Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Rules and Regulations 75039 

VI. Statutory and Executive Order 

Reviews 

This action, which requires the 

submission of data in support of 

tolerances in accordance with FFDCA 

section 408, is in the form of an order 

and not a rule (21 U.S.C. 346a(f)(1)(C)). 

Under the Administrative Procedures 

Act (APA), orders are expressly 

excluded from the definition of a rule (5 

U.S.C. 551(4)). Accordingly, the 

regulatory assessment requirements 

imposed on a rulemaking do not apply 

to this action, as explained further in 

the following discussion. 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

Because this order is not a ‘‘regulatory 

action’’ as that term is defined in 

Executive Order 12866 (58 FR 51735, 

October 4, 1993), this action is not 

subject to review by the Office of 

Management and Budget (OMB) under 

Executive Orders 12866 and 13563 (76 

FR 3821, January 21, 2011). 

B. Paperwork Reduction Act 

This action does not impose 

additional burdens that require approval 

by OMB under the Paperwork 

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

seq.). The information collection 

activities associated with the order 

requesting data from any party 

interested in supporting certain 

tolerances are already approved by OMB 

under OMB Control No. 2070–0174, and 

are identified by EPA ICR No. 2288.01. 

Burden is defined at 5 CFR 1320.3(b). 

Under the PRA, an Agency may not 

conduct or sponsor, and a person is not 

required to respond to a collection of 

information that requires OMB approval 

under PRA, unless it has been approved 

by OMB and displays a currently valid 

OMB control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument, or form, if 

applicable. 

C. Regulatory Flexibility Act 

Since this order is not a rule under 

the APA (5 U.S.C. 551(4)), and does 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. 

D. Unfunded Mandates Reform Act; 

Executive Order 13132: Federalism; and 

Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This order requests data from any 

party interested in supporting certain 

tolerances and does not impose 

obligations on any person or entity 

including 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 (64 FR 

43255, August 10, 1999) and Executive 

Order 13175 (65 FR 67249, November 9, 

2000) do not apply to this order. In 

addition, this order does not impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act (UMRA) (2 U.S.C. 1531– 

1538). 

E. Executive Orders 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks; Executive Order 

13211: Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use, and Executive 

Order 12898: Federal Actions To 

Address Environmental Justice in 

Minority Populations and Low Income 

Populations 

As indicated previously, this action is 

not a ‘‘regulatory action’’ as defined by 

Executive Order 12866. As a result, this 

action is not subject to Executive Order 

13045 (62 FR 19885, April 23, 1997) and 

Executive Order 13211 (66 FR 28355, 

May 22, 2001). In addition, this order 

also does not require any special 

considerations under Executive Order 

12898 (59 FR 7629, February 16, 1994). 

F. National Technology Transfer and 

Advancement Act 

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 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq. does not apply 

because this action is not a rule as that 

term is defined in 5 U.S.C. 804(3). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Difenzoquat, 

Pesticides and pests, Reporting and 

recordkeeping requirements. 

Dated: December 12, 2012. 

Richard P. Keigwin, Jr., 

Director, Pesticide Re-evaluation Division, 

Office of Pesticide Programs. 

[FR Doc. 2012–30617 Filed 12–18–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0772; FRL–9369–5] 

Propiconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of propiconazole 

in or on sugarcane, cane. Syngenta Crop 

Protection, LLC requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 19, 2012. Objections and 

requests for hearings must be received 

on or before February 19, 2013, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0772, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: Erin 

Malone, Registration Division (7505P), 


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Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–0253; email address: 

malone.erin@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://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–2011–0772 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 February 19, 2013. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any CBI) for inclusion in the public 

docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit the nonCBI copy of your objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0772, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at 

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

contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of November 

9, 2011 (Volume 76, FR 69690) (FRL– 

9325–1), EPA issued a notice pursuant 

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

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

pesticide petition (PP 1F7892) by 

Syngenta Crop Protection, LLC, P.O. 

Box 18300 Greensboro, NC 27419–8300. 

The petition requested that 40 CFR 

180.434 be amended by establishing 

tolerances for residues of the fungicide 

propiconazole, 1H-1,2,4-Triazole, 1-{[2- 

(2,4-dichlorophenyl)-4-propyl-1,3- 

dioxolan-2-yl]methyl}-, and its 

metabolites determined as 2,4- 

dichlorobenzoic acid and expressed as 

parent compound in or on sugarcane, 

cane at 1.0 parts per million (ppm). That 

notice referenced a summary of the 

petition prepared by Syngenta Crop 

Protection, LLC, 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 

proposed a different tolerance level for 

the reasons 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 FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for propiconazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with propiconazole 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. 

The toxicology database for 

propiconazole is adequate for evaluating 

and characterizing toxicity and selecting 

endpoints for purposes of this risk 

assessment. The primary target organ for 

propiconazole toxicity in animals is the 

liver. Increased liver weights were seen 

in mice after subchronic or chronic oral 

exposures to propiconazole. Liver 

lesions such as vacuolation of 

hepatocytes, ballooned liver cells, foci 

of enlarged hepatocytes, hypertrophy 

and necrosis are characteristic of 

propiconazole toxicity in rats and mice. 

Decreased body weight gain was also 

seen in subchronic, chronic, 

developmental and reproductive studies 

in animal studies. Dogs appeared to be 

more sensitive to the localized toxicity 

of propiconazole as manifested by 

stomach irritations at 6 mg/kg/day and 

above. 

In rabbits, developmental toxicity 

occurred at a higher dose than the 

maternally toxic dose, while in rats, 

developmental toxicity occurred at 


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lower doses than maternal toxic doses. 

Increased incidences of rudimentary 

ribs occurred in rat and rabbit fetuses. 

Increased cleft palate malformations 

were noted in two studies in rats. In one 

published study in rats, developmental 

effects (malformations of the lung and 

kidneys, incomplete ossification of the 

skull, caudal vertebrae and digits, extra 

rib (14th rib) and missing sternbrae) 

were reported at doses that were not 

maternally toxic. 

In the two generation reproduction 

study in rats, offspring toxicity occurred 

at a higher dose than the parental toxic 

dose suggesting lower susceptibility of 

the offspring to the toxic doses of 

propiconazole. 

Propiconazole was negative for 

mutagenicity in the in vitro BALB/3T3 

cell transformation assay, bacterial 

reverse mutation assay, Chinese hamster 

bone marrow chromosomal aberration 

assay, unscheduled DNA synthesis 

studies in human fibroblasts and 

primary rat hepatocytes, mitotic gene 

conversion assay and the dominant 

lethal assay in mice. It caused 

proliferative changes in the rat liver 

with or without pretreatment with an 

initiator, like phenobarbital, a known 

liver tumor promoter. Liver enzyme 

induction studies with propiconazole in 

mice demonstrated that propiconazole 

is a strong phenobarbital type inducer of 

xenobiotic metabolizing enzymes. 

Hepatocellular proliferation studies in 

mice suggest that propiconazole induces 

cell proliferation followed by treatmentrelated hypertrophy in a manner similar 

to the known hypertrophic agent 

phenobarbital. Propiconazole was 

carcinogenic to male mice. 

Propiconazole was not carcinogenic to 

rats or to female mice. The Agency has 

classified propiconazole as possible 

human carcinogen used the reference 

dose (RfD) approach for quantification 

of human risk. Propiconazole is not 

genotoxic and this fact, together with 

special mechanistic studies, indicates 

that propiconazole is a threshold 

carcinogen. Propiconazole produced 

liver tumors in male mice only at a high 

dose that was toxic to the liver. At doses 

below the RfD, liver toxicity is not 

expected; therefore, tumors are also not 

expected. 

Propiconazole has low to moderate 

toxicity in experimental animals by the 

oral (Category III), dermal (Category III) 

and inhalation routes (Category IV), is 

moderately irritating to the eyes 

(Category III), minimally irritating to the 

skin (Category IV) and is a dermal 

sensitizer. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by propiconazole as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

titled ‘‘Propiconazole Human Health 

Risk Assessment for an Amended 

Section 3 Registration on Sugarcane’’ on 

pages 12–18 in docket ID number EPA– 

HQ–OPP–2011–0772. 

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 propiconazole used for 

human risk assessment is discussed in 

Unit B of the final rule published in the 

Federal Register of Wednesday, May 11, 

2011 (76 FR 27261) (FRL–8873–2). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to propiconazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing propiconazole tolerances in 40 

CFR 180.434. EPA assessed dietary 

exposures from propiconazole in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. Such effects were identified 

for propiconazole. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). This 

dietary survey was conducted from 2003 

to 2008. As to residue levels in food, 

EPA conducted an acute dietary 

analysis for propiconazole residues of 

concern using tolerance levels and 

100% crop treated for all existing and 

proposed uses. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA’s National Health and 

Nutrition Examination Survey, What We 

Eat in America, (NHANES/WWEIA). 

This dietary survey was conducted from 

2003 to 2008. As to residue levels in 

food, EPA conducted a chronic dietary 

analysis for propiconazole residues of 

concern using tolerance levels for some 

commodities, average field trial residues 

for the remaining commodities, and 

100% crop treated for all existing and 

proposed uses. 

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 nonlinear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or nonlinear approach is 

used and a cancer RfD is calculated 

based on an earlier noncancer key event. 

If carcinogenic mode of action data is 

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 a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to propiconazole. Cancer 

risk was assessed using the same 

exposure estimates as discussed in Unit 

III.C.1.ii., Chronic exposure. 

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 


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levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

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

and authorized under FFDCA section 

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

submitted no later than 5 years from the 

date of issuance of these tolerances. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for propiconazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

propiconazole. 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) model, the estimated drinking 

water concentrations (EDWCs) of 

propiconazole for acute exposures are 

estimated to be 55.78 parts per billion 

(ppb) for surface water and 0.64 ppb for 

ground water. For chronic exposures for 

non-cancer assessments EDWCs are 

21.61 ppb for surface water and 0.64 

ppb for ground water. For chronic 

exposures for cancer assessment EDWCs 

are 13.24 ppb for surface water and 0.64 

ppb for groundwater. 

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). 

Propiconazole is currently registered for 

the following uses that could result in 

residential exposures: Turf, ornamentals 

and in paint. 

EPA assessed residential exposure 

using the following assumptions: Shortterm risk to toddlers was assessed for 

incidental oral and dermal exposure. 

The highest incidental oral and dermal 

exposure scenarios are expected from 

residential use on turf. Short-term risk 

to adults was assessed for dermal and 

inhalation residential handler exposure 

as well as from post-application dermal 

exposure. Adult handlers have some 

inhalation exposure; however, based on 

the low vapor pressure of 

propiconazole, negligible post 

application inhalation exposure is 

anticipated to occur. The highest post 

application exposure from residential 

use on turf was used to assess risk to 

short-term aggregate exposures. 

The only residential use scenario that 

will result in potential intermediateterm exposure to propiconazole is 

dermal and incidental oral post 

application exposure to children from 

wood treatment (antimicrobial use). 

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.’’ 

Propiconazole 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 (EPA, 2002). 

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. 

Propiconazole is a triazole-derived 

pesticide. This class of compounds can 

form the common metabolite 1,2,4- 

triazole and two triazole conjugates 

(triazolylalanine and triazolylacetic 

acid). To support existing tolerances 

and to establish new tolerances for 

triazole-derivative pesticides, including 

propiconazole, U.S. EPA conducted a 

human health risk assessment for 

exposure to 1,2,4-triazole, 

triazolylalanine, and triazolylacetic 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 for the protection of 

infants and children. The assessment 

includes evaluations of risks for various 

subgroups, including those comprised 

of infants and children. The Agency’s 

complete risk assessment is found in the 

propiconazole reregistration docket at 

http://www.regulations.gov, Docket 

Identification (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–2011– 

0072, in the document titled ‘‘Common 

Triazole Metabolites: Updated Dietary 

(Food + Water) Exposure and Risk 

Assessment to Address the Amended 

Propiconazole Section 3 Registration to 

Add Foliar Use on Sugarcane.’’ 

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. 

In the developmental toxicity study in 

rats, fetal effects observed in this study 

at a dose lower than that evoking 

maternal toxicity are considered to be 

quantitative evidence of increased 

susceptibility of fetuses to in utero 

exposure to propiconazole. In the 

developmental toxicity study in rabbits, 

neither quantitative nor qualitative 

evidence of increased susceptibility of 

fetuses to in utero exposure to 

propiconazole was observed in this 

study. In the 2-generation reproduction 

study in rats, neither quantitative nor 

qualitative evidence of increased 

susceptibility of neonates (as compared 

to adults) to prenatal and/or postnatal 

exposure to propiconazole was 

observed. There is no evidence of 


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neuropathology or abnormalities in the 

development of the fetal nervous system 

from the available toxicity studies 

conducted with propiconazole. In the 

rat acute neurotoxicity study, there was 

evidence of mild neurobehavioral 

effects at 300 mg/kg/day, but no 

evidence of neuropathology from 

propiconazole administration. Although 

there was quantitative evidence of 

increased susceptibility of the young 

following exposure to propiconazole in 

the developmental rat study, the Agency 

determined there is a low degree of 

concern for this finding and no residual 

uncertainties because the increased 

susceptibility was based on minimal 

toxicity at high doses of administration, 

clear NOAELs and LOAELs have been 

identified for all effects of concern, and 

a clear dose-response has been well 

defined. 

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 

propiconazole is complete except for the 

lack of immunotoxicity and subchronic 

neurotoxicity studies. In the absence of 

specific immunotoxicity studies, EPA 

has evaluated the available 

propiconazole toxicity data to determine 

whether an additional database 

uncertainty factor is needed to account 

for potential immunotoxicity. There was 

no evidence of adverse effects on the 

organs of the immune system in any 

propiconazole study. In addition, 

propiconazole does not belong to a class 

of chemicals (e.g., the organotins, heavy 

metals, or halogenated aromatic 

hydrocarbons) that would be expected 

to be immunotoxicity. Based on the 

considerations in this Unit, EPA does 

not believe that conducting a special 

Harmonized Guideline 870.7800 

immunotoxicity study will result in a 

POD less than the NOAEL of 10.0 mg/ 

kg/day used in calculating the cPAD for 

propiconazole, and therefore, an 

additional database uncertainty factor is 

not needed to account for potential 

immunotoxicity. 

ii. In the absence of the subchronic 

neurotoxicity study, EPA has evaluated 

the available propiconazole toxicity data 

to determine whether an additional 

database uncertainty factor is needed to 

account for potential neurotoxicity after 

repeated exposures. With the exception 

of the developmental studies in the rat, 

there were no indications in any of the 

repeated dose studies that 

propiconazole is neurotoxic. In the 

developmental studies in the rat, there 

were some clinical signs of 

neurotoxicity at 300 mg/kg/day but not 

at lower doses. Further, there is no 

evidence of neuropathology or 

abnormalities in the development of the 

fetal nervous system from the available 

toxicity studies conducted with 

propiconazole. In the rat acute 

neurotoxicity study, there was evidence 

of mild neurobehavioral effects at 300 

mg/kg, but no evidence of 

neuropathology from propiconazole 

administration. Based on the 

considerations in this Unit, EPA does 

not believe that conducting a 

Harmonized Guideline 870.6200b 

subchronic neurotoxicity study will 

result in a POD less than the NOAEL of 

10 mg/kg/day used in calculating the 

cPAD for propiconazole, and therefore, 

an additional database uncertainty 

factor is not needed to account for 

potential neurotoxicity from repeated 

exposures. 

iii. Although an apparent increased 

quantitative susceptibility was observed 

in fetuses and offspring, for the reasons 

noted in this Unit residual uncertainties 

or concerns for prenatal and/or 

postnatal toxicity are minimal. 

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 residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

propiconazole in drinking water. EPA 

used similarly conservative assumptions 

to assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by propiconazole. 

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. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

propiconazole will occupy 79% of the 

aPAD for children 1–2 years old, 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 propiconazole 

from food and water will utilize 21% of 

the cPAD for children 1–2 years old the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of propiconazole is not 

expected. 

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). Propiconazole is 

currently registered for uses that could 

result in short-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water and 

with short-term residential exposures to 

propiconazole. Using the exposure 

assumptions described in this unit for 

short-term exposures, EPA has 

concluded the combined short-term 

food, water, and residential exposure 

result in aggregate MOEs of 200 for 

children and adults. 

4. Intermediate-term risk. The only 

residential use scenario that will result 

in potential intermediate term exposure 

to propiconazole is post application 

exposure to children from wood 

treatment (antimicrobial use). The 

aggregate MOE is 120, which is greater 

than the target MOE of 100. Therefore, 

this scenario is not of concern. 

5. Aggregate cancer risk for U.S. 

population. Propiconazole is classified 

as a possible human carcinogen with 

risk quantitated using a reference dose 

(RfD) approach, this determination is 

further explained in section III.C.1.iii. 

As noted in Unit III.E.2., chronic 

exposure is below the cPAD. 

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 

propiconazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

a high performance liquid 

chromatography with ultraviolet 

detection method (HPLC/UV Method 

AG–671A) is available to enforce the 

tolerance expression. The method may 

be requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 


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75044 Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Rules and Regulations 

number: (410) 305–2905; email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has established MRLs for 

propiconazole per se in or on sugarcane, 

cane at 0.02 ppm. These MRLs are 

different than the tolerances established 

for propiconazole in the United States. 

Codex MRLs apply only to applications 

by seed piece treatment for sugarcane. 

The Agency considers seed piece 

treatment to be a non-food use and did 

not set a tolerance for that use. In the 

U.S., application to sugarcane is by 

foliar spray. This results in higher 

residues in sugarcane, and thus EPA has 

established a higher tolerance level for 

propiconazole on sugarcane than the 

Codex MRL. 

C. Response to Comments 

No comments received. 

D. Revisions to Petitioned-for 

Tolerances 

The petitioned for tolerance level of 

1.0 ppm has been revised to 0.40 ppm. 

The Organization for Economic 

Cooperation and Development tolerance 

calculation procedures were utilized in 

determining the appropriate tolerance 

level for the requested amended use. 

Changes in recommended tolerance are 

based on the use of these calculation 

procedures. Additionally, the registrant 

made a calculation error in choosing the 

tolerance value. 

V. Conclusion 

Therefore, tolerances are established 

for residues of propiconazole, 1-[[2-(2,4- 

dichlorophenyl)-4-propyl-1,3-dioxolan2-yl]methyl]-1H-1,2,4-triazole), in or on 

sugarcane, cane at 0.40 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 10, 2012. 

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 180.434 is amended by 

revising paragraph (a), introductory text, 

and by adding to the table, 

alphabetically, an entry for ‘‘sugarcane, 

cane’’ to read as follows: 

§ 180.434 Propiconazole; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of 

propiconazole, 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 those propiconazole 

residues convertible to 2,4- 

dichlorobenzoic acid (2,4–DCBA), 

expressed as the stoichiometric 

equivalent of propiconazole, in or on 

the commodity in the table below: 


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Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Rules and Regulations 75045 

Commodity Parts per 

million 

* * * * * 

Sugarcane, cane .................. 0.4 

* * * * * 

* * * * * 

[FR Doc. 2012–30447 Filed 12–18–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Federal Railroad Administration 

49 CFR Part 229 

[Docket No. FRA–2009–0094, Notice No. 5] 

RIN 2130–AC39 

Locomotive Safety Standards 

AGENCY: Federal Railroad 

Administration (FRA), Department of 

Transportation (DOT). 

ACTION: Final rule; response to petitions 

for reconsideration. 

SUMMARY: This document responds to 

eight petitions for reconsideration 

received in relation to FRA’s final rule, 

published on April 9, 2012, which 

revised the existing regulations 

containing safety standards for 

locomotives. In response to the 

petitions, this document amends and 

clarifies certain sections of the final 

rule. 

DATES: Effective Date: The rule is 

effective December 19, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Charles Bielitz, Office of Safety 

Assurance and Compliance, Motive 

Power & Equipment Division, RRS–14, 

Federal Railroad Administration, 1200 

New Jersey Avenue SE., Washington, 

DC, (202) 493–6314 (email 

charles.bielitz@dot.gov), or Michael 

Masci, Trial Attorney, Office of Chief 

Counsel, Federal Railroad 

Administration, 1200 New Jersey 

Avenue SE., Washington, DC, (202) 

493–6037 (email 

michael.masci@dot.gov). 

SUPPLEMENTARY INFORMATION: 

I. Background 

On February 22, 2006, FRA presented, 

and the Railroad Safety Advisory 

Committee (RSAC) accepted, the task of 

reviewing existing locomotive safety 

needs and recommending consideration 

of specific actions useful to advance the 

safety of rail operations. The RSAC 

established the Locomotive Safety 

Standards Working Group (Working 

Group) to handle this task. The Working 

Group met twelve times between 

October 30, 2006, and April 16, 2009. 

The Working Group successfully 

reached consensus on the following 

locomotive safety issues: locomotive 

brake maintenance, pilot height, 

headlight operation, danger markings 

placement, load meter settings, 

reorganization of steam generator 

requirements, and the establishment 

locomotive electronics requirements 

based on industry best practices. The 

full RSAC voted to recommend the 

consensus issues to FRA on September 

10, 2009, which were incorporated into 

the notice of proposed rulemaking 

(NPRM) issued in this proceeding on 

January 12, 2011. See 76 FR 2199. The 

specific regulatory language 

recommended by the RSAC was 

amended slightly for clarity and 

consistency. FRA independently 

developed proposals related to remote 

control locomotives, alerters, and 

locomotive cab temperature, issues that 

the Working Group discussed, but 

ultimately did not reach consensus. Id. 

Many comments were submitted to the 

public docket in response to the NPRM. 

The comment period closed on March 

14, 2011, and after considering the 

public comments FRA issued a final 

rule on April 9, 2012. See 77 FR 21312. 

In accordance with the provisions of 

Executive Order (E.O.) 13563, the final 

rule also modified the existing 

Locomotive Safety Standards based on 

what was been learned from FRA’s 

retrospective review of the regulation. 

E.O. 13563 requires agencies to review 

existing regulations to identify rules that 

are overly burdensome, and when 

possible, modify them to reduce the 

burden. As a result its retrospective 

review, FRA determined that reductions 

in the burdens imposed on the industry 

could be achieved by modifying the 

regulations related to periodic 

locomotive inspection and locomotive 

headlights. FRA continues to believe 

that the modifications related to 

periodic locomotive inspection and 

locomotive headlights that are 

contained in the final rule do not reduce 

railroad safety. 

Following publication of the final 

rule, parties filed petitions seeking 

FRA’s reconsideration of some of the 

final rule’s requirements. Petitioners 

included: The American Association for 

Justice (AAJ), the Association of 

American Railroads (AAR), the Central 

Railway MFG (CRM), D. P. Honold 

(Honold), David Lombardi (Lombardi), 

Paul, Reich & Myers, P.C. (PRM), 

Wabtec Corporation (Wabtec), and the 

ZTR Equipment Management (ZTR). 

The petitions filed by these parties 

principally relate to the following 

subject areas: locomotive electronics; 

locomotive alerters; remote control 

locomotives; periodic inspection of 

locomotives; preemption of State law; 

and, locomotive diesel exhaust. In 

addition to the issues raised in the 

petitions, FRA has determined that 

clarification or modification of the final 

rule is needed with respect to placement 

of the air flow method (AFM) indicator 

calibration date on the Form 6180–49A; 

the duration of the remote control 

locomotive (RCL) audio indication; and 

the date by which railroads and vendors 

must notify FRA regarding electronic 

locomotive control products that are 

under development. This document 

responds to all the issues raised in the 

petitions for reconsideration and 

clarifies and amends certain sections of 

the final rule in response to some of the 

issues raised in the petitions and 

clarifies certain other final rule 

requirements. 

II. Issues Raised by Petitions for 

Reconsideration 

In response to the petitions for 

reconsideration, FRA is modifying the 

Locomotive Safety Standards final rule 

related to: § 229.303, Applicability of 

the Locomotive Electronics; § 229.305, 

Definition of New or Next-Generation 

Locomotive; § 229.140(d), Locomotive 

Alerters; § 229.15(b)(4), RCL 

Conditioning Run; § 229.15(a)(12)(xii), 

RCL Audio Indication; and, 

§ 229.23(b)(2) Mechanical Inspection. 

FRA respectfully refers interested 

parties to the agency’s section-bysection analysis of the final rule and the 

NPRM for a full discussion of those 

aspects of the rulemaking that remain 

unchanged. See 76 FR 2199 and 77 FR 

21312. The following is a discussion of 

each of the issues raised in various 

petitions for reconsideration. These 

discussions should be read in 

conjunction with the specific sectionby-section analysis that identifies the 

specific modifications or clarifications 

being made to the text of the final rule. 

A. Locomotive Electronics 

Several of the petitions request 

clarification or revision of certain 

requirements related to locomotive 

electronics. FRA’s responses to each of 

the requests that were made in the 

petitions are provided in this discussion 

and the specific regulatory changes or 

modifications are discussed in the 

section-by-section analysis. For 

discussion purposes, the responses have 

been grouped into seven general 

categories: (1) Responsibility and 

Applicability, (2) Definitions, (3) Safety 

Analysis, (4) Appendix F, (5) 


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