UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTIO N PREVENTION

MEMORANDUM Date: August 13 , 2015 SUBJECT : Alpha-chlorohydrin: Tier I (Scoping) Review ofHuman Incidents and Epidemiology PC Code : 11 710 1 DP Barcode: 0428663 Decision No
. : 507994 Petition No.: NA Risk Assessment Type: NA TXR No.: NA MRID No
. : NA Registration No. : NA Regulatory Action : NA Case No.: NA CAS No.: 96-24

-2 40 CFR: NA Yer. Apr.08 FROM: Shanna Recore, Industrial Hygienist /)
_ _**.** /1 Toxicology and Epidemiology Branch 

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TO: Health Effect Division (7509P) _faQ\JA./11'-UJ)- and 

# c;{2;,__, Elizabeth Evans, Environmental Protection Specialist**~** 

## 0 Toxicology and Epidemiology Branch 

## S Health Effects Division (7509P) 

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-<l'f!J .UJl David Miller, Acting Branch Chief

# J Toxicology and Epidemiology Branch Health Effects Division (7509P) Joshua Godshall, Ri sk Assessor Risk Assessment Branch I Health Effects Division (7509P) and Matthew Manupella, Chemical Review Manager Risk Management & Implementation Branch 2 Pesticide Re

-evaluation Division (7508P) Summary and Conclusions There were no incident cases reported for alpha-chlorohydrin to either IDS or SENSORPesticides. There does not appear to be a concern at this time that would warrant further investi gation
. The Agency will continue to monitor the incident information and ifa concern is triggered , additional analys is will be included in the risk assessment.
Page l of4Detailed Review 

### I. ACTION REQUESTED This review is intended to fulfill our requirement to docket summaries ofincident data that were reported to the Agency, as well as to ensure human incident data and the Agricultural Health Study (AHS) are part ofthe problem formulation phase ofregistration 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 or otherwise confirmed. Typically, causation cannot be determined based on incident data
. However, incident information can be an important source offeedback 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 Alpha-chlorohydrin is a rodenticide that causes reversible infertility in male mammals at low doses and testicular lesions and/or mortality at high doses
. It is used in dumps, sewers, commercial/industrial/agricultural buildings, and similar man-made structures. There are no residential uses for alpha-chlorohydrin. ·

. , 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 alpha-chlorohydrin (pc code: 117101). The purpose ofthe database search is to identify potential patterns in the frequency and severity ofthe health effects attributed to alpha-chlorohydrin exposure. Alpha-chlorohydrin is not included in the AHS, and therefore this study does not provide information for this report. 

### III. RESULTS/DISCUSSION
a. IDS (Incident Data System) OPP's IDS includes reports ofalleged 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 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. IDS records incidents in one oftwo modules: Main IDS and Aggregate IDS:
Page 2of4o 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 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 ofexposure from the pesticide.
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. From January 1, 2010 to May 27 , 2015 , there were no incidents reported involving alphachlorohydrin either Main or Aggregate IDS. b. SENSOR-Pesticides The SENSOR-Pesticides database covers 12 states from 1998-2011, although reporting varies from state to state. Cases ofpesticide-related illnesses are ascertained from a variety of sources, including: reports from local Poison Control Centers, state Department ofLabor workers' compensation claims when reported by physicians, reports from State Departments of Agriculture, and physician reports to state**D~partments** 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 state coordinator at each ofthe 12 respective state Departments ofHealth 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 annually to be aggregated. A review of SENSOR-Pesticides 1998-2011 identifies no incidents involving alphachlorohydrin
. 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 . Ifthere 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 ofthe process and, if appropriate, fully reviewed in the risk assessment phase of the process. The AHS includes information on use of 80 diff erent pesticide active ingredients commonly used in agriculture
. Alpha-chlorohydrin is not included in the AHS , and therefore this study does not provide information for this report. IV
. CONCLUSION

Page 3of4There were no incident cases reported for alpha-chlorohydrin to either IDS or SENSORPesticides. 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 ifa concern is triggered, additional analysis will be included in the risk assessment. The Agency will continue to monitor the incident information and ifa concern is triggered, additional analysis will be included in the risk assessment.

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