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



### MEMORAN DUM Date: November I 0, 20 15 

### SU BJECT: Flu oxast rob in: Tier I (Scoping) Rev iew of Human In c ide nt s and Epidemiology

PC Co de : 028869 DP Barc o de: 0430065 Decis io n No .: 510090 Petition No.: NA Ri sk Assess m e nt Ty pe: A T XR No.: NA

1RID No.: I A R eg is tration No.: NA Re g ulatory Action: NA Cas e No .: A CAS No .: 361377-29-9 40 CFR: A


### FROM: Vcr.Apr.08 Elizabeth Evans, E nvironm enta l Protection

# Specialist**~~** Toxico logy and Ep idemio logy Branch Health Effec ts Division (7509P)



### THROUGH:

TO: and

# ~ Shanna Reco re , Industrial Hygieni s t Toxicology and Ep idemi o logy Branch Health Effect Division (7509 P) David Miller , Ac tin g Branch Chief Toxicology and Epidemiology Branch H eal th Effec t s Divi s ion (7509P) 

# j**//,~ /cJ** **n~-** lfl'JMinerva Mercado, Ri sk Assessor Ri s k Assessment Branch Ill Health Effec ts Di v ision (7509 P) and Bilin Basu , Chemica l Review Manager Risk Management 

### & Impl eme nt at io n Branch 5 Pesticide Re-eva luation Di vision (7508P) Summary and Conc lu sions Based on the low frequency and severity of incident cases reported for fluoxa s trobin in both ID S and SENSOR-Pesticides there does not appear to be a co ncern at this time th at would warrant further investigation. The Agency will continue to monitor the incident infom1ation and if a conce rn is triggered , additiona l analysis wil l be included in the ri sk assessme nt.

Page 

### I of 4

### Detailed Review 

### I. ACTION REQUESTED This review is intended to fulfill our requirement to docket summaries of incident data that were reported to the Agency, as well as to ensure human incident data and the Agricultural Health Study (AHS) are part of the prob lem formulation phase of registration review. Reports of adverse health effects allegedly due to a specific pesticide exposure 

### (i.e ., an " incident " ) are largely self-reported and therefore , generally 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 , or a suggested pattern or trend among less severe in cidents , can signal the Agency to further investigate a particu lar chem ica l or product. Observational epidemiology studies relate the risk of d isease , 

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

### II. BACKGROUND Fluoxastrobin is a fungicide registered for foliar use on peanuts, tuberous and corm vegetables , leaf petiole vegetab les, fruiting vegetables, and turf, as well as seed treatment for potato , peanut and turf. Fluoxastrobin is not an RUP, however, it is labeled for professiona l pest control operators on ly, not for homeowners. 1 

### For this evaluation , both the OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National In stitute for Occupational Safety and Health (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient fluoxastrobin (pc code : 028869). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to fluoxastrobin exposure. Fluoxastrobin is not included in the AHS , and therefore this study does not provide information for this report. 

### III. RESULTS/DISCUSSION

a. IDS (Incident Data System) OPP's IDS includes reports of alleged human health incidents from various sources , including mandatory Federal In sect icide, Fung ic ide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from registrants , other federal and state health and environmenta l agenc ies , and individual consumers. Since 1992 , OPP has compiled these reports in IDS. ID S conta ins reports from across the U

. S. and most incidents have all relevant product information recorded. Reports

1 EPA Factsheet , found online at: http ://www. epa.gov/ pes ticide s/ ch e m se arch/ r e g action s/ r e gi s tra ti o n / f

s PC

0 2 8869 01-Nov-0 5 .pdf



### Page 2 of 4submitted to th e lD S represent anecdotal reports o r a ll egat io n s o n ly, unle ss otherwi se stated in the report. ID S records incidents in o ne of two modul es: Main IDS and Agg rega te ID S:

o Main ID S contains incidents resulting in higher severi t y outcomes and pro vides more detail with regard to case specifics. This syste m s to res incident data fo r death , major and m o derate in c ide nt s, a nd it includes informati o n about the location , date and n ature of th e in c ide nt. Main ID S incident s in vo lving only one ac ti ve in g re di e nt ( as opposed to pe s ti cide produ c t s with multipl e active in g re di e nt s) are considered to provide more ce rt a i n information about the p o te ntia l effects of exposure from th e p es t ic ide.


### o Agg regate 

### l OS contains incident s re s u ltin g in less seve re human incidents (minor, unkn own, o r no effects outcomes). These are re ported by re g is trants only as cou nt s in wha t are aggregate summaries. For th e Main I DS, from January I , 20 l 0 to May 27, 20 1 5, there was o ne inc id ent reported involving fluoxastrobin. Thi s incident h ad two affected in d iv idu a ls, o ne case was classified as moderate severity and the other minor severity. Two a dult females were o n their way to work and were sprayed twice by a crop duster. One fe m ale developed tingling , throat irritation and h e r ches t fel t heav y. The other fema le claimed she was nauseou s all day. In Aggregate lDS , from January 

### 1 , 2010 to May 27, 20 1 5, there were 5 incide nt s rep o rted invo lvi ng fluoxastrobi n. These incidents we re classified as minor severity. Overall , there are few incidents reported to ID S in vo lv in g fluoxastrobin. 

### b . SENSO R- Pes ticid es The SENSO R-P est ic id es database covers 12 s tates fr o m 1998-20 l 1 , althoug h report ing varies from state to sta te . Cases of pesticide -re lated i lln esses are asce rta in e d from a variety of sources , in c ludin g: r epo rt s fro m local Poi s on Contro l Centers, state D e p art ment of Labor workers ' compe n sa ti on c laim s when reported by physicians , r e port s from S tate Departm e nts of Agr icu lture, a nd physician re port s to state D e partm e nt s of Hea lth

. Although both occupational a nd non-occupational incide nt s are includ ed in th e database , SENSO R-P es ticides focuses on occupationa l pest ic id e i ncide nt s, and is of particular va lu e in pro v idin g th at information. The sta te coordinator at each of the 12 respective state Departments of Health co nducts case followup act i v iti es suc h as obtaini ng m edica l records to veri fy sy mptoms an d severity. Us in g s tandardized protocol and case de finiti ons derived from poison ce nt e r reporti ng, the state SENSOR -Pe st icide coord in ato r enters th e incident information into th e state -ba se d syste m w hi c h is sent to N IOSH annually to be aggregated. A re view of SENSOR-P est ic id es from 1998- 201 1 identifies no inc id en t s in vo lvin g fluo xastrob in.



### c. Ag ri c ultu ra l H ea lth S tud y {A H S) The AHS is a hi gh quality , prospective epidemiology s tud y evaluating the link between pesticid e u se 

### and vari ous h ea lth ou tc o m es includin g cancer. The AHS includes private and commercial

Page 3of4pesticide applicators and their spouses. If there are Al-IS finding s relevant to a particular pesticide go in g through registration review , the Agency will ensure they are cons id ered in the problem formulation / scop in g phase o f the pro cess a nd , if ap propriate , fu ll y rev iewed in the ri sk assess ment phase of th e proce ss. The A l-I S includ es in format io n on u se of 

### 80 diffe rent pesticid e act ive ingredients commonly u se d in agriculture. F luo xastro bin is not in c lu ded in the AHS , a nd therefore this study does n ot provide info rm a ti on for this r eport. 

### I V. CONCLUS I ON Based on the low frequency and severity of incident cases reported for fluoxastrobin in both IDS a nd SENSO R-P es ti c id es th ere does not appear to be a concern at thi s time that wo uld warrant further inve s ti gat ion. T he Agency will continue to monitor the incid en t information and if a concern is trig ge re d , additional analysis will be included in the risk assessment.

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