UNIT ED STAT ES E NVIRONMENTAL PR OTECTION AGENCY WA SHINGTON, D.C. 20460

O FF ICE OF PREV ENTION
, P ES TICIDES AN D T OXIC S UBSTANCES

MEMORAND UM

Date: February 25
, 20 10

SUBJECT : Fosamine Ammonium: Revi ew of Human I ncidents

PC Code : 106 701 Decision No.: NA Petition No. : NA Risk Assessment T ype: N A TXRNo. : NA MRID No .: NA DPBareode : 0372172 Regi stration No.: N A Regulatory Action: NA Ca se No.: NA CAS No.: 25954

- 13-6 40 CFR: NA

FROM:

THRO UGH :

TO : S hanna Recore
, I ndustrial Hygi enist

# ~!&jt~ Khin 00
, M.D.
, MPH, E nvironmental Health

## Sci~nt**i ~** T oxicology and E pidemiology Branch Health E ffect Division (7509P)

Mary Manibusan, Branch C hief 

## J 

# 0--- Toxicology and Ep idemiology Bran H ealth Effects Division ( 7509P)

Sarah Winfield
, Chair /')}((

- --' 

### H ED I n c iden t Team

### ~~ Health E ffects Divi sion (7509P)

B ecky Daiss
, Risk Ass e ssor Risk Assessment B ranch IV Hea lth E ffects Division (7509P) and Ru ssell Wa sem , CRM 

### Ris k Management & 

### I mplementation Branch 1 Pesticide R e -evaluation Division (7 508P)

Page I of3 V eT .Apr. OS

### Page 2 of 3 I. CONCLUSION

Because there are no incident cases identified, there does not appear to be a concern at this time that would warrant further inves tigation. The Agency will con tinue to monitor the incident information and if a concern is triggered, add itional analysis will be included in the risk assessment.
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 hum an incident data, and th e Agricultural Health Study are part of the problem formulation phase of registration review. Repor ts of adverse health effects allegedly due to a specific pesticide exposure ( i.e. , an “incident”) are largely self-reported and therefore, generally speaking, neither exposur e to a pesticide or reported symptom (or the connection between the two) is validated. Typically, causation cannot be determined based on incident data. However, incident information can be an important feedback loop to the Agency – incidents of severe outcome, or a suggested pattern or trend among le ss severe incidents can signal the Agency to further i nvestigate a particul ar 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, both the O PP 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 Occupati onal Risk-Pesticides (SENSOR) database were consulted for pesticide incident data on the ac tive ingredient fosamine ammonium. Additionally, the Agency is looking to include findings from the Agricultural Health Study (AHS), beginning with the problem formulation phase of registration review. The pur pose of the database searches is to identify potential patterns on the extent a nd severity of the health effects attributed to fosamine ammonium exposure. The IDS includes reports of alleged human health incidents from various sources, including mandatory Federa l Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6 (a) (2) reports from regist rants, other federal and state health and environmental agencies and individual consum ers. Since 1992, OPP compiles these reports in IDS. IDS contains reports from across the U.S. and most incidents ha ve all relevant product information recorded. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report. The NIOSH SENSOR database covers 12 states from 1998-2006, although reporting varies from state to state (the database includes a total of 10,659 cases). Pesticide-related incidents are colle cted from Department of Labor workers’ compensation claims when reported by physicia ns, reports from State Departments of Agriculture, from poison control centers and fromState Departments of Health based on reports by physicians suspecting pesticide exposure. Although both occupationa l and non-occupational incidents are included in the da tabase, SENSOR focuses on occupa tional pesticide incidents, and is of particular value in providing that info rmation. A state SENSOR contact specialist does follow-up with workers and obtains medical re cords to verify symptoms, circumstances surrounding the exposure, severity, and outcome. Using standardized protocol and case definitions, derived from poison center reporting, SENSOR coordinators at State Departments of Health enter the incident interview descripti on provided by the worker, medical report, physician

### Page 3 of 3 and patient into the SENSOR data system, accessi ble to participating states and EPA. 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 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 incl udes information on use of 50 different pesticide active ingredients commonly us ed in agriculture.

IV. RESULTS/DISCUSSION
For IDS, we identified no incidents occurring in the United States from 2002 to the present for the single chemical only.

For NIOSH SENSOR, no cases for identified th at involve the active ingredient fosamine ammonium.

Fosamine ammonium is not included in the AHS, a nd therefore not considered in this report.

Because there are no incident cases identified, there does not appear to be a concern at this time that would warrant further inves tigation. The Agency will con tinue to monitor the incident information and if a concern is triggered, add itional analysis will be included in the risk assessment.