Document ID: EPA-HQ-OPP-2012-0710-0007
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Boscalid
Posted Date: 2013-11-08T05:00Z

[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Rules and Regulations]
[Pages 67042-67048]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[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: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://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

[[Page 67043]]

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.

[[Page 67044]]

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.

[[Page 67045]]

     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

[[Page 67046]]

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,

[[Page 67047]]

Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has 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).

[[Page 67048]]

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