[Federal Register Volume 64, Number 51 (Wednesday, March 17, 1999)]
[Rules and Regulations]
[Pages 13080-13086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6388]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300810; FRL-6068-4]
RIN 2070-AB78


Propiconazole; Establishment of Time-Limited Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
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 and expressed as parent compound 
in or on corn, peanuts and pineapples. Novartis Crop Protection, Inc. 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996. The 
tolerances will expire on December 31, 2000.
DATES: This regulation is effective March 17, 1999. Objections and 
requests for hearings must be received by EPA on or before May 17, 
1999.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300810], 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-300810, must also be submitted to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, bring a copy of 
objections and hearing requests to Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of electronic objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket control number [OPP-300810]. 
No Confidential Business Information (CBI) should be submitted through 
e-mail. Copies of electronic objections and hearing requests on this 
rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Mary L. Waller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Rm. 249, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9354, 
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of November 20, 1998 
(63 FR 64498) (FRL-6042-1), EPA issued a notice pursuant to section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as 
amended by the Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-
170) announcing the filing of pesticide petitions (PP) for tolerances 
by Novartis Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 
27419. This notice included a summary of the petitions prepared by 
Novartis Crop Protection, Inc., the registrant. There were no comments 
received in response to the notice of filing.
    The petitions requested that 40 CFR 180.434 be amended by 
establishing time-limited tolerances for combined residues of the 
fungicide propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-
dioxolan-2-yl]methyl]-1H-1,2,4-triazole and its metabolites determined 
as 2,4-dichlorobenzoic acid and expressed as parent compound on corn, 
fodder at 12 parts per million (ppm); corn, forage at 12 ppm; corn, 
grain at 0.1 ppm; corn, sweet (kernels plus cobs with husks removed) at 
0.1 ppm; peanuts at 0.2 ppm; peanuts, hay at 20 ppm; pineapple at 0.1 
ppm and pineapple, fodder at 0.1 ppm. These proposed tolerances will 
expire on December 31, 2000 and will replace previously established 
tolerances which expired on December 31, 1998.

I. Background and Statutory Findings

    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. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate

[[Page 13081]]

exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

II. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of 
propiconazole and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for time-limited tolerances for 
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 and expressed as parent compound 
on corn, fodder at 12 parts per million (ppm); corn, forage at 12 ppm; 
corn, grain at 0.1 ppm; corn, sweet (kernels plus cobs with husks 
removed) at 0.1 ppm; peanuts at 0.2 ppm; peanuts, hay at 20 ppm; 
pineapple at 0.1 ppm and pineapple, fodder at 0.1 ppm. EPA's assessment 
of the dietary exposures and risks associated with establishing the 
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by propiconazole are 
discussed in this unit.
    1. Acute toxicity data were as follows: acute oral LD50 
= 1,517 m/kg (toxicity category III); acute dermal LD50 > 
4,000 mg/kg (toxicity category III); acute inhalation LC50 = 
1.26 mg/L; primary eye irritation - clear by 72 hours (toxicity 
category III); primary skin irritation - slight irritation (toxicity 
category IV); and dermal sensitization - negative.
    2. A developmental toxicity study with rats which were gavaged with 
doses of 0, 30, 90 or 360/300 mg/kg/day. The developmental no observed 
adverse effect level (NOAEL) was 30 mg/kg/day. Evidence of 
developmental toxicity observed at the 90 mg/kg/day level lowest 
observed adverse effect level (LOAEL) included statistically 
significant increased incidence of unossified sternebrae, and nominally 
increased rudimentary ribs, and shortened or absent renal papillae. The 
maternal NOAEL was 30 mg/kg/day and the maternal LOAEL was 90 mg/kg/day 
based on reduced body weight gain and occurrence of rales in 1/24 
females.
    3. A developmental toxicity study with rabbits which were gavaged 
with doses of 0, 30, 90, or 180 mg/kg/day with no evidence of maternal 
or developmental toxicity observed under the conditions of the study.
    4. A developmental toxicity study with rabbits which were gavaged 
with doses of 0, 100, 250, or 400 mg/kg/day on gestation days 7 through 
19 with no developmental toxicity observed under the conditions of the 
study. The maternal NOAEL was 100 mg/kg/day and the maternal LOAEL was 
250 mg/kg/day based on decreased food consumption, weight gain, and an 
increase in the number of resorptions at the higher dose levels. The 
developmental NOAEL was 400 mg/kg/day.
    5. A 2-generation reproduction study with rats fed diets containing 
0, 1, 100, 500 or 2,500 ppm showed no reproductive effects under the 
conditions of the study. The developmental NOAEL was 500 ppm 
(equivalent to 25 mg/kg/day), and the developmental LOAEL was 2,500 ppm 
(equivalent to 125 mg/kg/day) based on decreased offspring survival, 
body weight depression, and increased incidence of hepatic lesions in 
rats. The parental NOAEL was 100 ppm (equivalent to 5 mg/kg/day) and 
the parental LOAEL was 500 ppm (equivalent to 25 mg/kg/day) based on 
increased incidence of hepatic cell change.
    6. A 1-year feeding study with dogs fed diets containing 0, 5, 50, 
or 250 ppm with a NOAEL of 50 ppm (equivalent to 1.25 mg/kg/day). The 
LOAEL was 250 ppm (equivalent to 6.25 mg/kg/day based on mild 
irritation of stomach mucosa.
     7. A 2-year chronic feeding/carcinogenicity study with rats fed 
diets containing 0, 100, 500, or 2,500 ppm with a systemic NOAEL of 100 
ppm (equivalent to 5 mg/kg/day) based on hepatocyte changes in males at 
the 500 ppm level and in both sexes at the 2,500 ppm level. There were 
no carcinogenic effects observed under the conditions of the study.
    8. A 2-year chronic feeding/carcinogenicity study with mice fed 
diets containing 0, 100, 500, or 2,500 ppm with a systemic NOAEL of 100 
ppm (equivalent to 15 mg/kg/day) based on decreased body weight, and 
increased liver lesions and liver weight in males. There was a 
statistically significant increase in combined adenomas and carcinomas 
of the liver in male mice at the 2,500 ppm level (equivalent to 375 mg/
kg/day).
    9. A battery of mutagenicity studies to determine the potential of 
propiconazole to induce gene mutation, chromosomal aberrations, and 
other genotoxic effects were all negative.

B. Toxicological Endpoints

    1. Acute toxicity. The acute reference dose (RfD) is 0.3 mg/kg/day 
based on the NOAEL of 30 mg/kg/day from a developmental toxicity study 
in rats and using an uncertainty factor (UF) of 100.
     2. Short- and intermediate-term toxicity. For short- and 
intermediate-term dermal margin of exposure (MOE) calculations, the 
developmental NOAEL of 30 mg/kg/day from a developmental toxicity study 
in rats was selected. For short- and intermediate-term inhalation MOE 
calculations the NOAEL of 92.8 mg/kg/day (0.5 mg/L), the highest dose 
tested, from a 5-day inhalation toxicity study was selected.
    3. Chronic toxicity. EPA has established the RfD for propiconazole 
at 0.013 milligrams/kilogram/day (mg/kg/day). This RfD is based on a 1-
year feeding study in dogs with a NOAEL of 1.25 mg/kg/day and an 
uncertainty factor of 100. The LOAEL of 6.25 mg/kg/day was based on 
mild irritation of the gastric mucosa.
    4. Carcinogenicity. Propiconazole has been classified as a Group C, 
``possible human carcinogen'', chemical. The Cancer Peer Review 
Committee recommended using the RfD approach for quantification of 
human risk.

C. Exposures and Risks 

    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 and 
expressed as parent compound, in or on a variety of raw agricultural 
commodities. Among these tolerances are stone fruits, various grain 
crops, grass, bananas, celery, mushrooms and pecans. Tolerances have 
also been established for meat, milk, poultry and eggs. Risk 
assessments were conducted by EPA to assess dietary exposure from 
propiconazole as follows:
    Section 408(b)(2)(E) authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on

[[Page 13082]]

such information, EPA must require that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. Following the initial data submission, EPA is authorized 
to require similar data on a time frame it deems appropriate. As 
required by section 408(b)(2)(E), EPA will issue a data call-in for 
information relating to anticipated residues to be submitted no later 
than 5 years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of food treated for assessing chronic dietary risk only 
if the Agency can make the following findings: That the data used are 
reliable and provide a valid basis to show what percentage of the food 
derived from such crop is likely to contain such pesticide residue; 
that the exposure estimate does not underestimate exposure for any 
significant population subgroup; and if data are available on pesticide 
use and food consumption in a particular area, the exposure estimate 
does not understate exposure for the population in such area. In 
addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of percent of crop treated as required by the section 408(b)(2)(F), EPA 
may require registrants to submit data on percent of crop treated.
    Percent of crop treated estimates are derived from Federal and 
private market survey data, which are reliable and have a valid basis. 
Typically, a range of estimates are supplied and the upper end of this 
range is assumed for exposure assessment. By using this upper end 
estimate of percent of crop treated, the Agency is reasonably certain 
that the percentage of the food treated is not likely to be an 
underestimated. Regional consumption information and consumption 
information for significant population subgroups is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant population subgroups including several regional groups. Use 
of this consumption information in EPA's risk assessment process 
ensures that EPA's exposure estimate does not understate exposure for 
any significant subpopulation group and allows the Agency to be 
reasonably certain that no regional population is exposed to residue 
levels higher than those estimated by the Agency. Other than the data 
available through national food consumption surveys, EPA does not have 
available information on the regional consumption of food to which 
propiconazole may be applied in a particular area.
    The Agency used percent of crop treated (PCT) information as 
follows: The percent crop treated data used in the risk estimates for 
propiconazole for the crops for which tolerances are being established 
are: corn, 6%; pineapples, 100%; and peanuts, 1%. Percent crop treated 
data was used in determinations for several crops for which tolerances 
are already established (pecans, peaches, rice, rye and wheat).
    i. Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1-day or single exposure. The acute dietary (food only) risk 
assessment used the theoretical maximum residue contribution (TMRC), 
individual food consumption data as reported in the USDA Nationwide 
Food Consumption Survey (NFCS) which accumulates exposure to 
propiconazole from each commodity, and the assumption that 100% of the 
crops were treated with propiconazole. This risk assessment used high-
end exposure estimates and should be viewed as a conservative risk 
assessment which overestimates the risk. The acute dietary exposure for 
the only population subgroup of concern, females 13 years and older, 
used 3.3% of the acute RfD of 0.3 mg/kg/day. The acute dietary risk 
(food only) does not exceed the Agency's level of concern.
    ii. Chronic exposure and risk. The chronic dietary risk assessment 
used the RfD of 0.013 mg/kg/day. EPA used data from the USDA NFCS, and 
made partial refinements to the exposure assumptions. Tolerance level 
residues were used for corn, pineapples and peanuts. Percent of crop 
treated estimates were made for corn (6%), pineapple (100%) and peanuts 
(1%). For some of the other crops included in the analysis, anticipated 
residue levels and percent crop treated estimates were used. The 
existing propiconazole tolerances (published and pending, including 
tolerances for emergency exemptions) resulted in exposure estimates 
that are equivalent to the following percentages of the RfD: U.S. 
population (48 states), 7%; non-nursing infants less than 1 year old, 
20%; children 1-6 years old, 13%; children 7-12 years old, 9%; all 
other subgroups, 6-9%. EPA generally has no concern for exposures below 
100% of the chronic RfD (when the FQPA factor has been removed) because 
this RfD represents the level at or below which daily aggregate dietary 
exposure over a lifetime will not pose appreciable risks to human 
health. Therefore, the chronic dietary risk (food only) does not exceed 
the Agency's level of concern. 
    2. From drinking water. In the absence of reliable, available 
monitoring data, EPA uses models to estimate concentrations of 
pesticides in ground and surface water. For propiconazole, modeling 
data were used to estimate surface water concentrations because very 
limited surface water monitoring data were available. EPA does not use 
these model estimates to quantify risk. Currently, EPA uses drinking 
water levels of comparison (DWLOCs) to estimate risk associated with 
exposure to pesticides in drinking water. A DWLOC is the concentration 
of a pesticide in drinking water that would be acceptable as an upper 
limit in light of total aggregate exposure to that pesticide from food, 
water, and residential uses. A DWLOC will vary depending on the residue 
level in foods, the toxicity endpoint and with drinking water 
consumption patterns and body weights for specific population 
subgroups. EPA believes model estimates to be overestimations of 
concentrations of propiconazole expected in drinking water. 
Propiconazole is moderately persistent and moderately mobile to 
immobile in soil and aqueous environments. It has the potential to be 
transported with water, particularly in coarse-textured soils low in 
organic matter. Propiconazole's persistence indicates the potential to 
reach surface water with run-off or adsorb to soil particles. There is 
no established Maximum Contaminant Level for residues of propiconazole 
in drinking water. No health advisory levels for propiconazole in 
drinking water have been established.
    i. Acute exposure and risk. The acute DWLOC is 8,700 g/L 
for the only population subgroup of concern, females 13 years old or 
older. The estimated environmental concentration (EEC) in surface water 
(0.11 g/L, peak value) is much lower than EPA's DWLOC of 8,700 
g/L for the population subgroup, females 13 years old or 
older. Therefore, EPA concludes with reasonable certainty that exposure 
to propiconazole in drinking water will result in no harm.
    ii. Chronic exposure and risk. The chronic DWLOC is 100 g/
L for the population subgroup with the lowest chronic DWLOC (non-
nursing infants < 1 year old). The lowest chronic DWLOC is 
substantially higher than the Generic Expected Environmental 
Concentration (GENEEC) 56-day EEC of 0.09 g/L. Therefore, EPA 
concludes with reasonable certainty that exposure of propiconazole in 
drinking water is less than EPA's level of concern.

[[Page 13083]]

    3. From non-dietary exposure. Propiconazole is currently registered 
for use on the following residential non-food sites: wood preservative. 
Under current Agency guidelines, this use does not present an acute or 
chronic exposure scenario, but may constitute a short- and/or 
intermediate-term dermal and inhalation exposure scenario for 
applicators. The Agency calculated short- and intermediate-term dermal 
and inhalation margins of exposure (MOEs) of 200 and 200,000 
respectively for the wood preservative use of propiconazole. MOEs above 
100 do not exceed the Agency's level of concern. For post application 
exposure, the Agency determined that propiconazole is volatile and not 
readily aerosolized. Therefore, post-application exposure from contact 
with treated wood is expected to be minimal and the Agency determined 
that a risk assessment for post-application exposure is not needed.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    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. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

    1. Acute risk. The acute dietary (food only) risk does not exceed 
the Agency's level of concern. Using the TMRC, the population subgroup 
of concern, females 13 years old and older, utilizes 3.3% of the 
dietary (food only) acute RfD . For drinking water, the acute DWLOC for 
this population subgroup is 8,700 g/L which is substantially 
higher that the peak EEC of 0.11 g/L. Therefore, the risk from 
acute aggregate exposure to propiconazole does not exceed the Agency's 
level of concern.
    2. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to propiconazole from 
food will utilize 7% of the RfD for the U.S. population. The major 
identifiable subgroup with the highest aggregate exposure is discussed 
below. EPA generally has no concern for exposures below 100% of the RfD 
because the RfD represents the level at or below which daily aggregate 
dietary exposure over a lifetime will not pose appreciable risks to 
human health. 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.
    3. Short- and intermediate-term risk.  Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus short- and 
intermediate-term dermal and inhalation exposure from residential uses. 
The dermal and inhalation endpoints used for estimating short- and 
intermediate-term exposure via the two routes of exposure measured 
different toxic effects. Therefore, the dermal margin of exposure (MOE) 
and the inhalation MOE should not be aggregated. For residential uses, 
dermal exposure of applicators was considered to be the driving factor 
in the short- and intermediate-term risk assessment, and the 
contribution of inhalation exposure to the short- and intermediate-term 
risk assessment was negligible (inhalation MOE = 200,000). Therefore, 
the inhalation exposure was not calculated in the aggregate short-and 
intermediate-term risk assessment. The aggregate short- and 
intermediate-term risk assessment estimated the dietary MOE to be 
33,000, the dermal MOE to be 200 and the DWLOC to be 4,500 g/L 
which is higher than the EEC of 0.09 g/L. Therefore, the 
short- and intermediate-term aggregate risk does not exceed the 
Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. EPA classified 
propiconazole as a Group C, possible human carcinogen and determined 
that the RfD approach be used to estimate the carcinogenic risk to 
humans. Risk concerns for carcinogenicity due to long-term consumption 
of propiconazole residues are adequately addressed by the aggregate 
chronic exposure analysis using the chronic RfD. Therefore, EPA 
concludes that there is reasonable certainty that no harm will result 
from aggregate exposure to propiconazole residue.
    5.  Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to residues of propiconazole.

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

    1. Safety factor for infants and children--i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of propiconazole, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a 2-generation 
reproduction study in the rat. The developmental toxicity studies are 
designed to evaluate adverse effects on the developing organism 
resulting from maternal pesticide exposure gestation. Reproduction 
studies provide information relating to effects from exposure to the 
pesticide on the reproductive capability of mating animals and data on 
systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre-and post-natal toxicity and the 
completeness of the database unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a margin of exposure (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 uncertainty factor (usually 100 for combined inter- 
and intra-species variability) and not the additional tenfold MOE/
uncertainty factor when EPA has a complete data base under existing 
guidelines and when the severity of the effect in infants or children 
or the potency or unusual toxic properties of a compound do not raise 
concerns regarding the adequacy of the standard MOE/safety factor.
    ii. Pre- and post-natal sensitivity. The pre- and post-natal 
toxicology data base for propiconazole is complete with respect to 
current FQPA-relevant toxicological data requirements. Propiconazole is 
not developmentally toxic in the rabbit. There is evidence that 
propiconazole is developmentally toxic in the rat at doses that are 
toxic to the parents. In the developmental toxicity study in rats, the 
toxicity noted

[[Page 13084]]

at the maternal LOAEL of 90 mg/kg/day consisted of rales and decreased 
weight gain on gestation days 6-8 whereas the toxicity noted at the 
developmental LOAEL of 90 mg/kg/day consisted of statistically 
significant increased incidences of unossified sternebrae, and 
nominally increased incidences of rudimentary ribs and shortened or 
absent renal papillae. Where fetotoxic effects occur at the maternally 
toxic dose levels, they generally are of less concern than those 
occurring at non-maternally toxic dose levels because of the influence 
of toxicity in the mothers on the fetal toxicity expressed. However, 
where the fetal effects are judged to be qualitatively more severe than 
the effects in the maternal animals, there may be greater sensitivity 
in the fetus and thus of greater concern. Here, the effects in the 
fetus (delayed development) were not judged to be more sever than the 
effects in the maternal animals (decreased weight gain).
    iii. Conclusion. There is a complete toxicity database for 
propiconazole and exposure data is complete or is estimated based on 
data that reasonably accounts for potential exposures. Based on the 
completeness of the data base and the lack of any data indicating 
increased pre- or post-natal sensitivity, EPA concludes that an 
additional safety factor is not necessary to protect the safety of 
infants and children.
    2. Acute risk. The available studies suggest the only acute risk 
infants and children face from propiconazole is through exposure to the 
developing fetus as a result of exposure to the mother. As shown in 
Unit II. D.1. of this preamble, the acute risk to the developing fetus 
from this exposure is not above the Agency's level of concern.
    3. Chronic risk. Using the conservative exposure assumptions 
described in this unit, EPA has concluded that aggregate exposure to 
propiconazole from food will utilize 50% of the RfD for infants and 
children. 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.
    4. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to propiconazole 
residues.

III. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the residues in plants and animals is adequately 
understood. The residues of concern are propiconazole and its 
metabolites determined as 2,4-dichlorobenzoic acid and expressed as 
parent compound.

B. Analytical Enforcement Methodology

     Adequate enforcement methodology (GC/ECD) is available to enforce 
the tolerance expression. The method may be requested from: Calvin 
Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location and telephone number: Rm 101FF, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA, (703) 305-5229.

C. Magnitude of Residues

    The currently established time-limited tolerances for corn, 
peanuts, and pineapple commodities are appropriate for these crops.

D. International Residue Limits

    There are no CODEX, Canadian, or Mexican Maximum Residue Limits 
(MRL) for propiconazole on corn, peanuts, or pineapple. Thus, 
harmonization of tolerances is not an issue for the extension of these 
tolerances.

E. Rotational Crop Restrictions

    Soybeans may be planted as a double crop following a cereal crop 
which has been treated with propiconazole. Crops intended for food, 
grazing, or any component of animal feed or bedding may not be rotated 
within 105 days of propiconazole application unless the crop appears on 
the product label.

IV. Conclusion

    Therefore, the time-limited tolerances are extended for 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 and expressed as parent compound on corn, 
fodder at 12 ppm; corn, forage at 12 ppm; corn, grain at 0.1 ppm; corn, 
sweet (kernels, plus cobs with husks removed) at 0.1 ppm; peanuts at 
0.2 ppm; peanuts, hay at 20 ppm; pineapple at 0.1 ppm and pineapple, 
fodder at 0.1 ppm. These tolerances will expire on December 31, 2000 
and will replace previously established tolerances which expired on 
December 31, 1998. These tolerances are time-limited because the Agency 
has not completed the review of a modified carcinogenicity study in 
mice which required testing at a mid-dose level. This study was 
requested to confirm or supplement findings in an Agency reviewed 
carcinogenicity study in mice in which testing was conducted at low and 
high dose levels.

V. 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 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 May 17, 1999, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given under ``ADDRESSES'' section (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) or a request for a fee waiver. EPA is authorized to 
waive any fee requirement ``when in the judgement of the Administrator 
such a waiver or refund is equitable and not contrary to the purpose of 
this subsection.'' For additional information regarding tolerance 
objection fee waivers, contact James Tompkins, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. Office location, telephone 
number, and e-mail address: Rm. 239, Crystal Mall #2, 1921 Jefferson 
Davis Hwy., Arlington, VA, (703) 305-5697, [email protected]. 
Requests for waiver of tolerance objection fees should be sent to James 
Hollins, Information Resources and Services

[[Page 13085]]

Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    If a hearing is requested, the objections must include a statement 
of the factual issues on which a hearing is requested, the requestor's 
contentions on such issues, and a summary of any evidence relied upon 
by the requestor (40 CFR 178.27). A request for a hearing will be 
granted if the Administrator determines that the material submitted 
shows the following: There is genuine and substantial issue of fact; 
there is a reasonable possibility that available evidence identified by 
the requestor would, if established, resolve one or more of such issues 
in favor of the requestor, taking into account uncontested claims or 
facts to the contrary; and resolution of the factual issues in the 
manner sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32). Information submitted in connection with an 
objection or hearing request may be claimed confidential by marking any 
part or all of that information as CBI. Information so marked will not 
be disclosed except in accordance with procedures set forth in 40 CFR 
part 2. A copy of the information that does not contain CBI must be 
submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice.

VI. Public Record and Electronic Submissions

    EPA has established a record for this regulation under docket 
control number [OPP-300810] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    Objections and hearing requests may be sent by e-mail directly to 
EPA at:
    [email protected].

    E-mailed objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption.
    The official record for this regulation, as well as the public 
version, as described in this unit will be kept in paper form. 
Accordingly, EPA will transfer any copies of objections and hearing 
requests received electronically into printed, paper form as they are 
received and will place the paper copies in the official record which 
will also include all comments submitted directly in writing. The 
official record is the paper record maintained at the Virginia address 
in ``ADDRESSES'' at the beginning of this document.

 VII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes time-limited tolerances under section 
408(d) of the FFDCA in response to a petition submitted to the Agency. 
The Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled Regulatory 
Planning and Review (58 FR 51735, October 4, 1993). This final rule 
does not contain any information collections subject to OMB approval 
under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or 
impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as 
specified by Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or 
special considerations as required by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994), 
or require OMB review in accordance with Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997).
    In addition, since tolerances and exemptions that are established 
on the basis of a petition under FFDCA section 408(d), such as the 
tolerances in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency 
previously assessed whether establishing tolerances, exemptions from 
tolerances, raising tolerance levels or expanding exemptions might 
adversely impact small entities and concluded, as a generic matter, 
that there is no adverse economic impact. The factual basis for the 
Agency's generic certification for tolerance actions published on May 
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for 
Advocacy of the Small Business Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected officials and other representatives of Indian tribal 
governments ``to provide

[[Page 13086]]

meaningful and timely input in the development of regulatory policies 
on matters that significantly or uniquely affect their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and the Comptroller General of the United 
States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: March 4, 1999.

James Jones,

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. 321(q), 346a and 371.

Sec. 180.434  [Amended]

    2. In Sec. 180.434, in the table to paragraph (a), by changing the 
expiration dates for corn, fodder; corn, forage; corn, grain; corn, 
sweet (kernels plus cobs with husks removed); peanuts; peanuts, hay; 
pineapple; and pineapple, fodder, to read ``12/31/00''.

[FR Doc. 99-6388 Filed 3-16-99; 8:45 am]
BILLING CODE 6560-50-F