[Federal Register Volume 68, Number 43 (Wednesday, March 5, 2003)]
[Rules and Regulations]
[Pages 10370-10377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5194]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0036; FRL-7292-8]


Hexythiazox; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of hexythiazox in or on date, dried fruit. The Interregional Research 
Project Number 4 (IR-4) requested this tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA).

DATES: This regulation is effective March 5, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0036, 
must be received on or before May 5, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Hoyt Jamerson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9368; 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 
potentially affected by this action if you an agricultural producer, 
food manufacturer, or pesticide manufacturer. Potentially affected 
entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] 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 Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0036. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., 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.
    2. Electronic access. 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 http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of March 14, 2002 (67 FR 11480) (FRL-6826-
3), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
a pesticide petition (1E6325) by the Interregional Research Project 
Number 4 (IR-4), 681 U.S. Highway 1 South, North Brunswick, NJ 
08902-3390. That notice included a summary of the petition prepared by 
Gowan Company, the registrant. There were no comments received in 
response to the notice of filing.
    The petition requested that 40 CFR 180.448 be amended by 
establishing a tolerance for combined residues of the miticide, 
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 date, dried 
fruit at 1.0 parts per million (ppm).
    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

[[Page 10371]]

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....''
    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 November 26, 1997 (62 FR 62961) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    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 and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for a tolerance for combined residues of 
hexythiazox on date, dried fruit at 1.0 ppm. EPA's assessment of 
exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile and Endpoints

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by hexythiazox and the 
endpoints use in risk assessment are discussed in Unit III. A. and B. 
of the final rule on hexythiazox pesticide tolerances published in the 
Federal Register of April 18, 2001 (66 FR 19879) (FRL-6778-8). Please 
refer to this document should you desire detailed toxicological 
information on hexythiazox.
    The Agency has identified an acute dietary endpoint for females 13 
years and older. The acute population adjusted dose (aPAD) for females 
is 2.4 milligrams/kilograms/day (mg/kg/day). No acute dietary endpoint 
was identified for the general population including infants and 
children; a dose and endpoint attributable to a single exposure were 
not identified from the available oral toxicity studies, including 
maternal toxicity in the developmental toxicity studies. The chronic 
population adjusted dose (cPAD) for all populations is 0.025 mg/kg/day. 
Hexythiazox has been classified as a category C, possible human 
carcinogen, for cancer. The calculated Q* for hexythiazox is 2.22 x 
10-2.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.448) for the 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 a variety of raw agricultural 
commodities (RAC) including tolerances for milk, fat, and meat 
byproducts of cattle, goat, horse, sheep, and swine. 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 Department of Agriculture (USDA) 
1989-1992 nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII) and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the acute exposure assessments: 
Default processing factors were used, and 100 percent crop treated 
(PCT) information 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 1989-1992 nationwide 
CSFII and accumulated exposure to the chemical for each commodity. The 
following assumptions were made for the chronic exposure assessments: A 
partially-refined dietary analysis was performed using anticipated 
residue levels for most crops (calculated from field trial data) and 
PCT or anticipated market-share information for all crops.
    iii. Cancer. A partially-refined dietary-exposure analysis was 
performed using anticipated residue (AR) levels for most crops, 
processing factors where applicable, and PCT or anticipated market 
share information for all crops.
    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 following Table 1 provides a summary of the anticipated residue 
(AR) and PCT information used for the chronic and cancer exposure 
assessments. The Agency has issued emergency exemptions to the state of 
California for use of hexythiazox on dates since 1998. The PCT 
information for dates is based on applications made under these 
emergency exemptions. The majority of dates grown in the United States 
are grown in California.

[[Page 10372]]



         Table 1.--Summary of Hexythiazox Anticipated Residues (AR) for Chronic and Cancer Dietary Exposure Assessment Based on Field-Trial Data
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                                                                      Established or HED Recommended                              CT/Anticipated Market
                             Commodity                                       Tolerances (ppm)                   AR (ppm)                Share (%)
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Almond hulls                                                                                        10                      2.7                        2
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Almond nutmeat                                                                                    0.30                    0.046                        2
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Apples                                                                                            0.50                     0.12                        4
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Apple juice                                                                                       0.50                     0.12                        4
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Apricots                                                                                           1.0                     0.20                        2
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Caneberry crop subgroup                                                                            1.0                     0.34                       15
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Cherries                                                                                           1.0                     0.20                       <1
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Cottonseed meal                                                                                   0.20                    0.059                        1
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Dates                                                                                              1.0                     0.24                       45
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Fat                                                                                               0.02                0.0000076
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Hog Fat                                                                                           0.02              6.3 x 10-10
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Hog Liver                                                                                         0.02               4.8 x 10-9
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Hog Meat by-products (except liver)                                                               0.02               2.0 x 10-9
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Hops                                                                                               2.0                      2.0                       45
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Liver                                                                                             0.02                 0.000058
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Meat by-products (except liver)                                                                   0.02                 0.000024
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Milk                                                                                              0.02                0.0000053
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Nectarines                                                                                         1.0                    0.054                        2
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Other nutmeat                                                                                     0.30                    0.046                       <1
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Peaches                                                                                            1.0                     0.14                        1
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Pears                                                                                             0.30                     0.30                        3
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Pecans                                                                                            0.30                     0.01                       <1
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Peppermint, tops                                                                                   2.0                     0.77                        5
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Plum                                                                                              0.10                    0.050                        1
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Plum, prune, dried                                                                                0.40                    0.050                       <1
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Plum, prune, fresh                                                                                0.10                    0.050                       <1
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Refined cottonseed oil                                                                            0.20                    0.059                        1
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Spearmint, tops                                                                                    2.0                     0.77                        5
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Strawberries                                                                                       3.0                     0.75                       14
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Undelinted cottonseed                                                                             0.20                    0.059                        1
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Wet apple pomace                                                                                  0.80                     0.12                        4
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    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)

[[Page 10373]]

tend to change continuously over time, such that an individual is 
unlikely to be exposed to more than the average PCT over a lifetime. 
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 groundwater. 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 pond scenario. The PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop 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 percent reference dose (%RfD) or 
percent population adjusted dose (%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).

D. Safety Factor for Infants and Children

    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 margin of exposure 
(MOE) analysis or through using uncertainty (safety) factors (UF) in 
calculating a dose level that poses no appreciable risk to humans.
    The prenatal and postnatal toxicology data base for hexythiazox is 
complete with respect to FQPA considerations. The nature of the toxic 
effects caused by hexythiazox are discussed in Unit III. D. of the 
final rule on hexythiazox pesticide tolerances published in the Federal 
Register of April 18, 2001 (66 FR 19879) (FRL-6778-8). Please refer to 
this document should you desire detailed toxicological information on 
hexythiazox regarding FQPA considerations.
    The results of the prenatal and postnatal toxicology studies 
indicated no increased susceptibility of rats or rabbits to in utero 
and/or postnatal exposure to hexythiazox. There is a complete toxicity 
data base for hexythiazox and exposure data are complete or are 
estimated based on data that reasonably accounts for potential 
exposures. EPA determined that the 10X safety factor to protect infants 
and children should be removed and reduced to 1X. The FQPA factor is 
removed because an additional safety factor is not needed to protect 
the safety of infants and children.

E. 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

[[Page 10374]]

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) = chronic (cPAD) - 
(average food + residential 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 U.S. EPA 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 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 the pesticide 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 residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. An acute dietary endpoint has only been identified 
for females (13 years and older). Using the exposure assumptions 
discussed in this unit for acute exposure, the acute dietary exposure 
from food to hexythiazox will occupy less than 1% of the aPAD for 
females 13 years and older. In addition, there is potential for acute 
dietary exposure to hexythiazox in drinking water. After calculating 
DWLOCs and comparing them to the EECs for surface 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
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                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13 years and older                               2.4          <1%         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 less than 1% of the cPAD for the 
U.S. population and all infants and children subpopulations. There are 
no residential uses for hexythiazox. There is potential for chronic 
dietary exposure to hexythiazox in drinking water. After calculating 
DWLOCs and comparing them to the EECs for 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)
----------------------------------------------------------------------------------------------------------------
U.S. population                                        0.025          <1%         0.91        0.009          870
----------------------------------------------------------------------------------------------------------------
Children                                               0.025          <1%         0.91        0.009          250
----------------------------------------------------------------------------------------------------------------
Infants                                                0.025          <1%         0.91        0.009          250
----------------------------------------------------------------------------------------------------------------

    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposures take 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 do not 
exceed the Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. Hexythiazox has been 
classified as a Category C possible human carcinogen 
(Q1* = 2.22 x 10-2). Using the 
exposure assumptions discussed in this unit for cancer, the 
carcinogenic risk estimate from food for the general U.S. population is 
2.5 x 10-7. There is potential for chronic dietary exposure 
to hexythiazox in drinking water. After calculating DWLOCs and 
comparing them to the EECs for surface water and ground water, EPA does 
not expect the estimated cancer risk for aggregate exposure to exceed 1 
x 10-6 as shown in the following Table 4:

[[Page 10375]]



                                  Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Hexythiazox
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                                                                                  Estimated
                   Population Subgroup                            Q1*         Carcinogenic Risk  Surface Water EEC   Ground Water EEC     Cancer DWLOC
                                                                                    (Food)             (ppb)              (ppb)              (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                                                  2.22 x 10-2         2.5 x 10-7               0.91              0.009                1.2
--------------------------------------------------------------------------------------------------------------------------------------------------------

    5. 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.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The high-performance liquid chromatography/ultraviolet (HPLC/UV) 
analytical method used for determining the combined residues of 
hexythiazox and its metabolites in dates is adequate for data 
collection purposes. Adequate method validation data were submitted. 
This method is based on Method AMR-985-87, which has been deemed 
acceptable as a tolerance enforcement method in conjunction with a 
petition for use on apples. The method has been validated for use on 
various crop commodities, and has been forwarded to the Food and Drug 
Administration (FDA) for inclusion in Pesticide Analytical Method 
Volume II (PAM II). This earlier method is considered sufficient to 
enforce the proposed permanent tolerances for residues in or on dates.

B. International Residue Limits

    There are no Mexican, Canadian or Codex maximum residue limits 
(MRLs) established for hexythiazox in or on dates.

C. Magnitude of Residues

    An adequate number of residue field trials reflecting the proposed 
use directions were submitted to EPA to demonstrate that the tolerance 
for date, dried fruits at 1.0 ppm will not be exceeded when hexythiazox 
products labeled for this use are used as directed.

D. Rotational Crop Restrictions

    As dates are a perennial crop, confined and field rotational crop 
studies are not required to support the subject petitions.

V. Conclusion

    Therefore, the tolerance is 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 date, dried 
fruit at 1.0 ppm.

VI. 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 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 ID number OPP-2002-0036 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 May 5, 
2003.
    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 (1900C), 
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 Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    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 VI.A., you 
should also send a copy of your request to the PIRIB for its

[[Page 10376]]

inclusion in the official record that is described in Unit I.B.1. Mail 
your copies, identified by docket ID number OPP-2002-0036, to: Public 
Information and Records Integrity Branch (PIRIB), 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 Unit I.B.1. 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).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this 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 
petition under section 408(d) of the FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. 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.

VIII. 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: February 24, 2003.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. Section 180.448 is amended by alphabetically adding the 
commodity ``date, dried fruit'' to the table in

[[Page 10377]]

paragraph (a), and by removing and reserving paragraph (b) as follows:


Sec.  180.448   Hexythiazox; tolerances for residues.

    (a) * * *

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Date, dried fruit                                                                                            1.0
----------------------------------------------------------------------------------------------------------------

    (b) [Reserved]
* * * * *
[FR Doc. 03-5194 Filed 3-4-03; 8:45 am]
BILLING CODE 6560-50-S