[Federal Register Volume 70, Number 182 (Wednesday, September 21, 2005)]
[Rules and Regulations]
[Pages 55286-55293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18830]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0259; FRL-7737-9]


Boscalid; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-
chloro[1,1'-biphenyl]-2-yl) in or on tangerines. This action is in 
response to EPA's granting of an emergency exemption under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
authorizing use of the pesticide on mandarin oranges and mandarin 
hybrids. ``Tangerines'' is the accepted regulatory term used for these 
crops and a tolerance on tangerines covers both mandarin oranges and 
mandarin hybrids. This regulation establishes a maximum permissible 
level for residues of boscalid in this food commodity. The tolerance 
will expire and is revoked on December 31, 2008.

DATES: This regulation is effective September 21, 2005. Objections and 
requests for hearings must be received on or before November 21, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0259. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other

[[Page 55287]]

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 either electronically in 
EDOCKET or in hard copy at the Public Information and Records Integrity 
Branch (PIRIB), Rm. 119, Crystal Mall <greek-i>2, 1801 S. Bell St., 
Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; e-mail address: <a href="/cdn-cgi/l/email-protection#5e0d3b3d736f6673133f37323c31261e3b2e3f70393128"><span class="__cf_email__" data-cfemail="c291a7a1eff3faef8fa3abaea0adba82a7b2a3eca5adb4">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111)
    <bullet> Animal production (NAICS code 112)
    <bullet> Food manufacturing (NAICS code 311)
    <bullet> Pesticide manufacturing (NAICS code 32532)
    This listing is not intended to be exhaustive, but rather provides 
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 and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a tolerance for residues of the fungicide 
boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-
2-yl) in or on tangerines at 2.0 parts per million (ppm). This 
tolerance will expire and is revoked on December 31, 2008. EPA will 
publish a document in the Federal Register to remove the revoked 
tolerance from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the 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 the 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. . . 
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Boscalid on Mandarin Oranges and Mandarin 
Hybrids and FFDCA Tolerances

    The state of California requested the use of boscalid (pre-mixed 
with the chemical pyraclostrobin as the product Pristine) on mandarin 
oranges and mandarine hybrids (termed ``tangerines'' for regulatory 
purposes) to control Alternaria alternata. The applicant reported that 
only two fungicides are registered for use to control this pathogen and 
that neither provide commercially acceptable disease control. It was 
also stated that crop yields have been declining since 1999 because of 
Alternaria alternata. EPA has authorized under FIFRA section 18 the use 
of boscalid (pre-mixed with pyraclostrobin as the product Pristine) on 
mandarins and mandarin hybrids for control of Alternaria alternata in 
California. After having reviewed the submission, EPA concurs that 
emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of boscalid in or on 
tangerines. In doing so, EPA considered the safety standard in section 
408(b)(2) of the FFDCA, and EPA decided that the necessary 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 an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment as provided in section 408(l)(6) of the FFDCA. 
Although this tolerance will expire and is revoked on December 31, 
2008, under section 408(l)(5) of the FFDCA, residues of the pesticide 
not in excess of the amounts specified in the tolerance remaining in or 
on tangerines 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 tolerance at 
the time of that application. EPA will take action to revoke this 
tolerance earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.

[[Page 55288]]

    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether boscalid meets 
EPA's registration requirements for use on tangerines or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of boscalid by a State for special local needs 
under FIFRA section 24(c). Nor does this tolerance serve as the basis 
for any State other than California 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. For additional information regarding the emergency exemption for 
boscalid, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    Consistent with section 408(b)(2)(D) of the 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 
boscalid and to make a determination on aggregate exposure, consistent 
with section 408(b)(2) of the FFDCA, for a time-limited tolerance for 
residues of the fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-
(4'-chloro[1,1'-biphenyl]-2-yl) in or on tangerines at 2.0 ppm. EPA's 
assessment of the dietary exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved 
in the toxicology study selected. An uncertainty factor (UF) is applied 
to reflect 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. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety factor 
(SF).
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the 
appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10<SUP>-6</SUP> or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOE<INF>cancer</INF> = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for boscalid used for human risk assessment is shown in the 
following Table 1:

       Table 1.--Summary of Toxicological Dose and Endpoints for Boscalid for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  Special FQPA SF and
          Exposure Scenario               Dose Used in Risk       Level of Concern for   Study and Toxicological
                                            Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary                          No appropriate endpoint  N/A                      N/A
                                        identified
--------------------------------------
Chronic Dietary (All populations)      NOAEL= 21.8              FQPA SF = 1              Chronic rat,
                                       UF = 100...............  cPAD = chronic RfD/FQPA   carcinogenicity rat
                                       Chronic RfD = 0.218 mg/   SF = 0.218 mg/kg/day.    and 1-year dog studies
                                        kg/day.                                          LOAEL = 57-58 mg/kg/day
                                                                                          based on liver and
                                                                                          thyroid effects
--------------------------------------
Incidental Oral (Short and             NOAEL= 21.8 mg/kg/day    Residential LOC for MOE  Chronic rat,
 intermediate term residential only)                             = 100                    carcinogenicity rat
                                                                                          and 1-year dog studies
                                                                                         LOAEL = 57-58 mg/kg/day
                                                                                          based on liver and
                                                                                          thyroid effects
--------------------------------------
Dermal (All Durations)                 Oral study NOAEL=21.8    Residential LOC for MOE  Chronic rat,
                                        mg/kg/day (dermal        = 100>                   carcinogenicity rat
                                        absorption rate = 15%)                            and 1-year dog studies
                                                                                         LOAEL = 57-58 mg/kg/day
                                                                                          based on liver and
                                                                                          thyroid effects
--------------------------------------

[[Page 55289]]

 
Inhalation (All Durations)             Oral study NOAEL= 21.8   Residential LOC for MOE  Chronic rat,
                                        mg/kg/day (inhalation    = 100                    carcinogenicity rat
                                        absorption rate =                                 and 1-year dog studies
                                        100%)                                            LOAEL = 57-58 mg/kg/day
                                                                                          based on liver and
                                                                                          thyroid effects
--------------------------------------
Cancer (oral, dermal, inhalation)          Classification: ``Suggestive evidence of carcinogenicity, but not
                                                  sufficient to assess human carcinogenic potential.''
----------------------------------------------------------------------------------------------------------------
\*\ The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established for residues of boscalid, 3-pyridinecarboxamide, 2-chloro-
N-(4'-chloro[1,1'-biphenyl]-2-yl) in or on a wide variety of crops and 
animal commodities. Tolerances on primary crops range from 0.05 ppm on 
the Tuberous and Corm Vegetable Crop Subgroup (1C) to 30 ppm on 
peppermint and spearmint tops. Tolerances on rotational crops range 
from 0.05 ppm on several commodities to 8.0 ppm on grasses. Animal 
commodity tolerances range from 0.02 ppm for eggs to 0.35 ppm for the 
meat byproducts of cattle, goats, horses, and sheep. Boscalid is a 
member of the carboxamide (anilide) class of compounds. In target crops 
and rotational crops, parent boscalid is the only residue of concern 
for both tolerance expression and risk assessment. In animal 
commodities, parent boscalid, a hydroxy metabolite, and the glucuronide 
of the hydroxy metabolite are the residues of concern for tolerance 
expression and risk assessment. In drinking water, parent boscalid is 
the only residue of concern for risk assessment. Risk assessments were 
conducted by EPA to assess dietary exposures from boscalid in food as 
follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. As there were no toxic effects attributable to a 
single dose, an endpoint of concern was not identified to quantitate 
acute-dietary risk to the general population or to the subpopulation 
females 13-50 years old. Therefore, there is no acute reference dose 
(aRfD) or acute population-adjusted dose (aPAD) for the general 
population or females 13-50 years old. An acute aggregate risk 
assessment is not needed.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM<SUP>TM</SUP>) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA-1994-1996 and 1998 nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure 
to the chemical for each commodity. The chronic dietary exposure 
analysis was based on tolerance level residues and 100% crop treated 
assumptions. DEEM (Version 7.81) default processing factors were used 
for some commodities.
    iii. Cancer. The Agency classified boscalid as having ``suggestive 
evidence of carcinogenicity, but not sufficient to assess human 
carcinogenic potential.'' The quantification of human cancer risk was 
therefore not conducted.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for boscalid in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of boscalid.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) 
to produce estimates of pesticide concentrations in an index reservoir. 
The screening concentration in groundwater (SCI-GROW) model is used to 
predict pesticide concentrations in shallow groundwater. For a 
screening-level assessment for surface water EPA will generally use 
FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The 
FIRST model is a subset of the PRZM/EXAMS model that uses a specific 
high-end runoff scenario for pesticides. While both FIRST and PRZM/
EXAMS incorporate an index reservoir environment, the PRZM/EXAMS model 
includes a percent crop area factor as an adjustment to account for the 
maximum percent crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a percent of reference dose (%RfD) 
or percent of population adjusted dose (%PAD). Instead, drinking water 
levels of comparison (DWLOCs) are calculated and used as a point of 
comparison against the model estimates of a pesticide's concentration 
in water. DWLOCs are theoretical upper limits on a pesticide's 
concentration in drinking water in light of total aggregate exposure to 
a pesticide in food, and from residential uses. Since DWLOCs address 
total aggregate exposure to boscalid they are further discussed in the 
aggregate risk sections below.
    Based on the FIRST and SCI-GROW models the EECs of boscalid for 
chronic exposures are estimated to be 26 parts per billion (ppb) for 
surface water and 0.6 ppb for groundwater.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).

[[Page 55290]]

    Boscalid is currently registered for use on golf courses. The 
boscalid label specifies that this product is intended for golf course 
use only, and not for use on residential turfgrass or turfgrass being 
grown for sale or other commercial use such as sod production. Although 
the label does not indicate that the product is applied by licensed or 
commercial applicators, it is acknowledged that the homeowner will not 
be applying the product to golf courses. Therefore, a risk assessment 
for residential handler exposure is not required. Boscalid is not 
packaged or marketed for home orchard use and, therefore, that use is 
not assessed.
    It has been determined that the potential exists for exposure to 
boscalid from entering areas previously treated with the fungicide. 
Based on the above discussion, there is only one potential non-
occupational post-application scenario associated with boscalid for 
which risk needs to be assessed: adults and youths golfing. Duration of 
exposure is anticipated to be short-term.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to boscalid and any other 
substances and boscalid does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has not assumed that boscalid has a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the policy statements released by EPA's Office of Pesticide Programs 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's website at  http://www.epa.gov/pesticides/cumulative/.

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold 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 that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. A complete discussion of the 
prenatal/postnatal sensitivity study was discussed in a final rule 
dated July 30, 2003 (68 FR 44640) (FRL-7319-6). No new information has 
been received to change this information.
    At that time, the Agency concluded that there are no residual 
uncertainties for pre- and post-natal toxicity as the degree of concern 
is low for the susceptibility seen in the available studies, and the 
dose and endpoints selected for the overall risk assessments will 
address the concerns for the body weight effects seen in the offspring. 
Although the dose selected for overall risk assessments (21.8 mg/kg/
day) is higher than the NOAELs in the 2-generation reproduction study 
(10.1 mg/kg/day) and the developmental neurotoxicity study (14 mg/kg/
day), these differences are considered to be an artifact of the dose 
selection process in these studies. For example, there is a tenfold 
difference between the LOAEL (106.8 mg/kg/day) and the NOAEL (10.1 mg/
kg/day) in the 2-generation reproduction study. A similar pattern was 
seen with regard to the developmental neurotoxicity study, where there 
is also a tenfold difference between the LOAEL (147 mg/kg/day) and the 
NOAEL (14 mg/kg/day). There is only a 2- to 3-fold difference between 
the LOAEL (57 mg/kg/day) and the NOAEL (21.8 mg/kg/day) in the critical 
study used for risk assessment. Because the gap between the NOAEL and 
LOAEL in the 2-generation reproduction and developmental neurotoxicity 
studies was large and the effects at the LOAELs were minimal, the true 
NOAEL was probably considerably higher. Therefore, the selection of the 
NOAEL of 21.8 mg/kg/day from the 1-year dog study is conservative and 
appropriate for the overall risk assessments. In addition, the 
endpoints for risk assessment are based on thyroid effects seen in 
multiple species (mice, rats and dogs) and after various exposure 
durations (subchronic and chronic exposures) which were not observed at 
the LOAELs in either the 2-generation reproduction or the developmental 
neurotoxicity studies. Based on these data, the Agency concluded that 
there are no residual uncertainties for pre- and post-natal toxicity.
    3. Conclusion. There is a complete toxicity database for boscalid 
and exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. There is no evidence of 
susceptibility following in utero exposure to rats and there is low 
concern and no residual uncertainties in the developmental toxicity 
study in rabbits, in the 2-generation reproduction study or in the 
developmental neurotoxicity study after establishing toxicity endpoints 
and traditional uncertainty factors to be used in the risk assessment. 
Based on these data and conclusions, EPA reduced the FQPA safety factor 
to 1X.

D. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water [e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + chronic non-dietary, non-occupational 
exposure)]. This allowable exposure through drinking water is used to 
calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, the Office of Pesticide Programs (OPP) concludes 
with reasonable certainty that exposures to

[[Page 55291]]

boscalid in drinking water (when considered along with other sources of 
exposure for which OPP has reliable data) would not result in 
unacceptable levels of aggregate human health risk at this time. 
Because OPP considers the aggregate risk resulting from multiple 
exposure pathways associated with a pesticide's uses, levels of 
comparison in drinking water may vary as those uses change. If new uses 
are added in the future, OPP will reassess the potential impacts of 
boscalid on drinking water as a part of the aggregate risk assessment 
process.
    1. Acute risk. As there were no toxic effects attributable to a 
single dose of boscalid, an endpoint of concern was not identified to 
quantitate acute dietary risk. As a result, an acute aggregate risk 
assessment is not needed.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to boscalid 
from food will utilize 7% of the cPAD for the U.S. population, 16% of 
the cPAD for all infants (<1 year old) and 26% of the cPAD for children 
1 to 2 years old. There are no residential uses for boscalid that 
result in chronic residential exposure to boscalid. In addition, 
despite the potential for chronic dietary exposure to boscalid in 
drinking water, after calculating DWLOCs and comparing them to 
conservative model of boscalid in surface and ground water, EPA does 
not expect the aggregate exposure to exceed 100% of the cPAD, as shown 
in Table 2 of this unit:

                Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Boscalid
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EDWC   Water EDWC    Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                        0.218            7           26         0.63        7,100
------------------------------------------------
All Infants (<1 year old)                              0.218           16           26         0.63        1,800
------------------------------------------------
Children 1-2 years                                     0.218           26           26         0.63        1,600
------------------------------------------------
Females 13-49                                          0.218            5           26         0.63        6,200
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. The short-term aggregate risk assessment takes 
into account average exposure estimates from dietary consumption of 
boscalid (food and drinking water) and non-occupational uses (golf 
courses). Postapplication exposures from the proposed use on golf 
courses is considered short-term, and applies to adults and youths. 
Therefore, a short-term aggregate risk assessment was conducted. Since 
all endpoints are from the same study, exposures from different routes 
can be aggregated. Table 3 summarizes the results. The MOE from food 
and non-occupational uses is 1,400, and the calculated short-term DWLOC 
is 6,100 ppb. Compared to the surface and groundwater EDWCs, the DWLOCs 
are considerably greater. Therefore, short-term aggregate risk does not 
exceed EPA's level of concern. The MOE and DWLOC are considered to be 
representative for youth because youth and adults possess similar body 
surface area to weight ratios, and because the dietary exposure for 
youth (13-19 years old) is less than that of the general U.S. 
population.

                                         Table 3.--Aggregate Risk Assessment for Short-Term Exposure to Boscalid
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                     Short-Term Scenario
                                    --------------------------------------------------------------------------------------------------------------------
                                                                        Average                   Aggregate                Ground    Surface     Short-
             Population              NOAEL mg/    Target      Max         Food     Residential    MOE (food   Max Water    Water      Water       Term
                                       kg/day      MOE      Exposure  Exposure mg/ Exposure mg/      and       Exposure     EDWC       EDWC      DWLOC
                                                           mg/kg/day     kg/day       kg/day    residential)  mg/kg/day    (ppb)      (ppb)      (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S                                       21.8        100      0.218     0.014631      0.0008         1,400      0.2026        0.6         26      6,100
--------------------------------------------------------------------------------------------------------------------------------------------------------

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). As no intermediate-term non-occupational exposures to boscalid 
are anticipated, an intermediate-term aggregate risk assessment is not 
needed.
    5. Aggregate cancer risk for U.S. population. EPA's review of 
toxicity data has resulted in a classification of boscalid as having 
``suggestive evidence of carcinogenicity, but not sufficient to assess 
human carcinogenic potential.'' Thus, a quantification of human cancer 
risk has not been performed.
    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, and to infants and children from aggregate 
exposure to boscalid residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example--gas chromatography) 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:<a href="/cdn-cgi/l/email-protection#ea988f99838e9f8f878f9e82858e99aa8f9a8bc48d859c"><span class="__cf_email__" data-cfemail="641601170d0011010901100c0b0017240114054a030b12">[email protected]</span></a>.

B. International Residue Limits

    There is neither a Codex proposal, nor a Canadian or Mexican 
maximum residue limit for residues of boscalid on tangerines. Therefore 
harmonization is not an issue.

[[Page 55292]]

VI. Conclusion

    Therefore, the tolerance is established for residues of the 
fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-
biphenyl]-2-yl) in or on tangerines at 2.0 ppm.

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. However, the period for filing objections is now 60 days, rather 
than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0259 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 on or before November 
21, 2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14<SUP>th</SUP> St., 
NW., Washington, DC 20005. The Office of the Hearing Clerk is open from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2.Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by the docket ID number OPP-2005-0259, to: Public 
Information and Records Integrity Branch, Information Technology and 
Resource Management Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. In person or by courier, bring a copy to the 
location of the PIRIB described in ADDRESSES. You may also send an 
electronic copy of your request via e-mail to: <a href="/cdn-cgi/l/email-protection#b9d6c9c994ddd6dad2dccdf9dcc9d897ded6cf"><span class="__cf_email__" data-cfemail="cca3bcbce1a8a3afa7a9b88ca9bcade2aba3ba">[email protected]</span></a>. 
Please use an ASCII file format and avoid the use of special characters 
and any form of encryption. Copies of electronic objections and hearing 
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section 
408 of the FFDCA. 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 rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). 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); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). 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). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 of the 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. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national

[[Page 55293]]

government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers, and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of the 
FFDCA. For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and 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: September 13, 2005
Meredith F. Laws,
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 180.589 is amended by adding text to paragraph (b) after the 
paragraph heading to read as follows:


Sec.  180.589  Boscalid; tolerances for residues.

* * * * *
    (b) * * * Time-limited tolerances are established for residues of 
the fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-
chloro[1,1 '-biphenyl]-2-yl) in connection with use of the pesticide 
under section 18 emergency exemptions granted by EPA. These tolerances 
will expire and are revoked on the dates specified in the following 
table:

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  million        Date
------------------------------------------------------------------------
Tangerine.....................................          2.0     12/31/08
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-18830 Filed 9-20-05; 8:45 am]
BILLING CODE 6560-50-S


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