Document ID: EPA-HQ-OPP-2013-0750-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-12-20T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

                                                  

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM

Date:   September 24, 2013

SUBJECT:	Dithiopyr: Tier I Review 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

Ver.Apr.08

                                                  

FROM:	Elizabeth Evans, Environmental  Protection Specialist Toxicology 
and Epidemiology  Branch              cj tf... Health Effects Division
(7509P)                         VJ

ShannaaRnedcore, Industrial Hygienist 	- 1

Toxicology and Epidemiology  Branch 	Health Effects Division (7509P)

I	/i,)  /;: ;JJ	li;/J_ruJl.:J

THROUGH: David J. Miller, Acting Branch Chief 	!.	v	/ /1J1

Toxicology  and Epidemiology  Branch Health Effects Division (7509P)

TO:		William Donovan, Risk Assessor Risk Assessment  Branch V Health
Effects Division (7509P)

and

V. Dutch, Chemical Review Manager

Risk Management & Implementation Branch 5

Pesticide Reevaluation Division (7508P)  Summary and Conclusions

Based on the low frequency and severity of incident cases reported for
Dithlopyr in both IDS and

NIOSH 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.

 

The Agricultural Health Study (AHS) is also a potential source of
information associated with human health effects associated with certain
pesticides.  Dithiopyr 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 registration 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 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 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 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

Dithiopyr 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 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 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.  Dithiopyr 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) 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 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 2 of5

                                        

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 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 IDS, from January 1, 2008 to June 11, 2013, there were 4
incidents reported for single 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 dithiopyr reported to IDS.

In Aggregate IDS, from January 1, 2008 to June 11,2013, there were 108
reported incidents involving dithiopyr.

b.  SENSOR-Pesticides

The SENSOR-Pesticides 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 claims when reported by physicians,
reports from State Departments of Agriculture, and physician reports to
state Departments of Health. Although both occupational and
non-occupational  incidents are included in the database,
SENSOR-Pesticides focuses on occupational pesticide 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
followSENSOR-Pesticide coordinator enters the incident 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 dithiopyr.  Seven of the cases were single
active ingredients and will be discussed here.  Of these, one was
moderate in severity and six were low in severity.  Five were
workestablishments made ill from exposure when handling packaged
products; one case was shelving

merchandise and one was a cashier at checkout.

One low severity, work-related case included the following case
description, "A 25 year-old male golf course worker was mixing Dimension
Ultra WSP (a turf and ornamental herbicide) in

a 300 gallon capacity tank. It was a very windy day and, as he poured
the powder into the tank of water, some blew into his eyes. He was not
wearing goggles but reports he usually does. He was wearing contact
lenses. Reportedly, he was also wearing a Tyvek spray suit with a hood,
latex gloves, rubber boots and a half-mask respirator, with the
appropriate cartridges. He was fit-tested for his respirator. He is a
turf grass management college graduate and is a certified pesticide
applicator in the state of Colorado.  He currently works under the
supervision of a NYS certified applicator."

A summary of reported symptoms  is provided in Table 2.

 

Table 2. SENSOR-Pesticides 1998-2009:Reported

Health Effects  for single ai Dithiopyr Cases (N=7)Health Effect# of
Times ReportedDennal2Ocular2Respiratory1Gastrointestinal3Renal0Nervous
System4Cardiovascul ar1MiscellaneousI* Cases may report multiple 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
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 formulationlscoping phase of the
process and, if appropriate, fully reviewed in the risk assessment phase
of the process. The AHS includes information on use of 50 different 
pesticide active ingredients commonly  used in agriculture.   Dithiopyr
is not included in the AHS, and therefore this study does not provide
information for this report.

IV. 	CONCLUSION

                                     

Based on the low frequency  and severity of incident cases reported for
Dithiopyr 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.