29908 Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Rules and Regulations 

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

indirect or inadvertent residues of the 

fungicide boscalid, including its 

metabolites and degradates, in or on the 

commodities listed below. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only boscalid, 3-pyridinecarboxamide, 

2-chloro-N-(4′-chloro[1,1’-biphenyl]-2- 

yl), in or on the following commodities: 

Commodity Parts per million 

Animal feed, nongrass, group 18, forage, except alfalfa 1.0 

Animal feed, nongrass, group 18, hay, except alfalfa 2.0 

*****

[FR Doc. 2010–12921 Filed 5–27–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0279; FRL–8828-–6] 

Prothioconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

prothioconazole and prothioconazoledesthio, calculated as parent in or on 

grain, cereal, group 15 (except sweet 

corn, sorghum, and rice), and grain, 

cereal, forage, fodder and straw, group 

16 (except sweet corn, sorghum, and 

rice) and sweet corn. Bayer CropScience 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective May 

28, 2010. Objections and requests for 

hearings must be received on or before 

July 27, 2010, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0279. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Tawanda Maignan, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

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

maignan.tawanda@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

To access the harmonized test 

guidelines referenced in this document 

electronically, please go http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. 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–2009–0279 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 July 27, 2010. 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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0279, 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 

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(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 August 19, 

2009 (74 FR 41898) (FRL–8426–7), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 8F7485) 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-thion, in or on grain, cereal, 

group 15, except sweet corn, sorghum 

and rice at 0.35 parts per million (ppm); 

forage, cereal, group 16, except sweet 

corn, sorghum and rice at 8.0 ppm; 

stover, cereal, group 16, except sweet 

corn, sorghum and rice at 10 ppm; hay, 

cereal, group 16, except sweet corn, 

sorghum and rice at 7.0 ppm; straw, 

cereal, group 16, except sweet corn, 

sorghum and rice at 5.0 ppm; corn, 

sweet, forage at 7.0 ppm; corn, sweet, 

stover at 8.0 ppm; and corn, sweet, 

kernel plus cob with husks removed at 

0.02 ppm. That notice referenced a 

summary of the petition prepared by 

Bayer CropScience, the registrant, 

which is available in the docket, http:// 

www.regulations.gov. A comment was 

received on the notice of filing. EPA’s 

response to the comment is discussed in 

Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

established and increased the proposed 

tolerance of 0.02 ppm for combined 

residues in/on sweet corn to a higher 

tolerance of 0.04 ppm. Further, EPA has 

modified crop group terminology and 

established tolerances for grain, cereal, 

group 15, except sweet corn, sorghum, 

and rice at 0.35 ppm; grain, cereal, 

group 16, except sorghum and rice; 

forage at 8.0 ppm; grain, cereal, group 

16, except sorghum and rice; stover at 

10 ppm; grain, cereal, group 16, except 

sorghum and rice; hay at 7.0 ppm; grain, 

cereal, group 16, except sorghum and 

rice; straw at 5.0 ppm. With the 

establishment of the above tolerances, 

EPA has revoked the following 

tolerances: barley, grain; barley, hay; 

barley, straw; wheat, forage; wheat, 

grain; wheat, hay; and wheat, straw. 

EPA is also not establishing the 

proposed tolerances for sweet corn 

forage at 7 ppm and sweet corn stover 

at 8 ppm because the commodities will 

be covered under grain, cereal, group 

16; forage and stover. 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. Prothioconazole 

and its metabolites may be primary 

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 prothioconazoledesthio suggest that these chemicals 

may not be primary 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 lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Prothioconazole. Human Health Risk 

Assessment for Proposed Section 3 Uses 

on Crop Group 15 and 16 (Cereal Grains 

and Forage, Fodder and Straw of the 

Cereal Grains Group Except Sweet Corn, 

Sorghum and Rice) and Sweet Corn,’’ 

pages 14 to 17 in docket ID number 

EPA–HQ–OPP–2009–0279. 

B. Toxicological Points of Departure and 

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 

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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 shown in the 

following Table. 

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

ASSESSMENT

Exposure/Scenario Point of Departure and Uncertainty/Safety Factors 

RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects 

Acute dietary 

(Females 13–49 years of age) 

NOAEL = 2.0milligrams/kilograms/day (mg/kg/day) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.02 mg/kg/day 

aPAD = 0.02 mg/kg/day 

Developmental Toxicity Study in 

Rabbits 

LOAEL = 10 mg/kg/day based on 

structural alterations including 

malformed vertebral body and 

ribs, arthrogryposis, and multiple malformations. 

Chronic dietary 

(All populations) 

NOAEL = 1.1 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.01 mg/kg/day 

cPAD = 0.01 mg/kg/day 

Chronic/Oncogenicity Study in 

Rats 

LOAEL = 8.0 mg/kg/day based 

on liver histopathology 

(hepatocellular vacuolation and 

fatty change (single cell, 

centrilobular, and periportal)). 

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

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. Loc = level of concern. 

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 U.S. 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. Average 

field trial values (because all of the 

crops included in this assessment are 

blended food forms, except sweet corn), 

empirical processing factors, and 

livestock maximum residues were 

incorporated into the refined acute 

assessment. The assessment also 

assumed 100% crop treated (CT). Since 

no observed effects would be 

attributable to a single dose exposure for 

the general U.S. population, females 13 

to 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% crop 

treated was assumed. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight-ofthe-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 noncancer 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 classified as ‘‘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 section 408(b)(2)(E) of 

FFDCA and authorized under section 

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Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Rules and Regulations 29911 

408(f)(1) of FFDCA. Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 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 (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

prothioconazole for the acute dietary 

risk assessment, the water concentration 

value of 94.7 parts per billion (ppb) was 

used to assess the contribution to 

drinking water. For the chronic dietary 

risk assessment, the 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, 

often referred to as the triazoles. EPA is 

not currently following a cumulative 

risk approach based on a common 

mechanism of toxicity for the conazoles. 

The conazole pesticides, as a whole, 

tend to exhibit carcinogenic, 

developmental, reproductive, and/or 

neurological effects in mammals. 

Additionally, all the members of this 

class of compounds are capable of 

forming, via environmental and 

metabolic activities, 1,2,4-triazole, 

triazolylalanine and/or triazolylacetic 

acid. These metabolites have also been 

shown to cause developmental, 

reproductive, and/or neurological 

effects. That these compounds, 

however, have structural similarities 

and share some common effects does 

not alone show 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. 

A number of potential events could 

contribute to the toxicity of conazoles 

(e.g., altered cholesterol levels, stress 

responses, altered DNA methylation). At 

this time, there is not sufficient 

evidence to determine whether 

conazoles share common mechanisms of 

toxicity. Without such understanding, 

there is no basis to make a common 

mechanism of toxicity finding for the 

diverse range of effects found. 

Investigations into the conazoles are 

currently being undertaken by the EPA’s 

Office of Research and Development. 

When the results of this research are 

available, the Agency will make a 

determination of whether there is a 

common mechanism of toxicity and, 

therefore, a basis for assessing 

cumulative risk. For information 

regarding EPA’s procedures for 

cumulating effects from substances 

found to have a common mechanism of 

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

www.epa.gov/pesticides/cumulative. 

To support existing tolerances and to 

establish new tolerances for conazole 

pesticides, including prothioconazole, 

EPA conducted human health risk 

assessments for exposure to 1,2 4- 

triazole, triazolylalanine, and 

triazolylacetic acid resulting from the 

use of all current and pending uses of 

triazole-containing pesticides (as of 9/1/ 

05). The risk assessment is a highly 

conservative, screening-level evaluation 

in terms of hazards associated with the 

common metabolites (e.g., use of 

maximum combination of uncertainty 

factors) and potential dietary and nondietary exposures (i.e., high-end 

estimates of both dietary and nondietary exposures). Acute and chronic 

aggregate risk estimates associated with 

these compounds are below the 

Agency’s level of concern for all 

durations of exposure and for all 

population subgroups, including those 

of infants and children. The Agency’s 

risk assessment for these common 

metabolites is available in the 

propiconazole reregistration docket at 

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

Number EPA–HQ–OPP–2005–0497. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA 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. 

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: 

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i. The toxicity database for 

prothioconazole is considered complete, 

with the exception of required 

functional immunotoxicity testing. The 

Agency began requiring functional 

immunotoxicity testing of all food and 

non-food use pesticides on December 

26, 2007. Although an immunotoxicity 

study in the mouse is part of the 

existing prothioconazole toxicity 

database, this study as reported does not 

satisfy the current guideline 

requirements for an immunotoxicity 

study (OPPTS 870.7800). As such, EPA 

is requiring that an immunotoxicity 

study be submitted which meets 

guideline requirements. EPA has 

evaluated the available prothioconazole 

toxicity database (including the nonguideline study in the mouse) to 

determine whether an additional 

database uncertainty factor is needed to 

account for potential immunotoxicity. 

In one chronic study in the rat (but not 

in the mouse or dog), blood leukocyte 

counts were significantly elevated at the 

high dose level (750 mg/kg/day) along 

with increased thrombocyte counts and 

decreased hemoglobin. However, this 

finding is made in the presence of 

toxicity to a broad range of organ 

systems such as the liver, urinary 

bladder, kidney, thyroid, and decreased 

body weight gains. In a chronic dog 

study, splenic effects (increased spleen 

weight with pigmentation and/or 

fibrosiderotic plaques) were seen at 40 

mg/kg/day and above, but these effects 

are not considered to be indicative of 

immunotoxicity, and occurred in the 

presence of toxicity to the liver, kidney, 

thyroid, and decreased body weights. 

Furthermore, no signs of 

immunotoxicity, such as changes in 

leukocyte counts and albumin/globulin 

ratio, changes in thymus and spleen 

weights, or histopathological changes in 

lymphoid tissues, were observed at dose 

levels up to 400 mg/kg/day in the nonguideline immunotoxicity study in the 

mouse. There appears to be no basis for 

concern for immunotoxicity, 

particularly at the Points of Departure 

(POD) for prothioconazole and its 

metabolites which, at 2.0 and 1.1 mg/kg/ 

day (Acute and Chronic Reference Dose 

(aRfD and cRfD), respectively) are two 

orders of magnitude lower than the 400 

and 750 mg/kg/day dose levels 

mentioned in this Unit. This finding, 

along with the absence of 

immunotoxicity observed in the 

subchronic and chronic studies with 

prothioconazole and its metabolites 

supports the reduction of the FQPA 

factor to 1X in the interim, pending 

receipt of an acceptable guideline 

immunotoxicity study. 

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 

utilized empirical processing factors, 

100% crop treated, 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. EPA 

made conservative (protective) 

assumptions in the ground 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 water to 

prothioconazole will occupy 38% of the 

aPAD for females 13 to 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 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. There are no residential uses 

for prothioconazole. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Because there is no 

residential exposure, prothioconazole is 

not expected to pose a short-term risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Because there is no residential 

exposure, prothioconazole is not 

expected to pose an intermediate-term 

risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

prothioconazole is not expected to pose 

a cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

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; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

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Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Rules and Regulations 29913 

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 (04/2010), and in oats, 

rye, and wheat at 0.05 ppm each and in 

the fodder (dry) of cereal grains at 4 

ppm and in the straw (dry) of cereal 

grains at 5 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), 

meat byproducts of cattle, goats, horses 

and sheep (0.2 ppm), meat byproducts 

of hogs (0.05 ppm), liver of poultry (0.02 

ppm), meat of cattle, goats, horses, and 

sheep (0.02 ppm), and milk (0.02 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 prothioconazole-desthio. Much of 

the Codex cereal grain supervised field 

trial data is from Europe, where the use 

pattern is different resulting in lower 

measured residues. The straw numerical 

value (5 ppm) is matched between the 

U.S. and Codex. 

The tolerance definition for plant 

commodities in Canada were recently 

changed (02/10/2010) and is now 

harmonized with the U.S. residue 

definition. The barley tolerance of 

Canada agrees with the recommended 

U.S. tolerance for cereal grains (except 

sweet corn, sorghum, and rice) of 0.35 

ppm. However, the Canadian tolerance 

for wheat is lower (0.07 ppm) than the 

recommended U.S. group tolerance. The 

0.07 ppm value is the current U.S. 

tolerance value for wheat, but will be 

replaced by the cereal grain group 

tolerance. Canada does not routinely 

establish animal feed commodity 

tolerances, and therefore there are no 

harmonization issues with forage, 

stover, hay, and straw. 

C. Response to Comments 

One comment was received from an 

anonymous source objecting to 

establishment of tolerances and stating 

that the Agency is not protecting human 

health. The response contained no 

scientific data or evidence to rebut the 

Agency’s conclusion that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to 

prothioconazole, including all 

anticipated dietary exposures and other 

exposures for which there is reliable 

information. 

D. Revisions to Petitioned-For 

Tolerances 

Prothioconazole tolerances for crop 

commodities listed in 40 CFR 

180.626(a)(1) are expressed in terms of 

the combined residues of the fungicide 

prothioconazole and prothioconazoledesthio, calculated as parent. EPA has 

also revised the tolerance expression to 

clarify (1) that, as provided in section 

408(a)(3) of FFDCA, the tolerance covers 

metabolites and degradates of 

prothioconazole not specifically 

mentioned; and (2) that compliance 

with the specified tolerance levels is to 

be determined by measuring only the 

specific compounds mentioned in the 

tolerance expression. 

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, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only prothioconazole and its 

metabolite prothioconazole-desthio, or 

a-(1-chlorocyclopropyl)-a-[(2- 

chlorophenyl)methyl]-1H-1,2,4-triazole1-ethanol, calculated as parent in or on 

the commodity. 

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, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only prothioconazole and its 

metabolites prothioconazole-desthio, or 

a-(1-chlorocyclopropyl)-a-[(2- 

chlorophenyl)methyl]-1H-1,2,4-triazole1-ethanol, and conjugates that can be 

converted to these two compounds by 

acid hydrolysis, calculated as parent in 

or on the commodity. 

The proposed tolerance of 0.02 ppm 

for combined residues in/on sweet corn 

K+CWHR should be increased to 0.04 

ppm (reflecting the combined limit of 

quantitation of 0.02 ppm each for 

prothioconazole and prothioconazoledesthio). 

The proposed tolerances of 7 ppm for 

sweet corn forage and 8 ppm for sweet 

corn stover should be removed. These 

commodities will be covered by the 

tolerance for group 16 grain, cereal, 

forage and group 16, cereal, grain, 

stover, respectively. 

With the establishment of the 

requested crop group tolerances for 

group 15 and 16, the established 

tolerances for the following 

commodities are no longer necessary 

and should be removed: barley, grain; 

barley, hay; barley, straw; wheat, forage; 

wheat, grain; wheat, hay; and wheat, 

straw. 

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, including its 

metabolites and degradates, in or on 

grain, cereal, group 15, except sweet 

corn, sorghum, and rice at 0.35 ppm; 

grain, cereal, group 16, except sorghum 

and rice; forage at 8.0 ppm; grain, cereal, 

group 16, except sorghum and rice; 

stover at 10 ppm; grain, cereal, group 

16, except sorghum and rice; hay at 7.0 

ppm; grain, cereal, group 16, except 

sorghum and rice; straw at 5.0 ppm.; 

corn, sweet, kernel plus cob with husks 

removed at 0.04 ppm. 

Further, the EPA is revoking the 

following eight existing tolerances 

because they are no longer needed as a 

result of this rule: barley, grain; barley, 

hay; barley, straw; wheat, forage; wheat, 

grain; wheat, hay; and wheat, straw. The 

EPA is also revising the prothioconazole 

crop and animal tolerance expressions. 

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, 

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29914 Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Rules and Regulations 

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: May 21, 2010. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Amend § 180.626 as follows: 

a. Revise the introductory text to 

paragraph (a)(1). 

b. Remove from the table in paragraph 

(a)(1) existing entries for barley, grain; 

barley, hay; barley, straw; wheat, forage; 

wheat, grain; wheat, hay; and wheat, 

straw. 

c. Add alphabetically new 

commodities to the table in paragraph 

(a)(1). 

d. Revise the introductory text to 

paragraph (a)(2). 

The added and revised text read as 

follows: 

§ 180.626 Prothioconazole; tolerances for 

residues. 

(a) * * * (1) 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, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only prothioconazole and its 

metabolite prothioconazole-desthio, or 

a-(1-chlorocyclopropyl)-a-[(2- 

chlorophenyl)methyl]-1H-1,2,4-triazole1-ethanol, calculated as parent in or on 

the commodity. 

Commodity Parts per million 

*****

Corn, sweet, kernel plus 

cob with husks removed ......................... 0.04 

Commodity Parts per million 

*****

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, and rice; straw 5.0 

Grain, cereal, group 15, 

except sweet corn, sorghum, and rice ............ 0.35 

*****

(2) 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, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only prothioconazole and its 

metabolites prothioconazole-desthio, or 

a-(1-chlorocyclopropyl)-a-[(2- 

chlorophenyl)methyl]-1H-1,2,4-triazole1-ethanol, and conjugates that can be 

converted to these two compounds by 

acid hydrolysis, calculated as parent in 

or on the commodity. 

* * * * * 

[FR Doc. 2010–12922 Filed 5–27–10 8:45 am] 

BILLING CODE 6560–50–S 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 64 

[CG Docket No. 03–123; WC Docket No. 

05–196; FCC 08–275] 

Telecommunications Relay Services, 

Speech–to–Speech Services, E911 

Requirements for IP–Enabled Service 

Providers 

AGENCY: Federal Communications 

Commission 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the 

Commission announces that the Office 

of Management and Budget (OMB) has 

approved, for a period of three years, the 

information collection requirements 

associated with the Commission’s 

Telecommunications Relay Services, 

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