### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D . C. 204 6 0 O FFI C E OF C HEMI CA L S AFET Y A ND P O LLUTI O N PRE VE NTI O N



### M E MORANDUM Date : October 22 , 20 15 

### SUBJECT: Flumetralin: Ti e r I (Scopin g) Re v iew of Human In c id e nt s and Ep idem i o logy

P C Code : 12300 1 OP B arco d e: 0429780 Dec i s io n No.: 505305 P eti tion No.: NA R eg i s t ra ti o n No .: A R egu l atory Ac tio n : A Case No.: NA R i s k Assess m e nt T y p e: NA TX R No. : NA CAS No.: 6292 4- 70-3 40 CFR: NA MRIO No.: NA


### FROM:

THRO UG H :

TO : S h a nn a Rec ore, Industri a l Hyg ieni s t Tox i co logy and Ep id e mi o l ogy Branch Hea lth Effect Di v i s ion (7509P) and E li zabeth Eva n s, Env ironm e nta l Prot ection Spec ia li s t Toxicology an d Ep ide mi o logy Branch H ealth Eff ects Divi s ion (7 509 P) 

# IJ**~** D av id Mille r , Actin g Bran c h C hief 

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. ) T ox icology and Epide mi ology Bran c h H ea lth Effects Di v i s i on (7509P) R onn ie B eve r , R i s k Assessor Ri s k Assessment Branch V II H ea lth Effects Di v i s ion (7 509 P) a nd Katherine St. C lair, Chemi ca l Rev iew Manager Ri s k Managem e nt & Impl e me ntation Branch 2 Pe s ticid e R e-eva lu a tion Di vis ion (750 8 P) Summary and Co nclu s i ons Vcr.Apr.08

Ba sed o n the low frequency and low sever it y of incid en t cases reported for flum e tra l i n i n b o th ID S a nd SENS OR-Pe sti cide s, there do es n ot appear to be a concern a t th i s t ime th a t wo uld warra n t further inv es tigation. Th e Agency wi ll contin u e to monitor th e in c id e nt infonnation a nd if a co ncern i s trig ge r ed, add iti o n al a n a l ys i s wi ll b e in c lud ed in the r i s k assess m e nt.

P age l of 4D eta il e d Re v iew 

### I. ACTION REQUESTED Thi s review i s inte nd e d to fulfill our requirement to d ocket s umm ar ies of incident data that were reported to the Agency, a s well as to ensure human incident data and the Agricultu ral Health Study (A H S) ar e part of th e problem formulation pha se of registrati o n review. Reports of adverse hea lth effects a ll eged l y due to a s pecific p es ti cide ex p os ur e 

### (i. e . , an "i nc id e nt ") are l arge ly se lf-repo rted and therefo re, gene ra ll y s peakin g, ne ither ex p os ur e to a p es ticide or re p o rted symptom (or the con nection b e tween the two) i s va lid ated o r o th erw i se co nfirm ed. Typically, causation cannot be determined based on incident data. Howeve r , incid e nt in fo rm a tion ca n b e an imp o rt ant so urc e of feedback to the Agency: incident s of sev ere o ut come, or a s u ggested pattern or tren d among l ess sev ere incident s, can s i g nal the A ge ncy to furth e r in ves ti gate a p a rti c ular che mi ca l o r prod u ct. Ob servati onal epidemi o lo gy studi es r e late th e ri s k of di sease, e.g., cance r , and expos ure to a n agent s u ch as a pesticide product in the gen e ra l p o pulation or s pecific sub-grou p s like p est ic id e appli cato rs . 

### II. BACKGROUND Flumetra l in i s a plant growth regulator that was fir s t reg i s tered in 1983 and rereg i s tered in 2007. It i s used on tobacco to control the growth of ax ill ary bud s (sucker s ). For this evalu at ion , both the OPP In ciden t D ata System ( ID S) and the Center s for Di sease Co ntrol and Preve ntio n/Na ti onal In stitute for O ccu p atio n a l Safet y and Health ( C DC/N IO S H ) Se ntin el Eve n t No tific at io n Sys tem for Occupational Risk-Pestic ide s (SENSO R) da tabases were con s ulted for pe s t icide in c id e nt data on the acti ve in gred ient flum e tralin (pc code: I 2300 l ). The purpose of th e database searc h i s to identif y potent ia l patte rns in th e fr e quen cy and seve rit y o f th e health effects attrib uted t o flumetral i n ex p osure. Fl um e tra lin i s n ot included in the A H S , and ther efo re thi s stu dy doe s not provide in formatio n for thi s report. 

### III. RESULTS/DISCUSSION
a. IDS ( I ncident Data System) OPP 's ID S in c lude s report s o f a ll eged human health in c id en t s from vario u s so ur ces, in clud in g mandatory Fed e ra l In secti c id e, Fungi cide a nd Rodenti c id e Act (FIFRA) Section 6(a)(2) re p orts fro m reg i strants , othe r federal a nd state hea lth and env ir o nm e ntal agenc ies, and i ndividual consume rs. Si nce 1992, OPP h as compiled th ese reports in ID S. ID S conta in s re ports from ac ross the U.S. a nd mo s t in c id e nt s h ave a ll relevant pro du c t in format ion re co rd e d
. Re port s s ubmitt e d to th e ID S repre se nt anecdota l re port s or all egation s on ly , unles s oth e rwi se s tat ed in th e report. ID S r eco rd s in c id e nt s in one of tw o m od ul es: Main ID S and Aggregate IDS :
o Main ID S contains incid e nt s result in g in hi gher seve rity outcomes and pro v id es m ore detai l with regard to case s pe cifics. T hi s system s tores incident data for

P age 2of 4d eath , major an d moderate incidents , and it includ es information about the locat io n , date and nature of the incident. Main ID S in c id ents in vo lvi ng onl y one active ingredient (as oppo sed to pe st ic id e p ro duct s w i th multipl e act ive ing r edi e nt s) a r e considered to provide m o re c ertain information about the pote nti al effec t s of exposure from th e pe s ticide.

o Aggregate IDS contains in cidents re s ultin g in le ss seve re human in c idents (min or, unknown , o r no effects outcomes)
. Th ese a r e re p or ted by reg i s trant s only as co unt s in what are aggregate s umm aries. For th e Main ID S, from January I , 2010 to February 2, 20 15 , there were 0 incide nt s report e d invol v ing flumetr a lin. In Aggrega te ID S , from J anuary 1 , 20 l 0 to February 2, 20 1 5, ther e was 2 in c id ents r eported involving flum etra lin. Th ese incidents were classified as mino r severi t y. Overall , th e re are few in c id en t s involving flumetr a li n re ported t o ID S. b. SENSO R-P es ti c id es Th e SENS OR-P est ic ide s d atabase covers 1 2 s tates fr om 1998

- 20 11 , a lth o ugh r e p o rting vari e s from state to s t ate. Cases of pesticide-related illne sses are asce rt a i ned from a v ari e t y of sources , includin g: report s from loca l Po i so n Co ntro l Centers, s t ate Department of Labor worke r s' compensation c l a im s when repo rted b y ph ys ic ians, rep o rt s from State D epartme nt s of Agriculture, and physician reports to s tat e D epa rtm e nt s of Heal th . A lth o ugh both occ upational and non-occupat io n al incid e n ts are includ ed i n th e d atabase, SENSOR-Pesticides focuses o n occupatio nal p estic id e incid e nt s , and i s of p art icular va lu e in providin g that in formation
. Th e s tate coo rdinator at eac h of the 1 2 respective s tate D e p artm e nt s of Hea lth conducts case fo ll owup activ ities s uch as obta inin g m e di cal r eco rd s t o ve rif y symptom s a nd seve rit y. Us in g standardi zed p rotocol and case definitio n s derived from poison ce nt er re p o rtin g , the s ta te SENSOR- P es ti ci d e coo rdinat or ente rs th e incident information int o th e s tate-ba sed sys tem wh ic h i s sent to N IOSH a nnually to be aggregated. A rev iew of SENSOR- P esti cides 1998

- 20 11 identifies four cases , stem ming from tw o events , involving flumetralin. All cases in vo lved multipl e ac ti ve ingredi ents. A ll four cases occ urred in North Ca rolin a and in vo lved p esti c id e applicat io n to to b acco . Three cases were low in sever ity a nd o ne case wa s m oderate in seve rit y. Th e three l ow seve rity cases occ urred in o ne nonocc up at ional event with littl e in fo rma t ion pro v ided about thi s event. Th e m ode ra t e seve rit y case wa s occu pati o n a l ; thi s case i nvolved a Hi spa nic farmwor ke r who "was t o ppin g and s uc kerin g tobacco and developed a rash w ith blisters o n foreanns and throat swe lling b y the end of th e d ay , despite PPE worn." T hi s case was given a preventi o n co de of " no label v iol at io n fou nd but ca se mad e ill "
. All fou r cases repo rt e d respirat ory s ymptom s : tlu·ee h a d burnin g/irr i t ated / swe llin g throat an d one h ad bre athin g problem s . Three cases experienced eye pain and irri tation.

c. Ag ri c ul tu ra l Hea l th Stud y (A HS) T he A H S i s a hi g h qualit y, prospective epid e mi o logy s tud y evalu ating the link between pe st ic id e use and vario u s health outcomes includin g cance r. Th e AHS includ es private and co mm e rci a l

Pa ge 3of4pes ticid e app li cators a nd th e ir s pouses. 

### If th e re are AHS finding s re le vant to a particular pe s ticid e go ing through reg i s tration r ev iew, th e Agency w ill ensu re they are co n s idered in th e problem form ulation/ scop in g phase of th e process and , if approp ri ate, full y rev iewed in the ri s k assessment phase of th e p rocess. T he A H S include s informati on o n use of 80 different pesticid e active ingredients commonly u sed in agriculture. Flumetralin i s n o t includ ed in the AHS, and ther efo re thi s s tud y does n ot provide in fo rm a ti o n for this repo rt. 

### I V. CONC L US IO N B ased on th e low freque n cy and low severi ty of in ci d ent cases reported for tlumetralin in both IDS and SENS OR

- Pesticides, there d oes not appear to b e a conce rn at thi s time th at would warrant furth e r inve s ti ga ti o n. The Agency wi ll continue to m o nitor the in c id e nt in fo rmati o n a nd if a concern i s triggered , additi o na l analy s i s w ill be includ e d in th e risk assessment .

P age 4 of 4