Document ID: EPA-HQ-OPP-2017-0155-0005
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Hexythiazox
Posted Date: 2017-10-30T04:00Z

[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Rules and Regulations]
[Pages 50084-50089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23439]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0155; FRL-9968-12]

Hexythiazox; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends an existing tolerance for residues of 
the ovicide/miticide hexythiazox in/on hop, dried cones, by increasing 
the current tolerance from 2.0 parts per million (ppm) to 20 ppm. Gowan 
Company requested modification of this tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 30, 2017. Objections and 
requests for hearings must be received

[[Page 50085]]

on or before December 29, 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-2017-0155, 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 L. Goodis, P.E., Director, 
Registration Division (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email 
address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2017-0155 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 29, 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-2017-0155, 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 June 8, 2017 (82 FR 26641) (FRL-9961-
14), EPA issued a document pursuant to the Federal Food, Drug, and 
Cosmetic Act (FFDCA) section 408(d)(3), 21 U.S.C. 346a(d)(3), 
announcing the filing of a pesticide petition (PP #6F8489) by Gowan 
Company, P.O. Box 5569, Yuma, AZ 85366-5569. This petition requested 
that 40 CFR 180.448 be amended by establishing a tolerance for residues 
of hexythiazox in or on hop, dried cones at 20 ppm. This document 
referenced a summary of the petition prepared by Gowan Company, the 
registrant, which is available in the docket, http://www.regulations.gov. No comments were received in response to the 
referenced 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 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, 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

[[Page 50086]]

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 two-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 Amended Use on Hops,'' dated September 5, 
2017, which can be found in docket ID number EPA-HQ-OPP-2017-0155.

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 
the Table of this unit.

   Table--Summary of Toxicological Doses and Endpoints for Hexythiazox for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)  NOAEL= 2.5 mg/kg/day  Chronic RfD = 0.025  One-Year Feeding Toxicity Study--
                                   UFA = 10x...........   mg/kg/day.           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 Study--
 30 days) and Intermediate-Term    UFA = 10x...........   MOE = 100.           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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
Inhalation Short-Term (1 to 30     Oral NOAEL= 30 mg/kg/ Residential LOC for  2-Generation Reproduction Study--
 days) and Intermediate-Term (1     day.                  MOE = 100.           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.
----------------------------------------------------------------------------------------------------------------

[[Page 50087]]

 
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 toxic effects 
attributable to a single dose of hexythiazox were observed in the 
toxicology database; therefore, a quantitative acute dietary exposure 
and risk 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.
    Surface water and groundwater estimated drinking water 
concentrations (EDWCs) do not result in any change to the existing 
EDWCs determined from a recent drinking water assessment derived on 
hops. Specifically, since hops is already a registered use that was 
recently assessed during registration review, no new drinking water 
scenarios were identified with this proposed increase in application 
rates that would require a new drinking water assessment to be 
conducted. In fact, the highest EDWCs associated with all uses of 
hexythiazox continue to be from use on sorghum in the Western U.S., 
using the Pesticide Root Zone Model (PRZM) surface water modeling 
scenario. Furthermore, based on the Agency's previous assessment, the 
EDWCs of hexythiazox for chronic exposures are estimated to be 4.3 
parts per billion (ppb) for surface water and 2.4 ppb for ground water 
(DP 433290, 5/9/2016; DP 404023, 1/17/2012), and the higher of these 
values was used in the dietary exposure model to assess chronic dietary 
risk.
    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. 
EPA uses the term ``post-application'' to describe exposure to 
individuals that occur as a result of being in an environment that has 
been previously treated with a pesticide. There is potential for post-
application for individuals exposed as a result of being in an 
environment that has been previously treated with hexythiazox. Adult 
residential post-application dermal exposures were not assessed since 
no dermal hazard was identified for hexythiazox. The residential post-
application exposure assessment for children included incidental oral 
exposure resulting from transfer of residues from the hand-to-mouth, 
object to- 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 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

[[Page 50088]]

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 Food Quality 
Protection Act Safety Factor (FQPA 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 toxic effects attributable to a single dose of 
hexythiazox were observed in the toxicology database; therefore, a 
quantitative acute aggregate risk assessment for hexythiazox is not 
required.
    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 1-2 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 
(7,500) 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; therefore, the Agency 
concludes that aggregate exposure to hexythiazox will not pose a cancer 
risk.
    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 High performance liquid chromatography using ultra-
violet detection (HPLC/UV) analytical method is available for the 
enforcement of tolerances for residues of 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. The limit of 
quantification (LOQ) for hexythiazox residues is 0.02 ppm.

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 Federal 
Food, Drug and Cosmetic Act (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,

[[Page 50089]]

FFDCA section 408(b)(4) requires that EPA explain the reasons for 
departing from the Codex level.
    Codex has established an MRL for residues of hexythiazox on hops at 
3 ppm. The U.S. tolerance for residues of hexythiazox on hops cannot be 
harmonized based on approved label instructions. Based on available 
residue data, compliance with label instructions would result in 
exceedances of a tolerance harmonized with the Codex MRL.

V. Conclusion

    Therefore, the existing tolerance for residues of the ovicide/
miticide hexythiazox and its metabolites containing the (4-
chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety in/on hop, dried 
cones is increased from 2.0 ppm to 20 ppm.

VI. Statutory and Executive Order Reviews

    This action amends an existing tolerance 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: October 6, 2017.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.448 is amended by revising the entry ``Hop, dried 
cones'' in the table in paragraph (a) to read as follows:

Sec.  180.448   Hexythiazox; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Hop, dried cones............................................          20
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-23439 Filed 10-27-17; 8:45 am]
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