57280 Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Rules and Regulations 

V. Conclusion 

Therefore, tolerances are established 

for residues of quinoxyfen (5,7-dichloro4-(4-fluorophen oxy)quinoline) in or on 

berry, low growing, subgroup 13–07G at 

1.0 ppm; fruit, small, vine climbing, 

except fuzzy kiwifruit, subgroup 13–07F 

at 2.0 ppm; and vegetable, fruiting, 

group 8–10 at 1.7 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 9, 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 § 180.588 amend paragraph (a) as 

follows: 

■ i. Revise the introductory text, 

■ ii. Remove entries for commodities: 

‘‘Grape’’; ‘‘Pepper, bell’’; ‘‘Pepper, 

nonbell’’; and ‘‘Strawberry’’, and 

■ iii. Alphabetically add the following 

commodities to the table. 

The additions read as follows: 

§ 180.588 Quinoxyfen; tolerance for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

quinoxyfen, including its metabolites 

and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

quinoxyfen (5,7-dichloro-4-(4- 

fluorophenoxy)quinoline). 

Commodity Parts per 

million 

* * * * * 

Berry, low growing, subgroup 

13–07G ................................. 1.0 

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 

13–07F .................................. 2.0 

* * * * * 

Vegetable, fruiting, group 8–10 1.7 

* * * * * 

[FR Doc. 2013–22597 Filed 9–17–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0635; FRL–9395–1] 

Chlorantraniliprole; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of the insecticide 

chlorantraniliprole in or on multiple 

commodities which are identified and 

discussed later in this document. In 

addition, this regulation removes 

established tolerances for certain 

commodities/groups superseded by this 

action. The Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 18, 2013. Objections and 

requests for hearings must be received 

on or before November 18, 2013, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0635, 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 


pmangrum on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Rules and Regulations 57281 

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. 

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–2012–0635 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 November 18, 2013. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0635, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at 

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

contacts.html. Additional instructions 

on commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of Wednesday, 

November 7, 2012 (77 FR 66781) (FRL– 

9367–5), EPA issued a document 

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

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

of a pesticide petition (PP 2E8064) by 

Interregional Research Project Number 4 

(IR–4), IR–4 Project Headquarters, 500 

College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.628 be 

amended by establishing tolerances for 

residues of the insecticide 

chlorantraniliprole, 3-bromo-N-[4- 

chloro-2-methyl-6- 

[(methylamino)carbonyl]phenyl]-1-(3- 

chloro-2-pyridinyl)-1H-pyrazole-5- 

carboxamide, including its metabolites 

and degradates, in or on cereal grain 

group 15, except rice at 6.0 parts per 

million (ppm); grain, cereal, forage, 

fodder and straw, group 16 at 30.0 ppm; 

fruit, citrus, group 10–10 at 1.4 ppm; 

and fruit, pome, group 11–10 at 1.2 

ppm. In addition, petition 2E8064 

proposed, upon approval of above 

tolerances, to remove established 

tolerances in or on the raw agricultural 

commodities/groups: Mayhaw at 0.6 

ppm; field corn forage, field corn stover, 

pop corn forage, pop corn stover, sweet 

corn forage, sweet corn stover at 14 

ppm; field corn grain, pop corn grain at 

0.04 ppm; sweet corn kernels plus cob 

with husk removed at 0.02 ppm; field 

corn milled byproducts at 0.1 ppm; 

citrus fruit group 10 at 1.4 ppm; and 

pome fruit group 11 except mayhaw at 

1.2 ppm. That document referenced a 

summary of the petition prepared by E. 

I. DuPont de Nemours and Company, 

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 

modified, removed and/or established 

chlorantraniliprole tolerances for certain 

commodities. 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 

chlorantraniliprole including exposure 

resulting from the tolerances established 

by this action. EPA’s assessment of 

exposures and risks associated with 

chlorantraniliprole follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 


pmangrum on DSK3VPTVN1PROD with RULES
57282 Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Rules and Regulations 

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. 

No mutagenicity concerns were 

reported in the genotoxicity studies. Nor 

does chlorantraniliprole exhibit 

immunotoxicity, neurotoxicity, 

carcinogenicity, or developmental 

toxicity. 

In oral and dermal toxicity studies in 

rats, minimally increased 

microvesiculation of adrenal cortex was 

observed in males only; however, 

supporting data demonstrated no effect 

on the capacity of the adrenal gland to 

produce corticosterone under either 

basal or following adrenocorticotropic 

hormone (ACTH) stimulation. 

Therefore, adrenal cortex effects 

observed in rat studies were not 

considered adverse. 

Chlorantraniliprole does not exhibit 

pre- or postnatal toxicity as there were 

no maternal or fetal effects in studies 

conducted in rats and rabbits. The 

relative absence of mammalian hazard 

may be due in part to 

chlorantranilprole’s selectivity for insect 

ryanodine receptor (RyR) over 

mammalian counterparts. In short-term 

studies, the most consistent effects are 

those associated with non-adverse 

pharmacological response to the 

xenobiotic, induction of liver enzymes 

and subsequent increase in liver 

weights. 

Chlorantraniliprole is classified as 

‘‘Not likely to be Carcinogenic to 

Humans’’ based on the weight of 

evidence of data: No treatment-related 

tumors were reported in the submitted 

chronic and oncogenicity studies in rats 

and mice (18-month carcinogenicity 

study) or in the subchronic studies in 

mice, dogs and rats. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by chlorantraniliprole as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Chlorantraniliprole: Human Health 

Risk Assessment for Proposed Uses on 

Cereal Grains Group 15 (except Rice) 

and Cereal Grains Forage, Fodder, and 

Straw Group 16, and Conversion of 

Citrus and Pome Fruit Groups,’’ dated 

May 12, 2013 at p.25 in docket ID 

number EPA–HQ–OPP–2012–0635– 

0005. 

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 chlorantraniliprole used 

for human risk assessment is discussed 

in Unit III.B of the final rule published 

in the Federal Register of July 27, 2011 

(76 FR 44815) (FRL–8875–5). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to chlorantraniliprole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing chlorantraniliprole tolerances 

in 40 CFR 180.628. EPA assessed dietary 

exposures from chlorantraniliprole in 

food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

No such effects were identified in the 

toxicological studies for 

chlorantraniliprole; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculture (USDA) 2003–2008 National 

Health and Nutrition Examination 

Survey, What We Eat in America 

(NHANES/WWEA). As to residue levels 

in food, EPA assumed tolerance levels 

residues for the proposed and registered 

crops, and assumed 100 percent crop 

treated (PCT). Where processing data 

indicated a reduction (or no increase) in 

residue upon processing, the residue 

level of the raw agricultural commodity 

(RAC) was used without reduction, for 

example mint oil from spearmint. 

Where processing data indicated an 

increase in residue in the processed 

commodity, tolerance-level residues 

based on tolerances established for 

those commodities were used, e.g., 

raisins from grapes. Where adequate 

processing data did not exist, Dietary 

Risk Evaluation System (DEEM) default 

concentration factors were used if 

available. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that chlorantraniliprole 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 percent 

crop treated (PCT) information. EPA did 

not use anticipated residue or PCT 

information in the dietary assessment 

for chlorantraniliprole. Tolerance level 

residues and 100 PCT were assumed for 

all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for chlorantraniliprole in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of chlorantraniliprole. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST), 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 chlorantraniliprole for 

chronic exposures for non-cancer 

assessments are estimated to be 39.87 

ppb for surface water and 0.842 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. No 

acute dietary risk assessment was 


pmangrum on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Rules and Regulations 57283 

performed because no acute hazard was 

identified. For chronic dietary risk 

assessment, the water concentration 

value of 39.87 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). 

Chlorantraniliprole is currently 

registered for the following uses that 

could result in residential exposures: 

Termiticide, sod farms/turf, landscape 

ornamentals and interiorscapes. 

Residential exposure is expected to 

occur for short-term and intermediateterm durations; however, due to the lack 

of toxicity identified for short- and 

intermediate-term durations via relevant 

routes of exposure, residential exposure 

was not assessed. 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 chlorantraniliprole 

to share a common mechanism of 

toxicity with any other substances, and 

chlorantraniliprole does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that chlorantraniliprole does 

not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s Web site at 

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

cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There were no effects on prenatal fetal 

growth or postnatal development up to 

the limit dose of 1,000 milligrams/ 

kilogram/day (mg/kg/day) in rats or 

rabbits in the development or 2- 

generation reproduction studies. 

Moreover, there were no treatment 

related effects on the numbers of litters, 

fetuses (live or dead), resorptions, sex 

ratio, or post-implantation loss. There 

were no effects on fetal body weights, 

skeletal ossification, and external, 

visceral, or skeletal malformations or 

variations. 

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 

chlorantraniliprole is complete. 

ii. There is no indication that 

chlorantraniliprole is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

chlorantraniliprole 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 chronic dietary assessment utilized 

tolerance level residues for all crops and 

assumed 100 PCT of the proposed and 

registered crops were treated with 

chlorantraniliprole. Default processing 

factors were used as appropriate. EPA 

made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to chlorantraniliprole in drinking water. 

Moreover, there is a lack of toxicity via 

the dermal route, as well as the lack of 

toxicity over the acute-, short- and 

intermediate-term via the oral route. 

These assessments will not 

underestimate the exposure and risks 

posed by chlorantraniliprole. 

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. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, chlorantraniliprole 

is not expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to 

chlorantraniliprole from food and water 

will utilize 6.3% of the cPAD for 

children 1–2 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 chlorantraniliprole is not 

expected. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposures take into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Because no short-term or intermediateterm adverse effects were identified, the 

aggregate short-term or intermediateterm risk is the same as the dietary risk, 

which will not be greater than the 

chronic aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

chlorantraniliprole is not expected to 

pose a cancer risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to 

chlorantraniliprole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography mass 

spectrometry (LC/MS/MS)); Method 

DuPont-11374) is available to enforce 

the tolerance expression. 


pmangrum on DSK3VPTVN1PROD with RULES
57284 Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Rules and Regulations 

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. 

Codex has established 

chlorantraniliprole maximum residue 

limits (MRLs) for a number of crop and 

animal commodities. The Codex MRLs 

for cereal grains, citrus fruit, and pome 

fruit are significantly lower than the 

recommended corresponding US 

tolerances. Because the permitted 

domestic use on these crops in 

accordance with the approved pesticide 

label results in residue levels higher 

than the Codex MRLs, the US tolerance 

cannot be harmonized (lowered) since 

doing so would result in residues in 

excess of the approved tolerance in spite 

of use consistent with label directions. 

Because the US tolerances for cereal 

grains are higher than the Codex MRLs 

for cereal grains, the US livestock 

tolerances at the values recommended 

are necessary to encompass possible 

residue levels from use of the pesticide 

according to label directions. 

C. Revisions to Petitioned-for Tolerances 

EPA converted, modified, removed 

and/or established chlorantraniliprole 

tolerances for certain commodities and, 

in some cases, re-defined the crop group 

tolerance expression and/or corrected 

the commodity definition, as needed. 

EPA determined that the proposed 

tolerance for grain, cereal, group 15, 

except rice at 6.0 ppm is not 

appropriate. Establishing the proposed 

tolerance would raise tolerance levels 

for corn, field, grain; corn, pop, grain, 

and corn, sweet, kernel plus cobs with 

husk removed much in excess of their 

actual residue levels: corn, field, grain 

and corn, pop, grain at 0.04 ppm and 

corn, sweet, kernel plus cobs with husk 

removed at 0.02 ppm. Therefore, the 

Agency determined that the grain, 

cereal, group 15 tolerance must exclude 

corn (including corn, field, grain; corn, 

pop, grain; and corn, sweet), and redefined the crop group tolerance 

expression as ‘‘grain, cereal, group 15, 

except rice and corn’’ at 6.0 ppm. 

Accordingly, although the petitioner 

requested the removal of the established 

tolerances for corn, field, grain at 0.04 

ppm and corn, pop, grain at 0.04 ppm 

and field corn milled byproducts at 0.1 

ppm because they would be subsumed 

within the proposed tolerance for grain, 

cereal, group 15, EPA is not leaving 

those tolerances in place. 

Based on field trial data and using the 

Organization of Economic Cooperation 

and Development (OECD) tolerance 

calculation procedures, EPA determined 

that the proposed tolerance on grain, 

cereal, forage, fodder, and straw, group 

16 at 30 ppm should be increased 40 

ppm. 

Upon the establishment of fruit, 

pome, group 11–10, the petitioner 

proposed that the tolerance for fruit, 

pome, group 11 and mayhaw, be 

deleted. The existing tolerance is for 

fruit, pome, group 11, except mayhaw at 

1.2 ppm and there is a separate 

tolerance for mayhaw at 0.6 ppm. These 

two tolerances will now be superseded 

by establishment of the group tolerance 

‘‘fruit, pome, group 11–10’’ at 1.2 ppm. 

The tolerances for certain livestock 

commodities were created or increased 

because expanded use of 

chlorantraniliprole to more cereal grains 

and cereal grain forages, fodders, and 

straws increased the dietary exposure of 

livestock. The increased dietary 

exposure of livestock necessitates 

increased tolerances for cattle, sheep, 

horse, and goat meat byproducts from 

0.2 ppm to 0.5 ppm and for milk from 

¥0.05 ppm to 0.1 ppm. Due to elevated 

hog dietary exposure from the crop 

group tolerance for grain, cereal, group 

15, EPA established a hog, meat 

tolerance at 0.02 ppm and increased 

both the hog, fat and the hog, meat 

byproducts tolerance from 0.02 to 0.05 

ppm. Likewise, the grain, cereal, group 

15 elevated the laying hen dietary 

exposure and, consequently, the Agency 

set a tolerance for poultry, meat at 0.05 

ppm and increased the tolerance for egg 

from 0.2 to 1.0 ppm; poultry, fat from 

0.01 to 0.2 ppm; and poultry, meat 

byproducts from 0.02 to 0.2 ppm. In 

accordance with the Agency commodity 

terminology, EPA is re-defining existing 

animal ‘‘meat byproducts, except liver’’ 

tolerances to ‘‘meat byproducts’’, which 

includes liver. Thus, EPA is deleting 

separate tolerances for goat, liver, horse, 

liver, and sheep, liver since they are 

covered by the respective meat 

byproducts tolerances. 

Lastly, at 180.628(d), the Agency 

removed the entry for commodity 

‘‘Grain, cereal, forage, fodder and straw, 

group 16 at 0.20 ppm, with expiration/ 

revocation date of 04/10/14, as this 

time-limited tolerance is superseded by 

this action. 

V. Conclusion 

Therefore, tolerances are established 

for residues of chlorantraniliprole, 3- 

bromo-N-[4-chloro-2-methyl-6- 

[(methylamino)carbonyl]phenyl]-1-(3- 

chloro-2-pyridinyl)-1H-pyrazole-5- 

carboxamide, including its metabolites 

and degradates, in or on Cattle, meat 

byproducts at 0.5 parts per million 

(ppm); Egg at 1.0 ppm; Fruit, citrus, 

group 10–10 at 1.4 ppm; Fruit, pome, 

group 11–10 at 1.2 ppm; Goat, meat 

byproducts at 0.5 ppm; Grain, cereal, 

group 15, except rice and corn at 6.0 

ppm; Grain, cereal, forage, fodder and 

straw, group 16 at 40.0 ppm; Hog, fat at 

0.05 ppm; Hog, meat at 0.02 ppm; Hog, 

meat byproducts at 0.05 ppm; Horse, 

meat byproducts at 0.5 ppm; Milk at 0.1 

ppm; Poultry, fat at 0.2 ppm; Poultry, 

meat at 0.05 ppm; Poultry, meat 

byproducts at 0.2 ppm; and Sheep, meat 

byproducts at 0.5 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 


pmangrum on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Rules and Regulations 57285 

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 tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 9, 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. 

§ 180.628 [Amended] 

■ 2. Section 180.628, the table in 

paragraph (a), is amended as follows: 

■ i. Remove the following commodities: 

‘‘Cattle, liver’’; ‘‘Cattle, meat 

byproducts, except liver’’; ‘‘Corn, field 

forage’’; ‘‘Corn, field, stover’’; ‘‘Corn, 

pop, forage’’; ‘‘Corn, pop, stover’’; 

‘‘Corn, sweet, forage’’; ‘‘Corn, sweet, 

stover’’; ‘‘Fruit, citrus group 10’’; ‘‘Fruit, 

pome group 11, except mayhaw’’; ‘‘Goat, 

liver’’; ‘‘Goat, meat byproducts, except 

liver’’; ‘‘Horse, liver’’; ‘‘Horse, meat 

byproducts, except liver’’; ‘‘Mayhaw’’; 

‘‘Sheep, liver’’; and ‘‘Sheep, meat 

byproducts, except liver.’’ 

■ ii. Revise the following commodities: 

‘‘Egg’’; ‘‘Hog, fat’’; ‘‘Hog, meat 

byproducts’’; ‘‘Milk’’; ‘‘Poultry, fat’’; and 

‘‘Poultry, meat byproducts.’’ 

■ iii. Add alphabetically the 

commodities: ‘‘Cattle, meat 

byproducts’’; ‘‘Fruit, citrus, group 10– 

10’’; ‘‘Fruit, pome, group 11–10’’; ‘‘Goat, 

meat byproducts’’; ‘‘Grain, cereal, 

except rice and corn, group 15’’; ‘‘Grain, 

cereal, forage, fodder and straw, group 

16’’; ‘‘Hog, meat’’; ‘‘Horse, meat 

byproducts’’; Poultry, meat’’; and 

‘‘Sheep, meat byproducts.’’ 

■ 3. Section 180.628, the table in 

paragraph (d) is amended by removing 

the entry ‘‘Grain, cereal, forage, fodder 

and straw, group 16.’’ 

The additions and revisions read as 

follows: 

§ 180.628 Chlorantraniliprole; tolerances 

for residues. 

(a) General. * * * 

Commodity Parts per 

million 

* * * * * 

Cattle, meat byproducts ........... 0.5 

* * * * * 

Fruit, citrus, group 10–10 ......... 1.4 

Fruit, pome, group 11–10 ......... 1.2 

* * * * * 

Goat, meat byproducts ............. 0.5 

* * * * * 

Grain, cereal, except rice and 

corn, group 15 ....................... 6.0 

Commodity Parts per 

million 

Grain, cereal, forage, fodder 

and straw, group 16 .............. 40 

* * * * * 

Hog, fat ..................................... 0.05 

Hog, meat ................................. 0.02 

Hog, meat byproducts .............. 0.05 

* * * * * 

Horse, meat byproducts ........... 0.5 

* * * * * 

Milk ........................................... 0.1 

* * * * * 

Poultry, fat ................................ 0.2 

Poultry, meat ............................ 0.05 

Poultry, meat byproducts .......... 0.2 

* * * * * 

Sheep meat byproducts ........... 0.5 

* * * * * 

* * * * * 

[FR Doc. 2013–22593 Filed 9–17–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0383; FRL–9398–4] 

2,5-Furandione, Polymer With 

Ethenylbenzene, Hydrolyzed, 3- 

(Dimethylamino)propyl Imide, Imide 

With Polyethylene-Polypropylene 

Glycol 2-Aminopropyl Me Ether, 2,2′- 

(1,2-Diazenediyl)bis[2- 

Methylbutanenitrile]-Initiated; 

Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 2,5-furandione, 

polymer with ethenylbenzene, 

hydrolyzed, 3-(dimethylamino)propyl 

imide, imide with polyethylenepolypropylene glycol 2-aminopropyl me 

ether, 2,2′-(1,2-diazenediyl)bis[2- 

methylbutanenitrile]-initiated (CAS Reg. 

No. 1062609–13–5) when used as an 

inert ingredient in a pesticide 

formulation. Evonik Goldschmidt 

Corporation (Evonik) submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of 2,5-furandione, polymer 

with ethenylbenzene, hydrolyzed, 3- 


pmangrum on DSK3VPTVN1PROD with RULES