### UNITED ST ATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEM ICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM Date: November 17 , 20 1 5 SU BJECT: Strychnine: T ie r I (Sc opin g) Review of Human Incid e nts a nd E pid e miology

PC Code : 07690 1 OP Barcode: 04 30 176 Decis io n No.: 5 111 55 Petition No.: NA Ri s k Assessment T y p e: A T X R No .: A MR ID No.: NA R egis tr ation No
. : NA R egu latory Ac ti o n : NA Case No.: A C A S No.: 57 - 24 - 9 40 C FR: A Vcr
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### FROM: Sha nn a Recore , Indu st rial H yg ie ni s t (} ,.. ,. El
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. Toxi cology and Epidem i ology Branch

### ~~**~** H ea lth Effect Divi s ion (7509 P)



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### Hea lth Effec ts Divi s ion (7509 P ) 

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David Miller , Act in g Branch Chi e f 

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# ;j !flt Toxico logy and E pidemi o logy Branch Hea lt h E ff ec t s Di v i s ion (7509P) Jamie D ' Agostino , Risk Assesso r Ri sk Assess m e nt Branch II Health Effects Di v isio n (7509 P) a nd S u sa n Bartow , C he mical Rev iew Manager Ri sk Management & Impl e m e nt a tion Branch 2 Pes ti cide R e -evaluati on D iv i s ion ( 7508P) S ummary and Conc lu s io n s (}> 

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Based o n the low frequency of incident cases repo rte d 

### fo r s tryc hnin e in both IDS and SENSOR

Pestic ides the re does not appear to be a concern at thi s time that wo uld warra nt further investigation. The Agency wi 

### 11 co ntinu e to monitor th e in c ident in fo rm a ti on and if a co n cern is triggered, additional a n alys is wi ll b e includ ed in th e ri sk assess ment.
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### Detailed Review 

### I. 

### ACTION REQUESTED This review is intended to fu lfill our r equ ireme nt to docket summaries of incident data that were reported to the Agency , as we ll as to ensme human incid ent data and the Agricultural Health Stud y (AHS) a r e part of the problem formulation phase of registration review. Reports of adve rse health effects alleged ly due to a spec i fic pesticide exposure 

### (i.e., an " in c ident") are largely self-reported and therefore , generally speaking, neither exposure to a pesticide or reported symptom (or the connection between the two) i s validated or other wise confirmed. Typically, cau sation canno t be determined based on incident data. However , incident infom1ation can be an important sourc e of feedback to the Agency: incidents of severe outcome, or a suggested pattern or trend among less severe in c ide nts, can s i gna l the Agency to further investigate a particular chemical or product. Observational ep idemi ology studies relate the risk of disease , 

### e.g., cance r, and expos ure to an agent such as a pesticide prod uct in the general population or spec i fic sub

- groups like pesticide applicators. 

### II. BACKGROUND Strychn in e is c urre ntl y registered for use o nl y below

- ground as a bait application to co ntrol pocket gop h ers . T he end -u se produ cts are fonnulated as a gra in-b ased bait o r a paste. Baiting can be done manually , or with the u se of app li cation e quipment. Typical application equipment includes a burrow-builder , which digs artific ial tunn e ls; o r an impin ger, which "injects" bait into the anima l's tunnel. 1 

### For this evaluation, both the OPP In c ident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute fo r Occupational Safety and Health (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were consu lted for pesticide incident data on the active ingredient strychnine (pc code: 128997). The purpose of the database search is to ide nt ify potential patterns in the frequency and severity of the health effects attributed to st r ychn in e exposure. Strychnine is not included in the AHS, and therefore this study does not provide information fo r this r eport . 

### III
. RESULTS/DISCUSSION
a . ID S (Incid ent Data System) OPP's IDS includes reports of alleged human h ealth incidents from various sources , including mandatory Federal In secticide , Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from re g istrants, oth er federa l and state health and env ironmental agenc ies, and individual consumers. Since 1 992 , OPP has compiled these reports in ID S
. ID S contains reports from across th e U.S
. and most in c i dents h ave all relevant product information recorded
. Reports submitted to th e IDS represent anecdota l reports or a ll egation s only , unless otherwise stated in the report.

1 http: // www.epa.gov/ pestic ide s / reregi stration/ REDs / factsheets/ 3 13 3 fact. pdf


### Page 2 of 4IDS records incidents in o ne of two modules: Main ID S and Aggregate J DS:


### o Ma in JDS con tai n s i nc id e nt s resulti ng in hi g her seve ri ty outcomes and pro vides more de ta il w ith regard to case spec ifi cs . This syste m s to res inc ide nt dat a fo r death, major and moderate incid e nts , and it in c lud es in fo rm ati o n about the lo cation , date and nature of the incident. Main ID S inc idents involving only one active ingredient (as opposed to pesticide products with multiple active ingredients) are considered to provide more certa in information about the potential effects of exposure from the pest icide.


### o Aggregate IDS contai n s incid e nt s res ulting in l ess severe hum a n incidents (minor , un k nown , o r no effec t s outco m es)
. These ar e repo rted by registrants o nl y as counts in w h at are aggregate su mm ari es. For the Main JDS , from January I , 20 10 to May 27, 2015, there were 3 incidents reported for the s ingle chemical strychnine only i n the database. One incident was involved three teenagers who s norted strychnine mistaking it for cocaine. Two of the individuals were classified as major severity and the third individual died. The other two i nc idents were classified as moderate seve rity. There were no additional incident s reported involv ing than one chemica l. In Aggregate ID S, from January 1 , 20 1 0 to May 27, 20 1 5, the re we re 3 in c id ents reported in vo lving st rychn ine. T hese incidents we r e c lass i fied as minor seve rity . Overa ll , there are few incidents reported to IDS involving strychnine. 

### b
. SENS OR

- Pesticides The SENSOR-Pesticides database covers 12 states from 1998

- 201 1 , a lth ough reporting varies from state to state. Cases of pesticide-related illnesses are ascertained from a vari ety of sources , includ i ng: reports from local Poison Control Cen te rs, state D e p artme nt of Labo r wo r kers' co mpensation c la im s w he n reporte d by physicians , reports from State D e partments of Agricu l ture, and p hysic ian reports to s tate D epartm e nt s of Health. Alt houg h both occupati o n a l and non-occupat io nal incidents are included in the database, SENSOR-Pesticides focuses on occupatio nal pesticide incidents, and is of particular va lue in providing that information. The s tate coord inator at each of the 12 respective state Departments of Health con duct s case followup activities suc h as obtaini ng medical records to verify symptoms and severity. Using s tandardized protocol and case definitions derived from poison center reporting, the state SENSO R-Pesticid e coordinator enters the incid e nt information into the s tate-based system which is sent to N I OS H a nn ua ll y to be agg regated. A query of SENSOR-Pest icides 1998-2011 id e nt i fies ten cases in vo lv in g s trychnine , nine of w hich involve a single a i. One case was fa tal as a resu lt of su ic id a l inge s tion. Of the remaining e ight single a i cases , one case was high severity , three cases were moderate in severity and four cases were low in severity. Little information is provided for the high seve rity case, but this case was admitted to 

### a hospital and expe rienced renal failure. The high severi ty case activity at the time of exposure is unknown. Five cases were work-related. Four of the five work

- related cases were mixing/ loadin g or handling the product.

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### Six cases reported various neurological symptoms primarily dizziness (n=3). Four cases reported gastro intestinal symptoms , three cases reported dermal symptoms and three cases reported respiratory symptoms.


### c. Agricultura l Health Study (AHS) The ABS is a high quality , prospective ep id emio logy study evaluating the link between pesticide use and various health outcomes including cancer. The ABS includes private and commercial pesticide app li cators and their spouses. 

### If there are ABS findings relevant to a particular pesticide going through registration review , the Agency will ensure they are considered in the problem formulation/scoping phase of the process and, if appropriate, fully reviewed in the ri sk assessment phase of the process. Th e AHS includes information on use of 80 different pesticide acti ve ingredients commonly used in agricu lture. Strychnine is not in cluded in the AHS , and therefore this study does not provide information for this report. 

### IV. CONCLUSION Based on the low frequency of incident cases reported for strychn in e i n both IDS and SENSOR

Pesticides there does not appear to be a concern at this time that wou ld wanant further investigation. The Agency wi ll continue to monitor the incident in fo1mat ion and if a concern is triggered , add i t ional ana lysis wi ll be in cluded in the risk assessment.

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