82_FR_10576 82 FR 10547 - Hexythiazox; Pesticide Tolerances

82 FR 10547 - Hexythiazox; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 29 (February 14, 2017)

Page Range10547-10553
FR Document2017-02481

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 The regulation also removes the existing time-limited tolerance for residues on beet, sugar, root because it is superseded by the new beet, sugar, root tolerance and removes the tolerance for residues ``Fruit, citrus group 10'' of 0.35 ppm because it is superseded by the existing tolerance for ``Fruit, citrus group 10-10'' of 0.6 ppm.

Federal Register, Volume 82 Issue 29 (Tuesday, February 14, 2017)
[Federal Register Volume 82, Number 29 (Tuesday, February 14, 2017)]
[Rules and Regulations]
[Pages 10547-10553]
From the Federal Register Online  [www.thefederalregister.org]
[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superseded by the new beet, sugar, root tolerance and removes the 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it is superseded by the existing tolerance for ``Fruit, citrus group 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
----------------------------------------------------------------------------------------------------------------
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
                                   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.
                                  ------------------------------------------------------------------------------
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]
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                                                               Federal Register / Vol. 82, No. 29 / Tuesday, February 14, 2017 / Rules and Regulations                                              10547

                                              experienced attorneys within the                        accordance with Executive Order 13132,                § 0.64–1 Central or Competent Authority
                                              organization and are responsible for                    it is determined that this rule does not              under treaties and executive agreements on
                                              providing legal and policy guidance to                  have sufficient federalism implications               mutual assistance in criminal matters.
                                              the Assistant Attorney General and                      to warrant the preparation of a                         * * * The Assistant Attorney
                                              Deputy Assistant Attorney General,                      Federalism Assessment.                                General, Criminal Division, is
                                              approving the arrest of international                                                                         authorized to re-delegate this authority
                                              fugitives, providing oversight of                       Executive Order 12988—Civil Justice                   to the Deputy Assistant Attorneys
                                              extradition litigation in U.S. and foreign              Reform                                                General, Criminal Division, and to the
                                              courts, and participating in the                                                                              Director, Deputy Directors, and
                                                                                                        This rule was drafted in accordance                 Associate Directors of the Office of
                                              negotiation of bilateral and multilateral
                                                                                                      with the applicable standards set forth               International Affairs, Criminal Division.
                                              law enforcement treaties. Authorizing
                                              these senior supervisory attorneys to                   in sections 3(a) and 3(b)(2) of Executive
                                                                                                                                                              Dated: February 8, 2017.
                                              sign outgoing MLA requests is                           Order 12988.
                                                                                                                                                            Dana J. Boente,
                                              commensurate with their existing duties                 Unfunded Mandates Reform Act of                       Acting Attorney General.
                                              and provides OIA with the capability to                 1995                                                  [FR Doc. 2017–02955 Filed 2–13–17; 8:45 am]
                                              more efficiently process these requests,
                                                                                                                                                            BILLING CODE 4410–14–P
                                              avoid unnecessary delays, and                             This rule will not result in the
                                              effectively satisfy MLA requests.                       expenditure by State, local and tribal
                                              Administrative Procedure Act—5                          governments, in the aggregate, or by the
                                                                                                      private sector of $100,000,000 or more                ENVIRONMENTAL PROTECTION
                                              U.S.C. 553                                                                                                    AGENCY
                                                                                                      in any one year, and it will not
                                                This rule is a rule of agency                         significantly or uniquely affect small
                                              organization and relates to a matter                                                                          40 CFR Part 180
                                                                                                      governments. Therefore, no actions were
                                              relating to agency management and is                    deemed necessary under the provisions                 [EPA–HQ–OPP–2015–0795, EPA–HQ–OPP–
                                              therefore exempt from the requirements                  of the Unfunded Mandates Reform Act                   2015–0796 and EPA–HQ–OPP–2015–0797;
                                              of prior notice and comment and a 30-                                                                         FRL–9957–22]
                                                                                                      of 1995.
                                              day delay in the effective date. See 5
                                              U.S.C. 553(a)(2), 553(b)(3)(A).                         Congressional Review Act                              Hexythiazox; Pesticide Tolerances
                                              Regulatory Flexibility Act                                                                                    AGENCY:  Environmental Protection
                                                                                                         This action pertains to agency
                                                                                                                                                            Agency (EPA).
                                                The Attorney General, in accordance                   management, personnel, and
                                                                                                                                                            ACTION: Final rule.
                                              with the Regulatory Flexibility Act (5                  organizations and does not substantially
                                              U.S.C. 605(b)), has reviewed this                       affect the rights or obligations of non-              SUMMARY:    This regulation establishes
                                              regulation and by approving it certifies                agency parties and, accordingly, is not               tolerances for residues of the ovicide/
                                              that this regulation will not have a                    a ‘‘rule’’ as that term is used by the                miticide hexythiazox in or on beet,
                                              significant economic impact on a                        Congressional Review Act, 5 U.S.C.                    sugar, root, and beet, sugar, dried pulp
                                              substantial number of small entities                    804(3)(B). Therefore, the reporting                   and establishes tolerances associated
                                              because it pertains to personnel and                    requirement of 5 U.S.C. 801 does not                  with regional registrations for residues
                                              administrative matters affecting the                    apply.                                                on Bermuda grass, forage and Bermuda
                                              Department. Further, a Regulatory                                                                             grass, hay. This regulation also modifies
                                              Flexibility Analysis is not required to be              List of Subjects in 28 CFR Part 0
                                                                                                                                                            the existing tolerances associated with
                                              prepared for this final rule because the                                                                      regional registrations in or on alfalfa,
                                                                                                        Authority delegations (Government
                                              Department was not required to publish                                                                        forage; and alfalfa, hay. Gowan
                                                                                                      agencies), Counterterrorism, Crime,
                                              a general notice of proposed rulemaking                                                                       Company requested these tolerances
                                              for this matter. 5 U.S.C. 604(a).                       Government employees, Law
                                                                                                      enforcement, National security                        under the Federal Food, Drug, and
                                              Executive Order 12866—Regulatory                        information, Organization and functions               Cosmetic Act (FFDCA). The regulation
                                              Planning and Review                                     (Government agencies), Privacy,                       also removes the existing time-limited
                                                                                                      Reporting and recordkeeping                           tolerance for residues on beet, sugar,
                                                 This action has been drafted and
                                                                                                      requirements, Terrorism,                              root because it is superseded by the new
                                              reviewed in accordance with Executive
                                                                                                                                                            beet, sugar, root tolerance and removes
                                              Order 12866, Regulatory Planning and                    Whistleblowing.
                                                                                                                                                            the tolerance for residues ‘‘Fruit, citrus
                                              Review, section 1(b), Principles of
                                                                                                        Accordingly, by virtue of the                       group 10’’ of 0.35 ppm because it is
                                              Regulation. This rule is limited to
                                                                                                      authority vested in me as Attorney                    superseded by the existing tolerance for
                                              agency organization, management, and
                                                                                                      General, including 5 U.S.C. 301 and 28                ‘‘Fruit, citrus group 10–10’’ of 0.6 ppm.
                                              personnel as described in section 3(d)(3)
                                              of Executive Order 12866 and, therefore,                U.S.C. 509 and 510, title 28 of the Code              DATES: This regulation is effective
                                              is not a ‘‘regulation’’ or ‘‘rule’’ as                  of Federal Regulations is amended as                  February 14, 2017. Objections and
                                              defined by the order. Accordingly, this                 follows:                                              requests for hearings must be received
                                              action has not been reviewed by the                                                                           on or before April 17, 2017, and must
                                                                                                      PART 0—ORGANIZATION OF THE                            be filed in accordance with the
                                              Office of Management and Budget.
                                                                                                      DEPARTMENT OF JUSTICE                                 instructions provided in 40 CFR part
                                              Executive Order 13132—Federalism                                                                              178 (see also Unit I.C. of the
sradovich on DSK3GMQ082PROD with RULES




                                                This rule will not have substantial                   ■ 1. The authority citation for part 0                SUPPLEMENTARY INFORMATION).
                                              direct effects on the States, on the                    continues to read as follows:                         ADDRESSES: The dockets for this action,
                                              relationship between the national                         Authority: 5 U.S.C. 301; 28 U.S.C. 509,             identified by docket identification (ID)
                                              government and the States, or on                        510, 515–519.                                         numbers EPA–HQ–OPP–2015–0795,
                                              distribution of power and                                                                                     EPA–HQ–OPP–2015–0796 and EPA–
                                              responsibilities among the various                      ■ 2. Revise the last sentence of § 0.64–              HQ–OPP–2015–0797, are available at
                                              levels of government. Therefore, in                     1 to read as follow:                                  http://www.regulations.gov or at the


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                                              10548            Federal Register / Vol. 82, No. 29 / Tuesday, February 14, 2017 / Rules and Regulations

                                              Office of Pesticide Programs Regulatory                 identify docket ID numbers EPA–HQ–                    (PP5F8413); and (2) modifying the
                                              Public Docket (OPP Docket) in the                       OPP–2015–0795, EPA–HQ–OPP–2015–                       existing tolerances for residues in or on
                                              Environmental Protection Agency                         0796 and EPA–HQ–OPP–2015–0797 in                      alfalfa, forage from 15 ppm to 20 ppm
                                              Docket Center (EPA/DC), West William                    the subject line on the first page of your            (PP 5F8396) and alfalfa, hay from 30
                                              Jefferson Clinton Bldg., Rm. 3334, 1301                 submission. All objections and requests               ppm to 60 ppm (PP 5F8396). These
                                              Constitution Ave. NW., Washington, DC                   for a hearing must be in writing, and                 documents referenced a summary of the
                                              20460–0001. The Public Reading Room                     must be received by the Hearing Clerk                 petitions prepared by Gowan Company,
                                              is open from 8:30 a.m. to 4:30 p.m.,                    on or before April 17, 2017. Addresses                the registrant, which are available in the
                                              Monday through Friday, excluding legal                  for mail and hand delivery of objections              docket, http://www.regulations.gov.
                                              holidays. The telephone number for the                  and hearing requests are provided in 40               Several comments were received in
                                              Public Reading Room is (202) 566–1744,                  CFR 178.25(b).                                        response to the notice of filing, objecting
                                              and the telephone number for the OPP                      In addition to filing an objection or               generally to the presence of pesticide
                                              Docket is (703) 305–5805. Please review                 hearing request with the Hearing Clerk                residues in food. Because none of the
                                              the visitor instructions and additional                 as described in 40 CFR part 178, please               comments provided any information for
                                              information about the docket available                  submit a copy of the filing (excluding                the Agency to consider in its review of
                                              at http://www.epa.gov/dockets.                          any Confidential Business Information                 the requested hexythiazox tolerances
                                              FOR FURTHER INFORMATION CONTACT:
                                                                                                      (CBI)) for inclusion in the public docket.            and because the Agency has concluded
                                              Michael L. Goodis, P.E., Registration                   Information not marked confidential                   based on available data that the
                                              Division (7505P), Office of Pesticide                   pursuant to 40 CFR part 2 may be                      tolerances requested meet the FFDCA
                                              Programs, Environmental Protection                      disclosed publicly by EPA without prior               safety standard, EPA is not granting the
                                              Agency, 1200 Pennsylvania Ave. NW.,                     notice. Submit the non-CBI copy of your
                                                                                                                                                            commenters’ requests to deny the
                                              Washington, DC 20460–0001; main                         objection or hearing request, identified
                                                                                                                                                            petition.
                                              telephone number: (703) 305–7090;                       by docket ID numbers EPA–HQ–OPP–
                                              email address: RDFRNotices@epa.gov.                     2015–0795, EPA–HQ–OPP–2015–0796                       III. Aggregate Risk Assessment and
                                                                                                      and EPA–HQ–OPP–2015–0797, by one                      Determination of Safety
                                              SUPPLEMENTARY INFORMATION:
                                                                                                      of the following methods:
                                              I. General Information                                    • Federal eRulemaking Portal: http://                  Section 408(b)(2)(A)(i) of FFDCA
                                                                                                      www.regulations.gov. Follow the online                allows EPA to establish a tolerance (the
                                              A. Does this action apply to me?                        instructions for submitting comments.                 legal limit for a pesticide chemical
                                                 You may be potentially affected by                   Do not submit electronically any                      residue in or on a food) only if EPA
                                              this action if you are an agricultural                  information you consider to be CBI or                 determines that the tolerance is ‘‘safe.’’
                                              producer, food manufacturer, or                         other information whose disclosure is                 Section 408(b)(2)(A)(ii) of FFDCA
                                              pesticide manufacturer. The following                   restricted by statute.                                defines ‘‘safe’’ to mean that ‘‘there is a
                                              list of North American Industrial                         • Mail: OPP Docket, Environmental                   reasonable certainty that no harm will
                                              Classification System (NAICS) codes is                  Protection Agency Docket Center (EPA/                 result from aggregate exposure to the
                                              not intended to be exhaustive, but rather               DC), (28221T), 1200 Pennsylvania Ave.                 pesticide chemical residue, including
                                              provides a guide to help readers                        NW., Washington, DC 20460–0001.                       all anticipated dietary exposures and all
                                              determine whether this document                           • Hand Delivery: To make special                    other exposures for which there is
                                              applies to them. Potentially affected                   arrangements for hand delivery or                     reliable information.’’ This includes
                                              entities may include:                                   delivery of boxed information, please                 exposure through drinking water and in
                                                 • Crop production (NAICS code 111).                  follow the instructions at http://                    residential settings, but does not include
                                                 • Animal production (NAICS code                      www.epa.gov/dockets/contacts.html.                    occupational exposure. Section
                                              112).                                                     Additional instructions on                          408(b)(2)(C) of FFDCA requires EPA to
                                                 • Food manufacturing (NAICS code                     commenting or visiting the docket,                    give special consideration to exposure
                                              311).                                                   along with more information about                     of infants and children to the pesticide
                                                 • Pesticide manufacturing (NAICS                     dockets generally, is available at http://            chemical residue in establishing a
                                              code 32532).                                            www.epa.gov/dockets.                                  tolerance and to ‘‘ensure that there is a
                                              B. How can I get electronic access to                   II. Summary of Petitioned-For                         reasonable certainty that no harm will
                                              other related information?                              Tolerance                                             result to infants and children from
                                                                                                                                                            aggregate exposure to the pesticide
                                                 You may access a frequently updated                     In the Federal Register of March 16,               chemical residue. . . .’’
                                              electronic version of EPA’s tolerance                   2016 (81 FR 14030) (FRL–9942–86),
                                                                                                      EPA issued a document pursuant to                        Consistent with FFDCA section
                                              regulations at 40 CFR part 180 through
                                                                                                      FFDCA section 408(d)(3), 21 U.S.C.                    408(b)(2)(D), and the factors specified in
                                              the Government Printing Office’s e-CFR
                                                                                                      346a(d)(3), announcing the filing of                  FFDCA section 408(b)(2)(D), EPA has
                                              site at http://www.ecfr.gov/cgi-bin/text-
                                                                                                      three (3) pesticide petitions (PP 5F8396,             reviewed the available scientific data
                                              idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                                                                                      5F8412 & 5F8413) by Gowan Company,                    and other relevant information in
                                              40tab_02.tpl.
                                                                                                      P.O. Box 5569, Yuma, AZ 85366–5569.                   support of this action. EPA has
                                              C. How can I file an objection or hearing               These petitions requested that 40 CFR                 sufficient data to assess the hazards of
                                              request?                                                180.448 be amended by (1) establishing                and to make a determination on
                                                Under FFDCA section 408(g), 21                        tolerances for residues of the                        aggregate exposure for hexythiazox
                                              U.S.C. 346a, any person may file an                     hexythiazox in or on Bermuda grass,                   including exposure resulting from the
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                                              objection to any aspect of this regulation              forage at 40 parts per million (ppm) (PP              tolerances established by this action.
                                              and may also request a hearing on those                 5F8412); Bermuda grass, hay at 70 ppm                 EPA’s assessment of exposures and risks
                                              objections. You must file your objection                (PP 5F8412); beet, sugar, dried pulp at               associated with hexythiazox follows.
                                              or request a hearing on this regulation                 0.60 ppm (PP 5F8413); beet, sugar,                    A. Toxicological Profile
                                              in accordance with the instructions                     molasses at 0.21 ppm (PP 5F8413); beet,
                                              provided in 40 CFR part 178. To ensure                  sugar, roots at 0.15 ppm (PP 5F8413);                   EPA has evaluated the available
                                              proper receipt by EPA, you must                         and beet, sugar, tops at 1.5 ppm                      toxicity data and considered its validity,


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                                                               Federal Register / Vol. 82, No. 29 / Tuesday, February 14, 2017 / Rules and Regulations                                         10549

                                              completeness, and reliability as well as                 a linear low dose extrapolation model                 toxicological points of departure (POD)
                                              the relationship of the results of the                   applied to the animal data (Q1*) for a                and levels of concern to use in
                                              studies to human risk. EPA has also                      quantitative estimation of human risk                 evaluating the risk posed by human
                                              considered available information                         because the common liver tumors                       exposure to the pesticide. For hazards
                                              concerning the variability of the                        (benign and malignant) were only                      that have a threshold below which there
                                              sensitivities of major identifiable                      observed in high-dose female mice, and                is no appreciable risk, the toxicological
                                              subgroups of consumers, including                        benign mammary gland tumors were                      POD is used as the basis for derivation
                                              infants and children.                                    only observed in high-dose male rats.                 of reference values for risk assessment.
                                                 Hexythiazox has low acute toxicity by                 Since the effects seen in the study that              PODs are developed based on a careful
                                              the oral, dermal, and inhalation routes                  serves as the basis for the chronic
                                                                                                                                                             analysis of the doses in each
                                              of exposure. It produces mild eye                        reference dose (cRfD) occurred at doses
                                                                                                                                                             toxicological study to determine the
                                              irritation and is not a skin irritant or                 substantially below the lowest dose that
                                                                                                       induced tumors (and there is no                       dose at which no adverse effects are
                                              skin sensitizer. Hexythiazox is                                                                                observed (the NOAEL) and the lowest
                                              associated with toxicity of the liver and                mutagenic concern for hexythiazox), the
                                                                                                       cRfD is considered protective of all                  dose at which adverse effects of concern
                                              adrenals following subchronic and                                                                              are identified (the LOAEL). Uncertainty/
                                              chronic exposure to dogs, rats, and                      chronic effects, including potential
                                                                                                       carcinogenicity.                                      safety factors are used in conjunction
                                              mice, with the dog being the most                                                                              with the POD to calculate a safe
                                                                                                          Specific information on the studies
                                              sensitive species. The prenatal
                                                                                                       received and the nature of the adverse                exposure level—generally referred to as
                                              developmental studies in rabbits and
                                                                                                       effects caused by hexythiazox as well as              a population-adjusted dose (PAD) or a
                                              rats and the 2-generation reproduction
                                                                                                       the no-observed-adverse-effect-level                  reference dose (RfD)—and a safe margin
                                              study in rats showed no indication of
                                                                                                       (NOAEL) and the lowest-observed-                      of exposure (MOE). For non-threshold
                                              increased susceptibility to in utero or
                                                                                                       adverse-effect-level (LOAEL) from the                 risks, the Agency assumes that any
                                              postnatal exposure to hexythiazox.
                                                                                                       toxicity studies can be found at http://              amount of exposure will lead to some
                                              Reproductive toxicity was not observed.
                                                                                                       www.regulations.gov within the                        degree of risk. Thus, the Agency
                                              There is no concern for immunotoxicity
                                                                                                       document entitled ‘‘Hexythiazox.                      estimates risk in terms of the probability
                                              or neurotoxicity following exposure to                   Human Health Risk Assessment for
                                              hexythiazox. The toxicology database                                                                           of an occurrence of the adverse effect
                                                                                                       Section 3 Registration on Bermuda                     expected in a lifetime. For more
                                              for hexythiazox does not show any                        Grass and Amended Registrations for
                                              evidence of treatment-related effects on                                                                       information on the general principles
                                                                                                       Use on Beet, sugars, Alfalfa, and
                                              the immune system.                                                                                             EPA uses in risk characterization and a
                                                                                                       Potatoes,’’ which can be found in docket
                                                 Hexythiazox is classified as ‘‘Likely to                                                                    complete description of the risk
                                                                                                       ID numbers EPA–HQ–OPP–2015–0795,
                                              be Carcinogenic to Humans’’ based on a                   EPA–HQ–OPP–2015–0796 and EPA–                         assessment process, see http://
                                              treatment-related increase in benign and                 HQ–OPP–2015–0797.                                     www.epa.gov/pesticides/factsheets/
                                              malignant liver tumors in female mice                                                                          riskassess.htm. A summary of the
                                              and the presence of mammary gland                        B. Toxicological Points of Departure/                 toxicological endpoints for hexythiazox
                                              tumors (fibroadenomas) in male rats;                     Levels of Concern                                     used for human risk assessment is
                                              however, the evidence as a whole was                       Once a pesticide’s toxicological                    shown in Table 1 of this unit.
                                              not strong enough to warrant the use of                  profile is determined, EPA identifies

                                                 TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR HEXYTHIAZOX FOR USE IN HUMAN HEALTH RISK
                                                                                           ASSESSMENT
                                                                                       Point of departure          RfD, PAD, LOC for
                                                     Exposure/scenario                  and uncertainty/                                                     Study and toxicological effects
                                                                                                                    risk assessment
                                                                                         safety factors

                                              Acute Dietary (All populations)         No risk is expected from this exposure scenario as no hazard was identified in any toxicity study for this dura-
                                                                                                                                    tion of exposure.

                                              Chronic Dietary (All popu-             NOAEL= 2.5 mg/kg/            Chronic RfD = 0.025       One-Year Feeding Toxicity
                                                lations).                             day.                          mg/kg/day.              Study—Dogs
                                                                                     UFA = 10x ................   cPAD = 0.025 ..........   LOAEL = 12.5 mg/kg/day based on increased absolute and rel-
                                                                                     UFH = 10x ................                               ative    adrenal    weights,   and   associated    adrenal
                                                                                     FQPA SF = 1x .........                                   histopathology.
                                              Incidental Oral Short-Term (1 to       NOAEL= 30 mg/kg/             Residential LOC for       2-Generation Reproduction
                                                30 days) and Intermediate-            day.                          MOE = 100.              Study—Rat
                                                Term (1 to 6 months).                UFA = 10x ................                             LOAEL = 180 mg/kg/day, based on decreased pup body
                                                                                     UFH = 10x ................                               weight during lactation and delayed hair growth and/or eye
                                                                                     FQPA SF = 1x .........                                   opening, and decreased parental body-weight gain and in-
                                                                                                                                              creased absolute and relative liver, kidney, and adrenal
                                                                                                                                              weights.

                                              Dermal Short- and Inter-               A quantitative dermal risk assessment is not necessary since no dermal hazard is anticipated. There is no evi-
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                                                mediate-term.                            dence of increased quantitative or qualitative susceptibility of the young following in utero and pre- and
                                                                                         post-natal exposure to hexythiazox.




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                                              10550            Federal Register / Vol. 82, No. 29 / Tuesday, February 14, 2017 / Rules and Regulations

                                                 TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR HEXYTHIAZOX FOR USE IN HUMAN HEALTH RISK
                                                                                     ASSESSMENT—Continued
                                                                                       Point of departure          RfD, PAD, LOC for
                                                     Exposure/scenario                  and uncertainty/                                                    Study and toxicological effects
                                                                                                                    risk assessment
                                                                                         safety factors

                                              Inhalation Short-Term (1 to 30         Oral NOAEL = 30              Residential LOC for      2-Generation Reproduction
                                                days) and Intermediate-Term            mg/kg/day.                   MOE = 100.             Study—Rat
                                                (1 to 6 months).                     UFA = 10x ................                            LOAEL = 180 mg/kg/day, based on decreased pup body
                                                                                     UFH = 10x ................                              weight during lactation and delayed hair growth and/or eye
                                                                                     FQPA SF = 1x .........                                  opening, and decreased parental body-weight gain and in-
                                                                                                                                             creased absolute and relative liver, kidney, and adrenal
                                                                                                                                             weights.

                                              Cancer (oral, dermal, and inha-        Classification: ‘‘Likely to be Carcinogenic to Humans.’’ A quantification of risk using a non-linear approach; i.e.,
                                                lation).                             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                                      iv. Anticipated residue and percent               flea and tick control on pets).
                                                                                                       crop treated (PCT) information. EPA did              Hexythiazox is currently registered for
                                                 1. Dietary exposure from food and                     not use anticipated residue and/or PCT               the following residential uses, including
                                              feed uses. In evaluating dietary                         information in the dietary assessment                ornamental landscape plantings, turf,
                                              exposure to hexythiazox, EPA                             for hexythiazox. Tolerance-level                     and fruit and nut trees in residential
                                              considered exposure under the                            residues and/or 100 PCT were assumed                 sites.
                                              petitioned-for tolerances as well as all                 for all food commodities.                               EPA assessed residential exposure
                                              existing hexythiazox tolerances in 40
                                                                                                          2. Dietary exposure from drinking                 using the following assumptions:
                                              CFR 180.448. EPA assessed dietary
                                                                                                       water. The Agency used screening level               Residential handler exposures are
                                              exposures from hexythiazox in food as
                                                                                                       water exposure models in the dietary                 expected to be short-term (1 to 30 days)
                                              follows:
                                                                                                       exposure analysis and risk assessment                via either the dermal or inhalation
                                                 i. Acute exposure. Quantitative acute                 for hexythiazox in drinking water.                   routes of exposures. Since a quantitative
                                              dietary exposure and risk assessments                    These simulation models take into                    dermal risk assessment is not needed for
                                              are performed for a food-use pesticide,                  account data on the physical, chemical,              hexythiazox, handler MOEs were
                                              if a toxicological study has indicated the               and fate/transport characteristics of                calculated for the inhalation route of
                                              possibility of an effect of concern                      hexythiazox. Further information                     exposure only. Both adults and children
                                              occurring as a result of a 1-day or single               regarding EPA drinking water models                  may be exposed to hexythiazox residues
                                              exposure. No such effects were                           used in pesticide exposure assessment                from contact with treated lawns or
                                              identified in the toxicological studies                  can be found at http://www.epa.gov/                  treated residential plants. Post
                                              for hexythiazox; therefore, a quantitative               oppefed1/models/water/index.htm.                     application exposures are expected to be
                                              acute dietary exposure assessment is                        Because surface water and                         short-term (1 to 30 days) and
                                              unnecessary.                                             groundwater estimated drinking water                 intermediate-term (1 to 6 months) in
                                                 ii. Chronic exposure. In conducting                   concentrations (EDWCs) from the                      duration. Adult post-application
                                              the chronic dietary (food and drinking                   proposed new uses on Bermuda grass                   exposures were not assessed since no
                                              water) exposure assessment, EPA used                     and sugar beets (ranging from 1.29 to                quantitative dermal risk assessment is
                                              the Dietary Exposure Evaluation Model                    2.78 mg/L) do not produce EDWCs                      needed for hexythiazox and inhalation
                                              (DEEM–FCID), Version 3.16, which uses                    greater than those produced from a                   exposures are typically negligible in
                                              food consumption data from the U.S.                      recent drinking water assessment                     outdoor settings. The exposure
                                              Department of Agriculture’s National                     (D429192, 9/21/2015) (ranging from 3.5               assessment for children included
                                              Health and Nutrition Examination                         to 7.3 mg/L) using the Mississippi                   incidental oral exposure resulting from
                                              Survey, What We Eat in America                           soybeans scenario, the Agency is relying             transfer of residues from the hands or
                                              (NHANES/WWEIA) from 2003–2008. As                        on the EDWCs from that previous                      objects to the mouth, and from
                                              to residue levels in food, EPA used                      drinking water assessment. Based on                  incidental ingestion of soil.
                                              tolerance-level residues, assumed 100                    that assessment, the EDWCs of                           Further information regarding EPA
                                              percent crop treated (PCT), and                          hexythiazox for chronic exposures are                standard assumptions and generic
                                              incorporated DEEM 7.81 default                           estimated to be 4.3 ppb for surface water            inputs for residential exposures may be
                                              processing factors when processing data                  and 2.4 ppb for ground water. The                    found at http://www.epa.gov/pesticides/
                                              were not available.                                      higher of these numbers was directly                 science/residential-exposure-sop.html.
                                                 iii. Cancer. Based on the data                        entered into the dietary exposure model                 4. Cumulative effects from substances
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                                              summarized in Unit III.A., EPA has                       for the chronic dietary risk assessment.             with a common mechanism of toxicity.
                                              concluded that a nonlinear RfD                              3. From non-dietary exposure. The                 Section 408(b)(2)(D)(v) of FFDCA
                                              approach is appropriate for assessing                    term ‘‘residential exposure’’ is used in             requires that, when considering whether
                                              cancer risk to hexythiazox. Cancer risk                  this document to refer to non-                       to establish, modify, or revoke a
                                              was assessed using the same exposure                     occupational, non-dietary exposure                   tolerance, the Agency consider
                                              estimates as discussed in Unit III.C.1.ii.,              (e.g., for lawn and garden pest control,             ‘‘available information’’ concerning the
                                              Chronic exposure.                                        indoor pest control, termiticides, and               cumulative effects of a particular


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                                                               Federal Register / Vol. 82, No. 29 / Tuesday, February 14, 2017 / Rules and Regulations                                        10551

                                              pesticide’s residues and ‘‘other                        assumptions in the ground and surface                    4. Intermediate-term risk.
                                              substances that have a common                           water modeling used to assess exposure                Intermediate-term aggregate exposure
                                              mechanism of toxicity.’’                                to hexythiazox in drinking water. EPA                 takes into account intermediate-term
                                                 EPA has not found hexythiazox to                     used similarly conservative assumptions               residential exposure plus chronic
                                              share a common mechanism of toxicity                    to assess post-application exposure of                exposure to food and water (considered
                                              with any other substances, and                          children as well as incidental oral                   to be a background exposure level).
                                              hexythiazox does not appear to produce                  exposure of toddlers. These assessments                  Hexythiazox is currently registered for
                                              a toxic metabolite produced by other                    will not underestimate the exposure and               uses that could result in intermediate-
                                              substances. For the purposes of this                    risks posed by hexythiazox.                           term residential exposure, and the
                                              tolerance action; therefore, EPA has                                                                          Agency has determined that it is
                                              assumed that hexythiazox does not have                  E. Aggregate Risks and Determination of
                                                                                                                                                            appropriate to aggregate chronic
                                              a common mechanism of toxicity with                     Safety
                                                                                                                                                            exposure through food and water with
                                              other substances. For information                          EPA determines whether acute and                   intermediate-term residential exposures
                                              regarding EPA’s efforts to determine                    chronic dietary pesticide exposures are               to hexythiazox. Using the exposure
                                              which chemicals have a common                           safe by comparing aggregate exposure                  assumptions described in this unit for
                                              mechanism of toxicity and to evaluate                   estimates to the acute PAD (aPAD) and                 intermediate-term exposures, EPA has
                                              the cumulative effects of such                          chronic PAD (cPAD). For linear cancer                 concluded the combined intermediate-
                                              chemicals, see EPA’s Web site at http://                risks, EPA calculates the lifetime                    term food, drinking water, and
                                              www.epa.gov/pesticides/cumulative.                      probability of acquiring cancer given the             residential oral exposures result in an
                                              D. Safety Factor for Infants and                        estimated aggregate exposure. Short-,                 aggregate MOE for children (1,150) that
                                              Children                                                intermediate-, and chronic-term risks                 greatly exceeds the LOC of 100, and is
                                                                                                      are evaluated by comparing the                        not of concern.
                                                1. In general. Section 408(b)(2)(C) of                estimated aggregate food, water, and                     5. Aggregate cancer risk for U.S.
                                              FFDCA provides that EPA shall apply                     residential exposure to the appropriate               population. As discussed in Unit III.
                                              an additional tenfold (10X) margin of                   PODs to ensure that an adequate MOE                   C.1.iii., EPA concluded that regulation
                                              safety for infants and children in the                  exists.                                               based on the cRfD will be protective for
                                              case of threshold effects to account for                   1. Acute risk. An acute aggregate risk             both chronic and carcinogenic risks. As
                                              prenatal and postnatal toxicity and the                 assessment takes into account acute                   noted in this unit, there are no chronic
                                              completeness of the database on toxicity                exposure estimates from dietary                       risks of concern.
                                              and exposure unless EPA determines                      consumption of food and drinking                         6. Determination of safety. Based on
                                              based on reliable data that a different                 water. No adverse effect resulting from               these risk assessments, EPA concludes
                                              margin of safety will be safe for infants               a single oral exposure was identified                 that there is a reasonable certainty that
                                              and children. This additional margin of                 and no acute dietary endpoint was                     no harm will result to the U.S. general
                                              safety is commonly referred to as the                   selected; therefore, hexythiazox is not               population, or to infants and children
                                              FQPA Safety Factor (SF). In applying                    expected to pose an acute risk.                       from aggregate exposure to hexythiazox
                                              this provision, EPA either retains the                     2. Chronic risk. Using the exposure                residues.
                                              default value of 10X, or uses a different               assumptions described in this unit for
                                              additional safety factor when reliable                                                                        IV. Other Considerations
                                                                                                      chronic exposure, EPA has concluded
                                              data available to EPA support the choice                that chronic exposure to hexythiazox                  A. Analytical Enforcement Methodology
                                              of a different factor.                                  from food and water will utilize 93% of
                                                2. Prenatal and postnatal sensitivity.                                                                        An adequate analytical enforcement
                                                                                                      the cPAD for children 1 to 2 years of                 methodology, high performance liquid
                                              The prenatal and postnatal toxicology
                                                                                                      age, the population group receiving the               chromatography method with UV
                                              data base indicates no increased
                                                                                                      greatest exposure. Based on the                       detection (HPLC/UV), is available to
                                              susceptibility of rats or rabbits to in
                                                                                                      explanation in Unit III.C.3., regarding               enforce the tolerance expression for
                                              utero and/or postnatal exposure to
                                                                                                      residential use patterns, chronic                     hexythiazox and its metabolites
                                              hexythiazox.
                                                3. Conclusion. EPA has determined                     residential exposure to residues of                   containing the PT–1–3 moiety in crop
                                              that reliable data show the safety of                   hexythiazox is not expected.                          and livestock commodities. This
                                              infants and children would be                              3. Short-term risk. Short-term                     method is listed in the U.S. EPA Index
                                              adequately protected if the FQPA SF                     aggregate exposure takes into account                 of Residue Analytical Methods under
                                              were reduced to 1X. That decision is                    short-term residential exposure plus                  hexythiazox as method AMR–985–87.
                                              based on the following findings:                        chronic exposure to food and water
                                                                                                      (considered to be a background                        B. International Residue Limits
                                                i. The toxicity database for
                                              hexythiazox is complete.                                exposure level).                                        In making its tolerance decisions, EPA
                                                ii. There is no indication that                          Hexythiazox is currently registered for            seeks to harmonize U.S. tolerances with
                                              hexythiazox is a neurotoxic chemical                    uses that could result in short-term                  international standards whenever
                                              and there is no need for a                              residential exposure, and the Agency                  possible, consistent with U.S. food
                                              developmental neurotoxicity study or                    has determined that it is appropriate to              safety standards and agricultural
                                              additional UFs to account for                           aggregate chronic exposure through food               practices. EPA considers the
                                              neurotoxicity.                                          and water with short-term residential                 international maximum residue limits
                                                iii. There is no evidence that                        exposures to hexythiazox. Using the                   (MRLs) established by the Codex
                                              hexythiazox results in increased                        exposure assumptions described in this                Alimentarius Commission (Codex), as
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                                              susceptibility in in utero rats or rabbits              unit for short-term exposures, EPA has                required by FFDCA section 408(b)(4).
                                              in the prenatal developmental studies or                concluded the combined short-term                     The Codex Alimentarius is a joint
                                              in young rats in the 2-generation                       food, drinking water, and residential                 United Nations Food and Agriculture
                                              reproduction study.                                     inhalation exposures result in an                     Organization/World Health
                                                iv. There are no residual uncertainties               aggregate MOE for adults (7,700) that                 Organization food standards program,
                                              identified in the exposure databases.                   greatly exceeds the LOC of 100, and is                and it is recognized as an international
                                              EPA made conservative (protective)                      not of concern.                                       food safety standards-setting


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                                              10552            Federal Register / Vol. 82, No. 29 / Tuesday, February 14, 2017 / Rules and Regulations

                                              organization in trade agreements to                     group 10–10 (CA, AZ, TX only).’’ The                  various levels of government or between
                                              which the United States is a party. EPA                 result is that the table in paragraph (c)             the Federal Government and Indian
                                              may establish a tolerance that is                       now contains two overlapping entries:                 tribes. Thus, the Agency has determined
                                              different from a Codex MRL; however,                    ‘‘Fruit, citrus group 10 (CA, AZ, TX                  that Executive Order 13132, entitled
                                              FFDCA section 408(b)(4) requires that                   only)’’ of 0.35 ppm and an entry for                  ‘‘Federalism’’ (64 FR 43255, August 10,
                                              EPA explain the reasons for departing                   ‘‘Fruit, citrus group 10–10 (CA, AZ, TX               1999) and Executive Order 13175,
                                              from the Codex level.                                   only)’’ of 0.6 ppm. Because ‘‘Fruit,                  entitled ‘‘Consultation and Coordination
                                                 The Codex has not established a MRL                  citrus group 10 (CA, AZ, TX only)’’ is                with Indian Tribal Governments’’ (65 FR
                                              for hexythiazox for alfalfa, forage and                 superseded by ‘‘Fruit, citrus group 10–               67249, November 9, 2000) do not apply
                                              hay; and beet, sugar roots and top.                     10 (CA, AZ, TX only),’’ EPA is removing               to this action. In addition, this action
                                              C. Revisions to Petitioned-For                          ‘‘Fruit, citrus group 10 (CA, AZ, TX                  does not impose any enforceable duty or
                                              Tolerances                                              only)’’ as a housekeeping measure.                    contain any unfunded mandate as
                                                                                                      VI. Statutory and Executive Order                     described under Title II of the Unfunded
                                                 The petitioner requested tolerances                                                                        Mandates Reform Act (UMRA) (2 U.S.C.
                                              for beet, sugar, molasses and beet, sugar,              Reviews
                                                                                                                                                            1501 et seq.).
                                              dried pulp based on the raw agricultural                   This action establishes tolerances                    This action does not involve any
                                              commodity (RAC) tolerance level                         under FFDCA section 408(d) in                         technical standards that would require
                                              instead of the HAFT (Highest Average                    response to a petition submitted to the               Agency consideration of voluntary
                                              Field Trial). Using the HAFT to                         Agency. The Office of Management and                  consensus standards pursuant to section
                                              determine the tolerance for these                       Budget (OMB) has exempted these types                 12(d) of the National Technology
                                              processed commodities, EPA                              of actions from review under Executive                Transfer and Advancement Act
                                              determined that residues in the                         Order 12866, entitled ‘‘Regulatory                    (NTTAA) (15 U.S.C. 272 note).
                                              molasses would be covered by the                        Planning and Review’’ (58 FR 51735,
                                              tolerance on the beet, sugar, root;                     October 4, 1993). Because this action                 VII. Congressional Review Act
                                              therefore, a separate molasses tolerance                has been exempted from review under                     Pursuant to the Congressional Review
                                              is not required. Using the HAFT for                     Executive Order 12866, this action is                 Act (5 U.S.C. 801 et seq.), EPA will
                                              beet, sugar, dried pulp, EPA determined                 not subject to Executive Order 13211,                 submit a report containing this rule and
                                              that the tolerance should be reduced to                 entitled ‘‘Actions Concerning                         other required information to the U.S.
                                              0.30 ppm. Beet, sugar, tops are no longer               Regulations That Significantly Affect                 Senate, the U.S. House of
                                              considered a major livestock food                       Energy Supply, Distribution, or Use’’ (66             Representatives, and the Comptroller
                                              commodity for regulatory purposes;                      FR 28355, May 22, 2001) or Executive                  General of the United States prior to
                                              therefore, a tolerance is not required for              Order 13045, entitled ‘‘Protection of                 publication of the rule in the Federal
                                              beet, sugar, tops.                                      Children from Environmental Health                    Register. This action is not a ‘‘major
                                                                                                      Risks and Safety Risks’’ (62 FR 19885,                rule’’ as defined by 5 U.S.C. 804(2).
                                              V. Conclusion                                           April 23, 1997). This action does not
                                                 Therefore, tolerances are established                contain any information collections                   List of Subjects in 40 CFR Part 180
                                              for residues of the ovicide/miticide                    subject to OMB approval under the                       Environmental protection,
                                              hexythiazox and its metabolites                         Paperwork Reduction Act (PRA) (44                     Administrative practice and procedure,
                                              containing the (4-chlorophenyl)-4-                      U.S.C. 3501 et seq.), nor does it require             Agricultural commodities, Pesticides
                                              methyl-2-oxo-3-thiazolidine moiety in                   any special considerations under                      and pests, Reporting and recordkeeping
                                              or on beet, sugar, root at 0.15 ppm and                 Executive Order 12898, entitled                       requirements.
                                              beet, sugar, dried pulp at 0.30 ppm.                    ‘‘Federal Actions to Address
                                                                                                                                                               Dated: January 10, 2017.
                                              Tolerances associated with regional                     Environmental Justice in Minority
                                              registrations are established for                       Populations and Low-Income                            Michael Goodis,
                                              Bermuda grass, forage (EPA Regions 9–                   Populations’’ (59 FR 7629, February 16,               Acting Director, Registration Division, Office
                                              10 only) at 40 parts per million (ppm)                  1994).                                                of Pesticide Programs.
                                              and Bermuda grass, hay (EPA Regions                        Since tolerances and exemptions that                 Therefore, 40 CFR chapter I is
                                              9–10 only) at 70 ppm. Also, existing                    are established on the basis of a petition            amended as follows:
                                              tolerances are modified for residues in                 under FFDCA section 408(d), such as
                                              or on Alfalfa, forage (EPA Regions 7–11                 the tolerance in this final rule, do not              PART 180—[AMENDED]
                                              only) at 20 ppm and Alfalfa, hay (EPA                   require the issuance of a proposed rule,
                                                                                                                                                            ■ 1. The authority citation for part 180
                                              Regions 7–11 only) at 60 ppm.                           the requirements of the Regulatory
                                                                                                                                                            continues to read as follows:
                                                 Because the new tolerance for beet,                  Flexibility Act (RFA) (5 U.S.C. 601 et
                                              sugar, root (in 40 CFR 180.448(a))                      seq.), do not apply.                                      Authority: 21 U.S.C. 321(q), 346a and 371.
                                              supersedes the existing time-limited                       This action directly regulates growers,            ■  2. In § 180.448:
                                              tolerance for beet, sugar, root (in 40 CFR              food processors, food handlers, and food              ■  i. Add alphabetically the entries for
                                              180.448(b)), the Agency is removing the                 retailers, not States or tribes, nor does             ‘‘Beet, sugar, dried pulp’’ and ‘‘Beet,
                                              time-limited tolerance.                                 this action alter the relationships or                sugar, root’’ to the table in paragraph (a).
                                                 In addition, in the previous                         distribution of power and                             ■ ii. Revise paragraph (b).
                                              rulemaking establishing hexythiazox                     responsibilities established by Congress              ■ iii. Revise the two entries for ‘‘Alfalfa’’
                                              tolerances, EPA instructed the Federal                  in the preemption provisions of FFDCA                 in the table in paragraph (c);
                                              Register staff to revise the existing entry             section 408(n)(4). As such, the Agency                ■ iv. Add alphabetically the entries for
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                                              in the table in paragraph (c) for ‘‘Fruit,              has determined that this action will not              ‘‘Bermuda grass, forage (EPA Regions 9–
                                              citrus group 10 (CA, AZ, TX only)’’ at                  have a substantial direct effect on States            10 only)’’ and ‘‘Bermuda grass, hay
                                              0.35 ppm to ‘‘Fruit, citrus group 10–10                 or tribal governments, on the                         (EPA Regions 9–10 only)’’ to the table in
                                              (CA, AZ, TX only)’’ at 0.6 ppm. (April                  relationship between the national                     paragraph (c); and
                                              6, 2016, 81 FR 19891). Instead of                       government and the States or tribal                   ■ v. Remove the entry for ‘‘Fruit, citrus
                                              revising the existing entry, a separate                 governments, or on the distribution of                group 10 (CA, AZ, TX only)’’ in the
                                              entry was created for ‘‘Fruit, citrus                   power and responsibilities among the                  table in paragraph (c).


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                                                               Federal Register / Vol. 82, No. 29 / Tuesday, February 14, 2017 / Rules and Regulations                                         10553

                                                The additions and revisions read as                            eastern zone of the Gulf of Mexico (Gulf)       Regulations at 50 CFR 622.8(b) and
                                              follows:                                                         exclusive economic zone (EEZ) using          622.388(a)(1) require NMFS to close any
                                                                                                               run-around gillnet gear. NMFS has            segment of the king mackerel
                                              § 180.448 Hexythiazox; tolerances for                            determined that the commercial annual        commercial sector when its quota has
                                              residues.
                                                                                                               catch limit (ACL, equivalent to the          been reached, or is projected to be
                                                 (a) * * *                                                     commercial quota) for king mackerel          reached, by filing a notification with the
                                                                                                               using run-around gillnet gear in the         Office of the Federal Register. NMFS has
                                                                                                      Parts    Florida west coast southern subzone of
                                                              Commodity                                per                                                  determined that the Gulf king mackerel
                                                                                                      million the Gulf EEZ will be reached by               commercial quota of 551,448 lb (250,133
                                                                                                               February 10, 2017. Therefore, NMFS           kg) for vessels using run-around gillnet
                                                                                                               closes the Florida west coast southern       gear in the Florida west coast southern
                                                  *            *              *               *          *     subzone to commercial king mackerel          subzone will be reached by February 10,
                                              Beet, sugar, dried pulp .....................              0.30 fishing using run-around gillnet gear in      2017. Accordingly, commercial fishing
                                              Beet, sugar, root ...............................          0.15 the Gulf EEZ. This closure is necessary
                                                                                                                                                            using such gear in the Florida west coast
                                                                                                               to protect the Gulf king mackerel            southern subzone is closed at 12:01
                                                  *            *              *               *          *
                                                                                                               resource.                                    p.m., eastern standard time, February
                                                 (b) Section 18 emergency exemptions. DATES: The closure is effective from                                  10, 2017, until 6 a.m., eastern standard
                                              [Reserved]                                                       12:01 p.m., eastern standard time,           time, January 16, 2018, the beginning of
                                                 (c) * * *                                                     February 10, 2017, until 6 a.m., eastern     the next fishing season, i.e., the day after
                                                                                                               standard time, January 16, 2018.             the 2018 Martin Luther King, Jr. Federal
                                                                                                      Parts    FOR FURTHER INFORMATION CONTACT:             holiday. Accordingly, the vessel
                                                              Commodity                                per     Kelli O’Donnell, NMFS Southeast              operator that has been issued a Federal
                                                                                                      million Regional Office, telephone: 727–824–          commercial permit to harvest Gulf king
                                              Alfalfa, forage (EPA Regions 7–11                                5305, email: kelli.odonnell@noaa.gov.        mackerel using run-around gillnet gear
                                                 only) ..............................................       20 SUPPLEMENTARY INFORMATION: The               in the Florida west coast southern
                                              Alfalfa, hay (EPA Regions 7–11                                   fishery for coastal migratory pelagic fish   subzone must have landed ashore and
                                                 only) ..............................................       60 includes king mackerel, Spanish              bartered, traded, or sold such king
                                                                                                               mackerel, and cobia, and is managed          mackerel prior to 12:01 p.m., eastern
                                                  *            *              *               *          *     under the Fishery Management Plan for        standard time, February 10, 2017.
                                              Bermuda grass, forage (EPA Re-                                   the Coastal Migratory Pelagic Resources
                                                 gions 9–10 only) ...........................               40                                                 Persons aboard a vessel for which a
                                              Bermuda grass, hay (EPA Regions
                                                                                                               of the Gulf of Mexico and Atlantic           commercial permit for king mackerel
                                                 9–10 only) .....................................           70 Region (FMP). The FMP was prepared           has been issued, except persons who
                                                                                                               by the Gulf of Mexico and South              also possess a king mackerel gillnet
                                                  *            *              *               *          *     Atlantic Fishery Management Councils         permit, may fish for or retain Gulf king
                                                                                                               and is implemented by NMFS under the         mackerel harvested using hook-and-line
                                              *      *        *         *         *                            authority of the Magnuson-Stevens            gear in the Florida west coast southern
                                              [FR Doc. 2017–02481 Filed 2–13–17; 8:45 am]                      Fishery Conservation and Management          subzone unless the commercial quota
                                              BILLING CODE 6560–50–P
                                                                                                               Act (Magnuson-Stevens Act) by                for hook-and-line gear has been met and
                                                                                                               regulations at 50 CFR part 622.              the hook-and-line segment of the
                                                                                                                  The Florida west coast subzone of the     commercial sector has been closed. A
                                                                                                               Gulf eastern zone for Gulf migratory         person aboard a vessel that has a valid
                                              DEPARTMENT OF COMMERCE                                           group king mackerel (Gulf king               charter vessel/headboat permit for
                                                                                                               mackerel) is divided into northern and       coastal migratory pelagic fish may
                                              National Oceanic and Atmospheric
                                                                                                               southern subzones, each with separate        continue to retain king mackerel in or
                                              Administration
                                                                                                               commercial quotas. From November 1
                                                                                                                                                            from closed zones or subzones under
                                                                                                               through March 31, the southern subzone
                                              50 CFR Part 622                                                                                               the bag and possession limits set forth
                                                                                                               encompasses an area of the EEZ south
                                                                                                                                                            in 50 CFR 622.382(a)(1)(ii) and (a)(2),
                                              [Docket No. 101206604–1758–02]                                   of a line extending due west of the Lee
                                                                                                                                                            provided the vessel is operating as a
                                                                                                               and Collier County, Florida, boundary
                                              RIN 0648–XF151                                                                                                charter vessel or headboat. A charter
                                                                                                               on the Florida west coast, and south of
                                                                                                                                                            vessel or headboat that also has a
                                              Fisheries of the Caribbean, Gulf of                              a line extending due east of the Monroe
                                                                                                                                                            commercial king mackerel permit is
                                              Mexico, and South Atlantic; Coastal                              and Miami-Dade County, Florida,
                                                                                                                                                            considered to be operating as a charter
                                              Migratory Pelagic Resources of the                               boundary on the Florida east coast,
                                                                                                                                                            vessel or headboat when it carries a
                                              Gulf of Mexico and Atlantic Region;                              which includes the EEZ off Collier and
                                                                                                                                                            passenger who pays a fee or when there
                                              2017 Commercial Run-Around Gillnet                               Monroe Counties, Florida. From April 1
                                                                                                               through October 31, the southern             are more than three persons aboard,
                                              Closure                                                                                                       including operator and crew.
                                                                                                               subzone is reduced to the EEZ off
                                              AGENCY: National Marine Fisheries                                Collier County, and the EEZ off Monroe          During the closure, king mackerel
                                              Service (NMFS), National Oceanic and                             County becomes part of the Atlantic          harvested using run-around gillnet gear
                                              Atmospheric Administration (NOAA),                               migratory group area (50 CFR                 in the Florida west coast southern
                                              Commerce.                                                        622.369(a)(1)(ii)(A)(2)).                    subzone may not be purchased or sold.
sradovich on DSK3GMQ082PROD with RULES




                                              ACTION: Temporary rule; closure.                                    The commercial quota for Gulf king        This prohibition does not apply to king
                                                                                                               mackerel in the Florida west coast           mackerel harvested using run-around
                                              SUMMARY: NMFS implements an                                      southern subzone is 551,448 lb (250,133      gillnet gear in the Florida west coast
                                              accountability measure (AM) through                              kg) for vessels using run-around gillnet     southern subzone that were harvested,
                                              this temporary rule for commercial                               gear (50 CFR 622.384(b)(1)(i)(B)(1)), for    landed ashore, and sold prior to the
                                              harvest of king mackerel in the Florida                          the current fishing year, July 1, 2016,      closure and were held in cold storage by
                                              west coast southern subzone of the                               through June 30, 2017.                       a dealer or processor.


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Document Created: 2017-02-13 23:40:35
Document Modified: 2017-02-13 23:40:35
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactMichael L. Goodis, P.E., Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
FR Citation82 FR 10547 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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