[Federal Register: August 4, 2004 (Volume 69, Number 149)]
[Rules and Regulations]
[Page 47005-47013]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04au04-9]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0086; FRL-7352-1]
Propiconazole; Time-Limited Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
combined residues of propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-
propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole and its metabolites
determined as 2,4-dichlorobenzoic acid and expressed as parent compound
in or on corn, field, forage; corn, field, grain; corn, field, stover;
corn, sweet, kernel plus cob with husks removed; peanut; peanut, hay;
pineapple; and pineapple, fodder. Syngenta Crop Protection, Inc.
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food Quality Protection Act of 1996
(FQPA). The tolerances will expire on November 30, 2008.
DATES: This regulation is effective August 4, 2004. Objections and
requests for hearings must be received on or before October 4, 2004.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
ID number OPP-2004-0086. 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 South 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: Mary L. Waller, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9354; e-mail address: waller.mary@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:
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
In the Federal Register of February 27, 2004 (69 FR 9315) (FRL-
7346-7), EPA issued a notice pursuant to section 408(d)(3) of the
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide
petitions (PP 8F3654 and 8F3674) by Syngenta Crop Protection, Inc.,
P.O. Box 18300, Greensboro, NC 27419-8300. This notice included a
summary of the petition prepared by Syngenta Crop Protection, Inc., the
[[Page 47006]]
registrant. There were no comments received in response to the notice
of filing.
The petition requested that 40 CFR 180.434 be amended by
establishing tolerances for combined residues of the fungicide
propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4-
dichlorobenzoic acid and expressed as parent compound in or on corn,
field, forage at 12 parts per million (ppm); corn, field, grain at 0.1
ppm; corn, field, stover at 12 ppm; corn, sweet, kernel plus cob with
husks removed at 0.1 ppm; peanut at 0.2 ppm; peanut, hay at 20 ppm
(8F3654); pineapple at 0.1 ppm; and pineapple, fodder at 0.1 ppm
(8F3674).
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....''
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).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA , for a tolerance for combined residues of
propiconazole on corn, field, forage at 12 ppm; corn, field, grain at
0.1 ppm; corn, field stover at 12 ppm; corn, sweet, kernel plus cob
with husks removed at 0.1 ppm; peanut at 0.2 ppm; peanut, hay at 20
ppm; pineapple at 0.1 ppm; and pineapple, fodder at 0.1 ppm. EPA's
assessment of exposures and risks associated with establishing these
tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by propiconazole are
discussed in this unit as well as the no observed adverse effect level
(NOAEL) and the lowest observed adverse effect level (LOAEL) from the
toxicity studies reviewed.
1. Acute toxicity data were as follows: Acute oral lethal dose
(LD)50 = 1,517 milligrams/kilogram (mg/kg) (toxicity
category III); acute dermal LD50 > 4,000 mg/kg (toxicity
category III); acute inhalation lethal concentration (LC)50
1.26 mg/liter (L); primary eye irritation - clear by 72 hours (toxicity
category III); primary skin irritation - slight irritation (toxicity
category IV); and dermal sensitization - negative.
2. A developmental toxicity study with rats which were gavaged with
doses of 0, 30, 90 or 360/300 mg/kg/day. The developmental NOAEL was 30
mg/kg/day. Evidence of developmental toxicity observed at the 90 mg/kg/
day level LOAEL included increased incidence of unossified sternebrae,
rudimentary ribs, shortened or absent renal papillae, and increased
cleft palate. The maternal NOAEL was 90 mg/kg/day and the maternal
LOAEL was 300 mg/kg/day based on severe clinical toxicity.
3. A development toxicity study with rabbits which were gavaged
with doses of 0, 30, 90, or 180 mg/kg/day with no evidence of maternal
or developmental toxicity observed under the conditions of the study.
4. A developmental toxicity study with rabbits which were gavaged
with doses of 0, 100, 250, or 400 mg/kg/day on gestation days 7 through
19 with no developmental toxicity observed under the conditions of the
study. The maternal NOAEL was 100 mg/kg/day and the maternal LOAEL was
250 mg/kg/day based on decreased food consumption, weight gain, and an
increase in the number of resorptions at the higher dose levels. The
developmental NOAEL was 250 mg/kg/day. The developmental LOAEL was 400
mg/kg/day based on increased incidence of fetuses/litters with 13\th\
rib and increased abortions.
5. A 2-generation reproduction study with rats fed diets containing
0, 100, 500, or 2,500 ppm showed no reproductive effects under the
conditions of the study. The offspring NOAEL was 500 ppm (equivalent to
43-52 mg/kg/day), and the offspring LOAEL was 2,500 ppm (equivalent to
192-263 mg/kg/day) based on decreased offspring survival, body weight
depression, and increased incidence of hepatic lesions in rats. The
parental NOAEL was 100 ppm (equivalent to 8 mg/kg/day) and the parental
LOAEL was 500 ppm (equivalent to 42 mg/kg/day) based on increased
incidence of hepatic cell change.
6. A 1-year feeding study with dogs fed diets containing 0, 5, 50,
or 250 ppm with a NOAEL of 50 ppm (equivalent to 1.25 mg/kg/day). The
LOAEL was 250 ppm (equivalent to 6.25 mg/kg/day based on mild
irritation of stomach mucosa.
7. A 2-year chronic feeding/carcinogenicity study with rats fed
diets containing 0, 100, 500, or 2,500 ppm with a systemic NOAEL of 500
ppm (equivalent to 18 mg/kg/day) based on liver lesions and reduced
body weight gain at the 2,500 ppm level (96 mg/kg/day). There were no
carcinogenic effects observed under the conditions of the study.
8. A 2-year chronic feeding/carcinogenicity study with mice fed
diets containing 0, 100, 500, or 2,500 ppm with a systemic NOAEL of 100
ppm (equivalent to 10 mg/kg/day) based on increased liver lesions and
liver weight in males. There was a statistically significant increase
in combined adenomas and carcinomas of the liver in male mice at the
2,500 ppm level (equivalent to 340 mg/kg/day).
9. An 18-month oncogenicity study with male mice fed diets
containing 0, 100, 500, or 850 ppm with a NOAEL of 100 ppm (11 mg/kg/
day) based on hepatoxicity and body weight gain effects at the LOAEL of
500 ppm (59 mg/kg/day). There was a treatment related increase in the
incidence of hepatocellular (liver) adenoma and combined liver adenomas
and carcinomas at the 850 ppm level when compared to controls.
10. A battery of mutagenicity studies to determine the potential of
propiconazole to induce gene mutation, chromosomal aberrations, and
other genotoxic effects were all negative.
[[Page 47007]]
B. 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 level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences. The
Agency retained a 3X database uncertainty factor for acute (single
dose) and short-term exposure scenarios to account for the lack of an
acute neurotoxicity study. These missing data are not expected to have
an impact on longer duration exposure scenarios.
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 Safety Factor
(SF).
For non-dietary risk assessments (other than cancer) the UF is used
to determine the 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 as1 x 10-\6\ or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for propiconazole used for human risk assessment is shown in
Table 1 of this unit:
Table 1.--Summary of Toxicological Dose and Endpoints for Propiconazole for Use in Human Risk Assessment
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Special FQPA SF* and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years of NOAEL = 30 mg/kg/day Special FQPA SF = 1X Developmental Toxicity
age) UF = 300............... aPAD = acute RfD / FQPA Study - Rats
Acute RfD = 0.1 mg/kg/ SF = 0.1 mg/kg/day. LOAEL = 90 mg/kg/day
day. based on developmental
toxicity manifested by
increased incidence of
rudimentary ribs,
cleft palate
malformations (0.3%),
unossified sternebrae,
as well as increased
incidence of shortened
and absent renal
papillae
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Acute Dietary (General population NOAEL = 90 mg/kg/day Special FQPA SF = 1X Developmental Toxicity
including infants and children) UF = 300............... aPAD = acute RfD / FQPA Study - Rats
Acute RfD = 0.3 mg/kg/ SF = 0.3 mg/kg/day. LOAEL = 300 mg/kg/day
day. based on severe
maternal toxicity:
Ataxia, coma,
lethargy, prostration,
audible and labored
respiration,
salivation and
lacrimation
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Chronic Dietary (All populations) NOAEL = 10 mg/kg/day Special FQPA SF = 1X 24 Month Oncogenicity
UF = 100............... cPAD = chronic RfD / Study - Mice
Chronic RfD = 0.1 mg/kg/ FQPA SF = 0.1 mg/kg/ LOAEL = 50 mg/kg/day
day. day. based on liver
toxicity (increased
liver weight in males
and increases in liver
lesions (masses/raised
areas/swellings/
nodular areas mainly
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Short-Term - Incidental Oral (1-30 Maternal NOAEL = 90 mg/ LOC for MOE = 300 Developmental Toxicity
days) (Residential) kg/day (Residential) Study
LOAEL = 300 mg/kg/day
based on severe
clinical signs
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Short-Term (1-30 days) Dermal Oral Developmental LOC for MOE = 300 Developmental Toxicity
(Females 13-50 years old) NOAEL = 30 mg ai/kg/ Study - Rats
day (dermal absorption LOAEL = 90 mg/kg/day
rate = 1%) based on developmental
toxicity: Increased
incidence of
rudimentary ribs,
unossified sternebrae,
shortened and absent
renal papillae, and
cleft palate
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Cancer N/A N/A Group C - possible
human carcinogen, non-
quantifiable
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA SF refers to any additional safety factor retained due to concerns unique to the
FQPA.
[[Page 47008]]
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.434) for the combined residues of
propiconazole, in or on a variety of raw agricultural commodities. The
commodities and/or crops are as follows: Bananas; barley; celery; corn;
cranberry; dry beans; stone fruits; mint; mushrooms; oats; peanuts;
pecans; pineapples; rice; rye; sorghum; wheat; wild rice; eggs, kidney,
liver and meat and meat by products of poultry; and milk, meat, fat,
kidney, liver, meat and meat by products of cattle, goats, hogs, horses
and sheep. Risk assessments were conducted by EPA to assess dietary
exposures from propiconazole 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 one day
or single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\)
analysis evaluated the individual food consumption as reported by
respondents in the U.S. Department of Agriculture (USDA) 1994-1996 and
1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII) and accumulated exposure to the chemical for each commodity.
The following assumptions were made for the acute exposure assessments:
Tolerance level residues were used for all food commodities and it was
assumed that 100% of all crops were treated.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the chronic
exposure assessments: Tolerance level residues were used for all food
commodities and it was assumed that 100% of all crops were treated.
iii. Cancer. A quantitative risk assessment using a cancer endpoint
was not performed. The chronic risk assessment is adequately protective
for cancer risk as well as other chronic effects.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for propiconazole 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 propiconazole.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The SCI-GROW model is used to predict pesticide concentrations in
shallow groundwater. For a screening-level assessment for surface water
EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2
model). The FIRST model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. While both FIRST and
PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to propiconazole they are
further discussed in the aggregate risk sections in unit III.
Based on the FIRST and SCI-GROW models the estimated EECs of
propiconazole for acute exposures are estimated to be 264 parts per
billion (ppb) for surface water and 1.5 ppb for ground water. The EECs
for chronic exposures are estimated to be 80 ppb for surface water and
1.5 ppb for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Propiconazole is currently registered for use on the following
residential non-dietary site: Residential lawns. The risk assessment
was conducted using the following residential exposure assumptions: For
adults treating residential lawns, it was assumed there was a
possibility of short-term dermal exposure, and for infants and small
children playing on treated lawns, it was assumed there was a
possibility of incidental oral and dermal exposure.
4. Cumulative exposure to 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.''
EPA has not made a common mechanism of toxicity finding as to
propiconazole and any other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that propiconazole 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 final rule for Bifenthrin Pesticide Tolerances (62
FR 62961, November 26, 1997) (FRL-5754-7).
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 its level of concern. This
assessment should be considered interim due to the ongoing series of
studies being conducted by the
[[Page 47009]]
U.S. Triazole Task Force (USTTF). Those studies are designed to provide
the Agency with more complete toxicological and residue information for
free triazole and are expected to be submitted to the Agency in late
2004. Upon completion of the review of these data, EPA will prepare a
more sophisticated assessment based on the revised toxicological and
exposure databases.
i. Toxicology. The toxicological database for 1,2,4-triazole is
incomplete. Preliminary summary data presented by the USTTF to EPA
indicate that the most conservative endpoint currently available for
use in a risk assessment for 1,2,4-triazole is a LOAEL of 15 mg/kg/day,
based on body weight decreases in male rats in the reproductive
toxicity study (currently underway). This endpoint, with an uncertainty
factor of 1,000 was used for both acute and chronic dietary risk,
resulting in an RfD of 0.015 mg/kg/day. The uncertainty factor of 1,000
addresses aspects of the toxicology of 1,2,4-triazole related to
potential enhanced susceptibility of infants and children. The
resulting PAD is 0.015 mg/kg/day.
ii. Dietary exposure. The USTTF conducted an acute dietary exposure
assessment based on the highest triazole-derivative fungicide tolerance
level combined with worst-case molecular weight and plant/livestock
metabolic conversion factors. This approach provides a conservative
estimate of all sources for 1,2,4-triazole except the in vivo
conversion of parent compounds to free-triazole following dietary
exposure. The degree of animal in vivo conversion is dependent on the
identity of the parent fungicide. In rats, this conversion ranges from
0 to 77%--the in vivo conversion for propiconazole is 5%. For purposes
of this interim assessment, EPA used the dietary exposure estimates
provided by the USTTF adjusted based on the highest rate of conversion
observed for any of the parent triazole-derivative fungicides to
account for this metabolic conversion. The assessment includes residue
estimates for all food commodities with either existing or pending
triazole-derivative fungicide registrations. The resulting acute
dietary exposure estimates are extremely conservative and range from
0.0032 mg/kg/day for males 20+ years old to 0.014 mg/kg/day for
children 1 to 6 years old. Estimated risks range from 22 to 93% of the
PAD. In order to estimate chronic exposures via food, EPA used the
70\th\ percentile of exposures from the acute assessment. Estimated
risks range from 10 to 47% of the PAD. The dietary assessment does not
include potential exposure via residues in water. It is emphasized that
the use of both highest-tolerance-level residues and the highest in
vivo conversion factor results in dietary risk estimates that far
exceed the likely actual risk.
iii. Non-dietary exposure. Triazole-derivative fungicides are
registered for use on turf, resulting in the potential for residues of
free triazole in grass and/or soil. Thus, dermal and incidental oral
exposures to children may occur. It is believed that residues of free
triazole occur within the plant matrices and are not available as
surface residues. Therefore, direct dermal exposure to 1,2,4-triazole
due to contact with plants is not likely to occur. However, dermal
exposure to parent fungicide and subsequent in vivo conversion to
1,2,4-triazole may occur. In order to account for this indirect
exposure to free triazole, EPA used a conversion factor of 10%, which
is the highest rate of in vivo conversion observed in rats for any of
the triazole-derivative fungicides with registrations on turf.
Incidental oral exposure may occur by direct and indirect routes. To
assess direct exposure, EPA used a conversion factor of 17%, which is
the highest rate of conversion to free triazole observed in any of the
plant metabolism studies. As with indirect dermal exposure, EPA used a
conversion factor of 10% in its assessment of indirect oral exposure.
Based on residential exposure values estimated for propiconazole
(0.0005 mg/kg/day via the dermal route and 0.03 mg/kg/day via the oral
route) and the conversion factors described in Unit III.C.4.ii.,
combined direct and indirect dermal exposures are estimated to be less
than 0.0001 mg/kg/day and combined oral exposures are estimated to be
less than 0.0019 mg/kg/day. The overall residential exposure is likely
to be less than 0.0020 mg/kg/day. Relative to the 15 mg/kg/day point of
departure, this gives an MOE of approximately 7,500 for children. Based
on the current set of uncertainty factors, the target MOE is 1,000,
indicating that the risk associated with residential exposure to 1,2,4-
triazole for children is below EPA's level of concern. The adult dermal
exposure estimate is slightly less than that of children. Incidental
oral exposure is not expected to occur with adults.
iv. Drinking water. Modeled estimates of 1,2,4-triazole residues in
surface and ground water, as reported by the USTTF, and the DWLOC
approach were used to address exposure to free triazole in drinking
water. EECs of free triazole in groundwater were obtained from the SCI-
GROW model and range from 0.0 to 0.026 ppb, with the higher
concentrations associated with uses on turf. Surface water EECs were
obtained using the FIRST model. Acute surface water EECs ranged from
0.29 to 4.64 ppb for agricultural uses and up to 32.1 ppb from use on
golf course turf. EPA notes that ground water monitoring studies in New
Jersey and California showed maximum residues of 16.7 and 0.46 ppb,
respectively, which exceed the SCI-GROW estimates significantly.
Contrariwise, preliminary monitoring data from USDA's Pesticide Data
Program for 2004 show no detectable residues of 1,2,4-triazole in any
drinking water samples, either treated or untreated (maximum limit of
detection (LOD) = 0.73 ppb, n=40 each).
v. Aggregate exposure. In estimating aggregate exposure, EPA
combined potential dietary and non-dietary sources of 1,2,4-triazole.
To account for the drinking water component of dietary exposure, EPA
used the DWLOC approach, as noted in Unit III.C.2. The DWLOC represents
a maximum concentration of a chemical in drinking water at or below
which aggregate exposure will not exceed EPA's level of concern. In
considering non-dietary exposure, EPA used the residential exposure
estimate for children and applied it to all population subgroups. As
previously noted, this estimate is considered to be highly conservative
for children. Since adults are not expected to have non-dietary oral
exposure to 1,2,4-triazole and that pathway makes up the majority of
the residential exposure estimate for children, application of that
exposure estimate to adults is considered to be extremely conservative.
Residential exposure is expected to occur for short- and/or
intermediate-term durations, and therefore is not a component in the
acute or chronic aggregate exposure assessment. In order to assess
aggregate short- and intermediate-term exposure, EPA combined the
residential exposure estimate and the chronic dietary exposure
estimate. The chronic dietary exposure estimate serves as a background
level of exposure to free triazole via food. Less than 1% of lawns in
the U.S. are expected to be treated with triazole fungicides, so the
likelihood of co-occurring dietary and residential exposures is very
low.
With the exception of the acute DWLOCs for infants and children 1-
6, all DWLOCs are greater than the largest EEC (surface water estimate
from use on turf), indicating that aggregate exposures are not likely
to exceed EPA's level of concern. Although the acute DWLOCs for infants
and children 1-6 indicate that aggregate exposure may exceed 0.015 mg/
kg/day, EPA does not believe
[[Page 47010]]
this to be the case due to the extremely conservative nature of the
overall assessment (highest-tolerance level residues, 100% crop
treated, 77% in vivo conversion factor). Furthermore, the drinking
water monitoring data from the Pesticide Data Program found no
detectable residues of either free triazole or parent triazole-
derivative fungicide in its preliminary 2004 dataset, indicating that
neither parent compounds nor 1,2,4-triazole are likely to occur in
drinking water. For all exposure durations and population subgroups,
EPA does not expect aggregate exposures to 1,2,4-triazole to exceed its
level of concern.
The Agency is planning to conduct a more sophisticated human health
assessment in early 2005 following submission and review of the ongoing
toxicology and residue chemistry studies for 1,2,4-triazole.
D. 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 database on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. The pre-natal and post-natal
toxicology database for propiconazole is complete with respect to
current FQPA-relevant toxicological data requirements. Propiconazole is
not developmentally toxic in the rabbit. There is evidence that
propiconazole is developmentally toxic in the rat. As noted in the
developmental toxicity study in rats, quantitative susceptibility was
evidenced by increased incidence of rudimentary ribs, unossified
sternebrae, as well as increased incidence of shortened and absent
renal papillae and increased cleft palate at 90 mg/kg/day, a dose lower
than that evoking maternal toxicity (severe clinical toxicity at 300
mg/kg/day). Considering the overall toxicity profile and the doses and
endpoints selected for risk assessment for propiconazole, the Agency
characterized the degree of concern for the effects observed in this
study as low, noting that there is a clear NOAEL and well-characterized
dose response for the developmental effects observed. No residual
uncertainties were identified, and no special FQPA safety factor is
needed.
Although there is no evidence of neurotoxicity, neuropathology, or
abnormalities in the development of the fetal nervous system based on
available data, neurotoxic effects (ataxia, lethargy, salivation,
rales) were noted in pregnant rats administered high doses (360 mg/kg/
day) during the gestation period. Therefore, the Agency has determined
that an acute neurotoxicity study is required, and that the need for a
developmental neurotoxicity study will be reconsidered upon review of
the acute neurotoxicity study. The Agency has determined that for acute
(single dose) and short-term exposure scenarios a 3X database
uncertainty factor is adequate to account for the lack of the acute
neurotoxicity study based on the following considerations:
It is assumed that an acute neurotoxicity study will be
conducted at dose levels similar to those used in the rat developmental
study wherein neurotoxic effects including ataxia, lethargy,
salivation, and rales were observed in pregnant rats at 360 mg/kg/day
(the highest dose tested for the first 5 days of dosing in the study).
The NOAEL for the observed neurotoxic effects was 300 mg/kg/day.
The results of the acute neurotoxicity study are not
expected to impact the current acute RfD (or endpoints selected for
short-term exposure scenarios) by more than 3X since the NOAELs used
for the these risk assessment endpoints (e.g., 90 mg/kg/day for acute
RfD for the general populations and 30 mg/kg/day for acute females 13-
50 and short-term incidental oral, dermal, and inhalation) are already
3 to 10-fold lower than the NOAEL for neurotoxic effects in the
developmental rate study conducted with propiconazole (300 mg/kg/day).
3. Conclusion. Although EPA has required that an acute
neurotoxicity study be submitted on propiconazole, EPA has concluded
that a 3X (acute) and a 1X (chronic) additional safety factor will be
sufficient to protect infants and children given the results seen in
the existing data bearing on neurotoxicity, which is discussed in Unit
III.D.2. This FQPA safety factor of 3X will be applied in the form of a
database uncertainty factor and thus used in deriving the aRfD.
As noted previously, an additional FQPA safety factor of 10X is
being used in assessing the risk of 1,2,4-triazole.
E. 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 + residential 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 groundwater are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in 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
propiconazole will occupy 2% of the aPAD for the U.S. population, 4% of
the aPAD for females 13 years and older, 4% of the aPAD for
[[Page 47011]]
all infants < 1 year old and 4% of the aPAD for children 1-2 years old.
In addition, there is potential for acute dietary exposure to
propiconazole in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in Table 2 of
this unit:
Table 2.--Aggregate Risk Assessment for Acute Exposure to Propiconazole
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. population 0.3 2 264 1.5 10,000
---------------------------------------------------------------------------
All infants (< 1 year old) 0.3 4 264 1.5 2,900
---------------------------------------------------------------------------
Children 1-2 years old 0.3 4 264 1.5 2,900
---------------------------------------------------------------------------
Females 13-49 years old 0.1 4 264 1.5 2,900
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
propiconazole from food will utilize 2% of the cPAD for the U.S.
population, 4% of the cPAD for all infants (< 1 year old) and 6% of the
cPAD for children 1-2 years old. Based the use pattern, chronic
residential exposure to residues of propiconazole is not expected. In
addition, there is potential for chronic dietary exposure to
propiconazole in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD, as shown in Table 3 of
this unit:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Propiconazole
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. population 0.1 2 80 1.5 3,400
---------------------------------------------------------------------------
All infants (< 1 year old) 0.1 4 80 1.5 960
---------------------------------------------------------------------------
Children 1-2 years old 0.1 6 80 1.5 940
----------------------------------------------------------------------------------------------------------------
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).
Propiconazole is currently registered for use 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 propiconazole. 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 2,400
for food, incidental oral and dermal exposure for infants and small
children. Only infants and small children were assessed as they
represent the worse case scenario because they have higher food
exposure plus two routes of exposure to turf residues. In addition, the
MOE's for adults exposed to turf residues are high (13,000 - lowest MOE
calculated from data from three locations. These aggregate MOEs do 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 propiconazole in ground
and surface water. After calculating DWLOCs and comparing them to the
EECs for surface 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 Propiconzole
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Infants and small children 2,400 300 264 1.5 2,600
----------------------------------------------------------------------------------------------------------------
4. Aggregate cancer risk for U.S. population. EPA classified
propiconazole as a Group C, possible human carcinogen. Risk concerns
for carcinogenicity due to long-term consumption of propiconazole
residues are adequately addressed by the aggregate chronic exposure
analysis using the chronic PAD. Therefore, EPA concludes that there is
reasonable certainty that no harm will result from aggregate exposure
to propiconazole residues.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general
[[Page 47012]]
population, and to infants and children from aggregate exposure to
propiconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (capillary gas chromotography) 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
International CODEX maximum residue limits are established for
almond, animal products, bananas, barley, coffee, eggs, grapes, mango,
meat, milk, oat, peanut-whole, peanut grains, pecans, rape, rye, stone
fruit, sugar cane, sugar beets, sugar beet tops, and wheat. The U.S.
residue definition includes both propiconazole and metabolites
determined as 2,4 dichlorobenzoic acid (DCBA), and the CODEX definition
is for propiconazole, per se, i.e. parent only. This difference results
in unique tolerance expressions with the U.S. definition resulting in
the higher tolerance levels (0.2 ppm versus CODEX 0.1 ppm for peanuts).
EPA includes the metabolites in its assessment because they also raise
hazard concerns.
C. Conditions
An acute neurotoxicity study will be required. The requirement for
a developmental neurotoxicity study will be held in reserve pending
receipt and review of the acute neurotoxicity study.
V. Conclusion
Therefore, the tolerance is established for combined residues of
propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4-
dichlorobenzoic acid and expressed as parent compound in or on corn,
field, forage at 12 ppm; corn, field, grain at 0.1 ppm; corn, field
stover at 12 ppm; corn, sweet, kernel plus cob with husks removed at
0.1 ppm; peanut at 0.2 ppm; peanut, hay at 20 ppm; pineapple at 0.1
ppm; and pineapple, fodder at 0.1 ppm.
VI. 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),
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.
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-2004-0086 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
4, 2004.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2004-0086, 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 issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any
[[Page 47013]]
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
petition under section 408(d) of the FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this rule does not have any ``tribal implications''
as described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VIII. 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 26, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR part 180 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 180.434 is amended as follows:
0
a. By revising the expiration date for several commodities in the table
in paragraph (a).
0
b. By removing the commodity Corn, stover in the table in paragraph
(a).
0
c. By removing the commodity Raspberry in the table in paragraph (b).
Sec. 180.434 Propiconazole; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per Expiration
Commodity million Date
------------------------------------------------------------------------
* * * * *
Corn, field, forage........................... 12 11/30/08
Corn, field, grain............................ 0.1 11/30/08
Corn, field, stover........................... 12 11/30/08
Corn, sweet, kernel plus cob with husks 0.1 11/30/08
removed......................................
* * * * *
Peanut........................................ 0.2 11/30/08
Peanut, hay................................... 20 11/30/08
* * * * *
Pineapple..................................... 0.1 11/30/08
Pineapple, fodder............................. 0.1 11/30/08
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 04-17509 Filed 8-3-04; 8:45 am]
BILLING CODE 6560-50-S