Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations 33159 

methylethyl)-5-phenyl-4H-1,3,5- 

thiadiazin-4-one, in the commodity. 

Commodity Parts per million 

*****

Brassica, head and stem, subgroup 5A .............................................................................................................................. 12.0 

*****

Coffee, green bean .............................................................................................................................................................. 0.35 

*****

Pomegranate ....................................................................................................................................................................... 1.9 

*****

* * * * * 

[FR Doc. E9–16367 Filed 7–9–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0271; FRL–8424–9] 

Indoxacarb; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

indoxacarb and its metabolites and 

degradates, to be determined by 

measuring only indoxacarb and its Renantiomer, in or on beet, garden, roots; 

beet, garden, tops; and bushberry 

subgroup 13–07B. Interregional 

Research Project Number 4 (IR–4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective July 

10, 2009. Objections and requests for 

hearings must be received on or before 

September 8, 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–2008–0271. 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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@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. 

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gpo/opptsfrs/home/ 

guidelin.htm. 

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–2008–0271 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 September 8, 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–2008–0271, 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. 


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• 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 May 16, 

2008 (73 FR 28461) (FRL–8361–6), 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 8E7324) by 

Interregional Research Project Number 4 

(IR–4), 500 College Road East, Suite 201 

W, Princeton, NJ 08540. The petition 

requested that 40 CFR 180.564 be 

amended by establishing tolerances for 

combined residues of the insecticide 

indoxacarb, (S)-methyl 7-chloro-2,5- 

dihydro-2-[[(methoxycarbonyl)[4- 

(trifluoromethoxy)phenyl]

amino]carbonyl]indeno[1,2-e]

[1,3,4][oxadiazine-4a(3H)-carboxylate, 

and its R-enantiomer, (R)-methyl 7- 

chloro-2,5-dihydro-2-

[[(methoxycarbonyl)[4- 

(trifluoromethoxy)

phenyl]amino]carbonyl]indeno[1,2- 

e][1,3,4][oxadiazine-4a(3H)-carboxylate, 

in or on beet, garden, roots at 0.30 parts 

per million (ppm); beet, garden, tops at 

6.0 ppm; and bushberry subgroup 13– 

07B at 1.5 ppm. That notice referenced 

a summary of the petition prepared on 

behalf of IR–4 by E.I. du Pont de 

Nemours and Company, the registrant, 

which is available to the public 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 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 combined residues of 

indoxacarb and its metabolites and 

degradates, to be determined by 

measuring only indoxacarb and its Renantiomer, on beet, garden, roots at 

0.30 ppm; beet, garden, tops at 6.0 ppm; 

and bushberry subgroup 13–07B at 1.5 

ppm. EPA’s assessment of exposures 

and risks associated with establishing 

these 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. 

Indoxacarb is the S-enantiomer of an 

isomeric compound containing two 

enantiomers, the S-enantiomer (DPX– 

KN128, the insecticidally active 

component) and its R-enantiomer (DPX– 

KN127, the insecticidally inactive 

component). DPX–MP062 is an 

enantiomeric mixture containing the Senantiomer and its R-enantiomer at 

approximately a 75:25 ratio. DPX– 

JW062 is the racemic mixture of the 

enantiomers at a 50:50 ratio. 

DPX–KN128, DPX–MP062 and DPX– 

JW062 appear to be of similar toxicity 

acutely. DPX–KN128 and DPX–MP062 

were moderately acutely toxic by the 

oral route while DPX–JW062 was 

practically non-toxic due to its poor 

solubility in the corn oil vehicle. 

However, it was equally toxic orally, 

when tested using a solvent where it 

had a higher solubility, such as 

polyethylene glycol (PEG). By the 

dermal route, they had low toxicity. 

DPX–MP062 and DPX–JW062 had low 

acute inhalation toxicity. DPX–MP062 

and DPX–JW062 had moderate to low 

ocular irritant properties, while DPX– 

KN128 was practically non-irritating to 

the rabbit’s eyes. By the maximization 

test, DPX–KN128 and DPX–MP062 were 

considered dermal sensitizers, while 

DPX–JW062 was not a sensitizer. 

There was possible evidence of lung 

damage in the acute inhalation studies 

with both DPX–MP062 and DPX– 

JW062. ‘‘Lung noise,’’ observed with 

JW062, may indicate the development of 

acute lung injury and high permeability 

pulmonary edema. This was not 

unexpected since an oxidant was 

generated during indoxacarb 

metabolism. ‘‘Hunched over back and 

gasping’’ were also present and 

suggested arterial hypoxemia that 

accompanies alveolar flooding. The 

acute inhalation study report with 

indoxacarb 70% manufacturing use 

product noted that a ‘‘red nasal 

discharge’’ was detected for 2 days after 

exposure. This may be indicative of a 

lung exudate, a sign of lung injury. 

Subchronic (28 days) inhalation toxicity 

of indoxacarb in rats was characterized 

by increased spleen weights, increased 

pigmentation and hematopoiesis in the 

spleen, and hematological changes. 

The toxicity profiles for DPX–KN128, 

DPX–MP062, and DPX–JW062 in rats, 

mice, and dogs with both subchronic 

and chronic oral exposures were 

similar. Dermal subchronic exposure in 

the rat also resulted in a similar profile. 

The toxic signs occurred at similar 

doses and with a similar magnitude of 

response, with females generally being 

more sensitive than males. The 

endpoints that most frequently defined 

the lowest-observed-adverse-effect-level 

(LOAEL) were non-specific, and 

included decreased body weight, weight 

gain, food consumption, and food 

efficiency. These compounds also 

affected the hematopoietic system by 

decreasing the red blood cell count, 

hemoglobin, and hematocrit in rats, 

dogs and mice. It was frequently 

accompanied by an increase in 

reticulocytes in all three species and an 

increase in Heinz bodies (dogs and mice 

only). None of these signs of toxicity 

appeared to get worse over time. In one 

subchronic rat study, the parameters 

appeared to return to normal levels 

following a four-week recovery period. 

High doses in the rats and mice also 

sometimes caused mortality. 

There was no evidence of increased 

susceptibility of fetuses or offspring 

from either in utero or neonatal 

exposure to DPX–MP062 or DPX– 

JW062. There was no evidence of 

increased susceptibility from in utero 

exposure of rats to DPX–KN128. There 

was no evidence of increased 

susceptibility in the developmental 

neurotoxicity study in rats with DPX– 

KN128. No evidence of teratogenicity 

was observed in rats and rabbits with 


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DPX–MP062 or DPX–JW062. No 

evidence of teratogenicity was observed 

in rats with DPX–KN128. There was no 

evidence of reproductive effects in the 

2-generation reproduction study in rats. 

Neurotoxicity was observed in both 

rats and mice; however, it did not occur 

in the absence of other signs of toxicity. 

Neurotoxicity was characterized by one 

or more of the following symptoms in 

both male and female rats and mice: 

Weakness, head tilting, and abnormal 

gait or mobility with inability to stand 

and ataxia. Acute and subchronic 

neurotoxicity screening batteries were 

performed using DPX–MP062 in rats. 

Neurotoxicity was characterized by 

clinical signs (depression, abnormal 

gait, head shake, salivation) and 

functional-observation battery (FOB) 

effects (circling behavior, 

incoordination, slow righting reflex, 

decreased forelimb grip strength, 

decreased foot splay, decreased motor 

activity). However, there was no 

evidence of neurohistopathology in any 

study. Learning and memory parameters 

were affected in the pups in the 

developmental neurotoxicity study in 

rats with DPX–KN128. 

There was no evidence of 

carcinogenicity in either the rat or 

mouse in acceptable studies using DPX– 

JW062. DPX–JW062 was not mutagenic 

in a complete battery of mutagenicity 

studies. There was also no evidence of 

mutagenicity with either DPX–KN128, 

or DPX–MP062. 

Both DPX–JW062 and DPX–MP062 

were rapidly absorbed and eliminated 

following oral administration. The 

absorption of DPX–JW062 was dose 

dependent and appeared to be saturated 

at the high dose. Both urine and feces 

represented major routes of excretion 

(35–45% and 33–47%, respectively). 

The distribution pattern did not vary 

with dosing regimen and overall tissue 

burden was limited to only 3.4–12.9% 

of the administered dose. The red blood 

cells of rats dosed with the 

trifluoromethoxyphenyl label 

consistently contained much greater 

levels of radioactivity than did plasma. 

Fat tissue contained the greatest level of 

radioactivity (1.76–8.76% of the 

administered dose) and, for both 

compounds, was greater in female rats. 

The finding also demonstrates a greater 

propensity for accumulation by female 

rats than by male rats. Both DPX–MP062 

and DPX–JW062 were extensively 

metabolized and the metabolites were 

eliminated in the urine, feces, and bile. 

With the exception of parent compound 

(DPX–JW062, which accounted for 

19.2% of a single low dose in the feces 

of female rats), none of the metabolites 

from any source represented more than 

12.3% of the administered dose. The 

metabolite profile for DPX–JW062 was 

dose dependent and varied 

quantitatively between males and 

females. Differences in metabolite 

profiles were also observed for the 

different label positions. All of the 

biliary metabolites appear to undergo 

further biotransformation in the gut. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by indoxacarb as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

Indoxacarb. Health Effects Division 

(HED) Human Health Risk Assessment 

for Bushberry Crop Subgroup 13–07B 

and Beets (Garden), page 13 in docket 

ID number EPA–HQ–OPP–2008–0271. 

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 the NOAEL in 

the toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, 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 indoxacarb used for 

human risk assessment can be found at 

http://www.regulations.gov in the 

document Indoxacarb. Health Effects 

Division (HED) Human Health Risk 

Assessment for Bushberry Crop 

Subgroup 13–07B and Beets (Garden), 

page 18 in docket ID number EPA–HQ– 

OPP–2008–0271. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to indoxacarb, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

indoxacarb tolerances in 40 CFR 

180.564. EPA assessed dietary 

exposures from indoxacarb 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. 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, for most currently registered 

commodities, EPA used anticipated 

residues derived from field trial data 

and maximum percent crop treated 

(PCT) estimates. EPA assumed 

tolerance-level residues and 100 PCT for 

the new commodities associated with 

this petition (garden beets and 

bushberries). Available processing data 

for indoxacarb were used to refine 

anticipated residues for apples/pears 

(juice), potato (dry, chips), cotton (oil), 

tomato (paste and puree), peanut (oil), 

soybean (oil), grapes (raisin and juice), 

prunes (dried), mint (oil), and other 

commodities where translation was 

appropriate. For all other processed 

commodities, DEEM–FCIDTM (ver. 7.81) 

default processing factors were 

assumed. 

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 

relied upon anticipated residues derived 

from field trial data for most of the 

registered and new commodities and an 

anticipated residue value for milk 

derived from monitoring data collected 

by the United States Department of 

Agriculture’s Pesticide Data Program 


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(PDP). Residue estimates were further 

refined using average PCT data and 

available processing data, as described 

in Unit III.C.i. EPA assumed 100 PCT for 

the new commodities, garden beets and 

bushberries. 

iii. Cancer. Based on the results of 

carcinogenicity studies in rats and mice, 

EPA classified indoxacarb as ‘‘not 

likely’’ to be carcinogenic to humans via 

relevant routes of exposure. Therefore, 

an exposure assessment for evaluating 

cancer risk is unnecessary. 

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. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

The Agency used PCT information as 

follows: 

Acute dietary exposure assessment: 

Apple 5%, broccoli 50%, cabbage 25%, 

cauliflower 55%, cherry 2.5%, corn 

(sweet) 2.5%, lettuce (head) 25%, 

lettuce (leaf) 11%, peach 2.5%, peanut 

2.5%, pear 2.5%, pepper 15%, potato 

2.5%, soybean 1%, spinach 5%, and 

tomato 25%. 

Chronic dietary exposure assessment: 

Apple 1%, broccoli 40%, cabbage 15%, 

cauliflower 35%, cherry 1%, lettuce 

(head) 18%, lettuce (leaf) 9%, peach 

1%, peanut 1%, pear 1%, pepper 10%, 

potato 1%, soybean 1%, spinach 5%, 

and tomato 15%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6 years. EPA uses an average PCT 

for chronic dietary risk analysis. The 

average PCT figure for each existing use 

is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which indoxacarb may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for indoxacarb in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of indoxacarb. 

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 Pesticide Root Zone 

Model /Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

indoxacarb for acute exposures are 

estimated to be 25.1 parts per billion 

(ppb) for surface water and 0.21 ppb for 

ground water. The EDWCs of 

indoxacarb for chronic exposures for 

non-cancer assessments are estimated to 

be 5.37 ppb for surface water and 0.21 

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 25.1 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 5.37 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). 

Indoxacarb is currently registered for 

several uses that could result in 

residential, non-dietary exposures. 

Indoxacarb is registered for use as a fire 

ant bait, which may be applied as a 

mound treatment or as a broadcast 

application to lawns, golf courses, and 

other recreational areas. Indoxacarb is 

also registered as a mole cricket bait 

applied as a broadcast treatment to 

lawns, golf courses, parks, recreational 

areas, and athletic fields. Finally, 

indoxacarb is registered as a foliar or 

broadcast spray to control lepidopterous 

larvae on landscape and recreational 

(including golf courses) turfgrass and 

ornamentals. EPA assessed residential 

exposure using the following 

assumptions: 

Based on the residential use patterns, 

commercial and private (i.e., grower/ 

homeowner) pesticide handlers are 

expected to have short-term (1–30 days) 

dermal and inhalation exposures to 

indoxacarb. Commercial handlers may 

also have intermediate-term exposures 

(1–6 months). The short- and 

intermediate-term toxicological points 

of departure are the same; therefore, the 


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risk estimates for intermediate-term 

exposures are the same as those for 

short-term exposures. 

There is also the potential for shortand intermediate-term postapplication 

exposure of adults and children from 

entering areas previously treated with 

indoxacarb. The postapplication 

exposure scenarios assessed include: 

Dermal exposure from treated lawns due 

to high contact lawn activities (adult 

and toddler); Dermal exposure from 

treated turf due to golfing (adults and 

youths); Hand-to-mouth transfer of 

pesticide residues on lawns (toddler); 

Episodic incidental ingestion of 

granules from pesticide-treated 

residential areas (toddler); Incidental 

ingestion of soil from pesticide-treated 

residential areas (toddler); and 

Incidental oral object-to-mouth 

exposure from pesticide-treated 

residential areas (toddler). 

Postapplication inhalation exposures 

are expected to be negligible and, 

therefore, were not assessed. 

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 indoxacarb to 

share a common mechanism of toxicity 

with any other substances, and 

indoxacarb does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that indoxacarb 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. 

There was no quantitative or qualitative 

evidence of increased prenatal or 

postnatal sensitivity in the two 

developmental toxicity studies in rats 

with DPX–JW062, one developmental 

toxicity study in rats with DPX–MP062 

and DPX–KN128, one developmental 

toxicity study in rabbits with DPX– 

JW062, one 2-generation reproduction 

studies in rats with DPX–JW062 and a 

developmental neurotoxicity (DNT) 

study in rats with DPX–KN128. In these 

studies, developmental toxicity was 

observed in the presence of maternal 

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. With the exception of an 

immunotoxicity study, now mandatory 

under the 40 CFR part 158 Data 

Requirements for Pesticides, the 

toxicological database for indoxacarb is 

complete. The available data do not 

indicate that indoxacarb is 

immunotoxic. In the 28–day inhalation 

study in rats, increased spleen weights, 

pigmentation and hematopoiesis in the 

spleen, and hematological changes were 

observed at the highest dose tested (75.6 

mg/kg/day). Increased spleen weights 

were also observed in the 28–day 

dermal rat study at 500 mg/kg/day. The 

increase in spleen weights is not 

considered immunological in origin but 

can be considered a result of the 

hemolytic effects, which is the mode of 

action of indoxacarb. Indoxacarb is 

currently regulated based on a NOAEL 

of 1.5 mg/kg/day for chronic dietary 

exposure (protective of hemolytic 

effects) and 9 mg/kg/day for acute 

dietary exposure. EPA does not believe 

that conducting a special series 

870.7800 immunotoxicity study will 

result in NOAELs lower than those 

currently identified for indoxacarb, and 

an additional uncertainty factor is not 

needed to account for immunotoxicity. 

ii. EPA has determined that an 

additional uncertainty factor is not 

needed to account for neurotoxicity. 

Neurotoxicity was seen in animal 

studies in rats and mice but at higher 

doses than the hematologic effects on 

which EPA’s risk assessments are based. 

To evaluate the potential for increased 

sensitivity of infants and children to 

neurotoxic effects, EPA required a rat 

developmental neurotoxicity (DNT) 

study. The study has been submitted 

and reviewed. There was no evidence of 

increased sensitivity of offspring in the 

submitted study. Clinical observations, 

motor activity, acoustic startle 

habituation, and learning and memory 

testing were all comparable between the 

control and treated groups. Mean brain 

weight, gross and microscopic 

examinations, and morphometric 

measurements of the brain were also 

comparable between the controls and 

treated groups. 

iii. There is no evidence that 

indoxacarb results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2–generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute and chronic dietary food 

exposure assessments utilize anticipated 

residues that are based on reliable field 

trial and monitoring data. They also 

utilize PCT data that have been verified 

by the Agency for most existing uses. 

For the new uses, a conservative 

estimate of 100 PCT is assumed. EPA 

made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to indoxacarb in drinking water. EPA 

used similarly conservative assumptions 

to assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by indoxacarb. 

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. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to indoxacarb will 


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33164 Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations 

occupy 63% of the aPAD for children 3 

to 5 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 indoxacarb 

from food and water will utilize 6.6% of 

the cPAD for children 1 to 2 years old, 

the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

indoxacarb is not expected. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposures take into account short- or 

intermediate-term residential exposure 

plus chronic exposure from food and 

water (considered to be a background 

exposure level). Indoxacarb is currently 

registered for uses that could result in 

short- and intermediate-term residential 

exposures and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short- and intermediateterm residential exposures to 

indoxacarb. 

Using the exposure assumptions 

described in this unit for short- and 

intermediate-term exposures, EPA has 

concluded the combined short-/ 

intermediate-term food, water, and 

residential exposures aggregated result 

in aggregate MOEs of 320 for adults and 

102 for children (toddlers). The 

aggregate MOE for adults includes 

dietary exposures from food and 

drinking water, as well as dermal 

handler and postapplication exposures 

from the residential use of indoxacarb 

on turf for mole cricket control, the 

residential scenario resulting in the 

highest estimated exposures. Similarly, 

the aggregate MOE for toddlers includes 

dietary (food and drinking water) and 

residential exposures. The residential 

exposure estimate for toddlers is also 

based on the worst-case turf scenario 

(mole cricket control) and includes 

dermal and incidental oral 

postapplication exposures. The highest 

estimated incidental oral exposures for 

toddlers are from hand-to-mouth 

activities on treated turf; therefore, the 

oral hand-to-mouth exposures were 

used to calculate the aggregate MOE for 

toddlers. 

5. Aggregate cancer risk for U.S. 

population. EPA has classified 

indoxacarb as ‘‘not likely’’ to be 

carcinogenic to humans via relevant 

routes of exposure. Indoxacarb is not 

expected to pose a cancer risk. 

6. 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 indoxacarb 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high-performance liquid 

chromatography (HPLC)/column 

switching/ultraviolet (UV) method AMR 

2712–93 with confirmation/specificity 

provided by gas chromatography (GC)/ 

mass-selective detector method AMR 

3493–95, Supplement No. 4) is available 

to enforce the tolerance expression. The 

method may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

There are no established or proposed 

Codex, Canadian or Mexican maximum 

residue limits (MRLs) for indoxacarb on 

bushberries or garden beets. 

C. Changes to Proposed Tolerances 

Tolerances for indoxacarb are 

currently expressed in terms of 

‘‘combined residues of indoxacarb, (S)- 

methyl 7-chloro-2,5-dihydro-2- 

[[(methoxycarbonyl)[4- 

(trifluoromethoxy)phenyl]

amino]carbonyl]indeno[1,2- 

e][1,3,4][oxadiazine-4a(3H)-carboxylate, 

and its R-enantiomer, (R)-methyl 7- 

chloro-2,5-dihydro-2- 

[[(methoxycarbonyl)[4- 

(trifluoromethoxy)

phenyl]amino]carbonyl]indeno[1,2- 

e][1,3,4][oxadiazine-4a(3H)- 

carboxylate.’’ EPA is revising the 

tolerance expression for existing 

tolerances and the proposed tolerances 

on garden beets and bushberries to 

clarify the chemical moieties that are 

covered by the tolerances and specify 

how compliance with the tolerances is 

to be measured. The revised tolerance 

expression makes clear that the 

tolerance covers ‘‘residues of 

indoxacarb, including its metabolites 

and degradates,’’ and that compliance 

with the tolerance levels will be 

determined by measuring only 

indoxacarb, (S)-methyl 7-chloro-2,5- 

dihydro-2-[[(methoxycarbonyl)[4- 

(trifluoromethoxy)phenyl]amino]

carbonyl]indeno[1,2-e]

[1,3,4][oxadiazine-4a(3H)-carboxylate, 

and its R-enantiomer, (R)-methyl 7- 

chloro-2,5-dihydro-2- 

[[(methoxycarbonyl)[4- 

(trifluoromethoxy)phenyl]amino]

carbonyl]indeno[1,2-e][1,3,4]

[oxadiazine-4a(3H)-carboxylate. 

EPA has determined that it is 

reasonable to make this change final 

without prior proposal and opportunity 

for comment, because public comment 

is not necessary, in that the change has 

no substantive effect on the tolerance, 

but rather is merely intended to clarify 

the existing tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of indoxacarb, including its 

metabolites and degradates, in or on 

beet, garden, roots at 0.30 ppm; beet, 

garden, tops at 6.0 ppm; and bushberry 

subgroup 13–07B at 1.5 ppm. 

Compliance with these tolerance levels 

is to be determined by measuring only 

indoxacarb, (S)-methyl 7-chloro-2,5- 

dihydro-2-[[(methoxycarbonyl)[4- 

(trifluoromethoxy)phenyl]]

amino]carbonyl]indeno[1,2-e][1,3,4]

[oxadiazine-4a(3H)-carboxylate, and its 

R-enantiomer, (R)-methyl 7-chloro-2,5- 

dihydro-2-[[(methoxycarbonyl)[4- 

(trifluoromethoxy)phenyl]amino]

carbonyl]indeno[1,2-e]

[1,3,4][oxadiazine-4a(3H)-carboxylate. 

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 


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Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations 33165 

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: July 1, 2009. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.564 is amended in 

paragraph (a) by revising the 

introductory text and by alphabetically 

adding the following commodities to the 

table to read as follows: 

§180.564 Indoxacarb; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of indoxacarb, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

indoxacarb, (S)-methyl 7-chloro-2,5- 

dihydro-2-[[(methoxycarbonyl)[4- 

(trifluoromethoxy)phenyl]

amino]carbonyl]indeno[1,2-e][1,3,4]

[oxadiazine-4a(3H)-carboxylate, and its 

R-enantiomer, (R)-methyl 7-chloro-2,5- 

dihydro-2-[[(methoxycarbonyl)[4- 

(trifluoromethoxy)phenyl]amino]

carbonyl]indeno[1,2- 

e][1,3,4][oxadiazine-4a(3H)-carboxylate. 

Commodity Parts per million 

* * * * * 

Beet, garden, roots .............................................................................................................................................................. 0.30 

Beet, garden, tops ............................................................................................................................................................... 6.0 

Bushberry subgroup 13–07B ............................................................................................................................................... 1.5 

* * * * * 

* * * * * 

[FR Doc. E9–16368 Filed 7–9–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0461; FRL–8422–5] 

Mandipropamid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of 

mandipropamid in or on hops, dried 

cones. Syngenta Crop Protection, Inc. 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective July 

10, 2009. Objections and requests for 

hearings must be received on or before 

September 8, 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–2007–0461. 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: Rose 

Mary Kearns, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5611; e-mail address: 

kearns.rosemary@epa.gov. 


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