S-Metolachlor; Pesticide Tolerances, 8611-8617 [2019-04251]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 84, Number 47 (Monday, March 11, 2019)]
[Rules and Regulations]
[Pages 8611-8617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04251]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0465; FRL-9983-79]


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 multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective March 11, 2019. Objections and 
requests for hearings must be received on or before May 10, 2019, 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-2017-0465, is available at https://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 https://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

[[Page 8612]]

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 https://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-2017-0465 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 10, 2019. 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-2017-0465, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of January 26, 2018 (83 FR 3658) (FRL-9971-
46), 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 
7E8587) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of NJ, 500 College Road East, Suite 201 W, Princeton, NJ 
08540. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the herbicide S-metolachlor 
including its metabolites and degradates in or on the raw agricultural 
commodities stevia, dried leaves at 15.0 parts per million (ppm); 
vegetable, leaves of root and tuber, group 2, except sugar beet at 2.0 
ppm; Swiss chard at 0.10 ppm; vegetable, Brassica, head and stem, group 
5-16 at 0.60 ppm; Brassica, leafy greens, subgroup 4-16B, except 
Chinese broccoli at 1.8 ppm; stalk and stem vegetable subgroup 22A, 
except celtuce, Florence fennel, and kohlrabi at 0.10 ppm; leaf petiole 
vegetable subgroup 22B at 0.10 ppm; cottonseed subgroup 20C at 0.10 
ppm; celtuce at 0.10 ppm; Florence fennel at 0.10 ppm; kohlrabi at 0.60 
ppm, and Chinese broccoli at 0.60 ppm. In addition, the petition 
requested to amend 40 CFR 180.368 by removing the tolerances for S-
metolachlor in or on asparagus at 0.10 ppm; beet, garden, leaves at 1.8 
ppm; turnip, greens at 1.8 ppm; Brassica, head and stem, subgroup 5A at 
0.60 ppm; Brassica, leafy greens, subgroup 5B at 1.8 ppm; cotton, 
undelinted seed at 0.10 ppm; and leaf petioles, subgroup 4B at 0.10 
ppm. That document referenced a summary of the petition prepared by 
Syngenta Crop Protection, the registrant, which is available in the 
docket, https://www.regulations.gov. Comments were received on the 
notice of filing. EPA's response to these comments is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified the levels at which tolerances are being established as well 
as some of the commodity definitions. The reason for these changes are 
explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .''
    Consistent with 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.
    Since the last time S-metolachlor was reviewed, the toxicology 
database was re-evaluated to incorporate new toxicity data and to 
update endpoints selected for points of departure to be consistent with 
current Agency policies and practices. An inhalation toxicity study for 
metolachlor was received and incorporated into the risk assessment and 
consequently, the 10x database uncertainty factor from previous 
assessments was removed for the inhalation scenarios since this is no 
longer a data gap. Also, new endpoints were selected and updated 
dietary and occupational/residential exposure

[[Page 8613]]

assessments were completed based on the updated toxicological endpoints 
and reflect recent updates to EPA's standard operating procedures 
(SOPs) and policies.
    The existing toxicological database is primarily comprised of 
studies conducted with metolachlor. The toxicology database for S-
metolachlor consists of bridging data. Bridging studies indicate that 
the metolachlor toxicology database can be used to assess toxicity for 
S-metolachlor, and vice versa. In subchronic (metolachlor and S-
metolachlor) and chronic (metolachlor) toxicity studies in dogs and 
rats decreased body weight was the most commonly observed effects. 
Chronic exposure to metolachlor in rats also resulted in increased 
liver weight and microscopic liver lesions (foci of cellular 
alteration) in both sexes. No systemic toxicity was observed in rabbits 
when metolachlor was administered dermally. There was no evidence of 
systemic toxicity at the limit dose in a 28-day inhalation study in 
rats with metolachlor, although portal of entry effects occurred in the 
nasal cavity at lower doses. These effects included hyperplasia of the 
squamous epithelium and subacute inflammation and mucous cell 
hyperplasia. 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 evidence of 
quantitative susceptibility. Decreased pup body weight in the F1 and F2 
litters was seen in the absence of maternal toxicity. There are no 
acute or subchronic neurotoxicity studies available for S-metolachlor 
or metolachlor. In the developmental rat study, clinical signs of 
neurotoxicity were observed in pregnant dams but only at the limit dose 
of 1,000 mg/kg/day. There was no other evidence of clinical signs of 
neurotoxicity in adult animals in the database. 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) adequately accounts 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 https://www.regulations.gov in the document titled ``S-metolachlor: Human 
Health Risk Assessment for (1) Establishment of Tolerances for New Uses 
on Chicory, Stevia and Swiss Chard; (2) Tolerance Translations from 
Table Beet Tops, Turnip Greens, and Radish Tops to Crop Group 2 (Leaves 
of Root and Tuber Vegetables), except Sugar Beets; (3) Tolerance 
Conversions (i) from Crop Subgroup 4B to Crop Subgroup 22B (Leaf 
Petiole Vegetable), (ii) from Crop Subgroup 5A to Crop Group 5-16 
(Brassica, Head and Stem Vegetable) and (iii) from Crop Subgroup 5B to 
Crop Subgroup 4-16B (Brassica Leafy Greens); and (4) Tolerance 
Expansions of Representative Commodities to (i) Cottonseed Subgroup 
20C, and (ii) Stalk and Stem Vegetable Subgroup 22A, except Kohlrabi'' 
on pages 54-64 in docket ID number EPA-HQ-OPP-2017-0465.

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

[[Page 8614]]



 Table 1--Summary of Toxicological Doses and Endpoints for S-Metolachlor for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk  assessment
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Acute dietary (All populations)..  An acute dietary assessment for all populations is not required. The adverse
                                    effects resulting from a single dose in the developmental rat study with
                                    metolachlor occurred at the limit dose of 1,000 mg/kg/day, which is a dose
                                    that is not relevant for risk assessment. In addition, an endpoint was not
                                    selected for Females 13-49 years old since no developmental effects
                                    attributable to a single exposure were identified in the metolachlor/S-
                                    metolachlor database.
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Chronic dietary (All populations)  NOAEL = 26 mg/kg/day  Chronic RfD = 0.26   2-generation reproduction study in
                                   UFA = 10x...........   mg/kg/day            rats (Metolachlor).
                                   UFH = 10x...........  cPAD = 0.26 mg/kg/   LOAEL = 86 mg/kg/day based on
                                   FQPA SF = 1x........   day.                 decreased pup body weight in F1
                                                                               and F2 litters.
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Incidental oral short-term (1 to   NOAEL = 26 mg/kg/day  LOC for MOE = 100..  2-generation reproduction study in
 30 days).                         UFA = 10x...........                        rats (Metolachlor).
                                   UFH = 10x...........                       LOAEL = 86 mg/kg/day based on
                                   FQPA SF = 1x........                        decreased pup body weight in F1
                                                                               and F2 litters.
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Dermal short- and intermediate-    NOAEL = 26 mg/kg/day  LOC for MOE = 100..  2-generation reproduction study in
 term (1-6 months) (Children       Dermal absorption                           rats (Metolachlor).
 only).                             factor (DAF) = 58%.                       LOAEL = 86 mg/kg/day based on
                                   UFA = 10x...........                        decreased pup body weight in F1
                                   UFH = 10x...........                        and F2 litters.
                                   FQPA SF = 1x........
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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.
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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). UFDB = to account for the absence of data or other
  data deficiency. 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 
tolerances in 40 CFR 180.368. 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.
    No such effects were identified in the toxicological studies for S-
metolachlor; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used 2003-2008 food consumption data 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).
    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 https://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 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

[[Page 8615]]

into the dietary exposure model. For the chronic dietary risk 
assessment, the water concentration of value 978 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: 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 and risk to residential handlers was assessed and 
resulted in no risks of concern. Based on current Agency policy, the 
Agency no longer considers these products to be intended for homeowner 
use due to label requirements for specific clothing and personal 
protective equipment; therefore, a quantitative residential handler 
assessment was not conducted.
    There is the potential for post-application exposure for 
individuals exposed as a result of being in an environment that has 
been previously treated with S-metolachlor. The population groups at 
risk are youth 11 to <16 years old, children 6 to <11 years old, and 
children 1 to <2 years old. The worst-case scenarios used in the 
aggregate risk assessment are as follows:
     For youth 11 to <16 years old, the scenario used is dermal 
exposures from post-application exposure to treated turf during golfing 
activities.
     For children 6 to <11 years old, the scenario used is 
dermal exposures from post-application contact with treated gardens.
     For children 1 to <2 years old, the scenario used is hand-
to-mouth exposures from post-application exposure to treated turf.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at https://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 https://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. Acceptable developmental 
toxicity studies in the rat and rabbit with both metolachlor and S-
metolachlor and an acceptable reproduction study in the rat with 
metolachlor are available with clearly defined LOAELs and NOAELs. No 
developmental toxicity was seen in rats or rabbits with either 
compound. In the metolachlor and S-metolachlor rat prenatal 
developmental toxicity studies there were no developmental effects seen 
up to the limit dose. In the rat developmental toxicity study with 
metolachlor, death and clinical signs (clonic and/or tonic convulsions, 
excessive salivation, urine-stained abdominal fur) were observed at the 
limit dose in maternal animals in the absence of developmental 
toxicity. In the S-metolachlor rabbit developmental toxicity study, 
clinical signs of toxicity (little/none/soft stool) were observed in 
maternal animals in the absence of developmental effects. In the two-
generation reproduction study in rats conducted with metolachlor, there 
was quantitative evidence of susceptibility. Decreased pup body weight 
in F1 and F2 litters was seen in the absence of maternal toxicity. The 
2-generation reproduction study was used for endpoint selection, 
therefore, the PODs selected are protective of the effects seen at this 
dose.
    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.
    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. In the 2-generation reproduction study in rats 
conducted with metolachlor, there was quantitative evidence of 
susceptibility, however, the 2-generation reproduction study was used 
for endpoint selection, therefore, the PODs selected are protective of 
the effects seen at this dose.
    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 exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by S-
metolachlor.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute

[[Page 8616]]

exposure estimates from dietary consumption of food and drinking water. 
No adverse effect resulting from a single oral exposure was identified 
and no acute dietary endpoint was selected. Therefore, S-metolachlor is 
not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure analysis, EPA has concluded that the risk 
estimates for chronic exposure to S-metolachlor from food and water are 
not of concern (<100% of cPAD) with a risk estimate at 22% 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 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 aggregate MOEs of 1,246 for youths 
11 to less than 16 years old, 106 for children 6 to less than 11 years 
old, and 207 for children 1 to less than 2 years old, the population 
groups of concern. 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.
    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 
(LOQs of 0.03 ppm and 0.05 ppm, respectively).

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

    Four comments were submitted to the docket for this action. One 
dealt with ``logging workers in the National Forest'', the second with 
critical habitat restrictions, the third with wind powered facilities 
threatening populations of bats, and the fourth with adverse economic 
impacts of regulations. All submitted comments are unrelated to S-
metolachlor in particular, or pesticides in general, and are not 
relevant to this action.

D. Revisions to Petitioned-For Tolerances

    The submitted Swiss chard field trial data support a tolerance of 
0.15 ppm instead of the proposed tolerance of 0.10 ppm. The reason for 
the difference is that EPA used the combined level of quantitation 
(LOQ) of CGA-37913 and CGA-49751 expressed in parent equivalents, 0.131 
ppm, which becomes 0.15 ppm in Organization for Economic Cooperation 
and Development (OECD) rounding class representing the tolerance value 
for Swiss chard. The petitioner, instead, used the combined LOQ of 0.10 
ppm for the input dataset of the OECD tolerance calculation procedure.
    Chinese broccoli was a member of subgroup 5A with a tolerance of 
0.60 ppm, which falls within the established tolerance for subgroup 4-
16B at 1.8 ppm. An individual tolerance for Chinese broccoli is not 
needed.
    Celtuce and Florence fennel, originally in crop subgroup 4B, have 
the same tolerance as subgroup 22A, 0.10 ppm. Following crop group 
conversion/revision the tolerances for celtuce and Florence fennel are 
now covered by the subgroup 22A.
    EPA also modified several commodity definitions to be consistent 
with Agency nomenclature.

V. Conclusion

    Therefore, tolerances are established for residues of S-metolachlor 
in or on Brassica, leafy greens, subgroup 4-16B at 1.8 ppm; Cottonseed 
subgroup 20C at 0.10 ppm; Kohlrabi at 0.60; Leaf petiole vegetable 
subgroup 22B at 0.10 ppm; Stalk and stem vegetable subgroup 22A, except 
kohlrabi at 0.10 ppm; Stevia, dried leaves at 15 ppm; Swiss chard at 
0.15 ppm; Vegetable, Brassica, head and stem, group 5-16 at 0.60 ppm; 
and Vegetable, leaves of root and tuber, group 2, except sugar beet at 
2.0 ppm.
    Additionally, due to the establishment of the aforementioned 
commodities, the following tolerances are removed as unnecessary: 
Asparagus; Beet, garden, leaves; Brassica, head and stem, subgroup 5A; 
Brassica, leafy greens, subgroup 5B; Cotton, undelinted seed; Leaf 
petioles, subgroup 4B; and Turnip greens.

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

[[Page 8617]]

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 tolerances 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 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 26, 2019.
Michael 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(a)(2):
0
a. Remove the entries for ``Asparagus''; ``Beet, garden, leaves''; 
``Brassica, head and stem, subgroup 5A''; and ``Brassica, leafy greens, 
subgroup 5B'' from the table.
0
b. Add alphabetically the entry for ``Brassica, leafy greens, subgroup 
4-16B'' to the table.
0
c. Remove the entry for ``Cotton, undelinted seed'' from the table.
0
d. Add alphabetically the entries for ``Cottonseed subgroup 20C'' and 
``Kohlrabi'' to the table.
0
e. Remove the entry for ``Leaf petioles, subgroup 4B'' from the table.
0
f. Add alphabetically the entries for ``Leaf petiole vegetable subgroup 
22B''; ``Stalk and stem vegetable subgroup 22A, except kohlrabi''; 
``Stevia, dried leaves''; and ``Swiss chard'' to the table.
0
g. Remove the entry for ``Turnip greens'' from the table.
0
h. Add alphabetically the entries for ``Vegetable, Brassica, head and 
stem, group 5-16'' and ``Vegetable, leaves of root and tuber, group 2, 
except sugar beet'' to the table.
    The additions read as follows:


Sec.  180.368  Metolachlor; tolerances for residues.

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

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Brassica, leafy greens, subgroup 4-16B..................             1.8
 
                                * * * * *
Cottonseed subgroup 20C.................................            0.10
 
                                * * * * *
Kohlrabi................................................            0.60
Leaf petiole vegetable subgroup 22B.....................            0.10
 
                                * * * * *
Stalk and stem vegetable subgroup 22A, except kohlrabi..            0.10
Stevia, dried leaves....................................              15
 
                                * * * * *
Swiss chard.............................................            0.15
 
                                * * * * *
Vegetable, Brassica, head and stem, group 5-16..........            0.60
 
                                * * * * *
Vegetable, leaves of root and tuber, group 2, except                 2.0
 sugar beet.............................................
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2019-04251 Filed 3-8-19; 8:45 am]
 BILLING CODE 6560-50-P