### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D.C. 20460 O FF I C E OF C HE MI CAL SA F ETY A ND P O L LUT I O N P R E V E NT IO N



### ME M O R AN D U M D a t e: June 30, 20 15 

### SU BJ ECT: Acrolein: Tier 

### I Review of Human Incident s and Epidemio logy

PC Code : 000701 DP B ar co d e: 04279 1 8 Deci s ion No.: 505481 Registratio n ' o.: A Peti t io n N o.: NA R egu latory Ac ti o n: /\ R i s k Assessment Ty p e: 1 A Case No .: A T XR No.: NA CAS No.: 107- 02-8 M RIO No.: A 40 CF R : NA


### FROM : ,( ;; hanna Reco . rc, Industrial Hyg ic n; s t 

# ,{J!t1 / ' Tox ic o lo gy and Epidemiology Branch ' 

# j Hea lth Effect Division (7509P) V\!r.Apr.08

and**~** E li zabeth Evans, Environmental Protection**Spccia li** **c..;~ '** **~** /**/1~** _) Toxicology and E pidemio l ogy Branch ()**1'** r 

### f**~** Hea lth Effects Di v i s ion (7509P) 

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,. ZJ,{j TH R O UG H : Da v id Miller , Ac tin g Branch Ch ief , 

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### TO : Toxicology and E pidemiol ogy Branch Health Effects D ivision (7509P) Wade Britton , Ri s k Assessor Ri s k Assessment Branch I Hea lth Effec t s Di v is ion (7509P) and Kelly Ballard , C hemical Rev iew Manager Risk Man age ment 

### & Implem e ntation Branch I Pes ticide Re-eva luation Di visio n (750 8P ) Su mm ary a nd Co nclu sio n s Based on th e low frequency and severity of inc ident case s reported for acrolein in bot h ID S and SENS OR-Pes tic ides there does not appear to be a concern at thi s time that would warrant further investigation. The Agency w ill co ntinu e to monitor the inciden t informati o n and if a concern is triggered. add iti ona l analysis w ill be included in the risk assess m ent.

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### Detail e d Review 

### I. ACT IO N REQUESTED This review is intended to fulfill our requireme nt to docket s ummari es of incident data that were reported to the Agency, as well as to ensure human in cident data and the Agricultural Health Study (A H S) are part of the problem formulation pha se of registration review. Re ports of adverse health effects allegedly due to a spec ific pesticide exposu r e 

### (i.e., an "inc iden t") are larg e l y self- reported and therefore , generally speaking. neither expo s ure to a pesticide or reported symptom (or the connection between the two ) i s validated or otherw i se confirmed. T yp icall y, cau sati o n cannot be d e termined based on incident data. Howe ver , incident in fo rmation can be an important source of f ee dback to th e Agency: incidents of se vere outcom e, or a s uggested pattern or trend among less severe incidents , can signa l the Agency to furth er inve s tigate a particular chemical or product. Observational epidemiology studie s relate the ri s k of disease, e.g. . 

### ca ncer , and exposure to an age nt such as a pesticide product in th e general population or spe c ifi c sub

- g roups like pe s ticide applicators. 

### II. BA C KGRO UN D Acro lcin is re g i s t e red as a re s tri cted use pes ticide for contro l of submerged and floating aquatic weeds and algae in irrigation canals as we ll as irrigation reservoirs in some states. In addition. acro le in is used as a biocide t o kill bacteria that accumulate within the pipes of petroleum producing systems. For thi s evaluation. both th e OPP In cident Data S ys tem ( IDS ) and th e Centers for Disease Control a nd Prevention/National Institute for Occupational Safety and H eal th (CDC/NIOSH) Sent in el Event Not ific a ti on Sys t em for Occupational Ri s k-Pesticide s (SENSOR) databases w e re consulted for pesticide incident data on th e active ingredient acrolein (pc code: 00070 I)
. The purpose of the database search i s to identif y potential patte rns in th e fre quenc y and sev erity of the hea lth effects attributed to acrolein exposure. Acrolein is not inc luded in the AHS, and therefore thi s study does not provide in formation for this report. 

### lll. RESULTS/DISCUSSION
a . ID S (Incident Data System) opp· s IDS includes report s of alleged hum an health in cidents from vari ous sou rces, includin g mandatory Federal Insecticide , F ungicide and Rodenticide Act (F IFRA ) Section 6(a)(2) report s from re g istrants , other federal and sta te health and env ironmental age ncies, and individual consumers . Since 1 992 , OPP has compiled these report s in IDS. ID S conta ins repo rts from across the U .S. and most incidents have all relevant prod uct infonn at ion re corded. Reports subm itted to the IDS represe nt anecdotal repo rts or allegations only. unless o th e rwi se stated in the r epo rt. IDS r eco rds incidents in one of two modul es: Main ID S and Aggre gate IDS:

Page 2of4o Ma in IDS contains incident s resulting in higher severity outcomes and pro v ides more detail with regard to case spec i fics
. This sys tem stores incid e nt data for death. major and moderate incident s. and it inc ludes information about the locati on . date and nature of the incide nt. Main IDS incid e nts involving only one active ingredient (as opposed to pe s ticide products with multiple active ingredie nt s) are considered to provide more certain information about the potential effects of exposure from th e pesticide.


### o Aggregate IDS contains incidents re s ulting in l ess severe human incidents (minor, unknown , or no effects outcomes). These are r e ported by registrants o nl y as counts in what are aggregate summaries. For the Main IDS, from January I , 20 l 0 to Februa ry 4, 2015. there were no incid e nt s r epor ted involving acrolein. In Aggregate IDS, from January I , 20 l 0 to February 4, 20 l 5, there were 3 incidents reported involving acrole in. These incidents were class ifi ed as minor severity. Ove rall, there are few incidents reported to ID S in vo lving acrolcin. 

### b. SENSOR-Pesticides T he SENSOR-Pestic ides databa se covers 

### 12 states from 1998-2011, although reporting varies from state to s tate . Cases of pesticide-related illne sses are ascertained from a variety of sources, including: r e ports from local Poison Control Centers, state Department of Labor workers' compensa ti on c laim s w hen repo rted by p h ys ician s, r eports from S tate D epartm e nt s of Agriculture
. and physician repo rt s to state Departments of Health. Although both occ upational and n on-occupational incident s are included in the database, SENSO R-P es ticide s focuses on occ upational pesticid e incident s, and is of particular valu e in providing that information
. Th e s tate coord in ator at each of the 

### 12 respective state Department s of Health conducts case followup activities such as obtaining medical records to verify symptoms and severi ty. Us ing s tandardi zed protocol and case definition s derived from poison center reporting, the state SENSOR-Pestic id e coord in ator enters th e incident information into the s tate-based system w hi c h is se nt to N IOSH annually to be aggregated. A review of SENSOR- Pesticides 1998

- 20 I I iden tifies one case involving acrolcin, this case is a s ingle ai. Th i s case was occupati onal and was low in seve rity. The case experienced ocu lar irritation and a headache. No case descriptio n was provided.


### c. Agricul tu ra l Hea lth St udy (A H S) The AHS i s a high quality, prospective epidemiology study eva luating th e link between pesticide use and various health outcomes including cancer. The AHS includes private and commercial pesticide appl i cators and their spo uses. 

### If there are AHS findings relevant to a particular pest ic ide go ing through registration review , the Agency will ensu re they a re con s idered in the problem fo rmulation/ scop ing phase of the process and. if appropriate. fully reviewed in the risk assessment phase of the process. The AHS include s informati o n on u se of 80 different pesticide act i ve in g red ients co mm only used in agricu lture. Acrolein is n ot includ e d in the A H S, and therefore this study does not prov ide information for this rep o rt.
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### IV
. C ONCL US IO N Based on the lov, 1 frequency and severity of inc ident cases reported for acro lei n in both ID S and SENSOR-Pesticides there does not appear to be a concern at this time that would warrant fu rth er investigation. The Age ncy w i 11 co ntinue to monitor th e incid e nt inform at ion and 

### if a concern is triggered, add iti o nal anal ys i s wi ll be included in the ri sk assessme nt.

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