Metaflumizone; Pesticide Tolerances, 18805-18810 [2014-07559]
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Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2013–0258; FRL–9907–67]
Metaflumizone; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of metaflumizone
in or on eggplant, pepper, tomato, and
tomato, paste. BASF Corporation
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
SUMMARY:
This regulation is effective April
4, 2014. Objections and requests for
hearings must be received on or before
June 3, 2014, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2013–0258, 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), EPA West
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: Lois
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. General Information
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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
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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/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–2013–0258 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 June 3, 2014. 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–
2013–0258, 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
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delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.htm.
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 June 5, 2013
(78 FR 33785) (FRL–9386–2), 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 3E8146) by BASF
Corporation, P.O. Box 13528, Research
Triangle Park, NC 27790. The petition
requested that 40 CFR 180.657 be
amended by establishing tolerances for
residues of the insecticide
metaflumizone, (E and Z isomers; 2-[2(4-cyanophenyl)-1-[3-(trifluoromethyl)
phenyl]ethylidene]-N-[4(trifluoromethoxy)phenyl]
hydrazinecarboxamide), and its
metabolite (4-{2-oxo-2-[3(trifluoromethyl) phenyl]ethyl}benzonitrile), in or on eggplant at 0.6
parts per million (ppm); pepper at 0.6
ppm; and tomato at 0.6 ppm. That
document referenced a summary of the
petition prepared by BASF Corporation,
the registrant, which is available in the
docket, https://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
determined that the tolerances for
eggplant and pepper should each be
established at 1.5 ppm, the tolerance for
tomato should be established at 0.60
ppm, and that an additional tolerance
for tomato, paste should be established
at 1.2 ppm. The reasons 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
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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 metaflumizone
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with metaflumizone 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.
Hematotoxicity (toxicity of the blood)
was the primary toxic effect of concern
following subchronic or chronic oral
exposures to metaflumizone. Splenic
extramedullary hematopoiesis,
increased hemosiderin, and anemia
were the most common hematotoxic
effects reported after repeated oral
dosing with metaflumizone. Chronic
oral (gavage) exposures to dogs resulted
in slight decreases in mean corpuscular
hemoglobin concentration and total
hemoglobin, leading to increased
plasma bilirubin, increased urinary
urobilinogen, and increased
hemosiderin in the liver. In a chronic
toxicity/carcinogenicity study in mice,
anemia was observed in the form of
increased hemosiderin in the spleen,
increased mean absolute reticulocyte
count, decreased mean corpuscular
volume, and mean corpuscular
hemoglobin.
The postulated pesticidal mode of
action of metaflumizone involves
inhibition of sodium channels in target
insect species; however, in mammals
(rats), there were only clinical signs of
neurotoxicity (i.e., piloerection and
body temperature variations) with no
neuropathology in the presence of
systemic toxicity (e.g., recumbency and
poor general state) following acute or
repeated exposures. Similarly, several
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immune system organs seem to be
affected following metaflumizone
administration via the oral, dermal, and
inhalation routes (e.g., the presence of
macrophages in the thymus, lymphocyte
necrosis in the mesenteric lymph nodes,
and diffuse atrophy of the mandibular);
however, there was no evidence of any
functional deficits at the highest dose
tested in a recently submitted and
reviewed guideline immunotoxicity
study. Therefore, the clinical
neurotoxicity signs and the effects on
the immune system organs following
metaflumizone administration are likely
to be secondary to the hematotoxic
effects.
Metaflumizone induced an increased
incidence of a missing subclavian artery
at a relatively high dose that also caused
severe maternal toxicity (e.g., late term
abortions) in the developmental toxicity
study in rabbits. There was no evidence
(quantitative or qualitative) of increased
susceptibility following in utero
exposures to rats or rabbit and following
pre- and post natal exposures. There
was no evidence that metaflumizone is
genotoxic and carcinogenicity studies
with mice and rabbits were negative.
Specific information on the studies
received and the nature of the adverse
effects caused by metaflumizone 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 document
‘‘Metaflumizone: Human-Health Risk
Assessment for Tolerances in/on
Imported Tomato, Pepper, and
Eggplant’’ in docket ID number EPA–
HQ–OPP–2013–0258.
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 (LOCs) 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
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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://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for metaflumizone used for
human risk assessment is provided
below:
i. Acute dietary endpoint (general
population including infants and
children). An acute dietary endpoint
was not established for this population
group since an endpoint of concern
(effect) attributable to a single dose was
not identified in the database. Studies
considered for this endpoint included
the acute neurotoxicity study for which
no toxicity was observed at any dose
including the highest dose tested: The
limit dose (1,000 mg/kg/day).
ii. Acute dietary endpoint (females
13–49 years old). This endpoint was
established based on a developmental
effect observed in the rabbit
developmental toxicity study that can
be potentially due to a single dose of
metaflumizone. This effect consisted of
an increased incidence of an absent
subclavian artery in the offspring at the
LOAEL of 300 mg/kg bw/day
metaflumizone (NOAEL = 100 mg/kg
bw/day). The rat developmental toxicity
study was also considered for this
endpoint; however, no developmental
effects were observed in this study at
the highest dose tested of 120 mg/kg
bw/day metaflumizone. A combined
uncertainty factor (UF) of 300 was
applied to account for interspecies (10x)
and intraspecies (10x) extrapolation. A
Food Quality Protection Act (FQPA)
safety factor (SF) of 3x was retained
because the rabbit developmental
toxicity study was performed via oral
gavage dosing. In an absorption study
submitted by the petitioner, dietary
exposures (which are more relevant for
human exposures) exhibited an
approximately 2-fold greater absorption
into the systemic circulation than oral
gavage dosing and, thus, can potentially
lead to toxicity at 2-fold lower levels of
exposure. Thus, the acute population
adjusted dose (aPAD) for females 13–49
years old is estimated to be 0.33 mg/kg
bw/day.
iii. Chronic dietary endpoint. This
endpoint was established based on the
systemic toxicity observed in the
chronic toxicity study with dogs. At the
LOAEL of 30 mg/kg bw/day (NOAEL =
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12 mg/kg bw/day), the effects consisted
of reduced general health condition,
slight to severe ataxia, recumbency, and
severe salivation, slight decreases in
mean corpuscular hemoglobin
concentration and total hemoglobin,
increased plasma bilirubin, increased
urinary urobilinogen, and increased
hemosiderin in the liver. A combined
UF of 300 was applied to account for
interspecies (10x) and intraspecies (10x)
extrapolation and an FQPA safety factor
of 3x. The FQPA safety factor of 3x was
retained because the chronic toxicity
study was performed via capsule
dosing, which is a bolus dose very
similar to gavage dosing (this accounts
for the 2-fold greater absorption
observed in dietary versus oral gavage
exposures, as described in Unit III.B.ii.).
Thus, the chronic population adjusted
dose (cPAD) is estimated to be 0.040
mg/kg bw/day.
iv. Incidental oral (short- and
intermediate-term). This endpoint was
selected on the basis of the maternal
effects observed in the rat 2-generation
reproductive toxicity study at the
LOAEL of 50 mg/kg bw/day
metaflumizone (NOAEL = 20 mg/kg bw/
day). Maternal toxicity consisted of poor
general health and body weight deficits
which were also associated with
improper nursing behavior. Similar
effects were also noted in a
developmental neurotoxicity study
(gavage, range finding) also considered
for this endpoint. In this study, poor
maternal health was also observed at the
LOAEL of 120 mg/kg bw/day
metaflumizone (NOAEL = 80 mg/kg bw/
day). Both studies considered for this
endpoint achieved a clear maternal
NOAEL for the offspring effects, but the
NOAEL of 20 mg/kg bw/day for the 2generation reproductive toxicity study is
considered more protective. The
Agency’s LOC for this scenario is 300
based on a 10x intraspecies factor, a 10x
interspecies factor, and an FQPA safety
factor of 3x (to account for the 2-fold
greater absorption observed in dietary
versus oral gavage exposures, as
described in Unit III.B.ii.).
v. Dermal (short- and intermediateterm). This endpoint was based on a rat
90-day dermal toxicity study in which
deficits in body weight, body-weight
gain and food consumption (in males
and females); anogenital smearing;
increased macrophages in the thymus;
lymphocyte necrosis in the mesenteric
lymph nodes; diffuse atrophy of the
mandibular lymph node; and increased
hemosiderin in the liver (females only)
were observed at the LOAEL of 300 mg/
kg bw/day (NOAEL = 100 mg/kg bw/
day). The Agency’s LOC for this
scenario is 100 based on a 10x
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interspecies factor and a 10x
intraspecies factor.
vi. Inhalation (short- and
intermediate-term). There is a 28-day
inhalation study that is adequate for
both exposure durations. There was no
NOAEL identified for female rats. At the
LOAEL of 0.10 mg/L metaflumizone
(NOAEL = 0.03 mg/L), histopathology of
the nasal tissues, lungs, thymus,
prostate, and adrenal cortex was
observed in males. The LOAEL
identified in females resulted in
lymphocyte necrosis in the mesenteric
lymph node.
The methods and dosimetry equations
described in EPA’s reference
concentration (RfC) guidance (1994) are
suited for calculating human-equivalent
concentrations (HECs) based on the
inhalation toxicity point of departure
(NOAEL, LOAEL) for use in MOE
calculations. The regional-depositeddose ratio (RDDR), which accounts for
the particulate diameter (mass median
aerodynamic diameter (MMAD) and
geometric standard deviation [sg] of
aerosols), can be used to estimate the
different dose fractions deposited along
the respiratory tract. The RDDR
accounts for interspecies differences in
ventilation and respiratory-tract surface
areas. Thus, the RDDR can be used to
adjust an observed inhalation
particulate exposure of an animal to the
predicted inhalation exposure for a
human. For the subchronic inhalation
toxicity study with metaflumizone, an
RDDR was estimated at 2.81 based on
systemic effects (lymphocyte necrosis in
the mesenteric lymph node) in females
at the LOAEL of 0.03 mg/L (no NOAEL
established) and a MMAD of 1.7mm and
sg of 2.7.
For this action with metaflumizone,
only residential handler scenarios are
being assessed for which 2-hr/day
inhalation exposures are assumed.
Adjustment to shorter exposure
scenarios relative to the animal toxicity
study duration (e.g., 2 hr residential
exposures) should only be made if there
is time-course information that would
support a shorter time-frame. Since
there is no such information available
for metaflumizone, the unadjusted
animal POD was used for HEC
estimation. The HEC equals the product
of the LOAEL from the study and the
RDDR or 0.084 mg/L. The FQPA SF of
10x is being retained for lack of a
NOAEL for females in the study. The
standard interspecies extrapolation UF
can be reduced from 10x to 3x due to
the HEC calculation accounting for
interspecies differences in
pharmacokinetics (not
pharmacodynamic). The intraspecies UF
remains at 10x. Therefore, the LOC for
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this scenario is 300, which includes the
FQPA SF of 10x, interspecies (3x), and
intraspecies (10x) extrapolation.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to metaflumizone, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing metaflumizone tolerances in 40
CFR 180.657. EPA assessed dietary
exposures from metaflumizone 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 metaflumizone. In estimating acute
dietary exposure, EPA used food
consumption information from the
United States Department of Agriculture
(USDA) National Health and Nutrition
Examination Survey, What We Eat in
America (NHANES/WWEIA). This
dietary survey was conducted from 2003
to 2008. As to residue levels in food,
EPA assumed tolerance-level residues. It
was further assumed that 100% of crops
with the requested uses of
metaflumizone were treated.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA NHANES/WWEIA. As
to residue levels in food, EPA assumed
tolerance-level residues. It was further
assumed that 100% of crops with the
requested uses of metaflumizone were
treated.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that metaflumizone does not
pose a cancer risk to humans. Therefore,
a dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue or PCT
information in the dietary assessment
for metaflumizone. Tolerance level
residues and/or 100% crop treated (CT)
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 metaflumizone in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
metaflumizone. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
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can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening
Concentration in Ground Water (SCI–
GROW) models, the estimated drinking
water concentrations (EDWCs) of
metaflumizone for acute exposures are
estimated to be 1.14 parts per billion
(ppb) for surface water and 0.00214 ppb
for ground water. The EDWCs of
metaflumizone for chronic exposures for
non-cancer chronic assessments are
estimated to be 0.597 ppb for surface
water and 0.00214 ppb for ground
water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 1.14 ppb was
used to assess the contribution of
drinking water. For chronic dietary risk
assessment, the water concentration
value of 0.597 ppb was used to assess
the contribution of drinking water.
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).
Metaflumizone is currently registered
for the following uses that could result
in residential exposures: As a fire ant
bait for application to lawns,
landscapes, golf courses, and other noncropland area; and as a fly bait for use
around industrial buildings, commercial
facilities, agricultural structures/
premises, and recreational facilities/
areas.
EPA assessed residential exposure
using the following assumptions: Fire
ant bait applications to home lawns are
expected to result in short-term,
residential handler exposure to adults.
Fire ant bait applications to lawns and
golf-courses are expected to result in
short-term, post-application dermal
exposure to adults, children 11 to <16
years old, and children 1 to <2 years
old, and incident oral exposure for
children 1 to <2 years old. For the fly
bait product, residential handler
exposure is not expected, because the
product is applied by commercial
handlers. The fly bait product is
expected to result in short-term, postapplication dermal exposure to adults,
children 11 to <16 years old, and
children 1 to <2 years old, and incident
oral exposure for children 1 to <2 years
old.
For residential handlers, dermal and
inhalation exposures are combined
since the endpoints are similar for these
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routes. For children (1- to <2-year-olds),
post-application hand-to-mouth and
dermal exposures are combined. Since
the LOCs for the dermal, inhalation and
incidental oral routes are not the same
(dermal LOC = 100, inhalation LOC =
300, and incidental oral LOC = 300),
these routes were combined using the
aggregate risk index approach. Further
information regarding EPA standard
assumptions and generic inputs for
residential exposures may be found at
https://www.epa.gov/pesticides/trac/
science/trac6a05.pdf.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found metaflumizone to
share a common mechanism of toxicity
with any other substances, and
metaflumizone does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that metaflumizone 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 https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10x) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10x, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There is no evidence for increased
qualitative or quantitative sensitivity/
susceptibility resulting from pre- and/or
postnatal exposures. In the rat prenatal
development toxicity study, there was
no offspring toxicity reported at any
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dose tested whereas in the rabbit study
a maltransformation based on an absent
subclavian artery was noted to occur
only in the presence of severe maternal
toxicity. Similarly, offspring mortality
in the 2-generation reproductive toxicity
occurred only in the presence of a poor
maternal health state. Thus, there is no
evidence for increased susceptibility.
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 from 10x to 3x for all oral
exposure scenarios; retained at 10x for
inhalation exposure scenarios; and
reduced to 1x for dermal exposures.
That decision is based on the following
findings:
i. The toxicity database for
metaflumizone is complete.
ii. There is no indication that
metaflumizone directly affects the
nervous system. Clinical signs
consisting of piloerection and body
temperature variations were observed
only in the absence of neuropathology
and in the presence of a poor general
state. There is no need for a
developmental neurotoxicity study or
additional uncertainty factors to account
for neurotoxicity.
iii. There is no evidence that
metaflumizone results in increased
susceptibility in the prenatal
developmental studies in rats and
rabbits or in developing rats in the 2generation reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary analyses assumed
tolerance-level residues, 100% CT, and
modeled drinking water estimates.
Therefore, EPA concludes that while the
submission of data/information by the
petitioner addressing the residue
chemistry deficiencies identified in a
previous petition may conceivably
result in adjustment of the maximum
theoretical residue estimate, actual
metaflumizone dietary exposure
estimates will not be greater than those
generated in the current risk assessment.
EPA made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to metaflumizone in drinking water.
EPA used similarly conservative
assumptions to assess postapplication
exposure of children as well as
incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by metaflumizone.
v. Dietary exposures (which are more
relevant for human exposures) exhibited
an approximately 2-fold greater
absorption into the systemic circulation
as compared to oral gavage and, thus,
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TKELLEY on DSK3SPTVN1PROD with RULES
can potentially lead to toxicity at 2-fold
lower levels of exposure. Applying a
FQPA SF of 3x for all oral exposure
scenarios is adequate to protect against
any greater toxicity that might occur in
dietary exposures (absorption was noted
to be 2-fold greater in dietary versus oral
gavage studies).
vi. The FQPA SF of 10x is being
retained for inhalation exposure
scenarios for the use of a LOAEL instead
of a NOAEL (no NOAEL achieved) for
histopathological lesions consisting of
lymphocyte necrosis in the mesenteric
lymph node. The FQPA SF of 10x is
adequate because the effect (lymphocyte
necrosis) is considered minimal to slight
and does not exhibit a strong dose
dependence.
vii. The FQPA SF for dermal exposure
scenarios is being reduced from 10x to
1x since there is a route-specific study
with a clear NOAEL.
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
metaflumizone will occupy 1.6% of the
aPAD for females 13–49 years old.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to metaflumizone
from food and water will utilize 5.8% 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 metaflumizone 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). Metaflumizone 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
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and water with short-term residential
exposures to metaflumizone. Since the
LOC and toxicological points of
departure for the short-term dermal and
oral routes of exposure differ, the
aggregate risk index method was used to
determine aggregate risk (aggregate risk
indices >1 are not a risk of concern).
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
risk indices of 43 for the general
population, and 27 for children 1–2
years old. Because EPA’s LOC for
metaflumizone is an aggregate risk
index less than 1, the aggregate risks 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).
Metaflumizone is currently registered
for uses that could result in
intermediate-term residential exposure;
however, since the PODs for the shortand intermediate-term durations are the
same for metaflumizone, the short-term
aggregate assessment is protective of
intermediate-term exposures.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
metaflumizone 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
metaflumizone residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(liquid chromatograph/mass
spectrometer/mass spectrometer (LC/
MS/MS) Method 531/0) is available to
enforce the tolerance expression. The
method may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
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
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18809
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 established an MRL for
metaflumizone in or on tomato at 0.6
ppm. This MRL is the same as the
tolerance established for metaflumizone
in or on tomato in the United States.
The Codex has established MRLs for
metaflumizone in or on eggplant at 0.6
ppm and pepper at 0.6 ppm. These
MRLs are different than the tolerances
established for metaflumizone in the
United States.
The currently established Codex
MRLs are based on the 2009 Joint Food
and Agricultural Organization/World
Health Organization (FAO/WHO)
Meeting on Pesticide Residues (JMPR)
metaflumizone report, and this report
was utilized in the Agency’s residue
chemistry review. The difference in the
United States tolerances and the Codex
MRLs is thus due to the following
issues:
i. The United States metaflumizone
tolerance expression for crops includes
metaflumizone (E and Z isomers) and
the metabolite M320I04. The Codex
MRL expression differs in that it does
not include M320I04. The Agency
determined that M320I04 should be
included as a residue of concern for risk
assessment and tolerance enforcement
purposes as it is identified at significant
concentrations in the submitted
metabolism study and is the primary
residue in some processed commodities.
ii. Harmonization with the Codex
MRLs for pepper and eggplant is not
appropriate because the U.S. residue
data for pepper (and eggplant by
translation) indicate maximum residues
of in excess of 0.6 ppm. The 1.5 ppm
tolerances for both pepper and eggplant
are based on the Organisation for
Economic Co-operation and
Development (OECD) tolerancecalculation procedure. The current
Codex MRLs were established using the
North American Free Trade Agreement
(NAFTA) tolerance-calculation
procedure which allowed the
establishment of tolerances less than the
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highest residues; the OECD tolerancecalculation procedure does not permit
this.
C. Revisions to Petitioned-for Tolerances
For pepper and eggplant, the available
data indicate that residues may be
greater than the proposed 0.6 ppm
tolerance. Using the OECD tolerancecalculation procedure, EPA determined
that a tolerance of 1.5 ppm is
appropriate for both pepper and
eggplant. Based on the highest-average
field-trial residue and an average tomato
paste processing factor of 2.94x, the
Agency concluded that a tomato, paste
tolerance of 1.2 ppm should be
established.
TKELLEY on DSK3SPTVN1PROD with RULES
V. Conclusion
Therefore, tolerances are established
for residues of metaflumizone, (E and Z
isomers; 2-[2-(4-cyanophenyl)-1-[3(trifluoromethyl)phenyl]ethylidene]-N[4-(trifluoromethoxy)phenyl]
hydrazinecarboxamide) and its
metabolite 4-{2-oxo-2-[3(trifluoromethyl)phenyl]ethyl}benzonitrile, in or on eggplant at 1.5
ppm; pepper at 1.5 ppm; tomato at 0.60
ppm; and tomato, paste at 1.2 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerances in this final rule, do not
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require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (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 of 1995
(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: March 28, 2014.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
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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 § 180.657:
a. Add alphabetically the
commodities to the table in paragraph
(a).
■ b. Add footnote 1 to the table in
paragraph (a).
The additions read as follows:
■
■
§ 180.657 Metaflumizone; tolerances for
residues.
(a) General. * * *
Parts per
million
Commodity
*
*
*
*
Eggplant 1 ..................................
*
*
*
*
*
Pepper 1 ....................................
Tomato 1 ....................................
Tomato, paste 1 .........................
*
1.5
1.5
0.60
1.2
1 There are no U.S. registrations as of April
4, 2014.
*
*
*
*
*
[FR Doc. 2014–07559 Filed 4–3–14; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0164; FRL–9903–11]
Proquinazid; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of proquinazid in
or on grape and raisin. DuPont Crop
Protection requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective April
4, 2014. Objections and requests for
hearings must be received on or before
June 3, 2014, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2012–0164, 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), EPA West
ADDRESSES:
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Agencies
[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Rules and Regulations]
[Pages 18805-18810]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07559]
[[Page 18805]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0258; FRL-9907-67]
Metaflumizone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
metaflumizone in or on eggplant, pepper, tomato, and tomato, paste.
BASF Corporation requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April 4, 2014. Objections and
requests for hearings must be received on or before June 3, 2014, 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-2013-0258, 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), EPA West 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: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 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 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-2013-0258 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
June 3, 2014. 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-2013-0258, 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.htm.
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 June 5, 2013 (78 FR 33785) (FRL-9386-2),
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 3E8146)
by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27790.
The petition requested that 40 CFR 180.657 be amended by establishing
tolerances for residues of the insecticide metaflumizone, (E and Z
isomers; 2-[2-(4-cyanophenyl)-1-[3-(trifluoromethyl)
phenyl]ethylidene]-N-[4-(trifluoromethoxy)phenyl]
hydrazinecarboxamide), and its metabolite (4-{2-oxo-2-[3-
(trifluoromethyl) phenyl]ethyl{time} -benzonitrile), in or on eggplant
at 0.6 parts per million (ppm); pepper at 0.6 ppm; and tomato at 0.6
ppm. That document referenced a summary of the petition prepared by
BASF Corporation, the registrant, which is available in the docket,
https://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
determined that the tolerances for eggplant and pepper should each be
established at 1.5 ppm, the tolerance for tomato should be established
at 0.60 ppm, and that an additional tolerance for tomato, paste should
be established at 1.2 ppm. The reasons 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
[[Page 18806]]
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 metaflumizone including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with metaflumizone
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.
Hematotoxicity (toxicity of the blood) was the primary toxic effect
of concern following subchronic or chronic oral exposures to
metaflumizone. Splenic extramedullary hematopoiesis, increased
hemosiderin, and anemia were the most common hematotoxic effects
reported after repeated oral dosing with metaflumizone. Chronic oral
(gavage) exposures to dogs resulted in slight decreases in mean
corpuscular hemoglobin concentration and total hemoglobin, leading to
increased plasma bilirubin, increased urinary urobilinogen, and
increased hemosiderin in the liver. In a chronic toxicity/
carcinogenicity study in mice, anemia was observed in the form of
increased hemosiderin in the spleen, increased mean absolute
reticulocyte count, decreased mean corpuscular volume, and mean
corpuscular hemoglobin.
The postulated pesticidal mode of action of metaflumizone involves
inhibition of sodium channels in target insect species; however, in
mammals (rats), there were only clinical signs of neurotoxicity (i.e.,
piloerection and body temperature variations) with no neuropathology in
the presence of systemic toxicity (e.g., recumbency and poor general
state) following acute or repeated exposures. Similarly, several immune
system organs seem to be affected following metaflumizone
administration via the oral, dermal, and inhalation routes (e.g., the
presence of macrophages in the thymus, lymphocyte necrosis in the
mesenteric lymph nodes, and diffuse atrophy of the mandibular);
however, there was no evidence of any functional deficits at the
highest dose tested in a recently submitted and reviewed guideline
immunotoxicity study. Therefore, the clinical neurotoxicity signs and
the effects on the immune system organs following metaflumizone
administration are likely to be secondary to the hematotoxic effects.
Metaflumizone induced an increased incidence of a missing
subclavian artery at a relatively high dose that also caused severe
maternal toxicity (e.g., late term abortions) in the developmental
toxicity study in rabbits. There was no evidence (quantitative or
qualitative) of increased susceptibility following in utero exposures
to rats or rabbit and following pre- and post natal exposures. There
was no evidence that metaflumizone is genotoxic and carcinogenicity
studies with mice and rabbits were negative.
Specific information on the studies received and the nature of the
adverse effects caused by metaflumizone 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 document ``Metaflumizone: Human-Health Risk
Assessment for Tolerances in/on Imported Tomato, Pepper, and Eggplant''
in docket ID number EPA-HQ-OPP-2013-0258.
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 (LOCs) 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://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for metaflumizone used for
human risk assessment is provided below:
i. Acute dietary endpoint (general population including infants and
children). An acute dietary endpoint was not established for this
population group since an endpoint of concern (effect) attributable to
a single dose was not identified in the database. Studies considered
for this endpoint included the acute neurotoxicity study for which no
toxicity was observed at any dose including the highest dose tested:
The limit dose (1,000 mg/kg/day).
ii. Acute dietary endpoint (females 13-49 years old). This endpoint
was established based on a developmental effect observed in the rabbit
developmental toxicity study that can be potentially due to a single
dose of metaflumizone. This effect consisted of an increased incidence
of an absent subclavian artery in the offspring at the LOAEL of 300 mg/
kg bw/day metaflumizone (NOAEL = 100 mg/kg bw/day). The rat
developmental toxicity study was also considered for this endpoint;
however, no developmental effects were observed in this study at the
highest dose tested of 120 mg/kg bw/day metaflumizone. A combined
uncertainty factor (UF) of 300 was applied to account for interspecies
(10x) and intraspecies (10x) extrapolation. A Food Quality Protection
Act (FQPA) safety factor (SF) of 3x was retained because the rabbit
developmental toxicity study was performed via oral gavage dosing. In
an absorption study submitted by the petitioner, dietary exposures
(which are more relevant for human exposures) exhibited an
approximately 2-fold greater absorption into the systemic circulation
than oral gavage dosing and, thus, can potentially lead to toxicity at
2-fold lower levels of exposure. Thus, the acute population adjusted
dose (aPAD) for females 13-49 years old is estimated to be 0.33 mg/kg
bw/day.
iii. Chronic dietary endpoint. This endpoint was established based
on the systemic toxicity observed in the chronic toxicity study with
dogs. At the LOAEL of 30 mg/kg bw/day (NOAEL =
[[Page 18807]]
12 mg/kg bw/day), the effects consisted of reduced general health
condition, slight to severe ataxia, recumbency, and severe salivation,
slight decreases in mean corpuscular hemoglobin concentration and total
hemoglobin, increased plasma bilirubin, increased urinary urobilinogen,
and increased hemosiderin in the liver. A combined UF of 300 was
applied to account for interspecies (10x) and intraspecies (10x)
extrapolation and an FQPA safety factor of 3x. The FQPA safety factor
of 3x was retained because the chronic toxicity study was performed via
capsule dosing, which is a bolus dose very similar to gavage dosing
(this accounts for the 2-fold greater absorption observed in dietary
versus oral gavage exposures, as described in Unit III.B.ii.). Thus,
the chronic population adjusted dose (cPAD) is estimated to be 0.040
mg/kg bw/day.
iv. Incidental oral (short- and intermediate-term). This endpoint
was selected on the basis of the maternal effects observed in the rat
2-generation reproductive toxicity study at the LOAEL of 50 mg/kg bw/
day metaflumizone (NOAEL = 20 mg/kg bw/day). Maternal toxicity
consisted of poor general health and body weight deficits which were
also associated with improper nursing behavior. Similar effects were
also noted in a developmental neurotoxicity study (gavage, range
finding) also considered for this endpoint. In this study, poor
maternal health was also observed at the LOAEL of 120 mg/kg bw/day
metaflumizone (NOAEL = 80 mg/kg bw/day). Both studies considered for
this endpoint achieved a clear maternal NOAEL for the offspring
effects, but the NOAEL of 20 mg/kg bw/day for the 2-generation
reproductive toxicity study is considered more protective. The Agency's
LOC for this scenario is 300 based on a 10x intraspecies factor, a 10x
interspecies factor, and an FQPA safety factor of 3x (to account for
the 2-fold greater absorption observed in dietary versus oral gavage
exposures, as described in Unit III.B.ii.).
v. Dermal (short- and intermediate-term). This endpoint was based
on a rat 90-day dermal toxicity study in which deficits in body weight,
body-weight gain and food consumption (in males and females);
anogenital smearing; increased macrophages in the thymus; lymphocyte
necrosis in the mesenteric lymph nodes; diffuse atrophy of the
mandibular lymph node; and increased hemosiderin in the liver (females
only) were observed at the LOAEL of 300 mg/kg bw/day (NOAEL = 100 mg/kg
bw/day). The Agency's LOC for this scenario is 100 based on a 10x
interspecies factor and a 10x intraspecies factor.
vi. Inhalation (short- and intermediate-term). There is a 28-day
inhalation study that is adequate for both exposure durations. There
was no NOAEL identified for female rats. At the LOAEL of 0.10 mg/L
metaflumizone (NOAEL = 0.03 mg/L), histopathology of the nasal tissues,
lungs, thymus, prostate, and adrenal cortex was observed in males. The
LOAEL identified in females resulted in lymphocyte necrosis in the
mesenteric lymph node.
The methods and dosimetry equations described in EPA's reference
concentration (RfC) guidance (1994) are suited for calculating human-
equivalent concentrations (HECs) based on the inhalation toxicity point
of departure (NOAEL, LOAEL) for use in MOE calculations. The regional-
deposited-dose ratio (RDDR), which accounts for the particulate
diameter (mass median aerodynamic diameter (MMAD) and geometric
standard deviation [[sigma]g] of aerosols), can be used to
estimate the different dose fractions deposited along the respiratory
tract. The RDDR accounts for interspecies differences in ventilation
and respiratory-tract surface areas. Thus, the RDDR can be used to
adjust an observed inhalation particulate exposure of an animal to the
predicted inhalation exposure for a human. For the subchronic
inhalation toxicity study with metaflumizone, an RDDR was estimated at
2.81 based on systemic effects (lymphocyte necrosis in the mesenteric
lymph node) in females at the LOAEL of 0.03 mg/L (no NOAEL established)
and a MMAD of 1.7[mu]m and [sigma]g of 2.7.
For this action with metaflumizone, only residential handler
scenarios are being assessed for which 2-hr/day inhalation exposures
are assumed. Adjustment to shorter exposure scenarios relative to the
animal toxicity study duration (e.g., 2 hr residential exposures)
should only be made if there is time-course information that would
support a shorter time-frame. Since there is no such information
available for metaflumizone, the unadjusted animal POD was used for HEC
estimation. The HEC equals the product of the LOAEL from the study and
the RDDR or 0.084 mg/L. The FQPA SF of 10x is being retained for lack
of a NOAEL for females in the study. The standard interspecies
extrapolation UF can be reduced from 10x to 3x due to the HEC
calculation accounting for interspecies differences in pharmacokinetics
(not pharmacodynamic). The intraspecies UF remains at 10x. Therefore,
the LOC for this scenario is 300, which includes the FQPA SF of 10x,
interspecies (3x), and intraspecies (10x) extrapolation.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to metaflumizone, EPA considered exposure under the
petitioned-for tolerances as well as all existing metaflumizone
tolerances in 40 CFR 180.657. EPA assessed dietary exposures from
metaflumizone 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 metaflumizone. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) National Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEIA). This dietary survey was
conducted from 2003 to 2008. As to residue levels in food, EPA assumed
tolerance-level residues. It was further assumed that 100% of crops
with the requested uses of metaflumizone were treated.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA. As to residue levels in food, EPA assumed tolerance-level
residues. It was further assumed that 100% of crops with the requested
uses of metaflumizone were treated.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that metaflumizone does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for metaflumizone. Tolerance level residues and/or 100% crop
treated (CT) 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 metaflumizone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of metaflumizone. Further information regarding EPA
drinking water models used in pesticide exposure assessment
[[Page 18808]]
can be found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
metaflumizone for acute exposures are estimated to be 1.14 parts per
billion (ppb) for surface water and 0.00214 ppb for ground water. The
EDWCs of metaflumizone for chronic exposures for non-cancer chronic
assessments are estimated to be 0.597 ppb for surface water and 0.00214
ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 1.14 ppb was used to
assess the contribution of drinking water. For chronic dietary risk
assessment, the water concentration value of 0.597 ppb was used to
assess the contribution of drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Metaflumizone is
currently registered for the following uses that could result in
residential exposures: As a fire ant bait for application to lawns,
landscapes, golf courses, and other non-cropland area; and as a fly
bait for use around industrial buildings, commercial facilities,
agricultural structures/premises, and recreational facilities/areas.
EPA assessed residential exposure using the following assumptions:
Fire ant bait applications to home lawns are expected to result in
short-term, residential handler exposure to adults. Fire ant bait
applications to lawns and golf-courses are expected to result in short-
term, post-application dermal exposure to adults, children 11 to <16
years old, and children 1 to <2 years old, and incident oral exposure
for children 1 to <2 years old. For the fly bait product, residential
handler exposure is not expected, because the product is applied by
commercial handlers. The fly bait product is expected to result in
short-term, post-application dermal exposure to adults, children 11 to
<16 years old, and children 1 to <2 years old, and incident oral
exposure for children 1 to <2 years old.
For residential handlers, dermal and inhalation exposures are
combined since the endpoints are similar for these routes. For children
(1- to <2-year-olds), post-application hand-to-mouth and dermal
exposures are combined. Since the LOCs for the dermal, inhalation and
incidental oral routes are not the same (dermal LOC = 100, inhalation
LOC = 300, and incidental oral LOC = 300), these routes were combined
using the aggregate risk index approach. Further information regarding
EPA standard assumptions and generic inputs for residential exposures
may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found metaflumizone to share a common mechanism of
toxicity with any other substances, and metaflumizone does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
metaflumizone 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 https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10x) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10x, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. There is no evidence for
increased qualitative or quantitative sensitivity/susceptibility
resulting from pre- and/or postnatal exposures. In the rat prenatal
development toxicity study, there was no offspring toxicity reported at
any dose tested whereas in the rabbit study a maltransformation based
on an absent subclavian artery was noted to occur only in the presence
of severe maternal toxicity. Similarly, offspring mortality in the 2-
generation reproductive toxicity occurred only in the presence of a
poor maternal health state. Thus, there is no evidence for increased
susceptibility.
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 from 10x to 3x for all oral exposure scenarios;
retained at 10x for inhalation exposure scenarios; and reduced to 1x
for dermal exposures. That decision is based on the following findings:
i. The toxicity database for metaflumizone is complete.
ii. There is no indication that metaflumizone directly affects the
nervous system. Clinical signs consisting of piloerection and body
temperature variations were observed only in the absence of
neuropathology and in the presence of a poor general state. There is no
need for a developmental neurotoxicity study or additional uncertainty
factors to account for neurotoxicity.
iii. There is no evidence that metaflumizone results in increased
susceptibility in the prenatal developmental studies in rats and
rabbits or in developing rats in the 2-generation reproduction study.
iv. There are no residual uncertainties identified in the exposure
databases.
The dietary analyses assumed tolerance-level residues, 100% CT, and
modeled drinking water estimates. Therefore, EPA concludes that while
the submission of data/information by the petitioner addressing the
residue chemistry deficiencies identified in a previous petition may
conceivably result in adjustment of the maximum theoretical residue
estimate, actual metaflumizone dietary exposure estimates will not be
greater than those generated in the current risk assessment. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to metaflumizone in drinking water.
EPA used similarly conservative assumptions to assess postapplication
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by metaflumizone.
v. Dietary exposures (which are more relevant for human exposures)
exhibited an approximately 2-fold greater absorption into the systemic
circulation as compared to oral gavage and, thus,
[[Page 18809]]
can potentially lead to toxicity at 2-fold lower levels of exposure.
Applying a FQPA SF of 3x for all oral exposure scenarios is adequate to
protect against any greater toxicity that might occur in dietary
exposures (absorption was noted to be 2-fold greater in dietary versus
oral gavage studies).
vi. The FQPA SF of 10x is being retained for inhalation exposure
scenarios for the use of a LOAEL instead of a NOAEL (no NOAEL achieved)
for histopathological lesions consisting of lymphocyte necrosis in the
mesenteric lymph node. The FQPA SF of 10x is adequate because the
effect (lymphocyte necrosis) is considered minimal to slight and does
not exhibit a strong dose dependence.
vii. The FQPA SF for dermal exposure scenarios is being reduced
from 10x to 1x since there is a route-specific study with a clear
NOAEL.
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 metaflumizone will occupy 1.6% of the aPAD for females 13-49 years
old.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
metaflumizone from food and water will utilize 5.8% 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
metaflumizone 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). Metaflumizone
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 metaflumizone. Since the LOC and
toxicological points of departure for the short-term dermal and oral
routes of exposure differ, the aggregate risk index method was used to
determine aggregate risk (aggregate risk indices >1 are not a risk of
concern).
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 risk indices of 43 for
the general population, and 27 for children 1-2 years old. Because
EPA's LOC for metaflumizone is an aggregate risk index less than 1, the
aggregate risks 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). Metaflumizone is currently registered for uses that could
result in intermediate-term residential exposure; however, since the
PODs for the short- and intermediate-term durations are the same for
metaflumizone, the short-term aggregate assessment is protective of
intermediate-term exposures.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, metaflumizone 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 metaflumizone residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatograph/mass
spectrometer/mass spectrometer (LC/MS/MS) Method 531/0) is available to
enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905;
email address: residuemethods@epa.gov.
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 established an MRL for metaflumizone in or on tomato
at 0.6 ppm. This MRL is the same as the tolerance established for
metaflumizone in or on tomato in the United States. The Codex has
established MRLs for metaflumizone in or on eggplant at 0.6 ppm and
pepper at 0.6 ppm. These MRLs are different than the tolerances
established for metaflumizone in the United States.
The currently established Codex MRLs are based on the 2009 Joint
Food and Agricultural Organization/World Health Organization (FAO/WHO)
Meeting on Pesticide Residues (JMPR) metaflumizone report, and this
report was utilized in the Agency's residue chemistry review. The
difference in the United States tolerances and the Codex MRLs is thus
due to the following issues:
i. The United States metaflumizone tolerance expression for crops
includes metaflumizone (E and Z isomers) and the metabolite M320I04.
The Codex MRL expression differs in that it does not include M320I04.
The Agency determined that M320I04 should be included as a residue of
concern for risk assessment and tolerance enforcement purposes as it is
identified at significant concentrations in the submitted metabolism
study and is the primary residue in some processed commodities.
ii. Harmonization with the Codex MRLs for pepper and eggplant is
not appropriate because the U.S. residue data for pepper (and eggplant
by translation) indicate maximum residues of in excess of 0.6 ppm. The
1.5 ppm tolerances for both pepper and eggplant are based on the
Organisation for Economic Co-operation and Development (OECD)
tolerance-calculation procedure. The current Codex MRLs were
established using the North American Free Trade Agreement (NAFTA)
tolerance-calculation procedure which allowed the establishment of
tolerances less than the
[[Page 18810]]
highest residues; the OECD tolerance-calculation procedure does not
permit this.
C. Revisions to Petitioned-for Tolerances
For pepper and eggplant, the available data indicate that residues
may be greater than the proposed 0.6 ppm tolerance. Using the OECD
tolerance-calculation procedure, EPA determined that a tolerance of 1.5
ppm is appropriate for both pepper and eggplant. Based on the highest-
average field-trial residue and an average tomato paste processing
factor of 2.94x, the Agency concluded that a tomato, paste tolerance of
1.2 ppm should be established.
V. Conclusion
Therefore, tolerances are established for residues of
metaflumizone, (E and Z isomers; 2-[2-(4-cyanophenyl)-1-[3-
(trifluoromethyl)phenyl]ethylidene]-N-[4-(trifluoromethoxy)phenyl]
hydrazinecarboxamide) and its metabolite 4-{2-oxo-2-[3-
(trifluoromethyl)phenyl]ethyl{time} -benzonitrile, in or on eggplant at
1.5 ppm; pepper at 1.5 ppm; tomato at 0.60 ppm; and tomato, paste at
1.2 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (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 of 1995 (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: March 28, 2014.
Lois Rossi,
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. 180.657:
0
a. Add alphabetically the commodities to the table in paragraph (a).
0
b. Add footnote 1 to the table in paragraph (a).
The additions read as follows:
Sec. 180.657 Metaflumizone; tolerances for residues.
(a) General. * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Eggplant \1\............................................... 1.5
* * * * *
Pepper \1\................................................. 1.5
Tomato \1\................................................. 0.60
Tomato, paste \1\.......................................... 1.2
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of April 4, 2014.
* * * * *
[FR Doc. 2014-07559 Filed 4-3-14; 8:45 am]
BILLING CODE 6560-50-P