73940 Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations 

‘‘Apple, wet pomace’’ and ‘‘Grape, 

raisin’’ to read as follows: 

§ 180.608 Spirodiclofen; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of spirodiclofen, 

including its metabolites and 

degradates, in or on the commodities 

listed below. Compliance with the 

following tolerance levels is to be 

determined by measuring only 

spirodiclofen, 3-(2,4-dichlorophenyl)-2- 

oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2- 

dimethylbutanoate. 

Commodity Parts per 

million 

* * * * * 

Apple, wet pomace ................... 2.4 

* * * * * 

Grape, raisin ............................. 6.0 

* * * * * 

* * * * * 

[FR Doc. 2012–29902 Filed 12–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0099; FRL–9373–3] 

Flubendiamide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation modifies 

tolerances for residues of flubendiamide 

in or on multiple food commodities 

which are identified, and discussed in 

detail later in this document. Bayer 

CropScience LP in c/o Nichino America, 

Inc. (U.S. subsidiary of Nihon Nohyaku 

Co., Ltd.) requested these tolerances, 

and revisions to tolerances under the 

Federal Food, Drug and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

December 12, 2012. Objections and 

requests for hearings must be received 

on or before February 11, 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–2007–0099, 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: 

Carmen Rodia, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Avenue NW., Washington, 

DC 20460–0001; telephone number: 

(703) 306–0327; fax number: (703) 308– 

0029; email address: 

rodia.carmen@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://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

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–2007–0099 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before February 11, 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– 

2007–0099, 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.htm. 

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 May 23, 

2012 (77 FR 30481) (FRL–9347–8), 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 2F7981) by Bayer 

CropScience LP in c/o Nichino America, 

Inc. (U.S. subsidiary of Nihon Nohyaku 

Co., Ltd.), P.O. Box 12014, Research 

Triangle Park, NC 27709–2014. The 

petition requested that the established 

tolerances listed in 40 CFR 180.639 for 

residues of the insecticide 

flubendiamide, N2-[1, 1-dimethyl-2- 

(methylsulfonyl)ethyl]-3-iodo-N1-[2- 

methyl-4-[l, 2,2,2-tetrafluoro-1- 

(trifluoromethyl)ethyl]phenyl]-1,2- 

benzenedicarboxamide, in or on Apple, 

wet pomace be increased from 2.0 parts 

per million (ppm) to 5.0 ppm; and Fruit, 

pome, group 11 be increased from 0.70 

ppm to 1.5 ppm. That document 


emcdonald on DSK67QTVN1PROD with 
Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations 73941 

referenced a summary of the petition 

prepared by Bayer CropScience LP in 

c/o Nichino America, Inc. (U.S. 

subsidiary of Nihon Nohyaku Co., Ltd.), 

the registrant, which is available in the 

docket, http://www.regulations.gov. 

There were no substantive 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 flubendiamide 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with flubendiamide 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. 

Flubendiamide has a low acute 

toxicity via the oral and dermal routes 

of exposure. Though it is a slight irritant 

to the eye, flubendiamide is not a skin 

irritant and it is not a skin sensitizer 

under the conditions of the guinea pig 

maximization test. 

In the mammalian toxicology 

database, the primary target organ of 

flubendiamide exposure is the liver, 

with secondary effects reported in the 

thyroid and kidney at equivalent or 

higher doses; no-observed-adverseeffect-levels (NOAELs) established to 

protect for liver toxicity are protective of 

effects seen in the thyroid and kidney. 

Adverse adrenal effects were also noted 

in the dog. 

Buphthalmia (eye enlargement), 

opacity, and exophthalmus with 

hemorrhage appearing only in infancy, 

were observed in rat offspring in the 

reproductive and developmental 

neurotoxicity (DNT) studies. There was 

no clear dose-response relationship for 

this effect, but ocular toxicity was noted 

in three rat studies and accompanied by 

histopathological findings of synechia, 

hemorrhage, keratitis, iritis, and 

cataracts. Therefore, bupthalmos is 

considered an effect of treatment. No 

evidence of cancer was seen for 

flubendiamide in cancer bioassays in 

mice and rats. Flubendiamide was also 

negative in mutagenicity testing. 

Accordingly, flubendiamide was 

classified as ‘‘Not Likely To Be 

Carcinogenic to Humans.’’ 

More detailed information on the 

studies received and the nature of the 

adverse effects caused by flubendiamide 

as well as the NOAEL and the lowestobserved-adverse effect-level (LOAEL) 

from the toxicity studies can be found 

in the document entitled, 

‘‘Flubendiamide: Human Health Risk 

Assessment for Proposed Uses on Corn, 

Cotton, Tobacco, Tree Fruit, Tree Nuts, 

Vine Crops and Vegetable Crops,’’ dated 

April 3, 2008, by going to http:// 

www.regulations.gov. The referenced 

document is available in the docket 

established by this action, which is 

described under ADDRESSES. Locate and 

click on the hyperlink for docket ID 

number EPA–HQ–OPP–2007–0099. 

Double-click on the document to view 

the referenced information on pages 65– 

70 of 105. 

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 flubendiamide used for 

human risk assessment is shown in the 

following Table 1. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUBENDIAMIDE 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, 13–49 

years of age).

Acute Dietary (General Population, including infants and 

children). 

NOAEL = 99.5 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

aRfD = 0.995 mg/kg/ 

day.

aPAD = 0.995 mg/ 

kg/day 

2-generation reproduction, 1-generation reproduction, and DNT 

studies as three co-critical studies (using 1,200 ppm [99.5 

mg/kg/day] from the DNT as the highest NOAEL for eye effects and a LOAEL from the 1-generation reproduction study 

of 127 mg/kg/day), based on buphthalmia (enlargement of 

eyes), ocular opacity, retinal degeneration, hemorrhage, cataract, and atrophy of the optic nerve. 


emcdonald on DSK67QTVN1PROD with 
73942 Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUBENDIAMIDE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Chronic Dietary (General Population, including infants and 

children).

NOAEL = 2.4 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

cRfD = 0.024 mg/kg/ 

day.

cPAD = 0.024 mg/ 

kg/day 

2-year rat cancer study, 1-year chronic dog study, and 1-year 

chronic rat study as three co-critical studies, using the chronic rat study NOAEL of 50 ppm (2.4 mg/kg/day) with LOAEL 

from the 2-year cancer rat study of 33.9 mg/kg/day, based 

on liver toxicity, fatty change, hypertrophy, ↑ liver weight and 

↑ Gamma Glutamyl Transferase (GGT). 

Cancer (oral, dermal, and inhalation).Classification: Not likely to be carcinogenic to humans based on negative genotoxicity and carcinogenicity in 

long-term cancer studies in rats and mice. 

FQPA SF = Food Quality Protection Act Safety Factor. milligrams/kilograms/day = mg/kg/day. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). Reference dose. Population adjusted 

dose. (a = acute; c = chronic). DNT = developmental neurotoxicity test. 

A summary of the toxicological 

endpoints for flubendiamide used for 

human risk assessment can be found in 

the document entitled, ‘‘Flubendiamide: 

Human Health Risk Assessment for 

Proposed Uses on Corn, Cotton, 

Tobacco, Tree Fruit, Tree Nuts, Vine 

Crops and Vegetable crops,’’ dated April 

3, 2008, by going to http:// 

www.regulations.gov. The referenced 

document is available in the docket 

established by this action, which is 

described under ADDRESSES. Locate and 

click on the hyperlink for docket ID 

number EPA–HQ–OPP–2007–0099. 

Double-click on the document to view 

the referenced information on pages 37– 

38 of 105. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to flubendiamide, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing flubendiamide tolerances in 40 

CFR 180.639. Acute and chronic 

aggregate dietary (food and drinking 

water) exposure and risk assessments 

were conducted using the Dietary 

Exposure Evaluation Model, Version 

3.16—Food Commodity Intake Database 

(DEEMFCIDTM) which uses food 

consumption information from the U.S. 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat In 

America (NHANES/WWEIA). This 

dietary survey was conducted from 2003 

to 2008. The analyses were performed to 

support Section 3 requests for increases 

in the tolerances for pome fruit and wet 

apple pomace 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 flubendiamide. In estimating acute 

dietary exposure, EPA used 

DEEMFCIDTM along with food 

consumption information from the 

USDA’s 2003–2008 NHANES/WWEIA 

survey. As to residue levels in food, for 

the acute assessment, the modeled 

exposure estimates are based on 

tolerance level residues, assuming 100% 

of crops were treated. In addition, 

experimental processing (where 

available) factors were assumed for both 

registered and requested crop uses. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA’s 2003–2008 NHANES/ 

WWEIA survey. EPA assumed a subset 

of the currently registered crops 

contains residues at the average residue 

levels found in the crop field trials. For 

the newly proposed crops, livestock 

commodities, and the remaining 

currently registered crops, EPA assumed 

tolerance level residues. In addition, 

experimental processing factors were 

used where available. Finally, EPA 

assumed 100% of crops were treated. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that flubendiamide should be 

classified as ‘‘Not Likely To Be 

Carcinogenic to Humans.’’ As a result, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary for flubendiamide, and was 

not conducted. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require, 

pursuant to FFDCA section 408(f)(1), 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

2. Dietary exposure from drinking 

water. The Agency used Tier II 

screening level water exposure models 

in the dietary exposure analysis and risk 

assessment for flubendiamide in 

drinking water. These simulation 

models take into account data on the 

physical, chemical and fate/transport 

characteristics of flubendiamide. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefedl/models/ 

water/index.htm. 

Flubendiamide is persistent and 

potentially mobile in terrestrial and 

aquatic environments. These fate 

properties suggest that it has a potential 

to move into surface water and ground 

water. Potential residues in drinking 

water were included in the acute and 

chronic dietary analyses based on 

surface water results from the Tier II, 

Pesticide Root Zone Modeling/Exposure 

Analysis Modeling System(PRZM/ 

EXAMS) Index Reservoir model as these 

values were higher than the 

groundwater estimates from the 

Screening Concentration in Ground 

Water (SCI–GROW) model. Estimated 

acute and chronic drinking water values 

were 24.57 parts per billion (ppb) and 

11.46 ppb, respectively. 

A summary of the dietary exposure 

from drinking water for flubendiamide 

used for human risk assessment can be 

found in the documents entitled, 

‘‘Flubendiamide: Acute and Chronic 

Aggregate Dietary (Food and Drinking 


emcdonald on DSK67QTVN1PROD with 
Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations 73943 

Water) Exposure Assessment for the 

Increased Tolerance on Pome Fruit,’’ 

dated September 11, 2012, by going to 

http://www.regulations.gov. The 

referenced document is available in the 

docket established by this action, which 

is described under ADDRESSES. Locate 

and click on the hyperlink for docket ID 

number EPA–HQ–OPP–2007–0099. 

Double-click on the document to view 

the referenced information on pages 2– 

4 of 29. 

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). 

Flubendiamide 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 flubendiamide to 

share a common mechanism of toxicity 

with any other substances, and 

flubendiamide does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that flubendiamide 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. 

While both the rat and rabbit 

developmental studies did not identify 

teratogenic effects and showed no 

evidence of increased prenatal 

susceptibility, adverse eye effects (eye 

enlargement) were noted in postnatal rat 

pups older than 14 days in multiple 

studies (the 2-generation reproduction 

and 1-generation supplemental studies). 

Additionally, the DNT study reported 

eye effects appearing in some offspring 

between lactation days 14 and 42, even 

though exposure stopped at lactation 

day 21, indicating a possible delay (a 

latent response) from the time of last 

exposure to onset of bupthalmos. These 

eye effects did not occur in adult rats. 

Since the iris and chamber angle are 

differentiating and specializing into 

definite structures during postnatal days 

5 to 20, neonatal rats appear to have an 

increased susceptibility to 

flubendiamide exposure as compared to 

adults. 

In addition to the reported eye effects 

in the DNT study, there was also a 

balanopreputial separation (separation 

of the prepuce (foreskin) from the glans 

penis (balanus)) delay. While this effect 

is generally considered adverse per se, 

it is not assumed to be a developmental 

effect from in utero exposure. Here, 

delayed balano-preputial separation is 

considered secondary to reduced 

postnatal pup body weight as a result of 

postnatal exposure. Furthermore, it was 

resolved within the appropriate age 

range of puberty and no effects on 

reproductive function were observed in 

the multigeneration study in rats. 

Delayed balanopreputial separation was 

seen only at doses causing maternal 

toxicity and is not more severe than the 

maternal effects of hepatotoxicity seen 

at the common pup/maternal LOAEL of 

the DNT study. Accordingly, the 

delayed balanopreputial separation seen 

in the DNT study does not cause 

concern for increased sensitivity to the 

young for flubendiamide. 

Human microsomes have been shown 

to be capable of approximately 4 times 

higher hydroxylation rates of 

flubendiamide as compared to female 

mouse microsomes and may be able to 

efficiently metabolize and excrete 

flubendiamide, preventing 

accumulation of the parent compound. 

It remains unclear whether the ability to 

metabolize and clear the parent 

compound is the only requirement to 

avoid ocular toxicity. Due to the 

potential ocular toxicity, this perinatal 

ocular effect is considered in the human 

health risk assessment for 

flubendiamide. 

3. Conclusion. EPA evaluated the 

quality of the toxicity and exposure data 

and, based on these data, has 

determined that the safety of infants and 

children would be adequately protected 

if the FQPA SF were reduced to lX. That 

decision is based on the following 

findings: 

i. The toxicology database for 

flubendiamide is complete with the 

exception of a subchronic neurotoxicity 

study which is now a new data 

requirement under 40 CFR part 158; 

however, the existing data are sufficient 

for endpoint selection for exposure/risk 

assessment scenarios, and for evaluation 

of the requirements under the FQPA. 

Flubendiamide is not a neurotoxic 

chemical based on neurotoxicity 

assessments conducted in the acute and 

developmental neurotoxicity studies 

and as part of the chronic rat study. 

Additionally, in several short-term 

studies in rats (subacute and subchronic 

feeding, plaque-forming cell assay, onegeneration pilot, developmental 

toxicity) no neurobehavioral signs were 

observed at doses up to and exceeding 

the limit dose; therefore, an additional 

database uncertainty factor is not 

needed to account for potential 

neurotoxicity. 

ii. Although susceptibility was 

identified in the toxicological database 

(eye effects), the selected regulatory 

PODs (which are based on clear 

NOAELs) are protective of these effects; 

therefore, the human health risk 

assessment is protective. 

iii. There are no residual uncertainties 

identified in the exposure databases and 

the exposure assessment is protective. 

The acute dietary food exposure 

assessment utilizes tolerance-level 

residues, the chronic dietary food 

exposure assessment utilizes, in part, 

average residue levels found in the crop 

field trials/livestock commodities and, 

in part, tolerance-level residues. Both 

assessments assume that 100% of crops 

with requested or existing uses of 

flubendiamide are treated. The drinking 

water assessment generated estimated 

drinking water concentrations (EDWCs) 

using models and associated modeling 

parameters which are designed to 

provide conservative, health protective, 

high-end estimates of water 

concentrations. The highest relevant 

EDWCs were used in the dietary (food 

and drinking water) exposure 

assessment. By using these screeninglevel exposure assessments in the acute 

and chronic dietary (food and drinking 

water) assessments, risk is not 

underestimated for flubendiamide. 


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73944 Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations 

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 population 

adjusted dose (aPAD) and chronic 

population adjusted dose (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. 

For this action, there is potential 

exposure to flubendiamide from food 

and drinking water, but not from 

residential use sites (as there are no 

proposed or existing residential uses for 

flubendiamide). Since hazard was 

identified via the oral route over both 

the acute and chronic duration, the 

aggregate risk assessments considers 

exposures from food and drinking water 

consumed over the acute and chronic 

durations. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, EPA has concluded that 

acute dietary exposure from food and 

water to flubendiamide will utilize 

3.1% of the aPAD for the general U.S. 

population and 5% of the aPAD for the 

most highly exposed population 

subgroup, children aged 1 to 2 years old. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic dietary exposure to 

flubendiamide from food and water will 

utilize 20% of the cPAD for the general 

U.S. population and 58% of the cPAD 

for the most highly exposed population 

subgroup, children aged 1 to 2 years old. 

There are no proposed or existing 

residential uses for flubendiamide. 

Based on the explanation in Unit 

III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of flubendiamide is not 

expected. 

3. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of cancer in cancer bioassays 

in mice and rat, flubendiamide is not 

expected to pose a cancer risk. 

4. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general U.S. 

population or to infants and children 

from aggregate exposure to 

flubendiamide residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Liquid Chromatography with tandem 

Mass Spectrometry detection ((LC/MS/ 

MS), Methods 00816/M002 and 00912) 

is available to enforce the tolerance 

expression. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Road, Fort 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

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. 

There are currently no established 

Codex, Canadian or Mexican MRLs for 

residues of flubendiamide in/on apple, 

wet pomace or fruit, pome, group 11 

commodities. 

C. Revisions to Petitioned-for Tolerances 

The Agency’s ‘‘Guidance for Setting 

Pesticide Tolerances Based on Field 

Trial Data,’’ was utilized for 

determining appropriate tolerance levels 

for many raw agricultural commodities 

(RACs) which showed quantifiable 

residues in or on samples that were 

treated according to the proposed use 

patterns. The following revisions to 

tolerance levels were made: 

The recommended tolerance levels 

are the same values as in the petition. 

The Organization of Economic 

Coordination and Development (OECD) 

calculation procedure was utilized to 

derive the tolerance estimate for pome 

fruit based on all apple field trial data 

and all pear field trial data (D386262, S. 

Funk, 04/01/2011). The new apple 

pomace tolerance is derived from the 

highest average apple field trial result 

(1.21 ppm) and the processing factor for 

conversion of apples to apple pomace 

(3.6X) from a previously reviewed 

study. The proposed increases in 

tolerances for pome fruit and wet apple 

pomace have no effect on the dietary 

burdens of livestock. Therefore, the 

established tolerances for meat, milk, 

poultry, and eggs are adequate. 

V. Conclusion 

Therefore, the established tolerances 

for residues of flubendiamide, N2-[1,1- 

dimethyl-2-(methylsulfonyl)ethyl]-3- 

iodo-N1-[2-methyl-4-[1,2,2,2-tetrafluoro1-(trifluoromethyl)ethyl]phenyl]-1,2- 

benzenedicarboxamidein or on apple, 

wet pomace is being increased to 5.0 

ppm. The established tolerance for fruit, 

pome, group 11 is being increased to 1.5 

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 


emcdonald on DSK67QTVN1PROD with 
Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations 73945 

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: December 6, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.639 is amended as 

follows: 

■ a. In paragraph (a)(1) revise the 

introductory text and the entries for 

‘‘apple, wet pomace,’’ and ‘‘fruit, pome, 

group 11.’’ 

■ b. Revise the introductory text to 

paragraph (d). 

The revised text reads as follows: 

§ 180.639 Flubendiamide; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of 

flubendiamide, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only 

flubendiamide N2-[1, 1-dimethyl-2- 

(methylsulfonyl)ethyl]-3-iodo-N1-[2- 

methyl-4- [1,2,2,2-tetrafluoro-1- 

(trifluoromethyl)ethyl]phenyl]-1,2- 

benzenedicarboxamide, in or on the 

following commodities: 

Commodity Parts per 

million 

* * * * * 

Apple, wet pomace ................... 5.0 

* * * * * 

Fruit, pome, group 11 ............... 1.5 

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for residues 

of flubendiamide, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only 

flubendiamide N2-[1, 1-dimethyl-2- 

(methylsulfonyl)ethyl]-3-iodo-N1-[2- 

methyl-4- [1,2,2,2-tetrafluoro-1- 

(trifluoromethyl)ethyl]phenyl]-1, 2- 

benzenedicarboxamide, in or on the 

following commodities: 

* * * * * 

[FR Doc. 2012–29979 Filed 12–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0541; FRL–9360–3] 

Fenpyroximate; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of the insecticide 

fenpyroximate in or on multiple 

commodities identified and discussed 

later in this document. In addition, this 

regulation removes established 

tolerances for certain commodities/ 

groups 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 

December 12, 2012. Objections and 

requests for hearings must be received 

on or before February 11, 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–2011–0541, is 

available either electronically through 

http://www.regulations.gov or in hard 

copy at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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. 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). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 


emcdonald on DSK67QTVN1PROD with