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

MEMORANDUM Date: J anuary 28, 20 1 5 SUBJECT: Penoxsulam: Tier I Review of Human Incidents

PC Code : J 19031 Decision No.: 499239 Petition No.: NA Ri sk Assessment Type: NA TXRNo.: NA MRID No.: NA DP Barcode: 0425276 Registration No.: NA Regulatory Act ion: NA Case No.: NA CAS No.: 24579-73

- 5 40CFR: NA Ver.Apr.08 FROM: Shanna Recore , Industrial Hygienist A 

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THROUGH:

TO: and Elizabeth Evans, Environmental Protection Specialist

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# k_,fL Toxicolo gy and Epidemiology Branch t2

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### .1uS David Miller , Acting Branch Chief /

# ~~ t)lll Toxicology and Epidemiology Branch Health Effects Division (7509P) Douglas Dotson , Risk Assessor Risk Assessment Branch II Health Effects Division (7509P) and Bonnie Adl e r , Chemical R evie w Manager Risk Management & Impl ementation Branch 5 Pesticide Re-evaluation Divi sion (7508 P) Summary and Conclusions Based on the low frequency and l ow severity of incident cases reported for penoxsulam in both IDS and SENS OR-Pestici des, there does not appear to be a concern at this time that would warrant further investigation. The Agency wi ll conti nue to monitor the incident information and if a concern is triggered, additional analysis w ill be included in the risk assessment.

Page 1 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 hwnan 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 la

rgely self-reported and therefore, ge nerally spea king , neither exposure to a pesticide or reported symptom (or the connection betwe en the two) is validated or otherwise confirmed. T ypicall y, causation cannot be determined based on incident data. However, incident information can be an important source of feedback to th e 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 ri sk of disease, 

### e.g., cancer, and exposure to an agent such as a pesticide product in the general popula t ion or specific sub -groups like pesticide applicators. 

### II. BACKGROUND Penoxsulam is a post-emergence, acetolactate synthase (ALS) inhibitor herbicide. Penoxsulam is used on ornamental turf, golf course, and rice. It is also used as an aquatic herbicide for management of freshwater aquatic vegetation in ponds, lakes, re servo irs , marshes, wetlands, bayous, drainage ditches, canals, and slow-moving or quiescent bodies of water; inc luding shoreline and riparian areas within or adjacent to these and other aquatic sites. For this evaluation, both the OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupational Sa fety and Heal th (CDC/NIOSH) Sent inel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pest icide incident data on the active ingredient penoxsulam (pc code: 1 1 9031 ). The purpose of the database search is to identify potential patterns in the frequency and severity of the h ealth effects attributed to penoxsulam exposure. Penoxsulam is not included in the AHS, and the re fore this study does not provide infonnat ion for this report. 

### III. RESULTS/DISCUSSION
a. IDS (Incident Data System) OPP's IDS includes reports of alleged human health inc ident s from various sources, including mandatory Federal Insecticide, Fungicide and R odent icide 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 th ese reports in IDS. IDS contains reports from across the U.S
. and most incidents have all relevant product inf ormation 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 2 of4o Main ID S contains inc idents resultin g in higher severi ty outcomes and provides more detail w ith regard to case specifics. This system stores incident data for death, major and moderate incidents, and it inc ludes inform ati on about the locat ion, date a nd nature of the i ncident. Main IDS incide n ts involving only o ne acti ve in gredi ent (as opposed to pesticide products with multiple active i ngredients) are considered to provide more certain information abo ut the potenti al effects of exposure from the pesticide
. o Aggregate ID S contains i ncidents resu lting in less severe human incidents (minor, unknown, or no effects outcomes). These are reported by registrants only a s counts in what are aggregate summar ies. For the Main ID S, from J anuary 1, 2010 to D ecember 17 ,20 1 4, there were no in ci dents reported involving penoxsulam for the s i ng le chemical only in the database. There was 1 incident reported involving more than one chemi cal. Thi s incident was classified as moderate severity. In Aggregate ID S, from J anuary 1, 2010 to Dec ember 1 7, 2014, there were 18 i ncidents reported involving penoxsulam. These incidents were classified as minor severity. Overall, there are few incidents involving penoxsulam reported to IDS. b. SENSOR - Pesticides The SENSOR-P estic i des database covers 12 states from 1998-2011 , a ltho u gh reporting varies from state to state. Cases of pesticide -rel ated illne sses are ascertained from a variety of sources, including: reports from local P oison Control Centers , state Dep artment of Labor worker s' compensat ion claims when reported by physicians , reports from State Departments of Agriculture, and phys ic ia n reports to state Departme nts of H ealth. Although both occupational and non - occupational incidents are included in the database, SENSOR-Pe st icides focuses on occupatio nal pe st ic ide in cidents, and is of particular va lu e in providing that information. The state coordinato r at each of th e 12 respecti ve s tate Depa rtments of Health conducts case followup activ iti e s such as obtaining m e dical records to verify symptoms and severity
. Using standard i zed protocol and case defin iti ons derived from poison center reportin g, the s tate SENSOR-Pesticide coordinator enters the incident information into the s tate-based system which is se nt to N IOSH annually to be aggregated. A rev i ew of SENSOR

- Pe st icides 1998-20 1 1 identifies no cases invo lving penoxsulam (pc code 1 19031 )
. c . Agr ic ultural Health Study {AHS) The AHS is a high quali ty, prospective epidemiology study evaluating th e link betwe en pe stic ide use and vari ous health outcomes including cancer . The AHS i ncl udes private and co mmerc ial pesticide applicators and their spouses. If there are AHS fmdings re levant to a particular pesticide going through registratio n review , the Agency will ensure they are considered in the p roblem formulatio n/seep ing phase of the process and , if appropriate, fu ll y reviewed in the risk assessment phase of th e p rocess. The AH S inc ludes i nformati on on use of 80 different pesticide

P age 3 of4active ingredients commonly used in agriculture. Penoxsulam is not included in the AHS, and therefore this study does not provide information for thi s report. 

### IV. CONCLUSION Based on the low frequency and low severity of incident cases reported for penoxsulam in both IDS and SENSOR-Pesticides, there does not appear to be a concern at this time that would warrant further investigation. The Agency w ill continue to monitor the incident information and if a concern is triggered, additional analysis will be inc lud ed in the risk assessment.

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