51732 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Corn, sweet, 

kernel plus 

cob with 

husks removed ........... 0.01 12/31/11 

Corn, sweet, 

stover ............ 6.0 12/31/11 

Milk ................... 0.03 12/31/11 

* * * * * 

* * * * * 

[FR Doc. E8–20520 Filed 9–5–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–1199; FRL–8376–6] 

Uniconazole-P; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for combined residues of 

uniconazole-P, its R-enantiomer and its 

Z-isomer in or on vegetable, fruiting, 

group 8. Interregional Research Project 

Number 4 (IR-4) requested this tolerance 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 5, 2008. Objections and 

requests for hearings must be received 

on or before November 4, 2008, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2007–1199. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

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

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S–

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305–

5805. 

FOR FURTHER INFORMATION CONTACT: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s pilot 

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

ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2007–1199 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before November 4, 2008. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA–

HQ–OPP–2007–1199, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket’s 

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

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of February 6, 

2008 (73 FR 6964) (FRL–8350–9), 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 7E7268) by 

Interregional Research Project Number 4 

(IR-4), 500 College Road East, Suite 201 

W, Princeton, NJ 08540. The petition 

requested that 40 CFR part 180 be 

amended by adding a section for the 

fungicide uniconazole-P and 


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establishing a tolerance therein for 

residues of uniconazole-P per se in or 

on vegetable, fruiting, group 8 at 0.01 

parts per million (ppm). That notice 

referenced a summary of the petition 

prepared by Valent USA 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 the tolerance expression to 

include uniconazole-P, its R-enantiomer 

and its Z-isomer. The reason for this 

change 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 

tolerance for combined residues of 

uniconazole-P, its R-enantiomer and its 

Z-isomer on vegetable, fruiting, group 8 

at 0.01 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing this tolerance 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. 

Uniconazole-P (hereafter referred to as 

uniconazole) is rapidly absorbed after 

oral ingestion and extensively 

metabolized by the liver. There is no 

accumulation in the tissues, and the 

metabolites are rapidly excreted in the 

feces and urine. Uniconazole has 

moderate acute oral toxicity and low 

acute dermal and inhalation toxicity. It 

is a slight eye irritant but not a skin 

irritant or skin sensitizer. In mouse, rat 

and dog repeated-dose studies, oral 

ingestion of high doses caused an 

increase in the size and weight of the 

liver. Fat accumulation in the liver was 

also consistently observed at high doses. 

Although observed less consistently, 

increases in the activity of some 

enzymes indicated altered liver function 

as a response to uniconazole exposure. 

There was no evidence of 

carcinogenicity in the combined chronic 

toxicity/carcinogenicity study in the rat; 

however, in the mouse study an 

increase in liver neoplasms was noted. 

Mutagenicity studies were generally 

negative except for the in vitro 

mammalian chromosome aberration test 

(CHO), which was positive with 

metabolic activation. Based on the 

limited evidence of carcinogenicity in 

the mouse, EPA classified uniconazole 

as a Group C (Possible Human) 

carcinogen but concluded that 

quantification of cancer risk using a low 

dose extrapolation model was not 

appropriate. The point of Departure 

(POD) selected for deriving the chronic 

reference dose will adequately account 

for all chronic effects determined to 

result from exposure to uniconazole in 

chronic animal studies, including 

potential cancer effects. Uniconazole 

had no effects on reproductive 

performance of rats in the 2-generation 

reproduction toxicity study and no 

effect on fetal development in the rabbit 

developmental toxicity study. In the 

developmental toxicity study in rats, 

developmental toxicity (increased 

incidence of 14th ribs) was noted, but 

only at doses that were also maternally 

toxic. There was no evidence of 

neurotoxicity in the submitted 

uniconazole toxicity studies or in the 

open literature. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by uniconazole, 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 

Uniconazole-P Human Health Risk 

Assessment for Proposed Uses on 

Fruiting Vegetables (Except Cucurbits), 

Crop Group 8 pages 52–75 in docket ID 

number EPA–HQ–OPP–2007–1199. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological 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-term, intermediate-term, 

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 uniconazole used for 

human risk assessment can be found at 

http://www.regulations.gov in the 

document Uniconazole-P Human 

Health Risk Assessment for Proposed 

Uses on Fruiting Vegetables (Except 

Cucurbits), Crop Group 8 pages 26–27 in 

docket ID number EPA–HQ–OPP–2007–

1199. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 


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exposure to uniconazole, EPA 

considered exposure under the 

petitioned-for tolerance on fruiting 

vegetables, the first food use of 

uniconazole. EPA assessed dietary 

exposures from uniconazole 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. EPA identified such an effect 

relevant to the population group 

females, 13 years of age and older 

(increased incidence of 14th rib 

following in utero exposure to 

uniconazole in the rat developmental 

toxicity study). No acute effects were 

identified for the general population, 

including infants and children. 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

1994–1996 Nationwide Continuing 

Surveys of Food Intakes by Individuals 

(CSFII). As to residue levels in food, 

EPA assumed that all foods covered by 

the fruiting vegetable tolerance contain 

tolerance-level residues and that 100% 

of fruiting vegetables are treated with 

uniconazole. 

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 

again assumed that all foods covered by 

the fruiting vegetable tolerance contain 

tolerance-level residues and that 100% 

of fruiting vegetables are treated with 

uniconazole. 

iii. Cancer. Based upon statistically 

significant increases in hepatocellular 

neoplasms in high-dose male mice, EPA 

classified uniconazole as a Group C 

(Possible Human) carcinogen but 

concluded that quantification of cancer 

risk using a low dose extrapolation 

model was not appropriate. This 

determination was based on the fact that 

the tumor induced is primarily of a 

benign nature, occurred at the highest 

dose tested in one sex of one species 

only with no acceleration in the rate of 

tumor formation and did not exhibit any 

uncommon biological behavior. The 

POD selected for deriving the chronic 

reference dose (cRfD) will adequately 

account for all chronic effects 

determined to result from exposure to 

uniconazole in chronic animal studies, 

including potential cancer effects. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for uniconazole. Tolerance level 

residues and 100 PCT 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 uniconazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

uniconazole. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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

oppefed1/models/water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST) and Screening 

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

water concentrations (EDWCs) of 

uniconazole for acute exposures are 

estimated to be 3.1 parts per billion 

(ppb) for surface water and 0.076 ppb 

for ground water; and for chronic 

exposures for non-cancer assessments 

are estimated to be 1.5 ppb for surface 

water and 0.076 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 3.1 ppb was used 

to assess the contribution to drinking 

water. For chronic dietary risk 

assessment, the water concentration of 

value 1.5 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). 

Uniconazole is not registered for any 

specific use patterns that would result 

in residential 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.’’

Uniconazole is a member of the 

triazole-containing class of pesticides, 

sometimes referred to as conazoles. 

Although conazoles act similarly in 

fungi by inhibiting ergosterol 

biosynthesis, there is not necessarily a 

relationship between their pesticidal 

activity and their mechanism of toxicity 

in mammals. Structural similarities do 

not constitute a common mechanism of 

toxicity. Evidence is needed to establish 

that the chemicals operate by the same, 

or essentially the same, sequence of 

major biochemical events. In conazoles, 

however, a variable pattern of 

toxicological responses is found. Some 

are hepatotoxic and hepatocarcinogenic 

in mice. Some induce thyroid tumors in 

rats. Some induce developmental, 

reproductive and neurological effects in 

rodents. Furthermore, the conazoles 

produce a diverse range of biochemical 

events, including altered cholesterol 

levels, stress responses, and altered 

DNA methylation. It is not clearly 

understood whether these biochemical 

events are directly connected to their 

toxicological outcomes. Thus, there is 

currently no evidence to indicate that 

conazoles share common mechanisms of 

toxicity and EPA is not following a 

cumulative risk approach based on a 

common mechanism of toxicity for the 

conazoles. For information regarding 

EPA’s 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. 

Uniconazole is a triazole-derived 

pesticide. This class of compounds can 

form the common metabolite 1,2,4- 

triazole and several triazole conjugates 

(including triazole alanine, triazole 

acetic acid, triazole pyruvic acid and 

triazole lactic acid). To support existing 

tolerances and to establish new 

tolerances for triazole-derivative 

pesticides, including uniconazole, EPA 

conducted a human health risk 

assessment for exposure to 1,2,4- 

triazole, triazole alanine, and triazole 

acetic acid resulting from the use of all 

current and pending uses of any 

triazole-derived fungicide. Triazole 

pyruvic acid and triazole lactic acid 

were not included in the risk 

assessment due to their low occurrence 

in metabolism studies. 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 ID EPA–


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Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations 51735 

HQ–OPP–2005–0497). Additional 

information regarding the uses proposed 

for uniconazole in this action can also 

be found at http://www.regulations.gov 

in the documents Dietary Exposure 

Assessments for the Common Triazole 

Metabolites 1,2,4-Triazole, 

Triazolylalanine, Triazolylacetic Acid, 

and Triazolylypyruvic Acid; Updated to 

Include New Uses of Fenbuconazole, 

Ipconazole, Metconazole, Tebuconazole, 

and Uniconazole; and a Change in 

Plant-back Restriction for Tetraconazole 

and Uniconazole-P: Acute, Chronic and 

Cancer Aggregate Dietary (Food and 

Drinking Water) Exposure Analyses for 

the Section 3 Registration Action in 

docket ID number EPA–HQ–OPP–2007–

1199. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicology 

database for uniconazole includes rat 

and rabbit developmental toxicity 

studies and a 2-generation reproduction 

toxicity study in rats. There was no 

evidence of increased qualitative or 

quantitative susceptibility of rabbit 

fetuses following in utero exposure to 

uniconazole and no evidence of 

increased susceptibility of offspring in 

the 2-generation reproduction study in 

rats. There was evidence of increased 

qualitatative susceptibility of fetuses in 

the rat developmental study. In this 

study, an increased incidence of 14th rib 

in the fetuses was observed in the 

presence of minimal maternal toxicity 

(decreased body weight). The degree of 

concern for the qualitative susceptibility 

seen in the rat developmental study is 

low because: 

• The additional rib was the only 

skeletal variation noted 

• The fetal effect occurred only in the 

presence of maternal toxicity 

• In the reproduction study in rats, 

higher doses resulted in minimal pup 

toxicity (slightly reduced body weights); 

and: 

• The NOAEL for the fetal effect is 

used for assessing acute risk of females 

13 years and older and is, therefore, 

protective of potential developmental 

effects. 

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 uniconazole database is 

adequate to assess prenatal and 

postnatal toxicity. 

ii. There is no indication that 

uniconazole is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. Although there is qualitative 

evidence of increased susceptibility in 

the prenatal developmental study in 

rats, EPA did not identify any residual 

uncertainties after establishing toxicity 

endpoints and traditional UFs to be 

used in the risk assessment of 

uniconazole. The degree of concern for 

prenatal and/or postnatal toxicity is 

low. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed assuming 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to uniconazole 

in drinking water. Residential exposure 

to uniconazole is not expected. These 

assessments will not underestimate the 

exposure and risks posed by 

uniconazole. 

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. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing 

the estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to uniconazole will 

occupy <1% of the aPAD for females 13 

to 49 years old, the only population 

group for which an acute endpoint of 

concern was identified. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to uniconazole 

from food and water will utilize <1% of 

the cPAD for the general population and 

all population subgroups, including 

infants and children. There are no 

residential uses for uniconazole. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Uniconazole is not registered for any 

use patterns that would result in 

residential exposure. Therefore, the 

short- and intermediate-term aggregate 

risk is the sum of the risk from exposure 

to uniconazole through food and water 

and will not be greater than the chronic 

aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. The Agency has determined 

that the chronic risk assessment based 

on the established cPAD is protective of 

potential cancer effects. Based on the 

results of the chronic risk assessment 

discussed above in Unit E.2, EPA 

concludes that uniconazole is not 

expected to pose a cancer risk. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to uniconazole 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Gas Chromatography/Nitrogen 

Phosphorus Detector (GC/NPD); Valent 

Method RM-25-1b) is available to 

enforce the tolerance expression. The 

method may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

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

B. International Residue Limits 

No Codex, Canadian, or Mexican 

MRLs have been established for 

uniconazole. 


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C. Revisions to Petitioned-For Tolerance 

The petitioner proposed a tolerance 

for residues of uniconazole-P per se in 

or on vegetable, fruiting, group 8. 

However, based on the results of plant 

metabolism studies, EPA has 

determined that the residues of concern 

to be included in the tolerance 

expression for fruiting vegetables are 

uniconazole-P, its R-enantiomer and its 

Z-isomer. Therefore, EPA has modified 

the tolerance expression to include all 

three compounds. 

V. Conclusion 

Therefore, the tolerance is established 

for combined residues of uniconazole-P, 

(E)-(S)-1-(4-chlorophenyl)-4,4-dimethyl2-(1H-1,2,4-triazol-1-yl)pent-1-en-3-ol, 

its R-enantiomer and its Z-isomer in or 

on vegetable, fruiting, group 8 at 0.01 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 26, 2008. 

Debra Edwards, 

Director, 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 180.643 is added to read as 

follows: 

§ 180.643 Uniconazole; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

fungicide/plant growth regulator 

uniconazole-P, (E)-(S)-1-(4- 

chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4- 

triazol-1-yl)pent-1-en-3-ol, its Renantiomer and its Z-isomer in or on the 

following raw agricultural commodities: 

Commodity Parts per 

million 

Vegetable, fruiting, group 8 0.01 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertant residues. 

[Reserved] 

[FR Doc. E8–20548 Filed 9–4–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0097; FRL–8376–7] 

Tebuconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; final order. 

SUMMARY: This order amends the 

pesticide tolerance regulation for 

tebuconazole by establishing a tolerance 

for pistachios. Pesticide tolerances are 

established under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). This 

order resolves an objection filed by 

Bayer CropScience in response to a final 

rule on tebuconazole tolerances 

published on May 14, 2008. 

DATES: This regulation is effective 

September 5, 2008. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2005–0097. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

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

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 


hsrobinson on PROD1PC76 with RULES