UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, 

### D.C. 20460
OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM Date: November 20, 2013 SUBJECT : Clopyralid: Tier I Review of Human Incidents
PC Code : 11 740 1, 117403 , 117404, 117423 Decision No.: 484816 Petition No.: NA DP Barcode: D416106 Registration No.: NA Regulatory Action: NA Case No.: NA Risk Assessment Type: NA TXRNo.: NA MRIDNo.: NA CAS No.: 577 54-85-5 , 170 2-1 7

- 6, 58509-83-4 40CFR: NA
FROM: Ver

.Apr.08 Elizabeth Evans, Environmental Protection Specialist , _,

# ~ Toxicology and Epidemiology Branch 

# c**~~~ ~V~**  Health Effects Division (7509P) 

### l 

# a ·- . and Shanna Recore, Industrial Hygienist 

## IJ,., A 6 " , Toxicology and Epidemiology Branch

## ~~/.A._ Health Effect Division (7509P) 

# 1/A /7/ l /. ]{J.fiJ/

. lot? THROUGH: David Miller, Acting Branch ChieaJ/

### ~ Toxicology and Epidemiology Branch Health Effects Division (7509P) TO: Michael Doherty, Risk Assessor Risk Assessment Branch II Health Effects Division (7509P) and Steven Snyderman, Chemical Review Manager Risk Management & Implementation Branch 3 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Based on the low frequency and generally low severity of incident cases reported for clopyralid 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. Page 1 of 5Detailed 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 of the problem formulation phase of registration review. Reports of adverse health effects allegedly due to a specific pesticide exposure (i.e., an " inc ident") are largely self-reported and therefore, genera ll y speaking, neither exposure to a pesticide or reported symptom (or the connection between the two) is validated or otherwise confirmed. Typicall y, 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 ofdisease, 

### e.g. , cancer, and exposure to an agent such as a pest icide product in the general population or specific sub-groups like pesticide applica tors. 

### D. BACKGROUND Clopyralid is a pyridine herbicide registered for use on a variety of food and feed crops in the U.S. for the postemergence control ofbroadleafweeds, particularly thistles and clover . The enduse product that IR-4 proposed for use on these commodities is Stinger®Herbicide (EPA Reg. No. 627 19-73) , which is a 3 lb acid equivalent (ae)/gal emulsifiable concentrate (EC) formulation of the monoethanolamine salt of clopyralid. 1 For thi s evalua tion, 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 Ri sk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient clopyralid (pc codes : 117401, 117403, 117404, and 117 423). The purpose of t he databas e search is to identify potential patterns in the frequency and severity of the health effects attributed to clopyralid exposure. Clopyra lid is included in the AHS, but is only in phase III and the data is not currently available. Therefore thi s study does not provide information for this report. 

### III. RESULTS/DISCUSSION

a. IDS (Incident Data System) OPP's IDS includes reports ofalleged human health incidents from various sources, including mandatory Federal Insectic ide, Fungicide and Rodenticide Act (FIFRA) Sect ion 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

1 Clopyralid Human Health Ri sk Assessment, OP Nos. 0391397,040 1055
Page 2 of5submitted to the IDS represent anecdotal reports or allegations only , unless otherwise stated in the report. It should be noted there is one incidents reported as a lawsuit to IDS that is not considered in this report. IDS records incidents in one oftwo 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 s. 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 le ss 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 September 11, 2013 , there were 0 incidents reported for single chemical only in the database. There were 5 incidents reported involving more than one chemical? These incidents were classified as moderate severity. Overall , there are few incidents involving clopyralid reported to IDS.

In Aggregate IDS , from January 1, 2008 to September 11,2013 , there were 39 reported incidents involving clopyralid. 

### 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 ofLabor workers' compensation claims when reported by physicians , reports from State Departments of Agriculture, and physician reports to state Departments of Health. Although both occupat ional and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupational pesticide incidents, and is ofparticular 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 standardi zed protoco l 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 NIO SH annually to be aggregated. A query of SENSOR-Pesticides identifies a total of 45 cases involving clopyralid. Three cases involved a single active ingredient and will be analyzed in this memo. All three cases were low

2 There was also one inci den t that occurred in Argentina an d one incident that occurred in China. Foreign incidents are not reviewed in detail because of the potential differences in the exposure patterns , use practices, and product formulation. Page 3 of5in severity. All three occurred at the case's place of work. All three cases reported respiratory symptoms
. One case occurred in Louisiana in 2003 and is described as follows, "Aerial drift from helicopter while complainant was working near a forest." Another case occurred in Washington in 2002 and is described as, "A 36 y/o female asparagus cutter developed systemic and topical symptoms after breathing pesticide vapors from an application approximately 75 feet away." The third case report did not include a case description

.

Table 1. SENSOR-Pesticides 1998

- 2009 : Reported Health Effect s for Clopyralid Cases

Health Effect Frequency Dermal 1 Ocular 1 Respiratory 3 Gastrointestinal 0 Renal 0 Nervous System 2 Cardiovascular 0 Miscellaneous 2 

### * 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 ofthe process. The AHS includes information on use of 50 different pesticide active ingredients commonl y used in agriculture. Clopyralid is included in the AHS, but i s only in phase III and the data is not currently avai lable. Therefore this study does not provide information for this report.


### IV

. CONCLUSION Based on the low frequency and generally low severity of incident cases reported for clopyralid 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 cont inue to monitor the incident

Page 4 of5information and if a concern is triggered, additional analysis will be included in the ri sk assessment.

Page 5 of5