75426 Federal Register / Vol. 80, No. 231 / Wednesday, December 2, 2015 / Rules and Regulations 

■ 10. Section 252.45 is amended by 

revising paragraph (b)(2) to read as 

follows: 

§ 252.45 Data and information required to 

be submitted in support of the Board’s 

analyses. 

* * * * * 

(b) * * * 

(2) Project a company’s pre-provision 

net revenue, losses, provision for loan 

and lease losses, and net income; and 

pro forma capital levels, regulatory 

capital ratios, and any other capital ratio 

specified by the Board under the 

scenarios described in § 252.44(b). 

* * * * * 

■ 11. Section 252.52 is amended by: 

■ a. Revising paragraph (n); and 

■ b. removing paragraph (t). 

The revision reads as follows: 

§ 252.52 Definitions. 

* * * * * 

(n) Regulatory capital ratio means a 

capital ratio for which the Board 

established minimum requirements for 

the company by regulation or order, 

including the company’s tier 1 and 

supplementary leverage ratios as 

calculated under 12 CFR part 217, 

including the deductions required 

under 12 CFR 248.12, as applicable, and 

the company’s common equity tier 1, 

tier 1, and total risk-based capital ratios 

as calculated under 12 CFR part 217, 

including the deductions required 

under 12 CFR 248.12 and the transition 

provisions at 12 CFR 217.1(f)(4) and 

217.300; except that the company shall 

not use the advanced approaches to 

calculate its regulatory capital ratios. 

* * * * * 

■ 12. Section 252.53 is amended by 

revising paragraph (b)(3) to read as 

follows: 

§ 252.53 Applicability. 

* * * * * 

(b) * * * 

(3) Transition periods for covered 

companies subject to the supplementary 

leverage ratio. Notwithstanding 

§ 252.52(n), only for purposes of the 

stress test cycle beginning on January 1, 

2016, a bank holding company shall not 

include an estimate of its 

supplementary leverage ratio. 

■ 13. Section 252.56 is amended by 

revising paragraphs (a)(2), (b)(2)(i), and 

(b)(2)(iv) to read as follows: 

§ 252.56 Methodologies and practices. 

(a) * * * 

(2) The potential impact on pro forma 

regulatory capital levels and pro forma 

capital ratios (including regulatory 

capital ratios and any other capital 

ratios specified by the Board), 

incorporating the effects of any capital 

actions over the planning horizon and 

maintenance of an allowance for loan 

losses appropriate for credit exposures 

throughout the planning horizon. 

(b) * * * 

(2) * * * 

(i) Common stock dividends equal to 

the quarterly average dollar amount of 

common stock dividends that the 

company paid in the previous year (that 

is, the first quarter of the planning 

horizon and the preceding three 

calendar quarters) plus common stock 

dividends attributable to issuances 

related to expensed employee 

compensation or in connection with a 

planned merger or acquisition to the 

extent that the merger or acquisition is 

reflected in the covered company’s pro 

forma balance sheet estimates; 

* * * * * 

(iv) An assumption of no issuances of 

common stock or preferred stock, except 

for issuances related to expensed 

employee compensation or in 

connection with a planned merger or 

acquisition to the extent that the merger 

or acquisition is reflected in the covered 

company’s pro forma balance sheet 

estimates. 

* * * * * 

■ 14. Section 252.58 is amended by 

revising paragraphs (b)(3)(v), (b)(4), and 

(c)(2) to read as follows: 

§ 252.58 Disclosure of stress test results. 

* * * * * 

(b) * * * 

(3) * * * 

(v) Pro forma regulatory capital ratios 

and any other capital ratios specified by 

the Board; 

(4) An explanation of the most 

significant causes for the changes in 

regulatory capital ratios; and 

* * * * * 

(c) * * * 

(2) The disclosure of pro forma 

regulatory capital ratios and any other 

capital ratios specified by the Board that 

is required under paragraph (b) of this 

section must include the beginning 

value, ending value, and minimum 

value of each ratio over the planning 

horizon. 

By order of the Board of Governors of the 

Federal Reserve System, November 25, 2015. 

Robert deV. Frierson, 

Secretary of the Board. 

[FR Doc. 2015–30471 Filed 12–1–15; 8:45 am] 

BILLING CODE P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0681; FRL–9934–60] 

Etoxazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of etoxazole in or 

on orange and orange oil. Sumitomo 

Chemical Latin America through Valent 

USA Corporation requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 2, 2015. Objections and 

requests for hearings must be received 

on or before February 1, 2016, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2014–0681, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 


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applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. To access the 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–2014–0681 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 February 1, 2016. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2014–0681, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

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

II. Summary of Petitioned-for Tolerance 

In the Federal Register of March 4, 

2015 (80 FR 11611) (FRL–9922–68), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 4E8304) by 

Sumitomo Chemical Latin America 

through Valent USA Corporation, 1600 

Riviera Avenue, Suite 200, Walnut 

Creek, CA 94596. The petition requested 

that 40 CFR 180.593 be amended by 

establishing tolerances for residues of 

the insecticide etoxazole (2-(2,6- 

difluorophenyl)-4-[4-(1,1- 

dimethylethyl)-2-ethoxyphenyl]- 

4,5dihydrooxazole), in or on orange and 

orange oil at 0.08 and 1.8 parts per 

million (ppm), respectively. That 

document referenced a summary of the 

petition prepared by Valent USA 

Corporation on behalf of Sumitomo 

Chemical Latin America, the registrant, 

which is available in the docket, 

http://www.regulations.gov. 

EPA received one comment to the 

Notice of Filing concerning another 

chemical (azoxystrobin) and not 

etoxazole. The commenter stated, in 

part, that zero residues should be 

allowed for pesticide residues. The 

Agency understands the commenter’s 

concerns and recognizes that some 

individuals believe that pesticides 

should be banned on agricultural crops. 

However, the existing legal framework 

provided by section 408 of the FFDCA 

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. 

Based upon review of the data 

supporting the petition, EPA has revised 

the petitioned-for tolerance levels of 

0.08 and 1.8 ppm for orange and orange, 

oil to 0.10 and 1.0 ppm, respectively. 

The reasons for these changes are 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

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 etoxazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with etoxazole follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The effects in the etoxazole database 

show liver toxicity in all species tested 

(enzyme release, hepatocellular 

swelling, and histopathological 

indicators), and the severity does not 

appear to increase with time. In rats 

only, there were effects on incisors 

(elongation, whitening, and partial loss 

of upper and/or lower incisors). There is 

no evidence of neurotoxicity or 

immunotoxicity. No toxicity was seen at 

the limit dose in a 28-day dermal 

toxicity study in rats. Etoxazole was not 

mutagenic. No increased quantitative or 

qualitative susceptibilities were 

observed following in utero exposure to 


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rats or rabbits in the developmental 

studies; however, offspring toxicity was 

more severe (increased pup mortality) 

than maternal toxicity (increased liver 

and adrenal weights) at the same dose 

(158.7 milligram/kilogram/day (mg/kg/

day)) in the rat reproduction study 

indicating increased qualitative 

susceptibility. Etoxazole is not likely to 

be carcinogenic based on the lack of 

carcinogenicity effects in the database. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by etoxazole 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 document, 

‘‘Etoxazole: Human Health Risk 

Assessment in Support of the Proposed 

Tolerances for Residues in/on Imported 

Oranges and Orange Oil’’ at pp. 16–18 

in docket ID number EPA–HQ–OPP– 

2014–0681. 

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 the NOAEL and the 

LOAEL are identified. 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 etoxazole used for human 

risk assessment is shown in Table 1 of 

this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETOXAZOLE 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 (all populations) .. N/A ............................................ N/A ............................................ A dose and endpoint attributable to a single dose were not identified in the database including the hazard database. An 

acute dietary assessment was not performed. 

Chronic dietary (all populations) NOAEL = 4.62 mg/kg/day ........

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.046 mg/kg/day 

cPAD = 0.046 mg/kg/day 

Chronic Oral Toxicity Study—Dog. LOAEL 

= 23.5 mg/kg/day based upon increased alkaline phosphatase activity, 

increased liver weights, liver enlargement (females), and incidences of 

centrilobular hepatocellular swelling in 

the liver. 

Cancer (Oral, dermal, inhalation).EPA classified etoxazole as ‘‘not likely to be carcinogenic to humans. 

Point of departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no-observed adverse-effect 

level. LOAEL = lowest-observed adverse-effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = 

potential variation in sensitivity among members of the human population (intraspecies). Food Quality Protection Act Safety Factor = FQPA SF. 

PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose. N/A = not applicable. 

Since the current proposal pertains to 

an import tolerance (no occupational 

exposure for workers in the U.S.) and 

since residential exposure is not 

anticipated from the proposed/

registered uses, only dietary 

toxicological endpoints are listed in 

Table 1. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to etoxazole, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

etoxazole tolerances in 40 CFR 180.593. 

EPA assessed dietary exposures from 

etoxazole in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

No such effects were identified in the 

toxicological studies for etoxazole; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA; 

2003–2008). As to residue levels in 

food, EPA assumed tolerance-level 

residues, 100% crop treated (PCT), and 

in the absence of empirical data, DEEM 

(ver 7.81) default processing factors. In 

addition, based on EPA’s conclusion 

that etoxazole has a high potential to 

bioaccumulate, residue estimates for 

fish/shellfish were included. 

iii. Cancer. EPA classified etoxazole 

as ‘‘not likely to be carcinogenic to 

humans’’. Therefore, a dietary exposure 

assessment for the 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 etoxazole. Tolerance-level residues 

and/or 100 PCT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. Although the orange and orange, 

oil tolerances will not result in residues 

in drinking water, as those uses are not 


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associated with a U.S. registration, the 

Agency used screening-level water 

exposure models in the dietary exposure 

analysis and risk assessment to assess 

etoxazole in drinking water resulting 

from existing U.S. registrations. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of etoxazole. 

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 First Index Reservoir 

Screening Tool (FIRST), and Pesticide 

Root Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS), the 

estimated drinking water concentrations 

(EDWCs) of etoxazole for chronic 

exposures for non-cancer assessments 

are estimated to be 4.761 parts per 

billion (ppb) for surface water and <0.1 

ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

For chronic dietary risk assessment, 

the water concentration of value 4.761 

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). 

Etoxazole is not registered for any 

specific use patterns that would result 

in residential exposure. 

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 etoxazole to share 

a common mechanism of toxicity with 

any other substances, and etoxazole 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that etoxazole 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. 

No increased quantitative or qualitative 

susceptibilities were observed following 

in utero exposure to rats or rabbits in 

the developmental studies. There is 

evidence of increased qualitative 

offspring susceptibility in the rat 

reproduction study, but the concern is 

low since: (1) The effects in pups are 

well-characterized with a clear NOAEL; 

(2) the selected endpoints are protective 

of the doses where the offspring toxicity 

is observed; and (3) offspring effects 

occur in the presence of parental 

toxicity. There are no residual 

uncertainties for pre-/post-natal 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: 

i. The toxicity database for etoxazole 

is complete. 

ii. There is no indication that 

etoxazole is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional 

uncertainty factors (UFs) to account for 

neurotoxicity. 

iii. The observed qualitative postnatal 

susceptibility is protected for by the 

selected endpoints. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to etoxazole in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by etoxazole. 

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, etoxazole is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to etoxazole from 

food and water will utilize 15% of the 

cPAD for children 1–2 years old the 

population group receiving the greatest 

exposure. There are no residential uses 

for etoxazole. 

3. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

etoxazole is not expected to pose a 

cancer risk to humans. 

4. 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 etoxazole 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

gas chromatography/nitrogen 

phosphorus detector (GC/NPD) is 

available to enforce the recommended 

tolerances. 

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 


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75430 Federal Register / Vol. 80, No. 231 / Wednesday, December 2, 2015 / Rules and Regulations 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has established MRLs for 

etoxazole in or on citrus fruits at 0.1 

ppm. EPA is establishing a tolerance for 

residues in or on orange of 0.10 ppm in 

order to harmonize with the Codex 

MRL. 

C. Revisions to Petitioned-For 

Tolerances 

EPA has revised the proposed 

tolerance levels for orange and orange 

oil from 0.08 and 1.8 ppm to 0.10 and 

1.0 ppm, respectively. EPA is 

establishing a tolerance of 0.10 ppm for 

orange in order to harmonize with the 

Codex MRL. Additionally, based on the 

orange raw agricultural commodity 

highest-average field-trial residue of 

0.048 ppm and the median orange oil 

processing factor of 20x, EPA is 

establishing a tolerance for orange, oil at 

1.0 ppm. In addition, EPA is revising 

the commodity terms for orange oil to 

read as orange, oil to be consistent with 

the Agency’s commodity vocabulary. 

V. Conclusion 

Therefore, tolerances are established 

for residues of etoxazole (2-(2,6- 

difluorophenyl)-4-[4-(1,1- 

dimethylethyl)-2-ethoxyphenyl]-4,5- 

dihydrooxazole), in or on orange and 

orange, oil at 0.10 ppm and 1.0 ppm, 

respectively. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

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

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: November 23, 2015. 

Susan Lewis, 

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 § 180.593, add alphabetically the 

following commodities and footnote 2 to 

the table in paragraph (a) to read as 

follows: 

§ 180.593 Etoxazole; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Orange 2 ...................................... 0.10 

Orange, oil 2 ................................ 1.0 

* * * * * 

2There are no U.S. registrations for orange 

and orange, oil as of December 2, 2015. 

* * * * * 

[FR Doc. 2015–30513 Filed 12–1–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0804; FRL–9937–02] 

Hexythiazox; Pesticide Tolerances; 

Technical Correction 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; technical correction. 

SUMMARY: EPA issued a final rule in the 

Federal Register of August 14, 2015, 

concerning the establishment of 

tolerances with regional registrations for 

residues of hexythiazox in or on wheat. 

This document corrects a technical 

error, specifically, the omission of 

regions in the commodity definitions. 

DATES: This final rule correction is 

effective December 2, 2015. 


jstallworth on DSK7TPTVN1PROD with RULES