[Federal Register Volume 78, Number 229 (Wednesday, November 27, 2013)]
[Rules and Regulations]
[Pages 70870-70877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28517]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0905; FRL-9902-39]
Etofenprox; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
etofenprox in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective November 27, 2013. Objections and
requests for hearings must be received on or before January 27, 2014,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0905, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0905 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
January 27, 2014. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2011-0905, by one of
the following methods:
Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
[[Page 70871]]
II. Summary of Petitioned-For Tolerance
In the Federal Register of December 8, 2011 (76 FR 76674) (FRL-
9328-8), 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
1E7925) by Interregional Research Project No. 4 (IR-4), 500 College
Road East, Suite 201 W, Princeton, NJ 08540. The petition requested
that 40 CFR 180.620 be amended by establishing tolerances for residues
of the insecticide etofenprox, [2-(4-ethoxyphenyl)-2-methylpropyl 3-
phenoxybenzyl ether], in or on food and feed commodities at 0.5 parts
per million (ppm). That document referenced a summary of the petition
prepared by Mitsui, the registrant, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
Currently there are two products that contain etofenprox registered
for mosquito control. However, the existing registrations do not allow
treatments on or over agricultural areas. IR-4 submitted this petition
to establish tolerances for residues of etofenprox in or on food and
feed commodities so that the registration can be modified to allow
repeated applications (aerial and ground) over agricultural crops,
pasture and rangeland.
Based upon review of the data supporting the petition, EPA has
modified the level at which tolerances are being established. The
reason for this change is 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 etofenprox including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with etofenprox 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.
In mammals, the major targets of etofenprox are the liver, thyroid,
kidney, and hematopoietic system. Results from subchronic and chronic
feeding studies in rats indicate that males may be more sensitive to
treatment-related effects of etofenprox than females. All subchronic
and chronic toxicity including carcinogenicity studies showed adverse
effects (organ weights, histopathology, biochemistry, hematology, and
clinical chemistry) in two or more of the target organs/systems.
Additionally, decreases in body weights and food consumption were
observed in most of the studies.
In a mouse carcinogenicity study, the kidney was the most sensitive
target organ, especially in males, and many deaths were attributed to
renal lesions. Males showed a positive trend in renal cortical adenomas
alone and in combined carcinomas and adenomas; however, tumor incidence
was within the historical control range. Other effects included
decreased body and thymus gland weights, and increased liver, spleen,
and pituitary gland weights. Microscopic changes included centrilobular
hepatocyte enlargement.
Relevant toxicity studies showed no quantitative or qualitative
evidence of increased susceptibility in offspring. A prenatal
developmental toxicity study in rabbits showed no quantitative or
qualitative evidence of increased susceptibility in offspring, in that
the developmental effects were seen at doses that resulted in maternal
toxicity, including death. There was no indication of increased
susceptibility of offspring in the 1-generation/developmental study in
rats. In the developmental portion of the study, effects were seen in
maternal animals, while no effects were observed in the offspring. In
the 2-generation reproductive toxicity study in rats, there was also no
evidence of increased susceptibility of offspring.
Although etofenprox exposure does result in some neurotoxic
effects, these effects only occur at high doses. An acute neurotoxicity
study in the adult rat revealed no treatment-related effects. The
subchronic neurotoxicity study in the rat showed decreased body weight
gains, increased liver weights in all dose groups, and increased
incidence of rearing behavior in males and abnormal gait in females.
The developmental neurotoxicity study in rats showed increased rearing
behavior in mothers at the highest dose tested (HDT). In offspring, eye
abnormalities were observed at the high-dose level and effects on
motor/locomotor activity and auditory startle response observed at the
high-dose level.
The immunotoxicity studies in the rat and mouse were both negative
for immunotoxicity.
The cancer classification for etofenprox is ``Not likely to be
carcinogenic to humans at doses that do not alter rat thyroid hormone
homeostasis.'' This decision was based on the following considerations:
i. Treatment-related thyroid follicular cell tumors were seen in
both male and female rats at a dose level considered to be adequate,
and not excessive, to assess carcinogenicity;
ii. No treatment-related tumors were seen in male or female mice
when tested at a dose that was considered adequate to assess
carcinogenicity;
iii. There is no mutagenicity concern for etofenprox based in vivo
or in vitro assays;
iv. The non-neoplastic toxicological evidence (i.e., thyroid growth
and thyroid hormonal changes) indicates that etofenprox disrupts the
thyroid-pituitary hormonal status; and
v. Rats are substantially more sensitive than humans to the
development of thyroid follicular cell tumors in response to thyroid
hormone imbalance. The overall weight-of-the-evidence was considered
sufficient to indicate that etofenprox induced thyroid follicular
tumors through an antithyroid mode of action.
Specific information on the studies received and the nature of the
adverse effects caused by etofenprox 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 http://www.regulations.gov in the document
[[Page 70872]]
titled ``Etofenprox: Section 3 Aggregate Human Health Risk Assessment
for a Label Amendment to Remove Application Restriction Over Crop,
Range, and Pasture land,'' pp. 36-41 docket ID number EPA-HQ-OPP-2011-
0905.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for etofenprox used for
human risk assessment is shown in the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Etofenprox for Use in Human Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (All populations).. No adverse effects attributable to a single dose were observed in oral
toxicity studies, including developmental toxicity studies in rats and
rabbits. Therefore, an acute reference dose was not established.
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Chronic dietary (All populations) NOAEL = 3.7 mg/kg/ cRfD = 0.037 mg/kg/ Combined Chronic Toxicity/
day. day. Carcinogenicity Study in Rat.
UFA = 10x........... cPAD = 0.037 mg/kg/ LOAEL = 25.5 mg/kg/day based on
UFH = 10x........... day. increased thyroid weights.
FQPA SF = 1x........ Related to increased liver
weights and histopathology
changes in liver and thyroid that
occurred at the higher dose.
Incidental oral short- and NOAEL = 20 mg/kg/day LOC for MOE = 100.. Subchronic Oral Toxicity in Rat.
intermediate-term (1 to 30 days UFA = 10x........... LOAEL = 120 mg/kg/day based on
and 1 to 6 months). UFH = 10x........... decreased body weight gain,
FQPA SF = 1x........ increased liver and thyroid
weights with corresponding
histopathology, changes in
hematology and clinical
chemistry.
Incidental oral long-term (> 6 NOAEL = 3.7 mg/kg/ LOC for MOE = 100.. Combined Chronic Toxicity/
months). day. Carcinogenicity Study in Rat.
UFA = 10x........... LOAEL = 25.5 mg/kg/day based on
UFH = 10x........... increased thyroid weights.
FQPA SF = 1x........ Related to increased liver
weights and histopathology
changes in liver and thyroid that
occurred at the higher dose.
Inhalation short- and Inhalation study.... LOC for MOE = 100.. 13-Week Inhalation Toxicity in
intermediate-term (1 to 30 days NOAEL = 10.6 mg/kg/ Rat.
and 1 to 6 months). day.. LOAEL = 52.3 mg/kg/day based on
UFA = 10x........... organ weight changes and
UFH = 10x........... histopathological changes in
FQPA SF = 1x........ liver, adrenals and thyroid.
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Cancer (Oral, dermal, inhalation) Classification: ``Not likely to be carcinogenic to humans at doses that do
not alter rat thyroid hormone homeostasis.''
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to etofenprox, EPA considered exposure under the petitioned-
for tolerances as well as all existing etofenprox tolerances in 40 CFR
180.620. EPA assessed dietary exposures from etofenprox 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 etofenprox; 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 U.S. Department
of Agriculture's (USDA's) National Health and Nutrition Examination
Survey, What We Eat in America (NHANES/WWEIA). The assessment assumed
tolerance level residues for all commodities, incorporated estimated
percent crop treated (PCT) values, and used the Dietary Exposure
Evaluation Model Food Commodity Intake Database (DEEM-FCID) default
processing factors. The submitted crop field trial data were conducted
at a rate (0.07 lb ai/A) 10X greater than the proposed application rate
of at 0.007 lb ai/A per site for mosquito control. The number and
locations of field trials were in accordance with the initial
[[Page 70873]]
recommendations put forth by the EPA. EPA recommended field trials be
conducted at the 1x and 10x rates and indicated that if there were
residues detected in the samples collected above the limit of
quantification (LOQ) at both 1x and 10x rates, then a tolerance would
be required at the level observed at the 1x rate. However, the
available crop field trial data do not reflect the number of
applications proposed or the use of ground application equipment.
Therefore, the Agency considered an analysis submitted by IR-4 of
different modeled runs to estimate the residues resulting from multiple
aerial applications using the Terrestrial Residue Exposure (TREX) model
following repeated ultra low volume (ULV) applications to estimate an
upper bound tolerance value. The EPA also evaluated the proposed
multiple application scenarios using AGricultural DISPersal (AGDISP)
8.25 and assumed the same application parameters (e.g., drop size
distribution, application material, and application height) as
considered in the TREX analysis. A deposition rate of 33% was assumed
for aerial and ground ULV applications, which corresponds to a residue
value of 4.8 ppm (to represent the worst case) with a wind speed of 1
mph. These analysis result in estimated an upper bound value of 4.77
ppm for ground and aerial applications. Therefore, the EPA determined
that a tolerance of 5 ppm, which is based on conservative assumptions,
is adequate to cover the expected residues. The proposed tolerance of 5
ppm on food and feed commodities significantly increases the dietary
burdens of etofenprox in livestock and necessitates establishing
tolerances on livestock commodities.
Specific information on the TREX and AGDISP analyses can be found
at http://www.regulations.gov in the document titled ``Spray Drift
Analysis for the Etofenprox Label Amendment (Petition No. 1E7925)''
docket ID number EPA-HQ-OPP-2011-0905.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that etofenprox does not pose a cancer risk to humans at
doses that do not alter rat thyroid hormone homeostasis. Because the
cPAD is protective of etofenprox's effect on thyroid hormones and
dietary exposure to etofenprox for the purpose of assessing cancer risk
would be the same or lower than dietary exposure relevant to other
chronic endpoints, a dietary exposure assessment for the purpose of
assessing cancer risk is unnecessary.
iv. Anticipated residue and PCT information. Section 408(b)(2)(F)
of FFDCA states that the Agency may use data on the actual percent of
food treated for assessing chronic dietary risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
The Agency estimated the PCT for proposed uses of etofenprox as a
mosquito adulticide which may result in residues on food and feed
commodities. The PCT estimates are for 35 agricultural crops which may
be exposed to mosquito adulticide applications of etofenprox. The
agricultural crops included in the analysis are apples, pears, oranges,
rice, field com, wheat, and 29 crops grown predominantly in California.
The EPA relied on national and state level usage data for the most
widely used mosquito insecticides to develop percent crop treated
estimates for new uses. The general approach to estimating PCT was to
assume that all etofenprox mosquito adulticide applications will be
made randomly across the landscape without regard to land use patterns.
Except for area wide vector control programs, this approach is highly
conservative in that mosquito adulticide applications are generally
made to populated urban and suburban areas. However, because of the
inherent drift of mosquito adulticides into non-target areas, it is
realistic to assume that some residues of etofenprox may be found on
agricultural crops in the urban-agricultural interface. Using this
approach, PCT estimates including residues on rice, which is a
registered use, are as follows:
Apples: 1%; almonds: 5%; apricots: 5%; artichokes: 5%; avocados:
5%; broccoli: 5%; Brussels sprouts: 5%; carrots: 5%; cauliflower: 5%;
celery: 5%; chicory: 5%; dates: 5%; field corn: 1%; figs: 5%; garlic:
5%; grapes: 5%; honeydew melon: 5%; kiwifruit: 5%; lemons: 5%;
nectarines: 5%; olives: 5%; oranges: 15%; pears: 1%; persimmons: 5%;
pistachios: 5%; plums: 5%; pluots: 5%; pomegranates: 5%; prunes: 5%;
raisins: 5%; rice: 3%; tomatoes: 5%; walnuts: 5%; wheat: 1%; all other
crops: (including livestock commodities, milk, and eggs) 3%.
The Agency used the market leader approach to develop upper bound
percent crop treated estimates for this new use. Under the market
leader approach, this upper bound is estimated as the percent of the
crop treated by the most widely used pesticide for the new use. The
EPA's usual application of the market leader approach for deriving PCT
traditionally focuses on broad categories of pesticides (e.g.,
insecticides, fungicides, or herbicides) applied directly to crops for
control of agricultural pests. In this case, however, EPA determined
that this would not be appropriate because mosquito adulticides fill a
unique niche in the pesticide marketplace. The amount of general
insecticide use on crops has no rational relationship to the amount of
mosquito adulticide use. Instead of using the insecticides applied
directly on these crops, EPA chose the most widely used mosquito
adulticide in the states/regions that the crop is grown in. For
occasional area wide vector control programs for West Nile Virus (WNV)
or Vector-borne encephalitis (Western Equine Encephalitis, Eastern
Equine Encephalitis, or St. Louis Encephalitis) this approach provides
an accurate estimate of the PCT for agricultural crops.
These estimates represent the upper bound of use expected during
the pesticide's initial five years of registration; that is, PCT for
etofenprox is a threshold of use that EPA is reasonably certain will
not be exceeded
[[Page 70874]]
for each registered use site. The PCT recommended for use in the
chronic dietary assessment is calculated as the average PCT of the
market leader or leaders, (i.e., the one(s) with the greatest PCT) on
that site over the three most recent years of available data. The
comparisons are only made among pesticides of the same pesticide type
(e.g., the market leader for insecticides on the use site is selected
for comparison with a new insecticide). The market leader included in
the estimation may not be the same for each year since different
pesticides may dominate at different times. Typically, EPA uses USDA
National Agricultural Statistics Service (NASS) as the source of data
because it is publicly available and directly reports values for PCT.
When a specific use site is not reported by USDA/NASS, EPA uses
proprietary data and calculates the PCT given reported data on acres
treated and acres grown. If no data are available, EPA may extrapolate
PCT from other crops (proxies), if the crop management and pest
spectrum are substantially similar. A retrospective analysis to
validate this approach shows few cases where the PCT for the market
leaders were exceeded. Further review of these cases identified factors
contributing to the exceptionally high use of a new pesticide. Given
the results of this review, to evaluate whether the PCT for etofenprox
could be exceeded, EPA considered whether there may be unusually high
mosquito pressure or disease transmission potential; whether the market
leaders are well established for that use; and whether pest resistance
issues with past market leaders provide etofenprox with significant
market potential. Given currently available information, EPA concludes
it is unlikely that actual PCT for etofenprox will exceed the estimated
PCT for new uses during the next five years.
Specific information on the methodology to estimate PCT can be
found at http://www.regulations.gov in the document titled ``BEAD
Estimate of the Percent Crop Treated for New Use (PCTn) of Etofenprox
when used as a Mosquito Adulticide in Agricultural Areas'' docket ID
number EPA-HQ-OPP-2011-0905.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which etofenprox may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for etofenprox in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of etofenprox. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Tier 1 Rice Model and Screening Concentration in
Ground Water (SCI-GROW) models, the estimated drinking water
concentrations (EDWCs) of etofenprox for chronic exposures are
estimated to be 1.2 ppb for surface water and 3.0 x 10-3 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 1.2 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). Etofenprox is
currently registered for the following uses that could result in
residential exposures: Cat and dog spot-on treatments, as a bed bug
treatment, as indoor space and crack and crevice sprays, and as indoor
and outdoor foggers. EPA assessed residential exposure using the
following assumptions: Adults can potentially be exposed to etofenprox
residues during residential application of etofenprox, including indoor
surface-directed and aerosol space spray and outdoor fogger use.
Handler exposure is expected to be short-term in duration and because
there was no adverse dermal effect identified for etofenprox, risk was
assessed only for exposure via the inhalation route. There is also
potential for post-application exposure for individuals as a result of
being in an environment that has been previously treated with
etofenprox. Because of the registered indoor uses, intermediate-term
post application exposures are possible. However, since the short- and
intermediate-term endpoints and PODs for inhalation and oral routes are
the same, the short-term exposure and risk estimates are considered to
be protective of potential intermediate-term exposure and risk. Because
adverse dermal toxicity effects were not identified for etofenprox,
only short- and intermediate-term post-application inhalation exposures
were assessed for adults and short- and intermediate-term post-
application inhalation and incidental oral exposures were assessed for
children. Additionally, long-term post-application incidental oral
exposure to children from petting treated cats or dogs was also
assessed.
The worst-case residential short-term exposure for adults is from
post-application inhalation exposure from treatment of flying insects.
The worst-case residential short-term exposure for children 1 to 2
years old is from combined inhalation and oral hand-to-mouth post-
application exposures from treatment of flying insects. EPA typically
combines exposures for treatments to control the same pests (e.g. flea
treatment on surfaces and on pets) because such treatments could
reasonably be expected to occur on the same day. But a similar
presumption is not generally followed for exposures for treatments to
control different pests. For etofenprox, EPA has not combined short-
term exposures from use of etofenprox to control flying insects and its
use to control fleas, ticks, and bed bugs. Several factors support this
approach for etofenprox. First, EPA's manner of estimating short-term
residential exposures is very conservative. When assessing individual
short-term residential post-application exposure scenarios, EPA assumes
exposure occurs at the level of zero-day residues (i.e., day of
application residues) on each day of the short-term exposure period (1-
30 days), instead of incorporating information on residue decline
values. EPA also assumes that an individual performs the same post-
application activities, intended to represent high-end exposures as
described in the Residential SOPs, for
[[Page 70875]]
the same amount of time every day over the short-term exposure period,
rather than averaging post-application activity levels and exposures
over that period. Second, these exposure estimates are then compared to
points of departure that are typically based on weeks of dosing in test
animals. Longer exposure periods generally produce lower points of
departure. For etofenprox, the short-term risk assessment is
particularly conservative because the point of departure for the short-
term (1 to 30-days) risk assessment is based on a toxicity study
involving continuous exposure over 90 days. Third, usage survey data
indicate that concurrent use of separate pesticide products that
contain the same active ingredient to treat the same or different pests
does not typically occur. Combining conservative exposure estimates
with a conservative point of departure for an event that is itself
improbable (co-occurrence of use of the same pesticide to control
different pests) would unrealistically overstate exposure.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
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 etofenprox. Although
etofenprox shares some structural characteristics with synthetic
pyrethroids, it is not included in the pyrethroid cumulative
assessment. Naturally occurring pyrethrins and the synthetic
pyrethroids (collectively called `pyrethroids') are grouped for
purposes of cumulative risk assessed based on the following shared
characteristics:
i. Common structure. Pyrethrins and pyrethroids share a common
structure; acid and alcohol moieties joined through an ether linkage;
ii. Sodium channel disruption. In vitro studies demonstrate the
ability of pyrethroids to modify mammalian sodium channel kinetics,
leading to alterations in membrane excitability and firing potentials;
iii. Neurotoxic effects. Pyrethroid toxicity is manifested through
neurological syndromes described as either T (fine tremors), CS
(choreoathetosis and salivation), or some combination thereof,
depending on the structure. Open literature supports a correlation
between the modification in sodium channel kinetics and the resulting
syndrome.
Etofenprox is not included in the pyrethroid common mechanism
grouping or included in the cumulative risk assessment because
etofenprox does not exhibit these key characteristics. Etofenprox is an
ether compound; pyrethroids are esters. Etofenprox exposure does not
result in the neurotoxic syndromes typical of pyrethroids and no
available data suggest the molecular target for etofenprox is the
sodium channel.
For the purposes of this tolerance action, therefore, EPA has not
assumed that etofenprox has a common mechanism of toxicity with other
pyrethroids. 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 the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's Web site at http://www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. There is no indication of
increased quantitative or qualitative susceptibility of the developing
offspring in toxicology database for etofenprox. Developmental effects
were seen at doses that caused maternal toxicity. No developmental
effects were seen in the rat 1-generation/developmental study. In the
2-generation reproduction toxicity study, toxicity in the offspring
occurred at the level of parental toxicity (increased organs weights
and associated pathological changes occurred in both the pups and
parents). In the developmental neurotoxicity study in rats, the
observed eye abnormalities associated with body injuries could not be
disassociated from possible altered, treatment-related maternal
behavior.
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 etofenprox is complete.
ii. An acute neurotoxicity study in the adult rat revealed no
treatment-related effects. The subchronic neurotoxicity study in the
rat showed decreased body weight gains, increased liver weights in all
dose groups, and increased incidence of rearing behavior and abnormal
gait, all in the absence of histopathological changes. The
developmental neurotoxicity study in rats showed increased rearing
behavior in mothers. In offspring, eye lesions (including sclera and
lens hemorrhage), which are sometimes associated with aggressive
maternal behavior, were observed prior to weaning at the highest dose
tested. Effects on motor/locomotor activity and auditory startle
response were also observed in the high-dose treatment groups on PND
58. These latter isolated, post-ontogenic effects of treatment are not
presumed to occur following a single dose.
Evidence of neurotoxicity was also observed in other studies. In a
subchronic mouse study piloerection, hunched posture, lethargy, body
tremors, and an unsteady gait were noted in both sexes above the limit
dose. The rat developmental study showed increased salivation in all
treatment groups of the F0 generation and decreased (non-
statistically significant) mobility (both sexes) and rearing behavior
(males) in the F1 generation. In the 2-generation
reproduction study F1 pups exhibited clinical signs of body
tremors, lethargy, unsteady gait, and abnormal movements during most of
the lactation period at the high dose.
However, residual concern for neurotoxicity is low based on the
following:
a. Signs of neurotoxicity in the database occur only at the high
dose level in each study;
b. The studies show clear and well-defined NOAELs;
[[Page 70876]]
c. The signs of neurotoxicity are well-characterized in terms of
their effects in offspring; and
d. The PODs used for risk assessment are protective of
neurotoxicity seen in the database.
No systemic toxicity was observed in the 28-day dermal study in
rabbits up to 1,000 mg/kg/day. In this study, clinical signs were
evaluated and signs such as piloerection, hunched posture, lethargy,
body tremors, an unsteady gait and salivation, seen in the oral
repeated dose studies discussed in this unit, were not observed. With
neurotoxic signs occurring only at high doses in the oral studies and a
dermal absorption factor (DAF) of 7% for etofenprox, neurotoxic
manifestations via the dermal route are not expected below the limit
dose. Therefore, concern for neurotoxicity following dermal exposure is
low.
iii. As discussed in this unit, there is no indication of increased
quantitative or qualitative susceptibility of the developing offspring
in the toxicology database for etofenprox.
iv. There are no residual uncertainties identified in the exposure
databases. The chronic dietary exposure assessment utilizes tolerance
residue levels for all commodities based on conservative modeled
estimates. The residue level of 5 ppm is considered an upper bound
estimate for both ground and aerial applications that assume the
conservative deposition onto surrounding crops following a ULV mosquito
adulticide application. The dietary assessment also assumes
conservative, upper-bound PCT estimates for the proposed uses. By using
these screening level assessments, actual exposures/risks are not
expected to be underestimated. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to etofenprox in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
etofenprox.
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,
etofenprox 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
etofenprox from food and water will utilize 32% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure.
There is potential chronic/long-term exposure to etofenprox via
dietary (which is considered background exposure) and residential
(which is considered primary) exposure pathways for children 1 to < 2
years old. Chronic/long-term exposure to etofenprox for adults is
expected via the dietary (background exposure) and residential
(primary) exposure pathways; however, there is no dermal hazard
identified for etofenprox, incidental oral exposure is not expected for
adults, and inhalation exposure is not expected for adults from
treating pets; therefore, chronic/long-term risk is best represented by
the risk from dietary exposure described in this unit.
The aggregate long-term MOE for children 1 to < 2 years old,
including dietary exposure (food and water) and incidental oral
exposures from contact with treated pets is 180. Because EPA's level of
concern for etofenprox is a MOE of 100 or below, this MOE is not of
concern.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Etofenprox is currently
registered for uses that could result in short- and intermediate-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short- and intermediate-term residential exposures to etofenprox.
As noted in Unit III.C.3., because the short- and intermediate-term
endpoints and PODs for inhalation and oral routes are the same, the
short-term exposure and risk estimates are considered to be protective
of potential intermediate-term exposure and risk.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 420 for children
1- < 2 years old, and 1,700 for adults. Because EPA's level of concern
for etofenprox is a MOE of 100 or below, these MOEs are not of concern.
4. Aggregate cancer risk for U.S. population. Based on the data
summarized in Units III.A. and III.C.1.iii., EPA has concluded that
etofenprox does not 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 etofenprox residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
For crop commodities, adequate enforcement methodology (liquid
chromatography/mass spectrometry/mass spectrometry (LC/MS/MS)) is
available to enforce the tolerance expression. For livestock
commodities, adequate enforcement methodology (gas chromatography/mass
spectrometry (GC/MS)) is available to enforce the tolerance expression.
The methods 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:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
[[Page 70877]]
Codex has established etofenprox MRLs on several crop and livestock
commodities at levels that range from 0.01-8.0 ppm. These MRLs are
different than the tolerances established for etofenprox in the United
States. Codex and U.S. MRLs/tolerances could not be harmonized due to
differences in the use pattern used to derive the tolerances. Codex
MRLs were based on field trial data from foliar and granular use of
etofenprox to kill crop pests in agricultural fields whereas the U.S.
tolerances were based on aerial application over crops to kill
mosquitoes. Different application amounts, frequencies, and techniques
are used for these different use patterns and thus harmonization with
Codex cannot be achieved.
C. Revisions to Petitioned-For Tolerances
The proposed tolerance at 0.5 ppm was estimated using limited field
trial data. These data were determined to be insufficient to support
the proposed use pattern. Subsequently, the applicant submitted
modeling results using the Terrestrial Residue Exposure Model (TREX)
which estimated residues following repeated ULV applications and
concluded residues were likely to peak at 1.5 ppm following repeated
aerial applications to agricultural crops. EPA estimated an upper-bound
crop residue estimate of 5.0 ppm following repeated ULV aerial and
ground applications. In addition, based on the Agency review, it was
determined that tolerances were required on livestock commodities as
well.
V. Conclusion
Therefore, tolerances are established for residues of etofenprox,
[2-(4-ethoxyphenyl)-2-methylpropyl 3-phenoxybenzyl ether], in or on
food commodities at 5.0 ppm; feed commodities at 5.0 ppm; eggs at 0.40
ppm; hog fat at 4.0 ppm; hog meat at 0.20 ppm; hog, meat byproducts at
4.0 ppm; fat of cattle, goat, horse, and sheep at 10.0 ppm; meat of
cattle, goat, horse, and sheep at 0.40 ppm; meat byproducts of cattle,
goat, horse, and sheep at 10.0 ppm; milk at 0.60 ppm; poultry, fat at
1.0 ppm; poultry, meat at 0.01 ppm; and poultry, meat byproducts at 1.0
ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 13, 2013.
G. Jeffrey Herndon,
Acting 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. 180.620, revise the table in paragraph (a) to read as
follows:
Sec. 180.620 Etofenprox; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat............................................... 10.0
Cattle, meat.............................................. 0.40
Cattle, meat byproducts................................... 10.0
Egg....................................................... 0.40
All food commodities (including feed commodities) not 5.0
otherwise listed in this subsection......................
Goat, fat................................................. 10.0
Goat, meat................................................ 0.40
Goat, meat byproducts..................................... 10.0
Hog, fat.................................................. 4.0
Hog, meat................................................. 0.20
Hog, meat byproducts...................................... 4.0
Horse, fat................................................ 10.0
Horse, meat............................................... 0.40
Horse, meat byproducts.................................... 10.0
Milk...................................................... 0.60
Poultry, fat.............................................. 1.0
Poultry, meat............................................. 0.01
Poultry, meat byproducts.................................. 1.0
Rice, grain............................................... 0.01
Sheep, fat................................................ 10.0
Sheep, meat............................................... 0.40
Sheep, meat byproducts.................................... 10.0
------------------------------------------------------------------------
* * * * *
[FR Doc. 2013-28517 Filed 11-26-13; 8:45 am]
BILLING CODE 6560-50-P