Federal Register / Vol. 78, No. 116 / Monday, June 17, 2013 / Rules and Regulations 36093 

final rule that governs ‘‘Payment or 

Reimbursement for Emergency Services 

for Nonservice-Connected Conditions in 

Non-VA Facilities’’ regulations to 

conform with a statutory change that 

expanded veterans’ eligibility for 

reimbursement. This document corrects 

a typographical error without making 

any substantive change to the content of 

the final rule. 

DATES: Effective Date: This correction is 

effective June 17, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Willie Douglas, Policy Specialist, Policy 

Management Department (CBOPC), 

Department of Veterans Affairs, 3773 

Cherry Creek North Drive, Suite 450, 

Denver, CO 80209 at (303) 331–7829. 

This is not a toll-free number. 

SUPPLEMENTARY INFORMATION: VA 

published a proposed rule in the 

Federal Register on May 26, 2011 (76 

FR 30598), which, among other things, 

revised 38 CFR 17.1005. These revisions 

eliminated certain exclusions from 

emergency care payment or 

reimbursement, and defined the 

payment limitations for those qualifying 

for payment or reimbursement under 

the law as amended by Public Law 111– 

137, enacted on February 1, 2010. In the 

proposed rule we stated that § 17.1005 

would be amended by adding new 

paragraphs (c) and (d). However, before 

VA published a final rule based on that 

proposed rule, on December 21, 2011 

(76 FR 79071), VA published an entirely 

separate final rule that added new 

paragraphs (c) and (d) to § 17.1005. 

Then, VA published a final rule on 

April 20, 2012 (77 FR 23615), where we 

acknowledged that VA had already 

added new paragraphs (c) and (d) to 

§ 17.1005 (in the December 21, 2011, 

final rule) and, accordingly, renumbered 

the proposed § 17.1005(c) as new 

§ 17.1005(e). However, in the final rule 

published on April 20, 2012, VA 

inadvertently failed to correct a crossreference in the newly renumbered 

§ 17.1005(e)(3), from (c)(2) (in the 

proposed rule) to the new (e)(2) (which 

should have been cited in the final rule). 

This document corrects that error by 

removing (c)(2) from § 17.1005(e)(3) and 

adding, in its place, (e)(2). 

List of Subjects in 38 CFR Part 17 

Administrative practice and 

procedure, Alcohol abuse, Alcoholism, 

Claims, Day care, Dental health, Drug 

abuse, Foreign relations, Government 

contracts, Grant programs—Health, 

Grant programs—Veterans, Health care, 

Health facilities, Health professions, 

Health records, Homeless, Medical and 

dental schools, Medical devices, 

Medical research, Mental health 

programs, Nursing homes, Philippines, 

Reporting and recordkeeping 

requirements, Scholarships and 

fellowships, Travel and transportation 

expenses, Veterans. 

William F. Russo, 

Deputy Director, Regulation Policy and 

Management, Office of the General Counsel, 

Department of Veterans Affairs. 

For the reasons set forth in the 

preamble, the Department of Veterans 

Affairs is correcting 38 CFR part 17 as 

follows: 

PART 17—MEDICAL 

■ 1. The authority citation for part 17 

continues to read as follows: 

Authority: 38 U.S.C. 501, and as noted in 

specific sections. 

■ 2. Amend § 17.1005(e)(3) by removing 

‘‘(c)’’ and adding, in its place, ‘‘(e)’’. 

[FR Doc. 2013–14249 Filed 6–14–13; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0716; FRL–9388–2] 

Fenpyroximate; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fenpyroximate 

in or on multiple commodities 

identified and discussed later in this 

document. In addition, this regulation 

removes an established tolerance for a 

certain commodity superseded by this 

action. 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 June 

17, 2013. Objections and requests for 

hearings must be received on or before 

August 16, 2013, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0716, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; email address: 

jackson.sidney@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&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 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0716 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 

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36094 Federal Register / Vol. 78, No. 116 / Monday, June 17, 2013 / Rules and Regulations 

before August 16, 2013. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0716, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

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

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

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

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of Wednesday, 

November 7, 2012 (77 FR 66781) (FRL– 

9367–5), EPA issued a document 

pursuant to FFDCA section 408(d)(3), 21 

U.S.C. 346a(d)(3), announcing the filing 

of a pesticide petition (PP 2E8072) by 

Interregional Research Project Number 4 

(IR–4), 500 College Road East, Suite 

201W, Princeton, NJ 08540. The petition 

requested that 40 CFR 180.566 be 

amended by establishing tolerances for 

residues of the insecticide 

fenpyroximate, (E)-1,1-dimethylethyl 4- 

[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol4-yl)methylene]amino]oxy]methyl]

benzoate and its Z-isomer, (Z)-1,1- 

dimethylethyl 4-[[[[(1,3-dimethyl-5- 

phenoxy-1H-pyrazol-4-yl)methylene]

amino]oxy]methyl]benzoate in or on 

fruit, stone, group 12–12 at 2.0 ppm; 

fruit, small, vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F at 1.0 ppm; 

and vegetable, tuberous and corm, 

subgroup 1C at 0.1 ppm. That document 

referenced a summary of the petition 

prepared by Nichino America, Inc., 

4550 New Linden Hill Rd., Wilmington, 

DE 19808, the registrant, which is 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for fenpyroximate 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fenpyroximate follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. 

Fenpyroximate was classified as 

having moderate acute oral and 

inhalation toxicity in rats. It exhibited 

low dermal acute toxicity and was 

neither a skin nor eye irritant. 

Fenpyroximate was a slight to moderate 

sensitizer by the maximization test 

method. Subchronic and chronic oral 

exposures to fenpyroximate resulted in 

overall systemic toxicity (no specific 

target organ/tissue was identified). The 

most sensitive species tested was the 

dog. The effects reported in the dog 

included slight bradycardia, deficits in 

food consumption, body weight, bodyweight gain, and an increased incidence 

of emesis and diarrhea. Emaciation and 

torpor (sluggish inactivity) were 

reported in female dogs at lower dose 

levels than males. The highest dose 

tested in the dog resulted in first- and 

second-degree heart block, increased 

urea concentration, decreased glucose, 

and altered plasma electrolyte levels 

among other signs of toxicity. In 

subchronic and chronic studies with 

rats, the primary effect was decreased 

body-weight gain in both sexes with 

hematological changes (e.g., higher 

counts of red blood cells) at higher 

doses. 

In a rat prenatal developmental 

toxicity study, a fenpyroximate dose 

level that marginally affected maternal 

body weight and food consumption also 

resulted in an increased litter incidence 

of increased thoracic ribs, indicating 

increased prenatal (qualitative) 

susceptibility. In the rabbits, there were 

no developmental effects reported at 

any of the dose levels tested. In the rat 

2-generation reproductive toxicity 

study, there was no indication of 

increased prenatal or postnatal 

susceptibility; maternal toxicity 

(decreased body weight) and offspring 

toxicity (decreased lactational weight 

gain in both generations) occurred at the 

same dose. Reproductive parameters 

were not affected. Acute and subchronic 

neurotoxicity studies in the rat show no 

evidence that fenpyroximate specifically 

targets the nervous system. In the acute 

neurotoxicity study, neurotoxicity signs 

such as decreases in motor activity 

occurred in the presence of other effects 

including decreases in body weight and 

food consumption, and in the absence of 

neuropathology. Similar results were 

noted in a delayed acute neurotoxicity 

study in the hen where no effects 

(neurotoxic or otherwise) were reported. 

The results of the rat subchronic 

neurotoxicity study did not indicate any 

neurotoxicity-specific effects; deficits in 

body weight and food consumption 

were the main effects reported. Effects 

reported in a rat immunotoxicity study 

were limited to decreased body-weight 

gain, indicating the fenpyroximate does 

not directly target the immune system. 

There is no evidence of carcinogenic 

potential for fenpyroximate based on the 

results of carcinogenicity studies via the 

oral route in either the rats or mice 

resulting in the carcinogenicity 

classification of ‘‘not likely’’ to be 

carcinogenic to humans. Genotoxicity 

studies including mutagenicity did not 

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Federal Register / Vol. 78, No. 116 / Monday, June 17, 2013 / Rules and Regulations 36095 

demonstrate any genotoxic potential 

resulting from fenpyroximate exposure. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fenpyroximate 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: 

‘‘Fenpyroximate. Human-Health Risk 

Assessment for Proposed Section 3 Uses 

on Stone Fruits (Group 12–12), 

Tuberous and Corm Vegetables 

(Subgroup 1C), and Small Vine 

Climbing Fruits Except Kiwifruit 

(Subgroup 13–07F), dated May 8, 2013 

at Appendix A’’, p. 30 in docket ID 

number EPA–HQ–OPP–2012–0716– 

0003. 

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 fenpyroximate used for 

human risk assessment is discussed in 

Unit III. of the final rule published in 

the Federal Register of Wednesday, 

December 12, 2012 (77 FR 73945) (FRL– 

9360–3). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fenpyroximate, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing fenpyroximate tolerances in 40 

CFR 180.566. EPA assessed dietary 

exposures from fenpyroximate 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. Such effects were identified 

for fenpyroximate. In estimating acute 

dietary exposure, EPA used the Dietary 

Exposure Evaluation Model—Food 

Consumption Intake Database (DEEM– 

FCID, ver. 3.16), which incorporates 

consumption information from the U.S. 

Department of Agriculture (USDA) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEIA); 2003– 

2008. As to residue levels in food, EPA 

assumed 100 percent crop treated (PCT), 

tolerance-level residues for all 

commodities, DEEM (ver. 7.81) default 

processing factors for all commodities 

except for apple, pear, and grape juice; 

grape, raisin; orange, grapefruit, 

tangerine, lemon and lime juice; tomato 

paste and puree; and peppermint and 

spearmint oil. Chemical-specific data 

were used to calculate empirical 

processing factors for these 

commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 NHANES/ 

WWEIA. As to residue levels in food, 

EPA assumed 100 PCT, tolerance-level 

residues for all commodities, DEEM 

(ver. 7.81) default processing factors for 

all commodities except for apple, pear, 

and grape juice; grape, raisin; orange, 

grapefruit, tangerine, lemon and lime 

juice; tomato paste and puree; and 

peppermint and spearmint oil. 

Chemical-specific data were used to 

calculate empirical processing factors 

for these commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fenpyroximate 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 or PCT information 

in the dietary assessment for 

fenpyroximate. 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 fenpyroximate in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fenpyroximate. 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, the 

Screening Concentration in Ground 

Water (SCI–GROW) model, and a 

Provisional Cranberry Model, the 

Agency calculated conservative 

estimated drinking water concentrations 

(EDWCs) of fenpyroximate. Tier 1, 

EDWCs reflect exposure in drinking 

water to the residues of fenpyroximate 

and its isomer/degradate, its cis isomer 

M–1, and its carboxylic acid M–3, all of 

which are assumed to have similar 

toxicity. 

For acute exposures, EDWCs are 

estimated to be 43 parts per billion 

(ppb) for surface water and 0.27 ppb for 

ground water. 

For chronic exposures, EDWCs are 

estimated to be 8.6 ppb for surface water 

and 0.27 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 43 ppb was used 

to assess the contribution to drinking 

water. For chronic dietary risk 

assessment, the water concentration of 

value 8.6 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, termiticide, and flea 

and tick control on pets). 

Fenpyroximate 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 fenpyroximate to 

share a common mechanism of toxicity 

with any other substances, and 

fenpyroximate does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

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36096 Federal Register / Vol. 78, No. 116 / Monday, June 17, 2013 / Rules and Regulations 

this tolerance action, therefore, EPA has 

assumed that fenpyroximate 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. 

There is evidence of increased prenatal 

(qualitative) susceptibility in a rat 

prenatal developmental toxicity study. 

A dose level that marginally affected 

maternal body weight and food 

consumption also resulted in an 

increased litter incidence of increased 

thoracic ribs. However, concern for 

prenatal and postnatal toxicity to 

fenpyroximate is low because: 

i. There was a clear NOAEL in the rat 

prenatal developmental toxicity study; 

ii. The NOAEL for this developmental 

study is being used as POD for the acute 

dietary risk assessment for the 

population of concern-females 13–49 

years old; 

iii. In the rabbit, there were no 

developmental effects reported at the 

levels tested; and 

iv. In the rat 2-generation 

reproductive toxicity study, there was 

no indication of increased prenatal or 

postnatal susceptibility. 

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 for all exposure 

scenarios. That decision is based on the 

following findings: 

i. The toxicity database for 

fenpyroximate is complete. 

ii. There is no indication that 

fenpyroximate is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is evidence that 

fenpyroximate results in increased 

susceptibility in utero rats or rabbits in 

the prenatal developmental studies or in 

young rats in the 2-generation 

reproduction study. Increased 

(qualitative) prenatal susceptibility was 

seen following oral exposures in the rat 

developmental toxicity study, but the 

concern for these effects is low, for the 

reasons noted in Unit III.D.2. Therefore, 

a 10X FQPA safety factor is not 

necessary to account for this increased 

susceptibility of infants and children. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessment 

utilizes tolerance-level residues 

(established or recommended) and 100 

PCT for all proposed/established 

commodities. By using these 

assumptions, the acute and chronic 

exposures/risks will not be 

underestimated. The dietary drinking 

water assessment utilizes water 

concentration values generated by 

models and associated modeling 

parameters, which are designed to 

provide conservative, health-protective, 

high-end estimates of water 

concentrations that will not likely be 

exceeded. There are no registered or 

proposed residential uses. These 

assessments will not underestimate the 

exposure and risks posed by 

fenpyroximate. 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

fenpyroximate will occupy 13% of the 

aPAD for females 13–49 years old and 

6.2% of the aPAD for children 1–2 years 

old, the population group receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fenpyroximate 

from food and water will utilize 15% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for fenpyroximate. 

3. Short- and intermediate-term risks. 

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). Short-, and 

intermediate-term adverse effects were 

identified; however, fenpyroximate is 

not registered for any use patterns that 

would result in short-, and 

intermediate-term residential exposures. 

Therefore, no further assessment of 

short-, and intermediate-term risks is 

necessary. EPA relies on the chronic 

dietary risk assessment for evaluating 

short-, and intermediate-term risks for 

fenpyroximate. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

fenpyroximate 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 

fenpyroximate residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography method with 

nitrogen/phosphorus detection (GC/ 

NPD), Method S19) is available to 

enforce the tolerance expression. 

Method S19 has passed an Agency 

validation and has a limit of 

quantitation (LOQ) of 0.05 ppm for the 

combined residues of fenpyroximate 

and M–1 in snap beans and avocados. 

A data-gathering liquid 

chromatography/mass spectroscopy/ 

mass spectroscopy (LC/MS/MS) method 

is also available. 

These 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; 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 

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Federal Register / Vol. 78, No. 116 / Monday, June 17, 2013 / Rules and Regulations 36097 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

Codex MRLs are established for 

residues of fenpyroximate per se in 

grapes (fresh and dried). Harmonization 

with the Codex MRLs is not possible 

because the U.S. tolerance expression 

includes an additional isomer and the 

U.S. use pattern requires a higher 

numerical value. 

C. Revisions to Petitioned-For 

Tolerances 

As EPA explained in its latest crop 

group rulemaking (77 FR 50617, August 

22, 2012), EPA will attempt to conform 

petitions seeking tolerances for crop 

groups to the newer established crop 

groups, rather than establish new 

tolerances under the pre-existing crop 

groups, as part of its effort to eventually 

convert tolerances for any pre-existing 

crop group to tolerances with coverage 

under the revised crop group. Therefore, 

although the petitioner requested 

tolerances for ‘‘Fruit, stone, group 12’’, 

EPA evaluated and is establishing 

tolerances for the crop group ‘‘Fruit, 

stone, group 12–12.’’ 

Lastly, the Agency is removing the 

entry for ‘‘grape’’ from the table at 40 

CFR 180.566 (a)(1) since the tolerance 

for ‘‘Fruit, small, vine climbing, except 

fuzzy kiwifruit, subgroup 13–07F’’ at 1.0 

ppm established by this action will 

subsume the existing tolerance. 

V. Conclusion 

Therefore, tolerances are established 

for residues the insecticide 

fenpyroximate, including its metabolites 

and degradates, in or on the 

commodities Fruit, small, vine 

climbing, except fuzzy kiwifruit, 

subgroup 13–07F at 1.0 ppm; Fruit, 

stone, group 12–12 at 2.0; and 

Vegetable, tuberous and corm, subgroup 

1C at 0.10 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 3, 2013. 

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 180.566 is amended by 

removing the entry for ‘‘grape, 1.0’’ and 

by alphabetically adding the following 

entries to the table in paragraph (a)(1) to 

read as follows: 

§ 180.566 Fenpyroximate; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

* * * * * 

Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 

13–07F .................................. 1.0 

Fruit, stone, group 12–12 ......... 2.0 

* * * * * 

Vegetable, tuberous and corm, 

subgroup 1C ......................... 0.10 

* * * * * 

[FR Doc. 2013–14213 Filed 6–14–13; 8:45 am] 

BILLING CODE 6560–50–P 

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