4284 Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 

Commodity Parts per million 

Grass forage, fodder, and 

hay crop group 17, 

straw ............................ 4.0 

* * * * * 

* * * * * 

[FR Doc. 2010–1610 Filed 1–26–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0276; FRL–8808–6] 

Triticonazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of triticonazole 

in or on grain, cereal, group 15, except 

rice, and grain, cereal, forage, fodder 

and straw, group 16, except rice. BASF 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

January 27, 2010. Objections and 

requests for hearings must be received 

on or before March 29, 2010, 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–2009–0276. 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: 

Tawanda Maignan, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308-8050; e-mail address: 

Maignan.Tawanda@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 

cite at http://www.gpoaccess.gov/ecfr. 

To access the OPPTS harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods & Guidelines’’ on the left-side 

navigation menu. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0276 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before March 29, 2010. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0276, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of August 19, 

2009, (74 FR 41900) (FRL–8426–7), 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 8F7420) by BASF 

Corporation, P.O. Box 13528, Research 

Triangle Park, NC 27709-3528. The 

petition requested that 40 CFR 180.583 

be amended by establishing tolerances 

for residues of the fungicide 

triticonazole, (1RS)-(E)-5-[(4- 

chlorophenyl)methylene]-2,2-dimethyl1-(1H-1,2,4-triazol-1- 

ylmethyl)cyclopentanol, in or on grain, 

cereal, group 15, except rice, and grain, 

cereal, forage, fodder and straw, group 

16, except rice, at 0.05 and 0.10 parts 

per million (ppm), respectively. That 

notice referenced a summary of the 

petition prepared by BASF Corporation, 

the registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. Based upon review of 

the data supporting the petition, EPA 

has modified both the crop group 

terminology, and tolerance levels for 


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Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 4285 

grain, cereal, group 15, except rice, at 

0.01 ppm, and the crop group 

terminology (only) for grain, cereal, 

forage, fodder and straw, group 16, 

except rice, at 0.10 ppm. These 

tolerances replace previously 

established individual tolerances for 

barley, grain; barley, hay; barley, straw; 

wheat, forage; wheat, grain; wheat, hay; 

and wheat, straw at 0.05 ppm. The 

reason for these changes is explained in 

Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’ 

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

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for residues of triticonazole, 

(1RS)-(E)-5-[(4- 

chlorophenyl)methylene]-2,2-dimethyl1-(1H-1,2,4-triazol-1- 

ylmethyl)cyclopentanol on grain, cereal, 

group 15, except rice, at 0.01 ppm, and 

grain, cereal, forage, fodder and straw, 

group 16, except rice, at 0.10 ppm. 

EPA’s assessment of exposures and risks 

associated with establishing tolerances 

follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Triticonazole has low acute toxicity, 

is not a skin, eye, or respiratory irritant, 

or a dermal sensitizer. Non-acute 

toxicity studies show that the liver (rat, 

mouse, dog) and adrenals (rat, dog, 

rabbit) are target organs across species. 

Adverse body weight changes (rat, dog, 

rabbit, mouse) and clinical signs (rat, 

dog, mouse) also were observed in 

multiple species. In the developmental 

and reproductive toxicity studies, 

adverse effects were seen at the same 

dose level in the offspring and parental 

animals, and the offspring were not 

qualitatively more susceptible compared 

with adults. In the rat subchronic study, 

decreased thymus weights were 

reported at a dose level (~2,300 

milligrams/kilogram/day (mg/kg/day)) 

two times higher than the limit dose 

(1,000 mg/kg/day). Triticonazole was 

negative for mutagenicity, and the 

cancer classification is ‘‘Not Likely to Be 

Carcinogenic to Humans’’ based on a 

lack of evidence of carcinogenicity in 

the two guideline studies conducted on 

rats and mice. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by triticonazole as well as 

the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in the document 

‘‘Triticonazole. Human Health Risk 

Assessment for Proposed Seed 

Treatment Use on Cereal Grains (Crop 

Group 15) Including Barley, Field Corn, 

Oats, Popcorn, Rye, Sorghum Grain, 

Sweet Corn, Triticale, and Wheat 

(Excluding Rice); and Forage, Fodder, 

and Straw of Cereal Grains (Crop Group 

16), Excluding Rice,’’ at pages 34 to 36 

in docket ID number EPA–HQ–OPP– 

2009–0276. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a benchmark dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the level of concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

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

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for triticonazole used for 

human risk assessment can be found at 

http://www.regulations.gov in the 

document ‘‘Triticonazole. Human Health 

Risk Assessment for Proposed Seed 

Treatment Use on Cereal Grains (Crop 

Group 15) Including Barley, Field Corn, 

Oats, Popcorn, Rye, Sorghum Grain, 

Sweet Corn, Triticale, and Wheat 

(Excluding Rice); and Forage, Fodder, 

and Straw of Cereal Grains (Crop Group 

16), Excluding Rice,’’ at pages 15 to 16 

in docket ID number EPA–HQ–OPP– 

2009–0276. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to triticonazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing triticonazole tolerances in 40 

CFR 180.583. EPA assessed dietary 

exposures from triticonazole in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the U.S. Department of 


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4286 Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 

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 of triticonazole 

were found in all commodities and that 

all commodities consumed were 100% 

crop treated. Anticipated residues and/ 

or percent crop treated (PCT) 

information were not used. 

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 in all 

commodities, and 100% crop treated for 

all treated commodities. Anticipated 

residues and/or PCT information were 

not used. 

iii. Cancer. Triticonazole is classified 

as ‘‘not likely to be carcinogenic to 

humans’’ based on the absence of 

significant tumor increases in two 

adequate rodent carcinogenicity studies. 

There is no evidence that triticonazole 

is carcinogenic to humans, therefore an 

exposure assessment to evaluate cancer 

risk is not needed. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for triticonazole. Tolerance level 

residues and/or 100% crop treated were 

assumed for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for triticonazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

triticonazole. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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

oppefed1/models/water/index.htm. 

The estimated drinking water 

concentrations (EDWCs) used in the 

dietary risk assessment were provided 

by OPP’s Environmental Fate and 

Effects Division and incorporated 

directly into the dietary assessment. The 

EDWCs used in the dietary assessment 

were modeled using the surface water 

model, Pesticide Root Zone Model/ 

Exposure Analysis Modeling System 

(PRZM/EXAMS). For the acute point 

estimate, the PRZM-EXAMS 1-in-10 

year annual maximum EDWC was used. 

For the chronic point estimate, the 

PRZM-EXAMS 1-in-10 year annual 

mean EDWC was used. PRZM-EXAMS 

EDWCs were used because they were 

higher (and therefore more protective) 

than the groundwater model’s, 

(Screening Concentration in Groudwater 

model (SCI-GROW’s)) EDWC. Based on 

the PRZM/EXAMS, the EDWCs of 

triticonazole for acute exposures are 

75.5 parts per billion (ppb) for surface 

water and 5.7 ppb for ground water, and 

chronic exposures for non-cancer 

assessments are estimated to be 32.8 

ppb for surface 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 75.5 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration 

value of 32.8 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). 

Triticonazole is currently registered for 

the following uses that could result in 

residential exposures: Residential and 

commercial turfgrass, golf courses, and 

sod farms. EPA quantitatively assessed 

the risk from residential exposure to 

children from children’s incidental oral 

post-application scenarios (hand to 

mouth, mouthing grass, and soil 

ingestion). Children and adults may also 

have post-application dermal exposure 

but dermal toxicity studies with 

triticonazole did not identify any 

adverse effects from such exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found triticonazole to 

share a common mechanism of toxicity 

with any other substances, and 

triticonazole does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that triticonazole does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

Triticonazole 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; and 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 website at http://www.epa.gov/ 

pesticides/cumulative. 

Triticonazole and other triazolecontaining pesticides 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 triticonazole, 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 


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Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 4287 

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 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. 

The prenatal and postnatal toxicity 

database for triticonazole includes rat 

and rabbit developmental toxicity 

studies and a two generation 

reproduction study in rats. There is no 

evidence of increased susceptibility 

following in utero and/or postnatal 

exposure in the developmental toxicity 

studies in rats or rabbits, and in the 2- 

generation rat reproduction study. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

triticonazole is complete with the 

exception of a newly required 

immunotoxicity study. In accordance 

with 40 CFR Part 158 toxicity data 

requirements, an immunotoxicity study 

(Harmonized guideline 870.7800) is 

required for triticonazole. In the absence 

of specific immunotoxicity studies, EPA 

has evaluated the available triticonazole 

toxicity data to determine whether an 

additional uncertainty factor is needed 

to account for potential immunotoxicity. 

The toxicological database for 

triticonazole does not indicate that the 

immune system is the primary target 

organ. Decreased thymus weight was 

observed in only one species (rat) at the 

highest dose tested (~2x the limit dose 

of 1,000 mg/kg/day); these findings may 

be due to secondary effects of overt 

systemic toxicity. Based on this 

evidence, EPA does not believe that 

conducting immunotoxicity testing will 

result in a point of departure lower than 

those already selected for triticonazole 

risk assessment, and an additional 

uncertainty factor is not needed to 

account for potential immunotoxicity. 

ii. There are no indications that 

triticonazole is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

triticonazole results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2–generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure database. The 

dietary food exposure assessments were 

performed based on 100% crop treated 

and tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to triticonazole 

in drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the acute population adjusted dose 

(aPAD) and chronic population adjusted 

dose (cPAD). The aPAD and cPAD 

represent the highest safe exposures, 

taking into account all appropriate SFs. 

EPA calculates the aPAD and cPAD by 

dividing the POD by all applicable UFs. 

For linear cancer risks, EPA calculates 

the probability of additional cancer 

cases given the estimated aggregate 

exposure. Short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing the estimated aggregate food, 

water, and residential exposure to the 

POD to ensure that the MOE called for 

by the product of all applicable UFs is 

not exceeded. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the combined acute 

dietary exposure from food and water to 

triticonazole will occupy < 1% of the 

aPAD for (females 13 to 49 years old), 

the population subgroups 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 triticonazole 

from food and water will utilize 1.4% of 

the cPAD for all infants (< 1 year old), 

the subgroup receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of triticonazole 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). Triticonazole is 

currently registered for use(s) 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 

triticonazole. 

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 aggregated result 

in aggregate MOEs of: 1,100 for children 

1 to 2 years old, and 1,100 for all infants 

< 1 year old. Because the level of 

concern is for MOEs below 100, these 

MOEs 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). 

Triticonazole is currently registered for 

use(s) that could result in intermediateterm residential exposure and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure to triticonazole through food 

and water with intermediate-term 

exposures for triticonazole. 

Using the exposure assumptions 

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

the combined intermediate-term food, 

water, and residential exposures 

aggregated result in aggregate MOEs of: 

780 for children 1 to 2 years old, and 

740 for all infants < 1 year old. Because 

the level of concern is for MOEs below 

100, these MOEs are not of concern. 

5. Aggregate cancer risk for U.S. 

population. Triticonazole is classified as 

‘‘not likely to be carcinogenic to 

humans’’ based on the absence of 

significant tumor increases in two 

adequate rodent carcinogenicity studies. 

Thus, triticonazole is not expected to 

pose a cancer risk. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to triticonazole 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography/mass 

spectrometry (LC/MS), and liquid 

chromatography/mass spectrometry/ 

mass spectrometry (LC/MS/MS) 

methods (Method 148.02) is available to 


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4288 Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 

enforce the tolerance expression. These 

methods may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

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

B. International Residue Limits 

There are no established Codex or 

Mexican maximum residue levels 

(MRLs)/tolerances for triticonazole on 

wheat or barley. Triticonazole is 

registered as a seed treatment in Canada 

for oats, barley, and wheat, and has 

established MRL levels at 0.01 ppm on 

barley, oats, and wheat and for livestock 

commodities at 0.05 ppm. The Canadian 

MRLs on barley, oats, and wheat are in 

harmony with the United States’ 0.01 

ppm tolerance level for grain, cereal, 

group 15, except rice. Additionally, no 

U.S. tolerances have been established on 

livestock commodities. No 

harmonization issues exist in 

connection with the proposed use on 

turf. 

C. Revisions to Petitioned-for Tolerances 

EPA determined the tolerances for 

grain, cereal, group 15, except rice, 

should be established at 0.01 ppm, 

based on a harmonization concern with 

Canada, and residue data which 

supported this tolerance level. Thus the 

proposed tolerance level of 0.05 ppm 

was deemed excessive. Upon 

establishing the grain, cereal, group 15, 

except rice, tolerance at 0.01 ppm, the 

individual tolerances established for 

barley, straw; wheat, forage; wheat, 

grain; wheat, hay; and wheat, straw at 

0.05 ppm are being removed from 40 

CFR 180.583(a). 

V. Conclusion 

Therefore, tolerances are established 

for residues of triticonazole, (1RS)-(E)-5- 

[(4-chlorophenyl)methylene]-2,2- 

dimethyl-1-(1H-1,2,4-triazol-1-

ylmethyl)cyclopentanol, in or on grain, 

cereal, group 15, except rice, at 0.01 

ppm, and grain, cereal, forage, fodder 

and straw, group 16, except rice, at 0.10 

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) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 19, 2010. 

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 180.583 is amended by 

revising the table in paragraph (a) to 

read as follows: 

§ 180.583 Triticonazole; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

Grain, cereal, forage, fodder 

and straw, group 16, except 

rice ........................................ 0.10 

Grain, cereal, group 15, except 

rice ........................................ 0.01 

* * * * * 

[FR Doc. 2010–1614 Filed 1–26–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0675; FRL–8805–3] 

Oxirane, 2-Methyl-, Polymer with 

Oxirane, Dimethyl Ether; Tolerance 

Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 


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