Sedaxane; Pesticide Tolerances, 60715-60720 [2013-23941]
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Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Rules and Regulations
60715
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Custard apple ...............................
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8.0
[EPA–HQ–OPP–2012–0885; FRL–9397–8]
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Fruit, pome, group 11–10 .............
Fruit, small, vine climbing, except
fuzzy kiwifruit, subgroup 13–
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AGENCY:
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).
1.0
SUMMARY:
This regulation establishes
tolerances for residues of sedaxane in or
on potato and potato, wet peel.
Syngenta Crop Protection, LLC
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
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.
Parts per
million
Commodity
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
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Grain, aspirated grain fractions ....
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Herb subgroup 19A, except chive
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400
Sedaxane; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
This regulation is effective
October 2, 2013. Objections and
requests for hearings must be received
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on or before December 2, 2013, and
Pea and bean, dried shelled, exmust be filed in accordance with the
cept soybean, subgroup 6C, exinstructions provided in 40 CFR part
cept pea, blackeyed, seed and
178 (see also Unit I.C. of the
pea, southern, seed ..................
0.50 SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
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identified by docket identification (ID)
Sorghum, grain, forage .................
15
number EPA–HQ–OPP–2012–0885, is
Sorghum, grain, grain ...................
6.0
available at https://www.regulations.gov
Sorghum, grain, stover .................
20
or at the Office of Pesticide Programs
Sorghum, sweet, forage ...............
15
Regulatory Public Docket (OPP Docket)
Sorghum, sweet, grain .................
6.0
in the Environmental Protection Agency
Sorghum, sweet, stalk ..................
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Docket Center (EPA/DC), EPA West
Sorghum, sweet, stover ................
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Soursop ........................................
0.60 Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
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Sugar apple ..................................
0.60 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
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Reading Room is (202) 566–1744, and
Vegetable, fruiting, group 8–10 ....
2.0
the telephone number for the OPP
Docket is (703) 305–5805. Please review
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the visitor instructions and additional
information about the docket available
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(b) Section 18 emergency exemptions. at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois
[Reserved]
Rossi, Registration Division, Office of
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Pesticide Programs, Environmental
(d) * * *
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001;
(2) * * *
telephone number: (703) 305–7090;
Parts per email address: RDFRNotices@epa.gov.
Commodity
million
SUPPLEMENTARY INFORMATION:
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Ilama .............................................
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Chive .............................................
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Rapeseed subgroup 20A ..............
Spice subgroup 19B .....................
Sunflower subgroup 20B ..............
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DATES:
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I. General Information
[FR Doc. 2013–24127 Filed 10–1–13; 8:45 am]
BILLING CODE 6560–50–P
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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
determine whether this document
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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–2012–0885 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 December 2, 2013. 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–
2012–0885, 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, 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://
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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.
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II. Summary of Petitioned-For
Tolerance
In the Federal Register of December
19, 2012 (77 FR 75082) (FRL–9372–6),
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 2F8113) by
Syngenta Crop Protection, Inc.,
Regulatory Affairs, P.O. Box 18300,
Greensboro, NC 27419–8300. The
petition requested that 40 CFR 180.665
be amended by establishing tolerances
for residues of the fungicide sedaxane,
in or on potato at 0.02 parts per million
(ppm) and potato, wet peel at 0.06 ppm.
That document referenced a summary of
the petition prepared by Syngenta Crop
Protection, Inc., 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
recommended that a different tolerance
be set for potato, wet peel. 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
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
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support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for sedaxane
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with sedaxane 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 toxicological
effects reported in the submitted animal
studies such as mitochondrial
disintegration and glycogen depletion in
the liver are consistent with the
pesticidal mode of action also being the
mode of toxic action in mammals. The
rat is the most sensitive species tested,
and the main target tissue for sedaxane
is the liver. Sedaxane also caused
thyroid hypertrophy/hyperplasia. In the
acute neurotoxicity (ACN) and subchronic neurotoxicity (SCN) studies,
sedaxane caused decreased activity,
decreased muscle tone, decreased
rearing and decreased grip strength.
There are indications of reproductive
toxicity in rats at the high dose, but
these effects did not result in reduced
fertility. In the rat, no adverse effects in
fetuses were seen in developmental
toxicity studies at maternally toxic
doses. However, in the rabbit, fetal
toxicity was observed at the same doses
as the dams. Offspring effects in the
reproduction study occurred at the same
doses causing parental effects, thus
there was no quantitative increase in
sensitivity in rat pups. Sedaxane is
tumorigenic in the liver in the rat and
mouse, and led to tumors in the thyroid
and uterus in the rat and was classified
as ‘‘likely to be carcinogenic to
humans.’’ Sedaxane was negative in the
mutagenicity studies. The 28-day
dermal study did not show systemic
toxicity at the limit dose of 1,000
milligrams/kilogram/day (mg/kg/day).
Sedaxane has low acute toxicity by the
oral, dermal, and inhalation routes. It is
not a dermal sensitizer, causes no skin
irritation and only slight eye irritation.
Specific information on the studies
received and the nature of the adverse
effects caused by sedaxane as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies are discussed in the
final rule published in the Federal
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Register of June 20, 2012 (77; FR 36920)
(FRL–9345–8).
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which the NOAEL and LOEAL
are identified. Uncertainty/safety factors
are used in conjunction with the POD to
calculate a safe exposure level—
generally referred to as a populationadjusted 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 sedaxane used for human
risk assessment is discussed in Unit B
of the final rule published in the
Federal Register of June 20, 2012 (77 FR
36920) (FRL–9345–8).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to sedaxane, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
sedaxane tolerances in 40 CFR 180.665.
EPA assessed dietary exposures from
sedaxane 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 sedaxane. In estimating acute dietary
exposure, EPA used 2003–2008 food
consumption information from the U.S.
Department of Agriculture’s (USDA’s)
National Health and Nutrition
Examination Survey, What We Eat in
America (NHANES/WWEIA). As to
residue levels in food, EPA conducted a
highly conservative acute dietary risk
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assessment which used tolerance level
residues and assumed that 100% of all
commodities were treated.
ii. Chronic exposure. In conducting
the chronic dietary exposure
assessment, EPA used the food
consumption data from the USDA’s
2003–2008 NHANES/WWEIA. As to
residue levels in food, EPA conducted a
partially refined chronic dietary risk
assessment which used anticipated
residues and assumed 100 percent crop
treated (PCT) for all commodities except
for soybean, wheat, and potato, where
average PCT estimates of 51, 32, and 67,
respectively, were used, and modeled
drinking water estimates were included.
iii. Cancer. EPA assessed exposure for
the purpose of estimating cancer risk
assuming anticipated residues and 100
PCT for all commodities except for
soybean, wheat, and potato, where
average percent crop treated estimates of
51, 32, and 67, respectively, were used,
and modeled drinking water estimates
were included.
iv. Anticipated residue PCT
information. Section 408(b)(2)(E) of
FFDCA authorizes EPA to use available
data and information on the anticipated
residue levels of pesticide residues in
food and the actual levels of pesticide
residues that have been measured in
food. If EPA relies on such information,
EPA must require pursuant to FFDCA
section 408(f)(1) that data be provided 5
years after the tolerance is established,
modified, or left in effect, demonstrating
that the levels in food are not above the
levels anticipated. For the present
action, EPA will issue such data call-ins
as are required by FFDCA section
408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be
required to be submitted no later than
5 years from the date of issuance of
these tolerances. Section 408(b)(2)(F) of
FFDCA states that the Agency may use
data on the actual percent of food
treated for assessing chronic dietary risk
only if:
• Condition A: The data used are
reliable and provide a valid basis to
show what percentage of the food
derived from such crop is likely to
contain the pesticide residue.
• Condition B: The exposure estimate
does not underestimate exposure for any
significant subpopulation group.
• Condition C: Data are available on
pesticide use and food consumption in
a particular area, the exposure estimate
does not understate exposure for the
population in such area. In addition, the
Agency must provide for periodic
evaluation of any estimates used. To
provide for the periodic evaluation of
the estimate of PCT as required by
FFDCA section 408(b)(2)(F), EPA may
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require registrants to submit data on
PCT.
The Agency estimated the PCT for
existing uses as follows:
For chronic and cancer dietary
exposure assessment, 100% was
assumed for all commodities except for
soybeans (51%) and wheat (32%),
which incorporated average PCT
estimates. Average PCT estimates were
also used for the proposed use on potato
(67%).
In most cases, EPA uses available data
from United States Department of
Agriculture/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, and the
National Pesticide Use Database for the
chemical/crop combination for the most
recent 6–7 years. EPA uses an average
PCT for chronic dietary risk analysis.
The average PCT figure for each existing
use is derived by combining available
public and private market survey data
for that use, averaging across all
observations, and rounding to the
nearest 5%, except for those situations
in which the average PCT is less than
one. In those cases, 1% is used as the
average PCT and 2.5% is used as the
maximum PCT. EPA uses a maximum
PCT for acute dietary risk analysis. The
maximum PCT figure is the highest
observed maximum value reported
within the recent 6 years of available
public and private market survey data
for the existing use and rounded up to
the nearest multiple of 5%.
The Agency believes that the three
conditions discussed in Unit III.C.1.iv.
have been met. With respect to
Condition A, PCT estimates are derived
from Federal and private market survey
data, which are reliable and have a valid
basis. The Agency is reasonably certain
that the percentage of the food treated
is not likely to be an underestimation.
As to Conditions B and C, regional
consumption information and
consumption information for significant
subpopulations is taken into account
through EPA’s computer-based model
for evaluating the exposure of
significant subpopulations including
several regional groups. Use of this
consumption information in EPA’s risk
assessment process ensures that EPA’s
exposure estimate does not understate
exposure for any significant
subpopulation group and allows the
Agency to be reasonably certain that no
regional population is exposed to
residue levels higher than those
estimated by the Agency. Other than the
data available through national food
consumption surveys, EPA does not
have available reliable information on
the regional consumption of food to
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which sedaxane may be applied in a
particular area.
EPA did not use anticipated residue
or PCT information in the acute dietary
assessment for sedaxane. However, for
the chronic and cancer dietary
assessments, anticipated residues were
used along with 100 PCT for all food
commodities except for soybean, wheat,
and potato, where average PCT
estimates of 51, 32, and 67, respectively,
were used, and modeled drinking water
estimates were included.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for sedaxane in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of sedaxane.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/oppefed1/models/
water/index.htm.
Based on the Tier I Food Quality
Protection Act (FQPA) Index Reservoir
Screening Tool (FIRST) and Tier II
pesticide root zone model PRZMGroundwater (PRZM–GW Version 1.0,
12/11/2012), the estimated drinking
water concentrations (EDWCs) of
sedaxane for acute exposures are
estimated to be 4.1 parts per billion
(ppb) for surface water and 15.1 ppb for
ground water. The water exposures for
the chronic dietary and cancer
assessments are estimated to be 1.2 ppb
for surface water and 13 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 15.1 ppb was
used to assess the contribution to
drinking water. For chronic and cancer
dietary risk assessment, the water
concentration value of 13 ppb was used
to assess the contribution to drinking
water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets). Sedaxane
is not registered for any specific use
patterns that would result in residential
exposure.
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
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cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’ EPA has not
found sedaxane to share a common
mechanism of toxicity with any other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that sedaxane 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
susceptibility following prenatal and/or
postnatal exposures to sedaxane based
on effects seen in developmental
toxicity studies in rabbits or rats. There
was no evidence of increased
susceptibility in a 2-generation
reproduction study in rats following
prenatal or postnatal exposure to
sedaxane. Clear NOAELs/LOAELs were
established for the developmental
effects seen in rats and rabbits as well
as for the offspring effects seen in the 2generation reproduction study. The
dose-response relationship for the
effects of concern is well characterized.
The NOAEL used for the acute dietary
risk assessment (30 mg/kg/day), based
on effects observed in the ACN study, is
protective of the developmental and
offspring effects seen in rabbits and rats
(NOAELs of 100–200 mg/kg/day).
In addition, there is no evidence of
neuropathology or abnormalities in the
development of the fetal nervous system
from the available toxicity studies
conducted with sedaxane.
3. Conclusion. EPA has determined
that reliable data show the safety of
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infants and children would be
adequately protected if the FQPA SF
were reduced to 1x. That decision is
based on the following findings:
i. The toxicity database for sedaxane
is complete.
ii. The sedaxane toxicology database
did not demonstrate evidence of
neurotoxicity. Although sedaxane
caused changes in endpoints such as
decreased activity, decreased muscle
tone, decreased rearing and decreased
grip strength in the ACN study and
reduced locomotor activity in the SCN
study, EPA believes these effects do not
support a finding that sedaxane is a
neurotoxicant. The observed effects in
the ACN and SCN studies were likely
secondary to inhibition of
mitochondrial energy production,
which is the pesticidal mode of action
for sedaxane. Furthermore, there was no
corroborative neuro-histopathology
demonstrated in any study, even at the
highest doses tested (i.e., 2,000 mg/kg/
day). Therefore, based on its chemical
structure, its pesticidal mode of action,
and lack of evidence of neurohistopathology in any acute and
repeated-dose toxicity study, sedaxane
does not demonstrate potential for
neurotoxicity. Since sedaxane did not
demonstrate increased susceptibility to
the young or specific neurotoxicity, a
developmental neurotoxicity (DNT)
study is not required.
iii. There is no evidence that sedaxane
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 as screening-level
(acute) or partially-refined (chronic)
assessments. EPA made conservative
(protective) assumptions in the ground
and surface water modeling used to
assess exposure to sedaxane in drinking
water. These assessments will not
underestimate the exposure and risks
posed by sedaxane.
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
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PODs to ensure that an adequate MOE
exists.
Sedaxane is a member of the pyrazole
carboxamide fungicides. Metabolic
processes involving cleavage of the
linkage between the pyrazole and
phenyl rings of these compounds have
the potential to produce common
pyrazole-metabolites. Indeed, confined
rotational crops studies for sedaxane
and isopyrazam demonstrate that low
levels of three common metabolites
form. However, due to the low levels of
these compounds in rotational crops
(<=0.01 ppm), and low concerns about
their potential toxicity relative to parent
molecules, any risks from aggregation of
exposures to common metabolites
across chemicals will be insignificant.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
sedaxane will occupy <1% of the aPAD
for all populations.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to sedaxane from
food and water will utilize <1% of the
cPAD for all populations. There are no
residential uses for sedaxane.
3. Short- and intermediate-term risk.
Short- and intermediate-term aggregate
exposure takes into account short- and
intermediate-term residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level). Short- and
intermediate-term adverse effects were
identified; however, sedaxane is not
registered for any use patterns that
would result in short- or intermediateterm residential exposures. Because
there is no short- or 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 short-term risk),
no further assessment of short- or
intermediate-term risk is necessary, and
EPA relies on the chronic dietary risk
assessment for evaluating short- and
intermediate-term risk for sedaxane.
4. Aggregate cancer risk for U.S.
population. The Agency has classified
sedaxane as ‘‘Likely to be Carcinogenic
to Humans’’ based on significant tumor
increases in two adequate rodent
carcinogenicity studies. Accordingly, a
cancer dietary risk assessment was
conducted, indicating a risk estimate of
1 × 10¥6 for the U.S. population. EPA
considers risks in the range of 1 × 10¥6
to be negligible.
5. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
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maximum label rate and the average
degree of sedaxane residue
concentration in wet potato peel.
no harm will result to the general
population, or to infants and children
from aggregate exposure to sedaxane
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
is available to enforce the tolerance
expression. A modification of the Quick,
Easy, Cheap, Effective, Rugged, and Safe
(QuEChERS) method was developed for
the determination of residues of
sedaxane (as its isomers SYN508210
and SYN508211) in/on various crops. A
successful independent laboratory
validation (ILV) study was also
conducted on the modified QuEChERS
method using samples of wheat green
forage and wheat straw fortified with
SYN508210 and SYN508211 at 0.005
and 0.05 ppm. The analytical standard
for sedaxane, with an expiration date of
June 30, 2014, is currently available in
the EPA National Pesticide Standards
Repository. 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 not
established MRLs for sedaxane.
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C. Revisions to Petitioned-For
Tolerances
The Agency determined that the
tolerance level for potato, wet peel
should be changed from the petitionedfor 0.06 ppm to 0.075 ppm based upon
EPA’s examination of the level of
residues that may remain on potatoes
following application of sedaxane at the
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V. Conclusion
Therefore, tolerances are established
for residues of sedaxane, including its
metabolites and degradates in or on
potato; and potato, wet peel at 0.02 and
0.075 ppm respectively.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
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Fmt 4700
Sfmt 4700
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: September 17, 2013.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
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 § 180.665, add alphabetically the
following commodities to the table in
paragraph (a) to read as follows:
■
§ 180.665 Sedaxane; tolerances for
residues.
(a) * * *
Parts
per million
Commodity
*
*
*
Potato .................................
Potato, wet peel ..................
*
E:\FR\FM\02OCR1.SGM
*
02OCR1
*
*
*
*
0.02
0.075
*
60720
Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Rules and Regulations
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).
C. When do these actions become
effective?
As stated in the DATES section, this
final rule is effective October 2, 2013.
The methyl parathion tolerances
expired more than 13 years ago and the
Agency believes that the informational
listing in § 180.121(e) is no longer
needed.
[EPA–HQ–OPP–2009–0332; FRL–9401–3]
B. How can I get electronic access to
other related information?
Methyl Parathion; Removal of Expired
Tolerances
You may access a frequently updated
electronic version of 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.
III. Statutory and Executive Order
Reviews
In this final rule, EPA is removing a
listing of already expired tolerances.
The Office of Management and Budget
(OMB) has exempted this type of action
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 due to its lack of
significance, 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). 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.), or 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.). Nor does it require any
special considerations as required by
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994); or OMB review or any other
Agency action under Executive Order
13045, entitled ‘‘Protection of Children
from Environmental Health Risks and
Safety Risks’’ (62 FR 19885, April 23,
1997). 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). Pursuant
to the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby
certifies that this final rule will not have
a significant economic impact on a
substantial number of small entities.
Furthermore, for the pesticide named in
this final rule, the Agency knows of no
extraordinary circumstances that exist
as to the present removal of listings for
already expired tolerances that would
change EPA’s analysis. In addition, the
Agency has determined that this action
will not have a substantial direct effect
*
*
*
*
*
[FR Doc. 2013–23941 Filed 10–1–13; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is removing listings in
the Code of Federal Regulations (CFR)
for already expired tolerances for
methyl parathion, for the purpose of
clarity and in accordance with current
EPA practice.
DATES: This regulation is effective
October 2, 2013.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2009–0332, 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:
Joseph Nevola, Pesticide Re-Evaluation
Division (7508P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (703) 308–8037; email address:
nevola.joseph@epa.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. General Information
sroberts on DSK5SPTVN1PROD with RULES
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
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15:59 Oct 01, 2013
Jkt 232001
II. Background
A. What action is the agency taking?
In this final rule, EPA is removing
listings in the CFR for already expired
tolerances for methyl parathion in
§ 180.121(e). In the Federal Register of
January 5, 2001 (66 FR 1242) (FRL–
6752–6), EPA promulgated a final rule
revoking methyl parathion uses in
commodities for which methyl
parathion use was unlawful after
December 31, 1999. The final rule listed
these expired tolerances in § 180.121(e).
However, some people have
inaccurately read § 180.121(e) to mean
that there are active methyl parathion
tolerances for these commodities. In
order to eliminate confusion, EPA is
removing paragraph (e) in its entirety.
EPA is not making any change in the
status of these expired tolerances, just
removing an informational listing that
the Agency believes is no longer needed
and that may be misleading if not read
correctly.
EPA is issuing a final rule for this
purpose without notice and opportunity
to comment. Section 553(b)(3)(B) of the
Administrative Procedure Act provides
that notice and comment is not
necessary ‘‘when the agency for good
cause finds (and incorporates the
finding and a brief statement of reasons
therefore in the rules issued) that notice
and public procedure thereon are
impracticable, unnecessary, or contrary
to the public interest.’’ EPA finds good
cause here because removing the listings
does not affect the legal status of the
already expired tolerances.
B. What is the agency’s authority for
taking this action?
EPA is not taking any action that
substantively changes a tolerance. EPA
is only taking administrative action to
remove the informational listing in
§ 180.121(e).
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]]>Agencies
[Federal Register Volume 78, Number 191 (Wednesday, October 2, 2013)]
[Rules and Regulations]
[Pages 60715-60720]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23941]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0885; FRL-9397-8]
Sedaxane; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
sedaxane in or on potato and potato, wet peel. Syngenta Crop
Protection, LLC requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective October 2, 2013. Objections and
requests for hearings must be received on or before December 2, 2013,
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-2012-0885, 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,
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-2012-0885 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
December 2, 2013. 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-2012-0885, 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, 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://
[[Page 60716]]
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 December 19, 2012 (77 FR 75082) (FRL-
9372-6), 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
2F8113) by Syngenta Crop Protection, Inc., Regulatory Affairs, P.O. Box
18300, Greensboro, NC 27419-8300. The petition requested that 40 CFR
180.665 be amended by establishing tolerances for residues of the
fungicide sedaxane, in or on potato at 0.02 parts per million (ppm) and
potato, wet peel at 0.06 ppm. That document referenced a summary of the
petition prepared by Syngenta Crop Protection, Inc., 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
recommended that a different tolerance be set for potato, wet peel. 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 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 sedaxane including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with sedaxane 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 toxicological effects reported in the submitted animal
studies such as mitochondrial disintegration and glycogen depletion in
the liver are consistent with the pesticidal mode of action also being
the mode of toxic action in mammals. The rat is the most sensitive
species tested, and the main target tissue for sedaxane is the liver.
Sedaxane also caused thyroid hypertrophy/hyperplasia. In the acute
neurotoxicity (ACN) and sub-chronic neurotoxicity (SCN) studies,
sedaxane caused decreased activity, decreased muscle tone, decreased
rearing and decreased grip strength.
There are indications of reproductive toxicity in rats at the high
dose, but these effects did not result in reduced fertility. In the
rat, no adverse effects in fetuses were seen in developmental toxicity
studies at maternally toxic doses. However, in the rabbit, fetal
toxicity was observed at the same doses as the dams. Offspring effects
in the reproduction study occurred at the same doses causing parental
effects, thus there was no quantitative increase in sensitivity in rat
pups. Sedaxane is tumorigenic in the liver in the rat and mouse, and
led to tumors in the thyroid and uterus in the rat and was classified
as ``likely to be carcinogenic to humans.'' Sedaxane was negative in
the mutagenicity studies. The 28-day dermal study did not show systemic
toxicity at the limit dose of 1,000 milligrams/kilogram/day (mg/kg/
day). Sedaxane has low acute toxicity by the oral, dermal, and
inhalation routes. It is not a dermal sensitizer, causes no skin
irritation and only slight eye irritation.
Specific information on the studies received and the nature of the
adverse effects caused by sedaxane as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal Register of June 20, 2012 (77; FR 36920) (FRL-
9345-8).
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and LOEAL are identified.
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for sedaxane used for
human risk assessment is discussed in Unit B of the final rule
published in the Federal Register of June 20, 2012 (77 FR 36920) (FRL-
9345-8).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to sedaxane, EPA considered exposure under the petitioned-for
tolerances as well as all existing sedaxane tolerances in 40 CFR
180.665. EPA assessed dietary exposures from sedaxane 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 sedaxane. In estimating acute dietary exposure, EPA used 2003-2008
food consumption information from the U.S. Department of Agriculture's
(USDA's) National Health and Nutrition Examination Survey, What We Eat
in America (NHANES/WWEIA). As to residue levels in food, EPA conducted
a highly conservative acute dietary risk
[[Page 60717]]
assessment which used tolerance level residues and assumed that 100% of
all commodities were treated.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA's 2003-
2008 NHANES/WWEIA. As to residue levels in food, EPA conducted a
partially refined chronic dietary risk assessment which used
anticipated residues and assumed 100 percent crop treated (PCT) for all
commodities except for soybean, wheat, and potato, where average PCT
estimates of 51, 32, and 67, respectively, were used, and modeled
drinking water estimates were included.
iii. Cancer. EPA assessed exposure for the purpose of estimating
cancer risk assuming anticipated residues and 100 PCT for all
commodities except for soybean, wheat, and potato, where average
percent crop treated estimates of 51, 32, and 67, respectively, were
used, and modeled drinking water estimates were included.
iv. Anticipated residue PCT information. Section 408(b)(2)(E) of
FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances. Section 408(b)(2)(F) of FFDCA states that
the Agency may use data on the actual percent of food treated for
assessing chronic dietary risk only if:
Condition A: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition B: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition C: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by FFDCA section 408(b)(2)(F), EPA may require registrants to submit
data on PCT.
The Agency estimated the PCT for existing uses as follows:
For chronic and cancer dietary exposure assessment, 100% was
assumed for all commodities except for soybeans (51%) and wheat (32%),
which incorporated average PCT estimates. Average PCT estimates were
also used for the proposed use on potato (67%).
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition A, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions B and C, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which sedaxane may be applied in a particular area.
EPA did not use anticipated residue or PCT information in the acute
dietary assessment for sedaxane. However, for the chronic and cancer
dietary assessments, anticipated residues were used along with 100 PCT
for all food commodities except for soybean, wheat, and potato, where
average PCT estimates of 51, 32, and 67, respectively, were used, and
modeled drinking water estimates were included.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for sedaxane in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of sedaxane. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Tier I Food Quality Protection Act (FQPA) Index
Reservoir Screening Tool (FIRST) and Tier II pesticide root zone model
PRZM-Groundwater (PRZM-GW Version 1.0, 12/11/2012), the estimated
drinking water concentrations (EDWCs) of sedaxane for acute exposures
are estimated to be 4.1 parts per billion (ppb) for surface water and
15.1 ppb for ground water. The water exposures for the chronic dietary
and cancer assessments are estimated to be 1.2 ppb for surface water
and 13 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 15.1 ppb was used to
assess the contribution to drinking water. For chronic and cancer
dietary risk assessment, the water concentration value of 13 ppb was
used to assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Sedaxane is not
registered for any specific use patterns that would result in
residential exposure.
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
[[Page 60718]]
cumulative effects of a particular pesticide's residues and ``other
substances that have a common mechanism of toxicity.'' EPA has not
found sedaxane to share a common mechanism of toxicity with any other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that sedaxane 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 susceptibility following prenatal and/or postnatal exposures
to sedaxane based on effects seen in developmental toxicity studies in
rabbits or rats. There was no evidence of increased susceptibility in a
2-generation reproduction study in rats following prenatal or postnatal
exposure to sedaxane. Clear NOAELs/LOAELs were established for the
developmental effects seen in rats and rabbits as well as for the
offspring effects seen in the 2-generation reproduction study. The
dose-response relationship for the effects of concern is well
characterized. The NOAEL used for the acute dietary risk assessment (30
mg/kg/day), based on effects observed in the ACN study, is protective
of the developmental and offspring effects seen in rabbits and rats
(NOAELs of 100-200 mg/kg/day).
In addition, there is no evidence of neuropathology or
abnormalities in the development of the fetal nervous system from the
available toxicity studies conducted with sedaxane.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
i. The toxicity database for sedaxane is complete.
ii. The sedaxane toxicology database did not demonstrate evidence
of neurotoxicity. Although sedaxane caused changes in endpoints such as
decreased activity, decreased muscle tone, decreased rearing and
decreased grip strength in the ACN study and reduced locomotor activity
in the SCN study, EPA believes these effects do not support a finding
that sedaxane is a neurotoxicant. The observed effects in the ACN and
SCN studies were likely secondary to inhibition of mitochondrial energy
production, which is the pesticidal mode of action for sedaxane.
Furthermore, there was no corroborative neuro-histopathology
demonstrated in any study, even at the highest doses tested (i.e.,
2,000 mg/kg/day). Therefore, based on its chemical structure, its
pesticidal mode of action, and lack of evidence of neuro-histopathology
in any acute and repeated-dose toxicity study, sedaxane does not
demonstrate potential for neurotoxicity. Since sedaxane did not
demonstrate increased susceptibility to the young or specific
neurotoxicity, a developmental neurotoxicity (DNT) study is not
required.
iii. There is no evidence that sedaxane 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 as
screening-level (acute) or partially-refined (chronic) assessments. EPA
made conservative (protective) assumptions in the ground and surface
water modeling used to assess exposure to sedaxane in drinking water.
These assessments will not underestimate the exposure and risks posed
by sedaxane.
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.
Sedaxane is a member of the pyrazole carboxamide fungicides.
Metabolic processes involving cleavage of the linkage between the
pyrazole and phenyl rings of these compounds have the potential to
produce common pyrazole-metabolites. Indeed, confined rotational crops
studies for sedaxane and isopyrazam demonstrate that low levels of
three common metabolites form. However, due to the low levels of these
compounds in rotational crops (<=0.01 ppm), and low concerns about
their potential toxicity relative to parent molecules, any risks from
aggregation of exposures to common metabolites across chemicals will be
insignificant.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to sedaxane will occupy <1% of the aPAD for all populations.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
sedaxane from food and water will utilize <1% of the cPAD for all
populations. There are no residential uses for sedaxane.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Short- and
intermediate-term adverse effects were identified; however, sedaxane is
not registered for any use patterns that would result in short- or
intermediate-term residential exposures. Because there is no short- or
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 short-term risk), no
further assessment of short- or intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
short- and intermediate-term risk for sedaxane.
4. Aggregate cancer risk for U.S. population. The Agency has
classified sedaxane as ``Likely to be Carcinogenic to Humans'' based on
significant tumor increases in two adequate rodent carcinogenicity
studies. Accordingly, a cancer dietary risk assessment was conducted,
indicating a risk estimate of 1 x 10-6 for the U.S.
population. EPA considers risks in the range of 1 x 10-6 to
be negligible.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that
[[Page 60719]]
no harm will result to the general population, or to infants and
children from aggregate exposure to sedaxane residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression. A modification of the Quick, Easy, Cheap,
Effective, Rugged, and Safe (QuEChERS) method was developed for the
determination of residues of sedaxane (as its isomers SYN508210 and
SYN508211) in/on various crops. A successful independent laboratory
validation (ILV) study was also conducted on the modified QuEChERS
method using samples of wheat green forage and wheat straw fortified
with SYN508210 and SYN508211 at 0.005 and 0.05 ppm. The analytical
standard for sedaxane, with an expiration date of June 30, 2014, is
currently available in the EPA National Pesticide Standards Repository.
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 not
established MRLs for sedaxane.
C. Revisions to Petitioned-For Tolerances
The Agency determined that the tolerance level for potato, wet peel
should be changed from the petitioned-for 0.06 ppm to 0.075 ppm based
upon EPA's examination of the level of residues that may remain on
potatoes following application of sedaxane at the maximum label rate
and the average degree of sedaxane residue concentration in wet potato
peel.
V. Conclusion
Therefore, tolerances are established for residues of sedaxane,
including its metabolites and degradates in or on potato; and potato,
wet peel at 0.02 and 0.075 ppm respectively.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (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: September 17, 2013.
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. 180.665, add alphabetically the following commodities to
the table in paragraph (a) to read as follows:
Sec. 180.665 Sedaxane; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Potato.................................................. 0.02
Potato, wet peel........................................ 0.075
* * * * *
------------------------------------------------------------------------
[[Page 60720]]
* * * * *
[FR Doc. 2013-23941 Filed 10-1-13; 8:45 am]
BILLING CODE 6560-50-P
