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

MEMORAND UM Date: February 4, 20 1 5 SUBJECT: Phenmedipham: Tier I Review of Human Inc idents

PC Co d e : 09870 I DP Barcode: 0425427 Decision No.: 494 473 Petition No.: NA Risk Assessment Ty pe: NA TXR No.: NA MRID No.: NA Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: 1 3684-63-4 40CFR: NA
FROM: /r}'"Elizabeth Evans, Environmental Protection

# Spec**alis~'1** / 1 T ox icology and Epidemiology Branch 

## J Health Effects Division (7509P) Ver.Apr.08

and 

# n f"- I S hanna Recore, Industrial Hygienist 

## f\ \ ,.. _. . "**~** T oxicology and Epidemiology**Branc ~~**  Health Effect Division (7509P) 

# I)

'

-/ ${/ b'/.1f MS THROUGH: David Miller, Acting Branch Chief 2/

### ///ff~ '/<;;· Tox ic ology and Epidemiology Branc Health Effects Division (7509P) TO: Monica H awkins, Risk Assessor Ri sk Assessment Branch IV Health Effects**Di visio~**  (7509 P) and Dana Friedman, Chemical Review Manager R isk Management 

### & Implementation Branch 2 Pesticide Re-ev aluation D ivision (7508P) Summary and Conclusions At the time of this memo there were no cases reported for phenmedipham in either IDS or SENSOR-Pesti c ides. T here is not a concern at this time that would warrant further investigat ion. T he Agency will continue to monito r the incident inf ormation and if a concern is triggered, add iti onal analysis will be included in the risk assessment.
Page 1 of 4Detailed R eview 

### I. ACTION REQ UESTED Thi s 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 da ta and the Agri-cultural Health S tudy (AHS) are part of the problem formulation phase of registration revi ew . Re p orts of adv erse health effects allegedly due to a specific p e sticide exposure (i.e., an " inci dent " ) are largely self-reported and therefore, generally speaking , neither exposure to a pesti c ide or reported symptom (or the connection between the two) is validated or otherwi se c o nfirmed. Typically , causation cannot be determined based on incident data. However, inci dent information can be an important 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 studi e s relate the risk of disease , 

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

### II. BACKGROUND Phenrnedipham is a broadleaf herbicide used on sugar beets, spinach , and garden (table) beets. It is also used on Swiss chard grown for seed. Currently , there are no labeled reside ntial uses or non-agricultural us es. In addition , the Agency considered a petition from IR-4 for use of phenrnedipham on fresh market spinach, wi t h a proposal to increase the spinach to lerance from 0.5 ppm to 4

. 0 ppm . Phenrnedipham was first registered in 1970. Approximately 200,000 pounds of phenrnedipham active ingredient are applied annually. Over 98% of the to tal po und s of phenrnedipham are applied to sugar beet crops. For this evaluation, both the OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Ins titute for Occupational Safety and Health (C D C/NIOSH) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for p e sticide incident data on the activ e ingredient phenrnedipham (pc c o des: 090201 , 090202). The purpose of the database search is to identify potential patterns in the frequency and severity ofthe health effects attributed to phenmedipham exposure. Phenmed ipham is not included in the AHS, and therefore this study does not provide information for thi s report. 

### III . RESULTS/DISCUSSION
a. IDS (Incident Data System) OPP ' s IDS includes reports of alleged human health incidents from various sourc e s, including manda t ory Federal Insecticide , Fungicide and Rodenticide Act (FIFRA) Section 6 (a)(2) reports fro m registrants, other federal and state health and environmental agencies , and individual consumers. Since 1992 , OPP has compiled these reports in IDS. IDS cont ains reports from across the U.S. and most incident s have all relevant product information recorded

. Reports submitted to the IDS represent anecdotal reports or allegation s only , unless otherw ise stated in the report.
Page 2 of4IDS records incidents in one of two modules: Main ID S and Aggregate IDS:

o Main ID S 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 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 ID S, from January 1 , 2009 to August 12 ,2 014, there were 0 incidents reported involving phenmedipham in the database. In Aggregate IDS, from January 1, 2009 to August 12 ,20 14, there were 0 incidents reported involving phenmedipham in the database. b. SENSOR-Pesticides The SENSOR-Pesticide 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' compensation claim s when reported by physicians, reports from State Departments of Agriculture , an d physi c ian reports to state Departments of Health. Although both occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupational pe st ic ide incidents, and is of particular value in providing that information. The state coordinator at each of the 11 respective state Departments of Health conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using standard ized 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 query of SENS OR-Pe sticides from 1998-2010 identifies no cases involving phenmedipham (pc code 09870 1 ).

c. Ag ricultural Health Study (AHS) The AHS is a hi gh quality , prospective epidemiology study evaluating the link between pesti cide u se 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 forrnulation/scoping phase of the proces s and, if appropriate, fully reviewed in the risk assessment phas e of the process. The AHS includes information on use of 80 different pesticide

Page 3 of 4active ingredients commonly used in agriculture. Phenmedipham is not included in the AHS , and therefore thi s study does not provide information for this report
. 

### IV. CONCLUSION At the time of this memo there were no case s reported for phenmedipham in either ID S or SENSOR

- Pestic ides. There is not a concern at this time that would warrant further investigati on. The Agency wi ll continue to moni to r the incident information and if a concern is triggered , additional analys is w ill be included 

### in the ri s k assessment.

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