Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 20537 

Appendix D to Part 75—Optional SO2

Emissions Data Protocol for Gas-Fired 

and Oil-Fired Peaking Units 

[FR Doc. C1–2011–6216 Filed 4–12–11; 8:45 am] 

BILLING CODE 1505–01–D 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0063; FRL–8867–5] 

Etoxazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of etoxazole in or 

on multiple commodities which are 

identified and discussed later in this 

document. Interregional Research 

Project #4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

13, 2011. Objections and requests for 

hearings must be received on or before 

June 13, 2011, 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–2010–0063. 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; e-mail 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://www.gpoaccess.gov/ecfr. 

To access the harmonized 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–2010–0063 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 June 13, 2011. 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–2010–0063, 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 May 19, 

2010 (75 FR 28009) (FRL–8823–2), 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 9E7675) by IR–4, 

Rutgers, The State University of New 

Jersey, 500 College Road East, Suite 201 

W., Princeton, NJ 08540. The petition 

requested that 40 CFR part 180 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 peppers, 

African eggplant, eggplant, martynia, 

okra, pea eggplant, pepino, roselle, and 

scarlet eggplant at 0.20 ppm; Crop 

Group 9: Cucurbit vegetables at 0.20 

ppm; Subgroup 13–07A: Caneberry at 

1.1 ppm; Subgroup 13–07F: Small fruit 

vine climbing subgroup except fuzzy 

kiwi at 0.50 ppm; Subgroup 13–07G: 

Low-growing berry subgroup at 0.50 

ppm and avocado, papaya, star apple, 

black sapote, mango, sapodilla, canistel, 

and mamey sapote at 0.20 ppm; and tea 

at 15 ppm. The petition also proposed 

to delete the established tolerances in or 

on strawberry, grape, cucumber, and 

vegetable, cucurbit subgroup 9A since 


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they would be covered by the proposed 

new tolerances. That notice referenced a 

summary of the petition prepared by 

Valent, the registrant, which is available 

in the docket, http:// 

www.regulations.gov. A comment was 

received on the notice of filing. EPA’s 

response to this comment is discussed 

in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

modified the levels at which some of the 

tolerances are being set and is setting a 

subgroup tolerance instead of separate 

tolerances for some commodities. It was 

also determined that the proposed 

deletion of the cucurbit subgroup 9A 

and establishment of a tolerance for the 

cucurbit vegetables crop group 9 could 

not be done due to differences in 

tolerance levels between subgroups 9A 

and 9B. Finally, the tolerance 

expression is being revised to be 

consistent with current Agency policy. 

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. 

The existing etoxazole data indicate 

that it 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 docket ID 

number EPA–HQ–OPP–2010–0063 in 

the document titled Etoxazole; ‘‘Human 

Health Risk Assessment for Proposed 

Tolerances and Uses on Peppers (Bell 

and Non-bell); Squash/Cucumbers 

(Subgroup 9B); Avocado; Tropical and 

Subtropical Fruits (Inedible Peel); 

Caneberry Subgroup 13–07A; Small 

Fruit Vine Climbing, Except Kiwifruit, 

Subgroup 13–07F; Low-growing Berry, 

Subgroup 13–07G; and Tea,’’ pp. 29–31. 

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 


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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 the 

following Table: 

TABLE—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 (Females 13–50 

years of age and general population including infants and children).

A dose and endpoint attributable to a single dose were not identified in the database including the developmental toxicity studies. 

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) .. Classification: ‘‘Not likely to be Carcinogenic to Humans.’’ 

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

(intraspecies). UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = 

population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

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 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 tolerancelevel residues for all agricultural 

commodities and 100 percent crop 

treated (PCT). 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. If quantitative cancer risk 

assessment is appropriate, Cancer risk 

may be quantified using a linear or 

nonlinear approach. If sufficient 

information on the carcinogenic mode 

of action is available, a threshold or 

non-linear approach is used and a 

cancer RfD is calculated based on an 

earlier noncancer key event. If 

carcinogenic mode of action data are not 

available, or if the mode of action data 

determines a mutagenic mode of action, 

a default linear cancer slope factor 

approach is utilized. 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. 

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 0.318 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 


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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 (10×) 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 (FQPA) 

Safety Factor (SF). In applying this 

provision, EPA either retains the default 

value of 10×, 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 1×. 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, EPA does not 

believe that conducting neurotoxicity 

and immunotoxicity studies will result 

in a NOAEL lower than the NOAEL of 

4.62 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 (10× for interspecies 

variation and 10× 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 

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 methodologies 

(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 


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Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 20541 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail 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 MRLs 

for etoxazole for the commodities 

discussed in this document. 

C. Response to Comments 

EPA received a comment from a 

private citizen expressing concerns for 

genetically modified vegetables and 

undue risks from pesticides. However, 

this action does not involve use of 

genetically modified vegetables. 

Additionally, when new or amended 

tolerances are requested for the presence 

of the residues of a pesticide and its 

toxicologically significant metabolite(s) 

in food or feed, the Agency, as is 

required by section 408 of the Federal 

Food, Drug and Cosmetic Act (FFDCA), 

estimates the risk of the potential 

exposure to these residues by 

performing an aggregate risk assessment. 

Such a risk assessment integrates the 

individual assessments that are 

conducted for food, drinking water, and 

residential exposures. Additionally, the 

Agency, as is further required by section 

408 of the FFDCA, considers available 

information concerning what are termed 

the cumulative toxicological effects of 

the residues of that pesticide and of 

other substances having a common 

mechanism of toxicity with it. The 

Agency has concluded after this 

assessment that there is a reasonable 

certainty that no harm will result from 

exposure to the residues of interest. 

Therefore, the proposed tolerances are 

found to be acceptable. These 

assessments consider body residue 

loads of the pesticide, as well as 

available information concerning the 

potential that other substances have a 

common mechanism of toxicity, in 

reaching a conclusion as to whether or 

not the reasonable certainty of no harm 

decision can be made. 

D. Revisions to Petitioned-for 

Tolerances 

Upon review of the data supporting 

the petition, EPA revised the tolerance 

for caneberry subgroup 13–07A from 1.1 

ppm to 1.5 ppm based on analysis of the 

residue field trial data using the 

Agency’s Tolerance Spreadsheet in 

accordance with the Agency’s Guidance 

for Setting Pesticide Tolerances Based 

on Field Trial Data. 

The Agency also corrected the 

commodity definition from ‘‘fruit, small, 

vine climbing, subgroup 13–07F, except 

fuzzy kiwifruit’’ to ‘‘fruit, small vine 

climbing, except fuzzy kiwifruit, 

subgroup 13–07F.’’ 

EPA has also determined that the 

petitioned-for tolerance on tea at 15 

ppm should be established as a 

tolerance with no U.S. registrations on 

tea, dried at 15 ppm. At least one U.S. 

residue field trial study is required to 

establish a domestic registration on tea; 

however, no U.S. residue field trial data 

were submitted in support of the use of 

etoxazole on tea. Therefore, the Agency 

has established a tolerance with no U.S. 

registrations on tea, dried at 15 ppm. 

Additionally, IR–4 petitioned for 

individual tolerances on peppers, 

African eggplant, eggplant, martynia, 

okra, pea eggplant, pepino, roselle, and 

scarlet eggplant (PP 9E7675). In the 

Federal Register of December 8, 2010 

(75 FR 76284–76292) (FRL–8853–8), 

EPA issued a final rule that revised the 

crop grouping regulations. As part of 

this action, EPA retained the preexisting Crop Group 8 and added a new 

group titled ‘‘Crop Group 8–10 Fruiting 

Vegetable Group.’’ The new crop group 

8–10 added new commodities and 

created new subgroups (including a 

subgroup consisting of the commodities 

requested in PP 9E7675). EPA indicated 

in the December 8, 2010 final rule as 

well as the earlier January 6, 2010 

proposed rule (75 FR 807) 

(FRL–8801–2) that, for existing petitions 

for which a Notice of Filing had been 

published, the Agency would attempt to 

conform these petitions to the rule. 

Therefore, consistent with this rule, 

EPA is establishing a tolerance on the 

pepper/eggplant subgroup 8–10B. EPA 

concludes it is reasonable to establish 

the tolerance on the newly created 

subgroup, since the individual 

commodities for which tolerances were 

requested are identical to those which 

comprise the pepper/eggplant subgroup 

8–10B. 

Also, because of differences in the 

tolerance levels between subgroup 9A 

(melon subgroup) and 9B (squash/ 

cucumber subgroup), the two cannot be 

combined into a single tolerance under 

Crop Group 9 Cucurbit Vegetables as 

proposed in the petition. Accordingly, 

other than the nomenclature change to 

the existing subgroup 9A tolerance 

noted below, EPA is leaving the existing 

subgroup 9A tolerance intact and 

adding a new tolerance for subgroup 9B. 

In order to use the correct 

nomenclature, the existing tolerance for 

‘‘vegetable, cucurbit subgroup 9A’’ is 

being re-named ‘‘melon subgroup 9A.’’ 

Finally, EPA has revised the tolerance 

expression to clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of etoxazole 

not specifically mentioned; and 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

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 pepper/ 

eggplant subgroup 8–10B at 0.20 ppm; 

tea, dried at15 ppm; berry, low growing, 

subgroup 13–07G at 0.50 ppm; fruit, 

small vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F at 0.50 ppm; 

squash/cucumber subgroup 9B at 0.02 

ppm; avocado at 0.20 ppm; papaya at 

0.20 ppm; star apple at 0.20 ppm; 

sapote, black at 0.20 ppm; mango at 0.20 

ppm; sapodilla at 0.20 ppm; canistel at 

0.20 ppm; sapote, mamey at 0.20 ppm; 

and caneberry subgroup 13–07A at 1.5 

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 


emcdonald on DSK2BSOYB1PROD with RULES
20542 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or Tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or Tribal governments, 

on the relationship between the national 

government and the States or Tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 1, 2011. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.593 is amended by: 

■ i. Revising the introductory text in 

paragraph (a); 

■ ii. Removing the commodities 

‘‘Cucumber,’’ ‘‘Grape’’ and ‘‘Strawberry’’ 

from the table in paragraph (a); 

■ iii. Revising the entry ‘‘Vegetable, 

cucurbit subgroup 9A’’ to read ‘‘Melon 

subgroup 9A’’ in the table; and 

■ iv. Alphabetically adding the 

following commodities to the table in 

paragraph (a) to read as follows: 

§ 180.593 Etoxazole; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of etoxazole, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only etoxazole 

(2-(2,6-difluorophenyl)-4-[4-(1,1- 

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

dihydrooxazole) in or on the 

commodity. 

Commodity Parts per 

million 

* * * * * 

Avocado .................................. 0 .20 

Berry, low growing, subgroup 

13–07G ............................... 0 .50 

Caneberry subgroup 13–07A 1 .5 

Canistel ................................... 0 .20 

* * * * * 

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13–07F ...................... 0 .50 

Commodity Parts per 

million 

* * * * * 

Mango ..................................... 0 .20 

Melon subgroup 9A ................ 0 .20 

* * * * * 

Papaya .................................... 0 .20 

Pepper/eggplant subgroup 8– 

10B ...................................... 0 .20 

* * * * * 

Sapodilla ................................. 0 .20 

Sapote, black .......................... 0 .20 

Sapote, mamey ...................... 0 .20 

* * * * * 

Squash/cucumber subgroup 

9B ........................................ 0 .02 

Star apple ............................... 0 .20 

* * * * * 

Tea, dried * ............................. 15 

* * * * * 

* There are currently no U.S. registrations 

for tea as of April 13, 2011. 

* * * * * 

[FR Doc. 2011–8550 Filed 4–12–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0274; FRL–8868–4] 

Escherichia coli O157:H7 Specific 

Bacteriophages; Temporary Exemption 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

temporary exemption from the 

requirement of a tolerance for residues 

of lytic bacteriophages that are specific 

to Escherichia coli O157:H7, sequence 

negative for shiga toxins I and II, and 

grown on atoxigenic host bacteria when 

applied/used on food contact surfaces in 

food processing plants in accordance 

with the terms of Experimental Use 

Permit (EUP) No. 74234–EUP–2. 

Intralytix, Inc. submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting the 

temporary tolerance exemption. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of lytic bacteriophages that 

are specific to Escherichia coli O157:H7, 

sequence negative for shiga toxins I and 

II, and grown on atoxigenic host 

bacteria. The temporary tolerance 

exemption expires on April 1, 2013. 


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