[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Rules and Regulations]
[Pages 12269-12274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05641]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0211; FRL-9973-11]


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 sugarcane, cane and sugarcane molasses. Syngenta 
Crop Protection requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 21, 2018. Objections and 
requests for hearings must be received on or before May 21, 2018, 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-2017-0211, 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), West William Jefferson Clinton 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 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: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main 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-2017-0211 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 21, 2018. 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-2017-0211, 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 September 15, 2017 (82 FR 43352) (FRL-
9965-43), 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 
6F8519) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC 27419. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the herbicide S-metolachlor in 
or on sugarcane at 0.4 parts per million (ppm) and sugarcane molasses 
at 1.5 ppm. That document referenced a summary of the petition prepared 
by Syngenta Crop Protection, the registrant, which is available in the 
docket, http://www.regulations.gov. A comment was received on the 
notice of filing. EPA's response to this comment is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA is

[[Page 12270]]

establishing a tolerance for sugarcane, cane below the level requested. 
The reason for this change is 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 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 body weight gain were the most commonly observed effects. No 
systemic toxicity was observed in rabbits 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 mouse 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. Although treatment with metolachlor did not result 
in an increase in treatment-related tumors in male rats or in male or 
female mice, metolachlor caused an increase in liver tumors in female 
rats. There was no evidence of mutagenic or cytogenetic effects in vivo 
or in vitro. Based on the information available in 1994, metolachlor 
was classified as a Group C possible human carcinogen, in accordance 
with the 1986 Guidelines for Carcinogen Risk Assessment. Based on that 
classification and consistent with the data available at that time, EPA 
determined that a non-linear approach (i.e., reference dose (RfD)) 
would be protective for all chronic toxicity, including 
carcinogenicity, that could result from exposure to metolachlor.
    In 2017, EPA re-assessed the cancer classification for metolachlor 
in order to take into account additional mechanistic studies on s-
metolachlor that were submitted to assess a human relevance framework 
analysis for a mitogenic mode of action (MOA) for liver tumors in 
female rats. Based on comparable effects of S-metolachlor and 
metolachlor shown in several associative events supporting the mode of 
action hypothesis, the Agency concluded that the in vitro and in vivo 
data reasonably explains the tumorigenic effects of metolachlor and 
adequately demonstrates dose and temporal concordance to support key 
events for the MOA leading to liver tumors in female rats. 
Specifically, the Agency found that the development of liver tumors in 
rats orally administered metolachlor is initiated by activation of 
constitutive androstane receptor (CAR) in liver hepatocytes followed by 
altered gene expression, transient increased cell proliferation, 
increased hepatocellular foci, and hepatocyte toxicity (increased liver 
weight and liver hypertrophy).
    Consequently, in accordance with the EPA's Final Guidelines for 
Carcinogen Risk Assessment (March 2005), EPA has reclassified 
metolachlor/S-metolachlor as ``Not Likely to be Carcinogenic to 
Humans'' at doses that do not induce cellular proliferation in the 
liver. This classification was based on convincing evidence of a CAR-
mediated mitogenic MOA for liver tumors in female rats. Because the 
current chronic RfD is protective for any proliferative responses in 
the liver and the other key events in the MOA for the formation of 
liver tumors, a non-linear approach (i.e., RfD) would adequately 
account for all the chronic toxicity, including carcinogenicity, that 
could result from exposure to metolachlor/S-metolachlor.
    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 the document titled ``S-metolachlor--Human 
Health Risk Assessment for the Establishment of Permanent Tolerances 
for Use of the Herbicide on Sugarcane (PP#6F8519)'' on pages 36-42 in 
docket ID number EPA-HQ-OPP-2017-0211.

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://www2.epa.gov/
pesticide-science-and-

[[Page 12271]]

assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for S-metolachlor used for 
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for S-metolachlor for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of  departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 300 mg/kg/    Acute RfD = 3.0 mg/  Developmental Toxicity Study--Rat.
 including infants and children).   day.                  kg/day.             Metolachlor LOAEL = 1,000 mg/kg/
                                   UFA = 10x...........  aPAD = 3.0 mg/kg/     day based increased incidence of
                                   UFH = 10x...........   day.                 death, clinical signs (clonic and/
                                   FQPA SF = 1x........                        or tonic convulsions, excessive
                                                                               salivation, urine-stained
                                                                               abdominal fur and/or excessive
                                                                               lacrimation) and decreased body
                                                                               weight gain.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 9.7 mg/kg/    Chronic RfD = 0.097  One Year Chronic Toxicity--Dog.
                                    day.                  mg/kg/day.          Metolachlor LOAEL = 33 mg/kg/day
                                   UFA = 10x...........  cPAD = 0.097 mg/kg/   based decreased body weight gain
                                   UFH = 10x...........   day.                 in females.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL = 50 mg/kg/day  LOC for MOE = 100..  Developmental Toxicity Study--Rat.
 30 days).                         UFA = 10x...........                       S-metolachlor LOAEL = 500 mg/kg/
                                   UFH = 10x...........                        day based on increased incidence
                                   FQPA SF = 1x........                        of clinical signs, decreased body
                                                                               weight/body weight gain, food
                                                                               consumption and food efficiency
                                                                               seen in maternal animals.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: Metolachlor/S-metolachlor has been classified as ``Not Likely
                                         to be Carcinogenic to Humans'' at doses that do not induce cellular
                                     proliferation in the liver, with risk quantitated using a non-linear (RfD)
                                                                      approach.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = Lowest-observed-adverse-effect-level. LOC = Level
  of concern. mg/kg/day = Milligram/kilogram/day. MOE = Margin of exposure. NOAEL = No-observed-adverse-effect-
  level. PAD = Population adjusted dose (a = Acute, c = Chronic). RfD = Reference dose. UF = Uncertainty factor.
  UFA = Extrapolation from animal to human (interspecies). UFH = Potential variation in sensitivity among
  members of the human population (intraspecies).

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 and 
metolachlor tolerances in 40 CFR 180.368. EPA assessed dietary 
exposures from S-metolachlor and 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) National Health and Nutrition 
Examination Survey/What We Eat in America, (NHANES/WWEIA). As to 
residue levels in food, EPA assumed tolerance-level residues and 100 
percent crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA. As to residue levels in food, EPA assumed tolerance-level 
residues and 100 PCT.
    iii. Cancer. 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. Therefore, a separate quantitative cancer 
exposure assessment is unnecessary since the chronic dietary risk 
estimate will be protective of potential cancer risk.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for S-
metolachlor. Tolerance-level residues and 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    The Agency assessed parent metolachlor, and the metabolites CGA-
51202 (metolachlor-OA), CGA-40172, and CGA-50720 together in the 
drinking water assessment using a total toxic residues (TTR) approach 
where half-lives were recalculated to collectively account for the 
parent and the combined residues of concern.
    Based on the Surface Water Concentration Calculator (SWCC), the 
Pesticide Root Zone Model Ground Water (PRZM GW), and the Screening 
Concentration in Ground Water (SCI-GROW), the estimated drinking water 
concentrations (EDWCs) of S-metolachlor and its metabolites for acute 
exposures are estimated to be 371 parts per billion (ppb) for surface 
water and 1,060 ppb for ground water, and for chronic exposures are 
estimated to be 43.70 ppb for surface water and 978 ppb in 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 1,060 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 978 ppb was used to assess 
the contribution to drinking water.

[[Page 12272]]

    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: On commercial (sod farm) and 
residential warm-season turf grasses and other non-crop land including 
golf courses, sports fields, and ornamental gardens. EPA assessed 
residential exposure using the following assumptions: For residential 
handlers, in previous human health risk assessments for S-metolachlor 
inhalation exposure/risk to residential handlers was assessed and 
resulted in no risks of concern. However, all registered S-metolachlor 
labels with residential use sites require that handlers wear specific 
clothing (e.g., long-sleeve shirt/long pants) and personal protective 
equipment (e.g., gloves). Based on current policy, the Agency assumes 
these products are not intended for homeowner use and, therefore, a 
quantitative residential handler assessment was not conducted.
    For residential post-application, there is the potential for short-
term incidental oral exposure for individuals exposed as a result of 
being in an environment that has been previously treated with S-
metolachlor. The quantitative exposure/risk assessment for residential 
post-application exposures is based on the following scenario: Hand-to-
mouth incidental oral exposure of children 1-2 years old playing on 
turf treated with S-metolachlor.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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. There was no evidence of 
increased quantitative or qualitative fetal susceptibility in the 
prenatal developmental studies in rats and rabbits or in the 
reproductive toxicity study in rats, with either metolachlor or S-
metolachlor. In general, significant developmental toxicity was not 
seen in rats or rabbits with either compound. The only effects observed 
in fetal animals were in the rat prenatal developmental study and 
included slightly decreased number of implantations per dam, decreased 
number of live fetuses/dam, increased number of resorptions/dam and 
significant decrease in mean fetal body weight. These effects occurred 
at maternally toxic doses (1,000 mg/kg/day).
    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 for all scenarios assessed as part of EPA's 
determination of safety for S-metolachlor. This decision is based on 
the following findings:
    i. The toxicology database for metolachlor and S-metolachlor is 
complete, with the exception of a required subchronic inhalation study 
for metolachlor. Although the Agency has determined that a 10X database 
uncertainty factor should be retained to account for the lack of the 
subchronic inhalation study, the Agency does not expect inhalation 
exposures to result from the use of S-metolachlor.
    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 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 post-application 
incidental oral exposure of children 1 to less-than 2 years old. 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 6.1% 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 58% 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 residential exposure to residues of 
S-metolachlor is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account

[[Page 12273]]

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 700 for 
children 1-2 years old, the only population group of concern. Because 
EPA's level of concern for S-metolachlor is a MOE of 100 or below, this 
MOE is 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 discussed in Unit 
III.A, the chronic dietary risk assessment is protective of any 
potential cancer effects. Based on the results of that assessment, EPA 
concludes that S-metolachlor is not expected to pose a cancer risk to 
humans.
    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 methodology is available for enforcing the established and 
recommended tolerances. PAM Vol. II, Pesticide Regulation Section 
180.368, lists a gas chromatography with nitrogen-phosphorus detector 
(GC/NPD) method (Method I) for determining residues in/on plant 
commodities and a gas chromatography with mass selective detector (GC/
MSD) method (Method II) for determining residues in livestock 
commodities. These methods determine residues of metolachlor and its 
metabolites as either CGA-37913 or CGA-49751 following acid hydrolysis.

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 any MRLs for either S-metolachlor or 
metolachlor.

C. Response to Comments

    One comment was received in response to the notice of filing. The 
commenter was against the establishment of any tolerances for S-
metolachlor and stated in part ``allow zero tolerance. Allow zero 
residue'' and ``no animals or people should be eating any toxic 
chemicals.''
    Although the Agency recognizes that some individuals believe that 
pesticides should be banned on agricultural crops, the existing legal 
framework provided by section 408 of the Federal Food, Drug and 
Cosmetic Act (FFDCA) authorizes EPA to establish tolerances when it 
determines that the tolerance is safe. Upon consideration of the 
validity, completeness, and reliability of the available data as well 
as other factors the FFDCA requires EPA to consider, EPA has determined 
that these S-metolachlor tolerances are safe. The commenter has 
provided no information supporting a contrary conclusion.

D. Revisions to Petitioned-For Tolerances

    Although the petitioner requested a tolerance on sugarcane at 0.4 
ppm, EPA is establishing the tolerance at 0.20 ppm based on available 
field trial data and the use of average values in the Organization for 
Economic Cooperation and Development (OECD) tolerance calculation 
procedure instead of every individual sample that the petitioner used. 
The Agency is also establishing the tolerance for ``sugarcane, cane'' 
to be consistent with its food and feed commodity vocabulary.

V. Conclusion

    Therefore, tolerances are established for residues of S-metolachlor 
in or on sugarcane, cane at 0.20 ppm and sugarcane molasses at 1.5 ppm.

VI. Statutory and Executive Order Reviews

    This action 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 action has been 
exempted from review under Executive Order 12866, this action 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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action 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 action directly regulates growers, food processors, food 
handlers, and food

[[Page 12274]]

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 action. In addition, this action does not impose any 
enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act (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 (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: February 28, 2018.
Michael L. Goodis,
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, add alphabetically entries for ``Sugarcane, cane'' 
and ``Sugarcane, molasses'' to the table in paragraph (a)(2) to read as 
follows:


Sec.  180.368  Metolachlor; tolerances for residues.

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

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Sugarcane, cane..............................................       0.20
Sugarcane, molasses..........................................        1.5
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-05641 Filed 3-20-18; 8:45 am]
BILLING CODE 6560-50-P