[Federal Register Volume 64, Number 12 (Wednesday, January 20, 1999)]
[Rules and Regulations]
[Pages 2995-3003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1255]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300770; FRL-6049-8]
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 propiconazole and its metabolites determined as
2,4-dichlorobenzoic acid in or on blueberries and raspberries. This
action is in response to EPA's granting of emergency exemptions under
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act
authorizing use of the pesticide on blueberries and raspberries. This
regulation establishes a maximum permissible level for residues of
propiconazole in these food commodities pursuant to section 408(l)(6)
of the Federal Food, Drug, and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996. The tolerances will expire and are
revoked on December 31, 1999.
DATES: This regulation is effective January 20, 1999. Objections and
requests for hearings must be received by EPA on or before March 22,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300770], 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 docket
control number, [OPP-300770], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), 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. 119, Crystal
Mall 2 (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: [email protected]. 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 5.1/6.1
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the docket control number [OPP-300770].
No Confidential Business Information (CBI) should be submitted through
e-mail. Copies of electronic objections and hearing requests on this
rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Stephen Schaible,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: CM #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 308-9362, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408 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
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 metabolite determined as 2,4-dichlorobenzoic acid, in or on
blueberries and raspberries at 1.0 part per million (ppm). These
tolerances will expire and are revoked on December 31, 1999. EPA will
publish a document in the Federal Register to remove the revoked
tolerances from the Code of Federal Regulations.
I. Background and Statutory Findings
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. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described in this preamble 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
[[Page 2996]]
result from the use of a pesticide under an emergency exemption granted
by EPA under section 18 of FIFRA. Such tolerances can be established
without providing notice or period for public comment.
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 Blueberries and
Raspberries and FFDCA Tolerances
Mummy berry (Monilinia vaccinii-corymbosi) is a fungal disease
which causes damage to the fruit, flower and leaf of blueberries. The
principal cause of significant yield reductions to wild blueberries is
the destruction of flowers/flower clusters in the spring by the primary
inoculum, though severe defoliation may also result in reduced berry
size. Triflorine was the preferred fungicide for controlling this
disease, but the use was voluntarily canceled by the registrant and
only a limited amount of existing stock is available. Sulfur, ziram,
neem oil, certain copper compounds, potassium salts of fatty acids, and
chlorothalonil are all alternative fungicides registered for use on
blueberries, but these are generally considered to provide unsuitable
or unknown levels of performance. The only non-chemical control measure
is the burning of fields to prune back vegetative growth; this practice
is no longer considered environmentally acceptable and has been
replaced by mowing, which does not reduce the fungal inoculum on the
mummified berries. The Agency concluded that while it was unclear
whether growers are expected to suffer ``significant'' economic losses
in 1998 from this disease, they may incur significant economic losses
in the 1999 growing season if the mummy berry disease intensifies
without adequate control.
Yellow rust of raspberry is caused by a fungal pathogen,
Phragmidium rubi-idaei. The pathogen is widespread in red raspberry
fields in Oregon and Washington States, particularly in years when
spring rains continue late. Historically, yellow rust has not been a
problem. Under normal winter weather conditions of the Pacific
Northwestern United States, teliospores of the pathogen are the sole
survivor and they do not infect raspberry plants directly;
urediniospores cause most damage to raspberry plants. However, last
winter urediniospores also overwintered due to mild winter weather
conditions. Urediniospores infected raspberry plants and disease
symptoms were seen during early spring season. Urediniospores are the
most damaging stage of yellow rust because they are normally produced
in repeating cycles during summer months, but this spring they provided
an immediate means to cause a rapid buildup of the pathogen, resulting
in damage that caused this emergency. In addition, during the 1998
spring season the climatic conditions were very conducive for the
disease development. The warm weather accompanied by rain caused the
plants to break bud about 2-3 weeks earlier than normal. The moisture
from dew and fog were sufficient to allow both spore germination and
infection. All of these conditions contributed to the current emergency
situation. EPA has authorized under FIFRA section 18 the use of
propiconazole on blueberries for control of mummy berry disease
(Monilinia vacinii-corymbosi) in Georgia, Maine and South Carolina and
the use on raspberries for control of yellow rust (Phragmidium rubi-
idaei) in Oregon and Washington. After having reviewed the 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 blueberries and raspberries. In doing so, EPA considered the new
safety standard in FFDCA section 408(b)(2), and EPA decided that the
necessary tolerances under FFDCA section 408(l)(6) would be consistent
with the new safety standard and with FIFRA section 18. Consistent with
the need to move quickly on the emergency exemption in order to address
an urgent non-routine situation and to ensure that the resulting food
is safe and lawful, EPA is issuing these tolerances without notice and
opportunity for public comment under section 408(e), as provided in
section 408(l)(6). Although these tolerances will expire and are
revoked on December 31, 1999, under FFDCA section 408(l)(5), residues
of the pesticide not in excess of the amounts specified in the
tolerances remaining in or on blueberries or raspberries after that
date will not be unlawful, provided the pesticide is applied in a
manner that was lawful under FIFRA, and the residues do not exceed a
level that was authorized by these tolerances at the time of that
application. EPA will take action to revoke these tolerances earlier if
any experience with, scientific data on, or other relevant information
on this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions EPA has not made any decisions about whether propiconazole
meets EPA's registration requirements for use on blueberries or
raspberries or whether permanent tolerances for these uses would be
appropriate. Under these circumstances, EPA does not believe that these
tolerances serve as a basis for registration of propiconazole by a
State for special local needs under FIFRA section 24(c). Nor do these
tolerances serve as the basis for any State other than Georgia, Maine,
Oregon, South Carolina and Washington to use this pesticide on these
crops 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 under the
``ADDRESSES'' section.
III. Aggregate Risk Assessment and Determination of Safety
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. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal 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 adversed effect level'' or
``NOAEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOAEL
from the study with the lowest NOAEL 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
[[Page 2997]]
(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 NOAEL 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 NOAEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute'', ``short-term'',
``intermediate term'', and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 3
sources are not typically added because of the very low probability of
this occurring in most cases, and because the other conservative
assumptions built into the assessment assure adequate protection of
public health. However, for cases in which high-end exposure can
reasonably be expected from multiple sources (e.g. frequent and
widespread homeowner use in a specific geographical area), multiple
high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOAEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
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. 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. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
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. For this
pesticide, the most highly exposed population subgroup (non-nursing
infants less than 1 year old) was not regionally based.
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, EPA has sufficient data to assess the hazards of
propiconazole and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for
[[Page 2998]]
time-limited tolerances for combined residues of propiconazole and its
metabolites determined as 2,4-dichlorobenzoic acid on blueberries and
raspberries at 1.0 ppm. EPA's assessment of the dietary exposures and
risks associated with establishing the tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by propiconazole are
discussed below.
1. Acute toxicity. For acute dietary risk assessment, EPA used the
developmental NOAEL of 30 mg/kg/day from a developmental toxicity study
in rats. The lowest observed adversed effect level (LOAEL) 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 the population of concern,
females 13 years and older.
2. Short- and intermediate-term toxicity. For short- and
intermediate-term dermal MOE calculations, EPA used the developmental
NOAEL of 30 mg/kg/day from the developmental toxicity study in rats.
For short- and intermediate-term inhalation MOE calculations, EPA used
the NOAEL of 92.8 mg/kg/day, the highest dose tested (HDT) from the 5-
day inhalation toxicity study in rats. This risk assessment evaluates
short- and intermediate-term risk to the population of concern, females
13 years and older.
3. Chronic toxicity. EPA has established the RfD for propiconazole
at 0.013 milligrams/kilogram/day (mg/kg/day). This RfD is based on a
NOAEL of 1.25 mg/kg/day taken from a one year feeding study in dogs.
The effect seen at the LOAEL of 6.25 mg/kg/day is mild irritation of
the gastric mucosa. An uncertainty factor of 100 was added to take into
account interspecies and intraspecies variation.
4. Carcinogenicity. Propiconazole has been classified as a Group C,
``possible human carcinogen'', chemical by the Agency. EPA has
determined that the RfD approach for quantitation of human risk is
appropriate. Therefore, the RfD noted above is deemed protective of all
chronic human health effects, including cancer.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.434) for the combined residues of propiconazole and its
metabolite determined as 2,4-dichlorobenzoic acid, in or on a variety
of raw agricultural commodities. Risk assessments were conducted by EPA
to assess dietary exposures and risks from propiconazole as follows:
i. Acute exposure and 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 assumed tolerance level residues and one hundred percent
crop treated. The resulting high-end exposure estimate of 0.01 mg/kg/
day, which results in a dietary (food only) MOE of 3,000 for females
13+ years old, should be viewed as conservative; refinement using
anticipated residue values and percent crop-treated data would result
in a lower acute dietary exposure estimate.
ii. Chronic exposure and risk. For the purpose of assessing chronic
dietary exposure from propiconazole, EPA assumed anticipated residues
and percent of crop treated refinements for many of the existing uses
to estimate the Anticipated Residue Contribution (ARC) from existing
and proposed uses. While more refined than TMRC exposure estimates, the
assumptions of tolerance level residues and one hundred percent of crop
treated for the proposed use and numerous existing uses still result in
overestimation of exposure. Based on the above assumptions, chronic
dietary exposure to the U.S. population represents 7% of the RfD.
Dietary exposure to the subgroup most highly exposed, non-nursing
infants less than one year, utilizes 20% of the RfD.
2. From drinking water. Available data suggest propiconazole is
moderately persistent and moderately mobile to immobile in soil and
aqueous environments. It has the potential to be transported with
water, particularly in coarse-textured soils low in organic matter.
Propiconazole's persistence indicates the potential to reach surface
water with run-off or adsorbed to soil particles. There is no
established Maximum Contaminant Level (MCL) for residues of
propiconazole in drinking water. No health advisory levels for
propiconazole in drinking water have been established.
The Agency has calculated drinking water levels of comparison
(DWLOCs) for acute and chronic exposure to propiconazole in surface and
groundwater. The DWLOCs are calculated by subtracting from the toxicity
endpoint (acute or chronic) the respective acute or chronic dietary
exposure attributable to food to obtain the acceptable exposure to
propiconazole in drinking water. Default body weights (70 kg for males,
60 kg for females, and 10 kg for non-nursing infants < 1 year old) and
default drinking water consumption estimates (2 L/day for adults, 1 L/
day for non-nursing infants) are then used to calculate the actual
DWLOCs. The DWLOC represents the concentration level in surface water
or groundwater at which aggregate exposure to the chemical is not of
concern.
Using Generic Expected Environmental Concentration (GENEEC)
(surface water) and Screening Concentration in Ground Water (SCI-GROW)
(groundwater) models, the Agency has calculated acute and chronic Tier
I Estimated Environmental Concentrations (EECs) for propiconazole for
use in human health risk assessments. These values represent the upper
bound estimates of the concentrations of propiconazole that might be
found in surface and ground water assuming the maximum application rate
allowed on the label of the highest use pattern. The EECs from these
models are compared to the DWLOCs to make the safety determination.
i. Acute exposure and risk. The subpopulation of concern for acute
risk is females 13 years and older. Using the GENEEC model, the acute
peak concentration in surface water was determined to be 110 parts per
trillion (ppt). The Tier I SCI-GROW model predicted that groundwater
concentrations of propiconazole are not likely to exceed 1.42 ppt.
Assuming an adult female body weight of 60 kg and a drinking water
consumption estimate of 2 L/day, the Agency calculated an acute DWLOC
of 8,700 parts per billion (ppb). As even the upper bound
concentrations of propiconazole are not expected to exceed 110 ppt in
surface water or 1.42 ppt in groundwater, and this value is well below
the acute DWLOC, the Agency concludes with reasonable certainty that
acute exposure to propiconazole in drinking water is not of concern.
ii. Chronic exposure and risk. Using the GENEEC model, the Agency
calculated a chronic concentration of propiconazole residues in surface
water of 90 ppt. As described above, groundwater concentrations of
propiconazole are not likely to exceed 1.42 ppt. Using the same body
weight and drinking water consumption
[[Page 2999]]
estimates as those in the acute risk assessment, the DWLOCs for chronic
exposure were calculated to be 420 ppb for the U.S. population, 430 ppb
for males 13 years and older, 360 ppb for nursing females 13 years and
older, and 100 ppb for infants and children. The estimated long-term
concentrations of propiconazole in surface water and groundwater are
well below any of these values, and the Agency concludes that chronic
exposure to propiconazole in drinking water is not of concern. Since
the RfD approach is recommended for quantification of cancer risk, the
cancer and chronic DWLOCs are identical. Therefore the Agency also
concludes that exposure is below the Agency's level of concern for
cancer effects arising from chronic exposure to propiconazole in
drinking water.
3. From non-dietary exposure. -- i. Propiconazole is currently
registered for residential use as a wood preservative and for
residential lawn and turf uses as well as on ornamental plants. Under
current OPP guidelines, these uses do not represent a chronic exposure
scenario, but may constitute a short- and/or intermediate-term exposure
scenario.
According to the acres-treated information available to the Agency
on lawn and turf use, between 0.004% and 0.007% of all households
nationally are treated with lawn products containing propiconazole as
an active ingredient. Of those households which are treated,
applications are mostly made by lawn care operators and landscapers
instead of homeowners. It is therefore the Agency's best scientific
judgement that potential residential exposure to propiconazole through
the registered lawn and turf uses and use on ornamental plants is
minimal. Based on this conclusion, risk assessments for these
residential uses were not performed.
ii. Short- and intermediate-term exposure and risk. The Agency
calculated exposure and risk from wood treatment use using recently
developed methodologies for residential exposure assessment. These
methodologies rely on high-end scenarios and the resulting exposure
assessments should be considered conservative. If initial assessments
using the assumptions in these methodologies indicate a potential
concern, a more detailed exposure assessment, possibly incorporating
chemical-specific or site-specific data, would be pursued. Because one
of the variables used for assessing residential handlers exposure comes
from the Pesticide Handlers Exposure Database (PHED), and is considered
to be a central tendency value, resulting exposure and risk estimates
are considered to be central tendency to high-end estimates. Using
these assumptions, short-term dermal and inhalation MOEs from the wood
treatment use were calculated to be 200 and 20,000, respectively. The
Agency is generally not concerned with MOEs which exceed 100.
4. 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.
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. Using TMRC exposure assumptions, the Agency
estimated the high-end exposure to females 13+ years, the population
subgroup of concern, to be 0.01 mg/kg/day , which results in a dietary
(food only) MOE of 3,000. Based on an adult female body weight of 60 kg
and 2L consumption of water per day, the acute DWLOC for females 13
years and older is 8,700 ppb. The estimated peak concentration (acute)
values of 110 ppt in surface water and 1.42 ppt in groundwater are
lower than the acute DWLOC for females 13 years and older; therefore,
the Agency concludes with reasonable certainty that the aggregate acute
exposure to propiconazole residues in food and drinking water is not
likely to exceed the Agency's level of concern for acute dietary
exposure.
2. Chronic risk. Using the 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. The major
identifiable subgroup with the highest aggregate exposure is non-
nursing infants less than one year old (discussed below). 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. Based
on body weight and drinking water consumption estimates discussed
earlier, the chronic DWLOC for the U.S. population is 424 ppb, 430 ppb
for males 13 years and older, and 360 ppb for females 13 years and
older. The estimated chronic concentrations of 90 ppt in surface water
and 1.42 ppt in groundwater are lower than these chronic DWLOCs. EPA
concludes that there is a reasonable certainty that no
[[Page 3000]]
harm will result from aggregate exposure to propiconazole residues.
3. 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.
Short- and intermediate-term endpoints were identified for females
13 years and older, the subpopulation of concern. The aggregate
exposure takes into account chronic dietary food and water (considered
to be a background exposure level) plus short- and intermediate-term
residential uses.
When endpoints from multiple studies are selected from risk
assessment, risks should only be aggregated if the endpoints (toxic
effects) are the same or if the multiple residential exposure scenarios
have a reasonable chance of occurring together. In this case the dermal
and inhalation endpoints do not have the same toxic effects. Therefore
the MOE dermal and MOE inhalation cannot be aggregated together.
Furthermore, because exposure from residential wood preservative uses
occurs mainly by the dermal route (dermal exposure = 0.15 mg/kg/day;
inhalation exposure = 0.00047 mg/kg/day), exposure via inhalation was
not considered in the calculation for risk from short- and
intermediate-term aggregate exposure.
Using the Agency's interim guidance, short- and intermediate-term
aggregate risk was calculated by considering short- and intermediate-
term dermal exposure from residential uses, and chronic dietary
exposure from food uses and drinking water. Because estimates for
chronic exposure from drinking water are not available (only
conservative estimates of environmental concentrations), the Agency
calculated a short- and intermediate-term DWLOC by estimating the
exposure level for drinking water which would result in an aggregate
MOE of 100, given the known MOEs for food uses and residential
exposure, and then deriving the DWLOC from this exposure value using
the consumption and body weight assumptions discussed earlier. The
short- and intermediate-term drinking water exposure was calculated to
be 0.15 mg/kg/day. Using this value, the short- and intermediate-term
DWLOC was calculated to be 4,500 ppb. Since chronic EECs are below this
value, it is concluded that short- and intermediate-term aggregate risk
does not exceed the Agency's level of concern.
D. Aggregate Cancer Risk for U.S. Population
Propiconazole has been classified as a Group C, ``possible human
carcinogen'', chemical by the Agency. EPA used the RfD approach for
quantitation of human risk. Therefore, the RfD is deemed protective of
all chronic human health effects, including cancer; as aggregate
chronic risk (discussed above) does not exceed the Agency's level of
concern, there is a reasonable certainty that no harm will result from
cancer effects arising from chronic aggregate exposure to propiconazole
residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children --i. In general. 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 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure during gestation.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
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.
ii. Developmental toxicity studies. In the developmental toxicity
study in rats, the maternal (systemic) NOAEL was 30 mg/kg/day. The
maternal lowest observed adverse effect level (LOAEL) of 90 mg/kg/day
was based on reduced body weight gain and rales in females. The
developmental NOAEL was also 30 mg/kg/day. The developmental LOAEL of
90 mg/kg/day was based on the increased incidence of unossified
sternebrae, rudimentary ribs, and shortened or absent renal papillae.
In the rabbit developmental toxicity study, the maternal (systemic)
NOAEL was 100 mg/kg/day. The maternal LOAEL 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
NOAEL was 400 mg/kg/day (HDT), based upon the lack of developmental
delays or alterations.
iii. Reproductive toxicity study. In the 2-generation reproductive
toxicity study in rats, the parental (systemic) LOAEL of 5 mg/kg/day
(lowest dose tested) 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
NOAEL for parental toxicity was not determined. The reproductive/
developmental NOAEL was 25 mg/kg/day. The reproductive LOAEL of 125 mg/
kg/day was based on decreased offspring survival of second generation
(F2) pups, and on decreased body weight throughout
lactation, and an increase in the incidence of hepatic cellular
swelling for both generations of offspring (F1 and
F2 pups).
iv. Pre- and post-natal sensitivity. The pre- and post-natal
toxicology data base for propiconazole is complete with respect to
current toxicological data requirements. There are no pre- or post-
natal toxicity concerns for infants and children, based on the results
of the rat and rabbit developmental toxicity studies and the 2-
generation rat reproductive study. Propiconazole is not developmentally
toxic in the rabbit. There is evidence in the 2-generation study that
propiconazole is developmentally toxic in rats; however, toxicity in
offspring occurred at doses toxic to the parents. Based on the
developmental and reproductive toxicity studies discussed above, for
propiconazole there does not appear to be an extra sensitivity for pre-
or post-natal effects.
v. Conclusion. Based on the above information, the Agency has
concluded that a 100-fold safety factor is adequately protective of
infants and children and that the 10-fold safety factor required by
FQPA should be removed.
2. Acute risk. Toxicological effects applicable to the children/
infants that
[[Page 3001]]
could be attributed to a single exposure (dose) were not observed in
oral toxicity studies in rats and rabbits. Therefore, a dose and
endpoint were not identified for acute dietary risk assessment for this
population subgroup.
3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to
propiconazole from food will utilize 20% of the RfD for infants and 13%
of the RfD for children aged 1 through 6. 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. Based on body
weight and drinking water consumption estimates discussed earlier, the
chronic DWLOC for infants and children is 100 ppb. The estimated
chronic concentrations of 90 ppt in surface water and 1.42 ppt in
groundwater are lower than this chronic DWLOC. Under current Agency
criteria, the registered, non-dietary uses of propiconazole do not
constitute a chronic exposure scenario. EPA concludes that there is a
reasonable certainty that no harm will result to infants and children
from chronic aggregate exposure to propiconazole residues.
V. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue in plants is understood for the purposes
of these section 18 emergency exemptions. The residues of concern are
propiconazole and its metabolites determined as 2,4-dichlorobenzoic
acid and expressed as parent compound (as specified in 40 CFR 180.434).
As no animal feed items are associated with these requests, the nature
of the residue in animals is not of concern.
B. Analytical Enforcement Methodology
Adequate methodology (Ciba-Geigy's Analytical Method AG-454) is
available to enforce the established tolerances. This enforcement
method for plants is a single moiety analytical method which detects
residues as 2,4-dichlorobenzoic acid methyl ester and reports them as
propiconazole equivalents. Separation and detection are performed by
gas chromatography with electron capture detection. This analytical
method has been validated by EPA's Analytical Chemistry Laboratory.
Pending publication in PAM II, the analytical method is available from
the Agency (IRSD/PIRIB)].
C. Magnitude of Residues
Residues of propiconazole and its regulated metabolites are not
expected to exceed 1.0 ppm in/on blueberries and raspberries. Time-
limited tolerances should be established at this level.
D. International Residue Limits
There are no CODEX, Canadian or Mexican Maximum Residue Limits
(MRL) for propiconazole on blueberries or raspberries. Thus,
harmonization of tolerances is not an issue for these tolerances.
E. Rotational Crop Restrictions
As blueberries and raspberries are not routinely rotated to other
crops, rotational crop restrictions are not applicable.
VI. Conclusion
Therefore, tolerances are established for combined residues of
propiconazole and its metabolite determined as 2,4-dichlorobenzoic acid
in blueberries and raspberries at 1.0 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 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 March 22, 1999, file written objections to any
aspect of this regulation 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 regulation. 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). EPA is authorized to waive any fee requirement ``when in
the judgment of the Administrator such a waiver or refund is equitable
and not contrary to the purpose of this subsection.'' For additional
information regarding tolerance objection fee waivers, contact James
Tompkins, Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Rm. 239, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5697,
[email protected]. Request for waiver of tolerance objection fees
should be sent to James Hollins, Information Resources and Services
Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460.
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 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 Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300770] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Rm. 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C)
Office of Pesticide Programs, Environmental Protection Agency, CM
[[Page 3002]]
#2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
[email protected].
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this regulation, as well as the public
version, as described above will be kept in paper form. Accordingly,
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 record which will also
include all comments submitted directly in writing. The official record
is the paper record maintained at the Virginia address in ``ADDRESSES''
at the beginning of this document.
IX. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerances under section 408 of the
FFDCA. The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4). Nor does it require any special considerations
as required 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 require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(l)(6), such as the
tolerances in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency has
previously assessed whether establishing tolerances, exemptions from
tolerances, raising tolerance levels or expanding exemptions might
adversely impact small entities and concluded, as a generic matter,
that there is no adverse economic impact. The factual basis for the
Agency's generic certification for tolerance actions published on May
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local, or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide to OMB, in a separately
identified section of the preamble to the rule, a description of the
extent of EPA's prior consultation with representatives of affected
tribal governments, a summary of the nature of their concerns, and a
statement supporting the need to issue the regulation. In addition,
Executive Order 13084 requires EPA to develop an effective process
permitting elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
X. 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 the rule in the 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: December 30, 1998.
Robert A. Forrest,
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, by alphabetically adding the following
commodities to the table in paragraph (b) 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) * * *
[[Page 3003]]
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
* * * * *
Blueberries..................... 1.0 12/31/99
* * * * *
Raspberries..................... 1.0 12/31/99
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-1255 Filed 1-19-99; 8:45 am]
BILLING CODE 6560-50-F