Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations 78731 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VIII. 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 20, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.940, alphabetically add the 

following inert ingredient to the table in 

paragraph (a) to read as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide chemical CAS reg. no. Limits 

*******

Copper sulfate pentahydrate ........................................ 7758–99–8 When ready for use, the end-use concentration is not to exceed 80 

ppm 

*******

* * * * * 

[FR Doc. 2013–31101 Filed 12–26–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0420; FRL–9903–92] 

Indoxacarb; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of indoxacarb in 

or on multiple commodities and 

removes previously established 

commodities that will be superseded by 

tolerances established in this action, 

which are identified and discussed later 

in this document. 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 27, 2013. Objections and 

requests for hearings must be received 

on or before February 25, 2014, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0420, 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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 


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78732 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0420 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 25, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0420, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

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

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of July 25, 

2012 (77 FR 43562) (FRL–9353–6), 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 2E8029) by IR–4, 500 

College Rd. East, Suite 201 W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.564 be 

amended by establishing tolerances for 

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 bean, dry, seed at 0.07 parts per 

million (ppm); bean, forage at 37 ppm; 

bean, succulent at 0.64 ppm; berry, low 

growing, except strawberry, subgroup 

13–07H at 0.9 ppm; small fruit, vine 

climbing, except fuzzy kiwifruit, 

subgroup 13–07F at 2.0 ppm. The 

petition additionally requested to 

remove established tolerances of 

indoxacarb in or on grape at 2.0 ppm 

and cranberry at 0.90 ppm, upon 

approval of the updated crop groups or 

subgroups. That document referenced a 

summary of the petition prepared on 

behalf of IR–4 by DuPont Crop 

Protection, the registrant, which is 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

several proposed tolerances, has 

corrected the commodity terminology 

for bean forage to cowpea forage, and 

has determined that a tolerance should 

be established on cowpea hay. The 

reasons for these changes are explained 

in Unit IV.C. 

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 indoxacarb 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with indoxacarb 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 products are frequently 

formulated as a mixture of the 

insecticidally active S-enantiomer 

(DPX–KN128) and the insecticidally 

inactive R-enantiomer (DPX–MP062). 

DPX–MP062 is an formula mixture 

containing the indoxacarb S-enantiomer 

and its R-enantiomer at approximately a 

75:25 ratio. DPX–JW062 is the racemic 

mixture of the enantiomers at a 50:50 

ratio. EPA has determined that it is 

appropriate to use data from DPX– 


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JW062 (50:50) to satisfy the 

requirements for dietary subchronic, 

chronic, oncogenicity and reproductive 

studies and that toxicology data using 

DPX–JW062 and DPX–MP062 may be 

bridged to DPX–KN128 formulations. 

The toxicity profile for KN128, 

MP062, and JW062 in rats, mice, and 

dogs with both subchronic and chronic 

oral exposures were qualitatively 

similar. Dermal subchronic exposure in 

the rat also resulted in a similar profile. 

Signs of toxicity occurred at similar 

doses and with a similar magnitude of 

response (females generally being more 

sensitive than males), and included 

decreases in 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. 

Exposure to indoxacarb was frequently 

accompanied by an increase in 

reticulocytes in all three species and an 

increase in Heinz bodies in dogs and 

mice only. These signs of toxicity did 

not appear to increase in severity over 

time. 

Neurotoxicity was observed in rats 

and mice, and 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 

or ataxia. There was possible evidence 

of lung damage in the acute inhalation 

studies with both MP062 and JW062. 

The immunotoxicity study in mice 

did not indicate toxicity to the immune 

system at the highest dose tested. 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. Increased spleen 

weights were also observed in the 28- 

day dermal rat study. The increase in 

spleen weights are not considered 

immunological in origin but can be 

considered a result of the hemolytic 

effects, which is the mode of action of 

indoxacarb. 

There was no evidence of 

carcinogenicity in either the rat or 

mouse in acceptable studies (JW062). 

JW062 was not mutagenic in a complete 

battery of mutagenicity studies. There 

was also no evidence of mutagenicity 

with either KN128 or MP062. Therefore, 

all formulations (KN128, MP062, and 

JW062) were classified as not likely to 

be carcinogenic in humans by all 

relevant routes of exposure. 

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 lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document: 

‘‘Indoxacarb. Human Health Risk 

Assessment for the Proposed New Use 

on Dry Beans, Succulent Beans, Small 

Fruit Vine Climbing Subgroup (except 

kiwifruit) 13–07F and Low Growing 

Berry Subgroup (except strawberry) 13– 

07H’’ at pp. 50–55 in docket ID number 

EPA–HQ–OPP–2012–0420. 

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 indoxacarb used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR INDOXACARB 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 (General population including infants and 

children and females 13–49 

years old).

NOAEL = 12 mg/kg/ 

day UFA = 10x.

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.12 

mg/kg/day.

aPAD = 0.12 mg/kg/ 

day 

Acute oral rat neurotoxicity study. LOAEL = 50 mg/kg based on 

decreased body weight and body-weight gain in females 

(MP062).* 

Chronic dietary (All populations) NOAEL= 2.0 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.02 

mg/kg/day.

cPAD = 0.02 mg/kg/ 

day 

Weight of evidence approach was used from four studies: 

1. Subchronic toxicity study—rat (MP062). 

2. Subchronic neurotoxicity study—rat (MP062). 

3. Chronic/carcinogenicity study—rat (JW062). 

4. 2-generation rat reproduction study (JW062). 

LOAEL = 3.3 mg/kg/day based on decreased body weight, 

body-weight gain, food consumption, and food efficiency; decreased hematocrit, hemoglobin, and red blood cells only at 

6 months. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR INDOXACARB 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 

Incidental oral short-term (1 to 

30 days), intermediate-term 

(1 to 6 months), and longterm (> 6 months).

NOAEL= 2.0 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Weight of evidence approach was used from four studies: 

1. Subchronic toxicity study—rat (MP062). 

2. Subchronic neurotoxicity study—rat (MP062). 

3. Chronic/carcinogenicity study—rat (JW062). 

4. Two generation rat reproduction study (JW062). 

LOAEL = 3.3 mg/kg/day based on decreased body weight, 

body-weight gain, food consumption, and food efficiency; decreased hematocrit, hemoglobin and red blood cells only at 6 

months. 

Inhalation short-term (1 to 30 

days).

Inhalation study 

NOAEL= 6 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 28-day rat inhalation toxicity study (MP062). The LOAEL of 

75.69 mg/kg/day is based on increased spleen weights, pigmentation, and hematopoiesis in the spleen, hematological 

changes and mortality (females). 

Cancer (Oral, dermal, inhalation).‘‘Not likely’’ to be carcinogenic to humans since no evidence of carcinogenicity in either the rat or mouse studies, and no evidence of mutagenicity. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFH = potential variation in sensitivity among members of the human population 

(intraspecies). 

* The LOAEL of 50 mg/kg was based on a 7% body weight decrease in females only on day 8. No significant differences were noted for days 

1, 2, or 15. Currently, a 10% decrease in adult body weight is the threshold for an adverse effect, thus this study NOAEL is considered to be 

conservative. 

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. Such effects were identified 

for indoxacarb. In estimating acute 

dietary exposure, EPA utilized Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

Database (DEEM-FCID) Version 3.16, 

which uses food consumption data from 

the U.S. Department of Agriculture’s 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA) from 2003 

to 2008. Anticipated residues (ARs) for 

most registered and proposed food 

commodities were based on field trial 

data, and in some crops tolerance-level 

residues were used. Residue estimates 

for some current uses were further 

refined using percent crop treated (PCT) 

data, and 100 PCT estimates were 

assumed for the remaining uses. 

Available processing data for 

indoxacarb were used to refine ARs for 

apples/pears (juice), cotton (oil), grapes 

(raisin and juice), peanut (oil), potato 

(dry, chips), prunes (dried), mint (oil), 

soybean (oil), and tomato (paste and 

puree), and other commodities where 

translation was applicable. DEEMFCIDTM (ver. 7.81) default processing 

factors were assumed for all other 

processed commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the same 

assumptions as described in Unit 

III.C.1.i. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that indoxacarb does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. 

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 estimated the PCT for 

existing uses as follows for the acute 

dietary assessment: Apples, 10%; 

broccoli, 70%; cabbage, 35%; 

cauliflower, 60%; cherries, 2.5%; 


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lettuce, 40%; peaches, 2.5%; peanuts, 

10%; pears, 2.5%; potatoes, 2.5%; 

soybeans, 2.5%; spinach, 5%; sweet 

corn, 10%; and tomatoes, 40%. 

The Agency estimated the PCT for 

existing uses as follows for the chronic 

dietary risk assessment: Apples, 5%; 

broccoli, 50%; cabbage, 25%; 

cauliflower, 40%; celery, 5%; cherries, 

1%; grapes, 1%; lettuce, 10%; peaches, 

2.5%; peanuts, 2.5%; pears, 1%; 

potatoes, 1%; soybeans, 1%; spinach, 

2.5%; sweet corn, 2.5%; and tomatoes, 

20%. 

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 6–7 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. In cases where the 

average PCT is less than 2.5, 2.5% is 

used as the average PCT. Similarly, in 

cases where the maximum PCT is less 

than 2.5, 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. A Total Toxic Residue (TTR) 

approach was used for the parent 

indoxacarb and the degradation 

products with toxicological concern 

(IN–JT333, IN–KG4333, IN–KT413, IN– 

ML437–0H) for the drinking water 

assessment. Therefore, the Agency used 

screening level water exposure models 

in the dietary exposure analysis and risk 

assessment for indoxacarb and its 

metabolites 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 Provisional Cranberry 

Model and Screening Concentration in 

Ground Water (SCI–GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of indoxacarb and its 

metabolites for surface water are 

expected to be 59.26 parts per billion 

(ppb) for acute exposures and 18.48 for 

chronic exposures. For ground water, 

the EDWC is estimated to be 0.33 ppb 

for acute and chronic exposures. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. The 

water concentration values of 59.26 ppb 

and 18.48 ppb were used to assess the 

contribution to drinking water for the 

acute and chronic dietary risk 

assessments, respectively. 

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 exposures: 

• Ready-to-use (RTU) bait stations. 

• Spot-on applications of gels (crack 

and crevices and indoor spot directed 

treatments) for household insect control 

(indoor treatments). 

• Spot-on treatments for the control 

of fleas and ticks on dogs and cats. 

• Broadcast, perimeter and ant 

mound treatment on ornamentals, trees, 

and lawns/turf, utilizing granular and 

liquid formulations (outdoor 

treatments). 

• Indoor spray applications with 

granular and liquid formulations for 

insect control on households/domestic 

dwellings (crack and crevice and spot 

directed treatments). 

Adult handlers were assessed for 

potential short-term inhalation toxicity 

from mixing/loading/applying the 

following: 

• Granular formulation for insect 

control on lawns/turf. 

• Liquid flowable formulation for 

insect control on lawns/turf. 

• Water-soluble packaging 

formulation for indoor spray 

applications with manually pressurized 

hand wand (crack and crevice and spot 

directed treatments) for insect control in 

households/domestic dwellings. 

• Liquid flowable formulation for 

indoor spray applications with 

manually pressurized hand wand (crack 

and crevice and spot directed 

treatments) for insect control on 

households/domestic dwellings. 

Residential handler exposure is 

expected to be short-term in duration 

only, as intermediate-term exposures are 

not likely because of the intermittent 

nature of applications by homeowners. 

Potential postapplication exposures to 

indoxacarb were considered for adults 

and children (1–<2 years old), based on 

the following scenarios: 

• Treated pets (dogs and cats) to 

children from short-, intermediate-, and 

long-term incidental oral exposures. 

• Physical activities on turf to 

children from short-term incidental oral 

exposures. 

• Crack and crevice and indoor spotdirected spray applications, including 

short-term inhalation exposures to 

adults and both short-term inhalation 

and short-term incidental oral exposures 

to children. 

Since there is no expectation of nondietary oral exposures to adults from 

contact with treated pets, that aggregate 

risk is not quantified. 

Since inhalation and incidental oral 

exposure routes share a common 

toxicological endpoint (i.e., 

hematological changes), risk estimates 

have been combined for those routes. 

Therefore, the postapplication exposure 

scenarios that were combined for 

children 1 < 2 years old are the 

inhalation and hand-to-mouth (the 

highest incidental oral exposure 

assessment) for the indoor surfaces 

directed spray applications. This 

combination is considered protective of 

children’s exposure to indoxacarb from 

residential uses. 

Because of the preventative nature of 

pet products and the potential for 

extended use in more temperate parts of 

the country, the residential 


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postapplication exposures to treated 

pets may be short-, intermediate-, or 

long-term in duration. Postapplication 

incidental oral exposures from treated 

golf courses were not quantified since 

youth old enough to play golf are not 

expected to exhibit significant hand-tomouth behavior. Furthermore, the 

residential lawn assessment provides 

the highest estimate of potential 

exposure from turf applications and is 

protective of any exposures to children 

from indoxacarb turf treatment 

scenarios. Finally, the residential 

handler and postapplication 

assessments consider inhalation and/or 

oral exposures only, since a dermal 

toxicity endpoint has not been 

identified for indoxacarb. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

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, an 

oxadiazine class insecticide, 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 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 

Food Quality Protection Act Safety 

Factor (FQPA 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 

the developmental neurotoxicity (DNT) 

study in rats with DPX–KN128. In these 

studies, developmental toxicity was 

observed only 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. The toxicity database for indoxacarb 

is complete. 

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. 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 utilized 

anticipated residues that are based on 

reliable field trial, as well as PCT data. 

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 dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to indoxacarb will 

occupy 49% of the aPAD for all infants 

less than 1 year 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 12% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Long-term (chronic) aggregate 

risk for indoxacarb also includes the 

contribution from dietary (food and 

drinking water) exposure plus the longterm postapplication exposure to treated 

pets. EPA has concluded the combined 

long-term food, water, and residential 

exposures result in an aggregate MOE of 

420 for children 1-<2 years old. Because 

EPA’s level of concern for indoxacarb is 

a MOE of 100 or below, this MOE is not 

of concern. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Indoxacarb is currently 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

indoxacarb. 

Using the exposure assumptions 

described in this unit for short-term 


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Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations 78737 

exposures, EPA has concluded the 

aggregate short-term exposure (food, 

water, and residential exposures) result 

in the lowest aggregate MOEs of 110 for 

children 1-<2 years old (resulting from 

the postapplication crack and crevice 

and spot directed treatment indoor 

spray) and 1,600 for adults (resulting 

from the handler turf use). Because 

EPA’s level of concern for indoxacarb is 

a MOE of 100 or below, these MOEs are 

not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Indoxacarb is currently registered for 

uses that could result in intermediateterm residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to indoxacarb. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures (from 

pet treatments) result in an aggregate 

MOE of 420 for children 1-<2 years old 

Because EPA’s level of concern for 

indoxacarb is a MOE of 100 or below, 

this MOE is not of concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

indoxacarb is not expected to pose a 

cancer risk to humans. 

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 

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. 

The Codex has established MRLs for 

indoxacarb in or on cranberries at 1 

ppm, dry chickpea at 0.2 ppm, dry 

cowpea at 0.1 ppm, dry mung bean at 

0.2 ppm, and grapes at 2 ppm, based on 

measurement of indoxacarb and its Renantiomer. U.S. tolerances for 

subgroup 13–07F (represented by grape) 

at 2 ppm and subgroup 13–07H 

(represented by cranberry) at 1 ppm are 

harmonized with the corresponding 

Codex MRLs. Additionally, the U.S. 

tolerance level for dry bean is being 

established at 0.2 ppm, in order to 

harmonize with the Codex MRLs for dry 

chickpea and dry mung bean. The 

Codex has not established MRLs for the 

other commodities associated with this 

action. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the data submitted with the 

petition, EPA revised the proposed 

tolerances for several commodities, as 

follows: Succulent bean from 0.64 ppm 

to 0.9 ppm; and low growing berry, 

except strawberry, subgroup 13–07H 

from 0.9 ppm to 1 ppm. EPA also 

determined that the proposed tolerance 

in or on bean forage at 37 ppm should 

be revised to 50 ppm, and the Agency 

determined that the commodity should 

be listed as cowpea forage because the 

cowpea forage and hay are the only 

significant feedstuffs associated with 

dry beans. Because of that reason, EPA 

also determined that a tolerance is 

necessary for cowpea hay at 100 ppm. 

Finally, EPA revised the tolerance on 

bean, dry, seed from 0.07 ppm to 0.2 

ppm in order to harmonize with Codex 

MRLs. The Agency revised these 

tolerance levels based on analysis of the 

residue field trial data using the 

Organization of Economic Cooperation 

and Development (OECD) tolerance 

calculation procedures. 

V. Conclusion 

Therefore, tolerances are established 

for 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, 

in or on bean, dry seed at 0.2 ppm; bean, 

succulent at 0.9 ppm; cowpea, forage at 

50 ppm; cowpea, hay at 100 ppm; berry, 

low growing, except strawberry, 

subgroup 13–07H at 1 ppm; and fruit, 

small vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F at 2 ppm. 

This regulation additionally removes 

the established tolerances in or on 

cranberry at 0.90 ppm and grape at 2.0 

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, 


tkelley on DSK3SPTVN1PROD with RULES
78738 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or Tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 16, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.564: 

■ a. Remove the commodities 

‘‘Cranberry’’ and ‘‘Grape’’ in the table in 

paragraph (a)(1). 

■ b. Add alphabetically the following 

commodities to the table in paragraph 

(a)(1). The amendments read as follows: 

§ 180.564 Indoxacarb; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Bean, dry, seed ........................ 0.2 

Bean, succulent ........................ 0.9 

* * * * * 

Berry, low growing, except 

strawberry, subgroup 13–07H 1 

* * * * * 

Cowpea, forage ........................ 50 

Cowpea, hay ............................. 100 

* * * * * 

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 

13–07F .................................. 2 

* * * * * 

* * * * * 

[FR Doc. 2013–30585 Filed 12–26–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0071; FRL–9904–04] 

Pendimethalin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

current tolerance for combined residues 

of pendimethalin and its metabolite, 

expressed as pendimethalin equivalents 

in or on almond, hulls. BASF 

Corporation, 26 Davis Drive, Research 

Triangle Park, NC 27709 requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 27, 2013. Objections and 

requests for hearings must be received 

on or before February 25, 2014, 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–2013–0071, 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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION:

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 


tkelley on DSK3SPTVN1PROD with RULES