[Federal Register Volume 78, Number 25 (Wednesday, February 6, 2013)]
[Rules and Regulations]
[Pages 8410-8416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02692]



[[Page 8410]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0311; FRL-9374-9]


Thiacloprid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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 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-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 
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.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 
thiacloprid ([3-[(6-chloro-3-pyridinyl)methyl]-2-
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

[[Page 8411]]

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 
children.
    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.

[[Page 8412]]



   Table--Summary of Toxicological Doses and Endpoints for Thiacloprid for Use in Human Health Risk Assessment
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                                     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
                                                                                      enzymes, thyroid
                                                                                      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 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1 day or single exposure.
    Such effects were identified for 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 
(PCT) assumptions.
    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 
assumptions.
    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

[[Page 8413]]

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 
different times.
    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 
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. 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

[[Page 8414]]

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 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 
developmental effects.
    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 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 
studies.
    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

[[Page 8415]]

(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: 
[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.
    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.

V. Conclusion

    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-
thiazolidinylidene]cyanamide.

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

[[Page 8416]]

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: January 29, 2013.
Lois Rossi,
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.  180.594, in paragraph (a) revise the introductory text and 
add alphabetically the following commodities to the table to read as 
follows:


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.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cherry subgroup 12-12A..................................            0.5
 
                                * * * * *
Peach subgroup 12-12B...................................            0.5
Pepper..................................................            1.0
Plum subgroup 12-12C....................................            0.05
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-02692 Filed 2-5-13; 8:45 am]
BILLING CODE 6560-50-P