UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Da te: June 16, 2015 

SUBJECT: Bromuconazole: Tier I (Scoping) Review of Human Incidents 

PC Code: 120503 

Decision No.: 504955 

Petition No.: NA 

Risk Assessment Type: NA 

TXR No.: NA 

MRID No.: NA 

OP Barcode: 0427797 

Registration No.: NA 

Regu la tory Action: NA 

Case No.: NA 

CAS No.: 116255·48-2 

40 CFR: NA 

FROM: Shanna Recore, Industrial Hygienist A 

1 . . • . 

Toxicology and Epidemiology ranch~ 

I lealth Effect Division (7509P) 

and 

Ver.Apr.OS 

Toxicology 

Elizabeth Evans, 

and Epidemiology 

nvironm ntal 

Branch 

Protection Specialisu::=;-.L.. 

v U ~ 

THROUGH: 

TO: 

Health Effects Division (7509P) /lj'fl IA /6°:_μ1 -1,J '() 

David Miller, Acting Branch Ch ef / 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

Barry O'Keefe, Risk Assessor 

Risk Assessment Branch III 

Health Effects Division (7509P) 

and 

James Parker, Chemical Review Manager 

Risk Management & Implementation Branch 1 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

There were no incident cases repo11ed for bromuconazole to either IDS or SENSOR-Pesticides, 

there does not appear to be a concern at this time that would warrant further investigation. The 

Agency wil l 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 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 "incident") are 

largely self-repo11ed 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. 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. 

11. BACKGROUND 

Bromuconazole is a fungicide applied to roses to control black spot. It is formulated as an 

emulsifiable concentrate. 1 

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 bromuconazole (pc code: 120503). 

The purpose of the database search is to identify potential patterns in the frequency and severity 

of the health effects attributed to bromuconazole exposure. Bromuconazole is not included in 

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

III. RES UL TS/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 individua l 

consumers. Since 1992, OPP has compiled these reports in IDS. IDS contains reports from 

across the U.S. and most incidents have all re levant product information recorded. Repo11s 

submitted to the lDS 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: 

1 h11p://www.epa.gov/pes1icides/chem_search/reg_actions/registration/fs_PC- I 20503 _ 0 l-Nov-02.pdf 

Page 2 of 4 
o Main lDS 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 involving 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 exposure from the pesti cide. 

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. 

For the Main IDS, from January I, 2010 to February 5, 2015, there were no incidents reported 

involving bromuconazole. 

In Aggregate IDS, from January I, 20 I 0 to February 5, 2015, there were no incidents repo1ted 

involving bromuconazolc. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 12 states from 1998-20 1 I, 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, 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-Pesticides focuses on 

occupational pesticide incidents, and is of particul ar value in providing that information. The 

state coordinator at each of the 12 respecti ve state Departments of Health conducts case fol lowup acti vities such as obtaining medical records to verify symptoms and severity. Using 

standardized protocol and case definjtions derived from poison center reporting, the state 

SENSOR-Pesticide coordinator enters the incident information into the state-based system which 

is sent to NIOSH annuall y to be aggregated. 

A review of SENSOR-Pesticides 1998-20 11 identifies no cases involving bromuconazole. 

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 considered in the 

problem formul ation/scoping phase of the process and, if appropriate, full y 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. Bromuconazole is not included in the AHS, 

and therefore this study does not provide infonnation for this report. 

IV. CONCLUSION 

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There were no incident cases reported for bromuconazole to either IDS or SENSOR-Pesticides, 

there does not appear to be a concern at this time that would warrant fu1ther 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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