Page 1 of 7 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND

POLLUTION PREVENTION

MEMORANDUM

Date: April 29, 2014

SUBJECT: Triclopyr, salts and esters : Tier I Review of Human Incidents

PC Code : 116001, 116002, 116004 DP Barcode: D 419814
Decision No.: 487442 Registration No.: NA
Petition No.: NA Regulatory Action: NA Risk Assessment Type: NA Case No.: NA

TXR No.: NA CAS No .: 55335

- 06

- 3
MRID No.: NA 40 CFR: NA Ver.Apr.08

FROM: Elizabeth Evans, Environmental Protection Specialist

Toxicology and Epidemiology Branch
Health Effect s Division (7509P)

and Shanna Recore, Industrial Hygienist Toxicology and Epidemiology Branch Health Effect Division (7509P)

THROUGH: David Miller, Acting Branch Chief

Toxicology and Epidemiology Branch Health Effects Division (7509P)

TO: Jennifer Tyler

, Risk Assessor

Risk Assessment Branch I
Health Effects Division (7509P )
and

Monica Wait , Chemical Review Manager Risk Management & Implementation Branch 3

Pesticide Re

- evaluation Division (7508P)

Summary and Conclusions

There is a moderately high absolute number of incidents reported involving triclopyr in IDS. Although vast majority of these incidents were of low severity, some high severity outcomes are reported in the IDS database. Based on t he IDS reports, incidents usually involved homeowners who were mixing/loading and/or applying and the symptoms most often reported were dermal and neurological.Page 2 of 7

W hile incident information can be an important source of feedback to the Agency, 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. Nevertheless, based on the absolute number of incidents and the few high severity outcomes that are reported, these incident data may warrant further analysis in the preliminary risk assessment phase of Registration
Review. Obtaining additional information on current usage data for triclopyr would improve

future assessments.

Detailed Review

I. ACTION REQUESTED

This review is intended to fulfill our requirement to d ocket 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 allegedl y 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

. 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 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 appli cators.

II. BACKGROUND

Triclopyr TEA and BEE products are used as selective herbicides to control broad leaf weeds and brush on a variety of sites

-- rights

- of

- way, pasture and rangelands, forests, rice, and turf, including home lawns. Triclopyr products are formulated as soluble concentrates, emulsifiable concentrates, liquids (pressurized and ready

- to

- use), granulars, wettable powders and pellets. 1

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 triclopyr, salts and esters (pc code: 116001, 116002, 116004 ). The purpose of the database sea rch is to identify potential patterns in the frequency and severity of the health effects attributed to triclopyr, salts and esters exposure. Triclopyr, salts and esters is not inc luded in the AHS, and therefore this study does not provide information for this report.

III. RESULTS/DISCUSSION

1 http://www.epa.gov/oppsrrd1/REDs/factsheets/2710fact.pdfPage 3 of 7 a. IDS (Incident Data System)

OPP’s IDS includes reports of alleged human health incidents from various sources, including mandatory Federal Insecti cide, 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.

IDS records incidents in one of two modules: Main IDS and Ag gregate 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
locat ion, 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 fr om 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 M ain IDS, from January 1, 20 0 9 to January 15, 2014, there were 7 3 incidents reported for single chemical only in the database. 2 Five incidents were classified as major severity and 68 incidents were classified as moderate severity. The incident narratives for incidents classified as major severity are included in Appendix 1. There were 1 08 additional incident s reported involving m

ore than one chemical.

In A ggregate IDS , from January 1, 200 9 to January 15, 2014, there were 721 reported incidents involving triclopyr

. Twelve eight incidents were classified as unknown or no effects and 709 incidents were classified as minor severity.

In Main IDS, the reported incidents usually involved homeowners who were mixing/loading and/or applying (n=53) . Based on the IDS reports, symptoms most often reported were dermal (n=34), neurological (n=21). Dermal symptoms reported include hives, swelling, rash, burning sensation, blotches, redness, and itchiness. Neurological symptoms reported include muscle

c ramps, headaches, paresthesia, ataxia, disorientation, and dizziness. It should be noted that in

2 There were 2 foreign incidents were not reviewed in detail because of the potential differences in the exposure patterns, use practices, and product formulation. These incidents occurred in Canada and China.Page 4 of 7

s ome of the incidents where people reported dermal symptoms , they were treating poison ivy. They may have been experiencing a reaction to poison ivy and not the implicated product

.

The most often implicated product in both Main and Aggregate IDS is Reg. No. 228

- 424

- 239 ( Weed

- B

- Gon Max). It was implicated in 29% of the tricl opyr incidents reported to IDS

. This may be potentially attributable to high use of t his product by consumers

. Obtaining additional information on current usage data for triclopyr would improve future assessments. Weed

- B

- Gon

Max is used by homeowners to control weeds on lawns . It is a concentrate that can be applied with either a tank sp rayer or hose end sprayer. In addition to containing 1.56 % triclopyr, this product also contains MCPA (13.72%) and dicamba (1.35%).

b. SENSOR

- Pesticides
The SENSOR

- Pesticides 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 claims when reported by p hysicians, 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 inci dents, and is of particular value in providing that information. The state coordinator at each of the 11 respective state Departments of Health conducts case follow

up activities such as obtaining medical records to verify symptoms and severity. Using

st andardized 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 SENSOR

- Pesticid es 1998

- 2010 identifies a total of 26 cases involving triclopyr, salts and esters (pc codes 116001, 116002, 116003). Twelve cases, stemming from five events, involve a single ai (116001). All 12 were low in severity. One multiple exposure event that led to eight case reports occurred in Michigan in 2010. The event description states, “Campers canoed out to an island, went swimming. After about 30 minutes, they saw sign that said the lake was treated that day.” These 8 campers reported itchy rashes and the camp nurse contacted the
local Poison Control Center.

Table 1. SENSOR

- Pesticides 1998

- 2010: Reported

Health Effects for Triclopyr Cases

N=12

Health Effect # of Times Reported

Dermal 10

Ocular 1

Respiratory 0

Gastrointestinal 2

Nervous System 1

Cardiovascular 1

* Cases may report multiple health effectsPage 5 of 7 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 formulation/scoping p hase 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. Triclopyr, salts and esters is not included in the AHS, and therefore this study does not provide information for this report.

IV. CONCLUSION

There is a moderately high absolute number of incidents reported involving triclopyr in IDS

. Although vast majority of these incidents w ere of low severity, some high severity outcomes are reported in the IDS database. Based on the IDS reports, incidents usually involved homeowners who were mixing/loading and/or applying and the symptoms most often reported were dermal

and neurological.

W hile incident info rmation can be an important source of feedback to the Agency, 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 pesticid e or reported symptom (or the connection between the two) is validated or otherwise confirmed. Typically, causation cannot be determined based on incident data. Nevertheless, based on the absolute number of incidents and the few high severity outcomes th at are reported, these incident data may warrant further analysis in the preliminary risk assessment phase of Registration
Review. Obtaining additional information on current usage data for triclopyr would improve

future assessments.Page 6 of 7

Appendix 1. Main IDS Major Severity Incidents Descriptions for Triclopyr, salts and esters

. Human Incident Chemical: Triclopyr, salts and esters PC Codes: 116001, 116002, 116004

I ncident Package Report Incident

Date Location Reg

Number Product Name Incident Description

022005

- 00004 5/3/2010 PITTSBURGH,
PA 000239

-

02587 ORTHO MAX

POISON IVY &
TOUGH BRUSH

KILLER READY
TO USE A 47 year old male was using a wood chipper to cut down hedges

and breathed in t he dust. Within hours he had a s evere headache and the next day went to the ER. The product had been use 1 year prior in the area he was working in 1 year prior to this event.

022933

- 00019 4/15/2010 NY 000239

- 02491 ORTHO MAX

POISON IVY &
TOUGH BRUSH

KILLER
CONCENTRATE An adult female was using product and removing brush and a

thorn went through her glove. Removed glove and where the thorn went in the skin swelled up right away. Two weeks later, she

went to dermatologist who gave medication that did not do anything. Went back two more times and finger was injected with cortisone. Eventually two nodules developed within the skin on her pinky finger where the thorn went through the skin. The caller's general practitioner recommended that she see a hand and hone specialist who is set on the diagnosis being arthritis. Radiographs were negative and today she is going in for an MRI.

022933

- 00033 4/26/2011 OH BRUSH

- B

- GON (NON

SPECIFIC) A 60 year old male applied product had some accidental contact

with fingertips and he was not wearing a respirator when spraying

. The next day the caller experienced muscle weakness and
describes difficulty in trying to stand and mental confusion. He
went to the ER and was d iagnosed with having had a mild stroke.

023382

- 00021 9/14/2010 TN 000239

- 02491 ORTHO MAX

POISON IVY &
TOUGH BRUSH
KILLER
CONCENTRATE About a year prior to reporting the incident, an 80 year old female

applied the product and got some on herself. She was hed the product off about 40 minutes later. She began to experience confusion and vertigo. As time progressed, she experience generalized throbbing through her entire body and all over body pain. She has seen numerous doctors and can only get relief with

m edication.

024332

- 00003 5/30/2012 JACKSONVILLE,

FL 062719

-

00040 ELEMENT 4

SPECIALTY
HERBICIDE A 59 year old male farmer used the product, and about 24 hrs

later he began to feel weak, and had paresthesias to face, and legs. He also complained of lumbar pain. He appears to have descending paralysis. The only information available is that he had used the product previously, however, there is no historyPage 7 of 7

Human Incident Chemical: Triclopyr, salts and esters PC Codes: 116001, 116002, 116004

I ncident Package Report Incident

Date Location Reg
Number Product Name Incident Description indicating any point of defined exposure. No obvious pulmonary symptoms observed. Only significant medica l hx is for HTN and acid reflux. The patient is deteriorating neurologically. Medical staff are trying to determine if exposure to this product could cause this type of illness.