Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Rules and Regulations 38981 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0284; FRL–9927–85] 

S-metolachlor; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of S-metolachlor 

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 July 

8, 2015. Objections and requests for 

hearings must be received on or before 

September 8, 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–2014–0284, 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–2014–0284 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 September 8, 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– 

2014–0284, 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 December 

17, 2014 (79 FR 75107) (FRL–9918–90), 

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 4E8248) by IR–4 

500 College Road East, Suite 201 W, 

Princeton, NJ 08540, requests to 

establish a tolerance in 40 CFR part 180 

for residues of S-metolachlor in or on 

the raw agricultural commodity lettuce 

at 1.5 parts per million (ppm); vegetable, 

cucurbit group 9 at 0.50 ppm; vegetable, 

fruiting, group 8–10, except tabasco 

pepper at 0.10 ppm; low growing berry 

subgroup 13–07G except cranberry at 

0.40 ppm; and sunflower subgroup 20B 

at 0.50 ppm and the concurrent deletion 

of the existing tolerances for okra; 

vegetable, fruiting, group 8 except 

tabasco pepper; cucumber; melon 

subgroup 9A; pumpkin; squash, winter; 

and sunflower, seed. That document 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

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 

modified the levels at which some of the 

tolerances are being established. The 

reason 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 


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38982 Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Rules and Regulations 

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 S-metolachlor 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with S-metolachlor 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. 

The existing toxicological database is 

primarily comprised of studies 

conducted with metolachlor. However, 

bridging studies indicate that the 

metolachlor toxicology database can be 

used to assess toxicity for Smetolachlor. In subchronic (metolachlor 

and S-metolachlor) and chronic 

(metolachlor) toxicity studies in dogs 

and rats decreased body weight and 

body weight (bw) gain were the most 

commonly observed effects. No systemic 

toxicity was observed in rabbits when 

metolachlor was administered dermally. 

There was no evidence of neurotoxic 

effects in the available toxicity studies, 

and there is no evidence of 

Immunotoxicity in the submitted mouse 

Immunotoxicity study. 

Prenatal developmental studies in the 

rat and rabbit with both metolachlor and 

S-metolachlor revealed no evidence of a 

qualitative or quantitative susceptibility 

in fetal animals. A 2-generation 

reproduction study with metolachlor in 

rats showed no evidence of parental or 

reproductive toxicity. There are no 

residual uncertainties with regard to 

pre- and/or postnatal toxicity. 

Metolachlor has been evaluated for 

carcinogenic effects in the mouse and 

the rat. Metolachlor did not cause an 

increase in tumors of any kind in mice. 

In rats, metolachlor caused an increase 

in benign liver tumors in rats, but this 

increase was seen only at the highest 

dose tested and was statistically 

significant compared to controls only in 

females. There was no evidence of 

mutagenic or cytogenetic effects in vivo 

or in vitro. Based on this evidence, EPA 

has concluded that metolachlor does not 

have a common mechanism of 

carcinogenicity with acetochlor and 

alachlor, compounds that are 

structurally similar to metolachlor. 

Metolachlor has been classified as a 

Group C, possible human carcinogen, 

based on liver tumors in rats at the 

highest dose tested (HDT). 

Taking into account the qualitatively 

weak evidence on carcinogenic effects 

and the fact that the increase in benign 

tumors in female rats occurs at a dose 

1,500 times the chronic reference dose 

(cRfD), EPA has concluded that the cRfD 

is protective of any potential cancer 

effect. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by S-metolachlor 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 the document 

‘‘S-metolachlor—Risk Assessment for 

Establishment of Tolerances for New 

Uses on Lettuce, Low Growing Berry 

Subgroup 13–07G, except Cranberry; 

Vegetable, Cucurbit, Group 9; Sunflower 

subgroup 20B; Vegetable, Fruiting, 

Group 8–10; except Tabasco Pepper and 

Okra’’ on pp. 40 in docket ID number 

EPA–HQ–OPP–2014–0284. 

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 S-metolachlor used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR S-METOLACHLOR FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (General population including infants and children).NOAEL = 300 mg/kg/

day.

Acute RfD = 3.0 mg/

kg/day.

Developmental Toxicity Study—Rat 

(metolachlor). 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x. 

aPAD = 3.0 mg/kg/day LOAEL = 1,000 mg/kg/day based increased 

incidence of death, clinical signs (clonic 

and/or tonic convulsions, excessive salivation, urine-stained abdominal fur and/or excessive lacrimation), and decreased body 

weight gain. 

Chronic dietary (All populations) ...................... NOAEL= 9.7 mg/kg/

day.

Chronic RfD = 0.097 

mg/kg/day.

One Year Chronic Toxicity—Dog 

(metolachlor). 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x. 

cPAD = 0.097 mg/kg/

day.

LOAEL = 33 mg/kg/day based decreased 

body weight gain in females. 


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Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Rules and Regulations 38983 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR S-METOLACHLOR FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Incidental oral short-term (1 to 30 days) .......... NOAEL= 50 mg/kg/

day.

LOC for MOE = 100 ... Developmental Toxicity Study—Rat (Smetolachlor). 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x. 

..................................... LOAEL = 500 mg/kg/day based on increased 

incidence of clinical signs, decreased body 

weight/body weight gain, food consumption 

and food efficiency seen in maternal animals. 

Inhalation short-term (1 to 30 days) ................. Inhalation (or oral) 

study NOAEL= 50 

mg/kg/day (inhalation absorption rate 

= 100%).

LOC for MOE = 1,000 Developmental Toxicity Study—Rat (Smetolachlor). 

UFA = 10x 

UFH = 10x 

FQPA SF = 10x UFDB. 

..................................... LOAEL = 500 mg/kg/day based on increased 

incidence of clinical signs, decreased body 

weight/body weight gain, food consumption 

and food efficiency seen at the LOAEL in 

maternal animals. 

Cancer (all routes) ............................................ Metolachlor has been classified as a Group C carcinogen with risk quantitated using a non-linear RfD approach. 

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

milligram/kilogram/day. MOE = margin of exposure. 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). UFDB = to account for the absence of data or other data deficiency. 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 S-metolachlor, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing S-metolachlor tolerances in 40 

CFR 180.368. EPA assessed dietary 

exposures from S-metolachlor 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 Smetolachlor. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture’s (USDA) 

National Health and Nutrition 

Examination Survey/What We Eat in 

America, (NHANES/WWEIA). As to 

residue levels in food, EPA assumed 

tolerance level residues and 100 percent 

crop treated (PCT). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA’s NHANES/WWEIA. As 

to residue levels in food, EPA assumed 

tolerance level residues and 100 PCT. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to S-metolachlor. Therefore, 

a separate quantitative cancer exposure 

assessment is unnecessary since the 

chronic dietary risk estimate will be 

protective of potential cancer risk. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for Smetolachlor. 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 S-metolachlor in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of Smetolachlor. 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. 

The Agency assessed parent 

metolachlor, and the metabolites CGA– 

51202 (metolachlor-OA), CGA–40172, 

and CGA–50720 together in the drinking 

water assessment using a total toxic 

residues (TTR) approach where halflives were recalculated to collectively 

account for the parent and the combined 

residues of concern. 

Based on the Surface Water 

Concentration Calculator (SWCC), the 

Pesticide Root Zone Model Ground 

Water (PRZM GW), and the Screening 

Concentration in Ground Water (SCI– 

GROW), the estimated drinking water 

concentrations (EDWCs) of Smetolachlor and its metabolites for 

acute exposures are estimated to be 371 

parts per billion (ppb) for surface water 

and 1,060 ppb for ground water, and for 

chronic exposures are estimated to be 

43.70 ppb for surface water and 14.3 

ppb in 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 1,060 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 43.70 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, termiticide, and flea 

and tick control on pets). 

S-metolachlor is currently registered 

for the following uses that could result 

in residential exposures: On commercial 

(sod farm) and residential warm-season 

turf grasses and other non-crop land 

including golf courses, sports fields, and 

ornamental gardens. EPA assessed 

residential exposure using the following 

assumptions: For residential handlers, 

short-term inhalation exposure is 


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expected. The following scenarios were 

evaluated: 

• Mixing/loading/applying gardens/

trees with manually-pressurized hand 

wand, hose-end sprayer, backpack, and 

sprinkler can equipment. 

• Mixing/loading/applying lawns/turf 

with manually-pressurized hand wand, 

hose-end sprayer, backpack, and 

sprinkler can equipment. 

For residential post-application, there 

is the potential for short-term incidental 

oral exposure for individuals exposed as 

a result of being in an environment that 

has been previously treated with Smetolachlor. The quantitative exposure/ 

risk assessment for residential postapplication exposures is based on the 

following scenario: 

• Hand-to-mouth incidental oral 

exposure of children 1–2 years old 

playing on turf treated with Smetolachlor. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

science/residential-exposure-sop.html. 

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 S-metolachlor to 

share a common mechanism of toxicity 

with any other substances, and Smetolachlor does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that S-metolachlor 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 (10×) 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 10×, 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 was no evidence of increased 

quantitative or qualitative fetal 

susceptibility in the prenatal 

developmental studies in rats and 

rabbits or in the reproductive toxicity 

study in rats, with either metolachlor or 

S-metolachlor. In general, significant 

developmental toxicity was not seen in 

rats or rabbits with either compound. 

The only effects observed in fetal 

animals were in the rat prenatal 

developmental study and included 

slightly decreased number of 

implantations per dam, decreased 

number of live fetuses/dam, increased 

number of resorptions/dam and 

significant decrease in mean fetal bw. 

These effects occurred at maternally 

toxic doses (1,000 milligram/kilogram/

day (mg/kg/day)). 

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 1× for all scenarios 

except inhalation. For inhalation 

scenarios a 10× database uncertainty 

factor (UF) still applies. This decision is 

based on the following findings: 

i. The toxicology database for 

metolachlor and S-metolachlor is 

complete, with the exception of a 

required subchronic inhalation study for 

metolachlor. As noted above, a 10× data 

base UF will be applied only for 

assessing risk for inhalation exposure 

scenarios. 

ii. There is no indication that Smetolachlor is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that Smetolachlor results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to Smetolachlor in drinking water. EPA 

used similarly conservative assumptions 

to assess post-application incidental 

oral exposure of children 1<2 years old. 

These assessments will not 

underestimate the exposure and risks 

posed by S-metolachlor. 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to Smetolachlor will occupy 6.1% of the 

aPAD for all infants (less than 1 year 

old), the population group receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to S-metolachlor 

from food and water will utilize 6.8% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of S-metolachlor 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). 

S-metolachlor 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 S-metolachlor. Potential 

short-term residential risk scenarios 

anticipated include adult inhalation 

handler exposure to turf via backpack 

sprayer and post-application incidental 

oral exposure of children playing on 

treated lawns. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 10,400 for adults and 1,100 for 

children 1–2 years old. Because EPA’s 

levels of concern for S-metolachlor is a 


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MOE of 1,000 or below for inhalation 

scenarios (adults) and 100 or below for 

incidental oral scenarios (children 1–2 

years old), 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, S-metolachlor 

is not registered for any use patterns 

that would result in intermediate-term 

residential 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 Smetolachlor. 

5. Aggregate cancer risk for U.S. 

population. As discussed in Unit III.A, 

the chronic dietary risk assessment is 

protective of any potential cancer 

effects. Based on the results of that 

assessment, EPA concludes that Smetolachlor 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 Smetolachlor residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate methodology is available for 

enforcing the established and 

recommended tolerances. PAM Vol. II, 

Pesticide Regulation Section 180.368, 

lists a gas chromatography with 

nitrogen-phosphorus detector (GC/NPD) 

method (Method I) for determining 

residues in/on plant commodities and a 

gas chromatography with mass selective 

detector (GC/MSD) method (Method II) 

for determining residues in livestock 

commodities. These methods determine 

residues of metolachlor and its 

metabolites as either CGA–37913 or 

CGA–49751 following acid hydrolysis. 

Adequate data are also available on the 

recovery of metolachlor through FDA’s 

Multiresidue Method Testing Protocols 

which indicate that metolachlor is 

completely recovered through Method 

302. 

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 S-metolachlor. 

C. Revisions to Petitioned-For 

Tolerances 

The tolerance being established for 

the sunflower subgroup 20B is 1.0 ppm, 

not 0.50 ppm as proposed. This is due 

to the Agency using the Organization for 

Economic Cooperation and 

Development (OECD) Tolerance 

Calculation procedures, which 

determined that a tolerance of 1.0 ppm 

is appropriate based on entry of the 4 

field trials for pre-emergence 

application. 

V. Conclusion 

Therefore, tolerances are established 

for residues of S-metolachlor in or on 

lettuce at 1.5 ppm; the low growing 

berry subgroup 13–07G, except 

cranberry at 0.40 ppm; the sunflower 

subgroup 20B at 1.0 ppm; the vegetable, 

cucurbit group 9 at 0.50 ppm; and the 

vegetable, fruiting, group 8–10, except 

tabasco pepper at 0.10 ppm. 

Additionally, due to the establishment 

of the tolerances listed above, the 

existing tolerances for vegetable, 

fruiting, group 8, except tabasco pepper; 

cucumber; melon subgroup 9A; okra; 

pumpkin; squash, winter; and 

sunflower, seed are removed as they are 

unnecessary. 

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). 


tkelley on DSK3SPTVN1PROD with RULES
38986 Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Rules and Regulations 

1This rule defines ‘‘trip limit’’ as the total 

allowable amount of a species by weight of fish that 

may be retained on board, transshipped, or landed 

during a single fishing trip. 

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: June 26, 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 § 180.368: 

■ a. Remove the entries ‘‘Cucumber,’’ 

‘‘Melon subgroup 9A,’’ ‘‘Okra,’’ 

‘‘Pumpkin,’’ ‘‘Squash, winter,’’ 

‘‘Sunflower, seed,’’ and ‘‘Vegetable, 

fruiting, group 8, except tabasco 

pepper,’’ in paragraph (a)(2). 

■ b. Add alphabetically the following 

commodities to the table in paragraph 

(a)(2). 

The amendments read as follows: 

§ 180.368 Metolachlor; tolerances for 

residues. 

(a) * * * 

(2) * * * 

Commodity Parts per 

million 

* * * * * 

Lettuce .................................. 1.5 

Low growing berry subgroup 

13–07G, except cranberry 0.40 

* * * * * 

Sunflower subgroup 20B ...... 1.0 

* * * * * 

Vegetable, cucurbit group 9 0.50 

* * * * * 

Vegetable, fruiting, group 8– 

10, except tabasco pepper 0.10 

* * * * * 

* * * * * 

[FR Doc. 2015–16523 Filed 7–7–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 300 

[Docket No. 141222999–5561–02] 

RIN 0648–BE71 

International Fisheries; Pacific Tuna 

Fisheries; 2015 and 2016 Commercial 

Fishing Restrictions for Pacific Bluefin 

Tuna in the Eastern Pacific Ocean 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule. 

SUMMARY: The National Marine 

Fisheries Service (NMFS) is issuing 

regulations under the Tuna Conventions 

Act to implement Resolution C–14–06 

of the Inter-American Tropical Tuna 

Commission (IATTC or the 

Commission) by establishing limits on 

U.S. commercial catch of Pacific bluefin 

tuna from waters of the IATTC 

Convention Area for 2015 and 2016. 

This action is necessary for the United 

States to satisfy its obligations as a 

member of the IATTC. 

DATES: The final rule is effective July 9, 

2015. 

ADDRESSES: Copies of the Regulatory 

Impact Review (RIR), Environmental 

Assessment, and other supporting 

documents are available via the Federal 

eRulemaking Portal: http://

www.regulations.gov, docket NOAA– 

NMFS–2014–0151, or contact with the 

Regional Administrator, William W. 

Stelle, Jr., NMFS West Coast Region, 

7600 Sand Point Way NE., Bldg 1, 

Seattle, WA 98115–0070, or 

RegionalAdministrator.WCRHMS@

noaa.gov. 

FOR FURTHER INFORMATION CONTACT: 

Celia Barroso, NMFS, Celia.Barroso@

noaa.gov, 562–432–1850. 

SUPPLEMENTARY INFORMATION: 

Background 

On March 9, 2015, NMFS published 

a proposed rule in the Federal Register 

(80 FR 12375) to revise regulations at 50 

CFR part 300, subpart C, to implement 

Resolution C–14–06, ‘‘Measures for the 

Conservation and Management of 

Bluefin Tuna in the Eastern Pacific 

Ocean, 2015–2016.’’ This resolution was 

adopted by the IATTC at its 88th 

meeting in October 2014. The public 

comment period was open until April 8, 

2015, and NMFS accepted public 

comment at a hearing held at the NMFS 

West Coast Region Long Beach office on 

March 26, 2015. Additionally, NMFS 

solicited public comment on the 

proposed trip limits, which are a new 

management tool in U.S. West Coast 

management of fisheries for Pacific 

bluefin tuna. The proposed trip limits 

were based on a recommendation from 

the Pacific Fishery Management Council 

(Council) at its November 2014 meeting. 

The final rule is implemented under 

the authority of the Tuna Conventions 

Act (16 U.S.C. 951 et seq.), which 

directs the Secretary of Commerce, after 

approval by the Secretary of State, to 

promulgate regulations as may be 

necessary to implement resolutions 

adopted by the IATTC. This authority 

has been delegated to NMFS. 

The proposed rule contains additional 

background information, including 

information on the IATTC, the 

international obligations of the United 

States as an IATTC member, and the 

need for regulations. Additional 

information on changes since the 

proposed rule is included below. 

New Regulations 

This final rule establishes catch limits 

for U.S. commercial vessels that catch 

Pacific bluefin tuna in the Convention 

Area (defined as the waters of the 

eastern Pacific Ocean (EPO)) for 2015 

and 2016. Since 1998, conservation 

resolutions adopted by the IATTC have 

further defined the Convention Area as 

the area bounded by the coast of the 

Americas, the 50° N. and 50° S. 

parallels, and the 150° W. meridian. In 

2015, the catch limit for the entire U.S. 

fleet is 425 metric tons (mt) with an 

initial trip limit 1 of 25 mt per vessel. 

When NMFS anticipates that the total 

catch for the fleet has reached 375 mt, 

NMFS will impose a 2-mt trip limit for 

each vessel that will be in effect until 

the total catch for 2015 reaches 425 mt. 

For calendar year 2016, NMFS will 

announce the catch limit in a Federal 

Register notice; NMFS will calculate the 

2016 catch limit to ensure compliance 

with Resolution C–14–06 (i.e., not to 

exceed 425 mt in either year and if catch 

exceeds 300 mt in 2015, then catch will 

be limited to 200 mt in 2016). The 2016 

catch limit will be calculated as the 

remainder from the 2015 catch limit 

(i.e., how much of 425 mt was not 


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