### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF C HEMI CAL SAFETY AND POLLUTION PRE V ENTI ON



### MEMORA N D UM Date: October 22, 20 1 5 

### SUBJECT : Diph e nylamin e: Tier 

### I (S cop in g) R eview of Hu man Incidents an d E pid e mi ology

PC Code : 038501 DP B a r codc: 0429 308 Decis ion No.: 509355 Peti t ion No.: A Ri s k As sess m e nt T y p e: A TXR No. : NA M RIO N o. : NA R eg i s tration No.: A R eg ul a t ory Ac ti o n : A Case No.: A CAS No.: 9436 1-06-5 40 C FR: NA 

### F ROM: Elizabeth Evans, Env ironm e nt a l Protec tion Specia li st Tox i cology and Epidemiology B ranch Health Effects Di vision (7509P ) and Ver.Apr.OS

Shanna R ecore, ln dustiia l H yg ieni s t

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## I\ 1 1 Toxicology a nd Epidemiology Branch**~'-..** Health Effect Div i sion (7509 P ) D avid Mi ll e r , Acting Branch Chief

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. "' '-' To x ic o logy a nd Epid emio logy Branch 

### THROUG H :

TO : H ealth Effects Di v i s io n (750 9P) Karlyn Middle ton, Ri sk Assessor Risk Assess m e nt Bran ch ll Health Effects Di vision (7509 P) and R. John so n , C h e mi ca l Review Ma n age r Risk Manageme nt & Imp le m e ntati o n B ranch 5 Pesticide R e-eva lu ation Di v i s ion (7508 P ) Summaiy and Conclusions Th e re are n o in c id ent cases repo rte d for diph e n y l a min e in JD S a nd SENSOR- P es ticid es . Th e r e does not appear to be a co n ce rn at th i s t ime that wo uld warrant further investigation. The Agency will co ntinue to monit o r the incident infom1ation and if a concern i s tri ggered, additi o nal analysis will be included in the risk assessmen t.
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### Detai led Review I. ACT IO N REQUESTED This r ev iew is intend ed to fulfill our re quir eme nt to d ocke t sum marie s of in c ide nt data that were rep orte d to th e Agency, as we ll as to ens ure human incid e nt d ata and th e Agric ultural Heal th Study (A HS ) are part of th e problem formul ati on pha se ofreg is tration rev iew. R e port s of adverse hea lth effects allegedly due to a s p ec ifi c p est icid e expos ure (i.e., a n " in c id e nt ") are l arge l y s e lf-re p orted and therefore , genera ll y s peaking, ne ith e r ex p os ure to a p esticide or reported s ymptom (or the connection betv. r een th e two) is va lid ated o r oth erw is e co nfinn ed. Typically , causatio n can not be determined b ased on in c id e nt data. Ho wever , in cide nt in formation can be an imp o rtant so urc e of feedback to the Agency: in c id e nt s of seve re o ut come , or a s uggested pattern or trend among l ess seve re incident s, can s i gnal th e Agency to fmther inv es ti gate a pa1ticul ar c hemica l o r product. Observati o n a l e pid e miology st udi es re l at e the ri sk of di sea s e , 

### e .g. , cancer , and expos ure to an agent s u ch as a p e s ti cide product in the general populatio n or s p ec ifi c s ub- gro up s like p es ti c id e applicators . II. BACKGROUND DPA is a plant growth regu l ato r u sed p ost- harves t to con tro l s tora ge sca ld o n app l es. This is an ind oor food e nd

- u se chemical. It can be app li e d by dippin g , drenchi ng , or sprayi ng. 1 

### For thi s eva lu at io n , b oth the O PP In c id en t D ata System ( I DS) and the Ce nt e rs for D isease Control and Preve ntio n/Na ti o n al In s titut e fu r O cc upati onal Safety an d H eal th (C D C/N lO S H) Sentine l Eve nt Notificat io n Sys t e m for O cc up ati o nal Ri s k-P es ticides (SEN SO R) databa ses were consulted fo r pe sticid e in c id e nt data on th e act ive ingredient diphen ylamin e (pc co d e: 038501 ). The purp os e of the databa s e s earch is to id en ti fy p o te nti a l patterns in th e frequ e ncy and seve1ity of the health effects attributed to diph enylamine ex p osu r e . Diphenylamine i s not inclu ded in th e AHS , and th erefore thi s study does not provide in formation 

### for thi s report. Ill. RESULTS/ DI SCUSS ION

a. IDS (Incid e nt Data System) OP P 's ID S includes report s of alleged hum an health incid ents from vari o u s s o ur ces, including mandat o ry Federal In sec ti c ide , Fungicide a nd Rod e nticid e Act (FIFRA) Section 6(a)(2) report s from regis trant s, othe r f ede ral and s tat e h ealth and e nv iro nm e nta l agencie s, and individual co n s um er s . S ince I 

### 992 , OPP has co mpil e d th ese reports in IDS. IDS co nt ains r epo rt s from acro ss th e U
. S. and most inc idents h ave 

### all relevan t produc t information recorded. Re p o rt s s ubmitted to th e ID S repre s ent a ne cdo tal report s or a l1 egatio n s o nl y , unle ss otherw ise stated in the report. ID S record s inci dent s in o ne of two modul es: Main ID S a nd Agg r egate LO S :

1 EPA Facts hee t, found on lin e at: hll p :// www . ep a.gov / o pp s rrd J /r

e regis tra 1 ion/RED s / fac 1 s hec 1 : 22 1 O

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### Page 2of4o Main ID S co nt ains incident s resulting in higher seve rit y o ut comes and provides more detail with regard to case spec ifics. This system stores incident data for death , major a nd m oderate incidents, a nd it includes in format io n abo ut th e locati o n , date a nd nature of the incident. M ai n IDS i nc ident s involvin g on l y o n e ac ti ve in gredie nt (as opp osed to pesticide products w ith multipl e active ingredients) are considered to provide more certain in format ion about th e potential effects of exposure from the pestic id e .
o Aggregate ID S co n tains in c id e nt s r es ultin g in less seve re hum a n in cide nt s (min o r , unknown, or no effects outco m es). Th ese are reported by registrant s o nJ y as counts i n what a re aggregate s ummarie s. T h ere we re n o incidents inv o lving diph e n y la mine re p o rte d to either Main or Aggregate ID S, from January I , 2010 to May 27, 2015. 

### b . SENSOR-Pestici d es The SENS OR

- Pest ici de s database cove r s 12 s tat es from 1 998 -2011 , a lthou g h re p o rtin g vari es from s tate to state. Cases of p est ic ide-rel ated illne sses are asce rtain ed from a varie ty of so ur ces, including: report s from local P oiso n Co ntro l Centers, state Department of Labor workers' compensat i on claim s when rep orted by phy sic ians , reports from State Department s of Agriculture, and physic ian reports to state Department s of H e alth
. Alt h ough both occ upati ona l and no n- occ up a ti o nal in c id e n t s a re includ e d in the d atabase, SENSOR-Pest ic id es focuses on occupational pe s ticide incidents, a nd i s of particular value in p roviding that information. Th e state coo rdinator at each of the 

### 1 2 respective state D epa1 1ments of H ealth conducts case fo ll owup activities s u ch as obtaini n g medical reco rd s to ve rify symptom s and seve rity. Using standardize d p rotoco l a nd case definitions d e rived fro m p o i so n center report in g, the state SENSO R-P est ic id e coo rdin ato r en te r s the in c id e nt infomrntion into th e s t ate -b ase d system w hi ch is sent to N IO SH annua ll y to b e aggregated. A r eview of SENSOR -Pe stic id es 

### 1 998-20 11 id e ntifi es 

### 20 11 identifies n o incid ents involving di ph e nyl am ine
.


### c . Ag ri c ultur al Hea lth Stu d y (A H S) The A H S is a high quality, pros pective ep id e miology st udy eva lu at in g the link between pe stici d e u se a nd vario u s h ealth outcome s including can ce r. The A H S i nclud es p1ivate and com mer c ia l pe st icide ap pli cators a nd th ei r s pouses. I f th e re are A H S findings relevant to a particular pesticide goi n g thro u gh regi s tration review, the Agen cy will ensure they are considered in the problem formulation/scopi n g pha se of the process and , if a ppropri ate, fully reviewed in the ri sk assessment pha se of the pro cess. The AHS in c ludes in fo rm at ion on u se o f 80 different pe stic ide active in gredients com monl y u sed in a g ri c ul tu re. Diph e n y lamin e i s n o t includ ed in the AHS , and therefore thi s st ud y doe s not pro v ide in fo rmation for thi s repo11.

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### I V. C ONCLUS I ON There arc no in c id ent cases reported for diphenylamine in 

### IDS and SENSOR-Pesticides. Th ere do es no t appear to be a concern at this 

### tim e that would warran t further in v e s tigati o n . The Agency will con tinu e to m o nitor the in cident infonnation and if a concern i s tri ggered, addition a l analysis will be includ ed in the risk asse ss ment.



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