11344 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 

of potassium hypochlorite in or on all 

commodities. 

[FR Doc. 2011–4534 Filed 3–1–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0823; FRL–8864–9] 

Difenoconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

difenoconazole in or on mango and wax 

jambu. Syngenta Crop Protection, 

Incorporated requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 2, 2011. Objections and requests 

for hearings must be received on or 

before May 2, 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–2009–0823. 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: 

Tony Kish, Registration Division, Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (703) 308– 

9443; e-mail address: 

kish.tony@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 get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 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 FFDCA section 408(g), 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–2009–0823 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 May 2, 2011. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

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–2009–0823, 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. Summary of Petitioned-For 

Tolerances 

In the Federal Register of January 6, 

2010 (75 FR 864) (FRL–8801–5), 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 9E7573) by 

Syngenta Crop Protection, Inc., P. O. 

Box 18300, Greensboro, NC 27419. The 

petition requested that 40 CFR 180.475 

be amended by establishing tolerances 

for residues of the fungicide, 

difenoconazole, [1-[2-[2-chloro-4-(4- 

chlorophenoxy)phenyl]-4-methyl-1,3- 

dioxolan-2-ylmethyl]-1H–1,2,4-triazole], 

in or on mango at 0.09 parts per 

million(ppm) and waxapple at 1.5 ppm. 

That notice referenced a summary of the 

petition prepared by Syngenta Crop 

Protection, Inc., the registrant, which is 

available 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 

the proposed tolerance for mango, fruit 

from 0.09 ppm to 0.07 ppm to reflect the 

Agency’s recommended tolerance level. 

Additionally, EPA corrected commodity 

definitions from ‘‘mango, fruit’’ to 

‘‘mango’’ and ‘‘waxapple’’ to ‘‘wax jambu’’ 

to reflect prescribed terminology. The 

reasons for these changes are explained 

in Unit IV.D. 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 11345 

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 difenoconazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with difenoconazole 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. 

Difenoconazole possesses low acute 

toxicity by the oral, dermal and 

inhalation routes of exposure. It is not 

considered to be an eye or skin irritant 

and is not a dermal sensitizer. 

In an acute neurotoxicity study in 

rats, reduced fore-limb grip strength was 

observed on day 1 in males and clinical 

signs of neurotoxicity in females at the 

limit dose of 2,000 milligrams/kilogram 

(mg/kg). This effect in males is 

considered as transient since it was not 

observed at later observation points and 

toxicity in females was observed only at 

doses exceeding the limit dose. In a 

subchronic neurotoxicity study in rats 

decreased hind limb strength was 

observed only in males, which was 

considered as nonspecific in nature. 

Difenoconazole is not a 

developmental or reproductive toxicant. 

Chronic effects in mice and rat studies 

are seen as cumulative decreases in 

body weight gains. 

Difenoconazole is not mutagenic. 

Evidence for carcinogenicity was seen 

only in the mice study, where liver 

tumors were induced at excessively 

high doses for carcinogenicity testing. 

Liver tumors were observed in mice at 

300 ppm and higher. Based on excessive 

toxicity observed at the two highest 

doses of 2,500 and 4,500 ppm, the 

absence of tumors at two lower doses of 

10 and 30 ppm, as well as, the absence 

of genotoxic effects, the Agency 

classified difenoconazole as a Group C, 

possible human carcinogen with a nonlinear margin-of-exposure (MOE) 

approach for human risk 

characterization. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by difenoconazole as well 

as the no-observed-adverse-effects-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in the document 

entitled, ‘‘Difenoconazole FQPA Human 

Health Risk Assessment to Support the 

Establishment of Import Tolerances on 

Mango and Waxapple (also known as 

Wax jambu),’’ at pages 28–35, dated 

January 28, 2010, Document No. EPA– 

HQ–OPP–2009–0823–003. 

B. 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 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 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose 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 difenoconazole used for 

human risk assessment is shown in the 

following Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DIFENOCONAZOLE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (All populations).NOAEL = 25 mg/kg/day ....

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

aRfD = 0.25 mg/kg/day .....

aPAD = 0.25 mg/kg/day 

Acute Neurotoxicity Study in rats LOAEL = 200 mg/kg/ 

day in males based on reduced fore-limb grip 

strength in males on day 1. 

Chronic dietary (All populations).NOAEL = 0.96 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

cRfD = 0.01 mg/kg/day .....

cPAD = 0.01 mg/kg/day 

Combined chronic toxicity/carcinogenicity (rat; dietary) 

LOAEL = 24.1/32.8 mg/kg/day (M/F) based on cumulative decreases in body-weight gains. 

WReier-Aviles on DSKGBLS3C1PROD with RULES

11346 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DIFENOCONAZOLE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Dermal short-term (1 to 30 

days) and intermediateterm (1 to 6 months).

Oral NOAEL = 1.25 mg/kg/ 

day (dermal absorption 

factor = 15.3%). 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for MOE 

= < 100.

Reproduction and fertility effects (rat; dietary) Offspring LOAEL = 12.5 mg/kg/day based on reduction 

in body weight of F0 females prior to mating, gestation and lactation. 

Inhalation short-term (1 to 

30 days) and Intermediate-term Inhalation (1 

to 6 months).

Oral NOAEL= 1.25 mg/kg/ 

day inhalation absorption 

rate = assumed as 100% 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for MOE 

< 100.

Reproduction and fertility effects (rat; dietary) Offspring LOAEL = 12.5 mg/kg/day based on reduction 

in body weight of F0 females prior to mating, gestation and lactation. 

Cancer (Oral, dermal, inhalation).Difenoconazole is classified as a Group C, possible human carcinogen with a non-linear (MOE) approach for 

human risk characterization. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to difenoconazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing difenoconazole tolerances in 40 

CFR 180.475. EPA assessed dietary 

exposures from difenoconazole 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. 

Such effects were identified for 

difenoconazole. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA assumed 

tolerance-level residues, 100 percent 

crop treated (PCT), and the available 

empirical or Dietary Exposure 

Evaluation Model (DEEMTM) (ver. 7.81) 

default processing factors. 

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 

assumed tolerance-level residues for 

some commodities, average field trial 

residues for the majority of 

commodities, the available empirical or 

DEEMTM (ver. 7.81) default processing 

factors, and 100 PCT. 

iii. Cancer. No evidence of 

carcinogenicity was seen in rats. 

Evidence for carcinogenicity was seen 

in mice, where liver tumors were 

induced at doses which were 

considered to be excessively high for 

carcinogenicity testing. Liver tumors 

were observed in mice at 300 ppm and 

higher; however, based on excessive 

toxicity observed at the two highest 

doses of 2,500 and 4,500 ppm (females 

terminated after 2 weeks due to 

excessive toxicity resulting in 

moribundity and death), the absence of 

tumors at two lower doses of 10 and 30 

ppm and the absence of genotoxic 

effects, the Agency classified 

difenoconazole as a Group C, possible 

human carcinogen with a non-linear 

MOE approach for human risk 

characterization. A MOE approach in 

risk assessment was chosen utilizing the 

NOAEL of 30 ppm (4.7 and 5.6 mg/kg/ 

day in males and females, respectively) 

and the LOAEL of 300 ppm (46 and 58 

mg/kg/day in males and females, 

respectively) from the mouse study 

using only those biological endpoints 

which were relevant to tumor 

development (i.e., hepatocellular 

hypertrophy, liver necrosis, fatty 

changes in the liver and bile stasis). 

However, EPA determined that a 

quantitative cancer exposure assessment 

is unnecessary since the NOAEL (4.7 

and 5.6 mg/kg/day in males and 

females, respectively) to assess cancer 

risk is higher than the NOAEL (0.96 and 

1.27 mg/kg/day in males and females, 

respectively) to assess chronic risks. 

Therefore, the chronic dietary risk 

estimate will be protective of potential 

cancer risk. 

iv. Anticipated residues and percent 

crop treated (PCT) information. EPA did 

not use PCT information in the dietary 

assessment of difenoconazole. EPA used 

anticipated residues including average 

field trial residues for the majority of 

commodities, the available empirical or 

DEEMTM (ver. 7.81) default processing 

factors; and 100 PCT information in the 

chronic dietary assessment for 

difenoconazole. 

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. 

2. Dietary exposure from drinking 

water. Although the subject petition is 

for import tolerances and therefore does 

not result in drinking water exposure, 

there are existing uses of difenoconazole 

registered in the United States. The 

drinking water assessment was 

conducted for parent compound only. 

The fate and transport database for 

difenoconazole were sufficient to 

conduct the drinking water assessment. 

The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for difenoconazole in drinking water. 

These simulation models take into 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 11347 

account data on the physical, chemical, 

and fate/transport characteristics of 

difenoconazole. 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 Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

difenoconazole for acute exposures are 

estimated to be 15.8 parts per billion 

(ppb) for surface water and 0.0128 ppb 

for ground water. 

Chronic exposures for non-cancer 

assessments are estimated to be 10.4 

ppb for surface water and 0.0128 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 15.8 ppb 

was used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 10.4 

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). 

Difenoconazole is currently registered 

for the following uses that could result 

in residential exposures: Ornamentals. 

EPA assessed residential exposure using 

the following assumptions: Adults may 

be exposed to difenoconazole from its 

currently registered use on ornamentals. 

Residential pesticide handlers may be 

exposed to short-term duration (1–30 

days) only. The dermal and inhalation 

(short-term) residential exposure was 

assessed for ‘‘homeowners’’ mixer/ 

loader/applicator wearing short pants 

and short-sleeved shirts as well as shoes 

plus socks using garden hose-end 

sprayer, ‘‘pump-up’’ compressed air 

sprayer, and backpack sprayer. 

No post-application exposure is 

expected. 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.’’ 

Difenoconazole is a member of the 

triazole-containing class of pesticides. 

Although conazoles act similarly in 

plants (fungi) by inhibiting ergosterol 

biosynthesis, there is not necessarily a 

relationship between their pesticidal 

activity and their mechanism of toxicity 

in mammals. Structural similarities do 

not constitute a common mechanism of 

toxicity. Evidence is needed to establish 

that the chemicals operate by the same, 

or essentially the same, sequence of 

major biochemical events. In conazoles, 

however, a variable pattern of 

toxicological responses is found. Some 

are hepatotoxic and hepatocarcinogenic 

in mice. Some induce thyroid tumors in 

rats. Some induce developmental, 

reproductive, and neurological effects in 

rodents. Furthermore, the conazoles 

produce a diverse range of biochemical 

events including altered cholesterol 

levels, stress responses, and altered 

DNA methylation. It is not clearly 

understood whether these biochemical 

events are directly connected to their 

toxicological outcomes. Thus, there is 

currently no evidence to indicate that 

conazoles share common mechanisms of 

toxicity and EPA is not following a 

cumulative risk approach based on a 

common mechanism of toxicity for the 

conazoles. For information regarding 

EPA’s procedures for cumulating effects 

from substances found to have a 

common mechanism of toxicity, see 

EPA’s Web site at http://www.epa.gov/ 

pesticides/cumulative. 

Difenoconazole is a triazole-derived 

pesticide. This class of compounds can 

form the common metabolite 1,2,4- 

triazole and two triazole conjugates 

(triazolylalanine and triazolylacetic 

acid). To support existing tolerances 

and to establish new tolerances for 

triazole-derivative pesticides, including 

difenoconazole, EPA conducted a 

human health risk assessment for 

exposure to 1,2,4-triazole, 

triazolylalanine, and triazolylacetic acid 

resulting from the use of all current and 

pending uses of any triazole-derived 

fungicide. The risk assessment is a 

highly conservative, screening-level 

evaluation in terms of hazards 

associated with common metabolites 

(e.g., use of a maximum combination of 

uncertainty factors) and potential 

dietary and non-dietary exposures (i.e., 

high end estimates of both dietary and 

non-dietary exposures). In addition, the 

Agency retained the additional 10X 

FQPA safety factor for the protection of 

infants and children. The assessment 

includes evaluations of risks for various 

subgroups, including those comprised 

of infants and children. The Agency’s 

complete risk assessment is found in the 

propiconazole reregistration docket at 

http://www.regulations.gov, Docket 

Identification (ID) Number EPA–HQ– 

OPP–2005–0497. 

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. 

EPA determined that the available data 

indicated no increased susceptibility of 

rats or rabbits to in utero and/or 

postnatal exposure to difenoconazole. In 

the prenatal developmental toxicity 

studies in rats and rabbits and the 2- 

generation reproduction study in rats, 

toxicity to the fetuses/offspring, when 

observed, occurred at equivalent or 

higher doses than in the maternal/ 

parental animals. In the prenatal 

developmental toxicity study in rats, 

maternal toxicity was manifested as 

decreased body weight gain and food 

consumption at the LOAEL of 85 mg/kg/ 

day; the NOAEL was 16 mg/kg/day. The 

developmental toxicity was manifested 

as alterations in fetal ossifications at 171 

mg/kg/day; the developmental NOAEL 

was 85 mg/kg/day. In a developmental 

toxicity study in rabbits, maternal and 

developmental toxicity were seen at the 

same dose level (75 mg/kg/day). 

Maternal toxicity in rabbits were 

manifested as decreased body weight 

gain and decreased food consumption, 

while developmental toxicity was 

manifested as decreased fetal weight. In 

a 2-generation reproduction study in 

rats, there were decreases in maternal 

body weight gain and decreases in body 

weights of F1 males at the LOAEL of 

12.5 mg/kg/day; the parental systemic 

and off spring toxicity NOAEL was 1.25 

mg/kg/day. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

WReier-Aviles on DSKGBLS3C1PROD with RULES

11348 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 

were reduced to 1x. That decision is 

based on the following findings: 

i. The toxicity database is adequate for 

conducting a FQPA risk assessment. At 

this time, an immunotoxicity study is 

not available. However, the toxicology 

database for difenocanazole does not 

show any evidence of treatment-related 

effects on the immune system. The 

overall weight of evidence suggests that 

this chemical does not directly target 

the immune system. An immunotoxicity 

study is now required as a part of new 

data requirements in the 40 CFR part 

158 for conventional pesticide 

registration; however, the Agency does 

not believe that conducting a functional 

immunotoxicity study will result in a 

lower point of departure (POD) than that 

currently in use for overall risk 

assessment, and therefore, a database 

uncertainty factor (UFDB) is not needed 

to account for lack of this study. 

ii. The acute and subchronic 

neurotoxicity studies in rats are 

available. These data show that 

difenoconazole exhibits some evidence 

of neurotoxicity in the database, but the 

effects are transient or occur at doses 

exceeding the limit dose. EPA 

concluded that difenoconazole is not a 

neurotoxic compound. Based on the 

toxicity profile, and lack of 

neurotoxicity, a developmental 

neurotoxicity study in rats is not 

required nor is an additional database 

uncertainty factor needed to account for 

the lack of this study. 

iii. There is no evidence that 

difenoconazole results in increased 

susceptibility of rats or rabbit fetuses to 

in utero and/or postnatal exposure in 

the developmental and reproductive 

toxicity data. 

iv. There are no residual uncertainties 

identified in the exposure databases. A 

conservative dietary food exposure 

assessment was conducted. Acute 

dietary food exposure assessments were 

performed based on tolerance-level 

residues, 100 PCT, and the available 

empirical or DEEMTM (ver. 7.81) default 

processing factors. Chronic dietary 

exposure assessments were based on 

tolerance-level residues for some 

commodities, average field trial residues 

for the majority of commodities, the 

available empirical or DEEMTM (ver. 

7.81) default processing factors, and 100 

PCT. These are conservative approaches 

and are unlikely to understate the 

residues in food commodities. 

EPA also made conservative 

(protective) assumptions in the ground 

water and surface water modeling used 

to assess exposure to difenoconazole in 

drinking water. Post-application 

exposure of children as well as 

incidental oral exposure of toddlers is 

not expected. These assessments will 

not underestimate the exposure and 

risks posed by difenoconazole. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (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. Cancer risk was assessed using 

the same exposure estimates as 

discussed in Unit III.C.1.ii., ‘‘chronic 

exposure.’’ 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

difenoconazole will occupy 16% of the 

aPAD for children 1 to 2 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 difenoconazole 

from food and water will utilize 45% of 

the cPAD for children 1 to 2 years old, 

the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

difenoconazole is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Difenoconazole is currently registered 

for ornamentals that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

difenoconazole. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 180 or greater. Because EPA’s 

level of concern for difenoconazole is a 

MOE of 100 or below, these MOEs 

resulting from short-termed exposure to 

difenoconazole are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, difenoconazole 

is not registered for any use patterns 

that would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

difenoconazole. 

5. Aggregate cancer risk for U.S. 

population. As discussed in Unit 

III.C.1.iii., the chronic dietary risk 

assessment is protective of any potential 

cancer effects. 

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 

difenoconazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate tolerance enforcement 

method, method AG–575B, is available 

to enforce the tolerance expression. The 

method determines residues of 

difenoconazole per se in or on crop 

commodities by gas chromatography 

with nitrogen-phosphorus detection 

(GC/NPD). The method’s limits of 

quantitation (LOQs) are 0.01–0.05 ppm. 

A confirmatory GC method with massselective detection (MSD) is also 

available for crop commodities. Samples 

from the submitted crop field trials were 

analyzed for residues of difenoconazole 

using a high performance liquid 

chromatography method with tandem 

mass spectrometry detection (LC/MS/ 

MS), Syngenta REM 147.08, or a similar 

method. The methods are adequate for 

data collection based on acceptable 

concurrent method recoveries. The LOQ 

was 0.01 ppm for difenoconazole in 

mango and wax jambu. 

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. 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 11349 

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 FFDCA section 408(b)(4). 

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, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has established a MRL for 

difenoconazole in or on mango at 0.07 

ppm. This MRL is the same as the 

tolerance established by this action for 

difenoconzole in the United States. 

Canadian and Mexican MRLs have been 

established for difenoconazole; 

however, no MRLs have been 

established for mango. No Codex, 

Canadian, and Mexican MRLs have been 

established for residues of 

difenoconazole in or on wax jambu. 

C. Response to Comments 

There were no public comments 

received on the Notice of Filing. 

D. Revisions to Petitioned-For 

Tolerances 

EPA has revised the tolerance levels 

proposed in the notice of filing for 

mango from 0.09 ppm to 0.07 ppm. The 

modification was made based on the 

available data supporting the use of 

difenoconazole on mango and to 

achieve harmonization with the 

established Codex MRL of 0.07 ppm 

residues in or on mango. 

Also, the Agency corrected the 

commodities named in the notice from 

‘‘mango fruit’’ to ‘‘mango’’ and 

‘‘waxapple’’ to ‘‘wax jambu’’ to reflect 

EPA’s prescribled terminology for these 

crops. 

V. Conclusion 

Therefore, tolerances are established 

for residues of difenoconazole, 1-[2-[2- 

chloro-4-(4-chlorophenoxy)phenyl]-4- 

methyl-1,3-dioxolan-2-ylmethyl]-1H1,2,4-triazole, in or on mango at 0.07 

ppm and wax jambu at 1.5 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, 

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 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) (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). 

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: February 18, 2011. 

Daniel J. Rosenblatt, 

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 180.475 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a)(1) to read as follows: 

§ 180.475 Difenoconazole; tolerance for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Mango 1 ................................... 0 .07 

* * * * * 

Wax jambu 1 ............................ 1 .5 

WReier-Aviles on DSKGBLS3C1PROD with RULES

11350 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 

* * * * * 

[FR Doc. 2011–4370 Filed 3–1–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–1994–0001; FRL–9274–1] 

National Oil and Hazardous 

Substances Pollution Contingency 

Plan; National Priorities List: Partial 

Deletion of the AT&SF Albuquerque 

Superfund Site 

AGENCY: Environmental Protection 

Agency. 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) Region 6 announces the 

deletion of the northern 62-acre parcel 

of the AT&SF Albuquerque Superfund 

Site (Site) located in Albuquerque, 

Bernalillo County, New Mexico, from 

the National Priorities List (NPL). The 

NPL, promulgated pursuant to section 

105 of the Comprehensive 

Environmental Response, 

Compensation, and Liability Act 

(CERCLA) of 1980, as amended, is an 

appendix of the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP). This partial 

deletion pertains to the soil and ground 

water associated with the northern 62- 

acre parcel. After this deletion, these 62 

acres will no longer be part of the Site. 

The other 27 acres will remain on the 

NPL and are not being considered for 

deletion as part of this action. The EPA 

and the State of New Mexico, through 

the New Mexico Environment 

Department (NMED), have determined 

that all appropriate response actions for 

this parcel under CERCLA, other than 

operation, maintenance, and five-year 

reviews, have been completed. 

However, the deletion of these parcels 

does not preclude future actions under 

Superfund. 

DATES: Effective Date: This action is 

effective March 2, 2011. 

ADDRESSES: EPA has established a 

docket for this action under Docket 

Identification No. EPA–HQ–SFUND– 

1994–0001. All documents in the docket 

are listed on the http:// 

www.regulations.gov Web site. Although 

listed in the index, some information is 

not publicly available, i.e., Confidential 

Business Information or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically through http:// 

www.regulations.gov or in hard copy at 

the site information repositories. 

Locations, contacts, and phone numbers 

are: 

• U.S. EPA Region 6 Library, 7th 

Floor, 1445 Ross Avenue, Suite 1200, 

Dallas, Texas 75202–2733, (214) 665– 

6424; 

• Albuquerque Public Library, Main 

Downtown Branch, 501 Copper Avenue, 

NW., Albuquerque, New Mexico 87102, 

Contact: John Vittal; and, 

• New Mexico Environment 

Department, Harold Runnels Building, 

1190 St. Francis Drive, Santa Fe, New 

Mexico 87505. 

FOR FURTHER INFORMATION CONTACT: 

Katrina Higgins-Coltrain, Remedial 

Project Manager (RPM), U.S. EPA 

Region 6 (6SF–RL), 1445 Ross Avenue, 

Dallas, TX 75202–2733, (214) 665–8143 

or 1–800–533–3508 

(coltrain.katrina@epa.gov). 

SUPPLEMENTARY INFORMATION: 

The portion of the site to be deleted 

from the NPL is: Northern 62-acre parcel 

of the AT&SF Albuquerque Superfund 

Site, located in Albuquerque, Bernalillo 

County, New Mexico. A Notice of Intent 

for Partial Deletion for this Site was 

published in the Federal Register on 

January 5, 2011 (76 FR 510). 

The closing date for comments on the 

Notice of Intent for Partial Deletion was 

February 4, 2011. One anonymous 

public comment was received and 

supported the partial deletion of the 

Site. EPA, in conjunction with the 

NMED, believes the partial deletion 

action remains appropriate. 

EPA maintains the NPL as the list of 

sites that appear to present a significant 

risk to public health, welfare, or the 

environment. Deletion of a site from the 

NPL does not preclude further remedial 

action. Whenever there is a significant 

release from a site deleted from the NPL, 

the deleted site may be restored to the 

NPL without application of the hazard 

ranking system. Deletion of portions of 

a site from the NPL does not affect 

responsible party liability, in the 

unlikely event that future conditions 

warrant further actions. 

List of Subjects in 40 CFR Part 300 

Environmental protection, Air 

pollution control, Chemicals, Hazardous 

waste, Hazardous substances, 

Intergovernmental relations, Penalties, 

Reporting and recordkeeping 

requirements, Superfund, Water 

pollution control, Water supply. 

Dated: February 16, 2011. 

Al Armendariz, 

Regional Administrator, Region 6. 

For reasons set out in the preamble, 

40 CFR part 300 is amended as follows: 

PART 300—[AMENDED] 

■ 1. The authority citation for part 300 

continues to read as follows: 

Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 

9601–9657; E.O. 12777, 56 FR 54757, 3 CFR 

1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 

3 CFR 1987 Comp., p. 193. 

■ 2. Table 1 of Appendix B to part 300 

is amended by revising the entry under 

NM for ‘‘AT&SF (Albuquerque)’’ to read 

as follows: 

Appendix B to Part 300—National 

Priorities List 

TABLE 1—GENERAL SUPERFUND SECTION

State Site name City/County Notes (a) 

*******

NM ............................................................ AT&SF Albuquerque ................................ Albuquerque ............................................. P 

*******

(a) * * * 

P = Sites with partial deletion(s). 

WReier-Aviles on DSKGBLS3C1PROD with RULES