Page 

### 1 ofS **UNITED STATES**  **ENVIRONMENTAL PROTECTION**  **AGENCY**

**WASHINGTON, D.C.**  **20460** OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM 

### Date: September 24, 2013 SUBJECT: Dithiopy

r: Tier I Re view of Human Incidents
PC Code: 128994 DP Barcode: 0415250 Decision No.: 481487 Petition No.: NA Risk Assessment Type: NA TXRNo.: NA MRID No.: NA Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: 97886
- 45
- 8 40CFR:NA Ve r .Apr.08 FROM: El i zabeth Evans, Environmental Protection Specialist

T oxic ol ogy and E pidemiol ogy Br an c h 

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. . . Health Effects Division (7509P) 

# VJ Shann aa R ne d core , Industrial Hygienist - 1 Toxicology and Epidemiolo gy Branch 

# · ( j1...JL Health Effects Division (750 9 P) I 

# /i,) /;: ;JJ li;/J

_ ru Jl .:J THROUGH: David 

### J. Miller, Acting Branch Chief !

. v / 

# / 1J1 Toxicology a

nd Epidemiology Branch · Health Effects Division (7509P) TO: William Donovan , Risk Assessor

Risk Assessment Branch V Health Effects Division (7509P) and V. Dutch, Chemical Review Manag er Risk Management & Implementation Branch 5 Pesticide Reevaluation Division (7508P) Summary and Conclusions Based on the low frequency and severity of inci d ent cases reported f o r Dithlop yr in b oth IDS and NIO SH SENSOR
- Pesticide s, there does not appear to be a concern at this tim e that wo u ld warrant further investigation. Th e Agency will continue to monitor the incident information and i f a concern is triggere d , additional analysis will be included in the risk assessment.The Agricultural Health Study (AHS) is also a potential source of information associated with

human health effects associated with certain pesticides. D i thiopyr is not included in the AHS, and therefore this study does not provide information for this report.
Detailed 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 ofthe problem formulation phase of registrat ion review. Reports of adverse health effects allegedly due to a specific pesticide exposure (i.e., an "incident") are largely self

- reported and therefore, generally speaking, neither exposure to a pesticide or reporte d sy mptom (or the connection between the two) is validated or otherwise confirmed. Ty pically , causation cannot be determined based on incident data. However, incident information can be an important source of feedback to the Agency: incidents of severe outcome, or a suggested pattern or trend among l ess severe incident s , 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 applicators. **II. BACKGROUND**  Dithiopy r is a pre - emergent herbicide for control of grasses and small
- seeded broad leaf weeds. Its primary use in is to control crabgrass in turf, ornamentals, and flowerbeds. For this evaluation, both the OPP Incident D a ta System (IDS) and the Centers for Disease Control and Prevention/National In s t i tute 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 ingredient dithiopyr (pc code: 128994). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to dithiopyr exposure . Dithiopy r 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 various sources, including mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Sec t i on 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 from across the U. S
. and most incidents have all relevant product information recorded. Reports submitted to the IDS represent anecdotal reports or allegations only , unless otherwise stated in the report. It should be noted there are two incidents reported as lawsuits to IDS that are not considered in this report. Page 

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### 3 ofS

IDS records incidents in one of t wo modules: Main IDS and Aggregate IDS:

o Main IDS contains incidents resulting in higher severity outcomes and provides more de tail with regard to case specific s . This system stores incident data fo r death , major and modera t e incident s , and it includes information about the location, date and nature of the incident. Main IDS incidents involving only one acti v e ingredient ( as opposed to pesticide produc t s with multiple active ingredients) are considered to provide more certain inform a tion about the pote ntial effe c t

s o f exposure from the pe s

ticide.
o Aggregate IDS contains incidents re sulting in less severe human incidents (minor, unknown, o

r no effects outcomes). These are reported by registrants only as counts in what are aggreg a t e summaries. For the Main ID S , from January 1, 2008 to June 11, 2013, there were 4 incidents r e ported for s ingle chemical only in the database. There were 8 additional incidents reported involving more than one chemical. These incidents were classified as moderate severity
. Overall, there are few incidents involving di thiopy r reported to IDS. In Aggregate IDS, from January **1,** 2008 to June 11,201 3 , there were 108 reported incidents involving dithiopyr.



### b. **S E**  **N SOR** **- Pes**  **t**

**i cides**  The SENSOR
- Pesticides database covers 11 states from 1998
- 2009, although reporting varies from state to state. Cases o f pe s ticide
- related illnesses are ascertained from a variety of sources, including: reports from local Poison Control Centers, st a t e Department of Labor workers' compensation claims when reported by physicians, reports from State Departments of Agriculture , and physi c i an re p orts to state Departments of Health. Although both occup a t ional and non - occup a

t ional incidents are included in the databas e , SENSOR
- Pesticides f ocuses on occupational pestici de incident s , and is of particular value in providing that information. The state coordinator a

t each of the 11 respective stat e Departments of Health conducts case followup activities such as obtaining medical records to verify sympto ms and severi ty. Using s tandardi z ed protocol and case definitions derived from poison ce n ter reporting, the state SE NSO R
-Pe s t icide coordinator enters the i ncident information into the state - based system which is sent to NIOSH annually to be aggregated. A query of SENSOR
- Pesticides 1998
- 2009 identifies 17 cases, stemming from 17 events, involving dithiopy

r. Seven of the cases were single active ingre dients and will be disc ussed here. Of these, one was mo d e rate in severity and six were low in severity
. Fi ve were workrelated and two were not. Two of the 5 work
- related cases were employees of ret a i l establ i s hments made 

### ill from exposure when handling packaged produ c t s; one ca s e was shelving merchandise and one was a cashier at checkout.Page 

### 4 ofS

One low seve rity , work
- related case included the following case desc riptio n , "A 25 ye ar - old male g ol f course worker was mixing Dim ension Ultra WSP (a turf a nd ornamental herbicide) in a 300 gallon capacity tank. It was a very windy day and, as he p o u red t h e powder into the tank of w at er, some b

lew into his eye s . He was n o t wearing goggles but reports he usual l y do e s . He was wearing conta ct lenses. Reportedly, he was also wearing a T yve k s pray suit with a hood, latex gloves, rubber boo t

s and a half

- m as k respirator, with the appropri ate cartridges. He was fi t- tested for his respirator. He is a turf gr ass management col l ege g ra d uate and is a certified pesticide applicator in the state of Colorado. He currently works under the supervision of a NYS certified applicator." A s ummar y of reported symp toms i s provided in Tab l e 2.

Tabl e 2. SEN SO

R
-Pesti cides 1 9 9 8
- 2 0 0 9 : R e p ort e d He a l th Ef f e cts for sin g l

e ai D it h iop yr C a ses (N = 7 )

Health Effect # o f T i m e s R e porte d Denn a l 2 Ocular 2 Respiratory 1 Gastrointesti n al 3 Renal 0 Nervous System 4 Cardiovas c

ul ar 1 Miscellan e

ous I 

### * Cases may report m u l tipl e health effects



### 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 cance r . The AHS in cludes private and commercial pesticide applicators and their spouse s . If there are AH S findin gs relevant to a p arti c ular pesticide going through r e gi str at ion review, the Age n

c y w ill ensure they are considered in the problem formulationlscoping ph ase of the process and, if appropriate, fully reviewed in th e risk assessment phase of th e process. The AHS i nc lud es information on use of 50 dif f e rent pesticide active in g

re d ients commonly used in agriculture. Dithiop yr is n o t included in the AH S , and therefore thi s s

t u dy does not pro vi

d e information for this report.


### IV. **CONCLUSION**Page 5 ofS

Based on the low frequency and severity of incident cases reported for Dithiopy r i n both IDS and SENSOR
- Pesticide s , 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.