26450 Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 

and address the comment in the 

proposed rulemaking. This action may 

not be challenged in later proceedings to 

enforce its requirements (see section 

307(b)(2)). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Ozone, Reporting and recordkeeping 

requirements, Volatile organic 

compounds. 

Dated: March 8, 2012. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

Part 52, Chapter I, Title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for Part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart F—California 

■ 2. Section 52.220 is amended by 

adding paragraphs (c)(88)(iii)(C) and 

(c)(391) to read as follows: 

§ 52.220 Identification of plan. 

* * * * * 

(c) * * * 

(88) * * * 

(iii) * * * 

(C) In Resolution 11–04 dated January 

18, 2011, Antelope Valley Air Quality 

Management District certified that no 

sources which would be subject to Rule 

1119, ‘‘Petroleum Coke Calcining 

Operations,’’ exist in the AVAQMD. 

Therefore, Rule 1119 has been rescinded 

and is removed from the SIP. 

* * * * * 

(391) New and amended regulations 

were submitted on June 21, 2011 by the 

Governor’s designee. 

(i) Incorporation by reference. 

(A) Eastern Kern Air Pollution Control 

District. 

(1) Rule 102, ‘‘Definitions,’’ amended 

on January 13, 2011. 

(B) Santa Barbara County Air 

Pollution Control District. 

(1) Rule 102, ‘‘Definitions,’’ revised on 

January 20, 2011. 

* * * * * 

[FR Doc. 2012–10734 Filed 5–3–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0179; FRL–9345–6] 

Metconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of Metconazole, 

including its metabolites and degradates 

in or on sugarcane, cane. BASF 

Corporation requested the tolerance 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

4, 2012. Objections and requests for 

hearings must be received on or before 

July 3, 2012, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2011–0179. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Tamue L. Gibson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–9096; email address: 

gibson.tamue@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2011–0179 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 3, 2012. 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 that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 


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Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 26451 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0179, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of April 20, 

2011 (76 FR 22067) (FRL–8869–7), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 0F7807) by BASF 

Corporation, 26 Davis Drive, P.O. Box 

13528, Research Triangle Park, NC 

27709–3528. The petition requested that 

40 CFR part 180 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, measured as 

the sum of cis- and trans-isomers, in or 

on sugarcane, cane at 0.06 parts per 

million (ppm); and sugarcane, molasses 

at 0.08 ppm. That notice referenced a 

summary of the petition prepared by 

BASF Corporation, the registrant, which 

is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, tolerances for 

sugarcane, molasses are not being 

established. The reason for this change 

is explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue * * *’’ 

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

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 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. 

Acute oral and dermal toxicities to 

metconazole are moderate, while acute 

inhalation toxicity is low. Metconazole 

is a moderate eye irritant and a mild 

skin irritant. It is not a skin sensitizer. 

Metconazole was shown to affect the 

liver, kidney, spleen, and certain blood 

parameters in all the species tested. 

Dose levels at which these effects occur 

are similar across species with the rat 

and dog being slightly more sensitive 

than the mouse. Like other triazoles, a 

primary target organ in mammalian 

toxicity studies is the liver. Liver 

toxicity was seen in the mouse, rat and 

dog following oral exposure to 

metconazole via subchronic or chronic 

exposure durations. While liver effects 

have been reported consistently across 

multiple durations and species, these 

effects were considered slight and 

minimal in some studies and appeared 

to be ‘‘adaptive’’ responses. However, 

based on the weight of evidence from 

the consistency of these reported effects 

and evidence that these effects increase 

in severity with duration, and leading to 

liver tumors in the chronic mouse 

study, they were considered ‘‘adverse’’ 

and formed the basis of the study lowest 

observed adverse effect levels (LOAELs). 

Metconazole is considered 

nongenotoxic and the liver tumors 

appear to have been formed via a 

mitogenic mode of action and therefore, 

metconazole is classified as ‘‘not likely 

to be carcinogenic to humans’’ at levels 

that do not cause mitogenesis. There is 

evidence of liver effects (microsomal 

induction, liver weight increases, 

hypertrophy) at 47.6 milligrams/ 

kilograms/day (mg/kg/day), but no 

effects at 4.5 mg/kg/day in the mode of 

action studies in the mouse. There is no 

concern for mutagenicity. The chronic 

Reference Dose of 0.04 mg/kg/day based 

on the 2-year chronic rat study with a 

no observed adverse effect level 

(NOAEL) of 4.3 mg/kg/day would be 

protective of early liver disturbances 

seen in the mouse studies. Therefore, 

the Agency has determined that the 

quantification of risk using a non-linear 

approach (i.e., Reference dose (RfD)) 

will adequately account for all chronic 

toxicity, including carcinogenicity, that 

could result from exposure to 

metconazole. 

Other major critical effects observed 

in oral studies were decreased body 

weight, decreased body weight gains, 

and blood effects (reductions in 

erythrocyte and/or platelet parameters) 

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

Splenic effects including increased 

spleen weight and hyperplasia were 

observed in the mouse, rat and dog at 

dose levels where liver effects were also 

observed. In dogs, lenticular 

degeneration (cataracts) was observed at 

the highest dose tested (HDT) (114 mg/ 

kg/day). Furthermore, at high dietary 

levels, there is evidence that 

metconazole is a gastrointestinal irritant 

in the dog. 

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). 

Metconazole did not demonstrate 

neurotoxicity in the standard battery of 

tests submitted. Information available 

from the submitted studies including 

acute, subchronic and chronic studies in 

several species, developmental toxicity 

studies in the rat and rabbit and a 2- 

generation reproduction study in the rat 

do not indicate any neurotoxic signs. No 

effects were noted on brain weights and 

no clinical signs possibly related to 

neurotoxicity were noted up to and 

including the high doses in all studies. 


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26452 Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 

Specific information on the studies 

received and the nature of the adverse 

effects caused by metconazole as well as 

the NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Metconazole: Human Health Risk 

Assessment for Proposed Uses on 

Sugarcane,’’ at page 36 in docket ID 

number EPA–HQ–OPP–2011–0179. 

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 metconazole 

used for human risk assessment is 

shown in the following Table. 

TABLE—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 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 

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). 

Incidental oral intermediate-term (1 

to 6 months).

NOAEL= 6.4 mg/kg/day

UFA= 10x 

UFH= 10x 

FQPA SF = 1x 

LOC for MOE = 100 ....... 90-Day oral toxicity study in rats. 

LOAEL = 19.2 mg/kg/day based on increased 

spleen wt (F) and hepatic vacuolation (M). 

Dermal short-term and intermediate-term.Quantification of dermal risk is not needed 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 target organ toxicity or neurotoxicity, and the lack of developmental or reproductive toxicity in the absence of parental effects which were 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 = 1x 

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). 


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Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 26453 

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

ASSESSMENT—Continued 

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Inhalation (1 to 6 months) ............... Inhalation (or oral) study 

NOAEL = 6.4 mg/kg/ 

day (inhalation absorption rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ....... 90-Day oral toxicity study in rats. 

LOAEL = 19.2 mg/kg/day based on increased 

spleen wt (F) and hepatic vacuolation (M). 

Cancer (Oral, dermal, inhalation) .... Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based on evidence that a non-genotoxic mode of 

action for mouse liver tumors was established and that carcinogenic effects were not likely below a defined 

dose that does not cause mitogenesis. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. M = male animals. F= female animals. Mg/kg/day = milligrams per kilogram per day. 

LOAEL= lowest observed adverse effect level. NOAEL = no observed adverse effect level. 

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. Such effects were identified 

for metconazole. In estimating acute 

dietary exposure, EPA used food 

consumption information from the U. S. 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA made the following 

assumptions for the acute exposure 

assessment: Tolerance-level residues 

and 100 percent crop treated (PCT). EPA 

used Dietary Exposure Evaluation 

Model (DEEMTM) version 7.81 default 

processing factors. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

made the following assumptions for the 

chronic exposure assessment: 

Tolerance-level residues and 100 PCT. 

EPA used DEEMTM version 7.81 default 

processing factors. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

determined that the quantification of 

risk using a non-linear approach will 

adequately account for all chronic 

toxicity, including carcinogenicity, that 

could result from exposure to 

metconazole. Therefore, the chonic RfD 

is expected to be protective of chronic 

toxicity including carcinogenicity. For 

the purpose of assessing cancer risk 

under this approach EPA relied upon 

the exposure estimate discussed in Unit 

III.C.1.ii. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for metconazole. Tolerance level 

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 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 

metconazole for acute exposures are 

estimated to be 45.48 parts per billion 

(ppb) for surface water and 0.38 ppb for 

ground water. 

Chronic exposures for non-cancer 

assessments are estimated to be 38.16 

ppb for surface water and 0.38 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 45.48 ppb was 

used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 38.16 

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: Adults, adolescents and 

children may be exposed to 

metconazole from its currently 

registered turf and ornamental uses. 

Adults and adolescents may experience 

short- and intermediate-term dermal 

exposure from golfing and other 

activities on treated turf, as well as from 

tending treated ornamentals. Children 

may experience short- and intermediateterm dermal and incidental oral 

exposure from activities on treated turf. 

However, because dermal toxicity 

endpoints for the appropriate durations 

of exposure were not identified, and 

because inhalation exposure is 

considered to be insignificant for 

postapplication exposures, only 

children’s incidental oral 

postapplication exposures have been 

assessed. Postapplication risks to 

children following the application of 

metconazole to home lawns were 

calculated for short- and intermediateterm incidental oral exposures. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 


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26454 Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 

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.’’ 

Metconazole 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. 

Triazole-derived pesticides can form 

the metabolite 1,2,4-triazole (T) and two 

triazole conjugates triazolylalanine (TA) 

and triazolylacetic acid (TAA). To 

support existing tolerances and to 

establish new tolerances for triazolederivative pesticides, EPA conducted an 

initial human-health risk assessment for 

exposure to T, TA, and TAA resulting 

from the use of all current and pending 

uses of any triazole-derived fungicide as 

of September 1, 2005. The risk 

assessment was 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 Food Quality Protection 

Act (FQPA) safety factor (SF) for the 

protection of infants and children. The 

assessment included evaluations of risks 

for various subgroups, including those 

comprised of infants and children. The 

Agency’s complete risk assessment can 

be found in the propiconazole 

reregistration docket at http:// 

www.regulations.gov, Docket 

Identification (ID) Number EPA–HQ– 

OPP–2005–0497 and an update to the 

aggregate human health risk assessment 

for free triazoles and its conjugates may 

be found in Docket Identification (ID) 

Number EPA–HQ–OPP–2011–0179 

entitled ‘‘Common Triazole Metabolites: 

Updated Aggregate Human Health Risk 

Assessment to Address Tolerance 

Petitions for Metconazole.’’ 

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 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. 

Developmental studies in rats and 

rabbits show some evidence of 

developmental effects, but only at dose 

levels that are maternally toxic. There 

was no quantitative susceptibility to the 

fetuses of rats or rabbits following in 

utero exposure to metconazole. In the 

developmental toxicity study in rats, 

skeletal variations (predominantly 

lumbar ribs) occurred in the presence of 

maternal toxicity (decreased body 

weight gains). In the prenatal 

developmental toxicity study in rabbits, 

developmental effects (increased postimplantation loss and reduced fetal 

body weights) were observed at the 

same dose that caused maternal toxicity 

(decreased body weight gains, reduced 

food consumption and alterations in 

hematology parameters). In the 2- 

generation reproduction study in rats, 

offspring toxicity (reduced fetal body 

weights F2 offspring and decreased 

viability in F1 and F2 offspring) was 

observed only at the HDT, a dose which 

also resulted in parental toxicity as 

evidenced by reduced parental body 

weight and body weight gains, increased 

incidence of fatty hepatocyte changes in 

male parental animals and increased 

incidence of spleen congestion in F1 

parental females. In the rat study, there 

is a concern for qualitative 

susceptibility (skeletal variation in the 

presence of minimal maternal toxicity) 

due to the presence of more severe 

effects at higher dose levels such as 

post-implantation loss, hydrocephaly 

and visceral anomalies. However, there 

is a clear NOAEL for these effects and 

the point of departure for this endpoint 

is based on skeletal variations. 

Therefore, it is concluded that there is 

no residual uncertainty for prenatal 

and/or postnatal toxicity. 

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: 

• The toxicity database is complete 

except for an acute neurotoxicity study. 

• There is no concern for 

neurotoxicity with metconazole. 

However, in accordance with the 

revised 40 CFR part 158 data 

requirements, a neurotoxicity battery is 

required for risk assessment. The 

existing metconazole database does not 

include an acute neurotoxicity study, 

and thus remains a data deficiency. An 

acceptable subchronic neurotoxicity 

study showed no neurotoxic effects at 

levels that produced systemic toxicity in 

the study, as well as in other subchronic 

and chronic studies. Therefore, concern 

for potential neurotoxicity is low and 

the 10X FQPA factor is not retained. 

• There is no evidence of 

susceptibility following in utero 

exposure in the rabbit developmental 

study. In the rat developmental study 

there is qualitative evidence of 

susceptibility, however the concern is 

low since the developmental effects 

occur in the presence of maternal 

toxicity, the NOAELs are well defined, 

and the dose/endpoint is used for acute 

dietary risk assessment for the sensitive 

population. There is no evidence of 

increased susceptibility in the offspring 

based on the result of the 2-generation 

reproduction study. Dietary exposure 

assessments were conducted using 

tolerance level residues and assumed 

100 PCT. Therefore, the acute and 

chronic dietary (food only) exposure is 

considered an upper bound 

conservative estimate. The contribution 

from drinking water is minimal. The 

Agency concludes that the acute and 


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Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 26455 

chronic exposure estimates in this 

analysis are unlikely to underestimate 

actual exposure. The drinking water 

component of the dietary assessment 

utilizes water concentration values 

generated by model and associated 

modeling parameters which are 

designed to provide conservative, health 

protective, high-end estimates of water 

concentrations which will not likely be 

exceeded. While there is potential for 

postapplication residential exposure, 

the Agency used the current 

conservative approaches for residential 

assessment. Exposures are unlikely to be 

under estimated because the assessment 

was a screening level assessment. 

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 3.8% of the 

aPAD for females 13–49 years old, the 

only population subgroup of 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 12.6% 

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 risk 

takes into account short-term residential 

exposure plus chronic exposure to food 

and drinking 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 

non-occupational/residential post 

application exposures result in 

aggregate MOEs of 420 for children 1– 

2 years old and 1,700 for adults. 

Because EPA’s level of concern for 

metconazole is a MOE of 100 or below, 

these MOEs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term risk takes into 

account intermediate-term residential 

exposure plus chronic exposure to food 

and drinking water (considered to be a 

background exposure level). 

Metconazole is currently registered for 

uses that could result in intermediateterm 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 metconazole. 

Using the exposure assumptions 

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

the combined intermediate-term food, 

water, and non-occupational residential 

exposures result in aggregate MOEs of 

460 for children 1–2 years old and 1,700 

for adults. Because EPA’s level of 

concern for metconazole is a MOE of 

100 or below, these MOEs are not of 

concern. 

5. Aggregate cancer risk for U.S. 

population. As explained in Unit III.A., 

the Agency has determined that the 

quantification of risk using a non-linear 

(i.e., RfD) approach will adequately 

account for all chronic toxicity, 

including carcinogenicity, that could 

result from exposure to metconazole. 

Therefore, based on the results of the 

chronic risk assessment discussed in 

Unit III.E.2., 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 

(high performance liquid 

chromatography/tandem mass 

spectrometry (HPLC/MS/MS) method 

BASF D0604) 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 U.N. 

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 on sugarcane. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the results of the sugarcane 

crop field data and the tolerance 

calculation procedures, EPA has 

determined that separate tolerances for 

sugarcane, molasses are unnecessary. 

The highest metconazole residue from 

the sugarcane field trials is 0.036 ppm. 

This residue multiplied by the 

processing factor for molasses (0.036 × 

1.2) yields 0.043 ppm. As this is less 

than the tolerance for sugarcane, cane at 

0.06 ppm, the sugarcane, cane tolerance 

will cover molasses. 

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, including its 

metabolites and degradates in or on 

sugarcane, cane at 0.06 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

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, 


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26456 Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 24, 2012. 

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. Section 180.617 is amended by 

alphabetically adding the following 

commodity to the table in paragraph (a) 

to read as follows: 

§ 180.617 Metconazole; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Sugarcane, cane ........................ 0.06 

* * * * * 

* * * * * 

[FR Doc. 2012–10689 Filed 5–3–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0428; FRL–9346–5] 

Carfentrazone-ethyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of carfentrazoneethyl in or on crop group 18, non-grass 

animal feed (forage, hay, and seed). 

FMC Corporation requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

4, 2012. Objections and requests for 

hearings must be received on or before 

July 3, 2012, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2011–0428. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Bethany Benbow, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8072; email address: 

benbow.bethany@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 


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