
[Federal Register Volume 78, Number 27 (Friday, February 8, 2013)]
[Rules and Regulations]
[Pages 9322-9327]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02924]



[[Page 9322]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0916; FRL-9376-9]


Hexythiazox; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective February 8, 2013. Objections and 
requests for hearings must be received on or before April 9, 2013, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2010-0916, 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: odiott.olga@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. If OCSPP test 
guidelines are cited, insert the following: To access the OCSPP test 
guidelines referenced in this document electronically, please go to 
http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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-2010-0916 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 9, 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-2010-0916, 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 Confidential Business 
Information (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.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 March 14, 2012 (77 FR 15012) (FRL-9335-
9), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
1F7934) by Gowan Company, 370 South Main Street, Yuma, AZ 85364. The 
petition requested that 40 CFR 180.448 be amended by establishing 
tolerances for residues of the insecticide hexythiazox (trans-5-(4-
chlorophenyl)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide) 
and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-
thiazolidine moiety, in or on wheat, forage at 3.0 parts per million 
(ppm); wheat, hay at 30 ppm; wheat, grain at 0.02 ppm; wheat, straw at 
7.0 ppm; alfalfa, forage at 7.0 ppm; alfalfa, hay at 14 ppm; timothy, 
forage at 35 ppm; and timothy, hay at 17 ppm. That document referenced 
a summary of the petition prepared by Gowan Company, the registrant, 
which is available in the docket, http://www.regulations.gov. There 
were no comments received in response to the notice of filing.
    Based on EPA's review of the data supporting the petition, Gowan 
Company revised their petition (PP 1F7934) as follows:
    i. By increasing the proposed tolerances for alfalfa, forage; 
alfalfa, hay; timothy forage; and timothy, hay;
    ii. By deleting the proposed tolerances for wheat commodities;
    iii. By adding a request for an increase in the established 
tolerances for cattle, fat; goat, fat; horse fat; sheep fat; and milk;
    iv. By adding a request for an increase in the established 
tolerances for cattle meat byproducts; goat, meat byproducts; horse, 
meat byproducts; and sheep, meat byproducts; and;
    v. By proposing tolerances for poultry, fat; and poultry, meat 
byproducts; and egg.
    The reasons for these changes are explained in Unit IV.D.

[[Page 9323]]

III. Aggregate Risk Assessment and Determination of Safety

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

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. 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 RfD occurred at doses substantially 
below the lowest dose that induced tumors, the chronic RfD is 
considered protective of all chronic effects including potential 
carcinogenicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by hexythiazox as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Hexythiazox. Human Health Risk 
Assessment to Support New Uses on Alfalfa and Timothy'' in docket ID 
number EPA-HQ-OPP-2010-0916.

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/    Chronic RfD = 0.025  One-Year Toxicity Feeding Study--
                                    day.                  mg/kg/day.           Dog.
                                   UFA = 10x...........  cPAD = 0.025.......  LOAEL = 12.5 mg/kg/day based on
                                   UFH = 10x...........                        increased absolute and relative
                                   FQPA SF = 1x........                        adrenal weights and associated
                                                                               adrenal histopathology.
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Incidental oral short-term (1 to   NOAEL = 30 mg/kg/day  LOC for MOE = 100..  2-Generation Reproduction Study--
 30 days) and intermediate-term    UFA = 10x...........                        Rat.
 (1 to 6 months).                  UFH = 10x...........                       LOAEL = 180 mg/kg/day based on
                                   FQPA SF = 1x........                        decreased pup body weight during
                                                                               lactation and delayed hair growth
                                                                               and/or eye opening, and decreased
                                                                               parental body-weight gain and
                                                                               increased absolute and relative
                                                                               liver, kidney, and adrenal
                                                                               weights.

[[Page 9324]]

 
                                                                              13-Week Oral Toxicity Study--Rat.
                                                                              NOAEL = 5.5 mg/kg/day.
                                                                              LOAEL = 38 mg/kg/day, based on
                                                                               increased absolute and relative
                                                                               liver weights in both sexes,
                                                                               increased relative ovarian and
                                                                               kidney weights, and fatty
                                                                               degeneration of the adrenal zona
                                                                               fasciculata.
                                                                              @ 397.5/257.6 mg/kg/day, decreased
                                                                               body-weight gain in females,
                                                                               slight swelling of hepatocytes in
                                                                               central zone (both sexes),
                                                                               increased incidence of
                                                                               glomerulonephrosis in males,
                                                                               increased adrenal weights.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)  Classification: ``Likely to be Carcinogenic to Humans''. Insufficient
                                    evidence to warrant a quantitative estimation of human risk using a cancer
                                    slope factor based on the common liver tumors (benign and malignant)
                                    observed only in high dose female mice, and benign mammary gland tumors of
                                    no biological significance, observed only in high dose male rats in the
                                    absence of mutagenic concerns. The chronic RfD is protective of all chronic
                                    effects including potential carcinogenicity of hexythiazox.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to hexythiazox, EPA considered exposure under the petitioned-
for tolerances as well as all existing hexythiazox tolerances in 40 CFR 
180.448. EPA assessed dietary exposures from hexythiazox in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for hexythiazox; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 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., 
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.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS), the estimated drinking water concentrations (EDWC) 
of hexythiazox for chronic exposures for non-cancer and cancer 
assessments are estimated to be 4.3 ppb for surface water. Since 
surface water residues values 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. Post application exposures are expected to be 
short-term (1 to 30 days) and intermediate-term (1 to 6 months) in 
duration. 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

[[Page 9325]]

transfer of residues from the hands or objects to the mouth, and from 
incidental ingestion of soil.
    Details of the residential exposure and risk assessment can be 
found at http://www.regulations.gov in document ``Hexythiazox. Human 
Health Risk Assessment to Support New Uses on Alfalfa and Timothy'' in 
docket ID number EPA-HQ-OPP-2010-0916. 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 
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. The dietary food exposure assessments were performed based 
on 100 PCT 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 63% of the cPAD for 
children 1-2 years of age, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
hexythiazox is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Hexythiazox is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to hexythiazox.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 12,000 for adults 
and 1,600 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 hexythiazox.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 12,000 for adults and 1,900 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 is 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.

[[Page 9326]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid 
chromatography method with UV detection (HPLC/UV) is available to 
enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

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.
    No Canadian or Mexican MRLs have been established for residues of 
hexythiazox in plants or livestock. There are no codex MRLs established 
for alfalfa or timothy; however, there are Code MRLs for livestock at 
0.05 ppm in/on the following: edible offal (mammalian); mammalian fats 
(except milk fats); milks; milk fats; poultry, edible offal; poultry 
meat (fat). The U.S. and Codes residue definitions in both plants and 
livestock are harmonized. There is no issue of international 
harmonization with respect to the recommended alfalfa, timothy, and egg 
tolerances since there are no established international tolerances for 
these commodities. The tolerance for livestock meat byproducts is not 
harmonized with Codex as the potential hexythiazox residue level in 
meat byproducts may exceed the current Codex MRL.

C. Revisions to Petitioned-for Tolerances

    Based on EPA's review of the data supporting the petition, Gowan 
Company revised their petition (PP 1F7934) as follows:
    i. By increasing the proposed tolerances for alfalfa, forage to 15 
ppm; alfalfa, hay to 30 ppm; timothy forage to 40 ppm; and timothy, hay 
to 40 ppm;
    ii. By deleting the proposed tolerances for wheat, forage; wheat, 
hay; wheat, grain; and wheat, straw;
    iii. By adding a request for an increase in the established 
tolerances for cattle, fat; goat, fat; horse fat; sheep fat; and milk 
to 0.05 ppm;
    iv. By adding a request for an increase in the established 
tolerances for cattle meat byproducts; goat, meat byproducts; horse, 
meat byproducts; and sheep, meat byproducts to 0.20 ppm; and
    v. By proposing tolerances for poultry, fat; and poultry, meat 
byproducts at 0.05 ppm; and egg at 0.01 ppm.
    The Agency concluded that based on the residue data, these changes 
are required to support the new uses. The increase in the alfalfa and 
timothy tolerances were recommended by the Agency as a result of 
analyzing the submitted field trial data for these commodities using 
the OEDC MRL (Maximum Residue Limit) calculator. The increase in the 
livestock tolerances in fat and meat byproducts of ruminants are 
required due to the increased livestock dietary burden expected with 
the new uses on alfalfa and timothy. The increase in the ruminant fat 
and milk tolerances are recommended in order to account for the 
increased dietary burden to livestock and to be harmonized with Codex. 
Additionally, because of the potential increase of hexythiazox in the 
poultry diet, largely due to alfalfa use, and based on updated maximum 
reasonably balanced diet (MRBD) calculations for poultry, tolerances 
for eggs, poultry fat, and meat byproducts are required.

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 revised petition.

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.

[[Page 9327]]

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: February 4, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. Section 180.448 is amended as follows:
0
i. In paragraph (a), in the table, revise the entries for ``cattle, 
fat;'' ``cattle, meat byproducts;'' ``goat, fat;'' ``goat, meat 
byproducts;'' ``horse, fat;'' ``horse, meat byproducts;'' ``sheep, 
fat;'' ``sheep, meat byproducts;'' and ``milk.''
0
ii. In paragraph (a), in the table, add entries for ``poultry, fat;'' 
``poultry, meat byproducts;'' and ``egg.''
0
iii. In paragraph (c), in the table, add entries for ``alfalfa, forage 
(EPA Regions 9-11 only;'' ``alfalfa, hay (EPA Regions 9-11 only;'' 
``timothy, forage (EPA Regions 9-11 only;'' and ``timothy, hay (EPA 
Regions 9-11 only.''
    The additions and revisions read as follows:


Sec.  180.448  Hexythiazox; tolerance for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cattle, fat.................................................        0.05
Cattle, meat byproducts.....................................        0.20
 
                                * * * * *
Egg.........................................................        0.01
 
                                * * * * *
Goat, fat...................................................        0.05
Goat, meat byproducts.......................................        0.20
 
                                * * * * *
Horse, fat..................................................        0.05
Horse, meat byproducts......................................        0.20
 
                                * * * * *
Milk........................................................        0.05
 
                                * * * * *
Poultry, fat................................................        0.05
Poultry, meat byproducts....................................        0.05
 
                                * * * * *
Sheep, fat..................................................        0.05
Sheep, meat byproducts......................................        0.20
------------------------------------------------------------------------

* * * * *
    (c) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage (EPA Regions 9-11 only).....................          15
Alfalfa, hay (EPA Regions 9-11 only)........................          30
 
                                * * * * *
Timothy, forage (EPA Regions 9-11 only).....................          40
Timothy, hay (EPA Regions 9-11 only)........................          40
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-02924 Filed 2-7-13; 8:45 am]
BILLING CODE 6560-50-P


