[Federal Register Volume 69, Number 217 (Wednesday, November 10, 2004)]
[Rules and Regulations]
[Pages 65073-65081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24926]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0329; FRL-7684-2]


Hexythiazox; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of 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 field corn grain, stover, and fodder. This 
action is in response to EPA's granting of an emergency exemption under 
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) authorizing use of the pesticide on field corn. This regulation 
establishes maximum permissible levels for residues of hexythiazox in 
these food commodities. The tolerances will expire and are revoked on 
December 31, 2007.

DATES: This regulation is effective November 10, 2004. Objections and 
requests for hearings must be received on or before January 10, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2004-0329. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
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 either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St.,

[[Page 65074]]

 Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; e-mail 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 affected entities may include, but are not limited to:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
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 Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(1)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing tolerances for combined residues of 
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 corn, 
field, grain at 0.05 ppm; corn, field, forage at 2.0 ppm; and corn, 
field, stover at 2.0 ppm. These tolerances will expire and are revoked 
on December 31, 2007. EPA will publish a document in the Federal 
Register to remove the revoked tolerances from the Code of Federal 
Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the 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 the 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 the 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. . . 
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Hexythiazox on Corn and FFDCA Tolerances

    The applicant stated that the development of resistance in spider 
mite populations to the standard acaricide used to control mites has 
created an urgent and non-routine situation. EPA has authorized under 
FIFRA section 18 the use of hexythiazox on corn for control of Banks 
grass mite and two-spotted spider mite in Texas. After having reviewed 
the submission, EPA concurs that emergency conditions exist for this 
State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of hexythiazox in or on field 
corn grain, stover, and fodder. In doing so, EPA considered the safety 
standard in section 408(b)(2) of the FFDCA, and EPA decided that the 
necessary tolerance under section 408(l)(6) of the FFDCA would be 
consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemption in 
order to address an urgent non-routine situation and to ensure that the 
resulting food is safe and lawful, EPA is issuing these tolerances 
without notice and opportunity for public comment as provided in 
section 408(l)(6) of the FFDCA. Although these tolerances will expire 
and are revoked on December 31, 2007, under section 408(l)(5) of the 
FFDCA, residues of the pesticide not in excess of the amounts specified 
in the tolerances remaining in or on field corn grain, stover, and 
fodder after that date will not be unlawful, provided the pesticide is 
applied in a manner that was lawful under FIFRA, and the residues do 
not exceed levels that were authorized by these tolerances at the time 
of that application. EPA will take action to revoke these tolerances 
earlier if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether hexythiazox 
meets EPA's registration requirements for use on corn or whether 
permanent tolerances for this use would be appropriate. Under these 
circumstances, EPA does not believe that these tolerances serve as a 
basis for registration of hexythiazox by a State for special local 
needs under FIFRA section 24(c). Nor do these tolerances serve as the 
basis for any State other than Texas to use this pesticide on this crop 
under section 18 of FIFRA without following all

[[Page 65075]]

provisions of EPA's regulations implementing FIFRA section 18 as 
identified in 40 CFR part 166. For additional information regarding the 
emergency exemption for hexythiazox, contact the Agency's Registration 
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
    Consistent with section 408(b)(2)(D) of the 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 
hexythiazox and to make a determination on aggregate exposure, 
consistent with section 408(b)(2) of the FFDCA, for time-limited 
tolerances for combined residues of 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 corn, field, grain at 0.05 ppm; corn, 
field, forage at 2.0 ppm; and corn, field, stover at 2.0 ppm. EPA's 
assessment of the dietary exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Endpoints

    The dose at which no observed adverse effect level (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
lowest observed adverse effect level (LOAEL)) is sometimes used for 
risk assessment if NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect uncertainties inherent 
in the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where 
the RfD is equal to the NOAEL divided by the appropriate UF (RfD = 
NOAEL/UF). Where an additional safety factor is retained due to 
concerns unique to the FQPA, this additional factor is applied to the 
RfD by dividing the RfD by such additional factor. The acute or chronic 
Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to 
accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the 
appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x10-6 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated.

     Table 1.--Summary of Toxicological Dose and Endpoints for Hexythiazox for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       FQPA SF and Endpoint   Study and Toxicological
          Exposure Scenario                 Assessment, UF        for Risk Assessment            Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females (13-50 years of  Developmental NOAEL =    FQPA SF = 1X             Developmental toxicity
 age)                                   240 mg/kg/day            aPAD= acute RfD/FQPA     study - rat
                                       UF = 100...............   SF = 2.4 mg/kg/day.     Developmental LOAEL =
                                       Acute RfD = 2.4 mg/kg/                             720 mg/kg/day based on
                                        day.                                              delayed ossification
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population      A dose and endpoint attributable to a single exposure were not identified
 including infants and children)        from the available oral toxicity studies, including maternal toxicity in
                                                           the developmental toxicity studies.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL= 2.5 mg/kg/day     FQPA SF = 1X             One-Year toxicity
                                       UF = 100 chronic.......  cPAD= chronic RfD/FQPA    feeding study - dog
                                       RfD= 0.025 mg/kg/day...   SF = 0.025 mg/kg/day.   LOAEL = 12.5 mg/kg/day
                                                                                          based on increased
                                                                                          absolute and relative
                                                                                          adrenal weights and
                                                                                          associated adrenal
                                                                                          histopathology
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Category C (possible     Q1* = 2.22 x 10-2        Increases in incidence
                                        human carcinogen)                                 of malignant and
                                                                                          combined benign/
                                                                                          malignant liver tumors
                                                                                          in mice
----------------------------------------------------------------------------------------------------------------


[[Page 65076]]

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.448) for the combined of hexythiazox, in or on 
a variety of raw agricultural commodities. Risk assessments were 
conducted by EPA to assess dietary exposures from hexythiazox in food 
as follows:
    i. Acute exposure. Acute dietary 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. The Dietary Exposure Evaluation Model 
(DEEMTM) analysis evaluated the individual food consumption 
as reported by respondents in the United States Department of 
Agriculture (USDA) 1994-1996, and 1998 nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII) and accumulated exposure to the 
chemical for each commodity. Published and proposed tolerance level 
residues were used. Default and specially assigned processing factors 
were assumed for all commodities.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment, the DEEMTM analysis evaluated the individual 
food consumption as reported by respondents in the USDA 1994-1996, and 
1998 nationwide CSFII and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: Partially refined, deterministic assessment using 
tolerance-level residue or anticipated residues, average weighted 
percent crop treated (% CT) information and modified DEEMTM 
(version 2.0) processing factors for some commodities based on 
guideline processing studies.
    iii. Cancer. The Agency believes that pesticidal use of hexythiazox 
is likely to pose a carcinogenic hazard to humans. Thus, a cancer 
dietary risk assessment is required. Hexythiazox was classified by the 
Agency as a ``Group C'' - possible human carcinogen-chemical. It has 
been assigned a Q1* = 2.22 x 10-2 milligrams/kilogram/day 
(mg/kg/day) for purposes of risk assessment. The estimated exposure of 
the U.S. population (total) to hexythiazox is 3.0 x 10-5 mg/kg/day.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of the FFDCA authorizes EPA to use available data and information on 
the anticipated residue levels of pesticide residues in food and the 
actual levels of pesticide chemicals that have been measured in food. 
If EPA relies on such information, EPA must require that data be 
provided 5 years after the tolerance is established, modified, or left 
in effect, demonstrating that the levels in food are not above the 
levels anticipated. Following the initial data submission, EPA is 
authorized to require similar data on a time frame it deems 
appropriate. As required by section 408(b)(2)(E) of the FFDCA, EPA will 
issue a Data Call-In for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if the Agency can make the following findings: 
Condition 1, that the data used are reliable and provide a valid basis 
to show what percentage of the food derived from such crop is likely to 
contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to 
submit data on PCT.
    The Agency used PCT information as follows:
    Almond nutmeat, 2%; pecans, <1%; other nutmeat, <1%; almond hulls, 
2%; apricots, 2%; cherries, <1%; peaches, 1%; nectarines, 2%; plum, 1%; 
plum, prune, fresh, <1%; plum, prune, dried, <1%; caneberry crop 
subgroup, 15%; spearmint tops, 5%; peppermint, tops, 5%; undelinted 
cottonseed, 1%; cottonseed meal, 1%; refined cottonseed oil, 1%; 
apples, 4%; apple juice, 4%; wet apple pomace, 4%; pears, 3%; hops, 
45%; dates, 45%; strawberries, 14%.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimation. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which hexythiazox 
may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for hexythiazox in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of hexythiazox.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in ground water. In 
general, EPA will use GENEEC (a Tier 1 model) before using PRZM/EXAMS 
(a Tier 2 model) for a screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. GENEEC incorporates a 
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous

[[Page 65077]]

pond scenario. The PRZM/EXAMS model includes a percent crop (PC) area 
factor as an adjustment to account for the maximum PC coverage within a 
watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to hexythiazox, they are 
further discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW models, the EECs of hexythiazox 
for acute exposures are estimated to be 1.81 parts per billion (ppb) 
for surface water and 0.009 ppb for ground water. The EECs for chronic 
exposures are estimated to be 0.91 ppb for surface water and 0.009 ppb 
for ground water.
    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 registered for use on any sites that would 
result in residential exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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 does not have, at this time, available data to determine 
whether hexythiazox has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
hexythiazox does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that hexythiazox has 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 the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold 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 data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Developmental toxicity studies--a. rats. In the rat 
developmental study, the maternal (systemic) NOEL was 240 mg/kg/day. 
The maternal LOEL of 720 mg/kg/day was based on decreased food 
consumption and decreased body weight. The developmental (fetal) NOEL 
was 240 mg/kg/day. The developmental LOEL was based on slight delayed 
ossification.
    b. Rabbits. In the rabbit developmental toxicity study, the 
maternal (systemic) NOEL was 1,080 mg/kg/day at the highest dose tested 
(HDT). The developmental (fetal) NOEL was 1,080 mg/kg/day at the HDT.
    3. Reproductive toxicity study--rats. In the 2-generation 
reproductive toxicity study in rats, the parental (systemic) NOEL was 
20 mg/kg/day. The LOEL of 120 mg/kg/day was based on decreased body 
weight and decreased food consumption. The developmental NOEL was 20 
mg/kg/day. The developmental LOEL of 120 mg/kg/day was based on 
decreased body weight and delayed maturation. The reproductive NOEL was 
120 mg/kg/day at the HDT.
    4. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicology data base for hexythiazox is complete with respect to 
current toxicological data requirements. There are no prenatal or 
postnatal toxicity concerns for infants and children, based on the 
results of the rat and rabbit developmental toxicity studies and the 2-
generation rat reproductive toxicity study. In the developmental study 
in rats, the developmental NOEL and LOEL is the same as the maternal 
NOEL and LOEL demonstrating that no extra-sensitivity for infants and 
children is present. In rabbits, there are no maternal or developmental 
effects up to the limit dose of 1,080 mg/kg/day HDT. In the 2-
generation reproductive toxicity study in rats, there are no pup 
effects at doses below maternal effects and the common effects in both 
pups and parental animals decreased body weight also demonstrates that 
there is no extra-sensitivity for infants and children.
    5. Conclusion. Based on the above, EPA concludes that reliable data 
support use of the standard 100-fold uncertainty factor and that the 
10x FQPA safety factor be removed since the hazard and exposure 
assessments do not indicate a concern for potential risk to infants and 
children.

D. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + chronic non-dietary, non-occupational exposure). 
This allowable exposure through drinking water is used to calculate a 
DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be

[[Page 65078]]

taken into account in more refined screening-level and quantitative 
drinking water exposure assessments. Different populations will have 
different DWLOCs. Generally, a DWLOC is calculated for each type of 
risk assessment used: Acute, short-term, intermediate-term, chronic, 
and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to hexythiazox in drinking water (when considered along with 
other sources of exposure for which EPA has reliable data) would not 
result in unacceptable levels of aggregate human health risk at this 
time. Because EPA considers the aggregate risk resulting from multiple 
exposure pathways associated with a pesticide's uses, levels of 
comparison in drinking water may vary as those uses change. If new uses 
are added in the future, EPA will reassess the potential impacts of 
hexythiazox on drinking water as a part of the aggregate risk 
assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
hexythiazox will occupy 0.12 of the aPAD for females 13-49 years old, 
the population sub-group of concern. In addition, despite the potential 
for acute dietary exposure to hexythiazox in drinking water, after 
calculating DWLOCs and comparing them to conservative model EECs of 
hexythiazox in surfacewater and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the aPAD, as shown in the 
following Table 2:

                      Table 2.--Aggregate Risk Assessment for Acute Exposure to Hexythiazox
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old)                                2.4         0.12         1.81        0.009       72,000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
hexythiazox from food will utilize 0.1% of the cPAD for the U.S. 
population, 0.2% of the cPAD for all infants, and 0.4% of the cPAD for 
children 1-5 years old. There are no residential uses for hexythiazox 
that result in chronic residential exposure to hexythiazox. In 
addition, despite the potential for chronic dietary exposure to 
hexythiazox in drinking water, after calculating DWLOCs and comparing 
them to conservative model EECs of hexythiazox in surface water and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in the following Table 3:

              Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Hexythiazox
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. population                                0.025          0.1        0.910        0.009          870
----------------------------------------------------------------------------------------------------------------
All Infants (< 1 year old)                             0.025          0.2        0.910        0.009          250
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                               0.025          0.4        0.910        0.009          250
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old)                              0.025          0.1        0.910        0.009          750
----------------------------------------------------------------------------------------------------------------
Youth (13-19 years old)                                0.025          0.1        0.910        0.009          750
----------------------------------------------------------------------------------------------------------------
Adults (20-49 years old)                               0.025          0.1        0.910        0.009          870
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Hexythiazox is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which were previously addressed.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Hexythiazox is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which were previously addressed.
    5. Aggregate cancer risk for U.S. population. Chronic (cancer) 
aggregate risk estimates are below the Agency's level of concern. A 
partially refined analysis was performed using anticipated residue 
levels for most crops, processing factors where applicable, and PCT or 
anticipated market share information for all crops. The chronic cancer 
analysis applied to the U.S. population only. The carcinogenic risk 
estimate (food only) for the general U.S. population was 6.6 x 
10-7. The Agency's level of concern is for risks that exceed 
1 x 10-6. Thus, the estimated dietary cancer risk to the 
U.S. population associated with the existing and pending uses is below 
the level the Agency generally considers negligible for excess lifetime 
cancer risk.
    The surface water and ground water EECs were used to compare 
against back-calculated DWLOCs for aggregate risk assessments. For the 
carcinogenic risk scenario, the DWLOC is 3.675 ppb for the U.S 
population. For ground water and surface water, the EECs for 
hexythiazox are less than EPA's DWLOCs for hexythiazox in drinking 
water as a contribution to carcinogenic aggregate exposure. Therefore, 
EPA concludes with reasonable certainty that residues of hexythiazox in 
drinking water do not contribute significantly to

[[Page 65079]]

the carcinogenic aggregate human- health risk at the present time.
    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, and to infants and children from aggregate 
exposure to hexythiazox residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example--gas chromatography) 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; e-mail address: [email protected].

B. International Residue Limits

    There are no international residues limits for hexythiazox on field 
corn, and therefore, this is not an issue.

VI. Conclusion

    Therefore, the tolerances are established for combined residues of 
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 corn, 
field, grain at 0.05 ppm; corn, field, forage at 2.0 ppm; and corn, 
field, stover at 2.0 ppm.

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. However, the period for filing objections is now 60 days, rather 
than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket identification (ID) number OPP-2004-0329 in the subject 
line on the first page of your submission. All requests must be in 
writing, and must be mailed or delivered to the Hearing Clerk on or 
before January 10, 2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3.Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by the docket ID number OPP-2004-0329, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

[[Page 65080]]

VIII. Statutory and Executive Order Reviews

    This final rule establishes time-limited tolerances under section 
408 of the FFDCA. 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 rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). 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., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). 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); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). 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). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 of the 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. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers, and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of the 
FFDCA. For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
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: October 27, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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 by adding text to paragraph (b) to read 
as follows:


Sec.  180.448  Hexythiazox; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for the combined residues of the insecticide hexythiazox 
and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-
thiazolidine moiety in connection with use of the pesticide under 
section 18 emergency exemptions granted by EPA. These tolerances will 
expire and are revoked on the dates specified in the following table.

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Corn, field, grain................           0.05 ppm           12/31/07
Corn, field, forage...............            2.0 ppm           12/31/07
Corn, field, stover...............            2.0 ppm           12/31/07
------------------------------------------------------------------------


[[Page 65081]]

* * * * *
[FR Doc. 04-24926 Filed 11-9-04; 8:45 am]
BILLING CODE 6560-50-S