Federal Register / Vol. 78, No. 76 / Friday, April 19, 2013 / Rules and Regulations 23497 

■ 2. § 52.720 is amended by adding 

paragraph (c)(194) to read as follows: 

§ 52.720 Identification of plan. 

* * * * * 

(c) * * * 

(194) On November 14, 2011, the 

Illinois Environmental Protection 

Agency (Illinois EPA) submitted 

amendments to 35 Illinois 

Administrative Code 218.208 and 

219.208. These sections add a ‘‘small 

container exemption’’ for pleasure craft 

surface coating operations in the 

Chicago and Metro-East St. Louis 8-hour 

ozone nonattainment areas. These 

exemptions are consistent with EPA 

volatile organic compound (VOC) 

reasonably available control technology 

(RACT) policy. 

(i) Incorporation by reference. The 

following sections of Illinois 

Administrative Code, Title 35: 

Environmental Protection, Subtitle B: 

Air Pollution, Chapter 1: Pollution 

Control Board, Subchapter c: Emission 

Standards and Limitations for 

Stationary Sources, are incorporated by 

reference. 

(A) Part 218: Organic Material 

Emission Standards and Limitations for 

the Chicago Area, Subpart F: Coating 

Operations, Section 218.208 Exemptions 

From Emission Limitations; effective 

October 25, 2011. 

(B) Part 219: Organic Material 

Emission Standards and Limitations for 

the Metro East Area, Subpart F: Coating 

Operations, Section 219.208 Exemptions 

From Emission Limitations; effective 

October 25, 2011. 

[FR Doc. 2013–08948 Filed 4–18–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 63 

[EPA–HQ–OAR–2010–0600; FRL–9801–4] 

RIN 2060–AQ60 

Reconsideration Petition From the 

National Association of Surface 

Finishers for the National Emission 

Standards for Hazardous Air Pollutant 

Emissions: Hard and Decorative 

Chromium Electroplating and 

Chromium Anodizing Tanks; and Steel 

Pickling—HCl Process Facilities and 

Hydrochloric Acid Regeneration Plants 

AGENCY: Environmental Protection 

Agency EPA). 

ACTION: Notice of Final Action Denying 

Petition for Reconsideration. 

SUMMARY: This action provides notice 

that on March 28, 2013, the Acting EPA 

Administrator, Bob Perciasepe, signed a 

letter denying a petition for 

reconsideration of the final rule 

published in the Federal Register on 

September 19, 2012. The rule 

established new emission limits for hard 

and decorative chromium electroplating 

and chromium anodizing tanks, and 

steel pickling—HCl process facilities 

and hydrochloric acid regeneration 

plants. 

DATES: Effective: April 19, 2013. 

Petitions: Any petitions for review of 

the letter and enclosure denying the 

petition for reconsideration described in 

this document must be filed in the Court 

of Appeals for the District of Columbia 

Circuit by June 18, 2013. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Phil Mulrine, Sector Policies and 

Programs Division (D243–02), Office of 

Air Quality Planning and Standards, 

Environmental Protection Agency, 

Research Triangle Park, North Carolina 

27711; telephone number: (919) 541– 

5289; fax number: (919) 541–3207; 

email address: mulrine.phil@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Description of Action: The EPA is 

providing notice that it has denied a 

petition for reconsideration of a final 

rule published in the Federal Register 

on September 19, 2012. The rule 

established new emission limits for hard 

and decorative chromium electroplating 

and chromium anodizing tanks, and 

steel pickling—HCl process facilities 

and hydrochloric acid regeneration 

plants, and was issued pursuant to the 

EPA’s authority under sections 112(d)(6) 

and (f)(2) of the Clean Air Act (CAA). 

After publication of the rule, the EPA 

received a petition for reconsideration 

of the final rule from the National 

Association of Surface Finishers 

(NASF). After carefully considering the 

petition and supporting information, the 

Acting EPA Administrator, Bob 

Perciasepe, denied the petition for 

reconsideration on March 28, 2013, in a 

letter to the petitioner. The EPA denied 

the petition because it failed to meet the 

criteria for reconsideration in CAA 

section 307(d)(7)(B). The letter and an 

accompanying enclosure explain in 

detail the EPA’s reasons for the denial. 

I. How can I get copies of this document 

and other related information? 

This Federal Register notice, the 

petition for reconsideration and the 

letter denying the petition for 

reconsideration are available in the 

docket that the EPA established under 

Docket ID No. EPA–HQ–OAR–2010– 

0600. The document identification 

number for the petition for 

reconsideration is: NASF, EPA–HQ– 

OAR–2010–0600–0693. The document 

identification number for EPA’s 

response letter is: NASF, EPA–HQ– 

OAR–2010–0600–0695. All documents 

in the docket are listed on the 

www.regulations.gov Web site. Although 

listed in the index, some information is 

not publicly available, e.g., confidential 

business information 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 either 

electronically through 

www.regulations.gov or in hard copy at 

the EPA Docket Center (Air Docket), 

EPA/DC, EPA West, Room 3334, 1301 

Constitution Ave. NW., Washington, 

DC. 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 Air 

Docket is (202) 566–1742. 

This Federal Register notice, the 

petition for reconsideration and the 

letter denying the petition can also be 

found on the EPA’s Web site at http:// 

www.epa.gov/ttn/atw/chrome/ 

chromepg.html. 

II. Judicial Review 

Any petitions for review of the letter 

and enclosure denying the petition for 

reconsideration described in this Notice 

must be filed in the Court of Appeals for 

the District of Columbia Circuit by June 

18, 2013. 

List of Subjects in 40 CFR Part 63 

Environmental protection, 

Administrative practice and procedure, 

Air pollution control, Intergovernmental 

relations, Reporting and recordkeeping 

requirements. 

Dated: April 12, 2013. 

Bob Perciasepe, 

Acting Administrator. 

[FR Doc. 2013–09304 Filed 4–18–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0246; FRL–9381–8] 

Propiconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 


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23498 Federal Register / Vol. 78, No. 76 / Friday, April 19, 2013 / Rules and Regulations 

SUMMARY: This regulation amends 

existing tolerances for residues of 

propiconazole in or on multiple 

commodities which are identified and 

discussed later in this document. 

Syngenta Crop Protection, LLC 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective April 

19, 2013. Objections and requests for 

hearings must be received on or before 

June 18, 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–2012–0246, 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: 

Heather Garvie, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–0034; email address: 

garvie.heather@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–2012–0246 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 June 18, 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–2012–0246, 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 May 23, 

2012 (Volume 77, FR 30481) (FRL– 

9347–8), 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 2F7975) 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 barley, hay 

from 1.4 parts per million (ppm) to 30 

ppm; barley, straw from 10 ppm to 20 

ppm; barley, grain from 0.3 ppm to 3 

ppm; oat, forage from 1.7 ppm to 4 ppm; 

oat, hay from 1.4 ppm to 15 ppm; oat, 

grain from 0.3 ppm to 3 ppm; rye, forage 

from 1.7 ppm to 9 ppm; rye, straw from 

10 ppm to 9 ppm; wheat, forage from 1.7 

ppm to 15 ppm; wheat, hay from 1.4 

ppm to 30 ppm; wheat, straw from 10 

ppm to 20 ppm; and grain, aspirated 

fractions from 30 ppm to 108 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 is 

revising the existing tolerance level for 

barley, bran; and grain, aspirated 

fractions. Additionally the Agency is 

maintaining the existing tolerance level 

for rye, straw. The reasons for these 

changes are explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 


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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. 

Propiconazole has low to moderate 

toxicity in experimental animals by the 

oral, dermal, and inhalation routes, is 

moderately irritating to the eyes, 

minimally irritating to the skin, and is 

a dermal sensitizer. 

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 

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. 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 classified propiconazole as 

a possible human carcinogen and 

recommended that for the purpose of 

risk characterization the reference Dose 

(RfD) approach be used for 

quantification of human risk. 

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. 

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 

percent crop treated (PCT) 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 NHANES/WWEIA. 

This dietary survey was conducted from 

2003 to 2008. As to residue levels in 

food, EPA conducted a chronic dietary 


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analysis for propiconazole residues of 

concern using tolerance levels for some 

commodities, average field trial residues 

for the remaining commodities, and 100 

PCT for all existing and proposed uses. 

iii. Cancer. 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 PCT 

information. Section 408(b)(2)(E) of 

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

section 408(f)(1) that data be provided 5 

years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

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

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

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 

EDWCs are 21.61 ppb for surface water 

and 0.64 ppb for ground 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). 

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. 

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 


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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 

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. 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 an 

immunotoxicity study. 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 immunotoxic. 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 safety factor is not needed to 

account for potential immunotoxicity. 

ii. Based on a weight of the evidence 

approach, EPA has waived the 

requirement for a subchronic 

neurotoxicity study for propiconazole. 

This approach considered all of the 

available hazard and exposure 

information for propiconazole, 

including: (1) The lack of neurotoxicity 

and neurobehavioral effects seen in the 

propiconazole toxicity database; (2) the 

liver is the primary target organ of 

propiconazole toxicity, and decreased 

body weight is the most sensitive 

endpoint in repeated-dose studies; (3) 

the exposure risk estimates using oral 

PODs and based on non-neurotoxic 

endpoints are conservative, health 

protective, and provide adequate 

margins of safety despite lacking a 

subchronic neurotoxicity study; and (4) 

a subchronic neurotoxicity study is 

unlikely to provide a lower endpoint 

than those currently used for risk 

assessment. 

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 acute dietary food exposure 

assessments were performed based on 

100 PCT and tolerance-level residues, 

while the chronic used average field 

trial residues and 100 PCT. 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 post-application 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 85% 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 24% 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 an aggregate MOE of 96 for 

toddlers (1–2 years old). 

This assessment is considered very 

conservative in that the residential 

incidental oral post-application 

exposure was calculated by combining 

three screening level assessments 

(which by themselves already have 

conservative estimates). Accordingly, 

even though this MOE is not as large as 

the target MOE of 100, the difference is 

small and is more than offset by the 

conservative exposure assumptions. 

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. EPA considers the chronic 

aggregate risk assessment to be 

protective of any aggregate 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 

propiconazole residues. 


emcdonald on DSK67QTVN1PROD with RULES
23502 Federal Register / Vol. 78, No. 76 / Friday, April 19, 2013 / Rules and Regulations 

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 

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 

Alimentarius Commission has 

established several maximum residue 

limits (MRLs) for propiconazole in/on 

straw and fodder of barley, rye, and 

wheat along with a MRL for barley grain 

at levels different than the U.S. 

tolerance levels. The reason for this is 

that the Codex MRLs are expressed in 

terms of residues of propiconazole 

alone, i.e., the Codex MRLs do not 

include residues of the metabolites in 

the tolerance values, while the U.S. 

tolerances are expressed in terms of 

combined residues of propiconazole and 

its metabolites containing the 2,4-DCBA 

moiety. In addition, the approved uses 

for propiconazole in the United States 

will result in residues that exceed the 

CODEX MRLs. 

C. Revisions to Petitioned-For 

Tolerances 

The petitioner requested a tolerance 

level of 9.0 ppm for rye, straw and a 

tolerance level of 108 ppm for grain, 

aspirated fractions. The petitioner did 

not request an amended tolerance level 

for barley, bran. Based on available 

residue data, the Agency has 

determined that the currently 

established tolerance of 10.0 ppm for 

rye, straw should remain and that no 

change to this tolerance level should be 

made. The Agency has revised the 

tolerance level of 108 ppm for grain, 

aspirated fractions to 110 ppm. 

Additionally, the Agency determined 

that the established tolerance level of 

0.6 ppm for barley, bran needed to be 

increased to 6.0 ppm. The petitioner has 

subsequently submitted a revised 

petition to the Agency requesting these 

changes. The Organization for Economic 

Cooperation and Development tolerance 

calculation procedures were utilized in 

determining the appropriate tolerance 

level for the requested amended uses. 

Changes in recommended tolerance are 

based on the use of these calculation 

procedures along with rounding of the 

recommended tolerance. 

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 

barley, grain at 3.0 ppm; barley, hay at 

30 ppm; barley, straw at 20 ppm; grain, 

aspirated fractions at 110 ppm; oat, 

forage at 4.0 ppm; oat grain at 3.0 ppm; 

oat, hay at 15 ppm; rye, forage at 9.0 

ppm; wheat, forage at 15 ppm; wheat, 

hay at 30 ppm; wheat, straw at 20 ppm. 

Additionally, EPA is revising the 

existing tolerance for barley, bran to 6.0 

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. 


emcdonald on DSK67QTVN1PROD with RULES
Federal Register / Vol. 78, No. 76 / Friday, April 19, 2013 / Rules and Regulations 23503 

Dated: April 11, 2013. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.434, paragraph (a), revise 

the following entries in the table to read 

as follows: 

§ 180.434 Propiconazole; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Barley, bran ............................ 6 .0 

Barley, grain ........................... 3 .0 

Barley, hay .............................. 30 

Barley, straw ........................... 20 

* * * * * 

Grain, aspirated fractions ....... 110 

* * * * * 

Oat, forage .............................. 4 .0 

Oat, grain ................................ 3 .0 

Oat, hay .................................. 15 

* * * * * 

Rye, forage ............................. 9 .0 

* * * * * 

Wheat, forage ......................... 15 

Wheat, hay ............................. 30 

Wheat, straw ........................... 20 

* * * * * 

[FR Doc. 2013–09271 Filed 4–18–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Pipeline and Hazardous Materials 

Safety Administration 

49 CFR Part 107 

[Docket No. PHMSA–2012–0185 (HM–208I)] 

RIN 2137–AE95 

Hazardous Materials; Temporary 

Reduction of Registration Fees 

AGENCY: Pipeline and Hazardous 

Materials Safety Administration 

(PHMSA), DOT. 

ACTION: Final rule. 

SUMMARY: The Federal hazardous 

materials transportation law requires 

DOT to adjust the amount of the annual 

registration fee to account for any 

unexpended balance in the Hazardous 

Materials Emergency Preparedness 

(HMEP) Fund. Due to an unexpended 

balance that has accumulated in the 

Fund, PHMSA is lowering the 

registration fees for registration year 

2013–2014 for all persons, as defined in 

PHMSA regulations, that transport or 

offer for transportation in commerce 

certain categories and quantities of 

hazardous materials. Specifically, for 

registration year 2013–2014 the fee for 

a small business or not-for-profit 

organization is revised to be $125 (plus 

a $25 processing fee), and for all other 

businesses the fee is $1300 (plus a $25 

processing fee). After the 2013–2014 

registration year, the registration fees 

will return to 2012–2013 registration 

year levels. 

Additionally, PHMSA is making an 

editorial change to its regulations to 

clarify the appropriate fee amounts; 

there are no substantive changes other 

than the addition of the fees for 2013– 

2014 and for 2014–2015 and later. 

In order to make the change effective 

for the 2013–2014 registration year and 

thus draw down the unexpended 

balance as soon as possible, PHMSA is 

issuing this final rule without a prior 

notice of proposed rulemaking in 

accordance with good cause exemption 

specified in the Administrative 

Procedures Act. Additionally, for good 

cause this final rule is effective 

immediately. 

DATES: Effective date: April 19, 2013. 

FOR FURTHER INFORMATION CONTACT: Mr. 

David Donaldson, Outreach, Training, 

and Grants Division (PHH–50), (202) 

366–4484, or Ms. Deborah Boothe, 

Standards and Rulemaking Division 

(PHH–10), (202) 366–8553, PHMSA, 

East Building, 1200 New Jersey Avenue 

SE., Washington, DC 20590. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The PHMSA Hazardous Materials 

(HM) Grants Program is designed to 

enhance the training of the nation’s 

emergency response personnel, and to 

encourage the development of local 

emergency planning. The HM Grants 

Program is comprised of three 

emergency preparedness grants: 

Hazardous Materials Emergency 

Preparedness (HMEP) Grants, 

Supplemental Public Sector Training 

(SPST) Grants, and Hazardous Materials 

Instructor Training (HMIT) Grants. The 

program is funded by registration fees 

collected from hazmat shippers and 

carriers that offer for transportation or 

transport certain hazmat in intrastate, 

interstate, or foreign commerce in 

accordance with 49 CFR part 107, 

Subpart G. 

These fees fund training and planning 

grants, monitoring and technical 

assistance, curriculum development, 

and staffing costs. Registration fees also 

fund the publication and distribution of 

the Emergency Response Guidebook 

(ERG). Planning activities are integral to 

the implementation of effective 

emergency preparedness programs. 

Grantee planning activities are often 

focused on the identification and 

assessment of hazmat transportation 

risks within their communities (e.g., 

which commodities are shipped, the 

volume and frequency of those 

shipments, availability of current 

emergency response plans, etc.). 

Training at more advanced levels is 

essential to assure emergency response 

personnel are capable of effectively and 

safely responding to releases of 

hazardous materials. PHMSA requires 

the use of the NFPA Standard 472, 

‘‘Standard for Competence of 

Responders to Hazardous Materials/ 

Weapons of Mass Destruction 

Incidents’’, available at: http:// 

www.nfpa.org, in the development of its 

PHMSA funded training programs. 

In accordance with the ‘‘Hazardous 

Materials Transportation Safety and 

Security Reauthorization Act of 2005’’ 

(Title VII of the Safe, Accountable, 

Flexible, Efficient Transportation Equity 

Act-A Legacy for Users (SAFETEA–LU), 

Pub. L. 109–59, 119 Stat. 1144, August 

10, 2005) an obligation limitation of 

$28.3 million may be expended each 

year from the HMEP Fund for the 

following purposes: 

• $21,800,000 to make emergency 

response planning and training grants to 

States and Indian tribes (of which at 

least 75% must be used for planning 

and training at the local level), under 49 

U.S.C. 5116(a) & (b) (HMEP Grants); 

• Up to $4,000,000 to make grants to 

nonprofit hazardous materials employee 

organizations to train instructors to train 

hazmat employees and for the 

instructors to train the hazmat 

employees, under 49 U.S.C. 5107(c) 

(HMIT Grants); 

• $1,000,000 to make grants to 

national nonprofit fire service 

organizations to train instructors to 

provide hazardous materials response 

training to emergency responders, under 

49 U.S.C. 5116(j) (SPST Grants); 

• $150,000 for monitoring emergency 

response planning and training and 

coordinating assistance through the 

National Response Team and Federal 


emcdonald on DSK67QTVN1PROD with RULES