
[Federal Register Volume 82, Number 6 (Tuesday, January 10, 2017)]
[Rules and Regulations]
[Pages 2900-2906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31824]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0695; FRL-9955-74]


Tetraconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
tetraconazole in or on vegetable, fruiting (Crop Group 8-10) at 0.30 
parts per million (ppm) and vegetable, cucurbit (Crop Group 9) at 0.15 
ppm and revises the tolerance for residues on beet, sugar, root; beet, 
sugar, dried pulp; and beet, sugar molasses. Isagro S.P.A. (d/b/a 
Isagro USA, Inc.) requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 10, 2017. Objections and 
requests for hearings must be received on or before March 13, 2017, 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-2015-0695, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
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-2015-0695 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 
March 13, 2017. 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-2015-0695, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 16, 2016 (81 FR 14030) (FRL-9942-
86), 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 
5F8400) by Isagro S.P.A. (d/b/a Isagro USA, Inc.), 430 Davis Drive, 
Suite 240, Morrisville, NC 27560. That document provided notice that 
the petition requested that 40 CFR 180.557 be amended by establishing 
tolerances for residues of the fungicide tetraconazole, in or on 
Vegetable, Fruiting (Crop Group 8-10) at 0.30 parts per million (ppm) 
and Vegetable, Cucurbit (Crop Group 9) at 0.15 ppm. In the Federal 
Register of August 29, 2016 (81 FR 59165) (FRL-9950-22), EPA issued 
another document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the remainder of that petition requesting 
revision of the existing tolerances for tetraconazole residues on beet, 
sugar, root to 0.15 ppm; beet, sugar, dried pulp to 0.20 ppm; and beet, 
sugar molasses to 0.25 ppm. Those documents referenced a summary of the 
petition prepared by Isagro S.P.A. (d/b/a Isagro USA, Inc.), the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to 
these notices 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

[[Page 2901]]

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 tetraconazole including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with tetraconazole 
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 liver and kidney are the primary target organs of 
tetraconazole in all species in oral toxicity studies of sub-chronic 
and chronic durations. Following long-term oral exposure, tetraconazole 
caused liver tumors in mice in both sexes. In the acute neurotoxicity 
study, loss of motor activity in both sexes, and clinical signs 
including hunched posture, decreased defecation, and/or red or yellow 
material on various body surfaces were observed in females. There was 
no evidence of immunotoxicity or neurotoxicity following sub-chronic 
exposure. There were no systemic effects observed in the 21-day dermal 
toxicity study up to the highest dose tested. Tetraconazole did not 
show evidence of mutagenicity in in vitro or in vivo studies.
    Oral rat and rabbit developmental toxicity studies showed no 
increased susceptibility of fetuses to tetraconazole. Maternal toxicity 
(decreased body weight gain and food consumption, increased water 
intake and increased liver and kidney weights) and developmental 
toxicity (increased incidence of small fetuses, supernumerary ribs and 
hydroureter and hydronephrosis) occurred at the same dose level in the 
rat study. No developmental toxicity was seen in the rabbit study, 
whereas maternal toxicity (decreased body weight gain) was noted at the 
highest dose tested. Similarly, there was no evidence of increased 
susceptibility of offspring in the 2-generation rat reproduction study.
    In contrast to the oral studies where the most sensitive effects 
were in the liver and kidney, inhalation exposure of tetraconazole to 
rats resulted in portal-of-entry effects including; squamous cell 
metaplasia of the laryngeal mucous, mono-nuclear cell infiltration, 
goblet cell hyperplasia, hypertrophy of the nasal cavity and 
nasopharyngeal duct, and follicular hypertrophy of the thyroid in 
males. At the highest concentration tested, there were treatment-
related increases in absolute lung weights in both sexes. Since the 
last risk assessment, a 28-day in vivo cancer mode-of-action study in 
mice was submitted and reviewed leading to the re-evaluation of 
tetraconazole's cancer potential and classification. EPA has now 
classified tetraconazole as ``Not likely to be carcinogenic to humans 
at levels that do not cause increased cell proliferation in the 
liver.'' Quantification of carcinogenic potential is not required.
    Specific information on the studies received and the nature of the 
adverse effects caused by tetraconazole 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 Risk Assessment for the 
Section 3 Registration for Application to Fruiting Vegetables (Crop 
Group 8) and Cucurbit Vegetables (Crop Group 9) and Amending the Sugar 
Beet Application Scenario and Tolerance'' in docket ID number EPA-HQ-
OPP-2015-0695.

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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for tetraconazole used for 
human risk assessment is shown in Table 1 of this unit.

    Table 1--Summary of Toxicological Doses and Endpoints for Tetraconazole for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50       NOAEL = 22.5 mg/kg/   Acute RfD = 0.225    Developmental toxicity study
 years of age).                     day.                  mg/kg/day.           (rat).
                                   UFA = 10x...........  aPAD = 0.225 mg/kg/  Developmental LOAEL = 100 mg/kg/
                                   UFH = 10x...........   day.                 day based on increased incidence
                                   FQPA SF = 1x........                        of small fetuses, supernumerary
                                                                               ribs, and hydroureter and
                                                                               hydronephrosis.

[[Page 2902]]

 
Acute dietary (General population  NOAEL = 50 mg/kg/day  Acute RfD = 0.5 mg/  Acute neurotoxicity (rat).
 including infants and children).  UFA = 10x...........   kg/day.             LOAEL = 200 mg/kg/day due to
                                   UFH = 10x...........  aPAD = 0.5 mg/kg/     decreased motor activity on day 0
                                   FQPA SF = 1x........   day.                 in both sexes, and clinical signs
                                                                               in females including hunched
                                                                               posture, decreased defecation,
                                                                               and/or red or yellow material on
                                                                               various body surfaces.
Chronic dietary (All populations)  NOAEL = 0.73 mg/kg/   Chronic RfD =        Chronic oral toxicity (dog).
                                    day.                  0.0073 mg/kg/day.   LOAEL = 2.95/3.33 (M/F) mg/kg/day,
                                   UFA = 10x...........  cPAD = 0.0073 mg/kg/  based on absolute and relative
                                   UFH = 10x...........   day.                 kidney weights and
                                   FQPA SF = 1x........                        histopathological changes in the
                                                                               male kidney.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days)   No hazard identified and therefore quantification is not required. There are
 and dermal intermediate-term (1    no developmental concerns via the dermal route and no systemic toxicity was
 to 6 months).                      seen following dermal exposure.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     * NOAEL not           LOC = 300..........  28-Day Inhalation toxicity--rat.
 days) and inhalation               established.                              LOAEL = 1.3 mg/kg/day (0.0048 mg/
 intermediate-term (1 to 6         UFA = 3x............                        kg/L, 0.0548 mg/L (rat)) for
 months).                          UFH = 10x...........                        males and females, based on
                                   UFL = 10x...........                        squamous cell metaplasia of
                                                                               laryngeal mucous, mononuclear
                                                                               cell infiltration, goblet
                                                                               hyperplasia and hypertrophy of
                                                                               nasal cavity and nasopharyngeal
                                                                               duct and follicular hypertrophy
                                                                               of thyroid in males.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Not likely to be carcinogenic to humans at levels that do
                                    not cause increased cell proliferation in the liver.'' Quantification of
                                    carcinogenic potential is not required (TXR #0056628, J. Rowland et al., 2-
                                    Apr-2013).
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
  UFL = use of a LOAEL to extrapolate a NOAEL.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tetraconazole, EPA considered exposure under the 
petitioned-for tolerances as well as all existing tetraconazole 
tolerances in 40 CFR 180.557. EPA assessed dietary exposures from 
tetraconazole 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 tetraconazole. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) National Health and Nutrition Examination Survey, 
What We Eat in America, (NHANES/WWEIA). This dietary survey was 
conducted from 2003 to 2008. As to residue levels in food, EPA utilized 
the Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database DEEM-FCID, Version 3.16 default processing factors and 
tolerance-level residues and 100 percent crop treated (PCT) for all 
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA dietary survey conducted from 2003 to 2008. As to residue levels 
in food, EPA utilized residue data from field trials and feeding 
studies to obtain average residues and assumed the PCT figures provided 
below. Empirically derived processing factors were used in these 
assessments when available
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that tetraconazole does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated Residues 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.
    100 PCT were assumed for all food commodities for the acute 
analysis. The chronic analysis used percent crop treated for new uses 
(PCTn).
    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.

[[Page 2903]]

    The Agency estimated the PCT for existing uses as follows:
    Sugarbeet, 70%; field corn, 9%; and soybean, 5%.
    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.
    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 tetraconazole 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 tetraconazole in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of tetraconazole. 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 Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of 
tetraconazole for acute exposures are estimated to be 11 parts per 
billion (ppb) for surface water and 120 ppb for ground water. The 
estimated EDWCs of tetraconazole for chronic exposures for non-cancer 
assessments are estimated to be 5.5 ppb for surface water and 118 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For acute dietary risk assessment, the water concentration value of 
120 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration value 
of 118 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). Tetraconazole is not 
registered for any specific use patterns that would result in 
residential exposure.
    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.''
    Tetraconazole is a member of the triazole-containing class of 
pesticides. 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 (EPA, 2002). In the case of 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 
evidence to indicate that tetraconazole shares a common mechanism of 
toxicity with any other conazole pesticide, and EPA is not following a 
cumulative risk approach for this tolerance action. 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/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
    Tetraconazole 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 for 
triazole-derivative pesticides, including tetraconazole, 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). 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.
    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 
completed on April 9, 2015, in association with registration requests 
for several triazole fungicides, propiconazole, difenoconazole, and 
flutriafol. The requested new uses of tetraconazole did not 
significantly change the dietary exposure estimates for free triazole 
or conjugated triazoles. Therefore, an updated dietary exposure

[[Page 2904]]

analysis was not conducted. The April 9, 2015 update for triazoles may 
be found in docket ID number EPA-HQ-OPP-2014-0788.

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. There are no residual 
uncertainties for pre- and post-natal toxicity. There is no evidence of 
increased quantitative susceptibility of rat or rabbit fetuses to in 
utero exposure to tetraconazole. There is evidence of increased 
qualitative susceptibility to fetuses in the rat prenatal developmental 
toxicity study (increased incidences of supernumerary ribs, and 
hydroureter and hydronephrosis). The LOC is low however because the 
fetal effects were seen at the same dose as the maternal effects, a 
clear NOAEL was established, the developmental NOAEL from a study in 
rats is being used as the POD for the acute dietary endpoint (females 
13-49 years of age), and there were no developmental effects in the 
rabbit study. There is also no evidence of increased quantitative or 
qualitative susceptibility to offspring in the two-generation 
reproduction study.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for tetraconazole is complete.
    ii. There were effects indicative of neurotoxicity in the acute 
neurotoxicity study in rats. However, the level of concern (LOC) is low 
since a clear NOAEL was established which is being used in endpoint 
selection. Furthermore, the dose at which these neurotoxic effects were 
observed is 2 to 100-fold higher than the primary effects seen in the 
other studies in the database (liver and kidney). After preliminary 
review, a sub-chronic neurotoxicity study has shown no evidence for 
neurotoxicity. Finally, there are no other signs of neurotoxicity in 
any of the other studies in the database. Therefore, there is no need 
for a developmental neurotoxicity study or additional uncertainty 
factors (UFs) to account for neurotoxicity.
    iii. There is no evidence that tetraconazole results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. There is evidence of increased qualitative susceptibility to 
fetuses in the rat prenatal developmental toxicity study (increased 
incidences of supernumerary ribs, and hydroureter and hydronephrosis). 
The LOC is low however because:
     The fetal effects were seen at the same dose as the 
maternal effects,
     a clear NOAEL was established,
     the developmental NOAEL from a study in rats is being used 
as the POD for the acute dietary endpoint (females 13-49 years of age), 
and
     there were no developmental effects in the rabbit study. 
There is also no evidence of increased quantitative or qualitative 
susceptibility to offspring in the two-generation reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. There are no residual uncertainties identified for pre- and 
post-natal toxicity in the exposure databases. Tolerance-level 
residues, 100 PCT, and modeled water estimates were incorporated into 
the acute dietary exposure analysis. Therefore, the acute analysis is 
highly conservative. The chronic and cancer dietary exposure analyses 
utilized empirical processing factors, average field trial residues, 
average residues from the feeding studies, percent crop treated 
estimates, and modeled drinking water estimates. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to tetraconazole in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
tetraconazole.

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 tetraconazole will occupy 4.6% 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 
tetraconazole from food and water will utilize 92% of the cPAD for all 
infants (<1 year old) the population group receiving the greatest 
exposure. There are no residential uses for tetraconazole
    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). A short-term 
adverse effect was identified; however, tetraconazole is not registered 
for any use patterns that would result in short-term residential 
exposure. Short-term risk is assessed based on short-term residential 
exposure plus chronic dietary exposure. Because there is no short-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 short-term risk), no further 
assessment of short-term risk is necessary, and EPA relies on the 
chronic dietary risk assessment for evaluating short-term risk for 
tetraconazole.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, 
tetraconazole 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 
tetraconazole.

[[Page 2905]]

    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., EPA has concluded that tetraconazole is ``Not likely to be 
carcinogenic to humans at levels that do not cause increased cell 
proliferation in the liver.'' Because the chronic endpoint is 
protective of cell proliferation in the liver, there is not likely to 
be a cancer risk from exposure to tetraconazole.
    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 tetraconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical methods are available to enforce the currently 
established tetraconazole plant and livestock tolerances (D280006, W. 
Donovan, 10-Jan-2002, D267481, 12-Oct-2000; D278236, W. Donovan, 22-
Oct-2001). Isagro has also submitted adequate method validation and 
independent laboratory validation (ILV) data which indicates that the 
QuEChERS multi-residue method L00.00-115 (48135104.der) is capable of 
quantifying tetraconazole residues in/on a variety of fruit, cereal 
grain, root, oilseed, and livestock commodities.
    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: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for tetraconazole.

C. Revisions to Petitioned-for Tolerances

    EPA revised two commodity definitions for vegetable, fruiting, 
group 8-10 and vegetable, cucurbit, group 9.

V. Conclusion

    Therefore, tolerances are established for residues of 
tetraconazole, in or on vegetable, fruiting, group 8-10 at 0.30 ppm and 
vegetable, cucurbit, group 9 at 0.15 ppm and revised for beet, sugar, 
root; beet, sugar, dried pulp; and beet, sugar, molasses.

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) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). 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: December 14, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In the table in paragraph (a) of Sec.  180.557:
0
a. Revise the commodities of ``Beet, sugar, dried pulp'', ``Beet, 
sugar, molasses'', and ``Beet, sugar, root''; and
0
b. Add alphabetically the commodities of ``Vegetable, cucurbit, group 
9'' and ``Vegetable, fruiting, group 8-10'' to read as follows:

[[Page 2906]]

Sec.  180.557  Tetraconazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Beet, sugar, dried pulp....................................         0.20
Beet, sugar, molasses......................................         0.25
Beet, sugar, root..........................................         0.15
 
                                * * * * *
Vegetable, cucurbit, group 9...............................         0.15
Vegetable, fruiting, group 8-10............................         0.30
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-31824 Filed 1-9-17; 8:45 am]
BILLING CODE 6560-50-P


