Document ID: EPA-HQ-OPP-2018-0094-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Tebuconazole
Posted Date: 2019-11-12T05:00Z

[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Rules and Regulations]
[Pages 60932-60937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24267]

[[Page 60932]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0094; FRL-10001-27]

Tebuconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
tebuconazole in or on multiple commodities which are identified and 
discussed later in this document. In addition, this regulation removes 
certain established tebuconazole tolerances that are superseded by new 
tolerances established in this final rule. Interregional Research 
Project Number 4 (IR-4) requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 12, 2019. Objections and 
requests for hearings must be received on or before January 13, 2020, 
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-2018-0094, 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 
Publishing 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-2018-0094 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 13, 2020. 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-2018-0094, 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 July 24, 2018 (83 FR 34968) (FRL-9980-
31), 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 
7E8648) by 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 180.474 be amended by establishing 
tolerances for residues of the fungicide tebuconazole, including its 
metabolites and degradates, determined by measuring only alpha-[2-(4-
chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-
ethanol, in or on Brassica, leafy greens, subgroup 4-16B, except 
watercress at 2.5 parts per million (ppm); Cottonseed, subgroup 20C at 
2.0 ppm; Fruit, pome, group 11-10 at 1.0 ppm; Fruit, small, vine 
climbing, except fuzzy kiwifruit, subgroup 13-07F at 6.0 ppm; Fruit, 
stone, group 12-12, except cherry at 1.0 ppm; Nut, tree, group 14-12 at 
0.05 ppm; Sunflower, subgroup 20B at 0.1 ppm; Tropical and subtropical, 
small fruit, inedible peel, subgroup 24A at 1.6 ppm; and Watercress at 
9.0 ppm.
    Upon establishment of the above tolerances, the petitioner 
requested that the following established tolerances be removed from 40 
CFR 180.474: Brassica, leafy greens, subgroup 5B at 2.5 ppm; Cotton, 
undelinted seed at 2.0 ppm; Fruit, pome, group 11 at 0.05 ppm; Fruit, 
stone, group 12, except cherry at 1.0 ppm; Grape at 5.0 ppm; Lychee at 
1.6 ppm; Nut, tree, group 14 at 0.05 ppm; Peach at 1.0 ppm; Pistachio 
at 0.05 ppm; Plum, pre- and post-harvest at 1.0 ppm; and Sunflower, 
seed at 0.05 ppm, as they are superseded by this regulation. That 
document referenced a summary of the petition prepared by Makhteshim 
Agan of North America (``ADAMA''), the registrant, which is available 
in the docket, http://www.regulations.gov. There were no comments 
received in response to the notice of filing.

[[Page 60933]]

    Based upon review of the data supporting the petition, EPA is 
establishing tolerances that vary slightly from what was requested. The 
reasons 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 tebuconazole including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with tebuconazole 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.
    A summary of the toxicological profile for tebuconazole can be 
found in the final rule published in the Federal Register on November 
15, 2013 (78 FR 68741) (FRL-9392-1). Specific information on the 
studies received and the nature of the adverse effects caused by 
tebuconazole 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, 
``Tebuconazole: Human Health Aggregate Risk Assessment for 
Establishment of Registrations and a Permanent Tolerance for Residues 
in/on Watercress, Add Greenhouse Tomato to Label and Crop Group 
Conversions/Expansions to Brassica Leafy Greens, Subgroup 4-16B, Except 
Watercress; Cottonseed, Subgroup 20C; Pome Fruit, Group 11-10, Stone 
Fruit, Group 12-12, Except Cherry; Small Vine Climbing Fruit, Except 
Fuzzy Kiwifruit, Subgroup 13-07F; Tropical and Subtropical Small Fruit, 
Inedible Peel, Subgroup 24A, Tree Nut, Group 14-12 and Sunflower, 
Subgroup 20B'' at pages 45-48 in docket ID number EPA-HQ-OPP-2018-0094.

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 tebuconazole used for 
human risk assessment is discussed in Unit III of the final rule 
published in the Federal Register of November 15, 2013 (78 FR 68741) 
(FRL-9392-1).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tebuconazole, EPA considered exposure under the petitioned-
for tolerances as well as all existing tebuconazole tolerances in 40 
CFR 180.474. EPA assessed dietary exposures from tebuconazole 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 tebuconazole. In estimating acute dietary exposure, EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID) Version 3.16. This software uses food 
consumption information from the United States Department of 
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination 
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in 
food, a partially refined acute probabilistic dietary exposure 
assessment was conducted for all existing and proposed uses of 
tebuconazole. For the acute assessment, anticipated residues for 
grapes, grape juice, tree nuts, pome fruits, fruiting vegetables, 
cucurbit vegetables, banana, plantain, asparagus, hops, bulb onion and 
green onion subgroups, lychee, Brassica leafy green subgroup, mango, 
livestock commodities, and stone fruit were used. Data for peach, 
grapes, and oranges were derived using the latest USDA Pesticide Data 
Program (PDP) monitoring data. Anticipated residues for all other 
registered and proposed food commodities were based on field trial data 
or feeding studies. Anticipated residues for all current uses were 
further refined using percent crop treated (PCT) data where available. 
Percentage of imported orange juice and oranges were also provided. 
DEEM 2018 default and some empirical processing factors were assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used DEEM-FCID, Version 3.16, which uses the food 
consumption data from the USDA 2003-2008 NHANES/WWEIA. As to residue 
levels in food, estimates from PDP data (mean residue levels) and 
average residues from field trials were used. Mean residue levels from 
PDP were used for apple, arugula, asparagus, snap bean, black bean, 
broad been, cowpea, great northern bean, kidney bean, lima bean, mung 
bean, navy bean, pinto bean, cantaloupe, cherry, chickpea, chives, 
fresh leaves, crabapple, garden and upland cress, cucumber, garden beet 
roots, goji berry, grape, raisin, grape juice, guar seed,

[[Page 60934]]

honeydew melon, leeks, lentil seed, loquat, milk, nectarine, mustard 
greens, oats, oat bran, green onion, oranges, orange juice, orange 
peel, peach, peach baby food, canned peach, peanut, peanut butter, 
pear, bell peppers, non-bell peppers, plum, rape greens, shallot bulb, 
shallot fresh leaves, soybean, summer squash, winter squash, tomatillo, 
tomato, tree tomato, watermelon, wheat grain and flour. In some cases, 
data were translated from representative commodities of their crop 
group.
    iii. Cancer. Based on the data cited in Unit III.A. of the 
previously referenced document, Federal Register, November 15, 2013 (78 
FR 68741) (FRL-9392-1), EPA has concluded that a nonlinear RfD approach 
is appropriate for assessing cancer risk to tebuconazole. The chronic 
risk assessment or RfD approach is considered to be protective of any 
cancer effects; therefore, a separate quantitative cancer risk 
assessment is not required.
    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, and 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.
    For the acute dietary risk assessment, the Agency used the maximum 
PCT estimates for the following crops that are currently registered for 
tebuconazole: almonds 15%; apples 2.5%; apricots 20%; asparagus 30%; 
barley 2.5%; beans, green 2.5%; cantaloupes 10%; cherries 45%; corn 
2.5%; cotton 2.5%; cucumbers 2.5%; dry beans/peas 5%; garlic 95%; 
grapes 40%; nectarines 30%; oats 2.5%; onions 5%; peaches 25%; peanuts 
65%; pears 5%; pecans 25%; pistachios 15%; plums/prunes 5%; pumpkins 
10%; soybeans 2.5%; squash 5%; sweet corn 5%; walnut 5%, and wheat 20%.
    In the chronic dietary risk assessment, EPA used the average 
percent crop treated estimates for the following crops that are 
currently registered for tebuconazole: almonds 5%; apples 2.5%; 
apricots 10%; asparagus 5%; barley 2.5%; beans, green 1%; cantaloupes 
2.5%; cherries 25%; corn 1%; cotton 1%; cucumbers 1%; dry beans/peas 
2.5%; garlic 65%; grapes 25%; nectarines 20%; oats 2.5%; onions 5%; 
peaches 10%; peanuts 45%; pears 5%; pecans 10%; pistachios 5%; plums/
prunes 2.5%; pumpkins 2.5%; soybeans 1%; squash 2.5%; sweet corn 2.5%; 
walnuts 2.5%; watermelons 15%; and wheat 15%.
    The following estimated percent import estimates for the import 
oranges were used: For acute risk, orange 16%; and orange juice 58%; 
and for chronic risk: orange 12%; orange juice 46%. For all other crops 
not listed above, EPA assumed 100 PCT.
    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 tebuconazole 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 tebuconazole in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of tebuconazole. 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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the EDWCs of tebuconazole for acute exposures are 
estimated to be 87.7 parts per billion (ppb) for surface water and 1.56 
ppb for ground water. For chronic exposures for non-cancer assessments 
are estimated to be 68.8 ppb for surface water and 1.56 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, a

[[Page 60935]]

distribution of 30-year daily surface water concentration was estimated 
for the EDWCs of tebuconazole. For chronic dietary risk assessment, the 
water concentration of value 68.8 ppb was used to assess the 
contribution to drinking water. The Agency is relying on the drinking 
water residues used in the dietary risk assessment previously provided, 
``Drinking water and ecological risk for new use of tebuconazole/
fluoxastrobin combination for turf and ornamental use'', which can be 
found at http://regulations.gov, under docket ID number EPA-HQ-OPP-
2013-0653-0007.
    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).
    Tebuconazole is currently registered for the following uses that 
could result in residential exposures: Golf course turf, flower 
gardens, trees and ornamentals, and pressure treated wood that were 
assessed previously. No new residential uses of tebuconazole are 
associated with this petition.
    EPA assessed residential exposure using the following assumptions: 
For residential handlers, exposure is expected to be short-term. 
Intermediate-term exposures are not likely because of the intermittent 
nature of applications by homeowners. For post-application exposures, 
the Agency assessed residential dermal and incidental oral post-
application exposure for adults and children golfing, working in 
gardens, and performing physical activities on pressure-treated wood 
after application of tebuconazole as scenarios where homeowners may 
receive exposure to tebuconazole residues. Post-application exposure is 
expected to be short-term in duration. For assessment of both handler 
and post-application exposures, dermal and inhalation exposures were 
combined since the same endpoint and point of departure (POD) are used 
for both routes of exposure.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticidescience-and-assessing-pesticide-risks/standard-operating-proceduresresidential-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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to tebuconazole and any other 
substances. Previously, HED concluded that there are no conclusive data 
that the conazoles share a common mechanism of toxicity; however, EPA 
is in the process of re-examining these data as part of registration 
review. Although the conazole fungicides (triazoles) produce 1,2,4 
triazole and its acid-conjugated metabolites (triazolylalanine and 
triazolylacetic acid), 1,2,4 triazole and its acid-conjugated 
metabolites do not contribute to the toxicity of the parent conazole 
fungicides (triazoles). Tebuconazole does not appear to produce any 
other toxic metabolite produced by other substances. For the purposes 
of this action, therefore, EPA has not assumed that tebuconazole has 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
    The Agency has assessed the aggregate risks from the 1,2,4 triazole 
and its acid-conjugated metabolites (triazolylalanine and 
triazolylacetic acid) separately. The most recent assessment is dated 
August 8, 2018, titled, ``Common Triazole Metabolites: Updated 
Aggregate Human Health Risk Assessment to Address New Section 3 
Registrations for Use of Prothioconazole and Tebuconazole.'' EPA 
concluded that the current uses of tebuconazole do not significantly 
change the results of that aggregate human health risk assessment. 
Therefore, the aggregate exposure to the triazole metabolites remains 
below EPA's level of concern.

D. Safety Factor for Infants and Children

    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.
    EPA has determined that reliable data support reducing the FQPA SF 
to 3X, as that factor will be safe for infants and children. Detailed 
discussions of the Agency's FQPA SF rationale can be found in the final 
rule published in the Federal Register on May 16, 2018 (83 FR 22995) 
(FRL9976-62), which also established tolerances for tebuconazole in/on 
various food commodities, and in the risk assessment document for the 
subject rulemaking found in docket ID number EPA-HQ-OPP-2018-0094 at 
http://www.regulations.gov, ``Tebuconazole: Human Health Aggregate Risk 
Assessment for Establishment of Registrations and a Permanent Tolerance 
for Residues in/on Watercress, Add Greenhouse Tomato to Label and Crop 
Group Conversions/Expansions to Brassica Leafy Greens, Subgroup 4-16B, 
Except Watercress; Cottonseed, Subgroup 20C; Pome Fruit, Group 11-10, 
Stone Fruit, Group 12-12, Except Cherry; Small Vine Climbing Fruit, 
Except Fuzzy Kiwifruit, Subgroup 13-07F; Tropical and Subtropical Small 
Fruit, Inedible Peel, Subgroup 24A, Tree Nut, Group 14-12 and 
Sunflower, Subgroup 20B''.

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. The 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 
tebuconazole will occupy 94% of the aPAD for children 1 to 2 years old, 
the population group receiving the greatest exposure.
    2. Chronic risk. There are no residential use patterns that result 
in chronic residential exposure to residues of tebuconazole. Dietary 
(food and water) route of exposure alone is

[[Page 60936]]

relevant to chronic aggregate risk. The combined chronic dietary 
exposure from food and drinking water is estimated to be 5.7% of the 
cPAD for the general U.S. population and 14% of the cPAD for all 
infants, the population subgroup with the highest estimated chronic 
dietary exposure to tebuconazole.
    3. Short- and Intermediate-term risks. Short- and intermediate-term 
aggregate exposure take into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). For short-term 
aggregate risk assessments, a deterministic approach was used in which 
point estimates of exposure from each source are added together; and 
each of the point estimates used are in turn deterministic. Dietary 
exposure estimates use point estimates for food and drinking water 
residues (anticipated residues based on PDP data, field trial data, 
tolerance level residues, and PCT) and the residential scenarios also 
employ point estimates (central to high-end values considered 
protective). Exposures are assumed to occur over the same time frame, 
and no use frequency data are considered. There is the potential for 
residential exposure to co-occur with background dietary exposure over 
the short-term (1-30 days), whereas co-occurring intermediate exposures 
(1-6 months) are less likely. However, since the POD employed for both 
durations are the same, the aggregate assessments address both exposure 
durations.
    EPA reassessed residential post-application exposure from 
registered golf course use and the impact on aggregate risk using the 
TTR study. Using data from the TTR study for non-irrigated and 
irrigated plots, EPA calculated residential post-application exposure 
and risk estimates for population subgroups including; adults, youths 
11 to <16 years old, and children 6 to <11 years old. For these age 
groups, the activity of golfing results in MOEs for irrigated turf 
ranging from 2,100 in youth 6 to less than 11 years old to 2,500 in 
adults. For non-irrigated turf, for the same population subgroups, MOEs 
range from 560 to 660. Under the golfing scenario for both irrigated 
and non-irrigated turf and for each population subgroup, resulting MOEs 
were all greater than the level of concern (LOC) of 300. Residential 
exposures and risk estimates from gardens, trees, ornamentals, and 
pressure treated wood were unchanged from the most recent previous 
assessments which reported MOEs greater than EPA's LOC of 300.
    4. Aggregate cancer risk for U.S. population. Based on the Agency's 
determination that the chronic risk assessment will be protective of 
any cancer effects, a separate quantitative cancer risk assessment was 
not conducted. Because there is no chronic risk of concern from 
aggregate exposure to tebuconazole, the Agency concludes that aggregate 
exposure to tebuconazole will not result in cancer risks of concern.
    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 tebuconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate gas chromatographic methods with nitrogen/phosphorus 
detection (GC/NPD) methods are available for enforcing tolerances in 
plant and livestock commodities. These methods have undergone an 
independent laboratory validation and a petition method validation 
(PMV). The methods are available in the residue analytical method index 
on EPA's website and may also 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 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. Tolerances established 
in this rulemaking are harmonized with established Codex MRLs, except 
for apricot. The Codex MRL for apricot is 2 ppm. EPA is establishing a 
tolerance of 1 ppm for plum subgroup 12-12C, which harmonizes with the 
Codex MRLs for eight commodities in that subgroup other than apricot.

C. Revisions to Petitioned-For Tolerances

    Instead of establishing a tolerance for Fruit, stone, group 12-12, 
except cherry, EPA is establishing tolerances for the subgroups in 
group 12-12 to harmonize with the relevant Codex MRLs. The Codex MRLs 
for nectarine and peach are 2 ppm, so EPA is establishing a U.S. 
tolerance for peach, subgroup 12-12B at 2 ppm. EPA is establishing a 
U.S. tolerance of 1 ppm for plum, subgroup 12-12C, which is harmonized 
with the Codex MRLs for eight commodities in that subgroup. In 
addition, several tolerances are being established at different levels 
than requested to conform with EPA rounding class practice by removing 
the trailing zero.

V. Conclusion

    Therefore, tolerances are established for residues of tebuconazole, 
including its metabolites and degradates, determined by measuring only 
alpha-[2-(4-chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-
triazole-1-ethanol, in or on Brassica, leafy greens, subgroup 4-16B, 
except watercress at 2.5 ppm; Cottonseed, subgroup 20C at 2 ppm; Fruit, 
pome, group 11-10 at 1 ppm; Fruit, small, vine climbing, except fuzzy 
kiwifruit, subgroup 13-07F at 6 ppm; Nut, tree, group 14-12 at 0.05; 
Peach subgroup 12-12B at 2 ppm; Plum subgroup 12-12C at 1 ppm; 
Sunflower, subgroup 20B at 0.1 ppm; Tropical and subtropical, small 
fruit, inedible peel, subgroup 24A at 1.6 ppm; and Watercress at 9 ppm. 
In addition, EPA is removing the following tolerances from paragraph 
(a)(1) because they are superseded by the new tolerances being 
established in this rulemaking: Brassica, leafy greens, subgroup 5B at 
2.5 ppm; Cotton, undelinted seed at 2.0 ppm; Fruit, pome, group 11 at 
0.05 ppm; Fruit, stone, group 12, except cherry at 1.0 ppm; Grape at 
5.0 ppm; Lychee at 1.6 ppm; Nut, tree, group 14 at 0.05 ppm; Peach at 
1.0 ppm; Pistachio at 0.05 ppm; Plum, pre- and post-harvest at 1.0 ppm; 
and Sunflower, seed at 0.05 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 Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory

[[Page 60937]]

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 tolerances 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: October 25, 2019.
Daniel Rosenblatt,
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. In Sec.  180.474, amend the table in paragraph (a)(1) as follows:
0
a. Remove the entry for ``Brassica, leafy greens, subgroup 5B'';
0
b. Add alphabetically the entry for ``Brassica, leafy greens, subgroup 
4-16B, except watercress'';
0
c. Remove the entry for ``Cotton, undelinted seed'';
0
d. Add alphabetically the entry for ``Cottonseed, subgroup 20C'';
0
e. Remove the entry for ``Fruit, pome, group 11'';
0
f. Add alphabetically the entries for ``Fruit, pome, group 11-10'' and 
``Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-
07F'';
0
g. Remove the entries for ``Fruit, stone, group 12, except cherry''; 
``Grape''; ``Lychee''; and ``Nut, tree, group 14'';
0
h. Add alphabetically the entry for ``Nut, tree, group 14-12'';
0
i. Remove the entry for ``Peach'';
0
j. Add alphabetically the entry for ``Peach subgroup 12-12B'';
0
k. Remove the entries for ``Pistachio'' and ``Plum, pre- and post-
harvest'';
0
l. Add alphabetically the entry for ``Plum subgroup 12-12C'';
0
m. Remove the entry for ``Sunflower, seed''; and
0
n. Add alphabetically the entries for ``Sunflower, subgroup 20B''; 
``Tropical and subtropical, small fruit, inedible peel, subgroup 24A''; 
and ``Watercress''.
    The additions read as follows:

Sec.  180.474  Tebuconazole; tolerances for residues.

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

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Brassica, leafy greens, subgroup 4-16B, except watercress...         2.5
 
                                * * * * *
Cottonseed, subgroup 20C....................................           2
Fruit, pome, group 11-10....................................           1
Fruit, small, vine climbing, except fuzzy kiwifruit,                   6
 subgroup 13-07F............................................
 
                                * * * * *
Nut, tree, group 14-12......................................        0.05
 
                                * * * * *
Peach subgroup 12-12B.......................................           2
 
                                * * * * *
Plum subgroup 12-12C........................................           1
 
                                * * * * *
Sunflower, subgroup 20B.....................................         0.1
Tropical and subtropical, small fruit, inedible peel,                1.6
 subgroup 24A...............................................
 
                                * * * * *
Watercress..................................................           9
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-24267 Filed 11-8-19; 8:45 am]
BILLING CODE 6560-50-P