[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Rules and Regulations]
[Pages 48902-48907]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20034]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0657; FRL-9356-9]


S-Metolachlor; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of S-
metolachlor in or on beet, garden, leaves, cilantro, leaves and 
coriander, seed. Interregional Research Project Number 4 requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective August 15, 2012. Objections and 
requests for hearings must be received on or before October 15, 2012, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2011-0657, is available at http://www.regulations.gov or at the OPP Docket in the Environmental 
Protection Agency Docket Center (EPA/DC), located in EPA West, Rm. 
3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; email address: jackson.sidney@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2011-0657 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
October 15, 2012. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0657, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at  http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 7, 2011 (76 FR 55329) (FRL-
8886-7), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
1E7898) by Interregional Research Project Number 4, 500 College Road 
East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 
CFR 180.368 be amended by establishing tolerances for residues of the 
herbicide S-metolachlor, S-2-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, in or on cilantro, leaves, fresh at 8.0 parts per million 
(ppm) cilantro, leaves, dried at 8.0 ppm, coriander, seed at 0.13 ppm 
and beet, garden, leaves at 1.8 ppm. That notice referenced a summary 
of the petition prepared by Syngenta Crop Protection, the registrant, 
which is available in the docket, http://www.regulations.gov.
    EPA received one comment to the Notice of Filing. That comment is 
addressed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA 
corrected the crop definition for ``cilantro'' to ``coriander'' and 
removed proposed tolerances for fresh and dried cilantro leaves. The 
reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the

[[Page 48903]]

legal limit for a pesticide chemical residue in or on a food) only if 
EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) 
of FFDCA defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) of 
FFDCA requires EPA to give special consideration to exposure of infants 
and children to the pesticide chemical residue in establishing a 
tolerance and to ``ensure that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to the 
pesticide chemical residue. * * *''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for S-metolachlor including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with S-metolachlor 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    S-Metolachlor exhibits low acute toxicity via oral, inhalation, and 
dermal routes of exposure. It causes slight eye irritation, and is non-
irritating dermally, but is a dermal sensitizer. In subchronic 
(metolachlor and S-metolachlor) and chronic (metolachlor) toxicity 
studies in dogs and rats decreased body weight and body weight gain 
were the most commonly observed effects. No systemic toxicity was 
observed when metolachlor was administered dermally. No neurotoxicity 
studies with metolachlor or S-metolachlor are available. However, there 
was no evidence of neurotoxic effects in the available toxicity 
studies. Prenatal developmental studies in the rat and rabbit with both 
metolachlor and S-metolachlor revealed no evidence of a qualitative or 
quantitative susceptibility in fetal animals. A 2-generation 
reproduction study with metolachlor in rats showed no evidence of 
parental or reproductive toxicity. There are no residual uncertainties 
with regard to pre- and/or postnatal toxicity. Metolachlor has been 
evaluated for carcinogenic effects in the mouse and the rat. 
Metolachlor did not cause an increase in tumors of any kind in mice. In 
rats, metolachlor caused an increase in benign liver tumors in rats but 
this increase was seen only at the highest dose tested and was 
statistically significant compared to controls only in females. There 
was no evidence of mutagenic or cytogenetic effects in vivo or in 
vitro. Based on this evidence, EPA has concluded that metolachlor does 
not have a common mechanism of carcinogenicity with acetochlor and 
alachlor which are structurally similar. Taking into account the 
qualitatively weak evidence on carcinogenic effects and the fact that 
the increase in benign tumors in female rats occurs at a dose 1,500 
times the chronic reference dose (cRfD), EPA has concluded that the 
cRfD is protective of any potential cancer effect.
    Specific information on the studies received and the nature of the 
adverse effects caused by S-metolachlor as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document entitled, ``S-Metolachlor. Human Health 
Risk Assessment for the Section 3 Requests for Use on Coriander 
(Cilantro) and Garden Beet Leaves,'' p. 13 in docket ID number EPA-HQ-
OPP-2011-0657.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD), and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for S-metolachlor used for 
human risk assessment is discussed in Unit III. of the final rule 
published in the Federal Register of September 17, 2010 (75 FR 56899) 
(FRL-8842-3).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to S-metolachlor, EPA considered exposure under the 
petitioned-for tolerances as well as all existing metolachlor and S-
metolachlor tolerances in 40 CFR 180.368. EPA assessed dietary 
exposures from 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's (USDA) Nationwide Continuing Surveys 
of Food Intake by Individuals (CSFII), 1994-1996 and 1998. As to 
residue levels in food, EPA assumed tolerance level residues for all 
uses, 100 percent crop treated (PCT) for all commodities and default 
processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's 
Nationwide CSFII, 1994-1996 and 1998. As to residue levels in food, EPA 
assumed tolerance level residues for all uses, 100 PCT for all 
commodities and default processing factors.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-

[[Page 48904]]

use pesticide based on the weight of the evidence from cancer studies 
and other relevant data. Cancer risk is quantified using a linear or 
nonlinear approach. If sufficient information on the carcinogenic mode 
of action is available, a threshold or nonlinear approach is used and a 
cancer RfD is calculated based on an earlier noncancer key event. If 
carcinogenic mode of action data are not available, or if the mode of 
action data determine a mutagenic mode of action, a default linear 
cancer slope factor approach is utilized. Based on the data summarized 
in Unit III.A., EPA has concluded that a nonlinear RfD approach is 
appropriate for assessing cancer risk to S-metolachlor. Cancer risk was 
assessed using the same exposure estimates as discussed in Unit 
III.C.1.ii.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for S-metolachlor. Tolerance level residues and 100 PCT were assumed 
for all food commodities with existing tolerances, and default 
processing factors.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for S-metolachlor in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of 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 
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). Groundwater EDWCs (peak 
and average) are 126 ppb (33 ppb parent + 64 ppb metolachlor ESA+ 30 
ppb metolachlor OA).y67
    For acute exposures are estimated to be 219 ppb for surface water 
and 126 ppb for ground water.
    For chronic exposures for non-cancer assessments are estimated to 
be 110 ppb for surface water and 126 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For acute dietary risk assessment, the water concentration value of 
219 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment (cancer and non-cancer), the 
water concentration of value 126 ppb was used to assess the 
contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    S-Metolachlor is currently registered for the following uses that 
could result in residential exposures: Residential lawns or turf by 
professional applicators. Pennant MAGNUM\TM (EPA Reg. No. 100-950) is 
labeled for use on commercial (sod farm) and residential warm-season 
turf grasses and other non-crop land including golf courses, sports 
fields, and ornamental gardens. Since Pennant MAGNUM\TM is not 
registered for homeowner purchase or use (i.e., used by professional/
commercial applicators), the only potential short-term residential risk 
scenario anticipated is 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.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Other than metolachlor, EPA has not found S-metolachlor to share a 
common mechanism of toxicity with any other substances, and S-
metolachlor does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that S-metolachlor does not have a common mechanism of 
toxicity with other substances.
    For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. No increase in 
susceptibility was seen in developmental toxicity studies in rat and 
rabbit or reproductive toxicity studies in the rat. Toxicity to 
offspring was observed at dose levels the same or greater than those 
causing maternal or

[[Page 48905]]

parental toxicity. Based on the results of developmental and 
reproductive toxicity studies, there is not a concern for increased 
qualitative and/or quantitative susceptibility following in utero 
exposure to metolachlor or S-metolachlor.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1x. That decision is based on the following 
findings:
    i. The toxicity database for S-metolachlor is complete, except for 
an immunotoxicity and acute and subchronic neurotoxicity studies 
required under the amendments to the data requirements. However, based 
on the results of the available toxicity studies, there is no evidence 
of immunotoxicity or neurotoxicity. Thus, EPA does not expect these 
data to change the existing POD for risk assessment.
    ii. There is no indication that 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, 
tolerance-level residues for all uses, and default processing factors. 
EPA made conservative (protective) assumptions in the ground and 
surface water modeling used to assess exposure to S-metolachlor in 
drinking water. EPA used similarly conservative assumptions to assess 
post-application exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by S-metolachlor.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer given the estimated aggregate exposure. 
Short-, intermediate-, and chronic-term risks are evaluated by 
comparing the estimated aggregate food, water, and residential exposure 
to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to S-metolachlor will occupy 1.5% of the aPAD for all infants < 1 year 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
S-metolachlor from food and water will utilize 11.6% of the cPAD for 
all infants < 1 year old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
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. Using the 
exposure assumptions described in this unit for short-term exposures, 
EPA has concluded the combined short-term food, water, and residential 
exposures including incidental oral exposure from all possible sources: 
Combined hand-to-mouth, object-to-mouth, and soil ingestion oral 
exposure result in an aggregate MOE of 860. Because EPA's level of 
concern for S-metolachlor is a MOE of 100 or below, these MOEs are not 
of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, S-
metolachlor is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on 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 cPAD (which is at least as protective as 
the PODs used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for S-
metolachlor.
    5. Aggregate cancer risk for U.S. population. As explained in Unit 
III.A. of this document, EPA has concluded that the chronic RfD is 
protective of cancer effects, and, as shown above, the chronic risk 
assessment indicated that aggregate exposure to S-metolachlor does not 
pose a risk of concern.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to S-metolachlor residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (gas chromatography with 
nitrogen phosphorous detector (GC/NPD) method (Method I) for 
determining residues in/on crop commodities and a gas chromatography 
with mass spectroscopy detector (GC/MSD) method (Method II) for 
determining residues in livestock commodities) are available to enforce 
the tolerance expression. IR-4 and Syngenta have proposed a high 
pressure liquid chromatography with mass spectroscopy/mass spectroscopy 
(HPLC/MS/MS) enantiomer-specific method for the enforcement of the 
proposed tolerances, Method 1848-01. The method uses a chiral HPLC 
column to separate out the S-enantiomers (SYN506357 and SYN508500) of 
the hydrolysis products CGA-37913 and CGA-49751. This method has been 
determined to be adequate for enforcement purposes.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international

[[Page 48906]]

food safety standards-setting organization in trade agreements to which 
the United States is a party. EPA may establish a tolerance that is 
different from a Codex MRL; however, FFDCA section 408(b)(4) requires 
that EPA explain the reasons for departing from the Codex level.
    Neither Codex, Canada, or Mexico has established or proposed 
maximum residue limits (MRLs) for S-metolachlor on cilantro or garden 
beet leaves.

C. Response to Comments

    In the one comment received, the commenter objected to EPA 
approving use of this chemical and asked that EPA ban further use of 
this ``toxic chemical.'' The commenter went on to state that there are 
several toxic effects attributed to this chemical including evidence of 
carcinogenicity. The Agency understands the commenter's concerns and 
recognizes that some individuals believe that certain pesticide 
chemicals should not be permitted in our food. However, the existing 
legal framework provided by section 408 of the FFDCA states that 
tolerances may be set when persons seeking such tolerances have 
demonstrated that the pesticide meets the safety standard imposed by 
that statute. When new or amended tolerances are requested for residues 
of a pesticide in food or feed, the Agency, as is required by section 
408 of the FFDCA, estimates the risk of the potential exposure to these 
residues. The Agency has concluded after this assessment, which 
includes the consideration of long-term animal studies with metolachlor 
and S-metolachlor, that there is a reasonable certainty that no harm 
will result from aggregate (food, water and non-dietary) human exposure 
to S-metolachlor and that, accordingly, the tolerances that will be 
established by this rule are ``safe.'' That assessment included a 
consideration of S-metolachlor's carcinogenic potential. As discussed 
in Unit III.A., EPA concluded that any potential cancer risk from S-
metolachlor is addressed by the chronic risk assessment. That risk 
assessment showed no risks of concern.

D. Revisions to Petitioned-For Tolerances

    The Agency does not differentiate between dry and fresh cilantro 
leaves. Therefore, the Agency is modifying the tolerance proposal and 
establishing a tolerance for S-metolachlor residues on cilantro, 
leaves.

V. Conclusion

    Therefore, tolerances are established for residues of S-metolachlor 
in or on beet, garden, leaves at 1.8 ppm, cilantro, leaves at 8.0 ppm, 
and coriander, seed at 0.13 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 8, 2012.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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 by alphabetically adding the following 
commodities to the table in paragraph (a)(2) to read as follows:


Sec.  180.368  S-metolachlor; tolerances for residues.

    (a) * * *
    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Beet, garden, leaves.......................................         1.8
 

[[Page 48907]]

 
                                * * * * *
Cilantro, leaves...........................................         8.0
Coriander, seed............................................         0.13
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-20034 Filed 8-14-12; 8:45 am]
BILLING CODE 6560-50-P