**UNITED STA TES ENVIRONMENTA**  **L PROTECTION A GENCY** 

**MEMORANDUM Date:**  May 25 , 2011 **SUBJECT:** Metsulfuron : Review of Human Incidents
**PC Code:** 122010 **Decision No.:** 44 8 313 **Petition No.:** NA **Risk Assessment Type:** NA **TXR No.:** NA **MRID No.:** NA **FROM:** Khin Swe Oo, Environmental Health Scientist

Toxicology

and Epidemiology Health Effect Division (7509P) **THROUGH:** David Miller , Acting

Toxicology

and Epidemiology Health Effects Division (7509P) **TO:** Charles W. Smith

Risk Assessment Branch Health Effects Division and Jill Bloom , Chemical Review Manager Risk Management & Pesticide Re

- evaluation Division (7508P) **I. CONCLUSION**  Based on the low frequency and severity

of incident cases, there does not appear to be a concern at this time that would warrant further investigation. The Agency will incident information and if a concern is triggered, additional anal ys is will be included in the risk assessment.

Page 1 of 3

**UNITED STA**

**TES ENVIRONMENTA L PROTECTION A** **GENCY WA** **SHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND** 

**P OLLUTION PREVENTION** 

Review of Human Incidents
**DP Barcode:** D 389637 **Registration No.:** NA **Regulatory Action:** NA **Case No.:** NA **CAS No.:** 7 4223

- 64

- 6 **40 CFR:** NA Khin Swe Oo, Environmental Health Scientist Toxicology

and Epidemiology Branch Health Effect Division (7509P)

Acting Branch Chief Toxicology

and Epidemiology Branch Health Effects Division (7509P) Charles W. Smith , Risk Assessor Risk Assessment Branch V I Health Effects Division (7509P )

, Chemical Review Manager Risk Management & Implementation Branch I I

evaluation Division (7508P)
Based on the low frequency and severity

of incident cases, 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 anal ys is will be included in the risk **UNITED STA**

**TES ENVIRONMENTA L PROTECTION A** **GENCY**

**OFFICE OF CHEMICAL SAFETY AND**

**OLLUTION PREVENTION**

Ver.Apr.08

Based on the low frequency and severity

of incident cases, there does not appear to be a concern continue to monitor the incident information and if a concern is triggered, additional anal ys is will be included in the riskPage 2 of 3

**II. 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 allegedl y due to a specific pesticide exposure ( i .e. , an “incident”) are largel y self

- reported and therefore, generall y speaking, neither exposure to a pesticide or reported s ymptom (or the connection between the two) is validated. Ty pically , causation cannot be determined based on incident data. Howev er, 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. **III. BACKGROUND**  For this evaluation, the OPP Incide nt Data Sy stem (IDS) w a s utilized for pesticide incident data on the active ingredient metsulfuron (PC Code 122010 ). The purpose of the database search is to identify potential patterns on the frequency and se verity

of the health effects attributed to metsulfuron exposure. The 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 healt h and environmental agencies and individual consumers. Since 1992, OPP compiles these reports in IDS. IDS contain reports from across the U.S. and most incidents have all relevant product information recorded. Reports submitted to the IDS represent anecdo tal reports or allegations onl y, unless otherwise stated in the report. 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 commerci al 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 the risk assessment phase of the process

. The AHS includes information on use of 50 different pesticide active ingredients commonly used in agriculture

. **IV. RESULTS/DISCUSSION** IDS records incidents resulting in high er severity outcomes in more detail, in a module called the Main IDS module . This sy stem stores incident data for death, major and moderate incidents, and it includes more details about the location, date and nature of the incident. Main IDS incidents involving onl y one pesticide are considered to provide more certain information about the potential effects of exposure from the pesticide

. The less severe human incidents (minor, unknown, or no effects outcomes) are reported b y registrants as counts called aggregate summaries and are recorded in a separate module called Aggregate IDS

. In A ggregate IDS , from January 1, 200 6 to March 31 , 2011 there are 37 incident s involving metsulfuron

. Because it falls within the categories reported as counts (which includes minor,Page 3 of 3

unknown or no effects) , there is no unique report that provides details about the incident and single chemical incidents are not distinguished from multiple chemical incidents ; however, a high frequency

of incidents indicates there is a high potenti al for exposure and vice versa

. For metsulfuron, there appears to be a low potential for exposure. For the M ain IDS, from January 1, 200 6 to March 23, 2011 , there are 1 2 cases reported that involve the active ingredient metsulfuron

. However, there is no incident reported for single chemical metsulfuron only in the database. Metsulfuron is not included in the AHS, and therefore does not provide information for this report. Based on the low frequency and severity

of incident cases, 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 anal ys is will be included in the risk assessment.