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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sunflower subgroup 20B at 5.0 ppm; 

cottonseed subgroup 20C at 1.0 ppm; 

and fruiting vegetable group 08–10 at 

1.0 ppm. Also, this notice further 

requests amending 40 CFR 180.458 by 

removing the following commodity 

listings: canola seed at 0.5 ppm, cotton, 

undelinted seed at 1.0 ppm, peach at 0.2 

ppm, onion, bulb at 0.2 ppm, strawberry 

at 3.0 ppm, and sunflower, seed at 5.0 

ppm, upon establishment of the 

aforementioned tolerances. That 

document referenced a summary of the 

petition prepared by Valent USA 

Corporation, the registrant, which is 

available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has made 

some modifications to petitioned-for 

crop tolerances. 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 clethodim 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with clethodim follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The liver is the target organ based on 

repeated dosing by either oral or dermal 

routes in rats, mice, and dogs. The 

observed liver effects are characterized 

by increased liver weights, clinical 

chemistry changes, and centrilobular 

hepatic hypertrophy. Most of the liver 

effects that occurred at or below 100 

milligrams/kilogram body weight (mg/

kg bw) were considered as adaptive 

effects and not adverse. Decreased body 

weight was also a common finding 

across studies and species. In the 1-year 

dog oral toxicity study, hematological 

changes such as increased platelet and 

leukocyte counts were also noted. 

Developmental effects were not 

present in rabbits; the rat developmental 

toxicity study showed reduced fetal 

body weights and an increase in the 

incidence of delayed ossification of the 

lower vertebrae at the same dose where 

maternal toxicity was found. Neither 

reproductive nor offspring effects were 

seen in the 2-generation rat 

reproduction study. Therefore, the data 

did not show an increased susceptibility 

in the young. The clethodim database 

also showed no potential for 

neurotoxicity or immunotoxicity. 

The rat and mouse carcinogenicity 

studies did not show treatment-related 

increases in tumor incidence. Clethodim 

is not genotoxic and 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 Clethodim as well as 

the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document’’, 

Clethodim. Human Health Aggregate 

Risk Assessment for the Proposed New 

Uses on Stevia, Pome Fruit Group 11– 

10, Stone Fruit Group 12–12, Bulb 

Onion Subgroup 3–07A, Low Growing 

Berry Subgroup 13–07G, (except 

Cranberry); Rapeseed Subgroup 20A 

(except Flax Seed), Sunflower Subgroup 

20B, Cottonseed Subgroup 20C, and 

Fruiting Vegetable Group 8–10, pages 

number 29 through 34 in docket ID 

number EPA–HQ–OPP–2015–0035. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for clethodim used for human 

risk assessment is shown in Table 1 of 

this unit. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CLETHODIM 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 (All populations) .. NOAEL = 100 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 1 mg/ 

kg/day.

aPAD = 1 mg/kg/day 

Acute neurotoxicity studies—rats. 

LOAEL = 1,000 mg/kg based on clinical observation from two 

acute neurotoxicity studies (one study was conducted in 

2006 and another was completed in 2012). The clinical observation included decreased spontaneous activity, ruffled 

fur, head tilt, and hunched posture. 

Chronic dietary (All populations) NOAEL = 30 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.3 

mg/kg/day.

cPAD = 0.3 mg/kg/ 

day 

Carcinogenicity study—mice. 

LOAEL = 150 mg/kg/day based on reduced survival; decreased 

red cell mass; and increased incidences of bile duct 

hyperplasia, of pigmentation of the liver, and of foci of 

amphophilic macrophages in the lung. 

Incidental Oral Short-Term (1– 

30 days).

NOAEL = 75 mg/kg/ 

day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 100 90-day oral toxicity—dogs. 

LOAEL = 125 mg/kg/day based on increased absolute and relative liver weights, and histological changes characterized by 

cytoplasmic vesiculation and vacuolation of the central lobular hepatocytes in both sexes. 

Inhalation Short-Term (1 to 30 

days).

NOAEL = 75 mg/kg/ 

day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 100 90-day oral toxicity—dogs 

LOAEL = 125 mg/kg/day based on increased absolute and relative liver weights, and histological changes characterized by 

cytoplasmic vesiculation and vacuolation of the central lobular hepatocytes in both sexes. 

Cancer (Oral, dermal, inhalation).Clethodim is classified as ‘‘Not Likely’’ to be carcinogenic based no treatment-related increase in tumor incidence in rat and mouse carcinogenicity studies. 

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

milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). 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 clethodim, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

clethodim tolerances in 40 CFR 180.458. 

EPA assessed dietary exposures from 

clethodim 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. 

Such effects were identified for 

clethodim. In estimating acute dietary 

exposure, EPA used the Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

Database (DEEM–FCID), Version 3.16, 

which incorporates 2003–2008 food 

consumption data from the U.S. 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). As to 

residue levels in food, EPA conducted 

unrefined acute dietary analyses 

assuming tolerance-level residues for all 

commodities and 100 percent crop 

treated (PCT). Unless tolerances were 

established for processed commodities, 

DEEM version 7.81 default processing 

factors were assumed. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the DEEM–FCID, Version 

3.16, which incorporates 2003–2008 

food consumption data from the USDA’s 

NHANES/WWEIA. As to residue levels 

in food, EPA conducted unrefined 

chronic dietary analyses assuming 

tolerance-level residues for all 

commodities and 100 PCT. Unless 

tolerances were established for 

processed commodities, DEEM version 

7.81 default processing factors were 

assumed. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that clethodim does not pose 

a cancer risk to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk was not 

conducted. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for clethodim. Tolerance-level residues 

and 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for clethodim in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of clethodim. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at: 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Based on the First Index Reservoir 

Screening Tool (FIRST) and Pesticide 

Root Zone Model Ground Water (PRZM 

GW) models, the estimated drinking 

water concentrations (EDWCs) of 

clethodim for acute exposures are 330 

parts per billion (ppb) for surface water 

and 1,430 ppb for ground water. 

For chronic exposures for non-cancer 

assessments are estimated to be 137 ppb 

for surface water and 1,150 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

For acute dietary risk assessment, the 

water concentration value of 1,430 ppb 

was used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 1,150 

ppb was used to assess the contribution 

to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

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occupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Clethodim is currently registered for 

the following uses that could result in 

residential exposures: In and around 

ornamental plant beds, landscaped area, 

trees, and ground covers (mulch). There 

are no residential uses associated with 

proposed new uses. EPA has previously 

assessed clethodim residential exposure 

using the following assumptions: Shortterm residential handler inhalation 

exposures represent the ‘‘worst case’’ 

high-end exposure. Because a dermal 

hazard was not identified, residential 

handler and post-application dermal 

risk assessments were not conducted. 

No other post-application exposures 

were assessed either because the 

potential for exposure via non-dietary 

ingestion for young children is unlikely 

due to the limited residential uses for 

clethodim products. The extent to 

which young children engage in the 

types of activities associated with these 

areas (i.e., ornamental landscapes) or 

utilize these areas for prolonged periods 

of play is low. No intermediate-term or 

chronic exposures are expected from the 

currently registered residential uses. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at: http://www2.epa.gov/

pesticide-science-and-assessingpesticide-risks/standard-operatingprocedures-residential-pesticide. 

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 clethodim to share 

a common mechanism of toxicity with 

any other substances, and clethodim 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that clethodim 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:// 

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no evidence of increased 

susceptibility of fetuses as compared to 

maternal animals following in utero 

and/or postnatal exposure to clethodim 

in the developmental toxicity studies in 

rats or rabbits, and no increased 

sensitivity in pups as compared to 

adults in the 2-generation rat 

reproduction toxicity study. There are 

no residual uncertainties concerning 

prenatal and postnatal toxicity and no 

neurotoxicity concerns. 

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 clethodim 

is complete. 

ii. There is no indication that 

clethodim 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 of increased 

susceptibility of fetuses as compared to 

maternal animals following in utero 

and/or postnatal exposure to clethodim 

in the developmental toxicity studies in 

rats or rabbits, and no increased 

sensitivity in pups as compared to 

adults in the 2-generation rat 

reproduction toxicity study. In the rat 

developmental study, reduced 

ossification seen at the same dose that 

resulted in maternal toxicity is 

considered secondary to reduced 

maternal body weight, and is not 

considered qualitative susceptibility. 

There are no residual uncertainties 

concerning prenatal and postnatal 

toxicity and no neurotoxicity concerns. 

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 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to clethodim in 

drinking water. Post application 

exposure of children and incidental oral 

exposures to toddlers are expected to be 

negligible. All exposure estimates are 

based on conservative assumptions that 

will not underestimate the exposure and 

risks posed by clethodim. 

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. Acute exposure is not expected 

for the residential exposure pathway. 

Therefore, the acute aggregate risk 

would be equivalent to the acute dietary 

exposure estimates. 

Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to clethodim will 

occupy 29% of the aPAD for all infants 

<1 year old, the population group 

receiving the greatest exposure. 

2. Chronic risk. There are no chronic 

residential exposure scenarios. 

Therefore, the chronic aggregate risk 

would be equivalent to the chronic 

dietary exposure (food and drinking 

water) estimate. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to clethodim from 

food and water will utilize 30% of the 

cPAD for all infants <1 year old, the 

population group receiving the greatest 

exposure. 

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). Clethodim 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 


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clethodim. 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 the short-term aggregate risk 

estimate for adults ages 20–49 is a MOE 

of 2,200. Because EPA’s level of concern 

for clethodim is a MOE of 100 or below, 

this MOE is not of concern. 

4. Intermediate-term risk. An 

intermediate-term adverse effect was 

identified; however, clethodim 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 

clethodim. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

clethodim 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 clethodim 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies 

are available: FDA Multiresidue 

Methods, gas chromatography/flame 

photometric detection in the sulfur 

mode (GC/FPD–S) and gas 

chromatography method with mass 

selective detection (GC/MSD). 

These methods have been adequately 

validated for the analyses of residues of 

clethodim in/on crop matrices. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has established MRLs for 

clethodim in or on onion bulb and garlic 

at 0.5 ppm, tomato at 1 ppm, rapeseed 

at 0.5 ppm, sunflower seed at 0.5 ppm, 

and cotton seed at 0.5 ppm. The U.S. 

tolerances for rapeseed subgroup 20A, 

fruiting vegetables crop group 8–10, and 

onion, bulb, subgroup 3–07A are 

harmonized with the Codex MRLs for 

rapeseed, tomato, and bulb onion and 

garlic, respectively. 

However, the U.S. tolerances for 

sunflower subgroup 20B and cottonseed 

subgroup 20C are not harmonized with 

the corresponding Codex MRLs for 

sunflower seed and cotton seed since 

the MRL values are lower than the U.S 

tolerances. The U.S. tolerances cannot 

be lowered to harmonize because doing 

so could result in residues above the 

tolerances when following the U.S. 

approved label directions. 

C. Revisions to Petitioned-for Tolerances 

The Agency made changes to the 

naming of certain petitioned-for 

commodities to reflect the current 

commodity definitions and significant 

figures used by the Agency. Although 

the petitioner requested a tolerance on 

stevia only, EPA established a tolerance 

on stevia, dried leaves because the dried 

commodity represents stevia that will be 

found in the U.S. trade market. 

Moreover, the Agency is removing 

certain commodities from the table at 

§ 180.458(a) in order to eliminate 

redundancies upon the establishment of 

new crop group tolerances that were not 

identified in the petition: mustard, seed 

at 0.5 ppm, safflower, seed at 5.0 ppm, 

sesame, seed at 0.35 ppm, vegetable, 

fruiting group 8 at 1.0 ppm. 

V. Conclusion 

Therefore, tolerances are established 

for residues of 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 berry, 

low growing, subgroup 13–07G, except 

cranberry at 3.0 ppm; cottonseed 

subgroup 20C at 1.0 ppm; fruit, pome, 

group 11–10 at 0.20 ppm; fruit, stone, 

group 12–12 at 0.20 ppm; onion, bulb, 

subgroup 3–07A at 0.50 ppm; rapeseed 

subgroup 20A, except flax seed at 0.50 

ppm; stevia, dried leaves at 12 ppm; 

sunflower subgroup 20B at 5.0 ppm; and 

vegetable, fruiting, group 8–10 at 1.0 

ppm. EPA is also removing the 

following established tolerances that are 

superseded by this action: Canola seed, 

at 0.50 ppm; cotton, undelinted seed at 

1.0 ppm; mustard, seed at 0.50 ppm; 

peach at 0.20 ppm; onion, bulb at 0.20 

ppm; strawberry at 3.0 ppm; safflower, 

seed at 5.0 ppm; sesame, seed at 0.35 

ppm; sunflower, seed at 5.0 ppm; 

vegetable, fruiting group 8 at 1.0 ppm. 

Finally, as a housekeeping measure, the 

Agency is removing two individual 

tolerances that are subsumed within 

other crop group tolerances contained in 

§ 180.458: Bean, dry, seed at 2.5 ppm is 

covered by the entry for vegetable, 

legume, group 6, except soybean at 3.5 

ppm and potato at 0.5 ppm is covered 

by the entry for vegetable, tuberous and 

corm, subgroup 1C at 1.0 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 


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27342 Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Rules and Regulations 

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: April 28, 2016. 

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 § 180.458, in the table in 

paragraph (a): 

■ a. Remove the entry for ‘‘Bean, dry, 

seed;’’ 

■ b. Add alphabetically an entry for 

‘‘Berry, low growing, subgroup 13–07G, 

except cranberry;’’ 

■ c. Remove the entry for ‘‘Canola 

seed;’’ 

■ d. Add alphabetically an entry for 

‘‘Cottonseed subgroup 20C;’’ 

■ e. Remove the entry for ‘‘Cotton, 

undelinted seed;’’ 

■ f. Add alphabetically entries for 

‘‘Fruit, pome, group 11–10’’ and ‘‘Fruit, 

stone, group 12–12;’’ 

■ g. Remove the entries for ‘‘Mustard, 

seed’’ and ‘‘Onion, bulb;’’ 

■ h. Add alphabetically an entry for 

‘‘Onion, bulb, subgroup 3–07A;’’ 

■ i. Remove the entries for ‘‘Peach’’ and 

‘‘Potato;’’ 

■ j. Add alphabetically an entry for 

‘‘Rapeseed subgroup 20A, except flax 

seed;’’ 

■ k. Remove the entries for ‘‘Safflower, 

seed,’’ ‘‘Sesame, seed,’’ and 

‘‘Strawberry;’’ 

■ l. Add alphabetically an entry for 

‘‘Stevia, dried leaves;’’ 

■ m. Remove the entries for ‘‘Sunflower, 

seed,’’ and ‘‘Vegetable, fruiting group 

8;’’ and 

■ n. Add alphabetically the entries for 

‘‘Sunflower subgroup 20B’’ and 

‘‘Vegetable, fruiting, group 8–10.’’ 

The additions read as follows: 

§ 180.458 Clethodim; tolerance for 

residues. 

(a) * * * 

Commodity 

Parts 

per 

million 

* * * * * 

Berry, low growing, subgroup 

13–07G, except cranberry ...... 3.0 

* * * * * 

Cottonseed subgroup 20C ......... 1.0 

* * * * * 

Fruit, pome, group 11–10 ........... 0.20 

Fruit, stone, group 12–12 ........... 0.20 

Commodity 

Parts 

per 

million 

* * * * * 

Onion, bulb, subgroup 3–07A .... 0.50 

* * * * * 

Rapeseed subgroup 20A, except 

flax seed .................................. 0.50 

* * * * * 

Stevia, dried leaves .................... 12 

* * * * * 

Sunflower subgroup 20B ............ 5.0 

* * * * * 

Vegetable, fruiting, group 8–10 .. 1.0 

* * * * * 

* * * * * 

[FR Doc. 2016–10738 Filed 5–5–16; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 11 

[ET Docket No. 04–296; FCC 16–32] 

Amendment of the Emergency Alert 

System 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the Federal 

Communications Commission (FCC or 

Commission) revises its rules governing 

the Emergency Alert System (EAS) to 

incorporate new multilingual alerting 

reporting requirements into its State 

EAS Plan reporting requirements. The 

Commission takes this action in 

response to a Petition for Immediate 

Interim Relief (Petition) jointly filed by 

the Independent Spanish Broadcasters 

Association (ISBA), the Office of 

Communication of the United Church of 

Christ, Inc., and the Minority Media and 

Telecommunications Council (now 

called The Multicultural, Media, 

Telecom and Internet Council) (MMTC) 

(collectively, ‘‘Petitioners’’). 

DATES: Effective June 6, 2016, except for 

the amendments to § 11.21(d) through 

(f), which contain modifications to 

information collection requirements that 

were previously approved by the Office 

of Management and Budget (OMB). 

Once OMB has approved the 

modifications to these collections, the 

Commission will publish a document in 

the Federal Register announcing the 

effective date of those paragraphs and 

rule amendments. 


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