Hexythiazox; Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: March 5, 2003 (Volume 68, Number 43)]
[Rules and Regulations]
[Page 10370-10377]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr03-10]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0036; FRL-7292-8]

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: jamerson.hoyt@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are
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:
? 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 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.regulations.gov/ 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
------------------------------------------------------------------------
Established or HED Recommended CT/Anticipated Market
Commodity Tolerances (ppm) AR (ppm) Share (%)
------------------------------------------------------------------------
Almond hulls 10 2.7 2
------------------------------------------------------------------------
Almond nutmeat 0.30 0.046 2
------------------------------------------------------------------------
Apples 0.50 0.12 4
------------------------------------------------------------------------
Apple juice 0.50 0.12 4
------------------------------------------------------------------------
Apricots 1.0 0.20 2
------------------------------------------------------------------------
Caneberry crop subgroup 1.0 0.34 15
------------------------------------------------------------------------
Cherries 1.0 0.20 <1
------------------------------------------------------------------------
Cottonseed meal 0.20 0.059 1
------------------------------------------------------------------------
Dates 1.0 0.24 45
------------------------------------------------------------------------
Fat 0.02 0.0000076
------------------------------------------------------------------------
Hog Fat 0.02 6.3 x 10-10
------------------------------------------------------------------------
Hog Liver 0.02 4.8 x 10-9
------------------------------------------------------------------------
Hog Meat by-products 0.02 2.0 x 10-9
(except liver)
------------------------------------------------------------------------
Hops 2.0 2.0 45
------------------------------------------------------------------------
Liver 0.02 0.000058
------------------------------------------------------------------------
Meat by-products 0.02 0.000024
(except liver)
------------------------------------------------------------------------
Milk 0.02 0.0000053
------------------------------------------------------------------------
Nectarines 1.0 0.054 2
------------------------------------------------------------------------
Other nutmeat 0.30 0.046 <1
------------------------------------------------------------------------
Peaches 1.0 0.14 1
------------------------------------------------------------------------
Pears 0.30 0.30 3
------------------------------------------------------------------------
Pecans 0.30 0.01 <1
------------------------------------------------------------------------
Peppermint, tops 2.0 0.77 5
------------------------------------------------------------------------
Plum 0.10 0.050 1
------------------------------------------------------------------------
Plum, prune, dried 0.40 0.050 <1
------------------------------------------------------------------------
Plum, prune, fresh 0.10 0.050 <1
------------------------------------------------------------------------
Refined cottonseed oil 0.20 0.059 1
------------------------------------------------------------------------
Spearmint, tops 2.0 0.77 5
------------------------------------------------------------------------
Strawberries 3.0 0.75 14
------------------------------------------------------------------------
Undelinted cottonseed 0.20 0.059 1
------------------------------------------------------------------------
Wet apple pomace 0.80 0.12 4
------------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 tompkins.jim@epa.gov,
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: opp-docket@epa.gov.
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 (59 FR 22951, 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

Notices For
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2003
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Hexythiazox; Pesticide Tolerance

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