[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Rules and Regulations]
[Pages 67042-67048]
[FR Doc No: 2013-26765]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0710; FRL-9401-5]

Boscalid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
boscalid in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective November 8, 2013. Objections and
requests for hearings must be received on or before January 7, 2014,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0710, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0710, 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
January 7, 2014. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0710, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of January 16, 2013 (78 FR 3377) (FRL-9375-
4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2E8068) by BASF

Corporation, 26 Davis Dr, P.O. Box 13528, Research Triangle Park, NC
27709-3528. However, BASF was listed in error. It was the IR-4, 500
College Rd. East, Suite 201W, Princeton, NJ 08540 that petitioned EPA
for these tolerances. The petition requested that 40 CFR 180.589 be
amended by establishing tolerances for residues of the fungicide
boscalid (BAS 510F), 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro(1,1'-
biphenyl)-2-yl)-, in or on artichoke, globe at 6.0 parts per million
(ppm); berry, low growing, subgroup 13-07G at 4.5 ppm; bushberry,
subgroup 13-07B at 13 ppm; caneberry, subgroup 13-07A at 6.0 ppm;
endive, Belgium at 5.0 ppm; fruit, citrus, group 10-10 at 1.6 ppm;
fruit, pome, group 11-10 at 3.0 ppm; fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F, at 3.5 ppm; oilseed, group 20
at 3.5 ppm; persimmon at 7.0 ppm; turnip, greens at 18.0 ppm;
vegetable, bulb group 3-07 at 3.0 ppm; vegetable, fruiting, group 8-10
at 1.2 ppm; and vegetable, root subgroup 1B, except sugarbeet, at 1.0
ppm. The petition also requested the removal of the established
tolerances, in or on bushberry, subgroup 13B at 13 ppm; caneberry,
subgroup 13A at 6.0 ppm; canola, seed at 3.5 ppm; cotton, undelinted
seed at 1.0 ppm; fruit, citrus, group 10 at 1.6 ppm; fruit, pome, group
11 at 3.0 ppm; grape at 3.5 ppm; strawberry at 4.5 ppm; sunflower, seed
at 0.6 ppm; vegetable, bulb, group 3 at 3.0 ppm; vegetable, fruiting,
group 8 at 1.2 ppm; and vegetable, root, subgroup 1A except sugarbeet,
garden beet, radish, and turnip at 1.0 ppm upon approval of the
tolerances listed in this unit, since the proposed new tolerances will
supersede the existing tolerances. That document referenced a summary
of the petition prepared by BASF, the registrant, which is available in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
revised the levels at which some of the tolerances are being
established. The reason for these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for boscalid including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with boscalid 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.
    In mammals, the primary targets are the liver and the thyroid
(indirectly from liver adaptive response). In subchronic and chronic
feeding studies in rats, mice, and dogs, boscalid generally caused
decreased body weights and body weight gains (primarily in mice) and
effects on the liver (increase in weights, changes in enzyme levels and
histopathological changes) as well as on the thyroid (increase in
weights and histopathological changes). Mode of action studies
conducted in rats indicated that boscalid has a direct effect upon the
liver and that the thyroid effects are secondary. A reversibility study
in rats indicated that both liver and thyroid parameters returned to
control values after the animals were placed on control diet. Absolute
and/or relative thyroid weights were elevated in rats and dogs, but
there were no histopathological changes observed in the thyroid in
either mice or dogs.
    In a developmental toxicity study in rats, no developmental
toxicity was observed in the fetuses at the highest dose tested (limit
dose). No effects were noted in the dams in this study. In a
developmental toxicity study in rabbits, an increased incidence of
abortions or early delivery was observed at the limit dose. There was
quantitative evidence of increased susceptibility in the 2-generation
reproduction study in rats, where decreases in body weights and body
weight gains in male offspring were seen at a dose that was lower than
the dose that induced parental/systemic toxicity. There was
quantitative evidence of increased susceptibility in the developmental
neurotoxicity study in rats, where decreases in pup body weights (PND
4) and body weight gains (PND 1-4) were seen in the absence of any
maternal toxicity.
    Although there is some evidence indicating increased incidence of
thyroid follicular cell adenomas in rats, EPA classified boscalid as
``suggestive evidence of carcinogenicity'' and has concluded that the
endpoint for chronic assessment would be protective of these effects.
This is based on the following: The adenomas occurred at dose levels
above the level used to establish the chronic population adjusted dose
(cPAD), statistically significant increases were only seen for benign
tumors (adenomas) and not for malignant ones (carcinomas), the increase
in adenomas in females was slight, and there was no concern for
mutagenicity.
    There was no evidence of neurotoxicity in rats in the acute,
subchronic, or developmental studies up to the limit dose. No
neurotoxic observations were noted in any of the other studies in any
species.
    Specific information on the studies received and the nature of the
adverse effects caused by boscalid as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Boscalid Human Health Risk
Assessment for a Section 3 Registration of New Uses on Globe Artichoke,
Belgium Endive, Persimmon, Greenhouse Grown Tomato Transplants for the
Home Consumer Market, and Residential Ornamentals, Landscape Gardens,
Fruit Trees and Nut Trees; Plus Crop Group Expansions/Revisions for
Bulb Vegetable Group 3-07, Fruiting Vegetable Group 8-10, Citrus Fruit
Group 10-10, Pome Fruit Group 11-10, Berry Subgroups 13-07A, B, F, and
G, Vegetable Root Subgroup 1B Except Sugar beet, and Oilseed Group 20''
on pp. 42-46 in docket ID number EPA-HQ-OPP-2012-0710.

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 (LOC) 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 boscalid used for
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Boscalid for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (All populations         No appropriate endpoint attributable to a single dose was identified.
 including infants and children
 and females 13-49 years of age).
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Chronic dietary (All populations)  NOAEL= 21.8 mg/kg/    Chronic RfD = 0.218  Co-critical chronic rat,
                                    day.                  mg/kg/day.           carcinogenicity rat, and 1-year
                                   UFA = 10x...........  cPAD = 0.218 mg/kg/   dog studies.
                                   UFH = 10x...........   day.                LOAEL = 57-58 mg/kg/day based on
                                   FQPA SF = 1x........                        liver and thyroid effects.
Dermal Short-Term (1-30 days)....  Oral study NOAEL =    LOC for MOE = 100..  Co-critical chronic rat,
                                    21.8 mg/kg/day                             carcinogenicity rat, and 1-year
                                    (dermal absorption                         dog studies.
                                    rate = 15%).                              LOAEL = 57-58 mg/kg/day based on
                                   UFA = 10x...........                        liver and thyroid effects.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
Inhalation Short-Term (1-30 days)  Oral study NOAEL=     LOC for MOE = 1,000  Co-critical chronic rat,
                                    21.8 mg/kg/day.                            carcinogenicity rat, and 1-year
                                   UFA = 10x...........                        dog studies.
                                   UFH = 10x...........                       LOAEL = 57-58 mg/kg/day based on
                                   FQPA SF UFDB = 10x..                        liver and thyroid effects.
                                  ------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)  Classification: ``Suggestive evidence of carcinogenicity.'' The cPAD is
                                    considered to be protective of any cancer effects; therefore, a separate
                                    cancer assessment is not required.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (c = chronic). RfD = reference dose. UF = uncertainty factor. UFA =
  extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other data
  deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to boscalid, EPA considered exposure under the petitioned-for
tolerances as well as all existing boscalid tolerances in 40 CFR
180.589. EPA assessed dietary exposures from boscalid 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.
    No such effects were identified in the toxicological studies for
boscalid; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used food consumption information from the 2003-2008
food consumption data from the U.S. Department of Agriculture's
(USDA's) National Health and Nutrition Examination Survey, What We Eat
in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed
tolerance-level residues and used some percent crop treated (PCT)
information as described in Unit III.C.1.iv.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that the chronic endpoint will be protective of potential
cancer effects. EPA's estimate of chronic exposure as described in this
unit is relied upon to evaluate whether any exposure could exceed the
cPAD and thus pose a cancer risk.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(F)
of FFDCA states that the Agency may use data on the actual percent of
food treated for assessing chronic dietary risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.

     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows: Almonds
40%; apples 15%; apricots 25%; blueberries 35%; broccoli 2.5%; cabbage
5%; caneberries 45%; cantaloupes 5%; carrots 15%; cauliflower 5%;
celery 2.5%; cherries 45%; cucumbers 5%; dry beans/dry peas 2.5%;
garlic 5%; grapes 30%; green beans 5%; green peas 1%; hazelnuts 5%;
lettuce 25%; nectarines 15%; onions 20%; peaches 20%; peanuts 1%; pears
15%; peppers 2.5%; pistachios 30%; plums/prunes 5%; potatoes 20%;
pumpkins 10%; squash 5%; strawberries 55%; tomatoes 5%; walnuts 1%; and
watermelons 25%.
    In most cases, EPA uses available data from USDA/National
Agricultural Statistics Service (NASS), proprietary market surveys, and
the National Pesticide Use Database for the chemical/crop combination
for the most recent 6-7 years. EPA uses an average PCT for chronic
dietary risk analysis. The average PCT figure for each existing use is
derived by combining available public and private market survey data
for that use, averaging across all observations, and rounding to the
nearest 5%, except for those situations in which the average PCT is
less than 1. In those cases, 1% is used as the average PCT and 2.5% is
used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk
analysis. The maximum PCT figure is the highest observed maximum value
reported within the recent 6 years of available public and private
market survey data for the existing use and rounded up to the nearest
multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which boscalid may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for boscalid in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of boscalid. 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 First Index Reservoir Screening Tool (FIRST) and
Pesticide Root Zone Model Ground Water (PRZMGW), the estimated drinking
water concentrations (EDWCs) of boscalid for chronic exposure
assessments are estimated to be 26.4 parts per billion (ppb) for
surface water and 697 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 697 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).
    Boscalid is currently registered for the following uses that could
result in residential exposures: Golf course turf. Additionally, new
residential uses proposed by the registrants Bonide (use on residential
fruit and nut trees) and BASF (new uses on residential ornamentals and
landscape gardens) were evaluated as part of this action. EPA assessed
residential exposure using the following assumptions: All residential
exposures are considered short-term in duration. The residential
handler assessment included short-term exposures via the dermal and
inhalation routes from treating residential ornamentals, landscape
gardens, and trees.
    In terms of post-application exposure, there is the potential for
dermal post-application exposure for individuals as result of being in
an environment that has been previously treated with boscalid. Short-
term dermal exposures were assessed for adults, youth 11 to 16 years
old, and children 6 to 11 years old. Incidental oral exposure to
children 1 to <2 years old is not expected from treated turf because
boscalid is registered for use only on golf course turf and proposed
for use on residential gardens and trees.
    The scenarios used in the aggregate assessment were those that
resulted in the highest exposures. The highest exposures for all age
groups were associated with only residential post-application dermal
exposures, not inhalation exposures, and consist of the following:
     The residential dermal exposure for use in the adult
aggregate assessment reflects dermal exposure from post-application
activities on treated gardens.
     The residential dermal exposure for use in the youth (11-
16 years old) aggregate assessment reflects dermal exposure from post-
application golfing on treated turf.
     The residential dermal exposure for use in the child (6-11
years old) aggregate assessment reflects dermal exposure from post-
application activities in treated gardens.
    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.''
    EPA has not found boscalid to share a common mechanism of toxicity
with 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 assumed that boscalid does not
have 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 EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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 Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
SF when reliable data available to EPA support the choice of a
different factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of
increased susceptibility in the rat developmental study as no
developmental toxicity was seen at the highest dose tested (limit
dose).
    There was evidence of increased qualitative susceptibility in the
rabbit developmental study as characterized by an increased incidence
of abortions or early delivery at the limit dose. It could not be
ascertained if the abortions were the result of a treatment-related
effect on the dams, the fetuses or both. It was concluded that the
degree of concern is low because the increased abortions or early
delivery was seen only at the limit dose and the abortions may have
been due to maternal stress.
    There was evidence of increased quantitative susceptibility seen in
the rat 2-generation reproduction study and the developmental
neurotoxicity study, in that reduced body weights were seen in the
offspring at dose levels where no parental toxicity was observed.
However, the degree of concern is low because the dose selected for
chronic dietary and non-dietary exposure risk assessments would address
the concern for the body weight effects, and the effect was shown to be
reversible in the developmental neurotoxicity study.
    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 for all scenarios, except residential
handler inhalation exposure. That decision is based on the following
findings:
    i. The toxicity database is complete, with the exception of a
subchronic inhalation study. EPA is retaining the 10X FQPA SF for
assessing residential inhalation risk to adult applicators.
    ii. For the reasons listed in Unit III.D.2., the Agency has
concluded that there are no residual uncertainties concerning the
potential for prenatal and postnatal toxicity.
    iii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessment assumed tolerances-
level residues and was moderately refined using some PCT data. The use
of the PCT data for some crops is based on reliable data and will not
underestimate the exposure and risk. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to boscalid in drinking water. EPA used similarly conservative
assumptions to assess post-application exposure of children. These
assessments will not underestimate the exposure and risks posed by
boscalid.

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
aPAD and 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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
boscalid is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
boscalid from food and water will utilize 56% of the cPAD for children
1-2 years old, the population group receiving the greatest exposure.
Based on the explanation in Unit III.C.3., regarding residential use
patterns, chronic residential exposure to residues of boscalid 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).
    Boscalid 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 boscalid. EPA used the dermal
exposure scenarios mentioned in Unit III.C.3., in the aggregate
assessment because those scenarios resulted in the highest exposures
and corresponding lowest MOEs.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the combined short-term food,
water, and residential exposures result in aggregate MOEs of 290 for
adults, 310 for children 6-11 years old, and 690 for youth 11-16 years
old. Because EPA's LOC for boscalid 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).
    An intermediate-term adverse effect was identified; however,
boscalid is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
boscalid.
    5. Aggregate cancer risk for U.S. population. Based on the data
summarized in Unit III.A., EPA has concluded that the cPAD is
protective of possible cancer effects. Given the results of the chronic
risk assessment, cancer risk resulting from exposure to boscalid is not
of concern.
    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 boscalid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/mass
spectrometry (GC/MS)) 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:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established an MRL for boscalid in/on globe
artichoke, Belgian endive, or persimmon.
    The tolerances being established by this document for the bulb
vegetable group 3-07; the caneberry subgroup 13-07A; the citrus fruit
group 10-10; the fruiting vegetable group 8-10; the small, vine
climbing fruit, except fuzzy kiwifruit, subgroup 13-07F; and turnip
greens align with existing Codex MRLs.
    The tolerances being established for the bushberry subgroup 13-07B;
the low growing berry subgroup 13-07G, except cranberry and the pome
fruit group 11-10; do not align with established MRLs. Harmonization
with Codex is not possible because the corresponding commodity group/
subgroup tolerance in the United States is higher than the Codex MRL.
The higher U.S. tolerance level reflects the likely residues resulting
from use in accordance with the approved application rates on the
domestic boscalid pesticide label. Reducing the tolerance value to
harmonize with Codex levels could result in violations of the tolerance
when boscalid is used according to the label.

C. Revisions to Petitioned-for Tolerances

    Based on evaluation of the field trial data with the Organization
of Economic Cooperation and Development (OECD) tolerance calculation
procedure, EPA has modified the proposed tolerance for Belgium endive
from 5.0 ppm to 6.0 ppm and the proposed tolerance for persimmon from
7.0 ppm to 8.0 ppm.
    The tolerances for the bulb vegetable group 3-07; the caneberry
subgroup 13-07A; the citrus fruit group 10-10; the fruiting vegetable
group 8-10; the small, vine climbing fruit, except fuzzy kiwifruit,
subgroup 13-07F; and turnip greens to align with existing Codex MRLs.
    With the establishment of the tolerance for oilseed group 20 the
flax, seed; cotton, gin byproducts; and cotton, undelinted seed will be
deleted from 40 CFR 180.589(d) since the oilseed group 20 tolerance
will supersede these existing tolerances.
    In regards to the request for a tolerance for ``vegetable, root
subgroup 1B, except sugarbeet,'' at 1.0 ppm, the petitioner did not
submit the data necessary to support establishment of a tolerance for
this crop subgroup; therefore, this tolerance is not being established
at this time.

 V. Conclusion

    Therefore, tolerances are established for residues of boscalid in
or on artichoke, globe at 6.0 ppm; berry, low growing, subgroup 13-07G,
except cranberry at 4.5 ppm; bushberry subgroup 13-07B at 13.0 ppm;
caneberry subgroup 13-07A at 10.0 ppm; endive, Belgium at 6.0 ppm;
fruit, citrus, group 10-10 at 2.0 ppm; fruit, pome, group 11.10 at 3.0
ppm; fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-
07F at 5.0 ppm; oilseed group 20 at 3.5 ppm; persimmon at 8.0 ppm;
turnip, greens at 40.0 ppm; vegetable, bulb, group 3-07 at 5.0 ppm; and
vegetable, fruiting, group 8-10 at 3.0 ppm.
    In addition, due to the establishment of the new tolerances, the
following tolerances are removed as unnecessary from 40 CFR 180.589(a),
bushberry subgroup 13B; caneberry subgroup 13A; canola, seed; cotton,
undelinted seed; fruit, citrus, group 10; fruit, pome, group 11; grape;
strawberry; sunflower, seed; vegetable, bulb, group 3; and vegetable,
fruiting, group 8; from 40 CFR 180.589 (d), cotton, gin byproducts;
cotton, undelinted seed and flax, seed.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: October 29, 2013.
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. In Sec.  180.589:
0
a. Remove from the table in paragraph (a)(1) the commodities bushberry
subgroup 13B; caneberry subgroup 13A; canola, seed; cotton, undelinted
seed; fruit, citrus, group 10; fruit, pome, group 11; grape;
strawberry; sunflower, seed; vegetable, bulb, group 3; and vegetable,
fruiting, group 8.
0
b. Remove from the table in paragraph (d) the commodities cotton, gin
byproducts; cotton, undelinted seed, and flax, seed.
0
c. Add alphabetically the following commodities to the table in
paragraph (a)(1). The additions read as follows:

Sec.  180.589  Boscalid; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Artichoke, globe........................................             6.0

                                * * * * *
Berry, low growing, subgroup 13-07G, except cranberry...             4.5

                                * * * * *
Bushberry subgroup 13-07B...............................            13.0
Caneberry subgroup 13-07A...............................            10.0

                                * * * * *
Endive, Belgium.........................................             6.0
Fruit, citrus, group 10-10..............................             2.0
Fruit, pome, group 11-10................................             3.0
Fruit, small vine climbing, except fuzzy kiwifruit,                  5.0
 subgroup 13-07F........................................

                                * * * * *
Oilseed group 20........................................             3.5

                                * * * * *
Persimmon...............................................             8.0

                                * * * * *
Turnip, greens..........................................            40.0

                                * * * * *
Vegetable, bulb, group 3-07.............................             5.0

                                * * * * *
Vegetable, fruiting, group 8-10.........................             3.0

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-26765 Filed 11-7-13; 8:45 am]
BILLING CODE 6560-50-P