[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Rules and Regulations]
[Pages 14009-14014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06141]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0797; FRL-9921-01]


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 dill seed, the herb subgroup 19A, the stone fruit 
group 12-12, and the tree nut group 14-12. Interregional Research 
Project Number 4 (IR-4) requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA). In addition, this regulation 
removes established tolerances for certain commodities/groups 
superseded by this action, and corrects the spelling of papaya.

DATES: This regulation is effective March 18, 2015. Objections and 
requests for hearings must be received on or before May 18, 2015, 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-2013-0797, 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), West William Jefferson Clinton 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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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 
Publishing 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

[[Page 14010]]

provided in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number EPA-HQ-OPP-2013-0797 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 May 18, 2015. 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-2013-0797, 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 February 25, 2014 (79 FR 10458) (FRL-
9906-77), 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 
3E8215) by (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.589 be amended by 
establishing tolerances for residues of the fungicide boscalid, 3-
pyridinecarboxamide,2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), in or 
on herb, subgroup 19A at 190 parts per million (ppm), and dill, seed at 
300 ppm as well as changing the existing tolerance for ``fruit, stone, 
group 12'' to ``fruit, stone, group 12-12'' and ``nut, tree, group 14'' 
to ``nut, tree, group 14-12'' and also removing the existing tolerance 
for pistachio at 0.70 ppm. 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 
modified the levels at which some of the tolerances are being 
established. The reason for these changes are 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 decreased 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. 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 in 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 in body weight gains (PND 1-4) were seen in the absence of any 
maternal toxicity, however, these effects were shown to be reversible 
in that no treatment-related effects on body weight, body weight gain 
or any other parameter were noted at PND 21.
    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

[[Page 14011]]

slight, and there was no evidence of 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 document, ``Boscalid--Human Health Risk 
Assessment for a Section 3 Registration of New Uses on Herb Subgroup 
19A and Dill Seed, Plus Crop Group Conversions on Stone Fruit Group 12-
12 and Tree Nut Group 14-12'' at pg. 35 in docket ID number EPA-HQ-OPP-
2013-0797.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL and the LOAEL are identified. 
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 discussed in Unit III.B. of the final rule 
published in the Federal Register of November 8, 2013 (78 FR 67042) 
(FRL-9401-5).

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 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 above 
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 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%; oranges 1%; peaches 20%; peanuts 1%; 
pears 15%; peppers 2.5%; pistachios 30%; plums/prunes 5%; potatoes 20%; 
pumpkins 10%; squash 5%; strawberries 60%; sugar beets 1%; tomatoes 5%; 
walnuts 1%; and watermelons 25%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/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 one. 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

[[Page 14012]]

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 (PRZM GW), 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, residential fruit 
and nut trees, and residential ornamentals and landscape gardens. 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 a 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 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 
safety factor 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 is lower than 
the dose that caused 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 for inhalation 
exposures where the 10X FQPA SF was retained. 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 a 10X FQPA SF for 
assessing residential inhalation risks 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 post-natal toxicity.
    iii There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessment assumed tolerance 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

[[Page 14013]]

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 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. 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 26% of the cPAD for all 
infants less than 1 year 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 380 for 
adults, 460 for children 6-11 years old, and 1,100 for youth 11-16 
years old. Because EPA's level of concern 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: (410) 305-2905; email address: 
[email protected].

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 MRLs for herbs or dill seed. For 
stone fruit, Codex has an MRL of 3 ppm and the U.S. tolerance is 3.5 
ppm. The U.S. tolerance cannot be lowered to 3 ppm to harmonize with 
Codex, because the cherry residue data used in support of the U.S. 
tolerances necessitate a higher value. The Codex tree nut MRL (0.05 
ppm) is lower than the U.S. tolerance (0.7 ppm), and harmonization is 
not possible.

C. Revisions to Petitioned-For Tolerances

    The petitioned for tolerance of 190 ppm for the herb subgroup 19A 
is not supported by the field trial data and the processing data and 
therefore, the tolerance is being established at 150 ppm based on the 
highest average field trial (HAFT) data for basil and the processing 
factor for drying. The tolerance for dill seed is being established at 
100 ppm, not the petitioned for level of 300 ppm, based on an 
evaluation of the residue data using the Organization for Economic 
Cooperation and Development (OECD) calculation procedure.

 V. Conclusion

    Therefore, tolerances are established for residues of boscalid in 
or on dill, seed at 100 ppm; fruit, stone, group 12-12 at 3.5 ppm; herb 
subgroup 19A at 150 ppm; and nut, tree, group 14-12 at 0.70 ppm. In 
addition, due to the establishment of these tolerances, the existing 
tolerances for fruit, stone, group 12; nut, tree, group 14; and 
pistachio are removed as unnecessary. Lastly, as an administrative 
correction, the existing entry for ``papya'' is changed to its correct 
spelling ``papaya.''

VI. Statutory and Executive Order Reviews

    This action 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,

[[Page 14014]]

October 4, 1993). Because this action has been exempted from review 
under Executive Order 12866, this action 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 action 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 action 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(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 (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: March 3, 2015.
Susan Lewis,
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. Revise Sec.  180.589(a)(1) as follows:
0
a. Add in alphabetical order entries for ``Dill, seed'' and ``Herb 
subgroup 19A''.
0
b. Remove the entries for ``Fruit, stone, group 12'' and ``Nut, tree, 
group 14'' and add in their place entries for ``Fruit, stone, group 12-
12'' and ``Nut, tree, group 14-12'', respectively.
0
c. Remove the entry for ``Pistachio.''
0
d. Remove the entry for ``Papya'' and add in its place an entry for 
``Papaya.''
    The addition and revisions read as follows:


Sec.  180.589  Boscalid; tolerances for residues.

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

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
Dill, seed..............................................             100
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
Fruit, stone, group 12-12...............................             3.5
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
Herb subgroup 19A.......................................             150
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
Nut, tree, group 14-12..................................            0.70
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
Papaya..................................................             1.5
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-06141 Filed 3-17-15; 8:45 am]
 BILLING CODE 6560-50-P