
[Federal Register Volume 81, Number 199 (Friday, October 14, 2016)]
[Rules and Regulations]
[Pages 70974-70980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24089]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0390; FRL-9951-92]


Pyridaben; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the 
insecticide pyridaben in or on multiple commodities which are 
identified and discussed later in this document. Interregional Research 
Project Number 4 (IR-4) requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 14, 2016. Objections and 
requests for hearings must be received on or before December 13, 2016, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number HQ-EPA-OPP-2015-0390, 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), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document 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

[[Page 70975]]

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 HQ-EPA-OPP-2015-0390 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 
December 13, 2016. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number HQ-EPA-OPP-2015-0390, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of Wednesday, August 26, 2015 (80 FR 51759) 
(FRL-9931-74), EPA issued a document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP 5E8363) by IR-4, IR-4 Project Headquarters, Rutgers, The 
State University of New Jersey, 500 College Road East, Suite 201 W., 
Princeton, NJ 08540. The petition requested that 40 CFR 180.494 be 
amended by establishing tolerances for residues of the insecticide 
pyridaben, [2-tert-butyl-5-(4-tert-butylbenzylthio)-4-chloropyridazin-
3(2H)-one] in or on berry, low growing subgroup 13-07G, except 
cranberry at 2.5 ppm; cucumber at 0.5 ppm; fruit, citrus group 10-10 at 
0.5 ppm; fruit, pome group 11-10 at 0.75 ppm; fruit, stone, group 12-12 
at 2.5 ppm; fruit, small, vine climbing, subgroup 13-07F, except fuzzy 
kiwifruit at 1.5 ppm; and nut, tree, group 14-12 at 0.05 ppm. In 
addition, the petitioner requests removal of established tolerances 
under 40 CFR 180.494 in or on apple at 0.5 ppm; pear at 0.75 ppm; nut, 
tree, group 14 at 0.05 ppm; citrus (fruit) at 0.5 ppm; fruit, stone, 
group 12 at 2.5 ppm; pistachio at 0.05 ppm; grape at 1.5 ppm; and 
strawberry at 2.5 ppm upon approval of tolerances mentioned above and 
thereby eliminating redundancies. That document referenced a summary of 
the petition prepared by Gowan Company, the registrant, which is 
available in the docket, http://www.regulations.gov. Two comments were 
received on the notice of filing in support of this action.
    Based upon review of the data supporting the petition, EPA has 
revised certain proposed tolerance levels, corrected crops/crop group 
definitions, as needed, and modified the tolerance expression for 
pyridaben to comply with current EPA policies. The reason for these 
changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for pyridaben including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with pyridaben follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity database 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 subchronic and chronic oral toxicity studies in rats and mice, 
the adverse effects were decreased body weight and food consumption; in 
dogs, toxicity consisted of increased incidences of clinical signs 
(i.e., ptyalism) and decreased body weight. In the repeat dose dermal 
toxicity studies in rabbits, the adverse effect was decreased body 
weight. In the repeat dose inhalation toxicity study in rats, there 
were no adverse effects up to the highest dose tested. In all animals 
where toxicity was observed, body weight decreases became more 
pronounced as study duration increased while incidences of clinical 
signs of toxicity did not become more severe or more frequent as the 
study duration increased.
    Susceptibility was observed in the rat prenatal developmental 
toxicity and rat developmental neurotoxicity studies. In the rat 
prenatal developmental toxicity study, fetal toxicity (i.e., decreased 
bodyweight and incomplete ossification) occurred in the absence of 
maternal toxicity at the highest dose tested (HDT) of 30 mg/kg/day. In 
the rat developmental neurotoxicity study, offspring toxicity (i.e., 
decreased bodyweight) occurred in the absence of maternal toxicity at 
the HDT of 8.4 mg/kg/day. In the rabbit prenatal developmental toxicity 
study, fetal and maternal toxicity consisted of abortions and occurred 
at the HDT of 15 mg/kg/day. There were no adverse effects observed in 
the rabbit dermal prenatal developmental toxicity study. In the rat 
reproduction and fertility effects study, parental and offspring 
toxicity (i.e., decreased bodyweight) occurred at the HDT of 6.3 mg/kg/
day.
    In the acute neurotoxicity study in rats, animals had increased 
incidences of clinical signs (i.e., piloerection, hypoactivity, 
tremors, and partially closed eyes). In the subchronic neurotoxicity 
study in rats, male animals had increased incidences of

[[Page 70976]]

impaired righting reflex. In the developmental neurotoxicity study in 
rats, there were no neurotoxicity effects up to the highest dose tested 
(17.7 mg/kg/day).
    Pyridaben has been classified as ``not likely to be carcinogenic in 
humans'' based on the results from carcinogenicity studies in rats and 
mice. The mutagenicity studies do not indicate increased mutagenic 
potential in the battery of in vivo and in vitro assays.
    Specific information on the studies received and the nature of the 
adverse effects caused by pyridaben as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Pyridaben--Human Health Risk 
Assessment for Proposed Uses on Greenhouse Cucumbers and Crop Group 
Expansions for Pome Fruit Group 11-10, Tree Nut Group 14-12, Stone 
Fruit Group 12-12, Citrus Fruit Group 10-10, Small Fruit Vine Climbing 
(except Fuzzy Kiwifruit) Subgroup 13-07F, and Low Growing Berry 
Subgroup 13-07G (except Cranberry), dated June 21, 2016'' at page 28 in 
docket ID number EPA-HQ-OPP-2015-0390.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for pyridaben used for 
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for pyridaben 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 (General population    NOAEL = 44 mg/kg/day..  Acute RfD = 0.44 mg/kg/ Acute Neurotoxicity Study
 including infants and children).    UFA = 10x.............   day.                    in Rats:
                                     UFH = 10x.............  aPAD = 0.44] mg/kg/day  LOAEL = 80 mg/kg/day based
                                     FQPA SF = 1x..........                           on increased incidences of
                                                                                      clinical signs (i.e.,
                                                                                      piloerection,
                                                                                      hypoactivity, tremors, and
                                                                                      partially closed eyes).
Chronic dietary (All populations)..  NOAEL= 2.2 mg/kg/day..  Chronic RfD = 0.022 mg/ Reproduction and Fertility
                                     UFA = 10x.............   kg/day.                 Effects in Rats LOAEL =
                                     UFH = 10x.............  cPAD = 0.022 mg/kg/day   6.3 mg/kg/day based on
                                     FQPA SF = 1x..........                           decreased parental and pup
                                                                                      body weight.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, and              Classification: ``Not Likely to be Carcinogenic to Humans'' based on the
 inhalation).                                    results of carcinogenicity studies in rats and mice.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pyridaben, EPA considered exposure under the petitioned-for 
tolerances as well as all existing pyridaben tolerances in 40 CFR 
180.494. EPA assessed dietary exposures from pyridaben 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 pyridaben. In estimating acute 
dietary exposure, EPA used the Dietary Exposure Evaluation Model-Food 
Commodity Intake Database (DEEM-FCIDTM), Version 3.16, which 
incorporates 2003-2008 food consumption information from the U.S. 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to 
residue levels in food, EPA used anticipated-residue estimates derived 
from proposed and established tolerance levels; DEEM-FCIDTM, 
Version 7.81 default processing factors were utilized for most 
processed commodities; and 100 percent crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCIDTM, Version 3.16, which 
incorporates 2003-2008 food consumption data from the USDA's NHANES/
WWEIA. As to residue levels in food, the chronic dietary exposure 
assessment is partially refined, assuming anticipated residue estimates 
derived from proposed and established tolerance levels and percent crop 
treated estimates for most crops.
    iii. Cancer. Pyridaben has been classified as not likely to be 
carcinogenic to humans. Based on the data summarized in Unit III.A., 
EPA has concluded that pyridaben does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA

[[Page 70977]]

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.
    The Agency estimated the PCT for chronic exposure for existing uses 
as follows: almonds 2.5%; apples 20%; cherries 2.5%; grapefruit 35%; 
grapes 5%; lemons 2.5%; nectarines 2.5%; oranges 10%; peaches 10%; 
pears 35%; pecans 2.5%; plums/prunes 5%; tangelos 15%; tangerines 25%; 
tomatoes 2.5%; and walnuts 5%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The 
maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency 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 pyridaben 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 pyridaben in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of pyridaben. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at: http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    The EPA's Tier II water models have been updated and applied in the 
drinking water analysis for total residues of concern (TRC) of 
pyridaben. The Pesticide Water Calculator (PWC), Ver.1.5001, has 
replaced the PE5 shell for the Pesticide Root Zone Model/Exposure 
Analysis Modeling System (PRZM/EXAMS) used previously to generate 
surface water estimated drinking water concentrations (EDWC) in dietary 
risk assessments. In addition, the PRZM-Ground Water (PRZM GW) model, 
version 1.07, has replaced Screening Concentration in Ground Water 
(SCI-GROW), which was used to generate groundwater EDWCs. These latest 
versions of the PWC and PRZM-GW models not only analyze for pyridaben, 
but its two degradates PB-7 and P-9, residues of concern for drinking 
water.
    Based on the PWC and PRZM GW, the maximum acute surface water EDWCs 
of pyridaben TRC for acute exposures are estimated to be 12 parts per 
billion (ppb) for surface water and an indeterminately low 
concentration for ground water.
    For chronic exposures for non-cancer assessments are estimated to 
be 0.91 ppb for surface water and an indeterminately low concentration 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For acute dietary risk assessment, the water concentration value of 
12 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 0.91 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). Pyridaben is not 
registered for any specific use patterns that would result in 
residential exposure.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at: http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 pyridaben to share a common mechanism of toxicity 
with any other substances, and pyridaben does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that pyridaben does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine

[[Page 70978]]

which chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at: http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence for 
increased susceptibility to pyridaben following pre- or post-natal 
exposure in the rat reproduction and fertility effects study, 
notwithstanding the observed decreased pup body weight since that is 
not considered to be more severe than decreased parental body weight. 
Parental and offspring toxicity (i.e., decreased bodyweight) occurred 
at the HDT of 6.3 mg/kg/day.
    Increased susceptibility following prenatal exposure in the rat 
prenatal developmental toxicity studies was observed including fetal 
toxicity (i.e., decreased bodyweight and incomplete ossification) 
occurring in the absence of maternal toxicity at the HDT of 30 mg/kg/
day. In the rabbit prenatal developmental toxicity study, fetal and 
maternal toxicity consisted of abortions and occurred at the HDT of 15 
mg/kg/day. There were no adverse effects observed in the rabbit dermal 
prenatal developmental toxicity study.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for pyridaben is complete.
    ii. Although there are signs that pyridaben causes neurotoxic 
effects, a developmental neurotoxicity study in rats demonstrated no 
observed neurotoxicity effects in offspring up to the HDT of 17.7 mg/
kg/day. Furthermore, the RfD of 0.44 mg/kg/day for acute dietary 
exposures is protective of the HTD in the developmental neurotoxicity 
study. Additionally, the acute RfD is based on clinical signs 
(piloerection, hypoactivity, tremors and partially closed eyes) in 
adults that could be signs of neurotoxicity, however tissue analysis 
did not confirm neurotoxicity. Similarly, the chronic RfD of 0.022 mg/
kg/day (based on parental and pup body weight decreases in a 
reproductive study) is protective of the impaired righting reflex 
observed in the subchronic neurotoxicity study at 8.5 mg/kg/day. There 
is no need to retain the FQPA 10X to account for any residual 
uncertainties concerning neurotoxicity.
    iii. There is evidence that pyridaben results in increased 
susceptibility following prenatal exposure in the rat prenatal 
developmental toxicity and rat developmental neurotoxicity studies. 
There was no evidence for increased susceptibility following pre- or 
post-natal exposure in the rat reproduction and fertility effects study 
since the decreased pup body weight is not considered to be more severe 
than decreased parental body weight. EPA concluded that selected 
endpoints based on the rat reproduction and fertility effects study's 
NOAELs/LOAELs are protective of the susceptibility observed in the rat 
prenatal developmental toxicity and rat developmental neurotoxicity 
studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. The pyridaben exposure databases are complete or are 
estimated based on data that reasonably account for potential 
exposures. The chronic dietary food exposure assessment was based on 
anticipated residue estimates derived from proposed and established 
tolerance levels and PCT assumptions and conservative ground water 
drinking water modeling estimates. All of the exposure estimates are 
not likely to result in underestimated exposure and risks posed by 
pyridaben.

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 pyridaben will occupy 7.8% of the aPAD for the general U.S. 
population and 29% of the aPAD for children 1-2 years 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 
pyridaben from food and water will utilize 5% of the cPAD for the 
general U.S. Population and 20% of the cPAD for children 1-2 years old, 
the population group receiving the greatest exposure. There are no 
residential uses for pyridaben.
    3. Short-term and Intermediate-term risks. Short-term and 
intermediate-term aggregate exposures take into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level). Pyridaben is not registered for use on any 
sites that would result in residential exposure. Therefore, the 
aggregate risk is the sum of the risk from food and water, which do not 
exceed the Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, pyridaben is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to pyridaben residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with mass 
spectrometry (GC/MS) detection using a modified version of BASF Method 
D9312A) 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: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the

[[Page 70979]]

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.
    There are no Codex maximum residue levels (MRLs) established for 
residues of pyridaben on the commodities for which tolerances are being 
established in this action.

C. Revisions to Petitioned-for Tolerances

    In order to harmonize tolerances with Canada and avoid trade 
irritants, EPA is establishing pyridaben tolerances as follows: (1) 
Fruit, stone, group 12-12 at 3.0 ppm, instead of at 2.5 ppm as 
requested; (2) Fruit, citrus, group 10-10 at 0.9 ppm, instead of at 0.5 
ppm as requested; and (3) Fruit, small, vine climbing, except fuzzy 
kiwifruit subgroup 13-07F at 2.0 ppm, instead of at 1.5 ppm, as 
requested.
    Finally, in accordance with EPA's policy to update its tolerance 
expressions where applicable, EPA is revising the tolerance expression 
to clarify that (1) as provided in FFDCA section 408(a)(3), the 
tolerance covers metabolites and degradates of pyridaben not 
specifically mentioned; and (2) compliance with the specified tolerance 
levels is to be determined by measuring only the specific compounds 
mentioned in the tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of the 
insecticide pyridaben, [2-tert-butyl-5-(4-tert-butylbenzylthio)-4-
chloropyridazin-3(2H)-one] in or on berry, low growing subgroup 13-07G, 
except cranberry at 2.5 ppm; cucumber at 0.50 ppm; fruit, citrus group 
10-10 at 0.9 ppm; fruit, pome group 11-10 at 0.75 ppm; fruit, stone, 
group 12-12 at 3.0 ppm; fruit, small, vine climbing except fuzzy 
kiwifruit subgroup 13-07F at 2.0 ppm; and nut, tree, group 14-12 at 
0.05 ppm. Additionally, the existing tolerances in or on apple at 0.50 
ppm; pear at 0.75 ppm; nut, tree, group 14 at 0.05 ppm; fruit, stone, 
group 12 at 2.5 ppm; citrus at 0.5 ppm; pistachio at 0.05 ppm; grape at 
1.5 ppm; and strawberry at 2.5 ppm are being removed as a result of 
being superseded by the new tolerances. Also, the tolerance expression 
is being updated to clarify that the tolerance covers metabolites and 
degradates of pyridaben not specifically mentioned and compliance with 
the specified tolerance levels is to be determined by measuring only 
the specific compounds mentioned in the tolerance expression. Finally 
in order to correct a typographical error that was made in a previous 
action (Federal Register of July, 14, 2000 (65 FR 43704) (FRL-6593-1)), 
where a number was inadvertently dropped from the table in paragraph 
(a), the EPA is revising the goat fat tolerance from 0.0 ppm to 0.05 
ppm in order to reinstate the original tolerance level published in the 
Federal Register of May 16, 1997 (62 FR 26954) (FRL-5178-4).

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the 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 action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 9, 2016.
Michael L. Goodis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.494 is amended by revising paragraphs (a) and (c) to 
read as follows:

[[Page 70980]]

Sec.  180.494  Pyridaben; tolerance for residues.

    (a) General. Tolerances are established for residues of the 
insecticide pyridaben, including its metabolites and degradates, in or 
on the commodities as indicated in the following table. Compliance with 
the tolerance levels specified below for plant commodities is to be 
determined by measuring the insecticide pyridaben [2-tert-butyl-5-(4-
tert-butylbenzylthio)-4-chloropyridazin-3(2H)-one] on the plant 
commodity. Compliance with the tolerance levels specified below for 
animal commodities is to be determined by measuring the insecticide 
pyridaben and its metabolites, [2-tert-butyl-5-(4-(1-carboxy-1-
methylethy 1) benzylthio)-4-chloropyridazin-3 (2H)one] and [2-tert-
butyl-5-[4(-1, l-dimethyl-2-hydroxyethyl)benzylthio-4-chloropyridazin-
3(2H)one] on the animal commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Almond, hulls...........................................             4.0
Apple, wet pomace.......................................            0.75
Berry, low growing, subgroup 13-07G, except cranberry...             2.5
Canistel................................................            0.10
Cattle, fat.............................................            0.05
Cattle, meat............................................            0.05
Cattle, meat byproducts.................................            0.05
Citrus, dried pulp......................................             1.5
Citrus, oil.............................................            10.0
Cucumber................................................            0.50
Fruit, citrus group 10-10...............................             0.9
Fruit, pome group 11-10.................................            0.75
Fruit, small, vine climbing, except fuzzy kiwifruit,                 2.0
 subgroup 13-07F........................................
Fruit, stone, group 12-12...............................             3.0
Goat, fat...............................................            0.05
Goat, meat..............................................            0.05
Goat, meat byproducts...................................            0.05
Hog, fat................................................            0.05
Hog, meat...............................................            0.05
Hog, meat byproducts....................................            0.05
Hop, dried cones........................................            10.0
Horse, fat..............................................            0.05
Horse, meat.............................................            0.05
Horse, meat byproducts..................................            0.05
Mango...................................................            0.10
Milk....................................................            0.01
Nut, tree, group 14-12..................................            0.05
Papaya..................................................            0.10
Sapodilla...............................................            0.10
Sapote, black...........................................            0.10
Sapote, mamey...........................................            0.10
Sheep, fat..............................................            0.05
Sheep, meat.............................................            0.05
Sheep, meat byproducts..................................            0.05
Star apple..............................................            0.10
Tomato..................................................            0.15
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional registrations. Tolerances with 
regional registration, as defined in Sec.  180.1(m) are established for 
residues of the insecticide pyridaben, including its metabolites and 
degradates, in or on the commodities in the table below. Compliance 
with the tolerance levels specified below is to be determined by 
measuring the insecticide pyridaben [2-tert-butyl-5-(4-tert-
butylbenzylthio)-4-chloropyridazin-3(2H)-one] on the following plant 
commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Cranberry...............................................             0.5
------------------------------------------------------------------------

* * * * *

[FR Doc. 2016-24089 Filed 10-13-16; 8:45 am]
 BILLING CODE 6560-50-P


