[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Rules and Regulations]
[Pages 48902-48907]
[FR Doc No: 2012-20034]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

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

S-Metolachlor; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

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

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

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

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

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

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

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 7, 2011 (76 FR 55329) (FRL-
8886-7), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1E7898) by Interregional Research Project Number 4, 500 College Road
East, Suite 201W, Princeton, NJ 08540. The petition requested that 40
CFR 180.368 be amended by establishing tolerances for residues of the
herbicide S-metolachlor, S-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-
methoxy-1-methylethyl)acetamide, its R-enantiomer, and its metabolites,
determined as the derivatives, 2-[2-ethyl-6-methylphenyl)amino]-1-
propanol and 4-[2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, in or on cilantro, leaves, fresh at 8.0 parts per million
(ppm) cilantro, leaves, dried at 8.0 ppm, coriander, seed at 0.13 ppm
and beet, garden, leaves at 1.8 ppm. That notice referenced a summary
of the petition prepared by Syngenta Crop Protection, the registrant,
which is available in the docket, http://www.regulations.gov.
    EPA received one comment to the Notice of Filing. That comment is
addressed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA
corrected the crop definition for ``cilantro'' to ``coriander'' and
removed proposed tolerances for fresh and dried cilantro leaves. The
reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

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

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

A. Toxicological Profile

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

B. Toxicological Points of Departure/Levels of Concern

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

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to S-metolachlor, EPA considered exposure under the
petitioned-for tolerances as well as all existing metolachlor and S-
metolachlor tolerances in 40 CFR 180.368. EPA assessed dietary
exposures from S-metolachlor in food as follows:
    Both the acute and chronic analyses assume tolerance-level residues
on all crops with established, pending, or proposed tolerances for
metolachlor and/or S-metolachlor. In cases where separate tolerance
listings occur for both metolachlor and S-metolachlor on the same
commodity, the higher value of the two is used in the analyses.
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for S-metolachlor. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture's (USDA) Nationwide Continuing Surveys
of Food Intake by Individuals (CSFII), 1994-1996 and 1998. As to
residue levels in food, EPA assumed tolerance level residues for all
uses, 100 percent crop treated (PCT) for all commodities and default
processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's
Nationwide CSFII, 1994-1996 and 1998. As to residue levels in food, EPA
assumed tolerance level residues for all uses, 100 PCT for all
commodities and default processing factors.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-

use pesticide based on the weight of the evidence from cancer studies
and other relevant data. Cancer risk is quantified using a linear or
nonlinear approach. If sufficient information on the carcinogenic mode
of action is available, a threshold or nonlinear approach is used and a
cancer RfD is calculated based on an earlier noncancer key event. If
carcinogenic mode of action data are not available, or if the mode of
action data determine a mutagenic mode of action, a default linear
cancer slope factor approach is utilized. Based on the data summarized
in Unit III.A., EPA has concluded that a nonlinear RfD approach is
appropriate for assessing cancer risk to S-metolachlor. Cancer risk was
assessed using the same exposure estimates as discussed in Unit
III.C.1.ii.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for S-metolachlor. Tolerance level residues and 100 PCT were assumed
for all food commodities with existing tolerances, and default
processing factors.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for S-metolachlor in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of S-metolachlor. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST),
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS) Screening Concentration in Ground Water (SCI-GROW) models and
the USGA National Water-Quality Assessment (NAWQA) Program monitoring
data, the Agency calculated conservative estimated drinking water
concentrations (EDWCs) of S-metolachlor and metolachlor originating
from ground water and surface water. EDWCs for metolachlor and
metolachlor were calculated for both the parent compound and the
ethanesulfonic acid (ESA) and oxanilic acid (OA) degradates. The
environmental fate data have been bridged from the racemic mixture
(50:50) of metolachlor to the newer isomer (88:12) S-metolachlor, based
on similarities in environmental fate behavior. Tier I and Tier II
screening models were employed for this assessment. For surface water,
PRZM/EXAMS and FIRST Version1.1.1 models were used to estimate drinking
water concentrations for the parent S-metolachlor and the ESA and OA
degradates, respectively. The SCI-GROW model was used to predict the
maximum acute and chronic concentrations present in shallow
groundwater. Current NAWQA monitoring data were also used to determine
EDWCs. Based on monitoring and modeling data, total EDWCs for peak and
average surface water respectively are 219 ppb (78 ppb parent + 48 ppb
metolachlor ESA+ 94 ppb metolachlor OA) and 119 ppb (18 ppb parent + 34
ppb metolachlor ESA+ 67 ppb metolachlor OA). Groundwater EDWCs (peak
and average) are 126 ppb (33 ppb parent + 64 ppb metolachlor ESA+ 30
ppb metolachlor OA).y67
    For acute exposures are estimated to be 219 ppb for surface water
and 126 ppb for ground water.
    For chronic exposures for non-cancer assessments are estimated to
be 110 ppb for surface water and 126 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
    For acute dietary risk assessment, the water concentration value of
219 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment (cancer and non-cancer), the
water concentration of value 126 ppb was used to assess the
contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    S-Metolachlor is currently registered for the following uses that
could result in residential exposures: Residential lawns or turf by
professional applicators. Pennant MAGNUM\TM (EPA Reg. No. 100-950) is
labeled for use on commercial (sod farm) and residential warm-season
turf grasses and other non-crop land including golf courses, sports
fields, and ornamental gardens. Since Pennant MAGNUM\TM is not
registered for homeowner purchase or use (i.e., used by professional/
commercial applicators), the only potential short-term residential risk
scenario anticipated is post-application hand-to-mouth exposure of
children playing on treated lawns. S-metolachlor incidental oral
exposure is assumed to include hand-to-mouth exposure, object-to-mouth
exposure and exposure through incidental ingestion of soil. Small
children are the population group of concern. Although the type of site
that S-metolachlor may be used on varies from golf courses to
ornamental gardens, the scenario chosen for risk assessment
(residential turf use) represents what the Agency considers the likely
upper-end of possible exposure.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Other than metolachlor, EPA has not found S-metolachlor to share a
common mechanism of toxicity with any other substances, and S-
metolachlor does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that S-metolachlor does not have a common mechanism of
toxicity with other substances.
    For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

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

parental toxicity. Based on the results of developmental and
reproductive toxicity studies, there is not a concern for increased
qualitative and/or quantitative susceptibility following in utero
exposure to metolachlor or S-metolachlor.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
    i. The toxicity database for S-metolachlor is complete, except for
an immunotoxicity and acute and subchronic neurotoxicity studies
required under the amendments to the data requirements. However, based
on the results of the available toxicity studies, there is no evidence
of immunotoxicity or neurotoxicity. Thus, EPA does not expect these
data to change the existing POD for risk assessment.
    ii. There is no indication that S-metolachlor is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that S-metolachlor causes an increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases.

The dietary food exposure assessments were performed based on 100 PCT,
tolerance-level residues for all uses, and default processing factors.
EPA made conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to S-metolachlor in
drinking water. EPA used similarly conservative assumptions to assess
post-application exposure of children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by S-metolachlor.

E. Aggregate Risks and Determination of Safety

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

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (gas chromatography with
nitrogen phosphorous detector (GC/NPD) method (Method I) for
determining residues in/on crop commodities and a gas chromatography
with mass spectroscopy detector (GC/MSD) method (Method II) for
determining residues in livestock commodities) are available to enforce
the tolerance expression. IR-4 and Syngenta have proposed a high
pressure liquid chromatography with mass spectroscopy/mass spectroscopy
(HPLC/MS/MS) enantiomer-specific method for the enforcement of the
proposed tolerances, Method 1848-01. The method uses a chiral HPLC
column to separate out the S-enantiomers (SYN506357 and SYN508500) of
the hydrolysis products CGA-37913 and CGA-49751. This method has been
determined to be adequate for enforcement purposes.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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.
    Neither Codex, Canada, or Mexico has established or proposed
maximum residue limits (MRLs) for S-metolachlor on cilantro or garden
beet leaves.

C. Response to Comments

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

D. Revisions to Petitioned-For Tolerances

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

V. Conclusion

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

VI. Statutory and Executive Order Reviews

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

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

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.368 is amended by alphabetically adding the following
commodities to the table in paragraph (a)(2) to read as follows:

Sec.  180.368  S-metolachlor; tolerances for residues.

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

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Beet, garden, leaves.......................................         1.8

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

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


[Federal Register Volume 86, Number 170 (Tuesday, September 7, 2021)]
[Notices]
[Pages 50101-50102]
[FR Doc No: 2021-19373]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC21-122-000.
    Applicants: RockGen Energy LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act of RockGen Energy LLC.
    Filed Date: 8/31/21.
    Accession Number: 20210831-5254.
    Comment Date: 5 p.m. ET 9/21/21.

    Docket Numbers: EC21-123-000.
    Applicants: Tidal Power Holdings III, LLC, Curtis/Palmer
Hydroelectric Company L.P., Innergex HQI USA LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of Tidal Power Holdings III, LLC, et al.
    Filed Date: 8/31/21.
    Accession Number: 20210831-5257.
    Comment Date: 5 p.m. ET 9/21/21.

    Take notice that the Commission received the following Complaints
and Compliance filings in EL Dockets:

    Docket Numbers: EL21-98-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Petition for Declaratory Order of Pacific Gas and
Electric Company.
    Filed Date: 8/23/21.
    Accession Number: 20210823-5242.
    Comment Date: 5 p.m. ET 9/22/21.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1355-010.
    Applicants: Southern California Edison Company.
    Description: Notice of Change in Status of Southern California
Edison Company.
    Filed Date: 8/31/21.
    Accession Number: 20210831-5256.
    Comment Date: 5 p.m. ET 9/21/21.

    Docket Numbers: ER13-1589-005.
    Applicants: RockGen Energy, LLC.
    Description: Compliance filing: RockGen Energy LLC submits tariff
filing per 35: Informational Filing Regarding Upstream Change in
Control to be effective N/A.
    Filed Date: 9/1/21.
    Accession Number: 20210901-5136.
    Comment Date: 5 p.m. ET 9/22/21.

    Docket Numbers: ER13-198-008.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: PJM submits Compliance Filing re:
Order No. 1000.
    Filed Date: 9/1/21.
    Accession Number: 20210901-5158.
    Comment Date: 5 p.m. ET 9/22/21.

    Docket Numbers: ER21-2349-001.
    Applicants: AR Searcy Project Company, LLC.
    Description: Tariff Amendment: AR Searcy Response to be effective
9/1/2021.
    Filed Date: 8/31/21.
    Accession Number: 20210831-5213.
    Comment Date: 5 p.m. ET 9/10/21.

    Docket Numbers: ER21-2350-001.
    Applicants: MS Sunflower Project Company, LLC.
    Description: Tariff Amendment: MS Sunflower Response to be
effective 9/1/2021.
    Filed Date: 8/31/21.
    Accession Number: 20210831-5215.
    Comment Date: 5 p.m. ET 9/10/21.

    Docket Numbers: ER21-2807-000.
    Applicants: Invenergy Wind Development LLC, Invenergy Solar
Development LLC.
    Description: Request for Prospective Tariff Waiver, et al. of
Invenergy Wind Development LLC, et al.
    Filed Date: 8/31/21.
    Accession Number: 20210831-5198.
    Comment Date: 5 p.m. ET 9/21/21.

    Docket Numbers: ER21-2810-000.
    Applicants: Florida Power & Light Company.
    Description: Baseline eTariff Filing: Florida Power & Light
Company's Re-Baseline of the RSA Database to be effective 9/1/2021.
    Filed Date: 8/31/21.
    Accession Number: 20210831-5214.
    Comment Date: 5 p.m. ET 9/21/21.

    Docket Numbers: ER21-2811-000.
    Applicants: Midcontinent Independent System Operator, Inc., Ameren
Illinois Company.
    Description: Sec.  205(d) Rate Filing: Midcontinent Independent
System Operator, Inc. submits tariff filing per 35.13(a)(2)(iii): 2021-
09-01_SA 3028 Ameren IL-Prairie Power Project #33 Sarah Bush Hosp to be
effective 11/1/2021.
    Filed Date: 9/1/21.
    Accession Number: 20210901-5043.
    Comment Date: 5 p.m. ET 9/22/21.

    Docket Numbers: ER21-2812-000.
    Applicants: American Electric Power Service Corporation, Ohio Power
Company, AEP Ohio Transmission Company, Inc., PJM Interconnection,
L.L.C.

    Description: Sec.  205(d) Rate Filing: American Electric Power
Service Corporation submits tariff filing per 35.13(a)(2)(iii): AEP
submits one FA re: ILDSA SA No. 1427 to be effective 11/1/2021.
    Filed Date: 9/1/21.
    Accession Number: 20210901-5076.
    Comment Date: 5 p.m. ET 9/22/21.

    Docket Numbers: ER21-2813-000.
    Applicants: American Electric Power Service Corporation, Indiana
Michigan Power Company, AEP Indiana Michigan Transmission Company,
Inc., PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: American Electric Power
Service Corporation submits tariff filing per 35.13(a)(2)(iii): AEP
submits one FA re: ILDSA SA No. 5120 to be effective 11/1/2021.
    Filed Date: 9/1/21.
    Accession Number: 20210901-5078.
    Comment Date: 5 p.m. ET 9/22/21.

    Docket Numbers: ER21-2814-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to ISA and ICSA,
Nos. 5866 and 5867; Queue No. AD1-082 to be effective 12/7/2020.
    Filed Date: 9/1/21.
    Accession Number: 20210901-5133.
    Comment Date: 5 p.m. ET 9/22/21.

    Docket Numbers: ER21-2815-000.
    Applicants: ISO New England Inc.
    Description: Sec.  205(d) Rate Filing: ISO-NE; Ministerial Filing
to Conform Exhibit IA, Financial Asssurance Policy to be effective 9/
10/2020.
    Filed Date: 9/1/21.
    Accession Number: 20210901-5142.
    Comment Date: 5 p.m. ET 9/22/21.

    Docket Numbers: ER21-2816-000.
    Applicants: Gratiot County Wind LLC.
    Description: Initial rate filing: Filing of Reactive Power Rate
Schedule to be effective 11/1/2021.
    Filed Date: 9/1/21.
    Accession Number: 20210901-5151.
    Comment Date: 5 p.m. ET 9/22/21.

    Docket Numbers: ER21-2817-000.
    Applicants: Consolidated Edison Company of New York, Inc.
    Description: Sec.  205(d) Rate Filing: Amendment PASNY Tariff 9-1-
2021 CDG-Remote Crediting to be effective 9/1/2021.
    Filed Date: 9/1/21.
    Accession Number: 20210901-5156.
    Comment Date: 5 p.m. ET 9/22/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 1, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-19373 Filed 9-3-21; 8:45 am]
BILLING CODE 6717-01-P