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

MEMORANDUM Date: August 5, 2014 

### SUBJECT: Fluazifop-B utyl & Fluazifop-P-butyl: Tier I Review of Human Incidents

PC Code: 122805 ,1 22809 Deci s ion No. : 492472 DP Barcode: D421768 Regi s tration No.: NA Regulatory Ac tion : NA Case No.: NA Pet it io n No.: NA Risk Assessment Type: NA TXR No.: NA CAS No.: 69806

-50

-4, 7924 1-4 6-6 40CFR: NA MRID No
. : NA
FRO M:



### THROUGH:

TO: Shanna Recore, Industrial Hygi eni st T oxico logy and E pidemiol ogy Bra nch Health Effect Division (7509P) and Elizabeth Evans, Environmental Protection Specialist Toxicology and Epidemiology Branch Health Effects Di vision (7509 P) 

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David Miller, Acting Branch Chie V' 

# :!**4~** Toxico logy and Epidemiology

### ~ " Health Effects Division (7509P) Alexandra LaMay, Risk Assessor Risk Assessment Branch V Health Effects Division (7509P) and Jill Bloom , Chemical Review Manager Risk Manage ment & Implementation Branch 5 Pesticide Re-eval uation Divi sion (7508P) S ummary and Conclus ions Ver.Apr.08

Based on the low frequency and low severity of incident cases reported fo r fluazifop

-butyl and fluazifop-p-bu ty l in both ID S and SENSOR-Pesticides , there does not appear to be a concern at th is time that would warrant further investigation
. The Agency will conti nue to monitor the incident informatio n and if a concern is triggered , additional analysis will be included in the risk assess ment. Page 1 of4Detailed 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 ofregistration review. Reports of adverse health effects allegedly due to a specific pesticide exposure (i.e., an " i nci dent") 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 importan t 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 app li cators. 

### II. BACKGROUND Fluazifop-P-butyl is a selective, post-emergent herbicide registered for the control of perennial and annual grass weeds. 1 Fluazifop-P-butyl's registered uses include food/feed use on asparagus, carrot, coffee, cotton, endive (escarole), garlic, macadamia nut, onion, pecan, pepper, rhubarb, soybeans, stone fruits, sweet potato, bananas, citrus, grapes, sugar beets, and yams. It is also registered for use on lawns/turf. Fluazifop-butyl has been cancelled and is no longer used in the U.S. 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 ingredients fluazifop-butyl and fluazifop-pbutyl (pc codes: 122805, 122809). The purpose ofthe database search is to identify potential patterns in the frequency and severity of the health effects attributed to fluazifop and fluazifop-pbutyl exposure. Fluazifop -butyl and fluazifop-p-butyl are included in the AHS, but are only in phase III and the data is not currently availab le. 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 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 f rom across the U.S. and most incidents have all relevant product information recorded. Reports

1 http: //www .epa.gov / oppsrrd l/REDs/ fluazifop
_tred.pdf Page 2 of 4submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report. IDS reco rds incidents in one of two modules: Main IDS and Aggregate IDS:
o Main IDS contains incidents resulting in higher severity outcomes and provide s more detail with regard to case specifics. Thi s sys tem stores incident data for death, major and moderate incidents, and it include s information about the location, date and nature of the incident. Main IDS incidents involving only one active ingredient (as opposed to pesticide products with mul tip le 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 effects outcomes). These are reported by registrants only as count s in what are aggregate summaries. Fluazifop-butyl: For the Main IDS, from January 1, 2009 to May 28, 2014, there were no incidents reported for fluazifop. In Aggregate IDS , fmm January I , 2009 to May 28, 2014, there were no incidents reported for fluazifop
. Fluazifop-P-butyl: For the Main IDS, from January 1, 2009 to May 28,2014, there were 10 incidents reported for the single chemical only in the database. There were 26 additional incidents reported involving more than one chemical. These incidents were classified as moderate severity. In Aggregate IDS, f r om January 1, 2009 to May 28,2014, there were 439 incidents reported involving fluazifop-p-butyl. These incidents were classified as minor severity. The product implicated most often is Chems ico Herbicide RTU DFC (Registration No
. 9688- 208). This product was implicated in 48% ofthe fluazifop -p-butyl inci dents reviewed in Aggregate IDS and 25% of the incidents reviewed in Main IDS. This product is a non-selective herbicide that is used to control common weeds and grasses. It can be used on driveways, walkways, curbs, along fences and foundations, and in flower and mulch beds. It can be applied with sprinkler cap applicator or trigger sprayer applicator. 

### b. SENSOR-Pesticides The SENSO R-Pes ticide s database covers 11 states from 1998-2010, 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' compens ation claims when reported by physicians, reports from State Departments of
Page 3 of4Agriculture, and physician reports to state Departments of Health. Although both occupational and non-occupational incidents are included in the database, SENSOR

- Pesticide s focuses on occupational pesticide incidents, and i s of particular value in providing that information. The state coordinator at each ofthe 11 respective state Departments of Health conducts case followup activ ities such as obtaining medical records to verify symptoms and severit y. Using standardized protocol and case definitions derived from poison center reporti ng, the state SENSOR-Pesticide coordinator enters the incident informa tion into the state-based system which is sent to NIOSH annually to be aggregated. A query of SENSOR-Pesticides 1998-2010 identifies a total of two cases involving fluazifopbutyl (pc code 122805); both cases involved multiple active ingredients and were low in severity. A query of SENSOR-Pesticides 1998-2010 identifies a total of33 cases, stemming from 24 events, involving fluazifop-P-butyl, isomers (pc code 122809). Three of these cases involves a single active ingredient which will be analyzed for this memo. These three cases were low in severity. One case (TX05717) involved the accidental ingestion of a root killer product that was transferred into a Gatorade bottle. This case experienced nervous system and gastrointestinal symptoms. Another case was splashed in the eye when inspecting the product packaging and experienced ocular and nervous system symptoms . The third case was a homeowner who experienced minor dermal symptoms (red, itchy hand) following the use of the product.
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 formulation/scoping phase of the process and, if appropriate, fully reviewed in the ri sk assessment phase of the process. The AHS includes information on use of 50 different pesticide active ingredients commonly used in agriculture. Fluazifop-butyl and fluazifop-p-butyl are included in the AHS, but are only in phase III and the data is not currently available. Therefore this study does not provide information for this report. IV . CONCLUSION Based on the low frequency and/or low severity of incident cases reported for fluazifop-butyl and fluazifop-P-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 is triggered, additional analysis will be included in the risk assessment.

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