[Federal Register Volume 83, Number 95 (Wednesday, May 16, 2018)]
[Rules and Regulations]
[Pages 22595-22601]
[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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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:<PHONE_NUMBER>; 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

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

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

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

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

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:<PHONE_NUMBER>; 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,

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