[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Rules and Regulations]
[Pages 52991-52996]
[FR Doc No: 2018-22854]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0310; FRL-9979-17]

Boscalid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective October 19, 2018. Objections and
requests for hearings must be received on or before December 18, 2018,
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-2017-0310, 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: Michael Goodis, 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 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
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0310 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
December 18, 2018. 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-2017-0310, 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 October 23, 2017 (82 FR 49020) (FRL-
9967-37), 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
7E8564) by IR-4, Rutgers, The State University of New Jersey, 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 Brassica leafy greens subgroup
4-16B at 50 parts per million; celtuce at 45 ppm; Florence, fennel at
45 ppm; kohlrabi at 6 ppm; leaf petiole vegetable subgroup 22B at 45
ppm; leafy greens subgroup 4-16A at 70 ppm; pea and bean, dried
shelled, except soybean, subgroup 6C at 2.5 ppm; pea and bean,
succulent shelled, subgroup 6B at 0.6 ppm; vegetable, Brassica head and
stem group 5-16 at 6 ppm; vegetable, cucurbit group 9 at 3 ppm; and
vegetable root, except sugar beet, subgroup 1B at 2.0 ppm. The petition
also requested the removal of the established tolerances of boscalid in
or on Brassica, head and stem, subgroup 5A at 3.0 ppm, Brassica,

leafy greens, subgroup 5B at 18 ppm, cucumber at 0.5 ppm, leaf petioles
subgroup 4B at 45 ppm; leafy greens subgroup 4A, except head lettuce
and leaf lettuce at 60 ppm, lettuce, head at 6.5 ppm, lettuce, leaf at
11 ppm, pea and bean, dried shelled, except soybean, subgroup 6C,
except cowpea, field pea and grain lupin at 2.5 ppm; pea and bean,
succulent shelled, subgroup 6B, except cowpea at 0.6 ppm; turnip,
greens at 40 ppm, vegetable, cucurbit group 9, except cucumber at 1.6
ppm, and vegetable, root, subgroup 1A, except sugar beet, garden beet,
radish and turnip at 1.0 ppm and the removal of the established
tolerances for indirect or inadvertent residues of boscalid, in or on
beet, garden, roots at 0.1 ppm; cowpea, seed at 0.1 ppm; lupin, grain,
grain at 0.1 ppm; pea, field, seed at 0.1 ppm; radish, roots at 0.1
ppm; and turnip, roots at 0.1 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 reasons 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 target organs 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 (primarily in mice) and effects on the liver
(increase in weights, changes in enzyme levels and histopathological
changes) as well as on the thyroid (increase in weights and
histopathological changes). Mode of action studies conducted in rats
indicated that boscalid has a direct effect upon the liver and that the
thyroid effects are secondary. A reversibility study in rats indicated
that both liver and thyroid parameters returned to control values after
the animals were placed on control diet. Absolute and/or relative
thyroid weights were elevated in rats and dogs, but there were no
histopathological changes observed in the thyroid in either mice or
dogs.
    In a developmental toxicity study in rats, no developmental
toxicity was observed in the fetuses at the highest dose tested (limit
dose). No effects were noted in the dams in this study. In a
developmental toxicity study in rabbits, an increased incidence of
abortions or early delivery was observed at the limit dose. There was
quantitative evidence of increased susceptibility in the two-generation
reproduction study in rats, where decreases in body weights 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 on post-natal day four (PND
4) and body weight gains (PND 1-4) were seen in the absence of any
maternal toxicity.
    In a 2-year chronic toxicity study and a 2-year carcinogenicity
study in male and female rats, the combined data showed an increased
trend in thyroid follicular cell adenomas that appeared to be
treatment-related in males. This was supported by thyroid hypertrophy
and hyperplasia of follicular cells at the same dose as well as
increased thyroid weights plus mechanistic data. Despite these
findings, the Agency has determined that quantification of the cancer
risk is not necessary because (1) the adenomas occurred at dose levels
above the level used to establish the chronic population adjusted dose
(cPAD); (2) statistically significant increases were only seen for
benign tumors (adenomas) and not for malignant ones (carcinomas); (3)
the increase in adenomas in females was slight; and (4) there was no
evidence of mutagenicity. Furthermore, the mouse carcinogenicity study
was negative.
    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.
Similarly, there was no evidence of immunotoxicity in the available
immunotoxicity study in rats, or in any of the other studies in the
database.
    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 on pages 35-40 of the document titled ``Boscalid.
Human Health Risk Assessment of Tolerance Requests for Brassica, Leafy
Greens, Subgroup 4-16B; Celtuce; Florence Fennel; Kohlrabi; Leaf
Petiole Vegetable Subgroup 22B; Leafy Greens Subgroup 4-16A; Pea and
Bean, Dried Shelled, Except Soybean, Subgroup 6C; Pea and Bean,
Succulent Shelled, Subgroup 6B; Vegetable, Brassica, Head and Stem,
Group 5-16, Vegetable, Cucurbit, Group 9; and Vegetable, Root, Except
Sugar Beet, Subgroup 1B; and Associated Registration Requests on
Greenhouse-grown Fruiting Vegetables, Cucurbit Vegetables, and Leafy
Vegetables'' in docket ID number EPA-HQ-OPP-2017-0310.

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 no adverse effects
are observed (the NOAEL) and the lowest dose at which adverse effects
of concern are identified (the LOAEL). Uncertainty/safety factors are
used in conjunction with the POD to calculate a safe exposure level--
generally referred to as a population-adjusted dose (PAD) or a
reference dose (RfD)--and a safe margin of exposure (MOE). For non-
threshold risks, the Agency assumes that any amount of exposure will
lead to some degree of risk. Thus, the Agency estimates risk in terms
of the probability of an occurrence of the adverse effect expected in a
lifetime. For more information on the general principles EPA uses in
risk characterization and a complete description of the risk assessment
process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    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 food consumption information from the 2003-2008
food consumption data from the U.S. Department of Agriculture's
(USDA's) National Health and Nutrition Examination Survey, What We Eat
in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed
tolerance-level residues and 100 percent crop treated (PCT).
    iii. Cancer. 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 chronic population adjusted doses (cPAD) and
thus pose a cancer risk.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
boscalid. Tolerance level residues and 100 PCT were assumed for all
food commodities.
    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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) model and Pesticide Root Zone Model Ground Water
(PRZM GW) model, the estimated drinking water concentrations (EDWCs) of
boscalid for chronic exposures are estimated to be 26.4 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 the 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, and the extent to which young children utilize these
areas is low.
    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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 FQPA Safety
Factor (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. There is no indication that boscalid is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. 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.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. 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 57% of the cPAD for children
1 to 2 years old, the population group receiving the greatest exposure.
Based on the explanation in Unit III.C.3., regarding residential use
patterns, chronic residential exposure to residues of boscalid is not
expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Boscalid is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to boscalid.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 300 for adults,
660 for youths 11 to 16 years old and 300 for children 6 to 11 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 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 established MRLs for boscalid in or on several of the
commodities that are different than the tolerances established for
boscalid in the United States, however, the tolerance expression in the
U.S. differs from the Codex MRL expression. Also, the submitted residue
data support higher tolerance levels than those set by Codex,
indicating that harmonization would cause legal application of
pyraclostrobin by U.S. users to result in exceedances of domestic
tolerances. Therefore, further harmonization of U.S. tolerances with
Codex MRLs is not possible at this time.

C. Revisions to Petitioned-For Tolerances

    The petitioner proposed a tolerance of 50 ppm for the Brassica,
leafy greens, subgroup 4-16B, but the Agency is establishing the
tolerance at 60 ppm, based on the Organization for Economic Cooperation
and Development (OECD) tolerance calculation procedures. The Agency has
also modified some of the tolerances to be consistent with EPA's policy
on significant figures.

V. Conclusion

    Therefore, tolerances are established for residues of boscalid in
or on Brassica, leafy greens subgroup 4-16B, except watercress at 60
ppm; celtuce at 45 ppm; Florence fennel at 45 ppm; kohlrabi at 6.0 ppm;
leaf petiole vegetable subgroup 22B at 45 ppm; leafy greens subgroup 4-
16A at 70 ppm; pea and bean, dried shelled, except soybean, subgroup 6C
at 2.5 ppm; pea and bean, succulent shelled, subgroup 6B at 0.60 ppm;
vegetable, Brassica, head and stem, group 5-16 at 6.0 ppm; vegetable,
cucurbit, group 9 at 3.0 ppm; and vegetable, root, except sugar beet,
subgroup 1B at 2.0 ppm.
    Additionally, the following existing tolerances and inadvertent
tolerances are removed as unnecessary due to the establishment of the
new tolerances. Tolerances: Brassica, head and stem, subgroup 5A;
Brassica, leafy greens, subgroup 5B; cucumber; leaf petioles, subgroup
4B; leafy greens, subgroup 4A, except head lettuce and leaf lettuce;
lettuce, head; lettuce, leaf; pea and bean, dried shelled, except
soybean, subgroup 6C, except cowpea, field pea, and grain lupin; pea
and bean, succulent shelled, subgroup 6B, except cowpea; turnip,
greens; vegetable, cucurbit, group 9, except cucumber; vegetable, root,
subgroup 1A, except sugar beet, garden beet, radish, and turnip.
Inadvertent tolerances: beet, garden, roots; cowpea, seed; lupin,
grain, grain; pea field, seed; radish, roots; turnip, roots.

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), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). 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: October 4, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

     Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.589:
0
a. In the table to paragraph (a):
0
i. Add in alphanumeric order entries for ``Brassica, leafy greens,
subgroup 4-16B, except watercress''; ``Celtuce''; ``Fennel, Florence'';
``Kohlrabi''; ``Leaf petiole vegetable subgroup 22B''; ``Leafy greens
subgroup 4-16A''; ``Pea and bean, dried shelled, except soybean,
subgroup 6C''; ``Pea and bean, succulent shelled, subgroup 6B'';
``Vegetable, Brassica, head and stem, group 5-16''; ``Vegetable,
cucurbit, group 9''; and ``Vegetable, root, except sugar beet, subgroup
1B''; and
0
ii. Remove the entries ``Brassica, head and stem, subgroup 5A'';
``Brassica, leafy greens, subgroup 5B''; ``Cucumber''; ``Leaf petioles,
subgroup 4B''; ``Leafy greens, subgroup 4A, except head lettuce and
leaf lettuce''; ``Lettuce, head''; ``Lettuce, leaf''; ``Pea and bean,
dried shelled, except soybean, subgroup 6C, except cowpea, field pea,
and grain lupin''; ``Pea and bean, succulent shelled, subgroup 6B,
except cowpea''; ``Turnip, greens''; ``Vegetable, cucurbit, group 9,
except cucumber''; ``Vegetable, root, subgroup 1A, except sugar beet,
garden beet, radish, and turnip''.
0
b. Remove from the table in paragraph (d) the entries ``Beet, garden,
roots''; ``Cowpea, seed''; ``Lupin, grain, grain''; ``Pea field,
seed''; ``Radish, roots''; and ``Turnip, roots''.
    The additions read as follows:

Sec.  180.589  Boscalid; tolerances for residues.

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

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

                                * * * * *
Brassica, leafy greens, subgroup 4-16B, except watercress...          60

                                * * * * *
Celtuce.....................................................          45

                                * * * * *
Fennel, Florence............................................          45

                                * * * * *
Kohlrabi....................................................         6.0
Leaf petiole vegetable subgroup 22B.........................          45
Leafy greens subgroup 4-16A.................................          70

                                * * * * *
Pea and bean, dried shelled, except soybean, subgroup 6C....         2.5
Pea and bean, succulent shelled, subgroup 6B................        0.60

                                * * * * *
Vegetable, Brassica, head and stem, group 5-16..............         6.0

                                * * * * *
Vegetable, cucurbit, group 9................................         3.0

                                * * * * *
Vegetable, root, except sugar beet, subgroup 1B.............         2.0

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

* * * * *
[FR Doc. 2018-22854 Filed 10-18-18; 8:45 am]
 BILLING CODE 6560-50-P