Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Rules and Regulations 24421 

1This date is June 15, 2004, unless otherwise noted. 

2This date is June 4, 2010. 

* * * * * 

[FR Doc. 2010–9599 Filed 5–4–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0611; FRL–8821–4] 

Tebuconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of tebuconazole 

in or on vegetable, fruiting, group 8. 

Bayer CropScience requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

5, 2010. Objections and requests for 

hearings must be received on or before 

July 6, 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–2009–0611. 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: 

Tracy Keigwin, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6605; e-mail address: 

keigwin.tracy @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 harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods and Guidelines.’’ 

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–2009–0611 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 July 6, 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–2009–0611, 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 September 

4, 2009 (74 FR 45848) (FRL–8434–4), 

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 9F7515) by Bayer 

CropScience, 2 T.W. Alexander Dr., P.O. 

Box 12014, Research Triangle Park, NC 

27709. The petition requested that 40 

CFR part 180 be amended by 

establishing tolerances for residues of 

the fungicide tebuconazole in or on the 

raw agricultural commodity vegetables, 

fruiting, group at 1.4 parts per million 

(ppm). That notice referenced a 

summary of the petition prepared by 

Bayer CropScience, the registrant, 

which is available to the public in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the proposed tolerance to 1.3 

ppm. The reason for this change is 

explained in Unit IV.C. 


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24422 Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Rules and Regulations 

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 tebuconazole 

on vegetables, fruiting, group 8 at 1.3 

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. 

Tebuconazole has low acute toxicity 

by the oral or dermal route of exposure, 

and moderate toxicity by the inhalation 

route. It is not a dermal sensitizer or a 

dermal irritant; however, it is slightly to 

mildly irritating to the eye. The main 

target organs are the liver, the adrenals, 

the hematopoetic system and the 

nervous system. Effects on these target 

organs were seen in both rodent and 

non-rodent species. In addition, ocular 

lesions are seen in dogs (including 

lenticular degeneration and increased 

cataract formation) following 

subchronic or chronic exposure. 

Oral administration of tebuconazole 

caused developmental toxicity in all 

species evaluated (rat, rabbit, and 

mouse), with the most prominent effects 

seen in the developing nervous system. 

In the available toxicity studies on 

tebuconazole, there was no 

toxicologically significant evidence of 

endocrine disruptor effects. 

Tebuconazole was classified as a Group 

C possible human carcinogen, based on 

an increase in the incidence of 

hepatocellular adenomas, carcinomas 

and combined adenomas/carcinomas in 

male and female mice. Submitted 

mutagenicity studies did not 

demonstrate any evidence of mutagenic 

potential for tebuconazole. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by tebuconazole 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 

entitled ‘‘Tebuconazole: Human Health 

Risk Assessment to support tolerances 

in/on Asparagus, Barley, Beans, Beets, 

Brassica leafy greens, Bulb Vegetables, 

Coffee (import), Commercial 

Ornamentals, Corn, Cotton, Cucurbits, 

Hops, Lychee, Mango, Okra, Pome fruit, 

Soybean, Stone fruit, Sunflower, Tree 

Nut Crop Group, Turf, Turnips and 

Wheat,’’ pages 83–105 in docket ID 

number EPA–HQ–OPP–2005–0097– 

0004. 

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 tebuconazole used for 

human risk assessment is shown in the 

Table of this unit. 


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Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Rules and Regulations 24423 

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

ASSESSMENT

Exposure/Scenario 

Point of Departure 

and Uncertainty/ 

Safety Factors 

RfD, PAD, LOC for 

Risk Assessment Study and Toxicological Effects 

Acute dietary 

(General population including infants and children, Females 13– 

50 years of age) 

LOAEL = 8.8 milligram/kilogram/day 

(mg/kg/day) 

UF = 300 

UFA = 10x 

UFH = 10x 

FQPA (UFL) = 3x 

Acute RfD = 0.029 

mg/kg/day 

aPAD = 0.029 mg/ 

kg/day 

Developmental Neurotoxicity Study – Rat. 

LOAEL = 8.8 mg/kg/day based on decreases in body 

weights, absolute brain weights, brain measurements 

and motor activity in offspring. 

Chronic dietary 

(All populations) 

LOAEL = 8.8 mg/kg/ 

day 

UF = 300 

UFA = 10x 

UFH = 10x 

FQPA (UFL) = 3x 

Chronic RfD = 0.029 

mg/kg/day 

cPAD = 0.029 mg/ 

kg/day 

Developmental Neurotoxicity Study – Rat. 

LOAEL = 8.8 mg/kg/day based on decreases in body 

weights, absolute brain weights, brain measurements 

and motor activity in offspring. 

Incidental oral short term/Intermediate term 

(1 to 30 days/1–6 months) 

LOAEL = 8.8 mg/kg/ 

day 

UF = 300 

UFA = 10x 

UFH = 10x 

FQPA (UFL) = 3x 

Residential LOC for 

MOE = 300 

Developmental Neurotoxicity Study – Rat. 

LOAEL = 8.8 mg/kg/day based on decreases in body 

weights, absolute brain weights, brain measurements 

and motor activity in offspring. 

Dermal short term/Intermediate term 

(1 to 30 days/1 to 6 months) 

LOAEL = 8.8 mg/kg/ 

day 

UF = 300 

UFA = 10x 

UFH = 10x 

UFL = 3x 

DAF = 23.1% 

Residential LOC for 

MOE = 300 

Developmental Neurotoxicity Study –Rat. 

LOAEL = 8.8 mg/kg/day based on decreases in body 

weights, absolute brain weights, brain measurements 

and motor activity in offspring. 

Inhalation short term/Intermediate 

term 

(1 to 30 days/1 to 6 months) 

LOAEL = 8.8 mg/kg/ 

day 

UF = 300 

UFA = 10x 

UFH = 10x 

UFL = 3x 

Inhalation and oral 

toxicity are assumed to be 

equivalent 

Residential LOC for 

MOE = 300 

Developmental Neurotoxicity Study – Rat. 

LOAEL = 8.8 mg/kg/day based on decreases in body 

weights, absolute brain weights, brain measurements 

and motor activity in offspring. 

Cancer 

(Oral, dermal, inhalation) 

Classification: Group C–possible human carcinogen based on statistically significant increase in the incidence of hepatocellular adenoma, carcinoma, and combined adenoma/carcinomas in both sexes of 

NMRI mice. Considering that there was no evidence of carcinogenicity in rats, there was no evidence of 

genotoxicity for tebuconazole, and tumors were only seen at a high and excessively toxic dose in mice, 

EPA concluded that the chronic RfD would be protective of any potential carcinogenic effect. The 

chronic RfD value is 0.029 mg/kg/day which is approximately 9,600 fold lower than the dose that would 

induce liver tumors (279 mg/kg/day). 

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

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. 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 tebuconazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing tebuconazole tolerances in 40 

CFR 180.474. EPA assessed dietary 

exposures from tebuconazole 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 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, anticipated residues for 

bananas, grapes, raisins, nectarines, 

peaches, peanut butter and wheat were 

derived using the latest USDA Pesticide 

Data Program (PDP) monitoring data. 

Anticipated residues for all other 

registered and proposed food 

commodities were based on field trial 

data. For uses associated with PP 

9F7515, 100 percent crop treated (PCT) 

was assumed. Dietary Exposure 

Evaluation Model (ver. 7.81) default 

processing factors were assumed for 

processed commodities associated with 

petition 9F7515. For several other uses 


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24424 Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Rules and Regulations 

EPA used PCT data as specified in Unit 

III.C.1.iv. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the same assumptions as 

stated in Unit III.C.1.i. for acute 

exposure. 

iii. Cancer. As explained in Unit 

III.B., the chronic risk assessment is 

considered to be protective of any 

cancer effects; therefore, a separate 

quantitative cancer dietary risk 

assessment was not conducted. 

iv. Anticipated residue and PCT 

information. 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. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by section 408(b)(2)(F) of 

FFDCA, EPA may require registrants to 

submit data on PCT. 

The Agency used PCT information as 

follows: 

Grapes: 25%; grape, raisin: 25%; 

nectarine 25%; oats 2.5%; peach: 20%; 

and peanuts 45%. 

In most cases, EPA uses available data 

from the USDA’s National Agricultural 

Statistics Service (NASS), proprietary 

market surveys, and the National 

Pesticide Use Database for the chemical/ 

crop combination for the most recent 6 

years. EPA uses an average PCT for 

chronic dietary risk analysis. The 

average PCT figure for each existing use 

is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency used projected percent 

crop treated (PPCT) information for 

tebuconazole on apples, apricots, 

cherries (preharvest), sweetcorn, hops, 

plums, and turnips. The PPCT for each 

crop is as follows: Apples, acute 

assessment 44%, chronic assessment 

41%; apricots: acute assessment 56%, 

chronic assessment 43%; cherries, 

preharvest: acute assessment 42%, 

chronic assessment 37%; corn, sweet: 

acute assessment 22%, chronic 

assessment 14%; hops: acute assessment 

64%, chronic assessment 64%; plum: 

acute assessment 26%, chronic 

assessment 24%; turnip: acute 

assessment 68%, chronic assessment 

44%. EPA estimates PPCT for a new 

pesticide use by assuming that its actual 

PCT during the initial 5 years of use on 

a specific use site will not exceed the 

recent PCT of the market leader (i.e., the 

one with the greatest PCT) on that site. 

An average market leader PCT, based on 

three recent surveys of pesticide usage, 

if available, is used for chronic risk 

assessment, while the maximum PCT 

from the same three recent surveys, if 

available, is used for acute risk 

assessment. The average and maximum 

market leader PCTs may each be based 

on one or two surveys if three are not 

available. Comparisons are only made 

among pesticides of the same pesticide 

types (i.e., the leading fungicide on the 

use site is selected for comparison with 

the new fungicide). The market leader 

PCTs used to determine the average and 

the maximum may be each for the same 

pesticide or for different pesticides 

since the same or different pesticides 

may dominate for each year. Typically, 

EPA uses USDA/NASS as the source for 

raw PCT data because it is publicly 

available. When a specific use site is not 

surveyed by USDA/NASS, EPA uses 

other sources including proprietary 

data. 

An estimated PPCT, based on the 

average PCT of the market leaders, is 

appropriate for use in chronic dietary 

risk assessment, and an estimated PPCT, 

based on the maximum PCT of the 

market leaders, is appropriate for use in 

acute dietary risk assessment. This 

method of estimating PPCTs for a new 

use of a registered pesticide or a new 

pesticide produces high-end estimates 

that are unlikely, in most cases, to be 

exceeded during the initial 5 years of 

actual use. Predominant factors that 

bear on whether the PPCTs could be 

exceeded may include PCTs of similar 

chemistries, pests controlled by 

alternatives, pest prevalence in the 

market and other factors. All relevant 

information currently available for 

predominant factors have been 

considered for tebuconazole on cherries, 

resulting in adjustments to the initial 

estimates for three crops to account for 

lack of confidence in projections based 

on less than three observations, old data 

and/or data based on expert opinion. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which tebuconazole may be applied in 

a particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for tebuconazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

tebuconazole. 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. 


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Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Rules and Regulations 24425 

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 

tebuconazole for acute exposures are 

estimated to be 47.23 micrograms/Liter 

(μg/L) for surface water and 0.447 μg/L 

for ground water. The EDWCs for 

chronic, noncancer are estimated to be 

16.97 μg/L for surface water and 0.447 

μg/L for ground water. The EDWCs for 

chronic, cancer exposures are estimated 

to be 12.14 for surface water and 0.447 

μg/L for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For the 

acute dietary risk assessment, the water 

concentration value of 47.23 μg/L was 

used to assess the contribution to 

drinking water. For the chronic dietary 

risk assessment (which is protective of 

any possible cancer effects), the water 

concentration value of 16.97 μg/L 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). 

Tebuconazole has currently registered 

uses that could result in residential 

exposures. Short term dermal and 

inhalation exposures are possible for 

residential adult handlers mixing, 

loading, and applying tebuconazole 

products outdoors to ornamental plants. 

Short- and intermediate-term dermal 

postapplication exposures to adults and 

children are also possible during golfing 

and/or playing on treated wood 

structures. Children may also be 

exposed via the incidental oral route 

when playing on treated wood 

structures. Long-term exposure is not 

expected. As a result, risk assessments 

have been completed for residential 

handler scenarios as well as residential 

post-application scenarios. 

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.’’ 

Tebuconazole is a member of the 

triazoles (and more specifically, 

triazole-derivative fungicides). Although 

triazoles 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 triazolederivative fungicides, 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 triazoles 

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 

triazole-derivative fungicides share 

common mechanisms of toxicity and 

EPA is not following a cumulative risk 

approach based on a common 

mechanism of toxicity for the triazolederivative fungicides. 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. 

However, the triazole-derivative 

fungicides can form the common 

metabolites 1,2,4-triazole and 

conjugated triazole metabolites. To 

support existing tolerances and to 

establish new tolerances for triazolederivative fungicides, including 

tebuconazole, 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-derivative 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 the Food Quality 

Protection Act (FQPA) Safety Factor 

(SF) 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 ID 

number EPA–HQ–OPP–2005–0497. 

In connection with the pending new 

uses of tebuconazole (and other triazolederivative fungicides), the Agency has 

revised the triazole dietary assessment 

to include the new uses of tebuconazole 

and has determined that aggregate risk 

(food, water and residential) remains 

below the Agency’s level of concern. 

This revised assessment can be found at 

http://www.regulations.gov in docket ID 

EPA–HQ–OPP–2009–0061. 

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 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 toxicity database for tebuconazole 

is complete, and includes prenatal 

developmental toxicity studies in three 

species (mouse, rat, and rabbit), a 

reproductive toxicity study in rats, acute 

and subchronic neurotoxicity studies in 

rats, and a developmental neurotoxicity 

study in rats. The data from prenatal 

developmental toxicity studies in mice 

and a developmental neurotoxicity 

study in rats indicated an increased 

quantitative and qualitative 

susceptibility following in utero 

exposure to tebuconazole. The NOAELs/ 

LOAELs for developmental toxicity in 

these studies were found at dose levels 

less than those that induce maternal 

toxicity or in the presence of slight 

maternal toxicity. There was no 

indication of increased quantitative 

susceptibility in the rat and rabbit 

developmental toxicity studies, the 

NOAELs for developmental toxicity 

were comparable to or higher than the 

NOAELs for maternal toxicity. In all 

three species, however, there was 

indication of increased qualitative 

susceptibility. For most studies, 

minimal maternal toxicity was seen at 

the LOAEL (consisting of increases in 

hematological findings in mice, 

increased liver weights in rabbits and 

rats, and decreased body weight gain/ 

food consumption in rats) and did not 


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increase substantially in severity at 

higher doses; however, there was more 

concern for the developmental effects at 

each LOAEL which included increases 

in runts, increased fetal loss, and 

malformations in mice, increased 

skeletal variations in rats, and increased 

fetal loss and frank malformations in 

rabbits. Additionally, more severe 

developmental effects (including frank 

malformations) were seen at higher 

doses in mice, rats and rabbits. In the 

developmental neurotoxicity study, 

maternal toxicity was seen only at the 

high dose (decreased body weights, 

body weight gains, and food 

consumption, prolonged gestation with 

mortality, and increased number of dead 

fetuses), while offspring toxicity 

(including decreases in body weight, 

brain weight, brain measurements and 

functional activities) was seen at all 

doses. 

Available data indicated greater 

sensitivity of the developing organism 

to exposure to tebuconazole, as 

demonstrated by increases in qualitative 

sensitivity in prenatal developmental 

toxicity studies in rats, mice, and 

rabbits, and by increases in both 

qualitative and quantitative sensitivity 

in the developmental neurotoxicity 

study in rats with tebuconazole. 

However, the degree of concern is low 

because the toxic endpoints in the 

prenatal developmental toxicity studies 

were well characterized with clear 

NOAELs established and the most 

sensitive endpoint from the 

developmental neurotoxicity study is 

used for overall risk assessments. 

Therefore, there are no residual 

uncertainties for prenatal and/or 

postnatal susceptibility. 

There is a concern with regard to the 

DNT study because of the failure to 

achieve a NOAEL in that study. This 

concern is addressed by the retention of 

FQPA SF in the form of UFL of 3x. 

Reduction of the FQPA safety factor 

from 10x to 3x is based on a Benchmark 

Dose (BMD) analysis of the datasets 

relevant to the adverse offspring effects 

(decreased body weight, decreases in 

absolute brain weights, changes in brain 

morphometric parameters, and 

decreases in motor activity) seen at the 

LOAEL in the DNT study. All of the 

BMDLs (the lower limit of a one-sided 

95% confidence interval on the BMD) 

modeled successfully on statistically 

significant effects are 1–2x lower than 

the LOAEL. The results indicate that the 

extrapolated NOAEL is not likely to be 

10x lower than the LOAEL and that the 

use of the FQPA SF of 3x would not 

underestimate risk. Using a 3x FQPA SF 

in the risk assessment (8.8 mg/kg/day ÷ 

3x = 2.9 mg/kg/day) is further supported 

by the NOAELs established in other 

studies in the tebuconazole toxicity 

database [i.e., 3 and 2.9 mg/kg/day, from 

a developmental toxicity study in mice 

and a chronic toxicity study in dogs, 

respectively (respective LOAELs 10 and 

4.5 mg/kg/day)]. 

3. Conclusion. The Agency has 

determined that reliable data show that 

it would be safe for infants and children 

to reduce the FQPA SF to 3x for all 

potential exposure scenarios. That 

decision is based on the following 

findings: 

i. The toxicity database for 

tebuconazole is complete with the 

exception of an immunotoxicity study 

requirement under the new 40 CFR part 

158 guidelines for toxicity data. The 

available guideline studies do not 

suggest that tebuconazole directly 

targets the immune system. A peerreviewed developmental neurotoxicity/ 

immunotoxicity literature study (Moser 

et al., 2001) found in high dose groups 

(60 mg/kg/day) increased spleen 

weights and alterations in splenic 

lymphocyte subpopulations. At the 

same dose there were no effects seen in 

the T-cell dependent antibody response 

to SRBC (sheep red blood cells) and 

natural killer (NK) cell activity 

indicating that tebuconazole did not 

alter the functional immune response in 

rats. Based on guideline and open 

literature, the overall weight of evidence 

suggests that tebuconazole does not 

directly target the immune system. The 

Agency does not believe that conducting 

a functional immunotoxicity study will 

result in a lower POD than currently 

used for overall risk assessment; 

therefore, a database uncertainty factor 

(UFDB) is not needed to account for the 

lack of the study. 

ii.Although there is qualitative 

evidence of increased susceptibility in 

the prenatal developmental studies in 

rats, the risk assessment team did not 

identify any residual uncertainties after 

establishing toxicity endpoints and 

traditional UFs to be used in the risk 

assessment of tebuconazole. The degree 

of concern for residual uncertainties for 

prenatal and/or postnatal toxicity is 

low. 

iii.The FQPA SF is retained as a UFL. 

Reduction of the UFL from 10 to 3x is 

based on a BMD analyses of the datasets 

relevant to the adverse offspring effects 

(decreased body weight and brain 

weight) seen at the LOAEL in the DNT 

study. All of the BMDLs modeled 

successfully on statistically significant 

effects are 1–2x lower than the LOAEL. 

The results indicate that an extrapolated 

NOAEL is not likely to be 10x lower 

than the LOAEL and that use of an UFL

of 3x would not underestimate risk. 

Using an UFL of 3x in risk assessment 

(8.8 mg/kg/day ÷ 3x = 2.9 mg/kg/day) is 

further supported by other studies in the 

tebuconazole toxicity database [with the 

lowest NOAELs being 3 and 2.9 mg/kg/ 

day, from a developmental toxicity 

study in mice and a chronic toxicity 

study in dogs, respectively (respective 

LOAELs 10 and 4.5 mg/kg/day)]. 

iv.There are no residual uncertainties 

identified in the exposure databases. 

Although the acute and chronic food 

exposure assessments are refined, EPA 

believes that the assessments are based 

on reliable data and will not 

underestimate exposure/risk. The 

drinking water estimates were derived 

from conservative screening models. 

The residential exposure assessment 

utilizes reasonable high-end variables 

set out in EPA’s Occupational/ 

Residential Exposure SOPs (Standard 

Operating Procedures). The aggregate 

assessment is based upon reasonable 

worst-case residential assumptions, and 

is also not likely to underestimate 

exposure/risk to any subpopulation, 

including those comprised of infants 

and children. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

tebuconazole will occupy 56% of the 

aPAD for the population group (children 

3–5 years old) receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to tebuconazole from food 

and water will utilize 4.9% of the cPAD 

for the U.S. population and 7.5% of the 

cPAD for the most highly exposed 

population group (children 1–2 years 

old). 


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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). Tebuconazole is 

currently registered for uses 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 

tebuconazole. 

Using the exposure assumptions 

described in this unit for short term 

exposures, EPA has concluded that the 

short-term aggregate MOE from dietary 

exposure (food + drinking water) and 

non-occupational/residential handler 

exposure for adults using a hose-end 

sprayer on ornamentals is 390. The 

short-term aggregate MOE from dietary 

exposure and exposure from golfing is 

1,700. The short-term aggregate MOE to 

children from dietary exposure and 

exposure from wood surfaces treated at 

the above ground use rate is 520. The 

short-term aggregate MOE to children 

from dietary exposure and exposure to 

wood surfaces treated at the below 

ground use rate is 230. The combined 

and aggregate MOEs for wood treated for 

below ground uses exceed the Agency’s 

LOC, and indicate a potential risk of 

concern. However, the combined MOE 

for wood treated for above-ground uses 

does not exceed the LOC, and therefore 

is not of concern. Exposure to aboveground wood is expected to more 

closely represent actual exposures to 

children. Frequency of exposures to 

above-ground wood should greatly 

exceed any exposures to below-ground 

wood, and exposures to below ground 

wood would be minimal, or negligible. 

It is unrealistic to expect a full duration 

of exposure to below ground wood. 

Therefore, this assessment should be 

characterized as a conservative 

screening-level assessment. 

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). 

Tebuconazole is currently registered for 

uses that could result in intermediateterm residential exposure and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to tebuconazole. Since the POD, 

relevant exposure scenarios and 

exposure assumptions used for 

intermediate-term aggregate risk 

assessments are the same as those used 

for short-term aggregate risk 

assessments, the short-term aggregate 

risk assessments represent and are 

protective of both short- and 

intermediate-term exposure durations. 

5. Aggregate cancer risk for U.S. 

population. As discussed in this unit, 

the chronic risk assessment is 

considered to be protective of any 

cancer effects; therefore, because the 

chronic risk assessment indicates 

exposure is lower than the cPAD, 

tebuconazole does not pose a cancer risk 

of concern. 

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 tebuconazole 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate gas chromatography/ 

nitrogen phosphorus detector (GC/NPD) 

and liquid chromatography/mass 

spectrometry (LC/MS/MS) methods are 

available for both collecting and 

enforcing tolerances for tebuconazole 

and its metabolites in plant 

commodities, livestock matrices and 

processing studies. The methods have 

been adequately validated by an 

independent laboratory in conjunction 

with a previous petition. The method 

may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

Codex and Canada have established 

maximum residue limits (MRLs) for 

tebuconazole in/on a variety of plant 

and livestock commodities. The 

tolerance expression for tebuconazole is 

harmonized between the United States, 

Codex, and Canada. There are currently 

no established Codex, Canadian, or 

Mexican MRLs for tebuconazole on 

fruiting vegetables. However, there are 

CODEX MRLs for chili pepper at 5 ppm 

and sweet pepper and tomato at 0.5 

ppm. The Codex MRLs are based on 

European field trials, where the single 

application rate is approximately 

equivalent to the U.S. single application 

rate but the pre-harvest interval (PHI) is 

3 days in the European Union as 

opposed to a PHI of 0 days in the United 

States. Given these different use 

practices, international harmonization is 

not possible at this time. 

C. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petition, EPA 

determined that the proposed tolerances 

for vegetable, fruiting, group 8, should 

be reduced to 1.3 ppm from 1.4 ppm. 

EPA revised these tolerance levels based 

on analysis of the residue field trial data 

using the Agency’s ‘‘Tolerance 

Spreadsheet’’ in accordance with the 

Agency’s ‘‘Guidance for Setting 

Pesticide Tolerances Based on Field 

Trial Data Standard Operating 

Procedure (SOP).’’ 

V. Conclusion 

Therefore, tolerances are established 

for residues of the fungicide 

tebuconazole, including its metabolites 

and degradates, in or on vegetable, 

fruiting, group 8 at 1.3 ppm Compliance 

with the tolerance levels specified in 

Unit IV.C. is to be determined by 

measuring only tebuconazole (alpha-[2- 

(4-chlorophenyl)ethyl]-alpha-(1,1- 

dimethylethyl)-1H-1,2,4-triazole-1- 

ethanol), in or on vegetable, fruiting, 

group 8. 

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 


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24428 Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Rules and Regulations 

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: April 20, 2010. 

G. Jeffrey Herndon, 

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 180.474 is amended by 

revising the introductory text of 

paragraphs (a)(1), (a)(2), and (c) and 

alphabetically add the commodity 

‘‘vegetable, fruiting, group 8’’ to the table 

in paragraph (a)(1) to read as follows: 

§ 180.474 Tebuconazole; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the fungicide 

tebuconazole, including its metabolites 

and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

tebuconazole (alpha-[2-(4- 

chlorophenyl)ethyl]-alpha-(1,1- 

dimethylethyl)-1H-1,2,4-triazole-1- 

ethanol), in or on the commodity. 

Commodity Parts per million 

* * * * * 

Vegetable, fruiting, 

group 8 .............. 1.3 

* * * * * 

(2) Tolerances are established for 

residues of the fungicide tebuconazole, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only the sum of tebuconazole 

(alpha-[2-(4-chlorophenyl)ethyl]-alpha- 

(1,1-dimethylethyl)-1H-1,2,4-triazole-1- 

ethanol) and its diol metabolite (1-(4- 

chlorophenyl)-4,4-dimethyl-3-(1H 

-1,2,4-triazole-1-yl-methyl)-pentane-3,5- 

diol), calculated as the stoichiometric 

equivalent of tebuconzole, in or on the 

commodity. 

* * * * * 

(c) Tolerances with Regional 

Registrations. Tolerances are established 

for residues of the fungicide 

tebuconazole, including its metabolites 

and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only tebuconazole, alpha-[2- 

(4-chlorophenyl)ethyl]-alpha-(1,1- 

dimethylethyl)-1H-1,2,4-triazole-1- 

ethanol, in or on the commodity. 

* * * * * 

[FR Doc. 2010–10406 Filed 5–4–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0139; FRL–8820–4] 

Spirodiclofen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of spirodiclofen 

per se (3-(2,4-dichlorophenyl)-2-oxo-1- 

oxaspiro[4,5]dec-3-en-4-yl 2,2- 

dimethylbutanoate) in or on multiple 

commodities which are identified and 

discussed later in this document. Bayer 

CropScience requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

5, 2010. Objections and requests for 

hearings must be received on or before 

July 6, 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–2009–0139. 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: Rita 

Kumar, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 


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