UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, 

### D
. C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTIO N PREVENTION



### MEMORANDUM Date: June 25, 2014 

### S UBJECT: Boscalid : T ier I Review of Hum an Incidents

P C C ode : 128008 DP Barcode: 0418675 Decision No. : 488836 Petition No.: NA Risk Assessment T y pe : NA TXR No.:NA M RJD No.:NA R eg istration N o. : NA Regulatory Actio n: NA Case No.: NA CAS No.: 188425

- 85-6 40 CFR: NA Ver
. Apr.08 

### FROM : S hann a Recore, Industrial Hygie ni st

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# ()I~**~vrt·zP~** THROUGH: David Miller, Ac ting Branch Chief " / 1(1 

### //(J:. Tox ico l ogy and Ep idemiol ogy Branch Health Effects Division (7509P) 

### TO : B arry 

### 0' Keefe, Risk Assessor Risk Assessment Branch III Heal t h Effec ts Di v ision (7509 P ) and Mar i a Piansay, Chemical Review Manager Risk Management & Imp lementation Branch 5 Pesti cide Re-evaluation Division (7508P) S ummarv and Conclusions Based on the low frequency and low severity of incident cases reported for boscalid in both IDS and SENSO R-P estic ides, there does not appear to be a concern at this time that would warrant further investigation. T he Agency wi ll continu e to monitor the incident in formation and if a concern is triggered , additional analysis will be included in the risk assessment.
Page 1 of 4Detailed 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 ens ure human incident data and the Agricultural Health Study (AHS) are part of the problem formulation phase of registration review. Reports of adverse health effects allegedly due to a specific pestic ide exposure (i.e., an " incid ent") are large ly self-reported and therefore, generally speaking, neither exposure to a pesticide or reported sy mptom (or the connection between th e tw o) i s validated or otherwise confirmed. Typically, causation cannot be determined based on incident data. Howe ver, 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 incidents , can signal the Agency to further investigate a particular chemical or product. Observational epidemio lo gy s tudi es re late the risk of disease, 

### e.g., cancer, and exposure to an agent such as a pesticide product in the general population or specific sub -groups like pesticide applicators. II. BACKGROUND Boscali d is a fungicide that work s inside the mitochondria of fun gi and stops fu n gi from producing the energy that they need to carry on basic functions. Boscalid prevents energy production by binding to the enzyme succ inate ubiquinone reductase. Boscalid is currently registered on numerous agricultural crops and on golf course turf. 1 For this eval uation, both the OPP Incident Data System (IDS) and the Centers for D isease Control and Prevention/National Institute for Occupational Safety and He alth (C D C/N IOSH) Sentinel Event Notification Sys tem for Occupational Risk

- Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient boscalid (pc code : 128008)
. The purpose of the database search is to identify potenti al patterns in the frequency and severity of th e health effects attributed to boscalid exposure. Boscalid is not inclu ded in the AHS, and therefore this study does no t 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 source s, including mandatory Federal Insecticide , Fungicide and Roden ticide Act (FIFRA) Section 6(a)(2) reports from registrant s, other federal and state health and environmental agencies, and individual consumers. Since 1992, OPP has compiled these reports in IDS. IDS contains reports from across the U.S. and most incidents have all relevant product information recorded. Reports submi tted to th e IDS represent anecdotal reports or allegations only, unless otherwise stated in the report. IDS records incidents in one oftwo modules: Main IDS and Aggregate ID S:

1 http: / /www.epa.gov/ oppOOOO 1/chem

_ search/reg
_ actions/registration/fs
_ PC-128008
_0 1-J ul -0 3 .pdf

Page 2 of 4o Main ID S contains incidents resulting in higher severity outcomes and pro vides more detail with regard to case specifics. This system stores incident data for death, major and moderate incidents, and it include s information about the location, date and nature of the incident. Main IDS incidents involving only one active ingredi ent (as opposed to pesticide products with multiple active ingredients) are considered to provide more certain information about the potential effects of exposure from the pesticide.

o Aggregate IDS contains incidents resulting in less severe human incidents (minor, unknown, o r no effec ts outcomes)
. These are reported b y regi strants onl y as counts in what are aggregate summaries. For the Main ID S, from January 1 , 2009 to May 28, 2014, there was 1 incident reported for the single chemical onl y in the database. Th ere were 2 add itional incidents reported involving more than one chemical. These incidents were classified as moderate severity. In Aggregate IDS, from January 1 , 2009 to May 28, 2014, there were 6 incidents reported involv ing boscalid. These incidents were classified as minor severity. Overall , the re are few incidents involving boscalid reported to IDS. 

### b. SENSOR- Pesticides The SENSOR-Pesticides database covers 11 states from 1998-2010 , although reporting varies from state to state. Cases of pesticide-related illnesses are ascertained from a variety of so urces, including: rep orts from local Poison Control Centers, state D epartment of Labor workers' compensation claims when reported by physicians, repo rts from State Departments of Agriculture, and physician reports to state Department s of Health. Although both occupational and non - occupational incidents are included in the database, SENSOR-Pesti cides focuses on occupational pesticide incidents, and is of particular va lue in providing that information. The state coordinator at each of the 11 respective state Departments of Health conducts case followup activities such as obtainin g medical records to verify symp toms and severity. Usi ng standardized protocol and case definitions derived from poison center reporting, the state SENSOR

- Pesticide coordinator e nter s the incident information into the state-based system which is sent to N IOSH annually to be aggregated. Bosca lid A query of SENSOR-Pesticides 1998- 20 10 identifies ten cases involving boscalid (pc code 128008). All cases involved multiple active ingredients. All ten cases were work-related ; seven cases involved field workers and three cases involved app li cator/handler expo sures. Nine cases occurred in Was hington and at least five cases invo lved orchard fruit production. Eight cases were low in severity and two cases were moderate in severity. Dermal symptoms were most frequently reported.

Page 3 of4Table 2. SENSOR-Pesticides 1998-2010 Health Effects Reported for Boscalid Cases
Health Effect Frequency D ennal 6 Ocular 1 Nervous System 4 Gastrointestinal 4 Respiratory 3 Miscellaneous 2 Cardiovascular l Renal 0 * Cases may report multiple health effects



### c. Agricultural Health Study (AHS) The AHS is a high quality, prospective epidemio l ogy study evalua t ing the link between pesticide use and various health outcomes including cancer. The AHS includes private and commercial pes t icide applicators and the ir spouses. If there are AHS findings relevant to a parti cular pest i cide going through registration review, the Agency will ensure they are considered in the prob lem formulationlscoping phase of the process and, if appropriate, fully rev i ewed i n the ri sk assessment phase of the process. The AHS includes information on use of 50 different pesticide active ingredients commonly u sed in agricu lture. Bosca li d is no t include d in the AHS, and therefore this study does no t prov i de i nformation for this report. 

### IV. CONCLUSION Based on the low frequency and low severity of incident cases reported for boscalid i n both IDS and SENSOR-Pesticides, th ere does not appear to be a concern at this time that would warrant further i nvestigatio n . The Agency will cont inue to monitor the incident information and if a concern is triggered, additional analysis wi ll be i ncluded in the ri sk asses sment.

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