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(2) The significant new uses are: 

(i) Release to water. Requirements as 

specified in § 721.90(a)(1), (b)(1), and 

(c)(1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2011–25497 Filed 10–4–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0053; FRL–8884–2] 

Prothioconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

prothioconazole 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 

October 5, 2011. Objections and 

requests for hearings must be received 

on or before December 5, 2011, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2011–0053. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Tawanda Maignan, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8050; e-mail 

address: maignan.tawanda@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&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–2011–0053 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before December 5, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0053, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of March 29, 

2011 (76 FR 17375) (FRL–8867–4), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petitions (PPs 0F7714 and 

0F7715) by Bayer CropScience, P.O. Box 

12014, 2 T.W. Alexander Drive, 

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- 

chlorocyclopropyl)-3-(2-chlorophenyl-2- 

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

triazole-3-thione and its desthio 

metabolite, in or on the raw or 

processed agricultural commodity rice, 


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grain at 0.25 parts per million (ppm); 

rice, hulls at 1.0 ppm; alfalfa, forage and 

alfalfa, hay at 0.02 ppm and potato, 

tuber at 0.02 ppm (PP 0F7714). In a 

separate petition (PP 0F7715) Bayer 

CropScience also proposed use of the 

currently established tolerances for 

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

chlorocyclopropyl)-3-(2-chlorophenyl-2- 

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

triazole-3-thione and its desthio 

metabolite, in or on the raw agricultural 

commodities pea and bean, dried 

shelled, except soybean, subgroup 6C; 

soybean, forage; soybean, hay; soybean, 

seed; rice, seed to support the use of 

prothioconazole as a seed treatment on 

these crops. That notice referenced a 

summary of the petitions 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 

determined that it is appropriate to 

modify the existing grain crop groups 

rather than establish separate rice grain 

and rice straw tolerances. The rice grain 

tolerance will now be covered by the 

modified tolerance of 0.35 ppm for 

grain, cereal group 15, except sweet 

corn and sorghum. Likewise, the rice 

straw tolerance will now be covered by 

the modified tolerance of 5.0 ppm for 

grain, cereal, forage, fodder, and straw, 

group 16, except sorghum; straw. Also, 

the EPA is establishing a tolerance for 

rice hulls at 0.90 ppm, instead of the 

proposed tolerance of 1.0 ppm. The 

reasons for these changes are explained 

in Unit IV.D. 

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 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. It is not 

a dermal sensitizer, or a 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 GI 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. Acute and 

subchronic neurotoxicity studies were 

conducted in the rat using 

prothioconazole. A developmental 

neurotoxicity study was conducted in 

the rat using prothioconazole-desthio. 

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 are discussed in the 

final rule published in the Federal 

Register of May 28, 2010 (75 FR 29910) 

(FRL–8828–6). 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for prothioconazole used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of May 28, 2010 (75 

FR 29910) (FRL–8828–6). 


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C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to prothioconazole and its 

metabolites and/or degradates, 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. 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA conducted a moderately 

refined acute dietary exposure 

assessment. Empirical processing 

factors, average field trial residues 

(since all of the plant commodities 

included in this assessment are blended 

food forms, except sweet corn), and 

livestock commodity residues derived 

from feeding studies and a reasonably 

balanced dietary burden (RBDB) were 

incorporated into the moderately 

refined acute assessment. The 

assessment also assumed 100 percent 

crop treated (PCT). Since no observed 

effects would be attributable to a single 

dose exposure for the general U.S. 

population (including infants and 

children), females 13–49 years of age 

was the only population subgroup 

included in the acute assessment. 

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 

conducted a moderately refined chronic 

dietary exposure assessment. Empirical 

processing factors, average field trial 

residues, and livestock commodity 

residues derived from feeding studies 

and a reasonably balanced dietary 

burden (RBDB) were incorporated into 

the chronic assessment; 100 PCT was 

assumed. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or non-linear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or non-linear approach is 

used and a cancer RfD is calculated 

based on an earlier non-cancer key 

event. If carcinogenic mode of action 

data are not available, or if the mode of 

action data determines a mutagenic 

mode of action, a default linear cancer 

slope factor approach is utilized. 

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 and percent 

crop treated (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 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. 

Average 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 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 Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

prothioconazole for the acute dietary 

risk assessment, the estimated surface 

water concentration value of 94.7 parts 

per million (ppb) was used to assess the 

contribution to drinking water. For the 

chronic dietary risk assessment, the 

estimated surface water concentration 

value of 84.3 ppb was used to assess the 

contribution to drinking water. Modeled 

estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

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 

triazole-containing class of pesticides. 

Although conazoles act similarly in 

plants (fungi) by inhibiting ergosterol 

biosynthesis, there is not necessarily a 

relationship between their pesticidal 

activity and their mechanism of toxicity 

in mammals. Structural similarities do 

not constitute a common mechanism of 

toxicity. Evidence is needed to establish 

that the chemicals operate by the same, 

or essentially the same, sequence of 

major biochemical events. In conazoles, 

however, a variable pattern of 

toxicological responses is found. Some 

are hepatotoxic and hepatocarcinogenic 

in mice. Some induce thyroid tumors in 

rats. Some induce developmental, 

reproductive, and neurological effects in 

rodents. Furthermore, the conazoles 

produce a diverse range of biochemical 

events including altered cholesterol 

levels, stress responses, and altered 

DNA methylation. It is not clearly 

understood whether these biochemical 

events are directly connected to their 

toxicological outcomes. Thus, there is 

currently no evidence to indicate that 

conazoles share common mechanisms of 

toxicity and EPA is not following a 

cumulative risk approach based on a 

common mechanism of toxicity for the 

conazoles. For information regarding 

EPA’s procedures for cumulating effects 

from substances found to have a 

common mechanism of toxicity, see 

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

pesticides/cumulative. 

Prothioconazole is a triazole-derived 

pesticide. Triazole-derived pesticides 

can form the common metabolite, 1,2,4- 

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 human health risk 


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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. 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 (SF) 

for the protection of infants and 

children. The assessment included 

evaluations of risks for various 

subgroups, including those comprised 

of infants and children. The Agency’s 

risk assessment can be found in the 

propiconazole reregistration docket at 

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

number EPA–HQ–OPP– 2005–0497 and 

an update to assess the addition of the 

commodities included in this action 

may be found in docket ID number 

EPA–HQ–OPP–2010–0621 in the 

document titled ‘‘Common Triazole 

Metabolites: Updated Aggregate Human 

Health Risk Assessment to Address 

Tolerance Petitions for Metconazole.’’ 

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 

Food Quality Protection Act Safety 

Factor (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 

prothioconazole-desthio and sulfonic 

acid K salt metabolites. 

ii. Rabbit developmental toxicity 

studies with prothioconazole-desthio. 

iii. A rat developmental neurotoxicity 

study with prothioconazole-desthio; and 

iv. Multi-generation reproduction 

studies in the rat with prothioconazoledesthio. 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 that 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 NOAEL for the fetal effect 

malformed vertebral body and ribs is 

used for assessing acute risk of females 

13 years and older and, because it is 

lower than the NOAELs in other 

developmental studies, is protective of 

all 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 toxicity database for 

prothioconazole is complete, including 

required functional immunotoxicity 

testing. The EPA began requiring 

functional immunotoxicity testing of all 

food and non-food use pesticides on 

December 26, 2007. 

ii. There is an acceptable battery of 

neurotoxicity studies including a 

developmental neurotoxicity study. 

Although offspring neurotoxicity was 

found, characterized by peripheral 

nerve lesions in the developmental 

neurotoxicity studies on 

prothioconazole-desthio, the increase 

was seen only in the highest dose group 

at 105 mg/kg/day, was not considered 

treatment related, and a clear NOAEL 

was established for this study. 

iii. Although increased susceptibility 

was seen in the developmental and 

reproduction studies, the Agency 

concluded that there is a low concern 

and no residual uncertainties for 

prenatal and/or postnatal toxicity effects 

of prothioconazole for the reasons 

explained in Unit III.D.2. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessment is 

moderately refined utilizing empirical 

processing factors, 100 PCT, average 

crop field trial residue levels, and 

livestock maximum residues. Results 

from ruminant feeding studies and 

poultry metabolism studies were used to 

determine the maximum residue levels 

for livestock commodities. The crop 

field trials were performed using 

maximum application rates and 

minimum pre-harvest intervals. 

Although the Agency is requiring 

extended confirmatory storage stability 

data; interim storage stability data do 

not indicate that residue concentrations 

decline and therefore the assessment 

should not underestimate risk from 

dietary exposure. EPA made 

conservative (protective) assumptions in 

the ground water and surface water 

modeling used to assess exposure to 

prothioconazole in drinking water. 

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 drinking water 

to prothioconazole will occupy 24% of 

the aPAD for females 13–49 years of age, 

the only population group at risk for 

acute effects. 

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 drinking 

water will utilize 21% of the cPAD for 

the general U.S. population and 62% of 

the cPAD for all infants <1 year old, the 

population group receiving the greatest 

exposure. 

3. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 


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Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Rules and Regulations 61591 

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 liquid chromatography 

methods with tandem mass 

spectrometry detection (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 U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has established MRLs for 

residues of desthio-prothioconazole in 

barley at 0.2 ppm; oats, rye, and wheat 

at 0.05 ppm each; in the fodder (dry) of 

cereal grains at 5 ppm; and in the straw 

(dry) of cereal grains at 4 ppm. There are 

currently no established Mexican MRLs 

for prothioconazole. Canadian MRLs 

have been established for 

prothioconazole per se in/on several 

commodities, including barley (0.35 

ppm), wheat (0.07 ppm). Harmonization 

of the proposed tolerances with the 

existing Codex for prothioconazole is 

not possible at this time because of 

differences in tolerance expression and 

use patterns. The MRL expression for 

Codex is prothioconazole-desthio and is 

thus not compatible with the U.S. 

tolerance definition, the sum of 

prothiocoanzole and prothioconazoledesthio. EPA generally includes the 

parent in all residue definitions for 

tolerance enforcement, whereas Codex 

routinely excludes the parent if it is 

shown to be a small part of the actual 

total residue. Prothioconazole is a minor 

component of the total residue on the 

crops tested. Much of the Codex cereal 

grain supervised field trial data are from 

Europe, where the use pattern is 

different resulting in lower measured 

residues. 

The tolerance definition for plant 

commodities in Canada was recently 

changed and is now harmonized with 

the U.S. residue definition. The barley 

tolerance of Canada agrees with the U.S. 

tolerance for cereal grains (except sweet 

corn, sorghum, and rice) of 0.35 ppm. 

However, the Canada tolerance for 

wheat is lower (0.07 ppm) than the 

existing U.S. group tolerance. EPA 

establishes crop group tolerances, as 

opposed to individual commodity 

tolerances, whenever there are adequate 

data for the representative commodities 

of that group and proposed use. There 

must be an acceptable range of residues 

over all the representative commodities. 

Wheat falls under this crop group 

practice in this case. Canada does not 

routinely establish animal feed 

commodity tolerances, and therefore 

there are no harmonization issues with 

forage, stover, hay, and straw. 

C. Revisions to Petitioned-For 

Tolerances 

The proposed rice grain tolerance 

level of 0.25 ppm is lower than the 

existing tolerance level (0.35 ppm) for 

grain, cereal group 15, except rice and 

sweet corn and sorghum. The existing 

cereal grain group 15 tolerance excludes 

rice, but the present evaluation of rice 

field trial data allows expansion of that 

group to include rice. Therefore, in this 

action, EPA is revising the existing 

cereal group to read grain, cereal group 

15 (except sweet corn and sorghum). 

Likewise, the rice straw tolerance level 

is lower than the existing tolerance level 

(5.0 ppm) for grain, cereal, forage, 

fodder, and straw, group 16, except 

sorghum and rice straw, and therefore 

this crop group is being revised to 

include rice straw. Also, the submitted 

data support a tolerance of 0.90 ppm for 

rice hulls as determined from the rice to 

hull processing factor (from the rice 

processing study) applied to the highest 

average field trial residue, or 4.4 × 0.19 

ppm, or 0.9 ppm instead of the 

proposed tolerance of 1.0 ppm. 

V. Conclusion 

Therefore, tolerances are established 

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

chlorocylcopropyl)-3-(2-chlorophenyl)- 

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

triazole-3-thion) and its metabolite 

prothioconazole-desthio (a-(1- 

chlorocyclopropyl)-a-[(2- 

chlorophenyl)methyl]-1H-1,2,4-triazole1-ethanol), in or on alfalfa, forage at 0.02 

ppm; alfalfa, hay at 0.02 ppm, potato at 

0.02 ppm and rice, hulls at 0.90 ppm. 

The existing tolerance for Grain, cereal, 

group 15, except sweet corn, sorghum, 

and rice is changed to Grain, cereal, 

group 15, except sweet corn and 

sorghum and the existing tolerance for 

Grain, cereal, forage, fodder and straw, 

group 16, except sorghum and rice; 

straw is changed to Grain, cereal, forage, 

fodder and straw, group 16, except 

sorghum, straw. 

Further, seed treatment uses on 

soybean, dried shelled pea and bean 

(except soybean) subgroup 6C and rice 

are covered by existing and currently 

established tolerances for these 

commodities. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or Tribes, 

nor does this action alter the 


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61592 Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Rules and Regulations 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or Tribal governments, 

on the relationship between the national 

government and the States or Tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 26, 2011. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.626 is amended by 

revising the table in paragraph (a)(1) to 

read as follows: 

§ 180.626 Prothioconazole; tolerances for 

residues. 

(a) * * * (1) * * * 

Commodity Parts per 

million 

Alfalfa, forage ........................... 0 .02 

Alfalfa, hay ................................ 0 .02 

Beet, sugar, roots ..................... 0 .25 

Corn, sweet kernel plus cob 

with husks removed .............. 0 .04 

Grain, aspirated grain fractions 11 

Grain, cereal, forage, fodder 

and straw, group 16, except 

sorghum, and rice; forage ..... 8 .0 

Grain, cereal, forage, fodder 

and straw, group 16, except 

sorghum, and rice; hay ......... 7 .0 

Grain, cereal, forage, fodder 

and straw, group 16, except 

sorghum, and rice; stover ..... 10 

Grain, cereal, forage, fodder 

and straw, group 16, except 

sorghum, straw ..................... 5 .0 

Grain, cereal, group 15, except 

sweet corn and sorghum ...... 0 .35 

Pea and bean, dried shelled, 

except soybean, subgroup 

6C .......................................... 0 .9 

Peanut ...................................... 0 .02 

Potato ....................................... 0 .02 

Rapeseed, seed ....................... 0 .15 

Rice, hulls ................................. 0 .90 

Soybean, forage ....................... 4 .5 

Soybean, hay ............................ 17 

Soybean, seed .......................... 0 .15 

* * * * * 

[FR Doc. 2011–25704 Filed 10–4–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0906; FRL–8874–6] 

Isopyrazam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of isopyrazam in 

or on banana. Syngenta Crop Protection, 

Inc., requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

October 5, 2011. Objections and 

requests for hearings must be received 

on or before December 5, 2011, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0906. 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: 

Shaunta Hill, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8961; e-mail address: hill.

shaunta@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 


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