80 FR 38981 - S-metolachlor; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 130 (July 8, 2015)

Page Range		38981-38986
FR Document		2015-16523

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).

Federal Register, Volume 80 Issue 130 (Wednesday, July 8, 2015)

[Federal Register Volume 80, Number 130 (Wednesday, July 8, 2015)]
[Rules and Regulations]
[Pages 38981-38986]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-16523]

[[Page 38981]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0284; FRL-9927-85]

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 July 8, 2015. Objections and
requests for hearings must be received on or before September 8, 2015,
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-2014-0284, 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: Susan Lewis, 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-2014-0284 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
September 8, 2015. 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-2014-0284, 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 December 17, 2014 (79 FR 75107) (FRL-
9918-90), 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
4E8248) by IR-4 500 College Road East, Suite 201 W, Princeton, NJ
08540, requests to establish a tolerance in 40 CFR part 180 for
residues of S-metolachlor in or on the raw agricultural commodity
lettuce at 1.5 parts per million (ppm); vegetable, cucurbit group 9 at
0.50 ppm; vegetable, fruiting, group 8-10, except tabasco pepper at
0.10 ppm; low growing berry subgroup 13-07G except cranberry at 0.40
ppm; and sunflower subgroup 20B at 0.50 ppm and the concurrent deletion
of the existing tolerances for okra; vegetable, fruiting, group 8
except tabasco pepper; cucumber; melon subgroup 9A; pumpkin; squash,
winter; and sunflower, seed. 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. There were no
comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
modified the levels at which some of the tolerances are being
established. The reason for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure

[[Page 38982]]

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 (bw) 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. Metolachlor did not cause an increase in tumors of
any kind in mice. In rats, metolachlor caused an increase in benign
liver tumors in rats, but this increase was seen only at the highest
dose tested and was statistically significant compared to controls only
in females. There was no evidence of mutagenic or cytogenetic effects
in vivo or in vitro. Based on this evidence, EPA has concluded that
metolachlor does not have a common mechanism of carcinogenicity with
acetochlor and alachlor, compounds that are structurally similar to
metolachlor. Metolachlor has been classified as a Group C, possible
human carcinogen, based on liver tumors in rats at the highest dose
tested (HDT).
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 the document ``S-metolachlor--Risk Assessment
for Establishment of Tolerances for New Uses on Lettuce, Low Growing
Berry Subgroup 13-07G, except Cranberry; Vegetable, Cucurbit, Group 9;
Sunflower subgroup 20B; Vegetable, Fruiting, Group 8-10; except Tabasco
Pepper and Okra'' on pp. 40 in docket ID number EPA-HQ-OPP-2014-0284.

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 the NOAEL and the LOAEL are identified.
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 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
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Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
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Acute dietary (General population NOAEL = 300 mg/kg/day. Acute RfD = 3.0 mg/kg/ Developmental Toxicity
including infants and children). day. Study--Rat (metolachlor).
UFA = 10x aPAD = 3.0 mg/kg/day.. LOAEL = 1,000 mg/kg/day
UFH = 10x............. based increased incidence
FQPA SF = 1x.......... of death, clinical signs
(clonic and/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/day.. Chronic RfD = 0.097 mg/ One Year Chronic Toxicity--
kg/day. Dog (metolachlor).
UFA = 10x cPAD = 0.097 mg/kg/day LOAEL = 33 mg/kg/day based
UFH = 10x............. decreased body weight gain
FQPA SF = 1x.......... in females.

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Incidental oral short-term (1 to 30 NOAEL= 50 mg/kg/day... LOC for MOE = 100..... Developmental Toxicity
days). Study--Rat (S-
metolachlor).
UFA = 10x ...................... LOAEL = 500 mg/kg/day based
UFH = 10x............. on increased incidence of
FQPA SF = 1x.......... clinical signs, decreased
body weight/body weight
gain, food consumption and
food efficiency seen in
maternal animals.
Inhalation short-term (1 to 30 Inhalation (or oral) LOC for MOE = 1,000... Developmental Toxicity
days). study NOAEL= 50 mg/kg/ Study--Rat (S-
day (inhalation metolachlor).
absorption rate =
100%).
UFA = 10x ...................... LOAEL = 500 mg/kg/day based
UFH = 10x............. on increased incidence of
FQPA SF = 10x UFDB.... clinical signs, decreased
body weight/body weight
gain, food consumption and
food efficiency seen at
the LOAEL in maternal
animals.
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Cancer (all routes)................ Metolachlor has been classified as a Group C carcinogen 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.
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://www.epa.gov/oppefed1/models/water/index.htm.
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 14.3 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 43.70 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,
termiticide, 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, short-term inhalation exposure is

[[Page 38984]]

expected. The following scenarios were evaluated:
Mixing/loading/applying gardens/trees with manually-
pressurized hand wand, hose-end sprayer, backpack, and sprinkler can
equipment.
Mixing/loading/applying lawns/turf with manually-
pressurized hand wand, hose-end sprayer, backpack, and sprinkler can
equipment.
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://www.epa.gov/pesticides/science/residential-exposure-sop.html.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found S-metolachlor to share a common mechanism of
toxicity with any other substances, and S-metolachlor does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that S-
metolachlor does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10x) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10x, or uses a different additional
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 bw. These effects occurred at
maternally toxic doses (1,000 milligram/kilogram/day (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 except inhalation. For
inhalation scenarios a 10x database uncertainty factor (UF) still
applies. 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. As noted above, a 10x data base UF will be applied
only for assessing risk for inhalation exposure scenarios.
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<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 6.8% of the cPAD for
children 1-2 years 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. Potential
short-term residential risk scenarios anticipated include adult
inhalation handler exposure to turf via backpack sprayer and post-
application incidental oral exposure of children playing on treated
lawns.
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 10,400 for adults
and 1,100 for children 1-2 years old. Because EPA's levels of concern
for S-metolachlor is a

[[Page 38985]]

MOE of 1,000 or below for inhalation scenarios (adults) and 100 or
below for incidental oral scenarios (children 1-2 years old), 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. 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.
Adequate data are also available on the recovery of metolachlor through
FDA's Multiresidue Method Testing Protocols which indicate that
metolachlor is completely recovered through Method 302.

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 a MRL for S-metolachlor.

C. Revisions to Petitioned-For Tolerances

The tolerance being established for the sunflower subgroup 20B is
1.0 ppm, not 0.50 ppm as proposed. This is due to the Agency using the
Organization for Economic Cooperation and Development (OECD) Tolerance
Calculation procedures, which determined that a tolerance of 1.0 ppm is
appropriate based on entry of the 4 field trials for pre-emergence
application.

V. Conclusion

Therefore, tolerances are established for residues of S-metolachlor
in or on lettuce at 1.5 ppm; the low growing berry subgroup 13-07G,
except cranberry at 0.40 ppm; the sunflower subgroup 20B at 1.0 ppm;
the vegetable, cucurbit group 9 at 0.50 ppm; and the vegetable,
fruiting, group 8-10, except tabasco pepper at 0.10 ppm. Additionally,
due to the establishment of the tolerances listed above, the existing
tolerances for vegetable, fruiting, group 8, except tabasco pepper;
cucumber; melon subgroup 9A; okra; pumpkin; squash, winter; and
sunflower, seed are removed as they are unnecessary.

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). 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 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).

[[Page 38986]]

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: June 26, 2015.
Susan Lewis,
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:
0
a. Remove the entries ``Cucumber,'' ``Melon subgroup 9A,'' ``Okra,''
``Pumpkin,'' ``Squash, winter,'' ``Sunflower, seed,'' and ``Vegetable,
fruiting, group 8, except tabasco pepper,'' in paragraph (a)(2).
0
b. Add alphabetically the following commodities to the table in
paragraph (a)(2).
The amendments read as follows:

Sec. 180.368 Metolachlor; tolerances for residues.

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

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

* * * * *
Lettuce................................................. 1.5
Low growing berry subgroup 13-07G, except cranberry..... 0.40

* * * * *
Sunflower subgroup 20B.................................. 1.0

* * * * *
Vegetable, cucurbit group 9............................. 0.50

* * * * *
Vegetable, fruiting, group 8-10, except tabasco pepper.. 0.10

* * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-16523 Filed 7-7-15; 8:45 am]
BILLING CODE 6560-50-P

Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Rules and Regulations 38981

ENVIRONMENTAL PROTECTION provides a guide to help readers • Hand Delivery: To make special
AGENCY determine whether this document arrangements for hand delivery or
applies to them. Potentially affected delivery of boxed information, please
40 CFR Part 180 entities may include: follow the instructions at http://
[EPA–HQ–OPP–2014–0284; FRL–9927–85]
• Crop production (NAICS code 111). www.epa.gov/dockets/contacts.html.
• Animal production (NAICS code Additional instructions on
S-metolachlor; Pesticide Tolerances 112). commenting or visiting the docket,
• Food manufacturing (NAICS code along with more information about
AGENCY: Environmental Protection 311). dockets generally, is available at
Agency (EPA). • Pesticide manufacturing (NAICS http://www.epa.gov/dockets.
ACTION: Final rule. code 32532). II. Summary of Petitioned-For
B. How can I get electronic access to Tolerance
SUMMARY: This regulation establishes
tolerances for residues of S-metolachlor other related information? In the Federal Register of December
in or on multiple commodities which 17, 2014 (79 FR 75107) (FRL–9918–90),
You may access a frequently updated
are identified and discussed later in this EPA issued a document pursuant to
electronic version of EPA’s tolerance
document. Interregional Research FFDCA section 408(d)(3), 21 U.S.C.
regulations at 40 CFR part 180 through 346a(d)(3), announcing the filing of a
Project Number 4 (IR–4) requested these the Government Printing Office’s e-CFR
tolerances under the Federal Food, pesticide petition (PP 4E8248) by IR–4
site at http://www.ecfr.gov/cgi-bin/text- 500 College Road East, Suite 201 W,
Drug, and Cosmetic Act (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
DATES: This regulation is effective July
Princeton, NJ 08540, requests to
40tab_02.tpl. establish a tolerance in 40 CFR part 180
8, 2015. Objections and requests for
C. How can I file an objection or hearing for residues of S-metolachlor in or on
hearings must be received on or before
request? the raw agricultural commodity lettuce
September 8, 2015, and must be filed in
at 1.5 parts per million (ppm); vegetable,
accordance with the instructions Under FFDCA section 408(g), 21 cucurbit group 9 at 0.50 ppm; vegetable,
provided in 40 CFR part 178 (see also U.S.C. 346a, any person may file an fruiting, group 8–10, except tabasco
Unit I.C. of the SUPPLEMENTARY objection to any aspect of this regulation pepper at 0.10 ppm; low growing berry
INFORMATION). and may also request a hearing on those subgroup 13–07G except cranberry at
ADDRESSES: The docket for this action, objections. You must file your objection 0.40 ppm; and sunflower subgroup 20B
identified by docket identification (ID) or request a hearing on this regulation at 0.50 ppm and the concurrent deletion
number EPA–HQ–OPP–2014–0284, is in accordance with the instructions of the existing tolerances for okra;
available at http://www.regulations.gov provided in 40 CFR part 178. To ensure vegetable, fruiting, group 8 except
or at the Office of Pesticide Programs proper receipt by EPA, you must tabasco pepper; cucumber; melon
Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ– subgroup 9A; pumpkin; squash, winter;
in the Environmental Protection Agency OPP–2014–0284 in the subject line on and sunflower, seed. That document
Docket Center (EPA/DC), West William the first page of your submission. All referenced a summary of the petition
Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing prepared by Syngenta Crop Protection,
Constitution Ave. NW., Washington, DC must be in writing, and must be the registrant, which is available in the
20460–0001. The Public Reading Room received by the Hearing Clerk on or docket, http://www.regulations.gov.
is open from 8:30 a.m. to 4:30 p.m., before September 8, 2015. Addresses for There were no comments received in
Monday through Friday, excluding legal mail and hand delivery of objections response to the notice of filing.
holidays. The telephone number for the and hearing requests are provided in 40 Based upon review of the data
Public Reading Room is (202) 566–1744, CFR 178.25(b). supporting the petition, EPA has
and the telephone number for the OPP In addition to filing an objection or modified the levels at which some of the
Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk tolerances are being established. The
the visitor instructions and additional as described in 40 CFR part 178, please reason for these changes are explained
information about the docket available submit a copy of the filing (excluding in Unit IV.C.
at http://www.epa.gov/dockets. any Confidential Business Information
(CBI)) for inclusion in the public docket. III. Aggregate Risk Assessment and
FOR FURTHER INFORMATION CONTACT: Determination of Safety
Information not marked confidential
Susan Lewis, Registration Division
pursuant to 40 CFR part 2 may be Section 408(b)(2)(A)(i) of FFDCA
(7505P), Office of Pesticide Programs,
disclosed publicly by EPA without prior allows EPA to establish a tolerance (the
Environmental Protection Agency, 1200
notice. Submit the non-CBI copy of your legal limit for a pesticide chemical
Pennsylvania Ave. NW., Washington,
objection or hearing request, identified residue in or on a food) only if EPA
DC 20460–0001; main telephone
by docket ID number EPA–HQ–OPP– determines that the tolerance is ‘‘safe.’’
number: (703) 305–7090; email address:
2014–0284, by one of the following Section 408(b)(2)(A)(ii) of FFDCA
RDFRNotices@epa.gov.
methods: defines ‘‘safe’’ to mean that ‘‘there is a
SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http:// reasonable certainty that no harm will
I. General Information www.regulations.gov. Follow the online result from aggregate exposure to the
instructions for submitting comments. pesticide chemical residue, including
A. Does this action apply to me? Do not submit electronically any all anticipated dietary exposures and all
You may be potentially affected by information you consider to be CBI or other exposures for which there is
tkelley on DSK3SPTVN1PROD with RULES

this action if you are an agricultural other information whose disclosure is reliable information.’’ This includes
producer, food manufacturer, or restricted by statute. exposure through drinking water and in
pesticide manufacturer. The following • Mail: OPP Docket, Environmental residential settings, but does not include
list of North American Industrial Protection Agency Docket Center (EPA/ occupational exposure. Section
Classification System (NAICS) codes is DC), (28221T), 1200 Pennsylvania Ave. 408(b)(2)(C) of FFDCA requires EPA to
not intended to be exhaustive, but rather NW., Washington, DC 20460–0001. give special consideration to exposure

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Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Rules and Regulations 38985

MOE of 1,000 or below for inhalation B. International Residue Limits Planning and Review’’ (58 FR 51735,
scenarios (adults) and 100 or below for In making its tolerance decisions, EPA October 4, 1993). Because this action
incidental oral scenarios (children 1–2 seeks to harmonize U.S. tolerances with has been exempted from review under
years old), these MOEs are not of international standards whenever Executive Order 12866, this action is
concern. possible, consistent with U.S. food not subject to Executive Order 13211,
4. Intermediate-term risk. safety standards and agricultural entitled ‘‘Actions Concerning
Intermediate-term aggregate exposure practices. EPA considers the Regulations That Significantly Affect
takes into account intermediate-term international maximum residue limits Energy Supply, Distribution, or Use’’ (66
residential exposure plus chronic (MRLs) established by the Codex FR 28355, May 22, 2001) or Executive
Alimentarius Commission (Codex), as Order 13045, entitled ‘‘Protection of
exposure to food and water (considered
required by FFDCA section 408(b)(4). Children from Environmental Health
to be a background exposure level).
The Codex Alimentarius is a joint Risks and Safety Risks’’ (62 FR 19885,
An intermediate-term adverse effect April 23, 1997). This action does not
United Nations Food and Agriculture
was identified; however, S-metolachlor contain any information collections
Organization/World Health
is not registered for any use patterns subject to OMB approval under the
Organization food standards program,
that would result in intermediate-term Paperwork Reduction Act (PRA) (44
and it is recognized as an international
residential exposure. Because there is U.S.C. 3501 et seq.), nor does it require
food safety standards-setting
no intermediate-term residential any special considerations under
organization in trade agreements to
exposure and chronic dietary exposure Executive Order 12898, entitled
which the United States is a party. EPA
has already been assessed under the ‘‘Federal Actions to Address
may establish a tolerance that is
appropriately protective cPAD (which is different from a Codex MRL; however, Environmental Justice in Minority
at least as protective as the POD used to FFDCA section 408(b)(4) requires that Populations and Low-Income
assess intermediate-term risk), no EPA explain the reasons for departing Populations’’ (59 FR 7629, February 16,
further assessment of intermediate-term from the Codex level. 1994).
risk is necessary, and EPA relies on the The Codex has not established a MRL Since tolerances and exemptions that
chronic dietary risk assessment for for S-metolachlor. are established on the basis of a petition
evaluating intermediate-term risk for S- under FFDCA section 408(d), such as
metolachlor. C. Revisions to Petitioned-For the tolerance in this final rule, do not
Tolerances require the issuance of a proposed rule,
5. Aggregate cancer risk for U.S.
population. As discussed in Unit III.A, The tolerance being established for the requirements of the Regulatory
the chronic dietary risk assessment is the sunflower subgroup 20B is 1.0 ppm, Flexibility Act (RFA) (5 U.S.C. 601 et
protective of any potential cancer not 0.50 ppm as proposed. This is due seq.), do not apply.
to the Agency using the Organization for This action directly regulates growers,
effects. Based on the results of that
Economic Cooperation and food processors, food handlers, and food
assessment, EPA concludes that S-
Development (OECD) Tolerance retailers, not States or tribes, nor does
metolachlor is not expected to pose a
Calculation procedures, which this action alter the relationships or
cancer risk to humans.
determined that a tolerance of 1.0 ppm distribution of power and
6. Determination of safety. Based on is appropriate based on entry of the 4 responsibilities established by Congress
these risk assessments, EPA concludes field trials for pre-emergence in the preemption provisions of FFDCA
that there is a reasonable certainty that application. section 408(n)(4). As such, the Agency
no harm will result to the general has determined that this action will not
population, or to infants and children V. Conclusion have a substantial direct effect on States
from aggregate exposure to S- Therefore, tolerances are established or tribal governments, on the
metolachlor residues. for residues of S-metolachlor in or on relationship between the national
lettuce at 1.5 ppm; the low growing government and the States or tribal
IV. Other Considerations
berry subgroup 13–07G, except governments, or on the distribution of
A. Analytical Enforcement Methodology cranberry at 0.40 ppm; the sunflower power and responsibilities among the
subgroup 20B at 1.0 ppm; the vegetable, various levels of government or between
Adequate methodology is available for cucurbit group 9 at 0.50 ppm; and the the Federal Government and Indian
enforcing the established and vegetable, fruiting, group 8–10, except tribes. Thus, the Agency has determined
recommended tolerances. PAM Vol. II, tabasco pepper at 0.10 ppm. that Executive Order 13132, entitled
Pesticide Regulation Section 180.368, Additionally, due to the establishment ‘‘Federalism’’ (64 FR 43255, August 10,
lists a gas chromatography with of the tolerances listed above, the 1999) and Executive Order 13175,
nitrogen-phosphorus detector (GC/NPD) existing tolerances for vegetable, entitled ‘‘Consultation and Coordination
method (Method I) for determining fruiting, group 8, except tabasco pepper; with Indian Tribal Governments’’ (65 FR
residues in/on plant commodities and a cucumber; melon subgroup 9A; okra; 67249, November 9, 2000) do not apply
gas chromatography with mass selective pumpkin; squash, winter; and to this action. In addition, this action
detector (GC/MSD) method (Method II) sunflower, seed are removed as they are does not impose any enforceable duty or
for determining residues in livestock unnecessary. contain any unfunded mandate as
commodities. These methods determine described under Title II of the Unfunded
residues of metolachlor and its VI. Statutory and Executive Order Mandates Reform Act (UMRA) (2 U.S.C.
metabolites as either CGA–37913 or Reviews 1501 et seq.).
CGA–49751 following acid hydrolysis. This action establishes tolerances This action does not involve any
tkelley on DSK3SPTVN1PROD with RULES

Adequate data are also available on the under FFDCA section 408(d) in technical standards that would require
recovery of metolachlor through FDA’s response to a petition submitted to the Agency consideration of voluntary
Multiresidue Method Testing Protocols Agency. The Office of Management and consensus standards pursuant to section
which indicate that metolachlor is Budget (OMB) has exempted these types 12(d) of the National Technology
completely recovered through Method of actions from review under Executive Transfer and Advancement Act
302. Order 12866, entitled ‘‘Regulatory (NTTAA) (15 U.S.C. 272 note).

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Document Created: 2018-02-23 09:12:26
Document Modified: 2018-02-23 09:12:26

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective July 8, 2015. Objections and requests for hearings must be received on or before September 8, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
Contact		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		80 FR 38981
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements