48902 Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 

* * * * * 

[FR Doc. 2012–19987 Filed 8–14–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0657; FRL–9356–9] 

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 beet, garden, leaves, cilantro, 

leaves and coriander, seed. Interregional 

Research Project Number 4 requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 15, 2012. Objections and 

requests for hearings must be received 

on or before October 15, 2012, 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–2011–0657, is 

available at http://www.regulations.gov 

or at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; email address: 

jackson.sidney@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. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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://ecfr.gpoaccess.gov/cgi/t/

text/text-idx?&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–2011–0657 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before October 15, 2012. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0657, 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 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 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.htm. 

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 September 

7, 2011 (76 FR 55329) (FRL–8886–7), 

EPA issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1E7898) by Interregional 

Research Project Number 4, 500 College 

Road East, Suite 201W, Princeton, NJ 

08540. The petition requested that 40 

CFR 180.368 be amended by 

establishing tolerances for residues of 

the herbicide S-metolachlor, S-2-chloroN-(2-ethyl-6-methylphenyl)-N-(2- 

methoxy-1-methylethyl)acetamide, its 

R-enantiomer, and its metabolites, 

determined as the derivatives, 2-[2- 

ethyl-6-methylphenyl)amino]-1- 

propanol and 4-[2-ethyl-6- 

methylphenyl)-2-hydroxy-5-methyl-3- 

morpholinone, in or on cilantro, leaves, 

fresh at 8.0 parts per million (ppm) 

cilantro, leaves, dried at 8.0 ppm, 

coriander, seed at 0.13 ppm and beet, 

garden, leaves at 1.8 ppm. That notice 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

the registrant, which is available in the 

docket, http://www.regulations.gov. 

EPA received one comment to the 

Notice of Filing. That comment is 

addressed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA corrected 

the crop definition for ‘‘cilantro’’ to 

‘‘coriander’’ and removed proposed 

tolerances for fresh and dried cilantro 

leaves. The reasons for these changes 

are explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 


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Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 48903 

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 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 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. 

S-Metolachlor exhibits low acute 

toxicity via oral, inhalation, and dermal 

routes of exposure. It causes slight eye 

irritation, and is non-irritating dermally, 

but is a dermal sensitizer. In subchronic 

(metolachlor and S-metolachlor) and 

chronic (metolachlor) toxicity studies in 

dogs and rats decreased body weight 

and body weight gain were the most 

commonly observed effects. No systemic 

toxicity was observed when metolachlor 

was administered dermally. No 

neurotoxicity studies with metolachlor 

or S-metolachlor are available. However, 

there was no evidence of neurotoxic 

effects in the available toxicity studies. 

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 which are structurally similar. 

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 document 

entitled, ‘‘S-Metolachlor. Human Health 

Risk Assessment for the Section 3 

Requests for Use on Coriander (Cilantro) 

and Garden Beet Leaves,’’ p. 13 in 

docket ID number EPA–HQ–OPP–2011– 

0657. 

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:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for S-metolachlor used for 

human risk assessment is discussed in 

Unit III. of the final rule published in 

the Federal Register of September 17, 

2010 (75 FR 56899) (FRL–8842–3). 

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 metolachlor and S-metolachlor 

tolerances in 40 CFR 180.368. EPA 

assessed dietary exposures from Smetolachlor in food as follows: 

Both the acute and chronic analyses 

assume tolerance-level residues on all 

crops with established, pending, or 

proposed tolerances for metolachlor 

and/or S-metolachlor. In cases where 

separate tolerance listings occur for both 

metolachlor and S-metolachlor on the 

same commodity, the higher value of 

the two is used in the analyses. 

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) 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII), 1994– 

1996 and 1998. As to residue levels in 

food, EPA assumed tolerance level 

residues for all uses, 100 percent crop 

treated (PCT) for all commodities and 

default processing factors. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA’s Nationwide CSFII, 

1994–1996 and 1998. As to residue 

levels in food, EPA assumed tolerance 

level residues for all uses, 100 PCT for 

all commodities and default processing 

factors. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a foodVerDate Mar<15>2010 17:27 Aug 14, 2012 Jkt 226001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\FR\FM\15AUR1.SGM 15AUR1

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48904 Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 

use pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or nonlinear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or nonlinear approach is 

used and a cancer RfD is calculated 

based on an earlier noncancer key event. 

If carcinogenic mode of action data are 

not available, or if the mode of action 

data determine a mutagenic mode of 

action, a default linear cancer slope 

factor approach is utilized. 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. Cancer risk 

was assessed using the same exposure 

estimates as discussed in Unit III.C.1.ii. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for S-metolachlor. Tolerance level 

residues and 100 PCT were assumed for 

all food commodities with existing 

tolerances, and default processing 

factors. 

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. 

Based on the First Index Reservoir 

Screening Tool (FIRST), Pesticide Root 

Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS) 

Screening Concentration in Ground 

Water (SCI–GROW) models and the 

USGA National Water-Quality 

Assessment (NAWQA) Program 

monitoring data, the Agency calculated 

conservative estimated drinking water 

concentrations (EDWCs) of Smetolachlor and metolachlor originating 

from ground water and surface water. 

EDWCs for metolachlor and metolachlor 

were calculated for both the parent 

compound and the ethanesulfonic acid 

(ESA) and oxanilic acid (OA) 

degradates. The environmental fate data 

have been bridged from the racemic 

mixture (50:50) of metolachlor to the 

newer isomer (88:12) S-metolachlor, 

based on similarities in environmental 

fate behavior. Tier I and Tier II 

screening models were employed for 

this assessment. For surface water, 

PRZM/EXAMS and FIRST Version1.1.1 

models were used to estimate drinking 

water concentrations for the parent Smetolachlor and the ESA and OA 

degradates, respectively. The SCI– 

GROW model was used to predict the 

maximum acute and chronic 

concentrations present in shallow 

groundwater. Current NAWQA 

monitoring data were also used to 

determine EDWCs. Based on monitoring 

and modeling data, total EDWCs for 

peak and average surface water 

respectively are 219 ppb (78 ppb parent 

+ 48 ppb metolachlor ESA+ 94 ppb 

metolachlor OA) and 119 ppb (18 ppb 

parent + 34 ppb metolachlor ESA+ 67 

ppb metolachlor OA). Groundwater 

EDWCs (peak and average) are 126 ppb 

(33 ppb parent + 64 ppb metolachlor 

ESA+ 30 ppb metolachlor OA).y67 

For acute exposures are estimated to 

be 219 ppb for surface water and 126 

ppb for ground water. 

For chronic exposures for non-cancer 

assessments are estimated to be 110 ppb 

for surface water and 126 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 219 ppb 

was used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment 

(cancer and non-cancer), the water 

concentration of value 126 ppb was 

used to assess the contribution to 

drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

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

indoor pest control, termiticides, and 

flea and tick control on pets). 

S-Metolachlor is currently registered 

for the following uses that could result 

in residential exposures: Residential 

lawns or turf by professional 

applicators. Pennant MAGNUM\TM 

(EPA Reg. No. 100–950) is labeled for 

use on commercial (sod farm) and 

residential warm-season turf grasses and 

other non-crop land including golf 

courses, sports fields, and ornamental 

gardens. Since Pennant MAGNUM\TM 

is not registered for homeowner 

purchase or use (i.e., used by 

professional/commercial applicators), 

the only potential short-term residential 

risk scenario anticipated is postapplication hand-to-mouth exposure of 

children playing on treated lawns. Smetolachlor incidental oral exposure is 

assumed to include hand-to-mouth 

exposure, object-to-mouth exposure and 

exposure through incidental ingestion of 

soil. Small children are the population 

group of concern. Although the type of 

site that S-metolachlor may be used on 

varies from golf courses to ornamental 

gardens, the scenario chosen for risk 

assessment (residential turf use) 

represents what the Agency considers 

the likely upper-end of possible 

exposure. 

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.’’ 

Other than metolachlor, EPA has not 

found S-metolachlor to share a common 

mechanism of toxicity with any other 

substances, and S-metolachlor does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that Smetolachlor does not have a common 

mechanism of toxicity with other 

substances. 

For information regarding EPA’s 

efforts to determine which chemicals 

have a common mechanism of toxicity 

and to evaluate the cumulative effects of 

such chemicals, see EPA’s Web site at 

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

cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

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. 

No increase in susceptibility was seen 

in developmental toxicity studies in rat 

and rabbit or reproductive toxicity 

studies in the rat. Toxicity to offspring 

was observed at dose levels the same or 

greater than those causing maternal or 


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Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 48905 

parental toxicity. Based on the results of 

developmental and reproductive 

toxicity studies, there is not a concern 

for increased qualitative and/or 

quantitative susceptibility following in 

utero exposure to metolachlor or Smetolachlor. 

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 Smetolachlor is complete, except for an 

immunotoxicity and acute and 

subchronic neurotoxicity studies 

required under the amendments to the 

data requirements. However, based on 

the results of the available toxicity 

studies, there is no evidence of 

immunotoxicity or neurotoxicity. Thus, 

EPA does not expect these data to 

change the existing POD for risk 

assessment. 

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 causes an 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, 

tolerance-level residues for all uses, and 

default processing factors. 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 exposure of 

children as well as incidental oral 

exposure of toddlers. 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 aPAD and 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 1.5% of the 

aPAD for all infants < 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 11.6% 

of the cPAD for all infants < 1 year 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 Smetolachlor 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. Using the 

exposure assumptions described in this 

unit for short-term exposures, EPA has 

concluded the combined short-term 

food, water, and residential exposures 

including incidental oral exposure from 

all possible sources: Combined hand-tomouth, object-to-mouth, and soil 

ingestion oral exposure result in an 

aggregate MOE of 860. Because EPA’s 

level of concern for S-metolachlor 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, S-metolachlor 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 PODs 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 explained in Unit III.A. 

of this document, EPA has concluded 

that the chronic RfD is protective of 

cancer effects, and, as shown above, the 

chronic risk assessment indicated that 

aggregate exposure to S-metolachlor 

does not pose a risk of concern. 

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 enforcement methodologies 

(gas chromatography with nitrogen 

phosphorous detector (GC/NPD) method 

(Method I) for determining residues in/ 

on crop commodities and a gas 

chromatography with mass 

spectroscopy detector (GC/MSD) 

method (Method II) for determining 

residues in livestock commodities) are 

available to enforce the tolerance 

expression. IR–4 and Syngenta have 

proposed a high pressure liquid 

chromatography with mass 

spectroscopy/mass spectroscopy (HPLC/ 

MS/MS) enantiomer-specific method for 

the enforcement of the proposed 

tolerances, Method 1848–01. The 

method uses a chiral HPLC column to 

separate out the S-enantiomers 

(SYN506357 and SYN508500) of the 

hydrolysis products CGA–37913 and 

CGA–49751. This method has been 

determined to be adequate for 

enforcement purposes. 

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 


srobinson on DSK4SPTVN1PROD with RULES
48906 Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 

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. 

Neither Codex, Canada, or Mexico has 

established or proposed maximum 

residue limits (MRLs) for S-metolachlor 

on cilantro or garden beet leaves. 

C. Response to Comments 

In the one comment received, the 

commenter objected to EPA approving 

use of this chemical and asked that EPA 

ban further use of this ‘‘toxic chemical.’’ 

The commenter went on to state that 

there are several toxic effects attributed 

to this chemical including evidence of 

carcinogenicity. The Agency 

understands the commenter’s concerns 

and recognizes that some individuals 

believe that certain pesticide chemicals 

should not be permitted in our food. 

However, the existing legal framework 

provided by section 408 of the FFDCA 

states that tolerances may be set when 

persons seeking such tolerances have 

demonstrated that the pesticide meets 

the safety standard imposed by that 

statute. When new or amended 

tolerances are requested for residues of 

a pesticide in food or feed, the Agency, 

as is required by section 408 of the 

FFDCA, estimates the risk of the 

potential exposure to these residues. 

The Agency has concluded after this 

assessment, which includes the 

consideration of long-term animal 

studies with metolachlor and Smetolachlor, that there is a reasonable 

certainty that no harm will result from 

aggregate (food, water and non-dietary) 

human exposure to S-metolachlor and 

that, accordingly, the tolerances that 

will be established by this rule are 

‘‘safe.’’ That assessment included a 

consideration of S-metolachlor’s 

carcinogenic potential. As discussed in 

Unit III.A., EPA concluded that any 

potential cancer risk from S-metolachlor 

is addressed by the chronic risk 

assessment. That risk assessment 

showed no risks of concern. 

D. Revisions to Petitioned-For 

Tolerances 

The Agency does not differentiate 

between dry and fresh cilantro leaves. 

Therefore, the Agency is modifying the 

tolerance proposal and establishing a 

tolerance for S-metolachlor residues on 

cilantro, leaves. 

V. Conclusion 

Therefore, tolerances are established 

for residues of S-metolachlor in or on 

beet, garden, leaves at 1.8 ppm, cilantro, 

leaves at 8.0 ppm, and coriander, seed 

at 0.13 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule 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 final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 8, 2012. 

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. Section 180.368 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a)(2) to read as follows: 

§ 180.368 S-metolachlor; tolerances for 

residues. 

(a) * * * 

(2) * * * 

Commodity Parts per 

million 

*****

Beet, garden, leaves ................ 1 .8 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 48907 

Commodity Parts per 

million 

*****

Cilantro, leaves ......................... 8 .0 

Coriander, seed ........................ 0 .13 

* * * * * 

[FR Doc. 2012–20034 Filed 8–14–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0395; FRL–9357–5] 

Fludioxonil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fludioxonil in 

or on multiple commodities which are 

identified and discussed later in this 

document, associated with pesticide 

petition (PP) 1E7853 and PP 1E7870. 

This regulation additionally revises 

several established tolerances, and 

removes several established permanent 

and time-limited tolerances. 

Interregional Research Project Number 4 

(IR–4) and Syngenta Crop Protection, 

LLC, requested the tolerances associated 

with PP 1E7853 and PP 1E7870, 

respectively, under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 15, 2012. Objections and 

requests for hearings must be received 

on or before October 15, 2012, 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–2011–0395, is 

available either electronically through 

http://www.regulations.gov or in hard 

copy at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; email address: 

nollen.laura@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. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS 

code 112). 

• Food manufacturing (NAICS 

code 311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&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–2011–0395 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before October 15, 2012. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0395, by one of 

the following methods: 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0395 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 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 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.htm. 

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 

Tolerances 

In the Federal Register of July 20, 

2011 (76 FR 43231) (FRL–8880–1), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition, PP 1E7853, by IR–4, 500 

College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.516 be 

amended by establishing tolerances for 

residues of the fungicide fludioxonil, (4- 

(2,2-difluoro-1,3-benzodioxol-4-yl)-1-H 

-pyrrole-3-carbonitrile), in or on acerola 

at 5.0 parts per million (ppm); atemoya 

at 20 ppm; biriba at 20 ppm; cherimoya 

at 20 ppm; custard apple at 20 ppm; 

feijoa at 5.0 ppm; guava at 5.0 ppm; 

ilama at 20 ppm; jaboticaba at 5.0 ppm; 

passionfruit at 5.0 ppm; soursop at 20 

ppm; starfruit at 5.0 ppm; sugar apple at 


srobinson on DSK4SPTVN1PROD with RULES