25156 Federal Register / Vol. 74, No. 100 / Wednesday, May 27, 2009 / Rules and Regulations 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA; and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (59 FR 22951, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the state, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

Reference, Intergovernmental relations, 

Ozone. 

Dated: May 14, 2009. 

Jane Diamond, 

Acting Regional Administrator, Region IX. 

■ Part 52, chapter I, title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

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

Subpart F—California 

■ 2. A new § 52.282 is added to read as 

follows: 

§ 52.282 Control strategy and regulations: 

Ozone. 

(a) Attainment determination. EPA 

has determined that the Ventura County 

severe 1-hour ozone nonattainment area 

attained the 1-hour ozone NAAQS by 

the applicable attainment date of 

November 15, 2005. EPA also has 

determined that the Ventura County 

severe 1-hour ozone nonattainment area 

is not subject to the requirements of 

section 185 of the Clean Air Act (CAA) 

for the 1-hour standard and that the 

State is not required to submit a SIP 

under Section 182(d)(3) of the CAA to 

implement a section 185 program for the 

1-hour standard in this area. In addition, 

the requirements of section 172(c)(9) 

(contingency measures) for the 1-hour 

standard do not apply to the area. 

(b) [Reserved] 

[FR Doc. E9–12135 Filed 5–26–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0554; FRL–8413–5] 

Etoxazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of etoxazole in or 

on stone fruit; plum; prune; spearmint 

tops and oil; peppermint tops and oil; 

tomato; and cucumber. This regulation 

also deletes the existing cherry 

tolerance, as it will be superseded by 

inclusion in the stone fruit crop group. 

The Interregional Research Project 

Number 4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

27, 2009. Objections and requests for 

hearings must be received on or before 

July 27, 2009, 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–2008–0554. 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: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; e-mail address: 

nollen.laura@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. 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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 


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C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2008–0554 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before July 27, 2009. 

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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0554, 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. Petition for Tolerance 

In the Federal Register of August 13, 

2008 (73 FR 47186) (FRL–8375–8), 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 8E7347) 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 180.593 be 

amended by establishing tolerances for 

residues of the insecticide etoxazole, 2- 

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

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

dihydrooxazole, in or on fruit, stone, 

group 12, except plum at 1.0 parts per 

million (ppm); plum at 0.12 ppm; plum, 

prune, dried at 0.4 ppm; cucumber at 

0.02 ppm; tomato at 0.25; spearmint, 

tops at 10 ppm; peppermint, tops at 10 

ppm; peppermint, oil at 20 ppm; and 

spearmint, oil at 20 ppm. The petition 

additionally requested to delete the 

tolerance for residues of etoxazole in or 

on the food commodity cherry at 1.0 

ppm. That notice referenced a summary 

of the petition prepared on behalf of IR4 by Valent U.S.A. Corporation, the 

registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance levels for plum; 

plum, prune, dried; and tomato. The 

reason for these changes is 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 the petitioned-for 

tolerances for residues of etoxazole on 

fruit, stone, group 12, except plum at 1.0 

ppm; plum at 0.15 ppm; plum, prune, 

dried at 0.30 ppm; cucumber at 0.02 

ppm; tomato at 0.20; spearmint, tops at 

10 ppm; peppermint, tops at 10 ppm; 

peppermint, oil at 20 ppm; and 

spearmint, oil at 20 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing tolerances 

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 possess 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 


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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 two-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 studiescan be found at http:// 

www.regulations.gov in document 

‘‘Etoxazole; Human Health Risk 

Assessment for Proposed Uses on Stone 

Fruits, Cucumber, Tomato, and Mint,’’ 

pages 29-31 in docket ID number EPA– 

HQ–OPP–2008–0554. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

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 greater than that 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 can be found at http:// 

www.regulations.gov in document 

‘‘Etoxazole; Human Health Risk 

Assessment for Proposed Uses on Stone 

Fruits, Cucumber, Tomato, and Mint,’’ 

page 15 in docket ID number EPA–HQ– 

OPP–2008–0554. 

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 

CSFII. As to residue levels in food, EPA 

used tolerance-level residues and 

empirically determined (when 

available) or DEEM default processing 

factors. Additionally, EPA assumed 100 

percent crop treated (PCT) for all 

commodities covered by proposed or 

existing tolerances. 

iii. Cancer. Two mouse studies 

showed no evidence of carcinogenicity 

at the high dose. While benign 

interstitial cell tumors in the testis and 

pancreas benign islet cell adenomas 

were observed in an unacceptable rat 

carcinogenicity study, these effects were 

not seen in a repeat study at higher 

doses. Furthermore, special mechanistic 

male rat studies resulted in no 

observable changes in serum hormone 

levels (estradiol, luteinizing hormone, 

prolactin and testosterone) or 

reproductive effects (interstitial cell 

proliferation or spermatogenesis). EPA 

determined that cancer risk concerns 

due to long-term consumption of 

etoxazole residues are adequately 

addressed by the chronic dietary 

exposure analysis; therefore, etoxazole 

was classified as ‘‘not likely to be 

carcinogenic to humans,’’ and a 

quantitative exposure assessment to 

evaluate cancer risk is unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for etoxazole. 

Tolerance level residues and 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) model for 

surface water, and Screening 

Concentration in Ground Water (SCIGROW) model for ground water, the 

estimated drinking water concentrations 

(EDWCs) of etoxazole and its major 

metabolites (R-8 and R-13) for surface 

water are estimated to be 15.73 parts per 

billion (ppb) for acute exposures and 

4.761 ppb for chronic exposures. For 

ground water, the estimated drinking 

water concentration is estimated to be 

0.746 ppb. 

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 


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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 website 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 above 

concerns, 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 than the 

doses that caused offspring 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 except for acute and 

subchronic neurotoxicity and 

immunotoxicity studies. Recent 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. Because these 

testing requirements went into effect 

shortly before the tolerance petition was 

submitted, these studies are not yet 

available for etoxazole. However, the 

available data for etoxazole do not show 

potential for immunotoxicity. 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 milligrams/kilograms/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 

Uncertainity Factors (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 

not underestimate the exposure and 

risks posed by etoxazole. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases 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 POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute 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 10% of the 

cPAD for children 1-2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for etoxazole to consider. 

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). 

Etoxazole is not registered for any use 

patterns that would result in residential 

exposure. Therefore, the short-, and 

intermediate-term aggregate risk is the 

sum of the risk from exposure to 

etoxazole through food and water and 

will not be greater than the chronic 

aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. As discussed in Unit 

III.C.1.iii., EPA has classified etoxazole 

as ‘‘not likely to be carcinogenic to 

humans,’’ and it 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. 


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25160 Federal Register / Vol. 74, No. 100 / Wednesday, May 27, 2009 / Rules and Regulations 

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 methods may be 

requested from: Chief, Analytical 

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 

Currently, there are no Codex, 

Canadian, or Mexican maximum residue 

limits (MRLs) established for residues of 

etoxazole in or on the subject 

commodities. 

C. Response to Comments 

EPA received one comment to the 

Notice of Filing that made a general 

objection to the presence of any 

pesticide residues on crops and stated 

that EPA should set no pesticide 

tolerance greater than zero. The Agency 

understands the commenter’s concerns 

and recognizes that some individuals 

believe that pesticides should be banned 

completely. However, the existing legal 

framework provided by section 408 of 

FFDCA states that tolerances greater 

than zero may be set when persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

that statute. This citizen’s comment 

appears to be directed at the underlying 

statute and not EPA’s implementation of 

it; the citizen has made no contention 

that EPA has acted in violation of the 

statutory framework. 

D. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petition, EPA revised 

tolerances for certain proposed 

commodities, as follows: Plum from 

0.12 ppm to 0.15 ppm; plum, prune, 

dried from 0.40 ppm to 0.30 ppm; and 

tomato from 0.25 ppm to 0.20 ppm. EPA 

revised the tolerance levels 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. 

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 fruit, stone, 

group 12, except plum at 1.0 ppm; plum 

at 0.15 ppm; plum, prune, dried at 0.30 

ppm; cucumber at 0.02 ppm; tomato at 

0.20 ppm; spearmint, tops at 10 ppm; 

peppermint, tops at 10 ppm; spearmint, 

oil at 20 ppm; and peppermint, oil at 20 

ppm. This regulation also deletes the 

existing tolerance in or on cherry at 1.0 

ppm, as it is superseded by inclusion in 

fruit, stone, group 12. 

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, 

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) (Public Law 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: May 15, 2009. 

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 removing the 

commodity ‘‘Cherry’’ and by 

alphabetically adding the following 

commodities to the table to read as 

follows: 

§ 180.593 Etoxazole; tolerances for 

residues. 

(a) General. * * * 


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Federal Register / Vol. 74, No. 100 / Wednesday, May 27, 2009 / Rules and Regulations 25161 

Commodity Parts per million 

*****

Cucumber ....................... 0.02 

*****

Fruit, stone, group 12, 

except plum ................. 1.0 

*****

Peppermint, oil ................ 20 

Peppermint, tops ............ 10 

*****

Plum ................................ 0.15 

Plum, prune, dried .......... 0.30 

*****

Spearmint, oil .................. 20 

Spearmint, tops .............. 10 

*****

Tomato ............................ 0.20 

*****

* * * * * 

[FR Doc. E9–12292 Filed 5–26–09; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

45 CFR Part 286 

RIN 0970–AC40 

Temporary Assistance for Needy 

Families (TANF) Carry-Over Funds 

AGENCY: Administration for Children 

and Families (ACF), Department of 

Health and Human Services (HHS). 

ACTION: Interim final rule. 

SUMMARY: This rule implements the 

statutory change to section 404(e) of the 

Social Security Act (42 U.S.C. 604(e)) as 

enacted by the American Recovery and 

Reinvestment Act of 2009 (Pub. L. 111– 

5). This change allows States, Tribes 

and Territories to use Temporary 

Assistance for Needy Families (TANF) 

program funds carried over from a prior 

year for any allowable TANF benefit, 

service or activity. Previously these 

funds could be used only to provide 

assistance. This interim final rule 

applies to States, local governments, 

and Tribes that administer the TANF 

program. 

DATES: Effective Date: May 27, 2009. 

Comment Date: Comments are due on 

or before July 27, 2009. 

ADDRESSES: You may mail or handdeliver comments regarding this interim 

rule to the Administration for Children 

and Families, Office of Family 

Assistance, 370 L’Enfant Promenade, 

SW., 5th floor, Washington, DC 20447. 

You also may transmit comments 

electronically via the Internet at: 

http://www.regulations.gov. You may 

download an electronic version of this 

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

All comments received, including any 

personal information provided, will be 

available for public inspection Monday 

through Friday, 8:30 a.m. to 5 p.m., at 

901 D St., SW., 5th Floor, Washington 

DC. 

FOR FURTHER INFORMATION CONTACT: 

Robert Shelbourne, Director, Division of 

State TANF Policy and Acting Director, 

Division of Tribal TANF Management, 

Office of Family Assistance, ACF, at 

(202) 401–5150. 

SUPPLEMENTARY INFORMATION: 

I. Statutory Authority 

Section 417 of the Social Security Act 

(42 U.S.C. 617) limits the authority of 

the Federal government to regulate State 

conduct or enforce the TANF provisions 

of the Social Security Act, except as 

expressly provided. We have interpreted 

this provision to allow us to regulate 

where Congress has charged HHS with 

enforcing certain TANF provisions by 

assessing penalties. Because the 

improper use of Federal TANF carryover funds can result in a financial 

penalty pursuant to 42 U.S.C. 609(a)(1), 

we have the authority to regulate in this 

instance. 

Justification for Interim Final Rule 

The Administrative Procedures Act 

requirements under 5 U.S.C. 553 for 

notice of proposed rulemaking do not 

apply to rules when the agency finds 

good cause that notice is impracticable, 

unnecessary, or contrary to the public 

interest (5 U.S.C. 553(b)). We find 

proposed rulemaking unnecessary 

because the policy was effective upon 

enactment and this regulatory action 

merely updates program regulations to 

reflect current law and avoid any 

unnecessary confusion on the part of 

States and Tribes. The change made to 

the TANF program by the Recovery Act 

on the use of carry-over funds was 

intended to provide increased flexibility 

immediately to States and Tribes to 

support work and families especially 

during this difficult economic period. If 

this regulation were delayed, States and 

Tribes might be hesitant to take 

advantage of the flexibility afforded by 

the statutory change because of the 

conflict with the regulation, and any 

confusion resulting from that conflict. 

For the same reason given above, we 

also find good cause for waiving the 

Administrative Procedures Act 

requirement under 5 U.S.C. 553(d) 

which provides that a rule generally 

may not become effective less than 30 

days after it is published in the Federal 

Register. Since the statute was effective 

upon enactment and because this 

regulation merely updates the 

regulations to reflect the current law, 

this rule is effective upon publication. 

II. American Recovery and 

Reinvestment Act of 2009 

On February 17, 2009, the President 

signed the American Recovery and 

Reinvestment Act of 2009 (Pub. L. 111– 

5), which included a provision to lift the 

restriction on unspent Federal TANF 

funds reserved or ‘‘carried over’’ into a 

succeeding fiscal year. Prior to Public 

Law 111–5, carry-over funds could only 

be used to provide assistance (i.e., 

ongoing basic needs payments, and 

supportive services such as 

transportation and child care to families 

who are not employed). Section 2103 of 

Division B of Public Law 111–5 amends 

section 404(e) of the Social Security Act 

(Act) by allowing States, District of 

Columbia, the Territories and Tribes to 

use the carry-over funds for any 

allowable TANF benefit, service, or 

activity (such as job skills training or retraining activities, employment 

counseling services, parental counseling 

services, teen pregnancy prevention 

activities, services for victims of 

domestic violence, after-school 

programs)—and not just assistance. 

Thus, the policy reflected in this 

interim final rule is effective 

immediately and applies to all Federal 

TANF funds carried over into fiscal year 

2009 as well as to all future Federal 

TANF funds carried over into a 

subsequent year. 

Herein after and as defined in section 

419(5) of the Social Security Act, we 

will use ‘‘States’’ to mean the 50 States 

of the United States, the District of 

Columbia, the Commonwealth of Puerto 

Rico, the United States Virgin Islands, 

Guam, and American Samoa. (However, 

American Samoa has chosen not to 

participate in the TANF program.) 

III. Regulatory Provisions 

As discussed below, section 2103 of 

Public Law 111–5 requires a change in 

the Tribal TANF regulation at 45 CFR 

286.60. The TANF regulations at 45 CFR 

Part 263, applicable to States and 

Territories, require no change. 

Part 286—Tribal TANF Provisions 

Section 286.60: Must Tribes obligate all 

Tribal Family Assistance Grant funds by 

the end of the fiscal year in which they 

are awarded? 

Under prior law, section 404(e) of the 

Act, entitled ‘‘Authority to Reserve 

Certain Amounts for Assistance,’’ 

allowed States and Indian Tribes 


PWALKER on PROD1PC71 with RULES