosulfuron-methyl

in the mouse or rat. EPA has classified

halosulfuron-methyl as a ‘‘Not-Likely’’

human carcinogen.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

halosulfuron-methyl in drinking water.

Because the Agency does not have

comprehensive monitoring data,

drinking water concentration estimates

are made by reliance on simulation or

modeling taking into account data on

the physical characteristics of

halosulfuron-methyl.

The Agency uses the 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 concentration in ground

water (SCI-GROW) model is used to

predict pesticide concentrations in

shallow ground water. For a screeninglevel assessment for surface water EPA

will generally 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 halosulfuronmethyl they are further discussed in the

aggregate risk sections below.

Based on the FIRST and SCI-GROW

models the EECs of halosulfuron-methyl

for acute exposures are estimated to be

5.39 parts per billion (ppb) for surface

water and 0.049 ppb for ground water.

The EECs for chronic exposures based

on FIRST and SCI-GROW models are

estimated to be 0.245 ppb for surface

water and 0.049 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).

Halosulfuron-methyl is currently

registered for use on the following

residential non-dietary sites: Residential

turf. The risk assessment was conducted

using the following exposure

assumptions: Halosulfuron-methyl

(trade name: ‘‘Manage’’) is a

sulfonylurea herbicide used for control

of broadleaf weeds and nutsedge.

Manage may be broadcast applied at a

rate of 0.031 to 0.062 lb ai/acre. For

residential handlers and postapplication

activities, short-term to intermediateterm exposures may occur. Chronic

exposures (greater than or equal to 6

months of continuous exposure) are not

expected. Adults may be dermally

exposed after treatment to lawns, and

children may be exposed through

dermal, hand-to-mouth and incidental

oral sources.

4. Cumulative exposure to substances

with a common mechanism of toxicity.

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

EPA does not have, at this time,

available data to determine whether

halosulfuron-methyl has a common

mechanism of toxicity with other

substances or how to include this

pesticide in a cumulative risk

assessment. Unlike other pesticides for

which EPA has followed a cumulative

risk approach based on a common

mechanism of toxicity, halosulfuronmethyl does not appear to produce a

toxic metabolite produced by other

substances. For the purposes of this

tolerance action, therefore, EPA has not

assumed that halosulfuron-methyl has a

common mechanism of toxicity with

other substances. For information

regarding EPA’s efforts to determine

which chemicals have a common

mechanism of toxicity and to evaluate

the cumulative effects of such

chemicals, see the final rule for

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997).

C. 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

66782 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations

calculating a dose level that poses no

appreciable risk to humans.

2. Developmental toxicity studies. In a

prenatal developmental toxicity study

in rats, the NOAEL for maternal toxicity

was 250 mg/kg/day and the LOAEL was

750 mg/kg/day based on increased

incidence of clinical observations

(primarily alopecia and urine stains)

and reduced body weight gains, food

consumption, and food efficiency. For

developmental toxicity, the NOAEL was

250 mg/kg/day and the LOAEL was 750

mg/kg/day based on decreased mean

litter size, increased number of

resorptions (total and per litter),

significantly decreased mean fetal body

weight, and increases in fetal and litter

incidences of soft tissue (primarily

dilation of the lateral ventricles and

other anomalies in the development of

the fetal nervous system) and skeletal

variations (anomalies or delays in

ossification in the thoracic vertebrae,

sternebrae, and ribs). EPA noted that

both the fetal and litter incidences of

dilated lateral ventricles of the brain

were statistically significant, and

appeared to be dose related, since the

finding was also observed at the middose in 2 fetuses of 2 litters. Due to the

lack of historical control data, it was not

possible to evaluate the biological

significance of the low incidence of this

finding at the mid-dose level. EPA

recommends that the study

developmental NOAEL and LOAEL as

defined by the data evaluation record

not be revised at this time.

In a prenatal developmental toxicity

study in the rabbit, the NOAEL for

maternal toxicity was 50 mg/kg/day and

the LOAEL was 150 mg/kg/day based on

decreased body weight gain, food

consumption, and food efficiency. For

developmental toxicity, the NOAEL was

50 mg/kg/day and the LOAEL was 150

mg/kg/day based on decreased mean

litter size, increased number of

resorptions (total and per dam) and

increased postimplantation loss. EPA

notes that these developmental findings,

while not statistically significant, define

a consistent pattern of effect. The

developmental NOAEL is 50 mg/kg/day

based on decreased mean litter size,

increased number of resorptions (total

and per dam) and increased

postimplantation loss at 150 mg/kg/day

(LOAEL). EPA recommends that this

dose and effect be used for assessing

acute dietary risks for the subpopulations, Females 13+ as well as

Infants and Children. Although the

endpoint is developmental toxicity

occurring in utero, and thus may not be

suitable for use in risk assessment for

Infants and Children, EPA determined

that it is appropriate to use for this

subpopulation (infants and children)

because there is evidence of alteration to

the development of the fetal nervous

system in the developmental study in

rats (see above). Thus, EPA determined

that potential effects on functional

development mandate the use of this

endpoint for females of child bearing

age (Females 13+) as well as for infants

and children. This endpoint is not

applicable for adult males. A dose and

endpoint was not identified for this

subpopulation since there were no

toxicological effects applicable to adult

males and attributable to a single

exposure (dose) observed in oral toxicity

studies including the developmental

toxicity studies in rats and rabbits.

3. Reproductive toxicity study. In the

2-generation reproduction study in rats,

effects in the offspring were observed

only at or above treatment levels which

resulted in evidence of parental toxicity.

4. Prenatal and postnatal sensitivity.

There was no evidence of increased

susceptibility of rats or rabbits to in

utero and/or postnatal exposure to

halosulfuron-methyl. In the prenatal

developmental toxicity studies in rats

and rabbits and the 2-generation

reproduction study in rats, effects in the

offspring were observed only at or above

treatment levels which resulted in

evidence of parental toxicity.

5. Conclusion. There is a complete

toxicity data base for halosufuronmethyl and exposure data are complete

or are estimated based on data that

reasonably accounts for potential

exposures. EPA determined that the 10X

safety factor to protect infants and

children should be removed. The FQPA

factor is removed because there was no

indication of increased susceptibility of

rats or rabbits to in utero and/or

postnatal exposure to halosulfuronmethyl. In the prenatal developmental

toxicity studies in rats and rabbits and

the 2-generation reproduction study in

rats, effects in the offspring were

observed only at or above treatment

levels which resulted in evidence of

parental toxicity. EPA determined that

the requirement of a developmental

neurotoxicity study in rats did not

warrant an application of additional

safety factors because: (a) The

alterations in the fetal nervous system

occurred in only one species (in rats and

not in rabbits); (b) the fetal effects which

will be investigated in the required

developmental neurotoxicity study were

seen only at a dose of 750 mg/kg/day

which is close to the Limit-Dose (1,000

mg/kg/day); (c) there was no evidence of

clinical signs of neurotoxicity, brain

weight changes, or neuropathology in

the subchronic or chronic studies in

rats; (d) the developmental

neurotoxicity study is required only as

confirmatory data to understand what

the effect is at a high exposure (dose)

level.

D. Aggregate Risks and Determination of

Safety

To estimate total aggregate exposure

to a pesticide from food, drinking water,

and residential uses, the Agency

calculates DWLOCs which are used as a

point of comparison against the model

estimates of a pesticide’s concentration

in water (EECs). DWLOC values are not

regulatory standards for drinking water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food and residential

uses. In calculating a DWLOC, the

Agency determines how much of the

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

available for exposure through drinking

water e.g., allowable chronic water

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

food + chronic non-dietary, nonoccupational exposure). This allowable

exposure through drinking water is used

to calculate a DWLOC.

A DWLOC will vary depending on the

toxic endpoint, drinking water

consumption, and body weights. Default

body weights and consumption values

as used by the USEPA Office of Water

are used to calculate DWLOCs: 2L/70 kg

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

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

weights and drinking water

consumption values vary on an

individual basis. This variation will be

taken into account in more refined

screening-level and quantitative

drinking water exposure assessments.

Different populations will have different

DWLOCs. Generally, a DWLOC is

calculated for each type of risk

assessment used: acute, short-term,

intermediate-term, chronic, and cancer.

When EECs for surface water and

groundwater are less than the calculated

DWLOCs, EPA concludes with

reasonable certainty that exposures to

halosulfuron-methyl in drinking water

(when considered along with other

sources of exposure for which EPA has

reliable data) would not result in

unacceptable levels of aggregate human

health risk at this time. Because EPA

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, EPA will

reassess the potential impacts of

halosulfuron-methyl on drinking water

as a part of the aggregate risk assessment

process.

Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations 66783

1. Acute risk. Using the exposure

assumptions discussed in this unit for

acute exposure, the acute dietary

exposure from food to halosulfuronmethyl will occupy < 1.0% of the aPAD

for females 13 years and older, 1.0% of

the aPAD for All Infants, < 1 year old

and < 1.0% of the aPAD for Children, 1–

6 years old. In addition, despite the

potential for acute dietary exposure to

halosulfuron-methyl in drinking water,

after calculating DWLOCs and

comparing them to conservative model

EECs of halosulfuron-methyl in surface

and ground water, EPA does not expect

the aggregate exposure to exceed 100%

of the aPAD, as shown in the following

Table 2:

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

Population Subgroup aPAD (mg/

kg)

% aPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Acute

DWLOC

(ppb)

All infants ............................................................................................. 0.50 1.0 5.39 0.049 5,000

Females, 13–50 years ......................................................................... 0.50 <1.0 5.39 0.049 15,000

Children, 1–6 years .............................................................................. 0.50 <1.0 5.39 0.049 5,000

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to halosulfuron-methyl

from food will utilize < 1.0% of the

cPAD for the U.S. population, < 1.0% of

the cPAD for All infants, < 1 year old

and < 1.0% of the cPAD for Children, 1–

6 years old. Based on the use pattern,

chronic residential exposure to residues

of halosulfuron-methyl is not expected.

In addition, despite the potential for

chronic dietary exposure to

halosulfuron-methyl in drinking water,

after calculating DWLOCs and

comparing them to conservative model

estimated environmental concentrations

of halosulfuron-methyl in surface and

ground water, EPA does not expect the

aggregate exposure to exceed 100% of

the cPAD, as shown in the following

Table 3:

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

Population Subgroup cPAD mg/

kg/day

% cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. Population .................................................................................... 0.10 < 1.0 0.245 0.049 3,500

All Infants ............................................................................................. 0.10 < 1.0 0.245 0.049 990

Children, 1–6 years .............................................................................. 0.10 < 1.0 0.245 0.049 1,000

Females, 13–50 years ......................................................................... 0.10 < 1.0 0.245 0.049 3,000

3. Short-term risk. Short-term

aggregate exposure takes into account

residential exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Halosulfuron-methyl is currently

registered for use(s) that could result in

short-term residential exposure and the

Agency has determined that it is

appropriate to aggregate chronic food

and water and short-term exposures for

halosulfuron-methyl. EPA concludes

with reasonable certainty that residues

of halosulfuron-methyl in drinking

water will not contribute significantly to

the short-term aggregate human health

risk and that the short-term aggregate

exposure from halosulfuron-methyl

residues in food and drinking water will

not exceed the Agency’s level of

concern (MOE ≤ 100) for short-term

aggregate exposure by any population

subgroup.

Using the exposure assumptions

described in this unit for short-term

exposures, EPA has concluded that food

and residential exposures aggregated

result in aggregate MOEs of 2,200 for

females and 2,900 for children. These

aggregate MOEs do not exceed the

Agency’s level of concern for aggregate

exposure to food and residential uses.

Short-term dermal MOEs for residential

handlers are all above 100 and do not

exceed EPA’s level of concern. Nonoccupational postapplication risk was

estimated for adults and children.Risk

estimates for all residential exposure

scenarios and time periods result in

MOEs that are 100 or greater, and

therefore do not exceed EPA’s level of

concern. In addition, short-term

DWLOCs were calculated and compared

to the EECs for chronic exposure of

halosulfuron-methyl in ground water

and surface water. After calculating

DWLOCs and comparing them to the

EECs for surface and ground water, EPA

does not expect short-term aggregate

exposure to exceed the Agency’s level of

concern, as shown in the following

Table 4:

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

Population Subgroup

Aggregate

MOE (Food

+ Residential)

Aggregate

Level of

Concern

(LOC)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Short-Term

DWLOC

(ppb)

Females ............................................................................................... 2,200 100 0.245 0.049 14,000

Children ................................................................................................ 2,900 100 0.245 0.049 4,800

4. Intermediate-term risk.

Intermediate-term aggregate exposure

takes into account non-dietary, nonoccupational exposure plus chronicexposure to food and water (considered

to be a background exposure level).

66784 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations

Halosulfuron-methyl is currently

registered for use(s) that could result in

intermediate-term residential exposure

and the Agency has determined that it

is appropriate to aggregate chronic food

and water and intermediate-term

exposures for halosulfuron-methyl.

Using the exposure assumptions

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

food and residential exposures

aggregated result in aggregate MOEs of

1,700 for females, 2,000 for males, and

1,000 for children. These aggregate

MOEs do not exceed the Agency’s level

of concern for aggregate exposure to

food and residential uses. In addition,

intermediate-term DWLOCs were

calculated and compared to the EECs for

chronic exposure of halosulfuronmethyl in ground water and surface

water. After calculating DWLOCs and

comparing them to the EECs for surface

and ground water, EPA does not expect

intermediate-term aggregate exposure to

exceed the Agency’s level of concern, as

shown in the following Table 5:

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

Population Subgroup

Aggregate

MOE (Food

+ Residential)

Aggregate

Level of

Concern

(LOC)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

IntermediateTerm

DWLOC

(ppb)

Females ............................................................................................... 1,700 100 0.245 0.049 2,800

Males .................................................................................................... 2,000 100 0.245 0.049 3,300

Children ................................................................................................ 1,000 100 0.245 0.049 900

5. Aggregate cancer risk for U.S.

population. Halosulfuron-methyl is

classified as a ‘‘not likely’’ human

carcinogen based on a lack of evidence

of carcinogenicity in male and female

mice and rats. A cancer risk assessment

is not required.

6. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to the general

population, and to infants and children

from aggregate exposure to

halosulfuron-methyl residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Analytical enforcement methodology

for the determination of halosulfuronmethyl in various plant commodities

has been sent to the Food and Drug

Administration for publication in the

Pesticide Analytical Methods, Volume II

(PAM II). Quantitation of residues is by

gas chromotography with nitrogen

specific detection (GC/TSD).

B. International Residue Limits

There are no Codex, Canadian, or

Mexican maximum residue limits for

halosulfuron-methyl in/on asparagus.

Therefore, harmonization is not an

issue.

VI. Conclusion

Therefore, the tolerance is established

for residues of halosulfuron-methyl,

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

pyrimidinyl)

amino]carbonylaminosulfonyl-3-chloro1-methyl-1H- pyrazole-4-carboxylate in

or on asparagus at 2.0 ppm.

VII. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations which govern the

submission of objections and requests

for hearings appear in 40 CFR part 178.

Although the procedures in those

regulations require some modification to

reflect the amendments made to the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) provides

essentially the same process for persons

to ‘‘object’’ to a regulation for an

exemption from the requirement of a

tolerance issued by EPA under new

section 408(d), as was provided in the

old FFDCA sections 408 and 409.

However, the period for filing objections

is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an

Objection or Request a Hearing?

You must file your objection or

request a hearing on this regulation in

accordance with the instructions

provided in this unit and in 40 CFR part

178. To ensure proper receipt by EPA,

you must identify docket control

number OPP–301197 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

Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations 66785

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

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

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by the docket control

number OPP–301197, 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).

VIII. Regulatory Assessment

Requirements

This final rule establishes a time

limited tolerance under FFDCA section

408. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). 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 FIFRA

section 18 exemption under FFDCA

section 408, such as the tolerance in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply. In

addition, the Agency has determined

that this action will not have a

substantial direct effect on States, on the

relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

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

For these same reasons, the Agency has

determined that this rule does not have

any ‘‘tribal implications’’ as described

in Executive Order 13175, entitled

Consultation and Coordination with

Indian Tribal Governments (65 FR

67249, November 6, 2000). Executive

Order 13175, requires EPA to develop

an accountable process to ensure

‘‘meaningful and timely input by tribal

officials in the development of

regulatory policies that have tribal

implications.’’ ‘‘Policies that have tribal

implications’’ is defined in the

Executive Order to include regulations

that have ‘‘substantial direct effects on

one or more Indian tribes, on the

relationship between the Federal

government and the Indian tribes, or on

the distribution of power and

responsibilities between the Federal

government and Indian tribes.’’ This

rule will not have substantial direct

effects on tribal governments, on the

relationship between the Federal

government and Indian tribes, or on the

distribution of power and

responsibilities between the Federal

government and Indian tribes, as

specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.

IX. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

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

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of this final

rule in the Federal Register. This final

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

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

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

66786 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations

Dated: December 14, 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 180.479 is amended by

adding text to paragraph (b) to read as

follows:

§ 180.479 Halosulfuron; tolerances for

residues.

* * * * *

(b) Section 18 emergency exemptions.

A time-limited tolerance is established

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

dimethoxy-2-pyrimidinyl)amino]

carbonylaminosulfonyl-3-chloro-1-

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

on asparagus in connection with use of

the pesticide under a section 18

exemption granted by EPA. The timelimited tolerance will expire on the date

specified in the following table.

Commodity Parts per million Expiration/revocation date

Asparagus .................................................................................................................................................... 2.0 12/31/03

* * * * *

[FR Doc. 01–31800 Filed 12–26–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301180; FRL–6804–1]

RIN 2070–AB78

Pymetrozine; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for residues of pymetrozine

1,2,4-triazin-3(2H)-one,4,5-dihydro-6-

methyl-4-[(3-pyridinylmethylene)

amino] in or on cotton seed, undelinted

at 0.3 parts per million (ppm); cotton

gin byproducts at 2.0 ppm; fruiting

vegetables at 0.2 ppm; cucurbit

vegetables at 0.1 ppm; leafy vegetables

(except Brassica) at 0.6 ppm; head and

stem Brassica vegetables at 0.5 ppm;

leafy Brassica and turnip greens at 0.25

ppm; hops (dried) at 6.0 ppm; and

pecans at 0.02 ppm. Syngenta Crop

Protection requested these tolerances

under the Federal Food, Drug, and

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996.

DATES: This regulation is effective

December 27, 2001. Objections and

requests for hearings, identified by

docket control number OPP–301180,

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–301180 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Daniel Peacock, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 305–5407; and e-mail

address: peacock.dan@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

theFederal 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_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–301180. 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 19,

2001 (66 FR 37677–37681 (FRL–6793–

9), EPA issued a notice pursuant to

section 408 of the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.