[Federal Register Volume 69, Number 149 (Wednesday, August 4, 2004)]
[Rules and Regulations]
[Pages 47005-47013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17509]


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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: [email protected].

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
----------------------------------------------------------------------------------------------------------------
                                                                  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
-----------------------------------------------------------------------------------------
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
-----------------------------------------------------------------------------------------
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
-----------------------------------------------------------------------------------------
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
-----------------------------------------------------------------------------------------
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
-----------------------------------------------------------------------------------------
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: [email protected].

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: [email protected]. 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