[Federal Register Volume 62, Number 114 (Friday, June 13, 1997)]
[Rules and Regulations]
[Pages 32224-32230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15373]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300494; FRL-5718-8]
RIN 2070-AB78


Propiconazole; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of the pesticide propiconazole in on or the raw 
agricultural commodities dry beans, dry bean forage and dry bean hay in 
connection with EPA's granting of emergency exemptions under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing 
use of propiconazole on dry beans in Minnesota, North Dakota, Nebraska, 
Colorado and Kansas. These tolerances will expire and are revoked on 
December 31, 1998.

DATES: This regulation becomes effective June 13, 1997. Objections and 
requests for hearings must be received by EPA on or before August 12, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300494], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
hearing requests filed with the Hearing Clerk identified by the 
document control number, [OPP-300494], must also be submitted to: 
Public Information and Records Integrity Branch, Information Resources 
and Services Division (7506C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
In person, bring a copy of objections and hearing requests to Rm. 1132, 
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA. A copy of objections 
and hearing requests filed with the Hearing Clerk may also be submitted 
electronically by sending electronic mail (e-mail) to: opp-
[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-
300494]. No Confidential Business Information (CBI) should be submitted 
through e-mail. Electronic copies of objections and hearing requests on 
this rule may be filed online at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Olga Odiott, Registration 
Division (7505W), Environmental Protection Agency, 401 M St., SW., 
Washington, D.C. 20460. Office location, telephone number, and e-mail: 
Sixth Floor, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, 
VA 22202. (703) 308-9363, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for 
the combined residues of the pesticide propiconazole (1-[[2-(2,4-
dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-
triazole)and its metabolites determined as 2,4-dichlorobenzoic acid 
(DCBA) and expressed as parent compound, in or on dry beans at 0.5 part 
per million (ppm), in or on dry bean forage at 8.0 ppm, and in or on 
dry bean hay at 8.0 ppm. These tolerances will expire and be revoked by 
EPA on December 31, 1998. After December 31, 1998, EPA will publish a 
document in the Federal Register to remove the revoked tolerance from 
the Code of Federal Regulations.

I. Background and Statutory Authority

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) 
was signed into law August 3, 1996. FQPA amends both the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq. Among other things, FQPA amends FFDCA to bring all EPA pesticide 
tolerance-setting activities under section 408 with a new safety 
standard and new procedures. These activities are described below and 
discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of 
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
    New section 408(b)(2)(A)(I)of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166. Section 408(l)(6) of the FFDCA 
requires EPA to establish a time-limited tolerance or exemption from 
the requirement for a tolerance for pesticide chemical residues in food 
that will result from the use of a pesticide under an emergency 
exemption granted by EPA under section 18 of FIFRA. Such tolerances can 
be established without

[[Page 32225]]

providing notice or a period for public comment.
    Because decisions on section 18-related tolerances must proceed 
before EPA reaches closure on several policy issues relating to 
interpretation and implementation of the FQPA, EPA does not intend for 
its actions on such tolerance to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemptions for Propiconazole on Dry Beans and FFDCA 
Tolerances

    The Applicants stated that Uromyces appendiculatus, the causal 
organism of the bean rust, has the potential to erupt in epidemic 
proportions. Due to the heavy precipitations during the winter in the 
Midwest and high rust buildup during previous years, the ideal 
environmental conditions are present for rapid development of the 
disease. The pathogen is capable of mutating and although resistance 
has been traditionally bred into bean varieties, the available 
cultivars are susceptible to the new races of the rust. The registered 
pesticides are protectant fungicides and must be applied before 
infection occurs. When disease pressure is high, effective control is 
difficult to attain with these pesticides unless all the growers in the 
region begin a calendar base spray program. Propiconazole is a curative 
fungicide and because of its post-infection activity allows an 
integrated pest management approach with applications made only at the 
first signs of infection. Propiconazole is also an antisporulant and 
thereby can reduce inoculum production. EPA has authorized under FIFRA 
section 18 the use of propiconazole on dry beans for control of rust 
(Uromyces appendiculatus). After having reviewed their submissions, EPA 
concurs that emergency conditions exist for these states.
    As part of its assessment of these emergency exemptions, EPA 
assessed the potential risks presented by residues of propiconazole in 
or on dry beans. In doing so, EPA considered the new safety standard in 
FFDCA section 408(b)(2), and EPA decided that the necessary tolerance 
under FFDCA section 408(l)(6) would be consistent with the new safety 
standard and with FIFRA section 18. These tolerances will permit the 
marketing of dry beans treated in accordance with the provisions of the 
section 18 emergency exemption. Consistent with the need to move 
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing these tolerances without notice and opportunity 
for public comment under section 408(e), as provided in section 
408(l)(6). Although these tolerances will expire and are revoked on 
December 31, 1998, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerances 
remaining in or on dry beans, dry bean forage, and dry bean hay after 
that date will not be unlawful, provided the pesticide is applied 
during the term of, and in accordance with all the conditions of, 
section 18 of FIFRA. EPA will take action to revoke these tolerances 
earlier if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    EPA has not made any decisions about whether propiconazole meets 
EPA's registration requirements for use on dry beans or whether 
permanent tolerances for this use would be appropriate. These 
tolerances do not serve as a basis for registration of propiconazole by 
a State for special local needs under FIFRA section 24(c). Nor do these 
tolerances serve as the basis for any State other than Minnesota, North 
Dakota, Nebraska, Colorado, and Kansas to use this pesticide on this 
crop under section 18 of FIFRA without following all provisions of 
section 18 as identified in 40 CFR part 166. For additional information 
regarding the emergency exemptions for propiconazole, contact the 
Agency's Registration Division at the address provided above.

III. Risk Assessment and Statutory Findings

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides based primarily on toxicological studies using 
laboratory animals. These studies address many adverse health effects, 
including (but not limited to) reproductive effects, developmental 
toxicity, toxicity to the nervous system, and carcinogenicity. For many 
of these studies, a dose response relationship can be determined, which 
provides a dose that causes adverse effects (threshold effects) and 
doses causing no observed effects (the ``no-observed effect level'' or 
``NOEL'').
    Once a study has been evaluated and the observed effects have been 
determined to be threshold effects, EPA generally divides the NOEL from 
the study with the lowest NOEL by an uncertainty factor (usually 100 or 
more) to determine the Reference Dose (RfD). The RfD is a level at or 
below which daily aggregate exposure over a lifetime will not pose 
appreciable risks to human health. An uncertainty factor (sometimes 
called a ``safety factor'') of 100 is commonly used since it is assumed 
that people may be up to 10 times more sensitive to pesticides than the 
test animals, and that one person or subgroup of the population (such 
as infants and children) could be up to 10 times more sensitive to a 
pesticide than another. In addition, EPA assesses the potential risks 
to infants and children based on the weight of the evidence of the 
toxicology studies and determines whether an additional uncertainty 
factor is warranted. Thus, an aggregate daily exposure to a pesticide 
residue at or below the RfD (expressed as 100% or less of the RfD) is 
generally considered acceptable by EPA. EPA generally uses the RfD to 
evaluate the chronic risks posed by pesticide exposure. For shorter 
term risks, EPA calculates a margin of exposure (MOE) by dividing the 
estimated human exposure into the NOEL from the appropriate animal 
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This 
100-fold MOE is based on the same rationale as the 100-fold uncertainty 
factor.
    Lifetime feeding studies in two species of laboratory animals are 
conducted to screen pesticides for cancer effects. When evidence of 
increased cancer is noted in these studies, the Agency conducts a 
weight of the evidence review of all relevant toxicological data 
including short term and mutagenicity studies and structure activity 
relationship. Once a pesticide has been classified as a potential human 
carcinogen, different types of risk assessments (e.g., linear low dose 
extrapolations or MOE calculation based on the appropriate NOEL) will 
be carried out based on the nature of the carcinogenic response and the 
Agency's knowledge of its mode of action.
    In examining aggregate exposure, FFDCA section 408 requires that 
EPA take into account available and reliable information concerning 
exposure from the pesticide residue in the food in question, residues 
in other foods for which there are tolerances, residues in groundwater 
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or 
buildings (residential and other indoor uses). Dietary exposure to 
residues of a pesticide in a food commodity are estimated by 
multiplying the average daily consumption of the food forms of that 
commodity by the tolerance level or the anticipated pesticide residue 
level.

[[Page 32226]]

The Theoretical Maximum Residue Contribution (TMRC) is an estimate of 
the level of residues consumed daily if each food item contained 
pesticide residues equal to the tolerance. The TMRC is a ``worst case'' 
estimate since it is based on the assumptions that food contains 
pesticide residues at the tolerance level and that 100% of the crop is 
treated by pesticides that have established tolerances. If the TMRC 
exceeds the RfD or poses a lifetime cancer risk that is greater than 
approximately one in a million, EPA attempts to derive a more accurate 
exposure estimate for the pesticide by evaluating additional types of 
information (anticipated residue data and/or percent of crop treated 
data) which show, generally, that pesticide residues in most foods when 
they are eaten are well below established tolerances.
    Percent of crop treated estimates are derived from federal and 
private market survey data. Typically, a range of estimates are 
supplied and the upper end of this range is assumed for the exposure 
assessment. By using this upper end estimate of percent of crop 
treated, the Agency is reasonably certain that exposure is not 
understated for any significant subpopulation group. Further, regional 
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations 
including several regional groups, to pesticide residues.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by propiconazole are 
discussed below.
    1. Acute toxicity. Based on the available acute toxicity data, the 
Office of Pesticide Programs (OPP) has determined that the NOEL of 30 
mg/kg/day from a developmental toxicity study in rats should be used to 
assess risks from acute toxicity. The developmental lowest effect level 
(LEL) of 90 mg/kg/day was based on the increased incidence of 
unossified sternebrae, rudimentary ribs, and shortened or absent renal 
papillae. This risk assessment evaluates acute dietary risk to females 
13+ years.
    2. Short- and intermediate-term toxicity. Based on the available 
data, OPP has determined that a NOEL of 30 mg/kg/day from a 
developmental toxicity study in rats should be used to assess risks 
from short- and intermediate-term dermal toxicity. At the developmental 
LEL of 90 mg/kg/day, there were increased incidences of unossified 
sternebrae, rudimentary ribs, and shortened or absent renal papillae. 
For short- and intermediate-term inhalation toxicity, OPP has 
determined that a NOEL of 92.8 mg/kg/day (0.5 mg/L), the highest dose 
tested from a 5-day inhalation toxicity study in rats should be used to 
assess risks for occupational and residential exposure scenarios.
    3. Chronic risk. Based on the available chronic toxicity data, OPP 
has established the RfD for propiconazole at 0.013 mg/kg/day. The RfD 
is based on a one-year feeding study in dogs with a NOEL of 1.25 mg/kg/
day and an uncertainty factor (UF) of 100. The LEL of 6.25 mg/kg/day 
was based on mild irritation of the gastric mucosa.
    4. Cancer risk. Using its Guidelines for Carcinogen Risk Assessment 
published September 24, 1986 (51 FR 33992), EPA has classified 
propiconazole as a Group C, ``possible human carcinogen'', chemical. 
The OPP Carcinogenicity Peer Review Committee (CPRC) recommended using 
the RfD approach for quantification of human risk.

B. Exposures and Risks

    In examining aggregate exposure, FQPA directs EPA to consider 
available information concerning exposures from the pesticide residue 
in food and all other non-occupational exposures. The primary non-food 
sources of exposure the Agency looks at include drinking water (whether 
from groundwater or surface water), and exposure through pesticide use 
in gardens, lawns, or buildings (residential and other indoor uses). In 
evaluating food exposures, EPA takes into account varying consumption 
patterns of major identifiable subgroups of consumers, including 
infants and children.
    1. From food and feed uses. Tolerances have been established (40 
CFR 180.434) for the combined residues of propiconazole (1-[[2-(2,4-
dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-
triazole)and its metabolites determined as 2,4-dichlorobenzoic acid 
(DCBA) and expresed as parent compound, in or on a variety of raw 
agricultural commodities at levels ranging from 0.05 ppm in milk to 60 
ppm in grass (seed screenings). Risk assessments were conducted by EPA 
to assess dietary exposures and risks from propiconazole as follows:
    i. Acute risk. Acute dietary risk assessments are performed for a 
food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure.
    The acute dietary (food only) risk assessment used tolerance level 
residues and 100% crop-treated information. Thus, the acute dietary 
risk estimate is an over-estimate of exposure and it is considered to 
be protective of any acute exposure scenario. In the best scientific 
judgment of OPP, the acute dietary risk from the currently registered, 
and this proposed Section 18 uses of propiconazole, do not exceed our 
level of concern. For the population subgroup of concern, females 13+ 
years, a MOE value of 3,000 was calculated. Further refinement using 
anticipated residue values and percent crop-treated data would result 
in lower acute dietary risk estimates.
    ii. Chronic risk. The chronic dietary risk assessment was partially 
refined using anticipated residue levels and percent crop-treated 
values for selected commodities. The population subgroup with the 
largest percentage of the RfD occupied is non-nursing infants less than 
1 year old, at 20% of the RfD. This risk estimate should be viewed as 
conservative; further refinement using anticipated residue levels and 
percent crop-treated values for all commodities would result in lower 
dietary exposure estimates.
    iii. Cancer risk. Based on the OPP Carcinogenicity Peer Review 
Committee's (CPRC) recommendation that the RfD approach be used to 
assess cancer risk, a quantitative cancer risk assessment was not 
performed. Human health risk concerns due to long-term exposure to 
propiconazole residues are adequately addressed by the aggregate 
chronic exposure analysis using the RfD.
    2. From drinking water. Based on available studies used in EPA's 
assessment of environmental risk, propiconazole is soluble in water but 
relatively immobile in most soils and fairly persistent in the 
environment. No Maximum Concentration Level has been established for 
residues of propiconazole in drinking water. No Health Advisory Levels 
for propiconazole in drinking water have been established.

[[Page 32227]]

    Because the Agency lacks sufficient water-related exposure data to 
complete a comprehensive drinking water risk assessment for many 
pesticides, EPA has commenced and nearly completed a process to 
identify a reasonable yet conservative bounding figure for the 
potential contribution of water related exposure to the aggregate risk 
posed by a pesticide. In developing the bounding figure, EPA estimated 
residue levels in water for a number of specific pesticides using 
various data sources. The Agency then applied the estimated residue 
levels, in conjunction with appropriate toxicological endpoints (RfD's 
or acute dietary NOEL's) and assumptions about body weight and 
consumption, to calculate, for each pesticide, the increment of 
aggregate risk contributed by consumption of contaminated water. While 
EPA has not yet pinpointed the appropriate bounding figure for exposure 
from contaminated water, the ranges the Agency is continuing to examine 
are all below the level that would cause propiconazole to exceed the 
RfD if the tolerances being considered in this document were granted. 
The Agency has therefore concluded that the potential exposures 
associated with propiconazole in water, even at the higher levels the 
Agency is considering as a conservative upper bound, would not prevent 
the Agency from determining that there is a reasonable certainty of no 
harm if the tolerances are granted.
    3. From non-dietary exposure. Propiconazole is registered for 
residential usage as a preservative for finished wood (fences, window 
moldings) and for ornamental turf/lawns. Lawn care usage data available 
to the Agency indicates that there is no reported usage of 
propiconazole products by homeowners. Two sources reported usage by 
lawn care operators and landscapers. Based on acres treated 
information, between 3,850 to 6,725 households are estimated to be 
potentially treated with propiconazole. This represents between 0.004% 
to 0.007% of all households nationally.
    i. Acute risk. EPA generally will not include residential or other 
non-dietary exposure as a component of the acute exposure assessment. 
Theoretically, it is also possible that a residential, or other non-
dietary, exposure could be combined with the acute total dietary 
exposure from food and water. However, the Agency does not believe that 
aggregating multiple exposure to large amounts of pesticide residues in 
the residential environment via multiple products and routes for a one 
day exposure is a reasonably probable event. It is highly unlikely 
that, in one day, an individual would have multiple high-end exposures 
to the same pesticide by treating their lawn and garden, treating their 
house via crack and crevice application, swimming in a pool, and be 
maximally exposed in the food and water consumed. Additionally, the 
concept of an acute exposure as a single exposure does not allow for 
including post-application exposures, in which residues decline over a 
period of days after application. Therefore, the Agency believes that 
residential exposures are more appropriately included in the short-term 
exposure scenario discussed below.
    ii. Chronic risk. Based on the nature of the outdoor and indoor 
residential uses of propiconazole, the Agency has concluded that a 
chronic residential exposure scenario does not exist.
    iii. Short- and intermediate-term risk. Considering the nature of 
the outdoor residential uses, the Agency has concluded that a short- to 
intermediate-term outdoor residential exposure scenario could exist. 
The contribution from indoor residential inhalation exposure resulting 
from propiconazole-treated window moldings to the short- and 
intermediate-term aggregate risk would be negligible, and has not been 
included in this risk characterization.
    In the absence of data, and until further data are provided, risks 
from residential uses will be assumed to account for 10% (5% each for 
outdoor and indoor residential usage) of the total allowable aggregate 
short- and intermediate-term risk. OPP considers this estimate of total 
aggregate short- and intermediate-term exposure as conservative and 
protective of the public health. In the best scientific judgment of 
OPP, the shortand intermediate-term aggregate risks from the currently 
registered, and the proposed Section 18 uses of propiconazole, do not 
exceed our level of concern.

C. Cumulative Exposure to Substances with Common Mechanism of Toxicity

    Section 408(b)(2)(D)(v) requires that, when considering whether to 
establish, modify, or revoke a tolerance, the Agency consider 
``available information'' concerning the cumulative effects of a 
particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also scientific policies and 
methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may turn out to be 
helpful in eventually determining whether a pesticide shares a common 
mechanism of toxicity with any other substances, EPA does not at this 
time have the methodologies to resolve the complex scientific issues 
concerning common mechanism of toxicity in a meaningful way. EPA has 
begun a pilot process to study this issue further through the 
examination of particular classes of pesticides. The Agency hopes that 
the results of this pilot process will increase the Agency's scientific 
understanding of this question such that EPA will be able to develop 
and apply scientific principles for better determining which chemicals 
have a common mechanism of toxicity and evaluating the cumulative 
effects of such chemicals. The Agency anticipates, however, that even 
as its understanding of the science of common mechanisms increases, 
decisions on specific classes of chemicals will be heavily dependent on 
chemical specific data, much of which may not be presently available.
    Although at present the Agency does not know how to apply the 
information in its files concerning common mechanism issues to most 
risk assessments, there are pesticides as to which the common mechanism 
issues can be resolved. These pesticides include pesticides that are 
toxicologically dissimilar to existing chemical substances (in which 
case the Agency can conclude that it is unlikely that a pesticide 
shares a common mechanism of activity with other substances) and 
pesticides that produce a common toxic metabolite (in which case common 
mechanism of activity will be assumed).
    EPA does not have, at this time, available data to determine 
whether propiconazole has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
propiconazole does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that propiconazole has a common mechanism of 
toxicity with other substances.

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. For the population subgroup of concern, females 13+ 
and older (accounts for both maternal and fetal exposure), the 
calculated MOE

[[Page 32228]]

value is 3,000. This MOE value does not exceed the Agency's level of 
concern for acute dietary exposure. Despite the potential for exposure 
to propiconazole from drinking water EPA concludes that the aggregate 
acute risk from the currently registered uses of propiconazole does not 
exceed the Agency's level of concern.
    2. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure. For propiconazole, EPA does not have concerns for 
short- and intermediate-term dietary exposure because of the very high 
values calculated for the MOEs. The calculated MOE value is 34,000 for 
the U.S. population. Despite the potential for exposure to 
propiconazole from drinking water EPA concludes that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to propiconazole residues.
    3. Chronic risk. Using the conservative ARC exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
propiconazole from food will utilize 7% of the RfD for the U.S. 
population. EPA generally has no concern for exposures below 100% of 
the RfD because the RfD represents the level at or below which daily 
aggregate dietary exposure over a lifetime will not pose appreciable 
risks to human health. Despite the potential for exposure to 
propiconazole in drinking water and from non-dietary, non-occupational 
exposure, EPA does not expect the aggregate exposure to exceed 100% of 
the RfD. EPA concludes that there is a reasonable certainty that no 
harm will result from aggregate exposure to propiconazole residues.
    4. Cancer risk. Based on the OPP Carcinogenicity Peer Review 
Committee's (CPRC) recommendation that the RfD approach be used to 
assess cancer risk, a quantitative cancer risk assessment was not 
performed. Human health risk concerns due to long-term exposure to 
propiconazole residues are adequately addressed by the aggregate 
chronic exposure analysis using the RfD.

E. Aggregate Risks and Determination of Safety for Infants and Children

    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre-and post-natal toxicity and the 
completeness of the database unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a MOE analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. EPA believes that reliable data support using the standard MOE 
and uncertainty factor (usually 100 for combined inter- and intra-
species variability)) and not the additional tenfold MOE/uncertainty 
factor when EPA has a complete data base under existing guidelines and 
when the severity of the effect in infants or children or the potency 
or unusual toxic properties of a compound do not raise concerns 
regarding the adequacy of the standard MOE/safety factor.
    In assessing the potential for additional sensitivity of infants 
and children to residues of propiconazole, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. The developmental toxicity 
studies are designed to evaluate adverse effects on the developing 
organism resulting from pesticide exposure during prenatal development 
to one or both parents. Reproduction studies provide information 
relating to effects from exposure to the pesticide on the reproductive 
capability of mating animals and data on systemic toxicity.
    1. Developmental toxicity studies.--i. Rat. The maternal (systemic) 
NOEL was 30 mg/kg/day. The maternal LEL of 90 mg/kg/day was based on 
reduced body weight gain and rales in females. The developmental NOEL 
was also 30 mg/kg/day. The developmental LEL of 90 mg/kg/day was based 
on the increased incidence of unossified sternebrae, rudimentary ribs, 
and shortened or absent renal papillae.
    ii. Rabbit. The maternal (systemic) NOEL was 100 mg/kg/day. The 
maternal LEL of 250 mg/kg/day was based on decreased food consumption 
and body weight gain. There was also an increased incidence of abortion 
at 400 mg/kg/day. The developmental NOEL was 400 mg/kg/day (HDT), based 
upon the lack of developmental delays or alterations.
    2. Reproductive toxicity study (rat). From the 2-generation 
reproductive toxicity study in rats, the parental (systemic) LEL of 5 
mg/kg/day, the lowest dose tested (LET), was based on the increased 
incidence of hepatic ``clear-cell change'' at all dose levels; 
additionally, at 25 and 125 mg/kg/day, decreased body weights, 
decreased food consumption, and/or an increased incidence of hepatic 
cellular swelling were observed. A NOEL for parental toxicity was not 
determined. The reproductive/ developmental NOEL was 25 mg/kg/day. The 
reproductive LEL of 125 mg/kg/day was based on decreased offspring 
survival of second generation (F.) pups, on decreased body weight 
throughout lactation, and on an increase in the incidence of hepatic 
cellular swelling for both generations of offspring (F1 and F. pups).
    3. Pre- and post-natal sensitivity. The developmental toxicity 
NOELs were 30 mg/kg/day in rats and 400 mg/kg/day (HDT) in rabbits. 
Developmental toxicity was observed in rats at 90 mg/kg/day; these 
effects occurred in the presence of maternal toxicity. In rabbits, no 
developmental delays or alterations were noted; however, increased 
abortions were observed at the maternally toxic dose of 400 mg/kg/day. 
The developmental NOELs are more than 24- and 320-fold higher in rats 
and rabbits, respectively, than the NOEL of 1.25 mg/kg/day from the 1-
year feeding study in dogs, which is the basis of the RfD.
    In the two-generation reproductive toxicity study in rats, the 
reproductive (pup) toxicity NOEL of 25 mg/kg/day was greater than the 
parental (systemic) toxicity NOEL (<5 mg/kg/day; LET). The NOEL of 25 
mg/kg/day for reproductive (pup) toxicity was 20-fold higher than the 
NOEL of 1.25 mg/kg/day from the 1-year feeding study in dogs, which is 
the basis of the RfD. The reproductive (pup) LEL of 125 mg/kg/day was 
based on decreased offspring survival of second generation (F.) pups, 
and on decreased body weight throughout lactation, and an increase in 
the incidence of hepatic cellular swelling for both generations of 
offspring (F. and F. pups). Because these reproductive effects occurred 
in the presence of parental (systemic) toxicity, these data do not 
suggest increased pre- or post-natal sensitivity to infants and 
children (that infants and children might be more sensitive than 
adults) to propiconazole exposure.
    4. Acute risk. For the population subgroup of concern, females 13+ 
years, an MOE value of 3,000 was calculated using the high end exposure 
value of 0.01 mg/kg/day. Tolerance level residues and 100% crop-treated 
information were used in conducting the analysis. Thus, this acute 
dietary risk estimate is considered conservative. The large acute 
dietary MOE calculated for females 13+ years old provides assurance 
that there is a reasonable certainty of no harm from aggregate 
exposures to females 13+ years and the pre-natal development of 
infants.
    5. Short- or intermediate-term risk. For the most highly exposed 
population subgroup (non-nursing infants less than

[[Page 32229]]

1 year old), a short- and intermediate-term MOE of 11,000 was 
calculated. The large MOE calculated for nonnursing infants provides 
assurance that there is a reasonable certainty of no harm for infants 
and children from short- and intermediate-term aggregate exposures to 
propiconazole residues.
    6. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that the percent of the RfD that 
will be utilized by aggregate exposure to residues propiconazole from 
food ranges from 8% for nursing infants, up to 20% for non-nursing 
infants (the most highly exposed population subgroup). EPA generally 
has no concern for exposures below 100% of the RfD because the RfD 
represents the level at or below which daily aggregate dietary exposure 
over a lifetime will not pose appreciable risks to human health. 
Despite the potential for exposure to propiconazole in drinking water 
and from non-dietary, non-occupational exposure, EPA does not expect 
the aggregate exposure to exceed 100% of the RfD. EPA concludes that 
there is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to propiconazole residues.

V. Other Considerations

    1. Metabolism in plants and animals. The metabolism of 
propiconazole in plants and animals is adequately understood for the 
purposes of these tolerance actions. The residues of concern are 
propiconazole (1-[[2-(2,4-dichloro-phenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl]-1H-1,2,4-triazole), and its metabolites determined as 2,4-
dichlorobenzoic acid (DCBA) and expressed as parent compound as per 40 
CFR 180.434.
    2. Analytical enforcement methodology. There are practical 
analytical methods for detecting and measuring levels of propiconazole 
in or on food with a limit of detection that allows monitoring of food 
with residues at or above the levels set in these tolerances. EPA has 
provided information on these method to FDA. These methods have been 
approved for publication in PAM II for enforcement purposes.
    3. Magnitude of residues. Residues of propiconazole are not 
expected to exceed 0.5 ppm in/on dry beans (seed), 8.0 ppm in/on dry 
bean forage, and 8.0 ppm in/on dry bean hay as a result of these 
Section 18 uses. Time-limited tolerances should be established at these 
levels. Secondary residues in animal commodities are not expected to 
exceed existing tolerances as a result of these Section 18 uses.
    4. International residue limits. There are no Codex, Canadian, or 
Mexican international residue limits established for use of 
propiconazole on dry beans.

VI. Conclusion

    Therefore, tolerances in connection with the FIFRA section 18 
emergency exemptions are established for the combined residues of 
propiconazole and its metabolites determined as 2,4-dichlorobenzoic 
acid (DCBA) and expressed as parent compound, in or on dry beans at 0.5 
ppm, in or on dry bean forage at 8.0 ppm, and in or on dry bean hay at 
8.0 ppm.

VII. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by August 12, 1997, file written objections to any 
aspect of this regulation (including the revocation provision) and may 
also request a hearing on those objections. Objections and hearing 
requests must be filed with the Hearing Clerk, at the address given 
above (40 CFR 178.20). A copy of the objections and/or hearing requests 
filed with the Hearing Clerk should be submitted to the OPP docket for 
this rulemaking. The objections submitted must specify the provisions 
of the regulation deemed objectionable and the grounds for the 
objections (40 CFR 178.25). Each objection must be accompanied by the 
fee prescribed by 40 CFR 180.33(I). If a hearing is requested, the 
objections must include a statement of the factual issues on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the requestor (40 CFR 178.27). A 
request for a hearing will be granted if the Administrator determines 
that the material submitted shows the following: There is genuine and 
substantial issue of fact; there is a reasonable possibility that 
available evidence identified by the requestor would, if established, 
resolve one or more of such issues in favor of the requestor, taking 
into account uncontested claims or facts to the contrary; and 
resolution of the factual issues in the manner sought by the requestor 
would be adequate to justify the action requested (40 CFR 178.32). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as Confidential Business Information (CBI). Information so 
marked will not be disclosed except in accordance with procedures set 
forth in 40 CFR part 2. A copy of the information that does not contain 
CBI must be submitted for inclusion in the public record. Information 
not marked confidential may be disclosed publicly by EPA without prior 
notice.

VIII. Public Docket

    A record has been established for this rulemaking under docket 
control number [OPP-300494]. A public version of this record, which 
does not include any information claimed as CBI, is available for 
inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The public record is located in Room 1132 of the Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7506C), Office of Pesticide Programs, Environmental 
Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway, 
Arlington, VA.
    The official record for this rulemaking, as well as the public 
version, as described above, is kept in paper form. Accordingly, in the 
event there are objections and hearing requests, EPA will transfer any 
copies of objections and hearing requests received electronically into 
printed, paper form as they are received and will place the paper 
copies in the official rulemaking record. The official rulemaking 
record is the paper record maintained at the address in ADDRESSES at 
the beginning of this document.

IX. Regulatory Assessment Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' and, since this 
action does not impose any information collection requirements as 
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is 
not subject to review by the Office of Management and Budget. In 
addition, this action does not impose any enforceable duty or contain 
any unfunded mandate as described in the Unfunded Mandates Reform Act 
of 1995 (Pub. L. 104-4), or require prior consultation with State 
officials as

[[Page 32230]]

specified by Executive Order 12875 (58 FR 58093, October 28, 1993), or 
special considerations as required by Executive Order 12898 (59 FR 
7629, February 16, 1994).
    Because FFDCA section 408(l)(6) permits establishment of this 
regulation without a notice of proposed rulemaking, the regulatory 
flexibility analysis requirements of the Regulatory Flexibility Act, 5 
U.S.C. 604(a), do not apply. Nonetheless, the Agency has previously 
assessed whether establishing tolerances or exemptions from tolerance, 
raising tolerance levels, or expanding exemptions adversely impact 
small entities and concluded, as a generic matter, that there is no 
adverse impact. (46 FR 24950, May 4, 1981).
    Under 5 U.S.C. 801(a)(1)(A) of the Small Business Regulatory 
Enforcement Fairness Act of 1996 (Title II of Pub. L. 104-121, 110 
Stat. 847), EPA submitted a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives and the Comptroller General of the General Accounting 
Office prior to publication of the rule in today's Federal Register. 
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

Dated: May 28, 1997.

James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR Chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 371.
    2. In Sec. 180.434, paragraph (b) is amended by alphabetically 
adding the tolerances to the table to read as follows:


Sec. 180.434  1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl]-1H-1,2,4-triazole; tolerances for residues.

*   *   *   *   *  
    (b) *   *   *  

----------------------------------------------------------------------------------------------------------------
                                                                                          Expiration/ Revocation
                           Commodity                               Parts per million               Date         
----------------------------------------------------------------------------------------------------------------
                                                                                                                
*                    *                    *                    *                    *                    *      
                                                              *                                                 
Dry bean forage...............................................                      8.0        December 31, 1998
Dry bean hay..................................................                      8.0        December 31, 1998
Dry beans.....................................................                      0.5        December 31, 1998
                                                                                                                
*                    *                      *                    *                    *                    *    
                                                               *                                                
----------------------------------------------------------------------------------------------------------------

*   *   *   *   *  
[FR Doc. 97-15373 Filed 6-12-97; 8:45 am]
BILLING CODE 6560-50-F