UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF PREVENTION , PES TICIDES AN D TOXIC SUBSTANCES

MEMORANDUM

Date: February 25, 20 10

SUBJECT: Fosamine Ammonium: Review ofHuman Incidents

PC Code: 106701

Decision No.: NA

Petition No.: NA

Risk Assessment Type: NA

TXRNo.: NA

MRID No.: NA

DPBareode: 0372172

Registration No.: NA

Regulatory Action: NA

Case No.: NA

CAS No.: 25954-13-6

40 CFR: NA

FROM:

THROUGH:

TO:

Shanna Recore, Industrial Hygienist ~!&jt~ Khin 00, M.D. , MPH, Environmental Health Sci~nti ~ Toxicology and Epidemiology Branch

Health Effect Division (7509P)

Mary Manibusan, Branch Chief J 0---

Toxicology and Ep idemiology Bran

Health Effects Division (7509P)

Sarah Winfield, Chair /')}(( - --'

HED Incident Team ~~

Health Effects Division (7509P)

Becky Daiss, Risk Assessor

Risk Assessment Branch IV

Health Effects Division (7509P)

and

Russell Wasem , CRM

Risk Management & Implementation Branch 1

Pesticide Re-evaluation Division (7508P)

Page I of3

VeT.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 investigation. The Agency will continue to monitor the incident 

information and if a concern is triggered, additional 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 human incident data, and the Agricultural Health 

Study 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, generally speaking, neither exposure 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 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, 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) database were 

consulted for pesticide incident data on the active 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 purpose of the database searches 

is to identify potential patterns on the extent and severity of the health effects attributed to 

fosamine ammonium 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 health and 

environmental agencies and individual consumers. Since 1992, OPP compiles 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 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 collected from Department of Labor workers’ 

compensation claims when reported by physicians, reports from State Departments of 

Agriculture, from poison control centers and from State Departments of Health based on reports 

by physicians suspecting pesticide exposure. 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 does 

follow-up with workers 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 State Departments of 

Health enter the incident interview description provided by the worker, medical report, physician 
Page 3 of 3 

and patient into the SENSOR data system, accessible 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 includes information on use of 50 different pesticide 

active ingredients commonly used 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 that involve the active ingredient fosamine 

ammonium. 

Fosamine ammonium is not included in the AHS, and 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 investigation. The Agency will continue to monitor the incident 

information and if a concern is triggered, additional analysis will be included in the risk 

assessment.