[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Rules and Regulations]
[Pages 75039-75045]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30447]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0772; FRL-9369-5]
Propiconazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
propiconazole in or on sugarcane, cane. Syngenta Crop Protection, LLC
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective December 19, 2012. Objections and
requests for hearings must be received on or before February 19, 2013,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0772, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Erin Malone, Registration Division
(7505P),
[[Page 75040]]
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 347-0253; email address: malone.erin@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0772 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
February 19, 2013. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any CBI) for inclusion in the public docket.
Information not marked confidential pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior notice. Submit the non-CBI copy
of your objection or hearing request, identified by docket ID number
EPA-HQ-OPP-2011-0772, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-for Tolerance
In the Federal Register of November 9, 2011 (Volume 76, FR 69690)
(FRL-9325-1), EPA issued a notice pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1F7892) by Syngenta Crop Protection, LLC, P.O. Box 18300 Greensboro, NC
27419-8300. The petition requested that 40 CFR 180.434 be amended by
establishing tolerances for residues of the fungicide propiconazole,
1H-1,2,4-Triazole, 1-{[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl{time} -, and its metabolites determined as 2,4-
dichlorobenzoic acid and expressed as parent compound in or on
sugarcane, cane at 1.0 parts per million (ppm). That notice referenced
a summary of the petition prepared by Syngenta Crop Protection, LLC,
the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
proposed a different tolerance level for the reasons explained in Unit
IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of 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) of FFDCA 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) of FFDCA 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 * *
*.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA 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 and to make a
determination on aggregate exposure for propiconazole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with propiconazole
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 toxicology database for propiconazole is adequate for
evaluating and characterizing toxicity and selecting endpoints for
purposes of this risk assessment. The primary target organ for
propiconazole toxicity in animals is the liver. Increased liver weights
were seen in mice after subchronic or chronic oral exposures to
propiconazole. Liver lesions such as vacuolation of hepatocytes,
ballooned liver cells, foci of enlarged hepatocytes, hypertrophy and
necrosis are characteristic of propiconazole toxicity in rats and mice.
Decreased body weight gain was also seen in subchronic, chronic,
developmental and reproductive studies in animal studies. Dogs appeared
to be more sensitive to the localized toxicity of propiconazole as
manifested by stomach irritations at 6 mg/kg/day and above.
In rabbits, developmental toxicity occurred at a higher dose than
the maternally toxic dose, while in rats, developmental toxicity
occurred at
[[Page 75041]]
lower doses than maternal toxic doses. Increased incidences of
rudimentary ribs occurred in rat and rabbit fetuses. Increased cleft
palate malformations were noted in two studies in rats. In one
published study in rats, developmental effects (malformations of the
lung and kidneys, incomplete ossification of the skull, caudal
vertebrae and digits, extra rib (14th rib) and missing sternbrae) were
reported at doses that were not maternally toxic.
In the two generation reproduction study in rats, offspring
toxicity occurred at a higher dose than the parental toxic dose
suggesting lower susceptibility of the offspring to the toxic doses of
propiconazole.
Propiconazole was negative for mutagenicity in the in vitro BALB/
3T3 cell transformation assay, bacterial reverse mutation assay,
Chinese hamster bone marrow chromosomal aberration assay, unscheduled
DNA synthesis studies in human fibroblasts and primary rat hepatocytes,
mitotic gene conversion assay and the dominant lethal assay in mice. It
caused proliferative changes in the rat liver with or without
pretreatment with an initiator, like phenobarbital, a known liver tumor
promoter. Liver enzyme induction studies with propiconazole in mice
demonstrated that propiconazole is a strong phenobarbital type inducer
of xenobiotic metabolizing enzymes. Hepatocellular proliferation
studies in mice suggest that propiconazole induces cell proliferation
followed by treatment-related hypertrophy in a manner similar to the
known hypertrophic agent phenobarbital. Propiconazole was carcinogenic
to male mice. Propiconazole was not carcinogenic to rats or to female
mice. The Agency has classified propiconazole as possible human
carcinogen used the reference dose (RfD) approach for quantification of
human risk. Propiconazole is not genotoxic and this fact, together with
special mechanistic studies, indicates that propiconazole is a
threshold carcinogen. Propiconazole produced liver tumors in male mice
only at a high dose that was toxic to the liver. At doses below the
RfD, liver toxicity is not expected; therefore, tumors are also not
expected.
Propiconazole has low to moderate toxicity in experimental animals
by the oral (Category III), dermal (Category III) and inhalation routes
(Category IV), is moderately irritating to the eyes (Category III),
minimally irritating to the skin (Category IV) and is a dermal
sensitizer.
Specific information on the studies received and the nature of the
adverse effects caused by propiconazole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Propiconazole Human Health
Risk Assessment for an Amended Section 3 Registration on Sugarcane'' on
pages 12-18 in docket ID number EPA-HQ-OPP-2011-0772.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for propiconazole used for
human risk assessment is discussed in Unit B of the final rule
published in the Federal Register of Wednesday, May 11, 2011 (76 FR
27261) (FRL-8873-2).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to propiconazole, EPA considered exposure under the
petitioned-for tolerances as well as all existing propiconazole
tolerances in 40 CFR 180.434. EPA assessed dietary exposures from
propiconazole in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and 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. Such effects were identified
for propiconazole. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) National Health and Nutrition Examination Survey,
What We Eat in America, (NHANES/WWEIA). This dietary survey was
conducted from 2003 to 2008. As to residue levels in food, EPA
conducted an acute dietary analysis for propiconazole residues of
concern using tolerance levels and 100% crop treated for all existing
and proposed uses.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's National
Health and Nutrition Examination Survey, What We Eat in America,
(NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. As
to residue levels in food, EPA conducted a chronic dietary analysis for
propiconazole residues of concern using tolerance levels for some
commodities, average field trial residues for the remaining
commodities, and 100% crop treated for all existing and proposed uses.
iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data is not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has concluded that a nonlinear RfD approach is appropriate
for assessing cancer risk to propiconazole. Cancer risk was assessed
using the same exposure estimates as discussed in Unit III.C.1.ii.,
Chronic exposure.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the
[[Page 75042]]
levels in food are not above the levels anticipated. For the present
action, EPA will issue such data call-ins as are required by FFDCA
section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data
will be required to be submitted no later than 5 years from the date of
issuance of these tolerances.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for propiconazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of propiconazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) model, the estimated drinking water concentrations (EDWCs) of
propiconazole for acute exposures are estimated to be 55.78 parts per
billion (ppb) for surface water and 0.64 ppb for ground water. For
chronic exposures for non-cancer assessments EDWCs are 21.61 ppb for
surface water and 0.64 ppb for ground water. For chronic exposures for
cancer assessment EDWCs are 13.24 ppb for surface water and 0.64 ppb
for groundwater.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Propiconazole is
currently registered for the following uses that could result in
residential exposures: Turf, ornamentals and in paint.
EPA assessed residential exposure using the following assumptions:
Short-term risk to toddlers was assessed for incidental oral and dermal
exposure. The highest incidental oral and dermal exposure scenarios are
expected from residential use on turf. Short-term risk to adults was
assessed for dermal and inhalation residential handler exposure as well
as from post-application dermal exposure. Adult handlers have some
inhalation exposure; however, based on the low vapor pressure of
propiconazole, negligible post application inhalation exposure is
anticipated to occur. The highest post application exposure from
residential use on turf was used to assess risk to short-term aggregate
exposures.
The only residential use scenario that will result in potential
intermediate-term exposure to propiconazole is dermal and incidental
oral post application exposure to children from wood treatment
(antimicrobial use).
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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.''
Propiconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events (EPA, 2002). In conazoles, however, a variable
pattern of toxicological responses is found; some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
of toxicity, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
Propiconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
triazole conjugates (triazolylalanine and triazolylacetic acid). To
support existing tolerances and to establish new tolerances for
triazole-derivative pesticides, including propiconazole, U.S. EPA
conducted a human health risk assessment for exposure to 1,2,4-
triazole, triazolylalanine, and triazolylacetic acid resulting from the
use of all current and pending uses of any triazole-derived fungicide.
The risk assessment is a highly conservative, screening-level
evaluation in terms of hazards associated with common metabolites
(e.g., use of a maximum combination of uncertainty factors) and
potential dietary and non-dietary exposures (i.e., high end estimates
of both dietary and non-dietary exposures). In addition, the Agency
retained the additional 10X FQPA safety factor for the protection of
infants and children. The assessment includes evaluations of risks for
various subgroups, including those comprised of infants and children.
The Agency's complete risk assessment is found in the propiconazole
reregistration docket at http://www.regulations.gov, Docket
Identification (ID) Number EPA-HQ-OPP-2005-0497 and an update to assess
the addition of the commodities included in this action may be found in
docket ID number EPA-HQ-OPP-2011-0072, in the document titled ``Common
Triazole Metabolites: Updated Dietary (Food + Water) Exposure and Risk
Assessment to Address the Amended Propiconazole Section 3 Registration
to Add Foliar Use on Sugarcane.''
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. In the developmental
toxicity study in rats, fetal effects observed in this study at a dose
lower than that evoking maternal toxicity are considered to be
quantitative evidence of increased susceptibility of fetuses to in
utero exposure to propiconazole. In the developmental toxicity study in
rabbits, neither quantitative nor qualitative evidence of increased
susceptibility of fetuses to in utero exposure to propiconazole was
observed in this study. In the 2-generation reproduction study in rats,
neither quantitative nor qualitative evidence of increased
susceptibility of neonates (as compared to adults) to prenatal and/or
postnatal exposure to propiconazole was observed. There is no evidence
of
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neuropathology or abnormalities in the development of the fetal nervous
system from the available toxicity studies conducted with
propiconazole. In the rat acute neurotoxicity study, there was evidence
of mild neurobehavioral effects at 300 mg/kg/day, but no evidence of
neuropathology from propiconazole administration. Although there was
quantitative evidence of increased susceptibility of the young
following exposure to propiconazole in the developmental rat study, the
Agency determined there is a low degree of concern for this finding and
no residual uncertainties because the increased susceptibility was
based on minimal toxicity at high doses of administration, clear NOAELs
and LOAELs have been identified for all effects of concern, and a clear
dose-response has been well defined.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
i. The toxicity database for propiconazole is complete except for
the lack of immunotoxicity and subchronic neurotoxicity studies. In the
absence of specific immunotoxicity studies, EPA has evaluated the
available propiconazole toxicity data to determine whether an
additional database uncertainty factor is needed to account for
potential immunotoxicity. There was no evidence of adverse effects on
the organs of the immune system in any propiconazole study. In
addition, propiconazole does not belong to a class of chemicals (e.g.,
the organotins, heavy metals, or halogenated aromatic hydrocarbons)
that would be expected to be immunotoxicity. Based on the
considerations in this Unit, EPA does not believe that conducting a
special Harmonized Guideline 870.7800 immunotoxicity study will result
in a POD less than the NOAEL of 10.0 mg/kg/day used in calculating the
cPAD for propiconazole, and therefore, an additional database
uncertainty factor is not needed to account for potential
immunotoxicity.
ii. In the absence of the subchronic neurotoxicity study, EPA has
evaluated the available propiconazole toxicity data to determine
whether an additional database uncertainty factor is needed to account
for potential neurotoxicity after repeated exposures. With the
exception of the developmental studies in the rat, there were no
indications in any of the repeated dose studies that propiconazole is
neurotoxic. In the developmental studies in the rat, there were some
clinical signs of neurotoxicity at 300 mg/kg/day but not at lower
doses. Further, there is no evidence of neuropathology or abnormalities
in the development of the fetal nervous system from the available
toxicity studies conducted with propiconazole. In the rat acute
neurotoxicity study, there was evidence of mild neurobehavioral effects
at 300 mg/kg, but no evidence of neuropathology from propiconazole
administration. Based on the considerations in this Unit, EPA does not
believe that conducting a Harmonized Guideline 870.6200b subchronic
neurotoxicity study will result in a POD less than the NOAEL of 10 mg/
kg/day used in calculating the cPAD for propiconazole, and therefore,
an additional database uncertainty factor is not needed to account for
potential neurotoxicity from repeated exposures.
iii. Although an apparent increased quantitative susceptibility was
observed in fetuses and offspring, for the reasons noted in this Unit
residual uncertainties or concerns for prenatal and/or postnatal
toxicity are minimal.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to propiconazole in drinking water. EPA used
similarly conservative assumptions to assess postapplication exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
propiconazole.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to propiconazole will occupy 79% of the aPAD for children 1-2 years
old, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
propiconazole from food and water will utilize 21% of the cPAD for
children 1-2 years old the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
propiconazole is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Propiconazole
is currently registered for uses that could result in short-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water and
with short-term residential exposures to propiconazole. Using the
exposure assumptions described in this unit for short-term exposures,
EPA has concluded the combined short-term food, water, and residential
exposure result in aggregate MOEs of 200 for children and adults.
4. Intermediate-term risk. The only residential use scenario that
will result in potential intermediate term exposure to propiconazole is
post application exposure to children from wood treatment
(antimicrobial use). The aggregate MOE is 120, which is greater than
the target MOE of 100. Therefore, this scenario is not of concern.
5. Aggregate cancer risk for U.S. population. Propiconazole is
classified as a possible human carcinogen with risk quantitated using a
reference dose (RfD) approach, this determination is further explained
in section III.C.1.iii. As noted in Unit III.E.2., chronic exposure is
below the cPAD.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to propiconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, a high performance liquid
chromatography with ultraviolet detection method (HPLC/UV Method AG-
671A) is available to enforce the tolerance expression. The method may
be requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
[[Page 75044]]
number: (410) 305-2905; email address: residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has established MRLs for propiconazole per se in or on
sugarcane, cane at 0.02 ppm. These MRLs are different than the
tolerances established for propiconazole in the United States. Codex
MRLs apply only to applications by seed piece treatment for sugarcane.
The Agency considers seed piece treatment to be a non-food use and did
not set a tolerance for that use. In the U.S., application to sugarcane
is by foliar spray. This results in higher residues in sugarcane, and
thus EPA has established a higher tolerance level for propiconazole on
sugarcane than the Codex MRL.
C. Response to Comments
No comments received.
D. Revisions to Petitioned-for Tolerances
The petitioned for tolerance level of 1.0 ppm has been revised to
0.40 ppm. The Organization for Economic Cooperation and Development
tolerance calculation procedures were utilized in determining the
appropriate tolerance level for the requested amended use. Changes in
recommended tolerance are based on the use of these calculation
procedures. Additionally, the registrant made a calculation error in
choosing the tolerance value.
V. Conclusion
Therefore, tolerances are established for residues of
propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl]-1H-1,2,4-triazole), in or on sugarcane, cane at 0.40 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
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). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). 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.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance 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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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 action 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: December 10, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.434 is amended by revising paragraph (a), introductory
text, and by adding to the table, alphabetically, an entry for
``sugarcane, cane'' to read as follows:
Sec. 180.434 Propiconazole; tolerances for residues.
(a) General. Tolerances are established for residues of
propiconazole, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only those
propiconazole residues convertible to 2,4-dichlorobenzoic acid (2,4-
DCBA), expressed as the stoichiometric equivalent of propiconazole, in
or on the commodity in the table below:
[[Page 75045]]
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Sugarcane, cane........................................ 0.4
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2012-30447 Filed 12-18-12; 8:45 am]
BILLING CODE 6560-50-P