[Federal Register Volume 78, Number 25 (Wednesday, February 6, 2013)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02692]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Thiacloprid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
thiacloprid in or on pepper; cherry subgroup 12-12A; peach subgroup 12-
12B; and plum subgroup 12-12C. Interregional Research Project Number 4
(IR-4) requested the stone fruit tolerance and Bayer CropScience
requested the pepper tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective February 6, 2013. Objections and
requests for hearings must be received on or before April 8, 2013, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2010-0311, 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: Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 308-9367; email address: email@example.com.
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-2010-0311 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
April 8, 2013. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2010-0311, 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
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.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-for Tolerance
In the Federal Register of June 8, 2010 (75 FR 32463) (FRL-8827-5),
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of pesticide petitions by IR-4, 681
US Highway 1 South, North Brunswick, NJ 08902 (PP0E7704) and
Bayer CropScience LLC, 2 T. W. Alexander Drive, Research Triangle Park,
NC 27709 (PP0F7706). The petitions requested that 40 CFR 180.594 be
amended by establishing tolerances for residues of the insecticide
thiazolidinylidene]cyanamide), in or on fruit, stone, group 12 at 0.5
parts per million (ppm) (PP0E7704) and pepper (bell and non-bell) at
1.1 ppm (PP0F7706). Bayer, in its petition (PP0F7706) also proposed to
amend 40 CFR 180.594 for residues of thiacloprid by revising the
tolerance expression under paragraph (a) to read: Tolerances are
established for residues of thiacloprid, including its metabolites and
degradates. Compliance with the tolerance levels specified is to be
determined by measuring only thiacloprid ([3-[(6-chloro-3-
pyridinyl)methyl]-2-thiazolidinylidene] cyanamide). That document
referenced a summary of the petition prepared by Bayer CropScience, the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
modified the levels at which the tolerances are being established as
well as some of the nomenclature. The reason for these changes 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 thiacloprid including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with thiacloprid 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
In mammalian systems, the liver appears to be the primary target
organ of thiacloprid with some relatively minor effects in the thyroid.
Liver effects (enzyme changes, hypertrophy, and histopathology) were
noted in the 90-day dog, 2-generation reproduction, 2-year rat, 2-year
mouse, and subchronic dermal and inhalation studies. Thyroid effects
(hormone levels, weights, follicular cell hypertrophy) were noted in
dog, rat, and mouse studies. Increased prostate weight and prostatic
hypertrophy were observed in the 90-day dog study, but not in the 1-
year dog study. Clinical signs were also noted in dermal (reduced
motility, decreased activity, and spastic gait) and 5-day inhalation
studies (respiratory effects, signs of ill health, piloerection,
reduced mobility, tremors, and increased grip strength).
There was no increase in either qualitative or quantitative
susceptibility of fetal animals or pups in the rabbit developmental or
the 2-generation rat reproduction studies. In the rabbit developmental
study, decreased fetal weights were observed in the presence of
maternal toxicity (body weight changes and decreased food consumption
and fecal output). In the reproduction study in rats, decreased body
weights were seen in pups at the same dose which resulted in thyroid
and liver effects in maternal animals.
In the rat developmental toxicity study, there was evidence of
increased qualitative susceptibility. Increased resorptions; skeletal
retardations and variations; dysplastic humerus, radius and scapulae;
and decreased fetal weights were seen in fetuses at the same dose
resulting in less severe maternal effects (decreased body weight, body
weight gain and food consumption, increased urination, and changes in
water consumption). In the developmental neurotoxicity study, increased
qualitative susceptibility was also seen: Decreased body weights in
both sexes as well as altered performance in passive avoidance testing
were seen in offspring animals, while deceased body weight gain and
food consumption were seen in maternal animals. However, there is a low
degree of concern and no residual uncertainties for the increase in
qualitative susceptibility since there are well-characterized dose
responses with clear NOAELs and LOAELs in the studies. Additionally,
the endpoints and PODs selected for risk assessment are protective of
potential developmental effects.
Thiacloprid affects nerve function through inhibition of nicotinic
acetylcholine receptors. In the neurotoxicity studies in rats, there
was a reduction in motor and locomotor activity, slight tremors and
ptosis of the eyelids, decreased hind limb grip strength, altered
performance in passive avoidance testing, and altered brain
morphometrics. Increased grip strength was also noted in a 5-day
inhalation toxicity study. There were no indications of neurotoxicity
in the remainder of the submitted toxicity studies.
A battery of genetic toxicity tests did not indicate a mutagenicity
or clastogenicity concern. Thiacloprid is classified as ``Likely to be
Carcinogenic to Humans'' based on increased uterine tumors in rats,
thyroid follicular adenomas in rat and ovarian tumors in mice. A cancer
slope factor of 4.06 x 10-2 milligrams/kilogram/day (mg/kg/
day)-1 was calculated based on the incidence of combined
uterine tumors in female rats.
Specific information on the studies received and the nature of the
adverse effects caused by thiacloprid 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 on pages 29-34 of the document titled
``Thiacloprid--Human Health Risk Assessment of New Uses on Stone Fruit
and Peppers'' in docket ID number EPA-HQ-OPP-2010-0311.
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 thiacloprid used for
human risk assessment is shown in the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Thiacloprid for Use in Human Health Risk Assessment
Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
Acute dietary (All Populations).... NOAEL = 4.4 mg/kg/day. Acute RfD = 0.044 mg/ Co-Critical Studies
UFA = 10x............. kg/day. Developmental
UFH = 10x............. aPAD = 0.044 mg/kg/day Neurotoxicity Study--rat
FQPA SF = 1x.......... LOAEL = 25.6 mg/kg bw
based on offspring effects
of altered performance in
passive avoidance testing.
Acute Neurotoxicity Study--
rat LOAEL = 22 mg/kg bw
based on a reduction of
motor and locomotor
activity in females (NOAEL
= 3.1 mg/kg bw).
Chronic dietary (All populations).. NOAEL = 1.2 mg/kg/day. Chronic RfD = 0.012 mg/ Chronic/Carcinogenicity
UFA = 10x............. kg/day. Study--rat LOAEL = 2.5/3.3
UFH = 10x............. cPAD = 0.012 mg/kg/day (M/F) mg/kg bw based on
FQPA SF = 1x.......... liver hypertrophy and
cytoplasmic changes as
well as induction of
epithelial hypertrophy in
males and retinal
degeneration in females.
Cancer (Oral, dermal, inhalation).. ``Likely to be Carcinogenic to Humans'' based on thyroid tumors in male
rats, uterine tumors in rats and ovarian tumors in mice. Cancer slope
factor = 4.06x10-2 (mg/kg/day)-1
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
milligrams/kilogram/day. 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 thiacloprid, EPA considered exposure under the petitioned-
for tolerances as well as all existing thiacloprid tolerances in 40 CFR
180.594. EPA assessed dietary exposures from thiacloprid in food as
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1 day or single exposure.
Such effects were identified for thiacloprid. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA), National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). This
dietary survey was conducted from 2003 to 2008. The acute assessment
was based on tolerance-level residues and 100 percent crop treated
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA. This dietary survey was conducted from 2003 to 2008. The chronic
assessment was based on tolerance-level residues and 100 PCT
iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
If quantitative cancer risk assessment is appropriate, cancer risk may
be quantified using a linear or nonlinear approach. If sufficient
information on the carcinogenic mode of action is available, a
threshold or nonlinear approach is used and a cancer RfD is calculated
based on an earlier noncancer key event. If carcinogenic mode of action
data are not available, or if the mode of action data determines a
mutagenic mode of action, a default linear cancer slope factor approach
is utilized. Based on the data summarized in Unit III.A., EPA has
concluded that thiacloprid should be classified as ``Likely to be
Carcinogenic to Humans'' and a linear approach has been used to
quantify cancer risk.
The cancer analysis is partially refined, using average residue
field trial data, and estimated PCT data for existing and proposed new
uses as appropriate.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such Data Call-Ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition A: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition B: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition C: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
In the cancer risk assessment, the Agency estimated the PCT for
existing uses as follows: Apples, 10%; pears, 5%.
In most cases, EPA uses available data from USDA/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%.
In the cancer risk assessment, the Agency estimated the PCT for new
uses as follows: Peaches, 43%; peppers, 45%.
EPA estimates of the PCT for new uses of thiacloprid represent the
upper bound of use expected during the pesticide's initial 5 years of
registration; that is, PCT for new uses for thiacloprid is a threshold
of use that EPA is reasonably certain will not be exceeded for each
registered use site. The PCT for new uses 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 PCT
for new uses recommended for use in the acute dietary assessment is the
maximum observed PCT over the same period. Comparisons are only made
among pesticides of the same pesticide types (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
Typically, EPA uses USDA/NASS as the source 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 for new uses
from other crops, if the production area and pest spectrum are
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. To evaluate whether the PCT for new uses for
thiacloprid could be exceeded, EPA considered whether there may be
unusually high pest pressure, as indicated in emergency exemption
requests for thiacloprid; the pest spectrum of the new pesticide in
comparison with the market leaders and whether the market leaders are
well established for that use; and whether pest resistance issues with
past market leaders provide thiacloprid with significant market
potential. Given currently available information, EPA concludes that it
is unlikely that actual PCT for thiacloprid will exceed the estimated
PCT for new uses during the next 5 years.
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 thiacloprid 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 thiacloprid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of thiacloprid. The drinking water estimates were also
refined to account for both percent cropped area and for the impact of
drinking water treatment processes. 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 Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
thiacloprid for acute exposures are estimated to be 18 parts per
billion (ppb) for surface water and 0.25 ppb for ground water, for
chronic exposures for non-cancer assessments are estimated to be 2.3
ppb for surface water and 0.25 ppb for ground water, and for chronic
exposures for cancer assessments are estimated to be 1.2 ppb for
surface water and <0.25 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, the water concentration value of 18 ppb was used to assess
the contribution to drinking water. For the chronic dietary risk
assessment, the water concentration of value 2.3 ppb was used to assess
the contribution to drinking water. For the cancer 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).
Thiacloprid is not registered for any specific use patterns that
would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found thiacloprid to share a common mechanism of
toxicity with any other substances, and thiacloprid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
thiacloprid does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at 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
2. Prenatal and postnatal sensitivity. There was no increase in
either qualitative or quantitative susceptibility of fetal animals or
pups in the rabbit developmental or the 2-generation rat reproduction
studies. In the rabbit developmental study, decreased fetal weights
were observed in the presence of maternal toxicity (body weight changes
and decreased food consumption and fecal output). In the reproduction
study in rats, decreased body weights were seen in pups at the same
dose which resulted in thyroid and liver effects in maternal animals.
In the rat developmental study, there was an increase in
qualitative susceptibility based on an increase in resorptions,
skeletal retardations and variations, dysplastic humerus, radius and
scapulae, as well as decreased fetal weights at the same dose (50 mg/
kg/day) at which less severe maternal effects were noted (decreased
body weight, body weight gain and food consumption, in addition to
increased urination and changes in water consumption). In the
developmental neurotoxicity study, increased qualitative susceptibility
was also seen. Decreased body weights in both sexes as well as altered
performance in passive avoidance testing were seen in offspring
animals, while decreased body weight gain and food consumption were
seen in maternal animals. However, there is a low degree of concern and
no residual uncertainties for the increase in qualitative
susceptibility since there is a well-characterized dose response with
clear NOAELs and LOAELs in the studies. Additionally, the endpoints and
PODs selected for risk assessment are protective of potential
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
i. The toxicology database concerning infants and children is
considered to be complete with the exception of an immunotoxicity
study. Submitted studies included: Developmental rat and rabbit, 2-
generation reproduction in rats as well as acute, subchronic and
developmental neurotoxicity in rats. Although an immunotoxicity study
has not been received by the Agency, there is relatively little concern
as it does not appear that thiacloprid directly targets the immune
system based on available studies. Although there were increases in the
incidence and severity of mesenteric and mandibular lymph node
vacuolization in a cancer study in mice, the effects were seen at very
high doses following long-term treatment. Additionally, thiacloprid
does not belong to a class of chemicals (e.g., the organotins, heavy
metals, halogenated aromatic hydrocarbons) that would be expected to be
immunotoxic. Furthermore, there were no indications of immunotoxicity
in other studies in the toxicology database. The Agency does not
believe that conducting the study will result in a lower POD than that
currently used for overall risk assessment; therefore, a database
uncertainty factor (UFDB) is not needed to account for the
lack of the study.
ii. Acute, subchronic and developmental neurotoxicity studies in
rats are available for thiacloprid. In the acute study, there were
reductions in motor and locomotor activities in females and slight
tremors and ptosis of the eyelids in males. In the subchronic
neurotoxicity study, decreased hind limb grip strength was seen in
males. Increased grip strength was noted in a 5-day inhalation toxicity
study. In the developmental neurotoxicity study, altered performance in
passive avoidance testing and a 4% decrease in the size of the corpus
striatum region of the brain were seen in offspring animals at the
highest dose tested (HDT). No data were received by the Agency
regarding the mid- and low-dose brain measurements. However, the lack
of a NOAEL for brain morphometric measurements in this study does not
warrant an additional uncertainty factor since the decrease in weight
at the high dose is considered marginal and variable, and a lower dose
would most likely result in less of an effect (the HDT was 10x greater
than the lowest dose tested), and the endpoints and PODs selected for
risk assessment are protective of the slight morphometric changes
observed at the high dose. Even if a 10x factor is applied to the dose
where the slight morphometric changes were seen in the developmental
neurotoxicity study, the result would be a POD comparable to those
currently selected for risk assessment. Therefore, the PODs currently
selected are protective of any potential effects. There were no
indications of neurotoxicity in the remainder of the submitted toxicity
iii. As noted in Unit III.D.2., although there was an increase in
qualitative susceptibility in the rat developmental study and
developmental neurotoxicity study, there is a low degree of concern and
no residual uncertainties for the increase in qualitative
susceptibility since there is a well-characterized dose response with
clear NOAELs and LOAELs.
iv. There are no residual uncertainties identified in the exposure
databases. The acute and chronic dietary food exposure assessments were
performed based on 100 PCT and tolerance-level residues. The cancer
assessment used PCT and anticipated residues for new and registered
uses. This is based on reliable data and will not underestimate the
exposure and risk. The drinking water residues used in this assessment
were partially refined to account for PCT area and drinking water
treatment processes. However, these drinking water estimates are still
considered to be conservative and upper-bound. These assessments will
not underestimate the exposure and risks posed by thiacloprid.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to thiacloprid will occupy 19% of the aPAD for infants less than 1 year
old, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
thiacloprid from food and water will utilize 26% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for thiacloprid.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Short- and intermediate-term adverse effect was identified;
however, thiacloprid is not registered for any use patterns that would
result in either short- or intermediate-term residential exposure.
Short- and intermediate-term risk is assessed based on short- and
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no short- or intermediate-term residential exposure
and chronic dietary exposure has already been assessed under the
appropriately protective cPAD (which is at least as protective as the
POD used to assess short-term risk), no further assessment of short- or
intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating short- and intermediate-term
risk for thiacloprid.
4. Aggregate cancer risk for U.S. population. Using the exposure
assumptions described in this unit for cancer, EPA has concluded that
the cancer risk estimate from exposure to thiacloprid through food and
water for the U.S. population is 2x10 -6, which is below the
Agency's level of concern.
EPA generally considers cancer risks in the range of 10
-6 or less to be negligible. The precision which can be
assumed for cancer risk estimates is best described by rounding to the
nearest integral order of magnitude on the log scale; for example,
risks falling between 3 x 10-7 and 3 x 10 -6 are
expressed as risks in the range of 10 -6. Considering the
precision with which cancer hazard can be estimated, the
conservativeness of low-dose linear extrapolation, and the rounding
procedure described above, cancer risk should generally not be assumed
to exceed the benchmark level of concern of the range of 10
-6 until the calculated risk exceeds approximately 3 x 10
-6. This is particularly the case where some conservatism is
maintained in the exposure assessment. Here, substantial conservatism
is incorporated by the use of food residue values from field trial
studies using maximum application procedures and upper-bound modeled
drinking water residues in the exposure assessment. Accordingly, EPA
has concluded the cancer risk for all existing thiacloprid uses and the
uses associated with the tolerances established in this action fall
within the range of 1 x 10 -6 and are thus negligible.
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 thiacloprid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high performance liquid
chromatography-mass spectrometer/mass spectrometer (HPLC-MS/MS)) is
available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has established MRLs for thiacloprid in or on sweet
peppers (including pimento or pimiento) at 1 ppm and stone fruit, crop
group 12 at 0.5 ppm. These MRLs are the same as the tolerances being
established for thiacloprid in the United States on these crops.
C. Revisions to Petitioned-for Tolerances
The Agency has modified the level at which the tolerance is being
established for pepper from the proposed level of 1.1 ppm to 1.0 ppm in
order to harmonize with the Codex MRL.
EPA has also revised the request for a tolerance for thiacloprid on
the stone fruit group 12. Subsequent to the filing of the petition
requesting a stone fruit group 12 tolerance, EPA issued a final rule
that revised the crop grouping regulations (77 FR 50617, August 22,
2012) (FRL-9354-3). As part of this action, EPA expanded and revised
the existing stone fruit group 12. Changes to crop group 12 included
adding the following commodities: Japanese apricot, capulin, black
cherry, nanking cherry, Chinese jujube, American plum, beach plum,
Canada plum, cherry plum, Klamath plum, and sloe; creating new
subgroups (the cherry subgroup 12-12A, the peach subgroup 12-12B, and
the plum subgroup 12-12C); and naming the new crop group ``Crop Group
12-12: Stone Fruit Group.'' EPA indicated in the August 22, 2012 final
rule as well as the earlier November 9, 2011 proposed rule (76 FR
69693) (FRL-8887-8) that, for existing petitions for which a notice of
filing had been published, the Agency would attempt to conform these
petitions to the rule. Therefore, consistent with this rule, and upon
review of the petition, the Agency concluded that it was appropriate to
establish tolerances for the cherry subgroup 12-12A and the peach
subgroup 12-12B at 0.5 ppm, and the plum subgroup 12-12C at 0.05 ppm. A
single tolerance for the entire stone fruit group 12-12 could not be
established due to the significantly different residue levels in the
trials with plums as compared to the other representative commodities
in the stone fruit crop group and thus tolerances were established for
each of the three separate subgroups.
Therefore, tolerances are established for residues of the
insecticide thiacloprid, including its metabolites and degradates, in
or on pepper at 1.0 ppm; cherry subgroup 12-12A at 0.5 ppm; peach
subgroup 12-12B at 0.5 ppm; plum subgroup 12-12C at 0.05 ppm.
Compliance with the tolerance levels is to be determined by measuring
only thiacloprid, (Z)-[3-[(6-chloro-3-pyridinyl)methyl]-2-
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
Dated: January 29, 2013.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.594, in paragraph (a) revise the introductory text and
add alphabetically the following commodities to the table to read as
Sec. 180.594 Thiacloprid; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide thiacloprid, including its metabolites and degradates in or
on the commodities in the following table. Compliance with the
tolerance levels specified in the following table is to be determined
by measuring only thiacloprid ([3-[(6-chloro-3-pyridinyl)methyl]-2-
thiazolidinylidene] cyanamide) in or on the commodity.
* * * * *
Cherry subgroup 12-12A.................................. 0.5
* * * * *
Peach subgroup 12-12B................................... 0.5
Plum subgroup 12-12C.................................... 0.05
* * * * *
* * * * *
[FR Doc. 2013-02692 Filed 2-5-13; 8:45 am]
BILLING CODE 6560-50-P