### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D.C. 20460 OFFICE OF CHEM I CAL SAFETY AND POLLUTION PREVENTION

MEMORAN D UM Date: June 9, 2015 SU BJ ECT : Profenofos: T i er I Update Review of H uman Incid ents/Epidem iology for Draft Risk Assessment

PC Code: 111401 Decision No. : 482022 Peti t io n No .: 1 /\ Ri sk Assessment Type: , /\ TXR No.: NA i\IR ID No.: NA D P Barco de: 0427690 Registration No.: NA R egu latory Act i on: A Case No.: NA CAS No. : .ti 198-08-7 .t O CF R: N/\ 

### FROM: ¥ ( Sha nn a Recore, In dustrial H yg ienis t

# ~ Tox ico logy and Epidem iology Branch 

# 1**~** 

# ' Health E ff ec ts Division (7509P) and Elizabeth Eva ns. Environmental Pro tection Specialist Toxicology and Epidemiology Branch Health Effects Division (7509 P) Ver.Apr.OS

T HRO UG H: David J. Miller , Actin g Branch Ch i ef

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# r;/<f/ /<;;; 

# .f rTox ico logy a nd Ep idemiol ogy B ra n c h /

- TO : Hea l th Effects Di vision (7509P) Monique Perron, Risk Assessor Risk Assessment Branch I Health Effects Division (7509 P ) and Christina Sche ltema, Chemical Review Manager Risk Management & Implementation Branch 3 Pesticide R e-eva luation Di vision (7508P) ummary and Conclusions Profen ofos was previously reviewed in 1996 (V. Dobozy. 02/ 29/1996. Pro.feno.fos

- R e \·iell' of Pesticide Poisoning Incident Dara). At the ti me. three human incident s were found in Main IDS. Upon review of the se incidents. it was concluded that ··The low number of cases of poisoning due to this chemical prevent s recommendations on specific use practices or labeling c ha n ges." Page I of 5

### The current I DS analys is from January I , 2010 through January 13 , 20 15, shows no i nc idents reported involving profenofo s in either Main IDS or Aggregate IDS. Further, a query of SE SOR-Pesticides 1998-2011 identifie s 1 3 s in g le ai incidents for profenofos. 12 of which were low in severity. Based on th e low frequency and mostly low seve rity of incid ent cases reported for profenofos in both IDS and NIOSH SENSOR-Pesticides. there does not appear to be a concern at th i s time that would warrant fu11her inve s ti gation. Th e Agency will continue to monitor the incident information and if a concern is triggered. additional analysis w ill be conducted. The Agricultural Health Stud y (AHS) is also a potential so urce of information assoc iated with human hea lth effects associated with certain pe s ticides. Profenofos is not included in the AHS. and therefore this study do es not provide informat ion for thi s report. Detailed Review I. 

### ACT ION RE Q UES T E D 

### Profenofo s arc being con s id e red under the FQPA-mandated Reg istrat ion Revi ew program established to review, on a 1 5 

### year cycle, pesticides for which a Re -registration Eli g ibi lity Deci s ion has been made. One compone nt of th e Agency's Registration Revie w Program is consi d eration of human in c ident data. In conjunction w ith a human health risk assessme nt based o n other data so urces , such human incid ent data can assist the Agency in bette r defining and characterizing the risk of pesticides/pesticide products. Reports of adverse health effects allegedly due to a specific pesticide exposure (i.e., 

### an ' ·incident
.. ) are largely self-reported and therefo re . generally speaki ng . neither exposure to a pesticide o r reported symptom (or the connection between th e two) is va lidated o r otherwise confim1ed. Typica ll y, causation cannot be detennined ba sed on incident data. 

## r I oweve r, incident in formation can be an i mportant source of feedback to the Agency: incidents of severe outcome, or a s uggested pattern or trend among less severe incidents, can s i gna l the Agency to further investigate a particular chemical or product. Ob servational epidemiology s tudies re late the risk of disease, 

### e.g.. cancer. and exposure to an agent such as a pesticide product in the general population or specific sub-gro up s like pesticide applicators. II . B AC K G RO U ND 

### Profenofos is a restricted use pesticide. It 

### is an insecticide / miticide use d so lel y on canon. to control the tobacco budworm. co tt on bollwom1. armyworm . cotton aphid. whitetlies. spider mites, plant bugs. and flea hoppers. For thi s eva luation , both OPP Incident Data Sys tem (IDS) and the Ce nte rs for D isease Control and Preventi o n/National In s titute for Occup at io nal Safety and I lealth (CDC/NIOSH) Sentine l Event Notification System fo r Occupational Ri sk -Pesticide s (SENSO R ) databa ses were consu lted for pesticide incident data o n the active ingredient profenofos (PC Code: 111401 ).

Page 2 of 5The purpose of the d atabase search is to identify potential patterns in th e frequency a nd severi ty of th e health effects attributed to profenofos exposu re. In add ition, findin gs from th e A g ric u ltural He a lth S tud y ( A H S) we r e r ev ie w e d. The A H S is a high quality, pro spec ti ve e pid e m iology s tud y eva l uating th e li nk b e tw ee n pesticide u se and vario u s health o utc o m es in cl udin g cancer. Profe n ofos is not includ ed in th e A H S. a nd th erefo re this study d oes not provide in formation fo r thi s report.


### III. RESU LTS/D I SCUSS IO N a . ID S ( In c i de nt Dat a Sys t e m) OPP's TDS include s r epo rt s of a ll eged human hea l th inc ide nts from various so urces, includ in g mandatory Federal In sec ti c id e, Fungicide a nd Rodenticide Act (FIFRA) Sec t io n 6(a)(2) reports from registrants, othe r fede ra l and state health a nd e n vironme ntal agenc ies. and individual consumers. S in ce 1992. OP P has compiled these reports in IDS. ID S con t a in s reports from across the U
. S
. and m ost incidents have a ll re levant product in format ion recorded. R eports submitted to the ID S represent anecdota l repor t s or allegations only, unless othe r w i se stated in the report. ID S r ecords incident s in o ne of two modul es: M a in ID S and Aggregate ID S :
o Main ID S co ntain s incident s resulting in hi g her seve r ity o ut co m es and provid es more detail w ith re gard to case spec ifi c . This sys tem stores in c id e nt data for death. major and moderate incidents, and it includes information about th e location. date a n d nature of the incident. Main ID S inciden t s involving on ly one pesticide are considered to provide more certa in informati on about the potentia l effec t s of exposure from the pes ti cide.

o Aggregate ID S contains incid e nt s res ultin g i n less severe human incidents ( minor , unkn ow n. o r no e ffec t s outcomes). These are report e d by r eg is trants on l y as counts in w h at a r e aggregate s umm a ri es. From Jan u ary I , 20 10 to Januar y 1 3
. 2015. there we re no incidents reported to eit h er Main or Aggregate IDS involving profenofos
. 

### b . SENSOR - P es ti cide s T he SENS OR

- Pe s ticides database cove rs 1 2 s t ates fr o m 1998-20 I 1 , although reporting varies from s ta te to state. Cases of pesticide-related illn esses are asce rtain e d fr om a va ri e ty of so urc es. including: reports from loca l Poison Control Cen te rs. state D epar tm en t of Labor workers· compensation claims when reported by physicians. reports from State D epartments o f Agriculture, and p hysician reports to state Departments of Health. Although both occupation al and non - occupationa l i ncidents are included in the database, SENSOR focuses on occupationa l pesticide incidents, and is of particular va lu e in providing th at in formation. A state SE SOR

P age 3of5contact s p ec ia li st attempts to fo ll ow -up with cases a nd obtain s medical reco rd s to ve ri fy sy mptom s. c ircumstances s urrounding the expos ure , severity, a nd o utcome. Us in g s tandardi zed protocol a nd case definiti o n s derived from po iso n ce nte r reporting. SENSOR coo rdinators at State D epartments of H ea l th enter the incident int erv iew descript io n provided by th e case, medical report. physician and patient into the SENSO R data sys tem. The SENSO R data sys tem is accessible lo participatin g s l a t es and EPA. A query o r SENS OR-Pe st ic ides from 1998 -20 11 identifi es a to tal of 20 cases in vo l v ing profenofos (pc code 11140 I): 1 3 of the se cases a re s ingle ai and \Viii be analyzed for the m emo. These 13 single a i cases stem from 3 eve nt s: o ne of these even t resulted in 11 cases. details o f the case are inc lud ed in th e next paragraph. Of th e 1 3 si ngle ai cases . 1 2 we r e low in severit y and o ne case was moderate in severit y. The m odera te sev erity cases occ urred in Ca lifornia in 1998 a nd there is no detail provid e d o n the circum s tance s . Of th e 1 3 s ing l e ai case s. 11 cases expe ri enced gas trointe st in a l sy mpt o m s, includin g abdomina l pain, nause a . a nd diarrhea. Eight cases expe ri enced r espiratory sym ptom s including respiratory pain and cough. So m e cases a lso reported headaches and eye irritat ion
. A lso . 

### 12 of the 

### 1 3 cases resul ted from ae ri al app licati o n s. Specifically 11 cases we re made ill from spray dri ft (a ll 11 narra ti ves indicate sp ray drift from ae rial applicat i o n and not vo la tili zat i on) and o ne case was direc tl y s prayed ove rh ead by th e ae ri a l app l icalor. On e event in T exas in 2005 led to I I cases made ill. Th i s eve nt occ urred w hen an ae ri al application as made to a cotto n fie ld th at was adjacent to a schoo l and residentia l area. Five young ch ildren and s ix adu l ts at the sc h oo l o r in their hom es were made ill 

### by thi s eve nt. SENSOR-Pesticides 1998-2011

Profenofos Cases (sing le ai) N = 13 Case ID Severi ty Case D esc riptions

- CA03698 moderate Descriptio n not provided
LA00989 low Working o n train and as crop duster fl ew ove rh ead subje ct r epo rt ed fee li ng a mist.
TX04630 low Expo sed to drift from aerial app lication made to nearby cotton field. case lives in s chool property. TX04713 low Exposed to residue from aerial app lic atio n to cotto n field next to sc hoo l, whe re case works. TX04714 low Outside when crop duster made app li cation to nearby co tt on field, felt mi s t a nd sme ll ed product TX04715 low Out s ide their residence play ing during aerial applica t ion to nearb y cotton field , exposed to drift
. TX047 16 I O \.V Kids we r e o ut s id e th e ir res i dence play in g duri ng ae rial applicati o n to nearby cotto n field. went o ut s id e to get them in TX04717 low Kid s were outside th eir re s idence playing durin g aerial application to nearby cotton field , went outside to get them in

Page 4 of 5TX04718 low Out s id e their residence playing during aerial application to nea rb y co tton field, expo s ed to drift. TX04 7 19 low In s id e home w / window down during aerial application to nearby cotton field. Went out s ide s hortl y after application TX04720 low In s ide home w / window down during aerial application to nearby cotton field. Went outside s hortly after applica ti on TX04 72 1 l ow In side home w / window down during aer ial app li cati on to nearby con· on field. Went out s id e s hortly after application TX04 722 low In s ide home w / window down during aerial appli c ation to nearb y cotto n field. Went out s id e s hortl y after application

c . Ag ri cu ltura l Hea lt h Study (A HS) The AHS i s a high quality . prospective epidemiology stud y evaluat in g the link between pesticide use and various health outcomes including cancer. The AHS includes private and commerc ial pesticide app lic ators and thei r spouses . The A HS includes information on use of 50 different pesticide activ e ingredient s commonly u sed in agricu lture. Prof c nofos i s not included in the AHS , and therefore this study does not provide information 

### fo r thi s report. IV . CONCLUS IO N Based on 

### the low frequency a nd mostly l ow seve rit y of incid e nt cases report ed for profenofos in both ID S a nd N IOSH SENSOR-Pesticides. there does not appear to be a concern at this time 

### that would warrant further inve st iga ti on. The Agency wi ll continue to monitor the incid e nt information and if 

### a concern is triggered. additional analysis will be conducted.

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