[Federal Register Volume 78, Number 137 (Wednesday, July 17, 2013)]
[Rules and Regulations]
[Pages 42693-42699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16911]



40 CFR Part 180

[EPA-HQ-OPP-2013-0412; FRL-9391-1]

Hexythiazox; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes new tolerances and revises 
existing tolerances for residues of hexythiazox in or on multiple 
commodities which are identified and discussed later in this document. 
Gowan Company and the Interregional Research Project Number 4 (IR-4) 
requested the tolerances under the Federal Food, Drug, and Cosmetic Act 

DATES: This regulation is effective July 17, 2013. Objections and 
requests for hearings must be received on or before September 16, 2013, 
and must be filed in accordance with the instructions

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provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY 

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2013-0412, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West 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: Olga Odiott, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9369; email address: [email protected].


I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2013-0412 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 
September 16, 2013. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2013-0412, 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 
     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.htm.
    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 September 28, 2012 (77 FR 59578) (FRL-
9364-6), January 16, 2013 (78 FR 3377) (FRL-9375-4), and August 22, 
2012 (77 FR 50661) (FRL-9358-9), EPA issued notices pursuant to FFDCA 
section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a 
pesticide petitions (PP 2F8054 and PP 2F8073 by Gowan Company, P.O. Box 
556, Yuma, AZ 85336; and PP 2E8016 by the Interregional Research 
Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, 
NJ 08540. The petitions requested that 40 CFR 180.448 be amended by 
establishing tolerances for residues of the insecticide hexythiazox, 
carboxamide) and its metabolites containing the (4-chlorophenyl)-4-
methyl-2-oxo-3-thiazolidine moiety, in or on grain, sorghum, grain at 
3.0 parts per million (ppm); grain, sorghum, forage at 5 ppm; grain, 
sorghum, stover at 6 ppm; egg at 0.05 ppm; poultry, meat at 0.05 ppm; 
poultry, meat byproducts at 0.05 ppm; by increasing the established 
tolerance for milk from 0.02 ppm to 0.05 ppm and the established 
tolerances for ruminant meat byproducts from 0.05 ppm to 0.5 ppm (PP 
2F8054); and by amending the regional restriction of the tolerances for 
cotton, gin byproducts; and cotton, undelinted seed by including 
Arizona (PP 2F8073). Petition 2E8016 requested that 40 CFR 180.448 be 
amended by establishing tolerances for residues of hexythiazox in or on 
pepper/eggplant subgroup 8-10B at 1.5 ppm; fruit, pome, group 11-10 at 
0.25 ppm; caneberry subgroup 13-07A at 1.0 ppm; fruit, small, vine 
climbing, except fuzzy kiwifruit, subgroup 13-07F at 1.0 ppm; and 
berry, low growing, subgroup 13-07G at 3.0 ppm. The documents 
referenced summaries of the petitions, which are available in the 
docket, http://www.regulations.gov by docket ID numbers EPA-HQ-OPP-
2012-0624 (PP 2F8054), EPA-HQ-OPP-2012-0923 (PP 2F8073), and EPA-HQ-
OPP-2012-0357 (PP 2E8016). There were no comments received in response 
to the notices of filing.
    Based on EPA's review of the data supporting the petitions, Gowan 
Company revised their petition PP 2F8054 by adding a request for an 
increase in the established tolerance for grain, aspirated fractions; 
deleting the proposed tolerance for poultry, meat; and by deleting the 
proposed changes to the established tolerances for milk; and for 
poultry, meat byproducts.
    The IR-4 revised their petition PP 2E8016 by increasing the 
proposed tolerances for fruit, pome, group 11-10; and for berry, low 
growing, subgroup13-07G. The reasons for these changes are explained in 
Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will

[[Page 42695]]

result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue. . . .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for hexythiazox including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with hexythiazox follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The toxicity database for hexythiazox is complete. 
Hexythiazox has low acute toxicity by the oral, dermal, and inhalation 
routes of exposure. It produces mild eye irritation, is not a dermal 
irritant, and is negative for dermal sensitization. Hexythiazox is 
associated with toxicity of the liver and adrenals following subchronic 
and chronic exposure to dogs, rats, and mice, with the dog being the 
most sensitive species. The prenatal developmental studies in rabbits 
and rats and the two-generation reproduction study in rats showed no 
indication of increased susceptibility to in utero and/or postnatal 
exposure to hexythiazox. Reproductive toxicity was not observed. There 
is no concern for immunotoxicity or neurotoxicity following exposure to 
hexythiazox. The toxicology database for hexythiazox does not show any 
evidence of treatment-related effects on the immune system. Hexythiazox 
is classified as ``likely to be carcinogenic to humans;'' however, the 
evidence as a whole is not strong enough to warrant a quantitative 
estimation of human risk. Since the effects seen in the study that 
serves as the basis for the chronic reference dose (RfD) occurred at 
doses substantially below the lowest dose that induced tumors, the 
Agency concluded that quantification of 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.
    Specific information on the studies received and the nature of the 
adverse effects caused by hexythiazox as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Hexythiazox. Human Health Risk 
Assessment to Support New Uses on Grain Sorghum, Pepper/Eggplant 
Subgroup 8-10B, Pome Fruit Group 11-10, Caneberry Subgroup 13-07A, 
Small Vine Climbing, Except Fuzzy Kiwifruit Subgroup 13-07F, and Low 
Growing Berry Subgroup 13-07G'' in docket ID number EPA-HQ-OPP-2013-

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 discussed in Unit III.B. of the final rule 
published in the Federal Register of February 8, 2013 (78 FR 9322) 

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 
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for hexythiazox; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA U.S. 
Department of Agriculture's 2003-2008 National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). As to 
residue levels in food, EPA used tolerance level residues, assumed 100 
percent crop treated (PCT), and incorporated DEEM default processing 
factors when processing data were not available.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or nonlinear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. Based on the data summarized in Unit 
III.A. of the Federal Register of March 17, 2010 (75 FR 12691) (FRL-
8813-7), EPA has concluded that a nonlinear RfD approach is appropriate 
for assessing cancer risk to hexythiazox. Cancer risk was assessed 
using the same exposure estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for hexythiazox. Tolerance level

[[Page 42696]]

residues and/or 100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for hexythiazox in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of hexythiazox. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS), the estimated drinking water concentrations 
(EDWCs) of hexythiazox for chronic exposures for non-cancer and cancer 
assessments is estimated to be 4.31 parts per billion (ppb) for surface 
water. Since surface water residues value greatly exceed groundwater 
EDWCs, surface water residues were used in the dietary risk assessment. 
Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Hexythiazox is 
currently registered for the following uses that could result in 
residential exposures: Ornamental plantings, turf, and fruit and nut 
trees in residential settings. EPA assessed residential exposure using 
the following assumptions: Residential handler exposures are expected 
to be short-term (1 to 30 days) via either the dermal or inhalation 
routes of exposures. Since a quantitative dermal risk assessment is not 
needed for hexythiazox; 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. Adult postapplication 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. Post application hand-to-
mouth and object-to-mouth exposures are expected to be short-term (1 to 
30 days) in duration due to the intermittent nature of applications in 
residential environments. Given the long half-life of hexythiazox in 
soil, intermediate-term (1 to 6 months) exposure is also possible from 
incidental ingestion of soil. Further information regarding EPA 
standard assumptions and generic inputs for residential exposures may 
be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' EPA has not found 
hexythiazox to share a common mechanism of toxicity with any other 
substances, and hexythiazox does not appear to produce a toxic 
metabolite 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 
    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 
    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 
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. The dietary risk assessment is 
highly conservative and not expected to underestimate risk. 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 postapplication 
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 82% of the cPAD for 
children 1-2 years of age the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
hexythiazox is not expected.

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    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Hexythiazox 
is currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to hexythiazox.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 9,100 for adults 
and 1,300 for children. Because EPA's level of concern for hexythiazox 
is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
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 
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 9,300 for adults and 1,500 for children. Because 
EPA's level of concern for hexythiazox is a MOE of 100 or below, these 
MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III. C.1.iii., EPA concluded that regulation based on the chronic 
reference dose will be protective for both chronic and carcinogenic 
risks. As noted in this unit there are no chronic risks of concern.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to hexythiazox residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    Codex MRLs for plant commodities are established for eggplant at 
0.1 ppm, pome fruit at 0.4 ppm, grapes at 1.0 ppm, and strawberry at 6 
ppm (proposed) for residues of hexythiazox and its metabolites 
containing the PT-1-3-moiety, expressed as hexythiazox. The U.S. is 
currently harmonized with Codex with respect to residue definition in 
plants, and is recommending tolerances for CG 11-10 (pome fruit), CSG 
13-07F (small, vine climbing fruit, except kiwifruit), and CSG 13-07G 
(low growing berry) that are harmonized with the current Codex MRLs for 
pome fruit, grapes (representative commodity of CSG 13-07F), and 
strawberry (representative commodity of CSG 13-07G). The current Codex 
MRL of 0.1 ppm for eggplant is based on a use in the Netherlands at a 
significantly lower application rate than the use currently proposed in 
the U.S. The Codex MRL would not cover residues seen in the U.S. field 
trial data; therefore harmonization with codex with respect to 
eggplants is not possible at this time.
    The Agency is currently harmonized with Codex with respect to the 
residue definition in livestock commodities. The current milk tolerance 
of 0.05 ppm is harmonized with the Codex MRL for milk. The Agency is 
recommending an increase in the ruminant meat byproduct tolerances to 
0.5 ppm and an increase in the current egg tolerance to 0.05 ppm to 
harmonize with Codex.
    The Agency classified the use on poultry meat at Sec.  180.6(a)(3), 
no reasonable expectation of finite residues; therefore the U.S. will 
not need to set a tolerance for this commodity. The relevant Codex MRL 
has been set at 0.05 ppm with a footnote that states ``absent at the 
limit of quantitation''. Effectively, the Codex MRL acknowledges the 
absence of residues and the U.S. determination that no tolerance is 
required results in a harmonized approach to residues in poultry meat. 
There are no Canadian or Mexican MRLs currently established for 

C. Revisions to Petitioned-For Tolerances

    Based on EPA's review of the data supporting the petitions, Gowan 
Company revised their petition PP 2F8054 as follows:
     By adding a request for an increase in the established 
tolerance for grain, aspirated fractions from 0.5 ppm to 5 ppm. The 
submitted residue chemistry data show that sorghum residues concentrate 
in aspirated grain fractions (AGF), and that an increased tolerance of 
5 ppm is needed to cover residues in sorghum AGF.
     By deleting the proposed tolerance for poultry, meat; and 
the proposed changes to the established tolerances for milk; and 
poultry, meat byproducts. Poultry metabolism and feeding studies 
demonstrate that there are not likely to be residues in poultry meat; 
therefore a tolerance on poultry meat is not required. The data also 
shows that the current tolerances for milk; and poultry, meat 
byproducts; are adequate and no changes are required at this time.
    The IR-4 revised their petition PP 2E8016 as follows:
     By increasing the proposed tolerances for fruit, pome, 
group,11-10 from 0.25 ppm to 0.4 ppm; and for berry, low growing, 
subgroup13-07G from 3 ppm to 6 ppm. The Agency is recommending these 
changes to harmonize with Codex MRLs.
    The Agency is also removing the established tolerances for fruit, 
pome, group 11; caneberry subgroup 13A; grape; and strawberry from 40 
CFR. These tolerances are being replaced by the fruit, pome, group 11-
10; caneberry subgroup 13-07A; fruit, small, vine climbing, subgroup 
13-07F, except fuzzy kiwifruit; and berry, low growing, subgroup 13-
07G, respectively. The Agency concluded that based on the residue data, 
these changes are required to support the new uses.

[[Page 42698]]

 V. Conclusion

    Therefore, tolerances are established for residues of hexythiazox 
and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-
thiazolidine moiety, as requested in the petitions.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
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 final rule 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (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: July 2, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


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

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

2. In Sec.  180.448:
a. Remove the following commodities in the table in paragraph (a) 
``Caneberry subgroup 13A;'' ``Fruit, pome, group 11;'' ``Grape;'' and 
b. Revise the following commodities in the table in paragraph (a) 
``Cattle, meat byproducts;'' ``Egg;'' ``Goat, meat byproducts;'' 
``Grain, aspirated fractions;'' ``Horse, meat byproducts;'' and 
``Sheep, meat byproducts.''
c. Add alphabetically the commodities to the table in paragraph (a).
d. Revise the following commodities in the table in paragraph (c) 
``Cotton, gin byproducts, CA only;'' and ``Cotton, undelinted seed, CA 
e. Add alphabetically the commodities to the table in paragraph (c).
    The revisions and additions read as follows:

Sec.  180.448  Hexythiazox; tolerance for residues.

    (a) General. * * *

                                                              Parts per
                         Commodity                             million
                                * * * * *
Berry, low growing, subgroup 13-07G........................         6
Caneberry subgroup 13-07A..................................         1
                                * * * * *
Cattle, meat byproducts....................................         0.5
                                * * * * *
Egg........................................................         0.05
Fruit, pome, group 11-10...................................         0.4
Fruit, small, vine climbing, subgroup 13-07F, except fuzzy          1
                                * * * * *
Goat, meat byproducts......................................         0.5
Grain, aspirated fractions.................................         5
                                * * * * *
Horse, meat byproducts.....................................         0.5
                                * * * * *
Pepper/eggplant subgroup 8-10B.............................         1.5
                                * * * * *
Sheep, meat byproducts.....................................         0.5
                                * * * * *

* * * * *
    (c) Tolerances with regional registrations. * * *

                                                              Parts per
                         Commodity                             million
                                * * * * *
Cotton, gin byproducts, CA and AZ only.....................         3.0
Cotton, undelinted seed, CA and AZ only....................         0.20
                                * * * * *
Sorghum, grain, forage (EPA Regions 6-8 only)..............         5
Sorghum, grain, grain (EPA Regions 6-8 only)...............         3
Sorghum, grain, stover (EPA Regions 6-8 only)..............         6

[[Page 42699]]

                                * * * * *

* * * * *
[FR Doc. 2013-16911 Filed 7-16-13; 8:45 am]