
[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)]
[Rules and Regulations]
[Pages 78917-78923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27206]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0722; FRL-9953-71]


Prothioconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

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

DATES: This regulation is effective November 10, 2016. Objections and 
requests for hearings must be received on or before January 9, 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-2015-0722, 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:

[[Page 78918]]

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-2015-0722 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 
January 9, 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-2015-0722, 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 November 25, 2015 (80 FR 73695) (FRL-
9937-14), 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 
5F8381) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, 
Research Triangle Park, NC. The petition requested that 40 CFR 180.626 
be amended by establishing tolerances for residues of the fungicide, 
prothioconazole in or on cotton, undelinted seed (crop subgroup 20C) at 
0.4 parts per million (ppm) and to amend the existing tolerance in or 
on sugar beet, roots from 0.25 ppm to 0.3 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. A comment was received in response to the notice 
of filing. EPA's response to this comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
determined that the sugar beet root tolerance does not need to be 
increased to 0.30 ppm. The reason for this determination is explained 
in Unit IV.D.
    In the Federal Register of August 29, 2016 (81 FR 59165) (FRL-9950-
22), 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 
5F8381) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, 
Research Triangle Park, NC. The petition requested that 40 CFR 180.626 
be amended by establishing tolerances for residues of the fungicide, 
prothioconazole in or on cotton, gin byproducts at 4.0 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. There were no comments received in response to the 
notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for 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.

[[Page 78919]]

    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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for prothioconazole used 
for human risk assessment is shown in Table 1. of this unit.

     Table 1--Summary of Toxicological Doses and Endpoints for Prothioconazole for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety    RfD, PAD, LOC for  risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 years of  NOAEL = 2.0 mg/kg/day    Acute RfD = 0.02 mg/kg/  Developmental Toxicity
 age).                                  UFA = 10x.               day.                     study in rabbits.
                                       UFH = 10x..............  aPAD = 0.02 mg/kg/day..  LOAEL = 10 mg/kg/day
                                       FQPA SF = 1x...........                            based on structural
                                                                                          alterations including
                                                                                          malformed vertebral
                                                                                          body and ribs,
                                                                                          arthrogryposis, and
                                                                                          multiple
                                                                                          malformations.
                                      --------------------------------------------------------------------------
Acute dietary (General population         No observed effects could be attributable to a single dose exposure.
 including infants and children).          Therefore, a dose and endpoint were not selected for this exposure
                                                                        scenario.
                                      --------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL = 1.1 mg/kg/day    Chronic RfD = 0.01 mg/   Chronic/Carcinogenicity
                                        UFA = 10x.               kg/day.                  study in rats.
                                       UFH = 10x..............  cPAD = 0.01 mg/kg/day..  LOAEL = 8.0 mg/kg/day
                                       FQPA SF = 1x...........                            based on liver
                                                                                          histopathology
                                                                                          [hepatocellular
                                                                                          vacuolation and fatty
                                                                                          change (single cell,
                                                                                          centrilobular, and
                                                                                          periportal)].
                                      --------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....       Not likely to be carcinogenic to humans based on the absence of
                                           significant tumor increases in two adequate rodent carcinogenicity
                                                                        studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day.
MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c
  = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).

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's National

[[Page 78920]]

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 and cucurbit vegetables, average field trial 
residues for all other commodities and empirical processing factors. 
With respect to sugar beet, the registrant-proposed tolerance value of 
0.30 was incorporated in the dietary assessment, however, the Agency is 
leaving the tolerance at 0.25 ppm. The use of this higher residue level 
in the dietary assessment will serve as an overestimate of actual 
exposure to residues in/on sugar beet roots. 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 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance-level 
values for the proposed new uses and existing tolerances on berries and 
cucurbit vegetables, average field trial residues for all other 
commodities and empirical processing factors. With respect to sugar 
beet, the registrant-proposed tolerance value of 0.30 was incorporated 
in the dietary assessment; however, the Agency is leaving the existing 
tolerance at 0.25 ppm. The use of this higher residue level in the 
dietary assessment will serve as an overestimate of actual exposure to 
residues in/on sugar beet roots. 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 assessment for the purpose of assessing 
cancer risk was not conducted.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    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) models, 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 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 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 
evidence to indicate that prothioconazole 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://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

[[Page 78921]]

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. 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. 
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 
The New Section 3 Registrations For Use of Propiconazole on Tea, Dill, 
Mustard Greens, Radish, and Watercress; Use of Difenoconazole on Globe 
Artichoke, Ginseng and Greenhouse Grown Cucumbers and Conversion of the 
Established Foliar Uses/Tolerances for Stone Fruit and Tree Nut Crop 
Groups to Fruit, Stone, Group 12-12 and the Nut, Tree, Group 14-12.; 
and Use of Flutriafol on Hops'' (located 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 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 EPA-recommended tolerance values for all of the proposed 
uses and existing tolerances on berries and cucurbit vegetables, 
average field trial residue levels for the remaining uses, 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 only population group of concern.
    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

[[Page 78922]]

from aggregate exposure to prothioconazole residues, including 
aggregate exposure to residues of the common metabolites of 
prothioconazole and other related conazole fungicides.

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: 
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.
    There are no Codex MRLs established for prothioconazole in or on 
cotton.
    The Codex has established MRLs for prothioconazole in or on sugar 
beet roots at 0.3 ppm. This MRL is different than the tolerances 
established for prothioconazole in the United States. The U.S. is 
keeping the tolerance previously established in or on beet, sugar, 
roots at 0.25 ppm based on an evaluation of the residue data and in 
order to remain harmonized with Canada. The registrant, Bayer 
CropScience, has indicated their wish is to harmonize with Canada. 
Bayer cited data from the International Trade Macro Analysis Branch 
within the Economic Indicators Division of the U.S. Census Bureau, 
indicating that Canada and Mexico are the largest trade partners for 
U.S. exports of processed and refined sugar beets. Therefore, it would 
be more beneficial for U.S. growers if the U.S. tolerance is harmonized 
with Canada instead of Codex.

C. Response to Comments

    A comment was submitted by the Center for Food Safety and was 
primarily concerned about EPA's consideration of the impacts of 
prothioconazole on the environment, pollinators, and endangered 
species. This comment is not relevant to the Agency's evaluation of 
safety of the prothioconazole tolerances under section 408 of the 
FFDCA, which requires the Agency to evaluate the potential harms to 
human health, not effects on the environment.

D. Revisions to Petitioned-For Tolerances

    Based on the review of the sugar beet residue data, EPA has 
determined that increasing the existing tolerance in or on beet, sugar, 
roots from 0.25 ppm to 0.30 ppm is not necessary, and therefore the 
sugar beet root tolerance will remain at 0.25 ppm. The registrant has 
indicated that they support this conclusion.

V. Conclusion

    Therefore, tolerances are established for residues of 
prothioconazole in or on cotton gin byproducts at 4.0 ppm and the 
cottonseed subgroup 20C at 0.4 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) 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.


[[Page 78923]]


    Dated: November 2, 2016.
Michael Goodis,
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 Sec.  180.626, add alphabetically the commodities ``Cotton, gin 
byproducts'' and ``Cottonseed subgroup 20C'' to the table in paragraph 
(a)(1) to read as follows:


Sec.  180.626  Prothioconazole; tolerances for residues.

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

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cotton, gin byproducts..................................             4.0
Cottonseed subgroup 20C.................................             0.4
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-27206 Filed 11-9-16; 8:45 am]
BILLING CODE 6560-50-P


