[Federal Register Volume 79, Number 88 (Wednesday, May 7, 2014)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10216]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Tebuconazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
tebuconazole in or on orange and orange, oil. Bayer CropScience, LP
requested these tolerances under the Federal Food, Drug, and Cosmetic
DATES: This regulation is effective May 7, 2014 Objections and requests
for hearings must be received on or before July 7, 2014, 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-2013-0653, 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), EPA West 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: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: [email protected].
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-2013-0653 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 7, 2014. 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-2013-0653, 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
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.htm.
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 October 25, 2013 (78 FR 63938) (FRL-
9901-96), 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
2E8138) by Bayer CropScience LP, P.O. Box 12014, 2 T. W. Alexander
Drive, Research Triangle Park, NC 27709. The petition requested that
EPA establish import tolerances for residues of the fungicide
tebuconazole, in or on orange, whole fruit at 1 part per million (ppm);
orange, juice at 0.15 ppm; and orange, oil at 400 ppm. That document
referenced a summary of the petition prepared by Bayer CropScience LP,
the registrant, which is available in the docket, http://www.regulations.gov. Subsequently, the petitioner submitted a revised
petition that requested different tolerance levels for orange juice and
orange oil. The Agency published a second notice of filing document in
the Federal Register of February 25, 2014 (79 FR 10458) (FRL-9906-77),
noting the revisions for the uses in/on orange, juice from 0.15 ppm to
0.7 ppm; orange, oil from 400 ppm to 20 ppm. There were no comments
received concerning this petition.
Based upon review of the data supporting the petition, the proposed
tolerance for orange, juice is unnecessary. The proposed tolerance for
orange, oil was lowered. The reasons for these changes are explained in
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.
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 hazard characterization remains unchanged from the
assessment upon which the final rule published in the Federal Register
on November 15, 2013 (78 FR 68741) (FRL-9392-1) is based.
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 are discussed in the preamble
to that final rule and its supporting documents as well as the most
recent human health risk assessment, ``Tebuconazole: Human Health Risk
Assessment for Tolerance on Imported Oranges'', which can be found at
http://www.regulations.gov, under docket ID number EPA-HQ-OPP-2013-
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 the NOAEL are observed and the LOAEL are
identified. 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://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for tebuconazole used for
human risk assessment is shown in the table contained in Unit III.B. of
the preamble to the final rule published in the Federal Register issue
of 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
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 probabilistic
dietary exposure assessment was conducted for all existing and proposed
food uses of tebuconazole. EPA used the latest USDA Pesticide Data
Program (PDP) monitoring data, field trial data, percent crop treated
(PCT) data and empirical and DEEM (ver. 7.81) default processing
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's (NHANES/
WWEIA) conducted from 2003-2008 as well. As to the residue levels in
food, EPA made the following assumptions for the chronic exposure
assessment: As to residue levels in food, EPA used field trial data,
USDA PDP data, assumed PCT data levels and used empirical and DEEM
(ver. 7.81) default processing factors as described in Unit III.C.1.iv.
iii. Cancer. The Agency determined that cancer dietary risk
concerns due to long-term consumption of tebuconazole residues are
adequately addressed by the chronic dietary exposure analysis using the
reference dose; i.e.. the chronic dietary risk assessments is
considered to be protective of any cancer effects, and therefore, a
separate cancer dietary exposure analysis was not performed.
iv. Anticipated residue and 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 maximum PCT
estimates for existing uses as follows: Almonds 2.5%; apples 2.5%;
apricots 20%; barley
2.5%; beans green 2.5%; cantaloupes 10%; cherries 45%; corn 2.5%;
cotton 2.5%; dry beans/peas 5%; garlic 95%; grapes 35%; onions 5%;
peaches 25%; peanuts 55%; pears 5%; plums/prunes 5%; soybeans 2.5%;
sweet corn 5%; and wheat 25%.
For the chronic assessment, the Agency estimated the average PCT
estimates for existing uses as follows: Almonds 1%; apples 1%; apricots
10%; asparagus 5%; barley 2.5%; beans green 1%; cantaloupes 5%;
cherries 30%; corn 1%; cotton 1%; dry beans/peas 2.5%; garlic 60%;
grapes 20%; nectarines 10%; onions 5%; peaches 15%; peanuts 40%; pears
5%; pecans 5%; pistachios 2.5%; plums/prunes 2.5%; pumpkins 2.5%;
soybeans 1%; squash 2.5%; sweet corn 2.5%; watermelons 10%; and wheat
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic 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 one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
Subsequently, the Agency use estimated percent import estimates
from the most recent (2013) screening level usage and analysis
available for orange juice and oranges at 27.7% and 7.7%, respectively.
Since usage data are not available for other countries, the Agency
assumes that all of the imported orange commodities are treated.
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://www.epa.gov/oppefed1/models/water/index.htm.
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 directly
entered into the dietary exposure model. For the acute dietary risk
assessment, a distribution of 30-year daily surface water
concentrations 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.
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. Dermal and inhalation exposures were combined since the
same endpoint and POD is used for both routes of exposure. Residential
post-application dermal exposure was assessed for adults and children
golfing, and working in gardens. Incidental oral post-application
exposure was assessed for children 1 to 2 years old performing physical
activities on pressure-treated wood after application of tebuconazole.
Both life stages may receive exposure to tebuconazole residues. Post-
application exposure is expected to be short-term in duration. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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 triazole-containing class of
pesticides, the conazoles. Although conazoles act similarly in plants
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 Web site at http://www.epa.gov/pesticides/cumulative.
Tebuconazole is a triazole-derived pesticide. This class of
compounds 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
fortriazole-derivative pesticides, including tebuconazole, 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-derived 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). In addition, the Agency has
reduced the 10X Food Quality Protection Act safety factor (FQPA SF) to
3X. The FQPA SF has been retained as an uncertainty fact for use of a
LOAEL to extrapolate a NOAEL uncertainty factor (UFL). The
Agency's complete risk assessment is found in the propiconazole
reregistration docket at http://www.regulations.gov, docket ID number
An updated dietary exposure and risk analysis for the common
triazole metabolites 1,2,4-triazole (T), triazolylalanine (TA),
triazolylacetic acid (TAA), and triazolylpyruvic acid (TP) was
conducted and completed in October 2013, in association with a
registration request for several other triazole fungicides. That
analysis concluded that risk estimates were below the Agency's level of
concern for all population groups. The addition of tolerances
associated with this action to the exposure analyses do not
significantly increase the exposure to triazole and its conjugates.
This assessment may be found on http://www.regulations.gov by searching
for the following titles and docket numbers: ``Common Triazole
Metabolites: Updated Aggregate Human Health Risk Assessment to Address
The New Section 3 Registrations For Use of Prothioconazole on Rapeseed
Crop Subgroup 20A; Use of Difenoconazole on Rapeseed Crop Subgroup 20A;
and Use of Tebuconazole on Imported Oranges'', located in docket ID
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
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, acute and subchronic neurotoxicity studies 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 with mortality, and increased number of dead
fetuses), while offspring toxicity (including decreases in body weight,
brain weight, brain measurements, and functional activities) was seen
at all doses.
Available data indicated greater sensitivity of the developing
organism to exposure to tebuconazole, as demonstrated by increases in
qualitative sensitivity in prenatal developmental toxicity studies in
rats, mice, and rabbits, and by increases in both qualitative and
quantitative sensitivity in the developmental neurotoxicity study in
rats with tebuconazole. However, the degree of concern is low because
the toxic endpoints in the prenatal developmental toxicity studies were
well characterized with clear NOAELs established and the most sensitive
endpoint, which is found in the developmental neurotoxicity study, has
been used for overall risk assessments. Therefore, there are no
residual uncertainties for prenatal and/or postnatal susceptibility.
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
i. The toxicity database for tebuconazole is complete.
ii. Tebuconazole demonstrated neurotoxicity in the acute
neurotoxicity study in rats; the LOAEL of 100 milligrams/kilogram/day
(mg/kg/day) was based on increased motor activity in male and female
rats and decreased footsplay in female rats.
Malformations indicative of nervous system development disruption
were seen in developmental toxicity studies in mice, rats, and rabbits.
Neurotoxicity was also seen in offspring in the developmental
neurotoxicity study in rats. The LOAEL of 8.8 mg/kg/day was based on
decreases in body weights, decreases in absolute brain weights, changes
in brain morphometric parameters, and decreases in motor activity. A
NOAEL could not be established. However, the LOAEL (8.8 mg/kg/day) was
employed as the point of departure in assessing the risk for all
exposure scenarios, and the FQPA SF is retained as a UFL
(i.e., use of a LOAEL to extrapolate a NOAEL). 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 DNT
study was conducted. All of the BMDLs
(benchmark dose limit) modeled successfully on statistically
significant effects are 1-2X lower than the LOAEL. The results also
indicate that 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. Therefore, the analysis supports reducing the
UFL from 10X to 3X. Using an UFL of 3X in risk
assessment (8.8 mg/kg/day / 3X = 2.9 mg/kg/day) is further supported by
other studies in the tebuconazole toxicity database: Those studies with
the lowest NOAELs were a developmental toxicity study in mice at 3 mg/
kg/day and a chronic toxicity study in dogs at 2.9 mg/kg/day, with
effects being seen at respective LOAELs of 10 and 4.5 mg/kg/day.
iii. Although there is qualitative evidence of increased
susceptibility in the prenatal developmental studies in rats, the
Agency did not identify any residual uncertainties after establishing
toxicity endpoints and traditional UFs to be used in the risk
assessment of tebuconazole. The degree of concern for residual
uncertainties for prenatal and/or postnatal toxicity is 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 refined estimates of residues in food
commodities from reliable field trial data reflecting maximum use
conditions, recent monitoring data from USDA's 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 pathway (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 84% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
tebuconazole from food and water will utilize 14.3% 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. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Tebuconazole is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to tebuconazole.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined chronic food, water, and
short-term residential exposures result in aggregate MOEs of 310 for
adult handlers (post-application); 1,200 for children 11-16 years old
(post-application); 510 for children 6-11 years old (post-application);
and 350 for children 1-2 years old (post-application). Because EPA's
level of concern for tebuconazole is a MOE of 300 or below, these MOEs
are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
An intermediate-term adverse effect was identified; however,
tebuconazole is not registered for any use patterns that would result
in intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
5. Aggregate cancer risk for U.S. population. Based on the results
of the chronic risk assessment, which the Agency considers to be
protective of any cancer effects, the Agency concludes that there is no
cancer risk from aggregate exposure to tebuconazole.
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) Method 101341) is available to enforce the
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:
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.
There are no Codex, Canadian or Mexican MRLs for tebuconazole in/or
on orange, oil and orange, juice.
C. Revisions to Petitioned-For Tolerances
Based on the analysis of orange processing data, EPA lowered the
tolerance level for orange, oil to 10 ppm. Tolerances for orange, juice
were unnecessary since the raw agricultural commodity tolerance of 1ppm
covers the proposed juice tolerance.
Therefore, tolerances are established for residues of tebuconazole,
in or on orange, oil at 10 ppm and orange, juice at 1.0 ppm.
VI. Statutory and Executive Order Reviews
This final rule 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 final rule has
been exempted from review under Executive Order 12866, this final rule
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). This final rule 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 final rule 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (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 of 1995 (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
Dated: April 28, 2014.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.474, in the table in paragraph (a)(1), add
alphabetically entries for ``Orange \1\'' and ``Orange, oil \1\'' and
revise footnote 1 to read as follows:
Sec. 180.474 Tebuconazole; tolerances for residues.
(a) * * *
(1) * * *
* * * * *
Orange \1\................................................. 1.0
Orange, oil \1\............................................ 10
* * * * *
\1\There are no U.S. registrations.
* * * * *
[FR Doc. 2014-10216 Filed 5-6-14; 8:45 am]
BILLING CODE 6560-50-P