BILLING CODE 6560-5 1). p 

### ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180

[EPA-HQ-OPP-2012-0593 ; FRL-9914-35) Fluensu lf one; Pesticide Tolerances AGENCY: Environme ntal Protection Agency (EPA). 

### ACTION: Fi nal rule. 

### SUMMARY: This regu lat io n estab li shes tolerances for residu es of flu e n su lfone in o r o n cucurb it vegetab les and fruiting vegetab les. Mak ht es h im Agan ofNo rth American 

### .I fl



### ~ . 

### doi0J

**b"'~ifle,ss o_~** 

**(MANA) ~**  ADAMA , requested the se tol e rances unde r the Federal Food , Drug , an d Cosmetic Act (FFDCA). 

### DATES: Th i s regulation is effect ive [in se rt date of publication in th e 

### Federal

**Regi**

**tt r].**  Objections and requests for hearin gs must be received on or befor e (in sert date 60 da : -: ; after date of publication in the 

### Federal Register], and must be filed in accordance wi t'·1 th e instructi o n s provided in 40 CFR part 178 (see a l so Unit l.C. of the 

### SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for thi s act ion , id e ntified by docket identification (10) number EPA-HQ-OPP-20 12-0593 , is available at http: //

www.regulations.gov or at th e Office of Pestkide Programs Regulatory Pub li c Docket (OPP Docket) in the Env ironmenta l Protection Agency Docket Ce nter (EPNDC) , West William Jeffe r son Clinton Bldg. , Rm. 33 34 , 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 Frid ay , excluding legal holiday s. 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 v i sitor in structions and additional information about the dock e t availab l e a t 

### http :// www. epa.gov l dockets. FOR FURTHER INFORMATION CONTACT: Loi s Rossi , Registration Divisio n (7505P), Office of Pest icide Program s, Environmenta l P r otection Agency , 1200 Pennsylvania Ave. , NW. , Wash in gton , DC 20 460-000 I ; main telephone number: (70 3 ) 305-7090; emai l addres s : 

### RDFRNotices @e pa.gov. SUPPLEMENTARY INFORMATION: I. General Information 

### A. 

### Does this Action Apply 

### to Me? You may be potentially affected by this action if yo u are an agricultural produ ce r , food manufact urer, or pesticide manufacturer. The following list of North American Indu strial Classification System (NAICS) codes i s not intend e d to be exhaustive , but rather provide s a guide to help readers determine whether this document applies to th e m. Potentiall y affected ent ities may include:

• Crop production (NAICS cod e 11 I) . • Animal production (NAICS co de 112).

• Food manufacturing (NAICS code 311 ).

• Pesticide manufa ct uring (NA ICS code 32532).3 

### B . How Can I Get Electronic Access to Other Related Information ? You may access a frequently updat ed electronic ve rsion of EPA's tolerance regulations at 40 CFR part 180 through th e Government Printing Office ' s e-CFR site 2 t 

### http :// www. ecjr.g ov !c

gi-bin/text-idx ? &c = e c fr&tp/=/ ecfrbrowse/Fitle40 14 0tab _ 02. tpl 

### T o access the OCSPP test gu id e line s referenced in thi s document e lectronically , please g o t o 

### http :// www.epa.gov /ocspp and select "Test Methods and Guidelines. " 

### C. Ho w Can I File an Objection or Hearing Request? U nd er FFDCA sectio n 408(g) , 2 1 U.S.C. 346a , any person may file an ob j ecti cn to any aspect of th i s regulation and may al s o request a hearing o n those objections.

**~HJ** must file your objectio n or reque st a hearin g o n this regulation in accordance with th e in s tructions pr ov id ed in 40 CFR part 178 . To e n s ure proper rece ipt by EPA, you mu n id e nti fy docket 10 number EPA -HQ-OPP -20 12-0593 in the subject I ine o n th e first

**.i.! e**  of your submission. A ll objections and requests for a hearing must be in writing , an d must be received by the Hearing Clerk on o r before 

### [insert date 60 days after date of publication in the Federal Register]. Addresses for mai l and hand d e liv e ry ofobjecti c ns and hearing requests are provided in 40 CFR l78.25(b). In add ition to filing an objection o r hearing re qu est with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filin g (excluding a n y Co nfidential Business Information (CBI)) for inclu s io n in the public docket. Inf orma t i 1

:tn not mark ed confidential pursuant to 40 CFR part 2 may be disclo sed publicly by EPA w ith out prior n otice. Sub mit the non-CBI copy of you r objection or hearing request,4 id e ntifi ed by dock et ID number EPA -HQ

- O PP -2 01 2-0593, by o ne of th e following m ethods:



### • Federal eRulemaki ng Portal: http :// www.regulations.gov. Follow the onlin e in s tructions for submitting comments. Do n o t submit e lectr o ni call y an y information y :JU cons ide r to be C BI or o ther information w h ose disclo sure is rest ricted b y sta t ute.


### • Mail: OPP Doc ket, E nviro nm e nt a l Protection Age ncy Docket Ce nte r (EPA /DC ) , (28221 T), 1200 Pennsy l van ia Ave. , NW ., Was h ington, DC 20460 -000 I.



### • Hand Delivery: To make spec ia l ar ra nge m e nts f or hand de li very o r de l ivery 

### c f boxed inform a ti o n , p l ease follow th e in s tru c tions at 

### http :// www.epa.gov /

dockets/contacts . html. Additio na l instructi ons on com me nting o r visitin g th e docket , a l ong wit h m ore inf or

m ation about d oc k ets generally , i s ava il able at 

### htt p :// www . epa. gov/dockets. II. S ummary of Petitioned-For Tolerance In the Federal Register of Septe mber 28, 20 1 2 (77 FR 59578) ( F RL-9364-6) , EPA i ss u e d a d oc u me nt purs uant to FFDCA sec tion 40 8 ( d)(3), 2 1 U.S.C. 346a(d)(3), a nn ounc ing th e filin g o f a pestic ide petition ( PP 2F80 19 ) by Makhte s h im Agan ofNo r :h Ame ri ca, Inc. (M ANA) , doing bu siness as ADAMA, 3 1 20 High woods Blvd, S uite 1C t \ Raleig h , NC 27 604. Th e petition requested that 40 CFR 1 80 be amended by estab li s h ng t o le r an ces fo r residue s o f the nematicid e flu e n sulfo ne , { 5

- C h loro-2

- [(3 , 4 , 4-triflu o ro - 3 · · buten-1-yl)sulfonyl]thiazole }, in o r o n cucu rbit veget ab l es at 1 .0 parts per million (pp m ) a nd fr ui t in g vegetable s at 0.6 ppm. T h at document referenced a summary of t h e petiti ) ll p repared by MANA , th e reg i strant , w h ich is ava il ab le in the docket ,

### 5 http :// www.regulations.gov. The re were no comments received in response to the not c e of filing. Based upon review ofthe data supporting the petition , EPA has revise d the £.•. 'SO proposed tolerance levels of 1.0 and 0.6 ppm for c u c urbi ts and fruiting vegetables to t H 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 Sectio n 408(b)(2)(A)( i) of FFDCA allows EPA to establish a tolerance ( the le g a l limit for a pe s ticide chem ica l residue in or on a food) on ly if EPA determines that the tolerance is " safe. " Section 408(b)(2)(A)(ii) of FFDCA defines " safe " to mean that "t h e re is a reasonab le certai nt y that n o harm will result from aggregate exposure to the pestic : de chemical re s idu e , including all anticipated dietary exposures and all othe r ex posures f ( · r wh ich there is reliable inf o rmation . " Thi s includes ex p os ure through drinking water a r d in resid ential setting s, but does not include occupationa l exposure. Secti o n 408(b)(2)( C) of FFDCA requires EPA to g i ve special conside r atio n to exposure of infants and chi le ren to the pe s ti c id e chem ical res idue in establishing a to le rance and to " ensu re that there

**,** a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue .... " Cons i stent with FFDCA section 408(b)(2)(0), and the factors spec ifi ed in FFDCA section 408( b) (2)(D), EPA has reviewed the ava i lable scie ntifi c data and oth e ' · relevant inform atio n in s upport of this action. EPA has suf ficient data to assess the hazards of and to make a determination on agg regate exposure for fluen s ulfone in clu d in g

### 6 exposure resulting fr o m the toleran ces es tablished by thi s action. EPA's assessment o f exposures and risks associate d with fluensulfone follow s . 

### A. Toxicological Profile E PA has eva lu ate d th e avai lable t ox icity data and co n s idered its validity, completeness , and r e l iab ilit y a s well as the rel ati o n s hip o f the re s ults of th e stu dies t o hu man ri s k. EPA ha s also co n sidered avai lab le inf ormation concerning th e variabilit y 

### 1 :. f th e se n s itivitie s of m a j o r id entifiabl e s ub gro ups of co n s um ers, including inf ants and ch ildr en. Fluen su lfone h as low acute tox icity vi a the o ral , d e rmal , and inh a l at io n rou tl

**.** of expos ure. It i s n ot a n eye or skin irri ta nt but is a s kin se n s itizer. Acute ora l tox i c it y studi es were also conducted with th e metabolites thiaz o le s ulf o nic acid (TSA) , butene s ulf o ni c acid (BSA) , and me th y l s ul fone (MeS). Th e res ult s indicate d TSA an d B SA were o f low t ox icity ( T ox icit y Category Ill ), while MeS was of moderat e toxicity (Toxicity Categor y II ) by the oral rout e of ex po s ure . The acu t e ora l toxic ity s tudi es ind icate d that BSA a nd T SA were co mpara b ly less tox ic tha n flu en su l fone. Twenty

e ig ht-da y o ral toxicity s tudie s conducted with BSA and T SA were s ubmi tte d and a l so indi cated that bo th m etabolites are of much lower to x ic ity than the par e nt co mp o und. Based o n the availab le data addressing toxicity of the BSA an d TS A metabolites , the Age ncy h as de te rmin ed that th ey are not of toxic o lo g ica l co ncern . Exposure t o tlu e n s ulfone re su lts in effec ts o n the h ematopoi etic sys t e m (dec reased plate l ets , in crease d w hi te b lood ce ll s, hemato crit , and reti c ul ocytes) , kidne y i, and lun gs. Bod y we ig ht and clinical c h emi s try chan ges we re observed ac ross multipl t st

udi es a nd s pecie s. Ev idence of qualitative increas e d s u sce ptibility of infant s and c h ildren t o the effects of tluensulf o n e was o b served in the 2-ge neratici n reproduction7

s tu dy in rat s, wh e re in pup death w a s o b se r ve d at a do se th at re s ulte d in b ody we i g ht effects in th e dams. The re was n o ev idence of eith e r q u a l itat ive or q ua nti ta ti ve susce pti b ilit y in d evelo pm e ntal tox ic i ty s tu di es in rats o r r a bbit s . D ie tary and inh a lation s tudi es in r at s s h owe d ev ide n ce o f po rt al- of-e ntr y e ff ec t:: in the foresto mac h , ph a ry n x , e p ig lo tti s , an d n asal cavity . T he mos t se n sitive en d poi n ts 

### f. )r assess in g human h ea lth r is k ar e th e i nc rease d pup-l oss effects fo r acut e di e t a ry e xpo s u · e ; b o d y we ig h t, h e m a t o l og ica l and clini ca l c h e mi s try c h an ges f o r ch ro ni c di etary as w e ll as 

### S'ho{-+

**li'\-\-t(flttd~C~.-k** -\{(a)

**derma**

**l** ex p os ures E£Aortl intermedi.at6-tefRl1; an d cl ottin g ti me , dec reased th y mu s we ig ht, and p ortal

- o f

- entry effects ( h i st o pa th o logy o f th e e pi g lo tti s a nd n as al cav i ty) fo r inh a l a ti o n e xp os ures ( s h o rt/inte rm e di at e te rm ). Dec re a sed locomo t o r activ i ty in fe mal es, an d decrease d s p o n ta n eo u s acti v ity, d ec rease d rearin g, a nd imp a ired ri g htin g res p o n se in b oth sexes wer e o b se rv e d in the ac ute n e urot oxicity s tud y a t th e lowes t d ose t e sted . N o oth e r ev id e n ce fo r n e urotoxi ci r y was o b serve d in th e ot he r stu di es in th e toxic i ty d atabase , in c lud in g a s u bch ro n ic n e urotox ic it y stu dy . T h e dos es and e ndp o ints cho se n fo r ri s k assess m ent a re a ll pro t ecti ve of th e e ff ec t s see n in th e a c ut e n euro t ox ic ity study . A d eve lo pm e n t al n e u rotox icity s t ud y i s not re qu ire d . A lthou g h th e mo u s e carcin oge ni c ity s tudy s h o w ed an a s sociati o n w ith a lveo la r /bro n c hi o lar ade n o ma s an d carc i no mas in th e fema le, EPA has d ete rmin e d th at q u ant ification of r is k u si n g th e c hronic re f ere n ce d ose (RID) wi ll accou n t fo r a ll c h ron .: t ox ic ity, includin g carc in oge ni c ity, th at co uld res u lt fro m ex po s ure to flu e n s ulfon e an d. it s m et a b o lit es. That co n cl u s ion i s ba se d o n th e f o llo w in g consi d e ration s:

### 8 1 . The tumors occu rred in only one sex in one species. 2. No carcinogenic re s ponse wa s see n in eith er sex in the rat. 3. T h e tumors in the mou se s tudy were o b s erved at a do se th at i s a lm ost 1 3 ti n es hi g her than the dose chosen for ri sk asse ss ment. 4. Flu ens ulf one and its m etabo lite s are n ot mutagenic. Specific inf o rmati o n on the studies received and the nature o f the adverse effe <:.l: :i caused by flu e n s ulf o n e as well as the no- o b se rved-adverse-effect-l eve l (NOA EL) an d :he lowest

- o b se rved-ad ve r se -· effect-le vel (LOAEL) from the t ox ic it y s tudi es ca n be fo un d at 

### http: / /

www.regulations .gov in docum e nt Flue n s ulf o ne: New Active Ingredi e nt Huma n Hea lth Risk A ssess men t of Proposed U ses o n C ucurbit Vegetables and Fruiting Vegetables o n pag es 32 -46 in dock et ID number EPA-HQ-OPP-20 1 2-0593 . 

### B. Toxicological Points of Departur e /

Levels of Concer n Once a pes ticide's toxicological pro fil e i s determined, E PA id e ntifie s toxicologi ca l points of departure (POD) a nd leve l s of concern to use in evaluating th e ·is k posed by human expos ure to the pesticid e. Fo r hazards that ha ve a thres ho ld b elow w hich there i s n o app reciab le risk , th e t ox i co logica l POD is u se d as th e bas i s for derivation o f r efe re n ce v alues f or risk assess me nt. PODs are d eve lo p ed based on a careful ana lysis of the doses in eac h t ox i co logical study to determine th e dose at whid no adverse effec t s are observed (the NOA EL) and the lo west d ose at which adverse effects of concern are identified (the LOA EL). U n cer taint y/safe ty factors are u s ed in conj un ction wi th th e P OD to ca lc ulate a saf e ex p osure le ve l- genera ll y re ferred to as 1 populati on-adjuste d d ose (PAD) or a re fere nce do s e ( RID )

- and a safe margin of9 expos ure (MO E) . For non-thres h o ld ri s k s, the Agency assumes that any am o un t of ex p os ure w i ll lead t o some degree of risk. Thu s, the Agency estimates ri sk in terms 

### ct the probability of an occ urrence of th e adverse effect expected in a li fetime. Fo r more inf o rm ati o n on t h e ge n e ral principl es E PA us es in ri sk c h aracterization and a complett. descript ion of th e r isk assess ment pr o ce ss , see 

### http :// www.e pa. gov / pesticides/factsheels l riskassess.htm. A s ummary of the to x ico log ical endp o in t s for fluen s ulf one use d for hum an ri s k assessment i s s how n in th e Tab le o f thi s unit. 

### Table-

- S umm ary of Toxicolog ical Doses and Endpoints f or Fluensulfone for

**Us**

**~:** 

### i i n Human Hea lth Risk Assess ment

-

E xposure / Scenario Point of Departure RfD , PAD, S tud y and Tox i co logi cal and LOC for Eff ec ts Uncertainty/Safety Risk Fa c tors Assessment

- Ac ut e dietary NOAEL = 1 6.2/ 23 Acut e RiD = 2-gene ra ti o n reproductio : l · m glkglday (M/F) 0.16 rat ( A ll popul ations , mglkglday in cluding infants and UFA = lOx Offsprin g L OAEL = c hild re n and females U FH = lO x 122 . 01169 .I m glkglday 1 3- 49 years o f age) base d on an in c rease in p FQPASF = l x aPAD = 0. 1 6 l oss betwee n PN D I and m glkglday in the Fl a n d F2 of f sprin up

w i

t h the m ajority of deatl occ urrin g o n day 2. C hronic dietary N OAEL= 3.1 Chronic RfD Co

- critical 90-day dog a r 1 m glkglday = 0 .03 ch ron ic do g (A ll popu l atio ns) mg/kglday UF A= lOx Chronic: UF H =lOx LOAEL = 16 mglkglday FQPA SF = l x cPAD = 0.03 based o n d ecrease d body mglkg/day weight, in creased mean hemoglobin co nce ntratio J distr i bution width , and increased rela t ive and

### 1 0 ab so lute r etic ul ocyte cou I t :; 

### in both sexes, decreased prothrombin tim e in mal1 ,.. ..... 

### and increased platelets in fema l es. Subchr oni c: NOAEL = 1.6 

### mg/kg/da) LOAEL = 17.1 

### mg/kg/d a based o n decreased bod y weight in fema le s and increased r e lativ e and absolute r et i cu lo cyte cou nl :;, 

### dec r eased bilirubin , decreased album in , dec r eased A/G ratio, in creased T SH, and pi g mented Kupffer ce lls i l l 

### both sexes. Cance r (Ora l , dermal , EPA has determined that quantification of ri s k u s in g the inhalation) chronic RID w ill ad e quately account f or all c hronic tox icity , including carc in ogenic i ty.

0 0 

### FQPA SF = F ood Quality Protection Act Sa f et

y Factor. LOAEL 

### =

**lo wes**  **t-ob se**  **ved -adver** 

**~; :-**  

### effe . ct-le vel. LOC = l evel of concern. mg/ kg/da y = milligram/kilogram/day. NOAEL = no · · observed-adverse-effect- l evel. PAD = population adjusted dose (a = acute , c = chronic) . RW = reference dose. UF = uncertainty factor. UF A = ext rapolation from ani ma l to human (interspecies) . U FH = potential variation in se ns itivit y among member s of the human popuhitic n (in t raspecies ) . C. 

### Expo su r e Assessmen t l. 

### Dietary expos ur e

from food and feed uses . In eva) uating di etar y exposure 

### t•. • tluensulfone , EPA considered exposure und e r the p etitioned-for tolerance s in 40 CFR part 180. 

### EPA assessed dietary expo s ures from tlu e nsulfone in fo o d a s follows: i . 

### Ac ut e exposure. Quantitati ve acute di etary exposure and r i sk assess m ents an ! performed for a f oo d-u se pesticide , if a toxico l ogica l s tudy ha s indicat ed th e poss ibili t y ofII

a n effec t of concern occ urring as a res ult o f a 1

- da y or s in g le expos ure. I n est imatin g acute d ie tary exposure , EP A used food co n s um ption informatio n from th e U ni ted

**Sta**

**:~ !;**  Departm ent o f Ag ri c u lture 's (USDA) Nationa l Health and N utrition Exa minat ion

**Sur**

**~· :y**  **,** W h at We E at In Am e rica (NHAN ES/WWEIA) conducted fro m 2003 -2 008 . As descr ib ed in U n its IV and V , t ole r an ces for flu e n su lfone are in t erms of the BSA metabolite. However , as previo u s ly noted, the BSA metabolite is not of tox i colog ical co n ce rn . T h eref ore, as to residue leve l s in food , EPA assumed I 00 p e r ce nt c rop treate. :l (PCT) ; li mit-o f

- qua ntita t ion res idu es offl ue n s ul fone , as reflected in crop fie ld tr i als (eq ui va l e nt to a flu e ns ul fo ne-base d to le r ance); an d empirica ll y de ri ved p r ocess in g fa c t o r s. ii . 

### Chron ic exposure. In conducti ng th e chron ic d ietary exposure assess ment E I > A used the Dietary Expos ur e Evaluati on Mode l software w ith the Food Com m o dity Inta k e Database ( D EEM

- FC ID) w hi ch u se d food co n sumptio n data from t h e USDA NHANES. WWEIA 2003-200 8 . As described in Un its IV a n d V , tolerances for fluensulfo ne are in terms of th e BSA metabo lite. However , as previously noted, t he

**A** m etabolite is not of t ox ico log ical co n ce rn . Theref ore, as t o res idue lev e l s in food, EP.J'• . assumed I 00 PCT ; limit-of-q uantitat io n residues of flu ensu lfone , as reflected in c rop field t rial s (equ i va l ent to a fluen s ul fone-base d toleran ce) : and e mpiricall y derived process in g facto r s. iii. 

### Can cer. Based o n the data summa r ize d in Unit III. A., E P A h as co n cluded t · tat a n o nlinear 

### RID approac h i s appropriate fo r assessing ca nc er risk to fluensulfo ne . Ca 'I G er ri s k was assessed u s in g the sa me exposure es timate s as di sc u sse d in U n it IJI. C. I . ii., 

### chronic exposure.12 iv. 

### Anticipated residue and percent crop treated (PCT) information. EPA did 'I nt use anticipated residu e a nd/or PCT information in the dietary assessment for tluensulfone . R esid u es equival ent to a tluensulfone-based tolerance and I 

### 00 PCT we n: ! assumed for ami food commod ities. 2. 

### Dietary exposure from drinking water. The Age n cy used sc re e ning level w ·1 ter ex p osure models in the dietary exposure analysis and ri sk assessment for tluensulfone : in drinkin g water. These sim ulation model s take into account data on the phy s ica l , chemical , and fate/tran s port char acteristics of tluen sulfone. Further inf ormatio n re gardin g EPA drinking water model s used in pesticide exposure assessment can be f ou nd at 

### http :// www . epa.gov/oppejed 1 /

models /

water /index. htm. Based on the Pestic ide Root Zone Model Ground Water (P RZMGW ) , the estimated drinking water concentrations (EDWCs) oftluensu lfone and it s metabo li te s 1 ) f to xic concern for acute exposures are estimated to be 

### 11 .80 parts per billi o n (ppb) for surface water and 77.6 ppb fo r ground water and fo r chro nic exposu re s are estimated tc • be 0. 1 73 ppb for su rfa ce water and 52.5 ppb for ground water. Mode led estimates of d rin king water concentrati o n s were directl y e ntered into th e di etary exposure mode l. For acute diet ary risk assessment, the water co n cent ration va l. te of 77.6 ppb was used to assess the contribution to drinking water. For chronic dietary ri s k assessment , the water concentration of value 52.5 ppb was used to assess the contributi o n t o drinking water.1 3 3. 

### From non-die tary exposure . The te rm " re s id ent i a l expos ure " is u se d in thi s d oc um ent t o refe r t o n o n- occu pat ional , n on -d ietary exposu re (e.g . , for law n a nd gard eu p est control, indoor pest co n tro l , term iticid es, a n d fl ea and tick control on p ets). Flue n s ulfone i s n ot registere d for any s p ec ific use pattern s that wo uld result in res ide 1 r: i al ex po s ure . 

### 4. C um ulative effec t s

from substances with a common mechani s m of toxicity . Section 408(b )(2)(D )(v) of FFDCA requ ir es th at, w h e n co n s id ering whether to establ

**~** h , modify, o r re vo ke a to le rance , the Agency co n side r " ava il ab l e inform atio n " co nce rni n

**~;** th e cum ulati ve effects o f a particular p est i c ide 's residue s a nd " other s ub s t ances that h a· ,•e a com mo n mechani s m of tox i c ity. " EPA has not found fluen su lfone to s hare a co mm o n me c hani sm o f tox icit y

**wi ~ll**  a n y ot h e r s ub s tanc es, and flu e n s ulf one d oes not appear t o pro d uce a tox i c m et a bolite pro duced by o th er s ub s tances. For th e purpos es of thi s t o le r ance acti o n , th e refo re , E P . t. has assu me d that flu e n s ulf o n e doe s not have a co mm on mechanis m of tox ic it y w ith o t ·,·er s ub s tance s. For inf o rm a tion regardin g E PA's efforts t o d et e rmine which c h e mi cal s h a ve a common mechani s m of toxicity and to evaluate th e cu mul ati ve effect s o f s u c h c hemi cd s , see EPA's webs ite at 

### hllp: //

www.epa.gov / pesticides/cumulative . D. Safety Factor for Inf ants and Chil dren I . 

### In general. Sectio n 408(b )(2)(C) o fFFDCA p rov i d es that EPA s hall a pply l 1 1 additi o na l tenfo ld ( I OX) margin of safe ty for infan ts and c h ildren in th e c ase of thresh dd e ff ec t s to acco unt for prenatal and p ostnatal tox ici ty and the comple te n ess o f the datab ::t:se o n tox icity and ex p osure unle ss EP A d e te rmines bas e d on re l iable data that a di ffere n·:

### 14 margin of s a fe ty will be saf e for infant s and ch ildr en. This additi o nal marg in of safet y i s commonly referred to as the Food Quality Prote c tion Act Safety Factor (FQPA SF). In applying thi s pr ov i s io n , EPA either r e tain s th e d e fault va lue of I 

### OX, o r u ses a differe nt add itional safe t y factor when reliable d ata ava il ab l e to EPA su pp o rt the c hoice o f a different factor. 2. 

### Pr e n a t a l and pos tnatal sensitivity. There was n o evidenc e of quantitative o r qu a litative susceptibi lity in developmental tox icity studies in rats and rabbit s.

**Off pri** 

**:~ ~**  effec t s in th ose stud ies occ urred in th e prese nce o f maternal t ox ic ity a nd were n ot cons id ere d m o re seve r e than th e par e ntal effects. H oweve r , th e re was evi d e n ce of in cre a s ed qualitati ve s u sc ep tibilit y of pup s in the 2 -generation r eprod u ctio n s tudy in n il s . 

## r1n

**~** Maternal effects obse rv ed in that study w e re decreases 'body w e ight and body weight gain; at the same dose , effects in offsprin g were d ec reased pup weights , d ec rea se d sp k en weight, and increased pup death. A lth o u g h t here is ev iden c e of in creased qu a l itative s u scept ibili ty in the 2- gene ration reprodu ctio n s tudy in rats , th e re are n o re s idu a l uncertai nti es with regard t o pre- and/o r po s t-na ta l toxicity followin g 

### in utero ex po s ure to rats or ra bb it s and pre and/or post - nat a l exposures t o rats. Co n side rin g the ove rall t ox icity profile , th e c lear NOAEL for th e pup effects observed in th e 2-generatio n reproduct io n study, and tha t t · te dose s and e ndp o int s se lected for ri s k assessment are equal to or less than the NOAEL from that study, the d eg ree of concern fo r the s u s ceptibility observed in th e 2-generati c n reproduction s tud y is lo w. The selected POD wi ll be protective of th ese d eve lopmentz .l effec ts.

### 15 3. 

### Conclus ion. EPA has determined that reliable data show the safety of infa n . .

**:** and children would be adequately protecte d ifthe lOX FQPA SF were reduced to IX. That decision i s ba se d on the following finding s: i. The toxicity database for fluen s ulfone is complete. ii. Decreased locomotor activity in females , and decreased s pontaneous activi ty, decreased rearing , a nd impaired righting re s ponse in both sexes were observed in the acute neuroto xicity stud y at the low es t d ose t es ted. No other evidence for

**eurotox ici**  **t:~ ·**  was observed in the other st udies in the t ox ic ity database , includin g a s ub c hronic neurotox icity s tudy. The doses and e ndp o int s c h osen for risk as sess m en t are all protec 1i ve of the effects see n in the acute neurotoxicity study. iii. There i s no evidence that fluen s u l fone results in increa sed s u sce ptibility in 

### m utero rats o r r abbits in the prenatal devel o pmental s tudie s . However , the re was e viden t ;; of increa se d qualitati ve susce ptibilit y o f yo ung rat s in the 2-gene rati o n repr o duction st

ud y. For the rea so ns discussed in Un it III.D.2. , EPA concludes that the I OX FQPA

**~** F i s not necessary to adequately protect infants and children. iv. There are no residual uncertaintie s identified in the expo s ure databases. T tw c urrent dietary assessment is ba sed on high- e nd assum pt i ons such as m ax imum residL t 

### PC. I levels from field trial s of the parent compound in food , lOOP sro p t:reateEI , and model e d estimates of re si dues in drinking water. EPA made co nservative (protective) assumpt ion s in the groundwater and su rface water m ode lin g used to assess expos ure to fluensulfo nc in drinking water. Furthermore , there are no proposed residentia l u ses . Th ese assess me nts wi ll not und e r es timate the exposure and ri s ks posed b y fluen s ulf one.

### 16 

### E. Aggregate Ri s ks and Determination of Safety EPA det e rmines whether acute and chronic dietary pesticide exposures are sa fe by comparing aggregate exposure estimates to th e aPAD and cPAD. For lin ear cancer ri s ks , EPA calcu lates the lifetime probabilit y of acquiring cancer given the estimated aggrew: . t e exposure. S h o rt- , intermediate- , and chronic-term risks are evaluated by co mparing t h·: : esti mated aggregate food, water, and re sidential exposu re to the appropriate PODs to ensure that an adequate MOE exists. 1. 

### Acute ri s k. Using the exposure assu mpti ons di scussed in this unit fo r ac ute expos ure , the acute dietary exposure from food and water to flu ensulfo ne w ill occup y 7.4% of the aPAD for all infants , th e population group receiving the greatest exposure . 2. 

### Chronic risk. Using the exposure assumptions describ ed in thi s unit for chr c nic ex po sure, EPA has concluded that chronic exposure to fluensulfone from food and w a · e r wi ll utili ze 

### 9.5% o f the c PAD f or all infants) the population group recei ving the greate 51 exposure. There are no residential uses for fluensulfone. 3. 

### Short- a nd intermediate -ter m risk. Short-and intermediate -te rm ri s k are assessed ba sed o n s h ort -term residential exposure plus chronic dietary expos ure. A sl w rtand intermediate-term adverse effect was id e ntified ; however, fluensulfone i s not registered for any use patterns that would result in s h ort - or intermediate-term residen t al exposure. Because there i s no short-term o r intermediate-term residential exposure aw :: chronic dietary exposu re has already been assessed unde r the appropriately protective cPAD (wh ic h is at least as protective as the POD used to assess short-term risk) , n o furthe r assessment of short- or intermediate-term risk is necessary , and EPA relies on t: 1e17

c hro nic dietar y ri s k assess me nt for evalu at in g s h ort- and interme diate- t er m ri s k for 

### f1 uen su I f o ne. 4. 

### Aggregate cancer riskfor U.S population. Based o n the data s ummari z ed in Un it III. C. l.iii ., EPA h as co n c lu ded that the cPAD is pr o tec tive of potentia l cancer e ff ects. G ive n th e res ul ts o f the c hronic ri s k assess ment , flu ensulfone is not ex p ec ted t) pose a cancer ri sk. 5. 

### De termination of s afety . Ba sed on thes e risk assessme nts , EPA con cludes t b t th ere is a r easonable certainty that n o harm wi ll result to th e genera l p opulation , or to inf ants and c hildren f ro m aggre gat e exposu re to fluensulf o n e re s idue s. 

### IV. Other Considerations 

### A. Analytical Enforcement Methodology S uitabl e m eth o d s for toleranc e e n force ment have bee n d eve loped a nd independe ntl y validated. For all matrices and a n alytes , the limit o f quantitati o n (LOQ ) . defined as the l owest sp iking level w h ere acce ptabl e pr ecis io n and accuracy dat a wen : 

# ot obta ined , was d ete rmin ed to be 0.01 mill igram/kilogram ( m g/kg). Th e

**limit**

**de ecti**  **n** (LOD) was defined to be 30% of the LOQ (i.e. 0.000 3 mglkg). The F ood a n d Drug Ad m in i s tration (FDA) multi-residu e meth ods are not s ui t ab le for d etection and e nf orceme nt of fluen s ulfone re sid u es (as th e s ulfoni c ac id metabol ite BSA) in non-fatt:1' m atrices. Adequa te enforcement meth o d o l ogy (reverse -ph ase hi g h perf o rm ance l iquid c hr o m atog raphy-mass s pectrome try/ma ss s pectrometry (H PLC-MS /MS)) i s avai labl e l l) e n fo r ce the to l era n ce express ion .18 The method may be requested from: C hi ef, Ana lyt ical Chemistry Branch, Environmental Sc i e nce Ce nter, 701 Mape s Rd. , Ft. Meade, MD 2 07 55-5350; t e lepho n 1 :: numb e r: (4 1 0) 3 05-2905 ; email address: 

### residuemethods@epa.gov. B. 

### International Residue Limits In m aking it s tolerance deci s io n s, EPA see ks to harmonize U.S. tole r ances w i ll internati o nal s t a nd ard s whenever possible , consistent with U.S. food safet y standard s r1n d agricultural practic es. EPA co n si ders the int ernat ional m aximum res idu e limit s

**(MR L~;**  **)** estab l i she d b y th e Codex A l ime ntarius Co mm ission (Codex) , as required by FFDCA section 408(b)(4). The Codex Alime nta riu s is a joint U ni ted N ati o n s Food and Ag ricul ture Orga ni zation /World Health O rga ni za tion food sta ndard s program, a nd it

**~: .**  rec og ni ze d a s an int e rnational food safe ty stan d ard s - setti ng organization in trade agreements to w hi ch the Un ite d States i s a party. EPA ma y estab l i s h a tolerance that b differe nt from a Co dex MRL; h owever, FFDCA sect ion 408(b)(4) r e quires th at EP A ex p lain the reasons f o r departing from the Co d ex level.

.

**~.~** T h e Codex ha s not establi s h ed 

### j MRL f o r fluensulf o ne . C. R ev i sions t o P etitioned-Fo r T o lerances T he pr opose d t o lera n ce leve l s , 1.0 a nd 0.6 ppm for c ucu rb it s and fruiting vegetab les , respective ly, di ffer from th ose being est ab l is hed by EPA. Although both peti tioner and E PA h ave u se d the OECD ca l c u lati o n p r ocedures t o o btai n to l eran c e leve l s, the re si due d e finitions b e in g used a re diff e rent. The p e titi oner ' s propose d leve l!: : are based o n re s i d u es of BSA and TSA , co mbined and expr essed as parent fluensulfo n

**~** whereas the E PA-calculated t o le rances are ba sed on residues of on ly th e BSA metab o l' t e,19 expressed as parent tluensu lf one. Furthermore, the petitioner combined residue data fr· :•m the r eprese ntati ve commod it ies to obtain their proposed tolerances. I n accordance w it h policy , EPA calculated se parate to lerance levels for each representative co mmodity an· :l then se lected the maximum to leran ce estimate within each group , re s ulting in toleran c: • t : levels of0.80 ppm and 0.70 ppm for cucurbits and fruiting vegetab le s, respectively.

However, in order to miti gate estimated worker risks assoc iated with chemigation ope rat o ns , Makhteshim ha s reduced the propo se d application rate fro m 3.5 lb . fluensulfone per

**acn**

**~** t o 2.5 lb. per acre. Fo r purpose s of es tablishing a t o lerance that i s refl ectiv e of the revi sed appl i catio 11 r . :lte, the r es idue da ta were re-evaluat ed. The resultin g tolerance level for both c ucurbit vegetables and f ru iting vegetables is 0.50 ppm . includin g its metabolites and degradates , in o r on vegetab le s, cuc urbit, group 9 at 

### (LS. H 

### 0 c:: 

### 0 

# .. .) ppm and vegetables, fruiting, group 8-10 at 

## 9--fO ppm. Co mpliance w ith the t o l erance 

### 0 

### .6t:J levels s pecified bel ow i s to be determined by measurin g o nly 3 , 4,4-tritl uoro-but-3-en e 

### · 1.

- su lf onic acid , ca lculated as the stoichiometric equivalent of fluensulfone. 

### VI. Statutory and Executive Order Reviews This final rul e estab l ishes tolerances under FFD CA sectio n 408(d) in response . o a petition submitted to the Agency. The Office of Management and Budget (OMB) h a 1 : : exempted these type s of actions from review under Execu tive Order 1 2866 , e ntitled

" Regulato ry P l anning and Revi ew" (58 FR 51735 , October 4, 1 993). Bec a u se thi s fin a l ru le has been exempted from review under Exec utive Order 12866, this final rul e i s n ot s ubj ect to Executive Order 1 321 1 , entitled "A ctions Concerning Regulation s That S ig nific antly Affect Energy Supp ly, Distribution , or Use " (66 FR 28355 , May 22 , 20(1 ) o r Exec uti ve Order 13045, e ntitled " Protection of Children from Environmental Heal tl Risks and Safety Risks " (62 FR 19885 , April 23, 1997). This final rule d oes not cont H



### 1 n any information collections subjec t to OMB approval under the Paperw o rk Reductio n20 Act (PRA) (44 U.S.C. 35 01 

### et seq.), n or doe s i t require any spec ial consid erations unc h: r Executive Order 12898 , e ntitled "Federa l Actions to Address Env ironmental Just ice in Mino r ity Populations and Low-Income Populations " (59 FR 7629, February 1 6, 1994 ) Since tolerance s and exemptions that a re establi shed o n the basi s of a petition under FFDCA secti on 408(d) , s uch as the to l erance s in this fina l rule , do not requi re

**~** i ss uan ce of a proposed rule, the require m en t s of th e Regu lato ry Flexibility Act (RFA ) 1 .

**~;** U.S.C. 601 

### et seq.), do n o t app l y. Th i s final rul e directly regulates growe r s, food processors, food handl ers , and food retailers, not States o r tr ibes, nor does thi s action a l te r the relation s hip s or distribution of power and responsibilities established by Cong ress in the preemption provisions ofFFDCA sectio n 408(n)(4). As suc h , the Agency has determined that th is action will not have a su b sta ntial direct effect on States o r tribal governments, on the relationship betwee n th e national government and the St a tes or tribal gove rnm e nts , or 1: • n the distribution o f power and resp o n s ibilitie s among the v ar i ous levels of govern me nt (1 r between the Federa l Gove rnment and Indian tribes. Thu s, the Agency h as determined that Executive Order 1 3 132 , entitl ed "Fe deralism " (64 FR 43255 , August I 0 , 1999) a nd Execut ive Order 13175 , entitled " Consultation and Coord inati on with Indian Tribal Governments" (65 FR 67249, Nove mb er 9 , 2000) do not apply to this final rule . In addition, this final rule does not impose any enforceable duty or contain any unfunde d mandate as described under Title 11 of the Unfunded Mandates Reform Act of 1 995 (UMRA)(2 U.S.C. 1 501 

### et seq.).21 This ac tio n d oes not involv e any technica l s tand a rd s that wou ld r equi re Agenc y consideration of vo lu nt ary consensus standards pursuant to section 12(d) of the Natio n.: t l Tech n o lo gy Tran sfer a nd A dvanc ement Act of 1995 (NTTAA) (15 U.S.C. 272 no te). 

### VII. Congressional Review Act Pu r s uant to the Co ngressio na l Review Ac t (5 U.S.C. 80 1 

### et seq . ) , EPA w ill s ubmit a report containing this ru le and oth e r required in f o rmation to the U.S. Se na te , 1 he U.S. Ho u se of Representatives, and the Co mptroll er General ofthe United S t at es pri o r to publication of th e ru le in th e 

### Federal Regist e r. Thi s act i o n is not a " major rule " as d e fin ed by 5 U .S.C. 804(2).

### 22 List of Subjects in 40 CFR Part 180 Environmental protection, Adm ini strative practice and procedure , Agricultura l commodities , Pesticides and pests , Rep ort in g and recordkeeping requ ir ements.



### 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 res idues of the nematicide fluensulfone , including its metabolites and degradates, in or on the commoditi e 'i in the table below. Co mpliance with the tolerance levels s pecified below is to b1: : 

### determined by measuring only 3,4,4-tritluoro-but-3-ene-l-sulfonic acid, calcu lated 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 re sidues. [Re se rved]