[Federal Register: August 4, 2005 (Volume 70, Number 149)]
[Rules and Regulations]
[Page 44857-44866]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04au05-6]
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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 http://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S.
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: 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 (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/.
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.
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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.
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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.
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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.
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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
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*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
http://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.................................... 2.0 6/30/08
------------------------------------------------------------------------
(2) Time-limited tolerances are established for the combined
residues of the fungicide tebuconazole (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 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
------------------------------------------------------------------------
Eggs............................................ 0.1 12/31/09
Poultry, fat.................................... 0.1 12/31/09
Poultry, meat................................... 0.1 12/31/09
Poultry, meat byproducts........................ 0.1 12/31/09
Hog, fat........................................ 0.1 12/31/09
Hog, meat....................................... 0.1 12/31/09
Hog, meat byproducts............................ 0.1 12/31/09
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-15440 Filed 8-3-05; 8:45 a.m.]
BILLING CODE 6560-50-S