58084 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0321; FRL–7682–3]

Fludioxonil; Pesticide Tolerances

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes 

tolerances for residues of fludioxonil in 

or on bean, dry; bean, succulent; citrus, 

crop group 10; fruit, pome, group 11; 

grapefruit, oil; kiwifruit; leafy greens 

subgroup 4A, except spinach; melon 

subgroup 9A; and yam, true. 

Interregional Research Project Number 4 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective 

September 29, 2004. Objections and 

requests for hearings must be received 

on or before November 29, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0321. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 South Bell 

St., Arlington, VA. This docket facility 

is open from 8:30 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT:

Sidney C. Jackson, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW.,Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; e-mail address: 

jackson.sidney@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to:

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers.

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers.

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users.

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 this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT.

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information?

In addition to using EDOCKET (http:/

/www.epa.gov/edocket/), you may 

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http://

www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

In the Federal Register of March 17, 

2004 (69 FR 12680) (FRL–7347–3), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petitions (PP 3E6551, 3E6639, 

3E6701, 3E6742, and 3E6803) by IR–4, 

681 US Highway #1 South, New 

Brunswick, NJ 08902–3390. These 

petitions requested that 40 CFR 180.516 

be amended by establishing tolerances 

for residues of the fungicide fludioxonil, 

4-(2,2-difluoro-1,3-benzodioxol-4-yl)-

1H-pyrrole-3-carbonitrile, in or on bean, 

dry and bean, succulent at 0.4 parts per 

million (ppm) (PP 3E6701); citrus, crop 

group 10 at 10 ppm; citrus, dried pulp 

at 20 ppm, citrus, oil at 500 ppm, and 

pomegranate at 2.0 ppm (PP 3E6803); 

fruit, pome, group 11 at 5.0 ppm, yam 

at 8.0 ppm, and melon subgroup 9A at 

0.03 ppm (PP 3E6742); kiwifruit at 20 

ppm (PP 3E6551); and leafy greens 

subgroup 4A, except spinach at 30 ppm 

(PP 3E6639). That notice included a 

summary of the petitions prepared by 

Syngenta Crop Protection, Incorporated, 

the registrant. Subsequently, PP 3E6803 

has been amended to delete citrus, dried 

pulp at 20 ppm, and pomegranate at 2.0 

ppm. In addition, ‘‘citrus, oil’’ at 500 

ppm, and ‘‘yam’’ at 8.0 ppm has been 

translated to ‘‘grapefruit, oil’’ at 500 

ppm, and ‘‘yam, true’’ at 8.0, 

respectively. There were no comments 

received in response to the notice of 

filing.

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

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) of FFDCA 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 of FFDCA 

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) 

of FFDCA, 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, 

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58085

consistent with section 408(b)(2) of 

FFDCA, for tolerances for residues of 

fludioxonil on bean, dry; bean, 

succulent at 0.4 ppm; citrus, crop group 

10 at 10 ppm; fruit, pome, group 11 at 

5.0 ppm; grapefruit, oil at 500 ppm; 

kiwifruit at 20 ppm; leafy greens 

subgroup 4A, except spinach at 30 ppm; 

melon subgroup 9A at 0.03; and yam, 

true at 8.0 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 fludioxonil as 

well as the no observed adverse effect 

level (NOAEL) and the lowest observed 

adverse effect level (LOAEL) from the 

toxicity studies reviewed are discussed 

in the Federal Register of December 29, 

2000 (65 FR 82927) (FRL–6760–9).

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.

Three other types of safety or 

uncertainty factors may be used: 

‘‘Traditional uncertainty factors;’’ the 

‘‘special FQPA safety factor;’’ and the 

‘‘default FQPA safety factor.’’ By the 

term ‘‘traditional uncertainty factor,’’

EPA is referring to those additional 

uncertainty factors used prior to FQPA 

passage to account for database 

deficiencies. These traditional 

uncertainty factors have been 

incorporated by the FQPA into the 

additional safety factor for the 

protection of infants and children. The 

term ‘‘special FQPA safety factor’’ refers 

to those safety factors that are deemed 

necessary for the protection of infants 

and children primarily as a result of the 

FQPA. The ‘‘default FQPA safety factor’’

is the additional 10X safety factor that 

is mandated by the statute unless it is 

decided that there are reliable data to 

choose a different additional factor 

(potentially a traditional uncertainty 

factor or a special FQPA safety factor).

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 an UF of 100 to account for 

interspecies and intraspecies differences 

and any traditional uncertainty factors 

deemed appropriate (RfD = NOAEL/UF). 

Where a special FQPA safety factor or 

the default FQPA safety factor is used, 

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 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). An example of how such a 

probability risk is expressed would be to 

describe the risk as one in one hundred 

thousand (1 X 10-5), one in a million (1 

X 10-6), or one in ten million (1 X 10-7). 

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 fludioxonil used for 

human risk assessment is shown in 

Table 1. of this unit:

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FLUDIOXONIL FOR USE IN HUMAN RISK ASSESSMENT

Exposure Scenario 

Dose Used in Risk Assessment, Interspecies and 

Intraspecies and any Traditional UF 

Special FQPA SF and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Acute Dietary (Females 13–49 

years of age)

NOAEL = 100 mg/kg/day 

UF = 100

Acute RfD = 1.0 mg/kg/day

Special FQPA SF = 1X 

aPAD = acute RfD ÷ Special FQPA SF = 1.0 mg/

kg/day

Developmental Toxicity Study 

LOAEL = 1,000 mg/kg/day based on increased incidence of fetuses and litters with 

dilated renal pelvis and dilated ureter

Chronic Dietary (All populations)NOAEL = 3.3 mg/kg/day 

UF = 100

Chronic RfD = 0.03 mg/kg/

day

Special FQPA SF = 1X 

cPAD = chronic RfD ÷

Special FQPA SF = 0.03 

mg/kg/day

One year chronic toxicity study - dog 

LOAEL = 35.5 mg/kg/day based on decreased 

body weight gain in female dogs

Incidental Oral, Short-Term 

Dermal

Oral study NOAEL = 10 mg/

kg/day

LOC for MOE = 100 (Residential)Rabbit developmental study 

LOAEL = 100 mg/kg/day based on decreased 

body weight gain during gestation

58086 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FLUDIOXONIL FOR USE IN HUMAN RISK

ASSESSMENT—Continued

Exposure Scenario 

Dose Used in Risk Assessment, Interspecies and 

Intraspecies and any Traditional UF 

Special FQPA SF and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Incidental Oral, IntermediateTerm DermalOral study NOAEL = 3.3 mg/

kg/day

LOC for MOE = 100 (Residential)One year chronic toxicity study - dog 

LOAEL = 35.5 mg/kg/day based on decreased 

body weight gain in female dogs

Short- and Intermediate-Term 

Dermal (1–30 days and 1–6 

months) (Occupational/Residential)

None No systemic toxicity was 

seen at the limit dose 

(1,000 mg/kg/day) in the 

28-day dermal toxicity 

study in rats. Additionally, there were no developmental concerns. 

There risk assessments 

are not required

Endpoint was not selected

Long-Term Dermal (6 monthslifetime) (Occupational/Residential)Oral study NOAEL = 3.3 mg/

kg/day (dermal absorption 

rate = 40% when appropriate)

LOC for MOE = 100 (Occupational) 

LOC for MOE = 100 (Residential)

One year chronic toxicity study - dog 

LOAEL = 35.5 mg/kg/day based on decreased 

body weight gain in females dogs

Short-Term Inhalation (1 to 30 

days) (Inhalation)

Inhalation (or oral) study 

NOAEL = 10 mg/kg/day 

(inhalation absorption rate 

= 100%)

LOC for MOE = 100 (Occupational) 

LOC for MOE = 100 (Residential)

Rabbit developmental study 

LOAEL = 100 mg/kg/day based on decreased 

body weight gain during gestation

Intermediate-Term Inhalation (1 

month–6 months) (Inhalation)

Oral study NOAEL = 3.3 mg/

kg/day (inhalation absorption rate = 100%)

LOC for MOE = 100 (Occupational) 

LOC for MOE = 100 (Residential)

One year chronic toxicity study 

LOAEL = 35.5 mg/kg/day based on decreased 

body weight gain in female dogs

Long-Term Inhalation (6 

months-lifetime) (Occupational/Residential)

Oral study NOAEL= 3.3 mg/

kg/day (inhalation absorption rate = 100%)

LOC for MOE = 100 (Occupational) 

LOC for MOE = 100 (Residential)

One year chronic toxicity study - dog 

LOAEL = 35.5 mg/kg/day based on decreased 

body weight gain in female dogs

Cancer (oral, dermal, inhalation)‘‘Group D’’ - not classified as 

to human carcinogenicity 

via relevant routes of exposure

Not applicable Acceptable oral rat and mouse carcinogenicity 

studies; evidence of carcinogenic and mutagenic potential

C. Exposure Assessment

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.516) for the 

residues of fludioxonil, in or on a 

variety of raw agricultural commodities 

which includes the following: Brassica, 

head and stem, Brassica, leafy greens, 

bushberry, caneberry, carrot, cereal 

grain, forage, fodder, and straw, cotton 

gin byproducts, cotton, undelinted seed, 

flax, seed, grape, grass, forage, fodder 

and hay, herb and spice group, 

juneberry, leafy vegetables except 

Brassica, lingonberry, longan, lychee, 

non-grass animal feed, dry bulb and 

green onion, peanut hay, peanut, 

pistachio, pulasan, rambutan, rapeseed 

and rapeseed forage, safflower seed, 

salal, Spanish lime, stone fruit, 

strawberry, sunflower seed, turnip 

greens, bulb vegetables, cucurbit 

vegetables, fruiting legume vegetables, 

root and tuber vegetables, foliage of 

legume vegetables, and watercress. Risk 

assessments were conducted by EPA to 

assess dietary exposures from 

fludioxonil 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 oneday or single exposure.

In conducting the acute dietary risk 

assessment EPA used the Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

Database (DEEM-FCIDTM), which 

incorporates food consumption data as 

reported by respondents in the United 

States Department of Agriculture 

(USDA) 1994–1996 and 1998 

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: An unrefined, 

Tier 1 acute dietary exposure 

assessment used tolerance-level residue 

values and 100% crop treated (CT) as 

assumptions for all of the registered and 

proposed uses.

ii. Chronic exposure. In conducting 

the chronic dietary risk assessment EPA 

used the DEEM-FCIDTM, which 

incorporates food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 Nationwide CSFII, 

and accumulated exposure to the 

chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: A 

partially refined, Tier 2 chronic dietary 

exposure assessment was conducted for 

the general U.S. population and related 

population subgroups. Tolerance-level 

values and a default of 100% CT were 

used for all the current and proposed 

fludioxonil tolerances except for apple, 

grapefruit, lemon, lime, orange, and 

pear. Average application rate (AR) 

values replaced tolerances for apple, 

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58087

grapefruit, lemon, lime, orange, and 

pear. In addition, processing factors 

from processing studies were used for 

apple juice and citrus juices.

iii. Cancer. EPA’s Cancer Peer Review 

Committee (CPRC) classified fludioxonil 

as a Group D chemical that is 

considered not classifiable as to human 

carcinogenicity. Therefore, a cancer risk 

assessment 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 

fludioxonil 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 

fludioxonil.

The Agency uses the FQPA 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 SCI-GROW model is used 

to predict pesticide concentrations in 

shallow ground water. For a screeninglevel 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. Both FIRST and PRZM/

EXAMS incorporate an index reservoir 

environment, and both models include 

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 

screen for sorting out pesticides for 

which it is unlikely that drinking water 

concentrations would 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), which are the 

model estimates of a pesticide’s 

concentration in water. EECs derived 

from these models are used 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 fludioxonil 

they are further discussed in the 

aggregate risk sections in Unit III.E.1.–

4.

Based on the FIRST and SCI-GROW 

models, the EECs of fludioxonil for 

acute exposures are estimated to be 132 

parts per billion (ppb) for surface water 

and 0.11 ppb for ground water. The 

EECs for chronic exposures are 

estimated to be 49 ppb for surface water 

and 0.11 ppb for ground water.

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets).

Fludioxonil is currently registered for 

use on the following residential nondietary sites: Turfgrass and ornamentals 

in residential landscapes (registered 

product: Medallion, EPA Reg. No. 

100–769). Medallion is a wettable 

powder in water-soluble packets, and 

the current label indicates that this 

product is ‘‘for professional use only.’’

As such, no residential handler (i.e. 

applicator) exposures are anticipated. 

However, short- and intermediate-term 

dermal (adults and toddlers), and 

incidental ingestion (toddlers) postapplication residential exposures are 

anticipated based on the use pattern for 

turfgrass applications detailed on the 

Medallion label (specifies that the 

product be applied at 14-day 

application intervals, with an annual 

maximum rate of 2 lbs ai/A/yr, which 

equates to about 3 applications at the 

maximum per application rate. Also, 

fludioxonil has half-lives ranging from 

95 to 440 days in thatch sod). A 

residential post-application dermal 

assessment was not performed since the 

risks from short- and intermediate-term 

dermal exposure are negligible. Shortand intermediate-term dermal endpoints 

were not selected due to the NOAEL of 

1,000 mg/kg/day (highest dose tested) in 

the 28-day dermal toxicity study in rats 

and also since there were no 

developmental concerns. EPA has 

concluded that there are no significant 

post-application exposures anticipated 

from treated landscape ornamentals. 

Therefore, the risk assessment was 

conducted using the following 

residential exposure assumption: Postresidential lawn applications for toddler 

incidental ingestion.

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

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.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

fludioxonil and any other substances 

and fludioxonil 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 fludioxonil 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 policy statements 

released by EPA’s OPP concerning 

common mechanism determinations 

and procedures for cumulating effects 

from substances found to have a 

common mechanism on EPA’s web site 

at http://www.epa.gov/pesticides/

cumulative/.

D. Safety Factor for Infants and 

Children

1. In general. Section 408 of FFDCA 

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 based on reliable data 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. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional safety 

factor value based on the use of 

traditional uncertainty factors and/or 

special FQPA safety factors, as 

appropriate.

2. Prenatal and postnatal sensitivity. 

The developmental and reproductive 

toxicity data did not indicate increased 

quantitative or qualitative susceptibility 

58088 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 

of rats or rabbits to in utero and/or 

postnatal exposure.

3. Conclusion. There is a complete 

toxicity data base for fludioxonil and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. EPA 

determined that the 10X SF to protect 

infants and children should be reduced 

to 1X because:

• The toxicology data base is 

complete.

• The developmental and 

reproductive toxicity data did not 

indicate increased quantitative or 

qualitative susceptibility of rats or 

rabbits to in utero and/or postnatal 

exposure.

• A developmental neurotoxicity 

study is not required because there was 

no evidence of neurotoxicity in the 

current toxicity data base.

• The exposure assessment approach 

will not underestimate the potential 

dietary (food and water) and non-dietary 

exposures for infants and children 

resulting from the use of fludioxonil.

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 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 EPA’s Office of Water are 

used to calculate DWLOCs: 2 liter (L)/

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

female), and 1L/10 kg (child). Default 

body weights and drinking water 

consumption values vary on an 

individual basis. This variation will be 

taken into account in more refined 

screening-level and quantitative 

drinking water exposure assessments. 

Different populations will have different 

DWLOCs. Generally, a DWLOC is 

calculated for each type of risk 

assessment used: Acute, short-term, 

intermediate-term, chronic, and cancer.

When EECs for surface water and 

ground water are less than the 

calculated DWLOCs, OPP concludes 

with reasonable certainty that exposures 

to the pesticide in drinking water (when 

considered along with other sources of 

exposure for which OPP has reliable 

data) would not result in unacceptable 

levels of aggregate human health risk at 

this time. Because OPP considers the 

aggregate risk resulting from multiple 

exposure pathways associated with a 

pesticide’s uses, levels of comparison in 

drinking water may vary as those uses 

change. If new uses are added in the 

future, OPP will reassess the potential 

impacts of residues of the pesticide in 

drinking water as a part of the aggregate 

risk assessment process.

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food to fludioxonil will 

occupy 0.13% of the aPAD for females 

13 years and older. In addition, there is 

potential for acute dietary exposure to 

fludioxonil 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 Table 2. of this 

unit:

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO FLUDIOXONIL

Population Subgroup aPAD (mg/

kg) 

% aPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Acute 

DWLOC 

(ppb) 

Female 13–49 years old 1.0 0.13 132 0.11 26,000

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to fludioxonil from food 

will utilize 39.4% of the cPAD for the 

U.S. population, 43.7% of the cPAD for 

all infants < 1 year old, 65.2% of the 

cPAD for children 1–2 years old, and 

39.4% of the cPAD for females 13–49 

years old. Based on the use pattern, 

chronic residential exposure to residues 

of fludioxonil is not expected. In 

addition, there is potential for chronic 

dietary exposure to fludioxonil in 

drinking water. After calculating 

DWLOCs and comparing them to the 

EECs for surface and ground water, EPA 

does not expect the aggregate exposure 

to exceed 100% of the cPAD, as shown 

in Table 3. of this unit:

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

Population Subgroup cPAD mg/

kg/day 

% cPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

U.S. population 0.03 39.4 49 0.11 630

All infants < 1 year old 0.03 43.7 49 0.11 170

Children 1–2 years old 0.03 65.2 49 0.11 100

Females 13–49 years old 0.03 39.4 49 0.11 570

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). 

Fludioxonil is currently registered for 

use that could result in short-term 

residential exposure and the Agency has 

determined that it is appropriate to 

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58089

aggregate chronic food and water and 

short-term exposures for fludioxonil.

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 390 for all 

infants < 1 year old, 300 for children 1–

2 years old, and 320 for children 3–5 

years old. 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 

fludioxonil 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 Table 4. of this unit:

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

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 < 1 year old 390 100 49 0.11 740

Children 1–2 years old 300 100 49 0.11 670

Children 3–5 years old 320 100 49 0.11 690

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). Fludioxonil 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 fludioxonil.

Using the exposure assumptions 

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

food and residential exposures 

aggregated result in aggregate MOEs of 

160 for all infants < 1 year old, 120 for 

children 1–2 years old, and 130 for 

children 3–5 years old. 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 fludioxonil 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 Table 5. of this unit:

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

Population Subgroup 

Aggregate 

MOE (Food 

+ Residential) 

Aggregate 

Level of 

Concern 

(LOC) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

IntermediateTerm 

DWLOC 

(ppb) 

All infants < 1 year old 160 100 49 0.11 100

Children 1–2 years old 120 100 49 0.11 30

Children 3–5 years old 130 100 49 0.11 50

5. Aggregate cancer risk for U.S. 

population. EPA has classified 

fludioxonil in ‘‘Group D’’ - not 

classifiable as to human carcinogenicity. 

Based on available data, the Agency 

concludes that the proposed use of 

fludioxonil does not present discernable 

aggregate cancer risk.

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 fludioxonil 

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology 

is available to enforce the tolerance 

expression. Apple, pear, kiwifruit, 

cantaloupe, yam, citrus, and 

pomegranate were analyzed for 

fludioxonil using Syngenta tolerance 

enforcement method AG–597B, 

Analytical Method for the 

Determination of CGA–219417 in Crops 

by High Performance Liquid 

Chromatography Including Validation 

Data, with Modifications. Head and leaf 

lettuce, lima bean, dry bean, and snap 

bean were analyzed for fludioxonil 

using Novartis working method AG–

631B, Determination of Residues of 

CGA–219417 in Crops by High 

Performance Liquid Chromatography 

with Column Switching.

Adequate enforcement methodology 

(liquid chromotography) is available to 

enforce the tolerance expression. The 

method may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; email address: residuemethods@epa.gov.

B. International Residue Limits

There are no CODEX, Canadian, or 

Mexican tolerances/maximum residue 

levels (MRLs) for fludioxonil residues 

on kiwifruit, yam, bean, dry and bean, 

succulent, citrus, leafy greens except 

spinach, melons, or pome fruit. Thus, 

harmonization is not an issue at this 

time.

V. Conclusion

Therefore, the tolerances are 

established for residues of fludioxonil, 

58090 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 

4-(2,2-difluoro-1,3-benzodioxol-4-yl)-

1H-pyrrole-3-carbonitrile, in or on bean, 

dry; bean, succulent at 0.4; citrus, crop 

group 10 at 10 ppm; fruit, pome, group 

11 at 5.0 ppm; grapefruit, oil at 500 

ppm; kiwifruit at 20 ppm; leafy greens 

subgroup 4A, except spinach at 30 ppm; 

melon subgroup 9A at 0.03; and yam, 

true at 8.0 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of FFDCA, as 

amended by 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 FFDCA 

by FQPA, EPA will continue to use 

those procedures, with appropriate 

adjustments, until the necessary 

modifications can be made. The new 

section 408(g) of FFDCA 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) of FFDCA, as was 

provided in the old sections 408 and 

409 of FFDCA. 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–2004–0321 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 29, 2004.

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 (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. 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) 564–6255.

2. 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 ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2004–0321, 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 20460–0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via email to: opp-docket@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. Statutory and Executive Order 

Reviews

This final rule establishes a tolerance 

under section 408(d) of FFDCA 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 section 408(d) of FFDCA, 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 

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58091

‘‘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 section 408(n)(4) of 

FFDCA. 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. Congressional Review Act

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 22, 2004.

Lois Rossi,

Director, Registration Division, Office of 

Pesticide Programs.

■ Therefore, 40 CFR part 180 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 180.516 is amended as 

follows:

a. By alphabetically adding 

commodities to the table in paragraph 

(a).

b. By removing the commodities 

‘‘Apricot,’’ ‘‘Caneberry,’’ ‘‘Nectarine,’’

‘‘Peach,’’ and ‘‘Plum’’ in the table in 

paragraph (b).

§ 180.516 Fludioxonil; tolerances for 

residues.

(a) * * *

Commodity Parts per 

million 

Bean, dry .................................. 0.4

Bean, succulent ........................ 0.4

*** * *

Citrus, crop group 10 ................ 10

*** * *

Fruit, pome, group 11 ............... 5.0

*** * *

Grapefruit, oil ............................ 500

*** * *

Kiwifruit ..................................... 20

Leafy greens subgroup 4A, except spinach .......................... 30

*** * *

Melon subgroup 9A .................. 0.03

*** * *

Yam, true .................................. 8.0

* * * * *

[FR Doc. 04–21803 Filed 9–28–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0312; FRL–7681–6]

Methoxyfenozide; Pesticide Tolerances

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a 

tolerance for residues of 

methoxyfenozide (benzoic acid, 3-

methyl-2-methyl-,2-(3,5-

methylbenzoyl)-2-(1,1-dimethylethyl) 

hydrazide) in or onblack sapote; 

canistel; coriander, leaves; mamey 

sapote; mango; papaya; pea and bean, 

succulent shelled, subgroup 6B; 

peppermint; sapodilla; spearmint; star 

apple; strawberries; vegetable, foliage of 

legume (except soybean), subgroup 7A; 

vegetable, leaves of root and tuber, 

group 2; vegetable, legume, edible 

podded, subgroup 6A; vegetable, root, 

subgroup 1A. Interregional Research 

Project Number 4 (IR-4) and Dow 

AgroSciences are requesting these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA).

DATES: This regulation is effective 

September 29, 2004. Objections and 

requests for hearings must be received 

on or before November 29, 2004.

ADDRESSES : To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under docket 

identification (ID) number OPP–2004–

0312. All documents in the docket are 

listed in the EDOCKET index athttp://

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT:

Joseph Tavano, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6411; e-mail 

address:tavano.joseph@epa.gov.

SUPPLEMENTARY INFORMATION: