Federal Register / Vol. 73, No. 176 / Wednesday, September 10, 2008 / Rules and Regulations 52597 

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: August 26, 2008. 

Donald R. Stubbs, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.448 is amended in 

paragraph (a), in the table by revising 

the entries for the following 

commodities to read as follows: 

§180.448 Hexythiazox; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Apple, wet pomace ................... 0.40 

* * * * * 

Cattle, meat byproducts ........... 0.02 

Citrus, dried pulp ...................... 0.60 

Citrus, oil ................................... 24 

* * * * * 

Fruit, pome, group 11 ............... 0.25 

* * * * * 

Goat, meat byproducts ............. 0.02 

* * * * * 

Horse, meat byproducts ........... 0.02 

* * * * * 

Sheep, meat byproducts .......... 0.02 

* * * * * 

[FR Doc. E8–20513 Filed 9–9–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0940; FRL–8379–9] 

Fludioxonil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fludioxonil in 

or on avocado; canistel; citrus, oil; 

mango; papaya; sapodilla; sapote, black; 

sapote, mamey; star apple; tomatillo; 

tomato; vegetable, cucurbit, crop group 

9; vegetable, leaves of root and tuber, 

crop group 2; vegetable, root, except 

sugar beet, subgroup 1B; and vegetable, 

tuberous and corm, except potato, 

subgroup 1D. The Interregional 

Research Project Number 4 (IR-4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA) on behalf of the registrant, 

Syngenta Crop Protection, Greensboro, 

NC 27409. 

DATES: This regulation is effective 

September 10, 2008. Objections and 

requests for hearings must be received 

on or before November 10, 2008, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2007–0940. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (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 in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S–

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305–

5805. 

FOR FURTHER INFORMATION CONTACT: 

Sidney Jackson, Registration Division 

(7505P), 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 those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide 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? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s pilot 

e-CFR site at http://www.gpoaccess.gov/ 

ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 


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52598 Federal Register / Vol. 73, No. 176 / Wednesday, September 10, 2008 / Rules and Regulations 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2007-0940 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 

as required by 40 CFR part 178 on or 

before November 10, 2008. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA–

HQ–OPP–2007-0940, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of October 24, 

2007 (72 FR 60369) (FRL–8150–8), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 7E7234) by the 

Interregional Research Project Number 4 

(IR-4), IR-4 Project Headquarters, 500 

College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

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)-1Hpyrrole-3-carbonitrile, in or on tomato at 

0.4 parts per million (ppm); tomatillo at 

0.4 ppm; tomato, paste at 1.0 ppm; 

avocado at 0.45 ppm; black sapote at 

0.45 ppm; canistel at 0.45 ppm; mamey 

sapote at 0.45 ppm; mango at 0.45 ppm; 

papaya at 0.45 ppm; sapodilla at 0.45 

ppm; star apple at 0.45 ppm; herb, 

subgroup 19A, fresh at 13 ppm; herb, 

subgroup19A, dried at 55 ppm; leaves of 

root and tuber vegetables at 40 ppm; 

root vegetables, except sugar beet, 

subgroup at 0.5 ppm; lemon at 0.25 

ppm; lime at 0.25 ppm; cucurbits at 0.6 

ppm; and tuberous and corm vegetables, 

except potato subgroup at 4.0 ppm. 

Additionally, IR-4 proposed that upon 

establishment of the above new 

tolerances, 40 CFR 180.516 be amended 

by removing the established tolerances 

for fludioxonil in or on the food 

commodities; herb, subgroup 19A, fresh 

at 10 ppm; herb, subgroup 19A, dried at 

65 ppm; carrot at 0.75 ppm; and turnip, 

greens at 10 ppm. That notice 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

Greensboro, NC 27409, the registrant, 

which is available to the public in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA made 

changes or modifications to some of the 

proposed tolerances and/or commodity 

listings as detailed in this document—

Unit IV.C. Revisions to Petitioned-For 

Tolerances. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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 * * *.’’

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

of FFDCA, and the factors specified in 

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 for the petitioned-for 

tolerances for residues of fludioxonil in 

or on tomato at 0.4 ppm; tomatillo at 0.4 

ppm; tomato, paste at 1.0 ppm; avocado 

at 0.45 ppm; black sapote at 0.45 ppm; 

canistel at 0.45 ppm; mamey sapote at 

0.45 ppm; mango at 0.45 ppm; papaya 

at 0.45 ppm; sapodilla at 0.45 ppm; star 

apple at 0.45 ppm; herb, subgroup 19A, 

fresh at 13 ppm; herb, subgroup19A, 

dried at 55 ppm; leaves of root and tuber 

vegetables at 40 ppm; root vegetables, 

except sugar beet subgroup at 0.5 ppm; 

lemon at 0.25 ppm; lime at 0.25 ppm; 

cucurbits at 0.6 ppm; and tuberous and 

corm vegetables, except potato subgroup 

at 4.0 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing tolerances follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. 

Fludioxonil is of low acute toxicity 

and is not a dermal sensitizer. For 

subchronic and chronic toxicity, the 

primary effects in the mouse and rat 

were similar and included decreased 

body weight and food consumption 

associated with clinical pathological 

and histopathological effects in the liver 

and kidney. In the subchronic dog 

study, diarrhea was the most sensitive 

indicator of toxicity. In contrast, 

decreased weight gain in females was 

the most sensitive indicator of toxicity 

in the chronic toxicity study in dogs. 

Liver toxicity was observed in both dog 

studies at higher doses. The available 

data did not indicate a need for acute or 

subchronic neurotoxicity studies. 

Fludioxonil was not teratogenic in 

rabbits. In a rat developmental toxicity 

study, it caused an increase in fetal 

incidence and litter incidence of dilated 

renal pelvis at the limit dose (1,000 mg/ 

kg/day). There was no quantitative or 

qualitative evidence of increased 

susceptibility following in utero 

exposure to rats and rabbits or following 

pre-/post-natal exposure to rats. 

EPA determined that fludioxonil was 

not classifiable as to human 

carcinogenicity but nonetheless poses a 

negligible cancer risk. This conclusion 

was based on the fact that cancer studies 

with fludioxonil only showed marginal 

evidence of cancer in one sex of the 

species. There was no evidence of 

carcinogenicity in mice when tested up 

to the limited dose 7,000 ppm. There 


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was no evidence of carcinogenicity in 

male rats, but there was a statistically 

significant increase, both trend and 

pairwise, of combined hepatocellular 

tumors in female rats. The pairwise 

increase for combined tumors was 

significant at p=0.03, which is not a 

strong indication of a positive effect. 

Further, statistical significance was only 

found when liver adenomas were 

combined with liver carcinomas. 

Finally, the increase in these tumors 

was within, but at the high end, of the 

historical controls. Fludioxonil was not 

mutagenic in the tests for gene 

mutations. However, based on the 

induction of polyploidy in the in vitro 

Chinese hamster ovary cell cytogenetic 

assay and the suggestive evidence of 

micronuclei induction in rat 

hepatocytes in vivo, additional 

mutagenicity testing was performed in 

three studies specifically designed to 

address the concerns regarding 

aneuploidy. The results of these assays 

were negative for aneuploidy activity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fludioxonil as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

Fludioxonil. Human Health Risk 

Assessment for Section 3 Tolerances on 

Avocado......and Brassica Vegetables, 

dated July 10, 2008 at page 20 in docket 

ID number EPA–HQ–OPP–2007–0940- 

003. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

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. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for fludioxonil used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

Fludioxonil. Human Health Risk 

Assessment for Section 3 Tolerances on 

Avocado......and Brassica Vegetables, 

dated July 10, at page 20 in docket ID 

number EPA–HQ–OPP–2007–0940- 

0003. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fludioxonil, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

fludioxonil tolerances in 40 CFR 

180.516. EPA assessed dietary 

exposures from fludioxonil in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

In estimating acute dietary exposure, 

EPA used the Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

(DEEM-FCIDTM, Version 2.03), which 

incorporates food consumption 

information from the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intakes by 

Individuals (CSFII). As to residue levels 

in food, acute dietary exposure analysis 

is based on tolerance-level residues. 

EPA assumed that 100% of the crops 

with fludioxonil tolerances are treated. 

The only population subgroup that is 

relevant for this acute assessment is 

females of child-bearing age (i.e., 

females 13 to 49 years old). 

ii. Chronic exposure. In conducting 

the chronic dietary (food + water) 

exposure assessment EPA used the food 

consumption data from the USDA 1994–

1996 and 1998 Nationwide CSFII. As to 

residue levels in food, the chronic 

dietary exposure analyses assumed 

tolerance-level residues for most 

commodities with existing and 

proposed tolerances. Anticipated 

residues (AR) values were determined 

for apple, grapefruit, lemon, lime, pear, 

orange and orange juices using average 

residues from field trials and processing 

factors from processing studies. 

Processing factors were set to 1X for all 

relevant processed commodities. DEEMFCID default processing factors were 

used for all other processed 

commodities. The population subgroup 

of highest exposure is children 1to 2 

years old. The Agency assumed 100% of 

crops with fludioxonil tolerances are 

treated. 

iii. Cancer. As explained above, EPA 

determined that fludioxonil was not 

classifiable as to human carcinogenicity. 

Therefore, no assessment of exposure 

for the purpose of estimating cancer risk 

is necessary. 

iv. Anticipated residue. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

Anticipated residue data were used in 

the chronic (non-cancer) dietary risk 

analyses but not in the acute dietary risk 

analysis. For certain proposed tolerance 

crops, the anticipated residues values 

were determined from the field trial 

studies. Additionally, results of 

processed commodities studies show 

that fludioxinil residues do not 

concentrate to the extent that the 

existing crop tolerance would be 

exceeded. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fludioxonil in drinking water. These 


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simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of fludioxonil. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

The maximum application rates for 

the new uses are less than the 

application rate for turfgrass. Therefore, 

the values for turfgrass (worst case) were 

used in the human health risk 

assessment. Tier 1 drinking water 

assessment for fludioxonil on turfgrass 

is based on the label application rate for 

turfgrass, which is used in this current 

assessment, and is three applications of 

0.67 lb active ingredient/Acre (ai/A) 

applied using 14-day intervals, for a 

total application rate of 2 lb ai/A/year. 

Based on the First Index Reservoir 

Screening Tool (FIRST and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

fludioxonil for acute and chronic (noncancer) exposures. EDWCs were 

modeled based on the use site with the 

highest application rate; i.e., spray/foliar 

applications to turfgrass of 2.0 lbs ai/A/ 

yr. For acute exposure, EDWCs are 

estimated to be 81.3 parts per billion 

(ppb) for surface water and 0.20 ppb for 

ground water. The EDWCs for chronic 

exposures for non-cancer assessments 

are estimated to be 37.4 ppb for surface 

water and 0.20 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 81.3 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 37.4 ppb was used to assess the 

contribution to drinking 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 

the following uses that could result in 

residential exposures: turfgrass and 

ornamentals. EPA assessed residential 

exposure using the following 

assumptions: The current petition for 

fludioxonil results in no residential/ 

non-occupational exposures. Since the 

product registered for residential uses, 

Medallion (EPA Reg. No. 100–769), is 

restricted for residential uses to 

commercial applicators-only, and since 

the Agency did not identify short- or 

intermediate-term dermal endpoints, 

only a toddler post-application 

assessment for incidental ingestion 

exposures to treated lawns was 

included. 

The combined short-term oral 

exposure risk estimate, which includes 

hand-to-mouth, object-to-mouth and soil 

ingestion pathways, was previously 

determined to be 0.013 milligrams/ 

kilogram of bodyweight/day (mg/kg bw/ 

day), while the intermediate-term was 

determined to be 0.0074 mg/kg bw/day. 

It should be noted that each of the 

incidental oral assessments (i.e., handto-mouth, object-to-mouth and soil 

ingestion) are considered conservative. 

Therefore, combining all the 

assessments is expected to provide a 

highly conservative assessment of 

children’s incidental oral exposure. 

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.’’

EPA has not found fludioxonil to 

share a common mechanism of toxicity 

with 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 

assumed that fludioxonil does not have 

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 EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(c) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) 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 database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There was no quantitative or qualitative 

evidence of increased susceptibility 

following in utero exposure to rats and 

rabbits or following prenatal/postnatal 

exposure to rats. In the rat 

developmental study, there was an 

increase in the number of fetuses and 

litters with dilated renal pelvis and 

dilated ureter. This finding was 

considered to be related to maternal 

toxicity rather than an indication of 

increased susceptibility. Therefore, it is 

concluded that there is no evidence of 

increased susceptibility in the 

developmental toxicity study in the rat. 

In the rabbit developmental study, no 

developmental toxicity was seen up to 

the highest dose tested. Materal toxicity 

was demonstrated at that dose. In the 2- 

generation rat reproduction study, 

offspring toxicity was seen at the dose 

that produced parental toxicity. The 

parental toxicity was manifested as 

increased clinical signs, decreased body 

weight, body weight gain and food 

consumption. Offspring toxicity was 

manifested as decreased weight gain in 

pups. Since parental and offspring 

toxicity were comparable, it was 

concluded that there is no increased 

susceptibility in the 2-generation 

reproduction study. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for fludioxonil 

is complete. 

ii. There is no indication that 

fludioxonil is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that 

fludioxonil results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100% CT and 

tolerance-level residues or residues from 

crop field trials. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to fludioxonil in 

drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of children as 

well as incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by fludioxonil. 


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Federal Register / Vol. 73, No. 176 / Wednesday, September 10, 2008 / Rules and Regulations 52601 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single-oral exposure was identified 

and no acute dietary endpoint was 

selected for the general population 

including infants and children. 

Therefore, fludioxonil is not expected to 

pose an acute risk. 

Using the exposure assumptions 

discussed in this unit for acute exposure 

for females 13 to 49 years old, the acute 

dietary exposure from food and water to 

fludioxonil will occupy 14% of the 

aPAD for (females 13 to 49 years old) 

the population group receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fludioxonil 

from food and water will utilize 89% of 

the cPAD for (children 1 to 2 years old) 

the population group receiving the 

greatest exposure. 

Based on the discussions above 

regarding residential use patterns, 

chronic residential exposure to residues 

of fludioxonil is not expected. The 

chronic aggregate risk does not exceed 

the Agency’s level of concern. 

3. Short-term risk. In aggregating 

short-term risk, EPA considers 

background chronic dietary exposure 

(food + water) and short-term, 

residential non-dietary oral and dermal 

exposures. Fludioxonil is restricted to 

commercial handlers. Therefore, the 

only non-occupational exposure 

expected to result from the residential 

uses of fludioxonil is post-application 

exposure. For adults, post-application 

exposures may result from dermal 

contact with treated turf. For toddlers, 

dermal and non-dietary oral postapplication exposures may result from 

dermal contact with treated turf as well 

as hand-to-mouth transfer of residues 

from turfgrass. However, the Agency did 

not identify short-term dermal 

endpoints for fludioxonil. Therefore, the 

short-term aggregate risk for fludioxonil 

considers food, water, and residential 

non-dietary oral exposures (for 

toddlers). 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures aggregated result 

in aggregate MOEs of 250 for children (1 

to 2 years old) and 280 for children (3 

to 5 years old) for short-term scenario. 

These values are well above the 

Agency’s level of concern of an 

aggregate MOE level of below 100. 

4. Intermediate-term risk. In 

aggregating intermediate-term risk, the 

Agency considers background chronic 

dietary exposure (food + water) and 

intermediate-term, residential nondietary oral and dermal exposures. 

Based on the residential use pattern, 

there is a possibility, although unlikely, 

that a toddler may experience 

intermediate-term exposures to 

fludioxonil residues on treated lawns. 

As with the short-term aggregate 

assessment, only non-dietary exposures 

are included. Therefore, the 

intermediate-term aggregate risk for 

fludioxonil considers food, water, and 

residential non-dietary oral exposures 

(for toddlers). 

All intermediate-term aggregate risk 

estimates result in MOEs greater than 

100, with the exception that the MOE 

for children 1 to 2 years old is 98, just 

below 100. Due to the conservative 

nature of the dietary exposure 

assessment (assumes 100% of crops 

with tolerances are treated and most 

crops have residues at the tolerancelevel and the fact that dietary exposure 

is 78 percent of the aggregate exposure), 

EPA does not have any concern for the 

purposes of this action. Intermediateterm aggregate exposure to fludioxonil, 

as a result of all registered and proposed 

uses, is below EPA’s level of concern. 

5. Aggregate cancer risk for U.S. 

population. Fludioxonil poses a 

negligible cancer risk. Cancer studies 

with fludioxonil only showed marginal 

evidence of cancer in one sex of one 

species. There was no evidence of 

carcinogenicity in mice when tested up 

to the limited dose 7,000 ppm. There 

was no evidence of carcinogenicity in 

male rats, but there was a statistically 

significant increase, both trend and 

pairwise, of combined hepatocellular 

tumors in female rats. The pairwise 

increase for combined tumors was 

significant at p=0.03, which is not a 

strong indication of a positive effect. 

Further, statistical significance was only 

found when liver adenomas were 

combined with liver carcinomas. 

Finally, the increase in these tumors 

was within, but at the high end, of the 

historical controls. 

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, or to infants and children 

from aggregate exposure to fludioxonil 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

High Performance Liquid 

Chromatography 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 Canadian or Mexican 

Maximum Residue Limits (MRLs) for 

residues of fludioxonil. There are Codex 

limits on tomato (higher than the U.S. 

limit; 0.5 ppm vs 0.40 ppm, proposed), 

herbs (equal to or lower than the U.S. 

limit), cucurbits (lower than the U.S. 

limit), and carrot (lower than the U.S. 

limit). Except for tomato, the Codex 

MRLs are not a restriction on items for 

which there is a significant import 

trade. Since having the U.S. tolerance 

lower than the Codex MRL would cause 

a barrier to tomato imports, the tomato 

and tomatillo tolerances were raised 

from 0.40 ppm to 0.50 ppm. 

C. Revisions to Petitioned-For 

Tolerances 

The Agency modified/amended 

certain tolerances as proposed by the 

registrant and/or indicated by available 

supporting data, as follows: 

i. Proposed new tolerances for herb 

subgroup 19A, fresh at 13 ppm and herb 

subgroup 19A, dried at 55 ppm were 

rejected by EPA and existing tolerances 

at 10 ppm and 60 ppm, respectively, 

were retained. The petitioner requested 

that the existing data for fresh and dry 

basil and chive be combined with the 

submitted parsley data and used in 

support of the requested tolerances on 

the herb subgroup 19A, fresh and dried 

at 13 ppm and 55 ppm, respectively. 

There are adequate residue field trials to 

support a tolerance on parsley, fresh 

and dried. The analytical results show 


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52602 Federal Register / Vol. 73, No. 176 / Wednesday, September 10, 2008 / Rules and Regulations 

that fludioxonil residues were 3.87 ppm 

in fresh parsley and 22.29 ppm in dried 

parsley. It is EPA policy to analyze each 

crop in a group separately and establish 

the group tolerance using the highest of 

the individual analyses. Since there are 

existing tolerances for herb subgroup 

19A, fresh and dried at 10 ppm and 65 

ppm, respectively, and the data from the 

parsley residue field trials do not exceed 

those established tolerances using the 

same treatment pattern, no change in 

the group tolerance is required. 

ii. Proposed tolerances for lime at 0.25 

ppm; and lemon at 0.25 ppm were 

determined to be unnecessary due to the 

existing tolerance on fruit, citrus, group 

10 at 10 ppm and the citrus, oil 

tolerance at 500 ppm established by this 

regulation. 

iii. Proposed tolerances for tomato at 

0.40 and tomatillo at 0.40 were both 

raised to 0.50 ppm to address 

international harmonization issues. 

Proposed tolerances for tomato paste at 

1.0 ppm is not needed. Results of 

processed commodities studies show 

that fludioxonil residues do not 

appreciably concentrate, and 

iv. Certain commodity definitions in 

the petition were corrected or revised to 

comply with EPA’s Pesticide Tolerance 

Crop Grouping Program outlined in the 

Federal Register of December 7, 2007, 

72 FR 69150 

V. Conclusion 

Therefore, tolerances are established 

for residues of the fungicide fludioxonil, 

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

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

avocado at 0.45 ppm, canistel at 0.45 

ppm, citrus, oil at 500 ppm, mango at 

0.45 ppm, papaya at 0.45 ppm, sapodilla 

at 0.45 ppm, sapote, black at 0.45 ppm, 

sapote, mamey at 0.45 ppm, star apple 

at 0.45 ppm, tomatillo at 0.50 ppm, 

tomato at 0.50 ppm, vegetable, cucurbit, 

crop group 9 at 0.45 ppm, vegetable, 

leaves of root and tuber, crop group 2 

at 30 ppm, vegetable, root, except sugar 

beet, subgroup 1B at 0.75 ppm, and 

vegetable, tuberous and corm, except 

potato, subgroup 1D at 3.5 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

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 final rule 

has been exempted from review under 

Executive Order 12866, this final 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) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

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., 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). 

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. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not 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). 

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). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report 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: August 25, 2008. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.516 the table to paragraph 

(a) is amended by removing the entries 

for ‘‘carrot;’’ ‘‘grapefruit oil’’ and 

‘‘leaves and roots of tuber vegetables,’’

and by alphabetically adding the 

following commodities, except for 

‘‘vegetable, cucurbit, group 9,’’ which is 

revised. The added and revised entries 

read as follows: 

§ 180.516 Fludioxonil; tolerance for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Avocado ........................................ 0.45 

* * * * * 

Canistel ......................................... 0.45 

* * * * * 

Citrus, oil ....................................... 500 

* * * * * 

Mango ........................................... 0.45 

* * * * * 

Papaya .......................................... 0.45 

* * * * * 

Sapodilla ....................................... 0.45 

Sapote, black ................................ 0.45 

Sapote, mamey ............................ 0.45 

* * * * * 

Star apple ..................................... 0.45 

* * * * * 

Tomatillo ....................................... 0.50 

Tomato .......................................... 0.50 

* * * * * 

Vegetable, cucurbit, crop group 9 0.45 


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Federal Register / Vol. 73, No. 176 / Wednesday, September 10, 2008 / Rules and Regulations 52603 

Commodity Parts per 

million 

* * * * * 

Vegetable, leaves of root and 

tuber, crop group 2 ................... 30 

Vegetable, root, except sugar 

beet, subgroup 1B .................... 0.75 

* * * * * 

Vegetable, tuberous and corn, except potato, subgroup 1D ......... 3.5 

* * * * * 

* * * * * 

[FR Doc. E8–20547 Filed 9–9–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0262; FRL–8379–8] 

Spiromesifen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation revises the 

tolerances for combined residues of 

spiromesifen and its enol metabolite in 

or on corn. Bayer CropScience requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 10, 2008. Objections and 

requests for hearings must be received 

on or before November 10, 2008, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2008–0262. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(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 in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S–

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305–

5805. 

FOR FURTHER INFORMATION CONTACT: 

Amer Al-Mudallal, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 605–0566; e-mail address: almudallal.amer@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 those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide 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? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s pilot 

e-CFR site at http://www.gpoaccess.gov/ 

ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2008–0262 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 

as required by 40 CFR part 178 on or 

before November 10, 2008. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA–

HQ–OPP–2008–0262, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of May 16, 

2008 (73 FR 28461) (FRL–8361–6), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 7F7274) by Bayer 

CropScience, P. O. Box 12014, 2 T. W. 

Alexander Drive, Research Triangle 

Park, NC 27709. The petition requested 

that 40 CFR 180.607 be amended by 

increasing tolerances for combined 

residues of the insecticide/miticide 

spiromesifen in or on corn, field, forage 

from 3.0 ppm to 6.0 ppm. That notice 

referenced a summary of the petition 

prepared by Bayer CropScience, the 

registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 


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