[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