Tebuconazole; Pesticide Tolerances for Emergency Exemptions, 44857-44866 [05-15440]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 149 (Thursday, August 4, 2005)]
[Rules and Regulations]
[Pages 44857-44866]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15440]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0208; FRL-7727-5]


Tebuconazole; 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 
residues of tebuconazole in or on soybeans; poultry, meat; poultry, 
fat; poultry, meat byproducts; hog, meat; hog, fat; hog, meat 
byproducts; and eggs. This action is in conjunction with 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 soybeans. This regulation establishes maximum permissible levels for 
residues of tebuconazole in or on these food commodities. The 
tolerances will expire and are revoked on December 31, 2009.

DATES: This regulation is effective August 4, 2005. Objections and 
requests for hearings must be received on or before October 3, 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-2005-0208. All documents in the docket 
are listed in the EDOCKET index at https://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: Andrew Ertman, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number:

[[Page 44858]]

 703-308-9367; e-mail address:sec-18-mailbox@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (https://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available on E-CFR Beta Site Two at https://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 tolerances for residues of the fungicide 
tebuconazole (alpha-[2-(4-chlorophenyl)-ethyl)-ethyl]-alpha-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol), in or on soybean at 0.1 
parts per million (ppm); and (alpha-[2-(4-chlorophenyl)-ethyl)-ethyl]- 
alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol) and its 1-(4-
chlorophenyl)-4,4-dimethyl-3-(1H-1,2,4-triazole-1-yl-methyl)-pentane-
3,5-diol metabolite in or on poultry, meat at 0.1 ppm; poultry, fat at 
0.1 ppm; poultry, meat byproducts at 0.1 ppm; hog, meat at 0.1 ppm; 
hog, fat at 0.1 ppm; hog, meat byproducts at 0.1 ppm; and eggs at 0.1 
ppm. These tolerances will expire and are revoked on December 31, 2009. 
EPA will publish a document in the Federal Register to remove the 
revoked tolerance 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 and the new safety standard 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.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Tebuconazole on Soybeans and FFDCA 
Tolerances

    The States of Minnesota and South Dakota, as lead State agencies in 
what is essentially a ``national'' section 18 request for all soybean 
growing States, have petitioned the Agency requesting an emergency 
exemption for tebuconazole to control soybean rust under section 18 of 
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). On 
November 10, 2004, the U.S. Department of Agriculture's Animal and 
Plant Health Inspection Service (USDA/APHIS) confirmed the presence 
ofPhakopsora pachyrhizi, the pathogen that causes soybean rust, on 
soybean leaf samples taken from two plots associated with a Louisiana 
State University research farm. Soybean rust has been designated as a 
biosecurity threat and therefore it is important that control measures 
be available for the disease. EPA has authorized under FIFRA section 18 
the use of tebuconazole on soybeans for control of soybean rust in 
Minnesota, South Dakota, and all the other States that have requested 
an exemption for this use. After having reviewed the submissions, EPA 
concurs that emergency conditions exist for these States.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of tebuconazole in or on 
soybean. In doing so, EPA considered the safety standard in section 
408(b)(2) of the FFDCA, and EPA decided that the necessary 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 tolerances without notice and opportunity 
for public comment as provided in section 408(l)(6) of the FFDCA. 
Although the tolerances will expire and are revoked on December 31, 
2009, under section 408(l)(5) of the FFDCA, residues of the pesticide 
not in excess of the amounts specified in the tolerance remaining in or 
on soybeans; poultry, meat; poultry, fat; poultry, meat byproducts; 
hog, meat; hog, fat; hog, meat byproducts; and eggs 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

[[Page 44859]]

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 tebuconazole 
meets EPA's registration requirements for use on soybeans or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of tebuconazole by a State for special local 
needs under FIFRA section 24(c). Nor does this tolerance serve as the 
basis for any State other than Minnesota and South Dakota to use this 
pesticide on this crop 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 tebuconazole, 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. For purposes of this section 18 emergency exemption, 
the only residue of concern is tebuconazole (alpha-[2-(4-chlorophenyl)-
ethyl)-ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol) in 
crops and its 1-(4- chlorophenyl)-4,4-dimethyl-3-(1H-1,2,4-triazole-1-
yl-methyl)-pentane-3,5-diol metabolite in edible animal tissues. EPA 
has sufficient data to assess the hazards of tebuconazole and to make a 
determination on aggregate exposure, consistent with section 408(b)(2) 
of the FFDCA, for a time-limited tolerance for residues of tebuconazole 
(alpha-[2-(4-chlorophenyl)-ethyl)-ethyl]-alpha-(1,1-dimethylethyl)-1H-
1,2,4-triazole-1-ethanol), in or on soybean at 0.1 ppm and (alpha-[2-
(4-chlorophenyl)-ethyl)-ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-
triazole-1-ethanol) and its 1-(4-chlorophenyl)-4,4-dimethyl-3-(1H-
1,2,4-triazole-1-yl-methyl)-pentane-3,5-diol metabolite in or on 
poultry, meat at 0.1 ppm; poultry, fat at 0.1 ppm; poultry, meat 
byproducts at 0.1 ppm; hog, meat at 0.1 ppm; hog, fat at 0.1 ppm; hog, 
meat byproducts at 0.1 ppm; and eggs at 0.1 ppm.

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. A 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. A UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intraspecies differences. A uncertainty factor of 10X was used for 
extrapolation from LOAEL to NOAEL from the developmental neurotoxicity 
(DNT) study in rats. A special FQPA safety factor was not applied 
because the health endpoint being used as the basis for regulation for 
all subpopulations is an adverse effect on young animals in a 
developmental neurotoxicity study.
    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). Where an additional safety factor is 
retained due to concerns unique to the FQPA, 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 x10-\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 tebuconazole used for human risk assessment is shown in 
the following Table 1:

 Table 1.--Summary of Toxicological Doses and Endpoints for Tebuconazole for Use in Dietary Exposure Assessment
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                                                                  Hazard and Exposure
          Exposure Scenario               Dose Used in Risk        Based Special FQPA    Study and Toxicological
                                            Assessment, UF           Safety Factor*              Effects
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Acute dietary (females 13+)            LOAEL = 8.8 mg/kg/day    FQPA SF = 1X             Developmental
                                       UF = 1,000.............  aPAD = acute RfD =        Neurotoxicity Study -
                                       Acute RfD = 0.0088 mg/    0.0088 mg/kg/day.        Rat
                                        kg/day.                                          Offspring toxicity
                                                                                          LOAEL = 100 ppm based
                                                                                          on decreases in body
                                                                                          weights and decreases
                                                                                          in absolute brain
                                                                                          weights. No NOAEL was
                                                                                          determined.
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[[Page 44860]]

 
Acute dietary (general population)     LOAEL = 8.8 mg/kg/day    FQPA SF = 1X             Developmental
                                       UF = 1000..............  aPAD = acute RfD =        Neurotoxicity Study -
                                       Acute RfD = 0.0088 mg/    0.0088 mg/kg/day.        Rat
                                        kg/day.                                          Offspring toxicity
                                                                                          LOAEL = 100 ppm based
                                                                                          on decreases in body
                                                                                          weights and decreases
                                                                                          in absolute brain
                                                                                          weights. No NOAEL was
                                                                                          determined.
-----------------------------------------------------------------------------------------
Chronic dietary (all populations)      LOAEL = 8.8 mg/kg/day    FQPA SF = 1X             Developmental
                                       UF = 1,000.............  cPAD = chronic RfD =      Neurotoxicity Study -
                                       Chronic RfD = 0.0088 mg/  0.0088 mg/kg/day.        Rat
                                        kg/day.                                          Offspring toxicity
                                                                                          LOAEL = 100 ppm based
                                                                                          on decreases in body
                                                                                          weights and decreases
                                                                                          in absolute brain
                                                                                          weights. No NOAEL was
                                                                                          determined.
-----------------------------------------------------------------------------------------
Dermal (short-term, intermediate-      LOAEL = 8.8 mg/kg/day;   MOE = 1,000 (10X for     Developmental
 term, long-term)                       dermal equivalent dose   interspecies, 10X for    Neurotoxicity Study -
                                        is estimated using a     intraspecies, and 10X    Rat
                                        23.1% dermal             for extrapolation from  Offspring toxicity
                                        absorption factor        LOAEL to NOAEL)          LOAEL = 100 ppm based
                                                                                          on decreases in body
                                                                                          weights and decreases
                                                                                          in absolute brain
                                                                                          weights. No NOAEL was
                                                                                          determined.
-----------------------------------------------------------------------------------------
Inhalation (any time period)           LOAEL = 8.8 mg/kg/day;   Occupational MOE =       Developmental
                                        inhalation absorption    1,000 (10X for           Neurotoxicity Study -
                                        is assumed equivalent    interspecies, 10X for    Rat
                                        to oral absorption       intraspecies, and 10X   Offspring toxicity
                                                                 for extrapolation from   LOAEL = 100 ppm based
                                                                 LOAEL to NOAEL)          on decreases in body
                                                                                          weights and decreases
                                                                                          in absolute brain
                                                                                          weights. No NOAEL was
                                                                                          determined.
-----------------------------------------------------------------------------------------
Cancer                                  Group C - possible human carcinogen and recommended that for the purpose
                                         of risk characterization the reference dose (RfD) approach be used for
                                                              quantification of human risk
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA SF refers to any additional SF retaineddue to concerns unique to the FQPA.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.474) for the residues of tebuconazole, in or on 
a variety of raw agricultural commodities. Meat, and milk tolerances 
have also been established for the combined residues of tebuconazole 
and its 1-(4-chlorophenyl)-4,4-dimethyl-3-(1H-1,2,4-triazole-1-yl- 
methyl)-pentane-3,5-diol metabolite. Risk assessments were conducted by 
EPA to assess dietary exposures from tebuconazole 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-FCID, 
Version2.00-2.02) 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 acute 
assessment was a refined assessment using a combination of tolerances 
as listed in 40 CFR 180.474, maximum residues from field trials, 
distributions of field trial data, distributions of Pesticide Data 
Program (PDP) monitoring data, percent crop treated, default DEEM 
processing factors and the results of processing studies, all 
incorporated into an analysis conducted with the DEEM-FCID program. The 
resulting exposure estimates were compared to the acute population 
adjusted dose (aPAD) for tebuconazole of 0.0088 milligrams/kilogram 
body weight/day (mg/kg bwt/day).
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM-FCID, Version 2.00-2.02 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 chronic dietary exposure assessment used tolerance level 
residues as listed in 40 CFR 180.474, mean residue values from field 
trials and from PDP monitoring, and estimates of percent crop treated 
with tebuconazole. These data were used with the chronic analysis 
module of the DEEM-FCID software. As with the acute assessment, 
processing factors from registrant studies as well as default DEEM 
processing factors were used. The resulting exposure estimates were 
compared to the cPAD for tebuconazole of 0.0088 mg/kg bwt/day.
    iii. Cancer. The Agency classified tebuconazole as a possible human 
carcinogen and recommended that for the purpose of risk 
characterization, the

[[Page 44861]]

RfD approach should be used for quantification of human 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.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if the Agency can make the following findings: 
Condition 1, that the data used are reliable and provide a valid basis 
to show what percentage of the food derived from such crop is likely to 
contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to 
submit data on PCT.
    The Agency used PCT information as follows:PCT data were used in 
the chronic assessment for garlic (40% crop treated), peanuts (35% crop 
treated), and wheat (5% crop treated).
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) 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 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 tebuconazole 
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 tebuconazole 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 tebuconazole.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW (screening concentration in ground water), which predicts 
pesticide concentrations in ground water. In general, EPA will use 
GENEEC (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model) for a 
screening-level assessment for surface water. The GENEEC model is a 
subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. GENEEC incorporates a farm pond scenario, 
while PRZM/EXAMS incorporate an index reservoir environment in place of 
the previous pond scenario. The PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOC) 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 tebuconazole, they are 
further discussed in the aggregate risk sections below.
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of 
tebuconazole for acute exposures are estimated to be 39 parts per 
billion (ppb) for surface water and 0.4 ppb for ground water. The EECs 
for chronic non-cancer exposures are estimated to be 23 ppb for surface 
water and 0.4 ppb for ground water. For chronic/cancer assessments, the 
36-year average from PRZM/EXAMS is 19 ppb.
    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).
    Non-dietary, non-occupational (residential), exposures are not 
expected from the proposed use of this section 18 request on soybeans. 
However, a few

[[Page 44862]]

residential use patterns are present on the labels of several 
registered end use products. Non-agricultural use sites include 
ornamental plants, shrubs, vines, trees and flowers, plus wood 
protection treatments, and other preservative/additive uses. Short-term 
dermal and inhalation exposures to residential handlers are possible 
with the use of residential home and garden products. Residential 
short-term postapplication exposure from these home and garden products 
is also possible. Additionally, residential postapplication exposure to 
wood products previously treated with tebuconazole are possible.
    For residential handlers, the exposure scenarios that should result 
in the highest exposure potentials include use of hose-end sprayers and 
pump sprayers. These two scenarios were assessed using the application 
rate for shrubs, since it should encompass the largest possible 
treatment exposure area and amount of product used. A low pressure hand 
wand scenario was used as a surrogate for the pump sprayer scenario, 
since no unit exposure data exist for this scenario. The watering can/
bucket scenario was not assessed, since it should result in much less 
exposure. Since the toxicological endpoint is the same for short-term 
dermal and inhalation exposures, the risk estimates are combined in 
this assessment. The combined exposures resulted in MOEs ranging from 
1,500 to 3,200, and therefore, do not exceed EPA's level of concern, 
i.e. all MOEs greater than or equal to 1,000.
    Residential short-term postapplication exposures from ornamental 
plants, shrubs, vines, trees and flowers previously treated with 
tebuconazole were not assessed, because the residential handler 
exposure and risk estimates for the uses resulted in risk estimates 
that do not exceed EPA's level of concern, and postapplication 
exposures should be considerably less.
    Residential postapplication exposure to wood products previously 
treated with tebuconazole are not quantified, because the exposure is 
expected to be negligible; i.e., the nature of the use patterns would 
result in very low, if any exposure that would impact aggregate risk. 
All wood products are commercially treated, and then most of these wood 
products are intended for uses (e.g., door jams, sills) that should not 
result in dermal or oral exposures in residential settings.
    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 tebuconazole and any other 
substances. For the purposes of this tolerance action, therefore, EPA 
has not assumed that tebuconazole 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 
https://www.epa.gov/pesticides/cumulative/.
    However, the Agency does have concern about potential toxicity to 
1,2,4-triazole and two conjugates, triazolylalanine and triazolyl 
acetic acid, metabolites common to most of the triazole fungicides. To 
support the extension of existing parent triazole-derivative fungicide 
tolerances, EPA conducted an interim human health assessment for 
aggregate exposure to 1,2,4-triazole. The exposure and risk estimates 
presented in this assessment are overestimates of actual likely 
exposures and therefore, should be considered to be highly 
conservative. Based on this assessment, EPA concluded that for all 
exposure durations and population subgroups, aggregate exposures to 
1,2,4-triazole are not expected to exceed EPA's level of concern. This 
assessment is presented in the April 22, 2005 Federal Register (70 FR 
2028) (FRL-7702-4) notice for another triazole fungicide, 
tetraconazole. This assessment should be considered interim due to the 
ongoing series of studies being conducted by the U.S. Triazole Task 
Force (USTTF). Those studies are designed to provide the Agency with 
more complete toxicological and residue information for free triazole. 
Upon completion of the review of these data, EPA will prepare a more 
sophisticated assessment based on the revised toxicological and 
exposure data bases.

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal susceptibility. The data from prenatal 
developmental toxicity studies provided no indication of increased 
quantitative susceptibility of mice, rats, or rabbits following in 
utero exposure to tebuconazole. In the prenatal developmental toxicity 
studies in mice, rats, and rabbits, the NOAELs for developmental 
toxicity were comparable to or higher than the NOAELs for maternal 
toxicity. There was, however, indication of increased qualitative 
susceptibility. In all three species, maternal toxicity was minimal at 
the LOAEL (consisting of increases in hematological findings in mice, 
increased liver weights in rats, and decreased body weight gain/food 
consumption in rats) and did not increase substantially in severity at 
higher doses; there was more concern for the developmental effects at 
each LOAEL, which included increases in runts and increased fetal loss 
in mice, increased skeletal variations in rats, and increased fetal 
loss and frank malformations in rabbits. Additionally, more severe 
developmental effects (including frank malformations) were seen at 
higher doses in mice (100 mg/kg/day), rats (120 mg/kg/day), and rabbits 
(100 mg/kg/day). In the 2-generation reproduction study, NOAELs/LOAELs 
were the same for offspring and parental systemic toxicity. In the 
developmental neurotoxicity study, increases in qualitative and 
quantitative susceptibility were seen in rats; maternal toxicity was 
seen only at the high dose of 65 mg/kg/day (decreased body weights, 
body weight gains, and food consumption, prolonged gestation with 
mortality, and increased number of dead fetuses), with a NOAEL of 22 
mg/kg/day, while offspring toxicity (including decreased body weight 
and brain weight) was seen at all doses (LOAEL = 8.8 mg/kg/day).
    3. Conclusion. The toxicity data base for tebuconazole is complete, 
and includes developmental toxicity studies in three species (mouse, 
rat, and rabbit), a reproductive toxicity study in the rat,

[[Page 44863]]

acute and subchronic neurotoxicity studies in rats, and a developmental 
neurotoxicity study in the rat. The exposure data are complete or 
estimated based on data that reasonably accounts for potential 
exposures in occupational and residential settings. Available data 
indicate greater sensitivity of the developing organism to exposure to 
tebuconazole, as demonstrated by increases in qualitative sensitivity 
in prenatal developmental toxicity studies in rats, mice, and rabbits, 
and by an increase in both qualitative and quantitative sensitivity in 
the developmental neurotoxicity study with tebuconazole. Clear NOAELs 
for developmental toxicity were seen in available prenatal 
developmental toxicity studies; these NOAELs are higher than those used 
in the current risk assessment. Although there was a NOAEL for maternal 
animals in the available developmental neurotoxicity study, there was 
no NOAEL for effects in the offspring. As the offspring LOAEL from this 
study is the lowest dose at which effects were seen following exposure 
to tebuconazole, this endpoint was selected for use in the current risk 
assessment, for both acute and chronic dietary exposure. Residual 
uncertainty due to the lack of a NOAEL in this study is accounted for 
by using a factor of 10X to extrapolate from the LOAEL seen in the 
study to a NOAEL. Thus, although the effects seen in the offspring in 
the DNT study occurred at doses below those causing effects in maternal 
animals, these effects are being used as the basis for the acute and 
chronic endpoints, and are thus accounted for in the current risk 
assessment. Any residual uncertainty regarding the lack of a NOAEL in 
the developmental neurotoxicity study is accounted for by including an 
additional uncertainty factor of 10X for extrapolation from the LOAEL 
seen in the study to a NOAEL. Thus, any residual uncertainty regarding 
toxicity to offspring has been accounted for in the risk assessment, 
and an additional special FQPA uncertainty factor is not required.

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 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, EPA concludes with reasonable certainty that 
exposures to tebuconazole in drinking water (when considered along with 
other sources of exposure for which EPA has reliable data) would not 
result in unacceptable levels of aggregate human health risk at this 
time. Because EPA considers the aggregate risk resulting from multiple 
exposure pathways associated with a pesticide's uses, levels of 
comparison in drinking water may vary as those uses change. If new uses 
are added in the future, EPA will reassess the potential impacts of 
tebuconazole 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 
tebuconazole will occupy 14% of the aPAD for the U.S. population, 7% of 
the aPAD for females 13 years and older, 25% of the aPAD for infants 
less than 1 year old, and 53% of the aPAD for children 1 to 2 years 
old. In addition, despite the potential for acute dietary exposure to 
tebuconazole in drinking water, after calculating DWLOCs and comparing 
them to conservative model EECs of tebuconazole in surface water and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the aPAD, as shown in Table 2:

                      Table 2.--Aggregate Risk Assessment for Acute Exposure to Tebuconazole
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                       0.0088          14%           39          0.4          266
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                              0.0088          53%           39          0.4           41
----------------------------------------------------------------------------------------------------------------
Females (13 years and older)                          0.0088           7%           39          0.4          245
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
tebuconazole from food will utilize 7% of the cPAD for the U.S. 
population, 15% of the cPAD for all infants less than 1 year old and 
16% of the cPAD for children 1 to 2 years old. Based on the use 
pattern, chronic residential exposure to residues of tebuconazole is 
not expected. In addition, despite the potential for chronic dietary 
exposure to tebuconazole in drinking water, after calculating DWLOCs 
and comparing them to conservative model EECs of tebuconazole in 
surface water and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD, as shown in Table 3:

[[Page 44864]]



             Table 3.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Tebuconazole
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                       0.0088           7%           23          0.4          285
----------------------------------------------------------------------------------------------------------------
All Infants (less than 1 year old)                    0.0088          15%           23          0.4           74
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                              0.0088          16%           23          0.4           74
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Tebuconazole is currently registered for use(s) that could result 
in short-term residential exposure and the Agency has determined that 
it is appropriate to aggregate chronic food and water and short-term 
exposures for tebuconazole.
    A short-term aggregate risk assessment based on exposure from 
inhalation and dermal routes was considered and performed for adults 
only. Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in an aggregate MOE of 1,300. This aggregate MOE does 
not exceed the Agency's level of concern for aggregate exposure to food 
and residential uses. In addition, short-term DWLOCs were calculated 
and compared to the EECs for chronic exposure of tebuconazole in ground 
water and surface water. After calculating DWLOCs and comparing them to 
the EECs for surface water and ground water, EPA does not expect short-
term aggregate exposure to exceed the Agency's level of concern, as 
shown in Table 4 of this unit:

                   Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Tebuconazole
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. Population                                1,300        1,000           23          0.4          280
----------------------------------------------------------------------------------------------------------------

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Though residential uses of tebuconazole are registered, 
intermediate-term dermal and inhalation exposures to residential 
handlers are not expected with the use of residential home and garden 
products.
    5. Aggregate cancer risk for U.S. population. Tebuconazole has been 
classified as a Group C possible human carcinogen, non-quantifiable. 
Consequently, the standard chronic dietary exposure analysis and risk 
assessment using the cPAD serves as the assessment for cancer. Since 
carcinogenic risk for tebuconazole is addressed with the cPAD, cancer 
risk from the proposed use on soybeans is not expected to be of 
concern.
    6. 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 tebuconazole residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example--gas chromatography) is 
available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    There are no CODEX, Canadian, or Mexican Maximum Residue Limits 
(MRLs) for tebuconazole on soybeans. Therefore, there are no 
international harmonization issues associated with this action.

VI. Conclusion

    Therefore, the tolerance is established for residues of the 
fungicide tebuconazole (alpha-[2-(4-chlorophenyl)-ethyl)-ethyl]-alpha-
(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol), in or on soybean at 
0.1 ppm; and (alpha-[2-(4-chlorophenyl)-ethyl)-ethyl]- alpha-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol) and its 1-(4-chlorophenyl)-
4,4-dimethyl-3-(1H-1,2,4-triazole-1-yl-methyl)-pentane-3,5-diol 
metabolite in or on poultry, meat at 0.1 ppm; poultry, fat at 0.1 ppm; 
poultry, meat byproducts at 0.1 ppm; hog, meat at 0.1 ppm; hog, fat at 
0.1 ppm; hog, meat byproducts at 0.1 ppm; and eggs at 0.1 ppm.

VII. Objections and Hearing Requests

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

[[Page 44865]]

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-2005-0208 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 October 
3, 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 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 14th 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-2005-0208, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issue(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, entitledRegulatory 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

[[Page 44866]]

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:July 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 180.474 is amended by revising paragraph (b) to read as 
follows:


Sec.  180.474  Tebuconazole; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. (1) Time-limited tolerances 
are established for residues of the fungicide tebuconazole (alpha-[2-
(4-chlorophenyl)-ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-
ethanol) in connection with use of the pesticide under section 18 
emergency exemptions granted by EPA. The tolerances will expire and are 
revoked on the dates specified in the following table.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Barley, grain...................................        2.0     6/30/08
Barley, hay.....................................       20.0     6/30/08
Barley, straw...................................       20.0     6/30/08
Garlic..........................................        0.1    12/31/05
Soybean.........................................        0.1    12/31/09
Sunflower, oil..................................        0.4    12/31/05
Sunflower, seed.................................        0.2    12/31/05
Wheat, hay......................................       15.0     6/30/08
Wheat, straw.............