Boscalid; Pesticide Tolerances, 52991-52996 [2018-22854]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Rules and Regulations]
[Pages 52991-52996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at https://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: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at https://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: https://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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://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,

[[Page 52992]]

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, https://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 https://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.

[[Page 52993]]

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 https://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 
https://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 https://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 https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

[[Page 52994]]

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: (410) 305-2905;

[[Page 52995]]

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:

[[Page 52996]]

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