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Triflumizole; Pesticide Tolerances for Emergency
Exemptions  [Federal Register: April 8, 2005 (Volume 70, Number 67)]
[Rules and Regulations]
[Page 17908-17916]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap05-5]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0054; FRL-7701-6]

Triflumizole; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
combined residues of triflumizole in or on parsley, leaves; dandelion,
leaves; swiss chard; collards; kale; kohlrabi; mustard greens; cabbage,
chinese, napa; broccoli; and coriander, leaves (cilantro). This action
is in response to EPA's granting of an emergency exemption under
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) authorizing use of the pesticide on parsley; dandelion; swiss
chard; collards; kale; kohlrabi; mustard greens; cabbage, chinese,
napa; broccoli; and coriander, leaves (cilantro). This regulation
establishes maximum permissible levels for residues of triflumizole in
these food commodities. These tolerances will expire and are revoked on
June 30, 2008.

DATES: This regulation is effective April 8, 2005. Objections and
requests for hearings must be received on or before June 7, 2005.

ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2005-0054. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket . Although
listed in the index, some information is not publicly available, i.e.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S.
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Libby Pemberton, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9364; e-mail address: Sec-18-Mailbox@epamail.epa.gov .

SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
• Crop production (NAICS code 111)
• Animal production (NAICS code 112)
• Food manufacturing (NAICS code 311)
• Pesticide manufacturing (NAICS code 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing time-limited tolerances for combined
residues of the fungicide triflumizole and its metabolites containing
the 4-chloro-2-trifluoromethylaniline moiety, calculated as the parent
compound, in or on parsley, leaves at 9.0 parts per million (ppm);
dandelion, leaves at 7.0 (ppm); swiss chard at 7.0 (ppm); collards at
9.0 ppm; kale at 9.0 ppm;

[[Page 17909]]

kohlrabi at 9.0 ppm; mustard greens at 9.0 ppm; cabbage, chinese, napa
at 9.0 ppm; broccoli at 1.0 ppm; and coriander, leaves (cilantro) at
9.0 ppm. These tolerances will expire and are revoked on June 30, 2008.
EPA will publish a document in the Federal Register to remove the
revoked tolerances from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA to other tolerances and
exemptions. Section 408(e) of the FFDCA allows EPA to establish a
tolerance or an exemption from the requirement of a tolerance on its
own initiative, i.e., without having received any petition from an
outside party.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' EPA has
established regulations governing such emergency exemptions in 40 CFR
part 166.

III. Emergency Exemption for Triflumizole on Various Commodities and
FFDCA Tolerances
Texas has declared a crisis exemption under FIFRA section 18 for
the use of triflumizole on parsley; dandelion; swiss chard; collards;
kale; kohlrabi; mustard greens; cabbage, chinese, napa; broccoli; and
coriander, leaves (cilantro) for control of powdery mildew. Texas
states the effective control of powdery mildew over the 70 to 90-day
growing season requires two additional applications of a systemic
pesticide beyond those permitted on the currently registered
alternative labels.

As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of triflumizole in or on
parsley; dandelion; swiss chard; collards; kale; kohlrabi; mustard
greens; cabbage, chinese napa; broccoli; and coriander, leaves
(cilantro). In doing so, EPA considered the safety standard in section
408(b)(2) of the FFDCA, and EPA decided that the necessary time-limited
tolerances under section 408(l)(6) of the FFDCA would be consistent
with the safety standard and with FIFRA section 18. Consistent with the
need to move quickly on the emergency exemption in order to address an
urgent non-routine situation and to ensure that the resulting food is
safe and lawful, EPA is issuing these time-limited tolerances without
notice and opportunity for public comment as provided in section
408(l)(6) of the FFDCA. Although these tolerances will expire and are
revoked on June 30, 2008, under section 408(l)(5) of the FFDCA,
residues of the pesticide not in excess of the amounts specified in the
tolerances remaining in or on parsley, leaves; dandelion, leaves; swiss
chard; collards; kale; kohlrabi; mustard greens; cabbage, chinese napa;
broccoli; and coriander, leaves (cilantro) after that date will not be
unlawful, provided the pesticide is applied in a manner that was lawful
under FIFRA, and the residues do not exceed a level that was authorized
by these tolerances at the time of that application. EPA will take
action to revoke these tolerances earlier if any experience with,
scientific data on, or other relevant information on this pesticide
indicate that the residues are not safe.

Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether triflumizole
meets EPA's registration requirements for use on parsley; dandelion;
swiss chard; collards; kale; kohlrabi; mustard greens; cabbage, chinese
napa; broccoli; and coriander, leaves (cilantro) or whether permanent
tolerances for this use would be appropriate. Under these
circumstances, EPA does not believe that these tolerances serve as a
basis for registration of triflumizole by a State for special local
needs under FIFRA section 24(c). Nor do these tolerances serve as the
basis for any State other than Texas to use this pesticide on these
crops under section 18 of FIFRA without following all provisions of
EPA's regulations implementing FIFRA section 18 as identified in 40 CFR
part 166. For additional information regarding the emergency exemption
for triflumizole, contact the Agency's Registration Division at the
address provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of
triflumizole and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for time-limited
tolerances for combined residues of triflumizole in or on parsley,
leaves at 9.0 parts per million (ppm); dandelion, leaves at 7.0 (ppm);
swiss chard at 7.0 (ppm); collards at 9.0 ppm; kale at 9.0 ppm;
kohlrabi at 9.0 ppm; mustard greens at 9.0 ppm; cabbage, chinese, napa;
at 9.0 ppm; broccoli at 1.0 ppm; and coriander, leaves at 9.0 ppm.
EPA's assessment of the dietary exposures and risks associated with
establishing the tolerances follows.

A. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among members

[[Page 17910]]

of the human population as well as other unknowns. An UF of 100 is
routinely used, 10X to account for interspecies differences and 10X for
intraspecies differences.

For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). The Food Quality Protection Act of
1996 (FQPA) added to FFDCA section 408(b)(2)(C) an additional safety
factor to protect children's health. Where this additional FQPA safety
factor is retained, this additional factor is applied to the RfD by
dividing the RfD by such additional factor. The acute or chronic
Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to
accommodate this type of FQPA SF.

For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non- linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for triflumizole used for human risk assessment is shown in
the following Table 1

[[Page 17911]]

B. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.476) for the combined residues of triflumizole,
in or on a variety of raw agricultural commodities. Risk assessments
were conducted by EPA to assess dietary exposures from triflumizole 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 (DEEM\TM\)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1994-1996 and 1998 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: Tolerance level residues and 100%
crop treated for all registered and proposed uses.

ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM\TM\ analysis evaluated the individual food
consumption as reported by respondents in the USDA 1994-1996 and 1998
nationwide CSFII and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: A refined, chronic dietary exposure assessment was
performed for the general U.S. population and various population
subgroups using anticipated residues (ARs) from average field trial
residues for apple, grape, pear, cherry, cucurbit, strawberry, and milk
commodities; registered and proposed tolerances for all other
commodities; percent crop treated (CT) information for apple, grape and
pear commodities; and 100% CT information for all other uses.

iii. Cancer. Triflumizole has been classified as not likely to be
carcinogenic to humans. Therefore, a quantitative exposure assessment
was not conducted to assess cancer risk.

iv. Anticipated residue and percent crop treated (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 pursuant
to section 408(f)(1) 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. For the present action, EPA will
issue such Data Call-Ins for information relating to anticipated
residues as are required by FFDCA section 408(b)(2)(E) and authorized
under FFDCA section 408(f)(1). Such Data Call-Ins will be required to
be submitted no later than 5 years from the date of issuance of this
tolerance.
The Agency used PCT information for the registered uses on grape,
apple, and pear. EPA based these assumptions on use data for the period
1996 to 1997 and 1998. For all other registered uses as well as these
uses, EPA assumed that 100% of the U.S. crop would be treated with
triflumizole.
The Agency believes that the three conditions previously discussed
have been met. With respect to Condition 1, PCT estimates are derived
from Federal and private market survey data, which are reliable and
have a valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of this

[[Page 17912]]

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 triflumizole
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 triflumizole 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 triflumizole.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS)
to produce estimates of pesticide concentrations in an index reservoir.
The Screening Concentrations in Groundwater (SCI-GROW) model is used to
predict pesticide concentrations in shallow ground water. For a
screening-level assessment for surface water, EPA will generally use
FIRST (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The
FIRST model is a subset of the PRZM/EXAMS model that uses a specific
high-end runoff scenario for pesticides. While both FIRST and PRZM/
EXAMS incorporate an index reservoir environment, 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 %RfD or %PAD. Instead, drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to triflumizole they are
further discussed in the aggregate risk sections below.
Based on the FIRST and SCI-GROW models the estimated environmental
concentrations (EECs) of triflumizole for acute exposures are estimated
to be 191 parts per billion (ppb) for surface water and 0.12 ppb for
ground water. The EECs for chronic exposures are estimated to be 40 ppb
for surface water and 0.12 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).
Triflumizole is not registered for use on any sites that would
result in residential exposure.

4. Cumulative effects from 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to triflumizole and any other
substances and triflumizole 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 triflumizole 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 policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

C. Safety Factor for Infants and Children

1. In general. Section 408(b)(2)(C) 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 database on toxicity and
exposure unless EPA determines that a different margin of safety will
be safe for infants and children. Margins of safety are incorporated
into EPA risk assessments either directly through use of a MOE analysis
or through using uncertainty (safety) factors in calculating a dose
level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity. There is qualitative
evidence of increased susceptibility demonstrated in the oral prenatal
developmental toxicity studies in rats. Developmental toxicity resulted
in fetal death as compared to maternal toxicity which included
decreases in body weight gain and food consumption and increases in
placental, spleen and liver weights at the same dosages. No
quantitative or qualitative evidence of increased susceptibility was
demonstrated in the prenatal developmental toxicity studies in rabbits
or the multi-generation reproduction studies in rats. In the rabbit
developmental studies, 24-hour fetal survival was decreased at the
highest dose tested. This endpoint is not a recommended guideline
parameter and is generally believed to have limited value in the
assessment of development toxicity; rather, it is more an indicator of
fetal endurance in the absence of critical maternal care, following
removal from the uterus. The Hazard Identification Assessment Review
Committee did not consider this effect to be a measurement of
treatment-related effects on fetal viability and, thus, did not
consider it to be relevant to the assessment of fetal susceptibility.
There was no evidence of quantitative or qualitative susceptibility in
the 2-generation reproduction study in rats. In that study, increased
gestation length was observed at the study LOAEL. In rats, this
alteration in normal reproductive function can result in equally
adverse consequences (i.e., mortality) in both dams and offspring.

3. Conclusion. In the Agency's previous triflumizole human health
risk assessment, the following toxicity studies were determined to be
data gaps:

A 28-day rat inhalation study Guideline Number (GLN) 870.3465)),

acute rat neurotoxicity study (GLN 870.6200), and

subchronic rat neurotoxicity study (GLN 870.6200).

[[Page 17913]]

The acute and sub-chronic neurotoxicity studies have
been submitted, reviewed by the Agency and determined to be acceptable.
As a result, the following has changed: (1) Selection of an acute
endpoint for the general U.S. population (including infants and
children); and (2) the removal of the 3x database uncertainty factor
(UFDB). All other aspects of the most recent risk assessment remain
unchanged.

As acceptable acute and sub-chronic neurotoxicity studies have been
submitted, the Agency has determined that the 3x UFDB should be removed
from the acute and chronic RfDs. In addition, the FQPA SFC recommended
a special FQPA SF be reduced to 1x. The Agency has re-evaluated the
quality of the exposure and hazard data; and, based on these data,
concluded that the special FQPA SF remain at 1x. The conclusion is
based on the following:
• The toxicity database is complete for FQPA assessment.
• There was no quantitative or qualitative evidence of
increased susceptibility in the rabbit fetuses following in utero
exposure or the rat following prenatal and postnatal exposure in the
rat reproduction study.
• There was evidence of qualitative susceptibility in the
developmental rat study; however, there are no residual uncertainties,
and the use of the developmental NOAEL and the endpoint for the acute
RfD for females 13 to 50 would be protective of the prenatal toxicity
following an acute dietary exposure.
• There is no evidence of increased quantitative or
qualitative susceptibility in the rat developmental neurotoxicity study.
• The acute dietary food exposure assessment utilizes
existing and proposed tolerance level residues and 100% CT information
for all commodities. By using these screening-level assessments, actual
exposures/risks will not be underestimated.
• The chronic dietary food exposure assessment utilizes ARs
and % CT data verified for several existing uses. For all proposed use,
tolerance-level residue and 100% CT is assumed. The chronic assessment
is somewhat refined and based on reliable data and will not
underestimate exposure/risk.
• The dietary drinking water assessment utilizes water
concentration values generated by model and associated modeling
parameters which are designed to provide conservative, health-
protective, high-end estimates of water concentrations which will not
likely be exceeded.
• There are no registered or proposed uses of triflumizole
that would result in residential exposure.

D. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the Populated adjusted dose (PAD)) is
available for exposure through drinking water (e.g., allowable chronic
water exposure (mg/kg/day) = cPAD - (average food + chronic non-
dietary, non-occupational exposure). This allowable exposure through
drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA, Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be 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, OPP concludes with reasonable certainty that
exposures to triflumizole in drinking water (when considered along with
other sources of exposure for which OPP has reliable data) would not
result in unacceptable levels of aggregate human health risk at this
time. Because OPP 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, OPP will reassess the potential impacts of
triflumizole on drinking water as a part of the aggregate risk
assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
triflumizole will occupy 6% of the aPAD for the U.S. population, 9% of
the aPAD for females 13 to 49 years old, and 21% of the aPAD for
children 1 to 2 years old, the population at greatest exposure. In
addition, despite the potential for acute dietary exposure to
triflumizole in drinking water, after calculating DWLOCs and comparing
them to conservative model EECs of triflumizole in surface water and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the aPAD, as shown in the following Table 2:

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
triflumizole from food will utilize 5% of the cPAD for the U.S.
population, 4% of the cPAD for all infants (< 1 year old) and 13% of the
cPAD for children 1 to 2 years old, the subpopulation at greatest exposure.
[[Page 17914]]
There are no residential uses for triflumizole that result in chronic
residential exposure to triflumizole. In addition, despite the
potential for chronic dietary exposure to triflumizole in drinking
water, after calculating DWLOCs and comparing them to conservative
model EECs of triflumizole in surface water and ground water, EPA does
not expect the aggregate exposure to exceed 100% of the cPAD, as shown
in the following Table 3:

3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure assessments take into account
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). For triflumizole, the
Agency did not perform short-term or intermediate-term assessments
because there are currently no registered or proposed uses for
homeowner application and residential post- application exposures are
expected to be negligible.

4. Aggregate cancer risk for U.S. population. Since triflumizole
has been determined not to be carcinogenic, it is not expected to pose
a cancer risk.

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 triflumizole residues.

V. Other Considerations

A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography/mass
spectrometry detector (GC/MSD) method (Morse Method METH-115, Revision
#3)) is available to enforce the tolerance expression. The
method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.

B. International Residue Limits
There are no Codex, Canadian or Mexican maximum residue limits
established for triflumizole residues in/on crop commodities.
Therefore, no compatibility issues exist with regard to the proposed
U.S. tolerances discussed in this risk assessment.

C. Conditions
The petitioner should submit adequate limited field rotational crop
data on wheat at plant-back intervals longer than 120 days.
Alternatively, the petitioner has the option of submitting a full set
of residue field trials on all intended rotational crops other than
leafy and root vegetables.

VI. Conclusion
Therefore, tolerances are established for combined residues of
triflumizole and its metabolites containing the 4-chloro-2-
trifluoromethylaniline moiety, calculated as the parent compound, in or
on parsley, leaves at 9.0 ppm; dandelion, leaves at 7.0 ppm; swiss
chard at 7.0 ppm; collards at 9.0 ppm; kale at 9.0 ppm; kohlrabi at 9.0
ppm; mustard greens at 9.0 ppm; cabbage, chinese, napa at 9.0 ppm;
broccoli at 1.0 ppm; and coriander, leaves at 9.0 ppm.

VII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, 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 that 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-2005-0054 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 June 7, 2005.

1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.

2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by the docket ID number OPP-2005-0054, to: Public
Information and Records Integrity Branch, Information Resources and

[[Page 17915]]

Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: 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).

VIII. Statutory and Executive Order Reviews
This final rule establishes time-limited tolerances under section
408 of the FFDCA. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under section 408 of the FFDCA, such as the
tolerances in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers, and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (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.

IX. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 28, 2005.
Lois Rossi,
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), 346a and 371.
• 2. Section 180.476 is amended by adding text to paragraph (b) to read
as follows:
Sec. 180.476 Triflumizole; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time limited tolerances are
established for the residues triflumizole (1-(1-((4-chloro-2-
(trifluoromethyl)phenyl)imino)-2-
[[Page 17916]]
propoxyethyl)-1H-imidazole) and its metabolites containing the 4-
chloro-2-trifluoromethylaniline moiety, calculated as the parent in
connection with use of the pesticide under section 18 emergency
exemptions granted by EPA. The tolerances are specified in the
following table, and will expire and are revoked on the dates specified.

* * * * *
[FR Doc. 05-7046 Filed 4-7-05; 8:45 am]
BILLING CODE 6560-50-S