UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , 

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. C. 20460 OFFIC E OF C HEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM Date: February 23 , 20**l~** SUBJECT: B enzyl Benzoate: Tier I ( Scoping) Review of Human incidents and Ep idemiolo gy

P CCode :009 1 0 1 ,009 103. 009 5 0 1 De c i s i on No.: 514096 P etitio n No.: NA Ri s k A ssess m e n t Type: A TXR No.: NA MRID No.: 1 A DP Barcod e: 4318 0 I Re g i s tration No.: NA Reg ul atory Action: A Case No.: 40 1 3 CAS No.: 1 20 -51-4 40 CF R: NA Ve r .A pr . OS 

### FROM: E li zabe th Evans , Env iro nm enta l Protection Specia li st

# ~**~** Tox icol ogy and Epidemio logy Branc h 

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# M/A~ H ea lth Effec t s Division 

### (7509 P ) 

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- ·· and Shanna Recore , I ndustrial Hy g ienist 

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. /1 Toxicology a nd E pidemiolo gy Branch 

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### ~ Health Effect Division 

### (7509P)

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### THRO UG H: David Miller, Acting Bran ch Chie[ /7,; 

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. tC/b T ox icology an d Epidemio logy

# Bran**~** Health Effects D iv i s ion 

### (7509 P) 

### TO : Wade Britton, Risk Assessor Ri sk A s sessment Branch I V H ealth Effects Di v i s ion 

### (7509 P) and M mma Appleyard , Chemical Rev iew Manager Ri sk Management & Impl ementation Branch 5 P estici d e R e-eva lu at io n Di v i sion 

### (7508P) Summarv and Conclusions B a s ed on the low frequenc y and s everity of incident cases reported for benzyl benzoate in both ID S and SENSO R-P esticides there d oes not appear to be a concern at this time that wo uld warrant further investigation. The Agency will co ntinu e to monitor the in c ident information and i f a concern i s tr igge red , addit i ona l analysi s will be included in the ri s k as s essment.

Page I of 5Detailed Review I. ACT IO N REQUEST E D This review i s intended to fulfill o ur requirement to docket s umm aries of incident data that wer e reported to the Agen cy, as we ll as to e n sure human incid e nt data and th e Agricultural

. H ealth St ud y (A H S) are part of the problem formulation phase of registration review. Reports of adverse health effects alleged ly due to a specific pestic id e exposure 

### (i.e., a n " incid ent") are la rge ly se lf- rep o rted and th e refo re, ge nera lly speak in g, ne ith e r expos ure to a pesticide o r reported symptom (or the connection between the two) i s validated or otherwise confinned. Typically , ca u sation cannot b e determined bas e d on incid e nt data. How eve r, incident inform ation can be an important so ur ce of feedback to the Age nc y: incidents of severe o ut come , or a suggested pattern o r tre nd a mon g l ess seve r e incidents, can signal th e Agency to further investigate a particular che mi cal or product. Observational epidemiology studies relate the risk of disease , 

### e . g. , cancer , and exposure to an agent suc h as a pesticide product in th e ge n eral population or specific s ub- gro up s like p est ic id e appl ica tors. II . BACKGROUND Benzyl benzoate ( P C Co de 009501) is 1 of3 ac tive in g redi e nt s which compose registration rev iew Case # 4013 whjch also includ es benzoic acid (PC Code 009101) a nd sod ium benzoate ( P C Code 009103)

. Of the 3 active ingredients , benzyl benzoate is the only with re g i s tere d product s and su bje ct to reg i stration re v iew. 1 Benzy l Ben z oate is an insecticide/miticid e u sed for co ntrol of dust mites in car pet s , m attresses, upholstery , and on furniture , and for con t rol of mites on dogs. B e nzy l be nzoate i s a mem b er of the benzyl deri vativ es family , w hich is u se d in food flavors and fragrances, and occurs n at urall y in m a ny foods

. Based on product labels , benzy l benzoate i s formulated as a li qui d sp ray (Aeroso l ) and as powder formulation; a ll are " r ea d y -to-u se" ( RTU ) products. Application r ate s vary depending upon the applicat ion method and use-site. There are no agricu ltura l (foo d ) uses for benzy l benzoate. Th e residential uses are limite d to indoor tre a tm e nt s. 2 For this evaluat ion , bot h the OPP Incident D ata Sys t em ( IDS ) and the Ce nters for Disease Contro l a nd Preve nti on/Natio nal Institute fo r Occupational Safe ty and Health (CDC/N I OSH) Se ntine l Event Notific atio n System fo r Occ up ational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the acti ve in g red ie nt b e nzy l benzoate (pc co de: 00910 l ). The purpose of the database searc h is to identify po te nti a l patterns in th e frequency and severity of t h e health effects attributed to benzy l benzoate exposure. B enzy l benzoate is not includ e d in the A H S , a nd therefore this study does not provid e informati o n for this report.

1 2016 Benz y l Ben z oate draft s copin g (W. Britton) 2 Benz y l Ben zoate: Ri s k asse s sment
- Preliminary ( Ph as e I) 1 IE

D C ha pter o f the R e-re g i stration Eli g ibility Decision Document ( RED ). P C Cod e : 0 09501. Reregi s tration C ase N o . 401 3

. DP 13arcodc D327107 Page 2 of 5

### Ill. RESULTS/DISCUSS IO N

a. ID S ( Incid e n t Data System) O PP ' s IDS includes r e ports of alleged hum a n health incident s from v arious sources , including mandatory F ede ral In se cticide , F ungicide and Rod en ticide Act (FIFRA) Section 6(a)(2) report s from re gistrant s, othe r federal and state health and environmenta l agenci es , and indi vid ual co nsum ers . S ince 19 92 , OPP h as compi led these repo rts in ID S. ID S co nt a in s re p o rt s from ac ross the U .S. and mo s t incid e nt s have all relevant product information rec orded. Reports s ubmitted to the IDS r e pre se nt anec dotal repor ts or a ll egation s only , w1 less otherw ise s tat e d in th e report. ID S record s incide nt s in one of two modul es: Main IDS and Agg regate ID S:

o Mai n ID S contains incident s resultin g in higher seve rit y ou tcome s and pro v id es more d e tail with regard to case specifics. This sys tem sto r es incid e nt data fo r d eath , major and moderat e incident s , a nd it includ es inform a tion about the location , date and nature of the incid e nt. Main ID S in cidents in vo l v ing on ly one active in g redient (as opposed to pe s ti c ide product s with mu l tipl e a c ti ve in g r ed ie nts) are considered to provid e more ce rt a in in fo rmation abo ut the potential effects of expos ure from the pesticide.

o Aggregate ID S co ntain s incidents re s ulting in less severe human in c id e nt s (m inor, unknown , or n o effec t s outcomes). These are reported b y r eg istrant s o nl y as count s in what are aggregate s ummari es . Fo r the Main IDS , from Janu ary 1 , 2010 t o Septe mb e r 25 , 20 1 5 , there we re two in c idents reported fo r the s in g le c hemica l benzy l ben z oate o nl y in the d atabase. Both incid e nt s were moderate in seve ri ty. Aggregate I DS , from J anuary l , 20 I 0 to Septe mber 25, 2015 , th ere were 16 inc id e nt s r e porte d in vo lvin g benzyl ben zo ate. Th ese incid ents were cl ass ified as minor seve rity. O ve rall , t he re are few incident s report ed to ID S involving b e nzy l ben zoa te. Note tha t a ll of the above incid e nt repo11 s invo lve d E PA R eg i s tration No 4822-43 3 (A ll erCare) w hich was cancelled in Februa ry 2 008. b. SENSO R -Pesti c id es T he SENSOR -P est icides databa se cover s 12 s tat es from 1998- 2 011 , although reporting varies fro m state to s tate. Cases of p es ticide

- re lat ed illne sses are ascertained fr o m a variet y of so urces , includ in g: reports from loc al Poison Contro l Centers, s tate D e partment of Labor worke r s' co mpen sat io n claim s when re ported b y physicians , re ports from State D e partment s of Ag ricultur e , and ph ys ician rep o rt s to state Departmen t s of He a lth. Althoug h b ot h occ up ationa l a nd non- occu pation a l incident s are includ e d in th e database , SENS OR-P esticides focuses on occ upational p esticid e i nc id e nt s , and i s of particular value in provid in g that inf ormation. T he sta te coordinator at eac h of the 12 respective state D e partment s of H ealt h co ndu cts case fo ll owP

age 3o f5up activ iti es suc h as obtaining medical reco rds to ve ri fy sy mptom s and seve ri ty. Us ing s tandard ized protocol and case d efin iti ons derived fro m poison ce nt e r reporting , the s tat e SENS OR-Pe s ti c ide coordinator enters the incident information int o the s tate-base d sys tem wh ich i s se nt to N IO S H an nu ally to be aggregated. A quer y of SENSO R-P es ti cides 1998-2011 id enti fi es a tota l of 1 1 cases invo lvi n g benzyl ben zoate. Ten cases in vo l ve a s ingle ai and the se are s ummarized. One case i s hi gh in severity , two cases are m odera te in severity , and se ven cas es are low in seve rity. A ll but one of the I 0 s in g le ai cases occurred in 1 999 or 2000 (o ne low seve rity case occurr ed in 2005). The high severity case in vo lve d a woman who was ho s pitalized twice for asthma and the pat ie nt be li eves it i s re lat e d to th e pro duct. The case's daughter applie d A ll erCare, a p es ti c id e produ ct m arketed to kill du st mites that le ad to a ll e rg ies and as thma , arou nd the home. Thi s product ha s be e n taken off the market: http: //www.cbs news.com/news/ allercare-warning/ In fact, four of th e c a se re p orts involve A ll e rCa re. A n addit ional four cases in vo lv ed unsp ec ified du st mite carpet powder whi c h may have been A ll e rCare. Th e 2005 case in vo lv ed an un spec ified pro duct that was " taken off the market years ear li er"

. Sym pt oms we re ge nerall y allerg ic reaction s followin g ex posure. Ni ne cases experie nced r es piratory sy mptoms includin g upp e r re s piratory pain ( n = 6) a n d w h eeze (n=4). Tabl e 1. SENSOR-Pesticide s 1998

-2 011 Symptoms reported for benzyl benzoate cas es ( n = lO) D ermal 6 Oc ul ar 2 R

e s oiratorv 9 Gas trointe stinal 4 Ne rvou s sys tem 

### s Renal I *Cases may report mulllplc symptom s
c. Ag ricultur a l H ea lth S tud y (AHS) Th e AHS i s a hi g h quality , pros p ecti ve ep idemiolog y s tud y e va lu a ting the link betwee n p es ti cide u se and variou s h ealth outcomes in cluding cancer. The AHS in c lud es private and c ommercia l pe s tic id e appli cato r s and th e ir s pou ses. If there are A H S finding s re levant to a p a rticular p es ti ci d e go in g through reg i s tration re v iew , the Agency wi ll ensure th ey are con si dered in th e p ro bl em formulatio n/s copin g phase of th e process a n d , i f appropriate , fully rev iewed in th e ri s k as sess m e nt pha se of the pro cess. The A l-I S includ es in fo rmation on use of 80 different p es ti c id e act i ve ingre di e nt s commonly u se d in ag ri c ulture

. Ben zy l benzoat e i s not includ e d in the AHS , and therefore th i s s tud y d oes not provide informati o n for thi s repo rt. 

### IV. CONCLUS IO N B ased on th e low frequ e nc y a nd seve ri ty of incide nt cases reported 

### fo r benzy l b enzoate in both ID S and SENS OR-Pesticid es t here doe s not appear to be a concern a t this time th at wo uld

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### warrant further in ves ti ga tion

. Th e Age n cy will co ntinu e to monit or the incid ent infonnation and if 

### a concern i s triggered , additional anal ys i s will be includ ed in the ri sk assessment.

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