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[Federal Register Volume 81, Number 105 (Wednesday, June 1, 2016)]
[Rules and Regulations]
[Pages 34896-34902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12722]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0569; FRL-9946-07]

Fluensulfone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluensulfone in or on multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) and Makhteshim Agan of North America, Inc (d/b/a ADAMA) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is June 1, 2016. Objections and requests for 
hearings must be received on or before August 1, 2016, 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-2015-0569, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: 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-2015-0569 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 August 
1, 2016. 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-2015-0569, 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 21, 2015 (80 FR 63731) (FRL-
9935-29), 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 
5E8384) by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ 
08540. The petition requested that 40 CFR part 180 be amended by 
establishing a tolerance for residues of fluensulfone equivalents 
(i.e., the sum of thiazole sulfonic acid (TSA) and butene sulfonic acid 
(BSA) expressed as total fluensulfone equivalents) in or on the raw 
agricultural commodity vegetable, tuberous and corm, subgroup 1C at 0.6 
ppm. That document referenced a summary of the petition prepared by 
Makhteshim Agan of North America, Inc., the registrant, which is 
available in the docket, http://www.regulations.gov. A comment was 
received on the notice of filing, however it related to the chemical 
propenicol, not fluensulfone.
    In the Federal Register of March 16, 2016 (81 FR 14030) (FRL-9942-
86), 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 
5F8351) by Makhteshim Agan of North America, Inc. (d/b/a ADAMA), 3120 
Highwoods Blvd., Suite 100, Raleigh, NC 27604. The petition requested 
that 40 CFR part 180 be amended by establishing a tolerance for 
residues of nematicide fluensulfone, including its metabolites and 
degradates, in or on berry, low growing, subgroup 13-07G at 0.30 ppm; 
head and stem Brassica subgroup 5A at 1.3 ppm; leafy Brassica greens 
subgroup 5B at 13 ppm; leafy vegetables, group 4, except Brassica 
vegetables at 2.6 ppm; leaves of root and tuber vegetables, group 2 at 
20 ppm; radish, oriental at 0.50 ppm; and root vegetables, subgroup

[[Page 34897]]

1B, except sugar beet and oriental radish at 3.3 ppm. In addition, the 
petition requested to amend 40 CFR 180.680 to revise the existing 
tolerance expression in the introductory paragraph (a) 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 below is to be determined by measuring only 3,4,4-trifluoro-
but-3-ene-1-sulfonic acid.'' That document referenced a summary of the 
petition prepared by Makhteshim Agan of North America, Inc., the 
registrant, which is available in the docket, EPA-HQ-OPP-2015-0478 at 
http://www.regulations.gov. Comments were received on the notice of 
filing. EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified the levels at which tolerances are being established for most 
commodities. 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.
    The residue of concern for dietary assessment is the parent 
compound, fluensulfone. Residues of the metabolites butene sulfonic 
acid (BSA) and thiazole sulfonic acid (TSA) occur at levels 
significantly greater than fluensulfone; however, these metabolites are 
considered non-toxic at levels that may occur from the use of 
fluensulfone. Based on the available data addressing toxicity of the 
BSA and TSA metabolites, the Agency has determined that they are not of 
toxicological concern.
    Exposure to fluensulfone results in effects on the hematopoietic 
system (decreased platelets, increased white blood cells, hematocrit, 
and reticulocytes), kidneys, and lungs. Body weight and clinical 
chemistry changes were observed across multiple studies and species. 
Evidence of qualitative increased susceptibility of infants and 
children to the effects of fluensulfone was observed in the 2-
generation reproduction study in rats, wherein pup death was observed 
at a dose that resulted in body weight effects in the dams. There was 
no evidence of either qualitative or quantitative susceptibility in 
developmental toxicity studies in rats or rabbits.
    The most sensitive endpoints for assessing safety of aggregate 
exposures to fluensulfone under the FFDCA are the increased pup-loss 
effects for acute dietary exposure; and body weight, hematological and 
clinical chemistry changes for chronic dietary as well as short/
intermediate term dermal exposures.
    Decreased locomotor activity in females, and decreased spontaneous 
activity, decreased rearing, and impaired righting response in both 
sexes were observed in the acute neurotoxicity study at the lowest dose 
tested. No other evidence for neurotoxicity was observed in the other 
studies in the toxicity database, including a subchronic neurotoxicity 
study. The doses and endpoints chosen for risk assessment are all 
protective of the effects seen in the acute neurotoxicity study. A 
developmental neurotoxicity study is not required.
    Although the mouse carcinogenicity study showed an association with 
alveolar/bronchiolar adenomas and carcinomas in the female, EPA has 
determined that quantification of risk using the chronic reference dose 
(RfD) will account for all chronic toxicity, including carcinogenicity, 
that could result from exposure to fluensulfone and its metabolites. 
That conclusion is based on the following considerations:
    1. The tumors occurred in only one sex in one species.
    2. No carcinogenic response was seen in either sex in the rat.
    3. The tumors in the mouse study were observed at a dose that is 
almost 13 times higher than the dose chosen for risk assessment.
    4. Fluensulfone and its metabolites are not mutagenic.
    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 Addressing Label Amendments, Changes to 
the Residue Definition, and New Uses on Multiple Crops'' on page 43 in 
docket ID number EPA-HQ-OPP-2015-0569.

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

[[Page 34898]]

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 shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Fluensulfone for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD,  LOC for    Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (All populations,    NOAEL = 16.2 mg/kg/   Acute RfD = 0.16 mg/ 2-generation reproduction--rat
 including infants and children     day                   kg/day.              offspring.
 and females 13-49 years of age).  UFA = 10x...........  aPAD = 0.16 mg/kg/   LOAEL = 122.0 mg/kg/day based on
                                   UFH = 10x...........   day.                 an increase in pup loss between
                                   FQPA SF = 1x........                        PND 1 and 4 in the F1 and F2
                                                                               offspring with the majority of
                                                                               deaths occurring on day 2.
Chronic dietary (All populations)  NOAEL= 9.6 mg/kg/day  Chronic RfD = 0.10   2-year toxicity/carcinogenicity-
                                   UFA = 10x...........   mg/kg/day.           rat.
                                   UFH = 10x...........  cPAD = 0.10 mg/kg/   LOAEL = 57.7 mg/kg/day based on
                                   FQPA SF = 1x........   day.                 decreased body weight in males,
                                                                               and hematology changes, clinical
                                                                               chemistry changes and
                                                                               histopathological effects in the
                                                                               lung and esophagus of both sexes.
Incidental oral short-term (1 to   NOAEL= 9.6 mg/kg/day  LOC for MOE = 100..  2-year toxicity/carcinogenicity-
 30 days).                         UFA = 10x...........                        rat.
                                   UFH = 10x...........                       LOAEL = 57.7 mg/kg/day based on
                                   FQPA SF = 1x........                        decreased body weight in males,
                                                                               and hematology changes, clinical
                                                                               chemistry changes and
                                                                               histopathological effects in the
                                                                               lung and esophagus of both sexes.
Dermal short-term (1 to 30 days).  Oral study NOAEL =    LOC for MOE = 100..  2-year toxicity/carcinogenicity-
                                    9.6 mg/kg/day                              rat.
                                    (dermal absorption                        LOAEL = 57.7 mg/kg/day based on
                                    factor = 9.5%)                             decreased body weight in males,
                                   UFA = 10x...........                        and hematology changes, clinical
                                   UFH = 10x...........                        chemistry changes and
                                   FQPA SF = 1x........                        histopathological effects in the
                                                                               lung and esophagus of both sexes.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  EPA has determined that quantification of risk using the chronic RfD will
                                    adequately account for all chronic toxicity, including carcinogenicity.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

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 existing fluensulfone tolerances in 40 
CFR 180.680. Parent fluensulfone occurs at residue levels well below 
those of the BSA metabolite, the residue defined for the enforcement of 
tolerances. As previously noted, the BSA metabolite is not of 
toxicological concern. Since tolerances do not include fluensulfone 
itself, EPA has used the Organization for Economic Cooperation and 
Development (OECD) maximum residue limit (MRL) calculation procedures 
to derive tolerance-equivalent residue levels for fluensulfone. For 
foods where the level of fluensulfone is expected to be below the limit 
of quantification (LOQ), 0.01 ppm, the Agency has assumed that residues 
occur at the LOQ. For foods with quantifiable levels of fluensulfone, 
EPA has assumed that residues occur at the tolerance-equivalent level. 
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's (USDA's) National Health 
and Nutrition Examination Survey, What We Eat in America, (NHANES/
WWEIA). As to residue levels in food, the acute dietary risk 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 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.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
fluensulfone. Tolerance-equivalent 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 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.

[[Page 34899]]

    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: Turf/lawns. EPA assessed residential exposure 
using the following assumptions: For residential handlers, a 
quantitative exposure/risk assessment was not developed because the 
product is not intended to be applied by homeowners. 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 Web site 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 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 and body weight gain; at the same 
dose, effects in offspring were decreased pup weights, decreased spleen 
weight, and increased pup loss (PND 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, 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-level residues. 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 9.3% of the aPAD for all infants less than 
1 year old, the population group receiving the greatest exposure.

[[Page 34900]]

    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 3.9% 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 5,700 for adults 
and 3,000 for children 1-2 years old. 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

    Adequate enforcement methodology (acetonitrile/water (1:1, v/v) 
extraction and analysis by reverse-phase high-performance liquid 
chromatography-mass spectrometry (HPLC-MS/MS)) is available to enforce 
the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
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 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 any MRLs for fluensulfone for the 
commodities covered by this document.

C. Response to Comments

    Three comments were submitted in response to the March 16, 2016 
Notice of Filing. Two of them opposed the petition generally due to 
there being too many toxic chemicals being used in America without 
citing any specific human health concerns about fluensulfone itself. 
The Agency understands the commenters' concerns and recognizes that 
some individuals believe that pesticides should be banned on 
agricultural crops. However, the existing legal framework provided by 
section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states 
that tolerances may be set when persons seeking such tolerances or 
exemptions have demonstrated that the pesticide meets the safety 
standard imposed by that statute. The comment appears to be directed at 
the underlying statute and not EPA's implementation of it; the citizen 
has made no contention that EPA has acted in violation of the statutory 
framework.
    The second comment was from the Center for Food Safety and 
primarily concerned about Agency compliance with any relevant 
obligations under the Endangered Species Act. This comment is not 
relevant to the Agency's evaluation of safety of the fluensulfone 
tolerances; section 408 of the FFDCA focuses on potential harms to 
human health and does not permit consideration of effects on the 
environment.

D. Revisions to Petitioned-For Tolerances

    Most of the petitioned-for tolerance levels differ from those being 
established by the Agency. In the cases of the tolerances proposed by 
ADAMA, it is not clear to the Agency how the tolerance levels proposed 
in the March 16, 2016 Notice of Filing (Federal Register 2016-05952) 
were derived. EPA's tolerance levels are based on residues of BSA only, 
without any conversion to fluensulfone equivalents. The Agency used the 
OECD MRL procedures to derive the levels being established in today's 
action. For crop groups, and per EPA's current policy, tolerance levels 
for each representative commodity were calculated separately, and then 
the maximum value within each crop group was selected as the tolerance 
level. For root vegetables except sugar beet (Subgroup 1B), the 
tolerance level is based on data from radish root (including Oriental 
radish root). Although a separate listing for Oriental radish was 
requested, EPA is not establishing a separate tolerance level since 
that crop is a member of crop subgroup 1B. For leaves of root and tuber 
vegetables (Crop Group 2), EPA is establishing a tolerance for residues 
in/on the leaves of root and tuber vegetable, except sugar beet because 
the petitioned-for uses do not include a use on sugar beet; the 
tolerance is based on data from radish tops (including Oriental radish 
tops). The tolerance for residues in/on leafy vegetables except 
Brassica vegetables (Group 4) is based on data from leaf lettuce and 
spinach, assessed separately. For head and stem Brassica (Subgroup 5A), 
the tolerance is

[[Page 34901]]

based on data from cabbage. For Brassica leafy greens (Subgroup 5B), 
data from mustard greens, komatsuna (Japanese mustard spinach), and 
mizuna (Japanese mustard) were combined to derive the tolerance level. 
All of EPA's tolerance levels are expressed to provide sufficient 
precision for enforcement purposes, and this may include the addition 
of trailing zeros (e.g., 0.30 ppm rather than 0.3 ppm).
    In the case of the tolerance proposed by IR-4, the petitioned-for 
tolerance is based on the sum of residues of BSA and TSA, expressed as 
fluensulfone, rather than on residues of BSA only, which is how the 
tolerance expression currently describes measurement of residues for 
compliance purposes. Basing enforcement on BSA alone provides a 
suitable marker of use, simplifies residue analysis, and avoids 
enforcement complications that may result from the potential for TSA to 
carry over in treated soil from one year to the next. Furthermore, IR-4 
did not propose tolerances for residues of fluensulfone in processed 
potato commodities. The submitted potato processing study indicates 
that during processing, residues of BSA in chips and in granules/flakes 
are likely to concentrate to levels greater than in tubers. Therefore, 
EPA is establishing separate tolerances to cover residues in those 
commodities.

V. Conclusion

    Therefore, tolerances are established for residues of fluensulfone 
in or on berry, low growing, subgroup 13-07G at 0.30 ppm; Brassica, 
head and stem, subgroup 5A at 1.50 ppm; Brassica, leafy greens, 
subgroup 5B at 9.0 ppm; potato, chips at 0.60 ppm; potato, granules/
flakes at 0.80 ppm; vegetables, leafy, except Brassica, group 4 at 2.0 
ppm; vegetable, leaves of root and tuber, group 2, except sugar beet at 
30 ppm; vegetables, root, except sugar beet, subgroup 1B at 3.0 ppm; 
and vegetables, tuberous and corm, subgroup 1C at 0.50 ppm. Also, the 
time-limited Section 18 tolerance for ``carrot'' is removed since it is 
now covered by the permanent tolerance for ``vegetables, root, except 
sugar beet, subgroup 1B.'' And lastly, the tolerance expression is 
changed as requested by the petitioner.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: May 19, 2016.
Daniel J. Rosenblatt,
Acting 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. Section 180.680 is revised 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 below. Compliance with the tolerance 
levels specified below is to be determined by measuring only 3,4,4-
trifluoro-but-3-ene-1-sulfonic acid.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Berry, low growing, subgroup 13-07G.........................        0.30
Brassica, head and stem, subgroup 5A........................        1.50
Brassica, leafy greens, subgroup 5B.........................         9.0
Potato, chips...............................................        0.60
Potato, granules/flakes.....................................        0.80
Tomato, paste...............................................         1.0
Vegetables, cucurbits, group 9..............................        0.50
Vegetables, fruiting, group 8-10............................        0.50
Vegetables, leafy, except Brassica, group 4.................         2.0
Vegetables, leaves of root and tuber, group 2, except sugar           30
 beet.......................................................
Vegetables, root, except sugar beet, subgroup 1B............         3.0
Vegetables, tuberous and corm, subgroup 1C..................        0.50
------------------------------------------------------------------------

[[Page 34902]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]
[FR Doc. 2016-12722 Filed 5-31-16; 8:45 am]
 BILLING CODE 6560-50-P
```