### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFE T Y AND POL L UTION PREVENTION

MEM ORAND UM Date: 

### August 25, 2015 

### SUBJECT : 

### Limonene and d-Limonene: Review of Domestic Ani mal Incidents

PC Code: 079701. 179701 Decision No.: -06380 Petition No.: NA Ri s k Assessmen t Type: NA TX R No.: NA :\1RID No.: N ;\ DP Barcodc: 042 7 958 Reg is trat ion l\o
. : NJ\ R egu la tory Ac ti o n: A Cas e No .: A CAS No.: 138-86-3. 5989-27

- - 40 CFR: : A**V~r.J\pr.08** FROM: Shanna Recore , Indus trial Hygienist 

# J I
.... ,_ n _ /)

### ~ Toxico logy and Epidem iology Branch**~V"--f'~ /~**  Health Effects 

### Division (7509P) 

# a**~** /J; ' TH RO UGH :



### TO: 

## r - ·**~** 

## !£-a ,**z.-/~-** David J. Mi ll e r, Acting Branch C hi ef 

# ,J**~** itJ Toxicology and Epidemiology 

### Branch Health Effec ts Division (7509P) 

### Mon ique Perron , Risk Assessor Risk Assessment Branch I Health 

### Effec ts Di vis ion (7509P) 

### and Caitlin Newcarnp , Chemical Rev iew 

### Manager Risk Management & 

### Implementation Branch 1 Pesticide Re-evaluation 

### Division (7508P) 

### Su mmary and Co nclusions A query of ID S for limonene 

### and d-limonene (PC 

### codes: 07970 I. 17970 I) domestic an imal 

### incidents from 

### January 1, 20 10 to 

### July 9 , 2015 , found 231 reported incidents
. 

### These incident were mostl y class ifi ed as minor severity which 

### means the an ima l exh ibi ted symptoms were min imally bothersome and resolved rapidly. Based on the**lov ~**  

### frequency of inciden ts reported to**IDS~** 

### there does not 

### appear to be a concern at th is 

### time. The Agency will continue to monitor 

### the incident data and 

### if a concern is triggered , additiona l analys is wi ll be conducted.

Page I of 4

### Detailed Review I. ACTIO REQUESTED
TEB has been a. kcd t r iew the domestic anima l in ident in IDS ·1ssociatcd with lim nene 

### and d-limonene (

### P ' codes: 

### 7970 L 17970 I) an i 

### prc1 ar a memorandum in support 

### of a re ponse to comment EP 

### A-HQ-OPP

-2 I 

### 0-0673-0**~4 •**  Report of ad\·cr ·c health effects allegedly duet pe itic pe ticidc exp ·urc (i.e
. . an

.. incident
.. ) are largely**clf-r** po11ed and th 

### ref re . generally speaking. ncith 

### r exposure to 

### a pc ticidc or report d sympt m (or the connection between the two) i va lid ated or otherwi c confi rm ed. Typically. cau ation cannot be determined ba ed on incident data and a certainty index i rarely a· ·igncd to incid ents reported in the ID '. The ymp tom s or signs experienced by 

### the animal may have been unrelated to 

### pe. ticidc tre atment or 

### ma.. have been 

### due to 

### misu e of the product. However. incident infonnation an b an important source 

## fr edback to the Ag ncy: incidents of evere outcome. r a suggest d pattern or trend among 1
. c\ ·crc incidents. an

·ign l the 

### g ncy t further im · tigate a 

### p rticular chemical or pr duct. 

### II. BACKGRO 

### ND d-Limonene ha a lemon

- like flavor and smell, 'rnd ccur, naturally in citrus and certain fruits. vegetables. meats and spices. d-Limone n i used as both an activ and inert ingredient in pesticide products. and as an ingredient in 

# rrn d produ ts. oap . and perfumes. As an acti\'e inJ..!,redi

-nt. it i: tL d as an insecticide. herbicide, in t rep llent. and animal (dog and cat) repellent. s a pc ·ticidc inert ingredient. it i u cd a a olvent or fragranc
. I· D · con ider dlim nene t be Generally Rccogniz d a afe IRA. a a food additive when u ed a a

ynthetic flarnring · ubstance and adju\'ant (21 'FR .'I 2.60). d-Limonenc i. n t registered fi r terr . tri al food or feed crop**use ~**  a an active ingredient but can be u 

# cu in insect-repellent tablecloth and in insect-repellent strip u. cd in 

# ro )d or feed-handling c ·tabli s hm nt ·. For this evaluation. OPP Incident Data ys tcm ( IDS) databa. e was cons ulted for pesticide in ident data on the acti\'t: ingredients limonen c and d-lim nene (P d s: 

### 07970 I. 

### 17970 I).

· 1h**~** purpo c of the dalaba c carch i to idcnti(v p tential pattern in th'-= frequency and e\'c:rity of th" health ffc t: attributed to limotknc and d-limonenc exp sure . 

### III. RE LTS/D I 

# c SSIO T Incident Data Sy · tcm (IDS) is a databas maintained 

### by 

### OPP and**hou c**  · pesticide incidents rcpor1ed to the flicc. ID is comprised mo ·tty of p1.;sticidc incident data submitted by rcgi trams in resp< n ' e to the Federal Insecticide fungicide and Rodenticidc Act (F IFRA) s cti n 6(a)(2). This is a I art 

### )f FlfRA that mand tcs rcgi ·trant report pe ticidc in id nt f which they bee me aware to 

### OPP. I a l o includ es thcr pesticide incident r p rted dircctl) to EPA 

### by citizen and th r rganization and agcnci'-=
. ID includi.:: infom1ati n n incident invoh ·ing
1 Imp : \\ \\ " \\
.rc 11 ulntion
.... . _ g.ov**:: !doc** **unH .:** **ntD tail** **D** I· P:\ - l IO -Ol 2_ P

_: _O 10-0 6 : -**JO ~O** 
Page 2 

# or 4

### humans , plants. and \vild and domestic animals where there is a claim of an adverse effect, as well as 

### detects of pesticides in \Vater. l 

### OS records incidents in one of t\vo modules: Main IDS and Aggregate IDS , each described belO\v:
• Main IDS includes incidents that arc reported in more detail, often with narrative information describing the circumstances of the incident: regi stran ts are required to include more detailed information 

### ifthe incident they are reporting in volves human s and a higher severity outcome, although some incidents involving domestic animals are submitted as detailed reports and thus entered into Main 

### IDS. For the Main 

### IDS , from January L 2010 to .July 9 , 2015, there were no domestic animal incidents reported ford

### limonene in the database.
• Aggregate IDS consists of counts of exposures and severity index associated \vi th a particular product or active ingredient. and registrants normally submit no narrati ve information with these counts. 2 

### Because EPA's reporting requirements allmv 

### registrants to submit domestic animal incidents (DA, DB, DC , DD. and DE) as aggregate exposure counts and exposure severity and provide no narrative**details~** 

### the majority of the domestic animal data are merely counts of exposure SC\ 

### erity types, by year and entered into the Aggregate (and not Main) 

### IDS Module. For the Aggregate 

### IDS , from .January 1, 

### 2010 to Jul y 9**2015~** 

### there were 231 domestic animal incidents reported involving d

### limonene the database. Although they differ in level of detail , Main and Aggregate IDS collect both the severity of the exposure (called an ··exposure severity**type·~** 

### in 

### IDS ) and the pesticide and/or pesticide product involved (when the information is provided 

### by the person reporting the inci dent)
. The focus of this report is domestic animals/pet , and the IDS exposure severity types for domestic animals. as defined by 40 CFR § 

### 159.184, are as follows:

• DA

- Death

- if the domestic animal died or was euthanized: • DB

- Major

- if the domestic animal exhibi ted or was alleged to have exhibited symptoms which may have been life-threatening or resulted in re si dual disability; • DC

- Moderate

- if the domestic anima l exhibited or was alleged to have exhibited ymptoms which are more pronounced, more prolonged or of a more systemic nature than minor symptoms and included some treatment and return to pre-exposure state ; • DD

- Minor

- if the domestic animal was alleged to have exhibited sy mptom s . but the y were minimally bothersome and resolved rapidly: • DE

- Unknown

- if ymptorn are .unknown or not specified
. A 

### total of 14 

### incidents deaths were rep011ed to Aggregate fDS which means that the domestic animal died or \Vas euthanizcd. There \Vere 10 major incidents in V·/hich symptoms may have been life-threatening or caused residual disability. The remaining incidents were less severe: 41 incidents \Vere classified moderate \Vhich means that treatment may have been r eq uired but the**~** No te: Main IDS is organized by incident (and each incident has a unique report associated with it). whereas as Aggregate urnm ar y IDS is organized by counts of exposure (each with n designated "exposure cvcrity type") ass ociated with each pesticide product for a certain time period
. Page 3 of 4animal returned to its pre-expo ure state of heal th\ ith no rcsi iual disability ; 164 incident · were cla s itic<l minor which means that symptoms may have been min imally bother ome and re o l cd rapidly: 2 incident were uns1 ccified and may ha\ · e been either moderate. minor. or \Vere un _ pcci fie I and no in id nt w re clas iticd a unknown L:\·crity. Breakdown of the incid nt · by Se\'erity classification i
. round in Table 1. Tab le I. d-Limoncne D o mc s lic A nimal lncidcnls in I OS (Main a nd Aggregate) fr o m 1 998-20 13 Code e rity Aggregate ummary M dule D Fatal it\**I~** DB Major 10 DC M dcratc 41 DD Minor 164 DE 0 D-C. 2 D. E

- "'I

Out f th I product a . ociatcd with incid nt r ported l ID
. them ·t im1 lie t d produ ' l is Holiday Flea & Tick hamp ( Regi tration N
. _7-4- 

### 7: )
. Thi product \\'a

- rep rtedly usL:d in

2% n= 189) o f the d-limonene dome tic animal incident. Thi

- product contain -% of th1.: active ingredient d-lim ncnc. It is a shampo o u don dog
. and cat for flea and tick control. IV. ' ON L US IO A query f ID · for lim nl!nc and d-lim nenc P code : 0797 1. 17970 I) d m tic animal in id nt · ri·om Janu ry I. 20 I0 to July 9, 20 15. found 2**~I** repon d inc id nt**.** The c inc id nt were m stly clas itied as minor seve rit y wh ich means the animal exh ibi ted :ymp t ms w re minimally bothersome and re so lved rapid ly. Ba ed on the I )\V frequency< 

## r incidents rep rtt!d to ID , there doe not appear to be a concern at thi s ti me . The Agency will continue to monitor the incid nt data and if a concern i**trigg~r ed.**  additional an ly · i
. wi ll be conducted. In dditi n. it i
. imp rtant to note. n ith r e '.\q osure t pe 11 1 e r rep rtcd ymp tom ( r the conncc ti n between the t\VO) is validated or otherw i e c nfirmcd. Typically. cau ation cann t be determined b·1sed on inciden t data. ymp to m or signs cxpe ri enc d by the anim al may have been unrelated to pesticide treatment or may have been due to misuse of the pr duct.

Page 4of4