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



### MEMORAN D UM Date: October 22, 2015 

### SUBJECT: Hymexazol: T ier 

### I Update Review of Human Incidents/Epidemiology for Draft Risk Assessment
PC Code: 129 1 07 DP Barcode: 0429771 Decision No.: 49934 I P etition No.: NA Ri sk Assess m e nt T y pe: NA TXR No .: NA MR ID No.: NA Re g is tration N o.: NA R eg ulatory Action: NA Case No
. : NA CAS No.: I 0004-44 -1 40 CFR: NA Ver.Apr.08 

### FROM: Shanna Recore, Industrial Hygienist

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... , ,_ /1 () ,.... n Toxicology and Epidemiology Branch

## ~l;V'-V'--**~** Health Effec ts Division (7509 P )



### THROUGH:

TO : and E li zabeth Evans, E nv ironm enta l Protection Specia li st 

# 47 · T oxicology and Epidem iol ogy Branch Health Effects Division (7509P) 

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· l,J !5 D avid J. Mi ll er, Ac tin g Branch C hi e 

# 'IJ g/{<. Tox ico logy and Ep idemio logy Branch Health Effects Di vision (7509 P ) Matthew Lloyd , Ri sk Assessor Risk Assessment Branch V II Health Effects D ivision (7509P) and Caitlin Newcamp , Chemical Review Manager Risk Management 

### & Impl ementation Bran ch 1 Pesticide Re-evaluat io n D ivis ion (7508P) Summary and Co nclus ions Hymexazol was previously reviewed in 2010 (S. Recore , 11124/2009 , D371893). At the time, there were no hymexazo l incidents found in ID S
. It was concl uded that " Because there are no incident cases identified, there does not appear to be a risk co nc ern at thi s time that would warrant further invest igation. " Page 1of4The cutTent IDS analysis from January 1 , 20 l 0 through March 19, 20 15 , shows no incidents reported involving hymexazol in IDS. Further, a query of SENSOR-Pesticides 1998-2011 identifies no cases involving h ymexazol. There are no incident cases reported for hymexazol in either ID S or N IO SH SENSOR-Pesticides , there does not appear to be a concern at this time that would warrant further investigation. The Agency wi ll continue to monitor the incident informat ion and if a concern is tri ggered, additional analysis will be conducted. The Agricultural Health Study (AHS) is also a potential source of information associated with human health effects assoc iated with certain pesticides. Hymexazol i s not included in the AHS , and the refo re th is study does not provide in formation fo r thi s r eport
. Detailed Review 

### I. ACT IO N REQUESTED Hymexazo l are be in g considered und e r the FQPA-mandated Reg istrat ion R eview program establi shed to review, on a 15 year cycle, pesticides for w hi c h a Re-registration El igibility Decision has been made. One component of the Agency ' s Registration Review Program is consideration of human inc id ent data. In conjunction with a human health risk assessment based on other data sou rc es , such human incident data can assist the Agency in better defining and characterizing the risk of pesticides/pesticide products. Rep orts of adverse health effects allegedly due to a specific pesticide exposure 

### (i.e ., an "incident") are largely self-reported and therefore, genera ll y speaking, neither exposure to a pesticide or reported symptom (or the connection between the two) is validated or otherwise confirmed. Typically , causation cannot be determined based on incident data. However, incident information can be an important source of feedback to the Agency: incidents of severe outcome , o r a suggested pattern or trend among less severe incid e nts , can sig nal the Agency to further in ves ti gate a pa11icular c hemi cal o r product. Ob servational epidemi o logy stud i es relate the risk of disease, 

### e.g. , cancer, and exposure to an agent such as a pesticide product in the gen eral population or specific sub-groups like pesticide applicators. 

### II . BA CKG RO U ND H ymexazo l is a fungicide, non-food use chemical used as a seed treatment for sugar beet seeds. There are no registered residential uses for hymexazol. For this evaluation, both OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and H ealth (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide inc ident data on the active ingredient hymexazol (P C Code: 129107). The purpose of the database search is to id entify potential patterns in the frequency and severity of the health effects attributed to hymexazol exposure.
Page 2of4In addition, findings from the Agricu ltura l Hea lth Study (AHS) were reviewe d
. The AHS is a high quality, prospective epidemio logy s tud y evaluating the link between pesticide use and various health outcomes including cancer. Hymexazol i s not included in the A HS , and therefore this study does not provide information for this report
.


### III. R ESULTS/ DISCUSS IO N a . ID S ( In cident D ata System) OPP's IDS includes reports of alleged hum an health incidents from variou s sources, includin g mandatory Federal In secticide, Fungi cide and Rodentic id e Act (FIFRA) Section 6(a)(2) reports from regist rants, other fede ra l a nd state heal th and environmental age n c ies, an d individual consume rs. Since l 992 , O PP ha s comp il ed th ese reports in IDS. IDS contains r epo rts from across the U.S. and most incidents have all relevant product information recorded. Reports submitted to the IDS represent anecdotal reports or allegations on ly, unless otherwise stated in the report. IDS record s in c idents in one of two modul es: Main ID S and Aggregate ID S:

o Main ID S contains incidents resulting in higher severity outcomes and provides more detail with regard to case speci fic. This sys te m sto res incident data for death, major and moderate incidents, and it includes informat ion about the location, date a nd nature of the incident. Main IDS incidents invo lving on ly one pest icide are co n s idered to provide more certain in formation abou t the potential effects of exposure from the pestic ide.

o Aggregate IDS contains incidents resulting in less severe human incidents (mino r , unknown , or no effects outcomes). These are reported by re gistrants only as cou nts in what are aggregate summaries. From January I, 20 I 0 to March 19 , 2015, th e re were no incidents reported to ei ther Main or aggregate IDS involving the active ingredient, hymexazo l.


### b. SENSO R-P est icide s The SENSOR-Pestic ides database covers 12 s tates from l 998-201 1 , although repo rting varies from state to state. Cases of pesticide-related illnesses are ascerta in ed from a variety of sources, including: reports from local Poison Control Cen te rs, state Department of Labor workers ' compensation claims when reported by physicians, reports from S tate D epar tm en ts of Ag ri cu lture , and p hysic ian repo rts to state Departments of H eal th
. Although both occupationa l and non-occupat iona l i ncidents are included in th e databas e, SENSOR foc u ses o n occ up at ional pesticide incidents, and is of particular va lu e in prov iding that informat ion. A state SENSOR contact specialist attempts to follow-up with cases and obtains medical records to verify symptoms , circumstances surrounding the exposu re , severity , and o utc ome. Using stand ardized
Page 3of4protocol and case definitions derived from poison center reporting, SENSOR coordinators at State D epa rtment s of Hea lth enter the incident interview de sc ription provided by the case, medical report , physician and patient into the SENSOR data system . The SENSOR data system is accessible to participating states and EPA. A query of SENSOR-Pesticides from 1998-201 1 id entifie s no cases in volving h ymexazo l.

c . Agric ultura l Health St ud y (AHS) The AHS is a high quality, prospective epidemio logy study evaluating the link between pesticide use and various health o utc omes including cancer. The AHS includes private and commercial pesticide app licators and their spouses. If there are AHS findings relevant to a particular pesticide going through registrat ion review , the Agency will ensure they are considered in the problem formulation/scoping phase of the process and , if appropriate, fully reviewed in the ri sk assessment phase of the process. The AHS includes information on use of 50 different pesticide act ive ing redient s commo nl y u sed in agriculture. Hymexazol is not included in the AHS , and therefore this study does not provide information for this report. 

### I V
. CONCLUSION There are no incident cases reported for hymexazol in either IDS or N IOSH SENSOR-Pesticides, there does not appear to be a concern at this time that would warrant further inv estiga tion. The Agenc y will continue to monitor the incident in format ion and if a concern is triggered, additional analysis will be conducted.

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