UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASH IN GTON, D.C. 20460
OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORAND UM Date: August 29, 2013 

### SUBJECT: Quinoxyfen: Tier 1 Review of Human Incidents

PC Code: 055459 DP Barcode: 0414421 Decision No.: 481952 Petition No.: NA Risk Assessment Type: NA TXR No.:NA MRIDNo.: NA Registration No. : NA Regulatory Action: NA Case No.: NA CAS No .: 124495-18-7 40C F R: NA



### FROM: Eliza beth Evans , Environmental Protection Specialist Toxico logy and Epidemiology Branch Ver

. Apr.08

# ~~ Health Effects Division (7509P) 

### o.,rf'- and Q Shanna Recore, Indus trial Hygieni st Toxicology and E pidemiology Branch Heal th Effect Division (7509P) 

# -

# ~**~** 

# -t:r**~** THROUGH: David Miller, Acting Branch Chief Toxicology and Epidemiology Branc Health Effects Division (7509P) 

### TO : George Kramer, Risk Assessor Risk Assessment Branch I Health Effects Division (7509P) and Katherine St. Clair, Chemical Review Manager Risk Management & Implementation Branch 2 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Based on the low frequency and generally low severity of incident cases re ported for quinoxyfen 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 triggered , additional analysis 

### will be included in the ri sk assessment.
Page 1 of4Detailed Review 

### I. ACTION REQUESTED This review is intended to fulfi ll 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 pestic ide exposure (i.e. , an " inc ident") 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, ca u sation cannot be dete rmined based on incident data. H owever, incident informat i o n can be an importan t source of feedback to the Agency: incidents of seve r e o utcome, or a suggested pattern or trend among less severe inc ide nts, can signa l the Age n cy to f urthe r 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 Quinoxyfen is a protectant fungici d e for the control of powdery mil dew in various crops in cluding artichoke, gourds, le ttu ce, m elo ns, pepper, pumpkin, stone f ru its, strawb erry, winter squash, cher ry, grapes , and hops. There are no residential uses for quinoxyfen. For this evaluation , both the OPP Incident Data System (ID S) and the Centers for Disease Control and Prevention/Nationa l Institute fo r 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 quinoxyfen (pc code: 055459). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to quinoxyfen exposure. Quinoxyfen is not included in the AH S, and therefo re this study does not provi d e 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 regis trants , other federal and state health and environmental agencies , a nd individual cons u mers. Since 1992, OPP has compiled these reports in IDS. IDS conta ins reports from across th e U.S. and most incidents have all re levant product in formation recorded. Rep orts submitted to the IDS represent anecdotal reports or a ll egations only , unless otherwise stated in the report. It should be noted there is one incidents reported as a lawsuit to IDS that is not considered in this report. IDS records incidents in one of two modules: Main IDS and Aggregate IDS:

Page 2 of4o Main IDS 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 includes information about the location , date and nature of the incident. Main ID S incidents involving only one active in gred ient (as opposed to pestic ide 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 incident s resu lting in less severe human incid ents (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, 2008 to June 11, 2013, there were no incidents reported in th e database involving quinoxyfe n. In Aggregate IDS, from January 1 , 2008 to Jun e 11,2013 , there was 1 reported incident involving quinoxyfen. This incident was classified as minor severity. 

### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states from 1998-2009 , although reporting varies from state to state. Cases of pesticide

-related illnesses are ascertained from a variet y of sources , including: reports from local Poison Control Center s, state Department of Labor workers' compensation claims whe n rep orted by physicians , reports from State Departments of Agriculture , and physician reports to state Departments of Health. Although both occupational and non-occupational incidents are included in the database , SENSOR-Pesticides focuses on occupational pesticide incidents, and is of particular valu e in providing that information. The state coordinator at each of th e 11 respective state Departments of Health conducts case follow

up activ ities such as obtaining medical records to verify symptoms a nd severity. Us ing standardized protocol and case definition s deriv ed from poison center reporting, the sta te SENSOR-Pesticide coordinator enters the incident information into the state- based system which is se nt to NIOSH annually to be aggregated. A query of SENSOR-Pesticides from 1998-2009 identifies a total of 11 cases, stemming from 7 events , invo lving quinoxyfen. There were no single active ingredient cases reported. All quinoxyfen cases involved multiple active ingredients. One case was high severity, one was moderate severity and nine were low severity. The case description for the high severity case states , " A 36 year o ld grape applicator reports that after turning on the air conditioner in the cab of the tractor he c ould smell the pesticide and became ill. He initially reported gastrointestinal, ocular and respiratory symptoms. He sought medical care eight days later for increasing respiratory sympto m s . "

Table 2. SENSOR-Pesticides 1998-2009: Reported Health Effects for Quinoxyfen Cases (N = ll)

Page 3 of4Health Effect # of Times Reported Dermal 4 Ocular 6 Respiratory 3 Gastrointestinal 7 Renal 0 Nervous System 7 Card iovascular I Miscellaneous I 

### * Cases may report multiple health effects



### 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 applicators 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 of the process and, if appropriate, fully reviewed in t he ri sk assessme nt phase of the process. The AHS includes information on use of 50 different pesticide act ive ingredients commonly used in agriculture. Quinoxyfen is not included in the AHS , and therefore this study does not provide information for this report. IV. CONCLUSION Based on the low frequency and generally low severity of incident cases reported for quinoxyfen 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 triggered, additional analysis will be included in the risk assessment.

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