52866 Federal Register / Vol. 67, No. 157 / Wednesday, August 14, 2002 / Rules and Regulations 

(2) Lower New York Bay Safety Zone.

(i) Location. All waters of Lower New 

York Bay within a 300-yard radius of 

the fireworks barge in approximate 

position 40°34′12.0′′ N 074°04′29.6′′ W, 

(NAD 1983) about 800 yards southeast 

of Midland Beach. 

(ii) Enforcement period. Paragraph 

(a)(2)(i) of this section will be enforced 

from 8:30 p.m. to 10 p.m. on Saturday, 

August 17, 2002. In the event of 

inclement weather on that date, this 

section will be enforced from 8:30 p.m. 

to 10 p.m. on Sunday, August 18, 2002. 

(b) Regulations. (1) The general 

regulations contained in 33 CFR 165.23 

apply. 

(2) All persons and vessels shall 

comply with the instructions of the 

Coast Guard Captain of the Port or the 

designated on-scene-patrol personnel. 

These personnel comprise 

commissioned, warrant, and petty 

officers of the Coast Guard. 

Upon being hailed by a U. S. Coast 

Guard vessel by siren, radio, flashing 

light, or other means, the operator of a 

vessel shall proceed as directed.

Dated: July 25, 2002. 

C.E. Bone, 

Captain, U.S. Coast Guard, Captain of the 

Port, New York.

[FR Doc. 02–20624 Filed 8–9–02; 4:02 pm] 

BILLING CODE 4910–15–P

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180

[OPP–2002–0181; FRL–7192–9] 

Chlorsulfuron; Pesticide Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes 

tolerances for residues of chlorsulfuron; 

(2-chloro-N-[(4-methoxy-6-methyl-1,3,5-

triazin-2-

yl)aminocarbonyl]benzenesulfonamide) 

in or on grass, forage and grass, hay. E.I. 

du Pont de Nemours and Company, Inc. 

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 

August 14, 2002. Objections and 

requests for hearings, identified by 

docket ID number OPP–2002–0181, 

must be received on or before October 

15, 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 ID number OPP-2002–0181 in 

the subject line on the first page of your 

response.

FOR FURTHER INFORMATION CONTACT: By 

mail: Joanne I. Miller, Registration 

Division (7505C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460; telephone 

number: 703–305–6224; e-mail address: 

miller.joanne@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be affected by this action if 

you are an agricultural producer, food 

manufacturer, or pesticide 

manufacturer. Potentially affected 

categories and entities may include, but 

are not limited to:

Categories NAICS Examples of Potentially Affected Entities 

Industry 111 Crop production 

112 Animal production 

311 Food manufacturing 

32532 Pesticide manufacturing 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in the table could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether or not this action might apply 

to certain entities. If you have questions 

regarding the applicability of this action 

to a particular entity, consult the person 

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional 

Information, Including Copies of this 

Document and Other Related 

Documents? 

1. Electronically. You may obtain 

electronic copies of this document, and 

certain other related documents that 

might be available electronically, from 

the EPA Internet Home Page at http://

www.epa.gov/. To access this document, 

on the Home Page select ‘‘Laws and 

Regulations,’’ ‘‘Regulations and 

Proposed Rules,’’ and then look up the 

entry for this document under the 

‘‘Federal Register—Environmental 

documents.’’ You can also go directly to 

the Federal Register listings at http://

www.epa.gov/fedrgstr/. A frequently 

updated electronic version of 40 CFR 

part 180 is available at http://

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

cfrhtml_00/Title_40/40cfr180_00.html, a 

beta site currently under development. 

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http://

www.epa.gov/opptsfrs/home/

guidelin.htm.

2. In person. The Agency has 

established an official record for this 

action under docket ID number OPP–

2002–0181. 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 March 8, 

2002 (67 FR pages 10722 – 10727) (FRL–

6825–8), EPA issued a notice pursuant 

to section 408 of the Federal Food, Drug, 

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

346a, as amended by the Food Quality 

Protection Act of 1996 (FQPA) (Public 

Law 104–170), announcing the filing of 

a pesticide petition (PP 6F4752) by E.I. 

du Pont de Nemours and Company, Inc., 

P.O. Box 30, Newark, Delaware 19714–

0030. This notice included a summary 

of the petition prepared by E.I. du Pont 

de Nemours and Company, the 

registrant. There were no comments 

received in response to the notice of 

filing. 

The petition requested that 40 CFR 

180.405 be amended by establishing 

tolerances for residues of the herbicide 

chlorsulfuron; (2-chloro-N-[(4-methoxy6-methyl-1,3,5-triazin-2-

yl)aminocarbonyl]benzenesulfonamide), 

in or on grass, forage at 11.0 part per 

million (ppm) and grass, hay at 19.0 

ppm. 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical

Federal Register / Vol. 67, No. 157 / Wednesday, August 14, 2002 / Rules and Regulations 52867

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 (62 FR 

62961, November 26, 1997) (FRL–5754–

7). 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

EPA has reviewed the available 

scientific data and other relevant 

information in support of this action. 

EPA has sufficient data to assess the 

hazards of and to make a determination 

on aggregate exposure, consistent with 

section 408(b)(2), for tolerances for 

residues of chlorsulfuron in or on grass, 

forage at 11.0 ppm and grass, hay at 19.0 

ppm. EPA’s assessment of exposures 

and risks associated with establishing 

the tolerances 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 chlorsulfuron are 

discussed in the following Table 1 as 

well as the no observed adverse effect 

level and the lowest observed adverse 

effect level from the toxicity studies 

reviewed.

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results 

870.3150 6 Month oral toxicity in nonrodents NOAEL = 18.5 mg/kg/day 

LOAEL = 82.3 mg/kg/day based on decreased body weight and body-weight 

gain. 

870.3700 Prenatal developmental in rodents Maternal NOAEL = 165 mg/kg/day 

LOAEL = 500 mg/kg/day based on clinical signs, vaginal discharge with associated alopecia. 

Developmental NOAEL = 500 mg/kg/day 

LOAEL = 1500 mg/kg/day based on decreased fetal body weight. 

870.3700 Prenatal developmental in nonrodents Maternal NOAEL = 75 mg/kg/day 

LOAEL = 200 mg/kg/day based on decreased body weight gain. 

Developmental NOAEL = 200 mg/kg/day 

LOAEL = 400 mg/kg/day based on a slight increase in visceral malformations 

and decreased fetal body weight. 

870.3800 3-Generation Reproduction in rodents Parental NOAEL = 125 mg/kg/day 

LOAEL is greater than 125 mg/kg/day, no effects observed. 

Reproductive NOAEL = 5 mg/kg/day 

LOAEL = 25 mg/kg/day based on decreased female fertility 

Offspring NOAEL = 125 mg/kg/day 

LOAEL = 125 mg/kg/day, no effects observed. 

870.4100 Chronic toxicity dogs NOAEL = 60.6 mg/kg/day 

LOAEL = 215 mg/kg/day based on decreased body-weight gain, erythrocyte 

counts and hemoglobin levels. 

870.4200 Carcino-genicity mice NOAEL = 108 mg/kg/day 

LOAEL = 750 mg/kg/day based on decreased body weight and body-weight 

gain. 

(no) evidence of carcinogenicity 

870.4300 Carcinogenicity rats NOAEL = 5 mg/kg/day 

LOAEL = 25 mg/kg/day based on decreased body weight in males. 

(no) evidence of carcinogenicity 

870.5385 Cytogenetics No evidence of chromosomal aberrations 

870.7485 Metabolism and pharmacokinetics Chlorsulfuron is rapidly absorbed, metabolized, and excreted following oral exposure. The major routes of elimination are the urine (58% – 72%) and 

feces (20% – 35%). 

52868 Federal Register / Vol. 67, No. 157 / Wednesday, August 14, 2002 / Rules and Regulations 

B. Toxicological Endpoints 

The dose at which no adverse effects 

are observed (the NOAEL) from the 

toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect uncertainties inherent 

in the extrapolation from laboratory 

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. An UF of 100 is 

routinely used, 10X to account for 

interspecies differences and 10X for 

intraspecies differences. The 3-

generation reproductive toxicity study is 

classified unacceptable, and it is 

considered a datagap. Reproductive 

toxicity was observed but was of 

questionable significance in both litters 

of the F3 generation, as evidenced by 

decreased female fertility. Offspring 

toxicity was not observed. This study 

had numerous deficiencies including 

but not limited to: 

1. No assessment of estrous cyclicity, 

sperm parameters. 

2. No assessment of male reproductive 

performance. 

3. Parental animals not subjected to 

gross pathology or histopathology 

examinations. 

4. No assessment of developmental 

landmarks. 

5. Pup histopathology evaluations 

conducted only for the F3B generation. 

Although this reproduction study on 

chlorsulfuron conformed to the old 

guideline requirements, it is 

unacceptable under the current 

guideline requirement in light of the fact 

that most of the parameters used for 

FQPA assessment are not provided in 

the available study. The Agency applied 

a FQPA database uncertainty factor of 

3X to account for the unacceptable 

reproduction study. Exposure estimates 

are upper bound and will not 

underestimate exposure to 

chlorsulfuron. The 3X FQPA database 

uncertainty factor applies to all dietary 

and non-dietary residential exposure 

scenarios and no Special FQPA safety 

factor is required. 

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (acute RfD or chronic RfD) where 

the RfD is equal to the NOAEL divided 

by the appropriate UF (RfD = NOAEL/

UF). Where an additional safety factor is 

retained due to concerns unique to the 

FQPA, this additional factor is applied 

to the RfD by dividing the RfD by such 

additional factor. The acute or chronic 

Population Adjusted Dose (aPAD or 

cPAD) is a modification of the RfD to 

accommodate this type of FQPA Safety 

Factor. 

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the LOC. For example, when 

100 is the appropriate UF (10X to 

account for interspecies differences and 

10X for intraspecies differences) the 

LOC is 100. To estimate risk, a ratio of 

the NOAEL to exposures (margin of 

exposure (MOE) = NOAEL/exposure) is 

calculated and compared to the LOC. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

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 chlorsulfuron used for human risk 

assessment is shown in the following 

Table 2:

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR CHLORSULFURON 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 

no appropriate endpoint for this exposure scenario was identified 

Acute Dietary general population including infants and children no appropriate endpoint for this exposure scenario was identified 

Chronic Dietary all populations NOAEL = 5 mg/kg/day 

UF = 300 ...................................

Chronic RfD = 0.02 mg/kg/day

FQPA SF = 1 

cPAD = chronic RfD ÷ FQPA 

SF = 0.02 mg/kg/day.

rat chronic toxicity/carcinogenicity LOAEL = 25 mg/kg/

day based on decreased 

body weight in males 

Incidental Oral, Short-Term Residential 

Only 

NOAEL = 75 mg/kg/day 

UF=300 .....................................

FQPA SF = 1 

LOC for MOE = 300 ..................

developmental toxicity study in 

rabbits LOAEL=200 mg/kg/

day based on decreased 

body-weight gain 

Incidental Oral, Intermediate-Term 

Residential Only 

NOAEL = 75 mg/kg/day 

UF=300 .....................................

FQPA SF = 1 

LOC for MOE = 300 ..................

developmental toxicity study in 

rabbits LOAEL=200 mg/kg/

day based on decreased 

body-weight gain 

Short-Term Dermal (1 to 7 days) (Residential) NOAEL = 75 mg/kg/day 

UF = 300 ...................................

FQPA SF = 1 

LOC for MOE = 300 (Residential).

developmental toxicity study in 

rabbits LOAEL = 200 mg/kg/

day based on decreased 

body-weight gain 

Federal Register / Vol. 67, No. 157 / Wednesday, August 14, 2002 / Rules and Regulations 52869

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

ASSESSMENT—Continued

Exposure Scenario Dose Used in Risk Assessment, 

UF 

FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects 

Intermediate-Term Dermal (1 week to 

several months) (Residential) 

NOAEL = 75 mg/kg/day 

UF = 300 ...................................

FQPA SF = 1 

LOC for MOE = 300 (Residential).

developmental toxicity study in 

rabbits LOAEL = 200 mg/kg/

day based on decreased 

body-weight gain 

Long-Term Dermal (several months to 

lifetime) (Residential) 

NOAEL = 5 mg/kg/day 

UF = 300 when appropriate) .....

FQPA SF = 1 

LOC for MOE = 300 (Residential).

chronic toxicity/carcinogenicity 

study in rats LOAEL = 25 mg/

kg/day based on decreased 

body weight in males 

Short-Term Inhalation (1 to 7 days) 

(Residential) 

NOAEL = 75 mg/kg/day 

UF = 300 ...................................

FQPA SF = 1 

LOC for MOE = 300 (Residential).

developmental toxicity study in 

rabbits LOAEL = 200 mg/kg/

day based on decreased 

body-weight gain 

Intermediate-Term Inhalation (1 week 

to several months) (Residential) 

NOAEL = 75 mg/kg/day 

UF = 300) ..................................

FQPA SF = 1 

LOC for MOE = 300 (Residential).

developmental toxicity study in 

rabbits LOAEL = 200 mg/kg/

day based on decreased 

body weight gain 

Long-Term Inhalation (several months 

to lifetime) (Residential) 

NOAEL = 5 mg/kg/day 

UF = 300) ..................................

FQPA SF = 1 

LOC for MOE = 300 (Residential).

chronic toxicity/carcinogenicity 

study in rats LOAEL = 25 mg/

kg/day based on decreased 

body weight in males 

* 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 180.405) for the 

residues of chlorsulfuron, in or on a 

variety of raw agricultural commodities. 

Risk assessments were conducted by 

EPA to assess dietary exposures from 

chlorsulfuron in food as follows: 

i. Acute exposure. Acute dietary risk 

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

indicated the possibility of an effect of 

concern occurring as a result of a one 

day or single exposure. No toxicological 

endpoint attributable to a single 

exposure was identified in the available 

toxicology studies. No appropriate 

studies available show any acute dietary 

effects of concern. 

ii. Chronic exposure. In conducting 

this chronic dietary risk assessment the 

Dietary Exposure Evaluation Model 

(DEEM) analysis evaluated the 

individual food consumption as 

reported by respondents in the USDA 

1989–1992 nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII) and accumulated exposure to 

the chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: 

Residue levels are at the recommended 

tolerances and 100% crop treated with 

chlorsulfuron. Results of dietary 

analyses showed exposure to 

chlorsulfuron consumed no more than 

19.3% of the cPAD. 

iii. Cancer. Chlorsulfuron was 

classified as having ‘‘no evidence of 

carcinogenicity’’ based upon lack of 

evidence of carcinogenicity in rats and 

mice. Therefore, a cancer dietary 

exposure analysis was not performed. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

chlorsulfuron 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 

chlorsulfuron. 

The Agency uses the First Index 

Reservoir Screening Tool (FIRST) or the 

Pesticide Root Zone Model/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 groundwater. For a 

screening-level assessment for surface 

water EPA will use FIRST (a tier 1 

model) before using PRZM/EXAMS (a 

tier 2 model). The FIRST model is a 

subset of the PRZM/EXAMS model that 

uses a specific high-end runoff scenario 

for pesticides. While both FIRST and 

PRZM/EXAMS incorporate an index 

reservoir environment, the PRZM/

EXAMS model includes a percent crop 

area factor as an adjustment to account 

for the maximum percent crop coverage 

within a watershed or drainage basin. 

None of these models include 

consideration of the impact processing 

(mixing, dilution, or treatment) of raw 

water for distribution as drinking water 

would likely have on the removal of 

pesticides from the source water. The 

primary use of these models by the 

Agency at this stage is to provide a 

coarse screen for sorting out pesticides 

for which it is highly unlikely that 

drinking water concentrations would 

ever exceed human health levels of 

concern. 

Since the models used are considered 

to be screening tools in the risk 

assessment process, the Agency does 

not use estimated environmental 

concentrations (EECs) from these 

models to quantify drinking water 

exposure and risk as a %RfD or %PAD. 

Instead, drinking water levels of 

comparison (DWLOCs) are calculated 

and used as a point of comparison 

against the model estimates of a 

pesticide’s concentration in water. 

DWLOCs are theoretical upper limits on 

a pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food, and from 

residential uses. Since DWLOCs address 

total aggregate exposure to 

chlorsulfuron, they are further 

discussed in the aggregate risk sections 

in Unit III. E. of this preamble. 

52870 Federal Register / Vol. 67, No. 157 / Wednesday, August 14, 2002 / Rules and Regulations 

Based on the FIRST and SCI-GROW 

models the EECs of total chlorsulfuron 

residues (both parent and degradation 

products) for acute exposures are 

estimated to be 59.7 parts per billion 

(ppb) and for chronic exposures are 

estimated to be 41.3 ppb in surface 

water. The EECs for acute and chronic 

exposures of chlorsulfuron (parent only) 

are estimated to be 3.5 ppb in 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). 

Chlorsulfuron is currently registered 

for use on the following residential nondietary sites: Lawns. The risk 

assessment was conducted using the 

following residential exposure 

assumptions: Adult handlers and adult 

and toddler postapplication exposure to 

treated turf. Residential exposure risk 

was assessed using the Residential 

Exposure Assessment Standard 

Operating Procedures (ResSOPs) 

standard values and assumptions. Adult 

handler exposure risk was not of 

concern with MOEs ranging between 

8,800 and 190,000. Postapplication 

exposure risks for adults and toddlers 

also exceeded target MOEs, ranging 

between 770 and 400,000. Since the 

ResSOPs ranged between median and 

high end assessments, and the use 

assessed was for spot treatment, not the 

entire lawn, the residential 

postapplication exposure risk 

assessment was conservative. 

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 

chlorsulfuron 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, chlorsulfuron 

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 chlorsulfuron has a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see the final rule for 

Bifenthrin Pesticide Tolerances (62 FR 

62961, November 26, 1997). 

D. Safety Factor for Infants and 

Children 

1. In general. FFDCA section 408 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base on 

toxicity and exposure unless EPA 

determines that a different margin of 

safety will be safe for infants and 

children. Margins of safety are 

incorporated into EPA risk assessments 

either directly through use of a 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 toxicology database for 

chlorsulfuron contains acceptable 

guideline developmental studies which 

show no quantitative or qualitative 

evidence of increased susceptibility 

following in utero exposure. 

Susceptibility cannot be assessed in the 

3-generation reproduction study in rats. 

The Agency determined that a 2-

generation reproduction study is 

required for chlorsulfuron. 

3. Conclusion. The existing 

toxicological database for chlorsulfuron, 

while not complete, supports the 

establishment of permanent tolerances 

for chlorsulfuron per se and exposure 

data are complete or are estimated based 

on data that reasonably accounts for 

potential exposures. For dietary 

exposure estimates, a FQPA safety factor 

of 3 was used. Due to data deficiencies 

in the toxicology database, the Agency 

determined that an additional 3X 

database UF is needed for the protection 

of infants and children. An UF of 3X (as 

opposed to a 10X) is adequate because 

the chronic RfD is based on the NOAEL 

of 5 mg/kg/day established in the 

Combined Chronic/Carcinogenicity 

Study in Rats. This dose (5 mg/kg/day) 

is 25X lower than the highest dose 

tested (125 mg/kg/day) in the existing 3-

generation Reproduction Study in 

which the effects noted were considered 

of questionable toxicological 

significance. 

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 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 

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. An appropriate 

endpoint attributable to a single dose 

was not identified, therefore, no acute 

risk is expected. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to chlorsulfuron from 

food will utilize no more than 6.6% of 

the cPAD for the U.S. population, 7.3% 

of the cPAD for all infants and 19.3% of 

the cPAD for children 1–6 years old. 

Based on the use pattern, chronic 

Federal Register / Vol. 67, No. 157 / Wednesday, August 14, 2002 / Rules and Regulations 52871

residential exposure to residues of 

chlorsulfuron is not expected. Since no 

chronic residential scenarios have been 

identified, chronic DWLOCs for 

chlorsulfuron were calculated based on 

residues in food alone. After calculating 

DWLOCs and comparing them to the 

EECs for surface and ground water, EPA 

does not expect the aggregate exposure 

to exceed 100% of the cPAD, as shown 

in the following Table 3:

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

Population Subgroup cPADmg/kg/

day 

%cPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

U.S. Population 0.02 6.6 41.3 3.5 654 

Females 13–50 years old 0.02 4.3 41.3 3.5 574 

Children 1–6 years old 0.02 19.3 41.3 3.5 161

All Infants 0.02 7.3 41.3 3.5 185

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). 

Chlorsulfuron 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 chlorsulfuron. 

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 1,265 for 

adult males, 1,274 for adult females and 

722 for toddlers. These aggregate MOEs 

do not exceed the Agency’s level of 

concern for aggregate exposure to food 

and residential uses. In addition, shortterm DWLOCs were calculated and 

compared to the EECs for chronic 

exposure of chlorsulfuron 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 4:

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

Population Subgroup 

Aggregate 

MOE (Food 

+ Residential) 

Aggregate 

Level of 

Concern 

(LOC) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Short-Term 

DWLOC 

(ppb) 

Adult Male 1,265 300 41.3 3.5 6,674 

Adult Female 1,274 300 41.3 3.5 5,734

Toddler 722 300 41.3 3.5 1,461

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). The intermediate-term 

aggregate risk is the same as the shortterm aggregate risk (Table 4) since the 

toxicity end points are the same for both 

exposures. 

5. Aggregate cancer risk for U.S. 

population. The carcinogenic potential 

of chlorsulfuron was classified as no 

evidence of carcinogenicity. Therefore, 

no cancer risk is expected. 

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 

chlorsulfuron residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Methods are available for the 

enforcement of tolerances for 

chlorsulfuron residues in/on plant and 

animal commodities. PAM Vol. II lists 

Methods I and II, High performance 

liguid chromotography methods with 

photoconductivity detection, for the 

determination of chlorsulfuron residues 

in plants and livestock commodities and 

milk. 

B. International Residue Limits 

There are no Codex, Canadian, or 

Mexican maximum residue limits, 

therefore, issues of compatibility do not 

exist. 

C. Conditions 

The following data gaps must be 

fulfilled; a 21–day repeat dermal 

toxicity study, a subchronic inhalation 

study, and a 2-generation reproduction 

study. 

V. Conclusion 

Therefore, tolerances are established 

for residues of chlorsulfuron in or on 

grass, forage at 11.0 ppm and grass, hay 

at 19.0 ppm. 

VI. Objections and Hearing Requests 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to the 

FFDCA by the FQPA of 1996, EPA will 

continue to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

52872 Federal Register / Vol. 67, No. 157 / Wednesday, August 14, 2002 / Rules and Regulations 

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 ID number 

OPP–2002–0181 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 October 15, 2002. 

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice. 

Mail your written request to: Office of 

the Hearing Clerk (1900), Environmental 

Protection Agency, 1200 Pennsylvania 

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

may also deliver your request to the 

Office of the Hearing Clerk in Rm. C400, 

Waterside Mall, 401 M St., SW., 

Washington, DC 20460. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 260–4865. 

2. Tolerance fee payment. If you file 

an objection or request a hearing, you 

must also pay the fee prescribed by 40 

CFR 180.33(i) or request a waiver of that 

fee pursuant to 40 CFR 180.33(m). You 

must mail the fee to: EPA Headquarters 

Accounting Operations Branch, Office 

of Pesticide Programs, P.O. Box 

360277M, Pittsburgh, PA 15251. Please 

identify the fee submission by labeling 

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee 

requirement ‘‘when in the judgement of 

the Administrator such a waiver or 

refund is equitable and not contrary to 

the purpose of this subsection.’’ For 

additional information regarding the 

waiver of these fees, you may contact 

James Tompkins by phone at (703) 305–

5697, by e-mail at 

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

request for information to Mr. Tompkins 

at Registration Division (7505C), Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460. 

If you would like to request a waiver 

of the tolerance objection fees, you must 

mail your request for such a waiver to: 

James Hollins, Information Resources 

and Services Division (7502C), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460. 

3. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

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

of your request to the PIRIB for its 

inclusion in the official record that is 

described in Unit I.B.2. Mail your 

copies, identified by docket ID number 

OPP–2002–0181, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460. In person or by 

courier, bring a copy to the location of 

the PIRIB described in Unit I.B.2. You 

may also send an electronic copy of 

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

file format and avoid the use of special 

characters and any form of encryption. 

Copies of electronic objections and 

hearing requests will also be accepted 

on disks in WordPerfect 6.1/8.0 or 

ASCII file format. Do not include any 

CBI in your electronic copy. You may 

also submit an electronic copy of your 

request at many Federal Depository 

Libraries. 

B. When Will the Agency Grant a 

Request for a Hearing? 

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

VII. Regulatory Assessment 

Requirements 

This final rule establishes a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

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

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

tolerances and exemptions that are 

established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

Federal Register / Vol. 67, No. 157 / Wednesday, August 14, 2002 / Rules and Regulations 52873

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

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

For these same reasons, the Agency has 

determined that this rule does not have 

any ‘‘tribal implications’’ as described 

in Executive Order 13175, entitled 

Consultation and Coordination with 

Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VIII. Submission to Congress and the 

Comptroller General 

The Congressional Review Act, 5 

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

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

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

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

List of Subjects in 40 CFR Part 180

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements.

Dated: July 30, 2002. 

Donald R. Stubbs, 

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 180.405 is revised to read 

as follows:

§ 180.405 Chlorsulfuron; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for the combined residues of 

chlorsulfuron (2-chloro-N-[(4-methoxy6-methyl-1,3,5-triazin-2-

yl)aminocarbonyl]benzenesulfonamide) 

and its metabolite, 2-chloro-5-hydroxyN-[(4-methoxy-6-methyl-1,3,5-triazin-2-

yl)aminocarbonyl] benzenesulfonamide 

in or on the following raw agricultural 

commodities:

Commodity Parts per 

million 

Barley, grain ............................. 0.1

Barley, straw ............................. 0.5

Oat, forage ................................ 20.0

Oat, grain .................................. 0.1

Oat, straw ................................. 0.5

Wheat, forage ........................... 20.0

Wheat, grain ............................. 0.1

Wheat, straw ............................. 0.5

(2) Tolerances are established for 

residues of chlorsulfuron (2-chloro-N-

[(4-methoxy-6-methyl-1,3,5-triazin-2- 

yl)aminocarbonyl] benzenesulfonamide) 

in or on the following raw agricultural 

commodities.

Commodity Parts per 

million 

Cattle, fat .................................. 0.3

Cattle, meat .............................. 0.3

Cattle, meat byproducts ........... 0.3

Goat, fat .................................... 0.3

Goat, meat ................................ 0.3

Goat, meat byproducts ............. 0.3

Grass, forage ............................ 11.0

Grass, hay ................................ 19.0

Hog, fat ..................................... 0.3

Commodity Parts per 

million 

Hog, meat ................................. 0.3

Hog, meat byproducts .............. 0.3

Horse, fat .................................. 0.3

Horse, meat .............................. 0.3

Horse, meat byproducts ........... 0.3

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

Sheep, fat ................................. 0.3

Sheep, meat ............................. 0.3

Sheep, meat byproducts .......... 0.3

(b) Section 18 emergency exemptions.

[Reserved]. 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 02–20229 Filed 8–13–02; 8:45 am] 

BILLING CODE 6560–50–S

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[DA 02–1898, MM Docket No. 01–161, RM–

10181] 

Digital Television Broadcast Service; 

Victoria, TX

AGENCY: Federal Communications 

Commission.

ACTION: Final rule.

SUMMARY: The Commission, at the 

request of Surtsey Productions, Inc., 

license of station KVCT–TV, Victoria, 

Texas, substitutes DTV channel 11 for 

DTV channel 34 at Victoria. See 66 FR 

39727, August 1, 2001. DTV channel 11 

can be allotted to Victoria, Texas, in 

compliance with the principle 

community coverage requirements of 

Section 73.625(a) at reference 

coordinates 28–50–26 N. and 97–07–47 

W. with a power of 18, HAAT of 311 

meters and with a DTV service 

population of 229 thousand. Since the 

community of Victoria is located within 

275 kilometers of the U.S.-Mexican 

border, concurrence from the Mexican 

government has been obtained for this 

allotment. 

With this action, this proceeding is 

terminated.

DATES: Effective September 23, 2002.

FOR FURTHER INFORMATION CONTACT: Pam 

Blumenthal, Media Bureau, (202) 418–

1600.

SUPPLEMENTARY INFORMATION: This is a 

synopsis of the Commission’s Report 

and Order, MM Docket No. 01–161, 

adopted August 2, 2002, and released 

August 9, 2002. The full text of this 

document is available for public 

inspection and copying during regular