Document ID: EPA-HQ-OPP-2012-0926-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: S-metolachlor
Posted Date: 2014-03-28T04:00Z

[Federal Register Volume 79, Number 60 (Friday, March 28, 2014)]
[Rules and Regulations]
[Pages 17436-17441]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07006]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0926; FRL-9907-61]

S-metolachlor; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends tolerances for residues of S-
metolachlor in or on corn, field, forage; corn, field, stover; corn, 
pop, stover; corn, sweet, forage; and corn, sweet, stover. Syngenta 
Crop Protection, LLC, requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 28, 2014. Objections and 
requests for hearings must be received on or before May 27, 2014, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0926, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and

[[Page 17437]]

the telephone number for the OPP Docket is (703) 305-5805. Please 
review the visitor instructions and additional information about the 
docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/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-2012-0926 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
May 27, 2014. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0926, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of January 16, 2013 (78 FR 3377) (FRL-9375-
4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
2F8155) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC 27419. The petition requested that 40 CFR 180.368 be amended by 
revising previously established tolerances for residues of the 
herbicide S-metolachlor, S-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-
methoxy-1-methylethyl)acetamide, in or on corn, field, forage at 20 
parts per million (ppm); corn, stover at 40 ppm; and corn, sweet, 
forage at 40 ppm. These tolerances were proposed in order to amend 
tolerances previously established on these commodities at 6.0 ppm. That 
document referenced a summary of the petition prepared by Syngenta Crop 
Protection, LLC, the registrant, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance level for corn, field, forage and has 
corrected the proposed commodity definition, corn stover, to the 
following commodity designations: Corn, field, stover; corn, pop, 
stover; and corn, sweet, stover. The reasons for these changes are 
explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

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

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The existing toxicological database is primarily comprised of 
studies conducted with metolachlor. However, bridging studies indicate 
that the metolachlor toxicology database can be used to assess toxicity 
for S-metolachlor. In subchronic (metolachlor and S-metolachlor) and 
chronic (metolachlor) toxicity studies in dogs and rats, decreased body 
weight and

[[Page 17438]]

body weight gain were the most commonly observed effects. No systemic 
toxicity was observed when metolachlor was administered dermally. There 
was no evidence of neurotoxic effects in the available toxicity 
studies, and there is no evidence of immunotoxicity in the submitted 
rat immunotoxicity study. Prenatal developmental studies in the rat and 
rabbit with both metolachlor and S-metolachlor revealed no evidence of 
a qualitative or quantitative susceptibility in fetal animals. A 2-
generation reproduction study with metolachlor in rats showed no 
evidence of parental or reproductive toxicity. There are no residual 
uncertainties with regard to pre- and/or postnatal toxicity.
    Metolachlor has been evaluated for carcinogenic effects in the 
mouse and the rat. Metolachlor did not cause an increase in tumors of 
any kind in mice. In rats, metolachlor caused an increase in benign 
liver tumors in rats, but this increase was seen only at the highest 
dose tested and was statistically significant compared to controls only 
in females. There was no evidence of mutagenic or cytogenetic effects 
in vivo or in vitro. Based on this evidence, EPA has concluded that 
metolachlor does not have a common mechanism of carcinogenicity with 
acetochlor and alachlor, compounds that are structurally similar to 
metolachlor. Taking into account the qualitatively weak evidence on 
carcinogenic effects and the fact that the increase in benign tumors in 
female rats occurs at a dose 1,500 times the chronic reference dose 
(cRfD), EPA has concluded that the cRfD is protective of any potential 
cancer effect.
    Specific information on the studies received and the nature of the 
adverse effects caused by S-metolachlor as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document: ``S-Metolachlor, PP2F8115. 
Human Health Risk Assessment for the petition for higher tolerances on 
Corn, field, forage; Corn, sweet, forage; and Corn stover'' at pp. 34-
46 in docket ID number EPA-HQ-OPP-2012-0926.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological 
endpoints for 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 56897, p. 56899) (FRL-8842-3).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to S-metolachlor, EPA considered exposure under the 
petitioned-for tolerances as well as all existing S-metolachlor 
tolerances in 40 CFR 180.368. Both the acute and chronic analyses 
assume tolerance-level residues on all crops with established, pending, 
or proposed tolerances for metolachlor and/or S-metolachlor. In cases 
where separate tolerance listings occur for both metolachlor and S-
metolachlor on the same commodity, the higher value of the two is used 
in the analyses. Therefore, EPA assessed dietary exposures from S-
metolachlor in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. Such effects were identified 
for S-metolachlor. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture's (USDA) Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII), 1994-1996 and 1998. As to residue levels in food, 
EPA assumed tolerance-level residues for all uses, 100 percent crop 
treated (PCT) for all commodities, and default processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's 
Nationwide CSFII, 1994-1996 and 1998. As to residue levels in food, EPA 
assumed tolerance-level residues for all uses, 100 PCT for all 
commodities, and default processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a non-linear RfD approach is appropriate for assessing 
cancer risk to S-metolachlor. Cancer risk was assessed using the same 
exposure estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for S-metolachlor. Tolerance level residues and/or 100 PCT were assumed 
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for S-metolachlor in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of 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 sources. EDWCs for metolachlor and 
S-metolachlor were calculated for both the parent compound, as well as 
the ethanesulfonic acid (ESA) and oxanilic acid (OA) degradates.
    For surface water, PRZM/EXAMS and FIRST Version1.1.1 models were 
used for EDWCs for the parent S-metolachlor and the ESA and OA 
degradates, respectively. The SCI-GROW model was used to predict the 
maximum acute and chronic concentrations present in shallow 
groundwater. Current NAWQA monitoring data were also used to determine 
EDWCs. Based on monitoring and modeling data, total EDWCs for acute and 
chronic exposures from surface water are 219 parts per billion

[[Page 17439]]

(ppb) and 119 ppb, respectively. Groundwater EDWCs are 126 ppb for 
acute and chronic exposures for non-cancer assessments.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 219 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 126 ppb was used to assess 
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to 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. S-metolachlor 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 S-
metolachlor is not registered for homeowner purchase or use, the only 
potential short-term residential risk scenario anticipated is 
postapplication hand-to-mouth exposure of children playing on treated 
lawns. S-metolachlor incidental oral exposure is assumed to include 
hand-to-mouth, object-to-mouth, and incidental soil ingestion 
exposures. No intermediate-term risk scenarios are anticipated for the 
existing and proposed uses of S-metolachlor.
    Small children are the population group of concern. Although the 
type of site that S-metolachlor may be used on varies from golf courses 
to ornamental gardens, the scenario chosen for risk assessment 
(residential turf use) represents what the Agency considers the likely 
upper-end of possible exposure. Further information regarding EPA 
standard assumptions and generic inputs for residential exposures may 
be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' EPA has not found S-
metolachlor to share a common mechanism of toxicity with any other 
substances, and S-metolachlor does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that 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 Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
SF when reliable data available to EPA support the choice of a 
different factor.
    2. Prenatal and postnatal sensitivity. No increase in 
susceptibility was seen in developmental toxicity studies in the rat 
and rabbit or in the reproductive toxicity studies in the rat. Toxicity 
to offspring was observed at dose levels the same or greater than those 
causing maternal or parental toxicity. Based on the results of 
developmental and reproductive toxicity studies, there is not a concern 
for increased qualitative and/or quantitative susceptibility following 
in utero exposure to metolachlor or S-metolachlor.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for S-metolachlor is complete to evaluate 
the safety of the tolerance.
    The last rule for S-metolachlor, published in the Federal Register 
of August 15, 2012 (77 FR 48902) (FRL-9356-9), noted that 
immunotoxicity and acute and subchronic neurotoxicity studies were 
required. However, since that time, EPA has reviewed the available 
hazard and exposure information for S-metolachlor and metolachlor and 
has determined that based on the weight of the evidence approach the 
acute and subchronic neurotoxicity studies are no longer required. 
Additionally, an immunotoxicity study has been submitted to EPA since 
the last published rule. No signs of immunotoxicity were noted in this 
study at any dose level.
    ii. There is no indication that S-metolachlor is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional uncertainty factors to account for neurotoxicity.
    iii. There is no evidence that S-metolachlor results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to S-metolachlor in drinking water. EPA used 
similarly conservative assumptions to assess postapplication incidental 
oral exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by S-metolachlor.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to S-metolachlor will occupy 1.5% of the aPAD for all infants less than 
1 year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
S-metolachlor from food and water will utilize 11.6% of the cPAD for 
all infants less than 1 year old, the population group receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic

[[Page 17440]]

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 result in an aggregate MOE of 680 for 
children 1-2 years old. Because EPA's level of concern for S-
metolachlor is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, S-
metolachlor is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on 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 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., EPA has concluded that the cRfD is protective of cancer 
effects. As previously discussed, the chronic risk assessment indicated 
that aggregate exposure to S-metolachlor does not pose a risk of 
concern.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to S-metolachlor residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available to enforce the 
tolerance expression, including: a gas chromatography with nitrogen 
phosphorous detector (GC/NPD) method (Method I) for determining 
residues in or on crop commodities; and a gas chromatography with mass 
spectroscopy detector (GC/MSD) method (Method II) for determining 
residues in livestock commodities.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established MRLs for S-metolachlor.

C. Revisions to Petitioned-For Tolerances

    Based on the available forage residue data submitted with the 
petition, EPA revised the proposed tolerance on corn, field, forage 
from 20 ppm to 40 ppm. The available data indicate that 20 ppm would 
not be sufficient to cover likely residues in corn, field, forage at 
approved application rates; a tolerance at 40 ppm is supported by the 
available residue data. Additionally, the proposed tolerance for corn 
stover has been revised to the following commodity entries: Corn, 
field, stover; corn, pop, stover; and corn, sweet, stover. This 
revision was made in order to accurately capture the correct commodity 
terminology for regulated corn stover commodities.

V. Conclusion

    Therefore, tolerances are amended for residues of S-metolachlor, S-
2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide, from 6.0 ppm to 40 ppm in or on the following 
commodities: Corn, field, forage; corn, field, stover; corn, pop, 
stover; corn, sweet, forage; and corn, sweet, stover.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian

[[Page 17441]]

Tribes. Thus, the Agency has determined that Executive Order 13132, 
entitled ``Federalism'' (64 FR 43255, August 10, 1999) and Executive 
Order 13175, entitled ``Consultation and Coordination with Indian 
Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to 
this final rule. In addition, this final rule does not impose any 
enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 
1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: March 21, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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. In Sec.  180.368, revise the following entries in the table in 
paragraph (a)(2) to read as follows:

Sec.  180.368  Metolachlor; tolerances for residues.

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

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Corn, field, forage.....................................              40
Corn, field, stover.....................................              40
 
                                * * * * *
Corn, pop, stover.......................................              40
Corn, sweet, forage.....................................              40
 
                                * * * * *
Corn, sweet, stover.....................................              40
 
                                * * * * *
------------------------------------------------------------------------

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