Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Rules and Regulations 7707 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 4, 2011. 

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 § 180.920, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

1,4-Benzenedicarboxylic acid, dimethyl ester, polymer with 

1,4-butanediol, adipic acid, and hexamethylene 

diisocyanate, minimum number average molecular weight 

(in amu) 30,000 (CAS Reg. No. 55231–08–8).

For use in honeybee hive miticide formulations.Component of controlled release agent. 

* * * * * * * 

[FR Doc. 2011–3111 Filed 2–10–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0982; FRL–8859–6] 

Fludioxonil; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

fludioxonil in or on pineapple. This 

action is in response to EPA’s granting 

of an emergency exemption under 

section 18 of the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) 

authorizing use of the pesticide on 

pineapple. This regulation establishes a 

maximum permissible level for residues 

of fludioxonil in or on this commodity. 

The time-limited tolerance expires on 

December 31, 2013. 

DATES: This regulation is effective 

February 11, 2011. Objections and 

requests for hearings must be received 

on or before April 12, 2011, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION section). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0982. All documents in the 

docket are listed in the docket index 

available in 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: 

Andrea Conrath, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9356; e-mail address: 

conrath.andrea@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 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 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 get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. How can I file an objection or hearing 

request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (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–2010–0982 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before April 12, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 


emcdonald on DSK2BSOYB1PROD with RULES
7708 Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Rules and Regulations 

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. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0982, 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. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 

408(l)(6) of FFDCA, 21 U.S.C. 346a(e) 

and 346a(1)(6), is establishing a timelimited tolerance for residues of 

fludioxonil, (4-(2,2-difluoro-1,3- 

benzodioxol-4-yl)-1H-pyrrole-3- 

carbonitrile), in or on pineapple at 13 

parts per million (ppm). This timelimited tolerance expires on December 

31, 2013. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on FIFRA section 18 related 

time-limited tolerances to set binding 

precedents for the application of section 

408 of FFDCA and the safety standard 

to other tolerances and exemptions. 

Section 408(e) of FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. 

Section 408(b)(2)(A)(i) of 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. * * *’’ 

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for 

Fludioxonil on Pineapple and FFDCA 

Tolerances 

The applicant stated that unforeseen 

changes in available options for 

shipping Hawaiian pineapple to the 

mainland of the United States resulted 

in increased storage and transport time 

for the fruit. The overall increased 

shipment time is allowing surface molds 

to become established, which is leading 

to rejection, downgrading, or dumping 

of the unacceptable fruit. The Applicant 

stated that because of this unanticipated 

situation, an emergency situation exists, 

with significant economic losses 

suffered. Further, the Applicant asserts 

that without a suitable fungicide, such 

as fludioxonil, to address this issue, the 

future viability of the pineapple 

industry in Hawaii is threatened. 

After having reviewed the 

submission, EPA determined that an 

emergency condition exists for this 

State, and that the criteria for approval 

of an emergency exemption are met. 

EPA has authorized a specific 

exemption under FIFRA section 18 for 

the use of fludioxonil on Hawaiian 

pineapple for control of surface molds. 

As part of its evaluation of the 

emergency exemption application, EPA 

assessed the potential risks presented by 

residues of fludioxonil in or on 

pineapple. In doing so, EPA considered 

the safety standard in section 408(b)(2) 

of FFDCA, and EPA decided that the 

necessary tolerance under section 

408(l)(6) of FFDCA would be consistent 

with the safety standard and with 

FIFRA section 18. Consistent with the 

need to move quickly on the emergency 

exemption in order to address an urgent 

non-routine situation and to ensure that 

the resulting food is safe and lawful, 

EPA is issuing this tolerance without 

notice and opportunity for public 

comment as provided in section 

408(l)(6) of FFDCA. Although this timelimited tolerance expires on December 

31, 2013, under section 408(l)(5) of 

FFDCA, residues of the pesticide not in 

excess of the amount specified in the 

tolerance remaining in or on pineapple 

after that date will not be unlawful, 

provided the pesticide was applied in a 

manner that was lawful under FIFRA, 

and the residues do not exceed a level 

that was authorized by this time-limited 

tolerance at the time of that application. 

EPA will take action to revoke this timelimited tolerance earlier if any 

experience with, scientific data on, or 

other relevant information on this 

pesticide indicate that the residues are 

not safe. 

Because this time-limited tolerance is 

being approved under emergency 

conditions, EPA has not made any 

decisions about whether fludioxonil 

meets FIFRA’s registration requirements 

for use on pineapple or whether a 

permanent tolerance for this use would 

be appropriate. Under these 

circumstances, EPA does not believe 

that this time-limited tolerance decision 

serves as a basis for registration of 

fludioxonil by a State for special local 

needs under FIFRA section 24(c). Nor 

does this tolerance by itself serve as the 

authority for persons in any State other 

than Hawaii to use this pesticide on the 

applicable crops under FIFRA section 

18 absent the issuance of an emergency 

exemption applicable within that State. 

For additional information regarding the 

emergency exemption for fludioxonil, 

contact the Agency’s Registration 

Division at the address provided under 

FOR FURTHER INFORMATION CONTACT. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with 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 expected as a result 

of this emergency exemption request 

and the time-limited tolerance for 

residues of fludioxonil on pineapple at 


emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Rules and Regulations 7709 

13 ppm. EPA’s assessment of exposures 

and risks associated with establishing 

the time-limited tolerance follows. 

A. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern (LOC) to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

level at which no adverse effects are 

observed (the NOAEL) and the lowest 

level at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). 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 

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 a Section 18 Emergency 

Tolerance on Pineapple,’’ dated August 

4, 2010, p. 23–24 in Docket ID number 

EPA–HQ–OPP–2010–0982. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fludioxonil, EPA considered 

exposure under the time-limited 

tolerance established by this action 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. Adverse effects 

from acute exposure were identified for 

fludioxonil for the population subgroup 

females 13–49 years old. The acute 

population adjusted dose (aPAD) is set 

at 1.0 milligrams/kilograms/day (mg/kg/ 

day) based upon acute effects of 

increased incidence of fetuses and 

litters with dilated renal pelvis and 

dilated ureter seen in the rat 

developmental study. In estimating 

acute dietary exposure, EPA used food 

consumption information from the U.S. 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA conducted an acute dietary 

assessment assuming established and 

proposed tolerance-level residues for all 

commodities and default 100 percent 

crop treated (PCT) information for the 

population subgroup females 13–49 

years old. No anticipated residue or 

estimated PCT data were used. The 

estimated peak drinking water 

concentration of 108 parts per billion 

(ppb) was directly incorporated into the 

acute risk assessment. There were no 

significant toxicological effects 

attributable to a single exposure (dose) 

for the general population or any other 

population subgroups; therefore these 

populations’ subgroups were not 

included in this assessment. For food 

and drinking water, the exposure to 

females 13–49 years old (the only 

population subgroup demonstrating 

acute effects) utilized 15% of the aPAD 

at the 95th percentile of exposure 

distribution. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

conducted a chronic dietary assessment 

assuming established and proposed 

tolerance-level residues with the 

exception of the following: Anticipated 

residues (ARs) were generated for apple, 

grapefruit, lemon, lime, orange, pear, 

tomato, lettuce (head and leaf), fresh 

parsley, Brassica leafy vegetables (crop 

group 5), grape, cherry, peach, and plum 

based upon field trial data. Empirical 

processing factors were determined 

from processing studies for the juices of 

tomato, apple, grapefruit, lemon, lime, 

grape, and orange, and for raisins; 

default processing factors were used in 

all other instances. No PCT data were 

used (100% crop treated was assumed). 

The estimated chronic drinking water 

concentration of 53 ppb was directly 

incorporated into the assessment. Food 

and water consumption were compared 

to the chronic population adjusted dose 

(cPAD) of 0.03 mg/kg/day, which is 

based upon the chronic effect of 

decreased weight gain in females seen 

in the 1-year dog feeding study. For food 

and water consumption, the chronic 

exposure to fludioxonil utilized 26% of 

the cPAD for the general U.S. 

population and 88% of the cPAD for 

children 1–2 years old, the most highly 

exposed population subgroup. 

iii. Cancer. Based on the available 

data, EPA has determined that 

fludioxonil is a ‘‘Group D’’ chemical, not 

classifiable as to human carcinogenicity, 

and 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 highest dose of 

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 statistically significant, but 

only 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. Therefore, the 

Agency concluded that a dietary 

exposure assessment for assessing 

cancer risk is unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use PCT 

information in the dietary assessment 

for fludioxonil. One hundred percent of 

the pineapple crop was assumed 

treated. 

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 section 408(f)(1) of 

FFDCA 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 section 408(b)(2)(E) of 

FFDCA and authorized under section 

408(f)(1) of FFDCA. Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 


emcdonald on DSK2BSOYB1PROD with RULES
7710 Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Rules and Regulations 

Anticipated residue data were used in 

the chronic (non-cancer) dietary risk 

analyses but not in the acute dietary risk 

analysis. For certain tolerances, the 

anticipated residue values were 

determined from the field trial studies. 

Additionally, results of processed 

commodities studies show that 

fludioxonil residues do not concentrate 

to the extent that the existing crop 

tolerances 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 

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. 

Based on the First Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

fludioxonil for acute exposures are 

estimated to be 108 ppb for surface 

water and 0.4 ppb for ground water. The 

EDWCs for chronic exposures for noncancer assessments are estimated to be 

53 ppb for surface water and 0.4 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure models. For 

acute dietary risk assessment, the water 

concentration value of 108 ppb was 

used to assess the contribution of 

fludioxonil from drinking water. For 

chronic dietary risk assessment, the 

water concentration of value 53 ppb was 

used to assess the contribution of 

fludioxonil from 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: Residential turf 

and ornamental use, restricted to 

commercial applicators only. EPA 

assessed residential exposure using the 

following assumptions: The use on 

pineapple discussed in this document 

does not result in any residential nonoccupational exposures. Since there are 

no short- or intermediate-term dermal 

toxicity endpoints for fludioxonil, only 

a toddler post-application assessment 

for incidental ingestion exposures to 

treated lawns was conducted (for all 

child/infant subgroups). The combined 

short-term oral exposure risk estimate, 

which includes hand-to-mouth, objectto-mouth and soil ingestion pathways, 

was determined to be 0.013 mg/kg bw/ 

day, while the intermediate-term was 

determined to be 0.0074 milligrams/ 

kilograms of bodyweight/day (mg/kg 

bw/day). It should be noted that each of 

the incidental oral assessments (i.e., 

hand-to-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. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

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

pesticides/trac/science/trac6a05.pdf. 

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 Web site at 

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

cumulative. 

C. Safety Factor for Infants and Children 

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

FFDCA, as modified by the Food 

Quality Protection Act (FQPA), 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 SF 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 of rats and 

rabbits or following prenatal/postnatal 

exposure of rats. In the developmental 

study in rats, there was an increase in 

the number of fetuses and litters with 

dilated renal pelvis and dilated ureter, 

as well as a reduction in maternal body 

weight gain, at the lowest observed 

adverse effect level. The developmental 

effect was considered to be related to 

maternal toxicity rather than an 

indication of increased susceptibility. 

Since the developmental effects 

occurred at the same exposure levels 

that caused maternal effects, no 

evidence of increased susceptibility in 

rats was demonstrated from the 

developmental study. In the 2- 

generation rat reproduction study, 

offspring toxicity was seen at the dose 

that produced parental (maternal) 

toxicity. The maternal toxicity was 

manifested as increased clinical signs, 

decreased body weight, body weight 

gain and food consumption. Fetal 

toxicity was manifested as decreased 

weight gain in pups. Since 

developmental effects occurred at the 

same exposure levels that caused 

maternal effects, maternal and fetal 

toxicity were comparable, and it was 

concluded that there is no increased 

susceptibility indicated by results from 

the 2-generation reproduction study. In 

rabbits, no developmental toxicity was 

seen up to the highest dose tested which 

demonstrated maternal toxicity, and 

therefore it is concluded that there is no 

evidence of increased susceptibility 

demonstrated in rabbits. 

3. Conclusion. EPA has determined 

that reliable data show that 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. There are no residual uncertainties 

in the toxicity database. Existing data 

are sufficient for endpoint selection for 

exposure/risk assessment. The 

fludioxonil toxicity database is 

complete with the exception of an 

immunotoxicity study, and acute and 

subchronic neurotoxicity studies. The 

immunotoxicity and acute and 

subchronic neurotoxicity studies are 

now required by new data requirements 

for conventional pesticide registration 

(40 CFR part 158). The available data do 

not show potential for neurotoxicity or 

immunotoxicity. The overall weight-ofevidence suggests that fludioxonil does 

not directly target the immune system. 

Further, there is no evidence of 


emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Rules and Regulations 7711 

neurotoxicity or neuropathology in the 

fludioxonil database. Therefore, the 

Agency does not believe that the 

immunotoxicity and acute and chronic 

neurotoxicity studies will result in a 

lower POD than that currently in use for 

overall risk assessment. Thus, the 

Agency believes that a database 

uncertainty factor is not needed to 

account for lack of these studies. 

ii. There is no indication that 

fludioxonil is a neurotoxic chemical and 

therefore EPA finds no need for a 

developmental neurotoxicity study or 

additional uncertainty factors (UFs) to 

account for neurotoxicity. 

iii. There is no evidence that 

fludioxonil results in increased 

susceptibility of 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 PCT, 

tolerance-level residues, and anticipated 

residues as follows: Anticipated residue 

values for apple, grapefruit, lemon, 

lime, orange, pear, tomato, head lettuce, 

leaf lettuce, grape, cherry, peach, and 

plum were generated from field trials; 

anticipated residues were also 

determined from processing studies for 

raisins, and for the juice of apple, grape, 

grapefruit, lemon, lime, orange and 

tomato. These data are reliable and will 

not underestimate the exposure and 

risk. 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. 

D. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the aPAD and cPAD. For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

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 appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Based on the 

explanation in Unit IV.B.3, regarding 

residential use patterns, acute 

residential exposure to residues of 

fludioxonil is not expected. Therefore, 

since the acute aggregate risk 

assessment only includes exposure from 

food and water, no further calculations 

are necessary beyond the acute dietary 

analysis. There were no significant 

toxicological effects attributable to a 

single exposure (dose) for the general 

population or any other population 

subgroups; therefore these population 

subgroups were not included in this 

assessment. An acute dietary assessment 

was therefore conducted for the 

population subgroup females 13–49 

years old. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute aggregate 

exposure (food and water) to fludioxonil 

will occupy 15% of the aPAD for 

females 13–49 years old. 

2. Chronic risk. Based on the 

explanation in IV.B.3, unit regarding 

residential use patterns, chronic 

residential exposure to residues of 

fludioxonil is not expected. Therefore, 

since the chronic aggregate risk 

assessment only includes exposure from 

food and water, no further calculations 

are necessary beyond the chronic 

dietary analysis. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic aggregate exposure to 

fludioxonil (food and water) utilized 

88% of the cPAD for children 1–2 years 

old, the population subgroup receiving 

the greatest exposure. For the U.S. 

population the chronic aggregate 

exposure (food and water) utilized 26% 

of the cPAD. 

3. Short- and intermediate-term risk. 

Short- and 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 

uses that could result in short- and 

intermediate-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

short- and intermediate-term residential 

exposures to fludioxonil. Using the 

exposure assumptions described in this 

unit for short- and intermediate-term 

exposures, EPA has concluded that 

combined short- and intermediate-term 

food, water, and residential exposures 

result in aggregate MOEs for the most 

highly exposed subgroup, children 1–2 

years old, of 250 for short-term 

exposures and 100 for intermediate-term 

exposures. Because EPA’s level of 

concern for fludioxonil is a MOE of less 

than 100, these MOEs are not of 

concern. 

4. Aggregate cancer risk for U.S. 

population. Fludioxonil is classified as 

a ‘‘Group D’’ chemical, as discussed 

previously, and not classifiable as to 

human carcinogenicity. However, EPA 

expects the cancer risk of fludioxonil to 

be negligible. 

5. 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. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate enforcement 

methodology (high-pressure liquid 

chromatography method AG–597B) 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; e-mail 

address: residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by section 408(b)(4) of FFDCA. 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, section 408(b)(4) of FFDCA 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for fludioxonil on pineapple. 

VI. Conclusion 

For the reasons described above, a 

time-limited tolerance is established for 

residues of fludioxonil, (4-(2,2-difluoro1,3-benzodioxol-4-yl)-1H-pyrrole-3- 

carbonitrile), in or on pineapple at 13 

ppm. This tolerance expires on 

December 31, 2013. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a timelimited tolerance under sections 408(e) 

and 408(l)(6) of FFDCA. The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 


emcdonald on DSK2BSOYB1PROD with RULES
7712 Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Rules and Regulations 

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, 

entitled 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 in accordance with 

sections 408(e) and 408(l)(6) 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) (Pub. L. 

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). 

VIII. 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: January 24, 2011. 

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. Section 180.516 is amended by 

alphabetically adding ‘‘pineapple’’ to the 

table in paragraph (b) to read as follows: 

§ 180.516 Fludioxonil; tolerances for 

residues. 

* * * * * 

(b) * * * 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Pineapple ........ 13 12/31/13 

* * * * * 

* * * * * 

[FR Doc. 2011–2405 Filed 2–10–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0217; FRL–8858–3] 

Clothianidin; Time-Limited Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

clothianidin in or on rice, seed. Valent 

U.S.A. Corporation requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). The 

tolerances expire on June 23, 2012. 

DATES: This regulation is effective 

February 11, 2011. Objections and 

requests for hearings must be received 

on or before April 12, 2011, 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–2010–0217. 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: 

Marianne Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8043; e-mail address: 

lewis.marianne@epa.gov. 

SUPPLEMENTARY INFORMATION: 


emcdonald on DSK2BSOYB1PROD with RULES