UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, 

### D
. C. 20460

MEMORANDUM Date: February 1 1 ,2014 

### SUBJECT : Pi caridin: T ier I Review of Human Incidents OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

PC C ode : 070705 DP Barcode: 04 1 7724 Decision No .: 486710 Petiti o n No. : NA Regi stration No.: NA Regu latory Action: NA C a se No.: NA Ri s k Assessment T y pe : NA TXRNo. : NA CAS No.: 119515

- 38-7 40CFR: NA MRIDNo.: NA
FROM : Elizabeth Evans, Environment a l Protection Specialist Toxicology and Epidemiology Branch Heal th Effects Division (7509P) and Shanna Recore, Industrial Hygienist Toxicology and Ep idemiology Branch Health Effect Division (7509P) 

### THROUGH: David Miller, Acting Branch Chief( / T ox ico logy and Epidemiology Branch Health Effects Divi s ion (7509P) 

### TO : Karlyn Middleton , Risk Assessor Ri sk Assessment Branch II Health Effects Division (7509P) and R. Jones , Chemical Review Manager Risk Management & Implementation Branch 5 Pesticide Re-evaluation Di vision (7508P) Summary and Conclusions Based on the low frequency and low severity of incident cases reported for picaridin in both ID S and SENSOR

-Pesticides , there does not appear to be a concern at th i s time that would warrant further investigation. The Agency will continue to monitor the incident information and if a concern is triggered , additional analysis will be included in the risk assessment.
Page 1 of4Detailed 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 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 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 Picaridin is an insect and acarid repellent applied to the human body to repel mosquitos, chiggers, biting flies and ticks. 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 picaridin (pc code: 070705). The purpose ofthe database search is to identify potential patterns in the frequency and severity of the health effects attributed to picaridin exposure. Picaridin 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 of two modules: Main IDS and Aggregate IDS:

o Main IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case specifics. This system stores incident data for
Page 2 of 4death, major and moderate incidents, and it includes information about the location, date and nature ofthe incident. Main IDS incidents involving only one ac tive ingredient (as opposed to pesticide products with multiple active ingredients) are considered to provide more certain information about the potential etiects 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 aggrega te summaries. For the Main IDS, from January 1, 2009 to January 15,2014, there were 26 incidents reported for single chemical only in the da tabase. These incidents were classified as moderate severity. There were no additional incidents reported involving more than one chemical. In Aggregate ID S , from January 1, 2009 to January 15, 2014, there were 214 reported incidents involving picaridin
. These incidents were classified as minor severity.


### b. SENSOR-Pesticides The S ENSOR-Pestic ides database covers 11 states from 1998

- 2010, although reporting varies from state to state. Cases of pe sticide-related illnesses are ascertained from a variety of sources, including : reports from local Poison Control Centers, state Department of Labor workers ' compensation claims when reported by physicians, reports from State Departments of Agriculture, and physician reports to s tate Departments of Health. Although both occupational and non -occupational incidents are included in the database, S ENSOR

-Pesticides focuses on occupational pesticide incidents, and is of particular 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 standardized protocol and cas e definitions derived from poison center reporting , the state S ENSOR-Pesticide coordina tor enters the incident information into the state-based system which is sent to NIOSH annually to be aggregated. A query of SENSOR-Pesticides 1998-2010 identifies 22 cases involving picaridin (pc code 070705) , 19 involving a single active ingredient and three involving multiple active ingredients. For this analysis the 19 single active ingred ient cases will be analyzed. Eighteen cases were low in severity and one case was moderate in severity. The moderate severity case occurred in Louisiana in 2003 and involved an infant. The narrative states, " Patient was in the care of a 12- year-old who tried to apply Skintastic to the baby's face; mother found the child crying, coughing, EMS was called; vomit smelled." Symptoms reported included eye irritation, dermal itching and hives. The symptoms by body system are summarized in Table I.

Page 3 of 4Table 1. SENSOR-Pesticides 1998-2010: Reported Healt h Effects for Picaridin Cases N = l9

Health Effect #of T imes Reported D ermal 6 Ocular II Respiratory 3 Gastrointestinal 2 Renal 0 Nervou s System 1 Cardiovascular 0 * Cases may report multiple health effects

• Nine cases involved the product Off! Skintastic Insect repellent VI (EPA reg. # 00312500547) • Seven cases involved the product KBR 3023 All- Family Insect Spray (EPA reg.# 00482200536) • Thirteen cases (68%) involved chil dren 16 years old or younger, including 9 cases ages five and under


### c. Agricultural Health Study (AHS) The AHS is a high quality , prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer. The AHS includes private and commercial pesticide app li cators and their spouses. If there are AHS findings relevant to a particular pesticide going through registration review, the Agency will ensure they are considered in the problem formulation/scoping phase ofthe process and, if appropriate, fu lly reviewed in the risk assessment phase ofthe process. The AHS includes information on use of 50 different pesticide active ingredients commonly used in agriculture. Picaridin is no t included in the AHS, and therefore this study does not provide information for this report. 

### IV. CONCLUSION Based on the low frequency and low severity of incident cases reported for picaridin in both IDS and 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 information and if a concern is triggered, additional analysis will be included in the ri sk assessment.

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