### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D . C . 20460 OFFICE OF CHEMICAL SAF ETY AND POLLUTION PR EVE NTION



### M EMORAN D UM D ate : D ecemb e r 1 5 , 2015 SU BJE CT : M etaldehyde : Review of D omestic Animal Incidents

PC Cod e: 05300 I D ecis io n No.: 51 11 8 0 P et it ion No
. : A R i s k Assess ment T ype: NA TXR No
. : N A MRID No.: A DP Bar c od e : 04 3 0 204 R eg i s tration No.: NA R eg ul a t ory Ac ti on: A Case No.: NA CAS No.: 10 8 -62

- 3 40 CFR: NA Vc r. Apr .08 

### FROM: Shann a Re co re, Industrial H ygie ni s t 

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# P ,... 1,1 n . Toxico logy and E pidemiology B ranch .J::lf'W 'f-.A '-.JI-..-**~** Hea lth Effects Di vis io n (7509P) 

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TO: David 

### J. Miller , Act in g Branch C hi ef / <t• 

# J Toxico lo gy a nd Epidemiolog y Branch Health Effec t s Di v is ion (7509P) R o nni e B eve r, Ri s k As s essor Ri s k A s sess men t Branch V ll H ea lth Effec ts D iv is ion (7509 P) 

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and Le igh Rimm er, Che mi ca l Review M a n age r Risk Manage ment & Implementation B ra nch I Pest ic ide R e-eval u at ion Divi s ion (7508P) and Melissa Pa nge r, Ph. D ., Senior Science Adv i so r Env i ronmental Ri s k Branch 2 Env iro nm enta l Fate and Effects Di v is ion (7507P)
S u mmary and C onclu s ion s In th e 200 6 Regi s tration Eligibi l ity D ecision ( RED ) for Metaldehyde 1
, the Agency found that risk to domest ic anim a ls we re of concern because there we re the number of poi s oning incident s

1 http ://arc hi ve.e pa.gov/p es ticid es/r ereg i s trati on/we b/pd f/ m e t

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### i nvolving in gest ion of metaldehyde products by domestic animals (primarily dogs) after application in re s id en tial settin gs , and incid e nt in fo1mat ion al so suggested that do gs also may ingest metaldehyde granules after opening product packaging. In the 2006 RED , the Agency impleme nted a number of label and formulation r e quirem e nts to address th e risk to domestic animals. The formulation mitigation required all residential u se products containing metaldehyde to be fo rmulated with a bittering agent approved b y the Agency, at s uffi c ient concentration to deter ingestion by dome s tic animals.
A qu ery of IDS for metaldehyde (PC code: 05300 I) domestic animal incidents from J anuary 1 , 2010 to September 24, 20 1 5, found 11 30 reported domest ic animal in c ident s. Th ese incident s included 125 deaths and 59 major severity incidents associated with metaldehyde reported to ID S. A qu ery of NPIC for metaldehyde from 20 1 0 to September 2015 found 1 02 repo rt ed anim al in cidents. T hese incidents included two deaths and three major severity in c ident s. A closer rev i ew of th e N Pl C incid e nt s indicates that th e animals are often being exposed b y ingesting pellets that h a ve been applied by the owners to their yard o r gard en. A trend of the ID S data , from 20 I 0 to 20 14 , s how s an apparent decrease in in c ident s over tim e. In general th e reduction in p o iso ning events over time after 2012, is l ikely due to the product cance ll ation s that took place at the time of the m eta ldehyde R ED. Additional anal ys i s may be performed during registration revi ew to d etermine if the mitigation s implemented will continue to impact the freque ncy of in cident s. D etailed Review I. 

### ACTION REQUESTED
TEB has been asked to review the domestic animal incidents in ID S a s sociated with metaldehyde to suppo rt th e metaldehyde scop ing d oc um e nt. Report s of adverse health e ffe cts alleged l y due to a specific pe s ticid e ex po s ure 

### (i.e. , an "incident") are largely self-reported and the refore , genera ll y speaking , ne ith er exposure to a pesti c ide or reported symp tom (or the connection between the two) is v alid ated or otherwise co n fi nn ed. Typically, causation cannot be detennined based on incident d ata and a certa inty index i s rarely assigned to incident s repo rt ed in th e IDS
. The symptoms or signs experienced by the animal may have been unre lated to pesticide treatment or m ay have be e n due to mi s u se of th e produ ct. H owever , incident in forma ti on can be an important source of feedback to the Agency: incid e nt s of severe o ut come , or a sugges ted pattern or tre nd among less severe in c ident s , can signal the Age ncy to further investigate a particular chemical o r product. 

### II. BA C KGRO UN D Metaladehyde is a mollu s cide used to ki ll snai l and s lu g pests of va ri ous food , seed , and o rnam e ntal plants. In the 2006 RED , the Agency found that ri sk to domestic animals were of concern because there were the numb e r of poisoning in c idents in vo l v ing in ges tion of Page 2of6metaldehyde products by domestic animals (primarily dogs) after app li cation in residentia l se tting s, and in cident inform ation al so suggested that dogs a lso may ingest metaldehyde granules afte r opening product packaging
. In the 2006 RED , th e Agency im plemented some labeling and fonnulation requirement s to add ress the risk to dome stic animals. The formulation mitigation required all reside ntial u se product s conta ining metald e hyde to be formulated with denatonium ben zo atc , or anot her bitt e ring ag e nt approved by the Agency, at sufficient concentrat ion to de ter inges tion by domestic animal s . For thi s eva luati o n , OPP In cident Data System (IDS) database was co n s ulted for pe s ticid e incident data on the active in gred ient metaldehyde (PC Code: 053001 ). The purpo se of the dat aba se search i s to identify potential pattern s in the frequ e nc y and sever it

y of the health effects attribute d to metald e hyd e exposure to domestic a nimal s. 

### Ill. RESULTS/DISCUSSION

a . Incident Data System (IDS) In cident D ata System (IDS) is a d atab ase maintain e d by OPP and ho u ses pe s ticid e incidents reported to the Office. IDS is comp ri se d mostly of pesticid e incident data subm itted by regis trants in re s pon se to the Fed e ral In secticide Fungicide and Rodenticide Act (FIFRA) section 6(a)(2). Thi s is a part of FIFRA that mandate s regi st rant s report p esticide incidents of which they become awa re to OPP. ID S also includes o ther pe s ticide in cidents re port ed directly to EPA b y citi z ens and o th e r orga ni zations and agenc ies. ID S include s infonnati on o n incident s involvin g human s, plants , and w ild and domesti c animals where there i s a claim of an adverse e ffe c t , as well as detects of pe s ticides in water. ID S reco rd s incident s in o ne o f two m o dules: Main ID S and Aggregate IDS , each desc ribed below:

• Main ID S includ es in c id e nts that are re porte d in more d e tail , ofte n with narrative information describing th e circum s tan ces o f the inc id ent: regis trant s are required to include more detailed information if the in cident they are reporting in volves human s and a higher s everity o utco m e, although some incident s involving dome s tic animals are s ubmitted as detailed reports and thus e ntered into Main IDS
. F o r th e Main IDS , from J anuary I, 20 I 0 to September 24 , 20 1 5 , there were two domestic anima l in cidents reported for metaldehyde in the databa se . One was a death and the other wa s a major severity. Th e reported death incident was invol v ed a dog and was a ss ociated w ith Regi s tration No
. 71096 -1 3. No furiher details were provided. The major severity incid e nt involved a dog who in gested product pellets that were app li e d to a garden.

• Aggregate ID S consi s ts of counts o f exposures and seve rity ind ex as so ciated with a particula r product or active ingredi e nt , and regi s trants n onnally s ubmit no narrntive informati o n with the s e count s. 2 B eca u se EPA 's rep o rtin g require ment s allow regi s trants

2 N o t e : Main IDS is o rga ni zed by in c id e nt (and each in c ident ha s a unique r e port assoc iated with it), whereas a s Aggregate Summar y ID S is o rgani ze d by co unt s of expos ures (each with a d es ignated
.. exposu r e seve rity type ") associa t ed with e ac h pes ti c id e pr o du c t for a ce rtain tim e p eri o d.
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### to submit domesti c animal i ncidents (DA , DB , D C , D D , and D E) as aggregate exposu re counts and exposure severity and prov ide no narrative detail s, the majority of the domestic animal data are merely c o unt s of exposure severity type s, by year and entered into the Aggregate (and not Main) ID S Modu le . For the Aggregate IDS , from January l , 20 I 0 to September 24 , 2015 , there were 112 8 domestic animal incident s reported involving metaldehyde the database. Although th e y di 

### ff er in lev e l of detail , Main and Aggregate IDS collect both the severity of the expo s ure (call ed an " expo s ure sever ity type " in IDS) and the pesticide and/ or pesticide product in vol ved (when the information is provide d by the person reporti ng the incident). The foc u s of this report is domestic animals /pet, and the IDS exposure s everity types for d o mestic animal s, as d e fin e d by 40 C FR 

### § t 

### 59.184 , are a s foll o ws:

• DA

- Death

- if th e d o mes ti c a nimal di e d o r w a s e uth a ni zed: • DB

- Maj o r - if th e d o mes ti c a nimal exhibited o r wa s alle ge d to have ex hibit e d s ymptom s whi c h ma y ha ve be e n lif e -thr e at e nin g o r re s ult e d in r es idu a l di s ab ility; • D C

- M o d e rat e - if th e dom es tic animal e xhibit e d or wa s all e ged to ha ve e xhibited s ympt o m s whi c h a r e mo re p ro n o un ce d , mo re prol o ng e d o r of a mo re sys te mi c n ature th a n min o r sy mpt o m s a nd inc lude d so m e treatment and re turn to pre -e xpo s ure s t a te; • DD

- Min o r - if th e d o mes ti c a nim a l was a ll ege d to ha ve ex h i bite d sy m p to m s, but th ey w e re minimall y both e rs ome and re s olved rapidly ; • DE

- U n kn own - if sympto m s are unkn own o r n o t s p ec ifi e d
. 

### A tot a l of 124 death s were rep o rted to Aggregate I DS which mean s that the dome s tic animal died or wa s euthani z cd
. The re were 58 major in cid e nts in which symptoms may have been life

threate nin g or caused residual di s ability . The re maining incident s were le s s sev ere: 75 8 incidents were classified moderate which mean s that treatment may have bee n requ i red but the animal returned to it s pre-exp os ure s tate o f health with no re s idual di s abi l ity ; 175 incid e nts were cla ss ifi e d minor which mean s that s ympt o ms may have been minimally bothersome and resolved rapidly; l 0 incidents were unsp e cified and may hav e been eith e r m o derate , minor , o r w e re un s p e cified and three incident s were cla ss ified a s unknown severity. Br e akdown of th e incid e nts reported to both Main and Aggregate IDS by s ever ity classification is found in Table 1. T ab l e I. Meta ld eh yd e Do mes ti c An im a l In c id e n ts in ID S (Main a nd Aggregate) fr o m J a nu ary 1, 20 1 0 to Se p temb er 24, 20 1 5 C o d e S e verity A g gre ga te Summary M o dul e D A Fata lit y 125 DB Maj o r 59 D C M o d e rat e 75 8 DD Min o r 175 D E Unkn o wn 3 D -C, M o d , 1 0 D , E Mino r , Un spec ifi e d T o tal 1 1 3 0



### Pag e 4of6A trend ove r time from 20 I 0 to 20 14 was a n a l yzed (Figure I)
. The number of reported in cident s ap p ears to peak in 20 11 and then begins to decline s lightl y in 20 1 2 and continued to decline into 20 1 4. In 20 14 , th e num ber o fr epo rted incident s {n = 9 1 ) h as decrea se 70% from the number of incide nts re p orted in 20 11 (n = 309)
. As m entioned above, several l ab el a nd fo n nulation miti ga tion s we re impl emented in th e 20 06 RED. T hese miti gation s may be co ntributin g the ap p are nt decrease in in c ident s shown below. A lth ough , the se miti gatio n s were impl e m e nted in the 2006 Meta ldeh yde RED , mo s t of the product s did not ad o pt chang es until 20 1 1120 1 2 an d so m e product s ma y h ave ente red the marke t a co upl e years after that. Figu re I. Met a ldeh y d e D omes ti c A n imal incid e nt s R eported to IDS from 20 10 to 20 14
350 300**~ ~**  250 -0

### ~ 200

._ 0**~** 150 .0 E 100 :::l 

### z 

### so 0 2010 2011 2012 

### Y

ear 2013

• death • major severity • moderates and minors 201 4

Out of th e 1 6 p rod u c t s associated wi th metaldehyde domestic animal in c id ents re p o rted to ID S, the most imp licated product is Con-y' s S lu g & S nail Pe ll e ts (M P) ( R egistration No. 8 119-13 ), r e portedly used in 48 % {n=542) of the met a ld ehyde dome s tic a nimal incid e nts. Thi s is fo llo we d by Co1Ty' s Slug & Snail Pellet s (3.25) ( R egistration No. 8 11 9 -1 3) , and OR- CA L Slug & S nail Bait (Reg is trat io n No. 7 109 6-00007), rep o rtedl y u sed in 23% ( n = 263 ) a nd 12% (n = l 3 1 ) o f th e metaldeh y de d o m est ic an im al in c id e nt s, res p ec ti vely
. Th ese product s are pe ll et s that contain 3.2 5 % of th e act ive in g r e dient metald e h yde and are u se d ar o und gardens to treat for s nail s and s lug s . b. Natio nal Pestic id e In fo rmati o n C enter (NPIC) T h e Nati o nal Pestic id e Jn fonnation Ce nte r or N P IC is a cooperative effort betw ee n Oregon State Uni vers ity and EPA w h ic h i s funded by EPA to s erve as a source of objective, sc ien ce -b ased pesticide informati o n and respo nd to inquiri es from the publi c and to incid e nt s. N PI C function s n at ionall y during weekday bu s in ess h ours through a toll -free telephone number in add i t io n to the int erne t (www.npi c.o rs t.edu) a nd e m a il. Sim il a r to Poi so n Con tro l Cen ters, NP I C's prim a ry purp ose i s no t to co ll ec t in cident d ata, but rath e r to provide infomrntion to inquire rs o n a w id e
Pa ge5of6range of pesticide topics , and direct caller s for pe s ticide incident inve s ti gation and e mer ge n cy tre a tment. Neve rth e less N PIC does co llect informati on about in c id e nt s (approxim a tely 4000 incidents per year) from ca ll ers an d records that infonnation in a datab ase . NP IC is a so urc e of n at io nal inc id e nt information but generally rece i ves fewer re port s than IDS. Regardle ss, if a high fre qu e ncy is ob se rved in ID S, N PIC provide s an addit ional so urce of infonnation to s ee whether there is ev id e nc e o f consistency across national data s et s or po ss ibl y dupli cation and add ition al information about th e s ame in c id e nt (s). On e hundred and tw o anima l incident in vo l v ing metaldehyde were reported to NP I C from 20 I 0 to Septe mb e r 20 15
. Ex p os ure s to th e foll ow in g s pecie s were rep o rted dogs (n = 9 l ) , cats (n=8 ) , p o tbelli e d pig ( n = 1 ) , mini a ture hors e (n= I) and bl uebird (n = I). Of the se incident s, 65 dogs , 1 cat , an d I potb e llied pig we re r e porte d to h ave inges te d the produ ct. O f the in ges ti on in c id e nt s tw o animal s di e d (b o th do gs)
. One d og was found d ead in neighb o ring agricu ltura l field s that h ad b ee n treated with m eta ld ehyde. The othe r dog ch ewed up a b ox of th e p ro duct an d was euthanized after experie n c in g p a ntin g and tremor s. Three incident s we re cla ss ifi ed as major severit y, I 0 in c ident s were clas s ified as m oderate s e verit y, nine in c id e nt s we re cl assi fi e d as min o r severit y, seve n in cidents were class ifi ed as having symptoms con s iste nt with m etalde h yde exposure , and 36 in c id e nt s w e re clas s ified as asymptomatic. IV. CONCLUS IO N In th e 2006 R eg istrat io n Eligibility D ec i s io n (R E D) for Metaldehyde 3
, th e Agency found th a t ri sk to d o me s tic animals were of conce rn becau se there were the numb e r of poisoning in c id ents in vo lvin g in ges ti o n of m etaldehyd e products b y domestic animal s (primarily dogs) after application in re s id e ntial se ttin gs, and in cident infonnation a l so s ugges te d that dog s also ma y in gest m e tald e h y d e gr anule s b y opening p rod u ct packag in g. In the 2006 RED , th e Agency impl e m ented a number of label and fonnu lation require ment s to address th e ri s k to dom es ti c animals. A query of ID S for metald e h yde (PC code: 05300 1) domestic animal in cidents from January I , 20 I 0 to Septe mb e r 24, 2015 , found I 130 re porte d dome stic anima l incid e nt s . Th ese in c id e nt s included 125 deaths and 59 maj o r seve rit y incid e nt s assoc iate d with m etald e hy de re porte d to ID S. A query ofNP IC fo r metaldeh yd e from 20 10 to September 20 1 5 found 102 reported animal incidents. Th ese incident s included two deaths a nd three m ajo r severit y in c ident s. A cl ose r r ev iew o f th e NP I C incid e nts indi cates th a t the a nim a ls are getting expos ure from in ges ting pellet s th at hav e been app l ied by the ow ners to th e yard. A tre nd of th e ID S d a ta , from 20 10 to 2 014 , s h ows an a ppare nt d ec rea se in incident s ove r tim e. In general the redu c tion in poi so nin g even ts over tim e after 2 012 , is like ly due to the product mitigati o n s th at were required in th e 2006 metaldeh y d e R E D and impl e ment ed i n 20 11 / 2012. Additional a n alysis may be performed during reg is trat io n r ev ie w to d e te rmin e if the mitigati o n s implemented w ill co ntinu e to impact the fre qu e ncy of incid e nts.

3 http : //archive.epa.gov/ pes ti cideslreregistration/web/pd f/ metaldehyde

_ red.pdf
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