[Federal Register Volume 83, Number 72 (Friday, April 13, 2018)]
[Rules and Regulations]
[Pages 15971-15977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07739]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0169; FRL-9975-76]


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 that are identified and 
discussed later in this document. Makhteshim Agan of North America 
(MANA) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective April 13, 2018. Objections and 
requests for hearings must be received on or before June 12, 2018, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2017-0169, 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

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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) 308-8157; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2017-0169 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 
June 12, 2018. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2017-0169, 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 September 15, 2017 (82 FR 43352) (FRL-
9965-43), 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 
6F8538) by Makhteshim Agan of North America (MANA) (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, in or on fruit, pome, crop group 11-10 
at 0.3 parts per million (ppm); fruit, stone crop group 12-12 at 0.06 
ppm; small fruit vine climbing subgroup 13-07D at 0.5 ppm; grape, 
raisin at 0.8 ppm; nut, tree, crop group 14-12 at 0.02 ppm; almond, 
hulls at 3.0 ppm; sugarcane at 0.03 ppm; sugarcane and molasses at 0.2 
ppm, and for inadvertent residues of fluensulfone, in or on (10-month 
plant-back interval): Grain, cereal, crop group 15 at 0.03 ppm; forage, 
fodder and straw of cereal grains, crop group 16 at 2 ppm; (90-day 
plant-back interval): Wheat, grain at 0.06 ppm; barley, grain at 0.06 
ppm; buckwheat, grain at 0.06 ppm; oat, grain at 0.06 ppm; teosinte, 
grain at 0.06 ppm; wheat, bran at 0.10 ppm; barley, bran at 0.10 ppm; 
wheat, middlings at 0.07 ppm; wheat, shorts at 0.08 ppm; wheat, germ at 
0.07 ppm; wheat, straw at 4 ppm; barley, straw at 4 ppm; oat, straw at 
4 ppm; wheat, forage at 4 ppm; oat, forage at 4 ppm; wheat, hay at 8 
ppm; barley hay at 8 ppm; and oat, hay at 8 ppm. That document 
referenced a summary of the petition prepared by MANA, the registrant, 
which is available in the docket, http://www.regulations.gov. A 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 petition, EPA has 
modified the levels at which tolerances are being established in 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,

[[Page 15973]]

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 decreased body weight 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 document ``Fluensulfone--Aggregate Human Health 
Risk Assessment in Support of Section 3 Registration of New Uses 
(Sugarcane, Small Vine Climbing Fruits, Pome Fruits, Stone Fruits, and 
Tree Nuts), Rotational Crop Tolerances, and Label Amendments'' on pages 
37-50 in docket ID number EPA-HQ-OPP-2017-0169.

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://www.epa.gov/pesticides/factsheets/riskassess.htm. 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 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 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., chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for fluensulfone. Tolerance-equivalent residue levels and 
100% CT 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/

[[Page 15974]]

pesticide-science-and-assessingpesticide-risks/about-water-
exposuremodels-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).
    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/pesticidescience-and-assessing-pesticide-risks/standard-operating-proceduresresidential-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-andassessing-pesticide-risks/cumulativeassessment-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 and body weight gain; 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, 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

[[Page 15975]]

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 post-application 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 5,600 adults and 
2,800 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

    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: [email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established a MRL for fluensulfone for commodities covered by this 
document.

C. Response to Comments

    One comment was submitted in response to the September 15, 2017 
Notice of Filing. The commenter opposed the petition generally, 
alleging that there are too many toxic chemicals being used in America 
without citing any specific human health concerns about fluensulfone 
itself. The Agency 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.

D. Revisions to Petitioned-For Tolerances

    Most of the petitioned-for tolerance levels differ from those being 
established by the Agency. In its petition, the petitioner stated that 
the proposed tolerances were derived using the Organization for 
Economic Cooperation and Development (OECD) MRL calculation procedure; 
however, the petitioner did not provide the OECD MRL calculator's input 
or output tables for any of the requested tolerances. When EPA ran the 
OECD MRL calculation procedure on the requested new use commodities 
(primary crops) using residue values from the field trials, the results 
obtained did not agree with any of the petitioned-for tolerances, 
except in pome fruits group 11-10 and molasses. Therefore, EPA is 
establishing tolerances that differ from those requested in stone 
fruits group 12-12, small vine climbing fruits subgroup 13-07D, 
raisins, tree nuts group 14-12, almond hulls, and sugarcane based on 
available data and the OECD calculation procedure. In the case of tree 
nuts group 14-12, EPA is establishing the tolerance in tree nuts at 
0.01 ppm (the LOQ) because residues in all samples of almonds and 
pecans were <0.01 ppm.
    With respect to tolerances for inadvertent residues, the Agency is 
establishing a tolerance for residues in/on cereal grains (crop group 
15) based on data from the representative commodities for that crop 
group and reflecting the labeled rotational crop plant-back restriction 
applicable to the crop group as a whole. Separate tolerances for 
inadvertent residues are being established for barley, buckwheat, oat, 
and wheat commodities due to a shorter plant-back restriction, specific 
to those crops, which results in higher residue levels. A separate 
tolerance was proposed for inadvertent residues in/on teosinte; 
however, a separate tolerance listing is not necessary since it is a 
member of crop group 15 and does not

[[Page 15976]]

have a separate, shorter, plant-back restriction. A tolerance in wheat 
milled byproducts, the preferred term covering wheat shorts and 
middlings, is being established at 0.08 ppm, rather than separate 
tolerances in wheat shorts and wheat middlings.
    Furthermore, EPA's tolerance levels are expressed to provide 
sufficient precision for enforcement purposes, and this may include the 
addition of trailing zeros (such as 0.30 ppm rather than 0.3 ppm). This 
is in order to avoid the situation where rounding of an observed 
violative residue to the level of precision of the tolerance expression 
would result in a residue considered non-violative (such as 0.34 ppm 
being rounded to 0.3 ppm). This revision has been made for pome fruits 
group 11-10; molasses; forage, fodder and straw of cereal grains group 
16; and straw, forage, and hay of wheat, barley and oats.

V. Conclusion

    Therefore, tolerances are established for residues of fluensulfone, 
in or on almond, hulls at 4.0 ppm; fruit, pome, group 11-10 at 0.30 
ppm; fruit, small, vine climbing, subgroup 13-07D at 0.60 ppm; fruit, 
stone group 12-12 at 0.07 ppm; grape, raisin at 0.90 ppm; nut, tree, 
group 14-12 at 0.01 ppm; sugarcane, cane at 0.04 ppm; and sugarcane, 
molasses at 0.20 ppm. In addition, tolerances for indirect or 
inadvertent residues of fluensulfone are established in or on barley, 
bran at 0.10 ppm; barley, grain at 0.06 ppm; barley hay at 8.0 ppm; 
barley, straw at 4.0 ppm; buckwheat, grain at 0.06 ppm; grain, cereal, 
forage, fodder and straw, group 16 at 2.0 ppm; grain, cereal, group 15 
at 0.03 ppm; oat, forage at 4.0 ppm; oat, grain at 0.06 ppm; oat, hay 
at 8.0 ppm; oat, straw at 4.0 ppm; wheat, bran at 0.10 ppm; wheat, 
forage at 4.0 ppm; wheat, germ at 0.07 ppm; wheat, grain at 0.06 ppm; 
wheat, hay at 8.0 ppm; wheat, milled byproducts at 0.08 ppm; and wheat, 
straw at 4.0 ppm.

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); Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771, 
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 
FR 9339, February 3, 2017). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: April 4, 2018.
Donna S. Davis,
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. In Sec.  180.680:
0
a. In the table to paragraph (a), add alphabetically the entries 
``Almond, hulls''; ``Fruit, pome, group 11-10''; ``Fruit, small, vine 
climbing, subgroup 13-07D''; ``Fruit, stone, group 12-12''; ``Grape, 
raisin''; ``Nut, tree, group 14-12''; ``Sugarcane, cane''; and 
``Sugarcane, molasses''.
0
b. Revise paragraph (d).
    The additions and revisions read as follows:


Sec.  180.680   Fluensulfone; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
Almond, hulls..................................................      4.0
 
                                * * * * *
Fruit, pome, group 11-10.......................................     0.30
Fruit, small, vine climbing, subgroup 13-07D...................     0.60
Fruit, stone, group 12-12......................................     0.07
Grape, raisin..................................................     0.90
Nut, tree, group 14-12.........................................     0.01
 
                                * * * * *
Sugarcane, cane................................................     0.04
Sugarcane, molasses............................................     0.20
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (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

[[Page 15977]]

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
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
Barley, bran...................................................     0.10
Barley, grain..................................................     0.06
Barley, hay....................................................      8.0
Barley, straw..................................................      4.0
Buckwheat, grain...............................................     0.06
Grain, cereal, forage, fodder and straw, group 16..............      2.0
Grain, cereal, group 15........................................     0.03
Oat, forage....................................................      4.0
Oat, grain.....................................................     0.06
Oat, hay.......................................................      8.0
Oat, straw.....................................................      4.0
Wheat, bran....................................................     0.10
Wheat, forage..................................................      4.0
Wheat, germ....................................................     0.07
Wheat, grain...................................................     0.06
Wheat, hay.....................................................      8.0
Wheat, milled byproducts.......................................     0.08
Wheat, straw...................................................      4.0
------------------------------------------------------------------------

[FR Doc. 2018-07739 Filed 4-12-18; 8:45 am]
 BILLING CODE 6560-50-P