58424 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

under FFDCA section 408(d), such as

the tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

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

seq.) do not apply. In addition, the

Agency has determined that this action

will not have a substantial direct effect

on States, on the relationship between

the national government and the States,

or on the distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

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

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: September 21, 2000.

Susan B. Hazen,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

371.

2. Section 180.564 is added to read as

follows:

§ 180.564 Indoxacarb; tolerances for

residues.

(a) General. Tolerances are

established for the combined residues of

the insecticide indoxacarb [(S)-methyl

7-chloro-2,5-dihydro-2-

[[(methoxycarbonyl)[4-

(trifluoromethoxy)phenyl]

amino]carbonyl]indeno[1,2-

e][1,3,4]oxadiazine-4a(3H)-carboxylate]

and its R-enantimomer [(R)-methyl 7-

chloro-2,5-dihydro-2-

[[(methoxycarbonyl)[4-

(trifluoromethoxy)phenyl]amino]

carbonyl]indeno[1,2-e][1,3,4]oxadiazine4a(3H)-carboxylate] in or on the

following raw agricultural commodities:

Commodity Parts per

million

Apple ......................................... 1.0

Apple, wet pomace ................... 3.0

Brassica, head and stem, subgroup ..................................... 5.0

Cattle, goat, horse, sheep and

hog fat ................................... 0.75

Cattle, goat, horse, sheep and

hog meat ............................... 0.03

Cattle, goat, horse, sheep and

hog meat byproducts ............ 0.02

Corn, sweet, forage .................. 10

Corn, sweet, kernel plus cob

with husk removed ................ 0.02

Corn, sweet, stover .................. 15

Cotton gin byproducts .............. 15

Cotton, undelinted seed ........... 2.0

Lettuce, head ............................ 4.0

Lettuce, leaf .............................. 10

Milk ........................................... 0.10

Milk fat ...................................... 3.0

Pear .......................................... 0.20

Vegetables, fruiting, group ....... 0.50

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 00–25052 Filed 9–28–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301058; FRL–6746–2]

RIN 2070–AB78

Halosulfuron–methyl; Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for residues of halosulfuron–

methyl in or on the squash/cucumber

subgroup. The Interregional Research

Project 4 (IR–4) 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

September 29, 2000. Objections and

requests for hearings,identified by

docket control number OPP–301058,

must be received by EPA on or before

November 28, 2000.

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–301058 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT By

mail: Sidney Jackson, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave.,

NW.,Washington, DC 20460; telephone

number: (703) 305–7610; and e-mail

address: jackson.sidney@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

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58425

Categories NAICS codes

Examples of potentially affected

entities

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/. To access the

OPPTS Harmonized Guidelines

referenced in the 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–301058. 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 23,

2000 (65 FR 51314) (FRL–6738–9), 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 (0E6085) for tolerance by IR–4,

681 U.S. Highway 1 South, North

Brunswick, New Jersey 08902–3390.

This notice included a summary of the

petition prepared by Monsanto

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)amino

carbonylaminosulfonyl-3-chloro-1-

methyl-1H-pyrazole-4-carboxylate, and

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

carboxylic acid, in or on the squash/

cucumber subgroup at 0.5 parts 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

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

November 26, 1997 (62 FR 62961) (FRL–

5754–7).

III. Aggregate Risk Assessment and

Determination of Safety

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

EPA has reviewed the available

scientific data and other relevant

information in support of this action.

EPA has sufficient data to assess the

hazards of and to make a determination

on aggregate exposure, consistent with

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

residues of halosulfuron-methyl on

squash/cucumber subgroup at 0.5 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 halosulfuronmethyl 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. Acute toxicological studies

placed the technical–grade

halosulfuron-methyl in Toxicity

Category III for acute dermal toxicity

and in Category IV for all other types of

acute toxicity.

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study type Results

870.3100 90–day oral toxicity rodents NOAEL = 116 males/147 females milligrams/

kilograms/day (mg/kg/day)

58426 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

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

Guideline No. Study type Results

LOAEL = 497 males/640 females mg/kg/day

based on decreased body weight gain, decreased absolute weights of adrenal, liver,

thymus, heart, and kidneys, decreased cholesterol, bilirubin, total protein, albumin, and

calcium; increases in MCH, ALT, and creatinine; and vacuolated livers and pigmented

kidney tubules.

870.3200 21/28–day dermal toxicity (rats) NOAEL = 100 (males), 1,000 (females) mg/kg/

day

LOAEL = 1,000/>1,000 mg/kg/day male/female (M/F) based on dose–related decrease in total body weight gain in males.

870.3700a Prenatal developmental in rodents (rat) Maternal NOAEL = 250 mg/kg/day

Maternal LOAEL = 750 mg/kg/day (increased

incidence of clinical observations; and reduced body weight gains, food consumption, and food efficiency)

Developmental NOAEL= 250 mg/kg/day

Developmental LOAEL = 750 mg/kg/day (decreased mean litter size, increased number

of resorptions, decreased mean fetal body

weight, increases in fetal and litter

incidences of dilation of the lateral ventricles

and other anomalies in the development of

the fetal nervous system, and skeletal variations such as anomalies or delays in ossification in the thoracic vertebrae, sternebrae,

and ribs)

870.3700b Prenatal developmental in nonrodents (rabbit) Maternal NOAEL = 50 mg/kg/day

Maternal LOAEL = 150 mg/kg/day (decreased

body weight gain, food consumption, and

food efficiency)

Developmental NOAEL= 50 mg/kg/day

Developmental LOAEL = 150 mg/kg/day (decreased mean litter size, increased number

of resorptions and increased post implantation loss)

870.3800 Reproduction and fertility effects Parental/Systemic NOAEL = 50.5 / 58.7 mg/

kg/day M/F

Parental/Systemic LOAEL = 223.2 / 261.4 mg/

kg/day M/F - reductions in body weight,

body weight gains, and food consumption

during the premating period in both sexes)

Offspring NOAEL > 261.4 mg/kg/day highest

dose tested (HDT).

870.4100b Chronic toxicity dogs NOAEL (systemic) = 10 mg/kg/day

LOAEL (systemic) = 40 mg/kg/day (decreased

body weight gains and changes in

hematological and blood chemistry parameters in females)

870.4200 Carcinogenicity mice NOAEL (systemic) = 410 / 1214.6 mg/kg/day

M/F

LOAEL (systemic) = 971.9 / 1214.6 mg/kg/day

M/F - decreased mean body weight in

males, increased incidence of microconcentration/mineralization in the testis and

epididymides) No evidence of carcinogenicity

870.4300 Combined toxicity/carcinogenicity rats NOAEL (systemic) = 108.3 / 56.4 mg/kg/day

M/F

LOAEL (systemic) = 225.2 / 138.6 mg/kg/day

M/F - marginal decreases in body weight

gains) No evidence of carcinogenicity

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58427

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

Guideline No. Study type Results

870.7485 Metabolism and pharmacokinetics Radiolabelled technical was administered to 5

rats/sex/group as a single low–dose (5 mg/

kg), single high–dose (250 mg/kg), or repeated low–dose (5 mg/kg/day x 14 days).

Absorption was rapid, incomplete sic, and

similar in both sexes. Elimination was via

urine and feces within 72 hours, and appeared to be independent of dose and sex.

Desmethyl halosulfuron-methyl and its 5–

hydroxy derivative were the major urinary

and fecal metabolites.

Genotoxicity Bacterial/mammalian microsomal mutagenicity

assays were performed and halosulfuronmethyl was found not to be mutagenic. Two

mutagenicity studies were performed to test

gene mutation and found to produce no

chromosomal aberrations or gene mutations

in cultured Chinese hamster ovary cells. An

in vivo mouse micronucleus assay did not

cause a significant increase in the frequency of micronucleated polychromatic

erythrocytes in bone marrow cells. A mutagenicity study was performed on rats and

found not to induce unscheduled DNA synthesis in primary rat hepatocytes.

Endocrine disruption No specific tests have been conducted with

halosulfuron-methyl to determine whether

the chemical may have an effect in humans

that is similar to an effect produced by a

naturally occurring estrogen or other endocrine effects. However, there were no significant findings in other relevant toxicity

tests, i.e., teratology and multi- generation

reproduction studies, which would suggest

that halosulfuron-methyl produces effects

characteristic of the disruption of the estrogenic hormone.

B. Toxicological Endpoints

The dose at which verved (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 intra species

differences.

For dietary risk assessment (other

than cancer) the Agency uses the UF to

calculate an acute or chronic reference

dose (acute RfD or chronic RfD) where

the RfD is equal to the NOAEL divided

by the appropriate UF (RfD=NOAEL/

UF). Where an additional safety factor is

retained due to concerns unique to the

FQPA, this additional factor is applied

to the RfD by dividing the RfD by such

additional factor. The acute or chronic

Population Adjusted Dose (aPAD or

cPAD) is a modification of the RfD to

accommodate this type of FQPA Safety

Factor.

For non–dietary risk assessments

(other than cancer) the UF is used to

determine the 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 2:

58428 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSES 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 assessment Study and toxicological effects

Acute dietary females 13-50 years

of age, 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 and

increases in resorptions and

post–implantation loss.

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 bodyweight gain

and alterations in hematology and clinical chemistry

parameters.

Short–term dermal (1 to 7 days)

(Residential)

oral 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

and increases in resorptions,

and post- implantation loss.

Interme diate–term dermal (1 week

to several months) (Residential)

oral 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 bodyweight gain

and alterations in hematology and clinical chemistry

parameters.

Long–term dermal (several months

to lifetime) (Residential)

oral NOAEL= 10 mg/kg/day (dermal absorption rate = 75%LOC for MOE = 100 (Residential) Chronic toxicity - dog LOAEL =

40 mg/kg/day based on decreased body weight gain

and alterations in hematology and clinical chemistry

parameters.

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

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.479) for the

residues of halosulfuron-methyl, in or

on various raw agricultural commodities

(RACs) with tolerances ranging from

0.05 to 0.8 ppm. Halosulfuron-methyl is

currently registered on a variety of use

sites, including agricultural crops and

residential lawns. Tolerances have been

established for plant and animal RACs

including field corn at 0.05 ppm, grain

sorghum (milo) at 0.05 ppm, sweet corn

(kernel + cobs with husks removed) at

0.05 ppm, pop corn grain at 0.05 ppm,

sugarcane cane at 0.05 ppm, tree nuts

nutmeat at 0.05 ppm, pistachio nuts

nutmeat at 0.05 ppm, cotton undelinted

seed at 0.05 ppm, and rice grain at 0.05

ppm; and secondary tolerances in meat

and meat by–products at 0.1 ppm

(cattle, goats, hogs, horses, and sheep).

Tolerances are established for indirect

or inadvertent residues of halosulfuronmethyl ranging from 0.1 to 0.5 ppm in

or on certain soybean and wheat RACs

when present therein as a result of the

application of halosulfuron-methyl to

growing crops. Indirect or inadvertent

tolerances including soybean forage at

0.5 ppm, soybean hay at 0.5 ppm,

soybean seed at 0.5 ppm, wheat forage

at 0.1, wheat grain at 0.1, and wheat

straw at 0.2 have also been established

for RACs. Tolerances for the fruiting

vegetable crop group 8 have been

proposed by Gowan Company at 0.05

ppm. An additional tolerance is herein

being requested for the crop group 9B,

squash/cucumber subgroup of the

cucurbit vegetable group, at 0.5 ppm.

Risk assessments were conducted by

EPA to assess dietary exposures from

halosulfuron-methyl in food as follows:

i. Acute exposure. Acute dietary risk

assessments are performed for a food–

use 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 acute

dietary endpoint for halosulfuronmethyl was based on developmental

effects (decreased mean litter size,

increased resorptions, and increased

postimplantation loss). The endpoint

applies only to subgroups consisting of

females (aged 13–50 years), infants and

children. The 10X FQPA factor was

removed, therefore, the acute RfD of 0.5

mg/kg/day is equal to the aPAD. 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: acute

dietary exposure analysis was

performed assuming tolerance level

residues and 100% crop treated for all

commodities for which halosulfuronmethyl is registered as well as for crops

in the cucumber/squash subgroup (9B),

which are being evaluated in this action.

Further, standard processing factors

were used for all processed

commodities. The results of the DEEM

analysis indicate that exposure for all

applicable subgroups is less than 1% of

the aPAD at the 95th percentile.

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 Continuing

Surveys of Food Intake by Individuals

(CSFII) and accumulated exposure to

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58429

the chemical for each commodity. The

following assumptions were made for

the chronic exposure assessments:

chronic dietary analysis was performed

assuming tolerance level residues and

100% crop treated for all commodities

for which halosulfuron-methyl is

registered as well as for crops in the

cucumber/squash subgroup (9B), which

are being evaluated in this action. The

results of the DEEM analysis indicate

that exposure for all applicable

subgroups is less than 1% of the cPAD.

The chronic dietary endpoint for

halosulfuron-methyl is based on

decreased body weight gains, changes in

hematological and blood chemistry

parameters. Since the 10X FQPA factor

was removed, the chronic RfD of 0.1

mg/kg/day is equal to the cPAD.

iii. Cancer. 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.

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 Generic

Estimated Environmental Concentration

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System

(PRZM/EXAMS) to estimate pesticide

concentrations in surface water and SCIGROW, which predicts pesticide

concentrations in ground water. In

general, EPA will use GENEEC (a tier 1

model) before using PRZM/EXAMS (a

tier 2 model) for a screening–level

assessment for surface water. The

GENEEC model is a subset of the PRZM/

EXAMS model that uses a specific high–

end runoff scenario for pesticides.

GENEEC incorporates a farm pond

scenario, while PRZM/EXAMS

incorporate an index reservoir

environment in place of the previous

pond scenario. The PRZM/EXAMS

model includes a percent crop area

factor as an adjustment to account for

the maximum percent crop coverage

within a watershed or drainage basin.

None of these models include

consideration of the impact processing

(mixing, dilution, or treatment) of raw

water for distribution as drinking water

would likely have on the removal of

pesticides from the source water. The

primary use of these models by the

Agency at this stage is to provide a

coarse screen for sorting out pesticides

for which it is highly unlikely that

drinking water concentrations would

ever exceed human health levels of

concern.

Since the models used are considered

to be screening tools in the risk

assessment process, the Agency does

not use estimated environmental

concentrations (EECs) from these

models to quantify drinking water

exposure and risk as a %RfD or %PAD.

Instead drinking water levels of

comparison (DWLOCs) are calculated

and used as a point of comparison

against the model estimates of a

pesticide’s concentration in water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food, and from

residential uses. Since DWLOCs address

total aggregate exposure to halosulfuronmethyl they are further discussed in the

aggregate risk sections below.

Based on the PRZM/EXAMS and SCI–

GROW models the estimated

environmental concentrations (EECs) of

halosulfuron-methyl in surface water

and ground water for acute exposures

are estimated to be 4.73 parts per billion

(ppb) for surface water and 0.097 ppb

for ground water. The EECs for chronic

exposures are estimated to be 1.4 ppb

for surface water and 0.097 ppb for

ground water.

3. From non–dietary exposure. The

term ‘‘residential exposure’’ is used in

this document to refer to non–

occupational, 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 site: residential

lawns. The risk assessment was

conducted using the following

residential exposure assumptions:

Adults may be dermally exposed after

treatments 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

November 26, 1997 (62 FR 62961).

D. Safety Factor for Infants and

Children

1. Safety factor for infants and

children— In general. FFDCA section

408 provides that EPA shall apply an

additional tenfold margin of safety for

infants and children in the case of

threshold effects to account for prenatal

and postnatal toxicity and the

completeness of the data base on

toxicity and exposure unless EPA

determines that a different margin of

safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a margin

of exposure (MOE) analysis or through

using uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans.

2. Prenatal and postnatal sensitivity.

The available data provided no

indication of increased susceptibility of

rats or rabbits to in utero and/or

postnatal exposure to halosulfuronmethyl.

3. Conclusion. A postnatal

developmental neurotoxicity study in

rats is required for confirmatory

purposes because of evidence of fetal

nervous system alterations in rats at 750

mg/kg/day. This requirement is a

condition of registration.

Notwithstanding the above study

requirement, there is an otherwise

complete toxicity data base for

halosulfuron-methyl and exposure data

are complete or are estimated based on

data that reasonably accounts for

potential exposures. EPA determined

that the 10X FQPA Safety Factor to

protect infants and children should be

removed because:

i. There was no indication 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

58430 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

and rabbits and the two–generation

reproduction study in rats, effects in the

offspring were observed only at or above

treatment levels which resulted in

evidence of parental toxicity.

ii. The committee determined that the

requirement of a developmental

neurotoxicity study in rats did not

warrant an application of additional

safety factors because:

a. The alterations observed 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 (LTD)

(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.

e. Exposure assessments do not

indicate a concern for potential risk to

infants and children based on the

results of the field trial studies and the

very low application rate ( 0.06 lbs.

active ingredient (a.i) per acre).

Detectable residues are not expected in

foods.

E. Aggregate Risks and Determination of

Safety

To estimate total aggregate exposure

to a pesticide from food, drinking water,

and residential uses, the Agency

calculates DWLOCs which are used as a

point of comparison against the model

estimates of a pesticide’s concentration

in water (EECs). DWLOC values are not

regulatory standards for drinking water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food and residential

uses. In calculating a DWLOC, the

Agency determines how much of the

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

available for exposure through drinking

water e.g., allowable chronic water

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

food + residential exposure). This

allowable exposure through drinking

water is used to calculate a DWLOC.

A DWLOC will vary depending on the

toxic endpoint, drinking 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, EPA concludes

with reasonable certainty that exposures

to the pesticide 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 residues of the pesticide in

drinking water as a part of the aggregate

risk assessment process.

1. Acute risk. Using the exposure

assumptions discussed in this unit for

acute exposure, the acute dietary

exposure from food to halosulfuronmethyl will occupy < 1.0 percent of the

aPAD for the U.S. population, < 1.0

percent of the aPAD for females 13 years

and older, < 1.0 percent of the aPAD for

infant subpopulation and < 1.0 percent

of the aPAD for children population. In

addition, there is potential for acute

dietary exposure to halosulfuron-methyl

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 aPAD, as shown

in following Table 3:

TABLE 3.—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 4.73 0.097 5,000

Female (13–50 years) 0.50 <1.0 4.73 0.097 15,000

Children (1–6 years) 0.50 <1.0 4.73 0.097 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, for infant

subpopulations at greatest exposure and

for children subpopulation at greatest

exposure]. Based the use pattern,

chronic residential exposure to

halosulfuron-methyl is not expected. In

addition, there is potential for chronic

dietary exposure to halosulfuron-methyl

in drinking water. After calculating the

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 4:

TABLE 4.—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 1.4 0.097 3,500

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58431

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON–CANCER) EXPOSURE TO HALOSULFURON-METHYL—

Continued

Population subgroup cPAD mg/

kg/day

%cPAD

(Food)

Surface

water EEC

(ppb)

Ground

water EEC

(ppb)

Chronic

DWLOC (ppb)

(All Infants 0.10 <1.0 1.4 0.097 990

Children (1–6 years) 0.10 <1.0 1.4 0.097 1,000

Females (13–50 years) 0.10 <1.0 1.4 0.097 2,300

Males (13–19 years) 0.10 <1.0 1.4 0.097 3,500

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 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.

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 310 and

2,200 for all infants and females (13 to

50 years), respectively. Note that there

is no oral residential exposure for

adults. These aggregate MOEs do not

exceed the Agency’s level of concern for

aggregate exposure to food and

residential uses. In addition, short–term

DWLOCs were calculated and compared

to the EECs for chronic exposure of

halosulfuron-methyl in ground 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 5:

TABLE 5.—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)

(All Infants) 310 100 1.4 0.097 4,900

Females (13–50 years) 2,200 100 1.4 0.097 10,000

4. Intermediate–term risk.

Intermediate–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 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 intermediate–

term exposures, EPA has concluded that

food and residential exposures

aggregated result in aggregate MOEs of

1,000, 1,700, and 2,000 for all infants,

females (13 to 50 years) and males (13

to 19), respectively. It should be noted

that there is no oral residential exposure

for adults. 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 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 6:

TABLE 6.—AGGREGATE RISK ASSESSMENT FOR INTERMEDIATE–TERM EXPOSURE TO HALOSULFURON-METHYL

Population subgroup

Aggregate MOE

(Food + Residential)(oral)

Aggregate level

of concern (LOC)

Surface water

EEC (ppb)

Ground water EEC

(ppb)

Intermediate–term

DWLOC (ppb)

(All Infants) 1,000 100 1.4 0.097 920

Females (13–50 years 1,700 100 1.4 0.097 2,800

Males (13–19 years) 2,000 100 1.4 0.097 3,300

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.

58432 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

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.

IV. Other Considerations

A. Analytical Enforcement Methodology

The analytical method for cucumber

and squash is based on ‘‘Analytical

Method for the Determination of MON

12000 and 3-Chlorosulfonamide Acid

Producing residues in Field Corn’’,

Monsanto Doc. No. RES–026–92. This

method has been submitted to FDA for

publication in the Pesticide Analytical

Manual (PAM) II. The analytical method

involves sample extraction, acid

hydrolysis under reflux to convert

halosulfuron-methyl to 3-

chlorosulfonamide acid (CSA), and

derivatization to convert the CSA to

chlorosufonamide ester (CSE). Detection

is by GC/ECD (gas chromatography

using electron capture detection).

Quantitation is expressed in terms of

halosulfuron-methyl equivalents.

Chromatograms, calibration curves and

calculations were included in this

submission. The Agency concludes that

the GC/ECD method is adequate for

enforcement of tolerances and data

collection on residues of halosulfuronmethyl in or on squash/cucumber

subgroup. Information regarding

availability of the method may be

requested from: Calvin Furlow, PIRIB,

IRSD (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW,

Washington, DC 20460; telephone

number: (703) 305–5229; e-mail address:

furlow.calvin@epa.gov.

B. International Residue Limits

There are no Codex, Canadian, or

Mexican maximum residue limits (MRL)

for halosulfuron-methyl in or on

squash/cucumber subgroup. Therefore,

international harmonization is not an

issue for this tolerance.

C. Conditions

The Agency requires a satisfactory

postnatal developmental neurotoxicity

study in rats for confirmatory purposes

because of evidence of fetal nervous

system alterations in rats at 750 mg/kg/

day. The study requirement is a

condition of this registration.

V. Conclusion

Therefore, the tolerance is established

for residues of halosulfuron-methyl,

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

pyrimidinyl)amino

carbonylaminosulfonyl-3-chloro-1-

methyl-1H-pyrazole-4-carboxylate, and

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

carboxylic acid, in or on the squash/

cucumber subgroup at 0.5 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

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–301058 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 November 28, 2000.

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–301058, 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: opp–

docket@epa.gov. Please use an ASCII

file format and avoid the use of special

characters and any form of encryption.

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58433

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 6.1/8.0 file

format or ASCII file format. Do not

include any CBI in your electronic copy.

You may also submit an electronic copy

of your request at many Federal

Depository Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

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 October 4, 1993

(58 FR 51735). This final rule does not

contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Public

Law 104–4). Nor does it require any

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments May 19,

1998 (63 FR 27655); special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low–Income

Populations February 16, 1994 (59 FR

7629); or require OMB review or any

Agency action under Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks April 23, 1997 (62 FR

19885). 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 August 10, 1999 (64 FR

43255). 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).

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: September 21, 2000.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

371.

2. Section 180.479 is amended by

alphabetically adding an entry to the

table in paragraph (a)(2) for ‘‘squash/

cucumber subgroup’’ to read as follows:

§ 180.479 Halosulfuron-methyl, tolerances

for residues.

* * * * *

(a)* * *

Commodity Parts per million

* * * **

Squash/cucumber subgroup 0.5

* * * **

58434 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

* * * * *

[FR Doc. 00–25048 Filed 9–28–00; 8:45 am]

BILLING CODE 6560–-50–-S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301067; FRL–6748–3]

RIN 2070–AB78

Yucca Extract; Exemption From the

Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an

exemption from the requirement of a

tolerance for residues of the yucca

extract on raw agricultural commodities

when applied/used in accordance with

good agricultural practices as an inert

ingredient in pesticide formulations

applied to growing crops. EDM

Corporation submitted a petition to EPA

under the Federal Food, Drug, and

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996

requesting an exemption from the

requirement of a tolerance. This

regulation eliminates the need to

establish a maximum permissible level

for residues of yucca extract.

DATES: This regulation is effective

September 29, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301067,

must be received by EPA on or before

November 28, 2000.

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 VIII. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301067 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Vera Soltero, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–9359; e-mail address:

soltero.vera@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/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301067. 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 November

20, 1998 (63 FR 64494) (FRL–6027–7),

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 (FQPA) (Public Law 104–

170) announcing the filing of a pesticide

tolerance petition by, EDM Corporation,

2278 S. Indiana St., Porterville, CA

93257. This notice included a summary

of the petition prepared by the

petitioner EDM Corporation. There were

no comments received in response to

the notice of filing.

The petition requested that 40 CFR

180.1001(d) be amended by establishing

an exemption from the requirement of a

tolerance for residues of yucca extract.

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

allows EPA to establish an exemption

from the requirement for 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....’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides. Second, EPA examines

exposure to the pesticide through food,

drinking water, and through other

exposures that occur as a result of

pesticide use in residential settings.

III. Toxicological Profile

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

of FFDCA, EPA has reviewed the

available scientific data and other

relevant information in support of this