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

MEMORANDUM 

### Date: July 1, 2014 

### SUBJECT: Yellow mustard seed & sulfonic acid s: Ti er I Review of Human Incidents

PC Code: 014901 & 000905 Decision No.: 490423 Petition No .: N A Risk Assessment Type: NA TXR No .: NA MRID No.: NA DP Barcode: 0419787 Registration No.: NA Regulatory Action: NA Case No.: NA CAS No

. : 40CFR: NA Ver.Apr .0 8 FROM : Elizabeth Evans, Environmental Protection Specialist**?~- ~**  

# / ') Toxicology and Epidemiology Branch .., 

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# · -**~** Health Effects Division (7509P)

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## y THROUGH: David Miller , Acting Branch Chief 

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. . Toxicology and Epidemio logy Branch Health Effects Division (7509P) 

### TO: Jul ie Van Alstine , Risk Assessor Risk Assessment Branch I Health Effects Division (7509P) and Shirley Keel, Chemica l Review Manager Risk Management & Implementation Branch 5 Pesticide Re-evaluation Division (75 08P) Summary and Conclusions There does not appear to be a concern at this time that would warrant further investigation, s ince there were no incidents involving yellow mustard seed or sulfonic acids reported to IDS and Page 1 of 4SENSOR-Pesticides. The Agency will continue to monitor the incident information and ifa concern is triggered, additional analysis will be included in the risk assessment. Detailed Review I. 

### ACTION REQUESTED This review is intended to fulfill our requirement to docket summaries of incid ent 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 "i ncident") are largely se lf-reported and therefore, generally speaking, neither exposure to a pesticide or reported sympto m (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 Limited information was avai lable for yellow mustard seed and su lfonic acids. An OPPIN query identifies one registered product with this pc code, "Vargon" EPA registration# 87972-1. Vargon active ingredients are yellow mustard seed powder and sulfonate acids. Vargon is a rodenticide for the control of Richardson's Ground Squirrels and Wyoming Ground Squirrels.

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 yellow mustard seed (pc code: 014901 ). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to yellow mustard seed exposure. Yellow mustard seed is not included in the AHS, and therefore this s tudy 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. ID S contains reports from across th e U.S. and most incidents have all relevant product informati on recorded. Reports Page 2 of4submitted to the IDS represent anecdotal reports or all egations only , unless otherwise stated in the report. IDS records incidents in one of two modules: Main ID S and Aggregate IDS:

o Main IDS contains incidents resulting in hi gher 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 nature of the incident. Main IDS incidents involving only one active ingredient (as opposed to pesticide products w ith multiple active ingredients) are considered to provide more certain in fo rmati on about the potential effects of exposure from the pesticide.

o Aggregate IDS contains incidents res ulting in less severe human incidents (minor, unknown, or no effects outcomes). These are reported by registrants only as counts in what are aggregate summaries. fo r the Main IDS , from January 1, 2006 to May 28, 2014, there were 0 incidents reported involving yellow mustard seed or sulfonic acids in the database. In Aggregate IDS , from January 1 , 2006 to May 28, 2014, there were 0 incident reported involving yellow mustard seed or sulfonic acids in the database.

b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states f rom 1998-20 I0, although reporting varie s from state to state. Cases of pesticide

-related illnesses are ascertained from a variety of sources , including: reports from loca l 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 occupationa l 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 coordi nator 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 case definitions derived from poison center reporting, the state SENSOR

-Pesticide coordinator enters the incident information into the state-based system which is sent to N IOSH annually to be aggregated. A query of SENSOR -Pesticides 1998-2010 identifies no cases involving yellow mustard seed or sulfonic acids.

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 consi dered in the Page 3 of 4

### problem formulationlscoping 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. Yellow mustard seed and sulfonic acids are not included in the AHS, and therefore this s tudy does not provide information fo r this report
. 

### IV. CONCLUSION There does not appear to be a concern at this time that would warrant further investigation, since there were no reported incidents involving yellow mustard seed or sulfonic acids reported to IDS and SENSOR-Pesticides. 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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