[Federal Register Volume 75, Number 180 (Friday, September 17, 2010)]
[Rules and Regulations]
[Pages 56897-56903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23130]


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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.

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SUMMARY: This regulation establishes tolerances for the residues of S-
metolachlor 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: <a href="/cdn-cgi/l/email-protection#8ce6edefe7ffe3e2a2ffe5e8e2e9f5cce9fceda2ebe3fa"><span class="__cf_email__" data-cfemail="1c767d7f776f7372326f75787279655c796c7d327b736a">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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

[[Page 56898]]

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:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> 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, S-metolachlor 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 S-metolachlor 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

[[Page 56899]]

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-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``S-Metolachlor: 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
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
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Acute dietary                          NOAEL = 300 milligrams/  Acute RfD = 3.0 mg/kg/   Developmental Toxicity
 (General population including women    kilograms/day (mg/kg/    day                      Study - Rat
 and children).                         day)                    aPAD = 3.0mg/kg/day....  LOAEL = 1,000 mg/kg/day
                                       UFA = 10x..............                            based on increased
                                       UFH = 10x..............                            incidence of death,
                                       FQPA SF = 1x...........                            clinical signs (clonic
                                                                                          and/or tonic
                                                                                          convulsions, excessive
                                                                                          salivation, urine-
                                                                                          stained abdominal fur
                                                                                          and/or excessive
                                                                                          lacrimation) and
                                                                                          decreased body weight
                                                                                          gain.
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL= 9.7 mg/kg/day     Chronic RfD = 0.097 mg/  Chronic toxicity - Dog
(All populations)....................  UFA = 10x..............   kg/day                  LOAEL = 33 mg/kg/day
                                       UFH = 10x..............  cPAD = 0.097 mg/kg/day.   based on decreased
                                       FQPA SF = 1x...........                            body weight gain in
                                                                                          females.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term             NOAEL= 50 mg/kg/day      Residential LOC for MOE  Developmental Toxicity
(1 to 30 days).......................  UFA = 10x..............   = 100                    Study - Rat
                                       UFH = 10x..............                           the LOAEL = 500 mg/kg/
                                       FQPA SF = 1x...........                            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                                     Metolachlor has been classified as a Group C carcinogen with risk
(Oral, dermal, inhalation)...........                quantitated using a non-linear (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.


[[Page 56900]]

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 S-metolachlor. 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 food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or 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 S-metolachlor. 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 S-metolachlor and metolachlor originating 
from ground water and surface water. EDWCs for metolachlor and S-
metolachlor were calculated for both the parent compound and the 
ethanesulfonic acid (ESA) and oxanilic acid (OA) degradates. The 
environmental fate data have been bridged from the racemic mixture 
(50:50) of metolachlor to the newer isomer (88:12) S-metolachlor, based 
on similarities in environmental fate behavior. Tier I and Tier II 
screening models were employed for this assessment. For surface water, 
PRZM/EXAMS and FIRST Version1.1.1 models were used to estimate drinking 
water concentrations for the parent 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 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 non-occupational, 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 MAGNUM\TM\ (EPA Reg. No. 100-
950) is labeled for use on commercial (sod farm) and residential warm-
season turf grasses and other non-crop land including golf courses, 
sports fields, and ornamental gardens. Since Pennant MAGNUM\TM\ is not 
registered for homeowner purchase or use (i.e., used by professional/
commercial applicators), the only potential short-term residential risk 
scenario anticipated is post-application hand-to-mouth exposure of 
children playing on treated lawns. S-metolachlor incidental oral 
exposure is assumed to include hand-to-mouth exposure, object-to-mouth 
exposure and exposure through incidental ingestion of soil. Small 
children are the population group of concern. Although the type of site 
that S-metolachlor may be used on varies from golf courses to 
ornamental gardens, the scenario chosen for risk assessment 
(residential turf use) represents what the Agency considers the likely 
upper-end of possible exposure. 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

[[Page 56901]]

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 S-metolachlor does not have a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see EPA's 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 S-metolachlor 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 S-metolachlor 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 S-metolachlor 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 S-metolachlor 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 S-metolachlor 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 S-metolachlor 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 short-term residential risk 
scenario anticipated is post-application hand-to-mouth exposure of 
children playing on treated lawns. S-metolachlor incidental oral 
exposure is assumed to include hand-to-mouth exposure, object-to-mouth 
exposure and exposure through incidental ingestion of soil. Residential 
post application exposure to S-metolachlor 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 S-metolachlor 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

[[Page 56902]]

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 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 S-metolachlor 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; e-mail address: 
<a href="/cdn-cgi/l/email-protection#97e5f2e4fef3e2f2faf2e3fff8f3e4d7f2e7f6b9f0f8e1"><span class="__cf_email__" data-cfemail="f88a9d8b919c8d9d959d8c90979c8bb89d8899d69f978e">[email protected]</span></a>.

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 Sec.  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 S-metolachlor 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

[[Page 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.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.368 is amended as follows:
0
i. In paragraph (a)(2), revise the introductory text;
0
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;
0
iii. In paragraphs (c)(2) and (d)(2), revise the introductory text.
    The amendments read as follows:


Sec.  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                        0.30
 1B, except carrot.............................
------------------------------------------------------------------------

* * * * *
    (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 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.
* * * * *
[FR Doc. 2010-23130 Filed 9-16-10; 8:45 am]
BILLING CODE 6560-50-S


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