17436 Federal Register / Vol. 79, No. 60 / Friday, March 28, 2014 / Rules and Regulations 

List of Subjects 

28 CFR Part 36 

Administrative practice and 

procedure, Alcoholism, Americans with 

disabilities, Buildings, Business and 

industry, Civil rights, Consumer 

protection, Drug abuse, Handicapped, 

Historic preservation, Penalties, 

Reporting and recordkeeping 

requirements. 

28 CFR Part 85 

Penalties. 

Accordingly, for the reasons set forth 

in the preamble, chapter I of Title 28 of 

the Code of Federal Regulations is 

amended as follows: 

PART 36—NONDISCRIMINATION ON 

THE BASIS OF DISABILITY BY PUBLIC 

ACCOMMODATIONS AND IN 

COMMERCIAL FACILITIES 

■ 1. The authority citation for part 36 

continues to read as follows: 

Authority: 5 U.S.C. 301; 28 U.S.C. 509, 

510; 42 U.S.C. 12188(b); Pub. L. 101–410, 104 

Stat. 890, as amended by Pub. L. 104–134, 

110 Stat. 1321. 

■ 2. Section 36.504 is amended by 

revising paragraphs (a)(3)(i) and (ii) to 

read as follows: 

§ 36.504 Relief. 

(a) * * * 

(3) * * * 

(i) Not exceeding $50,000 for a first 

violation occurring before September 

29, 1999, and not exceeding $55,000 for 

a first violation occurring on or after 

September 29, 1999, and before April 

28, 2014, and not exceeding $75,000 for 

a first violation occurring on or after 

April 28, 2014. 

(ii) Not exceeding $100,000 for any 

subsequent violation occurring before 

September 29, 1999, and not exceeding 

$110,000 for any subsequent violation 

occurring on or after September 29, 

1999, and before April 28, 2014, and not 

exceeding $150,000 for any subsequent 

violation occurring on or after April 28, 

2014. 

* * * * * 

PART 85—CIVIL MONETARY 

PENALTIES INFLATION ADJUSTMENT 

■ 3. The authority citation for part 85 

continues to read as follows: 

Authority: 5 U.S.C. 301, 28 U.S.C. 503; 

Pub. L. 101–410, 104 Stat. 890, as amended 

by Pub. L. 104–134, 110 Stat. 1321. 

■ 4. Section 85.3 is amended by revising 

the introductory text and paragraph (b) 

to read as follows: 

§ 85.3 Adjustments to penalties. 

The civil monetary penalties provided 

by law within the jurisdiction of the 

respective components of the 

Department, as set forth in paragraphs 

(a) through (d) of this section, are 

adjusted in accordance with the 

inflation adjustment procedures 

prescribed in section 5 of the Federal 

Civil Penalties Inflation Adjustment Act 

of 1990, Public Law 101–410, as 

follows. The adjusted penalties set forth 

in paragraphs (a), (c), and (d) of this 

section are effective for violations 

occurring on or after September 29, 

1999. 

* * * * * 

(b) Civil Rights Division. (1) 18 U.S.C. 

248(c)(2)(B), Freedom of Access to 

Clinic Entrances Act of 1994 

(Nonviolent Physical Obstruction): 

(i) The civil monetary penalty amount 

for a first order for nonviolent physical 

obstruction, initially set at $10,000, is 

adjusted to $11,000 for a violation 

occurring on or after September 29, 

1999, and before April 28, 2014, and is 

adjusted to $16,000 for a violation 

occurring on or after April 28, 2014. 

(ii) The civil monetary penalty 

amount for a subsequent order for 

nonviolent physical obstruction, 

initially set at $15,000, is adjusted to 

$16,500 for a violation occurring on or 

after April 28, 2014. 

(2) 18 U.S.C. 248(c)(2)(B), Freedom of 

Access to Clinic Entrances Act of 1994 

(Other Violations): 

(i) The civil monetary penalty amount 

for a first order other than for 

nonviolent physical obstruction, 

initially set at $15,000, is adjusted to 

$16,500 for a violation occurring on or 

after April 28, 2014. 

(ii) The civil monetary penalty 

amount for a subsequent order other 

than for nonviolent physical 

obstruction, initially set at $25,000, is 

adjusted to $27,500 for a violation 

occurring on or after September 29, 

1999, and before April 28, 2014, and is 

adjusted to $37,500 for a violation 

occurring on or after April 28, 2014. 

(3) 42 U.S.C. 3614(d)(1)(C), Fair 

Housing Act of 1968, as amended 

(Pattern or Practice Violation): 

(i) The civil monetary penalty amount 

for a first order, initially set at $50,000, 

is adjusted to $55,000 for a violation 

occurring on or after September 29, 

1999, and before April 28, 2014, and is 

adjusted to $75,000 for a violation 

occurring on or after April 28, 2014. 

(ii) The civil monetary penalty 

amount for a subsequent order, initially 

set at $100,000, is adjusted to $110,000 

for a violation occurring on or after 

September 29, 1999, and before April 

28, 2014, and is adjusted to $150,000 for 

a violation occurring on or after April 

28, 2014. 

(4) 50 U.S.C. App. 597(b)(3), 

Servicemembers Civil Relief Act of 

2003, as amended: 

(i) The civil monetary penalty amount 

for a first violation, initially set at 

$55,000, is adjusted to $60,000 for a 

violation occurring on or after April 28, 

2014. 

(ii) The civil monetary penalty 

amount for a subsequent violation, 

initially set at $110,000, is adjusted to 

$120,000 for a violation occurring on or 

after April 28, 2014. 

* * * * * 

Dated: March 21, 2014. 

Eric H. Holder, Jr., 

Attorney General. 

[FR Doc. 2014–06979 Filed 3–27–14; 8:45 am] 

BILLING CODE 4410–13–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0926; FRL–9907–61] 

S-metolachlor; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends 

tolerances for residues of S-metolachlor 

in or on corn, field, forage; corn, field, 

stover; corn, pop, stover; corn, sweet, 

forage; and corn, sweet, stover. Syngenta 

Crop Protection, LLC, requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 28, 2014. Objections and requests 

for hearings must be received on or 

before May 27, 2014, 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–2012–0926, 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), EPA West 

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 


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Federal Register / Vol. 79, No. 60 / Friday, March 28, 2014 / Rules and Regulations 17437 

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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; 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–2012–0926 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 May 27, 2014. 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– 

2012–0926, 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 January 16, 

2013 (78 FR 3377) (FRL–9375–4), 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 2F8155) by Syngenta Crop 

Protection, LLC, P.O. Box 18300, 

Greensboro, NC 27419. The petition 

requested that 40 CFR 180.368 be 

amended by revising previously 

established tolerances for residues of the 

herbicide S-metolachlor, S-2-chloro-N- 

(2-ethyl-6-methylphenyl)-N-(2-methoxy1-methylethyl)acetamide, in or on corn, 

field, forage at 20 parts per million 

(ppm); corn, stover at 40 ppm; and corn, 

sweet, forage at 40 ppm. These 

tolerances were proposed in order to 

amend tolerances previously established 

on these commodities at 6.0 ppm. That 

document referenced a summary of the 

petition prepared by Syngenta Crop 

Protection, LLC, 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 revised 

the proposed tolerance level for corn, 

field, forage and has corrected the 

proposed commodity definition, corn 

stover, to the following commodity 

designations: Corn, field, stover; corn, 

pop, stover; and corn, sweet, stover. 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 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 


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body weight gain were the most 

commonly observed effects. No systemic 

toxicity was observed 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 rat 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. 

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: ‘‘SMetolachlor, PP#2F8115. Human Health 

Risk Assessment for the petition for 

higher tolerances on Corn, field, forage; 

Corn, sweet, forage; and Corn stover’’ at 

pp. 34–46 in docket ID number EPA– 

HQ–OPP–2012–0926. 

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 Smetolachlor 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 

56897, p. 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 S-metolachlor tolerances in 40 

CFR 180.368. 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 Smetolachlor on the same commodity, 

the higher value of the two is used in 

the analyses. Therefore, 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 S-metolachlor. 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 tolerancelevel residues for all uses, 100 PCT for 

all commodities, and default processing 

factors. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a non-linear 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/or 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. 

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 

sources. EDWCs for metolachlor and Smetolachlor were calculated for both the 

parent compound, as well as the 

ethanesulfonic acid (ESA) and oxanilic 

acid (OA) degradates. 

For surface water, PRZM/EXAMS and 

FIRST Version1.1.1 models were used 

for EDWCs for the parent S-metolachlor 

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 

acute and chronic exposures from 

surface water are 219 parts per billion 


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(ppb) and 119 ppb, respectively. 

Groundwater EDWCs are 126 ppb for 

acute and chronic exposures for noncancer assessments. 

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, 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). Smetolachlor is currently registered for 

the following uses that could result in 

residential exposures: Residential lawns 

or turf by professional applicators. Smetolachlor is labeled for use on 

commercial (sod farm) and residential 

warm-season turf grasses and other noncrop land including golf courses, sports 

fields, and ornamental gardens. Since Smetolachlor is not registered for 

homeowner purchase or use, the only 

potential short-term residential risk 

scenario anticipated is postapplication 

hand-to-mouth exposure of children 

playing on treated lawns. S-metolachlor 

incidental oral exposure is assumed to 

include hand-to-mouth, object-tomouth, and incidental soil ingestion 

exposures. No intermediate-term risk 

scenarios are anticipated for the existing 

and proposed uses of S-metolachlor. 

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.’’ 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 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

No increase in susceptibility was seen 

in developmental toxicity studies in the 

rat and rabbit or in the reproductive 

toxicity studies in the rat. Toxicity to 

offspring was observed at dose levels 

the same or greater than those causing 

maternal or 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 S-metolachlor. 

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 to evaluate the 

safety of the tolerance. 

The last rule for S-metolachlor, 

published in the Federal Register of 

August 15, 2012 (77 FR 48902) (FRL– 

9356–9), noted that immunotoxicity and 

acute and subchronic neurotoxicity 

studies were required. However, since 

that time, EPA has reviewed the 

available hazard and exposure 

information for S-metolachlor and 

metolachlor and has determined that 

based on the weight of the evidence 

approach the acute and subchronic 

neurotoxicity studies are no longer 

required. Additionally, an 

immunotoxicity study has been 

submitted to EPA since the last 

published rule. No signs of 

immunotoxicity were noted in this 

study at any dose level. 

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

and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors 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 postapplication 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 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 1.5% 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 11.6% 

of the cPAD for all infants less than 1 

year old, the population group receiving 

the greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 


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17440 Federal Register / Vol. 79, No. 60 / Friday, March 28, 2014 / Rules and Regulations 

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 result in an 

aggregate MOE of 680 for children 1–2 

years old. 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 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 explained in Unit III.A., 

EPA has concluded that the cRfD is 

protective of cancer effects. As 

previously discussed, 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 

are available to enforce the tolerance 

expression, including: a gas 

chromatography with nitrogen 

phosphorous detector (GC/NPD) method 

(Method I) for determining residues in 

or on crop commodities; and a gas 

chromatography with mass 

spectroscopy detector (GC/MSD) 

method (Method II) for determining 

residues in livestock commodities. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established MRLs 

for S-metolachlor. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the available forage residue 

data submitted with the petition, EPA 

revised the proposed tolerance on corn, 

field, forage from 20 ppm to 40 ppm. 

The available data indicate that 20 ppm 

would not be sufficient to cover likely 

residues in corn, field, forage at 

approved application rates; a tolerance 

at 40 ppm is supported by the available 

residue data. Additionally, the proposed 

tolerance for corn stover has been 

revised to the following commodity 

entries: Corn, field, stover; corn, pop, 

stover; and corn, sweet, stover. This 

revision was made in order to accurately 

capture the correct commodity 

terminology for regulated corn stover 

commodities. 

V. Conclusion 

Therefore, tolerances are amended for 

residues of S-metolachlor, S-2-chloro-N- 

(2-ethyl-6-methylphenyl)-N-(2-methoxy1-methylethyl)acetamide, from 6.0 ppm 

to 40 ppm in or on the following 

commodities: Corn, field, forage; corn, 

field, stover; corn, pop, stover; corn, 

sweet, forage; and corn, sweet, stover. 

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 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 60 / Friday, March 28, 2014 / Rules and Regulations 17441 

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) (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 of 1995 

(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: March 21, 2014. 

Lois Rossi, 

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, revise the following 

entries in the table in paragraph (a)(2) to 

read as follows: 

§ 180.368 Metolachlor; tolerances for 

residues. 

(a) * * * 

(2) * * * 

Commodity Parts per 

million 

* * * * * 

Corn, field, forage ................. 40 

Corn, field, stover ................. 40 

Commodity Parts per 

million 

* * * * * 

Corn, pop, stover .................. 40 

Corn, sweet, forage .............. 40 

* * * * * 

Corn, sweet, stover ............... 40 

* * * * * 

* * * * * 

[FR Doc. 2014–07006 Filed 3–27–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–2005–0011; FRL–9908– 

65-Region 5] 

National Oil and Hazardous Substance 

Pollution Contingency Plan; National 

Priorities List: Deletion of the Eau 

Claire Municipal Well Field Superfund 

Site 

AGENCY: Environmental Protection 

Agency. 

ACTION: Direct final rule. 

SUMMARY: The U.S. Environmental 

Protection Agency (EPA) Region 5 is 

publishing a direct final notice of 

deletion of the Eau Claire Municipal 

Well Field Superfund Site (Site) located 

in Eau Claire, Wisconsin, from the 

National Priorities List (NPL). The NPL, 

promulgated pursuant to Section 105 of 

the Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA) of 1980, as amended, is 

an appendix to the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP). This direct 

final deletion is being published by EPA 

with the concurrence of the State of 

Wisconsin, through the Wisconsin 

Department of Natural Resources 

(WDNR), because EPA has determined 

that all appropriate response actions 

under CERCLA have been completed. 

However, this deletion does not 

preclude future actions under 

Superfund. 

DATES: This direct final deletion is 

effective May 27, 2014 unless EPA 

receives adverse comments by April 28, 

2014. If adverse comments are received, 

EPA will publish a timely withdrawal of 

the direct final deletion in the Federal 

Register informing the public that the 

deletion will not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID no. EPA–HQ– 

SFUND–2005–0011, by one of the 

following methods: 

• http://www.regulations.gov. Follow 

online instructions for submitting 

comments. 

• Email: Howard Caine, Remedial 

Project Manager, at howard.caine@

epa.gov or Susan Pastor, Community 

Involvement Coordinator, at 

pastor.susan@epa.gov. 

• Fax: Gladys Beard, NPL Deletion 

Process Manager at (312) 886–4071. 

• Mail: Howard Caine, Remedial 

Project Manager, U.S. Environmental 

Protection Agency (SR–6J), 77 West 

Jackson Boulevard, Chicago, IL 60604, 

(312) 353–9685, or Susan Pastor, 

Community Involvement Coordinator, 

U.S. Environmental Protection Agency 

(SI–7J), 77 West Jackson Boulevard, 

Chicago, IL 60604, (312) 353–1325 or 

(800) 621–8431. 

• Hand delivery: Susan Pastor, 

Community Involvement Coordinator, 

U.S. Environmental Protection Agency 

(SI–7J), 77 West Jackson Boulevard, 

Chicago, IL 60604. Such deliveries are 

only accepted during the docket’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. The 

normal business hours are Monday 

through Friday, 8:30 a.m. to 4:30 p.m. 

CST, excluding federal holidays. 

Instructions: Direct your comments to 

Docket ID no. EPA–HQ–SFUND–2005– 

0011. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http://

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http://

www.regulations.gov or email. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email comment directly 

to EPA without going through http://

www.regulations.gov, your email 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 


tkelley on DSK3SPTVN1PROD with RULES