[Federal Register Volume 79, Number 185 (Wednesday, September 24, 2014)]
[Rules and Regulations]
[Pages 56963-56968]
[FR Doc No: 2014-22466]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

 [EPA-HQ-OPP-2012-0593; FRL-9914-35]

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 cucurbit vegetables and fruiting vegetables.
Makhteshim Agan of North American Inc. (MANA), doing business as (dba)
ADAMA, requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective September 24, 2014. Objections and
requests for hearings must be received on or before November 24, 2014,
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-2012-0593, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
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/Title40/40tab02.tpl. To access the
OCSPP test guidelines referenced in this document electronically,
please go to http://

www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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-2012-0593 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
November 24, 2014. 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-2012-0593, 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 28, 2012 (77 FR 59578) (FRL-
9364-6), 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
2F8019) by Makhteshim Agan of North America, Inc. (MANA), dba ADAMA,
3120 Highwoods Blvd., Suite 100, Raleigh, NC 27604. The petition
requested that 40 CFR 180 be amended by establishing tolerances for
residues of the nematicide fluensulfone, {5-Chloro-2-[(3,4,4-trifluoro-
3-buten-1-yl)sulfonyl]thiazole{time} , in or on cucurbit vegetables at
1.0 parts per million (ppm) and fruiting vegetables at 0.6 ppm. That
document referenced a summary of the petition prepared by MANA, the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
revised the proposed tolerance levels of 1.0 and 0.6 ppm for cucurbits
and fruiting vegetables to 0.50 and 0.50 ppm, respectively. The reasons
for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for fluensulfone including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fluensulfone follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Fluensulfone has low acute toxicity via the oral, dermal, and
inhalation routes of exposure. It is not an eye or skin irritant but is
a skin sensitizer. Acute oral toxicity studies were also conducted with
the metabolites thiazole sulfonic acid (TSA), butene sulfonic acid
(BSA), and methyl sulfone (MeS). The results indicated TSA and BSA were
of low toxicity (Toxicity Category III), while MeS was of moderate
toxicity (Toxicity Category II) by the oral route of exposure. The
acute oral toxicity studies indicated that BSA and TSA were comparably
less toxic than fluensulfone. Twenty-eight-day oral toxicity studies
conducted with BSA and TSA were submitted and also indicated that both
metabolites are of much lower toxicity than the parent compound. Based
on the available data addressing toxicity of the BSA and TSA
metabolites, the Agency has determined that they are not of
toxicological concern.
    Exposure to fluensulfone results in effects on the hematopoietic
system (decreased platelets, increased white blood cells, hematocrit,
and reticulocytes), kidneys, and lungs. Body weight and clinical
chemistry changes were observed across multiple studies and species.
Evidence of qualitative increased susceptibility of infants and
children to the effects of fluensulfone was observed in the 2-
generation reproduction study in rats, wherein pup death was observed
at a dose that resulted in body weight effects in the dams. There was
no evidence of either qualitative or quantitative susceptibility in
developmental toxicity studies in rats or rabbits.
    Dietary and inhalation studies in rats showed evidence of portal-
of-entry effects in the forestomach, pharynx, epiglottis, and nasal
cavity. The most sensitive endpoints for assessing human health risk
are the increased pup-loss effects for acute dietary exposure; body
weight, hematological and clinical chemistry changes for chronic
dietary as well as short/intermediate term dermal exposures; and
clotting time, decreased thymus weight, and portal-of-entry effects
(histopathology of the epiglottis and nasal cavity) for inhalation
exposures (short/intermediate term).
    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: New Active Ingredient
Human Health Risk Assessment of Proposed Uses on Cucurbit Vegetables
and Fruiting Vegetables on pages 32-46 in docket ID number EPA-HQ-OPP-
2012-0593.

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 shown in
the Table of this unit.

  Table--Summary of Toxicological Doses and Endpoints for Fluensulfone for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations,    NOAEL = 16.2/23 mg/   Acute RfD = 0.16 mg/ 2-generation reproduction-rat
 including infants and children     kg/day (M/F).         kg/day.              Offspring LOAEL = 122.0/169.1 mg/
 and females 13-49 years of age).  UFA = 10x...........  aPAD = 0.16 mg/kg/    kg/day based on an increase in
                                   UFH = 10x...........   day.                 pup loss between PND 1 and 4 in
                                   FQPA SF = 1x........                        the F1 and F2 offspring with the
                                                                               majority of deaths occurring on
                                                                               day 2.
Chronic dietary (All populations)  NOAEL= 3.1 mg/kg/day  Chronic RfD = 0.03   Co-critical 90-day dog and chronic
                                   UFA = 10x...........   mg/kg/day.           dog
                                   UFH = 10x...........  cPAD = 0.03 mg/kg/   Chronic:
                                   FQPA SF = 1x........   day.                LOAEL = 16 mg/kg/day based on
                                                                               decreased body weight, increased
                                                                               mean hemoglobin concentration
                                                                               distribution width, and increased
                                                                               relative and absolute
                                                                               reticulocyte counts in both
                                                                               sexes, decreased prothrombin time
                                                                               in males and increased platelets
                                                                               in females.
                                                                              Subchronic:
                                                                              NOAEL = 1.6 mg/kg/day
                                                                              LOAEL = 17.1 mg/kg/day based on
                                                                               decreased body weight in females
                                                                               and increased relative and
                                                                               absolute reticulocyte counts,
                                                                               decreased bilirubin, decreased
                                                                               albumin, decreased A/G ratio,
                                                                               increased TSH, and pigmented
                                                                               Kupffer cells in both sexes.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  EPA has determined that quantification of risk using the chronic RfD will
                                    adequately account for all chronic toxicity, including carcinogenicity.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
  from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
  population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluensulfone, EPA considered exposure under the petitioned-
for tolerances in 40 CFR part 180. 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. In estimating acute dietary
exposure, EPA used food consumption information from the United States
Department of Agriculture's (USDA) National Health and Nutrition
Examination Survey, What We Eat In

America (NHANES/WWEIA) conducted from 2003-2008. As described in Units
IV and V, tolerances for fluensulfone are in terms of the BSA
metabolite. However, as previously noted, the BSA metabolite is not of
toxicological concern. Therefore, as to residue levels in food, EPA
assumed 100 percent crop treated (PCT); limit-of-quantitation residues
of fluensulfone, as reflected in crop field trials (equivalent to a
fluensulfone-based tolerance); and empirically derived processing
factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID) which used food
consumption data from the USDA NHANES.WWEIA 2003-2008. As described in
Units IV and V, tolerances for fluensulfone are in terms of the BSA
metabolite. However, as previously noted, the BSA metabolite is not of
toxicological concern. Therefore, as to residue levels in food, EPA
assumed 100 PCT; limit-of-quantitation residues of fluensulfone, as
reflected in crop field trials (equivalent to a fluensulfone-based
tolerance); and empirically derived processing factors.
    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 and/or PCT information in the
dietary assessment for fluensulfone. Residues equivalent to a
fluensulfone-based tolerance and 100 PCT were assumed for all food
commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluensulfone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluensulfone. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model Ground Water (PRZMGW), the
estimated drinking water concentrations (EDWCs) of fluensulfone and its
metabolites of toxic concern for acute exposures are estimated to be
11.80 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 acute dietary risk
assessment, the water concentration value of 77.6 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 52.5 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Fluensulfone is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found fluensulfone to share a common mechanism of
toxicity with any other substances, and fluensulfone does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fluensulfone does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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 Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of
quantitative or qualitative susceptibility in developmental toxicity
studies in rats and rabbits. Offspring effects in those studies
occurred in the presence of maternal toxicity and were not considered
more severe than the parental effects. However, there was evidence of
increased qualitative susceptibility of pups in the 2-generation
reproduction study in rats. Maternal effects observed in that study
were decreases in body weight and body weight gain; at the same dose,
effects in offspring were decreased pup weights, decreased spleen
weight, and increased pup death.
    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/or post-natal toxicity following
in utero exposure to rats or rabbits and pre- and/or 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 and endpoints selected for risk assessment
are equal to or less than the NOAEL from that study, the degree of
concern for the susceptibility observed in the 2-generation
reproduction study is low. The selected POD will be protective of these
developmental effects.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the 10X
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for fluensulfone is complete.
    ii. 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.
    iii. There is no evidence that fluensulfone results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies. However, there was evidence of increased
qualitative susceptibility of young rats in the 2-generation

reproduction study. For the reasons discussed in Unit III.D.2., EPA
concludes that the 10X FQPA SF is not necessary to adequately protect
infants and children.
    iv. There are no residual uncertainties identified in the exposure
databases. The current dietary assessment is based on high-end
assumptions such as maximum residue levels from field trials of the
parent compound in food, 100 PCT, and modeled estimates of residues in
drinking water. EPA made conservative (protective) assumptions in the
groundwater and surface water modeling used to assess exposure to
fluensulfone in drinking water. Furthermore, there are no proposed
residential uses. 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
aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-, intermediate-, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to fluensulfone will occupy 7.4% of the aPAD for all infants, 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 9.5% of the cPAD for all
infants, the population group receiving the greatest exposure. There
are no residential uses for fluensulfone.
    3. Short- and intermediate-term risk. Short-and intermediate-term
risk are assessed based on short-term residential exposure plus chronic
dietary exposure. A short- and intermediate-term adverse effect was
identified; however, fluensulfone is not registered for any use
patterns that would result in short- or intermediate-term residential
exposure. Because there is no short-term or 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 short-term risk), no further
assessment of short- or intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating short- and
intermediate-term risk for fluensulfone.
    4. Aggregate cancer risk for U.S. population. Based on the data
summarized in Unit III.C.1.iii., EPA has concluded that the cPAD is
protective of potential cancer effects. Given the results of the
chronic risk assessment, fluensulfone is not expected to pose a cancer
risk.
    5. 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

    Suitable methods for tolerance enforcement have been developed and
independently validated. For all matrices and analytes, the limit of
quantitation (LOQ), defined as the lowest spiking level where
acceptable precision and accuracy data were obtained, was determined to
be 0.01 milligram/kilogram (mg/kg). The limit of detection (LOD) was
defined to be 30% of the LOQ (i.e. 0.0003 mg/kg). The Food and Drug
Administration (FDA) multi-residue methods are not suitable for
detection and enforcement of fluensulfone residues (as the sulfonic
acid metabolite BSA) in non-fatty matrices.
    Adequate enforcement methodology (reverse-phase high performance
liquid chromotography-mass spectrometry/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:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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 MRLs for fluensulfone.

C. Revisions to Petitioned-For Tolerances

    The proposed tolerance levels, 1.0 and 0.6 ppm for cucurbits and
fruiting vegetables, respectively, differ from those being established
by EPA. Although both the petitioner and EPA have used the OECD
calculation procedures to obtain tolerance levels, the residue
definitions being used are different. The petitioner's proposed levels
are based on residues of BSA and TSA, combined and expressed as parent
fluensulfone whereas the EPA-calculated tolerances are based on
residues of only the BSA metabolite, expressed as parent fluensulfone.
Furthermore, the petitioner combined residue data from the
representative commodities to obtain their proposed tolerances. In
accordance with policy, EPA calculated separate tolerance levels for
each representative commodity and then selected the maximum tolerance
estimate within each group, resulting in tolerance levels of 0.80 ppm
and 0.70 ppm for cucurbits and fruiting vegetables, respectively.
    However, in order to mitigate estimated worker risks associated
with chemigation operations, Makhteshim has reduced the proposed
application rate from 3.5 lb. fluensulfone per acre to 2.5 lb. per
acre. For purposes of establishing a tolerance that is reflective of
the revised application rate, the residue data were re-evaluated. The
resulting tolerance level for both cucurbit vegetables and fruiting
vegetables is 0.50 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of the
nematicide fluensulfone, including its metabolites and degradates, in
or on vegetables, cucurbit, group 9 at 0.50 ppm and vegetables,
fruiting, group 8-10 at 0.50 ppm. Compliance with the tolerance levels
specified below is to be determined by measuring only 3,4,4-trifluoro-
but-3-ene-1-sulfonic acid, calculated as the stoichiometric equivalent
of fluensulfone.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (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 of 1995 (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: September 11, 2014.
Jack Housenger,
Director, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.680 is added to to subpart C to read as follows:

Sec.  [emsp14]180.680  Fluensulfone; tolerances for residues.

    (a) General. Tolerances are established for residues of the
nematicide fluensulfone, including its metabolites and degradates, in
or on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only 3,4,4-
trifluoro-but-3-ene-1-sulfonic acid, calculated as the stoichiometric
equivalent of fluensulfone.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Vegetables, cucurbits, group 9..............................        0.50
Vegetables, fruiting, group 8-10............................        0.50
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]

[FR Doc. 2014-22466 Filed 9-23-14; 8:45 am]
BILLING CODE 6560-50-P