Document ID: EPA-HQ-OPP-2006-0103-0001
Agency: epa
Document Type: Rule
Title: Triflumizole; Pesticide Tolerance
Posted Date: 2006-03-15T15:42:36Z

[Federal Register: March 15, 2006 (Volume 71, Number 50)]
[Rules and Regulations]               
[Page 13274-13279]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15mr06-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0103; FRL-7765-3]

 
Triflumizole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of triflumizole, 1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino-2-
propoxyethyl)-1H-imidazole, and its metabolites containing the 4-
chloro-2-trifluoromethylaniline moiety, calculated as the parent 
compound in or on filberts. Interregional Research Project Number 4 
(IR-4) requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act 
of1996 (FQPA).

DATES: This regulation is effective March 15, 2006. Objections and 
requests for hearings must be received on or before May 15, 2006.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0103. All documents in the 
docket are listed on the http://www.regulations.gov Web site. (EDOCKET, 

EPA's electronic public docket and comment system was replaced on 
November 25, 2005, by an enhancedFederal-wide electronic docket 
management and comment system located at http://www.regulations.gov/. 

Follow the on-line instructions.) 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: Barbara Madden, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; e-mail address: madden.barbara@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 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    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 on E-CFR Beta Site Two at  http://www.gpoaccess.gov/ecfr/. 

To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/
.

II. Background and Statutory Findings

    In the Federal Register of January 18, 2006 (71 FR 2930) (FRL-7757-
1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
3E6535) by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 
08902. The petition requested that 40 CFR 180.476 be amended by 
establishing a tolerance for combined residues of the fungicide 
triflumizole, 1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino-2-
propoxyethyl]-1H-imidazole, and its metabolites containing the 4-
chloro-2-trifluoromethylaniline moiety, calculated as the parent 
compound in or on filberts at 0.05 parts per million (ppm). That notice 
included a summary of the petition prepared by Chemtura, the 
registrant. There were no comments received in response to the notice 
of filing.
    Section 408(b)(2)(A)(i) of 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 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 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. . . 
.''

[[Page 13275]]

    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 FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for combined residues of 
triflumizole, 1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino-2-
propoxyethyl)-1H-imidazole, and its metabolites containing the 4-
chloro-2-trifluoromethylaniline moiety, calculated as the parent 
compound in or on filbert at 0.05 ppm. EPA's assessment of exposures 
and risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the toxic effects caused by triflumizole as well as the no observed 
adverse effect level (NOAEL) and the lowest observed adverse effect 
level (LOAEL) from the toxicity studies can be found at http://www.epa.gov/EPA-PEST/2002/June/Day-12/p14768.htm

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, 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 level of 
concern (LOC). 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 of the human population as well 
as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/pesticides/health/human.htm.

    A summary of the toxicological endpoints for triflumizole used for 
human risk assessment is discussed in Unit VI.A. of the final rule 
published in the Federal Register of April 8, 2005 (70 FR 17908) (FRL-
7701-6).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.476) for the combined residues of triflumizole, 
1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino-2-propoxyethyl)-1H-
imidazole, and its metabolites containing the 4-chloro-2-
trifluoromethylaniline moiety, calculated as the parent compound, in or 
on a variety of raw agricultural commodities. In addition, tolerances 
for livestock commodities have been established for the combined 
residues of triflumizole, the metabolite 4-chloro-2-hydroxy-6-
trifluoromethylaniline sulfate, and other metabolites containing the 4-
chloro-2-trifluoromethylaniline moiety, calculated as parent compound, 
in/on milk; eggs; meat, fat, and meat byproducts (mbyp) of cattle, 
goats, hogs, horses, and sheep; and in/on meat, and mbyp of poultry. 
Risk assessments were conducted by EPA to assess dietary exposures from 
triflumizole in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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.
    Dietary Exposure Evaluation Model - Food Commodity Intake Database 
(DEEM-FCID\TM\) (ver. 2.03) analysis evaluated the individual food 
consumption as reported by respondents in the United States Department 
of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys 
of Food Intake by Individuals (CSFII) and accumulated exposure to the 
chemical for each commodity. The following assumptions were made for 
the acute exposure assessments: tolerance level residues and 100 
percent crop treated (PCT) information for all registered and proposed 
uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM software with the DEEM-FCID\TM\, which 
incorporates food consumption data 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 using anticipated residues (ARs) from 
average field trial residues for apple, grape, pear, cherry, cucurbit, 
strawberry, and milk commodities; registered and proposed tolerance for 
all other commodities; PCT information for apples, grapes and pear 
commodities; and 100 PCT information for all other uses.
    iii. Cancer. Triflumizole is classified as a ``Group E'' (evidence 
of non-carcinogenicity in humans) chemical based on adequate studies in 
two species of animal. Therefore, a cancer dietary exposure assessment 
was not performed.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of 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.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if the Agency can make the following findings: Condition 1, 
that the data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to contain such 
pesticide residue;

[[Page 13276]]

Condition 2, that the exposure estimate does not underestimate exposure 
for any significant subpopulation group; and Condition 3, if data are 
available on pesticide use and food consumption in a particular area, 
the exposure estimate does not understate exposure for the population 
in such area. In addition, the Agency must provide for periodic 
evaluation of any estimates used. To provide for the periodic 
evaluation of the estimate of PCT as required by section 408(b)(2)(F) 
of FFDCA, EPA may require registrants to submit data on PCT.
    The Agency used PCT information as follows:
    Apples of 18%, grapes of 13%, pears of 29%.
    EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available federal, state, and private market survey data for that use, 
averaging by year, averaging across all years, and rounding up to the 
nearest multiple of five except for those situations in which the 
average PCT is less than one. In those cases < 1% is used as the average 
and < 2.5% is used as the maximum. EPA uses a maximum PCT for acute 
dietary risk analysis. The maximum PCT figure is the single maximum 
value reported overall from available federal, state, and private 
market survey data on the existing use, across all years, and rounded 
up to the nearest multiple of five. In most cases, EPA uses available 
data from USDA/National Agricultural Statistics Service (USDA/NASS), 
Proprietary Market Surveys, and the National Center for Food and 
Agriculture Policy (NCFAP) for the most recent 6 years.
    This method of projecting PCT for a new pesticide use, with or 
without regard to specific pest(s), produces an upper-end projection 
that is unlikely, in most cases, to be exceeded in actuality because 
the dominant pesticide is well-established and accepted by farmers. 
Factors that bear on whether a projection based on the dominant 
pesticide could be exceeded are whether the new pesticide is more 
efficacious or controls a broader spectrum of pests than the dominant 
pesticide, whether it is more cost-effective than the dominant 
pesticide, and whether it is likely to be readily accepted by growers 
and experts. These factors have been considered for this pesticide new 
use, and they indicate that it is unlikely that actual PCT for this new 
use will exceed the PCT for the dominant pesticide in the next 5 years.
    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. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the First Index Reservoir Screening Tool and Screening 
Concentrations in Groundwater 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 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/
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data 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. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    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 Agency 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

[[Page 13277]]

equally adverse consequences (i.e., mortality) in both dams and 
offspring.
    3. Conclusion. In the Agency's previous triflumizole human health 
risk assessments (refer to http://www.epa.gov/EPA-PEST/2002/June/Day-12/p14768.htm
) the following toxicity studies were determined to be 

data gaps: A 28-day rat inhalation study (OPPTS Harmonized Guideline 
Number 870.3465), acute rat neurotoxicity study (OPPTS Harmonized 
Guideline 870.6200), and subchronic rat neurotoxicity study (OPPTS 
Harmonized Guideline 870.6200). The acute and sub-chronic neurotoxicity 
studies have been submitted, reviewed by the Agency and determined to 
be acceptable.
    The Agency has re-evaluated the quality of the exposure and hazard 
data; and, based on these data, concluded that the additional 10X FQPA 
safety factor should be removed (previously, a 3X FQPA safety factor 
was retained). 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.
     The acute dietary food exposure assessment utilizes 
existing and proposed tolerance level residues and 100 PCT 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 PCT 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.

E. Aggregate Risks and Determination of Safety

    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 years and older, 11% of the aPAD for all 
infants (< 1 year old), and 21% of the aPAD for children 1-2 years old, 
the subpopulation at greatest exposure. In addition, there is potential 
for acute dietary exposure to triflumizole in drinking water. To 
estimate total aggregate exposure to a pesticide from food, drinking 
water, and residential uses, the Agency calculates drinking water 
levels of comparison (DWLOCs) which are used as a point of comparison 
against EECs. More information on the use of DWLOCs in dietary 
aggregate risk assessments can be found at http://www.epa.gov/oppfead1/trac/science/screeningsop.pdf.
 After calculating drinking water level 

of concentration DWLOCs and comparing them to the EECs for surface 
water and ground water, EPA does not expect the aggregate exposure to 
exceed 100% of the aPAD, as shown in Table 1 of this unit:

                     Table 1.--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                                         0.25            6          191         0.12        8,300
----------------------------------------------------------------------------------------------------------------
Females (13 years and older)                             0.1            9          191         0.12        2,700
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year)                                   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 chronic Population 
adjusted dose (cPAD) for the U.S. population, 4% of the cPAD for all 
infants (< 1 year old), and 13% of the cPAD for children 1-2 years old, 
the subpopulation at greatest exposure. There are no residential uses 
for triflumizole. There is potential for chronic dietary exposure to 
triflumizole in drinking water. After calculating DWLOCs and comparing 
them to the EECs for surface water and ground water, EPA does not 
expect the aggregate exposure to exceed 100% of the cPAD, as shown in 
Table 2 of this unit:

              Table 2.--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
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year)                                  0.015            4           40         0.12          140
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                               0.015           13           40         0.12          130
----------------------------------------------------------------------------------------------------------------

[[Page 13278]]

    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Triflumizole is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    4. Aggregate cancer risk for U.S. population. Triflumizole has been 
classified as not likely to be carcinogenic to humans. Therefore, 
triflumizole is expected to pose at most a negligible 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.

IV. 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 established Codex, Canadian or Mexican maximum residue 
limits (MRLs) for triflumizole in/on filberts. Therefore, harmonization 
is not an issue at this time.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
triflumizole, 1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino-2-
propoxyethyl)-1H-imidazole, and its metabolites containing the 4-
chloro-2-trifluoromethylaniline moiety, calculated as the parent 
compound in or on filbert at 0.05 ppm.

VI. Objections and Hearing Requests

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

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number EPA-HQ-OPP-2006-0103 in the subject line on 
the first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before May 15, 
2006.
    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 issue(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 VI.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 docket ID number EPA-HQ-OPP-2006-0103, to: Public 
Information and Records Integrity Branch, Information Technology and 
Resources Management 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. 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 issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under

[[Page 13279]]

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801et 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 3, 2006.
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 alphabetically adding the following 
commodity to the table in paragraph (a)(1) to read as follows:

Sec.  180.476  Triflumizole; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Filbert..............................................               0.05
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 06-2379 Filed 3-14-06; 8:45 am]

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