14744 Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 

contrary to the intention of the changes 

as discussed in the proposed rule. 

Notice and comment are unnecessary to 

correct an erroneous deletion of a 

tolerance that was neither intended nor 

discussed in rulemaking. EPA finds that 

this constitutes good cause under 5 

U.S.C. 553(b)(B). 

IV. Do Any of the Statutory and 

Executive Order Reviews Apply to this 

Action? 

The discussion in Unit IV. of the 

September 12, 2007 final rule also 

applies to this action. 

V. 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: March 18, 2009. 

Debra Edwards, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR Chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

371. 

■ 2. Section 180.185, is amended by 

alphabetically adding the following 

commodity to the table in paragraph (a) 

to read as follows: 

§ 180.185 DCPA; tolerances for residues. 

(a) General. * * * 

Commodity Parts per million 

* * * * * 

Onion, green 1.0 

* * * * * 

* * * * * 

[FR Doc. E9–7040 Filed 3–31–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0327; FRL– 8403–9] 

Prothioconazole; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation increases a 

tolerance for combined residues of 

prothioconzole and prothioconazoledesthio, calculated as parent in or on, 

wheat, forage. Bayer CropScience 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective April 

1, 2009. Objections and requests for 

hearings must be received on or before 

June 1, 2009 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–2008–0327. 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: 

Bryant Crowe, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–0025; e-mail address: 

crowe.bryant@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0327 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before June 1, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 14745 

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–2008–0327, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of June 4, 2008 

(73 FR 31863) (FRL–8365–3), 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 7F7279) by Bayer 

CropScience, P.O. Box 12014, 2 T.W. 

Alexander Dr., Research Triangle Park, 

NC 27709. The petition requested that 

40 CFR 180.626 be amended by 

increasing a tolerance for combined 

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 prothioconazoledesthio, in or on, wheat, forage from 6.0 

to 8.0 parts per million (ppm). That 

notice referenced a summary of the 

petition prepared by Bayer CropScience, 

the registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for combined residues of 

prothioconazole, and prothioconazoledesthio, calculated as parent, in or on 

wheat, forage at 8.0 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing tolerances 

follows. 

A.Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 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-observed-adverse 

effect level (the 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 primary developmental toxicants, 

producing effects including 

malformations in the conceptus at levels 

equal to or below maternally toxic levels 

in some studies; particularly those 

conducted using prothioconazoledesthio. Reproduction studies in the rat 

with prothioconazole and 

prothioconazole-desthio suggested 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 the lowest dose 

levels in the areas of subchronic, 

developmental, reproductive, and 

neurotoxic toxicities 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 prothioconazoledesthio, show no increase in tumor 

incidence. Therefore, EPA has 

concluded prothioconazole or its 

metabolites are not carcinogenic, and 

are classified ‘‘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 noobserved-adverse-effect-level (NOAEL) 

and LOAEL from the toxicity studies 

can be found at http:// 

www.regulations.gov in document 

Prothioconazole; Pesticide Tolerance 

pages 14714–14719 in docket ID number 

EPA–HQ–OPP–2007–0178. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the LOAEL at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

14746 Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-term, intermediate-term, 

and chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see: http://www.epa.gov/ 

oppfead1/trac/science; http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm; and http://www.epa.gov/ 

pesticides/trac/science/aggregate.pdf. 

A summary of the toxicological 

endpoints for prothioconazole used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

Prothioconazole: Human Health Risk 

Assessment for Proposed Section 3 Seed 

treatment Use on Wheat, Barley, and 

Triticale, Plus Increase Tolerance on 

Forage of Wheat, Barley, and Triticale 

pages 20–21 in docket ID number EPA– 

HQ–OPP–2008–0327. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to prothioconazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing prothioconazole tolerances in 

(40 CFR 180.626). EPA assessed dietary 

exposures from prothioconazole 

residues 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). A 

moderately refined acute dietary 

exposure (food and drinking water) 

assessment was conducted for 

prothioconazole. Average field trial 

values, empirical processing factors, and 

livestock maximum residues were 

incorporated into the refined acute 

assessment. The assessment also 

assumed 100 percent of crops covered 

by the existing tolerances, as well as the 

changed tolerance on wheat forage, are 

treated with prothioconazole. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. A moderately refined chronic 

dietary exposure (food and drinking 

water) assessment was conducted for 

prothioconazole. Average field trial 

values, empirical processing factors, and 

livestock maximum residues were 

incorporated into the refined acute 

assessment. The assessment also 

assumed 100 percent of crops covered 

by the existing tolerances, as well as the 

changed tolerance on wheat forage, are 

treated with prothioconazole. 

iii. Cancer. The available toxicology 

studies in the mouse and rat showed no 

increase in tumor incidence, and 

therefore the Agency has concluded that 

neither prothioconazole, nor its 

metabolites are carcinogenic. Thus 

classified, by the Agency, as ‘‘Not Likely 

to Carcinogenic to Humans’’ according 

to the 2005 Cancer Guidelines. 

Consequently, a quantitative dietary 

cancer assessment was not performed. 

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 section 408(f)(1) of FFDCA 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such Data Call-Ins as are 

required by section 408(b)(2)(E), and 

authorized under section 408(f)(1) of 

FFDCA. Data will be required to be 

submitted no later than 5 years from the 

date of issuance of this tolerance. 

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 acute exposures are 

estimated to be 29 parts per billion 

(ppb) for surface water and 0.67 ppb for 

ground water. The EDWCs for chronic 

exposures are estimated to be 13 ppb for 

surface water and 0.67 ppb for ground 

water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure models. For 

acute dietary risk assessment, the water 

concentration value of 29 ppb was used 

to assess the contribution from drinking 

water. For the chronic dietary risk 

assessment, the water concentration 

value of 13 ppb was used to assess the 

contribution from drinking water. EPA 

used the EDWCs from surface water 

only in assessing the risk from 

prothioconazole because the EDWCs for 

ground water source are less than 1 ppb, 

and considered minimal in comparison 

to surface water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Prothioconazole is not registered for 

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 conazoles. 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. Structural similarities and 

sharing a common effect does not 

constitute a common mechanism of 

toxicity. Evidence is needed to establish 

Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 14747 

that the chemicals operate ‘‘by the same, 

or essentially the same sequence of 

major biochemical events. Hence, the 

underlying basis of toxicity is the same, 

or essentially the same for each 

chemical.’’ (EPA, 2002) 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 efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

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

www.epa.gov/pesticides/cumulative. 

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 

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 as of 

September 1, 2005. The risk assessment 

is a highly conservative, screening-level 

evaluation in terms of hazards 

associated with common metabolites 

(e.g., use of a maximum combination of 

uncertainty factors) and potential 

dietary and non-dietary exposures (i.e., 

high end estimates of both dietary and 

non-dietary exposures). In addition, the 

Agency retained the additional 10X 

FQPA safety factor for the protection of 

infants and children. The assessment 

included evaluations of risks for various 

subgroups, including those comprised 

of infants and children. The Agency’s 

September 1, 2005 risk assessment can 

be found in the propiconazole 

reregistration docket at http:// 

www.regulations.gov (Docket ID EPA– 

HQ–OPP–2005–0497). In October and 

December of 2008, EPA updated the 

dietary and aggregate risk assessments 

for exposure to 1,2,4-triazole, triazole 

alanine, triazole acetic acid, and 

triazolylpyruvic acid resulting from the 

use of all current and pending uses of 

any triazole-derived fungicide to 

support existing tolerances and to 

establish new tolerances for new uses of 

metconazole (canola, corn, cotton, and 

sugarcane; PP 7F7221, 7F7292, and 

08FL03), propiconazole (beets, parsley, 

and pineapple; PP 7F7300), 

prothioconazole (wheat and barley; PP 

7F7279), and tetraconazole (grapes; PP 

7E7273). These updated dietary and 

aggregate assessments are below the 

Agency’s level of concern. These 

updated triazole risk assessments can be 

found in the Rule’s docket (EPA–HQ– 

OPP–2008–0327) and the following 

associated dockets at http:// 

www.regulations.gov (Docket IDs EPA– 

HQ–OPP–2007–514 and EPA–HQ–OPP– 

2008–0718). 

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 prematal/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, except for 

immunotoxicity testing. EPA 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 data base, 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 non-guideline 

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 milligrams/kilogram/day 

(mg/kg/day)) along with increased 

thrombocyte counts and decrease 

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. 

Furthermore, no signs of 

immunotoxicity, including evidence of 

toxicity to the lymphatic system, were 

observed at dose levels up to 400 mg/ 

kg/day in the non-guideline 

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 

14748 Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 

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. Previously, because of incomplete 

data reporting, there were uncertainties 

regarding dose levels at which 

neurotoxicities (brain morphometrics 

and peripheral nerve degeneration) were 

occurring in the pups. Because of this 

database uncertainty, the FQPA safety 

factor was retained at 10X in previous 

hazard characterizations. Critical data 

on brain morphometry and peripheral 

nerve lesions in a rat developmental 

neurotoxicity study have now been 

submitted and reviewed. Upon 

evaluation of these new data, neither the 

apparent increases in axonal 

degeneration at the high dose or the 

brain morphometric changes at the low 

and mid doses were considered 

treatment-related. Therefore, these data 

support the reduction of the FQPA 

factor to 1X. 

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 assessments 

were performed based on 100 PCT and 

tolerance-level or anticipated residues 

derived from reliable residue field trials. 

EPA made conservative (protective) 

assumptions in the ground water and 

surface water modeling used to assess 

exposure to prothioconazole in drinking 

water. Residential exposures are not 

expected. 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 pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the Acute Percent Adjusted Dose and 

Chronic Percent Adjusted Dose (aPAD 

and cPAD). The aPAD and cPAD 

represent the highest safe exposures, 

taking into account all appropriate SFs. 

EPA calculates the aPAD and cPAD by 

dividing the POD by all applicable UFs. 

For linear cancer risks, EPA calculates 

the probability of additional cancer 

cases given the estimated aggregate 

exposure. Short-term, intermediateterm, and chronic-term risks are 

evaluated by comparing the estimated 

aggregate food, water, and residential 

exposure to the POD to ensure that the 

MOE called for by the product of all 

applicable UFs is not exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single-oral exposure was identified 

and therefore no acute dietary endpoint 

was selected for the general population. 

However, an acute dietary endpoint was 

selected for the population subgroup 

females 13 to 49 years of age. Using the 

exposure assumptions discussed in this 

unit for acute exposure, the acute 

dietary exposure from food and drinking 

water to prothioconazole will occupy 

8% of the aPAD for (female 13 to 49 

years old). 

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 22% of the cPAD for (infants 

less than 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). 

Prothioconazole is not registered for 

any use patterns that would result in 

residential exposure. Therefore, the 

short-term aggregate risk is the sum of 

the risk from exposure to 

prothioconazole through food and water 

and will not be greater than the chronic 

aggregate 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). 

Prothioconazole is not registered for 

any use patterns that would result in 

intermediate-term residential exposure. 

Therefore, the intermediate-term 

aggregate risk is the sum of the risk from 

exposure to prothioconazole through 

food and water, which has already been 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Aggregate cancer risk for 

U.S. population. The available studies 

in the mouse and rat show no increase 

in tumor incidence, therefore the 

Agency has concluded that neither 

prothioconazole nor its metabolites are 

carcinogenic, and are classified ‘‘Not 

likely to be Carcinogenic to Humans’’ 

according to the 2005 Cancer 

Guidelines. Therefore, prothioconazole 

is not expected to pose a cancer risk. 

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 enforcement methodology 

are available to enforce the tolerance 

expression, consisting of liquid 

chromatography/tandem 

massspectrometry (LC/MS/MS) for both 

plant and livestock commodities, 

usingtandem mass spectrometry 

electrospray ionization in both the 

positive and negative modes. Both 

methods (LC/MS/MS Method RPA JA/ 

03/01 for plants and LC/MS/MS Method 

Bayer Report No. 200537 for animals) 

have successfully passed tolerance 

method validation at ACB/BEAD. 

Methods 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 

There are no maximum residue limits 

(MRLs) (tolerances) established for 

prothioconazole in Codex or in Mexico. 

MRLs have been established in Canada 

on barley grain at 0.35 ppm and wheat 

grain at 0.07 ppm. 

V. Conclusion 

Therefore, a tolerance is being revised 

for combined residues of 

prothioconazole, 2-[2-(1- 

chlorocyclopropyl)-3-(2-chlorophenyl)- 

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

triazole-3-thione, and prothioconazoledesthio, a-(1-chlorocyclopropyl)-a-[(2- 

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

wheat, forage, from 6.0 ppm to 8.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 14749 

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 

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: March 19, 2009. 

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 entry for ‘‘wheat, forage’’ in 

the table in paragraph (a)(1) to read as 

follows: 

§ 180.626 Prothioconazole; tolerances for 

residues. 

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

Commodity Parts per 

million 

*****

Wheat, forage .......................................... 8 

* * * * * 

[FR Doc. E9–7175 Filed 3–31–09; 8:45 am] 

BILLING CODE 6560–50–S