67048 Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Rules and Regulations 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: October 29, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.589: 

■ a. Remove from the table in paragraph 

(a)(1) the commodities bushberry 

subgroup 13B; caneberry subgroup 13A; 

canola, seed; cotton, undelinted seed; 

fruit, citrus, group 10; fruit, pome, group 

11; grape; strawberry; sunflower, seed; 

vegetable, bulb, group 3; and vegetable, 

fruiting, group 8. 

■ b. Remove from the table in paragraph 

(d) the commodities cotton, gin 

byproducts; cotton, undelinted seed, 

and flax, seed. 

■ c. Add alphabetically the following 

commodities to the table in paragraph 

(a)(1). The additions read as follows: 

§ 180.589 Boscalid; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Artichoke, globe .................... 6.0 

* * * * * 

Berry, low growing, subgroup 

13–07G, except cranberry 4.5 

* * * * * 

Bushberry subgroup 13–07B 13.0 

Caneberry subgroup 13–07A 10.0 

* * * * * 

Endive, Belgium .................... 6.0 

Commodity Parts per 

million 

Fruit, citrus, group 10–10 ..... 2.0 

Fruit, pome, group 11–10 ..... 3.0 

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13–07F .................... 5.0 

* * * * * 

Oilseed group 20 .................. 3.5 

* * * * * 

Persimmon ............................ 8.0 

* * * * * 

Turnip, greens ...................... 40.0 

* * * * * 

Vegetable, bulb, group 3–07 5.0 

* * * * * 

Vegetable, fruiting, group 8– 

10 ...................................... 3.0 

* * * * * 

* * * * * 

[FR Doc. 2013–26765 Filed 11–7–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0876; FRL–9400–4] 

Prothioconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

prothioconozole in or on bushberries 

(crop subgroup 13–07B); low growing 

berries, except strawberry (crop 

subgroup 13–07H); and cucurbit 

vegetables (crop group 9). Bayer 

CropScience requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 8, 2013. Objections and 

requests for hearings must be received 

on or before January 7, 2014, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0876, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions, and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (RD), Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (703) 305–7090; 

email address: RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0876, in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 


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before January 7, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0876, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of December 

19, 2012 (77 FR 75082) (FRL–9372–6), 

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 2F8044 by Bayer 

CropScience, 2 T.W. Alexander Drive, 

P.O. Box 12014, Research Triangle Park, 

NC 27709. The petition requested that 

40 CFR 180.626 be amended by 

establishing tolerances for residues of 

the fungicide prothioconazole, (2-(2-(1- 

chlorocyclpropyl)-3-(2-chlorophenyl)2- 

hydroxypropyl]-1,2-dihydro-3H-1,2,4- 

triazole-3-thione), in or on bushberry, 

subgroup 13–07B at 2.0 ppm; berry, low 

growing, except strawberry subgroup 

13–07H at 0.15 ppm; and vegetables, 

cucurbit, crop group 9 at 0.30 parts per 

million (ppm). That document 

referenced a summary of the petition 

prepared by Bayer CropScience, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

increased the 13–07H berry requested 

tolerance from 0.15 to 0.20 ppm. 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 FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), 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 prothioconazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with prothioconazole 

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. 

Prothioconazole has low acute 

toxicity by oral, dermal, and inhalation 

routes. It is not a dermal sensitizer, or 

a skin or eye irritant. Prothioconazole’s 

metabolite, prothioconazole-desthio, 

also has low acute toxicity by oral, 

dermal, and inhalation routes. This 

metabolite is not a dermal sensitizer, or 

skin irritant, but it is a slight eye 

irritant. The subchronic and chronic 

studies show that the target organs at 

the lowest observable adverse effects 

level (LOAEL) include the liver, kidney, 

urinary bladder, thyroid, and blood. In 

addition, the chronic studies showed 

body weight and food consumption 

changes, and toxicity to the lymphatic 

and gastrointestinal systems. 

Prothioconazole and its metabolites 

may be developmental toxicants 

producing effects including 

malformations in the conceptus at levels 

equal to or below maternally toxic levels 

in some studies, particularly those 

studies conducted using 

prothioconazole-desthio. Reproduction 

studies in the rat with prothioconazole 

and prothioconazole-desthio suggest 

that these chemicals may not be 

reproductive toxicants. 

The available data show that the 

prothioconazole-desthio metabolite 

produces toxicity at lower dose levels in 

subchronic developmental, 

reproductive, and neurotoxicity studies 

as compared with prothioconazole and 

the two additional metabolites that were 

tested. 

The available carcinogenicity and/or 

chronic studies in the mouse and rat, 

using both prothioconazole and 

prothioconazole-desthio, show no 

increase in tumor incidence. Therefore, 

EPA has concluded that 

prothioconazole and its metabolites are 

not carcinogenic, and are classified as 

‘‘Not likely to be carcinogenic to 

humans’’ according to the 2005 Cancer 

Guidelines. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by prothioconazole as 

well as the no-observed-adverse-effectlevel (NOAEL) and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Prothioconazole: Human Health Risk 

Assessment for Proposed Used on Low 

Growing Berry Subgroup (except 

Strawberry), Bushberry, Subgroup, and 

Cucurbit Vegetables’’ dated June 15, 

2013 in docket ID number EPA–HQ– 

OPP–2012–0876. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 


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toxicological study to determine the 

dose at which the NOAEL and the 

lowest dose at which adverse effects of 

concern are identified. Uncertainty/

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for prothioconazole used for 

human risk assessment is discussed in 

Unit III. of the final rule published in 

the Federal Register of October 5, 2011 

(76 FR 61587) (FRL–8884–2). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to prothioconazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing prothioconazole tolerances in 

40 CFR 180.626. EPA assessed dietary 

exposures from prothioconazole in food 

as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. Such effects were identified 

prothioconazole 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

2003–2008, Nationwide Health and 

Nutrition Examination Survey. As to 

residue levels in food, EPA conducted a 

moderately refined acute dietary 

exposure assessment. The acute 

assessment utilized EPA-recommended 

tolerance values for all of the proposed 

uses, average field trial residue levels 

for the existing uses, empirical 

processing factors, and livestock 

commodity residues derived from 

feeding studies and a balanced dietary 

burden. The assessment assumed 100 

percent crop treated (PCT). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008, National 

Health and Nutrition Survey. As to 

residue levels in food, EPA conducted a 

moderately refined chronic dietary 

exposure assessment. Empirical 

processing factors, average field trial 

residues for existing uses, EPArecommended tolerance values for all of 

the proposed uses, and livestock 

commodity residues derived from 

feeding studies and a reasonably 

balanced dietary burden were 

incorporated into the chronic 

assessment which assumed 100 PCT. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that prothioconazole is ‘‘Not 

Likely to be Carcinogenic to Humans.’’ 

Therefore a dietary exposure assessment 

for the purpose of assessing cancer risk 

is unnecessary. 

iv. Anticipated residue. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for prothioconazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

prothioconazole. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Tier 1 Rice 

Model and the Screening Concentration 

in Ground Water (SCI–GROW) models, 

the estimated drinking water 

concentrations (EDWCs) of 

prothioconazole for acute exposures are 

estimated to be 99.0 parts per billion 

(ppb) for surface water and 0.83 ppb for 

ground water. 

Chronic exposures for non-cancer 

assessments are estimated to be 0.83 

ppb for surface water and 91.9 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 99.0 ppb 

was used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 91.9 

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). 

Prothioconazole 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.’’ 

Prothioconazole is a member of the 

conazole (triazole) class of pesticides. 

Although conazoles act similarly in 

plants (fungi) by inhibiting ergosterol 

biosynthesis, there is not necessarily a 

relationship between their pesticidal 

activity and their mechanism of toxicity 

in mammals. Structural similarities do 

not constitute a common mechanism of 

toxicity. Evidence is needed to establish 

that the chemicals operate by the same, 

or essentially the same sequence of 

major biochemical events (EPA, 2002). 

In conazoles, however, a variable 

pattern of toxicological responses are 

found; some are heptotoxic and 

hepatocarconogenic 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 mechanism of toxicity. 

For information regarding EPA’s 

procedures for cumulating effects from 

substances found to have a common 

mechanism of toxicity, see EPA’s Web 

site at http//www.epa.gov/pesticides/

cumulative. 


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Prothioconazole is a triazole-derived 

pesticide. Triazole-derived pesticides 

can form the common metabolite, 2,3,4- 

triazole and three triazole conjugates 

(triazole alanine, triazole acetic acid, 

and triazolylpyruvic acid). To support 

existing tolerances and to establish new 

tolerances for triazole-derivative 

pesticides, including prothioconazole, 

EPA conducted a health risk assessment 

for the 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. 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). In 

addition, the Agency retained the 

additional 10X Food Quality Protection 

Act (FQPA) safety factor (SF) for the 

protection of infants and children. The 

Agency’s prior risk assessment can be 

found in the propiconazole registration 

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

Updates to assess the addition of the 

commodities included in this rule may 

be found in docket ID number EPA– 

HQ–OPP–2012–0876 in the document 

titled ‘‘Common Triazole Metabolites: 

Updated Dietary (Food + Water) 

Exposure and Risk Assessment to 

Address The New Section 3 

Registrations For Use of Prothioconazole 

on Bushberry crop Subgroup 13–07B, 

Low Growing Berry, Except Strawberry, 

Crop Subgroup 13–07H, and Cucurbit 

Vegetables Crop Group 9; Use of 

Flutriafol on Coffee; and Ipconazole on 

Crop Group 6’’ dated May 12, 2013. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

There is evidence of increased 

susceptibility following prenatal/or 

postnatal exposure in: 

i. Rat developmental toxicity studies 

with prothioconazole as well as its 

prothioconozole-desthio and sulfonic 

acid K salt metabolites. 

ii. Rabbit developmental toxicity 

studies with prothioconazole-desthio. 

iii. A rat developmental neurotoxicity 

study with prothioconazole-desthio. 

iv. Multi-generation reproduction 

studies in the rat with prothioconazoledestio effects, include skeletal structural 

abnormalities, such as cleft palate, 

deviated snout, malocclusion, extra ribs, 

and developmental delays. Available 

data also show that the skeletal effects 

such as extra ribs are not completely 

reversible after birth in the rat, but 

persist as development continues. 

Although increased susceptibility was 

seen in these studies, the Agency 

concluded there is a low concern and no 

residual uncertainties for prenatal and/ 

or postnatal toxicity effects of 

prothioconazole because: 

Developmental toxicity NOAELs and 

LOAELs from prenatal exposure are 

well characterized after oral and dermal 

exposure; the off-spring toxicity 

NOAELs and LOAELs from postnatal 

exposures are well characterized; and 

the lowest NOAEL from the 

developmental studies, the NOAEL for 

the fetal effect malformed vertebral body 

and ribs in the rat dermal 

developmental study, is used for 

assessing acute risk of females 13 years 

and older. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

prothioconazole is considered complete. 

ii. Evidence of quantitative and 

qualitative susceptibility of offspring 

were observed in the developmental 

studies. However, basing the POD on 

the offspring in the most sensitive of 

these studies provides the needed 

protection of offspring. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

EPA-recommended tolerance values for 

all of the proposed uses, average field 

trial residue levels for the existing uses, 

empirical processing factors, and 

livestock commodity residues derived 

from feeding studies and a balanced 

dietary burden. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to prothioconazole in 

drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of children as 

well as incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by prothioconazole. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

Based on the proposed and existing 

crop uses for prothioconazole, dietary 

aggregate exposures (i.e., food plus 

drinking water) are anticipated. There 

are no residential uses for 

prothioconazole and, therefore, no 

residential exposures are anticipated. 

Consequently, only dietary (food plus 

drinking water) exposures were 

aggregated for this assessment. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

prothioconazole will occupy 30% of the 

aPAD for females, 13–49 years of age, 

the population group receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to 

prothioconazole from food and water 

will utilize 57% of the cPAD for all 

infants (<1 year of age) the population 

group receiving the greatest exposure. 

There are no residential uses for 

prothioconazole. 

3. Aggregate cancer risk for U.S. 

population. Based on lack of evidence of 

carcinogenicity in two adequate rodent 

carcinogenicity studies, prothioconazole 

is not expected to pose a cancer risk to 

humans. 

4. 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 

prothioconazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies, 

liquid chromatography methods with 

tandem mass spectrometry detection 


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67052 Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Rules and Regulations 

(LC/MS/MS), are 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 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

There are no Canadian, Codex, or 

Mexican maximum residue limits 

(MRLs) in/on the proposed 

commodities. Canada will be 

establishing the same tolerances for 

members of the subject groups or 

subgroups. Therefore, harmonization is 

not an issue for this petition. 

C. Revisions to Petitioned-For 

Tolerances 

The petitioned-for tolerance for the 

low growing berry, except strawberry, 

crop subgroup 13–07H was requested at 

0.15 ppm. The Agency modified the 

requested 0.15 ppm tolerance to 0.20 

ppm which is appropriate based on an 

evaluation of the crop field trial data 

with the Organization of Economic 

Cooperation and Development (OECD) 

Maximum Residue Level (MRL) 

Calculation Procedures. 

V. Conclusion 

Therefore, tolerances are established 

for residues of prothioconazole, (2-(2-(1- 

chlorocyclpropyl)-3-(2-chlorophenyl)-2- 

hydroxypropyl]-1,2-dihydro-3H-1,2,4- 

triazole-3-thione), in or on bushberry, 

subgroup 13–07B at 2.0 ppm; berry, low 

growing, except strawberry, subgroup 

13–07H at 0.20 ppm; and vegetables, 

cucurbit, crop group 9 at 0.30 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: October 22, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.626, add alphabetically the 

following new entries to the table in 

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

§ 180.626 Prothioconazole; tolerances for 

residues. 

(a)(1) * * * 

Commodity Parts per 

million 

* * * * * 

Berry, low growing, except 

strawberry, subgroup 13– 

07H ...................................... 0 .20 

Bushberry, subgroup 13–07B 2 .0 

* * * * * 

Vegetable, cucurbit, crop 

group 9 ................................ 0 .30 

* * * * * 

[FR Doc. 2013–26772 Filed 11–7–13; 8:45 am] 

BILLING CODE 6560–50–P 


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