59114 Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0906; FRL–9361–8] 

Cyazofamid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of cyazofamid in 

or on multiple commodities which are 

identified and discussed later in this 

document. This regulation additionally 

removes several established tolerances 

that are superseded by tolerances 

established by this regulation. 

Interregional Research Project Number 4 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

September 26, 2012 Objections and 

requests for hearings must be received 

on or before November 26, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0906, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; email address: 

nollen.laura@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

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

Title40/40tab_02.tpl. To access the 

Office of Chemical Safety and Pollution 

Prevention (OCSPP) test guidelines 

referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2011–0906 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 November 26, 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 (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– 

2011–0906, 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.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of December 8, 

2011 (76 FR 76674) (FRL–9328–8), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1E7929) by IR–4, 500 

College Road East, Suite 201W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.601 be 

amended by establishing tolerances for 

residues of the fungicide cyazofamid, 4- 

chloro-2-cyano-N, N-dimethyl-5-(4- 

methylphenyl)-1H-imidazole-1- 

sulfonamide, and its metabolite CCIM, 

4-chloro-5-(4-methylphenyl)-1Himidazole-2-carbonitrile (CA), expressed 

as cyazofamid, in or on basil, dried 

leaves at 80.0 parts per million (ppm); 

basil, fresh leaves at 30.0 ppm; bean, 

succulent at 0.4 ppm; bean, succulent, 

shelled at 0.07 ppm; leafy greens, 

subgroup 4A at 9.0 ppm; vegetable, 

fruiting, group 8–10 at 0.40 ppm; and 

vegetable, tuberous and corm, subgroup 

1C at 0.02 ppm. Additionally, the notice 

requested that EPA remove the 

tolerances in 40 CFR 180.601 for 

residues of the fungicide cyazofamid 

and its metabolite CCIM, expressed as 

cyazofamid, in or on okra at 0.40 ppm; 

potato at 0.02 ppm; spinach at 9.0 ppm; 

and vegetable, fruiting, group 8 at 0.40 

ppm, as they will be superseded by 

inclusion in crop group or subgroup 

tolerances. That notice referenced a 

summary of the petition prepared on 

behalf of IR–4 by ISK Biosciences, the 

registrant, which is available in the 

docket, http://www.regulations.gov. 

Comments were received on the notice 

of filing. EPA’s response to these 

comments is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance levels for several 

commodities. The Agency has also 

determined that the time-limited 

tolerance on basil, fresh should be 

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Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Rules and Regulations 59115 

removed. The reasons for these changes 

are 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 cyazofamid 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with cyazofamid 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. 

Cyazofamid has a low order of acute 

toxicity via the oral, dermal, and 

inhalation routes of exposure. It 

produces minimal but reversible eye 

irritation, is a slight dermal irritant, and 

is a weak dermal sensitizer. In 

subchronic toxicity studies in rats, the 

kidney appeared to be the primary target 

organ, with kidney effects including an 

increased number of basophilic kidney 

tubules and mild increases in urinary 

volume, pH, and protein. However, no 

adverse kidney effects were noted in 

chronic toxicity studies in rats. There 

were no toxicity findings up to the limit 

dose in a subchronic toxicity study in 

dogs; in the chronic dog toxicity study, 

increased cysts in parathyroids were 

observed in males at the limit dose for 

chronic toxicity testing. 

There were no maternal or 

developmental effects observed in the 

prenatal developmental toxicity study 

in rabbits and no maternal, 

reproductive, or offspring effects in the 

2-generation reproductive toxicity study 

in rats. There was evidence of increased 

susceptibility following in utero 

exposure of rats in the prenatal 

developmental toxicity study at the 

highest dose tested; developmental 

effects, including an increased 

incidence of bent ribs, were observed in 

the absence of maternal toxicity. 

There was no evidence of 

neurotoxicity or evidence of biologically 

relevant structural effects on the 

immune system in any study in the 

exposure database for cyazofamid. Skin 

lesions, which may be due to a systemic 

allergy, were observed in male mice in 

a carcinogenicity study. There was no 

evidence of carcinogenicity in the rat or 

mouse carcinogenicity studies and no 

evidence that cyazofamid is mutagenic 

in several in vivo and in vitro studies. 

Based on the results of these studies, 

EPA has classified cyazofamid as ‘‘not 

likely to be carcinogenic to humans.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by cyazofamid as well as 

the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in the document, 

‘‘Cyazofamid. Human Health Risk 

Assessment for Proposed New Uses on 

Leafy Greens (Crop Subgroup 4A), 

Succulent-Podded and SucculentShelled Beans, Basil, Tuberous and 

Corm Vegetables (Subgroup 1C), and 

Fruiting Vegetables (Crop Group 8–10) 

with Updated Residential Risk 

Estimates of All Existing Residential 

Uses’’ at pp. 32–36 in docket ID number 

EPA–HQ–OPP–2011–0906. 

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 cyazofamid used for 

human risk assessment is shown in 

Table 1 of this unit. EPA notes that the 

last final rule for cyazofamid, published 

in the Federal Register of July 14, 2010 

(75 FR 40745) (FRL–8833–1), included 

endpoints and points of departure for 

intermediate-term residential scenarios, 

including postapplication incidental 

oral exposure for children and dermal 

exposures for adults. However, the 

Agency has reevaluated these scenarios 

and has determined that residential 

exposure to turf and ornamentals is not 

likely to occur over an intermediateterm duration (i.e., 1 month to 6 

months) for cyazofamid. Additionally, 

the Agency notes that the last final rule 

did not include an assessment of adult 

residential handler exposures. While the 

label for cyazofamid includes a 

statement that application by 

homeowners to residential turf is 

prohibited, it does not identify the 

product as a restricted use; therefore, a 

residential handler exposure assessment 

for short-term dermal and inhalation 

exposures was performed to be 

protective of potential residential 

handler exposures. 

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59116 Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CYAZOFAMID 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 (General population including infants and 

children).

An appropriate endpoint for a single exposure was not identified for the general population. 

Acute dietary (Females 13–49 

years of age).

NOAEL = 100 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 1.0 mg/ 

kg/day.

aPAD = 1.0 mg/kg/ 

day 

Rat Prenatal Developmental Toxicity Study. LOAEL = 1,000 

mg/kg/day based on developmental toxicity findings of increased incidence of bent ribs. 

Chronic dietary (All populations) NOAEL= 94.8 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.948 

mg/kg/day.

cPAD = 0.948 mg/ 

kg/day 

18-Month Mouse Oral Carcinogenicity Study. LOAEL = 985 

mg/kg/day based on increased skin lesions. 

Incidental oral, short-term (1 to 

30 days).

NOAEL= 30 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90-Day Rat Oral Toxicity Study. LOAEL = 295 mg/kg/day 

based on increased number of basophilic tubules of the kidneys, increased urinary volume, pH, and protein. This toxicity 

endpoint is also supported by the results of a 28-Day Oral 

Dose Range-Finding Study in rats. In this study, at 370 mg/ 

kg/day or above increased incidence of basophilic tubules in 

the kidneys was found. 

Dermal, short-term (1 to 30 

days).

For children: No toxicity was found at 1,000 mg/kg/day in a 28-Day Dermal Toxicity Study; therefore, in the absence of hazard identified for this population, a dermal risk assessment is not necessary. 

For adults: Dermal 

(or oral) study 

NOAEL = 100 mg/ 

kg/day (dermal absorption rate = 

37%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Rat Prenatal Developmental Toxicity Study. LOAEL = 1,000 

mg/kg/day based on developmental toxicity findings of increased incidence of bent ribs. 

Inhalation, short-term (1 to 30 

days).

Inhalation (or oral) 

study NOAEL= 

100 mg/kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Rat Prenatal Developmental Toxicity Study. LOAEL = 1,000 

mg/kg/day based on developmental toxicity findings of increased incidence of bent ribs. 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Not likely to be carcinogenic to humans’’ based on the absence of significant tumor increases 

in two adequate rodent carcinogenicity studies. 

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). 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 cyazofamid, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing cyazofamid tolerances in 40 

CFR 180.601. EPA assessed dietary 

exposures from cyazofamid 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. EPA identified such an effect 

(increased incidence of bent ribs in the 

rat prenatal developmental toxicity 

study) for the population subgroup 

females 13 to 49 years old; however, no 

such effect was identified for the general 

population, including infants and 

children. 

In estimating acute dietary exposure 

for females 13 to 49 years old, EPA used 

food consumption information from the 

United States Department of Agriculture 

(USDA) 1994 to 1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA assumed 

tolerance-level residues, DEEMTM ver. 

7.81 default processing factors and 100 

percent crop treated (PCT) for all 

existing and proposed commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994 to 1996 and 1998 

CSFII. As to residue levels in food, EPA 

assumed tolerance-level residues, 

DEEMTM ver. 7.81 default processing 

factors and 100 PCT for all existing and 

proposed commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that cyazofamid does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

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Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Rules and Regulations 59117 

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 cyazofamid. Tolerance level residues 

and/or 100 PCT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. Available environmental fate 

studies suggest cyazofamid is not very 

mobile and quickly degrades into a 

number of degradation products under 

different environmental conditions. 

Among the three major degradates for 

cyazofamid (CCIM, CCIM–AM, and 

CTCA), the two terminal degradates are 

CCIM and CTCA. The highest estimated 

drinking water concentrations resulted 

from modeling which assumed 

application of 100% molar conversion 

of the parent into the terminal degradate 

CTCA. EPA used these estimates of 

CTCA in its dietary exposure 

assessments, a conservative approach 

that likely overestimates the exposure 

contribution from drinking water. 

The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for cyazofamid and its degradates in 

drinking water. These simulation 

models take into account data on the 

physical, chemical, and fate/transport 

characteristics of cyazofamid and its 

degradates. 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) model for 

surface water and the Screening 

Concentration in Ground Water (SCI– 

GROW) model for ground water, the 

estimated drinking water concentrations 

(EDWCs) of CTCA for acute exposures 

are estimated to be 136 parts per billion 

(ppb) for surface water and 2.18 ppb for 

ground water. Chronic exposures for 

noncancer assessments are estimated to 

be 133 ppb for surface water and 2.18 

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 136 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 133 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). 

Cyazofamid is currently registered for 

use on turf at golf courses, sod farms, 

seed farms, college and professional 

sports fields, residential and 

commercial lawns, and on ornamental 

plants in landscapes and those grown in 

commercial greenhouses and nurseries. 

EPA assessed residential exposure using 

the following assumptions: For adult 

handlers, short-term dermal and 

inhalation exposures from mixing, 

loading, and applying cyazofamid in 

residential areas; for adults, short-term 

postapplication dermal exposure from 

contact with treated turf and 

ornamentals; and for children, shortterm postapplication incidental oral 

exposure to treated turf, including handto-mouth activity, object-to-mouth 

activity, and soil ingestion. No POD was 

identified for dermal exposures to 

treated turf for children, since no 

toxicity was seen in the 28-day dermal 

toxicity study at the highest dose tested 

(1,000 milligrams/kilograms/day (mg/ 

kg/day)); therefore, dermal 

postapplication exposure scenarios were 

not assessed for children. Based on the 

residential use profile, adult handler 

and adult and child postapplication 

exposures to cyazofamid are expected to 

be short-term only. Further information 

regarding EPA standard assumptions 

and generic inputs for residential 

exposures may be found at http:// 

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

trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found cyazofamid to 

share a common mechanism of toxicity 

with any other substances, and 

cyazofamid does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that cyazofamid does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

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

cumulative. 

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 

Food Quality Protection Act Safety 

Factor (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. 

The prenatal and postnatal toxicology 

database for cyazofamid includes rat 

and rabbit developmental toxicity 

studies and a 2-generation reproductive 

toxicity study in rats. There was no 

indication of increased susceptibility, as 

compared to adults, of rabbit fetuses to 

in utero exposure in a developmental 

study or of rat pups in the 2-generation 

reproduction study. There is evidence of 

increased quantitative susceptibility 

following in utero exposure of rats to 

cyazofamid in the prenatal 

developmental study; an increased 

incidence of bent ribs in fetuses at the 

highest dose tested was noted in the 

absence of maternal effects. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

cyazofamid is complete except for 

immunotoxicity and subchronic 

neurotoxicity testing. Recent changes to 

40 CFR part 158 imposed new data 

requirements for immunotoxicity testing 

(OCSPP Test Guideline 870.7800) and 

subchronic neurotoxicity testing 

(OCSPP Test Guideline 870.6200) for 

pesticide registration. However, the 

available data for cyazofamid do not 

show potential for immunotoxicity. 

Further, there is no evidence of 

neurotoxicity in any study in the 

toxicity database for cyazofamid. EPA 

does not believe that conducting 

neurotoxicity and immunotoxicity 

studies will result in a NOAEL lower 

than the regulatory dose for risk 

assessment. Consequently, the EPA 

believes the existing data are sufficient 

for endpoint selection for exposure/risk 

assessment scenarios and for evaluation 

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59118 Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Rules and Regulations 

of the requirements under the FQPA, 

and an additional database uncertainty 

factor does not need to be applied. 

ii. There is no indication that 

cyazofamid is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors (UFs) to 

account for neurotoxicity. 

iii. Although there is evidence of 

increased quantitative susceptibility in 

the prenatal developmental study in 

rats, the Agency determined that 

concern is low because the 

developmental effect (increased bent 

ribs) is well identified with a clear 

NOAEL and LOAEL. In addition, other 

considerations indicating a low concern 

include the following: Increased bent 

ribs are considered a reversible variation 

rather than a malformation; the effect 

was noted only at the limit dose of 1,000 

mg/kg/day and this endpoint was used 

to establish the RfD for females 13–49; 

and the overall toxicity profile indicates 

that cyazofamid is not a very toxic 

compound. Therefore, there are no 

residual concerns regarding 

developmental effects in the young. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to cyazofamid 

in drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of children as 

well as incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by cyazofamid. 

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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, cyazofamid is not 

expected to pose an acute risk. Using 

the exposure assumptions discussed in 

this unit for acute exposure, the acute 

dietary exposure from food and water to 

cyazofamid will occupy 2.5% of the 

aPAD for females 13 to 49 years old, the 

population group of concern for acute 

effects. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to cyazofamid 

from food and water will utilize 1.5% 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 cyazofamid 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). Cyazofamid 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 

cyazofamid. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 2,200 for children 1–2 years 

old and 390 for adults. Because EPA’s 

level of concern for cyazofamid is a 

MOE of 100 or below, these MOEs are 

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, cyazofamid 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 

cyazofamid. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

cyazofamid 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 cyazofamid 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate analytical methodology 

is available to enforce the proposed 

tolerances. Cyazofamid and the 

metabolite CCIM are completely 

recovered (>80% recovery) using the 

Food and Drug Administration’s (FDA) 

Multi-Residue Protocol D (without 

cleanup). In addition, a high 

performance liquid chromatography/ 

ultraviolet detector (HPLC/UV) method 

is available for use as a single analyte 

confirmatory method. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. The Codex has not 

established a MRL for cyazofamid. 

C. Response to Comments 

EPA received comments from a 

private citizen to the notice of filing for 

cyazofamid, PP# 1E7929, objecting to 

the establishment of tolerances 

associated with the petition. In addition, 

the commenter noted several adverse 

effects seen in animal toxicology studies 

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Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Rules and Regulations 59119 

for cyazofamid and claims because of 

these effects no tolerance should be 

approved. 

EPA has found, however, that there is 

a reasonable certainty of no harm to 

humans after considering these 

toxicological studies and the exposure 

levels of humans to cyazofamid. The 

Agency understands the commenter’s 

concerns and recognizes that some 

individuals believe that certain 

pesticide chemicals should not be 

permitted in our food. However, the 

existing legal framework provided by 

FFDCA section 408 states that 

tolerances may be set when persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

that statute. This citizen’s comment 

appears to be directed at the underlying 

statute and not EPA’s implementation of 

it; the citizen has made no contention 

that EPA has acted in violation of the 

statutory framework. 

D. Revisions to Petitioned-for 

Tolerances 

Based on the data supporting the 

petition, EPA revised the proposed 

tolerances on several commodities, as 

follows: Basil, dried leaves from 80 ppm 

to 90 ppm; bean, succulent from 0.4 

ppm to 0.5 ppm; bean, succulent shelled 

from 0.07 ppm to 0.08 ppm; leafy greens 

subgroup 4A from 9.0 ppm to 10 ppm; 

and vegetable, fruiting, group 8–10 from 

0.40 ppm to 0.9 ppm. The Agency 

revised these tolerance levels based on 

analysis of the residue field trial data 

using the Organization for Economic 

Cooperation and Development (OECD) 

tolerance calculation procedures. 

Additionally, the Agency has 

determined that the time-limited 

tolerance on basil, fresh at 12 ppm 

should be removed, as it will be 

superseded by the permanent tolerance 

on basil, fresh leaves. 

V. Conclusion 

Therefore, tolerances are established 

for residues of cyazofamid, 4-chloro-2- 

cyano-N,N-dimethyl-5-(4- 

methylphenyl)-1 H-imidazole-1- 

sulfonamide, and its metabolite, 4- 

chloro-5-(4-methylphenyl)-1H 

-imidazole-2-carbonitrile, calculated as 

the stoichiometric equivalent of 

cyazofamid, in or on basil, dried leaves 

at 90 ppm; basil, fresh leaves at 30 ppm; 

bean, succulent at 0.5 ppm; bean, 

succulent shelled at 0.08 ppm; leafy 

greens subgroup 4A at 10 ppm; 

vegetable, fruiting, group 8–10 at 0.9 

ppm; and vegetable, tuberous and corm, 

subgroup 1C at 0.02 ppm. This 

regulation additionally removes the 

established permanent tolerances on 

okra, potato, spinach, and fruiting 

vegetable group 8, and the time-limited 

tolerance on basil, fresh because these 

tolerances are superseded by new crop 

group or subgroup tolerances 

established by this action. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 12, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.601: 

■ a. Remove the commodities ‘‘Okra’’, 

‘‘Potato’’, ‘‘Spinach’’, and ‘‘Vegetable, 

fruiting, group 8’’ from the table in 

paragraph (a). 

■ b. Add alphabetically the following 

commodities to the table in paragraph 

(a). 

■ c. Remove the commodity ‘‘Basil, 

fresh’’ from the table in paragraph (b). 

The additions read as follows: 

§ 180.601 Cyazofamid; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

Basil, dried leaves .................. 90 

Basil, fresh leaves .................. 30 

Bean, succulent ...................... 0 .5 

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59120 Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Rules and Regulations 

Commodity Parts per 

million 

Bean, succulent shelled ......... 0 .08 

* * * * * 

Leafy greens subgroup 4A ..... 10 

* * * * * 

Vegetable, fruiting, group 8– 

10 ........................................ 0 .9 

Vegetable, tuberous and 

corm, subgroup 1C ............. 0 .02 

* * * * * 

[FR Doc. 2012–23355 Filed 9–25–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0171; FRL–9358–8] 

RIN 2070–ZA16 

Butylate, Clethodim, Dichlorvos, 

Dicofol, Isopropyl Carbanilate, et al.; 

Tolerance Actions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is revoking specific 

tolerances, in follow-up to canceled 

uses or where a commodity is no longer 

a significant feed item, for butylate, 

clethodim, dichlorvos, dicofol, 

isopropyl carbanilate, methanearsonic 

acid, methomyl, naled, primisulfuronmethyl, tralomethrin, and ziram, and 

the tolerance exemption for pine oil. 

However, EPA will not revoke the 

dicofol tolerances on tea and tolerance 

exemptions for rotenone, derris, or cube 

roots at this time. Also, EPA is making 

minor revisions to the tolerance 

expressions for dicofol, methanearsonic 

acid, methomyl, and tralomethrin, 

revising the nomenclature of specific 

tolerances for butylate, methomyl, and 

tralomethrin, and removing expired 

tolerances for certain pesticide active 

ingredients, in accordance with current 

EPA practice. In addition, EPA is 

reinstating popcorn tolerances for 

metolachlor to remedy an inadvertent 

omission and cover existing 

registrations. 

DATES: This regulation is effective 

March 25, 2013. Objections and requests 

for hearings must be received on or 

before November 26, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0171, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution 

Ave., NW., Washington, DC 20460– 

0001. The Public Reading Room is open 

from 8:30 a.m. to 4:30 p.m., Monday 

through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Joseph Nevola, Pesticide Re-evaluation 

Division (7508P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8037; email address: 

nevola.joseph@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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under the Federal Food, Drug, and 

Cosmetic Act (FFDCA) section 408(g), 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0171 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 November 26, 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 (excluding 

any CBI) for inclusion in the public 

docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

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

request, identified by docket ID number 

EPA–HQ–OPP–2012–0171, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at 

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

contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Background 

A. What action is the agency taking? 

In the Federal Register of May 9, 2012 

(77 FR 27164) (FRL–9345–2), EPA 

issued a proposed rule, in follow-up to 

canceled uses or where a commodity is 

no longer a significant feed item, to 

revoke specific tolerances for butylate, 

clethodim, dichlorvos, dicofol, 

isopropyl carbanilate, methanearsonic 

acid, methomyl, naled, primisulfuronmethyl, tralomethrin, and ziram, and 

tolerance exemptions for rotenone, 

derris, cube roots, and pine oil. Also, it 

proposed minor revisions to the 

tolerance expressions for dicofol, 

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