27332 Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Rules and Regulations 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by July 5, 2016. Filing a petition 

for reconsideration by the Administrator 

of this final rule does not affect the 

finality of this action for the purposes of 

judicial review nor does it extend the 

time within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. This action may not be 

challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Reporting and recordkeeping 

requirements, Sulfur oxides. 

Dated: April 27, 2016. 

Robert A. Kaplan, 

Acting Regional Administrator, Region 5. 

40 CFR part 52 is amended as follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

■ 2. In § 52.770 the table in paragraph 

(d) is amended by adding new entries 

for ‘‘A.B. Brown Generating Station’’ 

and ‘‘Clifty Creek Generating Station’’, 

to read as follows: 

§ 52.770 Identification of plan. 

* * * * * 

(d) * * * 

EPA-APPROVED INDIANA SOURCE-SPECIFIC PROVISIONS

CO date Title SIP rule EPA approval Explanation 

*******

1/11/2016 ............... A.B. Brown Generating Station.N.A. 5/6/16, [insert Federal Register citation].Limitation intended to support attainment designation. 

2/1/2016 ................. Clifty Creek Generating Station.N.A. 5/6/16, [insert Federal Register citation].Limitation intended to support attainment designation. 

* * * * * 

[FR Doc. 2016–10579 Filed 5–5–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0591; FRL–9945–28] 

Methoxyfenozide; Pesticide Tolerances 

for Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

methoxyfenozide in or on rice, grain 

and rice, bran resulting from use of 

methoxyfenozide in accordance with 

the terms of an emergency exemption 

issued under section 18 of the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA). This action is in response 

to the California Department of 

Pesticide Regulation’s issuance of a 

crisis emergency exemption under 

FIFRA section 18 authorizing use of the 

pesticide on rice, bran and rice, grain. 

This time-limited tolerance regulation 

establishes a maximum permissible 

level for residues of methoxyfenozide in 

or on these commodities. These timelimited tolerances expire on December 

31, 2019. 

DATES: This regulation is effective May 

6, 2016. Objections and requests for 

hearings must be received on or before 

July 5, 2016, 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 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 section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

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 


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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 July 5, 2016. 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. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with FFDCA sections 408(e) 

and 408(l)(6) of, 21 U.S.C. 346a(e) and 

346a(1)(6), is establishing time-limited 

tolerances for residues of 

methoxyfenozide in or on rice, bran and 

rice, grain at 4.0 and 0.50 parts per 

million (ppm), respectively. These timelimited tolerances expire on December 

31, 2019. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under FIFRA section 18. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on FIFRA section 18 related 

time-limited tolerances to set binding 

precedents for the application of FFDCA 

section 408 and the safety standard to 

other tolerances and exemptions. 

Section 408(e) of FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. 

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. . . .’’ 

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for 

Methoxyfenozide on Rice, Grain and 

Rice, Bran and FFDCA Tolerances 

The California Department of 

Pesticide Regulation asserted that an 

emergency condition existed in 

accordance with the criteria for 

approval of an emergency exemption, 

and utilized a crisis exemption under 

FIFRA section 18 to allow the use of 

methoxyfenozide on rice to control 

armyworm and Western yellow striped 

armyworm in Butte, Glenn, Sacramento, 

Sutter, Yolo, and Yuba counties. The 

California Department of Pesticide 

Regulation invoked the crisis exemption 

provision on August 27, 2015. After 

having reviewed the submission and 

determining that the risks associated 

with the emergency use were reasonable 

in comparison to the expected benefits 

to the California rice growers who faced 

the largest outbreak of armyworms in 25 

years and significant economic loss, 

EPA concurred on the crisis exemption. 

The crisis exemption expired on 

September 10, 2015. 

As part of its evaluation of the 

emergency exemption application, EPA 

assessed the potential risks presented by 

residues of methoxyfenozide in or on 

rice, bran and rice, grain. In doing so, 

EPA considered the safety standard in 

FFDCA section 408(b)(2), and EPA 

decided that the necessary tolerances 

under FFDCA section 408(l)(6) would be 

consistent with the safety standard and 

with FIFRA section 18. Consistent with 

the need to move quickly on the 

emergency exemption in order to 

address an urgent non-routine situation 

and to ensure that the resulting food is 

safe and lawful, EPA is issuing these 

tolerances without notice and 

opportunity for public comment as 

provided in FFDCA section 408(l)(6). 

Although these time-limited tolerances 

expire on December 31, 2019, under 

FFDCA section 408(l)(5), residues of the 

pesticide not in excess of the amounts 

specified in the tolerances remaining in 

or on rice, bran and rice, grain after that 

date will not be unlawful, provided the 

pesticide was applied in a manner that 

was lawful under FIFRA, and the 

residues do not exceed a level that was 

authorized by these time-limited 

tolerances at the time of that 

application. EPA will take action to 

revoke these time-limited tolerances 

earlier if any experience with, scientific 

data on, or other relevant information 

on this pesticide indicate that the 

residues are not safe. 

Because these time-limited tolerances 

are being approved under emergency 

conditions, EPA has not made any 

decisions about whether 

methoxyfenozide meets FIFRA’s 

registration requirements for use on rice, 

grain and rice, bran or whether 

permanent tolerances for this use would 

be appropriate. Under these 

circumstances, EPA does not believe 

that these time-limited tolerance 

decisions serve as a basis for registration 

of methoxyfenozide by a State for 

special local needs under FIFRA section 

24(c). Nor do these tolerances by 

themselves serve as the authority for 

persons in any State other than 

California to use this pesticide on the 

applicable crops under FIFRA section 

18 absent the issuance of an emergency 

exemption applicable within that State. 

For additional information regarding the 

crisis emergency exemption for 

methoxyfenozide, contact the Agency’s 

Registration Division at the address 


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provided under FOR FURTHER

INFORMATION CONTACT. 

IV. 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 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 expected as a result 

of this emergency exemption request 

and the time-limited tolerances for 

residues of methoxyfenozide on rice, 

bran and rice, grain at 4.0 and 0.50 ppm, 

respectively, measured as 3-methoxy-2- 

methylbenzoic acid 2-(3,5- 

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

hydrazide. EPA’s assessment of 

exposures and risks associated with 

establishing time-limited tolerances 

follows. 

A. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for 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). Further, the Agency’s 

exposure and risk assessment for the 

emergency use on rice, bran and rice, 

grain is discussed in greater detail in 

‘‘Methoxyfenozide: Human Health Risk 

Assessment for the Proposed Use of the 

Insecticide (Associated with Section 18 

Registration) on Rice in California,’’ 

January 5, 2016 is available in the 

docket at the address provided under 

ADDRESSES. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to methoxyfenozide, EPA 

considered exposure under the timelimited tolerances established by this 

action 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 aggregate dietary (food and 

drinking water) exposure and risk 

assessment, EPA used the Dietary 

Exposure Evaluation Model software 

(Version 3.16) with the Food 

Commodity Intake Database (DEEM– 

FCID). This software includes 2003 to 

2008 food consumption data from the 

United States Department of 

Agriculture’s (USDA’s) National Health 

and Nutrition Examination Survey, 

What We Eat in America (NHANES/

WWEIA). All current and proposed uses 

of methoxyfenozide, were included in 

this assessment. As to residue levels in 

food, the chronic dietary assessment 

assumes 100% crop treated (PCT). 

DEEM (Version 7.81) default processing 

factors were used for most processed 

commodities that do not have 

individual tolerances. The only 

exception was a processing factor of 

0.2X that was used for orange juice from 

a processing study. The chronic dietary 

assessment is highly conservative 

(protective); therefore, providing an 

upper-bound estimate of dietary 

exposure and risk. 

iii. Cancer. Based on the data 

referenced in Unit IV.A., EPA has 

concluded that methoxyfenozide should 

be classified as ‘‘Not Likely to Be 

Carcinogenic to Humans.’’ As a result, a 

cancer dietary exposure assessment for 

the purpose of assessing cancer risk is 

unnecessary for methoxyfenozide, and 

was not conducted. 

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 FPQA 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 


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(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. 

C. 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 SF 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 twogeneration 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, including 

studies addressing potential pre- and 

post-natal susceptibility, neurotoxicity, 

and immunotoxicity. 

ii. There is no evidence that 

methoxyfenozide is neurotoxic, and a 

developmental neurotoxicity study or 

additional uncertainty factors (UFs) to 

account for neurotoxicity are not 

required. 

iii. There is no residual uncertainty, 

and no evidence increased 

susceptibility in the developing or 

young animal. 

iv. The dietary exposure assessments 

do not underestimate potential exposure 

from food and drinking water, and the 

use pattern indicates a low potential for 

residential exposure. 

D. 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 so, there is no acute dietary 

endpoint of concern. 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 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 


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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. 

EPA concludes that there is 

reasonable certainty that no harm will 

result to the general population, or to 

infants and children, from aggregate 

exposure to methoxyfenozide residues 

because the Section 18 emergency use of 

methoxyfenozide on rice will result in 

negligible increases in dietary exposure 

to all subgroups relative to the safety 

findings reached in the August 27, 2014 

Federal Register document. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate enforcement 

methodology is available to enforce the 

tolerance expression, using high 

performance liquid chromatography 

(HPLC), with either tandem mass 

spectrometric detection (LC–MS/MS), or 

ultraviolet detection (UV). 

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. 

There are currently no established 

Codex or Canadian MRLs for 

methoxyfenozide residues in rice 

commodities. 

VI. Conclusion 

Therefore, time-limited tolerances are 

established for residues of 

methoxyfenozide, (3-methoxy-2- 

methylbenzoic acid 2-(3,5- 

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

hydrazide), in or on rice, grain at 0.50 

ppm; and rice, bran at 4.0 ppm. These 

tolerances will expire on December 31, 

2019. 

VII. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA sections 408(e) and 

408(l)(6). 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 in accordance with 

FFDCA sections 408(e) and 408(l)(6), 

such as the tolerances in this final rule, 

do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) do not apply. 

This 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). 

VIII. 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: April 21, 2016. 

Daniel J. Rosenblatt, 

Acting 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, revise paragraph (b) to 

read as follows: 

§ 180.544 Methoxyfenozide; tolerances for 

residues. 

* * * * * 


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Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Rules and Regulations 27337 

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for residues of the insecticide 

methoxyfenozide, including its 

metabolites and degradates in or on the 

commodities listed in the table below, 

resulting from use of the pesticide under 

a Section 18 emergency exemption 

granted by EPA. Compliance with the 

tolerance levels specified in the 

following table is to be determined by 

measuring only methoxyfenozide (3- 

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

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

hydrazide) in or on the commodity. 

Commodity Parts per 

million 

Expiration/ 

revocation date 

Rice, bran 4.0 December 31, 

2019. 

Rice, 

grain.

0.50 December 31, 

2019. 

* * * * * 

[FR Doc. 2016–09969 Filed 5–5–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0035; FRL–9945–68] 

Clethodim; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of clethodim 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 May 

6, 2016. Objections and requests for 

hearings must be received on or before 

July 5, 2016, 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–2015–0035, 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–2015–0035 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 July 5, 2016. 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– 

2015–0035, 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, 

May 20, 2015 (80 FR 28925) (FRL–9927– 

39), 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 4E8334) by 

Interregional Research Project Number 4 

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

W, Princeton, NJ 08540. The petition 

requested that 40 CFR 180.458 be 

amended by establishing tolerances for 

residues of the herbicide clethodim, 2- 

[(1E)-1-[[[(2E)-3-chloro-2- 

propenyl]oxy]imino]propyl]-5-[2- 

(ethylthio)propyl]-3-hydroxy-2- 

cyclohexen-1-one, and its metabolites 

containing the 5-(2- 

ethylthiopropyl)cyclohexene-3-one and 

5-(2-ethylthiopropyl)-5- 

hydroxycyclohexene-3-one moieties and 

their sulphoxides and sulphones, 

calculated as the stoichiometric 

equivalent of clethodim, in or on stevia 

at 12 parts per million (ppm); pome fruit 

group 11–10 at 0.2 ppm; stone fruit 

group 12–12 at 0.2 ppm; bulb onion 

subgroup 3–07A at 0.2 ppm; low 

growing berry subgroup 13–07G, except 

cranberry at 3.0 ppm; rapeseed 

subgroup 20A, except flax 0.5 ppm; 


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