83_FR_16043 83 FR 15971 - Fluensulfone; Pesticide Tolerances

83 FR 15971 - Fluensulfone; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 72 (April 13, 2018)

Page Range15971-15977
FR Document2018-07739

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).

Federal Register, Volume 83 Issue 72 (Friday, April 13, 2018)
[Federal Register Volume 83, Number 72 (Friday, April 13, 2018)]
[Rules and Regulations]
[Pages 15971-15977]
From the Federal Register Online  [www.thefederalregister.org]
[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



                                                                          Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Rules and Regulations                                                                                                15971

                                                                             DELEGATION STATUS FOR PART 63 STANDARDS—STATE OF NEW MEXICO—Continued
                                                                                                                                       [Excluding Indian Country]

                                                  Subpart                                                                         Source category                                                                           NMED 1 2               ABCAQCB 1 3

                                             BBBBBB .........           Gasoline Distribution Bulk Terminals, Bulk Plants, and Pipeline Facilities ................................                                                X                          X
                                             CCCCCC ........            Gasoline Dispensing Facilities ....................................................................................................                        X                          X
                                             DDDDDD ........            Polyvinyl Chloride and Copolymers Production Area Sources ..................................................                                               X                          X
                                             EEEEEE .........           Primary Copper Smelting Area Sources ....................................................................................                                  X                          X
                                             FFFFFF ..........          Secondary Copper Smelting Area Sources ................................................................................                                    X                          X
                                             GGGGGG ......              Primary Nonferrous Metals Area Source: Zinc, Cadmium, and Beryllium .................................                                                      X                          X
                                             HHHHHH ........            Paint Stripping and Miscellaneous Surface Coating Operations at Area Sources ....................                                                          X                          X
                                             IIIIII .................   (Reserved) ..................................................................................................................................   ........................   ........................
                                             JJJJJJ ............        Industrial, Commercial, and Institutional Boilers Area Sources .................................................                                           X                          X
                                             KKKKKK .........           (Reserved) ..................................................................................................................................   ........................   ........................
                                             LLLLLL ...........         Acrylic and Modacrylic Fibers Production Area Sources ...........................................................                                          X                          X
                                             MMMMMM .....               Carbon Black Production Area Sources .....................................................................................                                 X                          X
                                             NNNNNN ........            Chemical Manufacturing Area Sources: Chromium Compounds ...............................................                                                    X                          X
                                             OOOOOO ......              Flexible Polyurethane Foam Production and Fabrication Area Sources ...................................                                                     X                          X
                                             PPPPPP .........           Lead Acid Battery Manufacturing Area Sources ........................................................................                                      X                          X
                                             QQQQQQ ......              Wood Preserving Area Sources .................................................................................................                             X                          X
                                             RRRRRR ........            Clay Ceramics Manufacturing Area Sources .............................................................................                                     X                          X
                                             SSSSSS .........           Glass Manufacturing Area Sources ............................................................................................                              X                          X
                                             TTTTTT ..........          Secondary Nonferrous Metals Processing Area Sources ..........................................................                                             X                          X
                                             UUUUUU ........            (Reserved) ..................................................................................................................................   ........................   ........................
                                             VVVVVV .........           Chemical Manufacturing Area Sources ......................................................................................                                 X                          X
                                             WWWWWW ...                 Plating and Polishing Operations Area Sources ........................................................................                                     X                          X
                                             XXXXXX .........           Metal Fabrication and Finishing Area Sources ..........................................................................                                    X                          X
                                             YYYYYY .........           Ferroalloys Production Facilities Area Sources ..........................................................................                                  X                          X
                                             ZZZZZZ ..........          Aluminum, Copper, and Other Nonferrous Foundries Area Sources .........................................                                                    X                          X
                                             AAAAAAA ......             Asphalt Processing and Asphalt Roofing Manufacturing Area Sources ....................................                                                     X                          X
                                             BBBBBBB ......             Chemical Preparation Industry Area Sources ............................................................................                                    X                          X
                                             CCCCCCC .....              Paints and Allied Products Manufacturing Area Sources ..........................................................                                           X                          X
                                             DDDDDDD .....              Prepared Feeds Areas Sources .................................................................................................                             X                          X
                                             EEEEEEE ......             Gold Mine Ore Processing and Production Area Sources .........................................................                                             X                          X
                                             FFFFFFF–                   (Reserved) ..................................................................................................................................   ........................   ........................
                                                 GGGGGGG.
                                             HHHHHHH .....              Polyvinyl Chloride and Copolymers Production Major Sources .................................................                                              X                          X
                                                 1 Authoritieswhich may not be delegated include: § 63.6(g), Approval of Alternative Non-Opacity Emission Standards; § 63.6(h)(9), Approval of
                                             Alternative Opacity Standards; § 63.7(e)(2)(ii) and (f), Approval of Major Alternatives to Test Methods; § 63.8(f), Approval of Major Alternatives to
                                             Monitoring; § 63.10(f), Approval of Major Alternatives to Recordkeeping and Reporting; and all authorities identified in the subparts (e.g., under
                                             ‘‘Delegation of Authority’’) that cannot be delegated.
                                                2 Program delegated to New Mexico Environment Department (NMED) for standards promulgated by the EPA, as amended in the Federal
                                             Register through January 15, 2017.
                                                3 Program delegated to Albuquerque-Bernalillo County Air Quality Control Board (ABCAQCB) for standards promulgated by the EPA, as
                                             amended in the Federal Register through September 13, 2013.
                                                4 The NMED was previously delegated this subpart on February 9, 2004. The ABCAQCB has adopted the subpart unchanged and applied for
                                             delegation of the standard. The subpart was vacated and remanded to the EPA by the United States Court of Appeals for the District of Colum-
                                             bia Circuit. See, Mossville Environmental Action Network v. EPA, 370 F. 3d 1232 (D.C. Cir. 2004). Because of the D.C. Court’s holding this sub-
                                             part is not delegated to NMED or ABCAQCB at this time.
                                                5 This subpart was issued a partial vacatur by the United States Court of Appeals for the District of Columbia Circuit. See the Federal Register
                                             of October 29, 2007.
                                                6 Final rule. See the Federal Register of March 21, 2011, as amended at January 31, 2013; November 20, 2015.
                                                7 Final promulgated rule adopted by the EPA. See the Federal Register of October 26, 2015. Note that subpart KKKKK was amended to cor-
                                             rect minor typographical errors. See the Federal Register of December 4, 2015. Note that the ABCAQCB has not yet applied for updated dele-
                                             gation of these standards.
                                                8 Final Rule. See the Federal Register of February 16, 2012, as amended April 6, 2016. Final Supplemental Finding that it is appropriate and
                                             necessary to regulate HAP emissions from Coal- and Oil-fired EUSGU Units. See the FEDERAL REGISTER of April 25, 2016.


                                             *        *         *        *         *                                   ACTION:       Final rule.                                                  provided in 40 CFR part 178 (see also
                                             [FR Doc. 2018–07325 Filed 4–12–18; 8:45 am]                                                                                                          Unit I.C. of the SUPPLEMENTARY
                                             BILLING CODE 6560–50–P                                                    SUMMARY:   This regulation establishes                                     INFORMATION).
                                                                                                                       tolerances for residues of fluensulfone
                                                                                                                       in or on multiple commodities that are                                     ADDRESSES:   The docket for this action,
                                             ENVIRONMENTAL PROTECTION                                                  identified and discussed later in this                                     identified by docket identification (ID)
                                             AGENCY                                                                    document. Makhteshim Agan of North                                         number EPA–HQ–OPP–2017–0169, is
                                                                                                                       America (MANA) requested these                                             available at http://www.regulations.gov
                                             40 CFR Part 180                                                           tolerances under the Federal Food,                                         or at the Office of Pesticide Programs
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                                                                                                                       Drug, and Cosmetic Act (FFDCA).                                            Regulatory Public Docket (OPP Docket)
                                             [EPA–HQ–OPP–2017–0169; FRL–9975–76]                                                                                                                  in the Environmental Protection Agency
                                                                                                                       DATES: This regulation is effective April
                                                                                                                       13, 2018. Objections and requests for                                      Docket Center (EPA/DC), West William
                                             Fluensulfone; Pesticide Tolerances
                                                                                                                       hearings must be received on or before                                     Jefferson Clinton Bldg., Rm. 3334, 1301
                                             AGENCY: Environmental Protection                                          June 12, 2018, and must be filed in                                        Constitution Ave. NW, Washington, DC
                                             Agency (EPA).                                                             accordance with the instructions                                           20460–0001. The Public Reading Room


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                                             15972                Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Rules and Regulations

                                             is open from 8:30 a.m. to 4:30 p.m.,                    and hand delivery of objections and                   buckwheat, grain at 0.06 ppm; oat, grain
                                             Monday through Friday, excluding legal                  hearing requests are provided in 40 CFR               at 0.06 ppm; teosinte, grain at 0.06 ppm;
                                             holidays. The telephone number for the                  178.25(b).                                            wheat, bran at 0.10 ppm; barley, bran at
                                             Public Reading Room is (202) 566–1744,                    In addition to filing an objection or               0.10 ppm; wheat, middlings at 0.07
                                             and the telephone number for the OPP                    hearing request with the Hearing Clerk                ppm; wheat, shorts at 0.08 ppm; wheat,
                                             Docket is (703) 305–5805. Please review                 as described in 40 CFR part 178, please               germ at 0.07 ppm; wheat, straw at 4
                                             the visitor instructions and additional                 submit a copy of the filing (excluding                ppm; barley, straw at 4 ppm; oat, straw
                                             information about the docket available                  any Confidential Business Information                 at 4 ppm; wheat, forage at 4 ppm; oat,
                                             at http://www.epa.gov/dockets.                          (CBI)) for inclusion in the public docket.            forage at 4 ppm; wheat, hay at 8 ppm;
                                             FOR FURTHER INFORMATION CONTACT:                        Information not marked confidential                   barley hay at 8 ppm; and oat, hay at 8
                                             Michael Goodis, Registration Division                   pursuant to 40 CFR part 2 may be                      ppm. That document referenced a
                                             (7505P), Office of Pesticide Programs,                  disclosed publicly by EPA without prior               summary of the petition prepared by
                                             Environmental Protection Agency, 1200                   notice. Submit the non-CBI copy of your               MANA, the registrant, which is
                                             Pennsylvania Ave. NW, Washington, DC                    objection or hearing request, identified              available in the docket, http://
                                             20460–0001; main telephone number:                      by docket ID number EPA–HQ–OPP–                       www.regulations.gov. A comment was
                                             (703) 308–8157; email address:                          2017–0169, by one of the following                    received on the notice of filing. EPA’s
                                             RDFRNotices@epa.gov.                                    methods:                                              response to this comment is discussed
                                                                                                       • Federal eRulemaking Portal: http://               in Unit IV.C.
                                             SUPPLEMENTARY INFORMATION:
                                                                                                     www.regulations.gov. Follow the online                   Based upon review of the data
                                             I. General Information                                  instructions for submitting comments.                 supporting the petition, EPA has
                                                                                                     Do not submit electronically any                      modified the levels at which tolerances
                                             A. Does this action apply to me?                        information you consider to be CBI or                 are being established in most
                                                You may be potentially affected by                   other information whose disclosure is                 commodities. The reasons for these
                                             this action if you are an agricultural                  restricted by statute.                                changes are explained in Unit IV.D.
                                             producer, food manufacturer, or                           • Mail: OPP Docket, Environmental
                                                                                                     Protection Agency Docket Center (EPA/                 III. Aggregate Risk Assessment and
                                             pesticide manufacturer. The following
                                                                                                     DC), (28221T), 1200 Pennsylvania Ave.                 Determination of Safety
                                             list of North American Industrial
                                             Classification System (NAICS) codes is                  NW, Washington, DC 20460–0001.                           Section 408(b)(2)(A)(i) of FFDCA
                                             not intended to be exhaustive, but rather                 • Hand Delivery: To make special                    allows EPA to establish a tolerance (the
                                             provides a guide to help readers                        arrangements for hand delivery or                     legal limit for a pesticide chemical
                                             determine whether this document                         delivery of boxed information, please                 residue in or on a food) only if EPA
                                             applies to them. Potentially affected                   follow the instructions at http://                    determines that the tolerance is ‘‘safe.’’
                                             entities may include:                                   www.epa.gov/dockets/contacts.html.                    Section 408(b)(2)(A)(ii) of FFDCA
                                                • Crop production (NAICS code 111).                    Additional instructions on                          defines ‘‘safe’’ to mean that ‘‘there is a
                                                • Animal production (NAICS code                      commenting or visiting the docket,                    reasonable certainty that no harm will
                                             112).                                                   along with more information about                     result from aggregate exposure to the
                                                • Food manufacturing (NAICS code                     dockets generally, is available at http://            pesticide chemical residue, including
                                             311).                                                   www.epa.gov/dockets.                                  all anticipated dietary exposures and all
                                                • Pesticide manufacturing (NAICS                     II. Summary of Petitioned-For                         other exposures for which there is
                                             code 32532).                                            Tolerance                                             reliable information.’’ This includes
                                                                                                                                                           exposure through drinking water and in
                                             B. How can I get electronic access to                      In the Federal Register of September               residential settings, but does not include
                                             other related information?                              15, 2017 (82 FR 43352) (FRL–9965–43),                 occupational exposure. Section
                                                You may access a frequently updated                  EPA issued a document pursuant to                     408(b)(2)(C) of FFDCA requires EPA to
                                             electronic version of EPA’s tolerance                   FFDCA section 408(d)(3), 21 U.S.C.                    give special consideration to exposure
                                             regulations at 40 CFR part 180 through                  346a(d)(3), announcing the filing of a                of infants and children to the pesticide
                                             the Government Printing Office’s e-CFR                  pesticide petition (PP 6F8538) by                     chemical residue in establishing a
                                             site at http://www.ecfr.gov/cgi-bin/text-               Makhteshim Agan of North America                      tolerance and to ‘‘ensure that there is a
                                             idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    (MANA) (d/b/a ADAMA), 3120                            reasonable certainty that no harm will
                                             40tab_02.tpl.                                           Highlands Blvd., Suite 100, Raleigh, NC               result to infants and children from
                                                                                                     27604. The petition requested that 40                 aggregate exposure to the pesticide
                                             C. How can I file an objection or hearing               CFR part 180 be amended by
                                             request?                                                                                                      chemical residue. . . .’’
                                                                                                     establishing tolerances for residues of                  Consistent with FFDCA section
                                               Under FFDCA section 408(g), 21                        the nematicide fluensulfone, in or on                 408(b)(2)(D), and the factors specified in
                                             U.S.C. 346a, any person may file an                     fruit, pome, crop group 11–10 at 0.3                  FFDCA section 408(b)(2)(D), EPA has
                                             objection to any aspect of this regulation              parts per million (ppm); fruit, stone crop            reviewed the available scientific data
                                             and may also request a hearing on those                 group 12–12 at 0.06 ppm; small fruit                  and other relevant information in
                                             objections. You must file your objection                vine climbing subgroup 13–07D at 0.5                  support of this action. EPA has
                                             or request a hearing on this regulation                 ppm; grape, raisin at 0.8 ppm; nut, tree,             sufficient data to assess the hazards of
                                             in accordance with the instructions                     crop group 14–12 at 0.02 ppm; almond,                 and to make a determination on
                                             provided in 40 CFR part 178. To ensure                  hulls at 3.0 ppm; sugarcane at 0.03 ppm;              aggregate exposure for fluensulfone
                                             proper receipt by EPA, you must                         sugarcane and molasses at 0.2 ppm, and                including exposure resulting from the
                                             identify docket ID number EPA–HQ–                       for inadvertent residues of fluensulfone,
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                                                                                                                                                           tolerances established by this action.
                                             OPP–2017–0169 in the subject line on                    in or on (10-month plant-back interval):              EPA’s assessment of exposures and risks
                                             the first page of your submission. All                  Grain, cereal, crop group 15 at 0.03                  associated with fluensulfone follows.
                                             objections and requests for a hearing                   ppm; forage, fodder and straw of cereal
                                             must be in writing, and must be                         grains, crop group 16 at 2 ppm; (90-day               A. Toxicological Profile
                                             received by the Hearing Clerk on or                     plant-back interval): Wheat, grain at                   EPA has evaluated the available
                                             before June 12, 2018. Addresses for mail                0.06 ppm; barley, grain at 0.06 ppm;                  toxicity data and considered its validity,


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                                                                  Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Rules and Regulations                                         15973

                                             completeness, and reliability as well as                including carcinogenicity, that could                 discussed in Unit III.B. of the final rule
                                             the relationship of the results of the                  result from exposure to fluensulfone                  published in the Federal Register of
                                             studies to human risk. EPA has also                     and its metabolites. That conclusion is               June 1, 2016 (81 FR 34898) (FRL–9946–
                                             considered available information                        based on the following considerations:                07).
                                             concerning the variability of the                       (1) The tumors occurred in only one sex
                                                                                                                                                           C. Exposure Assessment
                                             sensitivities of major identifiable                     in one species. (2) no carcinogenic
                                             subgroups of consumers, including                       response was seen in either sex in the                   1. Dietary exposure from food and
                                             infants and children.                                   rat. (3) the tumors in the mouse study                feed uses. In evaluating dietary
                                                The residue of concern for dietary                   were observed at a dose that is almost                exposure to fluensulfone, EPA
                                             assessment is the parent compound,                      13 times higher than the dose chosen for              considered exposure under the
                                             fluensulfone. Residues of the                           risk assessment. (4) fluensulfone and its             petitioned-for tolerances as well as all
                                             metabolites butene sulfonic acid (BSA)                  metabolites are not mutagenic.                        existing fluensulfone tolerances in 40
                                             and thiazole sulfonic acid (TSA) occur                     Specific information on the studies                CFR 180.680. EPA assessed dietary
                                             at levels significantly greater than                    received and the nature of the adverse                exposures from fluensulfone in food as
                                             fluensulfone; however, these                            effects caused by fluensulfone as well as             follows:
                                             metabolites are considered non-toxic at                 the no-observed-adverse-effect-level                     i. Acute exposure. Quantitative acute
                                             levels that may occur from the use of                   (NOAEL) and the lowest-observed-                      dietary exposure and risk assessments
                                             fluensulfone. Based on the available                    adverse-effect-level (LOAEL) from the                 are performed for a food-use pesticide,
                                             data addressing toxicity of the BSA and                 toxicity studies can be found at http://              if a toxicological study has indicated the
                                             TSA metabolites, the Agency has                         www.regulations.gov in document                       possibility of an effect of concern
                                             determined that they are not of                         ‘‘Fluensulfone—Aggregate Human                        occurring as a result of a 1-day or single
                                             toxicological concern.                                  Health Risk Assessment in Support of                  exposure.
                                                Exposure to fluensulfone results in                  Section 3 Registration of New Uses                       Such effects were identified for
                                             effects on the hematopoietic system                     (Sugarcane, Small Vine Climbing Fruits,               fluensulfone. In estimating acute dietary
                                             (decreased platelets, increased white                   Pome Fruits, Stone Fruits, and Tree                   exposure, EPA used 2003–2008 food
                                             blood cells, hematocrit, and                            Nuts), Rotational Crop Tolerances, and                consumption information from the
                                             reticulocytes), kidneys, and lungs. Body                Label Amendments’’ on pages 37–50 in                  United States Department of Agriculture
                                             weight and clinical chemistry changes                   docket ID number EPA–HQ–OPP–2017–                     (USDA) National Health and Nutrition
                                             were observed across multiple studies                   0169.                                                 Examination Survey, What We Eat in
                                             and species. Evidence of qualitative                                                                          America, (NHANES/WWEIA). As to
                                             increased susceptibility of infants and                 B. Toxicological Points of Departure/                 residue levels in food, the acute dietary
                                             children to the effects of fluensulfone                 Levels of Concern                                     risk assumed tolerance-equivalent
                                             was observed in the 2-generation                           Once a pesticide’s toxicological                   residues and 100 percent crop treated
                                             reproduction study in rats, wherein pup                 profile is determined, EPA identifies                 (PCT).
                                             death was observed at a dose that                       toxicological points of departure (POD)                  ii. Chronic exposure. In conducting
                                             resulted in decreased body weight in the                and levels of concern to use in                       the chronic dietary exposure assessment
                                             dams. There was no evidence of either                   evaluating the risk posed by human                    EPA used 2003–2008 food consumption
                                             qualitative or quantitative susceptibility              exposure to the pesticide. For hazards                information from the USDA’s NHANES/
                                             in developmental toxicity studies in rats               that have a threshold below which there               WWEIA. As to residue levels in food,
                                             or rabbits. The most sensitive endpoints                is no appreciable risk, the toxicological             the chronic dietary risk assumed
                                             for assessing safety of aggregate                       POD is used as the basis for derivation               tolerance-equivalent residues and 100
                                             exposures to fluensulfone under the                     of reference values for risk assessment.              PCT.
                                             FFDCA are the increased pup-loss                        PODs are developed based on a careful                    iii. Cancer. Based on the data
                                             effects for acute dietary exposure; and                 analysis of the doses in each                         summarized in Unit III.A., EPA has
                                             body weight, hematological and clinical                 toxicological study to determine the                  concluded that a nonlinear RfD
                                             chemistry changes for chronic dietary as                dose at which no adverse effects are                  approach is appropriate for assessing
                                             well as short/intermediate term dermal                  observed (the NOAEL) and the lowest                   cancer risk to fluensulfone. Cancer risk
                                             exposures. Decreased locomotor activity                 dose at which adverse effects of concern              was assessed using the same exposure
                                             in females, and decreased spontaneous                   are identified (the LOAEL). Uncertainty/              estimates as discussed in Unit III.C.1.ii.,
                                             activity, decreased rearing, and                        safety factors are used in conjunction                chronic exposure.
                                             impaired righting response in both sexes                with the POD to calculate a safe                         iv. Anticipated residue and percent
                                             were observed in the acute                              exposure level—generally referred to as               crop treated (PCT) information. EPA did
                                             neurotoxicity study at the lowest dose                  a population-adjusted dose (PAD) or a                 not use anticipated residue or PCT
                                             tested. No other evidence for                           reference dose (RfD)—and a safe margin                information in the dietary assessment
                                             neurotoxicity was observed in the other                 of exposure (MOE). For non-threshold                  for fluensulfone. Tolerance-equivalent
                                             studies in the toxicity database,                       risks, the Agency assumes that any                    residue levels and 100% CT were
                                             including a subchronic neurotoxicity                    amount of exposure will lead to some                  assumed for all food commodities.
                                             study. The doses and endpoints chosen                   degree of risk. Thus, the Agency                         2. Dietary exposure from drinking
                                             for risk assessment are all protective of               estimates risk in terms of the probability            water. The Agency used screening level
                                             the effects seen in the acute                           of an occurrence of the adverse effect                water exposure models in the dietary
                                             neurotoxicity study. A developmental                    expected in a lifetime. For more                      exposure analysis and risk assessment
                                             neurotoxicity study is not required.                    information on the general principles                 for fluensulfone in drinking water.
                                                Although the mouse carcinogenicity                   EPA uses in risk characterization and a               These simulation models take into
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                                             study showed an association with                        complete description of the risk                      account data on the physical, chemical,
                                             alveolar/bronchiolar adenomas and                       assessment process, see http://                       and fate/transport characteristics of
                                             carcinomas in the female, EPA has                       www.epa.gov/pesticides/factsheets/                    fluensulfone. Further information
                                             determined that quantification of risk                  riskassess.htm. A summary of the                      regarding EPA drinking water models
                                             using the chronic reference dose (RfD)                  toxicological endpoints for fluensulfone              used in pesticide exposure assessment
                                             will account for all chronic toxicity,                  used for human risk assessment is                     can be found at http://www2.epa.gov/


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                                             15974                Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Rules and Regulations

                                             pesticide-science-and-                                  cumulative effects of a particular                    overall toxicity profile, the clear NOAEL
                                             assessingpesticide-risks/about-water-                   pesticide’s residues and ‘‘other                      for the pup effects observed in the
                                             exposuremodels-used-pesticide.                          substances that have a common                         2-generation reproduction study, and
                                                Based on the Pesticide Root Zone                     mechanism of toxicity.’’ EPA has not                  that the doses selected for risk
                                             Model/Exposure Analysis Modeling                        found fluensulfone to share a common                  assessment are protective of all effects
                                             System (PRZM/EXAMS) and Pesticide                       mechanism of toxicity with any other                  in the toxicity database including the
                                             Root Zone Model Ground Water (PRZM                      substances, and fluensulfone does not                 offspring effects, the degree of concern
                                             GW) models, the estimated drinking                      appear to produce a toxic metabolite                  for the susceptibility is low.
                                             water concentrations (EDWCs) for acute                  produced by other substances. For the                    3. Conclusion. EPA has determined
                                             exposures are estimated to be 11.8 parts                purposes of this tolerance action,                    that reliable data show the safety of
                                             per billion (ppb) for surface water and                 therefore, EPA has assumed that                       infants and children would be
                                             77.6 ppb for ground water and for                       fluensulfone does not have a common                   adequately protected if the FQPA SF
                                             chronic exposures are estimated to be                   mechanism of toxicity with other                      were reduced to 1x. That decision is
                                             0.173 ppb for surface water and 52.5                    substances. For information regarding                 based on the following findings:
                                             ppb for ground water. Modeled                           EPA’s efforts to determine which                         i. The toxicity database for
                                             estimates of drinking water                             chemicals have a common mechanism                     fluensulfone is complete.
                                             concentrations were directly entered                    of toxicity and to evaluate the                          ii. Evidence of potential neurotoxicity
                                             into the dietary exposure model. For the                cumulative effects of such chemicals,                 was only seen following acute exposure
                                             acute dietary risk assessment, the water                see EPA’s website at http://                          to fluensulfone and the current PODs
                                             concentration value of 77.6 ppb was                     www2.epa.gov/pesticide-science-                       chosen for risk assessment are
                                             used to assess the contribution to                      andassessing-pesticide-risks/                         protective of the effects observed. There
                                             drinking water. For the chronic dietary                 cumulativeassessment-risk-pesticides.                 is no need for a developmental
                                             risk assessment, the water concentration                                                                      neurotoxicity study or additional UFs to
                                             of value 52.5 ppb was used to assess the                D. Safety Factor for Infants and                      account for neurotoxicity.
                                             contribution to drinking water.                         Children                                                 iii. There is no indication of
                                                3. From non-dietary exposure. The                       1. In general. Section 408(b)(2)(C) of             quantitative susceptibility in the
                                             term ‘‘residential exposure’’ is used in                FFDCA provides that EPA shall apply                   developmental and reproductive
                                             this document to refer to non-                          an additional tenfold (10X) margin of                 toxicity studies, and there are no
                                             occupational, non-dietary exposure                      safety for infants and children in the                residual uncertainties concerning pre-
                                             (e.g., for lawn and garden pest control,                case of threshold effects to account for              or post-natal toxicity. In addition, the
                                             indoor pest control, termiticides, and                  prenatal and postnatal toxicity and the               endpoints and doses chosen for risk
                                             flea and tick control on pets).                         completeness of the database on toxicity              assessment are protective of the
                                                No residential handler exposure for                  and exposure unless EPA determines                    qualitative susceptibility observed in
                                             fluensulfone is expected because the                    based on reliable data that a different               the 2-generation reproduction study.
                                             products are not intended for                           margin of safety will be safe for infants                iv. There are no residual uncertainties
                                             homeowner use. The product label                        and children. This additional margin of               identified in the exposure databases.
                                             requires that handlers wear specific                    safety is commonly referred to as the                 The dietary food exposure assessments
                                             clothing (e.g., long sleeve shirt/long                  FQPA Safety Factor (SF). In applying                  were performed based on 100 PCT and
                                             pants) and/or personal protective                       this provision, EPA either retains the                tolerance equivalent-level residues. EPA
                                             equipment (PPE). The Agency has made                    default value of 10X, or uses a different             made conservative (protective)
                                             the assumption that the product is not                  additional safety factor when reliable                assumptions in the ground and surface
                                             for homeowner use and is intended for                   data available to EPA support the choice              water modeling used to assess exposure
                                             use by professional applicators. As a                   of a different factor.                                to fluensulfone in drinking water. EPA
                                             result, a residential handler assessment                   2. Prenatal and postnatal sensitivity.             used similarly conservative assumptions
                                             has not been conducted.                                 No evidence of increased quantitative or              to assess post-application exposure of
                                                For adult residential post-application               qualitative susceptibility was seen in                children as well as incidental oral
                                             exposure, the Agency evaluated dermal                   developmental toxicity studies in rats                exposure of toddlers. These assessments
                                             post application exposure only to                       and rabbits. Fetal effects in those studies           will not underestimate the exposure and
                                             outdoor turf/lawn applications (high                    occurred in the presence of maternal                  risks posed by fluensulfone.
                                             contact activities). The Agency also                    toxicity and were not considered more
                                             evaluated residential post-application                  severe than the maternal effects.                     E. Aggregate Risks and Determination of
                                             exposure for children via dermal and                    However, there was evidence of                        Safety
                                             hand-to-mouth routes of exposure,                       increased qualitative, but not                           EPA determines whether acute and
                                             resulting from treated outdoor turf/lawn                quantitative, susceptibility of pups in               chronic dietary pesticide exposures are
                                             applications (high contact activities).                 the 2-generation reproduction study in                safe by comparing aggregate exposure
                                             Further information regarding EPA                       rats. Maternal effects observed in that               estimates to the acute PAD (aPAD) and
                                             standard assumptions and generic                        study were decreased body weight and                  chronic PAD (cPAD). For linear cancer
                                             inputs for residential exposures may be                 body weight gain; at the same dose,                   risks, EPA calculates the lifetime
                                             found at http://www2.epa.gov/                           effects in offspring were decreased pup               probability of acquiring cancer given the
                                             pesticidescience-and-assessing-                         weights, decreased spleen weight, and                 estimated aggregate exposure. Short-,
                                             pesticide-risks/standard-operating-                     increased pup loss (post-natal day 1–4).              intermediate-, and chronic-term risks
                                             proceduresresidential-pesticide.                        Although there is evidence of increased               are evaluated by comparing the
                                                4. Cumulative effects from substances                qualitative susceptibility in the
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                                                                                                                                                           estimated aggregate food, water, and
                                             with a common mechanism of toxicity.                    2-generation reproduction study in rats,              residential exposure to the appropriate
                                             Section 408(b)(2)(D)(v) of FFDCA                        there are no residual uncertainties with              PODs to ensure that an adequate MOE
                                             requires that, when considering whether                 regard to pre- and post-natal toxicity                exists.
                                             to establish, modify, or revoke a                       following in utero exposure to rats or                   1. Acute risk. Using the exposure
                                             tolerance, the Agency consider                          rabbits and pre- and post-natal                       assumptions discussed in this unit for
                                             ‘‘available information’’ concerning the                exposures to rats. Considering the                    acute exposure, the acute dietary


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                                                                  Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Rules and Regulations                                         15975

                                             exposure from food and water to                         since it adequately accounts for all                  recognizes that some individuals believe
                                             fluensulfone will occupy 9.4% of the                    chronic toxicity, including                           that pesticides should be banned on
                                             aPAD for all infants less than 1 year old,              carcinogenicity, that could result from               agricultural crops; however, the existing
                                             the population group receiving the                      exposure to fluensulfone. As the chronic              legal framework provided by section
                                             greatest exposure.                                      dietary endpoint and dose are protective              408 of the Federal Food, Drug and
                                                2. Chronic risk. Using the exposure                  of potential cancer effects, fluensulfone             Cosmetic Act (FFDCA) states that
                                             assumptions described in this unit for                  is not expected to pose an aggregate                  tolerances may be set when persons
                                             chronic exposure, EPA has concluded                     cancer risk.                                          seeking such tolerances or exemptions
                                             that chronic exposure to fluensulfone                      6. Determination of safety. Based on               have demonstrated that the pesticide
                                             from food and water will utilize 4.1% of                these risk assessments, EPA concludes                 meets the safety standard imposed by
                                             the cPAD for all infants less than 1 year               that there is a reasonable certainty that             that statute. The comment appears to be
                                             old, the population group receiving the                 no harm will result to the general                    directed at the underlying statute and
                                             greatest exposure. Based on the                         population, or to infants and children                not EPA’s implementation of it; the
                                             explanation in Unit III.C.3., regarding                 from aggregate exposure to fluensulfone               citizen has made no contention that
                                             residential use patterns, chronic                       residues.                                             EPA has acted in violation of the
                                             residential exposure to residues of                                                                           statutory framework.
                                             fluensulfone is not expected.                           IV. Other Considerations
                                                3. Short-term risk. Short-term                                                                             D. Revisions to Petitioned-For
                                                                                                     A. Analytical Enforcement Methodology                 Tolerances
                                             aggregate exposure takes into account
                                             short-term residential exposure plus                      Adequate enforcement methodology                       Most of the petitioned-for tolerance
                                             chronic exposure to food and water                      (acetonitrile/water (1:1, v/v) extraction             levels differ from those being
                                             (considered to be a background                          and analysis by reverse-phase high                    established by the Agency. In its
                                             exposure level).                                        performance liquid chromatography                     petition, the petitioner stated that the
                                                Fluensulfone is currently registered                 mass spectrometry (HPLC–MS/MS)) is                    proposed tolerances were derived using
                                             for uses that could result in short-term                available to enforce the tolerance                    the Organization for Economic
                                             post-application residential exposure,                  expression. The method may be                         Cooperation and Development (OECD)
                                             and the Agency has determined that it                   requested from: Chief, Analytical                     MRL calculation procedure; however,
                                             is appropriate to aggregate chronic                     Chemistry Branch, Environmental                       the petitioner did not provide the OECD
                                             exposure through food and water with                    Science Center, 701 Mapes Rd., Ft.                    MRL calculator’s input or output tables
                                             short-term residential exposures to                     Meade, MD 20755–5350; telephone                       for any of the requested tolerances.
                                             fluensulfone.                                           number: (410) 305–2905; email address:                When EPA ran the OECD MRL
                                                Using the exposure assumptions                       residuemethods@epa.gov.                               calculation procedure on the requested
                                             described in this unit for short-term                                                                         new use commodities (primary crops)
                                                                                                     B. International Residue Limits
                                             exposures, EPA has concluded the                                                                              using residue values from the field
                                             combined short-term food, water, and                      In making its tolerance decisions, EPA              trials, the results obtained did not agree
                                             residential exposures result in aggregate               seeks to harmonize U.S. tolerances with               with any of the petitioned-for
                                             MOEs of 5,600 adults and 2,800 for                      international standards whenever                      tolerances, except in pome fruits group
                                             children. Because EPA’s level of                        possible, consistent with U.S. food                   11–10 and molasses. Therefore, EPA is
                                             concern for fluensulfone is a MOE of                    safety standards and agricultural                     establishing tolerances that differ from
                                             100 or below, these MOEs are not of                     practices. EPA considers the                          those requested in stone fruits group
                                             concern.                                                international maximum residue limits                  12–12, small vine climbing fruits
                                                4. Intermediate-term risk.                           (MRLs) established by the Codex                       subgroup 13–07D, raisins, tree nuts
                                             Intermediate-term aggregate exposure                    Alimentarius Commission (Codex), as                   group 14–12, almond hulls, and
                                             takes into account intermediate-term                    required by FFDCA section 408(b)(4).                  sugarcane based on available data and
                                             residential exposure plus chronic                       The Codex Alimentarius is a joint                     the OECD calculation procedure. In the
                                             exposure to food and water (considered                  United Nations Food and Agriculture                   case of tree nuts group 14–12, EPA is
                                             to be a background exposure level).                     Organization/World Health                             establishing the tolerance in tree nuts at
                                                An intermediate-term adverse effect                  Organization food standards program,                  0.01 ppm (the LOQ) because residues in
                                             was identified; however, fluensulfone is                and it is recognized as an international              all samples of almonds and pecans were
                                             not registered for any use patterns that                food safety standards-setting                         <0.01 ppm.
                                             would result in intermediate-term                       organization in trade agreements to                      With respect to tolerances for
                                             residential exposure. Intermediate-term                 which the United States is a party. EPA               inadvertent residues, the Agency is
                                             risk is assessed based on intermediate-                 may establish a tolerance that is                     establishing a tolerance for residues
                                             term residential exposure plus chronic                  different from a Codex MRL; however,                  in/on cereal grains (crop group 15)
                                             dietary exposure. Because there is no                   FFDCA section 408(b)(4) requires that                 based on data from the representative
                                             intermediate-term residential exposure                  EPA explain the reasons for departing                 commodities for that crop group and
                                             and chronic dietary exposure has                        from the Codex level. The Codex has not               reflecting the labeled rotational crop
                                             already been assessed under the                         established a MRL for fluensulfone for                plant-back restriction applicable to the
                                             appropriately protective cPAD (which is                 commodities covered by this document.                 crop group as a whole. Separate
                                             at least as protective as the POD used to                                                                     tolerances for inadvertent residues are
                                                                                                     C. Response to Comments                               being established for barley, buckwheat,
                                             assess intermediate-term risk), no
                                             further assessment of intermediate-term                   One comment was submitted in                        oat, and wheat commodities due to a
                                                                                                     response to the September 15, 2017                    shorter plant-back restriction, specific to
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                                             risk is necessary, and EPA relies on the
                                             chronic dietary risk assessment for                     Notice of Filing. The commenter                       those crops, which results in higher
                                             evaluating intermediate-term risk for                   opposed the petition generally, alleging              residue levels. A separate tolerance was
                                             fluensulfone.                                           that there are too many toxic chemicals               proposed for inadvertent residues in/on
                                                5. Aggregate cancer risk for U.S.                    being used in America without citing                  teosinte; however, a separate tolerance
                                             population. EPA assessed cancer risk                    any specific human health concerns                    listing is not necessary since it is a
                                             using a non-linear approach (i.e., RfD)                 about fluensulfone itself. The Agency                 member of crop group 15 and does not


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                                             15976                Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Rules and Regulations

                                             have a separate, shorter, plant-back                    Energy Supply, Distribution, or Use’’ (66             submit a report containing this rule and
                                             restriction. A tolerance in wheat milled                FR 28355, May 22, 2001); Executive                    other required information to the U.S.
                                             byproducts, the preferred term covering                 Order 13045, entitled ‘‘Protection of                 Senate, the U.S. House of
                                             wheat shorts and middlings, is being                    Children from Environmental Health                    Representatives, and the Comptroller
                                             established at 0.08 ppm, rather than                    Risks and Safety Risks’’ (62 FR 19885,                General of the United States prior to
                                             separate tolerances in wheat shorts and                 April 23, 1997); or Executive Order                   publication of the rule in the Federal
                                             wheat middlings.                                        13771, entitled ‘‘Reducing Regulations                Register. This action is not a ‘‘major
                                                Furthermore, EPA’s tolerance levels                  and Controlling Regulatory Costs’’ (82                rule’’ as defined by 5 U.S.C. 804(2).
                                             are expressed to provide sufficient                     FR 9339, February 3, 2017). This action
                                             precision for enforcement purposes, and                 does not contain any information                      List of Subjects in 40 CFR Part 180
                                             this may include the addition of trailing               collections subject to OMB approval                     Environmental protection,
                                             zeros (such as 0.30 ppm rather than 0.3                 under the Paperwork Reduction Act                     Administrative practice and procedure,
                                             ppm). This is in order to avoid the                     (PRA) (44 U.S.C. 3501 et seq.), nor does              Agricultural commodities, Pesticides
                                             situation where rounding of an observed                 it require any special considerations                 and pests, Reporting and recordkeeping
                                             violative residue to the level of                       under Executive Order 12898, entitled                 requirements.
                                             precision of the tolerance expression                   ‘‘Federal Actions to Address                             Dated: April 4, 2018.
                                             would result in a residue considered                    Environmental Justice in Minority                     Donna S. Davis,
                                             non-violative (such as 0.34 ppm being                   Populations and Low-Income
                                             rounded to 0.3 ppm). This revision has                                                                        Acting Director, Registration Division, Office
                                                                                                     Populations’’ (59 FR 7629, February 16,
                                                                                                                                                           of Pesticide Programs.
                                             been made for pome fruits group 11–10;                  1994).
                                             molasses; forage, fodder and straw of                      Since tolerances and exemptions that                 Therefore, 40 CFR chapter I is
                                             cereal grains group 16; and straw,                      are established on the basis of a petition            amended as follows:
                                             forage, and hay of wheat, barley and                    under FFDCA section 408(d), such as
                                             oats.                                                   the tolerance in this final rule, do not              PART 180—[AMENDED]
                                                                                                     require the issuance of a proposed rule,
                                             V. Conclusion                                                                                                 ■ 1. The authority citation for part 180
                                                                                                     the requirements of the Regulatory
                                                Therefore, tolerances are established                Flexibility Act (RFA) (5 U.S.C. 601 et                continues to read as follows:
                                             for residues of fluensulfone, in or on                  seq.), do not apply.                                      Authority: 21 U.S.C. 321(q), 346a and 371.
                                             almond, hulls at 4.0 ppm; fruit, pome,                     This action directly regulates growers,            ■  2. In § 180.680:
                                             group 11–10 at 0.30 ppm; fruit, small,                  food processors, food handlers, and food              ■  a. In the table to paragraph (a), add
                                             vine climbing, subgroup 13–07D at 0.60                  retailers, not States or tribes, nor does             alphabetically the entries ‘‘Almond,
                                             ppm; fruit, stone group 12–12 at 0.07                   this action alter the relationships or                hulls’’; ‘‘Fruit, pome, group 11–10’’;
                                             ppm; grape, raisin at 0.90 ppm; nut,                    distribution of power and                             ‘‘Fruit, small, vine climbing, subgroup
                                             tree, group 14–12 at 0.01 ppm;                          responsibilities established by Congress              13–07D’’; ‘‘Fruit, stone, group 12–12’’;
                                             sugarcane, cane at 0.04 ppm; and                        in the preemption provisions of FFDCA                 ‘‘Grape, raisin’’; ‘‘Nut, tree, group 14–
                                             sugarcane, molasses at 0.20 ppm. In                     section 408(n)(4). As such, the Agency                12’’; ‘‘Sugarcane, cane’’; and
                                             addition, tolerances for indirect or                    has determined that this action will not              ‘‘Sugarcane, molasses’’.
                                             inadvertent residues of fluensulfone are                have a substantial direct effect on States            ■ b. Revise paragraph (d).
                                             established in or on barley, bran at 0.10               or tribal governments, on the                            The additions and revisions read as
                                             ppm; barley, grain at 0.06 ppm; barley                  relationship between the national                     follows:
                                             hay at 8.0 ppm; barley, straw at 4.0                    government and the States or tribal
                                             ppm; buckwheat, grain at 0.06 ppm;                      governments, or on the distribution of                § 180.680 Fluensulfone; tolerances for
                                             grain, cereal, forage, fodder and straw,                power and responsibilities among the                  residues.
                                             group 16 at 2.0 ppm; grain, cereal, group               various levels of government or between                   (a) * * *
                                             15 at 0.03 ppm; oat, forage at 4.0 ppm;                 the Federal Government and Indian
                                             oat, grain at 0.06 ppm; oat, hay at 8.0                 tribes. Thus, the Agency has determined                                                                      Parts
                                             ppm; oat, straw at 4.0 ppm; wheat, bran                 that Executive Order 13132, entitled                                    Commodity                             per
                                                                                                                                                                                                                  million
                                             at 0.10 ppm; wheat, forage at 4.0 ppm;                  ‘‘Federalism’’ (64 FR 43255, August 10,
                                             wheat, germ at 0.07 ppm; wheat, grain                   1999) and Executive Order 13175,                       Almond, hulls ....................................          4.0
                                             at 0.06 ppm; wheat, hay at 8.0 ppm;                     entitled ‘‘Consultation and Coordination
                                             wheat, milled byproducts at 0.08 ppm;                   with Indian Tribal Governments’’ (65 FR                   *          *             *               *           *
                                             and wheat, straw at 4.0 ppm.                            67249, November 9, 2000) do not apply                  Fruit, pome, group 11–10 .................              0.30
                                                                                                     to this action. In addition, this action               Fruit, small, vine climbing, subgroup
                                             VI. Statutory and Executive Order                                                                                13–07D ..........................................     0.60
                                             Reviews                                                 does not impose any enforceable duty or
                                                                                                                                                            Fruit, stone, group 12–12 .................             0.07
                                                                                                     contain any unfunded mandate as                        Grape, raisin .....................................     0.90
                                               This action establishes tolerances                    described under Title II of the Unfunded
                                             under FFDCA section 408(d) in                                                                                  Nut, tree, group 14–12 .....................            0.01
                                                                                                     Mandates Reform Act (UMRA) (2 U.S.C.
                                             response to a petition submitted to the                 1501 et seq.).                                           *         *          *               *                *
                                             Agency. The Office of Management and                       This action does not involve any                    Sugarcane, cane ..............................          0.04
                                             Budget (OMB) has exempted these types                   technical standards that would require                 Sugarcane, molasses .......................             0.20
                                             of actions from review under Executive                  Agency consideration of voluntary
                                             Order 12866, entitled ‘‘Regulatory                      consensus standards pursuant to section                    *             *            *             *          *
                                             Planning and Review’’ (58 FR 51735,
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                                                                                                     12(d) of the National Technology
                                             October 4, 1993). Because this action                   Transfer and Advancement Act                          *     *     *     *    *
                                             has been exempted from review under                     (NTTAA) (15 U.S.C. 272 note).                           (d) Indirect or inadvertent residues.
                                             Executive Order 12866, this action is                                                                         Tolerances are established for residues
                                             not subject to Executive Order 13211,                   VII. Congressional Review Act                         of the nematicide fluensulfone,
                                             entitled ‘‘Actions Concerning                             Pursuant to the Congressional Review                including its metabolites and
                                             Regulations That Significantly Affect                   Act (5 U.S.C. 801 et seq.), EPA will                  degradates, in or on the commodities in


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                                                                        Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Rules and Regulations                                            15977

                                             the table below. Compliance with the                               20460–0001. The Public Reading Room                  before June 12, 2018. Addresses for mail
                                             tolerance levels specified below is to be                          is open from 8:30 a.m. to 4:30 p.m.,                 and hand delivery of objections and
                                             determined by measuring only 3,4,4-                                Monday through Friday, excluding legal               hearing requests are provided in 40 CFR
                                             trifluoro-but-3-ene-1-sulfonic acid.                               holidays. The telephone number for the               178.25(b).
                                                                                                                Public Reading Room is (202) 566–1744,                 In addition to filing an objection or
                                                                                                     Parts      and the telephone number for the OPP                 hearing request with the Hearing Clerk
                                                               Commodity                              per       Docket is (703) 305–5805. Please review              as described in 40 CFR part 178, please
                                                                                                     million                                                         submit a copy of the filing (excluding
                                                                                                                the visitor instructions and additional
                                             Barley, bran ......................................         0.10   information about the docket available               any Confidential Business Information
                                             Barley, grain .....................................         0.06   at http://www.epa.gov/dockets.                       (CBI)) for inclusion in the public docket.
                                             Barley, hay ........................................         8.0   FOR FURTHER INFORMATION CONTACT:                     Information not marked confidential
                                             Barley, straw .....................................          4.0   Michael Goodis, Registration Division                pursuant to 40 CFR part 2 may be
                                             Buckwheat, grain ..............................             0.06   (7505P), Office of Pesticide Programs,               disclosed publicly by EPA without prior
                                             Grain, cereal, forage, fodder and
                                                                                                                Environmental Protection Agency, 1200                notice. Submit the non-CBI copy of your
                                               straw, group 16 .............................              2.0                                                        objection or hearing request, identified
                                             Grain, cereal, group 15 ....................                0.03   Pennsylvania Ave. NW, Washington, DC
                                                                                                                20460–0001; main telephone number:                   by docket ID number EPA–HQ–OPP–
                                             Oat, forage ........................................         4.0                                                        2017–0072, by one of the following
                                             Oat, grain ..........................................       0.06   (703) 305–7090; email address:
                                                                                                                RDFRNotices@epa.gov.                                 methods:
                                             Oat, hay ............................................        8.0
                                             Oat, straw .........................................         4.0
                                                                                                                                                                       • Federal eRulemaking Portal: http://
                                                                                                                SUPPLEMENTARY INFORMATION:                           www.regulations.gov. Follow the online
                                             Wheat, bran ......................................          0.10
                                             Wheat, forage ...................................            4.0   I. General Information                               instructions for submitting comments.
                                             Wheat, germ .....................................           0.07                                                        Do not submit electronically any
                                             Wheat, grain .....................................          0.06
                                                                                                                A. Does this action apply to me?                     information you consider to be CBI or
                                             Wheat, hay .......................................           8.0      You may be potentially affected by                other information whose disclosure is
                                             Wheat, milled byproducts .................                  0.08   this action if you are an agricultural               restricted by statute.
                                             Wheat, straw .....................................           4.0   producer, food manufacturer, or                        • Mail: OPP Docket, Environmental
                                                                                                                pesticide manufacturer. The following                Protection Agency Docket Center (EPA/
                                             [FR Doc. 2018–07739 Filed 4–12–18; 8:45 am]
                                                                                                                list of North American Industrial                    DC), (28221T), 1200 Pennsylvania Ave.
                                             BILLING CODE 6560–50–P                                                                                                  NW, Washington, DC 20460–0001.
                                                                                                                Classification System (NAICS) codes is
                                                                                                                not intended to be exhaustive, but rather              • Hand Delivery: To make special
                                                                                                                provides a guide to help readers                     arrangements for hand delivery or
                                             ENVIRONMENTAL PROTECTION                                                                                                delivery of boxed information, please
                                                                                                                determine whether this document
                                             AGENCY                                                                                                                  follow the instructions at http://
                                                                                                                applies to them. Potentially affected
                                             40 CFR Part 180                                                    entities may include:                                www.epa.gov/dockets/contacts.html.
                                                                                                                   • Crop production (NAICS code 111).                 Additional instructions on
                                             [EPA–HQ–OPP–2017–0072; FRL–9975–77]                                   • Animal production (NAICS code                   commenting or visiting the docket,
                                                                                                                112).                                                along with more information about
                                             Sulfentrazone; Pesticide Tolerances                                   • Food manufacturing (NAICS code                  dockets generally, is available at http://
                                             AGENCY:  Environmental Protection                                  311).                                                www.epa.gov/dockets.
                                             Agency (EPA).                                                         • Pesticide manufacturing (NAICS                  II. Summary of Petitioned-For
                                             ACTION: Final rule.
                                                                                                                code 32532).                                         Tolerance
                                                                                                                B. How can I get electronic access to                   In the Federal Register of June 8, 2017
                                             SUMMARY:   This regulation establishes                             other related information?
                                             tolerances for residues of sulfentrazone                                                                                (82 FR 26641) (FRL–9961–14), EPA
                                             in or on multiple commodities which                                   You may access a frequently updated               issued a document pursuant to FFDCA
                                             are identified and discussed later in this                         electronic version of EPA’s tolerance                section 408(d)(3), 21 U.S.C. 346a(d)(3),
                                             document. Interregional Research                                   regulations at 40 CFR part 180 through               announcing the filing of a pesticide
                                             Project Number 4 (IR–4) requested these                            the Government Printing Office’s e-CFR               petition (PP 6E8532) by IR–4, Rutgers,
                                             tolerances under the Federal Food,                                 site at http://www.ecfr.gov/cgi-bin/text-            The State University of New Jersey, 500
                                             Drug, and Cosmetic Act (FFDCA).                                    idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                 College Road East, Suite 201–W,
                                                                                                                40tab_02.tpl.                                        Princeton, NJ 08540. The petition
                                             DATES: This regulation is effective April
                                                                                                                                                                     requested that 40 CFR part 180 be
                                             13, 2018. Objections and requests for                              C. How can I file an objection or hearing            amended by establishing tolerances for
                                             hearings must be received on or before                             request?                                             residues of the herbicide sulfentrazone
                                             June 12, 2018, and must be filed in                                  Under FFDCA section 408(g), 21                     in or on Chia, dry seed at 0.15 parts per
                                             accordance with the instructions                                   U.S.C. 346a, any person may file an                  million (ppm); Teff, forage at 0.50 ppm;
                                             provided in 40 CFR part 178 (see also                              objection to any aspect of this regulation           Teff, grain at 0.15 ppm; Teff, hay at 0.30
                                             Unit I.C. of the SUPPLEMENTARY                                     and may also request a hearing on those              ppm; Teff, straw at 1.5 ppm; Stalk and
                                             INFORMATION).
                                                                                                                objections. You must file your objection             stem vegetable subgroup 22A at 0.15
                                             ADDRESSES:   The docket for this action,                           or request a hearing on this regulation              ppm; Vegetable, brassica, head and
                                             identified by docket identification (ID)                           in accordance with the instructions                  stem, group 5–16 at 0.20 ppm; Brassica,
                                             number EPA–HQ–OPP–2017–0072, is                                    provided in 40 CFR part 178. To ensure               leafy greens, subgroup 4–16B at 0.60
                                             available at http://www.regulations.gov                            proper receipt by EPA, you must                      ppm; and Nut, tree, group 14–12 at 0.15
daltland on DSKBBV9HB2PROD with RULES




                                             or at the Office of Pesticide Programs                             identify docket ID number EPA–HQ–                    ppm. The petition also requested to
                                             Regulatory Public Docket (OPP Docket)                              OPP–2017–0072 in the subject line on                 remove the tolerances for Asparagus at
                                             in the Environmental Protection Agency                             the first page of your submission. All               0.15 ppm; Brassica, head and stem,
                                             Docket Center (EPA/DC), West William                               objections and requests for a hearing                subgroup 5A at 0.20 ppm; Brassica,
                                             Jefferson Clinton Bldg., Rm. 3334, 1301                            must be in writing, and must be                      leafy greens, subgroup 5B at 0.40 ppm;
                                             Constitution Ave. NW, Washington, DC                               received by the Hearing Clerk on or                  Nut, tree, group 14 at 0.15 ppm;


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Document Created: 2018-04-13 00:17:59
Document Modified: 2018-04-13 00:17:59
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactMichael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
FR Citation83 FR 15971 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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