[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Rules and Regulations]
[Pages 52986-52991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22857]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0531; FRL-9984-63]


Prothioconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
prothioconazole in or on rapeseed subgroup 20A. Bayer CropScience 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective October 19, 2018. Objections and 
requests for hearings must be received on or before December 18, 2018, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2017-0531, 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 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2017-0531 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 
December 18, 2018. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2017-0531, 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 February 27, 2018 (83 FR 8408) (FRL-
9972-17), 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 
7F8596) by Bayer CropScience, LP2, T.W. Alexander Dr., Research 
Triangle Park, NC 27709. The petition requested that 40 CFR 180.626 be 
amended by establishing tolerances for residues of the fungicide 
prothioconazole, 2-[2-(1-chlorocylcopropyl)-3-(2-chlorophenyl)-2-
hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione, and its desthio 
metabolite in or on rapeseed subgroup, Crop subgroup 20A at 0.15 parts 
per million (ppm). That document referenced a summary of the petition 
prepared by Bayer CropScience, the registrant, which is available in 
the docket, http://www.regulations.gov. Comments were received on the 
notice of filing. EPA's response to these comments is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing the tolerance requested by the petitioner as Rapeseed 
subgroup 20A, to be consistent with the commodity terminology commonly 
used by the Agency.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the

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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 prothioconazole including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with prothioconazole 
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.
    Prothioconazole degrades into different compounds in different 
matrices, with prothioconazole-desthio (desthio) being the metabolite 
and degradate of concern. The target organs of prothioconazole and the 
desthio metabolite include the liver, kidney, bladder, thyroid and 
blood. In addition, the chronic studies showed body weight and food 
consumption changes, and toxicity to the lymphatic and gastrointestinal 
systems.
    Developmental studies show that prothioconazole and its metabolites 
produce adverse effects including malformations in the conceptus at 
levels equal to or below maternally toxic levels, particularly those 
studies conducted using prothioconazole-desthio. Reproduction studies 
in the rat with prothioconazole and prothioconazole-desthio suggest 
that these chemicals do not adversely affect reproductive parameters or 
the offspring except at parentally toxic dose levels. Acute and 
subchronic neurotoxicity studies, as well as a developmental 
neurotoxicity study, raise no neurotoxicity concerns. Immunotoxicity 
data show that prothioconazole is not an immunotoxicant.
    The available carcinogenicity and/or chronic studies in the mouse 
and rat, using both prothioconazole and prothioconazole-desthio, show 
no increase in tumor incidence and EPA has concluded that 
prothioconazole and its metabolites are not carcinogenic.
    Specific information on the studies received and the nature of the 
adverse effects caused by prothioconazole 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 the document titled ``Prothioconazole: Human 
Health Risk Assessment for a Proposed Tolerance on Cottonseed Subgroup 
20C, a Tolerance Amendment on Sugar Beet Roots, and New Use Requests 
for Cotton, Sugar Beet, Soybean, and Dried Shelled Pea and Bean'' on 
page 32 in docket ID number EPA-HQ-OPP-2015-0722.

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.html.
    A summary of the toxicological endpoints for prothioconazole used 
for human risk assessment is discussed in Unit III.B of the final rule 
published in the Federal Register of November 10, 2016 (81 FR 78917) 
(FRL-9953-71).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to prothioconazole, EPA considered exposure under the 
petitioned-for tolerances as well as all existing prothioconazole 
tolerances in 40 CFR 180.626. EPA assessed dietary exposures from 
prothioconazole 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 prothioconazole for females 13-50 
years old. 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; 2003-2008). As to residue levels 
in food, EPA assumed tolerance-level values for the proposed new uses 
and existing tolerances on berries, cucurbit vegetables, cottonseed, 
sugar beet roots, and sunflower subgroup 20B, average field trial 
residues for all other commodities, and DEEM default and empirical 
processing factors. 100 percent crop treated (PCT) was assumed for all 
proposed and established commodities.
    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 assumed tolerance-
level values for the proposed new uses and existing tolerances on 
berries, cucurbit vegetables, cottonseed, sugar beet roots, and 
sunflower subgroup 20B, average field trial residues for all other 
commodities, and DEEM default and empirical processing factors. 100 PCT 
was assumed for all proposed and established commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that prothioconazole does not pose a cancer risk to humans. 
Therefore, a dietary exposure

[[Page 52988]]

assessment for the purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue 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.
    The Agency did not use percent crop treated estimates for the 
dietary assessment.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for prothioconazole in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of prothioconazole. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM/
GW), the estimated drinking water concentrations (EDWCs) of 
prothioconazole for acute exposures are estimated to be 109 parts per 
billion (ppb) for surface water and 132 ppb for ground water and for 
chronic exposures are estimated to be 97 ppb for surface water and 128 
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 132 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 128 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). Prothioconazole 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.''
    Prothioconazole is a member of the conazole class of pesticides 
containing the 1,2,4-triazole moiety. Although conazoles act similarly 
in plants (fungi) by inhibiting ergosterol biosynthesis, there is not 
necessarily a relationship between their pesticidal activity and their 
mechanism of toxicity in mammals. Structural similarities do not 
constitute a common mechanism of toxicity. Evidence is needed to 
establish that the chemicals operate by the same, or essentially the 
same, sequence of major biochemical events in mammals (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 conclusive data to indicate that conazoles share 
common mechanisms of toxicity, and EPA is not following a cumulative 
risk approach for this 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
    Prothioconazole 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 prothioconazole, 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 July 18, 2017, in association with registration requests 
for the triazole fungicides difenoconazole and tetraconazole. That 
analysis concluded that risk estimates were below the Agency's level of 
concern for all population groups. The proposed new uses of 
prothioconazole are not expected to significantly increase the dietary 
exposure estimates for free triazole or conjugated triazoles; thus, the 
Agency is relying on the July 18, 2017 analysis to support its 
conclusion that the exposure to the triazole metabolite, including 
exposures from the use of prothioconazole on the commodities in 
subgroup 20A, does not present risks of concern. This assessment may be 
found on http://www.regulations.gov by searching for the following 
title and docket number: ``Common Triazole Metabolites: Updated 
Aggregate Human Health Risk Assessment to Address New Section 3 
Registrations for Use of Difenoconazole and Tetraconazole.'' (located 
in docket ID number EPA-HQ-OPP-2016-0254).

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

[[Page 52989]]

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 adequate data in 
the prothioconazole/prothioconazole-desthio toxicological database to 
characterize the potential for pre-natal or post-natal risks to infants 
and children: Two-Generation reproduction studies in rats; 
developmental studies in rats and rabbits; and a DNT study in rats. The 
effects seen in these studies suggest that offspring are more 
susceptible. Offspring adverse effects were seen at levels below the 
LOAELs for maternal toxicity and, in general, were of comparable or 
greater severity compared to the effects observed in adults. However, 
clear NOAELs are established for offspring and fetal effects. The most 
sensitive effects (malformed vertebral body and ribs, anthrogryposis, 
and other multiple malformations) seen in the fetuses of a rabbit 
developmental study are established as the toxicity endpoints with a 
POD of 2 mg/kg/day. This POD is protective all fetal and offspring 
effects seen in the developmental toxicity and developmental 
neurotoxicity studies.
    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 prothioconazole is complete.
    ii. No neurotoxicity was seen in acute and subchronic neurotoxicity 
studies and other studies with prothioconazole or prothioconazole-
desthio. Although offspring neurotoxicity was found, characterized by 
peripheral nerve lesions in the developmental neurotoxicity study on 
prothioconazole-desthio, the increase was seen only in the highest dose 
group at 105 mg/kg/day. Further, a NOAEL was established for the 
peripheral nerve lesions and all of the PODs used in the risk 
assessment were protective of this finding.
    iii. Evidence of quantitative and qualitative susceptibility of 
offspring were observed in the developmental studies. However, basing 
the POD on the offspring in the most sensitive of these studies 
provides the needed protection of offspring.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues for the proposed new uses and 
existing tolerances on berries, cucurbit vegetables, cottonseed, sugar 
beet roots, and sunflower subgroup 20B, average field trial residue 
levels for the remaining uses, and DEEM default and empirical 
processing factors. EPA made conservative (protective) assumptions in 
the ground and surface water modeling used to assess exposure to 
prothioconazole in drinking water. These assessments will not 
underestimate the exposure and risks posed by prothioconazole.

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 prothioconazole will occupy 40% of the aPAD for females 13-49 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 
prothioconazole from food and water will utilize 77% of the cPAD for 
all infants less than 1-year-old the population group receiving the 
greatest exposure. There are no residential uses for prothioconazole.
    3. Short- and Intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Both short- and intermediate-term adverse effects were identified; 
however, prothioconazole is not registered for any use patterns that 
would result in either short- or intermediate-term residential 
exposure. Short- and intermediate-term risk is assessed based on short- 
and intermediate-term residential exposure plus chronic dietary 
exposure. Because there is no short- or 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 short-term risk), no further assessment of 
short- or intermediate-term risk is necessary, and EPA relies on the 
chronic dietary risk assessment for evaluating short- and intermediate-
term risk for prothioconazole.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, prothioconazole is not expected to pose a cancer risk to 
humans.
    5. 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 prothioconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate liquid chromatography with tandem mass spectrometry (LC/
MS/MS) methods are available for enforcing prothioconazole tolerances 
in crop 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: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established MRL for prothioconazole in or on rapeseed 
at 0.1 ppm. The MRL is different than the

[[Page 52990]]

tolerance established for prothioconazole in the United States. The 
residues of concern are not harmonized between the U.S. and Codex, 
since Codex only includes prothioconazole-desthio, whereas the U.S. 
includes prothioconazole parent as well as prothioconazole-desthio, and 
harmonization may result in tolerance exceedances from use in 
accordance with the label.

C. Response to Comments

    Two comments were submitted in response to the Notice of Filing for 
tolerance expansion. One comment (Comment A) requested that EPA deny 
this tolerance petition based on the radioactivity of prothioconazole 
and its role as a developmental toxicant. The other comment (Comment B) 
requested that EPA deny this petition based on the persistence of 
prothioconazole in the digestive system and effects on the liver, 
kidney, and thyroid.
    In response to Comment A, prothioconazole is not radioactive. In 
some studies, the prothioconazole is radio-labeled in order to track 
how the chemical moves through the body of an organism after 
consumption, but prothioconazole itself is not radioactive. Although 
evidence of quantitative and qualitative susceptibility of offspring 
was observed in the developmental studies in rats and rabbits including 
the developmental neurotoxicity study; points of departure (PODs) are 
based on the most sensitive endpoints in the fetuses of the rabbit 
developmental study; therefore, the risk assessment is protective of 
any developmental effects of this chemical.
    In response to Comment B, the effect of persistence and/or 
bioaccumulation on the toxicity of a chemical is evaluated in the 
repeated dose studies. For example, the severity of adverse effects and 
the relative dose levels at which they occur can be compared in a 
subchronic study versus a chronic study. In the case of 
prothioconazole, a comparison of the subchronic (90-day) study in the 
rat with the chronic (2-year) studies in the rat, using data on both 
the parent compound and the desthio metabolite, shows there is no basis 
for concern for potential persistence, because the PODs are not 
significantly different in the two time-periods. The same is true among 
the generations in the reproduction and fertility study where the 
subsequent generations are not shown to be more sensitive to 
prothioconazole toxicity than the first generation. The rat studies are 
referred to here because the metabolism studies which would show 
persistence and/or bioaccumulation were conducted in the rat. If a 
basis for concern were demonstrated in the toxicity database the PODs, 
which are based on the most sensitive endpoints, would be protective of 
this effect. The target organs of prothioconazole and the desthio 
metabolite include the liver, kidney, bladder, thyroid and blood. The 
risk assessment uses the most sensitive endpoints to set PODs, so the 
assessment is protective of all effects to the liver, kidney, and 
thyroid.

V. Conclusion

    Therefore, tolerances are established for residues of 
prothioconazole, 2-[2-(1-chlorocylcopropyl)-3-(2-chlorophenyl)-2-
hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione, and its desthio 
metabolite, in or on rapeseed subgroup 20A at 0.15 ppm. In addition, 
EPA is removing the existing tolerance for ``rapeseed, seed'' as it is 
superseded by the new tolerance for subgroup 20A.

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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: October 11, 2018.
Daniel 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:


[[Page 52991]]


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

0
2. In Sec.  180.626,
0
a. Remove the entry for ``Rapeseed, seed'' from the table in paragraph 
(a)(1).
0
b. Add alphabetically ``Rapeseed subgroup 20A'' to the table in 
paragraph (a)(1).
    The addition reads as follows:


Sec.  180.626  Prothioconazole; tolerances for residues.

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

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Rapeseed subgroup 20A.......................................        0.15
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-22857 Filed 10-18-18; 8:45 am]
 BILLING CODE 6560-50-P


