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

MEMORANDUM Date: May 15,2013 SUBJECT: Telone (1,3-D): Review ofHuman Incidents PC Code: 02900 I Decision No.: 476422 Petition No.: NA DP Barcode: 0411762 Registration No.: NA Regulatory Action: NA Case No.:NA Risk Assessment Type: NA TXRNo.:NA MRIDNo.: NA CAS No.: 542-75-6, 10061-01-5, 1 0061-02-6 40CFR: NA Ver.Apr.08 FROM : Elizabeth Evans, Environmental Protection Specialist ,1 

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## {~ Toxicology and Epidemiology Branch 

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### I"'"" Heal th E ffects Division (7509P) and Shanna Recore, Industrial Hygienist Toxicology and Epidemiology Branch Health Effec ts Division (7509P) THROUGH: David 

### J. Miller, Acting Branch Chief 

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# /lt..IA Toxicology and Epidemiology Branch Health Effects Division (7509P) TO: ldeliz Negron-Encarnacion, Risk Assessor Risk Assessment Branch VII Health Effec ts Division (7509P) and Andrea Mojica, Chemical Review Manager Risk Management & Implementation Branch IV Pes ticide Reevaluation Division (7508P) Summary and Conclusions Based on the low frequency and severity of incident cases reported for Telone 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. Page 1 of5The Agricultural Health Study (AHS) i s also a potential source of information associated with human health effects associated with certain pesticides. Telone i s 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 fu lfill our requirement to docket summaries of inc ident 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 alle gedly due to a specific pesticide exposure (i.e., an "incident") are largel y 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-group s like pesticide applicators. II. BACKGROUND Telone (1 ,3-D) i s a nematicide/f ung icide/in secticide/herbicide reg istered for preplant application to terrestrial food crop (fiel d and vegetable crop and orchard crop) and terrestrial nonfood (nursery stock and tobacco) use sites. Tel one is a Restric ted Use Pesticide (RUP). For thi s evalua tion, both the OPP Incident D ata System (IDS) and the Centers for Disease Control and Prevention/National In stitute 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 telone (pc code: 029001 ). The purpose of the database search is to identify potential patterns in the frequency and severi ty of the health effects attributed to telone exposure. Telone is not included in the AHS, and therefore this s tudy 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 Page 2 ofSthe report. It should be noted there are three incidents reported as laws uits to IDS that are not considered in this report . IDS reco rd s incidents in one of two modules: Main ID S and Agg re gate ID S:
o Main IDS contains incidents resulting in hi g her severity outcomes and provides more detail with regard to case specifics. This sys tem s tores incident data for d eat h, 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 informatio n about the potential effects of exposure from th e p es ticide
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### o Aggregate IDS contains incidents resulting in less severe human inc idents (minor, unknown, or no effects outcomes). These are r eported by registrants only as counts in what are aggregate summaries. For the Main ID S, from January 1, 2008 to February 19, 2013 , there were 5 incidents reported for s ingl e chemical only in the da ta

base 1

. One incident, an allergic reactio n that was classified as m ajo r sever i ty because it invo lved a severe allergic reaction , although this was determined to be a reaction to a prescription and not the pesticide (further described in Tab le 1)
. Howe v er, this incident does not appear to be related to the impli cated product. The case's physician diagnosed him with an a llergic reaction to new blood pre ss ure medic atio n . Thre e of the other incidents were classified as moderate severity and one was classified as minor severity
. These cases reported respiratory effects (2 cases), eye irritation (2 cases), and an infec tion to a lacerated fin ger following telone exposure (1 case). Symptoms are not mutually exclusive and several sy mp toms may be reported in one incident. There were 

### 7 additional incidents reported involving more than one chemical. Overall , there are few incidents involving telone reported to IDS. In Aggregate IDS, from January 1, 2008 to Febru ary 19, 2013, there were 20 reported incidents involving telone. These incidents were classified as minor severity. T bl 1 M
. IDS M
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a e a m aJor nc1 ents 

## £ th or e smgJe c h em1ca IT I e one Human Incident C h em ical: T e lone 

## I PC Code: 02 900 I Incident Expos ure Package Incident R eg Severit y Report Date Loca tion N umber Produc t Name Co d es Incident D escription A 74 year old male lives near a golf course that was spraying product; 02114 8 Orlando, 062719

- CURFEW SO IL however, the MD ruled out any 1 / 1

/2009 HB invo lvement with the product. The male -00003 FL 00032 FUMIGANT was h av in g a sev ere allergic reaction (anaph ylaxis) to a new blood pressure medication that he recently started takin g.

1 There was also one moderate incident reported that occurred in Au s tralia. Forei g n incidents are not reviewed in detail because of the p otential diffe rences in the exposure pattern s , use practices, and product formulation. Page 3 ofS*HB-Human Major (if the person alleged or exhibited symptoms which may have been life-threatening, or resulted in adverse reproductive effects or in residual di s ability)


### b. SENSOR-Pesticides The SENSOR-Pest icides database covers 11 states from 1998-2009, although reporting varies from state to state. Cases ofpesticide-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 occupation al and non - occupational incidents are included in the database, S ENSOR-Pestici des focuses on occupational pesticide incidents, and is of particular value in providing that information. The state coordinator at each of the 1 1 respective state Departments of Health conducts case fo ll owup activities such as obtaining medical records to verify symptoms and severity. Using standardized pro tocol and case definitions der ived 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 SENSOR-Pesticides 1998-2009 finds a total of 18 cases, stemming from ten events, involving Telone (pc code 029001)
. Twelve of these cases involved a s ing le ac tive ingredient and six invo lved multiple active ingredients. Ofthese 18 cases, 1 5 were low in severity, one was moderate in severity and two were high in severity. One high severity cases occurred in Washington in 2008 and involved a railroad switchman who was transporting Telone C-17 (active ingredients include both chloropicrin and telone). Two other cases (low and moderate in severity) were exposed during this event. The second high severity case occurred in North Caroli na in 2008 and involved Telone C-35 (active ingredients include bo th ch loropicrin and telone). 

### In this case, a private applicator was trying to unclog disconnected lines on a fumigator rig and was splashed in the eyes . Six cases were reported following one drift/volatilization2 event that occurred in Florida in 2006 in which a pestic ide application made to a golf course drifted onto a residential area . All 6 cases were low in severity
. Reported health effec ts are summarized in the T able 2.

Table 2
. SENSOR-Pesticides 1998-2009: Reported Health Effects for Telone Cases

Health Effect # of Occurrences Dermal 1 Ocu lar 8
2 The SENSOR-Pesticides program defmes drift as"
. .. the movement of pesticides away from the treatment site
. The pesticide spray, mist, fumes, or odor are carried from the target site by air
. " There is no clear distinction between cases exposed from volati lization versus spray drift when analyzing the SENSOR-Pesticides data. Page 4 ofSRespiratory 9 Gastrointestinal 9 Renal 0 Nervous System 15 Cardiovascular 2 Misc. 2 

### * Cases may report: multiple health effects
c. Agricultural Health Study (AHS) The AHS is a high quality, prospective epidemiolo gy 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 thro u gh re gistration review, the Agency will ensure they are considered in the problem formulation/scoping phase of the process and, if appropriate, fully rev iewed in the risk assessment phase of the process. The AHS includes info rmation on use of 50 different p esticide active ingredients commonly used in agriculture. Telone is not included in the AHS, and therefore thi s study does not provide information for this report.


### IV. CONCLUSION Based on the low frequency and severity of incident cases reported for Telone in both IDS and SENSOR-Pesticides, there does not appear to be a concern at this time that would warrant furthe r investigation. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the ri sk assessment.

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