Document ID: EPA-HQ-OPP-2017-0744-0014
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Azoxystrobin
Posted Date: 2018-11-15T05:00Z

[Federal Register Volume 83, Number 221 (Thursday, November 15, 2018)]
[Rules and Regulations]
[Pages 57333-57339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24974]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0744; FRL-9985-45]

Azoxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
azoxystrobin in or on beet, sugar, roots and vegetable, root, except 
sugar beet, subgroup 1B. Syngenta Crop Protection, LLC requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 15, 2018. Objections and 
requests for hearings must be received on or before January 14, 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-2017-0744, 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.

[[Page 57334]]

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-2017-0744 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
January 14, 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-2017-0744, 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 March 6, 2018 (83 FR 9471) (FRL-9973-
27), 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 
7F8590) by Syngenta Crop Protection, LLC, 18300 Greensboro Road, NC. 
The petition requested that 40 CFR 180.507 be amended by establishing 
tolerances for residues of the fungicide azoxystrobin, in or on beet, 
sugar, roots at 5.0 parts per million (ppm) and vegetable, root, 
subgroup 1B at 0.5 ppm. The petition also requested that the tolerance 
for vegetable, root, subgroup 1A be removed once these new tolerances 
are established. 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. Comments were 
received on the notice of filing. EPA's response to these comments is 
discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing the tolerance level for vegetable, root, subgroup 1B at 
1.0 ppm instead of 0.5 ppm. Additionally, the Agency has revised the 
commodity name to vegetable, root, except sugar beet, subgroup 1B. The 
reason for these changes are explained in Unit IV.D.

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 azoxystrobin including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with azoxystrobin 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.
    With repeated dosing by the oral route, the liver and bile ducts 
were consistently affected by azoxystrobin. Liver and biliary effects 
were seen in rats (increased liver weights, gross and histopathological 
lesions of the bile duct and liver), and in dogs (increased liver 
weights, clinical observations including fluid feces and salivation) 
and clinical chemistry alterations (including increased serum levels of 
alkaline phosphatase, and gamma-glutamyl transferase; and decreases in 
serum albumin). The effects seen are indicative of changes to liver/
biliary function. Decreased body weight (rats and mice)

[[Page 57335]]

and decreased body weight gain (rats and rabbits) were also consistent 
findings across studies and species. Other effects including decreased 
food intake/utilization, increased diarrhea and other clinical toxicity 
observations such as urinary incontinence, salivation, hunched postures 
and distended abdomens were also seen in various studies (developmental 
toxicity, reproduction, and 90-day oral toxicity) in rats. Inhalation 
exposure to a soluble-concentrate (SC) formulation of azoxystrobin 
resulted in adverse microscopic changes in the nasal cavity and larynx.
    No developmental effects were seen in the rabbit and rat 
developmental toxicity studies and no reproductive or offspring effects 
were seen in the 2-generation rat reproduction study. In the 
reproduction study, decreased body weights and increased adjusted liver 
weights were observed at the same dose in both offspring and parental 
animals. Therefore, the toxicity data showed no increased 
susceptibility in the young.
    In the acute and subchronic neurotoxicity studies, there were no 
consistent indications of treatment-related neurotoxicity. There was no 
evidence of neurotoxicity seen in the acute neurotoxicity study in rats 
from a single gavage dose up to 2,000 mg/kg. There was also no evidence 
of neurotoxicity seen in the subchronic neurotoxicity study in rats up 
to the highest dose tested (201 mg/kg/day). Based on the toxicity 
profile of azoxystrobin, a developmental neurotoxicity study in rats is 
not needed.
    Although azoxystrobin induced a weak mutagenic response in the 
mouse lymphoma assay (non-linear, slight but significant increases in 
the mutation frequency of mouse lymphoma cells), the activity expressed 
in vitro is not expected to be expressed in whole animals. There was no 
evidence of carcinogenicity in rats and mice at acceptable tested dose 
levels; therefore, azoxystrobin is classified as ``not likely to be 
carcinogenic to humans''.
    Azoxystrobin has a low order of acute toxicity via oral, dermal and 
inhalation routes of exposure. Azoxystrobin is not an eye or skin 
irritant and is not a skin sensitizer.
    Specific information on the studies received and the nature of the 
adverse effects caused by azoxystrobin 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 Azoxystrobin: Human Health Risk 
Assessment for a New Post-Harvest Use on Sugar Beets and Amend the 
existing Vegetable, Root, Subgroup 1A to Vegetable, Root, Subgroup 1B 
(except Sugar Beets) at pages 11-18 in docket ID number EPA-HQ-OPP-
2017-0744.

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 azoxystrobin used for 
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Azoxystrobin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                   Point of departure and     RfD, PAD, LOC for
       Exposure/scenario         uncertainty/safety factors    risk assessment   Study and toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All              LOAEL = 200 mg/kg/day.......  Acute RfD = 0.67   Acute Neurotoxicity--Rat.
 populations).                  UFA = 10x...................   mg/kg/day.        LOAEL = 200 mg/kg/day based on
                                UFH = 10x...................  aPAD = 0.67 mg/kg/  diarrhea at two-hours post
                                                               day.               dose at all dose levels
                                                                                  tested.
                                FQPA SF = 3x
Chronic dietary (All            NOAEL = 18 mg/kg/day........  Chronic RfD =      Combined Chronic Toxicity/
 populations).                  UFA = 10x...................   0.18 mg/kg/day.    Carcinogenicity Feeding Study--
                                UFH = 10x...................  cPAD = 0.18 mg/kg/  Rat.
                                                               day.              LOAEL = 82.4/117 mg/kg/day (M/
                                                                                  F) based on reduced body
                                                                                  weights in both sexes and bile
                                                                                  duct lesions in males.
                                FQPA SF = 1x
Episodic granule ingestion      LOAEL = 200 mg/kg/day.......  Residential LOC    Acute Neurotoxicity--Rat.
 (Children 1 to <2 years old).  UFA = 10x...................   for MOE = 300.    LOAEL = 200 mg/kg/day based on
                                UFH = 10x...................                      diarrhea at two-hours post
                                                                                  dose at all dose levels
                                                                                  tested.
                                FQPA SF = 3x
Incidental oral short-term (1-  NOAEL = 35 mg/kg/day........  Residential LOC    2-generation reproduction
 30 days) (Intermediate-term    UFA= 10x....................   for MOE = 100.     study--Rats.
 (1-6 months)).                 UFH = 10x...................                     LOAEL = 165 mg/kg/day based on
                                                                                  decreased pup weights in both
                                                                                  males and females ([darr]8-
                                                                                  21%).
                                FQPA SF = 1x
Inhalation (All durations)....  Inhalation study NOAEL = 3.8  LOC for MOE = 30.  28-Day inhalation toxicity
                                 [micro]g/L (inhalation                           study in rats on SC
                                 absorption rate = 100%).                         formulation\+\.
                                UFA = 3x....................                     LOAEL = 12.2 [micro]g/L based
                                                                                  on adverse histopathological
                                                                                  changes in the larynx
                                                                                  (squamous metaplasia) and
                                                                                  nasal cavity (metaplasia of
                                                                                  the respiratory epithelium).
                                                                                  There was an increase in
                                                                                  severity with increases in the
                                                                                  test concentrations.
                                UFH = 10x
                                FQPA SF = 1x................
                               ---------------------------------------------------------------------------------
Cancer (Oral, dermal,              Azoxystrobin is classified as ``not likely to be carcinogenic to humans''.
 inhalation).
----------------------------------------------------------------------------------------------------------------
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).

[[Page 57336]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to azoxystrobin, EPA considered exposure under the petitioned-
for tolerances as well as all existing azoxystrobin tolerances in 40 
CFR 180.507. EPA assessed dietary exposures from azoxystrobin 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 azoxystrobin. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) Nationwide Health and Nutrition Examination Survey, 
What We Eat in America (NHANES/WWEIA) conducted from 2003-2008. As to 
residue levels in food, the acute dietary analysis was obtained from 
the Dietary Exposure Evaluation Model using the Food Commodity Intake 
Database (DEEM-FCID; version 3.16). The assessment is based on 100% of 
the registered crops treated, and tolerance-level residues for all 
existing and proposed commodities, except citrus fruits where the 
highest field trial residue was used as a refinement.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA Nationwide 
Health and Nutrition Examination Survey, What We Eat in America 
(NHANES/WWEIA) conducted from 2003-2008. As to residue levels in food, 
the chronic dietary analysis was obtained from the Dietary Exposure 
Evaluation Model using the Food Commodity Intake Database (DEEM-FCID; 
version 3.16). The assessment was partially refined, and used 
tolerance-level residues for all commodities and average percent crop 
treated (PCT) estimates when available.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that azoxystrobin 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 Agency estimated the PCT for existing uses for the chronic 
dietary exposure assessment as follows: Almonds, 20%; apricots, 10%; 
artichokes, 20%; asparagus, <2.5%; barley, <2.5%; green beans, 15%; 
blueberries, 15%; broccoli, 10%; cabbage, 10%; caneberries, 5%; 
cantaloupes, 20%; carrots, 10%; cauliflower, <2.5%; celery, 10%; corn, 
<2.5%; cotton, <2.5%; cotton (seed treatment), 25%; cucumbers, 20%; dry 
beans/peas, <2.5%; eggplant, 30%; garlic, 70%; grapefruit, 20%; grapes, 
5%; hazelnuts, 5%; lemons, <2.5%; lettuce, <2.5%; nectarines, <2.5%; 
onions, 5%; oranges, 5%; peaches, 5%; peanuts, 20%; peanuts (seed 
treatment), 30%; green peas, <2.5%; pecans, 5%; peppers, 20%; 
pistachios, 5%; plums/prunes, <2.5%; potatoes, 40%; potatoes (seed 
treatment), <1%; pumpkins, 20%; rice, 40%; soybeans, 5%; soybeans (seed 
treatment), <1%; spinach, 10%; squash, 20%; strawberries, 25%; sugar 
beets, 10%; sugar beets (seed treatment), <2.5%; sweet corn, 15%; 
tangelos, 25%; tangerines, 10%; tobacco, 15%; tomatoes, 25%; walnuts, 
<2.5%; watermelons, 15%; wheat, 5%; wheat seed (seed treatment), <1%. 
For crops not specified, 100 PCT was used.
    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 azoxystrobin 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

[[Page 57337]]

for azoxystrobin in drinking water. These simulation models take into 
account data on the physical, chemical, and fate/transport 
characteristics of azoxystrobin. 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 Surface Water Concentration Calculator (SWCC) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of azoxystrobin for 
acute exposures are estimated to be 70.2 parts per billion (ppb) for 
surface water and 3.1 ppb for ground water. For chronic exposures for 
non-cancer assessments the EDWCs of azoxystrobin are estimated to be 
48.5 ppb for surface water and 3.1 ppb 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 70.2 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 48.5 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). Azoxystrobin is 
currently registered for the following uses that could result in 
residential exposures: Conventional residential use on turf and 
ornamentals and antimicrobial uses as a materials preservative in 
paints and plastics. The proposed use will not result in additional 
residential exposures. Existing residential uses result in (1) short-
term handler dermal and inhalation exposures for adults; (2) short-term 
post-application dermal exposures for adults, youth 11 to 16 years old, 
children 6 to 11 years old, and children 1 to <2 years old; and (3) 
short-term incidental oral exposures to children 1 to <2 years old. 
Since the effects from inhalation exposure differ from effects from 
oral exposure, the residential handler exposures are not aggregated 
with dietary exposures. No hazard was identified for dermal exposure. 
The Agency's assessment of risk aggregates residential exposure from 
hand-to-mouth incidental oral exposures to children 1 to <2 years old 
from preserved vinyl flooring.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at https://www.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 azoxystrobin to share a common mechanism of 
toxicity with any other substances, and azoxystrobin does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
azoxystrobin 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 website 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. No developmental effects 
were seen in the rabbit and rat developmental toxicity studies, and no 
reproductive or offspring effects were seen in the 2-generation rat 
reproduction study. In the reproduction study, decreased body weights 
and increased adjusted liver weights were observed at the same dose in 
both offspring and parental animals. Therefore, the toxicity data 
showed no increased susceptibility in the young.
    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 for all exposure scenarios except acute 
exposure and episodic granule ingestion. For assessing acute dietary 
risk and episodic oral ingestion of granules, EPA is retaining an FQPA 
factor of 3X to account for the use of a LOAEL from the acute 
neurotoxicity study to derive an acute reference dose. The Agency 
believes that a 3X FQPA SF (as opposed to a 10X) will be adequate to 
extrapolate a NOAEL in assessing acute risk based on the following 
considerations:
     The LOAEL is based on a transient effect (diarrhea in 
rats) expected to be relatively insignificant in nature. This effect is 
also seen in other chemicals of the same class.
     The diarrhea was only seen in studies using gavage dosing 
in the rat, but not in studies using repeat dosing through dietary 
administration in rats or mice, and not through gavage dosing in 
rabbits.
     The very high dose level needed to reach the acute oral 
lethal dose (LD)50 (>5,000 mg/kg), and the overall low 
toxicity of azoxystrobin.
    The decision to reduce the FQPA safety factor to 1X for the 
assessment of the remaining exposure scenarios is based on the 
following findings:
    i. The toxicity database for azoxystrobin is considered sufficient 
for selecting toxicity endpoints and PODs for risk assessment.
    ii. There is no indication that azoxystrobin is a neurotoxic 
chemical. There was no evidence of neurotoxicity seen in the acute 
neurotoxicity study in rats from a single gavage dose up to 2,000 mg/
kg. There was also no evidence of neurotoxicity seen in the subchronic 
neurotoxicity study in rats up to the highest dose tested (201 mg/kg/
day). Therefore, there is no need for a developmental neurotoxicity 
study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that azoxystrobin results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. In the reproduction study, the offspring and the parental 
effects occurred at the same dose level.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary (food) exposure assessments utilized 
conservative upper-bound inputs including assuming 100% CT and 
tolerance-level residues for all commodities except citrus fruits where 
the highest field trial residue was

[[Page 57338]]

used as a refinement. The chronic dietary exposure assessment was 
partially refined, and used tolerance-level residues for all 
commodities and PCT information for selected crops. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to azoxystrobin in drinking water. EPA 
used similarly conservative assumptions to assess post-application 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by azoxystrobin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
azoxystrobin will occupy 82% 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 
azoxystrobin from food and water will utilize 18% of the cPAD for 
children 1-2 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 
azoxystrobin 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). Azoxystrobin 
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 azoxystrobin.
    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 390 for children 
1 to <2 years old. Because EPA's level of concern for azoxystrobin 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). Because no intermediate-term adverse effect was identified, 
azoxystrobin is not expected to pose an intermediate-term risk. 
Therefore, the intermediate-term aggregate risk would be equivalent to 
the chronic dietary exposure estimate.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, azoxystrobin 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 azoxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with nitrogen-
phosphorus detector (GC/NPD) method, RAM 243/04) is available to 
enforce the tolerance expression for residues of azoxystrobin and its 
Z-isomer in crop commodities. This method (designated RAM 243, dated 5/
15/98) has been submitted to FDA for inclusion in the Pesticide 
Analytical Manual (PAM, Volume II).
    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 azoxystrobin in or on root and 
tuber vegetables (except potato) at 1.0 ppm. This MRL is the same as 
the tolerance being established for azoxystrobin in the United States.

C. Response to Comments

    EPA received ten comments to the docket EPA-HQ-OPP-2017-0744. 
However, only three comments were in response to the petition filed by 
Syngenta Crop Protection. One comment (ID: EPA-HQ-OPP-2017-0744-0007) 
among the three, is inclusive of the other two comments (ID: EPA-HQ-
OPP-2017-0744-0008 and EPA-HQ-OPP-2017-0744-0009), and describes 
portions of the content of the Federal Register notice EPA published on 
March 6, 2018 (83 FR 9471), and expresses support for tolerances. The 
remaining seven comments were not germane to this action, therefore no 
further response from the Agency is required.

D. Revisions to Petitioned-For Tolerances

    The Agency recommends increasing the tolerance for vegetable, root, 
except sugar beet, subgroup 1B from the proposed 0.5 ppm to 1.0 ppm to 
harmonize with the existing Codex MRL. Additionally, the Agency is 
revising the significant figure on root vegetables subgroup 1B based on 
current policy and revising the commodity definition to reflect the 
common commodity vocabulary currently used by the Agency. The commodity 
definition was revised from vegetable, root, subgroup 1B to vegetable, 
root, except sugar beet, subgroup 1B.

V. Conclusion

    Therefore, tolerances are established for residues of azoxystrobin, 
in or on beet, sugar, roots at 5.0 ppm and vegetable, root, except 
sugar beet, subgroup 1B at 1.0 ppm.

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

[[Page 57339]]

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: November 1, 2018.
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.  180.507:
0
a. Remove the entry for ``Vegetable, root, subgroup 1A'' from the table 
in paragraph (a)(1).
0
b. Add alphabetically ``Beet, sugar, roots''; and ``Vegetable, root, 
except sugar beet, subgroup 1B'' to the table in paragraph (a)(1).
    The additions read as follows:

Sec.  180.507  Azoxystrobin; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Beet, sugar, roots..........................................         5.0
 
                                * * * * *
Vegetable, root, except sugar beet, subgroup 1B.............         1.0
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-24974 Filed 11-14-18; 8:45 am]
 BILLING CODE 6560-50-P