Return to Index Page
 

http://www.epa.gov/fedrgstr/EPA-PEST/2006/March/Day-15/p2379.htm

 [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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.gov/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:

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:

[[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 (59 FR 22951, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 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.

• Therefore, 40 CFR chapter I is amended as follows:
PART 180--AMENDED

• 1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.

• 2. Section 180.476 is amended by 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) * * *

[FR Doc. 06-2379 Filed 3-14-06; 8:45 am]
BILLING CODE 6560-50-S