BILLING CODE 6560-51).p 

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. 

SUMMARY: This regulation establishes tolerances for residues of fluensulfone in or on 

cucurbit vegetables and fruiting vegetables. Makhteshim Agan of North American .I fl ~ . 

doi0J b"'~ifle,ss o_~ 

(MANA) ~ ADAMA, requested these tolerances under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective [insert date of publication in the Federal Regi tt r]. 

Objections and requests for hearings must be received on or before (insert date 60 da:-:; 

after date of publication in the Federal Register], and must be filed in accordance wit'·1 

the instructions provided in 40 CFR part 178 (see also Unit l.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, identified by docket identification (10) 

number EPA-HQ-OPP-20 12-0593, is available at http://www.regulations.gov or at the 

Office of Pestkide Programs Regulatory Public Docket (OPP Docket) in the 

Environmental Protection Agency Docket Center (EPNDC), West William Jefferson 

Clinton Bldg., Rm. 3334, 1301 Constitution Ave., NW., Washington, DC 20460-000 I . 
2 

The Public Reading Room is open from 8:30a.m. to 4:30p.m., Monday through Friday, 

excluding legal holidays. The telephone number for the Public Reading Room is (202 1 

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.govldockets. 

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 

(7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, DC 20460-000 I; main telephone number: (70 3) 

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 manufact urer, 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 11 I). 

• Animal production (NAICS code 112). 

• Food manufacturing (NAICS code 311 ). 

• Pesticide manufacturing (NAICS code 32532). 
3 

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 2 t 

http://www. ecjr.gov!cgi-bin/text-idx? &c=ecfr&tp/=/ecfrbrowse/Fitle40140tab _ 02. 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), 2 1 U.S.C. 346a, any person may file an objecticn 

to any aspect of this regulation and may also request a hearing on those objections. ~HJ 

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 rece ipt by EPA, you mun 

identify docket 10 number EPA-HQ-OPP-20 12-0593 in the subject I ine on the first .i.! e 

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 [insert date 60 days after date of 

publication in the Federal Register]. Addresses for mail and hand delivery ofobjectic ns 

and hearing requests are provided in 40 CFR l78.25(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. Informati1:tn 

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, 
4 

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 y :JU 

consider to be CBI or other information whose disclosure is restricted by statute. 

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), 

(28221 T), 1200 Pennsylvania Ave., NW ., Washington, DC 20460-000 I. 

• Hand Delivery: To make special arrangements for hand delivery or delivery c f 

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, 20 12 (77 FR 59578) (FRL-9364-6), 

EPA issued a document pursuant to FFDCA section 408(d)(3), 2 1 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide petition (PP 2F80 19) by Makhteshim Agan of Nor :h 

America, Inc. (MANA), doing business as ADAMA, 3 120 High woods Blvd, Suite 1 Ct\ 

Raleigh, NC 27604. The petition requested that 40 CFR 180 be amended by establish ng 

tolerances for residues of the nematicide fluensulfone, { 5-Chloro-2-[(3,4,4-trifluoro-3·· 

buten-1-yl)sulfonyl]thiazole }, 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 petiti ) ll 

prepared by MANA, the registrant, which is available in the docket, 
5 

http://www.regulations.gov. There were no comments received in response to the not ce 

of filing. 

Based upon review ofthe data supporting the petition, EPA has revised the 

£.•. 'SO 

proposed tolerance levels of 1.0 and 0.6 ppm for cucurbits and fruiting vegetables to tH H:t0.'50 

and~ 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 pestic: de 

chemical residue, including all anticipated dietary exposures and all other exposures f(· r 

which there is reliable information." This includes exposure through drinking water ar d 

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 chi le ren 

to the pesticide chemical residue in establishing a tolerance and to "ensure that there , 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)(0), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and othe'· 

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 
6 

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 1:.f 

the sensitivities of major identifiable subgroups of consumers, including infants and 

children. Fluensulfone has low acute toxicity via the oral, dermal, and inhalation routl . 

of exposure. It is not an eye or skin irritant but is a skin sensitizer. Acute oral toxicity 

studi es 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 Ill), 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. Twentyeight-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 tluensulfone results in effects on the hematopoietic system 

(decreased platelets, increased white blood cells, hematocrit, and reticulocytes), kidney i, 

and lungs. Body weight and clinical chemistry changes were observed across multiplt 

studies and species. Evidence of qualitative increased susceptibility of infants and 

children to the effects of tluensulfone was observed in the 2-generaticin reproduction 
7 

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 effect:: in 

the forestomach, pharynx, epiglottis, and nasal cavity. The most sensitive endpoints f.)r 

assessing human health risk are the increased pup-loss effects for acute dietary exposu ·e; 

body weight, hematological and clinical chemistry changes for chronic dietary as well as 

S'ho{-+ li'\-\-t(flttd~C~.-k -\{(a) 

derma l exposures E£Aortlintermedi.at6-tefRl1; 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 neurotoxiciry 

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 (RID) will account for all chron .: 

toxicity, including carcinogenicity, that could result from exposure to fluensulfone and. its 

metabolites. That conclusion is based on the following considerations: 
8 

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 tin es 

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 effe<:.l::i 

caused by fluensulfone as well as the no-observed-adverse-effect-level (NOAEL) and :he 

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-20 12-0593. 

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 ·isk 

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 whid 

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 1 

population-adjusted dose (PAD) or a reference dose (RID) - and a safe margin of 
9 

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 ct 

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 complett. 

description of the risk assessment process, see 

http://www.epa.gov/pesticides/factsheelslriskassess.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 Us ~: iin 

Human Health Risk Assessment 

-

Exposure/Scenario Point of Departure RfD, PAD, Study and Toxicological 

and LOC for Effects 

Uncertainty/Safety Risk 

Factors Assessment 

-

Acute dietary NOAEL = 16.2/23 Acute RiD = 2-generation reproductio: l · 

mglkglday (M/F) 0.16 rat (All populations, mglkglday including infants and UFA = lOx Offspring LOAEL = 

children and females 

UFH = lOx 

122.01169 .I mglkglday 

13-49 years of age) based on an increase in p 

FQPASF = lx 

aPAD = 0. 16 loss between PND I and 

mglkglday in the Fl and F2 offsprin 

up 

with the majority of deatl 

occurring on day 2. 

Chronic dietary NOAEL= 3.1 Chronic RfD Co-critical 90-day dog ar1 

mglkglday = 0.03 chronic dog (All populations) mg/kglday UFA = lOx Chronic: 

UFH =lOx LOAEL = 16 mglkglday 

FQPA SF = lx 

cPAD = 0.03 based on decreased body 

mglkg/day weight, increased mean 

hemoglobin concentratioJ 

distribution width, and 

increased relative and 
10 

absolute reticulocyte cou I t:; 

in both sexes, decreased 

prothrombin time in mal1 ,.. 

..... 

and increased platelets in 

females. 

Subchronic: 

NOAEL = 1.6 mg/kg/da) 

LOAEL = 17.1 mg/kg/da 

based on decreased body 

weight in females and 

increased relative and 

absolute reticulocyte cou nl:;, 

decreased bilirubin, 

decreased albumin, 

decreased A/G ratio, 

increased TSH, and 

pigmented Kupffer cells i l l 

both sexes. 

Cancer (Oral, dermal, EPA has determined that quantification of risk using the 

inhalation) chronic RID will adequately account for all chronic toxicity, 

including carcinogenicity. 

0 0 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-obse ved-adver~; :-

effe.ct-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). RW 

= reference dose. UF = uncertainty factor. UF A= extrapolation from animal to human 

(interspecies). UFH = potential variation in sensitivity among members of the human popuhitic n 

(intraspecies ). 

C. Exposure Assessment 

l. Dietary exposure from food and feed uses. In eva) uating dietary exposure t•.• 

tluensulfone, EPA considered exposure under the petitioned-for tolerances in 40 CFR 

part 180. EPA assessed dietary exposures from tluensulfone in food as follows: 

i. Acute exposure. Quantitative acute dietary exposure and risk assessments an! 

performed for a food-use pesticide, if a toxicological study has indicated the possibility of 
II 

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 Sta :~ !; 

Department of Agriculture's (USDA) National Health and Nutrition Examination Sur ~· :y, 

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 I 00 percent crop treate.:l 

(PCT); limit-of-quantitation residues offluensulfone, 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 EI>A 

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 A 

metabolite is not of toxicological concern. Therefore, as to residue levels in food, EP.J'•. 

assumed I 00 PCT; limit-of-quantitation residues of fluensulfone, as reflected in crop 

field trials (equiva lent to a fluensulfone-based tolerance): and empirically derived 

processing factors. 

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded t ·tat 

a nonlinear RID approach is appropriate for assessing cancer risk to fluensulfone. Ca'I Ger 

risk was assessed using the same exposure estimates as discussed in Unit IJI.C. I.ii., 

chronic exposure. 
12 

iv. Anticipated residue and percent crop treated (PCT) information. EPA did 'I nt 

use anticipated residue and/or PCT information in the dietary assessment for 

tluensulfone. Residues equivalent to a tluensulfone-based tolerance and I 00 PCT wen:! 

assumed for ami food commodities. 

2. Dietary exposure from drinking water. The Agency used screening level w·1 ter 

exposure models in the dietary exposure analysis and risk assessment for tluensulfone: in 

drinking water. These simulation models take into account data on the physical, 

chemical, and fate/transport characteristics of tluensulfone. Further information 

regarding EPA drinking water models used in pesticide exposure assessment can be 

found at http://www.epa.gov/oppejed 1 /models/water/index. htm. 

Based on the Pesticide Root Zone Model Ground Water (PRZMGW), the 

estimated drinking water concentrations (EDWCs) oftluensulfone and its metabolites 1)f 

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 tc • 

be 0. 173 ppb for surface water and 52.5 ppb for ground water. 

Modeled estimates of drinking water concentrations were directl y entered into the 

dietary exposure model. For acute dietary risk assessment, the water concentration val.te 

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. 
13 

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 gardeu 

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 reside1r:ial 

exposure. 

4. Cumulative effects from substances with a common mechanism oftoxicity. 

Section 408(b )(2)(D)(v) of FFDCA requires that, when considering whether to establ ~ h, 

modify, or revoke a tolerance, the Agency consider "available information" concernin ~; 

the cumulative effects of a particular pesticide's residues and "other substances that ha·,•e 

a common mechanism of toxicity." 

EPA has not found fluensulfone to share a common mechanism of toxicity wi~ll 

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, EP.t. 

has assumed that fluensulfone does not have a common mechanism of toxicity with ot ·,·er 

substances. For information regarding EPA's efforts to determine which chemicals have a 

common mechanism of toxicity and to evaluate the cumul ati ve effects of such chemicds, 

see EPA's website at hllp://www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and Children 

I. In general. Section 408(b)(2)(C) ofFFDCA prov ides that EPA shall apply l 11 

additional tenfold (I OX) margin of safety for infants and children in the case ofthreshdd 

effects to account for prenatal and postnatal toxicity and the completeness of the datab::t:se 

on toxicity and exposure unless EPA determines based on reliable data that a differen·: 
14 

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 I OX, 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. Off pri :~~ 

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 nils. 

r1n ~ Maternal effects observed in that study were decreases 'body weight and body weight 

gain; at the same dose, effects in offspring were decreased pup weights, decreased spk en 

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 preand/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 t ·te 

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-generatic n 

reproduction study is low. The selected POD will be protective of these developmentz.l 

effects. 
15 

3. Conclusion. EPA has determined that reliable data show the safety of infan .. : 

and children would be adequately protected ifthe lOX FQPA SF were reduced to IX. 

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 eurotox ici t:~ · 

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 protec1ive 

of the effects seen in the acute neurotoxicity study. 

iii. There is no evidence that fluensulfone results in increased susceptibility in m 

utero rats or rabbits in the prenatal developmental studies. However, there was evident ;; 

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 I OX FQPA ~ F 

is not necessary to adequately protect infants and children. 

iv. There are no residual uncertainties identified in the exposure databases. Ttw 

current dietary assessment is based on high-end assumptions such as maximum residL t 

PC. I 

levels from field trials of the parent compound in food, lOOP srop t:reateEI, 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 fluensulfonc in 

drinking water. Furthermore, there are no proposed residential uses. These assessments 

will not underestimate the exposure and risks posed by fluensulfone. 
16 

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 aggrew:.te 

exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing th·:: 

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 chrc nic 

exposure, EPA has concluded that chronic exposure to fluensulfone from food and wa· er 

will utilize 9.5% of the cPAD for all infants)the population group receiving the greate51 

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 slw rtand intermediate-term adverse effect was identified; however, fluensulfone is not 

registered for any use patterns that would result in short- or intermediate-term resident al 

exposure. Because there is no short-term or intermediate-term residential exposure aw:: 

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 t:1e 
17 

chronic dietary risk assessment for evaluating short- and intermediate-term risk for 

f1 uensu I fone. 

4. Aggregate cancer riskfor U.S population. Based on the data summarized in 

Unit III.C. l.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 t) 

pose a cancer risk. 

5. Determination of safety. Based on these risk assessments, EPA concludes t b t 

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 wen: 

ot 

obtained, was determined to be 0.01 milligram/kilogram (mg/kg). The limit de ecti n 

(LOD) was defined to be 30% of the LOQ (i.e. 0.0003 mglkg). 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-fatt:1' 

matrices. 

Adequate enforcement methodology (reverse-phase high performance liquid 

chromatography-mass spectrometry/mass spectrometry (HPLC-MS/MS)) is available l l) 

enforce the tolerance expression. 
18 

The method may be requested from: Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephon1:: 

number: (4 1 0) 305-2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances will 

international standards whenever possible, consistent with U.S. food safety standards r1nd 

agricultural practices. EPA considers the international maximum residue limits (MRL~;) 

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 ~:. 

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 b 

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 j MRL 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 

petitioner and EPA have used the OECD calculation procedures to obtain tolerance 

levels, the residue definitions being used are different. The petitioner's proposed level!:: 

are based on residues of BSA and TSA, combined and expressed as parent fluensulfon ~ 

whereas the EPA-calculated tolerances are based on residues of only the BSA metabol' te, 
19 

expressed as parent tluensulfone. Furthermore, the petitioner combined residue data fr· :•m 

the representative commodities to obtain their proposed tolerances. In accordance with 

policy, EPA calculated separate tolerance levels for each representative commodity an·:l 

then selected the maximum tolerance estimate within each group, resulting in toleranc:•t: 

levels of0.80 ppm and 0.70 ppm for cucurbits and fruiting vegetables, respectively. 

However, in order to mitigate estimated worker risks assoc iated with chemigation operat ons, 

Makhteshim has reduced the proposed application rate from 3.5 lb. fluensulfone per acn~ to 2.5 lb. per 

acre. For purposes of establishing a tolerance that is reflective of the revised applicatio11 r.:lte, the residue 

data were re-evaluated. The resulting tolerance level for both cucurbit vegetables and fru iting vegetables 

is 0.50 ppm. 

including its metabolites and degradates, in or on vegetables, cucurbit, group 9 at (LS.H 0 c:: 0 .. .) 

ppm and vegetables, fruiting, group 8-10 at 9--fO ppm. Compliance with the tolerance 

0 .6t:J 

levels specified below is to be determined by measuring only 3,4,4-tritluoro-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 .o 

a petition submitted to the Agency. The Office of Management and Budget (OMB) ha1:: 

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 1321 1, entitled "Actions Concerning Regulations That 

Significantly Affect Energy Supply, Distribution, or Use" (66 FR 28355, May 22, 20(1 ) 

or Executive Order 13045, entitled "Protection of Children from Environmental Healtl 

Risks and Safety Risks" (62 FR 19885, April 23, 1997). This final rule does not co ntH 1n 

any information collections subject to OMB approval under the Paperwork Reduction 
20 

Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations unch:r 

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 ~ 

issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RF A) 1. ~; 

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 ofFFDCA 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 1: •n 

the distribution of power and responsibilities among the various levels of government (1r 

between the Federal Government and Indian tribes. Thus, the Agency has determined 

that Executive Order 13 132, entitled "Federalism" (64 FR 43255, August I 0, 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 11 of the Unfunded Mandates Reform Act of 1995 

(UMRA)(2 U.S.C. 1501 et seq.). 
21 

This action does not involve any technical standards that would require Agency 

consideration of voluntary consensus standards pursuant to section 12( d) of the Nation.:tl 

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 , 1 he 

U.S. House of Representatives, and the Comptroller General ofthe 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). 
22 

List of Subjects in 40 CFR Part 180 

Environmental protection, Administrative practice and procedure, Agricultural 

commodities, Pesticides and pests, Reporting and recordkeeping requirements. 

Director, Office of Pesticide Programs 
23 

Therefore, 40 CFR chapter I is amended as follows: 

PART 180--[AMENDED] 

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

Authority: 21 U.S.C. 32I(q), 346a and 371. 

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

§ 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 commoditie'i 

in the table below. Compliance with the tolerance levels specified below is to b1:: 

determined by measuring only 3,4,4-tritluoro-but-3-ene-l-sulfonic acid, 

calculated as the stoichiometric equivalent of fluensulfone. 

Commodity Parts per million 

Vegetables, cucurbits, group 9 ()J50 - Vegetables, fruiting, group 8-1 0 0.66 

(b) Section 18 emergency exemptions. [Reserved) 

(c) Tolerances with regional registrations. [Reserved) 

(d) Indirect or inadvertant residues. [Reserved]