UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D.C
. 20460 OFFICE OF CHEM ICA L SAFETY AND POLLUTION PRE V ENTIO N

MEMORANDUM Date: Jun e 25, 2014 SUB.JECT: Cyh alofop -butyl: Tier I Re v iew of Human In cidents
PC Co d e : 082583 Decision No.: 488117 Petition No.: NA Risk Assessment T y p e: NA TXR No.: NA MRID No.: NA DP Barcode: 0418578 Registration No.: NA Regulatory Ac ti on: NA Case No.: NA CAS No.: 12 2008-85-9 40 CFR: NA FROM : Shanna Recore, Industrial Hygienist Ver.Apr.Q8 Toxicology and Epidem iology Branch ;._j...__ H ealth Eff ect Division (7509 P) 

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# j Hea lth Ef fects Divi sion (7509 P) 

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# r THROUGH: David Miller , Acting Branch Chief
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## j / fll:. Tox icology and Ep idemiology Bran Health Effects Division (7509P) TO: Doug l as Dotson, Risk Assesso r Risk Assessment Branch II Health Effects Division (7509P) and J. Tru jillo, Chemical Review Manager Risk Management & Implementati on Branch 5 Pesticide Re-evaluation Di vision (7508P) Summary and Concl usions Based on the low frequency and low severity of incident cases reported for cyhalofop

-butyl in both ID S and SENSOR- Pesticides, there does not appear to be a concern at this time that would warrant further investigation. T he Agency will continue to monitor the incident information and if a concern i s trigge red , additional analysis will be included in the risk assessment.

P age I of4Detailed Review 

### I . ACTION REQUESTED This review is intended to fulfill our requ irement 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 formula tion phase of reg i strat i on review
. Reports of adverse health effe cts allegedly due to a specific pesticide exposure (i.e., an "incident") are largely self

-reported and therefore, generally speaking, neither exposure to a pestici de 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 b e an important source of feedback to the Agency: in cidents 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. Observa tional epidemio lo gy s tudies re late the risk of disease, e.g., cancer, and exposure to an agent such as a pe sticide p roduct in th e general popul ation or s pecific sub

- groups like pesticide applicators
. 

### II. BACKGROUND Cyhalofop-butyl is a highl y selecti ve ary loxyphenoxypropionic herbicide , which was developed to contro l many annual and seedling perenni al grasses, inc luding barnyard grass (Echinochloa crus-galli) and s prangletop (Leptochloa spp) in rice. Cyhalofop-butyl acts through inhibition of the plant's acetyl coenzyme-A carboxylase, a pivotal enzyme in plant fatty acid biosynthesis. For this evaluation, both the OPP Incident Data System (IDS) and the Center s for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOS H) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient cyhalofop

-butyl (pc code: 082583). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects att ribu ted to cyh alofop

-butyl exposure . Cyha lofop-butyl 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 of alleged human health incidents from vari ous sources, includin g mandatory Federa l Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from registran ts, other federal and state health an d environmental agencies, and individual consumers. Since 1992 , OPP h as compi led these reports in ID S. ID S contains reports f rom across the U.S
. and most incidents have all relevant product infonnation recorded. Reports sub mi tted to the IDS represent anecdotal reports or a ll egations only, unle ss otherwise stated in the report. IDS records incidents in one of two module s: Main IDS an d Aggregate ID S:

Page 2 of 4o Main IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case specifics. This system stores in c ident data for death, major and moderate incidents , and it includes information about the location , date and nature of the incident. Main ID S incidents involving only one active ingredient (as opposed to pesticide products with multiple active ing redients) are considered to provide more certain information about the potential effects of exposure from the pesticide.

o Aggregate IDS contains incident s 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 1 , 2009 to March 5, 2014, there were 3 inc i dents reported for the single chemical only in the database. There were 4 additional incidents reported involv ing more than one chemica l. These incidents were classified as moderate severity. In Aggregate IDS , from January 1 , 2009 to March 5 , 2014 , there were 2 incidents reported involving cyhalofop-buty l. These incidents were classified as minor severity. Overall, there are few incidents involving cyhalofop -butyl reported to IDS. 

### b. SENSOR-Pesticides The SENSOR-Pesticide s database covers 11 states from 1998-2010 , alt h ough reporting varies from state to sta te. Cases of pesticide-related illnesses are ascertained from a variety of sources , includin g : 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. Althoug h both occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupat ional pesticide incidents, and is of particular value in providing that informati on. The state coordinator at each of the 11 respective s tate Departments of Health conducts case fo ll owup activities suc h as obtaining medical records to verify symptoms and severity. Using standardi zed protoco l and case definiti on s derived from poison center reporting, the state SENSOR-Pesticide coordinator enters the incident inform ation into the state-based system which i s sent to NIOSH annuall y to be aggregated. A query of SENSOR-Pesticides 1998

- 2010 identifies 0 cases involving cyhalofop-butyl (pc code 082583). 

### c. Agricultural Health Study (AHS) The AHS i s a high quality, prospective epidemiology study evaluating the link between pesticide use and variou s 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 goin g through registration review , the Agency will ensure they are co n sidered in the problem formulation/scoping phase of the process and , if approp ri ate , fu ll y 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. Cyhalofop-butyl is not included in the AHS, 

### and therefore this study does not provide informati on for this report.

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### IV . CONCLUSION Based on the low frequency and low severity of incident cases reported for cyhalofop-butyl 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 i s triggered, additional analysis will be included in the risk assessment.

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