UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Da te: June 23, 2015 

SUBJECT: Sabad ilia alkaloids: Tier I (Scoping) Review of Human Incidents 

PC Code: 002201 OP Barcode: 0427879 

Decision No.: 506017 

Petition o.: 1 A 

Risk Assessment Type: NA 

TXR No.: NA 

MRIO No.: NA 

Registration No.: NA 

Regulatory Action: A 

Case No.: A 

CAS No.: 8051-02-3 

40 CFR: NA 

Ver.Apr.OS 

FROM: Elizabeth Evans, Environmental Protection Specialist 

Toxicology and Epidemiology Branch <....~ · , 

Health Effects Division (7509P) 

and 

THROUGH: 

TO: 

Shanna Recore, Industrial Hygienist · /J - - Tox

Health 

icolog

Effect 

y and 

Divis

Epide

ion 

mi

(7509

ology 

P) 

Branch 62. -'\ ~ 

I 'r- f ~ ,;1 L/c.)111· 1.J t-S"" 

David Miller. Acting Branch Chie ~cl ///I' 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

Michael Doherty. Risk Assessor 

Risk Assessment Branch 1 

Health Effects Division (7509P) 

and 

R. Johnson, Chemical Review Manager 

Risk Management & Implementation Branch 5 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Based on the low frequency and severity of incident cases reported for sabadilla alkaloids in both 

IDS and 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 included in the risk assessment. 

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Detailed Review 

I. 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 Agri cultural 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 " incident") are 

largely self-reported and therefore, generally speaking. neither exposure to a pesticide or 

repo1ted symptom (or the connection between the two) is validated or otherwise confirmed. 

Typically, causation cannot be determined based on incident data. However. incident 

infom1ation 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 fu rther 

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 

Sabad ilia alkaloids are insecticides used for the control of th.rips on citrus, avocados. and 

mangos. Sabadilla alkaloids are formulated as a wettable powder for use as an insecticide on 

citrus. avocados, and mangos, and mixed with water and applied with either aerial or ground 

equipment. 

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/NTOSH) 

Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were 

consulted for pesticide incident data on the active ingredient sabadilla alkaloids (pc code: 

00220 I). The purpose of the database search is to identify potential patterns in the frequency 

and severity of the health effects attributed to sabadilla alkaloids exposure. Sabad ilia alkaloids is 

not included in the AHS, and therefore tbis study does not provide information for this report. 

III. RES UL TS/DISCUSSION 

a. IDS (Incident Data System) 

OPP's lDS includes reports of all eged human health incidents from various sources, including 

mandatory Federal Insecticide. Fungicide and Rodenticide Act (FJFRA) 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. lDS contains reports from 

across the U.S. and most incidents have all relevant product infom1ation recorded. Reports 

submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in 

the report. 

IDS records incidents in one of two modules: Main IDS and Aggregate IDS: 

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o Main IDS contains incidents resulting in higher 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 involvi11g only one 

active ingredient (as opposed to pesticide products with multiple active 

ingredients) are considered to provide more certain information about the 

potential effects of exposme from the pesticide. 

o Aggregate IDS contains incidents resulting in less severe human inc idents (minor, 

unknown, or no effects outcomes). These are reported by registrants only as 

counts in what are aggregate summaries. 

For the Main IDS, from January I, 20 I 0 to February 4, 2015, there were no incidents reported 

involving sabadilla alka loids. 

In Aggregate IDS. from January I, 2010 to February 4, 2015, there were 3 incidents reported 

involving sabadi lla alkaloids. TI1ese incidents were classified as minor severity. Overall, there 

are few incidents reported to IDS involving sabadilla alka loids. 

b. SENSOR-Pesticides 

The SE SOR-Pesticides database covers 12 states from 1998-20 11 , although reporting varies 

from state to state. Cases of pesticide-related illnesses are ascertained from a variety of sources. 

including: reports from local Poison Control Centers. state Department of Labor workers' 

compensation claims when reported by physicians. repo11s from State Departments of 

Agriculture, and physician. reports to state Depai1ments of Health. Although both occupational 

and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on 

occupational pesticide incidents, and is of particular va lue in providing that information. The 

state coordinator at each of the 12 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 NIOSH a1mually to be aggregated. 

A review of SE SOR-Pesticides 1998-20 I I identifies a total of three cases, stemming from 

three events, involving sabadi I la alkaloids (pc code 00220 l ). Two cases involved a single active 

ingredient. Both single a i cases were low in severity. One case was work-related and involved a 

nursery worker who "walked by trees that had been sprayed with a hand sprayer and the spray 

was still in the air". This case reported respiratory (cough. respiratory irritation and shortness of 

breath). gastrointestinal (nausea). neurological (headache and muscle weakness) and 

cardiovascular (hypertension) symptoms. The second case involved a homeowner making an 

appl ication to his residence and reported dermal, respiratory (cough) and gastrointestinal 

(diarrhea) symptoms. 

c. Agricultural Health Study (AHS) 

The /\ HS is a hjgh quality, prospective epidemiology study evaluating the link between pestic ide 

use and various health outcomes including cancer. The AHS includes private and commercial 

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pestic ide applicators and their spouses. Jf there are AHS findings relevant to a particular 

pesticide going through registration review, the Agency will ensure they are considered in the 

problem fonnulation/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 80 different pesticide 

active ingredients commonly used in agriculture. Sabadilla alkaloids 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 severity of incident cases reported for sabadilla alkaloids in both 

IDS and 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 included in the risk assessment. 

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