Federal Register / Vol. 79, No. 26 / Friday, February 7, 2014 / Rules and Regulations 7397 

from the operating regulations is 

authorized under 33 CFR 117.35. 

Dated: January 28, 2014. 

D.H. Sulouff, 

District Bridge Chief, Eleventh Coast Guard 

District. 

[FR Doc. 2014–02662 Filed 2–6–14; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0235; FRL–9905–56] 

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 revises existing 

tolerances in or on papaya, passionfruit, 

and spice subgroup 19B, and removes 

several previously established 

tolerances that will be superseded by 

tolerances established 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 

February 7, 2014. Objections and 

requests for hearings must be received 

on or before April 8, 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–2013–0235, 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. 

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–2013–0235 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 April 8, 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– 

2013–0235, 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 

Tolerances 

In the Federal Register of June 5, 2013 

(78 FR 33785) (FRL–9386–2), 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 3F8158) by DuPont Crop 

Protection, Stine-Haskell Research 

Center, P.O. Box 30, Newark, DE 19714. 

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-pyrozole-5- 

carboxamide, in or on peanuts at 0.06 

parts per million (ppm) and peanut, hay 

at 90 ppm. That document referenced a 

summary of the petition prepared 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. 

Additionally, in the Federal Register 

of July 19, 2013 (78 FR 43115) (FRL– 

9392–9), 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 3E8170) by 

Interregional Research Project Number 4 

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

W, Princeton, NJ 08540. The petition 

requested that 40 CFR 180.628 be 

amended by establishing tolerances for 

residues of the insecticide 

chlorantraniliprole in or on fruit, stone, 

group 12–12, except cherry, chickasaw 

mstockstill on DSK4VPTVN1PROD with RULES

7398 Federal Register / Vol. 79, No. 26 / Friday, February 7, 2014 / Rules and Regulations 

plum, and damson plum at 4.0 ppm; 

nut, tree, group 14–12 at 0.04 ppm; 

papaya at 4.0 ppm; passionfruit at 4.0 

ppm; and onion, green, subgroup 3–07B 

at 3.0 ppm. The petition also requested 

that tolerances for spice, subgroup 19B 

be increased to 40 ppm; and papaya and 

passionfruit be increased to 4.0 ppm. 

IR–4 is seeking to raise the tolerance on 

spice, subgroup 19B based on additional 

residue data on dill seed; IR–4 is 

seeking to raise the tolerances on 

papaya and passionfruit as a result of 

the request to shorten the existing preharvest intervals (PHIs) for the 

accompanying use directions for these 

commodities. 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. 

EPA was petitioned for a tolerance in 

or on fruit, stone, group 12–12, except 

cherry, chickasaw plum, and damson 

plum at 4.0 ppm; however, the proposed 

tolerance was incorrectly transcribed in 

the Federal Register Notice of the filing 

of the petition to propose a tolerance in 

or on fruit, stone, group 12, except 

cherry, chickasaw plum, and damson 

plum. However, the summary available 

in the docket lists stone fruit group 12– 

12, except cherry, chickasaw plum, and 

damson plum. EPA assessed the correct 

proposed tolerance on crop group 12–12 

rather than crop group 12, for which 

there is already an established tolerance. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerances for several 

commodities. The reasons for these 

changes are explained in Unit IV.C. 

Additionally, IR–4 later withdrew the 

request to establish a tolerance for tree 

nut group 14–12. 

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 

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. 

Chlorantraniliprole does not exhibit 

immunotoxicity, neurotoxicity, 

carcinogenicity, or developmental 

toxicity. Additionally, no mutagenicity 

concerns were reported in the 

genotoxicity studies. 

In oral and dermal toxicity studies in 

rats, minimally increased 

microvesiculation of adrenal cortex was 

observed mostly in males; however, 

supporting data demonstrated no effect 

on the capacity of the adrenal gland to 

produce corticosterone following 

stimulation. Therefore, adrenal cortex 

effects observed in rat studies were not 

considered adverse. 

Chlorantraniliprole does not exhibit 

prenatal 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 

mammalian studies, the most consistent 

effects are increased liver weights and 

mild induction of liver enzymes. 

Chlorantraniliprole is classified as not 

likely to be carcinogenic to humans, 

based on the weight of evidence of the 

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 

Green Onion Subgroup 3–07b, and 

Peanut; for the Requests to Update the 

Crop Groups of Stone Fruit, Tree Nut, 

and Spices; to Shorten the Pre-Harvest 

Intervals for Papaya, Passionfruit, and 

Mayhaw; and Evaluation of Condition of 

Registration Data on Rice, Coffee, 

Strawberry, and Tropical Fruits’’ at pp. 

25–30 in docket ID number EPA–HQ– 

OPP–2013–0235. 

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 (LOC) 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). 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 26 / Friday, February 7, 2014 / Rules and Regulations 7399 

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-level 

residues for the proposed and registered 

crops, and assumed 100 percent crop 

treated (PCT) for all commodities. 

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 the 

processed commodity, for example mint 

oil from spearmint. Where processing 

data indicated an increase in residue in 

the processed commodity, tolerancelevel residues based on tolerances 

established for those processed 

commodities were used, e.g., raisins 

from grapes. However, if residues do not 

concentrate or where processing data 

indicated a reduction in residues upon 

processing, the tolerance for the RAC is 

used without reduction and a separate 

tolerance for the processed commodity 

is not needed. Where adequate 

processing data do not exist, Dietary 

Risk Evaluation System (DEEM) default 

concentration factors were used. 

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 PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for chlorantraniliprole. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for 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 Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and PRZM 

Groundwater (GW) models, the 

estimated drinking water concentrations 

(EDWCs) of chlorantraniliprole for 

chronic exposures for non-cancer 

assessments are estimated to be 39.87 

parts per billion (ppb) for surface water 

and 207 ppb for groundwater. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. No 

acute dietary risk assessment was 

performed because no acute hazard was 

identified. For chronic dietary risk 

assessment, the water concentration 

value of 207 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: 

Sod farms/turf, landscape ornamentals 

and interiorscapes, and as a termiticide. 

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 

Food Quality Protection Act (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 developmental 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 losses. 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 uncertainty factor (UFs) to 

account for neurotoxicity. 

mstockstill on DSK4VPTVN1PROD with RULES

7400 Federal Register / Vol. 79, No. 26 / Friday, February 7, 2014 / Rules and Regulations 

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 that 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 a lack of 

toxicity over the acute-, short- and 

intermediate-term via the oral route of 

exposure. 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 6.7% 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. 

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 not established 

chlorantraniliprole MRLs for 

passionfruit, papaya, peanuts, green 

onions, or spice commodities. EPA 

cannot harmonize the requested 

tolerance for stone fruit group 12–12, 

except cherry, chickasaw plum, and 

damson plum with the Codex MRL for 

stone fruit, because the permitted 

domestic use on these crops in 

accordance with the approved pesticide 

label results in residue levels higher 

than the Codex MRL; EPA will not set 

tolerances at levels that could result in 

legally treated food in the United States 

bearing residues in excess of the 

approved tolerance. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the data supporting the 

petition, EPA has revised the following 

proposed tolerance level: Spice 

subgroup 19B from 40 ppm to 90. The 

Agency revised this tolerance level 

based on analysis of the residue field 

trial data using the Organization for 

Economic Cooperation and 

Development tolerance calculation 

procedures. 

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-pyrozole-5- 

carboxamide, including its metabolites 

and degradates, in or on fruit, stone, 

group 12–12, except cherry, chickasaw 

plum, and damson plum at 4.0 ppm; 

onion, green subgroup 3–07B at 3.0 

ppm; peanut, hay at 90 ppm; and peanut 

at 0.06 ppm. This regulation 

additionally revises previously 

established tolerances in or on the 

following commodities: Papaya from 2.0 

ppm to 4.0 ppm; passionfruit from 2.0 

ppm to 4.0 ppm; and spice subgroup 

19B from 14 ppm to 90 ppm. Finally, 

this regulation removes established 

permanent tolerances or time-limited 

tolerances for the indirect or inadvertent 

residues of chlorantraniliprole in or on 

fruit, stone, group 12, except cherry, 

chickasaw plum, and damson plum at 

4.0 ppm; leek at 0.20 ppm; onion, green 

at 0.20 ppm; onion, welsh at 0.20 ppm; 

peanut, hay at 0.20 ppm; and shallots, 

fresh leaves at 0.20 ppm. 

Fruit, stone, group 12, except cherry, 

chickasaw plum, and damson plum is 

being removed because the group 12–12 

tolerance being established, includes all 

commodities in group 12 at the same 

tolerance level. Leek; onion, green; 

onion, welsh; and shallots, fresh leaves 

are being removed because each of these 

commodities are included in the 

subgroup 3–07B, which is being 

established at 3.0 ppm, a level higher 

than the time-limited tolerances for the 

inadvertent residues of 

chlorantraniliprole in or on these 

commodities. 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 26 / Friday, February 7, 2014 / Rules and Regulations 7401 

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 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: January 31, 2014. 

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 § 180.628: 

■ a. Remove the entry ‘‘Fruit, stone, 

group 12, except cherry, chickasaw 

plum, and damson plum’’ in the table in 

paragraph (a). 

■ b. Add the entries: ‘‘Fruit, stone, 

group 12–12, except cherry, chickasaw 

plum, and damson plum’’; ‘‘Onion, 

green, subgroup 3–07B’’; ‘‘Peanut, hay’’; 

and ‘‘Peanut’’ to the table in paragraph 

(a). 

■ c. Revise the entries ‘‘Papaya’’, 

‘‘Passionfruit’’, and ‘‘Spice, subgroup 

19B’’ in the table in paragraph (a). 

■ d. Remove and reserve paragraph (d). 

The amendments read as follows: 

§ 180.628 Chlorantraniliprole; tolerances 

for residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Fruit, stone, group 12–12, except cherry, chickasaw plum, 

and damson plum ................. 4 .0 

* * * * * 

Onion, green, subgroup 3–07B 3 .0 

Papaya ...................................... 4 .0 

Passionfruit ............................... 4 .0 

Peanut ...................................... 0 .06 

Peanut, hay .............................. 90 

* * * * * 

Spice, subgroup 19B ................ 90 

* * * * * 

* * * * * 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2014–02568 Filed 2–6–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0736; FRL–9905–44] 

D-mannose; Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of D-mannose 

(CAS Reg. No. 3458–28–4) when used as 

an inert ingredient (sequestrant, binder, 

or filler) in pesticide formulations 

applied pre-harvest to growing crops. 

ISK Biosciences Corporation submitted 

a petition to EPA under the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of Dmannose. 

DATES: This regulation is effective 

February 7, 2014. Objections and 

requests for hearings must be received 

on or before April 8, 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–2011–0736, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

mstockstill on DSK4VPTVN1PROD with RULES