[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Rules and Regulations]
[Pages 14009-14014]
[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superseded by this action, and corrects the spelling of papaya.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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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:<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
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

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

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

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

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:<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 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,

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


[Federal Register Volume 78, Number 112 (Tuesday, June 11, 2013)]
[Proposed Rules]
[Pages 34970-34972]
[FR Doc No: 2013-13726]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2012-0451; FRL-9822-4]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Section 110(a)(2) Infrastructure Requirements for the 2008
Lead National Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the Commonwealth of Virginia addressing the basic
program elements specified in 110(a)(2) of the Clean Air Act (CAA)
necessary to implement, maintain, and enforce the 2008 lead national
ambient air quality standards (NAAQS). This submission is commonly
referred to as an infrastructure SIP. This action does not include the
nonattainment requirements of part D, Title I (referred to as element
I), since this element is not required to be submitted by the 3-year
submission deadline of CAA section 110(a)(1), and will be addressed in
a separate action. This action is being taken under the CAA.

DATES: Written comments must be received on or before July 11, 2013.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2012-0451 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2012-0451, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Air Protection Division,
Mailcode 3AP30, U.S. Environmental Protection Agency, Region III, 1650
Arch Street, Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2012-0451. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Virginia Department of Environmental Quality, 629
East Main Street, Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT: Ellen Schmitt,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On March 9, 2012, the Virginia Department of
Environmental Quality (VADEQ) submitted a revision to its SIP to
satisfy the requirements of section 110(a)(2) of the CAA for the 2008
lead NAAQS.

I. Background

    On October 15, 2008, EPA substantially strengthened the primary and
secondary lead NAAQS (hereafter the ``2008 lead NAAQS''), revising the
level of the primary (health-based) standard from 1.5 micrograms per
cubic meter ([mu]g/m\3\) to 0.15 [mu]g/m\3\, measured as total
suspended particles (TSP) and not to be exceeded with an averaging time
of a rolling 3-month period. EPA also revised the secondary (welfare-
based) standard to be identical to the primary standard, as well as the
associated ambient air monitoring requirements. See 40 CFR 50.16.
    Section 110(a) of the CAA requires states to submit SIPs to provide
for the implementation, maintenance, and enforcement of a new or
revised NAAQS within three years following the promulgation of such
NAAQS or within such shorter period as EPA may prescribe. The contents
of that submission may vary depending upon the facts and circumstances.
In particular, the data and analytical tools available at the time the
state develops and submits the SIP for a new or revised NAAQS affects
the content of the submission. The contents of such SIP submissions may
also vary depending upon what provisions the state's existing SIP
already contains.
    Pursuant to section 110(a)(1) of the CAA, states are required to
submit SIPs meeting the applicable requirements of section 110(a)(2)
within three years after promulgation of a new or revised NAAQS or
within such shorter period as EPA may prescribe. Section 110(a)(1)
provides the procedural and timing requirements for SIPs and section
110(a)(2) requires states to address basic SIP elements such as
requirements for monitoring, basic program requirements and legal
authority that are designed to assure attainment and maintenance of the
NAAQS. More specifically, section 110(a)(2) lists specific elements
that states must meet for ``infrastructure'' SIP requirements related
to a newly established or revised NAAQS.
    For the 2008 lead NAAQS, states typically have met many of the
basic program elements required in CAA section 110(a)(2) through
earlier SIP submissions in connection with previous lead NAAQS.
Nevertheless, pursuant to CAA section 110(a)(1), states will have to
review and revise, as appropriate, their existing lead NAAQS SIPs to
ensure that the SIPs are adequate to address the 2008 lead NAAQS. To
assist states in meeting this statutory requirement, EPA issued a
guidance on October 14, 2011, entitled, ``Guidance on Infrastructure
State Implementation Plan (SIP) Elements Required Under sections
110(a)(1) and 110(a)(2) for the 2008 Lead (Pb) National Ambient Air
Quality Standards (NAAQS)'' (hereafter the ``2011 Lead Infrastructure
Guidance''), which lists the basic

elements that states should include in their SIPs for the 2008 lead
NAAQS.

II. Summary of SIP Revision

    On March 9, 2012, VADEQ provided a submittal to satisfy the
requirements of section 110(a)(2) of the CAA for the 2008 lead NAAQS.
This submittal addressed the following infrastructure elements, which
EPA is proposing to approve: CAA section 110(a)(2)(A), (B), (C) (for
enforcement and regulation of minor sources), (D)(i)(I), (D)(i)(II)
(for visibility protection), (D)(ii), (E)(i), (E)(iii), (F), (G), (H),
(J), (K), (L), and (M), or portions thereof. EPA is taking separate
action on the portions of (C), (D)(i)(II), and (J) as they relate to
Virginia's PSD program and (E)(ii) as it relates to CAA section 128
(State Boards). Virginia did not submit element (I) which pertains to
the nonattainment requirements of part D, Title I of the CAA, since
this element is not required to be submitted by the 3-year submission
deadline of CAA section 110(a)(1), and will be addressed in a separate
process.
    In accordance with a decision from the U.S. Court of Appeals for
the D.C. Circuit, the EPA at this time is not treating the
110(a)(2)(D)(i)(I) SIP submission from the Commonwealth of Virginia as
a required SIP submission. See EME Homer City Generation, LP v. EPA,
696 F.3d 7 (D.C. Cir. 2012), reh'g denied 2013 U.S. App. LEXIS 1623
(Jan. 24, 2013). However, even if the submission is not considered to
be ``required,'' the EPA must act on the 110(a)(2)(D)(i)(I) SIP
submission from Virginia because section 110(k)(2) of the CAA requires
the EPA to act on all SIP submissions. Unless the EME Homer City
decision is reversed or otherwise modified by the Supreme Court, states
are not required to submit 110(a)(2)(D)(i)(I) SIPs until the EPA has
quantified their obligations under that section. In this notice, EPA is
proposing to act on the Commonwealth of Virginia's 110(a)(2)(D)(i)(I)
submission.

III. General Information Pertaining to SIP Submittals from the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-
1198, provides a privilege that protects from disclosure documents and
information about the content of those documents that are the product
of a voluntary environmental assessment. The Privilege Law does not
extend to documents or information that: (1) Are generated or developed
before the commencement of a voluntary environmental assessment; (2)
are prepared independently of the assessment process; (3) demonstrate a
clear, imminent and substantial danger to the public health or
environment; or (4) are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege
to documents and information ``required by law,'' including documents
and information ``required by Federal law to maintain program
delegation, authorization or approval,'' since Virginia must ``enforce
Federally authorized environmental programs in a manner that is no less
stringent than their Federal counterparts. . . .'' The opinion
concludes that ``[r]egarding Sec.  10.1-1198, therefore, documents or
other information needed for civil or criminal enforcement under one of
these programs could not be privileged because such documents and
information are essential to pursuing enforcement in a manner required
by Federal law to maintain program delegation, authorization or
approval.''
    Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that
``[t]o the extent consistent with requirements imposed by Federal
law,'' any person making a voluntary disclosure of information to a
state agency regarding a violation of an environmental statute,
regulation, permit, or administrative order is granted immunity from
administrative or civil penalty. The Attorney General's January 12,
1998 opinion states that the quoted language renders this statute
inapplicable to enforcement of any Federally authorized programs, since
``no immunity could be afforded from administrative, civil, or criminal
penalties because granting such immunity would not be consistent with
Federal law, which is one of the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
PSD, NSR, or Title V programs consistent with the Federal requirements.
In any event, because EPA has also determined that a state audit
privilege and immunity law can affect only state enforcement and cannot
have any impact on Federal enforcement authorities, EPA may at any time
invoke its authority under the CAA, including, for example, sections
113, 167, 205, 211 or 213, to enforce the requirements or prohibitions
of the state plan, independently of any state enforcement effort. In
addition, citizen enforcement under section 304 of the CAA is likewise
unaffected by this, or any, state audit privilege or immunity law.

IV. Proposed Action

    EPA is proposing to approve the following CAA section 110(a)(2)
elements of Virginia's SIP revision: (A), (B), (C) (for enforcement and
regulation of minor sources), (D)(i)(I), (D)(i)(II) (for visibility
protection), (D)(ii), (E)(i), (E)(iii), (F), (G), (H), (J), (K), (L),
and (M), or portions thereof. Virginia's SIP revision provides the
basic program elements specified in CAA section 110(a)(2) necessary to
implement, maintain, and enforce the 2008 lead NAAQS. This SIP revision
was submitted on March 9, 2012. This action does not include section
110(a)(2)(I) of the CAA which pertains to the nonattainment
requirements of part D, Title I of the CAA, since this element is not
required to be submitted by the 3-year submission deadline of CAA
section 110(a)(1), and will be addressed in a separate process.
Additionally, EPA is taking separate action on the portions of CAA
section 110(a)(2) infrastructure elements for the 2008 lead NAAQS as
they relate to Virginia's PSD program, as required by part C of Title I
of the CAA. This includes portions of the following infrastructure
elements of CAA section 110(a)(2): (C), (D)(i)(II), and (J). EPA is
soliciting public comments on the issues discussed in this document.
These comments will be considered before taking final action.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action

merely proposes to approve state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule, which satisfies certain
infrastructure requirements of section 110(a)(2) of the CAA for the
2008 lead NAAQS for the Commonwealth of Virginia, does not have tribal
implications as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is not approved to apply in Indian
country located in the state, and EPA notes that it will not impose
substantial direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Lead.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: May 28, 2013.
W.C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2013-13726 Filed 6-10-13; 8:45 am]
BILLING CODE 6560-50-P