Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Rules and Regulations 56897 

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) (Public Law 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: September 9, 2010. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—AMENDED 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.421, revise the 

introductory text of paragraph (a) and 

add alphabetically the entry ‘‘vegetable, 

cucurbit, group 9’’ to the table in 

paragraph (a) to read as follows: 

§ 180.421 Fenarimol; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of fenarimol, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only fenarimol alpha-(2 

chlorophenyl)-alpha-(4-chlorophenyl)-5- 

pyrimidinemethanol. 

Commodity Parts per million 

* * * * * 

Vegetable, 

cucurbit, group 

9* ....................... 0.20 ppm 

*There are no U.S. registrations as of August 27, 2010. 

* * * * * 

FR Doc. 2010–23120 Filed 9–16–10; 8:45 am 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0814; FRL–8842–3] 

S-metolachlor; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for the residues of Smetolachlor in or on multiple 

commodities which are identified and 

discussed later in this document. The 

Interregional Research Project Number 4 

(IR-4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

September 17, 2010. Objections and 

requests for hearings must be received 

on or before November 16, 2010, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0814. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

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; e-mail 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 


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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://www.gpoaccess.gov/ecfr. 

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–2009–0814 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 November 16, 2010. 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–2009–0814, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of January 6, 

2010 (75 FR 864) (FRL–8801–5), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 9E7607) by IR-4 

Project Headquarters, 500 College Road 

East, Suite 201 W, Princeton, NJ 08549. 

The petition requested that 40 CFR 

180.368 be amended by establishing 

tolerances for the residues (free and 

bound) of the herbicide S-metolachlor, 

S-2-chloro-N-(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, each expressed as the 

parent compound, in or on carrot at 0.3 

part per million (ppm); cucumber, okra, 

sesame seed, and sorghum sweet, at 0.1 

ppm; Brassica, leafy greens, subgroup 

5B, and turnip, greens at 1.2 ppm; 

melon, subgroup 9A, and caneberry, 

subgroup 13-07A at 0.08 ppm; 

blueberry, lowbush at 1.4 ppm; 

bushberry, subgroup 13-07B at 0.15 

ppm; onion, bulb, subgroup 3-07A at 0.1 

ppm; and onion, green, subgroup 3-07B 

at 2.0 ppm. That notice referenced a 

summary of the petition prepared by 

Syngenta Crop Protection, Inc., the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has made 

certain revisions/modifications to the 

petitioned-for tolerances because 

available data support different 

conclusions. 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 

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 section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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. 

The existing toxicological database is 

comprised primarily of studies 

conducted with metolachlor. Based on a 

comparison of the findings in toxicity 

studies with both chemicals, Smetolachlor is considered to be of 

comparable toxicity to metolachlor and 

data can be bridged between the two 

compounds. Both compounds are 

extensively absorbed and metabolized 

following oral administration. The 

combined metolachlor and Smetolachlor toxicity data bases are 

adequate to characterize the toxicity of 

S-metolachlor. 

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 


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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 

(RfD), EPA has concluded that the 

chronic RfD 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: HED Risk Assessment for 

Proposed New Use...on Bushberry, 

Caneberry....and Turnip Greens,’’ pp. 34 

– 44 in docket ID number EPA–HQ– 

OPP–2009–0814 -0004. 

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 shown in the 

Table of this unit. 

TABLE —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 women and children) 

NOAEL = 300 milligrams/ 

kilograms/day (mg/kg/day) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 3.0 mg/kg/day 

aPAD = 3.0mg/kg/day 

Developmental Toxicity 

Study – Rat 

LOAEL = 1,000 mg/kg/day 

based on 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 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.097 mg/kg/ 

day 

cPAD = 0.097 mg/kg/day 

Chronic toxicity - Dog 

LOAEL = 33 mg/kg/day 

based on decreased body 

weight gain in females. 

Incidental oral short-term 

(1 to 30 days) 

NOAEL= 50 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for MOE = 

100 

Developmental Toxicity 

Study - Rat 

the 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 

(Oral, dermal, inhalation) 

Metolachlor has been classified as a Group C carcinogen with risk quantitated using a nonlinear (RfD) approach. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose 

(a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 


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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: 

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 (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA assumed tolerance level 

residues and 100 percent crop treated 

(PCT) for all existing and proposed uses. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

conducted a chronic dietary exposure 

analysis of S-metolachlor based on the 

assumption of tolerance level residues 

and 100 PCT for all existing and 

proposed uses. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse 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 non-linear 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 determines 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 metolachlor. 

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. 

EDWCs for metolachlor and Smetolachlor 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 SCIGROW 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). Recommended 

groundwater EDWCs (peak and average) 

are 126 ppb (33 ppb parent + 64 ppb 

metolachlor ESA+ 30 ppb metolachlor 

OA). 

For acute exposures EDWCs are 

estimated to be 219 parts per billion 

(ppb) for surface water and 126 ppb for 

ground water. 

For chronic exposures EDWCs for 

cancer and non-cancer assessments are 

estimated to be 119 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). 

There is potential for residential 

exposure to S-metolachlor from use of 

registered products which are applied to 

residential lawns or turf by professional 

applicators. Pennant MAGNUMTM (EPA 

Reg. No. 100-950) 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 

Pennant MAGNUMTM is not registered 

for homeowner purchase or use (i.e., 

used by professional/commercial 

applicators), the only potential shortterm residential risk scenario 

anticipated is post-application hand-tomouth exposure of children playing on 

treated lawns. S-metolachlor incidental 

oral exposure is assumed to include 

hand-to-mouth exposure, object-tomouth 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. Post application 

exposures from various activities 

following lawn treatment are considered 

to be the most common and significant 

in residential settings. Since toxicity 

was not observed in a dermal toxicity 

study, up to a dose level of 1,000 mg/ 

kg/day, the only parameter of risk 

addressed in this assessment is the 

possible oral exposure of small children 

from treated turf, or soil. 

Further information regarding EPA 

standard assumptions and generic 


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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 website 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 with either 

metolachlor or S-metolachlor. 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 that it would be 

safe for infants and children to reduce 

the FQPA safety factor 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 recent 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 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 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 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 2% of the 

aPAD for 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% of 

the cPAD for 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 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. There is 

potential for residential exposure to Smetolachlor from use of registered 

products which are applied to 

residential lawns or turf by 

professional/commercial applicators. 

Since such products are not registered 

for homeowner purchase or use (i.e., 

used by professional/commercial 

applicators), the only potential shortterm residential risk scenario 

anticipated is post-application hand-tomouth exposure of children playing on 

treated lawns. S-metolachlor incidental 

oral exposure is assumed to include 

hand-to-mouth exposure, object-tomouth exposure and exposure through 

incidental ingestion of soil. Residential 

post application exposure to Smetolachlor for this scenario has been 

used to assess aggregate risk from 

exposure to food, drinking water, and 

residential lawns for this analysis. 

Based on the results of this analysis, 

short-term aggregate MOE of 860 is not 

of concern. EPA’s level of concern for Smetolachlor is a MOE of 100 or below. 

4. Intermediate-term aggregate 

exposure. 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 intermediate-term 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 


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cPAD (which is at least as protective as 

the POD used to assess intermediateterm risk), no further assessment of 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating intermediateterm risk for S-metolachlor. 

5. Aggregate cancer risk for U.S. 

population. As explained in Unit III.A. 

of this document, EPA has concluded 

that risks calculated based on the 

chronic RfD are protective of cancer 

effects. 

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 methodology 

is available for enforcing the current 

tolerances. The Pesticide Analytical 

Manual (PAM), Vol. II, lists a gas 

chromatography method with nitrogen 

phosphorus detection (GC/NPD) for 

determining residues in/on crop 

commodities (Method I) and a GC 

method with mass selective detection 

(GC/MSD) for determining residues in 

livestock commodities (Method II). 

These methods determine residues of 

metolachlor and its metabolites as either 

CGA-37913 or CGA-49751 following 

acid hydrolysis. 

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 U.N. 

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. 

No MRLs for S-metolachlor have been 

established or proposed by Codex. EPA 

and the Pest Management Regulatory 

Agency (PMRA) Health Canada have 

reviewed residue data as workshare 

projects on carrot, blueberry (Bushberry 

subgroup 13-07B), and cucumber. 

Therefore, MRLs for these commodities 

will be established at the same level in 

both the United States and Canada. For 

mustard greens the MRL in the United 

States will be established at a higher 

level than in Canada based on 

differences in the use pattern. There are 

no MRLs established in Canada for the 

remaining crops associated with this 

action. There are no MRLs established 

in Mexico. 

C. Revisions to Petitioned-For 

Tolerances 

The Agency determined that the 

requested tolerance for sweet sorghum 

at 0.10 ppm is not needed because of the 

existing tolerances for S-metolachlor in/ 

on sorghum grain at 0.3 ppm and 

sorghum stover at 4.0 ppm are adequate 

to cover residues in/on sweet sorghum 

commodities. However, the EPA has 

determined it is appropriate to establish 

a tolerance on ‘‘Sweet sorghum stalk’’ at 

4.0 ppm. 

The Agency is removing a tolerance, 

under § 180.368(a)(2), established at 

0.10 ppm for garlic; onion, bulb; and 

shallot, bulb as it is no longer needed 

because these commodities are covered 

under the tolerance established by this 

action for bulb onion subgroup 3-07A at 

0.10 ppm. Additionally, concomitant 

with the establishment of a separate and 

higher tolerance for carrot at 4.0 ppm by 

this action, the existing tolerance for 

‘‘Vegetable, root, except sugar beet, 

subgroup 1B’’at 0.30 is being revised to 

read; ‘‘Vegetable, root, except sugar beet, 

subgroup 1B, except carrot’’. 

Finally, EPA has revised the tolerance 

expression for S-metolachlor to clarify 

that, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of Smetolachlor not specifically mentioned; 

and that compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for the residues of S-metolachlor in or 

on bushberry, subgroup 13-07B at 0.15 

ppm, caneberry, subgroup 13-07A at 

0.10 ppm, carrot at 0.40 ppm, cucumber 

at 0.13 ppm, leafy Brassica greens, 

subgroup 5B at 1.8 ppm, melon 

subgroup 9B at 0.10 ppm, okra at 0.10 

ppm, onion, bulb, subgroup 3-07A at 

0.10 ppm, onion, green, subgroup 3-07B 

at 2.0 ppm, sesame, seed at 0.13 ppm, 

sorghum, sweet, stalk at 4.0 ppm, and 

turnip greens at 1.8 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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 


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Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Rules and Regulations 56903 

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) (Public Law 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: September 7, 2010. 

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. Section 180.368 is amended as 

follows: 

■ i. In paragraph (a)(2), revise the 

introductory text; 

■ ii. In paragraph (a)(2), in the table, 

remove the commodities Garlic, bulb 

and Shallot, bulb; revise the 

commodities Onion, bulb; Onion, green; 

and Vegetable, root, except sugar beet, 

subgroup 1B; and alphabetically add the 

following commodities; 

■ iii. In paragraphs (c)(2) and (d)(2), 

revise the introductory text. 

The amendments read as follows: 

§ 180.368 Metolachlor; tolerances for 

residues. 

(a) * * * 

(2) Tolerances are established for 

residues of S-metolachlor, including its 

metabolites and degradates, in or on the 

commodity(s), as defined. Compliance 

with the tolerance levels specified in the 

following table below is to be 

determined by measuring only the sum 

of free and bound S-metolachlor, S-2- 

chloro-N-(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, 

calculated as the stoichiometric 

equivalent of S-metolachlor, in or on the 

commodity. 

Commodity Parts per million 

* * * * * 

Brassica, leafy 

greens, subgroup 5B ........... 1.8 

Bushberry subgroup 13-07B .... 0.15 

Caneberry subgroup 13-07A .... 0.10 

Carrot, roots .......... 0.40 

* * * * * 

Cucumber ............. 0.13 

* * * * * 

Melon, subgroup 

9A ...................... 0.10 

* * * * * 

Okra ...................... 0.10 

Onion, bulb, subgroup 3-07A ...... 0.10 

Onion, green, subgroup 3-07B ...... 2.0 

* * * * * 

Sesame, seed ....... 0.13 

* * * * * 

Sorghum, sweet, 

stalk ................... 4.0 

* * * * * 

Turnip, greens ...... 1.8 

* * * * * 

Vegetable, root, 

except sugar 

beet, subgroup 

1B, except carrot 0.30 

* * * * * 

(c) * * * 

(2) Tolerances with regional 

registration are established for residues 

of S-metolachlor, including its 

metabolites and degradates, in or on the 

commodities identified in the following 

table below. Compliance with the 

tolerance levels specified in the 

following table below is to be 

determined by measuring only the sum 

of free and bound S-metolachlor, S-2- 

chloro-N-(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, 

calculated as the stoichiometric 

equivalent of S-metolachlor, in or on the 

commodity. 

* * * * * 

(d) * * * 

(2) Tolerances for are established for 

the indirect or inadvertent residues of Smetolachlor, including its metabolites 

and degradates, in or on the 

commodities identified in the following 

table below. Compliance with the 

tolerance levels specified in the 

following table below is to be 

determined by measuring only the sum 

of free and bound S-metolachlor, S-2- 

chloro-N-(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, 

calculated as the stoichiometric 

equivalent of S-metolachlor, in or on the 

commodity. 

* * * * * 

[FR Doc. 2010–23130 Filed 9–16–10; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 300 

[Docket No. 100503209–0430–02] 

RIN 0648–AY85 

Pacific Halibut Fisheries; Limited 

Access for Guided Sport Charter 

Vessels in Alaska 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule. 

SUMMARY: NMFS issues regulations 

amending the limited access program 

for charter vessels in the guided sport 

fishery for Pacific halibut in the waters 

of International Pacific Halibut 

Commission Regulatory Area 2C 

(Southeast Alaska) and Area 3A (Central 

Gulf of Alaska). These regulations revise 

the method of assigning angler 

endorsements to charter halibut permits 

to more closely align each endorsement 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1