[Federal Register Volume 83, Number 95 (Wednesday, May 16, 2018)]
[Rules and Regulations]
[Pages 22595-22601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10345]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0032; FRL-9976-62]


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 ginseng, fresh at 0.15 parts per million (ppm) 
and ginseng, dried at 0.40 ppm. Bayer CropScience LP, requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 16, 2018. Objections and 
requests for hearings must be received on or before July 16, 2018, 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-2017-0032, 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, Director, 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-2017-0032 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 
July 16, 2018. 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

[[Page 22596]]

by docket ID number EPA-HQ-OPP-2017-0032, 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 April 10, 2017 (82 FR 17175) (FRL-9959-
61), 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 
6E8534) by Bayer CropScience LP, 2 T.W. Alexander Drive, P.O. Box 
12014, Research Triangle Park, NC 27709. The petition requested that 40 
CFR part 180 be amended by establishing tolerances for residues of 
tebuconazole, [alpha]-[2-(4-Chlorophenyl)ethyl]-[alpha]-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol, in or on ginseng, fresh at 
0.15 ppm and ginseng, dried/red at 0.4 ppm. This document referenced a 
summary of the petition prepared by Bayer CropScience LP, the 
registrant, which is available in the docket, http://www.regulations.gov. No comments were received in response to the 
notice of filing.

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 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.
    The toxicological profile remains unchanged from the discussion 
contained in the final rule published in the Federal Register on 
November 15, 2013 (78 FR 68741) (FRL-9392-1), which is hereby 
incorporated into this document.
    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 Human Health Aggregate Risk Assessment 
for Establishment of a Permanent Tolerance Without U.S. Registration 
for Residues in/on Ginseng at pages 24-26 in docket ID number EPA-HQ-
OPP-2017-0032.

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 can be found in the preamble to the final rule 
published in the Federal Register on November 15, 2013.

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 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 somewhat refined acute probalistic dietary exposure assessment 
was conducted for all existing and proposed food uses of tebuconazole. 
For the acute assessment, anticipated residues for grapes, grape juice, 
and peaches 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. 
Anticipated residues for all current uses were further refined

[[Page 22597]]

using percent crop treated (%CT) data where available. Percentage of 
imported orange juice and oranges were also provided. Default DEEM 
(ver. 7.81) and empirical processing factors were assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
(NHANES/WWEIA). As to residue levels in food, EPA used field trial 
data, USDA PDP data, assumed PCT data levels and used empirical DEEM 
(ver. 7.81) default processing factors as described in Unit III.C.iv.
    iii. Cancer. Based on the data summarized in Unit III.A., 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 cancer assessment was not conducted.
    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.
    For the acute assessment, the Agency estimated the PCT for existing 
uses as follows: 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%; plums/prunes 5%; soybeans 2.5%; squash 5%; 
sweet corn 5%; and wheat 25%.
    For the chronic assessment, the Agency estimated the PCT for 
existing uses as follows: 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 5%.
    The following estimated percent import estimates for the import 
oranges were used: Acute: Orange 16%; and orange juice 58%; Chronic: 
orange 12%; orange juice 46%. For all other crops not listed above, EPA 
assumed that 100% of the crop was treated.
    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 (DPR) 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 figure for each existing 
use is derived by combining available public and private market survey 
data for that use, averaging across all observations, and rounding to 
the nearest 5%, except for those situations in which the average PCT is 
less than 2.5% or 1%. In those cases, EPA uses 2.5% or 1%, 
respectively, as the average PCT value. The maximum PCT figure is the 
highest observed maximum value reported within the 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 in those 
situations in which the maximum PCT is less than 2.5%, in which case, 
the Agency uses 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 estimated drinking water concentrations (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 and for 
chronic exposures are estimated to be 68.8 ppb for surface water and 
1.56 ppb for ground water.
    Modeled estimates of drinking water concentrations were previously 
entered into the dietary exposure model. For acute dietary risk 
assessment, a 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 previously 
used to assess the

[[Page 22598]]

contribution to drinking water. Because the use of tebuconazole on 
ginseng is not associated with a U.S. registration, there is no impact 
on drinking water residues. As a result, 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: Turf, flower gardens, trees, ornamentals, and 
pressure-treated wood.
    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 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) is 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/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    Because no new residential uses are being requested at this time, 
an updated residential exposure assessment would not normally be 
required. Each of the existing residential use patterns had been 
previously assessed and the resulting exposures and risk estimates did 
not exceed the agency's LOC. Since those assessments were conducted, 
however, a turf transferrable residue (TTR) study required by the 
Agency in 2013 was submitted to support a reevaluation of the aggregate 
exposures from the registered use on golf course turf. In addition, the 
agency updated the residential standard operating procedures and body 
weights to be used in all human health assessments. Therefore, the 
existing residential use patterns were reassessed using the updated 
procedures and data, since the residential exposures can impact the 
aggregate assessment for tebuconazole. The TTR study is reviewed in a 
separate HED memorandum available in the docket EPA-HQ-OPP-2017-0032.
    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.''
    Tebuconazole is a member of the conazole class of fungicides 
containing the 1,2,4-triazole moiety. Although conazoles act similarly 
in plants (fungi) by inhibiting ergosterol biosynthesis, there is not 
necessarily a relationship between their pesticidal activity and their 
mechanism of toxicity in mammals. Structural similarities do not 
constitute a common mechanism of toxicity. Evidence is needed to 
establish that the chemicals operate by the same, or essentially the 
same, sequence of major biochemical events. In conazoles, however, a 
variable pattern of toxicological responses is found; some are 
hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors 
in rats. Some induce developmental, reproductive, and neurological 
effects in rodents. Furthermore, the conazoles produce a diverse range 
of biochemical events including altered cholesterol levels, stress 
responses, and altered DNA methylation. It is not clearly understood 
whether these biochemical events are directly connected to their 
toxicological outcomes. Thus, there is currently no conclusive data to 
indicate that conazoles share common mechanisms of toxicity, and EPA is 
not following a cumulative risk approach based on a common mechanism of 
toxicity for the conazoles. For information regarding EPA's procedures 
for cumulating effects from substances found to have a common mechanism 
of toxicity, see EPA's website at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
    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. Although the conazoles 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 conazoles. The Agency has assessed the 
aggregate risks from the 1,2,4 triazole and its acid-conjugated 
metabolites (triazolylalanine and triazolylacetic acid) separately. 
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.

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. The toxicity database for 
tebuconazole includes prenatal developmental toxicity studies in three 
species (mouse, rat, and rabbit), a reproductive toxicity study in 
rats, and a developmental neurotoxicity study in rats. The data from 
prenatal developmental toxicity studies in mice and a developmental 
neurotoxicity study in rats indicated an increased quantitative and 
qualitative susceptibility following in utero exposure to tebuconazole. 
The NOAELs/LOAELs for developmental toxicity in these studies were 
found at dose levels less than those that induce maternal toxicity or 
in the presence of slight maternal toxicity. There was no indication of 
increased quantitative susceptibility in the rat and rabbit 
developmental toxicity studies, the NOAELs for developmental toxicity 
were comparable to or higher than the NOAELs for maternal toxicity. In 
all three species, however, there was indication of increased 
qualitative susceptibility. For most studies, minimal maternal toxicity 
was seen at the LOAEL (consisting of increases in

[[Page 22599]]

hematological findings in mice, increased liver weights in rabbits and 
rats, and decreased body weight gain/food consumption in rats) and did 
not increase substantially in severity at higher doses. However, there 
was more concern for the developmental effects at each LOAEL, which 
included increases in runts, increased fetal loss, and malformations in 
mice; increased skeletal variations in rats; and increased fetal loss 
and frank malformations in rabbits. Additionally, more severe 
developmental effects (including frank malformations) were seen at 
higher doses in mice, rats and rabbits. In the developmental 
neurotoxicity study, maternal toxicity was seen only at the high dose 
(decreased body weights, body weight gains, and food consumption, 
prolonged gestation and dystocia as well as decreased offspring 
survival).
    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 3X. That decision is based on the following 
findings:
    i. The toxicity database for tebuconazole is complete.
    ii. Tebuconazole demonstrated neurotoxicity in the acute 
neurotoxicity study in rats; the lowest observable adverse effect level 
(LOAEL) of 100 mg/kg/day was based on increased motor activity in male 
and female rats and decreased footsplay in female rats. Although the 
subchronic neurotoxicity study was unacceptable since there was 
inadequate dosing, a new subchronic neurotoxicity study is not needed 
to evaluate levels at which subchronic neurotoxicity might occur; 
neurotoxicity was seen in other studies in the database at considerably 
lower doses than those tested in the subchronic neurotoxicity study. 
Malformations indicative of nervous system development disruption were 
seen in developmental toxicity studies in mice, rats, and rabbits. 
Neurotoxicity was also seen in the rat developmental neurotoxicity 
study as decreases in body weights, decreases in absolute brain 
weights, changes in brain morphometric parameters, and decreases in 
motor activity in offspring at the LOAEL of 8.8 mg/kg/day; a no 
observable adverse effect level (NOAEL) could not be established. The 
LOAEL (8.8 mg/kg/day) was employed as the point of departure (POD) for 
assessing risk for all exposure scenarios, and an FQPA SF of 3X has 
been retained as an uncertainty factor for use of a LOAEL to 
extrapolate a NOAEL (UFL). To determine whether the UFL is protective 
of any potential neurotoxicity, a Benchmark Dose (BMD) analysis of the 
datasets relevant to the adverse offspring effects (decreased body 
weight and brain weight) seen at the LOAEL in the developmental 
neurotoxicity (DNT) study was conducted. All of the BMDLs (benchmark 
dose lower limit) modeled successfully on statistically significant 
effects were 1-2X lower than the LOAEL. Therefore, an extrapolated 
NOAEL is not likely to be 10X lower than the LOAEL and that use of an 
UFL of 3X would not underestimate risk. Using an FQPA SF of 3X in risk 
assessment results in a NOAEL of 2.9 mg/kg/day (8.8 mg/kg/day / 3X = 
2.9 mg/kg/day), which is further supported by other studies in the 
tebuconazole toxicity database, with the lowest NOAELs being 3 and 2.9 
mg/kg/day, from a developmental toxicity study in mice and a chronic 
toxicity study in dogs, respectively (respective LOAELs 10 and 4.5 mg/
kg/day).
    iii. There were increases in qualitative susceptibility in the 
prenatal developmental studies in rats, mice, and rabbits and in 
quantitative susceptibility in mice and developmental neurotoxicity in 
rats. However, the toxicity endpoint observed in developmental 
neurotoxicity study in rats was employed to establish the point of 
departure (POD) for risk assessment for all exposure scenarios. This 
toxicity endpoint was the most sensitive one, and the resulting POD was 
protective of all adverse effects found in the tebuconazole toxicity 
database. Therefore, the degree of concern for residual uncertainties 
for prenatal and/or postnatal toxicity was low.
    iv. There are no residual uncertainties identified in the exposure 
databases. EPA utilized a tiered approach in estimating exposure to 
tebuconazole. While some refinements were incorporated into dietary and 
residential exposure calculations, EPA is confident that the aggregate 
risk from exposure to tebuconazole in food, water and residential 
pathways will not be underestimated. The acute and chronic dietary 
exposure assessments incorporated somewhat refined estimates of 
residues in food commodities from reliable field trial data reflecting 
maximum use conditions, recent monitoring data from USDA's Pesticide 
Data Program (PDP), and relevant market survey data on the percentage 
of crops treated. Estimated concentrations of tebuconazole in drinking 
water were incorporated into the chronic dietary analysis as the upper 
bound point estimate and into the probabilistic acute dietary analysis 
as a distribution. For the residential exposure pathways (ornamentals, 
golf course turf, and treated wood products), potential exposure 
resulting from tebuconazole outdoor uses in the residential setting was 
assessed using screening-level inputs that assumes an adult or child 
will come in contact with turf and other surfaces immediately after 
application.

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 tebuconazole will occupy 77% of the aPAD for all infants (< 1 year 
old), the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
tebuconazole from food and water will utilize 22% of the cPAD for all 
infants (< 1 year 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 
tebuconazole is not expected.
    3. Short-term risk and Intermediate-term risk. Short-term and 
intermediate-term risk aggregate exposure takes into account short-term 
residential exposure and intermediate-term residential exposure plus 
chronic exposure to food and water (considered to be a background 
exposure level). Tebuconazole is currently registered for uses that 
could result in short-term residential exposure that could 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. Using 
the exposure assumptions described in this unit for short-term 
exposures, EPA has concluded that residential exposures result in 
aggregate MOEs of 580 for adults, 600 for youths 11 to <16 years old, 
and children 6 to <11 years

[[Page 22600]]

500 for the activity of golfing and 330 for children (1-2 years old) 
engaging in activities on pressure treated wood surfaces. Because EPA's 
level of concern (LOC) for tebuconazole is a MOE of 300 or below, these 
MOEs are not of concern. Therefore, aggregate risk estimates for all 
examined population subgroups were not of concern to the Agency.
    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. Aggregate Assessment for Free Triazole & its Conjugates. The 
conazole class of compounds, which includes tebuconazole, can form the 
common metabolite 1,2,4-triazole and two triazole conjugates 
(triazolylalanine and triazolylacetic acid). To support existing 
tolerances and to establish new tolerances for triazole-containing 
pesticides, including tebucaonazole, EPA conducted a human health risk 
assessment for exposure to 1,2,4-triazole, triazolylalanine, and 
triazolylacetic acid resulting from the use of all current and pending 
uses of any triazole-containing fungicide. The risk assessment is a 
highly conservative, screening-level evaluation in terms of hazards 
associated with common metabolites (e.g., use of a maximum combination 
of uncertainty factors) and potential dietary and non-dietary exposures 
(i.e., high end estimates of both dietary and non-dietary exposures). 
The Agency retained a 3X for the LOAEL to NOAEL safety factor when the 
reproduction study was used. In addition, the Agency retained a 10X for 
the lack of studies including a developmental neurotoxicity (DNT) 
study. The assessment includes evaluations of risks for various 
subgroups, including those comprised of infants and children. The 
Agency's complete risk assessment is found in the propiconazole 
reregistration docket at http://www.regulations.gov, Docket 
Identification (ID) Number EPA-HQ-OPP-2005-0497. The Agency's latest 
updated aggregate risk assessment for the triazole-containing 
metabolites was finalized on July 18, 2017 and includes the proposed 
new uses of tebuconazole. That assessment concluded that aggregate 
exposure to the triazole metabolites does not exceed the Agency's level 
of concern.
    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 tebuconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Gas Chromatography/Nitrogen 
Phosphorus Detector (GC/NPD) is available to enforce the tolerance 
expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established MRLs for tebuconazole in or on ginseng 
and ginseng, dried at 0.15 ppm and 0.40 ppm, respectively. These MRLs 
are the same as the tolerances established for tebuconazole in the 
United States.

C. Revisions to Petitioned-For Tolerances

    For dried ginseng, the Agency is revising the commodity definition 
for the requested tolerance to reflect the correct commodity vocabulary 
currently used by the Agency. Specifically, ginseng dried/red was 
changed to ginseng, dried. Additionally, the Agency is revising the 
significant figures for the tolerance level based on current policy.

V. Conclusion

    Therefore, tolerances are established for residues of tebuconazole, 
[alpha]-[2-(4-Chlorophenyl)ethyl]-[alpha]-(1,1-dimethylethyl)-1H-1,2,4-
triazole-1-ethanol, in or on ginseng, dried at 0.40 ppm and ginseng, 
fresh at 0.15 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 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); Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997); or 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,

[[Page 22601]]

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: April 30, 2018.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Program.
    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, add alphabetically the entries ``Ginseng, dried'' 
and ``Ginseng, fresh'' to the table in paragraph (a)(1) to read as 
follows:


Sec.  180.474   Tebuconazole; tolerances for residues.

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

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Ginseng, dried \1\......................................            0.40
Ginseng, fresh \1\......................................            0.15
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations.

* * * * *
[FR Doc. 2018-10345 Filed 5-15-18; 8:45 am]
 BILLING CODE 6560-50-P


