Etoxazole; Pesticide Tolerance, 72958-72963 [E7-24983]
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72958
Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Rules and Regulations
have sold under this section for each
TABLE 2 OF § 89.102.—CORRESPONDING TIER 3 AND TIER
POWER CATEGORIES
Tier 3
power categories
37≤kW<75* ...........................
37≤kW<75**, 75≤kW<130 ....
130≤kW<225, 225≤kW<450,
450≤kW<560.
4 power category. You may omit the
Tier 4
power
categories
19≤kW<56
56≤kW<130
130≤kW≤560
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* Applies only to use of engines rated between 37kW and 56kW by small volume
equipment manufacturers.
** Includes only equipment that uses engines
with a rated power greater than 56kw.
(iv) Manufacturers using allowances
under this paragraph (i) must comply
with the notification and reporting
requirements specified in paragraph
(i)(7) of this section.
(7) Notification and reporting. You
must notify us of your intent to use the
technical relief provisions of this
paragraph (i) and send us an annual
report to verify that you are not
exceeding the allowances, as follows:
(i) Before the first year you intend to
use the provisions of this section, send
the Designated Compliance Officer and
the Designated Enforcement Officer a
written notice of your intent, including:
(A) Your company’s name and
address, and your parent company’s
name and address, if applicable.
(B) Whom to contact for more
information.
(C) The calendar years in which you
expect to use the exemption provisions
of this section.
(D) The name and address of the
company that produces the engines you
will be using for the equipment
exempted under this section.
(E) Your best estimate of the number
of units in each power category you will
produce under this section and whether
you intend to comply under paragraph
(d)(1) or (d)(2) of this section.
(F) The number of units in each
power category you have sold in
previous calendar years under
paragraph (d) of this section.
(ii) For each year that you use the
provisions of this section, send the
Designated Compliance Officer and the
Designated Enforcement Officer a
written report by March 31 of the
following year. Include in your report
the total number of engines you sold in
the preceding year for each power
category, based on actual U.S.-directed
production information. Also identify
the percentages of U.S.-directed
production that correspond to the
number of units in each power category
and the cumulative numbers and
percentages of units for all the units you
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percentage figures if you include in the
report a statement that you will not be
using the percent-of-production
allowances in paragraph (d) of this
section.
(8) Recordkeeping. Keep the following
records of all equipment with exempted
engines you produce under this
paragraph (i) for at least five full years
after the final year in which allowances
are available for each power category:
(i) The model number, serial number,
and the date of manufacture for each
engine and piece of equipment.
(ii) The maximum power of each
engine.
(iii) The total number or percentage of
equipment with exempted engines, as
described in paragraph (d) of this
section and all documentation
supporting your calculation.
(iv) The notifications and reports we
require under paragraph (i)(7) of this
section.
(9) Equipment Labeling. Any engine
produced under this paragraph (i) must
meet the labeling requirements of 40
CFR 89.110, but add the following
statement instead of the compliance
statement in 40 CFR 89.110 (b)(10):
THIS ENGINE MEETS U.S. EPA
EMISSION STANDARDS UNDER 40
CFR 89.102. SELLING OR INSTALLING
THIS ENGINE FOR ANY PURPOSE
OTHER THAN FOR THE EQUIPMENT
FLEXIBILITY PROVISIONS OF 40 CFR
89.102 MAY BE A VIOLATION OF
FEDERAL LAW SUBJECT TO CIVIL
PENALTY.
(10) Enforcement. Producing more
exempted engines or equipment than we
allow under this paragraph (i) or
installing engines that do not meet the
applicable Tier 1 emission standards
described in § 89.112 violates the
prohibitions in § 89.1003(a)(1). You
must give us the records we require
under this paragraph (i) if we ask for
them (see § 89.1003(a)(2)).
[FR Doc. E7–24976 Filed 12–21–07; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0309; FRL–8342–8]
Etoxazole; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of etoxazole in or
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on cherry; hop, dried cones; and
vegetable, cucurbit subgroup 9A. The
Interregional Research Project No. 4 (IR–
4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
This regulation is effective
December 26, 2007. Objections and
requests for hearings must be received
on or before February 25, 2008, 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: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2007–0309. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7610; e-mail address:
jackson.sidney@epa.gov.
DATES:
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. Potentially
affected entities may include, but are
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not limited to those engaged in the
following activities:
• Crop production (NAICS code
111), e.g., agricultural workers;
greenhouse, nursery, and floriculture
workers; farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
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B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s pilot
e-CFR site at https://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 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–2007–0309 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before February 25, 2008.
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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 that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2007– 0309, by one of the
following methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
on-line instructions for submitting
comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of June 27,
2007 (72 FR 35237) (FRL–8133–4), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 6E7150) by the
IR–4, 500 College Road East, Suite 201
W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.593 be
amended by establishing a tolerance for
residues of the insecticide etoxazole, 2(2,6-difluorophenyl)-4-[4-(1,1dimethylethyl)-2-ethoxyphenyl]-4,5dihydrooxazole, in or on cherry at 0.70
parts per million (ppm), hops, dried
cones, at 7.0 ppm, and melon subgroup
9A at 0.15 ppm. That notice referenced
a summary of the petition prepared by
Valent U.S.A. Corporation, the
registrant, which is available to the
public in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
Based upon current data supporting
the petition, EPA has corrected the
commodity definition and revised
proposed tolerance levels as follows:
1. For commodity cherry, a revised
tolerance at 1.0 ppm from 0.70 ppm;
and
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2. For the melon subgroup, the crop
definition has been changed from
‘‘melon subgroup 9A’’ to ‘‘vegetable,
cucurbit subgroup 9A’’ and the
tolerance revised from 0.15 to 0.20 ppm.
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....’’ These provisions
were added to FFDCA by the Food
Quality Protection Act (FQPA) of 1996.
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 the petitioned-for
tolerance for residues of in or on cherry,
sweet at 0.60 ppm, cherry, tart at 0.20
ppm, hop, dried cones, at 5.0 ppm, and
vegetable, cucurbit subgroup 9A at 0.15
ppm. EPA’s assessment of exposures
and risks associated with establishing
the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered their
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. Specific
information on the studies received and
the nature of the adverse effects caused
by etoxazole as well as the no-observedadverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can
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be found at https://www.regulations.gov.
The referenced document is available in
the docket established by this action,
which is described under Docket #:
EPA–HQ–OPP–2007–0309 and is
identified in that docket as PP 6E7150;
Revised: Etoxazole in/on Cherries,
Hops, and Melon Subgroup 9A; Health
Effects Division (HED) Risk Assessment.
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B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the toxicological level of concern
(LOC) is derived from the highest dose
at which no adverse effects are observed
(the NOAEL) in the toxicology study
identified as appropriate for use in risk
assessment. However, if a NOAEL
cannot be determined, the lowest dose
at which adverse effects of concern are
identified (the LOAEL) is sometimes
used for risk assessment. Uncertainty/
safety factors (UFs) are used in
conjunction with the LOC to take into
account uncertainties inherent in the
extrapolation from laboratory animal
data to humans and in the variations in
sensitivity among members of the
human population as well as other
unknowns. Safety is assessed for acute
and chronic risks by comparing
aggregate exposure to the pesticide to
the acute population adjusted dose
(aPAD) and chronic population adjusted
dose (cPAD). The aPAD and cPAD are
calculated by dividing the LOC by all
applicable UFs. Short-term,
intermediate-term, and long-term risks
are evaluated by comparing aggregate
exposure to the LOC to ensure that the
margin of exposure (MOE) called for by
the product of all applicable UFs is not
exceeded.
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk and
estimates risk in terms of the probability
of occurrence of additional adverse
cases. Generally, cancer risks are
considered non-threshold. 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/fedrgstr/EPA–PEST/1997/
November/Day-26/p30948.htm.
A summary of the toxicological
endpoints for etoxazole used for human
risk assessment can be found at https://
www.regulations.gov in document PP#:
6E7150. Revised: Etoxazole in/on
Cherries, Hops, and Melon Subgrou 9A.
Health Effects Division (HED) Risk
Assessment in docket ID number EPA–
HQ–OPP–2007–0309.
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C. Exposure Assessment
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.
An endpoint of concern attributable to
a single oral dose was not selected for
either the general U.S. population
(including infants and children) or the
females 13–50 years old population
subgroup for etoxazole. The EPA
evaluated the suitability of the
developmental toxicity study in rabbits
in which the developmental NOAEL of
200 mg/kg/day is based upon increased
incidences of 27 presacral vertebrae and
27 presacral vertebrae with 13th ribs
(skeletal variations) in the fetuses at the
LOAEL of 1,000 mg/kg/day (limit dose).
Although these developmental effects
may be attributed to a single dose, the
EPA concluded that etoxazole is
unlikely to pose an acute risk because
these effects are minor in magnitude
and were observed only at the limit dose
(1000 mg/kg/day). Therefore, an acute
dietary exposure assessment was not
performed .
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used DEEM-FCID, Version 2.03),
which incorporates consumption data
from United States Department of
Agriculture’s (USDA’s) Continuing
Surveys of Food Intakes by Individuals
(CSFII), 1994–1996 and 1998. The 1994–
96, 1998 data are based on the reported
consumption of more than 20,000
individuals over two non-consecutive
survey days. Foods ‘‘as consumed’’ (e.g.,
apple pie) are linked to EPA-defined
food commodities (e.g. apples, peeled
fruit - cooked; fresh or N/S; baked; or
wheat flour - cooked; fresh or N/S,
baked) using publicly available recipe
translation files developed jointly by
USDA/ARS and EPA. Consumption data
are averaged for the entire U.S.
population and within population
subgroups for chronic exposure
assessment.
An unrefined, chronic dietary
exposure assessment was conducted for
the general U.S. population and various
population subgroups using EPAcalculated residues of concern (parent
and metabolites) for livestock
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commodities and tolerance-level
residues for all other commodities. For
all registered and proposed uses, 100%
crop treated (CT) information was used,
as well as DEEM 7.81 default processing
factors for all commodities other than
apple and grape (apple and grape
residue data showed that there was no
concentration in processed
commodities; therefore; these default
values were set to 1).
iii. Cancer. EPA classified etoxazole
as ‘‘not likely to be carcinogenic to
humans’’. This decision was based on
the lack of carcinogenicity in two
studies in mice, lack of carcinogenicity
in one study in rats, and the lack of
hormonal and reproductive effects in
special studies. Etoxozole is not a
mutagen. Therefore, an exposure
assessment related to cancer risk was
not performed.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring data to complete a
comprehensive dietary exposure
analysis and risk assessment for
etoxazole in drinking water. Because the
Agency does not have comprehensive
monitoring data, drinking water
concentration estimates are made by
reliance on simulation or modeling
taking into account data on the
environmental fate 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.
The Agency conducted Tier 1
estimated drinking water concentrations
(EDWCs) for etoxazole in assessing
water exposure. Environmental fate data
indicate that parent (etoxazole) has low
mobility and relatively low persistence
in soil. The major route of degradation
based on the label use pattern will likely
be aerobic soil degradation. Based on
the aerobic soil metabolism study,
Metabolite R–8 was found as a major
degradate in 4 out of 5 soils tested, with
a maximum of 38% of the applied dose.
Metabolite R–8 is mobile and relatively
persistent and could be available for
runoff and leaching for periods of up to
months. Metabolite R–13 was also found
as a major degradate in 3 out of 5 soils
tested, with a maximum of 30.0% (at 62
days) in an aerobic soil metabolism
study. Based on submitted mobility
data, Metabolite R–13 appears to be
immobile. The Agency believes that
metabolites R–8 and R–13 are likely to
have similar toxicity to the parent; and,
therefore, should be included in the
drinking water assessment. Metabolites
R–4 and R–7 were also found in aerobic
soil dissipation studies, but less
frequently. EPA concluded that the
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inclusion of Metabolite R–8 should
cover the exposure from R–4 and R–7.
In summary, the Agency finds that for
drinking water risk assessment, the
residues of concern are parent,
Metabolite R–8, and Metabolite R–13.
FQPA Index Reservoir Screening Tool
(FIRST) and Screening Concentrations
In Ground Water (SCI-GROW) models
were used to calculate the chronic
surface water and groundwater EDWCs
(parent and metabolites), respectively.
Drinking water was incorporated
directly in the dietary assessment using
the acute concentration for surface
water generated by the FIRST model.
Tier 1 EDWCs results for etoxazole and
metabolites R–8 and R–13 show annual
average surface water concentrations of
0.332 parts per billion (ppb), 0.913 ppb
and 0.0285 ppb, respectively. Tier 1
EDWCs results for etoxazole and
metabolites R–8 and R–13 show ground
water concentrations of 0.00173ppb,
0.316 ppb and 0.000322 ppb,
respectively.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
chronic dietary risk assessment, the
total sum of the annual average surface
water concentrations for etoxazole and
metabolites R–8 and R–13 of 1.27 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 use in
or on any sites 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
etoxazole and 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 not
assumed that etoxazole has a common
mechanism of toxicity with other
substances. For information regarding
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EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408 of FFDCA
provides that EPA shall apply an
additional (‘‘10X’’) tenfold margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA safety factor. In applying this
provision, EPA either retains the default
value of 10X when reliable data do not
support the choice of a different factor,
or, if reliable data are available, EPA
uses a different additional FQPA safety
factor value based on the use of
traditional UFs and/or special FQPA
safety factors, as appropriate.
2. Prenatal and postnatal sensitivity.
No quantitative or qualitative evidence
of increased susceptibility was seen
following in utero exposure to rats or
rabbits in developmental studies.
Offspring toxicity was more severe (pup
mortality) than maternal toxicity
(increased liver and adrenal weights) at
the same dose in the rat reproduction
study.
Since there is qualitative evidence of
increased susceptibility following
exposure to etoxazole in the rat
reproduction study, the EPA performed
a Degree-of-Concern Analysis to:
i. Determine the LOC for the effects
observed when considered in the
context of all available toxicity data; and
ii. Identify any residual uncertainties
after establishing toxicity endpoints and
traditional uncertainty factors to be used
in the risk assessment of this chemical.
There is evidence of increased
qualitative susceptibility in the rat
reproduction study, but the concern is
low since:
a. The effects in pups are wellcharacterized with a clear NOAEL;
b. The pup effects occur at the same
dose as maternal toxicity; and,
c. The doses selected for various risk
assessment scenarios are lower than the
doses that caused off spring toxicity.
Therefore, there are no residual
uncertainties for pre-/post-natal toxicity
in this study.
3. Conclusion. EPA has determined
that reliable data show that it would be
safe for infants and children to reduce
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the FQPA safety factor to 1X. That
decision is based on the following
findings:
i. The toxicity database for etoxazole
is complete for FQPA assessment.
ii. There is no indication that
etoxazole is a neurotoxic chemical and
there is no need for a developmental
neurotoxicity study or additional UFs to
account for neurotoxicity.
iii. No quantitative or qualitative
evidence of increased susceptibility was
seen following in utero exposure to rats
or rabbits in developmental studies.
Although there is qualitative evidence
of increased susceptibility in the rat
reproduction study, the Agency did not
identify any residual uncertainties after
establishing toxicity endpoints and
traditional UFs to be used in the risk
assessment of etoxazole. The degree of
concern for prenatal and/or postnatal
toxicity is low.
iv. There are no residual uncertainties
identified in the exposure databases.
The chronic dietary food exposure
assessment utilizes EPA-calculated
residues of concern (parent and
metabolites) for livestock commodities;
tolerance-level residues for other
commodities; and 100% crop treated
(CT) information for all proposed uses.
By using these screening-level
assumptions, actual exposures/risks will
not be underestimated. The dietary
drinking water assessment utilized
modeling results which included
conservative assumptions for the parent
and all degradates of concern.
Conservative assumptions were used in
the water models. Therefore, the water
exposure assessment will not
underestimate the potential risks for
infant and children.
v. There are no registered or proposed
residential uses for etoxazole.
E. Aggregate Risks and Determination of
Safety
Safety is assessed for acute and
chronic risks by comparing aggregate
exposure to the pesticide to the aPAD
and cPAD. The aPAD and cPAD are
calculated by dividing the LOC by all
applicable UFs. For linear cancer risks,
EPA calculates the probability of
additional cancer cases given aggregate
exposure. Short-term, intermediateterm, and long-term risks are evaluated
by comparing aggregate exposure to the
LOC to ensure that the MOE called for
by the product of all applicable UFs is
not exceeded.
1. Acute risk. An acute aggregate risk
assessment was not performed because
an endpoint of concern attributable to a
single oral dose was not selected for any
population subgroup (including infants
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and children). No acute risk is expected
from exposure to etoxazole.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to etoxazole from food
and water will utilize 8.3% of the cPAD
for children 1–2 years old, the most
highly exposed population subgroup.
There are no residential uses for
etoxazole that result in chronic
residential exposure to etoxazole.
Therefore, EPA does not expect the
aggregate exposure to exceed 100% of
the cPAD.
3. Short-term and intermediate-term
risk. Short-term and intermediate-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Etoxazole is not registered or
proposed for use on any sites that would
result in residential exposure.
Therefore, the aggregate risk is the sum
of the risk from food and water, which
do not exceed the Agency’s LOC.
4. Aggregate cancer risk for U.S.
population. A cancer aggregate risk
assessment was not performed because
etoxazole is not carcinogenic. Etoxazole
is not expected to pose a cancer risk to
humans.
5. 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
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A. Analytical Enforcement Methodology
Adequate enforcement methodology
is available to enforce the tolerance
expression.
The following analytical enforcement
methods have been validated: The gas
chromatography/mass-selective detector
(GC/MSD) method used to determine
etoxazole residues in/on cherry matrices
is a slightly modified version of a
previously-validated method (Method
RM–37HM). The validated limit of
quantitation (LOQ) was 0.0037 ppm and
the limit of detection (LOD) was 0.0012
ppm for etoxazole in/on cherries. The
GC with nitrogen-phosphorus detector
(NPD) method used to determine
etoxazole residues in/on hop matrices is
a modified version of a previouslyvalidated method (Method RM–37). The
validated LOQ was 0.2 ppm and the
LOD was 0.1 ppm for etoxazole in/on
dried hop cones.The nitrogenphosphorus specific flame-ionization
detector (NPD) method used to
determine etoxazole residues in/on
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cantaloupe matrices is a slightly
modified version of a previouslyvalidated method (Method RM–37). The
validated LOQ was 0.0046 ppm and the
LOD was 0.0015 ppm for etoxazole in/
on cantaloupe.
The methods may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Road, Fort Meade, MD 20755–
5350; telephone number: (410) 305–
2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no established or proposed
Codex, Canadian or Mexican maximum
residue limits (MRLs) for etoxazole.
Therefore, tolerances are established
for residues of the insecticide etoxazole,
2-(2,6-difluorophenyl)-4-[4-(1,1dimethylethyl)-2-ethoxyphenyl]-4,5dihydrooxazole, in or on cherry at 1.0
ppm, hop, dried cones at 7.0 ppm, and
vegetable, cucurbit subgroup 9A at 0.20
ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA 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 rule has
been exempted from review under
Executive Order 12866, this rule is not
subject to Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
PO 00000
Frm 00064
Fmt 4700
Sfmt 4700
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 section 408(n)(4) of FFDCA. 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 6, 2000) do not apply
to this rule. In addition, This rule does
not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act of 1995 (UMRA)
(Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. 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 this final rule in the
Federal Register. This final rule 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: December 14, 2007.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
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Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Rules and Regulations
identification (ID) number EPA–HQ–
OPP–2007–0545. To access the
I 1. The authority citation for part 180
electronic docket, go to https://
continues to read as follows:
www.regulations.gov, select ‘‘Advanced
Authority: 21 U.S.C. 321(q), 346a and 371.
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
I 2. Section 180.593 is amended by
and select the ‘‘Submit’’ button. Follow
alphabetically adding the following
the instructions on the regulations.gov
commodities to the table in paragraph
website to view the docket index or
(a) to read as follows:
access available documents. All
§ 180.593 Etoxazole; tolerances for
documents in the docket are listed in
residues.
the docket index available in
(a) * * *
regulations.gov. Although listed in the
index, some information is not publicly
Commodity
Parts per million
available, e.g., Confidential Business
Information (CBI) or other information
*
*
*
*
*
Cherry .............................
1.0 whose disclosure is restricted by statute.
Certain other material, such as
*
*
*
*
*
Hop, dried cones ............
7.0 copyrighted material, is not placed on
*
*
*
*
*
the Internet and will be publicly
Vegetable, cucurbit subavailable only in hard copy form.
group 9A .....................
0.20 Publicly available docket materials are
available in the electronic docket at
*
*
*
*
*
https://www.regulations.gov, or, if only
[FR Doc. E7–24983 Filed 12–21–07; 8:45 am]
available in hard copy, at the OPP
BILLING CODE 6560–50–S
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
ENVIRONMENTAL PROTECTION
Docket Facility is open from 8:30 a.m.
AGENCY
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
40 CFR Part 180
Facility telephone number is (703) 305–
[EPA–HQ–OPP–2007–0545; FRL–8342–1]
5805.
FOR FURTHER INFORMATION CONTACT:
Aspergillus Flavus AF36 on Corn;
Shanaz Bacchus, Biopesticides and
Temporary Exemption From the
Pollution Prevention Division (7511P),
Requirement of a Tolerance
Office of Pesticide Programs,
Environmental Protection Agency, 1200
AGENCY: Environmental Protection
Pennsylvania Ave., NW., Washington,
Agency (EPA).
DC 20460–0001; telephone number:
ACTION: Final rule.
(703) 308–8097; e-mail address:
SUMMARY: This regulation establishes a
bacchus.shanaz@epa.gov.
temporary exemption from the
SUPPLEMENTARY INFORMATION:
requirement of a tolerance for residues
I. General Information
of the Aspergillus flavus AF36 on corn
when applied/used before corn tasseling A. Does this Action Apply to Me?
occurs. Arizona Cotton Research and
You may be potentially affected by
Protection Council submitted a petition
this action if you are an agricultural
to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended producer, food manufacturer, or
pesticide manufacturer. Potentially
by the Food Quality Protection Act of
affected entities may include, but are
1996 (FQPA), requesting the temporary
not limited to:
tolerance exemption. This regulation
• Crop production (NAICS code 111).
eliminates the need to establish a
• Animal production (NAICS code
maximum permissible level for residues
112).
of Aspergillus flavus AF36. The
• Food manufacturing (NAICS code
temporary tolerance exemption expires
311).
on December 31, 2011.
• Pesticide manufacturing (NAICS
DATES: This regulation is effective
code 32532).
December 26, 2007. Objections and
This listing is not intended to be
requests for hearings must be received
exhaustive, but rather provides a guide
on or before February 25, 2008, and
for readers regarding entities likely to be
must be filed in accordance with the
affected by this action. Other types of
instructions provided in 40 CFR part
entities not listed in this unit could also
178 (see also Unit I.C. of the
be affected. The North American
SUPPLEMENTARY INFORMATION).
Industrial Classification System
ADDRESSES: EPA has established a
(NAICS) codes have been provided to
docket for this action under docket
assist you and others in determining
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PART 180—[AMENDED]
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72963
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
section 5 of Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA)
and the regulations promulgated to
carry out that provision of FIFRA (40
CFR part 172). If you have any questions
regarding the applicability of this action
to a particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this ‘‘Federal Register’’ document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, as
amended by FQPA, any person may file
an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
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–2007–0545 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before February 25, 2008.
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 that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2007–0545, by one of
the following methods.
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
E:\FR\FM\26DER1.SGM
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Agencies
[Federal Register Volume 72, Number 246 (Wednesday, December 26, 2007)]
[Rules and Regulations]
[Pages 72958-72963]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24983]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0309; FRL-8342-8]
Etoxazole; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
etoxazole in or on cherry; hop, dried cones; and vegetable, cucurbit
subgroup 9A. The Interregional Research Project No. 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective December 26, 2007. Objections and
requests for hearings must be received on or before February 25, 2008,
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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0309. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at https://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7610; e-mail address: jackson.sidney@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.
Potentially affected entities may include, but are
[[Page 72959]]
not limited to those engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 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-2007-0309 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before February 25, 2008.
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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007- 0309, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of June 27, 2007 (72 FR 35237) (FRL-8133-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6E7150) by the IR-4, 500 College Road East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40 CFR 180.593 be amended by
establishing a tolerance for residues of the insecticide etoxazole, 2-
(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole, in or on cherry at 0.70 parts per million (ppm), hops,
dried cones, at 7.0 ppm, and melon subgroup 9A at 0.15 ppm. That notice
referenced a summary of the petition prepared by Valent U.S.A.
Corporation, the registrant, which is available to the public in the
docket, https://www.regulations.gov. There were no comments received in
response to the notice of filing.
Based upon current data supporting the petition, EPA has corrected
the commodity definition and revised proposed tolerance levels as
follows:
1. For commodity cherry, a revised tolerance at 1.0 ppm from 0.70
ppm; and
2. For the melon subgroup, the crop definition has been changed
from ``melon subgroup 9A'' to ``vegetable, cucurbit subgroup 9A'' and
the tolerance revised from 0.15 to 0.20 ppm.
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....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
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 the petitioned-for tolerance
for residues of in or on cherry, sweet at 0.60 ppm, cherry, tart at
0.20 ppm, hop, dried cones, at 5.0 ppm, and vegetable, cucurbit
subgroup 9A at 0.15 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
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. 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
[[Page 72960]]
be found at https://www.regulations.gov. The referenced document is
available in the docket established by this action, which is described
under Docket : EPA-HQ-OPP-2007-0309 and is identified in that
docket as PP 6E7150; Revised: Etoxazole in/on Cherries, Hops, and Melon
Subgroup 9A; Health Effects Division (HED) Risk Assessment.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short-term, intermediate-term, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
A summary of the toxicological endpoints for etoxazole used for
human risk assessment can be found at https://www.regulations.gov in
document PP: 6E7150. Revised: Etoxazole in/on Cherries, Hops,
and Melon Subgrou 9A. Health Effects Division (HED) Risk Assessment in
docket ID number EPA-HQ-OPP-2007-0309.
C. Exposure Assessment
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.
An endpoint of concern attributable to a single oral dose was not
selected for either the general U.S. population (including infants and
children) or the females 13-50 years old population subgroup for
etoxazole. The EPA evaluated the suitability of the developmental
toxicity study in rabbits in which the developmental NOAEL of 200 mg/
kg/day is based upon increased incidences of 27 presacral vertebrae and
27 presacral vertebrae with 13th ribs (skeletal variations) in the
fetuses at the LOAEL of 1,000 mg/kg/day (limit dose). Although these
developmental effects may be attributed to a single dose, the EPA
concluded that etoxazole is unlikely to pose an acute risk because
these effects are minor in magnitude and were observed only at the
limit dose (1000 mg/kg/day). Therefore, an acute dietary exposure
assessment was not performed .
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used DEEM-FCID, Version 2.03), which incorporates
consumption data from United States Department of Agriculture's
(USDA's) Continuing Surveys of Food Intakes by Individuals (CSFII),
1994-1996 and 1998. The 1994-96, 1998 data are based on the reported
consumption of more than 20,000 individuals over two non-consecutive
survey days. Foods ``as consumed'' (e.g., apple pie) are linked to EPA-
defined food commodities (e.g. apples, peeled fruit - cooked; fresh or
N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using
publicly available recipe translation files developed jointly by USDA/
ARS and EPA. Consumption data are averaged for the entire U.S.
population and within population subgroups for chronic exposure
assessment.
An unrefined, chronic dietary exposure assessment was conducted for
the general U.S. population and various population subgroups using EPA-
calculated residues of concern (parent and metabolites) for livestock
commodities and tolerance-level residues for all other commodities. For
all registered and proposed uses, 100% crop treated (CT) information
was used, as well as DEEM 7.81 default processing factors for all
commodities other than apple and grape (apple and grape residue data
showed that there was no concentration in processed commodities;
therefore; these default values were set to 1).
iii. Cancer. EPA classified etoxazole as ``not likely to be
carcinogenic to humans''. This decision was based on the lack of
carcinogenicity in two studies in mice, lack of carcinogenicity in one
study in rats, and the lack of hormonal and reproductive effects in
special studies. Etoxozole is not a mutagen. Therefore, an exposure
assessment related to cancer risk was not performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for etoxazole in drinking water. Because
the Agency does not have comprehensive monitoring data, drinking water
concentration estimates are made by reliance on simulation or modeling
taking into account data on the environmental fate 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.
The Agency conducted Tier 1 estimated drinking water concentrations
(EDWCs) for etoxazole in assessing water exposure. Environmental fate
data indicate that parent (etoxazole) has low mobility and relatively
low persistence in soil. The major route of degradation based on the
label use pattern will likely be aerobic soil degradation. Based on the
aerobic soil metabolism study, Metabolite R-8 was found as a major
degradate in 4 out of 5 soils tested, with a maximum of 38% of the
applied dose. Metabolite R-8 is mobile and relatively persistent and
could be available for runoff and leaching for periods of up to months.
Metabolite R-13 was also found as a major degradate in 3 out of 5 soils
tested, with a maximum of 30.0% (at 62 days) in an aerobic soil
metabolism study. Based on submitted mobility data, Metabolite R-13
appears to be immobile. The Agency believes that metabolites R-8 and R-
13 are likely to have similar toxicity to the parent; and, therefore,
should be included in the drinking water assessment. Metabolites R-4
and R-7 were also found in aerobic soil dissipation studies, but less
frequently. EPA concluded that the
[[Page 72961]]
inclusion of Metabolite R-8 should cover the exposure from R-4 and R-7.
In summary, the Agency finds that for drinking water risk assessment,
the residues of concern are parent, Metabolite R-8, and Metabolite R-
13.
FQPA Index Reservoir Screening Tool (FIRST) and Screening
Concentrations In Ground Water (SCI-GROW) models were used to calculate
the chronic surface water and groundwater EDWCs (parent and
metabolites), respectively. Drinking water was incorporated directly in
the dietary assessment using the acute concentration for surface water
generated by the FIRST model. Tier 1 EDWCs results for etoxazole and
metabolites R-8 and R-13 show annual average surface water
concentrations of 0.332 parts per billion (ppb), 0.913 ppb and 0.0285
ppb, respectively. Tier 1 EDWCs results for etoxazole and metabolites
R-8 and R-13 show ground water concentrations of 0.00173ppb, 0.316 ppb
and 0.000322 ppb, respectively.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the total sum of the annual average surface water
concentrations for etoxazole and metabolites R-8 and R-13 of 1.27 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 use in or on any sites 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 etoxazole and 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 not assumed that etoxazole has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the FQPA safety factor. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. No quantitative or
qualitative evidence of increased susceptibility was seen following in
utero exposure to rats or rabbits in developmental studies. Offspring
toxicity was more severe (pup mortality) than maternal toxicity
(increased liver and adrenal weights) at the same dose in the rat
reproduction study.
Since there is qualitative evidence of increased susceptibility
following exposure to etoxazole in the rat reproduction study, the EPA
performed a Degree-of-Concern Analysis to:
i. Determine the LOC for the effects observed when considered in
the context of all available toxicity data; and
ii. Identify any residual uncertainties after establishing toxicity
endpoints and traditional uncertainty factors to be used in the risk
assessment of this chemical. There is evidence of increased qualitative
susceptibility in the rat reproduction study, but the concern is low
since:
a. The effects in pups are well-characterized with a clear NOAEL;
b. The pup effects occur at the same dose as maternal toxicity;
and,
c. The doses selected for various risk assessment scenarios are
lower than the doses that caused off spring toxicity.
Therefore, there are no residual uncertainties for pre-/post-natal
toxicity in this study.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
i. The toxicity database for etoxazole is complete for FQPA
assessment.
ii. There is no indication that etoxazole is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
iii. No quantitative or qualitative evidence of increased
susceptibility was seen following in utero exposure to rats or rabbits
in developmental studies. Although there is qualitative evidence of
increased susceptibility in the rat reproduction study, the Agency did
not identify any residual uncertainties after establishing toxicity
endpoints and traditional UFs to be used in the risk assessment of
etoxazole. The degree of concern for prenatal and/or postnatal toxicity
is low.
iv. There are no residual uncertainties identified in the exposure
databases. The chronic dietary food exposure assessment utilizes EPA-
calculated residues of concern (parent and metabolites) for livestock
commodities; tolerance-level residues for other commodities; and 100%
crop treated (CT) information for all proposed uses. By using these
screening-level assumptions, actual exposures/risks will not be
underestimated. The dietary drinking water assessment utilized modeling
results which included conservative assumptions for the parent and all
degradates of concern. Conservative assumptions were used in the water
models. Therefore, the water exposure assessment will not underestimate
the potential risks for infant and children.
v. There are no registered or proposed residential uses for
etoxazole.
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-term, intermediate-term,
and long-term risks are evaluated by comparing aggregate exposure to
the LOC to ensure that the MOE called for by the product of all
applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment was not performed
because an endpoint of concern attributable to a single oral dose was
not selected for any population subgroup (including infants
[[Page 72962]]
and children). No acute risk is expected from exposure to etoxazole.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to etoxazole
from food and water will utilize 8.3% of the cPAD for children 1-2
years old, the most highly exposed population subgroup. There are no
residential uses for etoxazole that result in chronic residential
exposure to etoxazole. Therefore, EPA does not expect the aggregate
exposure to exceed 100% of the cPAD.
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
Etoxazole is not registered or proposed for use on any sites that
would result in residential exposure. Therefore, the aggregate risk is
the sum of the risk from food and water, which do not exceed the
Agency's LOC.
4. Aggregate cancer risk for U.S. population. A cancer aggregate
risk assessment was not performed because etoxazole is not
carcinogenic. Etoxazole is not expected to pose a cancer risk to
humans.
5. 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 is available to enforce the
tolerance expression.
The following analytical enforcement methods have been validated:
The gas chromatography/mass-selective detector (GC/MSD) method used to
determine etoxazole residues in/on cherry matrices is a slightly
modified version of a previously-validated method (Method RM-37HM). The
validated limit of quantitation (LOQ) was 0.0037 ppm and the limit of
detection (LOD) was 0.0012 ppm for etoxazole in/on cherries. The GC
with nitrogen-phosphorus detector (NPD) method used to determine
etoxazole residues in/on hop matrices is a modified version of a
previously-validated method (Method RM-37). The validated LOQ was 0.2
ppm and the LOD was 0.1 ppm for etoxazole in/on dried hop cones.The
nitrogen-phosphorus specific flame-ionization detector (NPD) method
used to determine etoxazole residues in/on cantaloupe matrices is a
slightly modified version of a previously-validated method (Method RM-
37). The validated LOQ was 0.0046 ppm and the LOD was 0.0015 ppm for
etoxazole in/on cantaloupe.
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Road, Fort Meade, MD
20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no established or proposed Codex, Canadian or Mexican
maximum residue limits (MRLs) for etoxazole.
Therefore, tolerances are established for residues of the
insecticide etoxazole, 2-(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-
2-ethoxyphenyl]-4,5-dihydrooxazole, in or on cherry at 1.0 ppm, hop,
dried cones at 7.0 ppm, and vegetable, cucurbit subgroup 9A at 0.20
ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA 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 rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. 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 6, 2000) do not apply to this rule. In addition, This
rule does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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: December 14, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
[[Page 72963]]
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. Section 180.593 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:
Sec. 180.593 Etoxazole; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Cherry............................................... 1.0
* * * * *
Hop, dried cones..................................... 7.0
* * * * *
Vegetable, cucurbit subgroup 9A...................... 0.20
------------------------------------------------------------------------
* * * * *
[FR Doc. E7-24983 Filed 12-21-07; 8:45 am]
BILLING CODE 6560-50-S