S-Metolachlor; Pesticide Tolerances, 12269-12274 [2018-05641]
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Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Rules and Regulations
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and the telephone number for the OPP
[Reserved]
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(c) Tolerances with regional
the visitor instructions and additional
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information about the docket available
(d) Indirect or inadvertent residues.
at https://www.epa.gov/dockets.
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FOR FURTHER INFORMATION CONTACT:
■ 3. Add § 180.1354 to subpart D to read
Michael Goodis, Registration Division
as follows:
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
§ 180.1354 Flutianil; exemption from the
Pennsylvania Ave. NW, Washington, DC
requirement of a tolerance.
20460–0001; main telephone number:
An exemption from the requirement
(703) 305–7090; email address:
of a tolerance is established for indirect
RDFRNotices@epa.gov.
and inadvertent residues of the
SUPPLEMENTARY INFORMATION:
fungicide flutianil, including its
metabolites and degradates, in or on all
I. General Information
food commodities not listed in
A. Does this action apply to me?
§ 180.697(a), when residues are present
therein as a result of uptake by crops
You may be potentially affected by
rotated into fields containing the crops
this action if you are an agricultural
in § 180.697(a) that were previously
producer, food manufacturer, or
treated with flutianil.
pesticide manufacturer. The following
list of North American Industrial
[FR Doc. 2018–05640 Filed 3–20–18; 8:45 am]
Classification System (NAICS) codes is
BILLING CODE 6560–50–P
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
ENVIRONMENTAL PROTECTION
applies to them. Potentially affected
AGENCY
entities may include:
40 CFR Part 180
• Crop production (NAICS code 111).
• Animal production (NAICS code
[EPA–HQ–OPP–2017–0211; FRL–9973–11]
112).
• Food manufacturing (NAICS code
S-Metolachlor; Pesticide Tolerances
311).
AGENCY: Environmental Protection
• Pesticide manufacturing (NAICS
Agency (EPA).
code 32532).
ACTION: Final rule.
B. How can I get electronic access to
Commodity
Parts per
million
This regulation establishes
tolerances for residues of S-metolachlor
in or on sugarcane, cane and sugarcane
molasses. Syngenta Crop Protection
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
SUMMARY:
This regulation is effective
March 21, 2018. Objections and requests
for hearings must be received on or
before May 21, 2018, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
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DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2017–0211, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
ADDRESSES:
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other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2017–0211 in the subject line on
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12269
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before May 21, 2018. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2017–0211, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of September
15, 2017 (82 FR 43352) (FRL–9965–43),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 6F8519) by
Syngenta Crop Protection, LLC, P.O.
Box 18300, Greensboro, NC 27419. The
petition requested that 40 CFR part 180
be amended by establishing tolerances
for residues of the herbicide
S-metolachlor in or on sugarcane at 0.4
parts per million (ppm) and sugarcane
molasses at 1.5 ppm. That document
referenced a summary of the petition
prepared by Syngenta Crop Protection,
the registrant, which is available in the
docket, https://www.regulations.gov. A
comment was received on the notice of
filing. EPA’s response to this comment
is discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA is
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establishing a tolerance for sugarcane,
cane below the level requested. The
reason for this change is explained in
Unit IV.D.
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III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for S-metolachlor
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with S-metolachlor follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
The existing toxicological database is
primarily comprised of studies
conducted with metolachlor. However,
bridging studies indicate that the
metolachlor toxicology database can be
used to assess toxicity for
S-metolachlor. In subchronic
(metolachlor and S-metolachlor) and
chronic (metolachlor) toxicity studies in
dogs and rats decreased body weight
and body weight gain were the most
commonly observed effects. No systemic
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toxicity was observed in rabbits when
metolachlor was administered dermally.
There was no evidence of neurotoxic
effects in the available toxicity studies,
and there is no evidence of
immunotoxicity in the submitted mouse
immunotoxicity study.
Prenatal developmental studies in the
rat and rabbit with both metolachlor and
S-metolachlor revealed no evidence of a
qualitative or quantitative susceptibility
in fetal animals. A 2-generation
reproduction study with metolachlor in
rats showed no evidence of parental or
reproductive toxicity. There are no
residual uncertainties with regard to
pre- and/or postnatal toxicity.
Metolachlor has been evaluated for
carcinogenic effects in the mouse and
the rat. Although treatment with
metolachlor did not result in an increase
in treatment-related tumors in male rats
or in male or female mice, metolachlor
caused an increase in liver tumors in
female rats. There was no evidence of
mutagenic or cytogenetic effects in vivo
or in vitro. Based on the information
available in 1994, metolachlor was
classified as a Group C possible human
carcinogen, in accordance with the 1986
Guidelines for Carcinogen Risk
Assessment. Based on that classification
and consistent with the data available at
that time, EPA determined that a nonlinear approach (i.e., reference dose
(RfD)) would be protective for all
chronic toxicity, including
carcinogenicity, that could result from
exposure to metolachlor.
In 2017, EPA re-assessed the cancer
classification for metolachlor in order to
take into account additional
mechanistic studies on s-metolachlor
that were submitted to assess a human
relevance framework analysis for a
mitogenic mode of action (MOA) for
liver tumors in female rats. Based on
comparable effects of S-metolachlor and
metolachlor shown in several
associative events supporting the mode
of action hypothesis, the Agency
concluded that the in vitro and in vivo
data reasonably explains the
tumorigenic effects of metolachlor and
adequately demonstrates dose and
temporal concordance to support key
events for the MOA leading to liver
tumors in female rats. Specifically, the
Agency found that the development of
liver tumors in rats orally administered
metolachlor is initiated by activation of
constitutive androstane receptor (CAR)
in liver hepatocytes followed by altered
gene expression, transient increased cell
proliferation, increased hepatocellular
foci, and hepatocyte toxicity (increased
liver weight and liver hypertrophy).
Consequently, in accordance with the
EPA’s Final Guidelines for Carcinogen
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Risk Assessment (March 2005), EPA has
reclassified metolachlor/S-metolachlor
as ‘‘Not Likely to be Carcinogenic to
Humans’’ at doses that do not induce
cellular proliferation in the liver. This
classification was based on convincing
evidence of a CAR-mediated mitogenic
MOA for liver tumors in female rats.
Because the current chronic RfD is
protective for any proliferative
responses in the liver and the other key
events in the MOA for the formation of
liver tumors, a non-linear approach (i.e.,
RfD) would adequately account for all
the chronic toxicity, including
carcinogenicity, that could result from
exposure to metolachlor/S-metolachlor.
Specific information on the studies
received and the nature of the adverse
effects caused by S-metolachlor as well
as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document
titled ‘‘S-metolachlor—Human Health
Risk Assessment for the Establishment
of Permanent Tolerances for Use of the
Herbicide on Sugarcane (PP#6F8519)’’
on pages 36–42 in docket ID number
EPA–HQ–OPP–2017–0211.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www2.epa.gov/pesticide-science-and-
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assessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for S-metolachlor used for
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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
Exposure/scenario
Point of
departure and
uncertainty/
safety factors
RfD, PAD, LOC for
risk
assessment
Study and toxicological effects
Acute dietary (General population including infants and
children).
NOAEL = 300 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 3.0 mg/
kg/day.
aPAD = 3.0 mg/kg/
day
Developmental Toxicity Study—Rat.
Metolachlor LOAEL = 1,000 mg/kg/day based increased incidence 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.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 0.097
mg/kg/day.
cPAD = 0.097 mg/
kg/day
One Year Chronic Toxicity—Dog.
Metolachlor LOAEL = 33 mg/kg/day based decreased body
weight gain in females.
Incidental oral short-term (1 to
30 days).
NOAEL = 50 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Developmental Toxicity Study—Rat.
S-metolachlor LOAEL = 500 mg/kg/day based on increased incidence of clinical signs, decreased body weight/body weight
gain, food consumption and food efficiency seen in maternal
animals.
Cancer (Oral, dermal, inhalation).
Classification: Metolachlor/S-metolachlor has been classified as ‘‘Not Likely to be Carcinogenic to Humans’’ at
doses that do not induce cellular proliferation in the liver, with risk quantitated using a non-linear (RfD) approach.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = Lowest-observed-adverse-effect-level. LOC = Level of concern. mg/kg/day =
Milligram/kilogram/day. MOE = Margin of exposure. NOAEL = No-observed-adverse-effect-level. PAD = Population adjusted dose (a = Acute, c =
Chronic). RfD = Reference dose. UF = Uncertainty factor. UFA = Extrapolation from animal to human (interspecies). UFH = Potential variation in
sensitivity among members of the human population (intraspecies).
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to S-metolachlor, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing S-metolachlor and metolachlor
tolerances in 40 CFR 180.368. EPA
assessed dietary exposures from
S-metolachlor and metolachlor in food
as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1-day or single
exposure.
Such effects were identified for
S-metolachlor. In estimating acute
dietary exposure, EPA used food
consumption information from the
United States Department of
Agriculture’s (USDA) National Health
and Nutrition Examination Survey/
What We Eat in America, (NHANES/
WWEIA). As to residue levels in food,
EPA assumed tolerance-level residues
and 100 percent crop treated (PCT).
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA’s NHANES/WWEIA. As
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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 https://www2.epa.gov/
pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide.
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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 halflives were recalculated to collectively
account for the parent and the combined
residues of concern.
Based on the Surface Water
Concentration Calculator (SWCC), the
Pesticide Root Zone Model Ground
Water (PRZM GW), and the Screening
Concentration in Ground Water (SCI–
GROW), the estimated drinking water
concentrations (EDWCs) of
S-metolachlor and its metabolites for
acute exposures are estimated to be 371
parts per billion (ppb) for surface water
and 1,060 ppb for ground water, and for
chronic exposures are estimated to be
43.70 ppb for surface water and 978 ppb
in ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 1,060 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 978 ppb was used to assess the
contribution to drinking water.
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3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
S-metolachlor is currently registered
for the following uses that could result
in residential exposures: On commercial
(sod farm) and residential warm-season
turf grasses and other non-crop land
including golf courses, sports fields, and
ornamental gardens. EPA assessed
residential exposure using the following
assumptions: For residential handlers,
in previous human health risk
assessments for S-metolachlor
inhalation exposure/risk to residential
handlers was assessed and resulted in
no risks of concern. However, all
registered S-metolachlor labels with
residential use sites require that
handlers wear specific clothing (e.g.,
long-sleeve shirt/long pants) and
personal protective equipment (e.g.,
gloves). Based on current policy, the
Agency assumes these products are not
intended for homeowner use and,
therefore, a quantitative residential
handler assessment was not conducted.
For residential post-application, there
is the potential for short-term incidental
oral exposure for individuals exposed as
a result of being in an environment that
has been previously treated with
S-metolachlor. The quantitative
exposure/risk assessment for residential
post-application exposures is based on
the following scenario: Hand-to-mouth
incidental oral exposure of children
1–2 years old playing on turf treated
with S-metolachlor.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at https://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/
standard-operating-proceduresresidential-pesticide.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found S-metolachlor to
share a common mechanism of toxicity
with any other substances, and Smetolachlor 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
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have a common mechanism of toxicity
with other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s website at https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There was no evidence of increased
quantitative or qualitative fetal
susceptibility in the prenatal
developmental studies in rats and
rabbits or in the reproductive toxicity
study in rats, with either metolachlor or
S-metolachlor. In general, significant
developmental toxicity was not seen in
rats or rabbits with either compound.
The only effects observed in fetal
animals were in the rat prenatal
developmental study and included
slightly decreased number of
implantations per dam, decreased
number of live fetuses/dam, increased
number of resorptions/dam and
significant decrease in mean fetal body
weight. These effects occurred at
maternally toxic doses (1,000 mg/kg/
day).
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X for all scenarios
assessed as part of EPA’s determination
of safety for S-metolachlor. This
decision is based on the following
findings:
i. The toxicology database for
metolachlor and S-metolachlor is
complete, with the exception of a
required subchronic inhalation study for
metolachlor. Although the Agency has
determined that a 10X database
uncertainty factor should be retained to
account for the lack of the subchronic
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inhalation study, the Agency does not
expect inhalation exposures to result
from the use of S-metolachlor.
ii. There is no indication that Smetolachlor 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 Smetolachlor 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 Smetolachlor in drinking water. EPA
used similarly conservative assumptions
to assess post-application incidental
oral exposure of children 1 to less-than
2 years old. These assessments will not
underestimate the exposure and risks
posed by S-metolachlor.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to Smetolachlor will occupy 6.1% of the
aPAD for all infants less than 1-year old,
the population group receiving the
greatest exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to S-metolachlor
from food and water will utilize 58% of
the cPAD for all infants less than 1-year
old, the population group receiving the
greatest exposure. Based on the
explanation in Unit III.C.3., regarding
residential use patterns, chronic
residential exposure to residues of Smetolachlor is not expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
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short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
S-metolachlor is currently registered
for uses that could result in short-term
residential exposure, and the Agency
has determined that it is appropriate to
aggregate chronic exposure through food
and water with short-term residential
exposures to S-metolachlor.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures result in an
aggregate MOE of 700 for children 1–2
years old, the only population group of
concern. Because EPA’s level of concern
for S-metolachlor is a MOE of 100 or
below, this MOE is not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
An intermediate-term adverse effect
was identified; however, S-metolachlor
is not registered for any use patterns
that would result in intermediate-term
residential exposure. Intermediate-term
risk is assessed based on intermediateterm residential exposure plus chronic
dietary exposure. Because there is no
intermediate-term residential exposure
and chronic dietary exposure has
already been assessed under the
appropriately protective cPAD (which is
at least as protective as the POD used to
assess intermediate-term risk), no
further assessment of intermediate-term
risk is necessary, and EPA relies on the
chronic dietary risk assessment for
evaluating intermediate-term risk for Smetolachlor.
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 Smetolachlor 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 Smetolachlor 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,
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lists a gas chromatography with
nitrogen-phosphorus detector (GC/NPD)
method (Method I) for determining
residues in/on plant commodities and a
gas chromatography with mass selective
detector (GC/MSD) method (Method II)
for determining residues in livestock
commodities. These methods determine
residues of metolachlor and its
metabolites as either CGA–37913 or
CGA–49751 following acid hydrolysis.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established any
MRLs for either S-metolachlor or
metolachlor.
C. Response to Comments
One comment was received in
response to the notice of filing. The
commenter was against the
establishment of any tolerances for Smetolachlor and stated in part ‘‘allow
zero tolerance. Allow zero residue’’ and
‘‘no animals or people should be eating
any toxic chemicals.’’
Although the Agency recognizes that
some individuals believe that pesticides
should be banned on agricultural crops,
the existing legal framework provided
by section 408 of the Federal Food, Drug
and Cosmetic Act (FFDCA) authorizes
EPA to establish tolerances when it
determines that the tolerance is safe.
Upon consideration of the validity,
completeness, and reliability of the
available data as well as other factors
the FFDCA requires EPA to consider,
EPA has determined that these Smetolachlor tolerances are safe. The
commenter has provided no information
supporting a contrary conclusion.
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12273
D. Revisions to Petitioned-For
Tolerances
Although the petitioner requested a
tolerance on sugarcane at 0.4 ppm, EPA
is establishing the tolerance at 0.20 ppm
based on available field trial data and
the use of average values in the
Organization for Economic Cooperation
and Development (OECD) tolerance
calculation procedure instead of every
individual sample that the petitioner
used. The Agency is also establishing
the tolerance for ‘‘sugarcane, cane’’ to be
consistent with its food and feed
commodity vocabulary.
V. Conclusion
Therefore, tolerances are established
for residues of S-metolachlor in or on
sugarcane, cane at 0.20 ppm and
sugarcane molasses at 1.5 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997), nor is it considered a
regulatory action under Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). This action
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does
it require any special considerations
under Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
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retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: February 28, 2018.
Michael L. Goodis,
Director, Registration Division, Office of
Pesticide Programs.
sradovich on DSK3GMQ082PROD with RULES
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.368, add alphabetically
entries for ‘‘Sugarcane, cane’’ and
■
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Jkt 244001
‘‘Sugarcane, molasses’’ to the table in
paragraph (a)(2) to read as follows:
date of those information collection
requirements.
§ 180.368 Metolachlor; tolerances for
residues.
Synopsis
As required by the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507),
the FCC is notifying the public that it
received OMB approval on March 8,
2018, for the information collection
requirements contained in 47 CFR
73.151(c)(1)(ix) and (x) and (c)(3), 47
CFR 73.154(a), and 47 CFR 73.155, as
amended, in the Commission’s Report
and Order, FCC 17–119. Under 5 CFR
part 1320, an agency may not conduct
or sponsor a collection of information
unless it displays a current, valid OMB
Control Number. No person shall be
subject to any penalty for failing to
comply with a collection of information
subject to the Paperwork Reduction Act
that does not display a current, valid
OMB Control Number. The OMB
Control Number is 3060–0991. The
foregoing notice is required by the
Paperwork Reduction Act of 1995,
Public Law 104–13, October 1, 1995,
and 44 U.S.C. 3507.
The total annual reporting burdens
and costs for the respondents are as
follows:
OMB Control Number: 3060–0991.
OMB Approval Date: March 8, 2018.
OMB Expiration Date: March 31,
2021.
Title: AM Measurement Data.
Form Number: N/A.
Respondents: Business or other forprofit entities.
Number of Respondents and
Responses: 1,800 respondents; 3,135
responses.
Estimated Time per Response: 0.50
hours–25 hours.
Frequency of Response:
Recordkeeping requirement, Third Party
disclosure requirement, On occasion
reporting requirement.
Obligation To Respond: Required to
obtain or retain benefits. The statutory
authority for this collection of
information is contained in Sections
151, 152, 154(i), 303, and 307 of the
Communications Act of 1934, as
amended.
Total Annual Burden: 20,200 hours.
Total Annual Cost: $1,131,500.
Nature and Extent of Confidentiality:
There is no need for confidentiality
treatment with this collection of
information.
Privacy Act Impact Assessment: No
impact(s).
Needs and Uses: The Commission
revised this information collection to
reflect the September 22, 2017, adoption
of the Third Report and Order in MB
Docket No. 13–249, FCC 17–119, In the
Matter of Revitalization of AM Radio
*
*
*
(a)(2) * * *
*
*
Parts per
million
Commodity
*
*
*
*
*
Sugarcane, cane ..........................
Sugarcane, molasses ...................
*
*
*
*
*
*
*
0.20
1.5
*
*
*
[FR Doc. 2018–05641 Filed 3–20–18; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 73
[MB Docket No. 13–249; FCC 17–119]
Revitalization of the AM Radio Service
Federal Communications
Commission.
ACTION: Final rule; announcement of
effective date.
AGENCY:
In this document, the Federal
Communications Commission
(Commission) announces that the Office
of Management and Budget (OMB) has
approved, for a period of three years,
information collection requirements
adopted in the Commission’s Third
Report and Order, FCC 17–119. This
document is consistent with the Third
Report and Order, which stated that the
Commission would publish a document
in the Federal Register announcing
OMB approval and the effective date of
the rules.
DATES: The rule amendments to 47 CFR
73.151(c)(1)(ix) and (x) and (c)(3), 47
CFR 73.154(a), and 47 CFR 73.155,
published at 82 FR 51161, November 3,
2017, are effective on March 21, 2018.
FOR FURTHER INFORMATION CONTACT:
Cathy Williams by email at
Cathy.Williams@fcc.gov and telephone
at (202) 418–2918.
SUPPLEMENTARY INFORMATION: This
document announces that, on March 8,
2018, OMB approved information
collection requirements contained in the
Commission’s Report and Order, FCC
17–119, published at 82 FR 51161. The
OMB Control Number is 3060–0991.
The Commission publishes this notice
as an announcement of the effective
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Rules and Regulations]
[Pages 12269-12274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05641]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0211; FRL-9973-11]
S-Metolachlor; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of S-
metolachlor in or on sugarcane, cane and sugarcane molasses. Syngenta
Crop Protection requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective March 21, 2018. Objections and
requests for hearings must be received on or before May 21, 2018, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0211, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: [email protected].
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 https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0211 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
May 21, 2018. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0211, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of September 15, 2017 (82 FR 43352) (FRL-
9965-43), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F8519) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the herbicide S-metolachlor in
or on sugarcane at 0.4 parts per million (ppm) and sugarcane molasses
at 1.5 ppm. That document referenced a summary of the petition prepared
by Syngenta Crop Protection, the registrant, which is available in the
docket, https://www.regulations.gov. A comment was received on the
notice of filing. EPA's response to this comment is discussed in Unit
IV.C.
Based upon review of the data supporting the petition, EPA is
[[Page 12270]]
establishing a tolerance for sugarcane, cane below the level requested.
The reason for this change is explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for S-metolachlor including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with S-metolachlor
follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
The existing toxicological database is primarily comprised of
studies conducted with metolachlor. However, bridging studies indicate
that the metolachlor toxicology database can be used to assess toxicity
for S-metolachlor. In subchronic (metolachlor and S-metolachlor) and
chronic (metolachlor) toxicity studies in dogs and rats decreased body
weight and body weight gain were the most commonly observed effects. No
systemic toxicity was observed in rabbits when metolachlor was
administered dermally. There was no evidence of neurotoxic effects in
the available toxicity studies, and there is no evidence of
immunotoxicity in the submitted mouse immunotoxicity study.
Prenatal developmental studies in the rat and rabbit with both
metolachlor and S-metolachlor revealed no evidence of a qualitative or
quantitative susceptibility in fetal animals. A 2-generation
reproduction study with metolachlor in rats showed no evidence of
parental or reproductive toxicity. There are no residual uncertainties
with regard to pre- and/or postnatal toxicity.
Metolachlor has been evaluated for carcinogenic effects in the
mouse and the rat. Although treatment with metolachlor did not result
in an increase in treatment-related tumors in male rats or in male or
female mice, metolachlor caused an increase in liver tumors in female
rats. There was no evidence of mutagenic or cytogenetic effects in vivo
or in vitro. Based on the information available in 1994, metolachlor
was classified as a Group C possible human carcinogen, in accordance
with the 1986 Guidelines for Carcinogen Risk Assessment. Based on that
classification and consistent with the data available at that time, EPA
determined that a non-linear approach (i.e., reference dose (RfD))
would be protective for all chronic toxicity, including
carcinogenicity, that could result from exposure to metolachlor.
In 2017, EPA re-assessed the cancer classification for metolachlor
in order to take into account additional mechanistic studies on s-
metolachlor that were submitted to assess a human relevance framework
analysis for a mitogenic mode of action (MOA) for liver tumors in
female rats. Based on comparable effects of S-metolachlor and
metolachlor shown in several associative events supporting the mode of
action hypothesis, the Agency concluded that the in vitro and in vivo
data reasonably explains the tumorigenic effects of metolachlor and
adequately demonstrates dose and temporal concordance to support key
events for the MOA leading to liver tumors in female rats.
Specifically, the Agency found that the development of liver tumors in
rats orally administered metolachlor is initiated by activation of
constitutive androstane receptor (CAR) in liver hepatocytes followed by
altered gene expression, transient increased cell proliferation,
increased hepatocellular foci, and hepatocyte toxicity (increased liver
weight and liver hypertrophy).
Consequently, in accordance with the EPA's Final Guidelines for
Carcinogen Risk Assessment (March 2005), EPA has reclassified
metolachlor/S-metolachlor as ``Not Likely to be Carcinogenic to
Humans'' at doses that do not induce cellular proliferation in the
liver. This classification was based on convincing evidence of a CAR-
mediated mitogenic MOA for liver tumors in female rats. Because the
current chronic RfD is protective for any proliferative responses in
the liver and the other key events in the MOA for the formation of
liver tumors, a non-linear approach (i.e., RfD) would adequately
account for all the chronic toxicity, including carcinogenicity, that
could result from exposure to metolachlor/S-metolachlor.
Specific information on the studies received and the nature of the
adverse effects caused by S-metolachlor as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in the document titled ``S-metolachlor--Human
Health Risk Assessment for the Establishment of Permanent Tolerances
for Use of the Herbicide on Sugarcane (PP#6F8519)'' on pages 36-42 in
docket ID number EPA-HQ-OPP-2017-0211.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www2.epa.gov/
pesticide-science-and-
[[Page 12271]]
assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for S-metolachlor used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for S-metolachlor for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population NOAEL = 300 mg/kg/ Acute RfD = 3.0 mg/ Developmental Toxicity Study--Rat.
including infants and children). day. kg/day. Metolachlor LOAEL = 1,000 mg/kg/
UFA = 10x........... aPAD = 3.0 mg/kg/ day based increased incidence of
UFH = 10x........... day. death, clinical signs (clonic and/
FQPA SF = 1x........ or tonic convulsions, excessive
salivation, urine-stained
abdominal fur and/or excessive
lacrimation) and decreased body
weight gain.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL = 9.7 mg/kg/ Chronic RfD = 0.097 One Year Chronic Toxicity--Dog.
day. mg/kg/day. Metolachlor LOAEL = 33 mg/kg/day
UFA = 10x........... cPAD = 0.097 mg/kg/ based decreased body weight gain
UFH = 10x........... day. in females.
FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to NOAEL = 50 mg/kg/day LOC for MOE = 100.. Developmental Toxicity Study--Rat.
30 days). UFA = 10x........... S-metolachlor LOAEL = 500 mg/kg/
UFH = 10x........... day based on increased incidence
FQPA SF = 1x........ of clinical signs, decreased body
weight/body weight gain, food
consumption and food efficiency
seen in maternal animals.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classification: Metolachlor/S-metolachlor has been classified as ``Not Likely
to be Carcinogenic to Humans'' at doses that do not induce cellular
proliferation in the liver, with risk quantitated using a non-linear (RfD)
approach.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = Lowest-observed-adverse-effect-level. LOC = Level
of concern. mg/kg/day = Milligram/kilogram/day. MOE = Margin of exposure. NOAEL = No-observed-adverse-effect-
level. PAD = Population adjusted dose (a = Acute, c = Chronic). RfD = Reference dose. UF = Uncertainty factor.
UFA = Extrapolation from animal to human (interspecies). UFH = Potential variation in sensitivity among
members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to S-metolachlor, EPA considered exposure under the
petitioned-for tolerances as well as all existing S-metolachlor and
metolachlor tolerances in 40 CFR 180.368. EPA assessed dietary
exposures from S-metolachlor and metolachlor in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
Such effects were identified for S-metolachlor. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture's (USDA) National Health and Nutrition
Examination Survey/What We Eat in America, (NHANES/WWEIA). As to
residue levels in food, EPA assumed tolerance-level residues and 100
percent crop treated (PCT).
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA. As to residue levels in food, EPA assumed tolerance-level
residues and 100 PCT.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to S-metolachlor. Therefore, a separate quantitative cancer
exposure assessment is unnecessary since the chronic dietary risk
estimate will be protective of potential cancer risk.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for S-
metolachlor. Tolerance-level residues and 100 PCT were assumed for all
food commodities.
2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for S-metolachlor in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of S-metolachlor. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
The Agency assessed parent metolachlor, and the metabolites CGA-
51202 (metolachlor-OA), CGA-40172, and CGA-50720 together in the
drinking water assessment using a total toxic residues (TTR) approach
where half-lives were recalculated to collectively account for the
parent and the combined residues of concern.
Based on the Surface Water Concentration Calculator (SWCC), the
Pesticide Root Zone Model Ground Water (PRZM GW), and the Screening
Concentration in Ground Water (SCI-GROW), the estimated drinking water
concentrations (EDWCs) of S-metolachlor and its metabolites for acute
exposures are estimated to be 371 parts per billion (ppb) for surface
water and 1,060 ppb for ground water, and for chronic exposures are
estimated to be 43.70 ppb for surface water and 978 ppb in ground
water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 1,060 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 978 ppb was used to assess
the contribution to drinking water.
[[Page 12272]]
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
S-metolachlor is currently registered for the following uses that
could result in residential exposures: On commercial (sod farm) and
residential warm-season turf grasses and other non-crop land including
golf courses, sports fields, and ornamental gardens. EPA assessed
residential exposure using the following assumptions: For residential
handlers, in previous human health risk assessments for S-metolachlor
inhalation exposure/risk to residential handlers was assessed and
resulted in no risks of concern. However, all registered S-metolachlor
labels with residential use sites require that handlers wear specific
clothing (e.g., long-sleeve shirt/long pants) and personal protective
equipment (e.g., gloves). Based on current policy, the Agency assumes
these products are not intended for homeowner use and, therefore, a
quantitative residential handler assessment was not conducted.
For residential post-application, there is the potential for short-
term incidental oral exposure for individuals exposed as a result of
being in an environment that has been previously treated with S-
metolachlor. The quantitative exposure/risk assessment for residential
post-application exposures is based on the following scenario: Hand-to-
mouth incidental oral exposure of children 1-2 years old playing on
turf treated with S-metolachlor.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found S-metolachlor to share a common mechanism of
toxicity with any other substances, and S-metolachlor does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that S-
metolachlor does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. There was no evidence of
increased quantitative or qualitative fetal susceptibility in the
prenatal developmental studies in rats and rabbits or in the
reproductive toxicity study in rats, with either metolachlor or S-
metolachlor. In general, significant developmental toxicity was not
seen in rats or rabbits with either compound. The only effects observed
in fetal animals were in the rat prenatal developmental study and
included slightly decreased number of implantations per dam, decreased
number of live fetuses/dam, increased number of resorptions/dam and
significant decrease in mean fetal body weight. These effects occurred
at maternally toxic doses (1,000 mg/kg/day).
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for all scenarios assessed as part of EPA's
determination of safety for S-metolachlor. This decision is based on
the following findings:
i. The toxicology database for metolachlor and S-metolachlor is
complete, with the exception of a required subchronic inhalation study
for metolachlor. Although the Agency has determined that a 10X database
uncertainty factor should be retained to account for the lack of the
subchronic inhalation study, the Agency does not expect inhalation
exposures to result from the use of S-metolachlor.
ii. There is no indication that S-metolachlor is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that S-metolachlor results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to S-metolachlor in drinking water. EPA used
similarly conservative assumptions to assess post-application
incidental oral exposure of children 1 to less-than 2 years old. These
assessments will not underestimate the exposure and risks posed by S-
metolachlor.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to S-metolachlor will occupy 6.1% of the aPAD for all infants less than
1-year old, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
S-metolachlor from food and water will utilize 58% of the cPAD for all
infants less than 1-year old, the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
S-metolachlor is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account
[[Page 12273]]
short-term residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
S-metolachlor is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to S-metolachlor.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in an aggregate MOE of 700 for
children 1-2 years old, the only population group of concern. Because
EPA's level of concern for S-metolachlor is a MOE of 100 or below, this
MOE is not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
An intermediate-term adverse effect was identified; however, S-
metolachlor is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for S-
metolachlor.
5. Aggregate cancer risk for U.S. population. As discussed in Unit
III.A, the chronic dietary risk assessment is protective of any
potential cancer effects. Based on the results of that assessment, EPA
concludes that S-metolachlor is not expected to pose a cancer risk to
humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to S-metolachlor residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate methodology is available for enforcing the established and
recommended tolerances. PAM Vol. II, Pesticide Regulation Section
180.368, lists a gas chromatography with nitrogen-phosphorus detector
(GC/NPD) method (Method I) for determining residues in/on plant
commodities and a gas chromatography with mass selective detector (GC/
MSD) method (Method II) for determining residues in livestock
commodities. These methods determine residues of metolachlor and its
metabolites as either CGA-37913 or CGA-49751 following acid hydrolysis.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established any MRLs for either S-metolachlor or
metolachlor.
C. Response to Comments
One comment was received in response to the notice of filing. The
commenter was against the establishment of any tolerances for S-
metolachlor and stated in part ``allow zero tolerance. Allow zero
residue'' and ``no animals or people should be eating any toxic
chemicals.''
Although the Agency recognizes that some individuals believe that
pesticides should be banned on agricultural crops, the existing legal
framework provided by section 408 of the Federal Food, Drug and
Cosmetic Act (FFDCA) authorizes EPA to establish tolerances when it
determines that the tolerance is safe. Upon consideration of the
validity, completeness, and reliability of the available data as well
as other factors the FFDCA requires EPA to consider, EPA has determined
that these S-metolachlor tolerances are safe. The commenter has
provided no information supporting a contrary conclusion.
D. Revisions to Petitioned-For Tolerances
Although the petitioner requested a tolerance on sugarcane at 0.4
ppm, EPA is establishing the tolerance at 0.20 ppm based on available
field trial data and the use of average values in the Organization for
Economic Cooperation and Development (OECD) tolerance calculation
procedure instead of every individual sample that the petitioner used.
The Agency is also establishing the tolerance for ``sugarcane, cane''
to be consistent with its food and feed commodity vocabulary.
V. Conclusion
Therefore, tolerances are established for residues of S-metolachlor
in or on sugarcane, cane at 0.20 ppm and sugarcane molasses at 1.5 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food
[[Page 12274]]
retailers, not States or tribes, nor does this action alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of FFDCA section 408(n)(4). As
such, the Agency has determined that this action will not have a
substantial direct effect on States or tribal governments, on the
relationship between the national government and the States or tribal
governments, or on the distribution of power and responsibilities among
the various levels of government or between the Federal Government and
Indian tribes. Thus, the Agency has determined that Executive Order
13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999) and
Executive Order 13175, entitled ``Consultation and Coordination with
Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not
apply to this action. In addition, this action does not impose any
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 28, 2018.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.368, add alphabetically entries for ``Sugarcane, cane''
and ``Sugarcane, molasses'' to the table in paragraph (a)(2) to read as
follows:
Sec. 180.368 Metolachlor; tolerances for residues.
* * * * *
(a)(2) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Sugarcane, cane.............................................. 0.20
Sugarcane, molasses.......................................... 1.5
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2018-05641 Filed 3-20-18; 8:45 am]
BILLING CODE 6560-50-P
