UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFF IC E OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM Date: February 11 , 2014 SUBJECT: Rev is ed: Pyraclostrobin: Tier I Review of Human Incidents PC Co d e: 099 1 00 Decision No.: 487330 Petition No. : NA DP Barcode: 0417740 Re gi str at i on No.: NA Regulatory Action: NA Case No.: NA Ri s k Assessment Type: NA TXR No.: NA CAS No.: 175 0 13- 18-0 40CFR: NA MRID No.: NA
FROM:

THROUGH:

TO: S hanna Recore, Industrial Hygieni st Toxicology and Epidemiology Branch Healt h Effect Divisio n (7509 P) and Elizabeth Evans, Environmental Protection Specialist Toxicology and Epidemiology Branch Health Effects Division (7509P) Dav id Mille r, Acting Branch Chief 

# aJ/ life Toxicology and Epidemiology Branch Health Effects Di visi on (7509P) Barry O'Keefe, Ris k Assessor Ri sk Assessment Branch III Health Effects Division (7509P) and Jill Bloom, Chemical Review Manager Risk Management & Implementation Branch 2/4 Pesticide Re-e valuation Div ision (7508P) Summary and Conclusions Ver
.Apr.08

This assessment was modified to reflect a revised DB Barcode. Based on the low frequency and seve rit y of incident cases reported for pyraclostrobin , 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 information and if a concern is triggered , additional analysis will be included in the risk assessment. Page 1 of 5Detailed 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 problem 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 cormection 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 offeedback 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 epidemiology studies relate 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 Pyraclostrobin is an agricultural pesticide product used to kill fungi (e.g., blights, mildews , molds, and rusts). The agricultural use sites include com, peanuts, almonds, potatoes soybeans, wheat, Brassica, legumes , sugar beets, small grains, fruit trees (including citrus and nut trees), berries, tomatoes, peppers, and eggplant. Non-agricultural use sites include ornamental shrubs and bushes, and turf. For this evaluation, both the OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute 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 pyraclostrobin (PC codes: 0991 00). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to Pyraclostrobin exposure. Pyraclostrobin 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 Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from registrants, 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 submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report. IDS records incidents in one oftwo modules: Main IDS and Aggregate IDS:
Page 2 of5o Main IDS contains 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 abo ut the location, date and nature of the incident. Main IDS incidents involving only one active ingredient (as opposed to pesticide products w ith 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, or no effects outcomes)

. These are reported by registrants only as counts in what are aggregate summaries. For the Main IDS , from January 1, 2009 to January 15 , 2014, there were 5 incidents reported for single chemical only in the database. There were 

### 9 additional incidents reported involving more than one chemicaL One incident was classified as no or unknown effects, one incident was classified as minor severity and the rest were classified as moderate severity. In Aggregate IDS, from January 1 , 2009 to January 15,2014, there were 36 reported incidents involving pyraclostrobin. These incidents were classified as minor severity. Overall, there are few incidents involving pyraclostrobin reported to IDS. 

### b. SENSOR-Pesticides The SENSOR-Pe sticides database covers 11 states from 1998-2009, although reporting varies from state to state. Cases ofpesticide-related illne sses are ascertained from a variety of sources, inc luding: reports from local Poi so n Control Centers, state Dep artment o f Labor workers' compensa tion claim s when reported by physicians, reports from State Departments of Agriculture, and phy s ician reports to state Departments of Health. Although both occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupational pe sticide incidents, and is ofparticular value in providing that information. The state coordinator at each of the 11 respective state Departments of Health conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using s tandardized protocol and case defmitions derived from poison center reporting, the state SENSOR-Pesticide coordinator enters the incident information into the state-based system which i s sent to N IOSH annually to be aggregated. A query of SENSOR-Pesticides 1998-2010 identifies a tota l of 65 cases involving pyraclostrobin (pc code 0991 00) , stemm ing from 28 events. Of these, 52 cases involved a single ai, which will be ana lyzed here. Forty three cases (83%) were work-related. Forty one of the 52 cases (79%) resulted from aerial app li cations. Headline Fungicide (EPA reg # 00796900 186) is the product implicated in 42 of the 52 cases, including one multiple exposure agricultural drift event that occurred in Iowa in 2007 and led to 27 cases of pesticide illness. This event was documented in the CDC's Morbidity and Mortality Weekly R eport 1 • This event is documented in the MMWR as foiJows,

1 MMWR January 4 , 20 08 / 56 (5 1); 1343-1345 Page 

### 3 of 5On July 23, 200 7, the Iowa Department of Public Health (IDPH) received media reports that migrant workers in afield had been inadvertently exposed to pyracfostrobinfungicide by a crop-duster plane on July 22

. An IDPH investigation identified 27 cases of acute illness among the potentially exposed workers; all illnesses were associated with off-t arget drift of the pyracfostrobin to an adjacent field, owned by a different grower, where workers were detasselingfield corn. IDPH learned that the pilot had seen the nearby workers yet p roceeded to apply th e fungicide. Some workers reported feeling wet droplets on their skin and seeing mist coming from the aircraft. All 27persons with acute illness were Hispanic and residents ofTexas

... A/1 received skin decontamination on-site by a hazardous materials team before being transported to an emergency departmentfor observation until their symptoms resolved. All cases wer e categorized as being of low severity. The most common symptom was upper respiratory tract pain or irritation (2 6 patients), followed by chest pain (20 patients)

. Ano ther multiple exposure event occurred in Iowa in 2010 that resulted in four case reports (Headline again was the product implicated). The event narrative states, " 18 people were [over] sp rayed by a crop-duster while detasseling. 4 people went to the ER , the rest were decontaminated on -s ite
. Headline was the chemical used." 2 Ofthe 52 single ai pyraclostrobin cases, four were moderate in severity and 4 8 were low in sev erity (see Table 2 fo r de scriptions of the moderate s everi ty cases). Respiratory symptoms were the most frequently reported (63%) health effects invo lving pyraclostrobin cases (Tab le 1).

Tab le l. SENSOR-Pesticides 1998-2010: Reported

Health Ef fects for single ai Pyraclostrobin Cases N=52

Health Effect # of Times Reported Dermal 1 3 Ocular 1 3 Re spiratory 33 Gastrointestinal 9 Renal l Nervous System 14 Cardiovascular 4 

### * Cases may report multiple health effects


### c. Agricultural Health Study (AHS) The A HS is a high quality, prospec tive epidemiology s tudy evaluating the link between pesticide us e and v arious health outco me s includi ng cancer. T he AHS includes private and commercial pesticide applicators and their sp ous es . If there are AH S findings rele vant to a particular pesticide go ing through re gistration review, the Agency will ensure they are co n sidered in the problem form ulati on/scoping phase of the process and , if appropriate , fully reviewed in the ri sk assessment phas e of the process. The AHS includes inf ormation on use of 50 different pest icide

2 T he other 14 cases may not have met the S ENS OR case definition (two or more symptoms) and are therefo r e no t included as cases . Page 4 of5active ingredients commonly used in agriculture. Pyraclostrob in are not included in the AHS, and therefore this study does not provide information for this report.


### IV. CONCLUS ION Based on the low frequency and severity of incident cases reported for both pyraclostrobin in both IDS and SENSOR-Pesticides, there does not appear to be a concern at this time that would warrant further investigation. The Agency will continue to monitor the incident information and if a concern is tri ggered , additional analysis will be included in the risk assessment.

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