[Federal Register Volume 62, Number 114 (Friday, June 13, 1997)]
[Rules and Regulations]
[Pages 32224-32230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15373]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300494; FRL-5718-8]
RIN 2070-AB78
Propiconazole; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
combined residues of the pesticide propiconazole in on or the raw
agricultural commodities dry beans, dry bean forage and dry bean hay in
connection with EPA's granting of emergency exemptions under section 18
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing
use of propiconazole on dry beans in Minnesota, North Dakota, Nebraska,
Colorado and Kansas. These tolerances will expire and are revoked on
December 31, 1998.
DATES: This regulation becomes effective June 13, 1997. Objections and
requests for hearings must be received by EPA on or before August 12,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300494], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the
document control number, [OPP-300494], must also be submitted to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring a copy of objections and hearing requests to Rm. 1132,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA. A copy of objections
and hearing requests filed with the Hearing Clerk may also be submitted
electronically by sending electronic mail (e-mail) to: docket@epamail.epa.gov. Such copies of objections and hearing requests
must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Copies of objections and hearing
requests will also be accepted on disks in WordPerfect 5.1 file format
or ASCII file format. All copies of objections and hearing requests in
electronic form must be identified by the docket control number [OPP-
300494]. No Confidential Business Information (CBI) should be submitted
through e-mail. Electronic copies of objections and hearing requests on
this rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Olga Odiott, Registration
Division (7505W), Environmental Protection Agency, 401 M St., SW.,
Washington, D.C. 20460. Office location, telephone number, and e-mail:
Sixth Floor, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington,
VA 22202. (703) 308-9363, e-mail: odiott.olga@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for
the combined residues of the pesticide 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
(DCBA) and expressed as parent compound, in or on dry beans at 0.5 part
per million (ppm), in or on dry bean forage at 8.0 ppm, and in or on
dry bean hay at 8.0 ppm. These tolerances will expire and be revoked by
EPA on December 31, 1998. After December 31, 1998, EPA will publish a
document in the Federal Register to remove the revoked tolerance from
the Code of Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. Among other things, FQPA amends FFDCA to bring all EPA pesticide
tolerance-setting activities under section 408 with a new safety
standard and new procedures. These activities are described below and
discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
New 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....''
Section 18 of 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 FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166. 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
[[Page 32225]]
providing notice or a period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerance to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemptions for Propiconazole on Dry Beans and FFDCA
Tolerances
The Applicants stated that Uromyces appendiculatus, the causal
organism of the bean rust, has the potential to erupt in epidemic
proportions. Due to the heavy precipitations during the winter in the
Midwest and high rust buildup during previous years, the ideal
environmental conditions are present for rapid development of the
disease. The pathogen is capable of mutating and although resistance
has been traditionally bred into bean varieties, the available
cultivars are susceptible to the new races of the rust. The registered
pesticides are protectant fungicides and must be applied before
infection occurs. When disease pressure is high, effective control is
difficult to attain with these pesticides unless all the growers in the
region begin a calendar base spray program. Propiconazole is a curative
fungicide and because of its post-infection activity allows an
integrated pest management approach with applications made only at the
first signs of infection. Propiconazole is also an antisporulant and
thereby can reduce inoculum production. EPA has authorized under FIFRA
section 18 the use of propiconazole on dry beans for control of rust
(Uromyces appendiculatus). After having reviewed their submissions, EPA
concurs that emergency conditions exist for these states.
As part of its assessment of these emergency exemptions, EPA
assessed the potential risks presented by residues of propiconazole in
or on dry beans. In doing so, EPA considered the new safety standard in
FFDCA section 408(b)(2), and EPA decided that the necessary tolerance
under FFDCA section 408(l)(6) would be consistent with the new safety
standard and with FIFRA section 18. These tolerances will permit the
marketing of dry beans treated in accordance with the provisions of the
section 18 emergency exemption. 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 under section 408(e), as provided in section
408(l)(6). Although these tolerances will expire and are revoked on
December 31, 1998, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerances
remaining in or on dry beans, dry bean forage, and dry bean hay after
that date will not be unlawful, provided the pesticide is applied
during the term of, and in accordance with all the conditions of,
section 18 of FIFRA. 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.
EPA has not made any decisions about whether propiconazole meets
EPA's registration requirements for use on dry beans or whether
permanent tolerances for this use would be appropriate. These
tolerances do not 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 State other than Minnesota, North
Dakota, Nebraska, Colorado, and Kansas to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
section 18 as identified in 40 CFR part 166. For additional information
regarding the emergency exemptions for propiconazole, contact the
Agency's Registration Division at the address provided above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. For many
of these studies, a dose response relationship can be determined, which
provides a dose that causes adverse effects (threshold effects) and
doses causing no observed effects (the ``no-observed effect level'' or
``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100% or less of the RfD) is
generally considered acceptable by EPA. EPA generally uses the RfD to
evaluate the chronic risks posed by pesticide exposure. For shorter
term risks, EPA calculates a margin of exposure (MOE) by dividing the
estimated human exposure into the NOEL from the appropriate animal
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This
100-fold MOE is based on the same rationale as the 100-fold uncertainty
factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level.
[[Page 32226]]
The Theoretical Maximum Residue Contribution (TMRC) is an estimate of
the level of residues consumed daily if each food item contained
pesticide residues equal to the tolerance. The TMRC is a ``worst case''
estimate since it is based on the assumptions that food contains
pesticide residues at the tolerance level and that 100% of the crop is
treated by pesticides that have established tolerances. If the TMRC
exceeds the RfD or poses a lifetime cancer risk that is greater than
approximately one in a million, EPA attempts to derive a more accurate
exposure estimate for the pesticide by evaluating additional types of
information (anticipated residue data and/or percent of crop treated
data) which show, generally, that pesticide residues in most foods when
they are eaten are well below established tolerances.
Percent of crop treated estimates are derived from federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues.
IV. 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.
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 below.
1. Acute toxicity. Based on the available acute toxicity data, the
Office of Pesticide Programs (OPP) has determined that the NOEL of 30
mg/kg/day from a developmental toxicity study in rats should be used to
assess risks from acute toxicity. The developmental lowest effect level
(LEL) of 90 mg/kg/day was based on the increased incidence of
unossified sternebrae, rudimentary ribs, and shortened or absent renal
papillae. This risk assessment evaluates acute dietary risk to females
13+ years.
2. Short- and intermediate-term toxicity. Based on the available
data, OPP has determined that a NOEL of 30 mg/kg/day from a
developmental toxicity study in rats should be used to assess risks
from short- and intermediate-term dermal toxicity. At the developmental
LEL of 90 mg/kg/day, there were increased incidences of unossified
sternebrae, rudimentary ribs, and shortened or absent renal papillae.
For short- and intermediate-term inhalation toxicity, OPP has
determined that a NOEL of 92.8 mg/kg/day (0.5 mg/L), the highest dose
tested from a 5-day inhalation toxicity study in rats should be used to
assess risks for occupational and residential exposure scenarios.
3. Chronic risk. Based on the available chronic toxicity data, OPP
has established the RfD for propiconazole at 0.013 mg/kg/day. The RfD
is based on a one-year feeding study in dogs with a NOEL of 1.25 mg/kg/
day and an uncertainty factor (UF) of 100. The LEL of 6.25 mg/kg/day
was based on mild irritation of the gastric mucosa.
4. Cancer risk. Using its Guidelines for Carcinogen Risk Assessment
published September 24, 1986 (51 FR 33992), EPA has classified
propiconazole as a Group C, ``possible human carcinogen'', chemical.
The OPP Carcinogenicity Peer Review Committee (CPRC) recommended using
the RfD approach for quantification of human risk.
B. Exposures and Risks
In examining aggregate exposure, FQPA directs EPA to consider
available information concerning exposures from the pesticide residue
in food and all other non-occupational exposures. The primary non-food
sources of exposure the Agency looks at include drinking water (whether
from groundwater or surface water), and exposure through pesticide use
in gardens, lawns, or buildings (residential and other indoor uses). In
evaluating food exposures, EPA takes into account varying consumption
patterns of major identifiable subgroups of consumers, including
infants and children.
1. 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
(DCBA) and expresed as parent compound, in or on a variety of raw
agricultural commodities at levels ranging from 0.05 ppm in milk to 60
ppm in grass (seed screenings). Risk assessments were conducted by EPA
to assess dietary exposures and risks from propiconazole as follows:
i. Acute risk. 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 acute dietary (food only) risk assessment used tolerance level
residues and 100% crop-treated information. Thus, the acute dietary
risk estimate is an over-estimate of exposure and it is considered to
be protective of any acute exposure scenario. In the best scientific
judgment of OPP, the acute dietary risk from the currently registered,
and this proposed Section 18 uses of propiconazole, do not exceed our
level of concern. For the population subgroup of concern, females 13+
years, a MOE value of 3,000 was calculated. Further refinement using
anticipated residue values and percent crop-treated data would result
in lower acute dietary risk estimates.
ii. Chronic risk. The chronic dietary risk assessment was partially
refined using anticipated residue levels and percent crop-treated
values for selected commodities. The population subgroup with the
largest percentage of the RfD occupied is non-nursing infants less than
1 year old, at 20% of the RfD. This risk estimate should be viewed as
conservative; further refinement using anticipated residue levels and
percent crop-treated values for all commodities would result in lower
dietary exposure estimates.
iii. Cancer risk. Based on the OPP Carcinogenicity Peer Review
Committee's (CPRC) recommendation that the RfD approach be used to
assess cancer risk, a quantitative cancer risk assessment was not
performed. Human health risk concerns due to long-term exposure to
propiconazole residues are adequately addressed by the aggregate
chronic exposure analysis using the RfD.
2. From drinking water. Based on available studies used in EPA's
assessment of environmental risk, propiconazole is soluble in water but
relatively immobile in most soils and fairly persistent in the
environment. No Maximum Concentration Level has been established for
residues of propiconazole in drinking water. No Health Advisory Levels
for propiconazole in drinking water have been established.
[[Page 32227]]
Because the Agency lacks sufficient water-related exposure data to
complete a comprehensive drinking water risk assessment for many
pesticides, EPA has commenced and nearly completed a process to
identify a reasonable yet conservative bounding figure for the
potential contribution of water related exposure to the aggregate risk
posed by a pesticide. In developing the bounding figure, EPA estimated
residue levels in water for a number of specific pesticides using
various data sources. The Agency then applied the estimated residue
levels, in conjunction with appropriate toxicological endpoints (RfD's
or acute dietary NOEL's) and assumptions about body weight and
consumption, to calculate, for each pesticide, the increment of
aggregate risk contributed by consumption of contaminated water. While
EPA has not yet pinpointed the appropriate bounding figure for exposure
from contaminated water, the ranges the Agency is continuing to examine
are all below the level that would cause propiconazole to exceed the
RfD if the tolerances being considered in this document were granted.
The Agency has therefore concluded that the potential exposures
associated with propiconazole in water, even at the higher levels the
Agency is considering as a conservative upper bound, would not prevent
the Agency from determining that there is a reasonable certainty of no
harm if the tolerances are granted.
3. From non-dietary exposure. Propiconazole is registered for
residential usage as a preservative for finished wood (fences, window
moldings) and for ornamental turf/lawns. Lawn care usage data available
to the Agency indicates that there is no reported usage of
propiconazole products by homeowners. Two sources reported usage by
lawn care operators and landscapers. Based on acres treated
information, between 3,850 to 6,725 households are estimated to be
potentially treated with propiconazole. This represents between 0.004%
to 0.007% of all households nationally.
i. Acute risk. EPA generally will not include residential or other
non-dietary exposure as a component of the acute exposure assessment.
Theoretically, it is also possible that a residential, or other non-
dietary, exposure could be combined with the acute total dietary
exposure from food and water. However, the Agency does not believe that
aggregating multiple exposure to large amounts of pesticide residues in
the residential environment via multiple products and routes for a one
day exposure is a reasonably probable event. It is highly unlikely
that, in one day, an individual would have multiple high-end exposures
to the same pesticide by treating their lawn and garden, treating their
house via crack and crevice application, swimming in a pool, and be
maximally exposed in the food and water consumed. Additionally, the
concept of an acute exposure as a single exposure does not allow for
including post-application exposures, in which residues decline over a
period of days after application. Therefore, the Agency believes that
residential exposures are more appropriately included in the short-term
exposure scenario discussed below.
ii. Chronic risk. Based on the nature of the outdoor and indoor
residential uses of propiconazole, the Agency has concluded that a
chronic residential exposure scenario does not exist.
iii. Short- and intermediate-term risk. Considering the nature of
the outdoor residential uses, the Agency has concluded that a short- to
intermediate-term outdoor residential exposure scenario could exist.
The contribution from indoor residential inhalation exposure resulting
from propiconazole-treated window moldings to the short- and
intermediate-term aggregate risk would be negligible, and has not been
included in this risk characterization.
In the absence of data, and until further data are provided, risks
from residential uses will be assumed to account for 10% (5% each for
outdoor and indoor residential usage) of the total allowable aggregate
short- and intermediate-term risk. OPP considers this estimate of total
aggregate short- and intermediate-term exposure as conservative and
protective of the public health. In the best scientific judgment of
OPP, the shortand intermediate-term aggregate risks from the currently
registered, and the proposed Section 18 uses of propiconazole, do not
exceed our level of concern.
C. Cumulative Exposure to Substances with 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.'' The Agency believes that ``available
information'' in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical specific data, much of which may not be presently available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
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.
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. For the population subgroup of concern, females 13+
and older (accounts for both maternal and fetal exposure), the
calculated MOE
[[Page 32228]]
value is 3,000. This MOE value does not exceed the Agency's level of
concern for acute dietary exposure. Despite the potential for exposure
to propiconazole from drinking water EPA concludes that the aggregate
acute risk from the currently registered uses of propiconazole does not
exceed the Agency's level of concern.
2. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure. For propiconazole, EPA does not have concerns for
short- and intermediate-term dietary exposure because of the very high
values calculated for the MOEs. The calculated MOE value is 34,000 for
the U.S. population. Despite the potential for exposure to
propiconazole from drinking water EPA concludes that there is a
reasonable certainty that no harm will result from aggregate exposure
to propiconazole residues.
3. Chronic risk. Using the conservative ARC exposure assumptions
described above, EPA has concluded that aggregate exposure to
propiconazole from food will utilize 7% of the RfD for the U.S.
population. EPA generally has no concern for exposures below 100% of
the RfD because the RfD represents the level at or below which daily
aggregate dietary exposure over a lifetime will not pose appreciable
risks to human health. Despite the potential for exposure to
propiconazole in drinking water and from non-dietary, non-occupational
exposure, EPA does not expect the aggregate exposure to exceed 100% of
the RfD. EPA concludes that there is a reasonable certainty that no
harm will result from aggregate exposure to propiconazole residues.
4. Cancer risk. Based on the OPP Carcinogenicity Peer Review
Committee's (CPRC) recommendation that the RfD approach be used to
assess cancer risk, a quantitative cancer risk assessment was not
performed. Human health risk concerns due to long-term exposure to
propiconazole residues are adequately addressed by the aggregate
chronic exposure analysis using the RfD.
E. Aggregate Risks and Determination of Safety for Infants and Children
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 pre-and post-natal toxicity and the
completeness of the database 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. EPA believes that reliable data support using the standard MOE
and uncertainty factor (usually 100 for combined inter- and intra-
species variability)) and not the additional tenfold MOE/uncertainty
factor when EPA has a complete data base under existing guidelines and
when the severity of the effect in infants or children or the potency
or unusual toxic properties of a compound do not raise concerns
regarding the adequacy of the standard MOE/safety factor.
In assessing the potential for additional sensitivity of infants
and children to residues of propiconazole, EPA considered data from
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. The developmental toxicity
studies are designed to evaluate adverse effects on the developing
organism resulting from pesticide exposure during prenatal development
to one or both parents. Reproduction studies provide information
relating to effects from exposure to the pesticide on the reproductive
capability of mating animals and data on systemic toxicity.
1. Developmental toxicity studies.--i. Rat. The maternal (systemic)
NOEL was 30 mg/kg/day. The maternal LEL of 90 mg/kg/day was based on
reduced body weight gain and rales in females. The developmental NOEL
was also 30 mg/kg/day. The developmental LEL of 90 mg/kg/day was based
on the increased incidence of unossified sternebrae, rudimentary ribs,
and shortened or absent renal papillae.
ii. Rabbit. The maternal (systemic) NOEL was 100 mg/kg/day. The
maternal LEL of 250 mg/kg/day was based on decreased food consumption
and body weight gain. There was also an increased incidence of abortion
at 400 mg/kg/day. The developmental NOEL was 400 mg/kg/day (HDT), based
upon the lack of developmental delays or alterations.
2. Reproductive toxicity study (rat). From the 2-generation
reproductive toxicity study in rats, the parental (systemic) LEL of 5
mg/kg/day, the lowest dose tested (LET), was based on the increased
incidence of hepatic ``clear-cell change'' at all dose levels;
additionally, at 25 and 125 mg/kg/day, decreased body weights,
decreased food consumption, and/or an increased incidence of hepatic
cellular swelling were observed. A NOEL for parental toxicity was not
determined. The reproductive/ developmental NOEL was 25 mg/kg/day. The
reproductive LEL of 125 mg/kg/day was based on decreased offspring
survival of second generation (F.) pups, on decreased body weight
throughout lactation, and on an increase in the incidence of hepatic
cellular swelling for both generations of offspring (F1 and F. pups).
3. Pre- and post-natal sensitivity. The developmental toxicity
NOELs were 30 mg/kg/day in rats and 400 mg/kg/day (HDT) in rabbits.
Developmental toxicity was observed in rats at 90 mg/kg/day; these
effects occurred in the presence of maternal toxicity. In rabbits, no
developmental delays or alterations were noted; however, increased
abortions were observed at the maternally toxic dose of 400 mg/kg/day.
The developmental NOELs are more than 24- and 320-fold higher in rats
and rabbits, respectively, than the NOEL of 1.25 mg/kg/day from the 1-
year feeding study in dogs, which is the basis of the RfD.
In the two-generation reproductive toxicity study in rats, the
reproductive (pup) toxicity NOEL of 25 mg/kg/day was greater than the
parental (systemic) toxicity NOEL (<5 mg/kg/day;="" let).="" the="" noel="" of="" 25="" mg/kg/day="" for="" reproductive="" (pup)="" toxicity="" was="" 20-fold="" higher="" than="" the="" noel="" of="" 1.25="" mg/kg/day="" from="" the="" 1-year="" feeding="" study="" in="" dogs,="" which="" is="" the="" basis="" of="" the="" rfd.="" the="" reproductive="" (pup)="" lel="" of="" 125="" mg/kg/day="" was="" based="" on="" decreased="" offspring="" survival="" of="" second="" generation="" (f.)="" pups,="" and="" on="" decreased="" body="" weight="" throughout="" lactation,="" and="" an="" increase="" in="" the="" incidence="" of="" hepatic="" cellular="" swelling="" for="" both="" generations="" of="" offspring="" (f.="" and="" f.="" pups).="" because="" these="" reproductive="" effects="" occurred="" in="" the="" presence="" of="" parental="" (systemic)="" toxicity,="" these="" data="" do="" not="" suggest="" increased="" pre-="" or="" post-natal="" sensitivity="" to="" infants="" and="" children="" (that="" infants="" and="" children="" might="" be="" more="" sensitive="" than="" adults)="" to="" propiconazole="" exposure.="" 4.="" acute="" risk.="" for="" the="" population="" subgroup="" of="" concern,="" females="" 13+="" years,="" an="" moe="" value="" of="" 3,000="" was="" calculated="" using="" the="" high="" end="" exposure="" value="" of="" 0.01="" mg/kg/day.="" tolerance="" level="" residues="" and="" 100%="" crop-treated="" information="" were="" used="" in="" conducting="" the="" analysis.="" thus,="" this="" acute="" dietary="" risk="" estimate="" is="" considered="" conservative.="" the="" large="" acute="" dietary="" moe="" calculated="" for="" females="" 13+="" years="" old="" provides="" assurance="" that="" there="" is="" a="" reasonable="" certainty="" of="" no="" harm="" from="" aggregate="" exposures="" to="" females="" 13+="" years="" and="" the="" pre-natal="" development="" of="" infants.="" 5.="" short-="" or="" intermediate-term="" risk.="" for="" the="" most="" highly="" exposed="" population="" subgroup="" (non-nursing="" infants="" less="" than="" [[page="" 32229]]="" 1="" year="" old),="" a="" short-="" and="" intermediate-term="" moe="" of="" 11,000="" was="" calculated.="" the="" large="" moe="" calculated="" for="" nonnursing="" infants="" provides="" assurance="" that="" there="" is="" a="" reasonable="" certainty="" of="" no="" harm="" for="" infants="" and="" children="" from="" short-="" and="" intermediate-term="" aggregate="" exposures="" to="" propiconazole="" residues.="" 6.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" the="" percent="" of="" the="" rfd="" that="" will="" be="" utilized="" by="" aggregate="" exposure="" to="" residues="" propiconazole="" from="" food="" ranges="" from="" 8%="" for="" nursing="" infants,="" up="" to="" 20%="" for="" non-nursing="" infants="" (the="" most="" highly="" exposed="" population="" subgroup).="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" despite="" the="" potential="" for="" exposure="" to="" propiconazole="" in="" drinking="" water="" and="" from="" non-dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" propiconazole="" residues.="" v.="" other="" considerations="" 1.="" metabolism="" in="" plants="" and="" animals.="" the="" metabolism="" of="" propiconazole="" in="" plants="" and="" animals="" is="" adequately="" understood="" for="" the="" purposes="" of="" these="" tolerance="" actions.="" the="" residues="" of="" concern="" are="" propiconazole="" (1-[[2-(2,4-dichloro-phenyl)-4-propyl-1,3-dioxolan-2-="" yl]methyl]-1h-1,2,4-triazole),="" and="" its="" metabolites="" determined="" as="" 2,4-="" dichlorobenzoic="" acid="" (dcba)="" and="" expressed="" as="" parent="" compound="" as="" per="" 40="" cfr="" 180.434.="" 2.="" analytical="" enforcement="" methodology.="" there="" are="" practical="" analytical="" methods="" for="" detecting="" and="" measuring="" levels="" of="" propiconazole="" in="" or="" on="" food="" with="" a="" limit="" of="" detection="" that="" allows="" monitoring="" of="" food="" with="" residues="" at="" or="" above="" the="" levels="" set="" in="" these="" tolerances.="" epa="" has="" provided="" information="" on="" these="" method="" to="" fda.="" these="" methods="" have="" been="" approved="" for="" publication="" in="" pam="" ii="" for="" enforcement="" purposes.="" 3.="" magnitude="" of="" residues.="" residues="" of="" propiconazole="" are="" not="" expected="" to="" exceed="" 0.5="" ppm="" in/on="" dry="" beans="" (seed),="" 8.0="" ppm="" in/on="" dry="" bean="" forage,="" and="" 8.0="" ppm="" in/on="" dry="" bean="" hay="" as="" a="" result="" of="" these="" section="" 18="" uses.="" time-limited="" tolerances="" should="" be="" established="" at="" these="" levels.="" secondary="" residues="" in="" animal="" commodities="" are="" not="" expected="" to="" exceed="" existing="" tolerances="" as="" a="" result="" of="" these="" section="" 18="" uses.="" 4.="" international="" residue="" limits.="" there="" are="" no="" codex,="" canadian,="" or="" mexican="" international="" residue="" limits="" established="" for="" use="" of="" propiconazole="" on="" dry="" beans.="" vi.="" conclusion="" therefore,="" tolerances="" in="" connection="" with="" the="" fifra="" section="" 18="" emergency="" exemptions="" are="" established="" for="" the="" combined="" residues="" of="" propiconazole="" and="" its="" metabolites="" determined="" as="" 2,4-dichlorobenzoic="" acid="" (dcba)="" and="" expressed="" as="" parent="" compound,="" in="" or="" on="" dry="" beans="" at="" 0.5="" ppm,="" in="" or="" on="" dry="" bean="" forage="" at="" 8.0="" ppm,="" and="" in="" or="" on="" dry="" bean="" hay="" at="" 8.0="" ppm.="" vii.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" section="" 408(e)="" and="" (l)(6)="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" august="" 12,="" 1997,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" (including="" the="" revocation="" provision)="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" above="" (40="" cfr="" 178.20).="" a="" copy="" of="" the="" objections="" and/or="" hearing="" requests="" filed="" with="" the="" hearing="" clerk="" should="" be="" submitted="" to="" the="" opp="" docket="" for="" this="" rulemaking.="" the="" objections="" submitted="" must="" specify="" the="" provisions="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" each="" objection="" must="" be="" accompanied="" by="" the="" fee="" prescribed="" by="" 40="" cfr="" 180.33(i).="" if="" a="" hearing="" is="" requested,="" the="" objections="" must="" include="" a="" statement="" of="" the="" factual="" issues="" on="" which="" a="" hearing="" is="" requested,="" the="" requestor's="" contentions="" on="" such="" issues,="" and="" a="" summary="" of="" any="" evidence="" relied="" upon="" by="" the="" requestor="" (40="" cfr="" 178.27).="" a="" request="" for="" a="" hearing="" will="" be="" granted="" if="" the="" administrator="" determines="" that="" the="" material="" submitted="" shows="" the="" following:="" there="" is="" 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="" in="" the="" manner="" sought="" by="" the="" requestor="" would="" be="" adequate="" to="" justify="" the="" action="" requested="" (40="" cfr="" 178.32).="" information="" submitted="" in="" connection="" with="" an="" objection="" or="" hearing="" request="" may="" be="" claimed="" confidential="" by="" marking="" any="" part="" or="" all="" of="" that="" information="" as="" confidential="" business="" information="" (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.="" viii.="" public="" docket="" a="" record="" has="" been="" established="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300494].="" a="" public="" version="" of="" this="" record,="" which="" does="" not="" include="" any="" information="" claimed="" as="" cbi,="" is="" available="" for="" inspection="" from="" 8="" a.m.="" to="" 4:30="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" public="" record="" is="" located="" in="" room="" 1132="" of="" the="" public="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" division="" (7506c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" highway,="" arlington,="" va.="" the="" official="" record="" for="" this="" rulemaking,="" as="" well="" as="" the="" public="" version,="" as="" described="" above,="" is="" kept="" in="" paper="" form.="" accordingly,="" in="" the="" event="" there="" are="" objections="" and="" hearing="" requests,="" epa="" will="" transfer="" any="" copies="" of="" objections="" and="" hearing="" requests="" received="" electronically="" into="" printed,="" paper="" form="" as="" they="" are="" received="" and="" will="" place="" the="" paper="" copies="" in="" the="" official="" rulemaking="" record.="" the="" official="" rulemaking="" record="" is="" the="" paper="" record="" maintained="" at="" the="" address="" in="" addresses="" at="" the="" beginning="" of="" this="" document.="" ix.="" regulatory="" assessment="" requirements="" under="" executive="" order="" 12866="" (58="" fr="" 51735,="" october="" 4,="" 1993),="" this="" action="" is="" not="" a="" ``significant="" regulatory="" action''="" and,="" since="" this="" action="" does="" not="" impose="" any="" information="" collection="" requirements="" as="" defined="" by="" the="" paperwork="" reduction="" act,="" 44="" u.s.c.="" 3501="" et="" seq.,="" it="" is="" not="" subject="" to="" review="" by="" the="" office="" of="" management="" and="" budget.="" in="" addition,="" this="" action="" does="" not="" impose="" any="" enforceable="" duty="" or="" contain="" any="" unfunded="" mandate="" as="" described="" in="" the="" unfunded="" mandates="" reform="" act="" of="" 1995="" (pub.="" l.="" 104-4),="" or="" require="" prior="" consultation="" with="" state="" officials="" as="" [[page="" 32230]]="" specified="" by="" executive="" order="" 12875="" (58="" fr="" 58093,="" october="" 28,="" 1993),="" or="" special="" considerations="" as="" required="" by="" executive="" order="" 12898="" (59="" fr="" 7629,="" february="" 16,="" 1994).="" because="" ffdca="" section="" 408(l)(6)="" permits="" establishment="" of="" this="" regulation="" without="" a="" notice="" of="" proposed="" rulemaking,="" the="" regulatory="" flexibility="" analysis="" requirements="" of="" the="" regulatory="" flexibility="" act,="" 5="" u.s.c.="" 604(a),="" do="" not="" apply.="" nonetheless,="" the="" agency="" has="" previously="" assessed="" whether="" establishing="" tolerances="" or="" exemptions="" from="" tolerance,="" raising="" tolerance="" levels,="" or="" expanding="" exemptions="" adversely="" impact="" small="" entities="" and="" concluded,="" as="" a="" generic="" matter,="" that="" there="" is="" no="" adverse="" impact.="" (46="" fr="" 24950,="" may="" 4,="" 1981).="" under="" 5="" u.s.c.="" 801(a)(1)(a)="" of="" the="" small="" business="" regulatory="" enforcement="" fairness="" act="" of="" 1996="" (title="" ii="" of="" pub.="" l.="" 104-121,="" 110="" stat.="" 847),="" epa="" submitted="" 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="" general="" accounting="" office="" prior="" to="" publication="" of="" the="" rule="" in="" today's="" federal="" register.="" this="" 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:="" may="" 28,="" 1997.="" james="" jones,="" acting="" 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.="" 346a="" and="" 371.="" 2.="" in="" sec.="" 180.434,="" paragraph="" (b)="" is="" amended="" by="" alphabetically="" adding="" the="" tolerances="" to="" the="" table="" to="" read="" as="" follows:="" sec.="" 180.434="" 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-="" yl]methyl]-1h-1,2,4-triazole;="" tolerances="" for="" residues.="" *="" *="" *="" *="" *="" (b)="" *="" *="" *="" ----------------------------------------------------------------------------------------------------------------="" expiration/="" revocation="" commodity="" parts="" per="" million="" date="" ----------------------------------------------------------------------------------------------------------------="" *="" *="" *="" *="" *="" *="" *="" dry="" bean="" forage...............................................="" 8.0="" december="" 31,="" 1998="" dry="" bean="" hay..................................................="" 8.0="" december="" 31,="" 1998="" dry="" beans.....................................................="" 0.5="" december="" 31,="" 1998="" *="" *="" *="" *="" *="" *="" *="" ----------------------------------------------------------------------------------------------------------------="" *="" *="" *="" *="" *="" [fr="" doc.="" 97-15373="" filed="" 6-12-97;="" 8:45="" am]="" billing="" code="" 6560-50-f="">