65964 Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Rules and Regulations 

medical devices that are wholly or 

partially implanted in the body or by 

their corresponding personal monitoring 

systems, where such circumvention is 

undertaken by a patient for the sole 

purpose of lawfully accessing the data 

generated by his or her own device or 

monitoring system and does not 

constitute a violation of applicable law, 

including without limitation the Health 

Insurance Portability and 

Accountability Act of 1996, the 

Computer Fraud and Abuse Act of 1986 

or regulations of the Food and Drug 

Administration, and is accomplished 

through the passive monitoring of 

wireless transmissions that are already 

being produced by such device or 

monitoring system. 

* * * * * 

Dated: October 20, 2015. 

David S. Mao, 

Acting Librarian of Congress. 

[FR Doc. 2015–27212 Filed 10–27–15; 8:45 am] 

BILLING CODE 1410–30–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0591; FRL–9934–14] 

Methoxyfenozide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

methoxyfenozide in or on multiple 

commodities which are identified and 

discussed later in this document. 

Interregional Research Project Number 4 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

October 28, 2015. Objections and 

requests for hearings must be received 

on or before December 28, 2015, 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–2014–0591, 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: 

Susan Lewis, 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–2014–0591 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 December 28, 2015. 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– 

2014–0591, 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 March 4, 

2015 (80 FR 11611) (FRL–9922–68), 

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 4E8298) by IR–4, 

500 College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR part 180 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), under paragraph (a) in or 

on: Chive, fresh leaves at 30.0 parts per 

million (ppm); fruit, stone, group 12–12, 

except plum, prune, fresh at 3.0 ppm; 

and nut, tree, group 14–12 at 0.10 ppm. 

The petition also proposed the 

following tolerances under paragraph (a) 

be removed upon approval of the 

proposed tolerances listed above: Fruit, 

stone, group 12, except plum, prune, 

fresh at 3.0 ppm; nut, tree, group 14 at 

0.10 ppm; pistachio at 0.10 ppm; and in 

paragraph (d), chive at 4.5 ppm be 

removed. The petition additionally 


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requested to amend the tolerances in 40 

CFR 180.544 for residues of 

methoxyfenozide in or on onion, green, 

subgroup 3–07B at 5.0 ppm to onion, 

green, subgroup 3–07B, except chive at 

5.0 ppm; and herb subgroup 19A, except 

chive at 400 ppm to herb subgroup 19A, 

except chive, fresh leaves at 400 ppm. 

That document referenced a summary of 

the petition prepared on behalf of IR–4 

by Dow AgroSciences LLC, the 

registrant, which is available in the 

docket, http://www.regulations.gov. No 

FFDCA-related comments were received 

on the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

determined that the amended tolerance 

on onion, green, subgroup 3–07B, 

except chive should be established in or 

on onion, green, subgroup 3–07B, 

except chive, fresh leaves. The reasons 

for these changes are explained in Unit 

IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue . . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 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. 

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 transiently decreased RBC 

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. 

However, no accompanying 

histopathology was observed. 

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, and the 

only observed effect was increased liver 

weights. 

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

toxicity studies can be found at http:// 

www.regulations.gov in document, 

‘‘Methoxyfenozide. Human Health Draft 

Risk Assessment for Registration Review 

and New Use Risk Assessment to 

Support the Registration of Proposed 

Use on Chives, and Crop Group 

Expansions for Stone Fruit and Tree 

Nuts’’ in pp. 42–47 in docket ID number 

EPA–HQ–OPP–2014–0591. 

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 are identified. 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 

methoxyfenozide used for human risk 

assessment is discussed in Table 1 of 

Unit III.B. of the final rule published in 

the Federal Register of August 27, 2014 

(79 FR 51103) (FRL–9913–99). 

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 


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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 the food consumption data 

from the USDA under the National 

Health and Nutrition Examination 

Survey, What We Eat in America 

(NHANES/WWEIA), 2003 to 2008. As to 

residue levels in food, EPA used 

tolerance-level residues and the 

assumption of 100 percent crop treated 

(PCT) for all existing and proposed 

commodities. 

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 residues of concern in 

drinking water are methoxyfenozide and 

the degradates RH–117,236 and RH– 

131,154, which are only present at low 

concentrations. The Agency used 

screening-level water exposure models 

in the dietary exposure analysis and risk 

assessment for methoxyfenozide and its 

degradates in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of 

methoxyfenozide and its degradates. 

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 FQPA Index Reservoir 

Screening Tool (FIRST), Screening 

Concentration in Ground Water (SCI– 

GROW), and the Pesticide Root Zone 

Model Ground Water (PRZM GW) 

models, the estimated drinking water 

concentrations (EDWCs) of 

methoxyfenozide and its degradates for 

chronic exposures for non-cancer 

assessments are estimated to be 7.57 

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 use on ornamentals in and around 

home gardens, which could result in 

residential exposures. EPA assessed 

residential exposure using the following 

assumptions: Residential handlers were 

assessed for potential short-term 

inhalation exposures from mixing, 

loading, and applying methoxyfenozide. 

A quantitative dermal assessment for 

residential handlers was not conducted 

since there is no systemic toxicity 

associated with dermal exposures to 

methoxyfenozide. Adult postapplication 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 

treated 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 for 

methoxyfenozide. No developmental 

toxicity was observed in either the rat or 

rabbit developmental toxicity studies, 

and there was no evidence of offspring 

or reproductive toxicity in the rat 2- 

generation reproductive toxicity study. 

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 uncertainty factors (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 chronic dietary food exposure 

assessment was performed based on 100 

PCT and tolerance-level residues. EPA 


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made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to methoxyfenozide in drinking water. 

Based on the discussion Unit III.C.3., 

regarding residential use patterns, EPA 

does not expect residential uses of 

methoxyfenozide to result in 

postapplication exposure of children or 

incidental oral exposures of toddlers. 

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 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, 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 84% of the cPAD for 

children 1 to 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 an 

aggregate MOE 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 intermediateterm 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 intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

methoxyfenozide. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

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 

(UV) is available to enforce the tolerance 

expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for methoxyfenozide in or on chive or 

the commodities associated with herb 

subgroup 19A or green onion subgroup 

3–07B. Codex has established an MRL 

in or on tree nuts at 0.1 milligram/

kilogram (mg/kg), which is harmonized 

with the recommended tolerance of 0.10 

ppm in or on tree nut crop group 14– 

12. However, Codex has established a 

tolerance in or on stone fruit at 2 mg/ 

kg that cannot be harmonized with the 

EPA tolerance in or on stone fruit group 

12–12, except plum, prune, fresh at 3.0 

ppm because the Organization for 

Economic Cooperation and 

Development (OECD) tolerance 

calculations that EPA uses to calculate 

U.S. tolerance levels result in a 

tolerance that is higher than the Codex 

MRL, and reduction of the tolerance 

would result in the risk of violative 

residues resulting from proper use 

according to label directions. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the data supporting the 

petition, the Agency determined that the 

petitioned-for tolerance on chive, fresh 

leaves at 30.0 ppm should be 

established in or on chive, fresh leaves 

at 30 ppm because EPA establishes 

tolerances using whole numbers for 

tolerances of 10 ppm or more, per the 

OECD tolerance calculation procedures. 

The Agency also determined that the 

petitioned-for-amended tolerance in or 

on onion, green, subgroup 3–07B, 

except chive should be established in or 

on onion, green, subgroup 3–07B, 

except chive, fresh leaves. This is due 

to the fact that only chive, fresh leaves 

are included in subgroup 3–07B, and 

the Agency is establishing a separate 

tolerance for chive, fresh leaves at 30 

ppm. 

V. Conclusion 

Therefore, tolerances are established 

for residues of methoxyfenozide, (3- 

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


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

hydrazide), in or on chive, fresh leaves 

at 30 ppm; fruit, stone, group 12–12, 

except plum, prune, fresh at 3.0 ppm; 

herb subgroup 19A, except chive, fresh 

leaves at 400 ppm; onion, green, 

subgroup 3–07B, except chive, fresh 

leaves at 5.0 ppm; and nut, tree, group 

14–12 at 0.10 ppm. This rule 

additionally removes the established 

tolerances in or on fruit, stone, group 

12, except plum, prune, fresh at 3.0 

ppm; herb subgroup 19A, except chive 

at 400 ppm; nut, tree, group 14 at 0.10 

ppm; onion, green, subgroup 3–07B at 

5.0 ppm; pistachio at 0.10 ppm; and in 

paragraph (d)(2), chive at 4.5 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action 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 action 

has been exempted from review under 

Executive Order 12866, this action 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 action 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 action 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (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 

(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: October 20, 2015. 

Susan Lewis, 

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: 

■ a. Remove the following commodities 

from the table in paragraph (a): ‘‘Fruit, 

stone, group 12, except plum, prune, 

fresh’’; ‘‘Herb subgroup 19A, except 

chive’’; ‘‘Nut, tree, group 14’’; ‘‘Onion, 

green, subgroup 3–07B’’; and 

‘‘Pistachio’’. 

■ b. Remove the commodity ‘‘Chive’’ 

from the table in paragraph (d)(2). 

■ c. Add alphabetically add the 

following commodities to the table in 

paragraph (a). 

The additions and revisions read as 

follows: 

§ 180.544 Methoxyfenozide; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Chive, fresh leaves ............... 30 

* * * * * 

Fruit, stone, group 12–12, 

except plum, prune, fresh 3.0 

* * * * * 

Herb subgroup 19A, except 

chive, fresh leaves ............ 400 

* * * * * 

Nut, tree, group 14–12 ......... 0.10 

Onion, green, subgroup 3– 

07B, except chive, fresh 

leaves ................................ 5.0 

* * * * * 

* * * * * 

[FR Doc. 2015–27461 Filed 10–27–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[Docket ID FEMA–2015–0001] 

Final Flood Elevation Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: Base (1% annual-chance) 

Flood Elevations (BFEs) and modified 

BFEs are made final for the 

communities listed below. The BFEs 

and modified BFEs are the basis for the 

floodplain management measures that 

each community is required either to 

adopt or to show evidence of being 

already in effect in order to qualify or 

remain qualified for participation in the 

National Flood Insurance Program 

(NFIP). 

DATES: The date of issuance of the Flood 

Insurance Rate Map (FIRM) showing 

BFEs and modified BFEs for each 


Lhorne on DSK5TPTVN1PROD with RULES