[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Rules and Regulations]
[Pages 16200-16206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07888]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0573; FRL-9975-07]


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 multiple commodities which are identified and 
discussed later in this document. 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 April 16, 2018. Objections and 
requests for hearings must be received on or before June 15, 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-2016-0573, 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: [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-2016-0573 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 
June 15, 2018. Addresses for mail and hand delivery of objections and

[[Page 16201]]

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-2016-0573, 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 December 20, 2016 (81 FR 92758) (FRL-
9956-04), 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 
6F8507) by Isagro S.p.A (d/b/a Isagro USA, Inc.), 430 Davis Drive, 
Suite 240, Morrisville, NC 27560. The petition requested that 40 CFR 
180.557 be amended by establishing tolerances for residues of the 
fungicide tetraconazole, 1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-
tetrafluoroethoxy)propyl]-1H-1,2,4-triazole, in or on barley at 0.3 
parts per million (ppm); crop group 16, forage, fodder, and straw of 
cereal grains group (except corn) at 8.0 ppm; dried shelled pea and 
bean (except soybean) subgroup 6C, hay at 8.0 ppm; dried shelled pea 
and bean (except soybean) subgroup 6C, seed at 0.15 ppm; dried shelled 
pea and bean (except soybean) subgroup 6C, vine at 2.0 ppm; rapeseed 
crop subgroup 20A at 0.9 ppm; and wheat at 0.1 ppm. That document 
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 the notice of filing.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances that vary slightly from what the petitioner 
requested. The reason for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for 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 subchronic 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 subchronic 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 prenatal developmental studies showed no 
evidence for increased quantitative susceptibility in utero. 
Developmental effects (increased incidences of supernumerary ribs, and 
hydroureter and hydronephrosis) were seen in the presence of maternal 
effects in rats (decreased body weight gain, and food consumption and 
increased water intake, and increased liver and kidney weights), while 
no developmental effects were seen in rabbits. A 2-generation rat 
reproduction study also revealed no evidence for increased quantitative 
susceptibility in offspring. Decreased litter and mean pup weights and 
increased liver weights were noted in offspring at a dose higher than 
that which caused mortality in adult females. Effects in parental 
animals that survived the duration of the study were consistent with 
other studies in the database. 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.
    Although liver tumors were observed in mice in both sexes in a 
mouse carcinogenicity study, the agency has classified tetraconazole as 
``Not likely to be carcinogenic to humans at levels that do not cause 
increased cell proliferation in the liver.'' This classification is 
supported by an in vivo cancer mode-of-action study in mice, 
demonstrating that cancer risk is linked to increased cell 
proliferation in the liver. Because the current reference dose (RfD) of 
0.0073 mg/kg/day is below the level at which increased cell 
proliferation occurs in the liver, it would be protective of any liver 
effects caused by tetraconazole in the mouse carcinogenicity or MoA 
studies at higher doses. Quantification of carcinogenic potential is 
not required.

[[Page 16202]]

    Tetraconazole was categorized as having low acute toxicity via the 
oral, dermal, and inhalation routes (Toxicity Categories III-IV). It is 
not a dermal irritant or a dermal sensitizer. It is considered a slight 
eye irritant.
    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 add Crop Group 6C, Dried 
Shelled Pea and Bean (except Soybean) Subgroup, Barley, Canola, Wheat, 
and Crop Group 16, Forage Fodder, and Straw of Cereal Grains Group 
(except corn)'' in docket ID number EPA-HQ-OPP-2016-0573.

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 discussed in Unit B of the final rule 
published in the Federal Register of January 10, 2017 (82 FR 2900) 
(FRL-9955-74).

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 2003-
2008 United States Department of Agriculture (USDA) National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
As to residue levels in food, EPA used tolerance-level residues and 100 
percent crop treated (PCT) estimates.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA (2003-2008). As to residue levels in food, EPA utilized residue 
data from field trials and feeding studies to obtain average residues 
and assumed the PCT estimates provided in Unit III.C.1.iv. 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 has been classified as ``Not likely to be 
carcinogenic to humans at levels that do not cause increased cell 
proliferation in the liver.'' Therefore, a dietary exposure assessment 
for the purpose of assessing cancer risk is unnecessary.
    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 chronic dietary exposure assessment, the Agency used the 
following PCT estimates for existing uses as follows: Corn, 1%; grapes, 
5%; peanuts, 1%; strawberries, 2.5%; sugar beet, 25%; and soybean, 
2.5%.
    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 2.5% or 1%. In 
those cases, the Agency uses 2.5% or 1%, respectively, as the average 
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%, 
unless the maximum PCT value is estimated at less than 2.5%, in which 
case the Agency uses 2.5% as the maximum PCT value in the analysis.
    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

[[Page 16203]]

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 of value 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. 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 evidence 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.
    Tetraconazole, as a triazole-derived pesticide, is one of a class 
of compounds that 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 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 
nondietary exposures). In addition to the 10X interspecies factor and 
the 10X intraspecies factor, 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 July 18, 2017, in association with registration requests 
for tetraconazole and difenoconazole fungicides. 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 analysis was not conducted. The July 18, 2017 
update for triazoles may be found in docket ID number EPA-HQ-OPP-2016-
0573.

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 was no evidence 
of increased quantitative susceptibility of rat or rabbit fetuses 
following in utero exposures to tetraconazole. However, there was

[[Page 16204]]

evidence of increased qualitative susceptibility of fetuses in the rat 
prenatal developmental toxicity study where there were increased 
incidences of supernumerary ribs, and hydroureter and hydronephrosis 
were seen in fetuses at the same dose that caused maternal toxicity 
(decreased body weight gain, and food consumption and increased water 
intake, and increased liver and kidney weights). In addition, there was 
also no evidence of increased quantitative or qualitative 
susceptibility to offspring in the 2-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. Although there were effects indicative of neurotoxicity in the 
acute neurotoxicity study in rats, there were no such effects noted in 
the subchronic neurotoxicity study or any other studies in the 
database. The fact that a clear NOAEL was established for the 
neurotoxicity effects observed and the selected endpoints are 
protective of those effects, which were observed at doses 2- to 100-
fold higher than the most sensitive effects in the database (liver and 
kidney). Therefore, there is no need for a developmental neurotoxicity 
study or additional uncertainty factors (UFs) to account for 
neurotoxicity.
    iii. As discussed in Unit III.D.2., there is no evidence that 
tetraconazole results in increased quantitative 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 level of concern (LOC) 
is low because: (1) The fetal effects were seen at the same dose as the 
maternal effects; (2) a clear NOAEL was established; (3) 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 are 
protected for; and (4) there were no developmental effects in the 
rabbit study. There is also no evidence of increased quantitative or 
qualitative susceptibility to offspring in the 2-generation 
reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary food exposure assessments were performed 
based on 100 PCT, tolerance-level residues, and modeled water 
estimates. Therefore, the acute analysis is highly conservative. The 
chronic dietary exposure analysis utilized modeled drinking water 
estimates, empirical processing factors, average field trial residues, 
average residues from the feeding studies, PCT, and modeled drinking 
water estimates. Therefore, the chronic risk estimates provided in this 
document are unlikely to underestimate the risks posed by 
tetraconazole. 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 4.8% 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 91% 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.
    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 
established/recommended 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 that 
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,

[[Page 16205]]

Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

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

C. Revisions to Petitioned-for Tolerances

    Some of the terminology the petitioner used to describe requested 
tolerances is not the standard terminology the Agency uses for 
establishing tolerances. Tolerances requested for ``dried shelled pea 
and bean (except soybean) subgroup 6C'' and ``crop group 16, forage, 
fodder, and straw of cereal grains group'' are being issued for ``pea 
and bean, dried shelled, except soybean, subgroup 6C'' and ``grain, 
cereal, forage, fodder, and straw, group 16'', respectively. The 
subgroup 6C includes all edible pods and the dried and succulent seed 
forms of the commodities in the subgroup; the Agency does not 
specifically used the term ``seed'' in the naming of this subgroup, 
consistent with its food and feed commodity vocabulary. The petitioner 
also requested tolerances for hay and vine commodities in subgroup 6C. 
Hay and vine are plant parts of legume vegetables, which are covered 
under crop subgroup 7A. Therefore, the Agency is establishing this 
requested tolerance as ``vegetable, foliage of legume, except soybean, 
subgroup 7A''.
    Additionally, the Agency has determined that some of the field 
trials were replicates, which lead to the agency recommending for 
different tolerance levels than that proposed. EPA added significant 
figures for the tolerance values to be consistent with its practice.
    Although the petitioner requested tolerances for residues of 
tetraconazole in or on commodities in group 16 except corn, the 
tolerances for corn, field, forage and corn, field, stover as well as 
corn, pop, stover are superseded by the new group 16 tolerances. Based 
on cereal grain processing data, which indicate that tetraconazole 
residues concentrate in the processed commodities of barley and wheat, 
the Agency is establishing tolerances for residues in or on the flour 
and bran commodities of barley and the flour, bran, and germ 
commodities of wheat. In addition, because residue data indicate that 
there will be increased residues in aspirated grain fractions as a 
result of the use of tetraconazole on cereal grains, the Agency is 
modifying the existing tolerance for aspirated grain fractions, in 
accordance with the provisions at 40 CFR 180.40(f)(1)(i)(B).
    Finally, because the established tolerances will increase the 
ruminant dietary burdens, the Agency is increasing existing milk and 
meat tolerance levels as well, pursuant to 40 CFR 180.6(b).

V. Conclusion

    Therefore, tolerances are established for residues of 
tetraconazole, 1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-
tetrafluoroethoxy)propyl]-1H-1,2,4-triazole, in or on pea and bean, 
dried shelled (except soybean) subgroup 6C at 0.09 ppm; vegetable, 
foliage of legume (except soybeans) subgroup 7A at 8.0 ppm; barley, 
grain at 0.30 ppm; rapeseed subgroup 20A at 0.90 ppm; wheat, grain at 
0.05 ppm; wheat, germ at 0.50 ppm; grain, cereal, forage, fodder, and 
straw, group 16 at 7.0 ppm; barley, bran at 1.0 ppm; barley, flour at 
0.50 ppm; wheat, bran at 0.15 ppm; wheat, flour at 0.08 ppm. In 
addition, EPA is revising existing tolerances for grain, aspirated 
fractions to 4.0 ppm; milk to 0.06 ppm; cattle, meat to 0.02 ppm; goat, 
meat to 0.02 ppm; horse, meat to 0.02 ppm; and sheep, meat to 0.02 ppm. 
Additionally, the existing tolerances for corn, field, forage; corn, 
field, stover; and corn, pop, stover are being removed since they are 
superseded by this action.

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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section

[[Page 16206]]

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 4, 2018.
Donna Davis,
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.  180.557; in the table to paragraph (a):
0
a. Remove the entry for ``Aspirated grain fractions'';
0
b. Add alphabetically entries for ``Barley, bran''; ``Barley, flour''; 
and ``Barley, grain'';
0
c. Revise the entry for ``Cattle, meat'';
0
d. Remove the entries for ``Corn, field, forage''; ``Corn, field, 
stover''; and ``Corn, pop, stover'';
0
e. Add alphabetically entries for ``Grain, aspirated fractions''; 
``Grain, cereal, forage, fodder, and straw, group 16'';
0
f. Revise the entries for ``Goat, meat''; ``Horse, meat''; ``Milk'';
0
g. Add alphabetically entries for ``Pea and bean, dried shelled (except 
soybean) subgroup 6C''; ``Rapeseed subgroup 20A'';
0
h. Revise the entry for ``Sheep, meat''; and
0
i. Add alphabetically entries for ``Vegetable, foliage of legume 
(except soybeans) subgroup 7A''; ``Wheat, bran''; ``Wheat, flour''; 
``Wheat, germ''; and ``Wheat, grain''.
    The additions and revisions read as follows:


Sec.  180.557   Tetraconazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, bran...............................................          1.0
Barley, flour..............................................         0.50
Barley, grain..............................................         0.30
 
                                * * * * *
Cattle, meat...............................................         0.02
 
                                * * * * *
Goat, meat.................................................         0.02
Grain, aspirated fractions.................................          4.0
Grain, cereal, forage, fodder, and straw, group 16.........          7.0
 
                                * * * * *
Horse, meat................................................         0.02
 
                                * * * * *
Milk.......................................................         0.06
 
                                * * * * *
Pea and bean, dried shelled (except soybean) subgroup 6C...         0.09
 
                                * * * * *
Rapeseed subgroup 20A......................................         0.90
 
                                * * * * *
Sheep, meat................................................         0.02
 
                                * * * * *
Vegetable, foliage of legume (except soybeans) subgroup 7A.          8.0
 
                                * * * * *
Wheat, bran................................................         0.15
Wheat, flour...............................................         0.08
Wheat, germ................................................         0.50
Wheat, grain...............................................         0.05
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-07888 Filed 4-13-18; 8:45 am]
 BILLING CODE 6560-50-P


