Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Rules and Regulations 30619 

the original claim does not exceed 

$10,000,000; and 

* * * * * 

§ 0.169 [Amended] 

■ 5. Amend paragraph (b) of § 0.169 by 

removing the words ‘‘Customs 

Service’s’’ and adding in their place the 

words ‘‘United States Customs and 

Border Protection’s’’. 

Dated: May 21, 2015. 

Loretta E. Lynch, 

Attorney General. 

[FR Doc. 2015–12991 Filed 5–28–15; 8:45 am] 

BILLING CODE 4410–12–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0230; FRL–9927–11] 

Metconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of metconazole 

in or on multiple commodities which 

are identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). In 

addition, this regulation removes 

established tolerances for certain 

commodities/groups superseded by this 

action, and deletes expired tolerances. 

DATES: This regulation is effective May 

29, 2015. Objections and requests for 

hearings must be received on or before 

July 28, 2015, 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–2014–0230, 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), West William 

Jefferson Clinton 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: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main 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 Publishing Office’s eCFR site at http://www.ecfr.gov/cgi-bin/ 

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–2014–0230 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before July 28, 2015. 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– 

2014–0230, 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 May 23, 

2014 (79 FR 29729) (FRL–9910–29), 

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 4E8244) by 

Interregional Research Project Number 4 

(IR–4), 500 College Road East, Suite 201 

W, Princeton, NJ 08540. The petition 

requested that 40 CFR 180.617 be 

amended by establishing tolerances for 

residues of the fungicide metconazole, 

5-[(4-chlorophenyl)methyl]-2,-2- 

dimethyl-1-(1H-1,2,4-triazol-1- 

ylmethyl)-cyclopentanol, in or on fruit, 

stone, group 12–12 at 0.2 parts per 

million (ppm); nut, tree, group 14–12 at 

0.04 ppm; pea and bean, dried shelled, 

except soybean, subgroup 6C at 0.15 

ppm; rapeseed subgroup 20A at 0.08 

ppm; and sunflower subgroup 20B at 0.9 

ppm. The petition also requested that 

current established tolerances for 

residues of the fungicide metconazole in 

or on canola seed at 0.04 ppm; fruit, 

stone, group 12 at 0.20 ppm; pistachio 

at 0.04 ppm; and nut, tree, group 14 at 

0.04 ppm be removed once the proposed 

tolerances were approved. That 

document referenced a summary of the 

petition prepared by Valent U.S.A 

Corporation, the registrant, which is 

available in the docket, http://

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 


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response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

determined the tolerance for the 

sunflower subgroup 20B should be 0.7 

ppm. The reason for this change is 

explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for metconazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with metconazole 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. Metconazole 

affects the liver, kidney, spleen, and 

various blood parameters at various 

dose levels across species. Specifically, 

in the mouse, rat, and dog, liver toxicity 

was seen after oral exposure in both 

subchronic and chronic exposures. 

Metconazole produces liver tumors in 

mice through a mitogenic mode of 

action (i.e., non-genotoxic), and in the 

absence of a genotoxic mode of action, 

metconazole is classified as ‘‘not likely 

to be carcinogenic to humans’’ at levels 

that do not cause mitogenesis. 

Oral studies revealed critical effects of 

metconazole on body weight and blood 

erythrocyte and/or platelet parameters 

in the mouse, rat, dog and/or rabbit. 

Hyperplasia and increased weight were 

observed in the spleen in the mouse, rat, 

and dog at dose levels where liver 

affects were also observed. Lenticular 

degeneration (cataracts) were observed 

at the highest dose tested 114 

milligrams/kilogram/day (mg/kg/day) in 

dogs. In addition, there was evidence 

that at high dietary levels metconazole 

is a gastrointestinal irritant in the dog. 

In rats and rabbits developmental 

studies displayed some evidence of 

developmental effects but largely at 

dose levels that are maternally toxic. 

There was no quantitative or qualitative 

susceptibility in rabbit fetuses after in 

utero exposure to metconazole. In 

prenatal developmental toxicity studies 

in rabbits there was an increase in postimplantation loss and reduced fetal 

body weights at the same dose level that 

caused maternal toxicity. In rats, the 

developmental study showed skeletal 

variations at the lowest-observedadverse-effect-level (LOAEL) in the 

absence of maternal toxicity. The 2- 

generation reproduction studies 

revealed offspring and parental toxicity 

only at the highest tested dose. There is 

low concern for quantitative 

susceptibility (skeletal variations in the 

absence of maternal toxicity in the 

developmental study) because the 

endpoint and point of departure are 

based on the effects in the fetus, for 

which there is a clear NOAEL. 

Therefore, it is concluded that there are 

no residual uncertainties for pre- and/or 

post-natal toxicity. 

Metconazole did not demonstrate 

neurotoxicity in the subchronic 

neurotoxicity study, or any of the other 

studies in the toxicity data base. The 

requirement for an acute neurotoxicity 

study has been waived because of the 

absence of neurotoxic signs throughout 

the database, even at the highest dose 

levels tested. 

There was no evidence of 

immunotoxicity at dose levels that 

produced systemic toxicity. No 

immunotoxic effects are evident for 

metconazole at dose levels as high as 52 

(mg/kg/day) in rats, which is 12 times 

higher than the chronic dietary point of 

departure (4.3 mg/kg/day). 

EPA has classified metconazole as: 

‘‘Not Likely to be Carcinogenic to 

Humans’’ based on convincing evidence 

demonstrating the following: (1) That a 

non-genotoxic mode of action for liver 

tumors was established in the mouse; 

(2) that the carcinogenic effects were not 

likely to occur below a defined dose that 

does not cause mitogenesis based on 

bioassays in the rat and the mouse; and 

(3) a lack of in vitro or in vivo 

mutagenicity. The established chronic 

RfD, which is below the level at which 

mitogenesis occurred in the rat and 

mouse, is deemed to be protective of 

mitogenesis/carcinogenesis, and no 

quantification is required. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by metconazole as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document at 

‘‘Metconazole. Human Health Risk 

Assessment for a Section 3 Registration 

of New Uses on Dry Shelled Pea and 

Beans (Except Soybean) Crop Subgroup 

6C and Sunflower Crop Subgroup 20B; 

Crop Group Expansion to Rapeseed 

Subgroup 20A; and Crop Group 

Conversion to Fruit, Stone, Group 12– 

12; and Nut, Tree, Group 14–12’’ in 

docket ID number EPA–HQ–OPP–2014– 

0230. 

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. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR METCONAZOLE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (Females 13–50 

years of age).

NOAEL = 12 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.12 

mg/kg/day.

aPAD = 0.12 mg/kg/

day. 

Developmental toxicity in rats: 

LOAEL = 30 mg/kg/day based on increases in skeletal variations. At 75 mg/kg/day (the next higher dose level) increased incidence of post-implantation loss, hydrocephaly 

and visceral anomaliea (cranial hemorrhage, dilated renal 

pelvis, dilated ureters, and displaced testis) were reported. 

Acute dietary (General population including infants and 

children).

An appropriate dose/endpoint attributable to a single dose was not observed in the available oral toxicity studies reviewed. 

Chronic dietary (All populations) NOAEL= 4.3 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.04 

mg/kg/day.

cPAD = 0.04 mg/kg/

day. 

Chronic oral toxicity study in rats: 

LOAEL = 13.1 mg/kg/day based on increased liver (M) weights 

and associated hepatocellular lipid vacuolation (M) and 

centrilobular hypertrophy (M). Similar effects were observed 

in females at 54 mg/kg/day, plus increased spleen weight. 

Incidental oral short-term (1 to 

30 days).

NOAEL= 9.1 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for 

MOE = 100.

28-Day oral toxicity study in rats: 

LOAEL = 90.5 mg/kg/day based on decreased body weight 

(M), increased liver and kidney weight and hepatocellular hypertrophy and vacuolation (M/F). 

Dermal short-term (1 to 30 

days).

Quantification of dermal risk is not required due to lack of systemic or dermal toxicity at the Limit Dose in a 21- 

day dermal toxicity study in the rat, the lack of neurotoxicity, and the lack of developmental and/or reproductive toxicity in the absence of parental effects, which were not looked for in the dermal toxicity. 

Inhalation short-term (1 to 30 

days).

Inhalation (or oral) 

study NOAEL= 9.1 

mg/kg/day (inhalation absorption 

rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 10x 

(UFDB) 

Residential LOC for 

MOE = 1000.

28-Day oral toxicity study in rats: 

LOAEL = 90.5 mg/kg/day based on decreased body weight 

(M), increased liver and kidney weight and hepatocellular hypertrophy and vacuolation (M/F). 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Not likely to be Carcinogenic to Humans’’. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day= 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to metconazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing metconazole tolerances in 40 

CFR 180.617. EPA assessed dietary 

exposures from metconazole 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. 

No such effects were identified in the 

toxicological studies for metconazole for 

the general population including infants 

and children; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary for the general population. 

Such effects were identified for 

metconazole for females 13–49 years 

old. In estimating acute dietary 

exposure, EPA used food consumption 

information from the Dietary Exposure 

Evaluation Model with the Food 

Commodity Intake Database (DEEM– 

FCID). This software incorporates 2003– 

2008 food consumption data from the 

U.S. Department of Agriculture’s 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). As to 

residue levels in food, EPA assumed 100 

percent crop treated (PCT) and 

tolerance-level residues for most crops. 

For cereal grains and livestock 

commodities, maximum residue levels 

of metabolites from field trials were 

added to the metconazole tolerance 

levels. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used food 

consumption information from the 

DEEM–FCID. This software incorporates 

2003–2008 food consumption data from 

the NHANES/WWEIA. As to residue 

levels in food, EPA assumed 100 PCT 

and tolerance-level residues for most 

crops. For cereal grains and livestock 

commodities, maximum residue levels 

of metabolites from field trials were 

added to the metconazole tolerance 

levels. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that metconazole does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 


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purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for metconazole. Tolerance-level and 

metabolite residues and/or 100 PCT 

were assumed for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for metconazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

metconazole. 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 Tier I Pesticide Root 

Zone Model-Ground Water (PRZM– 

GW), the estimated drinking water 

concentrations (EDWC) of metconazole 

are estimated to be 51.8 parts per billion 

(ppb) for acute exposures and not 

applicable for chronic (non-cancer) 

exposures. Based on the Tier II Surface 

Water Concentration Calculator (SWCC) 

model, the EDWCs are estimated to be 

49.6 ppb for acute exposures and 43.9 

ppb for chronic (non-cancer) exposures. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment for 

females, the water concentration value 

of 51.8 ppb-was used to assess the 

contribution to drinking water. For 

chronic dietary risk assessment, the 

water concentration of value 43.9 ppb 

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). 

Metconazole is currently registered 

for the following uses that could result 

in residential exposures: Turf and 

ornamentals. EPA assessed residential 

exposure using the following 

assumptions: For residential handler 

exposure, the Agency assumed that 

residential use will result in short-term 

(1–30 days) dermal and inhalation 

exposures. Because there was no dermal 

endpoint chosen for metconazole, 

residential handler risk from exposure 

to metconazole was assessed for the 

inhalation route only. 

The Agency assumed that postapplication exposure in residential 

settings is short-term in duration only. 

No dermal endpoint was chosen for 

metconazole; therefore a dermal postapplication risk assessment was not 

conducted for adults or children. 

Residential post-application inhalation 

exposure in outdoor settings is 

considered negligible. The scenarios 

evaluated were short-term postapplication incidental oral exposure to 

children 1 to <2 years old from granular 

and water dispersible granular 

metconazole formulations. 

In the previous tolerance action for 

metconazole which published in the 

Federal Register of August 17, 2011 (76 

FR 50898) (FRL–8882–7), the Agency 

also assessed intermediate-term 

exposures. However, in 2012 the EPA 

revised the residential standard 

operating procedures (SOPs) and based 

on these revisions has determined that 

intermediate-exposures are not 

expected. Further information regarding 

EPA standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

science/residential-exposure-sop.html. 

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.’’ 

Metconazole is a member of the 

triazole-containing class of pesticides, 

the conazoles. Although conazoles act 

similarly in plants 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 conclusive data 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. 

Metconazole 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 

metconazole, 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 conducted in October 2013, in 

association with a registration request 

for several other triazole fungicides. 

That analysis concluded that risk 

estimates were below the Agency’s level 

of concern for all population groups. 

The proposed new uses of metconazole 

did not result in an increase in the 

dietary exposure estimates for free 

triazole or conjugated triazoles. 

Therefore, this last dietary exposure 

analysis for free triazole or conjugated 

triazoles did not need to be updated. A 

copy of this assessment may be found in 

the docket for this action at http://

www.regulations.gov. 

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 


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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. 

For analyzing the developmental and 

reproductive impact and toxicity of 

metconazole, two developmental 

studies in the rat, two developmental 

studies in the rabbit, and one multigeneration reproduction study were 

used. There was evidence of 

quantitative susceptibility in one 

developmental rat study, but not in the 

four other studies. Concern is for 

susceptibility low since susceptibility 

was not corroborated by the other 

studies; concern is low also because the 

NOAELs are well defined, and the dose/ 

endpoint is used for acute dietary risk 

assessment for the sensitive population. 

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, except for 

inhalation exposure scenarios for which 

the Agency is retaining the 10X. That 

decision is based on the following 

findings: 

i. The toxicity database for 

metconazole is complete, except for the 

subchronic inhalation study. A 10x 

uncertainty factor has been retained for 

purposes of determining the inhalation 

endpoint to account for the absence of 

this data. However, only adult handlers 

are expected to be exposed via the 

inhalation route. 

ii. There is no indication that 

metconazole is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. Although one developmental rat 

study showed indications of 

quantitative susceptibility, EPA has 

determined that additional safety factors 

are not necessary to account for any 

potential risk because that susceptibility 

was not corroborated by the other 

developmental and reproduction studies 

and the developmental NOAEL for the 

study that showed quantitative 

susceptibility is well defined. Moreover, 

the dose/endpoint identified in the rat 

developmental study is being used for 

acute dietary risk assessment for the 

sensitive population. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues for most crops. 

For cereal grains and livestock 

commodities, maximum residue levels 

of metabolites from field trials were 

added to the metconazole tolerance 

levels. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to metconazole in 

drinking water. EPA used similarly 

conservative assumptions to assess post 

application exposure of children as well 

as incidental oral exposure of children 

1 to <2 years old. These assessments 

will not underestimate the exposure and 

risks posed by metconazole. 

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 

metconazole will occupy 4.6% of the 

aPAD for females 13 to 49 years old, the 

only population subgroup of potential 

concern. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to metconazole 

from food and water will utilize 14% 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 metconazole 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). Metconazole 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 metconazole. 

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 an 

aggregate MOEs of 630 for children 1 to 

<2 years old, which is not of concern. 

For adults, oral dietary and inhalation 

risk estimates were combined using the 

total aggregated risk index (ARI) 

methodology since the levels of concern 

(LOC) for oral dietary exposure (LOC = 

100) and inhalation exposure (LOC = 

1,000) are different. The short-term 

aggregate ARI for adults is 5.3, which is 

greater than 1 and is therefore not of 

concern. 

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). An 

intermediate-term adverse effect was 

identified; however, metconazole is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

metconazole. 

5. Aggregate cancer risk for U.S. 

population. As discussed in Unit III.A., 

metconazole is not expected to pose a 

cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to metconazole 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Nitrogen-Phosphorus-Detection (GC/

NPD) method, Valent Method RM–41C– 

1–1) 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; 


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30624 Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Rules and Regulations 

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 not established a MRL 

for metconazole. 

C. Response to Comments 

EPA received two comments to the 

Notice of Filling. One comment 

concerned a chemical other than 

metconazole and therefore is not 

relevant to this action. The other was a 

request to reconsider ‘‘loosening 

tolerances’’ for several pesticide 

petitions, including for metconazole. 

The commenter points to an American 

Academy of Pediatrics Policy statement 

regarding pesticide exposure in 

children, a Centers for Disease Control 

and Prevention report on human 

exposure to environmental chemicals, 

and a President’s Cancer Panel 

regarding reducing environmental 

cancer risks in supporting the request to 

reconsider the tolerance amendments 

proposed for metconazole. 

The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

certain pesticide chemicals should not 

be permitted in our food, or that 

pesticide tolerances should be 

‘‘significantly tightened’’ as the 

commenter notes. However, the existing 

legal framework provided by section 

408 of the Federal Food, Drug and 

Cosmetic Act (FFDCA) states that 

tolerances may be set when EPA 

determines that aggregate exposure to 

that pesticide is safe, i.e., that there is 

a reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue. When 

making this determination, EPA 

considers the toxicity, including any 

potential carcinogenicity, of the 

pesticide and all anticipated dietary 

exposures and all other exposures for 

which there is reliable information. EPA 

also gives special consideration to the 

potential susceptibility and exposures of 

infants and children to the pesticide 

chemical residue when making this 

determination. For metconazole, the 

Agency has considered all the available 

data, including all available data 

concerning the potential for 

carcinogenicity of metconazole and its 

metabolites, and concluded after 

conducting a risk assessment, that there 

is a reasonable certainty that no harm 

will result from aggregate human 

exposure to metconazole and that, 

accordingly, the metconazole tolerances 

are safe. 

D. Revisions to Petitioned-For 

Tolerances 

The petitioner requested a tolerance 

on the sunflower subgroup 20B at 0.9 

ppm. EPA is establishing a tolerance for 

that subgroup at 0.7 ppm based on the 

Organisation for Economic Co-operation 

and Development (OECD) tolerance 

calculation procedures. 

V. Conclusion 

Therefore, tolerances are established 

for residues of metconazole, 5-[(4- 

chlorophenyl)-methyl]-2,-2-dimethyl-1- 

(1H–1,2,4-triazol-1-ylmethyl)- 

cyclopentanol, in or on fruit, stone, 

group 12–12 at 0.2 ppm; nut, tree, group 

14–12 at 0.04 ppm; pea and bean, dried 

shelled, except soybean, subgroup 6C at 

0.15 ppm; rapeseed subgroup 20A at 

0.08 ppm; and sunflower subgroup 20B 

at 0.7 ppm. Additionally, the existing 

tolerances for canola seed; fruit, stone, 

group 12; nut, tree, group 14; and 

pistachio are being removed since they 

are superseded by this action. 

VI. Statutory and Executive Order 

Reviews 

This action 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 action 

has been exempted from review under 

Executive Order 12866, this action 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 action 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 tolerances 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 action 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

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 

(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). 


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Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Rules and Regulations 30625 

List of Subjects in 40 CFR part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 19, 2015. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.617: 

■ a. Remove the entries in the table in 

paragraph (a) for ‘‘Canola seed,’’ ‘‘Fruit, 

stone, group 12,’’ ‘‘Nut, tree, group 14,’’ 

and ‘‘Pistachio;’’ 

■ b. Add alphabetically the entries for 

‘‘Fruit, stone, group 12–12’’, ‘‘Nut, tree, 

group 14–12’’, ‘‘Pea and bean, dried 

shelled, except soybean, subgroup 6C’’, 

‘‘Rapeseed subgroup 20A’’, and 

‘‘Sunflower subgroup 20B’’ to the table 

in paragraph (a). 

■ c. Revise paragraph (b). 

The additions and revision read as 

follows: 

§ 180.617 Metconazole; tolerance for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Fruit, stone, group 12–12 ....... 0 .2 

* * * * * 

Nut, tree, group 14–12 ........... 0 .04 

* * * * * 

Pea and bean, dried shelled, 

except soybean, subgroup 

6C ........................................ 0 .15 

* * * * * 

Rapeseed subgroup 20A ........ 0 .08 

* * * * * 

Sunflower subgroup 20B ........ 0 .7 

* * * * * 

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. 2015–12936 Filed 5–28–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0303; FRL–9927–75] 

Mesotrione; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of mesotrione in 

or on almond, hulls, fruit, citrus, group 

10–10; fruit, pome, group 11–10; fruit, 

stone, group 12–12; and nut, tree, group 

14–12. Syngenta Crop Protection, LLC 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective May 

29, 2015. Objections and requests for 

hearings must be received on or before 

July 28, 2015, 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–2014–0303, 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), West William 

Jefferson Clinton 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: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main 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 Publishing Office’s eCFR site at http://www.ecfr.gov/cgi-bin/ 

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–2014–0303 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before July 28, 2015. 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– 

2014–0303, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 


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