[Federal Register Volume 74, Number 56 (Wednesday, March 25, 2009)]
[Rules and Regulations]
[Pages 12606-12613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-6273]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1202; FRL-8403-7]


Propiconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of propiconazole in or on beet, garden, roots at 0.30 ppm; beet, 
garden, tops at

[[Page 12607]]

5.5 ppm; cilantro, leaves at 13 ppm; parsley, fresh leaves at 13 ppm; 
parsley, dried leaves at 35 ppm; pineapple at 4.5 ppm; and pineapple, 
process residue at 7.0 ppm. The Interregional Research Project Number 4 
(IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective March 25, 2009. Objections and 
requests for hearings must be received on or before May 26, 2009, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-1202. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: [email protected].

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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr..

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-1202 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before May 26, 2009.
    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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-1202, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of February 6, 2008 (73 FR 6964) (FRL- 
8350-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
7E7300) by the Interregional Research Project Number 4 (IR-4), 500 
College Road East, Suite 201 W, Princeton, NJ 08540. The petition 
requested that 40 CFR 180.343 be amended by establishing 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 in or on food commodities beet, garden, 
roots at 0.6 ppm; parsley, leaves at 13 ppm; parsley, dried leaves at 
60 ppm; coriander, fresh at 13 ppm; vegetable, leaves of root and 
tuber, group 2 at 8.0 ppm; pineapple (post harvest) at 0.9 ppm; and 
turnip, roots at 0.2 ppm. That notice referenced a summary of the 
petition prepared by Syngenta Crop Protection, the registrant, which is 
available to the public 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 
corrected commodity definition, revised, deleted and/or modified 
tolerances petitioned for as follows:
     Revised the tolerance level (adjusted for 1x application 
rate) for beet, garden, roots from 0.6 to 0.30 ppm and established a 
tolerance for beet, garden, tops at 5.5 ppm,
     Revised the tolerance level for parsley, dried from 60 to 
35 ppm,
     Revised the tolerance level for pineapple from 0.9 to 4.5 
ppm, replacing existing pineapple tolerance of 0.1 ppm, and establish a 
tolerance for pineapple, process residue at 7.0 ppm,
     Corrected the commodity name from ``coriander, fresh'' to 
``cilantro, leaves''.

[[Page 12608]]

    At this time, the Agency is not making a decision on the proposed 
tolerance for vegetable, leaves of root and tuber, group 2 at 8.0 ppm, 
and the proposed tolerance for turnip, roots at 0.2 ppm. That aspect of 
the petition remains pending. The reasons for these changes are 
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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for 
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 food commodities: beet, garden, 
roots at 0.30 ppm; beet, garden, tops at 5.5 ppm, cilantro, leaves at 
13 ppm; parsley, fresh at 13 ppm; parsley, dried at 35 ppm; pineapple 
at 4.5 ppm; and pineapple, process residue at 7.0 ppm. EPA's assessment 
of exposures and risks associated with establishing tolerances follows.

A. Toxicological Profile

    Propiconazole has low to moderate toxicity in experimental animals 
by the oral, dermal and inhalation routes. It is moderately irritating 
to the eyes, and minimally irritating to the skin. It is a dermal 
sensitizer. Propiconazole is readily absorbed by the rat skin with 40% 
absorption within 10 hours of dermal application.
    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 at doses >50 mg/kg/day. 
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. Mice appear 
to be more susceptible to its toxicity than rats. Decreased body weight 
gain in experimental animals was seen in subchronic, chronic, 
developmental and reproductive studies. Dogs appeared to be more 
sensitive to the localized toxicity of propiconazole as manifested by 
stomach irritation at 6 mg/kg/day and above.
    In rabbits, developmental toxicity occurred at a higher dose than 
the maternal toxic dose, while in rats, developmental toxicity occurred 
at 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 (incomplete ossification 
of the skull, caudal vertebrae and digits, extra rib (14\th\ rib) and 
missing sternebrae, malformations of the lung and kidneys) were 
reported at doses that were not maternally toxic.
    In the 2-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 in 
this study.
    Propiconazole was negative for mutagenicity in the in vitro BALB/ C 
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. 
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 CD-1 male mice. Propiconazole was 
not carcinogenic to rats nor to female mice. The Agency classified 
propiconazole as Group C - possible human carcinogen and recommended 
that for the purpose of risk characterization the reference dose (RfD) 
approach be used for quantification of human risk. Propiconazole is not 
genotoxic and this fact, together with special mechanistic studies 
indicate 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, 
and therefore tumors are also not expected.
    EPA has evaluated the available toxicity data and considered their 
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. 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 document: ``Propiconazole FQPA Human Health Risk 
Assessment for the Section 3 Registrations on Garden Beets, Turnips, 
Parsley, Cilantro and Pineapple.'' Petition No. 7E7300, dated September 
30, 2008, page 21 in Docket ID number: EPA-HQ-OPP-2007-1202-0003.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which the 
NOAEL in the toxicology study identified as appropriate for use in risk 
assessment. However, if a NOAEL cannot be determined, the LOAEL or a 
Benchmark Dose (BMD) approach is sometimes used for risk assessment. 
Uncertainty/safety factors (UFs) are used in conjunction with the POD 
to take into account uncertainties inherent in the extrapolation from 
laboratory animal data to humans and in the variations in sensitivity 
among members of the human population as well as other unknowns. Safety 
is assessed for acute and chronic dietary risks by comparing aggregate 
food and water exposure to the pesticide to the acute population 
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The 
aPAD and cPAD are calculated by dividing the POD by all applicable UFs. 
Aggregate short-, intermediate-, and chronic-term risks are evaluated 
by comparing food, water, and residential exposure to the POD to ensure 
that the

[[Page 12609]]

margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    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 
greater than that 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 can be found at http://www.regulations.gov in 
document: ``Propiconazole FQPA Human Health Risk Assessment for the 
Section 3 Registrations on Garden Beets, Turnips, Parsley, Cilantro and 
Pineapple.'' Petition No. 7E7300, dated September 30, 2008, page 21 in 
docket ID number EPA-HQ-OPP-2007-1202-0003.

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.
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII). As to residue levels in food, EPA conducted acute 
dietary analysis for propiconazole using tolerance level residues and 
100 percent crop treated (PCT) 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 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA conducted chronic 
dietary analysis for propiconazole using tolerance level residues and 
100 PCT for all existing and proposed uses.
    iii. Cancer. As explained in this Unit, the chronic RfD is 
protective of propiconazole's cancer effects. For the purpose of 
assessing cancer risk under the chronic RfD, EPA used the same exposure 
estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for propiconazole. Tolerance level residues and/or 100 PCT were assumed 
for all food commodities.
    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) models, the estimated environmental concentrations (EECs) of 
propiconazole for acute exposures are estimated to be 55.8 parts per 
billion (ppb) for surface water and 0.64 ppb for ground water. The EECs 
for chronic exposures are estimated to be 21.6 ppb for surface water 
and 0.64 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model (DEEM-FCID\TM\). For acute 
dietary risk assessment, the peak water concentration value of 55.8 ppb 
was used to access the contribution to drinking water. For chronic 
dietary risk assessment, the annual average concentration of 21.6 ppb 
was used to access the contribution to drinking water.
    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 
antimicrobial uses in wood preservation treatments and paint. No new 
residential uses are associated with the petitioned-for tolerances. 
However, adults, adolesescents and toddlers may be exposed to 
propiconazole from currently registered uses. EPA assessed residential 
exposure using the following assumptions: Homeowners can be exposed to 
propiconazole through dermal and inhalation routes while applying home 
use products. All risk calculations were conducted using the maximum 
turf application rate (1.8 lb ai/acre). The anticipated use patterns 
and current labeling indicate three major residential exposure 
scenarios based on the types of equipment and techniques that can 
potentially be used to make propiconazole applications. The 
quantitative exposure/risk assessment developed for residential 
handlers is based on these scenarios:
     Mixer/Loader/applying liquids and wettable powder in water 
soluble packets via low pressure handwand.
     Mixer/Loader/applying liquids and wettable powder in water 
soluble packets via hose-end sprayer.
     Applying treated paint using airless sprayer and hose-end 
spray.
    Residential handler exposure scenarios are considered to be short-
term only due to the infrequent uses associated with homeowner 
products.
    The existing residential use patterns result in post application 
dermal exposures to adults, and dermal and oral exposures to infants 
and children. These exposure scenarios are considered short term only, 
due to the fact that:
     i. Post-application exposures were calculated using propiconazole 
as the parent compound;
     ii. Compound specific turf transferable residue (TTR) data 
indicate that at the Indiana, California, and Pennsylvania test sites, 
average total propiconazole residues declined to below the minimum 
quantifiable limit (MQL) by 14, 10 and 8 days after treatment, 
respectively. These dissipation rates, combined with label specific use 
rates and frequency of use specifications, reinforce the hand to mouth 
short-term exposure scenario; and
     iii. For short term exposure to children 1-2 years old, the 
driving factors for this risk assessment are hand to mouth, object to 
mouth, and dermal exposure. Soil ingestion is insignificant (margin of 
exposure (MOE) >300,000) compared to these factors, indicating that the 
post application scenario should be short term only. Although both 
residential and antimicrobial uses result in incidental oral and dermal 
exposure to children, the highest incidental oral and dermal exposure 
scenarios are from residential use on turf, which were used in the 
short term aggregate risk assessment.
     In addition to using the EPA's Standard Operational Procedure 
(SOP) for residential assessment, the study

[[Page 12610]]

specific turf transferable residue (TTR) was used to estimate 
exposures. The EPA combined exposures resulting from separate post-
application exposure scenarios when it is likely they can occur 
simultaneously based on the use-pattern and the behavior associated 
with the exposed population. The assumptions used for each of the 
scenarios separately are considered to account for potential high 
levels of exposure (i.e., time spent outdoors, dislodgeable residues) 
therefore, combining all these activities together is considered a very 
high end estimate of exposure.
    Propiconazole is classified as a non-volatile chemical; therefore a 
residential inhalation post-application assessment was not assessed.
    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) from 
incidental oral and dermal contact activities. Propiconazole is used on 
many different types of wood including playground structures. EPA 
assessed the risk to children playing on propiconazole-treated 
structures using screening level assessment.
    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. In conazoles, however, a variable pattern of 
toxicological responses is found. Some include 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 website 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, 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. Also, see document: ``Common Triazole 
Metabolites: Updated Aggregate Human Health Risk Assessment to Address 
Tolerance Petitions for Metconazole, Propiconazole, Prothioconazole, 
and Tetraconazole,'' dated November 8, 2008, Docket: EPA-HQ-OPP-2007-
1202-0006.

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. The Agency concluded that 
there is low concern for pre- and/or postnatal toxicity resulting from 
exposure to propiconazole. In the developmental toxicity study in 
rabbits, the EPA determined that 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, EPA determined that neither quantitative 
nor qualitative evidence of increased susceptibility of neonates (as 
compared to adults) to pre- and/or postnatal exposure to propiconazole 
was observed in this study. In the developmental rat study, however, 
quantitative susceptibility was evidenced as increased incidence of 
rudimentary ribs, unossified sternebrae, as well as increased incidence 
of shortened and absent renal papillae and increased cleft palate at 90 
mg/kg/day, a dose lower than that evoking maternal toxicity (severe 
clinical toxicity at 300 mg/kg/day). nsidering the overall toxicity 
profile and the doses and endpoints selected for risk assessment for 
propiconazole, the EPA characterized the degree of concern for the 
effects observed in this study as low, noting that there is a clear no 
observed adverse effect level (NOAEL) and well-characterized dose 
response for the developmental effects observed. No residual 
uncertainties were identified. The NOAEL for developmental effects in 
this study (30 mg/kg/day) is used as the basis for the acute reference 
dose (aRfD) for the female 13-50 population subgroup as well as for 
short-term incidental oral, dermal and inhalation endpoints. For all 
other toxicity endpoints established for propiconazole, a NOAEL lower 
than this developmental NOAEL is used.
    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 
immunotoxicity testing. EPA began requiring functional immunotoxicity 
testing of all food and non-food use pesticides on December 26, 2007. 
Since this requirement went into effect after the tolerance petition 
was submitted,

[[Page 12611]]

these studies are not yet available for propiconazole. 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 at the LOAEL in any study propiconazole. 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 immunotoxic. Based on the considerations in 
this Unit, EPA does not believe that conducting a special series 
870.7800 immunotoxicity study will result in a point of departure less 
than the NOAEL of 10.0 mg/kg/day used in calculation the cPAD for 
propiconazole, and therefore, an additional database uncertainty factor 
is not needed to account for potential immunotoxicity.
    ii. EPA also began requiring acute and subchronic neutotoxicity 
testing of all food and non-food use pesticides on December 26, 2007. 
An acute neurotoxicity study has been submitted to the Agency, but 
since the requirement for neurotoxicity testing went into effect after 
the tolerance petition was submitted, the subchronic neurotoxicity 
study is not yet available for propiconazole. 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. Based on the considerations in 
this Unit, EPA does not believe that conducting a series 870.6200b 
subchronic neurotoxicity study will result in a point of departure less 
than the NOAEL of 10 mg/kg/day used in calculation the cPAD for 
propiconazole, and therefore, an additional database uncertainty factor 
is not needed to account for potential neurotoxicity from repeated 
exposures. There is no indication in the developmental and reproduction 
studies, nor in the acute neurotoxicity study that a developmental 
neurotoxicity study should be required.
    iii. There is no evidence that propiconazole results in increased 
susceptibility in in utero in rabbits in the rabbit prenatal 
developmental study or in young rats in the 2-generation reproduction 
study. Although quanititative susceptibility of the young was observed 
in the rat developmental study, there is low concern for the prenatal 
toxicity seen in this study for the reasons described in this Unit.
    iv. There are no residual uncertainties identified in the exposure 
databases. Dietary food exposure assessments were performed based on 
100 PCT and tolerance-level residues. The exposure databases (dietary 
food, drinking water, and residential) are complete and the risk 
assessment for each potential exposure scenario includes all 
metabolites and/or degradates of concern and does not underestimate the 
potential risk for infants and children. 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 pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    Acute and chronic aggregate dietary (food and drinking water) 
exposure and risk assessments were conducted for parent propiconazole 
using the Dietary Exposure Evaluation Model DEEM-FCID\TM\, Version 2.03 
which use food consumption data from the U.S. Department of 
Agriculture's Continuing Surveys of Food Intakes by Individuals (CSFII) 
from 1994-1996 and 1998. This dietary assessment is for the parent 
propiconazole only. The common metabolites- triazole, triazolylalanine 
(TA), and triazolylacetic acid (TAA) are also residues of concern. 
Since these are common metabolites from several triazole pesticides, 
the risk assessment for triazoles was assessed separately. The updated 
risk assessment for triazole metabolites indicated that adding the new 
uses of propiconazole will not result in unacceptable risk to the 
triazole metabolites (see ``Common Triazole Metabolites: Updated 
Aggregate Human Health Risk Assessment to Address Tolerance Petitions 
for Metconazole, Propiconazole, Prothioconazole, and Tetraconazole,'' 
dated November 8, 2008, ID Docket Number: EPA-HQ-OPP-2007-1202-0006.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
propiconazole will occupy 16% of the aPAD for all infants <1 year 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 17% 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 
with short-term residential exposures to propiconazole.
    An aggregated risk to toddlers from exposures to residential turf 
use including:
    i. Hand-to-mouth activity,
    ii. Object to mouth activity,
    iii. Soil ingestion, and
    iv. Turf-general high-contact activities was evaluated and resulted 
in an aggregate MOE of 170 which is below the Agency's level of concern 
(MOE of 100 or less).
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential and antimicrobial exposures aggregated result in 
aggregate combined MOE of 160 resulting from all exposure

[[Page 12612]]

scenarios (oral and dermal). The highest incidental oral and dermal 
exposure scenarios are from residential use on turf, which were used in 
the short-term aggregate risk assessment. The short-term aggregate risk 
does not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-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 
intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic exposure to propiconazole 
through food and water with intermediate-term exposures for 
propiconazole.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures aggregated 
result in aggregate MOEs of 120 (exposure to Children 1-2 years old), 
which is below the Agency's level of concern (MOE of 100 or less). 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).
    5. Aggregate cancer risk for U.S. population. The Agency considers 
the chronic aggregate risk assessment, making use of the cPAD, to be 
protective of the aggregate cancer risk. See Unit III.A.
    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 (gas chromatography (GC) method 
using flame ionization detection (Method AG-354) 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 number: (410) 305-2905; 
e-mail address: [email protected].

B. International Residue Limits

    The Codex Alimentarius Commission has established several maximum 
residue limits (MRLs) for propiconazole in/on various raw agricultural 
commodities. In addition, both Canada and Mexico have established MRLs 
for propiconazole in/on various commodities. No Codex, Mexican, or 
Canadian MRLs have been established for any crop commodity associated 
with this petition.

C. Revisions to Petitioned-For Tolerances

    Based upon review of available data supporting the petition, EPA 
revised the tolerance levels, added or deleted tolerances, or otherwise 
modified the petition as proposed in the notice of filing, as follows:
     Revised the tolerance level for beet, garden, roots from 
0.6 to 0.30 ppm and established a tolerance for beet, garden, tops at 
5.5 ppm, Adequate field trial residue data were submitted for garden 
beets at 1.5 times the proposed maximum treatment rate. Adjusting to 
the 1x rate, the Agency is setting a 0.30 ppm tolerance on garden beet 
roots and a 5.5 ppm tolerance on garden beet tops.
     Corrected the commodity name from ``coriander, fresh'' to 
``cilantro, leaves'' based on the Agency's current crop naming 
guidelines,
     Revised the tolerance level for parsley, dried from 60 to 
35 ppm. Available processing data show that propiconazole residues 
concentrate in parsley, dried (processing factor of 5.5). The highest 
average field trial (HAFT) value from field studies is 6.3 ppm. 
Multiplying the processing factor by the HAFT value indicates that a 
tolerance level of 35 is needed.
     Revised the proposed tolerance level for pineapple from 
0.9 ppm to 4.5 ppm, replacing the existing pineapple tolerance of 0.1 
ppm. The appropriate tolerance level for propiconzole in/on pineapple 
was calculated from HAFT values in a dataset of eighteen (18) samples 
from pineapple postharvest field trials using application rates within 
25% of the maximum label use rate. These data indicate a propiconazole 
residue tolerance level for pineapple at 4.5 ppm is appropriate, and
     Established a tolerance for pineapple, process residue at 
7.0 ppm. Propiconazole residues in pineapple process residue 
concentrate with a processing factor of 1.7. Multiplying the processing 
factor for pineapple by the HAFT value (3.6 ppm) indicates that a 
tolerance level of 7.0 ppm is needed.

V. Conclusion

    Therefore, tolerances are established 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 food 
commodities: Beet, garden, roots at 0.30 ppm; beet, garden, tops at 5.5 
ppm; cilantro, leaves at 4.5 ppm; parsley, fresh at 13 ppm; parsley, 
dried at 35 ppm; pineapple at 4.5 ppm; and pineapple, process residue 
at 7.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
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). 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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,

[[Page 12613]]

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) (Public Law 
104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
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 this final rule in the Federal 
Register. This final 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: February 27, 2009.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

0
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 the tolerance for pineapple 
and by alphabetically adding the following commodities to the table in 
paragraph (a) to read as follows:


Sec. 180.434  Propiconazole; tolerance for residues.

     (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Beet, garden, roots........................................         0.30
Beet, garden, tops.........................................          5.5
                                * * * * *
Cilantro, leaves...........................................           13
                                * * * * *
Parsley, fresh leaves......................................           13
Parsley, dried leaves......................................           35
                                * * * * *
Pineapple..................................................          4.5
Pineapple, process residue.................................          7.0
------------------------------------------------------------------------


* * * * *
[FR Doc. E9-6273 Filed 3-24-09; 8:45 am]
BILLING CODE 6560-50-S