[Federal Register Volume 84, Number 39 (Wednesday, February 27, 2019)]
[Rules and Regulations]
[Pages 6339-6344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03426]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0037; FRL-9987-32]


Abamectin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
abamectin in or on bananas and tea. Syngenta Crop Protection, LLC, 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective February 27, 2019. Objections and 
requests for hearings must be received on or before April 29, 2019, 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-2018-0037, 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: [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-2018-0037 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 29, 2019. 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-2018-0037, 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

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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 April 11, 2018 (83 FR 15528) (FRL-9975-
57), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
7E8636 and 7E8637) by Syngenta Crop Protection, LLC, P.O. Box 18300, 
Greensboro, NC 27419. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the insecticide 
avermectin B1 (a mixture of avermectins containing greater than or 
equal to 80% avermectin B1a (5-O-demethyl avermectin A1) and less than 
or equal to 20% avermectin B1b (5-O-demethyl -25-de(1-methylpropyl)-25-
(1-methylethyl) avermectin A1)) in or on the raw agricultural 
commodities tea (7E8636) at 1 parts per million (ppm) and banana at 
0.002 ppm (7E8637). That document referenced a summary of the petition 
prepared by Syngenta Crop Protection, the registrant, which is 
available in the docket, http://www.regulations.gov. Two comments were 
received on the notice of filing; however, neither comment refers to 
abamectin in particular or pesticides in general, and are therefore not 
relevant to this action.
    Based upon review of the data supporting the petition, EPA has 
modified the levels at which tolerances are being established for tea 
and banana as well as the commodity definition for tea. 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 abamectin including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with abamectin 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.
    A summary of the toxicological effects of abamectin as well as 
specific information on the studies received and the nature of the 
adverse effects caused by abamectin and the no-observed-adverse-effect-
level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from 
the toxicity studies are discussed in the final rule published in the 
Federal Register of May 2, 2016 (81 FR 26147) (FRL-9945-29) and its 
supporting documents. Because nothing has changed since the publication 
of that rule, EPA is incorporating that discussion into this preamble.

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 abamectin used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of May 2, 2016 (81 FR 26147) (FRL-
9945-29).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to abamectin, EPA considered exposure under the petitioned-for 
tolerances as well as all existing abamectin tolerances in 40 CFR 
180.449. EPA assessed dietary exposures from abamectin 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 abamectin. In estimating acute 
dietary exposure, EPA used food consumption information from the 2003-
2008 United States Department of Agriculture (USDA) National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As 
to residue levels in food, a refined acute dietary (food and drinking 
water) exposure assessment was conducted for all established food uses 
of abamectin. Acute anticipated residues derived from field trial data 
were used. Empirical and 2018 DEEM default processing factors and PCT 
estimates were used, as available. No monitoring data were used.
    ii. Chronic exposure. The Agency selected a point of departure for 
chronic effects that is the same as the point of departure for acute 
effects and so is relying on the acute assessment to be protective of 
chronic effects. The Agency assessed chronic exposure for purposes of 
providing background dietary exposure for use in the residential short-
term assessments and to incorporate residues/exposure from

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the food handling establishment (FHE) uses. In conducting the chronic 
dietary exposure assessment EPA used the food consumption data from the 
2003-2008 USDA NHANES/WWEIA. As to residue levels in food, a refined 
chronic dietary (food and drinking water) exposure assessment was 
conducted for all established food uses of abamectin. Average residues 
from field trials were used. Residues from use in FHE were included. 
Empirical and default processing factors and PCT estimates were used, 
as available.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that abamectin 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 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 following maximum PCT estimates for abamectin were used in the 
acute dietary risk assessment for the following crops: Almond: 80%; 
apple: 30%; apricot: 30%; avocado: 60%; bean, dry: 2.5%; blackberry: 
68%; boysenberry: 68%; cantaloupe: 45%; celery: 70%; cherry: 20%; corn, 
sweet: 57%; cotton: 30%; cucumber: 10%; grape: 35%; grapefruit: 90%; 
hazelnut: 2.5%; honeydew: 35%; lemon: 55%; lettuce: 45%; loganberry: 
68%; nectarine: 20%; onion, bulb: 10%; orange: 70%; peach: 25%; pear: 
85%; pecan: 2.5%; pepper: 30%; pistachio: 2.5%; plum/prune: 35%; 
potato: 20%; pumpkin: 10%; raspberry: 68%; soybean: 11%; spinach: 45%; 
squash: 15%; strawberry: 45%; tangerine: 55%; tomato: 25%; walnut: 55%; 
and watermelon: 15%.
    The PCT values that were used to refine the livestock commodities 
for the acute assessment were based on: Sweet corn (57%) for beef, 
goat, horse, and sheep commodities; and the FHE uses (5%) for hog and 
poultry meat and meat byproducts.
    The following average PCT estimates for abamectin were used in the 
chronic dietary risk assessment for the following crops: Almond: 70%; 
apple: 10%; apricot: 15%; avocado: 35%; bean, dry: 2.5%; blackberry: 
56%; boysenberry: 56%; cantaloupe: 25%; celery: 45%; cherry: 5%; corn, 
sweet: 45%; cotton: 20%; cucumber: 5%; grape: 15%; grapefruit: 70%; 
hazelnut: 2.5%; honeydew: 20%; lemon: 40%; lettuce: 20%; loganberry: 
56%; nectarine: 20%; onion, bulb: 2.5%; orange: 40%; peach: 10%; pear: 
70%; pecan: 1%; pepper: 15%; pistachio: 2.5%; plum/prune: 10%; potato: 
5%; pumpkin: 5%; raspberry: 56%; soybeans: 8%; spinach: 25%; squash: 
5%; strawberry: 30%; tangerine: 35%; tomato: 10%; walnuts: 25%; and 
watermelons: 5%.
    The PCT values that were used to refine the livestock commodities 
for the chronic assessment were based on: Cotton (20%), soybean (8%), 
and sweet corn (45%). The PCT for poultry and hog commodities is based 
on the FHE PCT (5%) since the tolerances for FHE uses result in 
residues considerably higher than secondary residues from hogs and 
poultry consuming treated feed.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and California Department of 
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the 
chemical/crop combination for the most recent 10 years. EPA uses an 
average PCT for chronic dietary risk analysis and a maximum PCT for 
acute dietary risk analysis. The average PCT figures for each existing 
use is derived by combining available public and private market survey 
data for that use, averaging across all observations, and rounding up 
to the nearest 5%, except for those situations in which the average PCT 
is less than 1% or less than 2.5%. In those cases, the Agency would use 
less than 1% or less than 2.5% as the average PCT value, respectively. 
The maximum PCT figure is the highest observed maximum value reported 
within the most recent 10 years of available public and private market 
survey data for the existing use and rounded up to the nearest multiple 
of 5%, except where the maximum PCT is less than 2.5%, in which case, 
the Agency uses less than 2.5% as the maximum PCT.
    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 abamectin 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 abamectin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of abamectin. 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.
    Based on the Tier I Pesticide Root Zone Model--Ground Water (PRZM-

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GW) and Tier I Screening Concentration in Ground Water (SCI-GROW) 
models and the Tier II surface water concentration calculator (SWCC) 
computer model, the estimated drinking water concentrations (EDWCs) of 
abamectin for acute exposures are estimated to be 3.76 parts per 
billion (ppb) for surface water and 0.074 ppb for ground water, and for 
chronic exposures are estimated to be 1.21 ppb for surface water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the Agency used a residue distribution file for water based 
upon the maximum single application rate to ornamentals. For the 
chronic dietary risk assessment, the water concentration of value 1.21 
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).
    Abamectin is currently registered for the following uses that could 
result in residential exposures: Golf course turf, homeowner bait and 
bait station products that include an outdoor granular bait formulation 
for use on fire ant mounds, and several indoor ready-to-use baits of 
both dust and gel formulations. In addition, there is a pending action 
for use on professional and collegiate sports fields that has been 
incorporated into this review.
    EPA assessed residential exposure using the following assumptions: 
For residential handlers, both dermal and inhalation short-term 
exposure is expected from the currently registered bait and bait 
station uses. Residential post-application exposure for adults and 
children (6 to <11 and 11 to <16) is possible for the use of abamectin 
on golf courses and collegiate and professional sports fields. Adults 
and children (6 to <11 and 11 to <16) performing physical post-
application activities may receive dermal exposure to abamectin 
residues. For the indoor liquid spray application as a spot or crack 
and crevice treatment, residential post-application exposures are 
possible. However, for the outdoor liquid spray application, exposures 
are expected to be negligible, and therefore, were not quantitatively 
assessed. Adults and children performing physical post-application 
activities on carpets and hard surfaces may receive exposure to 
abamectin residues.
    The following residential post application scenarios were used in 
the aggregate assessment because they result in the lowest MOEs: Adults 
(dermal) from exposure to collegiate sports field turf; children 11 to 
less than 16 years old (dermal) from exposure to golf course turf; 
children 6 to less than 11 years old (dermal) from exposure to golf 
course turf; and children 1 to less than 2 years old (dermal, 
inhalation, and incidental oral) from exposure to carpets.
    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 determined that abamectin and emamectin share 
characteristics to support a testable hypothesis for a common mechanism 
of action. Following this determination, the Agency conducted a 
screening-level cumulative risk assessment to determine if cumulative 
exposures to these chemicals would pose a risk of concern. This 
screening assessment indicates that that cumulative dietary and 
residential aggregate exposures for abamectin and emamectin are below 
the Agency's levels of concern. No further cumulative evaluation is 
necessary for abamectin and emamectin.
    The Agency's screening-level cumulative analysis can be found at 
http://www.regulations.gov in the document titled ``Avermectin 
Macrocyclic Lactones, Abamectin and Emamectin. Cumulative Screening 
Risk Assessment'' in docket ID number EPA-HQ-OPP-2018-0037.

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. An increase in qualitative 
susceptibility was seen in the rabbit developmental toxicity study, 
where decreases in body weight and food consumption were seen in 
maternal animals at 2.0 mg/kg/day. In contrast, the fetal effects were 
much more severe, consisting of cleft palate, clubbed foot, and death 
at 2.0 mg/kg/day. The point of departure (0.25 mg/kg/day) selected from 
the dog studies is 8x lower than the dose where rabbit fetal effects 
were seen. Therefore, it is protective of fetal effects seen in the 
rabbit developmental toxicity study.
    The rat reproduction toxicity and developmental neurotoxicity 
studies demonstrated both qualitative and quantitative susceptibility 
in the pups to the effects of abamectin (decrease pup weights and 
increased postnatal pup mortality). This observation is consistent with 
the finding that P-gp is not fully developed in rat pups until 
postnatal day 28. Therefore, during the period from birth to postnatal 
day 28, the rat pups are substantially more susceptible to the effects 
of abamectin than adult rats. However, in humans, P-gp has been 
detected in the fetus at 22 weeks of pregnancy, and the human newborns 
have functioning P-gp. Therefore, human infants and children are not 
expected to have enhanced sensitivity as seen in rat pups.
    3. Conclusion. Currently, the toxicity endpoints and points of 
departure for all exposure scenarios are selected from the subchronic 
and chronic oral toxicity studies in the dogs. The points of departure 
selected from the dog studies are based on clear NOAELs and protective 
of all the adverse effects seen in the studies conducted in human 
relevant studies with rats, CD-1 mice, and rabbits. Therefore, EPA has 
determined that 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 abamectin is complete.
    ii. The proposed mode of action (MOA) is interaction with GABA 
receptors leading to neurotoxicity. The findings of neurotoxic signs 
observed in the abamectin database are consistent with the proposed 
MOA. Signs of neurotoxicity ranging from decreases in foot splay 
reflex, mydriasis (i.e., excessive dilation of the pupil), curvature of 
the spine, decreased fore- and hind-limb grip strength, tip-toe gate,

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tremors, ataxia, or spastic movements of the limbs are reported in 
various studies with different durations of abamectin exposure. In 
dogs, mydriasis was the most common finding at doses as low as 0.5 mg/
kg/day at one week of treatment. No neuropathology was observed. 
Because the PODs used for assessing aggregate exposure to abamectin and 
the PODs for assessing cumulative exposure for abamectin and emamectin 
are protective of these neurotoxic effects in the U.S. population, as 
well as infants and children, no additional data concerning 
neurotoxicity is needed at this time to be protective of potential 
neurotoxic effects.
    iii. As explained in Unit III.D.2 ``Prenatal and postnatal 
sensitivity'', the enhanced susceptibility seen in the rabbit 
developmental toxicity, the rat reproduction, and the rat developmental 
neurotoxicity studies do not present a risk concern.
    iv. There are no residual uncertainties identified in the exposure 
databases. The chronic and acute dietary food exposure assessment are 
refined including use of anticipated residues, default processing 
factors, and percent crop treated; however, these refinements are 
considered protective because field trials are conducted to represent 
use conditions leading to the maximum residues in food when the product 
is used in accordance with the label and do not underestimate 
exposures. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to abamectin in 
drinking water. EPA used similarly conservative assumptions to assess 
post-application exposure of children. These assessments will not 
underestimate the exposure and risks posed by abamectin.

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 abamectin will occupy 64% of the aPAD for children 1 to 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 
abamectin from food and water will utilize 13% of the cPAD for children 
1 to 2 years old, the population group receiving the greatest exposure. 
Based on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of abamectin is not 
expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Abamectin is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to abamectin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 790 for adults, 
2,900 for children aged 11 to less than 16 years old, 1,800 for 
children aged 6 to less than 11 years old, and 180 for children 1-2 
years old. Because EPA's level of concern for abamectin is a MOE of 100 
or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Intermediate-term adverse effects were identified; however, 
abamectin is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no 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 intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
abamectin.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, abamectin is not expected to pose a cancer risk to humans.
    6. 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 abamectin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods for abamectin in plant and livestock 
commodities are available in the Pesticide Analytical Manual, Volume II 
(PAM II).

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 not established a MRL for abamectin on either tea or 
banana.

C. Revisions to Petitioned-For Tolerances

    The petitioner proposed a tolerance level of 0.002 ppm for residues 
in/on banana. The tolerance is being established at the level of the 
combined limit of quantitation (LOQs) for the residues of concern which 
is 0.006 ppm. The tolerance level for tea, dried is being established 
at 1.0 ppm, which alters the proposed tolerance of 1 ppm to adjust for 
significant figures and commodity definition revision.

V. Conclusion

    Therefore, tolerances are established for residues of abamectin, in 
or on banana at 0.006 ppm and tea, dried at 1.0 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in

[[Page 6344]]

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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). 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: February 8, 2019.
Michael Goodis,
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.  180.449, add alphabetically the entries ``Banana'' and 
``Tea, dried'' to the table in paragraph (a) to read as follows:


Sec.  180.449  Avermectin B1 and its delta-8,9-isomer; tolerances for 
residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Banana \1\..................................................       0.006
 
                                * * * * *
Tea, dried \1\..............................................         1.0
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for use of abamectin on banana or
  tea.

* * * * *
[FR Doc. 2019-03426 Filed 2-26-19; 8:45 am]
 BILLING CODE 6560-50-P