
[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Rules and Regulations]
[Pages 27261-27268]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11564]


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ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Part 180

[EPA-HQ-OPP-2009-1009; FRL-8873-2]


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 multiple commodities which are identified and 
discussed later in this document. Interregional Research Project 
4 (IR-4) requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA). In addition, this action establishes a 
time-limited tolerance for residues of propiconazole in or on avocado, 
in response to the approval of a quarantine exemption under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use to 
control the disease, laurel wilt (caused by Raffaelea lauricola) in the 
state of Florida. This regulation establishes a maximum permissible 
level of residues of propiconazole in this food commodity. The time-
limited tolerance expires and is revoked on December 31, 2013.

DATES: This regulation is effective May 11, 2011. Objections and 
requests for hearings must be received on or before July 11, 2011, 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-2009-1009. 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.),

[[Page 27262]]

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: Andrew Ertman, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; e-mail address: ertman.andrew@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. 
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 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://www.gpoaccess.gov/ecfr. To 
access the harmonized test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/ocspp and select ``Test 
Methods and Guidelines.''

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-2009-1009 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 
July 11, 2011. 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 that does not contain 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2009-1009, 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. Summary of Petitioned-For Tolerance

    In the Federal Register of March 19, 2010 (75 FR 13277) (FRL-8813-
2), 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 
9E7659) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.434 be amended by 
establishing tolerances for 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 onion, bulb, subgroup 
3-07A at 0.2 parts per million (ppm); onion, green, subgroup 3-07B at 
9.0 ppm; caneberry subgroup 13-07A at 1.0 ppm; bushberry subgroup 13-
07B at 1.0 ppm; and low growing berry subgroup 13-07G, except cranberry 
at 1.3 ppm. The petition also proposed to amend the tolerances in 40 
CFR 180.434 by increasing the tolerances in or on peppermint, tops and 
spearmint, tops from 3.5 ppm to 10 ppm; and by removing the tolerances 
for berry group 13 at 1.0 ppm; onion, bulb at 0.2 ppm; onion, green at 
9.0 ppm and strawberry at 1.3 ppm. That notice referenced a summary of 
the petition prepared by Syngenta, the registrant, which is available 
in the docket, http://www.regulations.gov. Comments were received on 
the notice of filing. EPA's response to these comments is discussed in 
Unit IV.C.
    EPA is also establishing a time-limited tolerance for residues of 
propiconazole in or on avocado at 10 ppm. This tolerance expires and is 
revoked on December 31, 2013. The Agency is establishing this time-
limited tolerance in response to a quarantine exemption request under 
FIFRA section 18 on behalf of the Florida Department of Agriculture and 
Consumer Services for emergency use of propiconazole to control the 
disease, laurel wilt, in avocado.
    According to the applicant, an emergency situation exists due to 
the introduction of laurel wilt, a disease affecting avocado trees 
caused by the pathogenic fungus Raffaelea lauricola. This fungus is 
vectored by the redbay ambrosia beetle, a newly introduced species, 
native to Asia, which has moved rapidly toward the avocado production 
area since its initial discovery in Georgia in 2002. Avocado tree death 
from laurel wilt has been documented and research has demonstrated that 
the redbay ambrosia beetle attacks healthy avocado trees from all 22 
cultivars tested so far. Control of the vector, the redbay ambrosia 
beetle, is problematic since inoculation of a tree requires only 1 
beetle, the beetle is capable of flight to escape insecticide 
treatments, and the two currently registered insecticides will not 
provide the necessary year-round control due to limits in residual 
activity and number of applications allowed. Once a tree is infected 
with the disease, there is no cure and the tree will die. For these 
reasons, the applicant states that the potential impact of this disease 
on avocado growing and production could be devastating. The applicant 
states that the avocado producing areas are under severe threat from 
laurel wilt, and control through a suitable fungicide, such as the 
requested material, is essential to protecting

[[Page 27263]]

continued production of avocado in Florida as well as protecting other 
susceptible tree species in the U.S. EPA has authorized under FIFRA 
section 18 the use of propiconazole on avocado in Florida. After having 
reviewed the submission, EPA concurs that emergency conditions exist 
for this state.
    As part of its assessment of the emergency exemption request, EPA 
assessed the potential risks presented by the residues of propiconazole 
in avocado, as discussed below. In doing so, EPA considered the safety 
standard in section 408(b)(2) of the FFDCA and EPA decided that the 
necessary time-limited tolerance under section 408(l)(6) of the FFDCA 
would be consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemption in 
order to address the urgent non-routine situation and to ensure that 
the resulting food is safe and lawful, EPA is issuing this time-limited 
tolerance without notice and opportunity for public comment as provided 
in section 408(l)(6) of the FFDCA. Although, this time-limited 
tolerance expires and is revoked on December 31, 2013, under section 
408(l)(5) of the FFDCA, residues of the pesticide not in excess of the 
amount specified in the tolerance remaining in or on avocado after that 
date will not be unlawful provided the pesticide is applied in a manner 
that was lawful under FIFRA, and the residues do not exceed a level 
that was authorized by this time-limited tolerance at the time of 
application. EPA will take action to revoke this time-limited tolerance 
earlier if any experience with, scientific data, or other relevant 
information on this pesticide indicates that the residues are not safe.
    Because this time-limited tolerance is being approved under 
emergency conditions, EPA has not made any decision about whether 
propiconazole meets EPA's registration requirements for use on avocado 
or whether a permanent tolerance for this use would be appropriate. 
Under this circumstance, EPA does not believe that the time-limited 
tolerance serves as a basis for registration of propiconazole by a 
State for special local needs under FIFRA section 24(c). Nor does the 
time-limited tolerance serve as the basis for any State other than 
Florida to use this pesticide on this crop under section 18 of FIFRA 
without following all provisions of EPA's regulations implementing 
FIFRA section 18 as identified in 40 CFR part 166.

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 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.
    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 greater than 50 
milligrams/kilograms/day (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 (14th 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 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

[[Page 27264]]

toxicity is not expected, and therefore tumors are also not expected.
    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 docket ID number EPA-HQ-OPP-2009-1009 on pages 
34-40 in the document titled ``Revised Propiconazole Human Health Risk 
Assessment for a Section 3 Registration on Mint, Bulb Vegetables, 
Caneberry Subgroup 13-07A, Bushberry Subgroup 13-07B, and Low Growing 
Berry Subgroup 13-07G''

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 shown in the following Table:

  Table--Summary of Toxicological Doses and Endpoints for Propiconazole for Use in Human Health Risk Assessment
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                                     Point of departure and
         Exposure/scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
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Acute dietary (Females 13-50 years   NOAEL = 30 milligrams/  Acute RfD =0.3 mg/kg/   DNT Study--Rat.
 of age).                             kilograms/day (mg/kg/   day.                   LOAEL = 90 mg/kg/day based
                                      day).                  aPAD = 0.3 mg/kg/day..   on increased incidence of
                                     UFA = 10x.............                           rudimentary ribs, un-
                                     UFH = 10x.............                           ossified sternebrae, as
                                     FQPA SF = 1x..........                           well as increased
                                                                                      incidence of shortened and
                                                                                      absent renal papillae and
                                                                                      increased cleft palate.
Acute dietary (General population    NOAEL = 30 mg/kg/day..  Acute RfD = 0.3 mg/kg/  Acute neurotoxicity study
 including infants and children).    UFA = 10x.............   day.                    Rat.
                                     UFH = 10x.............  aPAD = 0.3 mg/kg/day..  LOAEL = 100 mg/kg/day based
                                     FQPA SF = 1x..........                           on clinical signs of
                                                                                      toxicity (piloerection in
                                                                                      one male, diarrhea in one
                                                                                      female, tip toe gait in 3
                                                                                      females).
Chronic dietary (All populations)..  NOAEL= 10 mg/kg/day...  Chronic RfD = 0.1 mg/   24-month oncogenicity study
                                     UFA = 10x.............   kg/day.                 on CD-1 mice.
                                     UFH = 10x.............  cPAD = 0.1 mg/kg/day..  LOAEL = 50 mg/kg/day based
                                     FQPA SF = 1x..........                           on non-neoplastic liver
                                                                                      effects (increased liver
                                                                                      weight in males and
                                                                                      increase in liver lesions:
                                                                                      masses/raised areas/
                                                                                      swellings/nodular areas
                                                                                      mainly).
Incidental Oral Exposure (Short-     Oral study............  LOC for MOE = 100.....  Acute Neurotoxicity Study--
 Term) and Dermal short-term (1 to   NOAEL = 30 mg/kg/day                             Rats.
 30 days).                            dermal absorption                              LOAEL = 100 mg/kg/day based
                                      rate = 40% exposures.                           on clinical signs of
                                     UFA = 10x.............                           toxicity (piloerection in
                                     UFH = 10x.............                           one male, diarrhea in one
                                     FQPA SF = 1x..........                           female, tip toe gait in 3
                                                                                      females).
Incidental Oral Exposure             Oral study............  LOC for MOE = 100.....  24 Month Oncogenicity
 (Intermediate-Term) and Dermal      NOAEL= 10 mg/kg/day                              Study--Mice.
 intermediate-term (1 to 6 months).   dermal absorption                              LOAEL = 50 mg/kg/day based
                                      rate = 40% for dermal                           on non-neoplastic liver
                                      exposures.                                      effects (increased liver
                                     UFA = 10x.............                           weight in males and
                                     UFH = 10x.............                           increase in liver lesions:
                                     FQPA SF = 1x..........                           masses/raised areas/
                                                                                      swellings/nodular areas
                                                                                      mainly).
Inhalation short-term (1 to 30       Inhalation (or oral)    LOC for MOE = 100.....  Acute Neurotoxicity Study--
 days).                               study.                                          Rats.
                                     NOAEL= 30 mg/kg/day                             LOAEL = 100 mg/kg/day based
                                      (inhalation                                     on clinical signs of
                                      absorption rate =                               toxicity (piloerection in
                                      100%).                                          one male, diarrhea in one
                                     UFA = 10x.............                           female, tip toe gait in 3
                                     UFH = 10x.............                           females).
                                     FQPA SF = 1x..........
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Cancer (Oral, dermal, inhalation)..   Classification: Group C, possible human carcinogen, RfD approach for risk
                                                                   characterization.
----------------------------------------------------------------------------------------------------------------
 UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of
  concern.

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 U.S. 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, EPA used tolerance levels 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 used tolerance levels 
and 100 PCT 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 non-linear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are 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 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 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 are estimated to be 21.61 
ppb for surface water and 0.64 ppb for ground water and for chronic 
exposures for cancer assessments are estimated to be 13.24 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. For acute dietary risk 
assessment, the water concentration value of 55.8 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 21.6 ppb was used to 
assess 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 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 dermal 
exposure for residential post-application. 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).
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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,

[[Page 27266]]

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 Food Quality Protection Act (FQPA) safety 
factor (SF) 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-
2009-1009 in the documents titled ``Common Triazole Metabolites: 
Updated Dietary (Food + Water) Exposure and Risk Assessment to Address 
The Section 3 Request for Propiconazole on Mint, Bulb Vegetables 
Subgroups 3-07A and 3-07B, Caneberry Subgroup 13-07A, Bushberry 
Subgroup 13-07B, and Low growing Berry Subgroup 13-07G'' and ``Common 
Triazole Metabolites: Updated Dietary (Food + Water) Exposure and Risk 
Assessment to Address The Section 18 Request for Propiconazole on 
Avocado in Florida.''

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 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. There is low concern for 
prenatal and/or postnatal toxicity resulting from exposure to 
propiconazole. 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 in this study. 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. Since there was 
quantitative evidence of increased susceptibility of the young 
following exposure to propiconazole in the developmental rat study, the 
Agency performed a Degree of Concern Analysis and concluded that the 
degree of concern for the effects observed in this study was low and no 
residual uncertainties were identified, for the reasons explained in 
this Unit.
    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 neutotoxicity 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 immunotoxic. 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.
    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 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. There is no indication 
in the developmental and reproduction studies, or in the acute 
neurotoxicity

[[Page 27267]]

study that a developmental neurotoxicity study should be required.
    ii. 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.
    iii. Although an apparent increased quantitative susceptibility was 
observed in fetuses and offspring 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. Since this increased susceptibility is occurring at high doses 
and a clear dose response has been well defined for all effects of 
concern, 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 population adjusted dose (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 17% of the aPAD for children 1 to 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 18% of the cPAD for 
children 1 to 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.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 160 for toddlers 
(children 1 to 2 years old), between 120 and 4,400 for adults from 
handler activities, and 330 for adults from post-application 
activities. Because EPA's level of concern for propiconazole is a MOE 
of 100 or below, these MOEs are not 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 through food and 
water with intermediate-term residential exposures to 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 result in an 
aggregate MOE of 120 for toddlers (children 1 to 2 years old). Because 
EPA's level of concern for propiconazole is a MOE of 100 or below, 
these MOEs are not of concern.
    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 any aggregate cancer risk.
    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 (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 
number: (410) 305-2905; e-mail 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 U.N. 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 not established a MRL for propiconazole for any of 
the subject crops in this document.

C. Response to Comments

    A comment was received from a private citizen objecting to 
establishment of tolerances stating that residues should be zero. The 
Agency has received similar comments from this commenter on numerous 
previous occasions. Refer to Federal Register 70 FR 37686, June 30, 
2005; 70 FR 1354, January 7, 2005; 69 FR 63096, October 29, 2004 for 
the Agency's response to these objections.

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) and its metabolites determined as 2,4-
dichlorobenzoic acid and expressed as parent compound as set forth in 
the regulatory text. In addition this regulation establishes a time-
limited tolerance for residues of propiconazole in or on avocado at 10 
ppm.

[[Page 27268]]

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, 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 (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, 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 (Pub. L. 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, 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: May 2, 2011.
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. Amend Sec.  180.434 as follows:
0
i. In the table to paragraph (a), remove the entries for ``berry group 
13,'' ``onion, bulb,'' ``onion, green,'' and ``strawberry''; revise the 
entries for ``peppermint, tops'' and ``spearmint, tops'', and add 
alphabetically entries for ``bushberry, subgroup 13-07B,'' ``caneberry, 
subgroup 13-07A,'' ``low growing berry subgroup 13-07G, except 
cranberry,'' ``onion, bulb subgroup 3-07A,'' and ``onion, green, 
subgroup 3-07B.''
0
ii. In the table to paragraph (b) add alphabetically and entry for 
``avocado.''
    The added and revised text reads as follows:


Sec.  180.434  Propiconazole; tolerances for residues.

    (a) * * *

 
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Bushberry, subgroup 13-07B.................................          1.0
Caneberry, subgroup 13-07A.................................          1.0
 
                                * * * * *
Low growing berry subgroup 13-07G, except cranberry........          1.3
 
                                * * * * *
Onion, bulb subgroup 3-07A.................................          0.2
Onion, green, subgroup 3-07B...............................          9.0
 
                                * * * * *
Peppermint, tops...........................................         10.0
 
                                * * * * *
Spearmint, tops............................................         10.0
 
                                * * * * *
------------------------------------------------------------------------

     (b) * * *

 
------------------------------------------------------------------------
                                                             Expiration/
                  Commodity                     Parts per    revocation
                                                 million        date
------------------------------------------------------------------------
Avocado.....................................            10      12/31/13
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-11564 Filed 5-10-11; 8:45 am]
BILLING CODE 6560-50-P


