Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Rules and Regulations 3617 

[FR Doc. 2012–1360 Filed 1–24–12; 8:45 am] 

BILLING CODE P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0968; FRL–9334–9] 

Etoxazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of etoxazole in or 

on field corn and popcorn. Valent 

U.S.A. Corporation requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

January 25, 2012. Objections and 

requests for hearings must be received 

on or before March 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0968. 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: 

Autumn Metzger, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5314; email address: metzger.

autumn@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. To access the 

harmonized 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–2010–0968 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 March 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 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 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0968, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

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 February 

25, 2011 (76 FR 10584) (FRL–8863–3), 

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 0F7783) by 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 miticide/ovicide 

etoxazole, 2-(2,6-difluorophenyl)-4-[4- 

(1,1-dimethylethyl)-2-ethoxyphenyl]- 

4,5-dihydrooxazole, in or on corn, field, 

grain at 0.01 parts per million (ppm); 

corn, field, forage at 0.6 ppm; corn, 

field, stover at 2.5 ppm; corn, field, 

refined oil at 0.03 ppm; corn, pop, grain 

at 0.01 ppm; corn, pop, stover at 2.5 

ppm; poultry, fat at 0.01 ppm; and 

poultry, liver at 0.02 ppm. That notice 

referenced a summary of the petition 

prepared by Valent, 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, EPA has 

modified the levels at which some of the 

tolerances are being set and determined 

tolerances are not needed for poultry. 


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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 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 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. 

Etoxazole possesses low acute toxicity 

via all routes of exposure. It is not an 

eye or dermal irritant or a dermal 

sensitizer. No toxicity was seen at the 

limit dose in a 28-day dermal toxicity 

study in rats. 

The liver is the main target organ in 

mice, rats and dogs. In a 90-day toxicity 

study in dogs, increased liver weights 

and centrilobular hepatocellular 

swelling in the liver were observed. 

Similar effects were observed in a 

chronic toxicity study in dogs at similar 

doses, indicating that systemic effects 

(mainly liver effects) occur at similar 

dose levels following short- through 

long-term exposure without increasing 

in severity. In a 90-day toxicity study in 

mice, hepatotoxicity (increased relative 

liver weight, liver enlargement, and 

centrilobular hepatocellular swelling) 

was observed at high doses. Similar 

effects were observed at the high dose 

in a mouse carcinogenicity study. 

Subchronic and chronic toxicity studies 

in rats produced similar effects 

(increased liver weights, centrilobular 

hepatocellular swelling, etc.) to those 

seen in mice and dogs. In addition, 

slight increases in thyroid weights and 

incisors were observed in subchronic 

and chronic toxicity studies in rats at 

high doses and at terminal stages of the 

study. Toxicity was not observed at the 

highest dose tested (HDT) in another 

carcinogenicity study in mice. There is 

no evidence of immunotoxicity or 

neurotoxicity in any of the submitted 

studies. 

Two studies in mice showed no 

evidence of carcinogenicity up to the 

HDT. In a rat carcinogenicity study, 

which was deemed unacceptable due to 

inadequate dosing, benign interstitial 

cell tumors (testis) and pancreas benign 

islet cell adenomas were observed (in 

females) at the high dose. These effects 

were not observed in an acceptable 

carcinogenicity study in rats at higher 

doses. In special mechanistic male rat 

studies there were no observable 

changes in serum hormone levels 

(estradiol, luteinizing hormone (LH), 

prolactin and testosterone) or 

reproductive effects (interstitial cell 

proliferation or spermatogenesis) noted. 

EPA classified etoxazole as ‘‘not likely 

to be carcinogenic to humans.’’ 

Etoxazole is not mutagenic. 

The toxicology data for etoxazole 

provides no indication of increased 

susceptibility, as compared to adults, of 

rat and rabbit fetuses to in utero 

exposure in developmental studies. The 

rabbit developmental toxicity study 

included maternal toxic effects (liver 

enlargement, decreased weight gain, and 

decreased food consumption) at the 

same dose as developmental effects 

(increased incidences of 27 presacral 

vertebrae and 27 presacral vertebrae 

with 13th ribs). In the 2-generation 

reproduction study conducted with rats, 

offspring toxicity was more severe (pup 

mortality) than parental toxicity 

(increased liver and adrenal weights) at 

the same dose, indicating increased 

qualitative susceptibility. 

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 titled 

‘‘Etoxazole. Human Health Risk 

Assessment for Proposed Uses in/on 

Field Corn and Pop Corn,’’ pp. 24–27 in 

docket ID number EPA–HQ–OPP–2010– 

0968. 

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 etoxazole used for human 

risk assessment is discussed in Unit 

III.B., in the Table of the final rule 

published in the Federal Register of 

April 13, 2011 (76 FR 20537) (FRL– 

8867–5) (http://www.gpo.gov/fdsys/pkg/ 

FR-2011-04-13/pdf/2011-8550.pdf.) 

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 


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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 United States Department of 

Agriculture (USDA) 1994–1996 and 

1998 Continuing Surveys for Food 

Intake by Individuals (CSFII). As to 

residue levels in food, an unrefined, 

chronic dietary exposure assessment 

was performed for the general U.S. 

population and various population 

subgroups using tolerance-level residues 

for all agricultural commodities and 100 

percent crop treated (PCT) information. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that etoxazole does not pose 

a cancer risk to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and 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. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for etoxazole in drinking water. 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 Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

etoxazole for chronic exposures for noncancer assessments are estimated to be 

4.761 parts per billion (ppb) for surface 

water and 0.746 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 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The toxicology data for etoxazole 

provides no indication of increased 

susceptibility, as compared to adults, of 

rat and rabbit fetuses to in utero 

exposure in developmental studies. In a 

rat reproduction study, offspring 

toxicity was more severe (pup mortality) 

than parental toxicity (increased liver 

and adrenal weights) at the same dose; 

thereby indicating increased qualitative 

susceptibility. Based on the concerns in 

this unit, a Degree of Concern Analysis 

was performed by EPA, which 

concluded that concern is low since: 

i. The effects in pups are wellcharacterized with a clear NOAEL; 

ii. The pup effects occur at the same 

dose as parental toxicity; and 

iii. The doses selected for various risk 

assessment scenarios are lower (∼3000- 

fold lower) than the doses that caused 

offspring toxicity in the rat 2-generation 

reproduction study. Therefore, the 

endpoints selected for risk assessment 

are protective of the effects seen in the 

rat reproduction study. 

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 except for acute and 

subchronic neurotoxicity and 

immunotoxicity studies. Changes to 40 

CFR 180.158 make acute and subchronic 

neurotoxicity testing (OPPTS Guideline 

870.6200), and immunotoxicity testing 

(OPPTS Guideline 870.7800) required 

for pesticide registration. Although 

these studies are not yet available for 

etoxazole, the available data do not 

show any evidence of treatment-related 

effects on the immune system. Further, 

there is no evidence of neurotoxicity in 

any study in the toxicity database for 

etoxazole. Therefore, the EPA does not 

believe that conducting neurotoxicity 

and immunotoxicity studies will result 

in a NOAEL lower than the NOAEL of 

4.62 milligrams/kilograms/day (mg/kg/ 

day) already established for etoxazole. 

Consequently, an additional database 

uncertainty factor does not need to be 

applied. 

ii. There is no indication that 

etoxazole is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. Although there is qualitative 

evidence of increased susceptibility of 

offspring (pup mortality) compared to 

less severe parental effects (increased 

liver and adrenal weights) at the same 

dose in the rat multi-generation 

reproduction study, the Agency did not 

identify any residual uncertainties after 

establishing toxicity endpoints and 

traditional UFs (10X for interspecies 

variation and 10X for intraspecies 

variation) to be used in the risk 

assessment. 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 etoxazole in 

drinking water. These assessments will 


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3620 Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Rules and Regulations 

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 11% of the 

cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for etoxazole. 

3. Short and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

A short- and/or intermediate-term 

adverse effect was identified; however, 

etoxazole is not registered for any use 

patterns that would result in short- and/ 

or intermediate-term residential 

exposure. Short- and/or intermediateterm risk is assessed based on shortand/or intermediate term residential 

exposure plus chronic dietary exposure. 

Because there is no short- and/or 

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 short- and/or intermediate-term 

risk), no further assessment of shortand/or intermediate-term risk is 

necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short- and/or intermediateterm risk for etoxazole. 

4. 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. 

5. 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/nitrogenphosphorus detection (GC/NPD) and gas 

chromatography/mass selective 

detection (GC/MSD) methods) are 

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 etoxazole for the commodities 

discussed in this document. 

C. Revisions to Petitioned-For 

Tolerances 

Based upon analysis of the data 

supporting the petition using the 

Organization for Economic Cooperation 

and Development tolerance calculation 

procedures, the EPA revised the 

tolerance levels for corn, field, forage 

from 0.6 ppm to 0.80 ppm; corn, field, 

stover from 2.5 ppm, to 4.0 ppm and 

corn, pop, stover from 2.5 ppm to 4.0 

ppm. 

There is no reasonable expectation of 

finding quantifiable residues of 

etoxazole in poultry commodities based 

on the calculated maximum reasonable 

dietary burden (MRDB) for poultry 

(0.0077 ppm) and the results from the 

poultry metabolism study. Therefore, 

tolerances for residues of etoxazole in 

poultry, fat and poultry, liver were not 

required for this petition. 

V. Conclusion 

Therefore, tolerances are established 

for residues of etoxazole in or on corn, 

field, grain at 0.01 ppm; corn, field, 

forage at 0.80 ppm; corn, field, stover at 

4.0 ppm; corn, field, refined oil at 0.03 

ppm; corn, pop, grain at 0.01 ppm; corn, 

pop, stover at 4.0 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, 

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, 


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Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Rules and Regulations 3621 

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: January 13, 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. Section 180.593 is amended in 

paragraph (a) by alphabetically adding 

the following commodities to the table 

to read as follows: 

§ 180.593 Etoxazole; tolerances for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

*****

Corn, field, forage ................... 0 .80 

Corn, field, grain ..................... 0 .01 

Corn, field, refined oil ............. 0 .03 

Corn, field, stover ................... 4 .0 

Corn, pop, grain ...................... 0 .01 

Corn, pop, stover .................... 4 .0 

*****

* * * * * 

[FR Doc. 2012–1254 Filed 1–24–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–1017; FRL–9332–1] 

Rimsulfuron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of rimsulfuron in 

or on the caneberry subgroup 13–07A 

and the bushberry subgroup 13–07B. 

Interregional Research Project No. 4 (IR– 

4) requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

January 25, 2012. Objections and 

requests for hearings must be received 

on or before March 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–1017. 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: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; email address: 

ertman.andrew@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 


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