Propiconazole; Time-Limited Pesticide Tolerances
[Federal Register: April 18, 2001 (Volume 66, Number 75)]
[Rules and Regulations]
[Page 19863-19870]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ap01-12]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301115; FRL-6778-1]
RIN 2070-AB78
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, peanuts and pineapples. Syngenta Crop Protection, Inc.,
formerly known as Novartis Crop Protection, Inc., requested these
tolerances under the Federal Food, Drug, and Cosmetic Act, as amended
by the Food Quality Protection Act of 1996. The tolerances will expire
on March 30, 2004.
DATES: This regulation is effective April 18, 2001. Objections and
requests for hearings, identified by docket control number OPP-301115,
must be received by EPA on or before June 18, 2001.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301115 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Mary L. Waller, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-9354; and e-mail address:
waller.mary@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person
[[Page 19864]]
listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_00/Title_40/40cfr--00.html, a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301115. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of December 6, 2000 (65 FR 235) (FRL-6537-
7), EPA issued a notice pursuant to section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food
Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing
the filing of a pesticide petition (8F3654 and 8F3674) for tolerances
by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC
27419. This notice included a summary of the petition prepared by
Syngenta Crop Protection, Inc., the registrant. There were no comments
received in response to the notice of filing.
The petitions 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, in or on corn, field,
stover at 12 parts per million (ppm); corn, field, forage at 12 ppm;
corn, field, grain at 0.1 ppm; corn, sweet, kernel plus cob with husks
removed at 0.1 ppm; pineapple at 0.1 ppm; pineapple, fodder at 0.1 ppm
(8F3674); peanut at 0.2 ppm; and peanut, hay at 20 ppm (8F3654). These
proposed tolerances will expire on March 30, 2004 and will replace
previously established tolerances which expired on December 31, 2000.
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) 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)
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 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), 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), for 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 on corn, field, stover at 12 parts per
million (ppm); corn, field, forage at 12 ppm; corn, field, grain at 0.1
ppm; corn, sweet, kernel plus cob with husks removed at 0.1 ppm;
pineapple at 0.1 ppm; pineapple, fodder at 0.1 ppm; peanut at 0.2 ppm;
and peanut, hay at 20 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance 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 the following section.
1. Acute toxicity data were as follows: acute oral LD50
= 1,517 mg/kg (toxicity category III); acute dermal LD50 >
4,000 mg/kg (toxicity category III); acute inhalation LC50
1.26 mg/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 no observed
adverse effects level (NOAEL) was 30 mg/kg/day. Evidence of
developmental toxicity observed at 90 mg/kg/day, the lowest observed
adverse effect level (LOAEL) included increased incidence of unossified
sternebrae, rudimentary ribs, and shortened or absent renal papillae.
The maternal NOAEL was 30 mg/kg/day and the maternal LOAEL was 90 mg/
kg/day based on reduced body weight gain and occurrence of rales in 1/
24 females.
3. A developmental 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
[[Page 19865]]
increase in the number of resorptions at the higher dose levels. The
developmental NOAEL was 400 mg/kg/day.
5. A two-generation reproduction study with rats fed diets
containing 0, 1, 100, 500 or 2,500 ppm showed no reproductive effects
under the conditions of the study. The developmental NOAEL was 500 ppm
(equivalent to 25 mg/kg/day), and the developmental LOAEL was 2,500 ppm
(equivalent to 125 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 5 mg/kg/day) and
the parental LOAEL was 500 ppm (equivalent to 25 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 100
ppm (equivalent to 5 mg/kg/day) based on hepatocyte changes in males at
the 500 ppm level and in both sexes at the 2,500 ppm level. 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 15 mg/kg/day) based on decreased body weight, and
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 375 mg/
kg/day).
9. A battery of mutagenicity studies to determine the potential of
propiconazole to induce gene mutation, chromosomal aberrations, and
other genotoxic effects were all negative.
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 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 Safety Factor.
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 as 1 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 is discussed below.
1. Acute toxicity. The acute RfD is 0.3 mg/kg/day based on the
NOAEL of 30 mg/kg/day from a developmental toxicity study in rats and
using an UF of 100.
2. Short- and intermediate-term toxicity. For short- and
intermediate-term dermal margin of exposure (MOE) calculations, the
developmental NOAEL of 30 mg/kg/day from a developmental toxicity study
in rats was selected. For short- and intermediate-term inhalation MOE
calculations, the NOAEL of 92.8 mg/kg/day (0.5 mg/L), the highest dose
tested, from a 5-day inhalation toxicity study was selected. The level
of concern is 100.
3. Chronic toxicity. EPA has established the RfD for propiconazole
at 0.013 mg/kg/day. This RfD is based on a 1-year feeding study in dogs
with a NOAEL of 1.25 mg/kg/day and an UF of 100. The LOAEL of 6.25 mg/
kg/day was based on mild irritation of the gastric mucosa.
4. Carcinogenicity. Propiconazole has been classified as a Group
C, ``possible human carcinogen,'' chemical. The RfD approach for
quantification of human risk was used. Since the RfD approach used the
same endpoint to assess chronic toxicity, the chronic risk assessment
addresses both the cancer risk as well as chronic effects.
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, 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 a
variety of raw agricultural commodities. Among these tolerances are
stone fruits, various grain crops, grass, bananas, celery, mushrooms
and pecans. Tolerances have also been established for meat, milk,
poultry and eggs. 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 Risk Exposure System was used for
calculating acute dietary exposure. This analysis evaluated the
individual food consumption as reported by respondents in the USDA
1977-1978 Nationwide Food Consumption Survey (NFCS) and accumulated
exposure to the chemical for each commodity. The following assumptions
were made for the acute exposure assessments: The acute dietary (food
only) risk assessment used the Theoretical Maximum Residue Contribution
(TMRC). Percent Crop Treated (PCT) data and anticipated residue values
were not used. This risk assessment used high-end exposure estimates
and should be viewed as a conservative risk assessment which
[[Page 19866]]
overestimates the risk. The acute dietary exposure for the only
population subgroup of concern, females 13 years and older, used 3.3%
of the acute RfD of 0.3 mg/kg/day. The acute dietary risk (food only)
does not exceed the Agency's level of concern.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Risk Exposure System was used. This analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1977-1978 NFSC and accumulated exposure to the chemical for
each commodity. The following assumptions were made for the chronic
exposure assessments: Anticipated residues and percent crop treated
data were used for various commodities.
The chronic dietary risk assessment used the RfD of 0.013 mg/kg/
day. EPA used data from the USDA NFCS, and made partial refinements to
the exposure assumptions. Tolerance level residues were used for corn,
pineapples and peanuts. Anticipated residue levels were used for the
following crops: pecans; bananas; plantains; barley; eggs; milk and
milk-by-products; poultry, beef, goat, sheep, swine and by-products;
rice, rye, wheat and by-products. Percent of crop treated estimates
were made for corn (6%), pineapple (100%) and peanuts (1%). The
existing propiconazole tolerances (published and pending, including
tolerances for emergency exemptions) resulted in exposure estimates
that are equivalent to the following percentages of the RfD: U.S.
population (48 states), 7%; non-nursing infants less than 1 year old,
20%; children 1-6 years old, 13%; children 7-12 years old, 9%; all
other subgroups, 6-9%. EPA generally has no concern for exposures below
100% of the chronic RfD (when the FQPA factor has been removed) because
this RfD represents the level at or below which daily aggregate dietary
exposure over a lifetime will not pose appreciable risks to human
health. Therefore, the chronic dietary risk (food only) does not exceed
the Agency's level of concern.
iii. Cancer. A quantitative risk assessment using a cancer endpoint
was not performed since the RfD approach was identical to the chronic
assessement. The chronic risk assessment is adequately protective for
cancer risk as well as other chronic effects.
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings: Condition 1, that the
data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of percent crop
treated (PCT) as required by section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used percent crop treated (PCT) information as follows:
Percent crop treated data was used for the following crops: corn (6%),
peanuts (1%), pecans (47%), fresh peaches (13%), barley (2%), rice
(25%), rye and wheat (1%) and corn and peanut oil (1%). It was assumed
that propiconazole was used on 100% of the pineapple crop.
The Agency believes that the three conditions previously discussed
have been met. With respect to Condition 1, PCT estimates are derived
from Federal and private market survey data, which are reliable and
have a valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation.
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 Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW (Screening concentration in ground water), which predicts
pesticide concentrations in groundwater. In general, EPA will use
GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a
screening-level assessment for surface water. The GENEEC model is a
subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. GENEEC incorporates a farm pond scenario,
while PRZM/EXAMS incorporates an index reservoir environment in place
of the previous pond scenario. The PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water
[[Page 19867]]
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 below.
Based on the GENEEC and SCI-GROW models the estimated environmental
concentrations (EECs) of propiconazole for acute exposures are
estimated to be .11 parts per billion (ppb) for surface water and .0014
ppb for ground water. The EECs for chronic exposures are estimated to
be .09 ppb for surface water and .0014 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: preservative for wood. The risk
assessment was conducted using the following residential exposure
assumptions: This use does not present an acute or chronic exposure
scenario, but may constitute a short- and/or intermediate-term dermal
and inhalation exposure scenario for applicators. The Agency calculated
short- and intermediate-term dermal and inhalation margins of exposure
(MOEs) of 200 and 200,000 respectively for the wood preservative use of
propiconazole. MOEs above 100 do not exceed the Agency's level of
concern. For post application exposure, the Agency determined that
propiconazole is volatile and not readily aerosolized. Therefore, post-
application exposure from contact with treated wood is expected to be
minimal and the Agency determined that a risk assessment for post-
application exposure is not needed.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) 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 does not have, at this time, available data to determine
whether propiconazole has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
propiconazole does not appear to produce a toxic metabolite produced by
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).
D. Safety Factor for Infants and Children
1. Safety factor for infants and children--i. In general. FFDCA
section 408 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 margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans.
ii. Prenatal and postnatal sensitivity. The pre- 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 at doses that are
toxic to the parents. In the developmental toxicity study in rats, the
toxicity noted at the maternal LOAEL of 90 mg/kg/day consisted of rales
and decreased weight gain on gestation days 6-8 whereas the toxicity
noted at the developmental LOAEL of 90 mg/kg/day consisted of
statistically significant increased incidences of unossified
sternebrae, and nominally increased incidences of rudimentary ribs and
shortened or absent renal papillae.
iii. Conclusion. There is a complete toxicity database for
propiconazole and exposure data are complete or are estimated based on
data that reasonably account for potential exposures. EPA determined
that the 10X safety factor to protect infants and children should be
removed. The FQPA factor is removed because, in cases, where fetotoxic
effects occur at the maternally toxic dose levels, the effects
generally are of less concern than those occurring at non-maternally
toxic dose levels because of the influence of toxicity in the mothers
on the fetal toxicity expressed. However, where the fetal effects are
judged to be qualitatively more severe than the effects in the maternal
animals, there may be greater sensitivity in the fetus and thus of
greater concern. Here, the effects in the fetus (delayed development)
were not judged to be more severe than the effects in the maternal
animals (decreased weight gain).
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: 2L/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, EPA's Office of Pesticide Programs (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
[[Page 19868]]
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 3.3% of the aPAD for females 13 years and
older, the only population subgroup of concern. 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.
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 7% of the cPAD for the U.S.
population, 20% of the cPAD for non-nursing infants < 1 year old and
13% of the cPAD for children 1-6 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
the following Table 1:
Table 1.--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)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................ .009 7 .09 .0014 420
Non-nursing infants < 1 year................... .0026 20 .09 .0014 100
Children 1-6 years............................. .0017 13 .09 .0014 > 100
----------------------------------------------------------------------------------------------------------------
3. Short- and/or intermediate-term risk. Short- and/or
intermediate-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- and intermediate-term residential exposure and the Agency has
determined that it is appropriate to aggregate chronic food and water
and short- and intermediate-term exposures for propiconazole.
Using the exposure assumptions described in this unit for short-
and intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in an aggregate MOE of 200.
This aggregate MOE does not exceed the Agency's level of concern for
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic
exposure of 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- and intermediate-term
aggregate exposure to exceed the Agency's level of concern, as shown in
the following Table 2:
Table 2.--Aggregate Risk Assessment for Short- and Intermediate-Term Exposure to Propiconazole
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate level of Surface Ground Short-term
Population subgroup MOE (food + concern water EEC water EEC DWLOC (ppb)
residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13 years and older.................... 200 100 .09 .0014 4,500
----------------------------------------------------------------------------------------------------------------
5. Aggregate cancer risk for U.S. population. EPA classified
propiconazole as a Group C, possible human carcinogen and determined
that the RfD approach be used to estimate the carcinogenic risk to
humans. Risk concerns for carcinogenicity due to long-term consumption
of propiconazole residues are adequately addressed by the aggregate
chronic exposure analysis using the chronic RfD.
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.
IV. 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: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.
B. International Residue Limits
International CODEX values 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 (0.1 ppm for peanuts) with the U.S.
definition resulting in the higher tolerance levels (0.2 ppm for
peanuts). EPA includes the metabolite in its assessment because it also
raises hazard concerns.
C. Conditions
Soybeans may be planted as a double crop following a cereal crop
which has been treated with propiconazole. Crops
[[Page 19869]]
intended for food, grazing, or any component of animal feed or bedding
may not be rotated within 105 days of propiconazole application unless
the crop appears on the product label.
V. Conclusion
Therefore, tolerances are 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, stover at 12 ppm; corn, field, forage at 12 ppm; corn, field,
grain at 0.1 ppm; corn, sweet, kernel plus cob with husks removed at
0.1 ppm; pineapple at 0.1 ppm; pineapple, fodder at 0.1 ppm; peanut at
0.2 ppm; and peanut, hay at 20 ppm. These tolerances will expire on
March 30, 2004 and will replace previously established tolerances which
expired on December 31, 2000. These tolerances are time-limited because
the Agency requested a modified carcinogenicity study in mice conducted
at a mid-dose level to confirm or supplement findings in an Agency
reviewed carcinogenicity study in mice conducted at low and high dose
levels. Although the Agency has completed the review of the mid-dose
level carcinogenicity study, the Agency has not yet reevaluated the
data as a whole and the cancer classification.
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 of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) 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 FFDCA sections 408 and 409.
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 control number OPP-301115 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 June 18,
2001.
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 (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. 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) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. 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 Unit I.B.2. Mail your
copies, identified by docket control number OPP-301115, 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.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
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). This final rule does not contain
any information collections subject to OMB approval under the
[[Page 19870]]
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 by
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 other
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4).
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. Submission to Congress and the Comptroller General
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: April 2, 2001.
James Jones,
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), 346(a) and 371.
2. Section 180.434 is amended by revising the section heading, and
in the table to paragraph (a) by removing the entries for corn, forage;
and corn, grain; by adding an entry for corn, field, stover; corn,
field, forage; corn, field, grain; and by revising the entries for
corn, sweet, kernel plus cob with husks removed; peanuts; peanuts, hay;
pineapple; and pineapple, fodder, to read as follows:
Sec. 180.434 Propiconazole; tolerances for residues.
(a) General. * * *
------------------------------------------------------------------------
Parts per Expiration
Commodity million Date
------------------------------------------------------------------------
* * * * *
Corn, field, forage............................. 12 3/30/04
Corn, field, grain.............................. 0.1 3/30/04
Corn, field, stover............................. 12 3/30/04
Corn, sweet (kernel plus cob with husks removed) 0.1 3/30/04
* * * * *
Peanut.......................................... 0.2 3/30/04
Peanut, hay..................................... 20 3/30/04
* * * * *
Pineapple....................................... 0.1 3/30/04
Pineapple, fodder............................... 0.1 3/30/04
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 01-9366 Filed 4-17-01; 8:45 am]
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