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



### MEMORANDUM Date: November 13, 2013 

### SUBJECT: Fenoxaprop-p-ethyl: Tier I U pdated Review of Human In cidents for Preliminary Risk Assessment
PC Code: 129092 Decision No.: 477911 Petition No.: NA Risk Assessment Type: NA TXRNo.: NA MRIDNo.: NA DP Barcode: 0416023 Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: 98967-40-9 40CFR: NA Ver.Apr.08 

### FROM: Shanna Recore, Industrial Hygieni st {)
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_ Toxicolog y and Epidemiology Branch

### ~**n~~ ~**  Health Effects Division (7509P)**~** and Elizabeth Evans, Environmenta l Protection Specialist /'
. r?'-::? Toxicolo gy and Epidemiology Branch**~ ~**  Health Effects Division (7509 P ) 

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### THROUGH: David J. Miller, Acting Branch Chief 1 

### '//f-1:

TO: Tox icolo gy and Epidemio lo gy Branch Health Effects Division (7509P) Donald Wilbur , Ri sk Assessor Risk Assessment Branch VI Health Effects Division (7509P) and Molly Clayton, Chemical Review Manager Risk Management 

### & Implementation Branch 3 Pesticide R e-evaluation Divi sion (7508 P ) Summary and Conclusions TEB has been asked to review the incidents in IDS and NIOSH SENSOR-Pesticides and revi ew the findings in the AHS for the fenoxaprop-p-ethyl preliminary ri sk assessment due September 2013. Based on the low frequency and sever it

y of incident cases reported for fenoxaprop -p- eth yl in both IDS and NIOSH SENSOR-Pesticides, there does not appear to be a concern at this time
Page I of 4that would warrant further investigation. The Agency w ill continue to monitor the inc ident information and if a concern is triggered, additio nal analysis will be conducted
. The Agric ul tural Health Study (AHS) is also a pote nt ial source of information associated with human health effects associated with certa in pesticides. Fenoxaprop-p-ethy l is included in the AHS, but it i s only in phase III and there are n o stud ie s availabl e yet to consider. Detailed Review 

### I . ACTION REQUESTED Fenoxaprop-p-ethyl is a pesticide being consi dered under the FQPA-mandated R eg i st ration Review p rogram established to review, on a 15 year cycle, pesticides for which a Re-registration Eligibility Decision has been made. One component of the Agency's Reg i stration Review Program is consideration of human inc ident data . In conjunction with a h uman heal th risk assessment based on other data so urc es, suc h human incident data can assist the Agency in better de fining and characterizing th e risk of pesticides/pesticide products. Reports of adverse health effec ts allegedly due to a specific pesticide exposure (i.e., an "incident") are largely self-reported and the refore, generally speaking, n either exposure to a pestic i de or rep orted symptom (or th e connec t ion between t he two) i s validated or otherwise confirmed. Typ i cally, causation cannot be determined based on incident data. However, i ncident inf o rmation can be an important so u rce of feedback to the Agen cy: 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 ep idemio l ogy studies re l ate the risk of disease, 

### e. g., cancer, and exposure to an agent s uch as a p estic ide product in the general population o r spec ific sub-groups like pesticide applicators. 

### II. BACKGROUND Fen oxaprop -P-ethyl is a postemergent herbicide of the arylo x yphenoxy propiona te gro u p (formerl y the oxyphenoxy ac id ester group). This group is known for hi gh he rbicidal activ ity agai n st grasses and can be sprayed over the top of broadleaf crops, including cotton and soybean, without signi ficant inj ury to the cro p. Feno xap rop-P -ethy l is also registered for use in the culture of small grains and peanut as well as on turf and around ornamentals, including golf courses , sod farms, and residenti a l lawn s. For th i s evaluation, both OPP Inc i dent Data System (IDS) and the Ce nters for D isease Co nt ro l and Preve n tio n/National Institute for Occu pational Safety and Healt h (C D C/NIOS H) Sentine l Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were cons ulted for pes t icide incident data on the active ingredien t fenoxaprop-p-ethyl (PC Code: 129092). The purpose of the database searc h is to ident ify potential patterns in the f re quency and severity of the he alth effects attributed to f en ox aprop-p-e th yl exposure. In addit ion, findings from the Agric ultural Health S tudy (AHS) were reviewed. The AHS is a high quality , prospective epi d emiology study evaluating the link between pesticide use and
Page 2 of4various health outcomes including cancer. Fenoxaprop-p-ethyl is included in the AHS, but it is only in phase III and there are no studies avai l able yet to consider.



### III. RESULTS/DISCUSSION a . IDS (Incident Data System) OPP's ID S 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 federa l 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 ID S represent anecdotal reports or all egations only, unless otherwise stated in the report. IDS records incidents in one of two modules: Main IDS and Aggregate IDS:
o Main IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case specific. 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 pesticide 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 counts in what are aggregate summaries. For the Main IDS, from January 1, 2008 to July 31,2013, there were 4 incidents reported for single chemical only in the database involving fenoxaprop-p

- ethyl. There was 1 additional incident reported involving more than one chemical. All of these incidents were classified as moderate severity. In Aggregate ID S , from January 1, 2008 to July 31,2013, there were 22 reported incidents involving fenoxaprop-p-ethyl. These incidents were classified as minor severity
. Overa ll , there are few incidents involving fenoxaprop

- p-ethyl reported to IDS.


### b
. SENSOR

- Pesticides The SENSOR-P esticides database covers 11 states from 1998-2009, 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 cl a im s 

### when reported by physicians, reports from State Departments of Agriculture, and physician reports to state Departments of Health. Al though both occupational
Page 3 of4and non-occupational incidents are included in the database, SENSO R focuses on occupational pesticide incidents, and is of particular value in providing that information. A state SENSOR contact specialist attempts to fo llow-up with cases and obtains medical records to verify s ymptoms , circumstances surrounding the exposure, severity , and outcome. U sing standardi zed protocol and case definitions derived from poison center reporting , SENSOR coordinators at State Departments of Health enter the incident interview description provided by the case, medical report, physician and patient into the SENSOR data system. The SENSOR data system is accessible to participating states and EPA. A query of SENSOR-Pesticides 1998-2009 identifies no cases involving fenoxaprop -p- ethyl.


### c. Agricultural Health Study (AHS) The AHS is a high quality, prospective epidemio logy 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 formulat i on/scoping phase of the process and, if appropriate, fully reviewed in the risk assessment phase of th e process. The AHS includes informati on on use of 50 different pesticide active in gredients commonly used in agriculture. Fenoxaprop-p-ethyl is included in the AHS , but it is only in phase III and there are no studies available yet to consider.


### IV. CONCLUSION Based on the low frequency and severity of incident cases reported for fenoxaprop-p-ethyl in both IDS and NIOSH SENSOR-Pe sticides , 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 conducted.

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