
[Federal Register Volume 79, Number 185 (Wednesday, September 24, 2014)]
[Rules and Regulations]
[Pages 56963-56968]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[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 (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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab02.tpl. To access the 
OCSPP test guidelines referenced in this document electronically, 
please go to http://

[[Page 56964]]

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

[[Page 56965]]

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
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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

[[Page 56966]]

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

[[Page 56967]]

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: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

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

[[Page 56968]]

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


