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

MEMORANDUM 

### Date: February 

### 6, 2014 

### SUBJECT : Mesotrione: Tier I Review of Human Inci dents PC C ode : 122990 DP Barcode: 041 7803 Decis io n No. : 4866 16 Petiti on No.: NA Risk Assessment Ty p e: NA TXRNo.: NA M RID No.: NA Registration No .: NA Reg ul ato r y Actio n : NA Case No.: NA CAS No.: 104206 -82-8 40 CFR: NA Ver.A pr.08 FROM : Eli zabeth Evans, Environmenta l Protection Speciali st**~** T oxicology and Epidemio logy Branch**~ l** **..r--v</~** Health Effects Division (7 509P) 

# 0 v and Shanna Recore , Industrial Hygienist Tox icology and Epidemio logy Branch He al th Effect Divisio n (7509 P) 

### THROUGH: David Miller, Acting Branch Chief ( Toxico logy and Epidemi ology Bran Health Effects Divi sion (7509P) 

### TO: Sarah Levy, Risk Assessor Risk Assessment Branch I Health Effects Division (75 09P) and 1. Trujillo , Chemical Re view Manager Risk Management & Implementation Branch 5 Pesticide Re-evaluation Divi sion (7 508P) S ummary and Conclusions Based on the low freq uency and low severity of incident cases reported for mesotrione 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 a nd if a concern is triggered, additional analysis will be included in the risk assessme nt.

Page I 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 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, generall y 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 ofdisease , 

### 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 Mesotrione is a systemic, pre-emergent and post-emergent herbicide proposed for the selective contact and residual control of annual broadleaf weeds in field corn. 1 For this evaluation, both the OPP Incident Data System (ID S) and the Centers for Disease Control and Prevention/Na tional Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel Event No tification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient mesotrione (pc code: 122990)
. The purpose ofthe database search is to identify potential patterns in the frequency and severity of the health effects attributed to mesotrione exposure . Mesotrione is not included in the AHS, and therefore this study does not pro vide information fo r 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 Insect icide, 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 ID S represent anecdotal reports or allegations only, unless otherwise stated in the report. IDS record s incidents in one of two modules : Main IDS and Aggregate IDS:

1 http:/ / www.epa.gov/oppOOOOI!chem

_ search / cleared

_reviews/csr_pC-l22990_7-May-Ol

_ ll5.pdf Page 2 of 4o 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 about the location , date and n ature of the incident. Main IDS incidents involving only one active ingredient (as opposed to pesticide products with mu ltiple 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 Jess 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 2 incidents reported for the sing le chemical on ly in the database
. The se two incidents were classified as moderate severity. There were 13 additional incidents reported involving more than one chemical. One incident was classified as major severity and 12 incidents were classified as moderate severity. In Aggregate IDS, from January l, 2009 to January 15, 2014, there were 20 reported incidents invo lving mesotrione. These incidents were classified as minor severity. Overall, there are few incidents involving mesotrione 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 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 state Departments of Health. Although both occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupa tional pesticide incidents, and is of particular value in providing that information. The state coordinator at each of the 11 re spective state Departments of Health conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using standardized protocol and case definitions derived from poison center reporting, the state SENSOR-Pesticid e coordinator 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 4 cases, stemming from 3 events, involving mesotrione (pc code 122990). Multiple active ingredients were implicated in all 4 cases. Narratives are provided below in Table 1. Table 2 provides a summary of symptoms reported.

Page 3 of 4Table 1. SENSOR-Pesticides 1998-2010 Meso trione Case Descriptions N=4 ID Year Severity Description NY00846 2004 Moderate Couple lives near com fields and experienced drift from application. Dog also ill. DEC samp led and had hits. NY00847 2005 Low Farm fields adjacent to home were sprayed whi le woman and dog outside. Vegetation there died
. Sampling s howed actives. MIO I 993 2008 Low Applicator treated com in field across from his property in high winds. IA00437 2009 Low Exposed to seed chemicals at work

- caused contact dermatitis. Did not wash off when exposed
.

Table 2. SENSOR-Pesticides 1998-2010: Reported Health .Effects for Mesotrione Cases N=4
Health Effect # of Times Reported Ne rvous System 3 Respiratory 2 Gastrointestinal 0 Dermal l Ocular I Cardiovascular 0 *Cases may report multiple health effects


### c. Agricultural Health Study (AHS) The AHS is a high quali ty, prospective epidemiology study evaluating the link between pesticide use and various health outc omes including cancer. The AHS include s private and commercial pesticide applicators and their spouses. If there are AHS findings relevant to a particu lar pesticide going through registra tion review, the Agency will ensure they are considered in the prob lem formulation/scoping phase ofthe process and, if appropriate, fully reviewed in the risk assessment phase ofthe process. The AHS includes information on use of 50 different pesticide active ingredients commonly used in agriculture. Mesot rione is not included in the AH S, 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 mesotrione 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 i s triggered, additional analysis will be included in the risk assessment.

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