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

MEMORANDUM 

### Date: June 30. 20 15 

### SUBJECT: Th iram: Ti e r 

### J R ev iew of Human In cidents and Epidemiology

P C Co de : 07980 1 DP Barcode: 0427919 Deci s i on No .: 505988 P etit i o n No .: NA R isk A ssess ment T y pe : NA TXR No.: NA MRIO No.: NA R egi s t ratio n N o.: 1 A R egu latory Action: 1 A Case No. : NA CAS No.: 1 37

- 26-8 40 CF R : NA
FROM: 

# IrShanna Recore . ' Industrial Hy .gie nist 

# 1211(\ f

11 Toxicology and Ep idemiology Branch \ ) 1 1 ( Hea lth Effect D iv i s ion (7509 P) Ver.Apr.OS

and

# ~ E li za beth Evans. E nvironme ntal Protecti o n Specia li s t 

# c; (( , L2J,!:. Toxicology a nd Epidemi ology Branch v 

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### r · Health Effect s Division (7509 P) 

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# ;/J**·~J -n**  VY THRO UGH: D av id Miller. Acting Branch C hief 11

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. Tox icolo gy and Epidemiology Branch Hea lth Effects D ivision (7509 P) 

### TO: Dennis McNea ly . Ri sk Assessor Ri s k Assessmen t Branch 

### IV Hea lth Effects Division (7509 P) and Wilhelmena Livingston. Chem ical Review Manager Ri s k Managemen t 

### & Implementation Branch 

### 4 Pes ticide Re-evaluation Di vision ( 7508P ) Summarv and Conclusions Ba sed o n the low frequenc y and lo w severity of in c ident cases reporte d for thiram in ID S , SENSOR- P esticides , and NPJC there does no t appear to be a concern at this tim e that would warrant further inv es tigation. The Agency w ill co ntinu e to monitor th e incident in format ion a nd i f a concern i s tri ggered, additional anal ys i s w ill be includ ed in the ri sk assessme nt.

Pag e I of 4Detailed Review I. ACTION REQUESTED This review i s intended to fulfill our r equ ireme nt to docket s ummari es of incid e nt d ata that were reported to the Agency, as we ll as to e n s ure human incide nt dat a and the Ag ri c ultural Health St

ud y (A H S) are part of th e problem formulation phase of reg is tration rev i ew. Repo rt s of adve r se h ea lth effects alleged ly du e to a spec ifi c pesticid e expos ure 

### (i.e., an " in c id e nt' ') are largely se l f -repo rted and th e r efo re. generally speaking , neith e r exposu re to a pesticide or reported symp tom (o r the connectio n between th e two ) is valid ated o r otherwise confi rm ed. Typically, ca u sation cannot be d e te rmin ed based on incid e nt da ta
. Howe ve r. in c id e nt informati o n ca n be an important so urce of fee dback to the Age ncy : incident s of severe outcome, o r a s u ggeste d pattern o r trend among less seve r e incident s, ca n s ig nal th e Agency to further investigate a particular chemical or product. Obs e rvational ep ide miology studies re late t he ri s k of di sease. 

### e.g. . cancer , and ex p os ure to an agen t s uch as a pest ic id e produ c t in the general population or spec ific sub-g roups like pestic id e a pplicat ors . II. BACKGRO UN D T hiram is a non-systemic fung icide used to prevent crop dama ge in the fie ld and to protect harvested c rops (app le s, peaches. and strawbe rri es) from deterioration in s torage or transport. It is also used as a seed protectant (e
. g. s mall seeded vegetables . la rge see ded vege tab les, cereal grains and o th er seed s , conifero u s see d s, co tto n see d , o rnamen ta l see ds , and soybean s) and to protect turf from fungal di seases . In additi o n , thiram is used as a n ani mal r epe ll e n t to protect crops from damage by rabbit s , rode nt s, and dee r. Fo r this eva luati o n , both the OPP Incide nt Data Syste m ( I D S) and the Center s for Di sease Control an d Preve nti on/Nati ona l In s titute for Occ upational Safety and Health (C DC/N IOSH ) Se ntin e l Event Notificati on System for Occupa ti o nal Ri s k-P es ti cides (SENSO R) databases were consu lte d for pes ticide in c id e nt data on the ac tive ingred i ent thiram (pc code: 07980 I). The purpo se of th e databa se searc h is to ident i f y p o t en ti al patte rn s in th e frequency a nd severity of the health effects attri buted to thiram exposure. Thi ram is not in c lu ded in the A HS , and therefore this s tud y does not prov ide informatio n for thi s report. 

### III. RESU L TS/DI SCUSS ION


### a. IDS (Incident D ata System) OPP's IDS includes reports of a ll eged human health incidents from vario u s sources . includin g mandatory Federa l In sectic ide , Fun gicide and Rodenticide Ac t (F IFRA ) Section 6(a)(2) reports from registrants, other federa l a nd state hea lth and env iron mental agencies, and indi v idual consumers. S ince 1992 , OPP ha s compiled th ese re ports in ID S. ID S contain s r e ports from across the U.S. and mo s t incid e nt s have all re levant product in fo rm ation recorded. Rep011s s ubmitted to th e IDS represen t anecdotal repo rt s o r a ll egations o nl y, unle ss otherwise s tated in the report.

Page 2of4IDS records incidents in one of two modul es: Ma in ID S and Agg r egate IDS:

o Main ID S conta in s incidents resulting in higher severity outcomes and provides more detail with regard to case specifics. This system stores incident data for death, major and moderate incidents, and it includes information about the location , date and nature of the incid ent. Main IDS incidents involving only one act ive ingredie nt (as opposed to pesticide products with mu lt iple ac t ive ingredients) are considered to provide more cert a in information about the potential effects of exposure from the pesticide.

o Aggregate IDS contains incidents resulting in less severe human incidents (minor. unknown , or no effects outcomes). These are r epo rted by registrants only as counts in what are aggregate s ummaries. For the Main IDS, from January l, 2010 to December 30. 2014. there were 0 incidents reported involving thiram. In Aggregate IDS , from January I, 20 l 0 to December 30 , 20 14 , there were 28 incidents reported involv ing th iram . T hese incidents were cla ssifie d as minor sever ity. Overall , th e r e are few incidents involving thiram reported to ID S. 

### b . SENSOR-Pest ic ides The SE SOR-Pesticides database covers 12 states from 1998-2011, although reporting varies from state to state. Cases of pesticide-related illn esses are asce11ained from a variety of sources , inc lu ding: reports from l ocal Poi so n Control Ce nters , state Depar tm ent of Labo r workers' compensation claims when reported by physicians , reports from State D epar tm ents of Agriculture. and physician reports to state Departments of Health. Although both occupational and non-occupationa l incidents are included in the database , SENSOR-P estic ides focuses on occupational pesticide incidents , and is of particular va lu e in providing that information. The state coordi nator at each of the 12 respective state Departm ents of Health conducts case followup activities s uch as obtai ning medical record s to ve ri fy symp tom s a nd severity. Us in g standardized protocol and case definitions derived from poison center reporting , the state SENSOR-Pesticide coordinator enters the incident information into the state-based syste m which is sent to IOSH. annuall y to be aggregated. A review of SENSO R-P esticides 1998-201 I ide ntifies 14 cases invo lving thiram (pc code 079801); nine cases involve a s in g le ai. Eig ht of the nine cases were wo rk-related. E ig ht cases were low in severity and one case was moderate in seve rity. Dermal symptoms we re reported by five cases. four cases experienced respiratory irritation.



### c. Nati onal Pe s ti c id e Informati on Ce nte r (NPJ C) The Nationa l Pesticide In format ion Center or NP IC is a cooperative effort between Oregon State University and EPA which is funded by E P A to serve as a source of objective. science

- based pesticide infomiation and res pond to inquiri es from the public and to incidents. NPIC function s
Page 3of4nationally du ri ng weekday bus i ness hours through a toll

- free te lephone number in addition to the internet (www.npic.orst.edu) and email. Similar to Poison Control Centers, NP IC's pr i mary purpose is not to collect incident data , but rather to provide information to inquirers on a wide range of pesticide topic s, and direct ca ll ers for pesticide inciden t investigation and emergency treatment. Neverth eless N PIC does collect information about incidents (ap proximately 4000 incident s per year) from inquirers and record s that information in a database. NPIC is a source of national incident information but genera ll y receives fewer reports than ID S. Regardless , if a high frequency is observed in 

### IDS , NPIC prov ides an add itional sou rce of informat ion to see whether there is evidence of co nsistency across national data sets or possibly duplication and additional information about the same inciden t (s). From 2010 to 2014, 1 incident was reported to NPIC involvin g thiram. NPIC est imates a certainty ind ex as to whethe r an in cident (including reported sy mptoms) was ei ther definite ly, probably , possib l y, o r unlikely to have been caused by the reported exposure to a pesticide , or whether the incident was unre lated to pesticide s or if the incide nt was unclassifiable. This incident was classified wi th a certainty index of possible and a seve rity of m oderate. The incident involves a 45 year o ld male who se ll s vegetab le seeds. He was handlin g seeds treated with a fungicide containing thiram and did no t wear 

### PPE. H e developed a rash on both his hands and feet. d
. Ag ricultur a l H ea lth Study (AHS) The AHS is a high quality, prospective epidemiology study evaluating the link between pesticid e use and various health outcomes includin g cancer. The AHS includes private and commercial pesticide app li cators and thei r spouses . 

### If the r e are AHS find ings releva nt to a particu lar pesticide go ing through reg is tration rev iew, the Agency will ensure they are considered in the problem formulation/scoping phase of the process and, if appropriate, fully revi ewe d in the risk assessmen t phase of the proc ess. The AHS includes informati on on use of 

### 80 different pesticide acti ve ingredients commonly used in agriculture. Thiram is n o t i ncluded in the AHS , and therefore this study doe s not provide information for th is report. 

### IV
. C O NC L US IO N Based o n the low frequency and low severity of incident cases reported for thiram in IDS , SENSOR-Pesticides, and NP lC there does not appear to be a co ncern at this time that would warrant further investigation. The Agency will continue to monitor the incident information and if a concern i s triggered , add itional analysis wi ll be inc l uded in the risk assessment.

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