[Federal Register Volume 70, Number 67 (Friday, April 8, 2005)]
[Rules and Regulations]
[Pages 17908-17916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7046]


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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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 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:

   Table 1.--Summary of Toxicological Dose and Endpoints for Triflumizole for Use in Human Risk Assessment\1\
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       FQPA SF and Endpoint   Study and Toxicological
          Exposure Scenario                 Assessment, UF        for Risk Assessment            Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (females 13-50 years of  NOAEL = 10 mg/kg/day     FQPA SF = 1X             Developmental Toxicity
 age)                                  UF = 100...............  aPAD = acute RfD/FQPA     Study - Rat
                                       Acute RfD = 0.1 mg/kg/    SF = 0.1 mg/kg/day.     Developmental LOAEL =
                                        day.                                              35 mg/kg/day based on
                                                                                          decreased numbers of
                                                                                          viable fetuses,
                                                                                          increased dead or
                                                                                          resorbed fetuses,
                                                                                          increased numbers of
                                                                                          late resorptions,
                                                                                          decreased fetal body
                                                                                          weight, and increased
                                                                                          incidences of cervical
                                                                                          ribs
--------------------------------------
Acute Dietary (general U.S.            NOAEL = 25 mg/kg/day     FQPA SF = 1X             Acute Neurotoxicity
 population) (including infant and     UF = 100...............  aPAD = acute RfD/FQPA     Study - Rat
 children)                             Acute RfD = 0.25 mg/kg/   SF = 0.03 mg/kg/day.    LOAEL = 100 mg/kg/day
                                        day.                                              based on functional
                                                                                          observational battery
                                                                                          findings
                                                                                          (neuromuscular
                                                                                          impairment) and
                                                                                          decreased locomotor
                                                                                          activity
--------------------------------------
Chronic Dietary (all populations)      NOAEL= 1.5 mg/kg/day     FQPA SF = 1X             Multi-generation
                                       UF = 100...............  cPAD = chronic/RfD.....   Reproduction Study -
                                       Chronic RfD = 0.015 mg/  FQPA SF = 0.015 mg/kg/    Rat
                                        kg/day.                  day.                    Reproductive LOAEL =
                                                                                          3.5 mg/kg/day based on
                                                                                          increased gestation
                                                                                          length in dams of the
                                                                                          F3a interval
--------------------------------------
Short-Term Oral (1-30 days)            Oral NOAEL = 8.5 mg/kg/  LOC for MOE = 100        Multi-generation
(Residential)........................   day                     (Residential, includes    Reproduction Study -
                                                                 the FQPA SF).            Rat
                                                                                         LOAEL = 21 mg/kg/day,
                                                                                          based on decreased
                                                                                          body weight gain in
                                                                                          pups during lactation
--------------------------------------
Intermediate-Term Oral (1-6 months)    Oral NOAEL = 8.5 mg/kg/  LOC for MOE = 100        Multi-generation
(Residential)........................   day                     (Residential, includes    Reproduction Study -
                                                                 the FQPA SF).            Rat
                                                                                         LOAEL = 21 mg/kg/day,
                                                                                          based on decreased
                                                                                          body weight gain in
                                                                                          pups during lactation
                                                                                          and decreased body
                                                                                          weight and body weight
                                                                                          gain in parental
                                                                                          animals
--------------------------------------
Short-Term Dermal (1-30 days)          Oral NOAEL= 8.5 mg/kg/   LOC for MOE = 100        Multi-generation
(Occupational/Residential)...........   day (dermal absorption  (Occupational).........   Reproduction Study -
                                        rate = 3.5%)            LOC for MOE = 100......   Rat
                                                                (Residential, includes   LOAEL = 21 mg/kg/day,
                                                                 the FQPA SF).            based on decreased
                                                                                          body weight gain in
                                                                                          pups during lactation
--------------------------------------
Intermediate- and Long-Term Dermal (1- Oral NOAEL = 1.5 mg/kg/  LOC for MOE = 100        Multi-generation
 6 months and 6 month or longer)        day (dermal absorption  (Occupational).........   Reproduction Study -
(Occupational/Residential)...........   rate = 3.5%)            LOC for MOE = 100......   Rat
                                                                (Residential, includes   LOAEL = 3.5 mg/kg/day
                                                                 the FQPA SF).            based on increased
                                                                                          gestation length in
                                                                                          the dams of the F3a
                                                                                          interval
--------------------------------------

[[Page 17911]]

 
Short-Term Inhalation (1-30 days)      Oral NOAEL= 8.5 mg/kg/   LOC for MOE = 100        Multi-generation
(Occupational/Residential)...........   day (inhalation         (Occupational).........   Reproduction Study -
                                        absorption rate =       LOC for MOE = 100......   Rat
                                        100%)                   (Residential, includes   LOAEL = 21 mg/kg/day,
                                                                 the FQPA SF).            based on decreased
                                                                                          body weight gain in
                                                                                          pups during lactation
--------------------------------------
Intermediate- and Long-Term            Oral NOAEL = 1.5 mg/kg/  LOC for MOE = 100        Multi-generation
 Inhalation (1-6 months and 6 month     day (inhalation         (Occupational).........   Reproduction Study -
 or longer)                             absorption rate =       LOC for MOE = 100......   Rat
(Occupational/Residential)...........   100%)                   (Residential, includes   LOAEL = 3.5 mg/kg/day
                                                                 the FQPA SF).            based on increased
                                                                                          gestation length in
                                                                                          the dams of the F3a
                                                                                          interval
--------------------------------------
Cancer (oral, dermal, inhalation)      Evidence for non-        Not applicable           Combined Chronic
                                        carcinogenicity for                              Toxicity/
                                        humans                                            Carcinogenicity Study
                                                                                           Rat
                                                                                         Carcinogenicity Study -
                                                                                          Mouse
                                                                                         No evidence of
                                                                                          carcinogenicity in
                                                                                          rats and mice
----------------------------------------------------------------------------------------------------------------
\1\UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL =
  lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference
  dose, MOE = margin of exposure, LOC = level of concern.

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

[[Page 17913]]

 (GLN 870.6200). 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:

                     Table 2.--Aggregate Risk Assessment for Acute Exposure to triflumizole
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population (total)                                 0.25            5          191         0.12        8,300
------------------------------------------------
Females, (13-49 years)                                   0.1            9          191         0.12        2,700
------------------------------------------------
All Infants (<1 year old)                               0.25           11          191         0.12        2,200
------------------------------------------------
Children (1-2 years old)                                0.25           21          191         0.12        2,000
----------------------------------------------------------------------------------------------------------------

    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:

             Table 3.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Triflumizole
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                        0.015            5           40         0.12          500
------------------------------------------------
Children (1-2 years old)                               0.015           13           40         0.12          130
------------------------------------------------
Infants (<1 year old)                                  0.015            4           40         0.12          140
----------------------------------------------------------------------------------------------------------------

    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: 
[email protected].

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: [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).

VIII. Statutory and Executive Order Reviews

    This final rule establishes time-limited tolerances under section 
408 of the FFDCA. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 of the FFDCA, such as the 
tolerances in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers, and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of the 
FFDCA. For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

IX. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 28, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. Section 180.476 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.

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Broccoli......................................          1.0      6/30/08
Cabbage, chinese, napa........................          9.0      6/30/08
Collards......................................          9.0      6/30/08
Coriander, leaves.............................          9.0      6/30/08
Dandelion, leaves.............................          7.0      6/30/08
Kale..........................................          9.0      6/30/08
Kohlrabi......................................          9.0      6/30/08
Mustard greens................................          9.0      6/30/08
Parsley, leaves...............................          9.0      6/30/08
Swiss chard...................................          7.0      6/30/08
------------------------------------------------------------------------

* * * * *

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