Sedaxane; Pesticide Tolerances, 57867-57872 [2017-26519]
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Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0537; FRL–9970–04]
Sedaxane; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of sedaxane in or
on grain, cereal, forage, fodder and
straw, group 16; grain, cereal, group 15;
peanut; and peanut, hay. Syngenta Crop
Protection, LLC requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
December 8, 2017. Objections and
requests for hearings must be received
on or before February 6, 2018, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2016–0537, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael L. Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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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
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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–2016–0537 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 February 6, 2018. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2016–0537, 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.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of November
30, 2016 (81 FR 86312) (FRL–9954–06),
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 6F8458) by
Syngenta Crop Protection, LLC, P.O.
Box 18300, Greensboro, NC 27419. The
petition requested that 40 CFR 180.665
be amended by establishing tolerances
for residues of the fungicide sedaxane,
in or on grain, cereal, forage, fodder and
straw, group 16 at 0.06 parts per million
(ppm); grain, cereal, group 15 at 0.01
ppm; peanut at 0.01 ppm; and peanut,
hay at 0.08 ppm. The petition also
requested that tolerances for residues of
sedaxane on the following commodities
be removed upon the establishment of
the petitioned-for tolerances: barley,
grain at 0.01 ppm; barley, hay at 0.04
ppm; barley, straw at 0.01 ppm; corn,
field, forage at 0.01 ppm; corn, field,
grain at 0.01 ppm; corn, field, stover at
0.01 ppm; corn, pop, grain at 0.01 ppm;
corn, pop, stover at 0.01 ppm; corn,
sweet, forage at 0.01 ppm; corn, sweet,
kernel plus cob with husks removed at
0.01 ppm; corn, sweet, stover at 0.01
ppm; oat, forage at 0.015 ppm; oat, grain
at 0.01 ppm; oat, hay at 0.06 ppm; oat,
straw at 0.01 ppm; rye, forage at 0.015
ppm; rye, grain at 0.01 ppm; rye, straw
at 0.01 ppm; sorghum, grain, forage at
0.01 ppm; sorghum, grain, grain at 0.01
ppm; sorghum, grain, stover at 0.01
ppm; wheat, forage at 0.015 ppm; wheat,
grain at 0.01 ppm; wheat, hay at 0.06
ppm; and wheat, straw at 0.01 ppm.
That document referenced a summary of
the petition prepared by Syngenta Crop
Protection, LLC, 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 is
establishing tolerances and removing
tolerances as requested in the petition,
with one exception. The tolerance for
crop group 16 is being established at
0.10 ppm to harmonize with Codex
Alimentarius Commission maximum
residue level (MRL).
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III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for 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
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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 main target tissue for sedaxane
was found to be the liver. Sedaxane also
caused thyroid hypertrophy/hyperplasia
in male rats. In the acute neurotoxicity
(ACN) and sub-chronic neurotoxicity
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(SCN) studies, sedaxane caused
decreased activity, muscle tone, rearing
and grip strength; however, because no
specific neurotoxic effects or adverse
histopathology were observed, EPA has
concluded that there is low concern for
neurotoxicity.
In the rat, no adverse effects in fetuses
were seen in developmental toxicity
studies at maternally toxic doses. In the
rabbit, fetal toxicity was observed at the
same doses as the dams. Offspring
effects in the rat reproduction study
occurred at the same doses causing
parental effects.
The available data show evidence of
high dose liver tumors (in male rats and
mice), thyroid tumors (in male rats), and
uterine tumors (in female rats) resulting
from exposure to sedaxane. Based on a
weight of evidence of the available data,
a constitutive androstane receptor/
pregnane-X receptor (CAR/PXR)mediated mitogenic mode-of action
(MOA) was established for liver tumors
in male mice and rats and a livermediated altered thyroid hormone
homeostasis MOA was established for
thyroid tumors in male rats. At this
time, a MOA for the uterine tumors has
not been identified.
To assess the carcinogenic potential
for sedaxane, EPA has concluded that a
non-linear approach (i.e., RfD) is
appropriate for the following reasons:
(1) There is a clear understanding of the
threshold (non-linear) doses associated
with the key events in the established
MOAs leading to liver and thyroid
tumors in rodents (the key events occur
only at doses that well exceed the
chronic reference dose (0.11 mg/kg/
day)); (2) sedaxane is not mutagenic or
genotoxic; (3) the dose at which uterine
tumors was observed is at 261 mg/kg/
day, which greatly exceeds the chronic
reference dose (0.11 mg/kg/day) being
used to assess chronic exposure to
sedaxane. Sedaxane has been
reclassified as ‘‘Suggestive Evidence of
Carcinogenic Potential’’.
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
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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 can be found at https://
www.regulations.gov in document titled
‘‘Sedaxane Human Health Risk
Assessment to Support New Seed
Treatment Uses on Cereal Grains Crop
Group 15; Forage, Fodder and Straw of
Cereal Grains Crop Group 16; Peanut;
and Cancer Reclassification’’, pages 11–
19 in docket ID number EPA–HQ–OPP–
2016–0537.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for sedaxane used for human
risk assessment is shown in the Table of
this unit.
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TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SEDAXANE FOR USE IN
HUMAN HEALTH RISK ASSESSMENT
Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
Acute dietary (General population including infants and
children and Females 13–49
years of age).
NOAEL = 30 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 0.30
mg/kg/day.
aPAD = 0.30 mg/kg/
day.
Rat ACN Study NOAEL = 30 mg/kg
LOAEL = 250 mg/kg based on reduced activity, decreased
rearing, initial inactivity, piloerection, ruffled fur and recumbency, decreased body weight (BW), decreased body weight
gain (BWG) and food consumption (males). In females,
weakened condition, swaying gait, decreased activity, reduced muscle tone, and decreased locomotor activity and
rearing. The weakened condition, swaying gait and decreased activity were observed on days 2–7, while the other
effects were on day 1.
Chronic dietary (All populations)
NOAEL= 11 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 0.11
mg/kg/day.
cPAD = 0.11 mg/kg/
day.
Chronic Rat Study
NOAEL = 11/14 mg/kg bw/day .//
LOAEL = 67/86 mg/kg bw/day .// in males based on decreased hind limb grip strength, increased liver weight, increased incidences of hepatocyte hypertrophy and
eosinophilic foci, and thyroid follicular cell hypertrophy, basophilic colloid, epithelial desquamation and increased phosphate levels (.). In females, it was based on decreased BW
and BWG, increased liver weight and the same thyroid
histopathology noted above for males.
Cancer (Oral, dermal, inhalation).
Classification: ‘‘Suggestive Evidence of Carcinogenic Potential’’. A non-linear approach (i.e., RfD) would adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to sedaxane.
Exposure/scenario
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day=
milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies).
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to 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 food consumption
information from the United States
Department of Agriculture (USDA)
under the Continuing Surveys of Food
Intake by Individuals (CSFII) and the
CDC under the National Health and
Nutrition Examination Survey What We
Eat in America (NHANES/WEIA) 2003–
2008. EPA assumed tolerance-level
residues for all commodities and 100%
crop treated. Default processing factors
were used with the exception of peanut
butter.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
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EPA used the food consumption data
from the USDA NHANES/WEIA 2003–
2008. EPA assumed tolerance-level
residues for all commodities and 100%
crop treated (CT). Default processing
factors were used with the exception of
peanut butter.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that a nonlinear RfD
approach is appropriate for assessing
cancer risk to sedaxane. Cancer risk was
assessed using the same exposure
estimates as discussed in Unit III.C.1.ii.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for sedaxane. Tolerance-level residues
and/or 100% 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 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/pesticide-science-
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and-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide.
Based on the FQPA Index Reservoir
Screening Tool (FIRST) and Pesticide
Root Zone Model Ground Water (PRZM
GW), 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 and for
chronic exposures for non-cancer
assessments are estimated to be 1.2 ppb
for surface water and 13.0 ppb for
ground water. The surface water
estimates include contributions from all
drinking water residues of concern
identified for risk assessment purposes;
nevertheless, the ground water EDWCs
were higher than the surface water
EDWCs and were selected for use in the
dietary exposure assessments.
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 dietary risk
assessment, the water concentration of
value 13.0 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-
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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
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
sedaxane and any other substances, and
sedaxane does not appear to produce a
toxic metabolite produced by 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/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
Food Quality Protection Act Safety
Factor (FQPA SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There is no evidence for increased
susceptibility following prenatal or
post-natal exposures to sedaxane based
on effects seen in developmental
toxicity studies in rabbits or rats. In
range-finding and definitive
developmental toxicity studies in rats,
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neither quantitative nor qualitative
evidence of increased susceptibility of
fetuses to in utero exposure to sedaxane
was observed. In these studies, there
were no single-dose effects. There was
no evidence of increased susceptibility
in a two-generation reproduction study
in rats following prenatal or post-natal
exposure to sedaxane. There was no
evidence of neuropathology or
abnormalities in the development of the
fetal nervous system from the available
toxicity studies conducted with
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
two-generation reproduction study. The
dose-response relationship for the
effects of concern is well characterized.
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. Given the available information,
there is low concern that sedaxane is a
neurotoxic chemical and there is no
need for a developmental neurotoxicity
study or additional uncertainty factors
(UFs) to account for neurotoxicity.
iii. In the rat, no adverse effects in
fetuses were seen in developmental
toxicity at maternally toxic doses. In the
rabbit, fetal toxicity was observed at the
same doses as the dam (increased
unossified sternebrae and 13th
rudimentary ribs and a decrease in fetal
weights of ¥9% and increased
abortions). In the dam, at the same
doses, the effects were decreased body
weight, reduced food consumption, and
decreased defecation. In reproduction
studies, offspring effects occurred at the
same doses causing parental effects;
thus, there was no quantitative increase
in sensitivity in rat pups. The LOAELs
and NOAELs for the developmental and
reproduction studies were clearly
defined. 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 with the
NOAELs of 100–200 mg/kg/day. Based
on these considerations, there are no
residual uncertainties for pre-and/or
post-natal susceptibility.
iv. There were no residual
uncertainties identified in the exposure
databases. The dietary food exposure
assessments were performed based on
100% CT and tolerance-level residues.
EPA made conservative (protective)
assumptions in the ground and surface
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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.
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 infants (<1-year-old), the
population group receiving the greatest
exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to sedaxane from
food and water will utilize <1% of the
cPAD for all population subgroups.
There are no residential uses for
sedaxane.
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). Because there are no
proposed or registered residential uses
of sedaxane, a short-term risk
assessment was not performed. The
chronic risk assessment is protective for
any short-term exposures from food and
drinking water.
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).
Because there are no proposed or
registered residential uses of sedaxane,
an intermediate-term risk assessment
was not performed. The chronic risk
assessment is protective for any
intermediate-term exposures from food
and drinking water.
5. Aggregate cancer risk for U.S.
population. As discussed in Unit III.A.,
EPA has concluded that using the
nonlinear approach based on the
chronic RfD will be protective of
potential carcinogenicity.
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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 sedaxane
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate analytical method is
available to enforce the proposed
tolerances for sedaxane in plant
commodities. 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. The sedaxane isomers
(SYN508210 and SYN508211) are
quantitatively determined by LC/MS/
MS. The validated limit of quantitation
(LOQ) reported in the method is 0.005
ppm for both sedaxane isomers.
The analytical standard for sedaxane,
with an expiration date of February 28,
2018, is currently available in the EPA
National Pesticide Standards
Repository.
sradovich on DSK3GMQ082PROD with RULES
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 MRL established by the
Codex Alimentarius Commission
(Codex), as required by FFDCA section
408(b)(4). The Codex 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.
Codex has established MRLs for
sedaxane in or on grain, cereal, forage,
fodder and straw, group 16 at 0.10 ppm
and grain, cereal, group 15 at 0.01 ppm.
Codex has not established a MRL for
sedaxane in or on peanut. Tolerances
are harmonized with the Codex MRLs
for groups 16 and 15.
V. Conclusion
Therefore, tolerances are established
for residues of sedaxane in or on grain,
cereal, forage, fodder and straw, group
16 at 0.10 ppm; grain, cereal, group 15
VerDate Sep<11>2014
16:24 Dec 07, 2017
Jkt 244001
at 0.01 ppm; peanut at 0.01 ppm; and
peanut, hay at 0.08 ppm. In addition,
EPA is removing the following existing
tolerances for residues of sedaxane as
they are superseded by the tolerances
established in this rulemaking: Barley,
grain at 0.01 ppm; barley, hay at 0.04
ppm; barley, straw at 0.01 ppm; corn,
field, forage at 0.01 ppm; corn, field,
grain at 0.01 ppm; corn, field, stover at
0.01 ppm; corn, pop, grain at 0.01 ppm;
corn, pop, stover at 0.01 ppm; corn,
sweet, forage at 0.01 ppm; corn, sweet,
kernel plus cob with husks removed at
0.01 ppm; corn, sweet, stover at 0.01
ppm; oat, forage at 0.015 ppm; oat, grain
at 0.01 ppm; oat, hay at 0.06 ppm; oat,
straw at 0.01 ppm; rye, forage at 0.015
ppm; rye, grain at 0.01 ppm; rye, straw
at 0.01 ppm; sorghum, grain, forage at
0.01 ppm; sorghum, grain, grain at 0.01
ppm; sorghum, grain, stover at 0.01
ppm; wheat, forage at 0.015 ppm; wheat,
grain at 0.01 ppm; wheat, hay at 0.06
ppm; and wheat, straw at 0.01 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
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Frm 00053
Fmt 4700
Sfmt 4700
57871
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: November 22, 2017.
Michael L. Goodis,
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, revise the table in
paragraph (a) to read as follows:
■
E:\FR\FM\08DER1.SGM
08DER1
57872
Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Rules and Regulations
§ 180.665 Sedaxane; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
Beet, sugar, roots .......................
Canola, seed ..............................
Cotton, gin byproducts ...............
Cotton, undelinted seed .............
Grain, cereal, forage, fodder and
straw, group 16 .......................
Grain, cereal, group 15 ..............
Pea and bean, dried shelled, except soybean, subgroup 6C ....
Peanut ........................................
Peanut, hay ................................
Potato .........................................
Potato, wet peel ..........................
Rapeseed, subgroup 20A ...........
Soybean, forage .........................
Soybean, hay ..............................
Soybean, seed ............................
Vegetable, foliage of legume, except soybean, subgroup 7A ....
*
*
*
*
0.01
0.01
0.01
0.01
0.10
0.01
0.01
0.01
0.08
0.02
0.075
0.01
0.05
0.04
0.01
0.01
*
[FR Doc. 2017–26519 Filed 12–7–17; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
40 CFR Part 180
[EPA–HQ–OPP–2016–0687; FRL–9969–96]
Bacillus subtilis Strain BU1814;
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of Bacillus subtilis
strain BU1814 in or on all food
commodities when used in accordance
with label directions and good
agricultural practices. BASF
Corporation submitted a petition to EPA
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting an
exemption from the requirement of a
tolerance. This regulation eliminates the
need to establish a maximum
permissible level for residues of Bacillus
subtilis strain BU1814 under FFDCA.
DATES: This regulation is effective
December 8, 2017. Objections and
requests for hearings must be received
on or before February 6, 2018, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
sradovich on DSK3GMQ082PROD with RULES
SUMMARY:
VerDate Sep<11>2014
16:24 Dec 07, 2017
Jkt 244001
number EPA–HQ–OPP–2016–0687, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave., NW., Washington,
DC 20460–0001. The Public Reading
Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The telephone number
for the Public Reading Room is (202)
566–1744, and the telephone number for
the OPP Docket is (703) 305–5805.
Please review the visitor instructions
and additional information about the
docket available at https://www.epa.gov/
dockets.
FOR FURTHER INFORMATION CONTACT:
Robert McNally, Biopesticides and
Pollution Prevention Division (7511P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
BPPDFRNotices@epa.gov.
SUPPLEMENTARY 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 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(g), 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
PO 00000
Frm 00054
Fmt 4700
Sfmt 4700
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–2016–0687 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 February 6, 2018. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2016–0687, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.,
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Background
In the Federal Register of February 7,
2017 (82 FR 9555) (FRL–9956–86), EPA
issued a document pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
tolerance petition (PP 6F8490) by BASF
Corporation, 26 Davis Dr., P.O. Box
13528, Research Triangle Park, NC
27709. The petition requested that 40
CFR part 180 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of the fungicide Bacillus subtilis strain
BU1814 in or on all food commodities.
That document referenced a summary of
the petition prepared by the petitioner
BASF Corporation, which is available in
the docket via https://
www.regulations.gov. There were no
E:\FR\FM\08DER1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Rules and Regulations]
[Pages 57867-57872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26519]
[[Page 57867]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0537; FRL-9970-04]
Sedaxane; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
sedaxane in or on grain, cereal, forage, fodder and straw, group 16;
grain, cereal, group 15; peanut; and peanut, hay. Syngenta Crop
Protection, LLC requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 8, 2017. Objections and
requests for hearings must be received on or before February 6, 2018,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0537, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0537 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
February 6, 2018. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2016-0537, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of November 30, 2016 (81 FR 86312) (FRL-
9954-06), 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
6F8458) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR 180.665 be amended by
establishing tolerances for residues of the fungicide sedaxane, in or
on grain, cereal, forage, fodder and straw, group 16 at 0.06 parts per
million (ppm); grain, cereal, group 15 at 0.01 ppm; peanut at 0.01 ppm;
and peanut, hay at 0.08 ppm. The petition also requested that
tolerances for residues of sedaxane on the following commodities be
removed upon the establishment of the petitioned-for tolerances:
barley, grain at 0.01 ppm; barley, hay at 0.04 ppm; barley, straw at
0.01 ppm; corn, field, forage at 0.01 ppm; corn, field, grain at 0.01
ppm; corn, field, stover at 0.01 ppm; corn, pop, grain at 0.01 ppm;
corn, pop, stover at 0.01 ppm; corn, sweet, forage at 0.01 ppm; corn,
sweet, kernel plus cob with husks removed at 0.01 ppm; corn, sweet,
stover at 0.01 ppm; oat, forage at 0.015 ppm; oat, grain at 0.01 ppm;
oat, hay at 0.06 ppm; oat, straw at 0.01 ppm; rye, forage at 0.015 ppm;
rye, grain at 0.01 ppm; rye, straw at 0.01 ppm; sorghum, grain, forage
at 0.01 ppm; sorghum, grain, grain at 0.01 ppm; sorghum, grain, stover
at 0.01 ppm; wheat, forage at 0.015 ppm; wheat, grain at 0.01 ppm;
wheat, hay at 0.06 ppm; and wheat, straw at 0.01 ppm. That document
referenced a summary of the petition prepared by Syngenta Crop
Protection, LLC, 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 is
establishing tolerances and removing tolerances as requested in the
petition, with one exception. The tolerance for crop group 16 is being
established at 0.10 ppm to harmonize with Codex Alimentarius Commission
maximum residue level (MRL).
[[Page 57868]]
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 main target tissue for sedaxane was found to be the liver.
Sedaxane also caused thyroid hypertrophy/hyperplasia in male rats. In
the acute neurotoxicity (ACN) and sub-chronic neurotoxicity (SCN)
studies, sedaxane caused decreased activity, muscle tone, rearing and
grip strength; however, because no specific neurotoxic effects or
adverse histopathology were observed, EPA has concluded that there is
low concern for neurotoxicity.
In the rat, no adverse effects in fetuses were seen in
developmental toxicity studies at maternally toxic doses. In the
rabbit, fetal toxicity was observed at the same doses as the dams.
Offspring effects in the rat reproduction study occurred at the same
doses causing parental effects.
The available data show evidence of high dose liver tumors (in male
rats and mice), thyroid tumors (in male rats), and uterine tumors (in
female rats) resulting from exposure to sedaxane. Based on a weight of
evidence of the available data, a constitutive androstane receptor/
pregnane-X receptor (CAR/PXR)-mediated mitogenic mode-of action (MOA)
was established for liver tumors in male mice and rats and a liver-
mediated altered thyroid hormone homeostasis MOA was established for
thyroid tumors in male rats. At this time, a MOA for the uterine tumors
has not been identified.
To assess the carcinogenic potential for sedaxane, EPA has
concluded that a non-linear approach (i.e., RfD) is appropriate for the
following reasons: (1) There is a clear understanding of the threshold
(non-linear) doses associated with the key events in the established
MOAs leading to liver and thyroid tumors in rodents (the key events
occur only at doses that well exceed the chronic reference dose (0.11
mg/kg/day)); (2) sedaxane is not mutagenic or genotoxic; (3) the dose
at which uterine tumors was observed is at 261 mg/kg/day, which greatly
exceeds the chronic reference dose (0.11 mg/kg/day) being used to
assess chronic exposure to sedaxane. Sedaxane has been reclassified as
``Suggestive Evidence of Carcinogenic Potential''.
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 can be found at https://www.regulations.gov in document titled ``Sedaxane Human Health Risk
Assessment to Support New Seed Treatment Uses on Cereal Grains Crop
Group 15; Forage, Fodder and Straw of Cereal Grains Crop Group 16;
Peanut; and Cancer Reclassification'', pages 11-19 in docket ID number
EPA-HQ-OPP-2016-0537.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for sedaxane used for
human risk assessment is shown in the Table of this unit.
[[Page 57869]]
Table--Summary of Toxicological Doses and Endpoints for Sedaxane for Use in
Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population NOAEL = 30 mg/kg/day Acute RfD = 0.30 mg/ Rat ACN Study NOAEL = 30 mg/kg
including infants and children UFA = 10x........... kg/day. LOAEL = 250 mg/kg based on reduced
and Females 13-49 years of age). UFH = 10x........... aPAD = 0.30 mg/kg/ activity, decreased rearing,
FQPA SF = 1x........ day.. initial inactivity, piloerection,
ruffled fur and recumbency,
decreased body weight (BW),
decreased body weight gain (BWG)
and food consumption (males). In
females, weakened condition,
swaying gait, decreased activity,
reduced muscle tone, and
decreased locomotor activity and
rearing. The weakened condition,
swaying gait and decreased
activity were observed on days 2-
7, while the other effects were
on day 1.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL= 11 mg/kg/day. Chronic RfD = 0.11 Chronic Rat Study
UFA = 10x........... mg/kg/day. NOAEL = 11/14 mg/kg bw/day [male]/
UFH = 10x........... cPAD = 0.11 mg/kg/ [female]
FQPA SF = 1x........ day.. LOAEL = 67/86 mg/kg bw/day [male]/
[female] in males based on
decreased hind limb grip
strength, increased liver weight,
increased incidences of
hepatocyte hypertrophy and
eosinophilic foci, and thyroid
follicular cell hypertrophy,
basophilic colloid, epithelial
desquamation and increased
phosphate levels ([male]). In
females, it was based on
decreased BW and BWG, increased
liver weight and the same thyroid
histopathology noted above for
males.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classification: ``Suggestive Evidence of Carcinogenic Potential''. A non-
linear approach (i.e., RfD) would adequately account for all chronic
toxicity, including carcinogenicity, that could result from exposure to
sedaxane.
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day= milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to 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 food consumption information from the United
States Department of Agriculture (USDA) under the Continuing Surveys of
Food Intake by Individuals (CSFII) and the CDC under the National
Health and Nutrition Examination Survey What We Eat in America (NHANES/
WEIA) 2003-2008. EPA assumed tolerance-level residues for all
commodities and 100% crop treated. Default processing factors were used
with the exception of peanut butter.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/WEIA
2003-2008. EPA assumed tolerance-level residues for all commodities and
100% crop treated (CT). Default processing factors were used with the
exception of peanut butter.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to sedaxane. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for sedaxane. Tolerance-level residues and/or 100%
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 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/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the FQPA Index Reservoir Screening Tool (FIRST) and
Pesticide Root Zone Model Ground Water (PRZM GW), 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 and for chronic exposures for non-cancer
assessments are estimated to be 1.2 ppb for surface water and 13.0 ppb
for ground water. The surface water estimates include contributions
from all drinking water residues of concern identified for risk
assessment purposes; nevertheless, the ground water EDWCs were higher
than the surface water EDWCs and were selected for use in the dietary
exposure assessments.
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 dietary risk
assessment, the water concentration of value 13.0 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-
[[Page 57870]]
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 cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to sedaxane and any other
substances, and sedaxane does not appear to produce a toxic metabolite
produced by 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/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity. There is no evidence for
increased susceptibility following prenatal or post-natal exposures to
sedaxane based on effects seen in developmental toxicity studies in
rabbits or rats. In range-finding and definitive developmental toxicity
studies in rats, neither quantitative nor qualitative evidence of
increased susceptibility of fetuses to in utero exposure to sedaxane
was observed. In these studies, there were no single-dose effects.
There was no evidence of increased susceptibility in a two-generation
reproduction study in rats following prenatal or post-natal exposure to
sedaxane. There was no evidence of neuropathology or abnormalities in
the development of the fetal nervous system from the available toxicity
studies conducted with 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 two-generation reproduction study.
The dose-response relationship for the effects of concern is well
characterized.
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. Given the available information, there is low concern that
sedaxane is a neurotoxic chemical and there is no need for a
developmental neurotoxicity study or additional uncertainty factors
(UFs) to account for neurotoxicity.
iii. In the rat, no adverse effects in fetuses were seen in
developmental toxicity at maternally toxic doses. In the rabbit, fetal
toxicity was observed at the same doses as the dam (increased
unossified sternebrae and 13th rudimentary ribs and a decrease in fetal
weights of -9% and increased abortions). In the dam, at the same doses,
the effects were decreased body weight, reduced food consumption, and
decreased defecation. In reproduction studies, offspring effects
occurred at the same doses causing parental effects; thus, there was no
quantitative increase in sensitivity in rat pups. The LOAELs and NOAELs
for the developmental and reproduction studies were clearly defined.
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 with the
NOAELs of 100-200 mg/kg/day. Based on these considerations, there are
no residual uncertainties for pre-and/or post-natal susceptibility.
iv. There were no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. 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.
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 infants (<1-year-old),
the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
sedaxane from food and water will utilize <1% of the cPAD for all
population subgroups. There are no residential uses for sedaxane.
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). Because there
are no proposed or registered residential uses of sedaxane, a short-
term risk assessment was not performed. The chronic risk assessment is
protective for any short-term exposures from food and drinking water.
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). Because there are no proposed or registered residential uses of
sedaxane, an intermediate-term risk assessment was not performed. The
chronic risk assessment is protective for any intermediate-term
exposures from food and drinking water.
5. Aggregate cancer risk for U.S. population. As discussed in Unit
III.A., EPA has concluded that using the nonlinear approach based on
the chronic RfD will be protective of potential carcinogenicity.
[[Page 57871]]
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 sedaxane residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate analytical method is available to enforce the proposed
tolerances for sedaxane in plant commodities. 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. The sedaxane isomers
(SYN508210 and SYN508211) are quantitatively determined by LC/MS/MS.
The validated limit of quantitation (LOQ) reported in the method is
0.005 ppm for both sedaxane isomers.
The analytical standard for sedaxane, with an expiration date of
February 28, 2018, is currently available in the EPA National Pesticide
Standards Repository.
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 MRL established by the Codex Alimentarius
Commission (Codex), as required by FFDCA section 408(b)(4). The Codex
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.
Codex has established MRLs for sedaxane in or on grain, cereal,
forage, fodder and straw, group 16 at 0.10 ppm and grain, cereal, group
15 at 0.01 ppm. Codex has not established a MRL for sedaxane in or on
peanut. Tolerances are harmonized with the Codex MRLs for groups 16 and
15.
V. Conclusion
Therefore, tolerances are established for residues of sedaxane in
or on grain, cereal, forage, fodder and straw, group 16 at 0.10 ppm;
grain, cereal, group 15 at 0.01 ppm; peanut at 0.01 ppm; and peanut,
hay at 0.08 ppm. In addition, EPA is removing the following existing
tolerances for residues of sedaxane as they are superseded by the
tolerances established in this rulemaking: Barley, grain at 0.01 ppm;
barley, hay at 0.04 ppm; barley, straw at 0.01 ppm; corn, field, forage
at 0.01 ppm; corn, field, grain at 0.01 ppm; corn, field, stover at
0.01 ppm; corn, pop, grain at 0.01 ppm; corn, pop, stover at 0.01 ppm;
corn, sweet, forage at 0.01 ppm; corn, sweet, kernel plus cob with
husks removed at 0.01 ppm; corn, sweet, stover at 0.01 ppm; oat, forage
at 0.015 ppm; oat, grain at 0.01 ppm; oat, hay at 0.06 ppm; oat, straw
at 0.01 ppm; rye, forage at 0.015 ppm; rye, grain at 0.01 ppm; rye,
straw at 0.01 ppm; sorghum, grain, forage at 0.01 ppm; sorghum, grain,
grain at 0.01 ppm; sorghum, grain, stover at 0.01 ppm; wheat, forage at
0.015 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.06 ppm; and wheat,
straw at 0.01 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
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: November 22, 2017.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.665, revise the table in paragraph (a) to read as
follows:
[[Page 57872]]
Sec. 180.665 Sedaxane; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Beet, sugar, roots.......................................... 0.01
Canola, seed................................................ 0.01
Cotton, gin byproducts...................................... 0.01
Cotton, undelinted seed..................................... 0.01
Grain, cereal, forage, fodder and straw, group 16........... 0.10
Grain, cereal, group 15..................................... 0.01
Pea and bean, dried shelled, except soybean, subgroup 6C.... 0.01
Peanut...................................................... 0.01
Peanut, hay................................................. 0.08
Potato...................................................... 0.02
Potato, wet peel............................................ 0.075
Rapeseed, subgroup 20A...................................... 0.01
Soybean, forage............................................. 0.05
Soybean, hay................................................ 0.04
Soybean, seed............................................... 0.01
Vegetable, foliage of legume, except soybean, subgroup 7A... 0.01
------------------------------------------------------------------------
* * * * *
[FR Doc. 2017-26519 Filed 12-7-17; 8:45 am]
BILLING CODE 6560-50-P
