### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D.C

. 20460 OFFI C E OF CHEMI C AL SAFETY AND POLLUTION PREVENTION



### MEM ORAN D UM D a t e: June 23, 2015 

### SUB J EC T : Sabadilia alkaloids: Tier 

### I (Sco ping ) Rev i ew of Human I ncident s P C Co de : 002201 OP Barcode: 0427879 Deci s i o n No.: 506017 P eti ti on o.: 1 A R i s k A ssess m ent T y pe: NA TX R No.: NA M RIO No.: NA Regi s tratio n No .: NA Regula t ory Action: A Case No.: A CAS No. : 8051-02-3 40 CF R : NA Ver.Apr.OS 

### F RO M: E li zabeth Evans, E n v ironme ntal Protection Spec ial ist Toxicology and Ep idemiol ogy Branch

## <....~**·** , Hea lth Effects Div i sio n (7509 P) and



### THR OUG H :

TO : Shan n a Recore , Indu strial H yg ienist

## · 

# /J
- - Tox ico log y and Epide mi ology Branch

### ~ H ea lth Effect Divis ion (7509 P) 

# 62. -'\

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## f**~** ,;1 L/c.)111· 1.J t-S"" David Miller. Acting Bran ch Chie

### ~cl 

### ///I' Toxicology and Epidemiology Branch H ea lth Effects D ivis ion (7509P) Michael Doherty. Risk Assessor Risk Assess m e nt Branch 

### 1 Health Effects Division (7509 P ) and R
. J ohnson, Chem ical Rev iew Manager Ri s k Management & Implementation Br a n ch 

### 5 Pe s ticide Re-evaluation Di visio n (7508P) Summary and Co n c lusion s Based on the l ow frequency and severity of incident cases reported for sabad illa a lk a loids in both ID S and SENSOR-Pesticides, there do es not appear to be a concern at thi s time that wou ld warrant further inv es tigation. The Agency w ill continue to mon i tor the inc i dent i nformatio n and if a concern i s triggered, additional analysis will be included in the risk assess m e nt.
Page I of 4D etai led Revi ew 

### I. 

### ACT I ON REQUESTED This r ev ie w is intend ed to fulfill o ur r e quirem e nt to do cke t summaries of incid e nt data th at were rep orte d t o th e Age n cy, as we ll as to ens ure human in cide nt data a nd th e Ag ri cu ltural Health Study ( AHS ) are part of t he prob le m fo rmulati on phase of regi s trat i on rev iew . R e port s of ad ve rse health effec t s allegedl y due to a s pecifi c pesticide ex p osu re 

### (i.e., a n " in cident ") are largely se lf-reported and therefo re, generally s p eak in g . neither expos ure to a pesticide or repo1ted symptom (o r the connection between th e two) is validated or ot h erwise co nfirm e d. T yp ica ll y, ca u sation cannot be determi ned based o n in c id e nt data. Ho weve r. in c id en t infom1ation can be an important sou rce of feedback to th e Age ncy: in cidents of s evere o utcome . or a s uggested pattern or trend amo ng less seve r e incid e nt s, can s ig nal th e Age ncy t o fu rth e r in ves ti g ate a particular c h e mi cal or product. Observational ep id emiology s tudies r e late th e ri s k of di sease, 

### e.g., canc er, and ex posure to an a ge nt s uch as a pesticide produ c t in the ge neral popu lation o r s pec ifi c sub

-groups li ke pesticide a ppli cato rs. 

### II. BA C KGRO UN D Sabadilia a l ka lo id s are in sectic ide s u sed for th e co ntro l of th.rip s o n citru s, avocados. and man gos. Sabadilla alkaloids are formulated as a wettable powder fo r u se as an insecticide on cit r u s. avocados , and mango s, and mi xed w ith wate r and ap pli ed with eithe r ae ri a l or ground equipment. Fo r thi s evaluation , both the OPP In cident Dat a System ( IDS ) a nd the Ce nt e rs 

### fo r Di sease Co ntro l and Prevention/National In s titute 

### for Occupati o n al Safety and H ea lth (CDC/N T OSH) Se ntin e l Event N oti fic at io n Sys tem for Occupational Ri sk-P es ti c ides (SENSO R ) databases were con s u lte d 

### fo r pestic i d e i ncid e nt data o n the activ e in g r e di e nt sabadilla a lkaloids ( pc code: 00 220 I )
. Th e purpose of the database search is to identi fy p o te nti a l patterns in th e frequency and seve rity of the he a lth effects attributed to saba dilla alkaloids ex po s ure . Sabad ilia alkaloids is not inc lud e d in th e AHS, and th erefore tbis s tud y doe s no t prov i de informat ion for thi s r e p o rt. 

### III. RES UL TS/D ISCUSSION
a . IDS (Incident Data Sys tem ) OPP 's lDS in c lud es r eports of a ll eged human health in cidents from various so u rces , inc ludin g m anda to ry Federal In sec tici de. Fun g ic id e an d Ro denti cide Act (FJFRA) Sec ti o n 6(a)(2) r eports fro m regi s tra nt s, oth e r federa l a nd s tate health and en v ironment a l age nc ies. and indi v idu a l co n s umers . S ince 

### 1 992 , O PP has compiled the se report s in ID S. lDS co ntains r epo rts from acr oss the U.S. and most in c id e nt s ha ve all re levant prod uct infom1ati o n r eco rd ed. R epo rt s submitted t o th e ID S re prese nt anecdotal r epo rt s or allegations on ly, unl ess otherwise sta t ed in th e r epo rt . ID S r ecords inc id e nt s in on e o f two m od ule s : Ma in ID S and Aggregate ID S:

P age 2of4o Main IDS contains incid e nt s res ultin g in hi g her severity outcomes and pro v ide s more detail with regard to case speci fi cs . This sys te m s tore s in c id en t data fo r death. maj or and moderate incidents , and it incl udes information about th e locatio n , date a nd nature of the in cident. Main IDS in c id ents in vo lv i11 g onl y o ne active ingredi e nt (as oppo sed to pesticide product s w ith multipl e active i n gredients) a re co n s idered to provide m ore certain in fo rmati o n a b ou t the po t e n tial effect s of expos m e from th e pesticide.
o Agg regate I D S contains in c idents re s ultin g in less seve re human inc i dents (mino r , unknown, or no effec ts o utcomes)
. These are reported by reg i s tra nt s o nly as coun t s in what are agg r egate s ummari es. Fo r the Main ID S , from January 

### I, 20 I 0 to February 

### 4 , 20 1 5, there we re no incid e nt s reported inv o lv in g sabadill a a lk a loids. In Aggregate ID S. from January I , 

### 20 1 0 to F ebruary 4, 

### 2015 , th ere were 3 incidents re p orted involving sabadi lla alka lo id s. TI1ese in ci d en ts we r e classified a s min o r seve rit y . Overal l , th e r e are few incident s repo rted to ID S involvin g sa badilla alka loids. b. SENSOR-Pestic ide s The 

### SE SO R -Pest ic id es database cove rs 

### 12 states fro m 

### 19 9 8

- 20 11 , alt houg h reporting varies from state to state. Cases of pesticide-related illn esses are as certaine d from a va ri ety of sources. includin g : reports from loc a l Po i so n Control Ce nte rs. stat e D e partm e nt of Labor wo rkers ' compensati on claims when r eported by ph y sician s . repo11s from State Departments of Agricu l ture , an d physic ian
. reports to sta t e Depai1ments of Health. A lth ough both occupational and non-occupational incident s are includ ed in the dat abase, SENSOR-Pesticides foc uses on occupational p est ic ide incid ents, and i s of particu lar va lu e in providin g that in formation. 

### The state coo rdinat o r a t each of the 

### 12 respective s ta te D e p ar tm e nts of Health co ndu cts case fo ll owup ac ti vities such as ob tainin g medical records to veri fy sympto m s a nd severi ty. Us in g standard ized protoco l and case definitions derived fr om poison ce nter re portin g, th e state SENSO R-Pe s ticid e coo rdina to r e nters th e in c ident in format i on into the s tate-ba sed system wh i ch is sent t o NIOSH a 1 muall y to 

### be aggregated. 

### A review of SE SO R

-Pesticides 

### 1998

- 20 I I id e ntifi es 

### a total of three cases, ste mmin g fro m three eve nt s, in vo lv in g sabad i 

### I l a a lkaloid s (pc code 

### 00 220 l )

. Two cases invol ved a s ingl e act ive in g r e di e nt. B oth s in g le a i cases were low in seve rity. One case was wo rk-re late d a nd inv o l ve d a nursery worke r w ho "wa lked by trees that h ad been sprayed with a hand s praye r a nd the spray wa s s till in the air". Th i s cas e reported re s p i rato r y (coug h. respiratory irritation and s hortness of breath). gastro intes tin al ( n a u sea)
. neurol ogical ( h eadac he a nd mu sc l e weakn ess) a nd cardiovascular (hypertension) sy mptom s. The s econd case involv ed a homeowne r making a n a ppl i ca ti o n to hi s r es id e nc e and repo rted dermal, respiratory (co ugh ) and gastrointestina l ( diarrhea) symptom s .
c. Ag ri c ultura l H ea l th Study (A H S) The /\ H S i s a hj g h qualit y , prospective ep id e miolog y stu d y evaluating th e link b e tw ee n pe s ti c id e use and various health o utcomes includin g cance r. The AHS includ es p rivate and co mmerci a l

Page 3of4pe s ti c id e applicators a nd their s pouse s . 

### Jf there are AHS finding s r e le vant to a particular pesticide go in g through reg i s tra tion r ev i ew, the Ag enc y w ill ensure the y are considered in the probl e m fonn ulati on/sco pin g phase o f the pro cess and, if appropriate , fully reviewed in th e ri sk ass ess ment phase of th e proce ss . Th e A HS includ es in formation on u se of 80 diff e r

e nt p es ticid e acti ve in g r ed i e nt s common ly u se d in agri culture. Sabadilla a lkaloids i s n ot in c lud ed in th e A H S, and th erefore thi s study does n o t prov id e in fo rmation for this report. 

### IV. CONC L US IO N Ba se d on the low frequency a nd seve rity of in c ident cases report e d 

### for sa badi ll a alka loi ds in both ID S and SENSOR- P est icid es. there does not appe ar to be a concern at thi s time that wo uld warrant further in ves ti gat ion. T he Age nc y wi ll co ntinu e to m o nit o r the in cident in fo rm at ion and i f a co ncern i s tr iggered. additiona l a n a lys i s w ill be in c lu ded in th e ri sk assessme nt.

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