### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D .C. 20460 OFF I CE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM Date: Sep tembe r I 0 , 20 l 5 

### SUBJECT: Bcnsulide: Tier I Update Revi ew of Human Incid e nts and Epidemiology for Draft Ri s k Assessment
PC C ode : 00980 1 OP Barcode: 0428879 Deci sio n No.: 507866 Pelition o.: NA Reg istration No.: NA Regu latory Ac ti o n : NJ\ Case No.: NA Ri sk Assessment Type: NA TXR o.: NA CAS No.: 7.J 1-58-2 40 CFR: J\ MRID No.: J\ 

### FROM:

THROUGH: S h anna Recore , Indu s trial H ygie ni st Toxicology and E pide mi o logy Branch Health Effects Di vision (7509 P ) and Elizabeth Evans, E nv ironmental Protec ti on Spec ialis t Tox ico logy an d Ep idemiol ogy Bran c h H ealth Effects Division (7509P) /.) 

# rj,

David 

### J. Miller, Act in g Bran ch Chief 

# fl.fa 

# )!'tf/t. Toxicology and Ep id emiology Branch H ea lth Effects Division (7509P) 

### TO: ld e li z E ncarnac ion , Risk Assessor Risk Assessment Branch V Health Effects Division (7509 P) and Ma rgaret Hathaway , Chemical Review Manag e r Risk Management & Impl ementati on Branch 2 Pesticide Re-evaluation Division (7508P) Summary and Co nclusions Ver.Apr.OS

Ben s ulide was previously reviewed in 1998 (J. Blondell and M. Spann, 2/ 911998, D2 39353)

. Al the tim e , th e re were two incidents reported for bensulide in ID S from 199 2- February 1998. Upon review of these in c id e nt s, no recommendations were m ade a nd it was conc luded that , " Very few illne ss cases hav e been repo rted due to ben s ulid e and none h ave been confirmed." Page I of 5The current IDS analysis from January l , 

### 20 10 through August 

### 25, 20 1 5 , s how s 

### 2 moderate severity incident repo11ed involv ing be n sulide in Main I DS and 5 m inor seve ri ty incidents r epo1 1ed to Aggregate IDS

. The query of SENSOR-Pesticides 

### 1998-2011 identified a total of 

### 38 cases involving (pc code 

### 009801). Of these 

### 38 cases, 

### 17 cases, ste mmin g from seven events, involve a single ai and were reviewed further. The Agricu ltural H ea lth Study (A HS) is also a potential source of information associated with human health effects associated with certain pesticides. Bensul ide i s not inc luded in the AHS , therefore no AHS information is avail able fo r thi s chemical. Based on the lo w frequency of incidents in vo l v in g bensulide reported to both ID S and SENSORPesticides , there does not appear to be a concern at this time. The Agency w ill continue to monitor the in ci d en t information and if a concern is tri gge red , additional ana lys is will be co nducted. Detailed Review I. A C TIO N R E Q UES TED Bensulide is being considered under the FQPA-mand ated Registration Rev iew program established to review , on a 

### 1 5 year cycle , pesticides fo r whic h a Re-regis tration E li gibi lit y Decision ha s been m ade.**On~** component of the Agency's R egistrati on Review Program is consideration of hum a n incident data. In conjunct io n w ith a hum an he alt h risk assessment based on other data sou rc es, s uch human incident data can assist the Agency in better defining and characterizing the ri sk of pesticides/ pesticide products. Reports of adverse health effec ts allegedly clu e to a specific pest ic ide exposure (i.e., an " incident") are large ly se lf-reported and therefore, generally speaking, ne ither exposure to a pesticide or reported symp to m (o r the cormection between the two) is va lid ated o r otherwi se co nfirmed. T yp ically, ca u sation cannot be determined based on incident data. H owever, incident information can be an important source of feedback to the Age n cy: incidents of severe outco m e, or a sugges ted pattern or trend among less severe incidents , can s ignal the Agency to further investigate a particular chemical or product. Observational epidemiology stud ie s relate th e ri s k of disea se, 

### e.g., cancer, and exposure to an age nt such as a p est ic ide product in the genera l popu lation or s pec i fic sub-groups like pesticide app l icators. II. B AC K G R OUN D Bensulide i s an organophosp hate herbic id e used 

### for weed control in ag ri cultural, residential and occupat ional sett i ng s.

Page 

### 2of5

### For this evaluation , both OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupationa l Safety and Health (CDC/N I OSH) Sentinel Event Notification System for Occ u pational Risk

- Pesticides (S ENSOR) databases were consulted for pesticide inc ident data on the active ingred ient bensulide (PC Code: 00980 1 )

. The purpose of the database search is to identify potential patterns in the frequency and severity of the health e ff e cts attributed to bensul i de exposure. 

### III. RESU LTS/ DI SCUSS I ON a . ID S (I ncid ent D a t a Sys t em) OPP ' s IDS includes reports of alleged human health incidents from var ious sources, including mandatory Federal Insecticide, Fungic ide and Rodenticide Act (FJFRA) Sect ion 6(a)(2) reports from registrants, other federal and state health and environmental agenc ies , and individua l consumers . S ince 1992 , OPP has compiled these reports in IDS. IDS contains reports from a cro s s the U.S

. and most incidents have a ll re l evant product infomrntion recorded. Reports s ubmitted to the IDS represent anecdota l reports or allegations only , un l ess otherwise stated in the report. IDS records incidents in one of two modu les: Main IDS and Aggregate IDS:



### o Main IDS contains incidents resulting in higher severi ty outcomes and provides more detail with r egard to case specific. This system stores incident data for death , major and moderate incidents , and it inc ludes information about the location , date and nature of the incident. Main IDS incidents involving only one pesticide are consid e red to provide more certain infonnation about the potential effects of exposure from the pesticide.



### o Aggregate IDS contains incidents r esulting in less severe h uman i ncidents (minor , unknown , or no effects outcomes). These are reported by registrants only as counts in what are aggregate summar ies. From January 1 , 2010 to August 25, 2015 , there was one incident reported to Main ID S in v olving the single active ingredient , bensulide. This incident was classified as moderate s everity

. It involved nine farm employees who were exposed during a product (EPA Reg. No
. 10163-200) application being made by a licensed pest contro l business to a nearby field. One worker was moving irrigation pipe when he was exposed. He complained of symptoms of burning eyes, numbness of tongue , extreme nausea, abdom ina l pa in, headache and pa in to h i s arms and legs. He was seen at a hosp ital emergency room and was treated w i th atropine, admitted to the hospital , and re leased after twelve hours. The o t her eight fie l dworkers were h arvestin g leafy greens at the time of exposure. They reported various symptoms including: burnin g e yes , headache , sore t hroat , nausea , vomiti ng, heavy legs, and numbness in tongue
. Two of th e workers sought medical attention and s ix workers d id not. There was one additional incident reported to Main IDS , involving multiple act ive ingredients. Thi s incident was classified as moderate sever i ty
. Page 3 of 5From J a nu ar y I , 20 I 0 to M arc h 18 , 20 1 5, there were 5 in c id e nt s reporte d to Agg r egate IDS involving bensu lide. Th ese incidents we re c l assi fi ed as min o r severity. O vera ll , there were few in c id e n ts repo rted to ID S involving ben sulide. 

### b. SE N S OR - Pes ticide s The SENSOR-Pesticides database covers 12 states from 1998-201 I , although reporting varies from sta te to s tate
. Cases of pesticide-related illnesses are ascerta ined from a variety of sources, including: reports from local Po ison Control Ce nter s, state D e partment of Labor worker s · compensation claims w hen reported by phy s ic ian s, reports from State D epartments of Ag ri c ulture, and ph ys ic ia n repo rt s to s tate Departments of H ea lth. A lth oug h both occup ational and non-oc c upationa l incid e nt s are includ e d in the databa se, SENS OR focuses on occupational pesticide in c id en t s, and i s of particular va lu e in prov idin g th at in fo rmation. A s ta t e SENS OR contact special ist attempt s to follow -up w ith cases a nd ob ta in s medical records to verify symptoms , circumstances s urrounding the exposure, severity, an d outcome. Us ing standardized protocol a nd case definitions derived from poison center reporting , SENSOR coo rdin ato rs at S tate D e p artments of Health enter th e in c id e nt interv iew description provided by the case , medical re p o rt , phys icia n and pat ie nt into th e S ENSOR dat a sys tem
. Th e SENSO R data sys te m i s accessible to participatin g states and E P A. A query of SENSO R-P est icides 1998

- 201 1 identifies a tota l of 38 cases invol v ing (pc code 00980 I ). Of these 38 cases , 17 cases , stemming from seven events, in volve a s in g le ai and will be reviewed he re. Fourteen cases we r e low in sever ity a nd three cases were m oderate in seve rity. S i x tee n ca ses were occupational expos ure . A tot a l o f 14 of th e s in g le ai cases repo rt s were ca u sed by drift. 1 One drift eve nt w hi ch occur red in Ca li forn ia in 2008, resulted in eigh t symp tomatic cases, in cluding all three of the three moderate severity case rep o rts. This event was in ves ti gated by CD P R and resulted in vio latio n s that ci ted, in particular , the applicator fa ilin g to notify worke rs in the adjacen t fi el d that an application was taking place. A second d ri ft event w hi c h aJso occurred in California in 2008, resulted in fo ur sy mptomat ic cases. Eleven cases repo rte d gas trointes tinal sy mptom s inc l uding nau sea ( n = 9) and vomitin g ( n = 6) and e leve n cases reported n ervo u s sys tem symp tom s, primarily headac he (n = 9).



### c. Ag ri cultura l H ea lth S tud y (A HS) The AI-IS is a hi g h qualit y, prospective ep idemi o log y s tud y eva lu a tin g the link between pesticide u se a nd va riou s hea lth outcomes includin g ca nc e r. The AI-IS includ e s priv a te a nd commercial pesticide app li cato rs a nd their s p o u ses. If there are A HS findings re le vant to a parti c ular pesticide go ing through regi s tration review , the Age ncy will e nsure they are considered in the problem formulation/scoping phase of th e process and, if app ropriate, fully reviewed in the risk assessment phase of the process. T he A H S in cludes information on use of 50 d i fferent pesticide active ingredients commonly u se d in agriculture

. Ben s ulicl e is not i nclud ed in the AHS , a nd therefore thi s s tudy do es n o t provide info rmation for this rep o rt.

1 SENSOR-Pesticides defines drift as "off -target movement of pesticide" which includes cases of volatilization. Page 4 of 5

### IV. CONCLUS ION 

### Based on the low frequency of incidents , involv in g bensulide reported to both ID S and SENSO R-Pe stic ides , there does not appear to be a co ncern at th is tim e . The Agency w ill contin ue to monitor the incident informat ion and if a concern is tri gge red, add iti ona l analysis wi ll be conducted.

Page 5 of 5