UNITED STAT E S E N VIRONMENTAL P R OTECTION AGENC Y WASHINGTON, D. C . 2 0460 OFF I CE O F CHEMICAL SAFE TY AN D PO LLUTI O N PREVENTI ON



### MEMORANDUM Date: Apri l 15, 2015 

### SUBJECT: Antimycin A: Tier I (Scoping) Review of Human Incidents

PC Code: 006314 DP Barco d e: 0426688 Decision No. : 503159 Petition No.: NA Risk Assess ment Typ e: NA TXRNo.:NA MRID No
. : NA Reg ist r ation No .: NA Reg ul ato r y Action: NA Case No.: NA CAS No.: 1397

-94-0 40 CFR: NA Yer.Apr.OS 

### FROM: Shanna Recore, Indu str ial Hygienist
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. II Toxico logy and Epidemiology Branch

### ~~~ Health Effect D ivi sion (7509P) and Elizabeth Evans, Environmental Protection Specialist Toxicology and Epidemiology Branch Health Effects Division (7509P) 

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### THROUGH: David Miller, Acting Branch Chief , ,, 

# llft'tlt Toxico logy and Epi demiology Branc H ealth Effects Division (7 509P) 

### TO: Alexandra Gavelek, Risk Assessor Risk Assessment Branch VII Health Effects Division (7509P) and Christina Scheltema, Chemical Review Manager Risk Management 

### & Implementation Branch 3 Pesticide Re-evaluat io n Di vision (7508P) Summary and Conclusions There were no incident cases reported for antimycin A to either ID S or 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.

Page I of 4Detailed 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

-reported and therefore, generally speaking, neither exposure to a pesticide or reported symptom (or the connection b etween 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. 

### II. BACKGROUND Antimycin A, or 3-methylbutanoic acid 3[[3-(formylamino)

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- hydroxylbenzoyl]amino]-8- hexyl-2,6-dimethyl-4,9 -dioxo-1,5-dioxonan

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-yl ester, is a Restricted Use Pesticide registered by EPA for piscicidal (fish kill) uses. Derived as a fermentation product from Streptomyces mold , the chemical is applied directly to water to renovate recreational fish populations and to remove scaled fish from catfish fingerling and food-fish production ponds. 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 antimycin A (pc code: 006314). The purpose of the database search is to identify potential patterns in the frequency and severity ofthe health effects attributed to antimycin A exposure. Antimycin A is not included in the AHS, and therefore this study does not provide information for this report. 

### III. RES U LTS/DISCUSSION
a. IDS (Incident Data System) OPP's IDS includes reports of all eged 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 environmenta l 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 relevant product information recorded. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report.

1 Reregistration Eligibility Decision for Antim ycin A http: //www.epa .gov/pesticides/reregistration/REDs/ antimycin-a.pdf Page 2 of 4IDS records incidents in one of two modules: Main IDS and Aggregate IDS:
o Main ID S contains incidents resu lting in higher severi ty 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 invo lving only one active ingredient (as opposed to pe sticide products with multiple active ingredients) 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 effect s outcomes)
. T h ese are reported by r egis trants only as counts in what are aggregate summaries
. For the Main ID S, from January 1, 2010 to February 4, 2015, there were no incidents reported involving antimycin A. In Aggregate IDS , from January I, 20 I 0 to February 4 , 2015, there were no incidents reported invo lving antimycin A. 

### b. SENSOR-Pesticides The SENSOR-Pes ticides database covers 12 states from 1998

- 2011 , a lthough 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 phys icians, 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 ofparticular value in providing that information. The sta te coordinator at each of the 12 respective state D epartments of Heal th conducts case followup activities such as obta i ning medical record s to verify symptoms and severity. Using s tandardized protocol and case definitions derived from poi son center reporting, the state SENSOR-Pestic ide coordinator enters the incident information into the state-based system which i s sent to NIOSH a nnually to be aggregated. A review of SENSOR-Pesticides 1998

- 201 1 identifies no cases involving antimycin A.


### c. Agricultural Health Study (AHS) The AHS i s a h igh quality, prospective epidemiology s tudy evaluating the link between pesticide use and various health outcomes including cancer. The A H S includes private and commercial pesticide applicators and their spouses. Ifth ere are AHS fin dings relevant to a particular pesticide going through registration review, the Agency will ensure they are considered in the problem formulati on/scoping phase of the proces s and, if appropri ate, fu ll 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. Antimycin A is not included in the AHS, 

### and therefore this study does not provide information for this report.
Page 3of4

### IV
. CONCLUSION There were no incident cases reported for antimycin A to either IDS or 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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