57276 Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Rules and Regulations 

* * * * * 

[FR Doc. 2013–22623 Filed 9–17–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0911; FRL–9398–9] 

Quinoxyfen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of quinoxyfen in 

or on multiple commodities which are 

identified and discussed later in this 

document. This regulation also deletes 

the established tolerances in or on 

grape; pepper, bell; pepper, nonbell; and 

strawberry as they will be superseded 

by crop group/subgroup tolerances 

established by this tolerance rule. The 

Interregional Research Project Number 4 

(IR–4) Project Headquarters 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–2012–0911, 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–2012–0911 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– 

2012–0911, 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, 

January 16, 2013 (78 FR 3377) (FRL– 

9375–4), 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 2E8117) by 

IR–4 Project Headquarters, 500 College 

Road East, Suite 201W, Princeton, NJ 

08540. The petition requested that 40 

CFR 180.588 be amended by 

establishing tolerances for residues of 

the fungicide quinoxyfen, 5,7-dichloro4-(4-fluorophenoxy)quinoline, in or on 

berry, low growing, subgroup 13–07G at 

0.90 parts per million (ppm); fruiting, 

small, vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F at 0.60 ppm 

and vegetable, fruiting, group 8–10 at 

1.7 ppm. In addition, the petition 

requested removal of established 

tolerances in or on grape at 0.60 ppm; 

strawberry at 0.90 ppm; pepper, bell at 

0.35 ppm; and pepper, nonbell at 1.7 

ppm, as these will be superseded upon 

approval of the proposed tolerances. 

That document referenced a summary of 

the petition prepared by Dow 

AgroSciences LLC, 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 has revised proposed tolerance 

levels for several commodities and 

revised the quinoxyfen tolerance 

expression for all established 

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 


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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 quinoxyfen 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with quinoxyfen 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. 

The primary target organs affected by 

quinoxyfen are the liver and kidney. 

The most sensitive species was the rat. 

Liver effects were seen in the 

subchronic rat and mouse studies as 

well as the chronic dog study. 

Subchronic effects observed in rats and 

mice at high doses included increased 

liver weights, hepatocellular 

hypertrophy, and individual cell 

hepatocellular necrosis. Chronic effects 

observed in the dog included increased 

liver weights, increased alkaline 

phosphatase levels, and increased 

incidence of very slight to slight 

microscopic hepatic lesions. Kidney 

effects were noted in the rat combined 

chronic/carcinogenicity study that 

resulted in an increased severity of 

chronic progressive 

glomerulonephropathy in males. Bodyweight decrements were seen in the rat 

and/or mouse subchronic, chronic and 

carcinogenicity studies as well as the 

rabbit developmental and rat 

reproduction studies. 

Oral rat and rabbit developmental 

studies showed no increased qualitative 

or quantitative susceptibility of 

offspring to quinoxyfen in utero. In the 

rabbit developmental toxicity study, 

maternal and developmental toxicity 

were observed at the highest dose tested 

(HDT) (lowest-observed adverse-effect 

level; LOAEL = 200 mg/kg/day). 

Maternal effects included inanition 

(exhaustion due to lack of nourishment), 

clinical signs, decreased body weight 

and body-weight gains, decreased food 

consumption, and increased incidence 

of abortion late in pregnancy. 

Developmental toxicity was evidenced 

as increased incidence of abortion late 

in pregnancy. No maternal or 

developmental toxicity was observed in 

the rat developmental study up to the 

limit dose of 1,000 mg/kg/day. In the 2- 

generation rat reproduction study, no 

parental effects were observed up to the 

HDT (100 mg/kg/day) while firstgeneration pup weights were reduced at 

the same dose. There is apparent 

quantitative susceptibility when looking 

at the 2-generation reproductive study 

in isolation, but when using a weightof-evidence approach that puts the 

offspring findings in the 2-generation 

reproduction toxicity study in context 

with the full toxicological database 

there is no concern for susceptibility to 

offspring since it is anticipated that 

parental toxicity would have been 

observed at the same dose (see Unit 

III.D.2). 

No evidence of neurotoxicity or 

neuropathology was seen in any of the 

submitted studies. 

A 28-day immunotoxicity study 

showed no evidence that quinoxyfen 

elicits an immunotoxic response up to 

the HDT. 

The EPA has classified quinoxyfen as 

‘‘not likely to be carcinogenic to 

humans’’ based on no evidence of 

carcinogenicity in rat or mice studies. 

Moreover, quinoxyfen did not show 

evidence of mutagenicity in in vitro or 

in vivo studies. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by quinoxyfen 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: 

‘‘Quinoxyfen. Human-Health Risk 

Assessment for the Proposed Uses on 

Vegetable, Fruiting, Group 8–10; Fruit, 

Small Vine Climbing, Except Fuzzy 

Kiwifruit, Subgroup 13–07F; and Berry, 

Low Growing Subgroup 13–07G,’’ dated 

August 20, 2013, pp. 27–30 in docket ID 

number EPA–HQ–OPP–2012–0911. 

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. 

Following is a summary of the ‘‘DoseResponse Assessment’’ with the 

appropriate toxicological endpoints 

used if available from the human health 

risk assessment. 

1. Acute dietary endpoint (all 

populations). There were no adverse 

effects observed attributable to a single 

dose for the general population 

(including infants and children) or 

females 13–49 years of age; therefore, an 

acute RfD and PAD were not calculated 

for this exposure scenario. 

2. Chronic dietary endpoint (all 

populations). The chronic RfD (cRfD) 

was established based on the NOAEL 

(20 mg/kg/day) from the rat combined 

chronic toxicity/carcinogenicity study. 

The LOAEL of 80 mg/kg/day in this 

study is based on increases in severity 

of chronic progressive 

glomerulonephropathy in the males and 

minimal decreases in body weight and 

body-weight gain in both sexes. The 

NOAEL of 20 mg/kg was chosen because 

the study and endpoint are appropriate 

for the route and duration of exposure. 

The cPAD of 0.2 mg/kg/day is derived 

from the NOAEL of 20 mg/kg/day and 

a 100-fold uncertainty factor (10X for 

interspecies extrapolation, 10X for 


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intraspecies variation, and 1X for FQPA 

SF). 

3. Cancer classification. The Agency 

classified quinoxyfen as ‘‘not likely to 

be carcinogenic to humans’’ by all 

routes of exposure based upon lack of 

evidence of carcinogenicity in rats and 

mice. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to quinoxyfen, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing quinoxyfen tolerances in 40 

CFR 180.588. EPA assessed dietary 

exposures from quinoxyfen 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 one-day or 

single exposure. No such effects were 

identified in the toxicological studies 

for quinoxyfen; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used Dietary Exposure Evaluation 

Model—Food Consumption Intake 

Database (DEEM–FCID), ver. 3.16 which 

incorporates 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). The 

unrefined chronic analysis assumed 100 

percent crop treated (PCT), DEEM 7.81 

default concentration factors, and 

tolerance-level residues for all existing 

and proposed crop uses. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that quinoxyfen 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 or PCT information 

in the dietary assessment for 

quinoxyfen. 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 quinoxyfen in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of quinoxyfen. 

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) for surface 

water, and the Screening Concentration 

in Ground Water (SCI–GROW) models 

for ground water, the estimated drinking 

water concentrations (EDWCs) of 

quinoxyfen for chronic exposure, 

assessments are estimated to be 0.66 

ppb for surface water and for ground 

water, the estimated drinking water 

concentration is 0.0034 ppb. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 0.66 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). 

Quinoxyfen is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found quinoxyfen to 

share a common mechanism of toxicity 

with any other substances, and 

quinoxyfen does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that quinoxyfen 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. 

Oral rat and rabbit developmental 

studies showed no increased qualitative 

or quantitative susceptibility of 

offspring to quinoxyfen in utero. In 

isolation, there is evidence of increased 

quantitative susceptibility in the 

2-generation reproduction toxicity 

study. No parental effects were observed 

up to the HDT (100 mg/kg/day) while 

first-generation pup weights were 

reduced at the same dose. Concern is 

low since: 

i. The effects in pups are well 

characterized with a clear NOAEL of 20 

mg/kg/day. 

ii. The pup effects are minimal at the 

LOAEL and only noted in the firstgeneration offspring. 

iii. The doses and endpoints selected 

for regulatory purposes would address 

concerns for the pup effects noted in the 

rat reproduction study. 

Additionally, taking into consideration 

the full toxicological database, there 

would be no susceptibility to offspring 

since assessments to parental animals 

are intentionally limited in the 2- 

generation reproduction study to avoid 

stressing dams and affecting the rearing 

and care of offspring. If additional 

evaluations had been performed on 

parental animals in the 2-generation 

reproduction study, including 

histopathology and organ weight 

assessments, then it is expected that the 

kidney and liver effects observed in the 

rat subchronic oral study and in the 

interim (12 months) and final sacrifices 

of the rat chronic toxicity/

carcinogenicity study would have been 

seen at the 100 mg/kg/day dose in the 

reproduction study. Therefore, when 

using a weight-of-evidence approach 

that puts the offspring findings in the 2- 

generation reproduction toxicity study 

in context with the full toxicological 

database there is no concern for 

susceptibility to offspring since it is 

anticipated that parental toxicity would 

have been observed at the same dose. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF is 

reduced to 1X. That decision is based on 

the following findings: 


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i. The toxicity database for 

quinoxyfen is complete. 

ii. There is no indication that 

quinoxyfen is a neurotoxic chemical 

based on available acute and subchronic 

neurotoxicity studies. EPA determined 

that there is no need to require a 

developmental neurotoxicity study or 

apply additional uncertainty factors to 

account for neurotoxicity. 

iii. Using the full toxicological 

database, there is no indication that 

quinoxyfen will result in increased 

susceptibility to offspring (see Unit 

III.D.2). 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT, 

tolerance-level residues, and DEEM 7.81 

default processing factors. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to quinoxyfen 

in drinking water. These assessments 

will not underestimate the exposure and 

risks posed by quinoxyfen. 

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 and no acute 

dietary endpoint was identified for any 

segment of the United States (U.S.) 

population. Therefore, quinoxyfen 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 quinoxyfen 

from food and water will utilize 8.5% of 

the cPAD for children 1–2 years old the 

population group receiving the greatest 

exposure. There are no residential uses 

for quinoxyfen. 

3. Short-term and intermediate-term 

risks. Short-term and intermediate-term 

aggregate exposure takes into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Quinoxyfen is not registered for any use 

patterns that would result in residential 

exposure. Therefore, the short-term and 

intermediate-term aggregate risk is the 

sum of the risk from exposure to 

quinoxyfen through food and water and 

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, 

quinoxyfen 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 quinoxyfen 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate gas chromatography/

mass-selective detector (GC/MSD) 

method is available for enforcing 

quinoxyfen tolerances (DowElanco 

Procedure ERC95.26); a successful 

petition method validation (PMV) has 

been completed. The lowest level of 

method validation (LLMV) was 0.01 

ppm. Samples from the submitted field 

and processing studies were analyzed 

using a high-performance liquid 

chromatography/mass spectrometry 

(HPLC/MS) method derived from Dow 

AgroSciences Report RF 98–200 dated 

May 31, 1999; method entitled 

‘‘Determination of Residues of 

Quinoxyfen Applied as EF–1295 in 

Hops.’’ The LLMV was 0.01 ppm for 

quinoxyfen in all tomato matrices. 

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 MRLs are established for 

residues of quinoxyfen per se in/on 

grapes, strawberries, and peppers. EPA 

is raising the level of the requested U.S. 

tolerances for residues of quinoxyfen in/ 

on the berry, low growing subgroup 13– 

07G and the fruit, small, vine climbing, 

except fuzzy kiwifruit, subgroup 13–07F 

in order to harmonize with the Codex 

MRLs. Harmonization of the requested 

U.S. tolerance for residues of 

quinoxyfen in/on the vegetable, fruiting, 

group 8–10 (1.7 ppm) with the Codex 

MRL for peppers (1 ppm) is not possible 

because residue data from field trials 

conducted in the U.S. with quinoxyfen 

show that residues levels resulting from 

use of quinoxyfen under the existing 

U.S. registration on peppers may exceed 

the Codex MRL. 

C. Revisions to Petitioned-for Tolerances 

EPA increased the proposed tolerance 

levels for fruit, small, vine climbing, 

except fuzzy kiwifruit, subgroup 13–07F 

and berry, low growing, subgroup 13– 

07G to 2.0 ppm and 1.0 ppm, 

respectively, in order to harmonize with 

international Codex maximum residue 

limits (MRLs). EPA relied on 

Organization for Economic Co-operation 

and Development (OECD) tolerancecalculation procedures and the 

submitted residue data sets in 

establishing these tolerances. 

In addition, EPA revised the 

quinoxyfen tolerance expression to 

clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of 

quinoxyfen not specifically mentioned; 

and 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 


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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 


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