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



### MEMORANDUM Date: March 3 , 2015 

### SUBJECT: Novaluron: Tier I Review of Human Incide nt s

PC Code : 124002 DP Barcode: 0425887 Decision No.: 4 9 4066 Petition No.: A Registrati o n No.: NA Regulator y Acti o n : NA C ase No
. : N A Risk Assessment Type: NA TXR No.: NA CAS N o.: 116714-46-6 40CFR: NA MRID No.: NA 

### FROM:

THROUGH:

TO: Eliza beth Evans , Environmental Pro tection Specialist Toxicology and Epidemiology Branch Health Effects Division (7509P) and Shanna Recore, Industrial Hy gienis t To xi colo gy and Ep idemi ology Branch Health Effect Di vision (7509P) 

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David M iller , Acting Branch Chie / ' r 

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.**oJfo~ ~cr**  Tox i cology and Epi demiolo gy Bra li Health Effects Division (7509P) Anwar Dunbar , Risk Assessor Risk Assessment Branch I Health Effects Division (7509P) and Margaret H athaway , Chemical Review Manager Ri sk Management & Impl e mentation Bran c h 2 Pesticide Re-evaluation Di vision (750 8P) Summary and Concl us ions Based on t he low frequency and low severity of cases involvin g novaluron in both IDS and SENSOR-Pesticides, there d oes not appear to b e a concern at this time that would warrant furth e r investigation. The Agency will continu e to monitor the inci d ent information and if a concern is triggered , ad d itional analysis w ill be i ncluded in the ri sk assessme nt.
Page 1 of 4Detailed 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 ofthe 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, causat i on cannot be determined based on inc i dent data. Howe v er , incident inf ormation can be an important source of feedback to the Agency: incidents of severe outcome , or a suggested pattern or trend amo n g less severe incidents, can s i gnal the Agency to further investigate a part i cu l ar chemical or product. Observational ep i demiology studies relate the risk of disease, 

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

### II . BACKGROUND Novaluron is an insect growt h regulators (IGR). IGRs slowly kill the insects over a period of few days by d i srupting the normal growth and deve l opment of imm ature insects. Novaluron acts as an insecticide mainly by in gestion , but has some contact activ ity
. Rimon® Technical i s sold for formulating other end-use-product formulations
. Rimon® I 0 EC is an emu l s ifiab le concentrate recommended for the control of whi teflies, thrips, leafminers and armyworms on containerized ornamenta l s grown in greenhouses. The Rimon® I 0 EC is mixed with water and app li ed as a fo li age spray using conventional spray equipment. T o prevent buildup of resistance, rotation with other insecticides having d i ssimil ar mode of action is recommended between successive applications. For this evaluation, both the OPP Incident Data System (IDS) and the Centers for Disease Control and Preventi on/National Institute for Occupational Safety and Health (CDC/NIOSH) Sent ine l Event Noti ficat ion System for Occupati onal Ri sk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient novaluron (pc code: I 24002). T he purpose of the database search i s to identify potential patterns in the frequency and severity of the health effects attributed to n ovaluron exposure. Novaluron is not included in the AHS, and therefore this study does not provide information for this report. 

### III . RESULTS/DISCUSSION
a. IDS**(lnc~dent** 

### Data System) OPP's IDS includes reports of all eged human health inc idents from various sources , including mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from reg i strants, other federal and state health and env ironmental agencies, and individual consumers. Since 1992, OPP has compiled these reports in IDS. IDS contains reports from
Page 2 of 4across th e U.S. and mo st incid ents have all relevant p roduct information record ed. Reports submitted to the IDS represe nt anecdotal reports or allegations only, unl ess otherwise stated in the report. IDS records incidents in one of two modul es: Main IDS and Aggregate ID S:

o Main IDS contains inc i dents re s ulting in higher sev erity outcom es and p rovide s more detail with regard to case s pecifics. This sys tem stores incident data for death , major and moderate incidents, and it include s information about the location , date and nature of the in ci dent. Main ID S incidents involving only one active ingredient (as opposed to pesticide products with multiple active ingredients) are considered to provide more certain information about the potent ial effects of exposure fro m 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 M ai n IDS, from January 1 , 2009 to August 12,20 1 4 , there were 0 incidents reported for the single chemical only in the database. There was 1 incident reported involving more than one chemical. This incident was classified as moderate severity. In Aggregate IDS, from January 1, 2009 to August 12, 2014, there were 17 incidents reported involving novaluron in the database
. These incidents were classified as minor severi ty. Overall, there are few inc i dents invo lving novaluron reported to IDS. 

### b. SENSOR-Pesticides T he SENSOR-Pesticides database covers 11 states from 1 998-20 1 0, although reporting varies from state to state. Cases of pesticide-related illnesses are ascertained from a vari ety of sources, including: r eports from local Poison Control Ce nters , state Department of Labor workers' compensation claims when r epo rted by physicians, reports from State Departm ents 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 value in providing that information. The state coordinator at each of the 11 respectiv e state Departments of Health conducts case followup activiti es s uch as obtaining medical record s to verify symptoms and severity. Using standardized protocol and case defin it i ons derived from poison center reporting , the state SENSOR-Pesticide coordinator enters the incident informati on into the state-based system which is sent to NIOSH annually to be aggregated
. A query of SENSO R

- Pesticides from 19 98-20 10 identifies five cases involving novaluron (pc code 124002 ); one case involves a single active ingredient and will be analyz ed for this memo. This case was low in severity. The case was occupational and expos ure was coded as agricultural " drift" by the state SENSOR coordinator. SENSOR-Pesticides defines drift to be "off-target movement of pest ic ide" and thi s definition includ es both spray drift a nd volatilization. The case was in a truck checking tarps in a fi eld with the windows rolled down Page 3 of 4and he smelled the chem ical. This case reported experie ncing symptoms including dermal and oc ular irritation.

c. Agricultural Health Study (AHS) The AHS is a hi gh quality , pro s pective epidemi o l ogy stu dy e valuatin g th e li nk between pes tic ide use and various hea lth outcomes including cancer. The AHS includes private and commercial pest i cide app licat ors an d their spouses. If there are A HS findin gs relevant to a part i cular pesticide going through registration review, the Agency will en sure they a re consi dered in the problem fo rmul ation/scop in g phase of the process and, if appropriate, fully reviewed in the risk assessme nt phase of the process. The AHS includes information on use of 80 different pesticide active ingred i ents commonly used in a gricu lture. Novaluron is not included in the AHS , and therefore this s tudy does not provide information for this report
. IV. CONCLUSION Based on the low frequency and l ow severi ty of cases in volv in g novaluron in bot h ID S and SENS OR

- Pe sticides , there do es not appear to be a concern at this time th at wo uld warrant further inves tigation. The Agency w ill continue to monitor the incident information and if a concern is tri ggered , additional analysis will be included in the ri sk assessment.

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