[Federal Register Volume 62, Number 70 (Friday, April 11, 1997)]
[Rules and Regulations]
[Pages 17710-17717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9371]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300474; FRL-5600-5]
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 or on the raw
agricultural commodities almonds and cranberries 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 almonds in California and cranberries in Wisconsin.
This regulation establishes maximum permissible levels for residues of
propiconazole in these foods pursuant to section 408(l)(6) of the
Federal Food, Drug and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996.
DATES: This regulation becomes effective April 11, 1997. Objections and
requests for hearings must be received by EPA on or before June 10,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300474], 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-300474], must also be submitted to: Public
Response and Program Resources Branch, Field Operations 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: opp-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-300474]. 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, DC 20460. Office location, telephone number, and e-mail:
Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway,
Arlington, VA 22202. (703) 308-6418, e-mail:
odiott.olga@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, 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 residues of the pesticide
propiconazole (1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl]-1H-1,2,4-triazole) in or on almond nutmeats at 0.1 part per
million (ppm), in or on almond hulls at 2.5 ppm, and in or on
cranberries at 1.0 ppm.
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. 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 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) 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
[[Page 17711]]
exposures for which there is reliable information.'' This includes
exposure through drinking water, 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) 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. Section 408(l)(6) also requires EPA to promulgate regulations
by August 3, 1997, governing the establishment of tolerances and
exemptions under section 408(l)(6) and requires that the regulations be
consistent with section 408(b)(2) and (c)(2) and FIFRA section 18.
Section 408(l)(6) allows EPA to establish tolerances or exemptions
from the requirement for a tolerance, in connection with EPA's granting
of FIFRA section 18 emergency exemptions, without providing notice or a
period for public comment. Thus, consistent with the need to act
expeditiously on requests for emergency exemptions under FIFRA, EPA can
establish such tolerances or exemptions under the authority of section
408(e) and (l)(6) without notice and comment rulemaking.
In establishing section 18-related tolerances and exemptions during
this interim period before EPA issues the section 408(l)(6) procedural
regulation and before EPA makes its broad policy decisions concerning
the interpretation and implementation of the new section 408, EPA does
not intend to set precedents for the application of section 408 and the
new safety standard to other tolerances and exemptions. Rather, these
early section 18 tolerance and exemption decisions will be made on a
case-by-case basis and will not bind EPA as it proceeds with further
rulemaking and policy development. EPA intends to act on section 18-
related tolerances and exemptions that clearly qualify under the new
law.
II. Emergency Exemptions for Propiconazole on Almonds and on
Cranberries and FFDCA Tolerances
The California EPA Department of Pesticide Regulation availed
itself of the authority to declare the existence of a crisis situation
within the state on February 3, 1997, thereby authorizing use under
FIFRA Section 18 of propiconazole on almonds to control anthracnose
(Colletotrichum acutatum). California has also requested a specific
exemption for this use of propiconazole. California stated that an
emergency situation was present due to persistent and extended periods
of rainfall during 1991 to 1995, which caused anthracnose levels to
reach epidemic proportions in the northern and central almond growing
areas of the state. California also stated that the causal organism is
relatively insensitive to registered pesticides and that significant
production and revenue losses are expected to occur without the
availability of propiconazole. After having reviewed their submission,
EPA concurs that an emergency condition exists.
The Wisconsin Department of Agriculture, Trade and Consumer
Protection have requested a specific exemption for the use of
propiconazole on cranberries to control cottonball disease. Production
and distribution of triforine (Funginex), the only fungicide registered
for control of cottonball disease, has been discontinued by its
manufacturer. Most growers depleted their supplies of Funginex during
the 1996 growing season. Wisconsin states that the lack of a fungicide
to control cottonball disease can have devastating effects on cranberry
growers' production and revenue. After having reviewed their
submission, EPA concurs that an emergency condition exists.
As part of its assessment, EPA assessed the potential risks
presented by residues of propiconazole in or on almonds nutmeats, in or
on almond hulls, and in or on cranberries. In doing so, EPA considered
the new safety standard in FFDCA section 408(b)(2), and EPA decided to
grant the section 18 exemptions only after concluding that the
necessary tolerances under FFDCA section 408(l)(6) would clearly be
consistent with the new safety standard and with FIFRA section 18.
These tolerances for propiconazole will permit the marketing of almonds
and cranberries treated in accordance with the provisions of the
section 18 emergency exemptions. Consistent with the need to move
quickly on the emergency exemptions 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 for
in section 408(l)(6). Although these tolerances will expire as intended
in the table, under FFDCA section 408(l)(5), residues of propiconazole
not in excess of the amount specified in the tolerances remaining in or
on almonds after that date will not be unlawful, provided the pesticide
is applied during the term of, and in accordance with all the
conditions of, the emergency exemption. 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
the requirements for registration under FIFRA section 3 for use on
almonds and cranberries, or whether permanent tolerances for
propiconazole for these commodities would be appropriate. This action
by EPA does not serve as a basis for registration of propiconazole by a
State for special local needs under FIFRA section 24(c). Nor does this
action serve as the basis for any State other than California and
Wisconsin to use this product 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 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
[[Page 17712]]
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 by EPA
to pose a reasonable certainty of no harm.
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
relationships. Once a pesticide has been classified as a potential
human carcinogen, different types of risk assessments (e.g., linear
low-dose extrapolations or margin of exposure 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, and other non-
occupational exposures, such as where residues leach into groundwater
or surface water that is consumed as drinking water. 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. 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.
IV. Aggregate Risk Assessments, Cumulative Risk Discussion, 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. Propiconazole is registered by EPA for use on pecans for
control of scab, and on stone fruits for control of brown rot. At this
time EPA is not in possession of a registration application for
propiconazole on almonds or on cranberries. However, based on
information submitted to the Agency, 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 the time-limited
tolerances for residues of propiconazole in or on almond nutmeats at
0.1 part per million (ppm), in or on almond hulls at 2.5 ppm, and in or
on cranberries at 1.0 ppm. EPA's assessment of the dietary exposures
and risks associated with establishing these tolerances follows.
A. Toxicological Profile
1. Chronic toxicity. Based on the available chronic toxicity data,
the Office of Pesticide Programs (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 lowest effect level (LEL) of 6.25 mg/kg/day was
based on mild irritation of the gastric mucosa.
2. Acute toxicity. Based on the available acute toxicity data, 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 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.
3. 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.
4. Carcinogenicity. 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. Aggregate Exposure
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).
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-trizole) and its metabolites determined
as 2,4-dichlorobenzoic acid (DCBA) and expressed as parent compound, in
or on certain raw agricultural commodities ranging from 0.05 ppm in
milk to 60 ppm in grass (seed screenings). For purposes of these
Section 18 uses, the nature of the residue in plants and animals is
adequately understood. Almond hulls (proposed tolerance, 2.5 ppm) is
not fed to poultry or swine, but can be fed up to 10% of the diet of
beef and dairy cattle. This is a negligible contribution, comparatively
speaking, and is not expected to increase the daily dietary burden to
livestock. Secondary residues in animal commodities are not expected to
exceed existing tolerances as a result of these Section 18 uses.
1. Chronic exposure. Given the emergency nature of these requests
for the use of propiconazole and the
[[Page 17713]]
resulting need for a timely analysis and risk assessment, the chronic
dietary (food only) risk assessment was partially refined using
anticipated residue levels and percent crop-treated values for selected
commodities. Further refinement using anticipated residue levels and
percent crop-treated values for all commodities would result in lower
dietary exposure estimates.
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.
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
consumption of 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.
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.
Based on the nature of the outdoor and indoor residential uses of
propiconazole, OPP has concluded that a chronic residential exposure
scenario does not exist for outdoor residential use. A chronic
residential exposure scenario may exist for indoor residential use. The
indoor residential use (window moldings) will be assumed to account for
5% of the total aggregate chronic risk until additional data are
provided. This value is considered conservative and protective of the
public health. The aggregate chronic risk is equal to the sum of the
chronic risk from food + water + residential (indoor and outdoor) uses.
In the best scientific judgment of OPP, this aggregate chronic risk for
propiconazole does not exceed our level of concern.
2. Acute 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 aggregate acute risk
(food and water) from the currently registered, and this proposed
Section 18 uses of propiconazole, do not exceed our level of concern.
While EPA has not yet pinpointed the appropriate bounding figure for
consumption of contaminated water, 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 from
acute aggregate exposure.
3. Short- and intermediate-term aggregate risk assessment. Short-
and intermediate-term aggregate risk estimates take into account
exposure from chronic dietary food and water (considered to be a
background exposure level) plus potential indoor and outdoor
residential exposures.
Considering the nature of the outdoor residential uses, OPP 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.
The chronic food and water exposure estimates for the aggregate short-
and intermediate-term risk assessments are considered conservative for
the reasons mentioned above.
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.
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.
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
[[Page 17714]]
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 EPA has not
assumed that propiconazole has a common mechanism of toxicity with
other substances.
D. Determination of Safety for U.S. Population
1. Chronic risk. Using the conservative exposure assumptions
described above, taking into account the completeness and reliability
of the toxicity data, EPA has concluded that dietary exposure to
propiconazole will utilize 6% 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 from
drinking water and indoor uses, 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.
2. Acute risk. For the population subgroup of concern, females 13+
years (accounts for both maternal and fetal exposure), the calculated
Margins of Exposure (MOE) 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.
3. Short- and intermediate-term risk. For propiconazole, EPA does
not have concerns for short- and intermediate-term dietary exposure
because of the very high values calculated for the MOE. The calculated
MOE value is 37,000 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.
E. Determination of Safety for Infants and Children
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.
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;="" ldt).="" 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="" (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).="" 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.="" 1.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" the="" percent="" of="" the="" rfd="" that="" will="" be="" utilized="" by="" exposure="" to="" residues="" of="" propiconazole="" ranges="" from="" 8%="" for="" children="" 7="" -="" 12="" years="" old,="" up="" to="" 20%="" for="" non-nursing="" infants="" (the="" most="" highly="" exposed="" population="" subgroup).="" despite="" the="" potential="" for="" exposure="" to="" propiconazole="" from="" drinking="" water="" and="" indoor="" uses,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" therefore,="" taking="" into="" account="" the="" completeness="" and="" reliability="" of="" the="" toxicity="" data="" and="" the="" conservative="" exposure="" assessment,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" propiconazole="" residues.="" 2.="" 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.="" 3.="" short-="" and="" intermediate-term="" risk.="" for="" the="" most="" highly="" exposed="" population="" subgroup="" (non-nursing="" infants="" less="" than="" 1="" year="" old),="" a="" short-="" and="" intermediate-term="" moe="" of="" 12,000="" was="" calculated.="" the="" large="" moe="" calculated="" for="" non-="" nursing="" 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.="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" apply="" an="" additional="" tenfold="" margin="" of="" exposure="" (safety)="" for="" infants="" and="" children="" in="" the="" case="" of="" threshold="" effects="" [[page="" 17715]]="" to="" account="" for="" pre-and="" post-natal="" toxicity="" and="" the="" completeness="" of="" the="" database="" unless="" epa="" determines="" that="" a="" different="" margin="" of="" exposure="" (safety)="" will="" be="" safe="" for="" infants="" and="" children.="" margins="" of="" exposure="" (safety)="" are="" often="" referred="" to="" as="" uncertainty="" (safety)="" factors.="" epa="" believes="" that="" reliable="" data="" support="" using="" the="" standard="" margin="" of="" exposure="" (usually="" 100x="" for="" combined="" inter-="" and="" intra-species="" variability)="" and="" not="" the="" additional="" tenfold="" margin="" of="" exposure="" 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="" margin="" of="" exposure.="" based="" on="" current="" toxicological="" data="" requirements,="" the="" database="" for="" propiconazole="" relative="" to="" pre-="" (provided="" by="" rat="" and="" rabbit="" developmental="" studies)="" and="" post-natal="" (provided="" by="" the="" rat="" reproduction="" study)="" toxicity="" is="" complete.="" further,="" as="" noted="" above,="" the="" acute="" dietary="" moe="" for="" children="" 13+="" years="" is="" 3,000.="" this="" large="" moe="" demonstrates="" that="" the="" prenatal="" exposure="" to="" infants="" is="" not="" a="" toxicological="" concern="" at="" this="" time,="" and="" the="" additional="" uncertainty="" factor="" is="" not="" needed="" to="" protect="" the="" safety="" of="" infants="" and="" children.="" the="" acute="" dietary="" risk="" assessment="" used="" tolerance="" level="" residues="" and="" 100%="" crop-treated="" information.="" further="" refinement="" using="" anticipated="" residue="" levels="" and="" percent="" crop-treated="" values="" would="" result="" in="" a="" lower="" dietary="" exposure="" estimate.="" the="" chronic="" dietary="" risk="" assessment="" was="" partially="" refined="" using="" anticipated="" residue="" levels="" and="" percent="" crop-treated="" values="" for="" selected="" commodities.="" this="" risk="" estimate="" should="" be="" viewed="" as="" conservative;="" further="" refinement="" using="" anticipated="" residue="" levels="" and="" percent="" crop-="" treated="" values="" for="" all="" commodities="" included="" in="" the="" analysis="" would="" result="" in="" lower="" dietary="" exposure="" estimates.="" therefore,="" epa="" concludes="" that="" there="" is="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" propiconazole="" residues.="" v.="" other="" considerations="" the="" metabolism="" of="" propiconazole="" in="" plants="" and="" animals="" is="" adequately="" understood="" for="" the="" purposes="" of="" these="" tolerance="" actions.="" there="" is="" a="" codex="" maximum="" residue="" level="" (mrl)="" of="" 0.05="" ppm="" for="" residues="" of="" propiconazole="" in/on="" almonds.="" the="" section="" 18="" tolerance="" on="" almond="" nut="" meats="" is="" proposed="" at="" 0.1="" ppm="" and="" that="" on="" almond="" hulls="" at="" 2.5="" ppm.="" the="" available="" field="" trial="" data="" on="" almonds="" do="" not="" support="" harmonization="" with="" the="" codex="" mrl="" of="" 0.05="" ppm="" because="" they="" indicate="" that="" residues="" used="" under="" the="" use="" patterns="" approved="" for="" the="" emergency="" exemption="" could="" exceed="" 0.05="" ppm.="" there="" are="" no="" canadian="" or="" mexican="" levels="" established="" for="" residues="" of="" propiconazole="" on="" almonds.="" there="" are="" no="" mexican,="" canadian,="" or="" codex="" mrls="" established="" for="" residues="" of="" propiconazole="" on="" cranberries.="" 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,="" but="" have="" not="" yet="" appeared="" in="" pam="" ii.="" in="" the="" interim,="" a="" copy="" of="" the="" methods="" is="" available="" to="" anyone="" who="" is="" interested="" in="" pesticide="" residue="" enforcement="" from:="" by="" mail,="" calvin="" furlow,="" public="" response="" and="" program="" resources="" branch,="" field="" operations="" division="" (7506c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.="" sw.,="" washington,="" dc="" 20460.="" office="" location="" and="" telephone="" number:="" crystal="" mall="" #2,="" rm="" 1128,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va,="" 703-305-5805.="" vi.="" conclusion="" therefore,="" time-limited="" tolerances="" in="" connection="" with="" the="" fifra="" section="" 18="" emergency="" exemptions="" are="" established="" for="" residues="" of="" propiconazole="" in="" or="" on="" almond="" nutmeats="" at="" 0.1="" part="" per="" million="" (ppm),="" in="" or="" on="" almond="" hulls="" at="" 2.5="" ppm="" and="" in="" on="" or="" cranberries="" 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="" 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="" june="" 10,="" 1997,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" (including="" the="" automatic="" 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-300474].="" 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="" response="" and="" program="" resources="" branch,="" field="" operations="" 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="" [[page="" 17716]]="" 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.="" this="" action="" does="" not="" impose="" any="" enforceable="" duty,="" or="" contain="" any="" ``unfunded="" mandates''="" as="" described="" in="" title="" ii="" of="" the="" unfunded="" mandates="" reform="" act="" of="" 1995="" (pub.="" l.="" 104-4),="" or="" require="" prior="" consultation="" as="" specified="" by="" executive="" order="" 12875="" (58="" fr="" 58093,="" october="" 28,="" 1993),="" entitled="" enhancing="" the="" intergovernmental="" partnership,="" or="" special="" consideration="" 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="" 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:april="" 4,="" 1997.="" penelope="" a.="" fenner-crisp,="" acting="" director,="" 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.="" by="" revising="" sec.="" 180.434="" 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.="" (a)="" general.="" tolerances="" are="" established="" for="" the="" combined="" residues="" of="" the="" fungicide="" 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]="" methyl]-1h-1,2,4-triazole="" and="" its="" metabolites="" determined="" as="" 2,4-="" dichlorobenzoic="" acid="" and="" expressed="" as="" parent="" compound="" in="" or="" on="" the="" following="" commodities:="" ------------------------------------------------------------------------="" parts="" per="" expiration="" commodity="" million="" date="" ------------------------------------------------------------------------="" apricots...................................="" 1.0="" none="" bananas....................................="" 0.2="" none="" barley,="" grain..............................="" 0.1="" none="" barley,="" straw..............................="" 1.5="" none="" cattle,="" fat................................="" 0.1="" none="" cattle,="" kidney.............................="" 2.0="" none="" cattle,="" liver..............................="" 2.0="" none="" cattle,="" mbyp="" (except="" kidney="" and="" liver).....="" 0.1="" none="" cattle,="" meat...............................="" 0.1="" none="" celery.....................................="" 5.0="" none="" corn,="" fodder...............................="" 12="" december="" 31,="" 1998="" corn,="" forage...............................="" 12="" december="" 31,="" 1998="" corn,="" grain................................="" 0.1="" december="" 31,="" 1998="" corn,="" sweet="" (kernels,="" plus="" cobs="" with="" husks="" removed)..................................="" 0.1="" december="" 31,="" 1998="" eggs.......................................="" 0.1="" none="" goats,="" fat.................................="" 0.1="" none="" goats,="" kidney..............................="" 2.0="" none="" goats,="" liver...............................="" 2.0="" none="" goats,="" mbyp="" (except="" kidney="" and="" liver)......="" 0.1="" none="" goats,="" meat................................="" 0.1="" none="" grass,="" forage..............................="" 0.5="" none="" grass,="" hay="" (straw).........................="" 40="" none="" grass,="" seed="" screenings.....................="" 60="" none="" hogs,="" fat..................................="" 0.1="" none="" hogs,="" kidney...............................="" 2.0="" none="" hogs,="" liver................................="" 2.0="" none="" hogs,="" mbyp="" (except="" kidney="" and="" liver).......="" 0.1="" none="" hogs="" meat..................................="" 0.1="" none="" horses,="" fat................................="" 0.1="" none="" horses,="" kidney.............................="" 2.0="" none="" horses,="" liver..............................="" 2.0="" none="" horses,="" mbyp="" (except="" kidney="" and="" liver).....="" 0.1="" none="" horses,="" meat...............................="" 0.1="" none="" milk.......................................="" 0.05="" none="" mushrooms..................................="" 0.1="" none="" nectarines.................................="" 1.0="" none="" oats,="" forage...............................="" 10.0="" none="" oats,="" grain................................="" 0.1="" none="" oats,="" hay..................................="" 30.0="" none="" oats,="" straw................................="" 1.0="" none="" peaches....................................="" 1.0="" none="" peanuts....................................="" 0.2="" december="" 31,="" 1998="" peanuts,="" hay...............................="" 20.0="" december="" 31,="" 1998="" peanuts,="" hulls.............................="" 1.0="" december="" 31,="" 1998="" pecans.....................................="" 0.1="" none="" pineapple..................................="" 0.1="" december="" 31,="" 1998="" pineapple,="" fodder..........................="" 0.1="" december="" 31,="" 1998="" plums......................................="" 1.0="" none="" poultry,="" fat...............................="" 0.1="" none="" poultry,="" kidney............................="" 0.2="" none="" poultry,="" liver.............................="" 0.2="" none="" poultry,="" mbyp="" (except="" kidney="" and="" liver)....="" 0.1="" none="" poultry,="" meat..............................="" 0.1="" none="" prunes,="" fresh..............................="" 1.0="" none="" rice,="" grain................................="" 0.1="" none="" rice,="" straw................................="" 3.0="" none="" rye,="" grain.................................="" 0.1="" none="" rye,="" straw.................................="" 1.5="" none="" sheep,="" fat.................................="" 0.1="" none="" sheep,="" kidney..............................="" 2.0="" none="" sheep,="" liver...............................="" 2.0="" none="" sheep,="" mbyp="" (except="" kidney="" and="" liver)......="" 0.1="" none="" sheep,="" meat................................="" 0.1="" none="" stonefruit="" group...........................="" 1.0="" none="" wheat,="" grain...............................="" 0.1="" none="" wheat,="" straw...............................="" 1.5="" none="" ------------------------------------------------------------------------="" (b)="" section="" 18="" emergency="" exemptions.="" time-limited="" tolerances="" are="" established="" permitting="" the="" combined="" residues="" of="" 1-[[2-(2,4-="" dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1h-1,2,4-triazole="" and="" its="" metabolites="" determined="" as="" 2,4-dichlorobenzoic="" acid="" and="" expressed="" as="" parent="" compound,="" in="" connection="" with="" use="" of="" the="" pesticide="" under="" section="" 18="" emergency="" exemptions="" granted="" by="" epa.="" [[page="" 17717]]="" residues="" in="" these="" commodities="" not="" in="" excess="" of="" the="" established="" tolerances="" resulting="" from="" the="" uses="" described="" in="" this="" paragraph="" remaining="" after="" expiration="" of="" the="" time-limited="" tolerances="" will="" not="" be="" considered="" to="" be="" actionable="" if="" the="" pesticide="" is="" applied="" during="" the="" term="" of="" and="" in="" accordance="" with="" the="" provisions="" of="" this="" paragraph.="" the="" tolerances="" are="" specified="" in="" the="" following="" table.="" these="" tolerances="" expire="" on="" the="" date="" specified="" in="" the="" table.="" ------------------------------------------------------------------------="" expiration/="" commodity="" parts="" per="" revocation="" million="" date="" ------------------------------------------------------------------------="" almond="" hull................................="" 2.5="" july="" 31,="" 1998="" almond="" nut="" meats...........................="" 0.1="" july="" 31,="" 1998="" cranberries................................="" 41.0="" july="" 31,="" 1998="" grain="" sorghum..............................="" 0.1="" october="" 31,="" 1998="" grain="" sorghum="" stover.......................="" 1.5="" october="" 31,="" 1998="" ------------------------------------------------------------------------="" (c)="" tolerances="" with="" regional="" registrations.="" a="" tolerance="" with="" regional="" registration,="" as="" defined="" in="" sec.="" 180.1(n),="" is="" established="" for="" residues="" of="" 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-="" yl]methyl]-1h-1,2,4-triazole="" and="" its="" metabolites="" determined="" as="" 2,4-="" dichlorobenzoic="" acid="" and="" expressed="" as="" parent="" compound,="" in="" or="" on="" the="" following="" commodities:="" ------------------------------------------------------------------------="" parts="" per="" commodity="" million="" ------------------------------------------------------------------------="" mint,="" tops="" (leaves="" and="" stems)..............................="" 0.3="" wild="" rice..................................................="" 0.5="" ------------------------------------------------------------------------="" (d)="" indirect="" or="" inadvertent="" residues.="" [reserved]="" [fr="" doc.="" 97-9371="" filed="" 4-10-97;="" 8:45="" am]="" billing="" code="" 6560-50-f="">