Etoxazole; Pesticide Tolerances, 75426-75430 [2015-30513]
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10. Section 252.45 is amended by
revising paragraph (b)(2) to read as
follows:
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§ 252.45 Data and information required to
be submitted in support of the Board’s
analyses.
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(b) * * *
(2) Project a company’s pre-provision
net revenue, losses, provision for loan
and lease losses, and net income; and
pro forma capital levels, regulatory
capital ratios, and any other capital ratio
specified by the Board under the
scenarios described in § 252.44(b).
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■ 11. Section 252.52 is amended by:
■ a. Revising paragraph (n); and
■ b. removing paragraph (t).
The revision reads as follows:
§ 252.52
Definitions.
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(n) Regulatory capital ratio means a
capital ratio for which the Board
established minimum requirements for
the company by regulation or order,
including the company’s tier 1 and
supplementary leverage ratios as
calculated under 12 CFR part 217,
including the deductions required
under 12 CFR 248.12, as applicable, and
the company’s common equity tier 1,
tier 1, and total risk-based capital ratios
as calculated under 12 CFR part 217,
including the deductions required
under 12 CFR 248.12 and the transition
provisions at 12 CFR 217.1(f)(4) and
217.300; except that the company shall
not use the advanced approaches to
calculate its regulatory capital ratios.
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■ 12. Section 252.53 is amended by
revising paragraph (b)(3) to read as
follows:
§ 252.53
Applicability.
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(b) * * *
(3) Transition periods for covered
companies subject to the supplementary
leverage ratio. Notwithstanding
§ 252.52(n), only for purposes of the
stress test cycle beginning on January 1,
2016, a bank holding company shall not
include an estimate of its
supplementary leverage ratio.
■ 13. Section 252.56 is amended by
revising paragraphs (a)(2), (b)(2)(i), and
(b)(2)(iv) to read as follows:
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§ 252.56
Methodologies and practices.
(a) * * *
(2) The potential impact on pro forma
regulatory capital levels and pro forma
capital ratios (including regulatory
capital ratios and any other capital
ratios specified by the Board),
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incorporating the effects of any capital
actions over the planning horizon and
maintenance of an allowance for loan
losses appropriate for credit exposures
throughout the planning horizon.
(b) * * *
(2) * * *
(i) Common stock dividends equal to
the quarterly average dollar amount of
common stock dividends that the
company paid in the previous year (that
is, the first quarter of the planning
horizon and the preceding three
calendar quarters) plus common stock
dividends attributable to issuances
related to expensed employee
compensation or in connection with a
planned merger or acquisition to the
extent that the merger or acquisition is
reflected in the covered company’s pro
forma balance sheet estimates;
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(iv) An assumption of no issuances of
common stock or preferred stock, except
for issuances related to expensed
employee compensation or in
connection with a planned merger or
acquisition to the extent that the merger
or acquisition is reflected in the covered
company’s pro forma balance sheet
estimates.
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14. Section 252.58 is amended by
revising paragraphs (b)(3)(v), (b)(4), and
(c)(2) to read as follows:
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§ 252.58
Disclosure of stress test results.
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(b) * * *
(3) * * *
(v) Pro forma regulatory capital ratios
and any other capital ratios specified by
the Board;
(4) An explanation of the most
significant causes for the changes in
regulatory capital ratios; and
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(c) * * *
(2) The disclosure of pro forma
regulatory capital ratios and any other
capital ratios specified by the Board that
is required under paragraph (b) of this
section must include the beginning
value, ending value, and minimum
value of each ratio over the planning
horizon.
By order of the Board of Governors of the
Federal Reserve System, November 25, 2015.
Robert deV. Frierson,
Secretary of the Board.
[FR Doc. 2015–30471 Filed 12–1–15; 8:45 am]
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2014–0681; FRL–9934–60]
Etoxazole; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of etoxazole in or
on orange and orange oil. Sumitomo
Chemical Latin America through Valent
USA Corporation requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
December 2, 2015. Objections and
requests for hearings must be received
on or before February 1, 2016, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2014–0681, 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:
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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
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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. To access the OCSPP test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’
jstallworth on DSK7TPTVN1PROD with RULES
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2014–0681 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 1, 2016. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2014–0681, 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/
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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 March 4,
2015 (80 FR 11611) (FRL–9922–68),
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 4E8304) by
Sumitomo Chemical Latin America
through Valent USA Corporation, 1600
Riviera Avenue, Suite 200, Walnut
Creek, CA 94596. The petition requested
that 40 CFR 180.593 be amended by
establishing tolerances for residues of
the insecticide etoxazole (2-(2,6difluorophenyl)-4-[4-(1,1dimethylethyl)-2-ethoxyphenyl]4,5dihydrooxazole), in or on orange and
orange oil at 0.08 and 1.8 parts per
million (ppm), respectively. That
document referenced a summary of the
petition prepared by Valent USA
Corporation on behalf of Sumitomo
Chemical Latin America, the registrant,
which is available in the docket,
https://www.regulations.gov.
EPA received one comment to the
Notice of Filing concerning another
chemical (azoxystrobin) and not
etoxazole. The commenter stated, in
part, that zero residues should be
allowed for pesticide residues. The
Agency understands the commenter’s
concerns and recognizes that some
individuals believe that pesticides
should be banned on agricultural crops.
However, the existing legal framework
provided by section 408 of the FFDCA
states that tolerances may be set when
persons seeking such tolerances or
exemptions have demonstrated that the
pesticide meets the safety standard
imposed by that statute. This citizen’s
comment appears to be directed at the
underlying statute and not EPA’s
implementation of it; the citizen has
made no contention that EPA has acted
in violation of the statutory framework.
Based upon review of the data
supporting the petition, EPA has revised
the petitioned-for tolerance levels of
0.08 and 1.8 ppm for orange and orange,
oil to 0.10 and 1.0 ppm, respectively.
The reasons for these changes are
explained in Unit IV.C.
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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 etoxazole
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with etoxazole 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 effects in the etoxazole database
show liver toxicity in all species tested
(enzyme release, hepatocellular
swelling, and histopathological
indicators), and the severity does not
appear to increase with time. In rats
only, there were effects on incisors
(elongation, whitening, and partial loss
of upper and/or lower incisors). There is
no evidence of neurotoxicity or
immunotoxicity. No toxicity was seen at
the limit dose in a 28-day dermal
toxicity study in rats. Etoxazole was not
mutagenic. No increased quantitative or
qualitative susceptibilities were
observed following in utero exposure to
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rats or rabbits in the developmental
studies; however, offspring toxicity was
more severe (increased pup mortality)
than maternal toxicity (increased liver
and adrenal weights) at the same dose
(158.7 milligram/kilogram/day (mg/kg/
day)) in the rat reproduction study
indicating increased qualitative
susceptibility. Etoxazole is not likely to
be carcinogenic based on the lack of
carcinogenicity effects in the database.
Specific information on the studies
received and the nature of the adverse
effects caused by etoxazole 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,
‘‘Etoxazole: Human Health Risk
Assessment in Support of the Proposed
Tolerances for Residues in/on Imported
Oranges and Orange Oil’’ at pp. 16–18
in docket ID number EPA–HQ–OPP–
2014–0681.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which the NOAEL and the
LOAEL are identified. Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for etoxazole used for human
risk assessment is shown in Table 1 of
this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETOXAZOLE FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Point of departure and
uncertainty/safety factors
RfD, PAD, LOC for risk
assessment
Study and toxicological effects
Acute dietary (all populations) ..
N/A ............................................
N/A ............................................
Chronic dietary (all populations)
NOAEL = 4.62 mg/kg/day ........
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 0.046 mg/kg/day
cPAD = 0.046 mg/kg/day
A dose and endpoint attributable to a single dose were not identified in the database including the hazard database. An
acute dietary assessment was not performed.
Chronic Oral Toxicity Study—Dog. LOAEL
= 23.5 mg/kg/day based upon increased alkaline phosphatase activity,
increased liver weights, liver enlargement (females), and incidences of
centrilobular hepatocellular swelling in
the liver.
Cancer (Oral, dermal, inhalation).
EPA classified etoxazole as ‘‘not likely to be carcinogenic to humans.
Point of departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no-observed adverse-effect
level. LOAEL = lowest-observed adverse-effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH =
potential variation in sensitivity among members of the human population (intraspecies). Food Quality Protection Act Safety Factor = FQPA SF.
PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose. N/A = not applicable.
Since the current proposal pertains to
an import tolerance (no occupational
exposure for workers in the U.S.) and
since residential exposure is not
anticipated from the proposed/
registered uses, only dietary
toxicological endpoints are listed in
Table 1.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to etoxazole, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
etoxazole tolerances in 40 CFR 180.593.
EPA assessed dietary exposures from
etoxazole in food as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
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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.
No such effects were identified in the
toxicological studies for etoxazole;
therefore, a quantitative acute dietary
exposure assessment is unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA National Health and
Nutrition Examination Survey, What We
Eat in America (NHANES/WWEIA;
2003–2008). As to residue levels in
food, EPA assumed tolerance-level
residues, 100% crop treated (PCT), and
in the absence of empirical data, DEEM
(ver 7.81) default processing factors. In
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addition, based on EPA’s conclusion
that etoxazole has a high potential to
bioaccumulate, residue estimates for
fish/shellfish were included.
iii. Cancer. EPA classified etoxazole
as ‘‘not likely to be carcinogenic to
humans’’. Therefore, a dietary exposure
assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for etoxazole. Tolerance-level residues
and/or 100 PCT were assumed for all
food commodities.
2. Dietary exposure from drinking
water. Although the orange and orange,
oil tolerances will not result in residues
in drinking water, as those uses are not
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associated with a U.S. registration, the
Agency used screening-level water
exposure models in the dietary exposure
analysis and risk assessment to assess
etoxazole in drinking water resulting
from existing U.S. registrations. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of etoxazole.
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 First Index Reservoir
Screening Tool (FIRST), and Pesticide
Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS), the
estimated drinking water concentrations
(EDWCs) of etoxazole for chronic
exposures for non-cancer assessments
are estimated to be 4.761 parts per
billion (ppb) for surface water and <0.1
ppb for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model.
For chronic dietary risk assessment,
the water concentration of value 4.761
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).
Etoxazole 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.’’
EPA has not found etoxazole to share
a common mechanism of toxicity with
any other substances, and etoxazole
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that etoxazole 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.
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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.
No increased quantitative or qualitative
susceptibilities were observed following
in utero exposure to rats or rabbits in
the developmental studies. There is
evidence of increased qualitative
offspring susceptibility in the rat
reproduction study, but the concern is
low since: (1) The effects in pups are
well-characterized with a clear NOAEL;
(2) the selected endpoints are protective
of the doses where the offspring toxicity
is observed; and (3) offspring effects
occur in the presence of parental
toxicity. There are no residual
uncertainties for pre-/post-natal toxicity.
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 etoxazole
is complete.
ii. There is no indication that
etoxazole is a neurotoxic chemical and
there is no need for a developmental
neurotoxicity study or additional
uncertainty factors (UFs) to account for
neurotoxicity.
iii. The observed qualitative postnatal
susceptibility is protected for by the
selected endpoints.
iv. There are no residual uncertainties
identified in the exposure databases.
EPA made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to etoxazole in drinking water. These
assessments will not underestimate the
exposure and risks posed by etoxazole.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
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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. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, etoxazole is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to etoxazole from
food and water will utilize 15% of the
cPAD for children 1–2 years old the
population group receiving the greatest
exposure. There are no residential uses
for etoxazole.
3. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
etoxazole is not expected to pose a
cancer risk to humans.
4. 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 etoxazole
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
gas chromatography/nitrogen
phosphorus detector (GC/NPD) is
available to enforce the recommended
tolerances.
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
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required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has established MRLs for
etoxazole in or on citrus fruits at 0.1
ppm. EPA is establishing a tolerance for
residues in or on orange of 0.10 ppm in
order to harmonize with the Codex
MRL.
C. Revisions to Petitioned-For
Tolerances
EPA has revised the proposed
tolerance levels for orange and orange
oil from 0.08 and 1.8 ppm to 0.10 and
1.0 ppm, respectively. EPA is
establishing a tolerance of 0.10 ppm for
orange in order to harmonize with the
Codex MRL. Additionally, based on the
orange raw agricultural commodity
highest-average field-trial residue of
0.048 ppm and the median orange oil
processing factor of 20x, EPA is
establishing a tolerance for orange, oil at
1.0 ppm. In addition, EPA is revising
the commodity terms for orange oil to
read as orange, oil to be consistent with
the Agency’s commodity vocabulary.
jstallworth on DSK7TPTVN1PROD with RULES
V. Conclusion
Therefore, tolerances are established
for residues of etoxazole (2-(2,6difluorophenyl)-4-[4-(1,1dimethylethyl)-2-ethoxyphenyl]-4,5dihydrooxazole), in or on orange and
orange, oil at 0.10 ppm and 1.0 ppm,
respectively.
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
VerDate Sep<11>2014
13:21 Dec 01, 2015
Jkt 238001
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 tolerances in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This 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
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
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 23, 2015.
Susan Lewis,
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 § 180.593, add alphabetically the
following commodities and footnote 2 to
the table in paragraph (a) to read as
follows:
■
§ 180.593 Etoxazole; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
*
*
*
*
Orange 2 ......................................
Orange, oil 2 ................................
*
*
*
*
*
0.10
1.0
*
2 There
are no U.S. registrations for orange
and orange, oil as of December 2, 2015.
*
*
*
*
*
[FR Doc. 2015–30513 Filed 12–1–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2014–0804; FRL–9937–02]
Hexythiazox; Pesticide Tolerances;
Technical Correction
Environmental Protection
Agency (EPA).
ACTION: Final rule; technical correction.
AGENCY:
EPA issued a final rule in the
Federal Register of August 14, 2015,
concerning the establishment of
tolerances with regional registrations for
residues of hexythiazox in or on wheat.
This document corrects a technical
error, specifically, the omission of
regions in the commodity definitions.
DATES: This final rule correction is
effective December 2, 2015.
SUMMARY:
E:\FR\FM\02DER1.SGM
02DER1
Agencies
[Federal Register Volume 80, Number 231 (Wednesday, December 2, 2015)]
[Rules and Regulations]
[Pages 75426-75430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30513]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2014-0681; FRL-9934-60]
Etoxazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
etoxazole in or on orange and orange oil. Sumitomo Chemical Latin
America through Valent USA Corporation requested these tolerances under
the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 2, 2015. Objections and
requests for hearings must be received on or before February 1, 2016,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0681, 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: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document
[[Page 75427]]
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. To access the OCSPP
test guidelines referenced in this document electronically, please go
to https://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0681 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 1, 2016. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0681, 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 March 4, 2015 (80 FR 11611) (FRL-9922-
68), 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
4E8304) by Sumitomo Chemical Latin America through Valent USA
Corporation, 1600 Riviera Avenue, Suite 200, Walnut Creek, CA 94596.
The petition requested that 40 CFR 180.593 be amended by establishing
tolerances for residues of the insecticide etoxazole (2-(2,6-
difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-
4,5dihydrooxazole), in or on orange and orange oil at 0.08 and 1.8
parts per million (ppm), respectively. That document referenced a
summary of the petition prepared by Valent USA Corporation on behalf of
Sumitomo Chemical Latin America, the registrant, which is available in
the docket, https://www.regulations.gov.
EPA received one comment to the Notice of Filing concerning another
chemical (azoxystrobin) and not etoxazole. The commenter stated, in
part, that zero residues should be allowed for pesticide residues. The
Agency understands the commenter's concerns and recognizes that some
individuals believe that pesticides should be banned on agricultural
crops. However, the existing legal framework provided by section 408 of
the FFDCA states that tolerances may be set when persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by that statute. This citizen's comment appears
to be directed at the underlying statute and not EPA's implementation
of it; the citizen has made no contention that EPA has acted in
violation of the statutory framework.
Based upon review of the data supporting the petition, EPA has
revised the petitioned-for tolerance levels of 0.08 and 1.8 ppm for
orange and orange, oil to 0.10 and 1.0 ppm, respectively. 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 etoxazole including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with etoxazole 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 effects in the etoxazole database show liver toxicity in all
species tested (enzyme release, hepatocellular swelling, and
histopathological indicators), and the severity does not appear to
increase with time. In rats only, there were effects on incisors
(elongation, whitening, and partial loss of upper and/or lower
incisors). There is no evidence of neurotoxicity or immunotoxicity. No
toxicity was seen at the limit dose in a 28-day dermal toxicity study
in rats. Etoxazole was not mutagenic. No increased quantitative or
qualitative susceptibilities were observed following in utero exposure
to
[[Page 75428]]
rats or rabbits in the developmental studies; however, offspring
toxicity was more severe (increased pup mortality) than maternal
toxicity (increased liver and adrenal weights) at the same dose (158.7
milligram/kilogram/day (mg/kg/day)) in the rat reproduction study
indicating increased qualitative susceptibility. Etoxazole is not
likely to be carcinogenic based on the lack of carcinogenicity effects
in the database.
Specific information on the studies received and the nature of the
adverse effects caused by etoxazole 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, ``Etoxazole: Human Health Risk
Assessment in Support of the Proposed Tolerances for Residues in/on
Imported Oranges and Orange Oil'' at pp. 16-18 in docket ID number EPA-
HQ-OPP-2014-0681.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and the LOAEL are identified.
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for etoxazole used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Etoxazole for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations).... N/A................... N/A................... A dose and endpoint
attributable to a single
dose were not identified
in the database including
the hazard database. An
acute dietary assessment
was not performed.
Chronic dietary (all populations).. NOAEL = 4.62 mg/kg/day Chronic RfD = 0.046 mg/ Chronic Oral Toxicity
UFA = 10x............. kg/day. Study--Dog. LOAEL = 23.5
UFH = 10x............. cPAD = 0.046 mg/kg/day mg/kg/day based upon
FQPA SF = 1x.......... increased alkaline
phosphatase activity,
increased liver weights,
liver enlargement
(females), and incidences
of centrilobular
hepatocellular swelling in
the liver.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation).. EPA classified etoxazole as ``not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
Point of departure (POD) = A data point or an estimated point that is derived from observed dose-response data
and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
relevant human exposures. NOAEL = no-observed adverse-effect level. LOAEL = lowest-observed adverse-effect
level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
variation in sensitivity among members of the human population (intraspecies). Food Quality Protection Act
Safety Factor = FQPA SF. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose. N/A =
not applicable.
Since the current proposal pertains to an import tolerance (no
occupational exposure for workers in the U.S.) and since residential
exposure is not anticipated from the proposed/registered uses, only
dietary toxicological endpoints are listed in Table 1.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to etoxazole, EPA considered exposure under the petitioned-for
tolerances as well as all existing etoxazole tolerances in 40 CFR
180.593. EPA assessed dietary exposures from etoxazole 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.
No such effects were identified in the toxicological studies for
etoxazole; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA National
Health and Nutrition Examination Survey, What We Eat in America
(NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA assumed
tolerance-level residues, 100% crop treated (PCT), and in the absence
of empirical data, DEEM (ver 7.81) default processing factors. In
addition, based on EPA's conclusion that etoxazole has a high potential
to bioaccumulate, residue estimates for fish/shellfish were included.
iii. Cancer. EPA classified etoxazole as ``not likely to be
carcinogenic to humans''. Therefore, a dietary exposure assessment for
the purpose of assessing cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for etoxazole. Tolerance-level residues and/or 100
PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. Although the orange and
orange, oil tolerances will not result in residues in drinking water,
as those uses are not
[[Page 75429]]
associated with a U.S. registration, the Agency used screening-level
water exposure models in the dietary exposure analysis and risk
assessment to assess etoxazole in drinking water resulting from
existing U.S. registrations. These simulation models take into account
data on the physical, chemical, and fate/transport characteristics of
etoxazole. 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 First Index Reservoir Screening Tool (FIRST), and
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), the estimated drinking water concentrations (EDWCs) of
etoxazole for chronic exposures for non-cancer assessments are
estimated to be 4.761 parts per billion (ppb) for surface water and
<0.1 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
For chronic dietary risk assessment, the water concentration of
value 4.761 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).
Etoxazole 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.''
EPA has not found etoxazole to share a common mechanism of toxicity
with any other substances, and etoxazole does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that etoxazole 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 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. No increased quantitative or
qualitative susceptibilities were observed following in utero exposure
to rats or rabbits in the developmental studies. There is evidence of
increased qualitative offspring susceptibility in the rat reproduction
study, but the concern is low since: (1) The effects in pups are well-
characterized with a clear NOAEL; (2) the selected endpoints are
protective of the doses where the offspring toxicity is observed; and
(3) offspring effects occur in the presence of parental toxicity. There
are no residual uncertainties for pre-/post-natal toxicity.
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 etoxazole is complete.
ii. There is no indication that etoxazole is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional uncertainty factors (UFs) to account for neurotoxicity.
iii. The observed qualitative postnatal susceptibility is protected
for by the selected endpoints.
iv. There are no residual uncertainties identified in the exposure
databases.
EPA made conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to etoxazole in drinking
water. These assessments will not underestimate the exposure and risks
posed by etoxazole.
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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
etoxazole is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
etoxazole from food and water will utilize 15% of the cPAD for children
1-2 years old the population group receiving the greatest exposure.
There are no residential uses for etoxazole.
3. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, etoxazole is not expected to pose a cancer risk to humans.
4. 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 etoxazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology gas chromatography/nitrogen
phosphorus detector (GC/NPD) is available to enforce the recommended
tolerances.
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
[[Page 75430]]
required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint
United Nations Food and Agriculture Organization/World Health
Organization food standards program, and it is recognized as an
international food safety standards-setting organization in trade
agreements to which the United States is a party. EPA may establish a
tolerance that is different from a Codex MRL; however, FFDCA section
408(b)(4) requires that EPA explain the reasons for departing from the
Codex level.
The Codex has established MRLs for etoxazole in or on citrus fruits
at 0.1 ppm. EPA is establishing a tolerance for residues in or on
orange of 0.10 ppm in order to harmonize with the Codex MRL.
C. Revisions to Petitioned-For Tolerances
EPA has revised the proposed tolerance levels for orange and orange
oil from 0.08 and 1.8 ppm to 0.10 and 1.0 ppm, respectively. EPA is
establishing a tolerance of 0.10 ppm for orange in order to harmonize
with the Codex MRL. Additionally, based on the orange raw agricultural
commodity highest-average field-trial residue of 0.048 ppm and the
median orange oil processing factor of 20x, EPA is establishing a
tolerance for orange, oil at 1.0 ppm. In addition, EPA is revising the
commodity terms for orange oil to read as orange, oil to be consistent
with the Agency's commodity vocabulary.
V. Conclusion
Therefore, tolerances are established for residues of etoxazole (2-
(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole), in or on orange and orange, oil at 0.10 ppm and 1.0
ppm, respectively.
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 tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This 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 23, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.593, add alphabetically the following commodities and
footnote 2 to the table in paragraph (a) to read as follows:
Sec. 180.593 Etoxazole; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Orange \2\.................................................. 0.10
Orange, oil \2\............................................. 1.0
* * * * *
------------------------------------------------------------------------
\2\ There are no U.S. registrations for orange and orange, oil as of
December 2, 2015.
* * * * *
[FR Doc. 2015-30513 Filed 12-1-15; 8:45 am]
BILLING CODE 6560-50-P