[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]
[Rules and Regulations]
[Pages 77703-77709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-32086]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0916; FRL-9327-7]


Hexythiazox; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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 
(FFDCA).

DATES: This regulation is effective December 14, 2011. Objections and 
requests for hearings must be received on or before February 13, 2012, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0916. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

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].

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. 
Potentially

[[Page 77704]]

affected entities may include, but are not limited to those engaged in 
the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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://ecfr.gpoaccess.gov/cgi/t/text/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-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 
February 13, 2012. 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 that does not contain any 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 a copy of 
your non-CBI 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 on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-for Tolerance

    In the Federal Registers of December 15, 2010 (75 FR 78240) (FRL-
8853-1) and February 4, 2011 (76 FR 6465) (FRL-8858-7), EPA issued 
notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of pesticide petitions (PP 0F7773) by Gowan 
Company, 370 South Main St., Yuma, AZ 85364; and (PP 0E7787) 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,(trans-5-(4-chlorophenyl)-N-cyclohexyl-4-
methyl-2-oxothiazolidine-3-carboxamide), including its metabolites 
containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety, 
in or on aspirated grain fractions (PP 0F7773) at 0.5 parts per million 
(ppm) and greenhouse tomatoes (PP 0E7787) at 0.5 ppm; by increasing the 
existing tolerance for corn, field, stover from 2.5 ppm to 6 ppm, and 
by removing the designation of ``Tolerances with regional 
registrations'' from the tolerances for corn, field, forage; corn, 
field, grain; and corn, field, stover (PP 0F7773). That notice 
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, Gowan Company revised their petition (PP 
0F7773) as follows:
    i. By increasing the proposed tolerance for corn, field, stover to 
7.0 ppm;
    ii. By adding a request for an increase in the established 
tolerances for cattle, meat byproducts; goat, meat byproducts; hog, 
meat byproducts; horse, meat byproducts; and sheep, meat byproducts to 
0.05 ppm; and
    iii. By adding a request for a decrease in the established 
tolerance for corn, field, forage to 3.0 ppm.
    The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

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

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Hexythiazox has low acute toxicity by the oral, dermal and 
inhalation routes of exposure. It produces mild eye irritation, is not 
a dermal irritant, and is negative for dermal sensitization. The

[[Page 77705]]

target organs of hexythiazox are the liver and adrenal glands. 
Developmental toxicity was not observed in rabbits at the limit dose. 
Developmental effects observed in the rat occurred only at a dose level 
where maternal toxicity was observed. Hexythiazox is not a reproductive 
toxicant. The toxicology database for hexythiazox provides no 
indication of increased susceptibility in rats or rabbits from in utero 
and postnatal exposure to hexythiazox. The database does not show any 
evidence of treatment-related effects on the nervous system or the 
immune system. Hexythiazox is classified as ``likely to be carcinogenic 
to humans''. EPA has determined that a non-quantitative risk assessment 
approach (i.e., nonlinear, reference dose (RfD) approach) was 
appropriate and protective of all chronic effects including potential 
carcinogenicity of 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 Amended Use on Field Corn and New Use on 
Greenhouse Tomatoes'' 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 and
         Exposure/scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
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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.
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Chronic dietary (All populations)..  NOAEL= 2.5 mg/kg/day..  Chronic RfD = 0.025 mg/ One-Year Toxicity Feeding
                                                              kg/day.                 Study--Dog.
                                     UFA = 10x               cPAD = 0.025 mg/kg/day  LOAEL = 12.5 mg/kg/day
                                     UFH = 10x.............                           based on increased
                                     FQPA SF = 1x..........                           absolute and relative
                                                                                      adrenal weights and
                                                                                      associated adrenal
                                                                                      histopathology.
Incidental oral short-term (1 to 30  NOAEL= 30 mg/kg/day...  LOC for MOE = 100.....  2-Generation Reproduction
 days ) and intermediate-term (1 to  UFA = 10x.............                           Study--Rat.
 6 months).                          UFH = 10x.............                          LOAEL = 180 mg/kg/day based
                                     FQPA SF = 1x..........                           on 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.
                                                                                     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.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of
  concern.


[[Page 77706]]

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 United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, EPA used tolerance level residues, assumed 100 percent 
crop treated (PCT), and incorporated DEEM default processing factors.
    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 non-linear 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 concentration (EDWC) 
of hexythiazox for chronic exposures for non-cancer and cancer 
assessments is estimated to be 4.5 parts per billion 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 not currently registered for any specific use 
patterns that would result in residential exposure. However, the 
following uses that could result in residential exposures are pending 
registration and are included in this risk assessment: Turf, ornamental 
landscape plantings, ornamental plants, trees and vines in nurseries, 
residential fruit trees, nut trees, caneberries, and orchids.
    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 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 Amended Use on Field Corn and New Use 
on Greenhouse Tomatoes,'' 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.

[[Page 77707]]

    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 with the 
exception of certain new generic testing requirements under revised 40 
CFR part 158, including acute and subchronic neurotoxicity studies and 
an immunotoxicity study. However, the toxicology database does not show 
any evidence of treatment-related effects on the nervous system or the 
immune system. The overall weight of evidence suggests that this 
chemical does not directly target either system. Although acute and 
subchronic neurotoxicity studies and an immunotoxicity study are 
required as a part of new data requirements in 40 CFR part 158 for 
conventional pesticide registrations, the Agency does not believe that 
conducting these studies will result in a lower POD than any currently 
used for risk assessment, and therefore, a database uncertainty factor 
(UFDB) is not needed to account for the lack of these 
studies.
    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 population adjusted dose (aPAD) and chronic population adjusted 
dose (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 51% 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).
    There are potential short-term exposures from the pending 
residential uses for hexythiazox. 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 14,000 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.
    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).
    There are potential intermediate-term exposures from the pending 
residential uses for hexythiazox. 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 14,000 for adults and 2,100 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 ultra violet 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: 
[email protected].

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 U.N. 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 are established for residues of hexythiazox on ``edible 
offal (mammalian)'' and ``poultry, edible offal'' at 0.05 ppm. A Codex 
MRL is established for tomatoes at 0.1 ppm. No other Codex, Canadian or 
Mexican MRLs are established for the commodities that are the subject 
of these petitions. Codex and U.S.

[[Page 77708]]

tolerance expressions are harmonized at this time. Since the maximum 
residue seen in the U.S. green house tomato data is 0.34 ppm, 
harmonizing with the Codex MRL of 0.1 ppm at this time is not possible 
as over tolerance residues in the U.S. could result if the Codex MRL 
were adopted.

C. Revisions to Petitioned-For Tolerances

    Based on EPA's review, Gowan Company revised their petition (PP 
0F7773) by increasing the proposed tolerance for corn, field, stover to 
7.0 ppm; by requesting an increase in the established tolerances for 
cattle, meat byproducts; goat, meat byproducts; hog, meat byproducts; 
horse, meat byproducts; and sheep, meat byproducts to 0.5 ppm; and by 
requesting a decrease in the established tolerance for corn, field, 
forage to 3.0 ppm. The Agency concluded that based on the residue data, 
these changes are required to support the amended and new uses. The 
decrease in the field corn forage tolerance and the increase in the 
stover tolerance were recommended by the Agency as a result of 
analyzing the submitted field trial data for these commodities using 
the OECD MRL (Maximum Residue Limit) calculator. The increase in the 
meat byproduct tolerances is driven by the anticipated increase in 
residues in field corn animal feed items as a result of the revised use 
pattern for hexythiazox on field corn and was set numerically to be 
harmonized with the current Codex MRL for meat byproducts.
    EPA is also removing expired Section 18 tolerances for corn, field, 
forage; corn, field, grain; and corn, field, stover.

V. Conclusion

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

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to petitions 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 section 408(d) of FFDCA, such as the tolerances 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: November 23, 2011.
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. Amend Sec.  180.448 as follows:
0
i. In the table to paragraph (a), revise the entries for ``cattle, meat 
byproducts;'' ``goat, meat by products;'' ``hog, meat byproducts;'' 
``horse, meat byproducts;'' and ``sheep, meat byproducts.''
0
ii. In the table to paragraph (a), add entries for ``corn, field, 
forage;'' ``corn, field, grain;'' ``corn, field, stover;'' ``grain, 
aspirated fractions;'' and ``tomato.''
0
iii. In the table to paragraph (b), remove the entries for ``corn, 
field, forage;'' ``corn, field, grain;'' and ``corn, field, stover.''
    The added and revised text reads as follows:


Sec.  180.448  Hexythiazox; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cattle, meat byproducts...................................          0.05
 
                                * * * * *
Corn, field, forage.......................................          3.0
Corn, field, grain........................................          0.02
Corn, field, stover.......................................          7.0
 
                                * * * * *
Goat, meat byproducts.....................................          0.05
Grain, aspirated fractions................................          0.50
 
                                * * * * *
Hog, meat byproducts......................................          0.05

[[Page 77709]]

 
 
                                * * * * *
Horse, meat byproducts....................................          0.05
 
                                * * * * *
Sheep, meat byproducts....................................          0.05
 
                                * * * * *
Tomato....................................................          0.50
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-32086 Filed 12-13-11; 8:45 am]
BILLING CODE 6560-50-P