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

MEMORANDUM Date: April 21, 2015 SUBJECT: Cyanamide: Tier I Update Review of Human Incidents/Epidemiology for Draft Risk Assessment PC Code: 014002 DP Barcode: 0426758 Decision No.: 453348 Petition No.: NA Registrati on No.: NA Regulatory Action: NA Case No.: NA Risk Assessment Type: NA TXR No.: NA CAS No.: 420-04 -2 40CFR: NA MRID No.: NA FROM: Shanna Recore, Industrial Hygienist Toxicology and Epidemiology Branch Health Effects Division (7509P)

# fB**lizabe~~vans ,**  Environmental Protection Specialist 

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# JI if (. UJ THROUGH: David J. Miller, Acting Branch

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. Toxicology and Epidemiology Branch Health Effects Division (7509P) TO: Jessica Kidwell, Risk Assessor Risk Assessment Branch IV Health Effects Division (7509P) and Dana Friedman, Chemical Review Manager Risk Management & Implementation Branch 2 Pesticide Re

-evaluation Division (7508P) Summary and Conclusions Ver. Apr.08

Cyanamide was previously reviewed in 2007 (M. Hawkins and H
. Allender, 08/ 31/2007, D339292). At the time, there were no thifensulfuron-methyl incidents found in Main IDS and one incident reported to SENSOR

-Pesticides
. Upon review ofthese incidents, it was concluded that "Due to discontinued use, no mitigation actions are necessary for cyanamide at this time
." Page 1of4The current IDS analysis from January 1, 2008 through April 2, 2015, shows no incidents reported involving cyanamide in Main or Aggregate IDS. A query of SENSOR-Pesticides 1998- 2011 identifies four cases involving cyanamide. These incidents were classified as low severity. Based on the low frequency and low severity of incident cases reported for cyanamide in both IDS and NIOSH 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 conducted. The Agricultural Health Study (AHS) is also a potential source of infonnation associated with human health effects associated with certain pesticides. Cyanamide is not inc luded in the AHS, and therefore this study does not provide infonnation for this report. Detailed Review 

### I. ACTION REQUESTED Cyanamide are being considered under the FQPA-mandated Registration Review program established to review, on a 15 year cycle, pesticides for which a Re-registration Eligibility Decision has been made. One component ofthe Agency's Registration Review Program is consideration ofhuman incident data. 

### In conjunction with a human health risk assessment based on other data sources, such human incident data can assist the Agency in better defining and characterizing the risk ofpesticides/pesticide products. 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, causation cannot be determined based on incident data. Ho wever, 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 Cyanamide is a plant growth regulator used to promote uniform bud break in fruit trees. It is currently used on blackberries, grapes, blueberries, peaches, apples, cherries, and kiwis. For this evaluation, both 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 cyanamide (PC Code: 014002)
. The purpose ofthe database search is to identify potential patterns in the frequency and severity ofthe health effects attributed to cyanamide exposure.
Page 2 of4In addition, findings from the Agricultural Health Study (AHS) were reviewed. The AHS is a high quality, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer. Cyanamide is not included in the AHS, and therefore this study 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 sta te 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 rel evant product information recorded
. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report. IDS records incidents in one oftwo modules: Main IDS and Aggregate ID S:
o Main IDS contains incidents resulting in higher severity outcomes and provides more detai l with regard to case specific. 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 pesticide are considered to provide more certain information about the potential effects of exposure from 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. From January 1, 2008 to April 2, 2015, there were no incidents reported to Main IDS or Aggregate IDS involving cyanamide. b. SENSOR-Pesticides The SENSOR-Pesticides database covers 12 states from 1998 -2011 , although reporting varies from state to state. Cases ofpesticide-related illnesses are ascertained from a variety of sources, including: reports from local Poison Control Centers, state Department of Labor workers' compensation claims when r eported 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 focuses on occupational pesticide incidents, and is of particular value in providing that information. A state SENSOR contact specialist attempts to follow

-up with cases and obtains medical records to verify symptoms, circumstances surrounding the exposure, severity, and outcome. Using standardized protocol and case definitions derived from poison center reporting, SENSOR coordinators at
Page 3of4State Departments of Health enter the incident interview description provided by the case, medical report, physician and patient into the SENSOR data system. The SENSOR data system is accessible to participating states and EPA. A query of SENSOR

-Pesticides from 1998-2011 identifies a total offour cases, stemming from four events, involving cyanamide
. All four cases were work-related; three cases were agricultural workers including two fieldworkers and one handler who became ill while making the pesticide application. All were low in severity; the majority of cases (n= 3) had neurological symptoms, primarily headache two cases experienced dermal irritation , two experienced coughing. One case also experienced ocular irritation and one case experience gastrointestinal symptoms.
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. The AHS includes information on use of 50 different pesticide active ingredients commonly used in agriculture. Cyanamide 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 low severity of incident cases reported for cyanamide in both IDS and N IOSH 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 conducted.

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