Propiconazole; Pesticide Tolerances for Emergency Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: July 27, 2005 (Volume 70, Number 143)]
[Rules and Regulations]
[Page 43284-43292]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jy05-8]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0196; FRL-7727-1]

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 in or on
soybean, soybean forage, and soybean hay. This action is in response to
EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing
use of the pesticide on soybeans. This regulation establishes maximum
permissible levels for residues of propiconazole in these food commodities.
The tolerances will expire and are revoked on December 31, 2009.

DATES: This regulation is effective July 27, 2005. Objections and
requests for hearings must be received on or before September 26, 2005.

ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2005-0196. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S.
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:(703) 308-9367; e-mail address: Sec-18-Mailbox@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

In addition to using EDOCKET (http://www.regulations.gov/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance 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-

[[Page 43285]]

dichlorobenzoic acid and expressed as parent, in or on soybean at 2.0
parts per million (ppm); soybean, forage at 10 ppm; and soybean, hay at
25 ppm. These tolerances will expire and are revoked on December 31,
2009. EPA will publish a document in the Federal Register to remove the
revoked tolerances from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.

III. Emergency Exemption for Propiconazole on Soybeans and FFDCA
Tolerances

The States of Minnesota and South Dakota, as lead state agencies in
what is essentially a national section 18 request for all soybean
growing states, have petitioned the Agency requesting an Emergency
Exemption for propiconazole to control soybean rust under Section 18 of
the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). On
November 10, 2004, U.S. Department of Agriculture's Animal and Plant
Health Inspection Service (USDA/APHIS) confirmed the presence of
Phakopsora pachyrhizi, the pathogen that causes soybean rust, on
soybean leaf samples taken from two plots associated with a Louisiana
State University research farm. Soybean rust has been designated as a
biosecurity threat and therefore it is important that control measures
be available for the disease. EPA has authorized under FIFRA section 18
the use of propiconazole on soybeans for control of soybean rust in
Minnesota, South Dakota, and all the other states that have requested
an exemption for this use. After having reviewed the submission, EPA
concurs that emergency conditions exist for these States.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of propiconazole in or on
soybean, soybean forage, and soybean hay. In doing so, EPA considered
the safety standard in section 408(b)(2) of the FFDCA, and EPA decided
that the necessary tolerances under section 408(l)(6) of the FFDCA
would be consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment as provided in
section 408(l)(6) of the FFDCA. Although these tolerances will expire
and are revoked on December 31, 2009, under section 408(l)(5) of the
FFDCA, residues of the pesticide not in excess of the amounts specified
in the tolerances remaining in or on soybean, soybean forage, and
soybean hay after that date will not be unlawful, provided the
pesticide is applied in a manner that was lawful under FIFRA, and the
residues do not exceed a level that were authorized by these tolerances
at the time of that application. EPA will take action to revoke these
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether propiconazole
meets EPA's registration requirements for use on soybeans or whether
permanent tolerances for this use would be appropriate. Under these
circumstances, EPA does not believe that these tolerances serve as a
basis for registration of propiconazole by a State for special local
needs under FIFRA section 24(c). Nor do these tolerances serve as the
basis for any States other than those which have been granted
exemptions as part of the soybean rust section 18 to use this pesticide
on this crop under section 18 of FIFRA without following all provisions
of EPA's regulations implementing FIFRA section 18 as identified in 40
CFR part 166. For additional information regarding the emergency
exemption for propiconazole, contact the Agency's Registration Division
at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
Consistent with section 408(b)(2)(D) of the FFDCA , EPA has
reviewed the available scientific data and other relevant information
in support of this action. EPA has sufficient data to assess the
hazards of propiconazole and to make a determination on aggregate
exposure, consistent with section 408(b)(2) of the FFDCA, for a time-
limited tolerance 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 in or on soybean at 2.0 ppm; soybean forage at 10
ppm; and soybean hay at 25 ppm.

A. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at

[[Page 43286]]

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 intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x10-\6\ or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOE_cancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for propiconazole used for human risk assessment is shown in
the following Table 1:

Table 1.--Summary of Toxicological Dose and Endpoints for Propiconazole for Use in Human Risk Assessment
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Dose Used in Risk FQPA SF* and Level of
Exposure Scenario Assessment, UF Concern for Risk Assessment Study and Toxicological Effects
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Acute Dietary (Females 13-50) NOAEL = 30 mg/kg/day FQPA SF = 1X Developmental Toxicity Study - Rats.
UF =300 aPAD =acute RfD LOAEL = 90 mg/kg/day based on developmental
Acute RfD = 0.1 mg/kg/day = 0.1 mg/kg/day 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 FQPA SF = 1X Developmental Toxicity Study - Rats.
UF =300 aPAD =acute RfD LOAEL = 300 mg/kg/day based on developmental
Acute RfD = 0.3 mg/kg/day = 0.3 mg/kg/day toxicity manifested by 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 FQPA SF = 1X 24 Month Oncogenicity Study - Mice.
UF = 100 cPAD =chronic RfD LOAEL = 50 mg/kg/day based on liver toxicity
Chronic RfD = 0.1 mg/kg/day = 0.1 mg/kg/day (increased liver weight in males and increase
in liver lesions (masses/raised areas/
swellings/nodular areas mainly)
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Short Term (1-30 days) Incidental Oral Maternal NOAEL = 90 mg ai/kg/ Residential MOE =300 Developmental Toxicity Study - Rats.
day LOAEL = 360 mg/kg/day based on severe
clinical signs
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Short Term (1-30 days) Dermal (Females 13-50 Oral Developmental NOAEL = Residential MOE = 300 Developmental Toxicity Study - Rats.
years old) 30 mg ai/kg/dayDermal LOAEL = 90 mg/kg/day based on developmental
absorption rate1 = 1% toxicity: increased incidence of rudimentary
ribs, unossified sternebrae, and shortened
and absent renal papillae.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 43287]]

Short Term (1-30 days) Dermal (General Oral Maternal NOAEL = 90 mg Residential MOE = 300 Developmental Toxicity Study - Rats.
Populations, including infants and children) ai/kg/dayDermal absorption LOAEL = 300 mg/kg/day based on severe
rate1 = 1%) maternal clin-ical toxicity (ataxia, coma,
lethargy, prostration, audible and labored
respiration, salivation and lacrimation)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Short Term (1-30 Days) Inhalation Oral Developmental NOAEL = Residential MOE = 300 Developmental Toxicity Study - Rats.
30 mg/kg/day(Inhalation LOAEL = 90 mg/kg/day based on developmental
absorption rate = 100%) toxicity manifested by increased incidence of
rudimentary ribs, unossified sternebrae, as
well as increased incidence of shortened and
absent renal papillae.
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Cancer Group C - possible human carcinogen, non-quantifiable
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B. Exposure Assessment

1. Dietary exposure from food and drinking water. Tolerances are
established for residues of propiconazole and its metabolites
determined as 2,4-dichlorobenzoic acid and expressed as parent compound
in/on various plant and animal commodities. The established permanent
tolerances for plant and animal commodities range from 0.05 ppm (milk)
to 40 ppm (grass hay). Time-limited tolerances are established for
cranberry, dry bean forage, dry bean hay, and dry beans. In addition,
time-limited tolerances are established for aspirated grain fractions
(20 ppm), sorghum grain, and stover. Tolerances with regional
registration are also established for mint at 0.3 ppm and wild rice at
0.5 ppm. No tolerances are established for rotational crops.
In conducting the acute and chronic dietary risk assessments, EPA
used the Dietary Exposure Evaluation Model (DEEM\T\) software. Modeled
estimates of drinking water concentrations were directly entered into
the exposure model to assess the contribution from drinking water. 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 software with
the Food Commodity Intake Database (DEEM-FCID\TM\) 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 acute exposure
assessments: A Tier I assessment was conducted using tolerance-level
residues, 100% crop treated (CT) information for all commodities, and
default processing factors from DEEM were used for processed
commodities when available. EPA estimated exposure based on the 95th
percentile value in this Tier I assessment. Aggregate acute food and
water exposure was determined by including modeled estimates of
drinking water concentrations in the dietary model. The Agency used the
acute water concentration (264 ppb) derived from surface water modeling
results, which was significantly higher than the modeled ground water
concentration, and therefore protective of potential exposures via
ground water sources of drinking water.
ii. Chronic exposure. The chronic dietary exposure assessment also
used tolerance level residues and the chronic analysis module of the
DEEM-FCID\TM\ software. As with the acute assessment, default DEEM
processing factors were used, and no adjustments were made for percent
crop treated. Aggregate chronic food and water exposure was determined
by including modeled estimates of drinking water concentrations in the
dietary model. The Agency used the chronic water concentration (80 ppb)
derived from surface water modeling results, which was significantly
higher than the modeled ground water concentration, and therefore
protective of potential exposures via ground water sources of drinking
water.
iii. Cancer. Propiconazole has been classified as a Group C
possible human carcinogen, non-quantifiable. Consequently, the standard
chronic dietary exposure analysis (as discussed above) and risk
assessment using the cPAD serves as the assessment for cancer.
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 generally 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

[[Page 43288]]

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.
Based on the FIRST and SCI-GROW models the estimated environmental
concentrations (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 a fungicide that can be used to control turfgrass
diseases on residential lawns, sod farms and golf courses. There is
potential, therefore, for dermal exposures to propiconazole residues on
treated turf. The short-term aggregate risk assessment takes into
account average exposure estimates from dietary consumption of
propiconazole (food and drinking water) and non-occupational exposures
(turf). Postapplication exposures from the use on turf is considered
short-term. Therefore, a short-term aggregate risk assessment was
conducted, using children with combined dermal and oral exposures from
the turf use as a worst case.
The assessment is considered conservative because it assumes
reentry immediately after the application of propiconazole at the
highest recommended rate of 1.79 pounds ai per acre and that it was
estimated that all of the propiconazole available for the consumer
market is applied to lawns. Therefore, aggregate exposure is considered
to be an overestimate of potential exposure and risk.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and`` other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to 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 policy
statements released by EPA's Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative/.
However, the Agency does have concern about potential toxicity to
1,2,4-triazole and two conjugates, triazolylalanine and triazolyl
acetic acid, metabolites common to most of the triazole fungicides. To
support the extension of existing parent triazole-derivative fungicide
tolerances, EPA conducted an interim human health assessment for
aggregate exposure to 1,2,4-triazole. The exposure and risk estimates
presented in this assessment are overestimates of actual likely
exposures and therefore, should be considered to be highly
conservative. Based on this assessment EPA concluded that for all
exposure durations and population subgroups, aggregate exposures to
1,2,4-triazole are not expected to exceed EPA's level of concern. This
assessment is presented in the final rule published in the Federal
Register on April 22, 2005 (70 FR 20821) (FRL-7702-4) for another
triazole fungicide, tetraconazole. This assessment should be considered
interim due to the ongoing series of studies being conducted by the
U.S. Triazole Task Force (USTTF). Those studies are designed to provide
the Agency with more complete toxicological and residue information for
free triazole. Upon completion of the review of these data, EPA will
prepare a more sophisticated assessment based on the revised
toxicological and exposure databases.

C. Safety Factor for Infants and Children

1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Prenatal and postnatal 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:
i. 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

[[Page 43289]]

NOAEL for the observed neurotoxic effects was 300 mg/kg/day.
ii. 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. This FQPA safety factor of
3X will be applied in the form of a database uncertainty factor and
thus used in deriving the aRfD.

D. Aggregate Risks and Determination of Safety

The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against estimated environmental concentrations
(EECs). The DWLOC values are not regulatory standards for drinking
water, but 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 propiconazole 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 propiconazole on drinking water as a part of the aggregate risk
assessment process.
More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface and ground water EECs are
directly incorporated into the dietary exposure analysis, along with
food. This provides a more realistic estimate of exposure because
actual body weights and water consumption from the CSFII are used. The
combined food and water exposures are then added to estimated exposure
from residential sources to calculate aggregate risks. Combining
screening level estimates of pesticide residues in drinking water from
drinking water models with what may be more realistic values for
residues in food is not ideal. Once screening level values are combined
with more realistic values it is easy to lose sight of the fact that
aggregate exposure estimate is based on a mixture of very conservative
and less conservative estimates. Nonetheless, this concern with mixing
screening level and more realistic values is outweighed by the
advantages of being able to incorporate information on actual body
weights and water consumption into the aggregate exposure calculation.
This risk assessment for propiconazole was conducted using this approach.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to propiconazole will occupy 7% of the aPAD for the U.S. population,
16% of the aPAD for females 13 years and older, 20% of the aPAD for all
infants (< 1 year old) and 11% of the aPAD for children 1-2 years old.
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
------------------------------------------------------------------------
% aPAD (food +
Population Subgroup aPAD (mg/kg) water)
------------------------------------------------------------------------
General U.S. Population 0.3 7%
------------------------------------------------------------------------
All Infants (< 1 year old) 0.3 20%
------------------------------------------------------------------------
Children 1-2 years old 0.3 11%
------------------------------------------------------------------------
Children 3-5 years old 0.3 10%
------------------------------------------------------------------------
Children 6-12 years old 0.3 7%
------------------------------------------------------------------------
Youth 13-19 years old 0.3 5%
------------------------------------------------------------------------
Adults 20-49 years old 0.3 5%
------------------------------------------------------------------------
Adults 50+ years old 0.3 5%
------------------------------------------------------------------------
Females 13-49 years old 0.1 16%
------------------------------------------------------------------------

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
propiconazole from food and water will utilize 5% of the cPAD for the
general U.S. population, and 12% of the cPAD for all infants < 1 year
old (the most highly exposed subgroup). Based on the use pattern,
chronic residential exposure to residues of propiconazole is not
expected. 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
------------------------------------------------------------------------
Population Subgroup cPAD (mg/kg/day) % cPAD
------------------------------------------------------------------------
General U.S. Population 0.1 5%
------------------------------------------------------------------------
All Infants (< 1 year old) 0.1 12%
------------------------------------------------------------------------
Children 1-2 years old 0.1 11%
------------------------------------------------------------------------
Children 3-5 years old 0.1 9%
------------------------------------------------------------------------

[[Page 43290]]

Children 6-12 years old 0.1 6%
------------------------------------------------------------------------
Youth 13-19 years old 0.1 4%
------------------------------------------------------------------------
Adults 20-49 years old 0.1 4%
------------------------------------------------------------------------
Adults 50+ years old 0.1 4%
------------------------------------------------------------------------
Females 13-49 years old 0.1 4%
------------------------------------------------------------------------

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(s) that could result
in short-term residential exposure and the Agency has determined that
it is appropriate to aggregate chronic food and water and short-term
exposures for propiconazole.
The short-term aggregate risk assessment takes into account average
exposures estimates from dietary consumption of propiconazole (food and
drinking water) and non-occupational uses (turf). Postapplication
exposures from the use on turf is considered short-term. Therefore, a
short-term aggregate risk assessment was conducted, using children with
combined dermal and oral exposures from the turf use as a worst case.
The MOE from food, water, and non-occupational uses is 2,000.
Therefore, short-term aggregate risk does not exceed the Agency's level
of concern.

Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Propiconazole
----------------------------------------------------------------------------------------------------------------
Average
Max Food + Residential
Population Group NOAEL mg/kg/ Exposure\1\ Water Exposure\2>\ Aggregate
day mg/kg/day Exposure mg/ mg/kg/day MOE\3\
kg/day
----------------------------------------------------------------------------------------------------------------
All Infants 90 0.3 0.011512 0.033 2,000
----------------------------------------------------------------------------------------------------------------
\1\Maximum Exposure (mg/kg/day) = NOAEL/Target MOE of 300
\2\Residential Exposure = Combined dermal and incidental oral ingestion for infants. Only infants were assessed
since the represent a worst case with their higher food exposure plus incidental oral exposure to treated
turf.
\3\Aggregate MOE = [NOAEL / (Avg Food Exposure + Residential Exposure)]

4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure level).
There are currently no intermediate-term exposure scenarios for the
use of propiconazole, therefore, quantification of intermediate-term
risk is not required.
5. Aggregate cancer risk for U.S. population. Propiconazole has
been classified as a Group C possible human carcinogen, non-
quantifiable. Consequently, the standard chronic dietary exposure
analysis and risk assessment using the cPAD serves as the assessment
for cancer. Since carcinogenic risk for propiconazole is addressed with
the cPAD, cancer risk from the proposed use on soybeans is not expected
to be of concern.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to propiconazole residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (example--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

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

VI. Conclusion

Therefore, the tolerances are established for 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 in or on soybean at 2.0
ppm; soybean forage at 10 ppm; and soybean hay at 25 ppm.

VII. Objections and Hearing Requests

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

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,

[[Page 43291]]

you must identify docket ID number -OPP-2005-0196 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
September 26, 2005.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issue(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2.Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by the docket ID number -OPP-2005-0196, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

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

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issue(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VIII. Statutory and Executive Order Reviews

This final rule establishes time-limited tolerances under section
408 of the FFDCA. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under section 408 of the FFDCA, such as the
tolerances in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers, and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (59 FR 22951, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.

[[Page 43292]]

Thus, Executive Order 13175 does not apply to this rule.

IX. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: July 15, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

? Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

? 1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

? 2. Section 180.434 is amended by alphabetically adding commodities to
the table in paragraph (b) to read as follows:

Sec. 180.434 Propiconazole; tolerances for residues.

* * * * *
(b)* * *

------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
* * * * * * *
Soybean......................... 2.0............... December 31, 2009
Soybean, forage................. 10.0.............. December 31, 2009
Soybean, hay.................... 25................ December 31, 2009
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-14599 Filed 7-26-05; 8:45 am]
BILLING CODE 6560-50-S

Notices For
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
1995
1994

Propiconazole; Pesticide Tolerances for Emergency Exemptions

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