Document ID: EPA-HQ-OPP-2015-0338-0003
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Hexythiazox
Posted Date: 2016-04-06T04:00Z

[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Rules and Regulations]
[Pages 19891-19896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07661]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0338 and EPA-HQ-OPP-2015-0339; FRL-9942-32]

Hexythiazox; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends tolerances for residues of hexythiazox 
in or on citrus and cotton. Gowan Company requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 6, 2016. Objections and 
requests for hearings must be received on or before June 6, 2016, 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) number EPA-HQ-OPP-2015-0338 and EPA-HQ-OPP-2015-
0339, are 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: Susan Lewis, 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:

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-2015-0338 and EPA-HQ-OPP-2015-0339 in the 
subject line on the first page of your submission. All objections and 
requests for a hearing must be in writing, and must be received by the 
Hearing Clerk on or before June 6, 2016. 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-2015-0338 and EPA-
HQ-OPP-2015-0339, 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 July 17, 2015 (80 FR 42462) (FRL-9929-
13), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
5F8346 and PP 5F8356) by Gowan Company, P.O. Box 5569, Yuma, AZ 85366-
5569. The petitions requested that tolerances currently listed in 40 
CFR 180.448 be amended for residues of the insecticide hexythiazox and 
its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-
thiazolidine moiety, in or on citrus, dried pulp at 0.6 parts per 
million (ppm); citrus, oil at 26 ppm; fruit, citrus, group 10 at 0.6 
ppm; cotton gin byproducts at 15 ppm; and cotton, undelinted seed at 
0.5 ppm. That document referenced a summary of the petitions prepared 
by Gowan Company, the registrant, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revoked citrus, dried pulp tolerance as it is covered by the 
recommended fruit, citrus, group 10-10 tolerance. For citrus oil, EPA 
revised the tolerance to 25 ppm and for cotton undelinted seed to 0.4

[[Page 19892]]

ppm. The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for 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 oral, dermal and 
inhalation routes of exposure. It is not a dermal irritant, is negative 
for dermal sensitization and produces only mild eye irritation. 
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 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;'' however, the weight of evidence indicates 
that assessing chronic risk using the chronic population adjusted dose 
will be protective for any potential carcinogenic effects. Since the 
effects seen in the study that serves as the basis for the chronic PAD 
occurred at doses substantially below the lowest dose that induced 
tumors, the chronic PAD 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 in the document: Hexythiazox. Human Health Risk 
Assessment to Support Amended Uses on Cotton and Citrus in docket ID 
number EPA-HQ-OPP-2015-0338 or EPA-HQ-OPP-2015-0339.

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
----------------------------------------------------------------------------------------------------------------
                                    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/    Chronic RfD = 0.025  1-year toxicity feeding study--Dog
                                    day UFA = 10x.        mg/kg/day.          LOAEL = 12.5 mg/kg/day based on
                                   UFH = 10x...........  cPAD = 0.025 mg/kg/   increased absolute and relative
                                   FQPA SF = 1x........   day.                 adrenal weights and associated
                                                                               adrenal histopathology.
----------------------------------------------------------------------------------------------------------------

[[Page 19893]]

 
Incidental oral short-term (1 to   NOAEL = 30 mg/kg/day  LOC for MOE = 100..  2-generation reproduction study--
 30 days) and intermediate-term     UFA = 10x.                                 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.
                                                                              Co-critical
                                                                              13-Week Oral Toxicity Study--Rat.
                                                                              NOAEL = 5.5 mg/kg/day
                                                                              LOAEL = 38 mg/kg/day, based on
                                                                               increased absolute and relative
                                                                               liver weights in both sexes,
                                                                               increased relative ovarian and
                                                                               kidney weights, and fatty
                                                                               degeneration of the adrenal zona
                                                                               fasciculata.
                                                                              @397.5/257.6 mg/kg/day, decreased
                                                                               body-weight gain in females,
                                                                               slight swelling of hepatocytes in
                                                                               central zone (both sexes),
                                                                               increased incidence of
                                                                               glomerulonephrosis in males,
                                                                               increased adrenal weights.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     Oral study NOAEL =    LOC for MOE = 100..  2-generation reproduction study--
 days) and                          30 mg/kg/day                               Rat.
intermediate-term (1 to 6 months)   (inhalation                               LOAEL = 180 mg/kg/day based on
                                    absorption rate =                          decreased pup body weight during
                                    100%).                                     lactation and delayed hair growth
                                   UFA = 10x...........                        and/or eye opening, and decreased
                                   UFH = 10x...........                        parental body-weight gain and
                                                                               increased absolute and relative
                                                                               liver, kidney, and adrenal
                                                                               weights.
                                                                              Co-Critical
                                                                              13-Week Feeding Study--Rat.
                                                                              LOAEL = 38.1 mg/kg/day, based on
                                                                               increased absolute and relative
                                                                               liver weights in both sexes,
                                                                               increased relative ovarian and
                                                                               kidney weights, and fatty
                                                                               degeneration of the adrenal zona
                                                                               fasciculata.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Likely to be Carcinogenic to Humans''. Insufficient
                                    evidence to warrant a quantitative estimation of human risk using a cancer
                                    slope factor based on the common liver tumors (benign and malignant)
                                    observed only in high dose female mice, and benign mammary gland tumors of
                                    no biological significance, observed only in high dose male rats in the
                                    absence of mutagenic concerns. The chronic RfD is protective of all chronic
                                    effects including potential carcinogenicity of 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 exposure 
assessment EPA used the food consumption data from the U.S. Department 
of Agriculture's 2003-2008 National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in 
food, EPA used tolerance-level residues, assumed 100 percent crop 
treated (PCT), and incorporated DEEM 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.
    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% CT 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.
    Based on the Surface Water Concentration Calculator, the estimated 
drinking water concentrations (EDWCs) of hexythiazox for chronic 
exposures for non-cancer assessments are estimated to be 4.3 parts per 
billion (ppb) for surface water. Since groundwater residues are not 
expected to exceed surface water residues, surface water residues were 
used in the dietary risk assessment. Modeled estimates of drinking 
water

[[Page 19894]]

concentrations were directly entered into the dietary exposure model.
    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 uses that 
could result in residential exposures: Ornamental plantings, lawns, 
recreational sites such as campgrounds and golf courses, turf, and 
fruit and nut trees in residential settings. 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. 
Intermediate-term exposures are not likely because of the intermittent 
nature of applications by residential applicators. Since hexythiazox 
does not pose a significant dermal risk, a quantitative dermal risk 
assessment was not performed and handler margins of exposure (MOE) 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) in 
duration for most exposure scenarios, and intermediate-term (1 to 6 
months) in duration for soil ingestion only due to the aerobic soil 
metabolism half-life for hexythiazox. 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/trac/science/trac6a05.pdf.
    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. 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 development 
studies in rabbits and rats and the two-generation reproduction study 
in rats showed no indication of increased susceptibility 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 81% 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, water, 
and residential exposures result in aggregate MOEs of 1,300 for 
children and 9,900 for adults. Because EPA's level of concern for 
hexythiazox is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic

[[Page 19895]]

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 that the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 1,500 for children and 9,900 for adults. Because 
EPA's level of concern for hexythiazox is a MOE of 100 or below, these 
MOEs are 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 chronic 
reference dose 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 general population, or to infants and children from aggregate 
exposure to hexythiazox residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid 
chromatography method with ultraviolet detection (HPLC/UV)) is 
available to enforce the tolerance expression. 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 organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established MRLs for residues of hexythiazox on 
citrus, fruits but not for cotton. The Codex plant residue definition 
is for hexythiazox as opposed to the U.S. definition which includes 
hexythiazox plus metabolites containing the (4-chlorophenyl)-4-methyl-
2-oxo-3-thiazolidine moiety. The differences in U.S. and Codex residue 
definitions prohibits harmonization.

C. Revisions to Petitioned-for Tolerances

    Although the petitioner requested an amended tolerance for citrus, 
dried pulp at 0.6, the Agency has determined that no such tolerance is 
necessary because that commodity is covered by the established citrus 
group 10-10 tolerance. The Agency is revising the tolerance for citrus 
oil to 25 ppm based on the following: By multiplying the citrus oil 
processing factor (104X) from the 2006 processing study (D334889, 07/
03/2006, T. Bloem) by the highest average field trial (HAFT) residue 
for lemons (0.243 ppm) from the submitted citrus study since lemons are 
the citrus crop that produced the highest residues.
    As noted in its most recent crop group rulemaking in the Federal 
Register of August 22, 2012 (77 FR 50617) (FRL-9354-3), EPA generally 
does not establish new tolerances under pre-existing crop groups that 
have been updated. EPA updated crop group 10 in 2010, making the new 
group 10-10. Therefore, EPA is establishing citrus fruit group 
tolerances for group 10-10, rather than crop group 10 as requested.
    The Agency is amending the tolerance for cotton, undelinted seed at 
0.4 ppm based on the available cotton data that reflect a national use 
at the label specified 35 day pre-harvest internal (PHI) to calculate 
the 0.4 ppm tolerance.

V. Conclusion

    Therefore, tolerances are amended for residues of hexythiazox and 
its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-
thiazolidine moiety, in or on citrus, oil at 25 ppm; fruit, citrus, 
group 10-10 at 0.6 ppm; cotton, gin byproducts at 15 ppm; cotton, 
undelinted seed at 0.4 ppm. The current citrus, dried pulp tolerance is 
revoked because it is unnecessary due to the establishment of the 
fruit, citrus, group 10-10 tolerance.

VI. Statutory and Executive Order Reviews

    This action amends 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

[[Page 19896]]

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: March 22, 2016.
Susan Lewis,
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 ``Cotton, gin byproducts'' and 
``Cotton, undelinted seed'' to the table in paragraph (a).
0
ii. Remove the entry for ``Citrus, dried pulp'' from the table in 
paragraph (a).
0
iii. Revise the entry for ``Citrus, oil'' in the table in paragraph 
(a).
0
iv. Remove the entries for ``Cotton, gin byproducts, CA and AZ only'', 
and ``Cotton, undelinted seed, CA and AZ only'' from the table in 
paragraph (c).
0
v. Revise the entry for ``Fruit, citrus group 10 (CA, AZ, TX only)'' in 
the table in paragraph (c).
    The additions and revisions read as follows:

Sec.  180.448  Hexythiazox; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Citrus, oil.................................................          25
 
                                * * * * *
Cotton, gin byproducts......................................          15
Cotton, undelinted seed.....................................         0.4
 
                                * * * * *
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Fruit, citrus group 10-10 (CA, AZ, TX only).................         0.6
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2016-07661 Filed 4-5-16; 8:45 am]
 BILLING CODE 6560-50-P