### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 O FFI C E O F C HEMI CA L SAFETY A ND POLLUTION PRE V E N T IO N



### MEMO RAN D UM Date: November 24, 2015 SUBJECT : Rod e nticide : Tier I 

### (Scoping) Review of Human Incidents and Ep idemio logy Assessment
PC Code: 112701 , 112001 , 112802. 1 19901 , 128967 , 067 701 , 067705 , 067707.086002
. 086003 , 08860 1, 20290 1 Dec i s ion No. : 502964 , 502942 P

etition No .: NA Ri sk As ses s men t Type : NA TXR No.: NA MRID No
. : NA DP Barcode: 0426573 , 0426554 Reg i s tration No.: NA Regulatory Action: NA Case No .: NA CASNo
. :NA 40 CfR: NA


### FROM: Shanna Recore, Industrial Hy g ienist El izabeth Evans, E nv ironm ental Protection Speci alist Toxicolo gy and Epidemiology Branch H ealth Effect Division 

### (7509P) Ver
.Apr.OS



### David J. Miller, Acting Chief

## ]~**1** 1 

# ft:\**~-v?-** Tox icology and Epidemiology Branch ,,. 

# j;//J; Health Effects Di vis ion 

### (7509P)

.' I '

. ' 

### /jffel 

### ,,Jl,l/Aw
- UJ < S T H ROUGH :

TO: Matthew Crowley, Risk Assessor R isk Assessment Branch 

### JI Health Effects Divi s ion 

### (75 09P) and Christopher Schlosser, Ri s k Assessor Ri sk Assessment Branch V I Health Effects Divis ion 

### (7509P) and Caitlyn Newcamp , Chemica l R ev i ew Manager Ri sk Management & 

### Impleme ntation Branch I Pesticide Re -eval uation Div ision 

### (7508P)

Page 1 of 15

### Summary and Conclusions In order to minimize ch ildren and wildlife exposure to rodenticide products the 2008 RMD inc lud ed risk mitigation measures requiring rodenticide products used in homes and marketed to general residential consumers be sold only with bait stations. Most rodenticide products complied with the mitigation measures required in the RMD as of June 4, 20 11. The phase out production of the final 12 non-compliant products began in June 2014 and production of these products stopped on December 3 1 , 2014
. Distribution to retailers ended March 31, 2015. Due to the fact that these safety measures were on ly recently fully implemented , there is insufficient information availab l e, at the time of thi s report, to determine if the mitigations have impacted the frequency of incidents occurr in g. However ; AAPCC data is reviewed arurnally for reduction in reported rodenticide incidents as a Strate gi c Measure. For FY 2014 (using the CY 2013 AAPCC annual report data) , there was a reduction of 17% incidents reported to the AAPCC annual reports compared to the number of rodenticide exposures to children ages 1 

### to 6 years o ld in 2011
. The reductions in child exposures are expected to become more prominent beginning in the 2016 AAPCC annual report; which will be reflected in the FY 2018 Strategic Measure. The target reduction for FY 2018 is to reduce rodentic ide exposure incidents by 75% compared to a base line measure of 11,674 reported incidents in 2008 in children ages l to 6 years o ld
. The Agency will continue to mon itor the incid ent information and provide an updated review of incident, considering pre- and post-mitigation incidents separately, when the infonnation becomes avai l able. Detailed Review 

### I. 

### ACTION REQUESTED This review i s 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 Agricu ltural Health Study (AHS) are part of the prob lem formu lat ion phase of registration review. Repo11s of adverse health effects allegedly due to a specific pesticide exposure 

### (i.e., an " incide nt ") are largely self-reported and therefore , generally speaking, neither exposure to a pesticide or reported symptom (or the corrnection between the t wo) is va lid ated or otherwise confirmed. Typically , causation cannot be determined based on incident data. However , incident information can be an important source of feedback to th e 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. Observationa l epidemiology studies re late the risk of disease , 

### e.g., cancer , and exposure to an agent such as a pesticide product in the general population or spec ific sub-groups like pesticide applicators. 

### II. BACKGROUND

Page 2of15In the U
. S., rodenticides are reg istered for use by the E nvironmenta l Protec ti o n Agency's (E P A or Age ncy) Office of Pesticide Pro grams ( OPP o r Offic e) for use agai n s t p es t rode n ts (e
. g . , rats, mice , gop hers, etc
. ) associa te d w ith a variety of u se s ite s (e .g. , agricultural fie ld s, restaurant s, homes , e tc. )
. Ro d e nti c ides were reviewed und e r OPP 's Reregistrat io n pro g ram in th e 1990s
. As a r esult of these reviews, potential risk s fro m ro d e nticide agricultural fi e ld u ses an d r es ident ial tracking powder produc t s were successfu ll y miti gated via c lass ifi cat ion as restr ic ted use pesticides ( RUP ; the o ne excep ti on was manual underground baiting products for u se in ag ricultural fields, which d id not ne cessitate an R U P c lass ification )
. Add iti ona ll y, rodent ic ides employed to prese rve native p lant and anim a l spec ies o n islands were dete r mined to be approp riately managed by the U.S
. Fi s h and Wildlife Serv ice , rendering mitigation unnece ssary. The path forward to mitigate ri sk (w hi ch includ ed c hildre n and w ildlife expos ure to rodentieide products) from the re m a ini ng rod e nticide u se p attern (rodentieides formulated as bait s/ p e llet s used agai nst commensal r odents 1 in res id e ntial-ty pe set tings) r es ulted in th e Rodenticide Stakeho ld e r Workgro up ( RSW ), a s ub committee under the federally-charte r ed adv is ory bod y, the Pestici d e Program Di a l ogue Co mmittee ( PPD C). The RSW issued recommendations , and helped inform the Age ncy's 2008 Ri sk Mitigation Decision fo r Ten Rode nti c ides (RM D ). Under the terms of the 2008 RMD , products mar keted to th e general no n-prof essiona l user or homeowner as well as tho se applied by profes s ional appl icato r s were to be modified to adopt a va riety of mitigation m eas ure to cont inu e to meet th e FIFRA standard. T hese ri sk miti gation measures in c l uded requiring rodentic id e products used in h o mes or m arke ted to general res iden ti a l consumers be u se d in bait stations. The RMD a lso r e quire d th e seco nd- generat ion a nti coag ulant class of ro d e nti c ides to b e so ld in a way to limit sa les to ge nera l res idential consume rs . The R MD provided re g istrant s until Ju ne 4, 20 11 to comply with the mitigati o n measures. H owever , as of June 4, 20 11 not a ll rode nti c ide produ cts comp li ed w ith the RMD requireme n ts. On Janu a r y 29, 2013, the Agency issued a Notice of Inten t to Cancel (N OIC ) for the remaining 12 non-compliant products 2 manufactured by Reck itt B e nc ki ser that did not meet the Agency's current safe t y standards
. In May 2014, E P A reached an agreeme nt wi th R eckitt Benckiser to begin p hase out production of the 12 d-CON non-compliant p rod uct s in June 20 14, and stop all production by December 31 , 20 14. In March 31, 20 1 5, R ec kitt cease d di stributi o n of exist in g s tock s of th ese produc t s . An ana l ys is of human in cide nt s in vo l vi n g ex p os ure to commensa l rodenticides was cond ucted previously in 2011 (S
. Reco re , I 0/ 28 / 20 11 , 0 395567) in su pport of the Rode nti c id e Risk Mitigation Decision ( RMD) , and the s ub sequent Not ice of Intent to Cancel (NO IC). 

### It was concluded that "When lookin g across human incident data sourc es, as we ll as the ope n lite r a ture , rodent ic id es a rc fo und to be inv o l ved in numerous incidents, especia ll y in vo lvin g c hildre n less th an 6 yea rs o ld. These ex p os ures to c hildren a re es p ec ia ll y evident in th e a nal ysis of th e /\A PCC data w hi c h s how e d a n ave r age of 1 5 , 000 expos ures per year
1 Com mcn sal rodents arc rode nt s th at live in close associat i on with humans and depend upon them for s he lter and/or for some of their sus tenance
. In the continental U.S

. . the term commcn sal rodent s includes Norway rats (Rau11 s 11 orvegic 11s), roof rats (Rauus ra1t11s)

. and house mice ( Mus 11111sc11/11s).
2 Registration Numbers: 3282-3, 3282

-4, 3282

- 9
. 3282-15
. 3282-65, 3282

- 66, 3282- 74, 3282 -81, 3282-85 , 3282

- 86, 3282 -87 , and 3282-88
Page 3 of 15occur to chi ld ren under 

### 6 ye ars old from 

### 1 999 to 

### 2009
. While expos ures ge nerall y result in no clinic a l harm to chi ldren, th e res ultin g human ex posure s to rode nticid es have the potential to res ult in severe outcome s and / or medical care. " "S ub seque ntl y, it fo ll ows that the RMD propo s al (co ntainin g rodent ic id es in bait stations that are tamp e r-res is tant) may miti ga te child incidents involvin g r oden ticide s . "
For thi s evaluation , both the OPP In cident D ata Sys t em ( IDS ) and th e Centers fo r Disease Con trol and Pre vention/Nation a l In st itute fo r Occupat io nal Safety and Health (C DC/N IO S H ) Se ntinel Eve nt No tifi cati o n Sys te m for Occupational Risk-Pesticides (SENSOR) databases were co n s ulted for pe s ticid e incident data for the commensal rode nti cides. Th ese ro de nticide s are not included in the A H S , a nd th e refore this stud y d oes not provide in fo rm a ti on for thi s re port. They can be grouped acco rd in g to thre e main catego ri es : first-generation ant icoag ulant s 3
, se condge n eration anticoagulants4 and non - antico agu lant s . 5 Th ey are classified as fo ll ows:

• First-generation ant icoag ulant 

### o chlorophacinone (P C code 

### 067707) 

### o diphacinone ( P C code 

### 06770 I ) 

### o diphacinone sod ium salt ( PC code 

### 06 770 5) 

### o warfarin ( PC code 

### 086002 ) o warfarin so dium salt ( P C code 

### 086003)

• Second

- ge ne rati o n a nticoagulant o brodifacoum (PC code 

### 11 2701) o bromadiolone (P C code 

### 11200 I ) o difenacoum (PC code 

### 11 990 I ) o difethialone ( PC code 

### 128 967)

• Non

- anticoagu lant o brom e th alin (PC code 

### 11 2802) o chol eca lcifero l (PC code 

### 20290 I) o z inc pho sphide (PC code 

### 08860 I ) The purpose o f the databa se search is to ide nti fy potential patterns in th e frequency and severity o f the health effec ts attrib ute d to co mmensal rodenticide expos ure. 

### III. RESULTS ! DISCUSSION

a. IDS (Incident Data System)

3 First-generation anti-coagulants rodenticides disrupt th e production in the li ver of vitamin K dependent bloodc l

ottin g factors II (pro thrornbin), VII , I X, and X.

•1 The seco nd-generation an ti coagu lant s rodenticide s. like th e first generation anticoagulant s, block the formation of the active form of vitamin K, which in tum inhi bits th e prod ucti o n of coagulation fac tors in the liver. These are m ore acu tely toxic than first ge ne ration agents and can cause le thal effects to rodents in a si ng le dose. 5T he non-anticoagulant s rodc nticide s wo rk in a var i ety of ways and no sing le common me c hani sm exists. Page 4 of 15OPP's ID S includes rep o rt s of alleged human health inc id e nt s from var i ous so urce s, including mandatory federal In secticide, Fungic ide and Rodenticid e Act (fl FR A) Section 6(a)(2) rep orts from registrants, o th e r federal and state health and e n v ironmental agencies, and individual consumers. Since 19 92, O PP has co mpil ed the se rep o rt s in ID S. ID S co nt a in s reports from across th e U.S. and most incidents have a ll re levant product in fo rm ati o n reco rd ed
. Rep o r ts subm i ned to the IDS represe nt anecdotal reports or allegations on ly, unle ss oth erw i se stated in the report. ID S reco rd s in c idents in one of nvo modul es : Main ID S and Aggregate ID S :
o Main ID S co nt ain s incid e nt s resulting in hi g he r seve rity outcomes and pro v ide s m ore detail with rega rd to case s p ec ifi cs. Thi s sys tem s tore s incident data for death , m a j o r and moderate incid e nt s, and i t includ es information about the location , date and nature of the inc id e nt. M a in IDS incid e nt s involving on ly one act ive in g r ed ie nt (as oppose d to pesticide product s w ith multiple active ingred ien t s) are co n s idered to provide m ore ce rt a in in fonnat ion about the potentia l effects of ex p osu r e from the pe s ticide.



### o Aggregate IDS contai n s incidents res ultin g in less seve re hum an incidents (m in or, unkn own, or no effects outcomes). These are reported b y registrants only as counts in what are aggregate s ummarie s. 

### FIRST-GEN E RATION AN TICOAG ULANTS C hl orop hac in onc: For the Main IDS , from January 

### 1 , 20 

### l 0 to May 27 , 20 

### I 5 , th e re was 

### 1 incident reporte d for c hl orop h acinone in th e database
. Thi s incident in vo lved a n ad ul t female s uicide attempt and was classi fted as m odera te severit y. In Agg r egate ID S, from Janu ary 

### 1 , 2010 to May 27 , 20 1 5 , there was 

### l incid e nt reported in vo l v in g chlo r ophac in o ne . Thi s incident was c lass ifi ed as h av in g no or unknown effects. Overa ll , th e re a re few in c id ents repo rte d to IDS in vo lv in g c hl orop h aci no ne. Diph ac in o ne and sa lt s : For the Main IDS , from J an uary 

### 1 , 2010 to May 27 , 20 1 5 , th e r e were 27 incidents reported for the s ingle chemica l diphac in one or its salts in th e database. One of these incide n ts was classified as major severity and 26 of these incidents were classified as moderate seve rity
. Ther e were four additio n a l incidents repo rted in vo lv ing m ore than o ne c he mi ca l (inc lu ding diphacinone o r it s sa lt s). Two of these incidents were class i fied as mod erate seve rit y. One incident was a death that was the resu lt of a suic ide and the other incident was c lass ifi ed as major severity that was th e result of a s ui c id e attempt. In Agg re ga te ID S , from January 1 , 20 10 to May 2 7 , 20 15 , the re were 9 4 incidents reported in vo lv in g d ip h ac in one and s alts. These in c id e nt s were c lass i fied as minor seve ri ty.
P age S of ISWarfarin and it s Na Salts: For the Main ID S, from J anuary I , 20 I 0 to May 27 , 20 1 5 , there were no incidents reported fo r the sing le chemical warfarin and its sodi um salts in the database. The re was one inc id ent reported in vo l vi ng more than one chemical ( including warfarin and it s sod ium sa lts ) and was classified as moderate severity
. In Agg regate ID S , from January 1 , 20 I 0 to May 27, 20 15 , there was l in cident reported in vo lvi ng warfari n a nd it s so dium salt s. This incident was class ifi ed as minor severity. Overall , there are few incidents reported to IDS in volv in g war fa rin and it s sod ium sal t s. 

### SECOND-GENERATlON ANTICOAGULANT Brodifac o um For th e Main ID S , from January l , 2010 to May 27 , 2015 , th e r e were 46 in cide nt s reported for the s in g le c hemical brodifacoum in the database. For1y one of th ese incidents were classified as a m o d e rate severity and five of these incidents were cla ss i fied as major seve rity . In cident descriptio n fo r the incidents classified as major severity a r e provided in Appendix 1. There were three add itional in cide n ts reported in volving more th an one chemical besi d es brod i facoum. In Aggregate IDS , from January 1 , 2010 to May 27 , 20 1 5 , th e re 25 1 i ncidents reported in vo lvi ng brodifacoum. One incident was class ifi ed as hav in g no o r unkn ow n effects and 250 incidents were cla ss ifi ed as minor severit y. B romadio lone For the Main IDS , from January 1 , 2010 to May 27 , 2015 , there we re 12 incidents rep orted for the s in g le c he mi ca l bromadiolone in the databa se. E leve n of the se in cidents were classified as m oderate severity and one of the s e incid e nts was c lassified as major sever ity . An incident description fo r the in c id e nt cla ss ified as major severity is provided in Appendix 1
. There was one add iti ona l incident reported in volving more than o ne c h e mi cal besides bromadiolone. In Agg r egate IDS , from J an uary 1 , 2010 to May 27 , 20 I 5 , th e re 171 incidents reported involving brornadiolo ne. Fifty two incidents were classified as havin g no o r unknown effects and 11 9**i~1cid nt** **s** were c lassified as minor severity. D ifenacoum F or the Main ID S, from January 1 , 20 l 0 to May 27 , 20 15 , th ere were no incidents reported inv o lv i ng d i fenacoum. In Aggregate ID S , from Janu ary 1 , 2010 to May 27 , 20 15 , th e re was one inc ident reported invo l vi n g difenacoum. The incident was classified as h aving no o r unknown effects. Overall , th e re a re few inc idents reported to IDS in vo l v in g difenacoum.
Page 6 of 15Di fethialone Fo r the Main IDS , from January I , 2010 to M ay 27, 2015, there was one incid ent reported for th e s ingle che mi ca l difethialone in th e database. This incident was classified as moderate severity. There were no additional incident reported involving more than one chemical besides difethialone. In Agg regate ID S, from January 1 , 2010 to May 27, 20 15 , there were 21 incidents reported involving difethialone. Nine incidents were classified as having no or unknown effects and 12 incidents we re classified as minor severity. Overall , there are few in cidents reported to IDS involving difethialone. 

### NON-AN TI COAGULANTS Bromethalin For the Main IDS , from January I , 2010 to May 27, 2015, there were 16 incidents reported for the s ingle chemical bromethalin in the database. There was one death reported to ID S associated with bromethalin , but upon further review , it does not appear to be related to brometha lin exposure. An approximately 35 year old man was found dead in bed who may hav e had a history of depression. When found, he was "foaming at the mouth with an orange colored sp utum." A box of bromethalin was found in a cabinet in his room, but there was no evidence he cons umed it. The medical examiner ruled this as a suspected heart attack. One incident was class ified as major severity, 13 incidents were classified as moderate severi ty and one incid ent had n o or unknown effec t s . There was one addit ional incident reported involving more than one chemical besides brometha lin
. In Aggregate IDS , from Janu ary 

### 1 , 20 10 to May 27, 2015, there were 1 60 in c id ents reported involving bromethalin. Two incidents were classified as having no or unknown effects and 158 incidents were classified as minor severity. Overall , there are few incidents reported to IDS involving bromethalin. Choleca lciferol For the Main IDS , from January l , 20 l 0 to May 27, 2015, there were no incidents reported involving choleealcifcrol. In Aggregate IDS , from January I, 2010 to May 27, 20 15 , there was one incid e nt reported involving cholecalciferol. The incident was classified as minor severity. Overa ll , there are few incidents reported to ID S involving cholecalciferol. Zinc Phosphide For the Main IDS , from January l , 2010 to May 27, 2015, there were 7 incidents reported for the s ingle chemical zinc phosphide in the database. These incidents were classified as moderate
Page 7 of 15

### severity. There were two additional incident s reported involving more than one chemical besides zinc phosphide. In Aggregate ID S, from January 1, 2010 

### to May 27, 2015, 

### there were 20 

### in c idents repor1ed involv in g zinc phosphide. One incidents were c lassified as having no or unknown effects and 19 incidents were classified as minor severity. Overall, there are few incidents reported to IDS involving zinc phosphide.

b. SENSOR-Pesticides 

### The SENSOR-Pesticides database covers 12 sta t es from 1998-2011 , although reporting varies fro m state to state. Cases of pesticide-related illnesses are ascertained from a variety of sources , including: repor1s from local Poison Control Centers, s tate Department of Labor workers' co mpensation claims when reporte d by physicians, reports from State D epa rtm ents of Agric ulture , and physician reports to state Departments of Health
. Although both occupational and non - occupat ional incidents are included in the database, SENSOR-Pesticides focuses on occupational pesticide incidents , and is of particular value in providing th at infonnation. The state coordinator at each of the 12 

### respective state Departments of Health conducts case followup activities s uch as obta ining medical records to verify symptoms and sever ity. Us ing standard ized protocol and case definitions derived from poison center repo rtin g, the state SENSOR-Pesticide coordinator enters the incid ent information into the s tate-based system which is sent to NIOSH annually to be aggregated. In 2009, 

### SENSOR-Pesticides began requiring prevention coding for cases that had an identifiab le contributing facto rs , such as: ea rl y re-entry , PPE not worn , spill/splash , equipment failure , improper s torage , drift , etc. The new prevention codes will allow for more focused incident review and an alysis by contributing facto r w ithin the database. F IRST - GENERAT I ON ANT I COAGULANTS 

### C hlorophacinon e : A query of SENSOR-Pesticides from 1998-2011 , identifies 12 cases involving chlorophacinone. Of th ese , nine cases involve a single ai which will be reviewed for this memorandum. One case was moderate severity and eight cases were low seve rity. Eight of the nine cases involved inh alation of the product " dust. " The moderate severity case occurred after an in s ulation worker was working in a sc hool attic. The in su lation work wa s generating dust in th e attic. That evenin g th e case expe rienced s hak ine ss, fever and vomiting but felt better afler a few hours. The case expe rienced respiratory, neurological , gastroi ntestinal , renal , and cardiovascular symptoms following exposure. "Rat pellets " were found throughout the attic and the school , but the wo rkers were not notified of this.

Page 

### 8of15Eight cases experienced respiratory symptoms after exposure, and eight cases experienced neurological symptoms after exposure. Five cases exper ienced gastroin t estina l symptoms. Eight cases were occupa ti o nal and one case was a hom eowner. The hom eowner case occurred when the user opened a can of gopher bait and accidentall y inhaled it, experienced shortness of breath and coughing and called Poison Control. Oiphacinone and salts: A query of SENSOR-Pesticides from 1998-2011, identifies 11 cases involving diphacinone. Seven of these cases involved a s in g le active in gredient and were reviewed for this memorandum. These cases included one fatal case , one moderate seve rity case and five low severity cases. One low severi t y case was inte ntional ingesti on for self-harm. The remaining s ix cases were unintentional. Fo ur cases reported gastroin te stina l symptoms. T hree cases were handling the product at the time of exposure. Two cases were exposed while cleaning up product spills. One case was exposed via intentional in gestion, and the fatal case was exposed fro m dust applied to the air vent at his place of work and is reviewed in detail below. The fatality occurred in Florida in 2002. This fatal case was a 35

- year old man who was exposed to Ditrac Powder , EPA Reg. # 12455 -5 6 , a Restricted Use Product that was app li ed by a certified pesticide app li cato r. This exposure occurred as the man opened a tire shop that , unbeknown st to him, had it s a ir conditioning vents recently treated with Ditrac powder and the dust from vents blew into his face. He immediately became ill and was hospitalized for a n infiltrate in the right lowe r lung. Later , this case had to be re-admit1ed to the hospital because of an acute episode of an upper gastro intest in al bleed. D octors treaced for circulatory shock but eventually neither me dications nor surgical interventions could be utilized to control bleeding a nd the patient died o ne month after the inhalation exposure. The autopsy report confim1ed severe gastroin testinal bleeding. Review of th e tire shop demonstrated that no application , storage , or equipment v iolations had occurred
. Warfarin and its Na Sa lt s: A query of SENSO R-P e s ticides from 1998-2011 , identifies 35 cases in vo l ving warfarin and its s odium salt. Thirty four of these cases involved a single active ingredient and were reviewed for thi s memorandum. Of these 34 cases, five cases were hi gh severity , 14 cases were moderate s everity and 15 cases were low severity. Eight cases were work-related , 26 cases were not workrelated , and 22 cases w e re exposed in a private re s idence . Of the five high sever it y cases, three cases were intentio nal self-harm ingestions. Of th e two unintentional hi g h seve rity cases, both were in ges tion s; one in volved a 4 year old in ges ti on of product and one involv ed an 82 year old ingestion of product.


### SECON D- GENERAT IO N ANT ICOAG ULANT Brodifacoum

Page 9 of 15A query of SENSOR-Pesticides from 1998-2011, id entifies a total of 52 case s involving brodifacoum. Forty s ix of these cases involved a sing le active in gredient. fifteen of these case s were intentional in gestions for se lf-harm. The r emainin g 31 unintentional cases were reviewed for thi s memorandum. Nine cases were moderate severity and 22 were low seve rity. Nineteen cases were ingestions , including 13 cases involvin g children und er s i x years old. Since 2009 (the year in whic h the SENSOR prevention code was required) all child cases are coded for

" improper s torage of pesticide. " Of the nine moderate severity cases , seven were ingestions and two were via inhalation. Nine cases (including three occupat iona l and six residential cases) were made ill from inhalation of the product under various case-specific scenarios includin g: five cases that had accidental contact with product o r res idu e and four cases were made ill whi le applying the product. The remaining three cases were exposed vi a th e dermal o r ocular routes. Fifteen cases repo rted gas trointestinal sy mptoms including abdomina l pain , vom iting and diarrhea; fo llo wed by ten cases reporting respiratory symp toms including cough and upper respiratory pain and e ight cases reported neurological symptoms. Four cases reported cardiovascular symptoms including heart palpitations and c hest pain ( T able 1 )

. Tab le 1. SENSOR-Pestic ides 1998-2011 Brod ifacoum Case H ea lth Effects N=3 1 Body System Co unt of Cases Gas trointestinal 15 Respiratory 10 Neurological 8 Ocular 5 Cardiovascular 4 Dermal 4
Bromadiolone A query of SENSOR-Pesticides from 1998- 201 1 , id entifie s a total of 15 cases involving bromadiolone. Of these , ten cases in vo lve a si ng le active ingredient and were reviewed for this memorandum. One case was 

### high severity , t wo cases were moderate severity and seven cases were low severit y. Four cases were intentiona l ingestion for self -h arm. The s e four intentional cases include the high severity case and both moderate severity cases as well a s one low se v erity case. Of the remaining six unintentional cases , a ll are low severity
. One case opened a bag of rodenticide and powder blew into h is face and eye . Another case was working at a cash register and she inhal ed product from th e opened bag of rodenticide. Another case got a piece of the product in his eye. One case was exposed when he entered a building that was being treated. One case was sickened after bait was applied in his home. The final case did not have case narrative information. Three of these six reported ocular symptoms in cluding eye pain and conjunctivitis , three reported respiratory symptom s in cluding upper respiratory pain , two reported neurological s ymptoms and one reporte d gastrointestinal symptom s . Page 10 of 1 5Difenacoum A query of SENSO R -Pest ic id es from 

### 1998-20 11 , identified no cases in vo lv in g difenacoum. Di f e thialone A query of SENSOR-Pesticides from 

### 1998-201 I , ide ntifie s a total of fo ur cases in v olving difet hi a l o ne , a ll of wh i c h are s ingle ai cases in vo lv in g only difethialon e. A ll four cases were exposed via ingestion. O ne case was high severi ty, two cases we re m odera te severity and o ne case was low seve rity. Th ree cases, inc ludin g the high severity case, one moderate severity and th e lo w severity case , were intentional ing es tion s for self-harm. Th e r e maining case was an infant (9 months old) who acc ident a lly in gested "a s ig nificant amount of 0-con Rat 

### & Mouse Bait Blocks " and exper i enced nausea a nd vo mitin g (c lass ified as moderate severit y)
. 

### NON - ANTICOAGULANTS Bromet halin A query of SENSOR- Pes ticide s from 

### 19 98-20 11 , id e ntifies a total of e ight cases involving bromethalin ; seven cases involved only bromethalin. A ll cases were resid e nti a l. Three cases involved ingestion of product , including one infant case and two adu lt cases . Of these adult ingestion cases, o ne was an intenti o nal self-harm attempt and the othe r was a s u spicious po ss ibl e self-harm a ttemp t. The suspicio u s in gestio n case was moderate severity. A ll o th e r cases ( n=6) were low severity. Two cases in vo lv ed produc t s pill s. One case in vo lved a warehouse worker who applied produ ct and did n o t was h hand s afte rward s a nd was ex p ose d wh il e drinking wate r and touching her face. T hree cases reported d e rmal symptoms in clud in g edema and rash) , three cases reported ne urolo g ical symptoms inc luding sl urred speec h , two cases reported ocular sy mptoms , two cas es r epo rt ed gastrointestina l sy mptoms , and one case r e ported respiratory sy mptoms. Cholecalciferol A query of SENSOR-Pesticides from 

### 1998

- 20 11 , identified no cases in vo lv in g cholecalciferol. Z in c Phos phid e A query of SENSOR- Pes ti cides from 

### 1998-2011 , id e ntifies a total of 

### 25 cases in volv ing z inc p hosp hide ; 23 of which invol ved on l y zinc pho s phid e and were revi ewe d for this memorandum. These 23 s in g l e a i cases s t e m from 

### 15 events. One case was high severity , two cases were modera t e s e verit y and twe nty cases were low seve rity. T he high severit y cas e s invol ved an intent io nal in gest ion for se lf-harm. Regarding the 

### 20 low severi ty cases: in 

### 11 cases ve terinarians (n = 4) o r pet ow ners ( n=7) exposed while treating dogs th a t had in ges te d product (p rim aril y phosphin e gas pe ll e ts or " peanuts "). Page J 

### l 

### of 1 5

### Four cases were exposed following extenninator applications. T wo cases were applying product and exposed. One case was a child who "got int o rat poison powder in a dish on the floor." Two cases did not have case descriptions. All of these cases were low severity and sy mptoms were commonl y d izz ines s, headache , and sho rtnes s of breath, nausea, and chest tightness. Regarding the moderate severity cases, one involv ed a man in a grocery store who was accidentally exposed to rodenticide fumes. This case experienced chest ti ghtness , difficulty swallowing and nasal irritation. The second moderate seve rit y case apparently involved the accidenta l ingestion of product Moletox 2. Thi s case experienced chest pain , lacrimation, coughing, and loss of appetite
.


### c. A me ri ca n Asso ci a tio n of Po i so n Co n t r o l Cen te r s (AAPCC) The American Association of Poison Contro l Centers (AAPCC) is a non-p rofit, national organization founded in 1958 that represents the poison control centers of th e United States and the interests of poison prevention and treatment of poisoning. All of the calls to a poison control ce nte r are managed by a medical professional trained to answer questions about poisons. The American Association of Poison Control Centers (AAPCC) produces an an nu a l summary report g i vi ng statistics and in format io n on all the poisonings reported to PCCs in a cale nd ar year. A lth ough AAPCC data was reviewed by HED fo r the 20 I I human incidents report (0395567) analyzing exposure to commensal rodenticides , it is not being reviewed for this incident analysis. At the time of this repo rt there is insufficient information available to determine if the mitigations have impacted the frequency of inc idents occurring. The mo s t current AAPCC annua l report available is for year 2013 and the phase out of the remaining non-compliant products began in June 20 14 and was complete as of March 31, 2015. However, AAPCC data is reviewed annually fo r reduction in reported rodenticide incidents as an EP A Strategic Measure. For FY 2014 (using th e 2013 AA PCC annual repor t data) , there was a reduction of 17 % incidents reported to the AAPCC annual reports compared to the number of rodenticide exposures to children ages l to 6 years old in 2011. The reductions in child exposures are expected to become more p r ominent beginning in the 2016 AAPCC annual repo rt ; which wil l be reflected in the FY 20 1 8 Strategic Mea s ure . The target red uction for FY 2018 i s to reduced rodenticide expos ure incidents by 75% from the baseline of 11 ,674 reported incident s in ch ildren ages I to 6 years o ld.



### d. Ag ri c ultu ra l H ealth S tud y (A H S) The AHS is a high quality, prospective epidemiology s tudy evaluating the link between pesticide u se and various hea lth outcomes including cancer. The AHS inc lude s private and commercia l pesticide applicators and their spouses . 

### If th ere are Al-IS findings rele van t to a particular pesticide going through registration review , the Agency will ensure they are co n s id e red in the problem formulation/ scoping phase of the process and, if appropriate , fully reviewed in the risk assessment phase of the process. The AHS inclu des infonnation on use of 80 different pesticide active ingredients common ly u sed in agriculture. The commensal rode nti cides are not included in the AHS, and therefore this study does not provide information for thi s report. Page 12 of 15

### IV. CONCLUS IO N


### In order to minimize c hil dren and wi ldl ife expos ure t o rodenticide product s the 2008 RMD included risk miti ga tion measures requ irin g rodent icide products used in ho mes and marketed to genera l residential consumers be sold only with ba it stations. Most rodenticide products complied with the mitigation measures required in th e RMD as of Jun e 4 , 20 11. The phase out production of the final 12 no n-compliant products began in June 20 14 and production of these products sto pped on December 31, 2014. Distribution to retailers e nded March 3 1 , 2015
. Due to the fact that these safe ty measure s were only recently fully impl eme nted, there is insufficient in fo rm at ion available, at the time of thi s repor t , to determin e if the mitigations have impacted the frequ ency of incidents occ urrin g. However ; AAPCC data is r ev iewed annually for reduction in reported rode nti cide incidents as a Strategic Measure
. For FY 20 14 (u sing the 2013 AAPCC annual report data) , there was a reducti o n of 17% incidents rep o rted to the AAPCC annual reports compared to the number of rodenticide exposures to chi ldren ages I 

### to 6 

### years old in 2011. The reductions in child exposures are expec ted to become more prominent beginning in the 2016 AAPCC annual report; which \viii be renected in the FY 2018 Strategic Measure
. The target reduction fo r FY 20 18 is to reduce rodenticide expos ure incidents by 75% compared to a base line mea s ure of I 1 ,6 74 repo rt ed incid e nt s in 2008 in c hil dren ages 1 to 6 years old

. 

### The Agency w ill continue to mo nitor th e incident in format ion and provide an updated review of incident , cons idering pre- and post-mitigat ion incidents se parately , when the information becomes available.



### P age 13 of 15

### Appendix A. Commensal Rodenticide Death and Ma ior 

### S

- - - - - - - - --- - - - - - - --- - - - - - 

### ·!Y Incident R d to IDS fo 

### 2010 

### to Mav 27. 2015



## . In cid e nt P ac kage Jn cid c nt Reg In g re di ent E xp os ure R epo rt Date Locatio n N um be r P ro du ct Na me Na m e Sev e ri ty In c id e nt Desc rip tion 021982

- 003282- D-CON MOUSE 00005 5 / 10 /2010 CA 00065 PRUFE II Brodifacoum Major A 23 year old male suicide artempt 025040

- D-CON 00011 1 /4/2013 CA BROD IFACOUM Brodifacoum Major A 45 year old male suicide anempt. 027024

- 003282- D-CON MOUSE 00003 811 / 2014 LA 00065 PR UFE II Brodifac oum Majo r An adult female s uicide anempt. 027333

- LOS ANGELES, 003282- D- CON MOUSE 00012 3 1 2 1

2012 CA 00065 PRUF E II Brodifacoum Major A 62 year old male suicide attempt A 53 year old male was drunk and take n to the ER. The police suspected that he ate some of the product just because it was around his home. He was taken to one hospital and upon ER admission where his blood pressure was 87/50 and his heart rate was I08. He was then transported to another hospital and he was plac ed in the cardiac 027563

- 003282

- D- CON BA I T unit. He was discharged 4 days 0000 1 217/20 15 FRI TCH, TX 00066 PELLETS Brodifacoum Major later. Seven children, ages 10 thro u gh 1 2, were ho spita li zed after coming into contact with rat poison th ey mistook for candy. A student found the rat poison on top of a high filing cabinet in the classroom and shared it with c l assmates. One of the s tud e nts who was exposed contacted her father who called 022579

- 911.The chemica l in th e rat poison 00010 1 / 13/20 11 CA BROMADIOLONE Bromadiolone Major was bromadiolone, a blood thinn er.



### Page 1 4of 15Incident Package Incid e nt Reg In gredie nt Expos ure Report Date Location Numb er Product Name Name Severity Incident Description An approximately 35 year old man was found dead in bed who may have had a history of depression. When found , he was "foam in g at the mouth with an orange colored s putum." A box ofbromethalin was found in a cabinet in hi s room, but 012455- there wa s no ev id ence he con s umed 025024

- 00120- TOMCAT MOUSE it. The med ic al examiner ruled this 0000 1 31 20 1 20 1 3 ELSA, TX 003240 KILLER I Bromethalin Death as a suspected heart attack. A 56 year old male opened the product. The air that came out of the bag and hit hi s face
. For approximately one hour afte r he opened the bag he continued to tas te the product. Two days after hi s exposure he began to experienc e TOMCAT MOUSE edema/swell in g , numbness , KILLER I abdominal distension , taste 012455- (REFILLABLE alteration, fever/hyperthermia , 026696

- STATEN 00120

- RESISTANT BAIT confusion , ocular irritation and 00001 5114/ 20 14 ISLAND , NY 003240 STATION) Bromethalin Major redness, and insomnia. An adult male may have inhal ed so m e of the product that had been on the roadside during the winter and spring. He s uspects that dust wafted into the road grader cab that he was operatin g while he was RAMIK MINI BARS doing his road work. He developed 022153

- CARROL L TON, 061282- ALL WEATHER RAT diabetes with pancreatic and li ve r 00001 511 / 2010 MO 00026 & MOUSE KILLER Diphacinone Major s hutdown
.



### Page 15 of15