51102 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations 

regulated area, unless it receives 

permission from the on-scene Patrol 

Commander. Spectator vessels may 

safely transit outside the regulated area 

but may not anchor, block, loiter, or 

impede participants or official patrol 

vessels. The Coast Guard may be 

assisted by other federal, state or local 

law enforcement agencies in enforcing 

this regulation. 

This notice is issued under authority 

of 33 CFR 100.801 and 33 U.S.C. 1233. 

In addition to this notice in the Federal 

Register, the Coast Guard will provide 

the maritime community with 

notification of this enforcement period 

via Local Notice to Mariners, Marine 

Information Broadcasts, and Marine 

Safety Information Bulletins. 

If the Captain of the Port or his 

designated on-scene Patrol Commander 

determines that the regulated area need 

not be enforced for the full duration 

stated in this notice, he or she may use 

a Broadcast Notice to Mariners to grant 

general permission to enter the 

regulated area. 

Dated: July 30, 2014. 

R.S. Ogrydziak, 

Captain, U.S. Coast Guard, Captain of the 

Port, Port Arthur. 

[FR Doc. 2014–20329 Filed 8–26–14; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0476; FRL–9913–99] 

Methoxyfenozide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

methoxyfenozide in or on pineapple. 

Dow AgroSciences, LLC, requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 27, 2014. Objections and 

requests for hearings must be received 

on or before October 27, 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–2013–0476, 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), West William 

Jefferson Clinton 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; main 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–2013–0476 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 October 27, 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– 

2013–0476, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

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

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

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

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of July 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 3F8179) by Dow 

AgroSciences, LLC, 9330 Zionsville Rd., 

Indianapolis, IN 46268. The petition 

requested that 40 CFR 180.544 be 

amended by establishing tolerances for 

residues of the insecticide 

methoxyfenozide, 3-methoxy-2- 

methylbenzoic acid 2-(3,5- 

dimethylbenzoyl)-2-(1,1-dimethylethyl) 

hydrazide, in or on pineapple at 0.7 

parts per million (ppm). 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. No 

comments were received on the notice 

of filing. 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations 51103 

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 methoxyfenozide 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with methoxyfenozide 

follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Methoxyfenozide 

is of low acute toxicity by the oral, 

dermal, and inhalation routes and is not 

a dermal sensitizer. Many of the 

available short-term or subchronic 

toxicity studies on methoxyfenozide 

showed little or no toxicity. The main 

target organs identified from the toxicity 

studies in the rat and dog were the liver, 

thyroid, and red blood cells (RBCs). The 

most consistent findings across species 

and studies were decreased red blood 

cell parameters and increased liver, 

thyroid, adrenal, and spleen weights. 

Increases in thyroid and adrenal weights 

were observed in the rat chronic oral 

study. Thyroid weights were also 

increased in the dog following chronic 

exposure, but no accompanying 

histopathology was observed. The 

effects of methoxyfenozide on the blood 

in mammals (methemoglobinemia, 

decreased red blood cell parameters, 

Heinz body formation) are consistent 

with those of other hydrazine 

compounds. 

Acute and subchronic oral 

neurotoxicity studies in the rat did not 

show evidence of potential 

neurotoxicity. In the acute study, 

decreased hindlimb grip strength on day 

0 was reported in males. This finding 

was only observed at the limit dose in 

males and was not observed in the 

subchronic neurotoxicity study and was 

therefore not considered evidence of 

neurotoxicity. No clinical signs of 

neurotoxicity or neurohistopathology 

were observed in other guideline 

studies. 

No maternal or developmental effects 

were observed in either the rat or rabbit 

oral developmental toxicity studies. In 

the rat 2-generation reproductive 

toxicity study, parental effects were 

limited to increased liver weight and 

microscopic periportal hypertrophy. No 

offspring or reproductive toxicity was 

observed. In a 28-day dietary 

immunotoxicity study in the rat, no 

immunotoxicity was observed. 

There was no evidence of 

carcinogenicity in the rat dietary 24- 

month chronic toxicity/carcinogenicity 

study or the mouse dietary 18-month 

carcinogenicity study. No mutagenic or 

clastogenic potential was observed in 

the battery of genotoxicity studies on 

methoxyfenozide. Based on these 

findings, methoxyfenozide is classified 

as ‘‘not likely to be carcinogenic to 

humans.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by methoxyfenozide as 

well as the No-observed-adverse-effectlevel (NOAEL) and the Lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

at http://www.regulations.gov in 

document ‘‘Methoxyfenozide. Human 

Health Risk Assessment to Support 

Proposed New Section 3 Use on 

Pineapple’’ at p. 34 in docket ID number 

EPA–HQ–OPP–2013–0476. 

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 the NOAEL and the 

LOAEL at which adverse effects of 

concern. Uncertainty/safety factors are 

used in conjunction with the POD to 

calculate a safe exposure level— 

generally referred to as a populationadjusted 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 methoxyfenozide used for 

human risk assessment is shown in 

Table 1 of this unit. 

mstockstill on DSK4VPTVN1PROD with RULES

51104 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR METHOXYFENOZIDE FOR USE IN HUMAN HEALTH

RISK ASSESSMENT

Exposure/scenario 

Point of 

departure and 

uncertainty/safety 

factors 

RfD, PAD, LOC 

for risk 

assessment 

Study and toxicological effects 

Acute dietary (General population including infants and 

children).

No hazard was identified for a single oral exposure. 

Chronic dietary (All populations) NOAEL = 10.2 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic ....................

RfD = 0.10 mg/kg/

day 

cPAD = 0.10 mg/kg/

day 

Co-critical studies: 

Combined oral chronic toxicity/carcinogenicity-rat 

LOAEL = 411/491 mg/kg/day M/F, based on hematological 

changes (decreased RBC parameters), periportal liver hypertrophy, thyroid hypertrophy and altered colloid; possibly increased adrenal weight. 

Chronic oral toxicity-dog = 9.8/12.6 mg/kg/day M/F 

LOAEL = 106.1/110.6 mg/kg/day based on hematological 

changes (decreased RBC parameters, slight 

methemoglobinemia) and increased serum bilirubin. 

Inhalation short-term (1 to 30 

days) and intermediate-term 

(1 to 6 months).

Inhalation (or oral) 

study NOAEL = 16 

mg/kg/day.

(Inhalation absorption rate = 100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE ≤100 Two-week oral range-finding study-dog 

LOAEL = 90.8 mg/kg/day based on hematological changes 

(decreased RBC parameters, increased Heinz body count, 

reticulocyte counts, erythrocyte morphology and 

methemoglobinemia) and increased spleen weights. 

Cancer (Oral, dermal, inhalation).Classification: Not likely to be carcinogenic to humans. 

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

milligram/kilogram/day. M/F = male/female MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted 

dose (a = acute, c = chronic). RBC = red blood cells. RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human 

(interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to methoxyfenozide, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing methoxyfenozide tolerances in 

40 CFR 180.544. EPA assessed dietary 

exposures from methoxyfenozide 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 methoxyfenozide; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, EPA used 

tolerance-level residues from the 

existing and proposed use and the 

assumption of 100% crop treated (PCT) 

for all crops. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that methoxyfenozide 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 methoxyfenozide. 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 methoxyfenozide in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

methoxyfenozide. 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 the 

Pesticide Root Zone Model Ground 

Water (PRZM GW), the estimated 

drinking water concentrations (EDWCs) 

of methoxyfenozide for chronic 

exposures for non-cancer assessments 

are estimated to be 51 parts per billion 

(ppb) for surface water and 214 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 214 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). 

Methoxyfenozide is currently 

registered for the following uses that 

could result in residential exposures: 

Ornamental uses. EPA assessed 

potential inhalation exposure for 

residential handlers treating 

ornamentals in and around home 

gardens using a backpack sprayer. A 

quantitative dermal assessment for 

residential handlers was not conducted 

since there is no systemic toxicity 

associated with dermal exposure to 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations 51105 

methoxyfenozide. MOEs were 

calculated for the inhalation route of 

exposure only. 

Adult post-application exposures 

were not quantitatively assessed since 

no dermal hazard was identified for 

methoxyfenozide and inhalation 

exposures are typically negligible in 

outdoor settings. Furthermore, the 

inhalation exposure assessment 

performed for residential handlers is 

representative of worse case inhalation 

exposures and is considered protective 

for post-application inhalation exposure 

scenarios. 

Post-application oral exposure to 

children is not expected since the extent 

to which young children engage in 

activities associated with areas where 

residential ornamentals are grown or 

utilize these areas for prolonged periods 

of play is low. Therefore, an incidental 

oral post-application exposure 

assessment was not conducted. 

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 methoxyfenozide 

to share a common mechanism of 

toxicity with any other substances, and 

methoxyfenozide does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that methoxyfenozide does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no evidence of qualitative or 

quantitative susceptibility of the 

developing fetus or offspring, based on 

the developmental and reproductive 

toxicity study results. 

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 

methoxyfenozide is complete. 

ii. There is no indication that 

methoxyfenozide 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 

methoxyfenozide 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 dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

highly conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to methoxyfenozide in drinking water. 

These assessments will not 

underestimate the exposure and risks 

posed by methoxyfenozide. 

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 population 

adjusted dose (aPAD) and chronic 

population adjusted dose (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, methoxyfenozide 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 

methoxyfenozide from food and water 

will utilize 83% 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 methoxyfenozide is not 

expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Methoxyfenozide is currently 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

methoxyfenozide. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 540. Because EPA’s level of 

concern for methoxyfenozide is a MOE 

of 100 or below, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, 

methoxyfenozide is not registered for 

any use patterns that would result in 

intermediate-term residential exposure. 

Intermediate-term risk is assessed based 

on intermediate-term residential 

exposure plus chronic dietary exposure. 

Because there is no intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess intermediateterm risk), no further assessment of 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating intermediateterm risk for methoxyfenozide. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

mstockstill on DSK4VPTVN1PROD with RULES

51106 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Rules and Regulations 

adequate rodent carcinogenicity studies, 

methoxyfenozide is not expected to 

pose a cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

methoxyfenozide residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(using high performance liquid 

chromatography (HPLC), with either 

tandem mass spectrometric detection 

(LC–MS/MS), or ultraviolet detection 

(HPLC–UV) is available to enforce the 

tolerance expression. It is also noted 

that the European Food Safety Authority 

(EFSA) has concluded that the 

multiresidue QuEChERS method, 

combined with an HPLC–MS/MS, is 

adequate for tolerance enforcement in 

plant and animal commodities (EFSA, 

2014)). 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for methoxyfenozide in pineapple. 

V. Conclusion 

Therefore, tolerances are established 

for residues of methoxyfenozide, 3- 

methoxy-2-methylbenzoic acid 2-(3,5- 

dimethylbenzoyl)-2-(1,1-dimethylethyl) 

hydrazide, in or on pineapple at 0.70 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

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: August 19, 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 § 180.544, add alphabetically the 

commodity ‘‘Pineapple’’ to the table in 

paragraph (a)(1) to read as follows: 

§ 180.544 Methoxyfenozide; Tolerance for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Pineapple .................................. 0.70 

* * * * * 

* * * * * 

[FR Doc. 2014–20376 Filed 8–26–14; 8:45 am] 

BILLING CODE 6560–50–P 

mstockstill on DSK4VPTVN1PROD with RULES