Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Rules and Regulations 18461 

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: March 21, 2014. 

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 180.425 is amended by 

removing the entry for ‘‘Cabbage’’ from 

the table in paragraph (a), and by 

alphabetically adding the following 

entries 

‘‘Brassica, head and stem, subgroup 

5A’’, ‘‘Cowpea, forage’’, ‘‘Cowpea, hay’’, 

‘‘Pea, southern, dry seed’’, ‘‘Pea, 

southern, succulent seed’’, and 

‘‘Rhubarb’’ to the table in paragraph (a) 

to read as follows. 

§ 180.425 Clomazone; tolerances for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

* * * * * 

Brassica, head and stem, subgroup 5A ................................. 0.10 

* * * * * 

Cowpea, forage .......................... 0.05 

Cowpea, hay ............................... 0.05 

* * * * * 

Pea, southern, dry seed ............. 0.05 

Pea, southern, succulent seed ... 0.05 

* * * * * 

Rhubarb ...................................... 0.30 

* * * * * 

* * * * * 

[FR Doc. 2014–07008 Filed 4–1–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0051; FRL–9907–05] 

Propiconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of propiconazole 

in or on the rapeseed crop subgroup 

20A. Syngenta Crop Protection 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective April 

2, 2014. Objections and requests for 

hearings must be received on or before 

June 2, 2014, 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–2013–0051, 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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@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 


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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://www.ecfr.gov/cgi-bin/textidx?&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–2013–0051 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 2, 2014. 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 Confidential Business Information 

(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 non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0051, 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 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.html. 

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 February 

15, 2013 (78 FR 11126) (FRL–9378–4), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 2F8135) 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, 1-[[2-(2,4- 

dichlorophenyl)-4-propyl-1,3-dioxolan2-yl] methyl]-1H-1,2,4-triazole, and its 

metabolites determined as 2,4,- 

dichlorobenzoic acid and expressed as 

parent compound, in or on rapeseed 

subgroup 20A at 0.3 parts per million 

(ppm). That document referenced a 

summary of the petition prepared by 

Syngenta Crop Protection, the registrant, 

which is available in the docket, 

http://www.regulations.gov. Comments 

were received on the notice of filing. 

EPA’s response to these comments is 

discussed 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 

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 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 2-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. 

The acute neurotoxicity study 

resulted in decreased motor activity at 

300 mg/kg. The current acute dietary 

assessment is based on an endpoint 

more sensitive than the neurotoxicity in 

the acute neurotoxicity study. Based on 

a weight of evidence evaluation by the 

Agency, the subchronic neurotoxicity 

data requirement (SCN) was waived. 


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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 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. 

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 Section 3 

Registration on Rapeseed Crop 

Subgroup 20A,’’ pp. 41–47 in docket ID 

number EPA–HQ–OPP–2013–0051. 

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 III.B. of the final rule published in 

the Federal Register of 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 

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. 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 are 

not available, or if the mode of action 

data determines a mutagenic mode of 

action, a default linear cancer slope 

factor approach is utilized. Based on the 

data summarized in Unit III.A., EPA has 

concluded that 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. 

iv. Anticipated residue 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) models, the estimated drinking 

water concentrations (EDWCs) of 


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propiconazole for acute exposures are 

estimated to be 55.78 parts per billion 

(ppb) for surface water and 0.64 ppb for 

ground water, and for chronic exposures 

are estimated to be 21.61 ppb for surface 

water and 0.64 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 55.78 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 21.61ppb was used to assess the 

contribution to drinking 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. The highest 

incidental oral and dermal exposure 

scenarios are expected from residential 

use on turf. EPA assessed short term risk 

to toddlers from incidental oral and 

dermal exposure and short-term risk to 

adults from dermal and inhalation 

residential handler exposure as well as 

from post-application dermal exposure. 

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 intermediate 

term exposure to propiconazole is 

dermal and incidental oral post 

application exposure to children from 

wood treatment. Further information 

regarding EPA standard assumptions 

and generic inputs for residential 

exposures may be found at http://

www.epa.gov/pesticides/trac/science/

trac6a05.pdf. 

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. 

An updated dietary exposure and risk 

analysis for the common triazole 

metabolites 1,2,4-triazole (T), 

triazolylalanine (TA), triazolylacetic 

acid (TAA), and triazolylpyruvic acid 

(TP) was completed on October 24, 

2013, in association with registration 

requests for several triazole fungicides 

(propiconazole, difenoconazole, and 

tebuconazole). That analysis concluded 

that risk estimates were below the 

Agency’s level of concern for all 

population groups. This assessment may 

be found on http://www.regulations.gov 

by searching for the following title and 

docket number: ‘‘Common Triazole 

Metabolites: Updated Aggregate Human 

Health Risk Assessment to Address The 

New Section 3 Registrations For Use of 

Propiconazole on Rapeseed Crop 

Subgroup 20A; Use of Difenoconazole 

on Rapeseed Crop Subgroup 20A; and 

Use of Tebuconazole on Imported 

Oranges’’ (located in docket ID number 

EPA–HQ–OPP–2013–0051). 

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 

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 


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Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Rules and Regulations 18465 

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. The most 

recently published Federal Register 

notice on April 19, 2013 (78 FR 23497) 

(FRL–9381–8) cited an immunotoxicity 

study as a data gap, but since the 

publication of that final rule, the 

Agency has evaluated and granted a 

waiver request for this data requirement 

for the conazoles as a class based on the 

following considerations: 

• There was no evidence of adverse 

effects on the immune system in mice, 

rats, or dogs in the data base for any of 

the conazole pesticides. 

• The liver, not the immune system, 

is generally the target organ for this 

chemical class, and hepatotoxicity or 

body weight changes are the primary 

toxicological endpoints of concern and 

were used in risk assessments. 

• The conazoles do not belong to a 

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

heavy metals, or halogenated aromatic 

hydrocarbons) that would be expected 

to be immunotoxic. 

There was no evidence of 

immunotoxicity with six other 

structurally-related conazole fungicides, 

namely, flutriafol, metconazole, 

tebuconazole, tetraconazole, 

triadimefon, and triticonazole. For 

another conazole fungicide, 

triflumizole, the effects on the immune 

system occurred only at the highest dose 

tested. Immunotoxicity was 

demonstrated with difenoconazole, 

however it was observed in the presence 

of systemic toxicity and at a relatively 

high dose. PODs based on the most 

sensitive endpoints obtained via the 

appropriate routes of exposure in the 

most sensitive species are currently 

used for dietary and non-dietary risk 

assessments. 

All these factors indicate that an 

immunotoxicity study would most 

likely not result in an adverse effect that 

could be used as an endpoint for 

conazole risk assessment. Based on a 

weight of evidence approach, the 

Agency concluded that immunotoxicity 

studies are not required for 

propiconazole. An immunotoxicity 

study is not anticipated to provide a 

lower POD or result in a more sensitive 

endpoint than those already used. Based 

on a weight of the evidence approach, 

EPA has waived the requirement for a 

subchronic neurotoxicity study for 

propiconazole. This data waiver was 

based on the following considerations: 

i. Other than the mild effects seen at 

300 mg/kg in the acute neurotoxicity 

study, the lack of neurotoxicity and 

neurobehavioral effects seen in the 

propiconazole toxicity database; 

ii. The liver, not the nervous system, 

is the primary target organ of 

propiconazole toxicity, and decreased 

body weight is the most sensitive 

endpoint in repeated-dose studies. EPA 

concludes that a subchronic 

neurotoxicity study is unlikely to 

provide a lower endpoint than those 

currently used for risk assessment. 

Finally, EPA waived the requirement 

for a subchronic inhalation data based 

on, among other things, its conclusion 

that even if an additional 10X safety 

factor was applied, inhalation exposure 

would not raise a risk of concern. 

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 a combination of 

tolerance-level residues and reliable 

data on 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 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 

propiconaozle will occupy 84% 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 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 exposures result in aggregate 

MOEs from post-application activities 

(the highest exposure scenario) of 200 

for adults and 96 for children 1–2 years 

old. This assessment is considered 

conservative since it is based on a 

combination of tolerance-level residues 

and reliable data on average field trial 

residues and 100 PCT, conservative 

assumptions in the ground and surface 

water modeling, and conservative 

assumptions to assess post-application 

exposure of children as well as 

incidental oral exposure of toddlers. 

Additionally, the assessment could be 

further refined by using PCT estimates 

and anticipated residues for all crops. 

Accordingly, even though this MOE for 

children 1–2 years old is slightly below 

the target MOE of 100, the difference is 

small and is more than offset by the 

conservative exposure assumptions and 

therefore not of concern. 


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4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Propiconazole is currently registered 

for use as a wood treatment that could 

result in intermediate-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with intermediate-term 

residential exposures to propiconazole. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in an aggregate MOE of 110 for children 

1–2 years old. Because EPA’s level of 

concern for propiconazole is a MOE of 

100 or below, this MOE 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. 

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 has established MRLs for 

propiconazole in or on rapeseed at 0.02 

ppm. This MRL is different than the 

tolerance being established for 

propiconazole in the United States, 

which, as noted earlier, is 0.3 ppm. The 

approved uses for propiconazole in the 

United States will result in residues that 

exceed the Codex MRLs. 

C. Response to Comments 

The Agency received a comment 

objecting to the presence of any 

pesticide residues on crops and stated 

that EPA should set no pesticide 

tolerance greater than zero. The 

comment also stated that the Agency 

should have more information on long 

term testing before moving forward. A 

second comment also objected to this 

petition and stated that this product 

should be banned and never used and 

never produced in the USA. In addition, 

the second comment also noted several 

adverse effects seen in animal 

toxicology studies with propiconazole 

and claims because of these effects no 

tolerance should be approved. The 

Agency understands the concerns raised 

in the comments and recognizes that 

some individuals believe that pesticides 

should be banned completely. However, 

the existing legal framework provided 

by section 408 of the Federal Food, Drug 

and Cosmetic Act (FFDCA), 

contemplates that tolerances greater 

than zero may be set when persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

that statute. The comments appear to be 

directed at the underlying statute and 

not EPA’s implementation of it; no 

contention has been made that EPA has 

acted in violation of the statutory 

framework. In addition, EPA has found 

that there is a reasonable certainty of no 

harm to humans after considering these 

toxicological studies and the exposure 

levels of humans to propiconazole. 

A third comment dealt with a 

different chemical entirely and thus 

needs no response. 

V. Conclusion 

Therefore, a tolerance is established 

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

dichlorophenyl)-4-propyl-1,3-dioxolan2-yl]methyl]-1H-1,2,4-triazole, and its 

metabolites determined as 2,4,- 

dichlorobenzoic acid and expressed as 

parent compound, in or on rapeseed 

subgroup 20A at 0.30 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 


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Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Rules and Regulations 18467 

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: March 21, 2014. 

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. In § 180.434, add alphabetically the 

following commodity to the table in 

paragraph (a) to read as follows: 

§ 180.434 Propiconazole; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Rapeseed subgroup 20A .......... 0.30 

* * * * * 

* * * * * 

[FR Doc. 2014–07100 Filed 4–1–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0011; FRL–9907–47] 

Forchlorfenuron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

forchlorfenuron in or on multiple 

commodities which are identified and 

discussed later in this document. KIM– 

C1, LLC requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

2, 2014. Objections and requests for 

hearings must be received on or before 

June 2, 2014, 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–2013–0011, 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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@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://www.ecfr.gov/cgi-bin/textidx?&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–2013–0011 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 2, 2014. 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 Confidential Business Information 

(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 non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0011, 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 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. 


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