Document ID: EPA-HQ-OPP-2017-0572-0006
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fluensulfone
Posted Date: 2019-05-24T04:00Z

[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Rules and Regulations]
[Pages 24042-24048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10793]

[[Page 24042]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0572; FRL-9992-69]

Fluensulfone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes and amends tolerances for residues 
of fluensulfone in or on multiple commodities which are identified and 
discussed later in this document. Makhteshim Agan of North America (d/
b/a ADAMA) requested these tolerances and tolerance amendments under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 24, 2019. Objections and 
requests for hearings must be received on or before July 23, 2019, 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-2017-0572, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2017-0572 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 
July 23, 2019. 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-2017-0572, 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 27, 2018 (83 FR 8408) (FRL-
9972-17), 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 
7F8614) by Makhteshim Agan of North America d/b/a ADAMA, 3120 Highlands 
Blvd., Suite 100, Raleigh, NC 27604. The petition requested that 40 CFR 
part 180 be amended by establishing tolerances for residues of the 
nematicide, fluensulfone, including its metabolites and degradates, in 
or on the following commodities: Citrus dried pulp at 0.4 parts per 
million (ppm); Crop Group 10-10, citrus fruit at 0.15 ppm; peanut at 
0.15 ppm; peanut, hay at 8.0 ppm; and peanut, meal at 0.30 ppm. That 
document referenced a summary of the petition prepared by Makhteshim 
Agan of North America, the registrant, which is available in docket ID 
number EPA-HQ-OPP-2017-0572 at http://www.regulations.gov. One comment 
was received on the notice of filing. EPA's response to this comment is 
discussed in Unit IV.C.
    In the Federal Register of May 18, 2018 (83 FR 23247) (FRL-9976-
87), 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 
7F8650) by Makhteshim Agan of North America, d/b/a ADAMA, 3120 
Highlands Blvd., Suite 100, Raleigh, NC 27604. The petition requested 
to amend the tolerances in 40 CFR 180.680 for residues of the 
nematicide, fluensulfone and its metabolite BSA expressed as 
fluensulfone equivalents, in or on Berry, low growing, subgroup 13-07G 
at 0.5 parts per million (ppm); Brassica, head and stem, subgroup 5A at 
1.5 ppm; Brassica, leafy greens, subgroup 5B at 20 ppm; Potato, chips 
at 2 ppm; Potato, granules/flakes at 2 ppm; Tomato, paste at 1.5 ppm; 
Vegetables, cucurbits, group 9 at 0.7 ppm; Vegetables, fruiting, group 
8-10 at 0.7 ppm; Vegetables, leafy, except Brassica, group 4 at 4 ppm; 
Vegetables, leaves of root and tuber, group 2, except sugar beet at 50 
ppm;

[[Page 24043]]

Vegetables, root, except sugar beet, subgroup 1B at 4 ppm; and 
Vegetables, tuberous and corm, subgroup 1C at 0.8 ppm. That document 
referenced a summary of the petition prepared by Makhteshim Agan of 
North America, the registrant, which is available in docket ID number 
EPA-HQ-OPP-2018-0030 at http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    In the Federal Register of March 18, 2019 (84 FR 9737) (FRL-9989-
71), 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 
7F8650) by Makhteshim Agan of North America, d/b/a ADAMA, 3120 
Highlands Blvd., Suite 100, Raleigh, NC 27604. The petition requested 
to: (1) Amend the tolerance expression in 40 CFR 180.680 paragraphs (a) 
and (d) to read ``Tolerances are established for residues of the 
nematicide fluensulfone, including its metabolites and degradates, in 
or on the commodities in the table below. Compliance with the tolerance 
levels specified in the following table below is to be determined by 
measuring only the sum of fluensulfone, 5-chloro-2-[(3,4,4-trifluoro-3-
buten-1-yl)sulfonyl]thiazole and its metabolite, 3,4,4-trifluoro-but-3-
ene-1-sulfonic acid, calculated as the stoichiometric equivalent of 
fluensulfone, in or on the commodity''; and (2) amend the tolerances in 
40 CFR 180.680 for residues of the nematicide, fluensulfone and its 
metabolite BSA expressed as fluensulfone equivalents, on the raw 
agricultural commodities as follows: Almond hulls at 5 parts per 
million (ppm); Fruit, pome, group 11 at 0.4 ppm; Fruit, small vine 
climbing subgroup 13-07D at 0.8 ppm; Fruit, stone, group 12 at 0.1 ppm; 
Grain cereal, forage, fodder and straw, group 16 at 3 ppm; and, rotated 
wheat (inadvertent residues with 90-day PBI): Grain, cereal, group 15 
at 0.05 ppm; Molasses at 0.3 ppm; and, rotated cereal grains 
(inadvertent residues with 10-month PBI): Nut, tree, group 14 at 0.04 
ppm; Sugarcane at 0.05 ppm and Wheat grain (includes triticale) (Barley 
grain; Buckwheat grain; Oat grain; and Teosinte grain) at 0.1 ppm; 
Wheat bran (Barley bran) at 0.14 ppm; Wheat forage (Oat forage) at 6 
ppm; Wheat germ at 0.10 ppm; Wheat hay (Barley hay and Oat hay) at 15 
ppm; Wheat middlings at 0.10 ppm; Wheat shorts at 0.11 ppm; and, Wheat 
straw (Barley straw and Oat straw) at 6 ppm. That document referenced a 
summary of the petition prepared by Makhteshim Agan of North America, 
the registrant, which is available in docket ID number EPA-HQ-OPP-2018-
0793 at http://www.regulations.gov. One comment was received on the 
notice of filing. EPA's response to this comment is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petitions, EPA has 
modified the levels at which tolerances are being established as well 
as which commodities will have tolerances. The reasons for these 
changes are explained in Unit IV.D.

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 fluensulfone including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with fluensulfone 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.
    A summary of the toxicological effects of fluensulfone are 
discussed in the final rule published in the Federal Register of April 
13, 2018 (83 FR 15971) (FRL-9975-76).
    Specific information on the studies received and the nature of the 
adverse effects caused by fluensulfone as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Fluensulfone--Aggregate 
Human Health Risk Assessment in Support of Section 3 Registration of 
New Uses on Citrus and Peanut, and Change in the Tolerance Expression'' 
on pages 39-49 in docket ID number EPA-HQ-OPP-2017-0572.

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 fluensulfone used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of June 1, 2016 (81 FR 34898) (FRL-
9946-07).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluensulfone, EPA considered exposure under the petitioned-
for tolerances as well as all

[[Page 24044]]

existing fluensulfone tolerances in 40 CFR 180.680. EPA assessed 
dietary exposures from fluensulfone 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.
    Such effects were identified for fluensulfone. In estimating acute 
dietary exposure, EPA used 2003-2008 food consumption information from 
the United States Department of Agriculture (USDA) National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
As to residue levels in food, the acute dietary risk assessment assumed 
tolerance-equivalent residues and 100 percent crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used 2003-2008 food consumption information from the 
USDA's NHANES/WWEIA. As to residue levels in food, the chronic dietary 
risk assessment assumed tolerance-equivalent residues and 100 PCT.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a nonlinear RfD approach is appropriate for assessing 
cancer risk to fluensulfone. Cancer risk was assessed using the same 
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
fluensulfone. Tolerance-equivalent residue levels 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 fluensulfone in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fluensulfone. 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) and Pesticide Root Zone Model Ground Water (PRZM 
GW) models, the estimated drinking water concentrations (EDWCs) for 
acute exposures are estimated to be 11.8 parts per billion (ppb) for 
surface water and 77.6 ppb for ground water and for chronic exposures 
are estimated to be 0.173 ppb for surface water and 52.5 ppb for ground 
water. Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 77.6 ppb was used to 
assess the contribution to drinking water. For the chronic dietary risk 
assessment, the water concentration of value 52.5 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).
    Fluensulfone is currently registered for the following uses that 
could result in residential exposures: Golf courses and residential 
lawns. EPA assessed residential exposure using the following 
assumptions: No residential handler exposure for fluensulfone is 
expected because the products are not intended for homeowner use. The 
product label requires that handlers wear specific clothing (e.g., long 
sleeve shirt/long pants) and/or personal protective equipment (PPE). 
The Agency has made the assumption that the product is not for 
homeowner use and is intended for use by professional applicators. As a 
result, a residential handler assessment has not been conducted.
    For adult residential post-application exposure, the Agency 
evaluated dermal post-application exposure only to outdoor turf/lawn 
applications (high contact activities). The Agency also evaluated 
residential post-application exposure for children via dermal and hand-
to-mouth routes of exposure, resulting from treated outdoor turf/lawn 
applications (high contact activities). 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 fluensulfone to share a common mechanism of 
toxicity with any other substances, and fluensulfone does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
fluensulfone 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. No evidence of increased 
quantitative or qualitative susceptibility was seen in developmental 
toxicity studies in rats and rabbits. Fetal effects in those studies 
occurred in the presence of maternal toxicity and were not considered 
more severe than the maternal effects. However, there was evidence of 
increased qualitative, but not quantitative, susceptibility of pups in 
the 2-generation reproduction study in rats. Maternal effects observed 
in that study were decreased body weight; at the same dose, effects in 
offspring were decreased pup weights, decreased spleen weight, and 
increased pup loss (post-natal day 1-4). Although there is evidence of 
increased qualitative susceptibility in the 2-generation reproduction 
study in rats, there are no residual uncertainties with regard to pre- 
and post-natal toxicity following in utero exposure to rats or rabbits 
and pre- and post-natal exposures to rats. Considering the overall 
toxicity profile, the clear NOAEL for the pup effects observed in the 
2-generation reproduction study, and that the doses selected for risk 
assessment are protective of all effects in the toxicity database 
including the offspring effects,

[[Page 24045]]

the degree of concern for the susceptibility is low.
    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. That decision is based on the following 
findings:
    i. The toxicity database for fluensulfone is complete.
    ii. Evidence of potential neurotoxicity was only seen following 
acute exposure to fluensulfone and the current PODs chosen for risk 
assessment are protective of the effects observed. There is no need for 
a developmental neurotoxicity study or additional UFs to account for 
neurotoxicity.
    iii. There is no indication of quantitative susceptibility in the 
developmental and reproductive toxicity studies, and there are no 
residual uncertainties concerning pre- or post-natal toxicity. In 
addition, the endpoints and doses chosen for risk assessment are 
protective of the qualitative susceptibility observed in the 2-
generation reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-equivalent residue levels. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to fluensulfone in drinking water. EPA 
used similarly conservative assumptions to assess post-application 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by fluensulfone.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to fluensulfone will occupy 9.4% of the aPAD for all infants less than 
1 year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fluensulfone from food and water will utilize 4.1% 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 
fluensulfone 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).
    Fluensulfone 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 fluensulfone.
    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 5300 for adults 
and 2500 for children. Because EPA's level of concern for fluensulfone 
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, 
fluensulfone 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 
fluensulfone.
    5. Aggregate cancer risk for U.S. population. EPA assessed cancer 
risk using a non-linear approach (i.e., RfD) since it adequately 
accounts for all chronic toxicity, including carcinogenicity, that 
could result from exposure to fluensulfone. As the chronic dietary 
endpoint and dose are protective of potential cancer effects, 
fluensulfone is not expected to pose an aggregate cancer risk.
    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 fluensulfone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An enforcement analytical method for the BSA metabolite was 
previously submitted and found to be acceptable. The method extracts 
residues from matrices into an acetonitrile-based solvent, involves 
minimal cleanup, and uses high-performance liquid chromatography with 
tandem mass spectrometric detection (LC-MS/MS) in negative-ion mode to 
isolate, identify and quantify residues. For all matrices and analytes, 
the limit of quantitation (LOQ), defined as the lowest level of method 
validation (LLMV), was 0.01 ppm. With the change to the tolerance 
expression, an enforcement method is now needed for parent 
fluensulfone. A method for analysis of fluensulfone residues was 
previously submitted and has been found to be suitable for enforcement. 
The method is essentially identical to that used for BSA analysis but 
omits the cleanup step and uses LC-MS/MS in the positive-ion mode for 
isolation, identification, and quantification of residues.
    The FDA multi-residue protocols are not suitable for the analysis 
of fluensulfone or its metabolites BSA and TSA. The Agency notes that 
QuEChERS multi-residue method may be suitable for the analysis of these 
compounds, based on extraction solvents and clean-up strategies being 
similar to the analytical method described above.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture

[[Page 24046]]

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 a MRL for fluensulfone for citrus.
    The Codex has established MRLs for fluensulfone in or on some of 
the commodities or parts of some of the crop groups that are being 
revised in this document. The U.S. tolerances are harmonized with the 
Codex MRLs to the extent possible. In several cases (below), there is 
disharmony between U.S. crop group tolerances and Codex MRLs for 
individual commodities covered by the crop group. Because EPA has data 
supporting the establishment of the crop groups and no data that 
indicate a need to establish separate individual commodities, the 
effect is that tolerances for some individual commodities are not 
harmonized with Codex MRLs.

------------------------------------------------------------------------
                                       Tolerance
             Commodity                (ppm) U.S.      MRL (mg/kg) Codex
------------------------------------------------------------------------
Brassica, leafy green, subgroup 5B              20  1 (Group of leafy
                                                     vegetables) 9
                                                     (Komatsuna).
Vegetables, cucurbits, group 9....            0.70  0.3 (Melons, except
                                                     watermelon).
Vegetables, leafy, except                      4.0  1 (Group of leafy
 Brassica, group 4.                                  vegetables).
Vegetables, leaves of root and                  50  1 (Group of leafy
 tuber, group 2, except sugar beet.                  vegetables) 10
                                                     (Turnip greens).
Vegetables, root, except sugar                 4.0  3 (Root and tuber
 beet, subgroup 1B.                                  vegetables).
------------------------------------------------------------------------

C. Response to Comments

    One comment generally opposing the use of fluensulfone was received 
in response to the notice of filing for citrus and peanut uses (EPA-HQ-
OPP-2017-0572). Although the Agency recognizes that some individuals 
believe that pesticides should be banned on agricultural crops, the 
existing legal framework provided by section 408 of the Federal Food, 
Drug and Cosmetic Act (FFDCA) authorizes EPA to establish tolerances 
when it determines that the tolerance is safe. Upon consideration of 
the validity, completeness, and reliability of the available data as 
well as other factors the FFDCA requires EPA to consider, EPA has 
determined that these fluensulfone tolerances are safe. The commenter 
has provided no information supporting a contrary conclusion.
    One comment was received in response to the notice of filing to 
amend the tolerance expression for fluensulfone to harmonize with the 
Codex residue definition (EPA-HQ-OPP-2018-0793). The commenter 
supported the federal government regulating the chemicals in pesticides 
and specifically wanted EPA to set higher safety standards for 
pesticides. As explained in the previous paragraph, EPA evaluated 
fluensulfone using the existing safety standard in the FFDCA and has 
determined that these fluensulfone tolerances are safe.

D. Revisions to Petitioned-For Tolerances

    For stone fruit (Crop Group 12-12) and sugarcane, the tolerances 
being established by the Agency are derived using the Organization for 
Economic Cooperation and Development (OECD) MRL calculation procedures 
and based on available residue data.
    The tolerance for tree nuts is based on the requested revision to 
the tolerance expression. As such, it is the combination of 0.01 ppm 
BSA and 0.01 ppm fluensulfone, resulting in the level of 0.02 ppm as 
opposed to the proposed 0.04 ppm.
    Inadvertent tolerances in barley bran and wheat bran are being 
revised to 0.15 ppm (based on the OECD calculation procedure rounding 
classes), rather than the proposed tolerances at 0.14 ppm.
    The petitioner had requested a higher tolerance for inadvertent 
residues on teosinte grain than the tolerance level set for crop group 
15, based on the residue data used to establish the higher tolerance 
for wheat grain. These higher tolerances are based on residue data that 
indicate higher tolerances are necessary for crops for which the 
pesticide label permits a shorter plant-back interval (i.e., wheat, 
barley, buckwheat, oats). For other crops, including teosinte, the 
pesticide label establishes a longer plant-back interval, and 
associated residue data indicate that such intervals result in lower 
residues on those crops. It is this latter set of residue data and the 
pesticide label instructions for plant-back intervals that support the 
crop group 15 tolerance as well as the Agency's conclusion that 
residues in teosinte will be covered by the crop group 15 tolerance. A 
tolerance in wheat milled byproducts is being established at 0.15 ppm 
(based on the OECD calculation procedure rounding classes); because a 
tolerance on wheat milled byproducts covers residues in both wheat 
shorts and wheat middlings, tolerances on those individual commodities 
are unnecessary.
    Although the petitioner did not request a revision of the existing 
grape, raisin tolerance, EPA is modifying that tolerance to 1.5 ppm. As 
noted in 40 CFR 180.40(f)(1), EPA will not establish crop group 
tolerances unless necessary tolerances for processed foods are also 
established. In this action, the petitioner has requested an increase 
in the tolerance for subgroup 13-07D, which includes grape. Based on 
available data, EPA has determined that an amended tolerance for grape, 
raisin would be necessary. This tolerance is derived from the revised 
highest average field trial (HAFT) of 0.49 ppm from the grape field 
trials, using the revised residue definition (fluensulfone + BSA, in 
terms of fluensulfone), multiplied by the median processing factor for 
raisins from the processing study (2.7X), resulting in 1.32 ppm; 
therefore, a tolerance of 1.5 ppm in raisin is appropriate.
    For citrus, EPA used processing factors of 233X for fluensulfone 
and <0.5X for BSA in citrus oil. Application of these processing 
factors and OECD MRL rounding classes indicates that residues will 
concentrate in dried pulp at higher levels than requested as well as in 
citrus oil. In accordance with 40 CFR 180.40(f)(1), EPA is establishing 
a tolerance for fruit, citrus, group 10-10, oil at 15 ppm. Based on the 
Agency's calculations, EPA is also establishing the proposed tolerance 
for citrus, dried pulp as a tolerance for fruit, citrus, group 10-10, 
dried pulp at 0.9 ppm, rather than 0.4 ppm.
    Although the petitioner requested tolerances on peanut commodities, 
after EPA determined that the submitted field trial data were not 
adequate to support a tolerance the petitioner withdrew its request for 
those tolerances; therefore,

[[Page 24047]]

EPA is not establishing tolerances for residues on peanut; peanut, hay; 
or peanut, meal.

V. Conclusion

    Therefore, tolerances are established for residues of fluensulfone, 
and its metabolite BSA expressed as fluensulfone equivalents, in or on 
fruit, citrus, group 10-10 at 0.3 ppm; fruit, citrus, group 10-10, 
dried pulp at 0.9 ppm; and fruit, citrus, group 10-10, oil at 15 ppm.
    Additionally, existing tolerances under paragraphs (a) and (d) are 
revised as follows for residues of fluensulfone, and its metabolite BSA 
expressed as fluensulfone equivalents, as follows: Paragraph (a): 
Almond, hulls at 5 ppm; berry, low growing, subgroup 13-07G at 0.5 ppm; 
Brassica, head and stem, subgroup 5A at 1.5 ppm; Brassica, leafy 
greens, subgroup 5B at 20 ppm; fruit, pome, group 11-10 at 0.4 ppm; 
fruit, small, vine climbing, subgroup 13-07D at 0.8 ppm; fruit, stone, 
group 12-12 at 0.15 ppm; grape, raisin at 1.5 ppm; nut, tree, group 14-
12 at 0.02 ppm; potato, chips at 2 ppm; potato, granules/flakes at 2 
ppm; sugarcane, cane at 0.06 ppm; sugarcane, molasses at 0.3 ppm; 
tomato, paste at 1.5 ppm; vegetables, cucurbits, group 9 at 0.7 ppm; 
vegetables, fruiting, group 8-10 at 0.7 ppm; vegetables, leafy, except 
Brassica, group 4 at 4 ppm; vegetables, leaves of root and tuber, group 
2, except sugar beet at 50 ppm; vegetables, root, except sugar beet, 
subgroup 1B at 4 ppm; and vegetables, tuberous and corm, subgroup 1C at 
0.8 ppm; Paragraph (d): barley, bran at 0.15 ppm; barley, grain at 0.1 
ppm; barley, hay at 15 ppm; barley, straw at 6 ppm; buckwheat, grain at 
0.1 ppm; grain, cereal, forage, fodder and straw, group 16 at 3 ppm; 
grain, cereal, group 15 at 0.05 ppm; oat, forage at 6 ppm; oat, grain 
at 0.1 ppm; oat, hay at 15 ppm; oat, straw at 6 ppm; wheat, bran at 
0.15 ppm; wheat, forage at 6 ppm; wheat, germ at 0.1 ppm; wheat, grain 
at 0.1 ppm; wheat, hay at 15 ppm; wheat, milled byproducts at 0.15 ppm; 
and wheat, straw at 6 ppm.
    Lastly, the tolerance expressions for fluensulfone currently 
established under 40 CFR 180.680 (a) and (d) are revised to read as 
follows ``Tolerances are established for residues of the nematicide 
fluensulfone, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified in the following table below is to be determined by measuring 
only the sum of fluensulfone, 5-chloro-2-[(3,4,4-trifluoro-3-buten-1-
yl)sulfonyl]thiazole and its metabolite, 
3,4,4[hyphen]trifluoro[hyphen]but[hyphen]3[hyphen]ene[hyphen]1[hyphen]su
lfonic acid, calculated as the stoichiometric equivalent of 
fluensulfone, in or on the commodity.''

VI. Statutory and Executive Order Reviews

    This action establishes and modifies 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 tolerances 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: May 16, 2019.
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. Revise Sec.  180.680 to read as follows:

Sec.  180.680  Fluensulfone; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
nematicide fluensulfone, including its metabolites and degradates, in 
or on the commodities in the table 1 to Sec.  180.680. Compliance with 
the tolerance levels specified in the following table below is to be 
determined by measuring only the sum of fluensulfone, 5-chloro-2-
[(3,4,4-trifluoro-3-buten-1-yl)sulfonyl]thiazole and its metabolite, 
3,4,4[hyphen]trifluoro[hyphen]but[hyphen]3[hyphen]ene[hyphen]1[hyphen]su
lfonic acid, calculated as the stoichiometric equivalent of 
fluensulfone, in or on the commodity.

[[Page 24048]]

                        Table 1 to Sec.   180.680
------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
Almond, hulls..................................................        5
Berry, low growing, subgroup 13-07G............................      0.5
Brassica, head and stem, subgroup 5A...........................      1.5
Brassica, leafy greens, subgroup 5B............................       20
Fruit, citrus, group 10-10.....................................      0.3
Fruit, citrus, group 10-10, dried pulp.........................      0.9
Fruit, citrus, group 10-10, oil................................       15
Fruit, pome, group 11-10.......................................      0.4
Fruit, small, vine climbing, subgroup 13-07D...................      0.8
Fruit, stone, group 12-12......................................     0.15
Grape, raisin..................................................      1.5
Nut, tree, group 14-12.........................................     0.02
Potato, chips..................................................        2
Potato, granules/flakes........................................        2
Sugarcane, cane................................................     0.06
Sugarcane, molasses............................................      0.3
Tomato, paste..................................................      1.5
Vegetables, cucurbits, group 9.................................      0.7
Vegetables, fruiting, group 8-10...............................      0.7
Vegetables, leafy, except Brassica, group 4....................        4
Vegetables, leaves of root and tuber, group 2, except sugar           50
 beet..........................................................
Vegetables, root, except sugar beet, subgroup 1B...............        4
Vegetables, tuberous and corm, subgroup 1C.....................      0.8
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established 
for residues of the nematicide fluensulfone, including its metabolites 
and degradates, in or on the commodities in table 2 to Sec.  180.680. 
Compliance with the tolerance levels specified in the following table 
below is to be determined by measuring only the sum of fluensulfone, 5-
chloro-2-[(3,4,4-trifluoro-3-buten-1-yl)sulfonyl]thiazole and its 
metabolite, 
3,4,4[hyphen]trifluoro[hyphen]but[hyphen]3[hyphen]ene[hyphen]1[hyphen]su
lfonic acid, calculated as the stoichiometric equivalent of 
fluensulfone, in or on the commodity.

                        Table 2 to Sec.   180.680
------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
Barley, bran...................................................     0.15
Barley, grain..................................................      0.1
Barley, hay....................................................       15
Barley, straw..................................................        6
Buckwheat, grain...............................................      0.1
Grain, cereal, forage, fodder and straw, group 16..............        3
Grain, cereal, group 15........................................     0.05
Oat, forage....................................................        6
Oat, grain.....................................................      0.1
Oat, hay.......................................................       15
Oat, straw.....................................................        6
Wheat, bran....................................................     0.15
Wheat, forage..................................................        6
Wheat, germ....................................................      0.1
Wheat, grain...................................................      0.1
Wheat, hay.....................................................       15
Wheat, milled byproducts.......................................     0.15
Wheat, straw...................................................        6
------------------------------------------------------------------------

[FR Doc. 2019-10793 Filed 5-23-19; 8:45 am]
 BILLING CODE 6560-50-P