[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: [email protected]. 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: 
[email protected].

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