[Federal Register Volume 82, Number 29 (Tuesday, February 14, 2017)]
[Rules and Regulations]
[Pages 10547-10553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02481]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0795, EPA-HQ-OPP-2015-0796 and EPA-HQ-OPP-2015-0797; 
FRL-9957-22]


Hexythiazox; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the 
ovicide/miticide hexythiazox in or on beet, sugar, root, and beet, 
sugar, dried pulp and establishes tolerances associated with regional 
registrations for residues on Bermuda grass, forage and Bermuda grass, 
hay. This regulation also modifies the existing tolerances associated 
with regional registrations in or on alfalfa, forage; and alfalfa, hay. 
Gowan Company requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA). The regulation also removes the existing 
time-limited tolerance for residues on beet, sugar, root because it is 
superseded by the new beet, sugar, root tolerance and removes the 
tolerance for residues ``Fruit, citrus group 10'' of 0.35 ppm because 
it is superseded by the existing tolerance for ``Fruit, citrus group 
10-10'' of 0.6 ppm.

DATES: This regulation is effective February 14, 2017. Objections and 
requests for hearings must be received on or before April 17, 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 dockets for this action, identified by docket 
identification (ID) numbers EPA-HQ-OPP-2015-0795, EPA-HQ-OPP-2015-0796 
and EPA-HQ-OPP-2015-0797, are available at http://www.regulations.gov 
or at the

[[Page 10548]]

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 L. Goodis, P.E., 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 numbers EPA-HQ-OPP-2015-0795, EPA-HQ-OPP-2015-0796 and EPA-
HQ-OPP-2015-0797 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 April 
17, 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 numbers EPA-HQ-OPP-2015-0795, EPA-HQ-
OPP-2015-0796 and EPA-HQ-OPP-2015-0797, by one of the following 
methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 16, 2016 (81 FR 14030) (FRL-9942-
86), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of three (3) pesticide 
petitions (PP 5F8396, 5F8412 & 5F8413) by Gowan Company, P.O. Box 5569, 
Yuma, AZ 85366-5569. These petitions requested that 40 CFR 180.448 be 
amended by (1) establishing tolerances for residues of the hexythiazox 
in or on Bermuda grass, forage at 40 parts per million (ppm) (PP 
5F8412); Bermuda grass, hay at 70 ppm (PP 5F8412); beet, sugar, dried 
pulp at 0.60 ppm (PP 5F8413); beet, sugar, molasses at 0.21 ppm (PP 
5F8413); beet, sugar, roots at 0.15 ppm (PP 5F8413); and beet, sugar, 
tops at 1.5 ppm (PP5F8413); and (2) modifying the existing tolerances 
for residues in or on alfalfa, forage from 15 ppm to 20 ppm (PP 5F8396) 
and alfalfa, hay from 30 ppm to 60 ppm (PP 5F8396). These documents 
referenced a summary of the petitions prepared by Gowan Company, the 
registrant, which are available in the docket, http://www.regulations.gov. Several comments were received in response to the 
notice of filing, objecting generally to the presence of pesticide 
residues in food. Because none of the comments provided any information 
for the Agency to consider in its review of the requested hexythiazox 
tolerances and because the Agency has concluded based on available data 
that the tolerances requested meet the FFDCA safety standard, EPA is 
not granting the commenters' requests to deny the petition.

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 hexythiazox including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with hexythiazox follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity,

[[Page 10549]]

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.
    Hexythiazox has low acute toxicity by the oral, dermal, and 
inhalation routes of exposure. It produces mild eye irritation and is 
not a skin irritant or skin sensitizer. Hexythiazox is associated with 
toxicity of the liver and adrenals following subchronic and chronic 
exposure to dogs, rats, and mice, with the dog being the most sensitive 
species. The prenatal developmental studies in rabbits and rats and the 
2-generation reproduction study in rats showed no indication of 
increased susceptibility to in utero or postnatal exposure to 
hexythiazox. Reproductive toxicity was not observed. There is no 
concern for immunotoxicity or neurotoxicity following exposure to 
hexythiazox. The toxicology database for hexythiazox does not show any 
evidence of treatment-related effects on the immune system.
    Hexythiazox is classified as ``Likely to be Carcinogenic to 
Humans'' based on a treatment-related increase in benign and malignant 
liver tumors in female mice and the presence of mammary gland tumors 
(fibroadenomas) in male rats; however, the evidence as a whole was not 
strong enough to warrant the use of a linear low dose extrapolation 
model applied to the animal data (Q1*) for a quantitative 
estimation of human risk because the common liver tumors (benign and 
malignant) were only observed in high-dose female mice, and benign 
mammary gland tumors were only observed in high-dose male rats. Since 
the effects seen in the study that serves as the basis for the chronic 
reference dose (cRfD) occurred at doses substantially below the lowest 
dose that induced tumors (and there is no mutagenic concern for 
hexythiazox), the cRfD is considered protective of all chronic effects, 
including potential carcinogenicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by hexythiazox 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 within the document entitled ``Hexythiazox. Human 
Health Risk Assessment for Section 3 Registration on Bermuda Grass and 
Amended Registrations for Use on Beet, sugars, Alfalfa, and Potatoes,'' 
which can be found in docket ID numbers EPA-HQ-OPP-2015-0795, EPA-HQ-
OPP-2015-0796 and EPA-HQ-OPP-2015-0797.

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 hexythiazox used for human risk assessment is shown in 
Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Hexythiazox for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute Dietary (All populations)..   No risk is expected from this exposure scenario as no hazard was identified
                                                in any toxicity study for this duration of exposure.
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Chronic Dietary (All populations)  NOAEL= 2.5 mg/kg/day  Chronic RfD = 0.025  One-Year Feeding Toxicity
                                   UFA = 10x...........   mg/kg/day.          Study--Dogs
                                   UFH = 10x...........  cPAD = 0.025.......  LOAEL = 12.5 mg/kg/day based on
                                   FQPA SF = 1x........                        increased absolute and relative
                                                                               adrenal weights, and associated
                                                                               adrenal histopathology.
Incidental Oral Short-Term (1 to   NOAEL= 30 mg/kg/day.  Residential LOC for  2-Generation Reproduction
 30 days) and Intermediate-Term    UFA = 10x...........   MOE = 100.          Study--Rat
 (1 to 6 months).                  UFH = 10x...........                       LOAEL = 180 mg/kg/day, based on
                                   FQPA SF = 1x........                        decreased pup body weight during
                                                                               lactation and delayed hair growth
                                                                               and/or eye opening, and decreased
                                                                               parental body-weight gain and
                                                                               increased absolute and relative
                                                                               liver, kidney, and adrenal
                                                                               weights.
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Dermal Short- and Intermediate-    A quantitative dermal risk assessment is not necessary since no dermal hazard
 term.                                    is anticipated. There is no evidence of increased quantitative or
                                    qualitative susceptibility of the young following in utero and pre- and post-
                                                           natal exposure to hexythiazox.
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[[Page 10550]]

 
Inhalation Short-Term (1 to 30     Oral NOAEL = 30 mg/   Residential LOC for  2-Generation Reproduction
 days) and Intermediate-Term (1     kg/day.               MOE = 100.          Study--Rat
 to 6 months).                     UFA = 10x...........                       LOAEL = 180 mg/kg/day, based on
                                   UFH = 10x...........                        decreased pup body weight during
                                   FQPA SF = 1x........                        lactation and delayed hair growth
                                                                               and/or eye opening, and decreased
                                                                               parental body-weight gain and
                                                                               increased absolute and relative
                                                                               liver, kidney, and adrenal
                                                                               weights.
                                  ------------------------------------------------------------------------------
Cancer (oral, dermal, and           Classification: ``Likely to be Carcinogenic to Humans.'' A quantification of
 inhalation).                       risk using a non-linear approach; i.e., RfD, for hexythiazox will adequately
                                       account for all chronic toxicity, including carcinogenicity, that could
                                                        result from exposure to hexythiazox.
----------------------------------------------------------------------------------------------------------------
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 hexythiazox, EPA considered exposure under the petitioned-
for tolerances as well as all existing hexythiazox tolerances in 40 CFR 
180.448. EPA assessed dietary exposures from hexythiazox 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. No such effects were 
identified in the toxicological studies for hexythiazox; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary (food and 
drinking water) exposure assessment, EPA used the Dietary Exposure 
Evaluation Model (DEEM-FCID), Version 3.16, which uses food consumption 
data from the U.S. Department of Agriculture's National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) 
from 2003-2008. As to residue levels in food, EPA used tolerance-level 
residues, assumed 100 percent crop treated (PCT), and incorporated DEEM 
7.81 default processing factors when processing data were not 
available.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a nonlinear RfD approach is appropriate for assessing 
cancer risk to hexythiazox. Cancer risk was assessed using the same 
exposure estimates as discussed in Unit III.C.1.ii., Chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for hexythiazox. Tolerance-level residues and/or 100 
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for hexythiazox in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of hexythiazox. 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.
    Because surface water and groundwater estimated drinking water 
concentrations (EDWCs) from the proposed new uses on Bermuda grass and 
sugar beets (ranging from 1.29 to 2.78 [mu]g/L) do not produce EDWCs 
greater than those produced from a recent drinking water assessment 
(D429192, 9/21/2015) (ranging from 3.5 to 7.3 [mu]g/L) using the 
Mississippi soybeans scenario, the Agency is relying on the EDWCs from 
that previous drinking water assessment. Based on that assessment, the 
EDWCs of hexythiazox for chronic exposures are estimated to be 4.3 ppb 
for surface water and 2.4 ppb for ground water. The higher of these 
numbers was directly entered into the dietary exposure model for the 
chronic dietary risk assessment.
    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). Hexythiazox is 
currently registered for the following residential uses, including 
ornamental landscape plantings, turf, and fruit and nut trees in 
residential sites.
    EPA assessed residential exposure using the following assumptions: 
Residential handler exposures are expected to be short-term (1 to 30 
days) via either the dermal or inhalation routes of exposures. Since a 
quantitative dermal risk assessment is not needed for hexythiazox, 
handler MOEs were calculated for the inhalation route of exposure only. 
Both adults and children may be exposed to hexythiazox residues from 
contact with treated lawns or treated residential plants. Post 
application exposures are expected to be short-term (1 to 30 days) and 
intermediate-term (1 to 6 months) in duration. Adult post-application 
exposures were not assessed since no quantitative dermal risk 
assessment is needed for hexythiazox and inhalation exposures are 
typically negligible in outdoor settings. The exposure assessment for 
children included incidental oral exposure resulting from transfer of 
residues from the hands or objects to the mouth, and from incidental 
ingestion of soil.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    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

[[Page 10551]]

pesticide's residues and ``other substances that have a common 
mechanism of toxicity.''
    EPA has not found hexythiazox to share a common mechanism of 
toxicity with any other substances, and hexythiazox does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action; therefore, EPA has assumed that 
hexythiazox does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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. The prenatal and postnatal 
toxicology data base indicates no increased susceptibility of rats or 
rabbits to in utero and/or postnatal exposure to hexythiazox.
    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 hexythiazox is complete.
    ii. There is no indication that hexythiazox is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that hexythiazox results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to hexythiazox in 
drinking water. EPA used similarly conservative assumptions to assess 
post-application exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by hexythiazox.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected; therefore, 
hexythiazox is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
hexythiazox from food and water will utilize 93% of the cPAD for 
children 1 to 2 years of age, the population group receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
hexythiazox is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Hexythiazox is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to hexythiazox. Using the 
exposure assumptions described in this unit for short-term exposures, 
EPA has concluded the combined short-term food, drinking water, and 
residential inhalation exposures result in an aggregate MOE for adults 
(7,700) that greatly exceeds the LOC of 100, and is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Hexythiazox is currently registered for uses that could result in 
intermediate-term residential exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with intermediate-term residential exposures to hexythiazox. 
Using the exposure assumptions described in this unit for intermediate-
term exposures, EPA has concluded the combined intermediate-term food, 
drinking water, and residential oral exposures result in an aggregate 
MOE for children (1,150) that greatly exceeds the LOC of 100, and is 
not of concern.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III. C.1.iii., EPA concluded that regulation based on the cRfD will be 
protective for both chronic and carcinogenic risks. As noted in this 
unit, there are no chronic risks of concern.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the U.S. general population, or to infants and children from 
aggregate exposure to hexythiazox residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical enforcement methodology, high performance 
liquid chromatography method with UV detection (HPLC/UV), is available 
to enforce the tolerance expression for hexythiazox and its metabolites 
containing the PT-1-3 moiety in crop and livestock commodities. This 
method is listed in the U.S. EPA Index of Residue Analytical Methods 
under hexythiazox as method AMR-985-87.

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

[[Page 10552]]

organization in trade agreements to which the United States is a party. 
EPA may establish a tolerance that is different from a Codex MRL; 
however, FFDCA section 408(b)(4) requires that EPA explain the reasons 
for departing from the Codex level.
    The Codex has not established a MRL for hexythiazox for alfalfa, 
forage and hay; and beet, sugar roots and top.

C. Revisions to Petitioned-For Tolerances

    The petitioner requested tolerances for beet, sugar, molasses and 
beet, sugar, dried pulp based on the raw agricultural commodity (RAC) 
tolerance level instead of the HAFT (Highest Average Field Trial). 
Using the HAFT to determine the tolerance for these processed 
commodities, EPA determined that residues in the molasses would be 
covered by the tolerance on the beet, sugar, root; therefore, a 
separate molasses tolerance is not required. Using the HAFT for beet, 
sugar, dried pulp, EPA determined that the tolerance should be reduced 
to 0.30 ppm. Beet, sugar, tops are no longer considered a major 
livestock food commodity for regulatory purposes; therefore, a 
tolerance is not required for beet, sugar, tops.

V. Conclusion

    Therefore, tolerances are established for residues of the ovicide/
miticide hexythiazox and its metabolites containing the (4-
chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety in or on beet, 
sugar, root at 0.15 ppm and beet, sugar, dried pulp at 0.30 ppm. 
Tolerances associated with regional registrations are established for 
Bermuda grass, forage (EPA Regions 9-10 only) at 40 parts per million 
(ppm) and Bermuda grass, hay (EPA Regions 9-10 only) at 70 ppm. Also, 
existing tolerances are modified for residues in or on Alfalfa, forage 
(EPA Regions 7-11 only) at 20 ppm and Alfalfa, hay (EPA Regions 7-11 
only) at 60 ppm.
    Because the new tolerance for beet, sugar, root (in 40 CFR 
180.448(a)) supersedes the existing time-limited tolerance for beet, 
sugar, root (in 40 CFR 180.448(b)), the Agency is removing the time-
limited tolerance.
    In addition, in the previous rulemaking establishing hexythiazox 
tolerances, EPA instructed the Federal Register staff to revise the 
existing entry in the table in paragraph (c) for ``Fruit, citrus group 
10 (CA, AZ, TX only)'' at 0.35 ppm to ``Fruit, citrus group 10-10 (CA, 
AZ, TX only)'' at 0.6 ppm. (April 6, 2016, 81 FR 19891). Instead of 
revising the existing entry, a separate entry was created for ``Fruit, 
citrus group 10-10 (CA, AZ, TX only).'' The result is that the table in 
paragraph (c) now contains two overlapping entries: ``Fruit, citrus 
group 10 (CA, AZ, TX only)'' of 0.35 ppm and an entry for ``Fruit, 
citrus group 10-10 (CA, AZ, TX only)'' of 0.6 ppm. Because ``Fruit, 
citrus group 10 (CA, AZ, TX only)'' is superseded by ``Fruit, citrus 
group 10-10 (CA, AZ, TX only),'' EPA is removing ``Fruit, citrus group 
10 (CA, AZ, TX only)'' as a housekeeping measure.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: January 10, 2017.
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.  180.448:
0
i. Add alphabetically the entries for ``Beet, sugar, dried pulp'' and 
``Beet, sugar, root'' to the table in paragraph (a).
0
ii. Revise paragraph (b).
0
iii. Revise the two entries for ``Alfalfa'' in the table in paragraph 
(c);
0
iv. Add alphabetically the entries for ``Bermuda grass, forage (EPA 
Regions 9-10 only)'' and ``Bermuda grass, hay (EPA Regions 9-10 only)'' 
to the table in paragraph (c); and
0
v. Remove the entry for ``Fruit, citrus group 10 (CA, AZ, TX only)'' in 
the table in paragraph (c).

[[Page 10553]]

    The additions and revisions read as follows:


Sec.  180.448  Hexythiazox; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
 
                                * * * * *
Beet, sugar, dried pulp........................................     0.30
Beet, sugar, root..............................................     0.15
 
                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) * * *

------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
Alfalfa, forage (EPA Regions 7-11 only)........................       20
Alfalfa, hay (EPA Regions 7-11 only)...........................       60
 
                                * * * * *
Bermuda grass, forage (EPA Regions 9-10 only)..................       40
Bermuda grass, hay (EPA Regions 9-10 only).....................       70
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2017-02481 Filed 2-13-17; 8:45 am]
 BILLING CODE 6560-50-P