### Docket N umb er EPA-HQ-OPP

- 20 1 5 -00 63 www .regulation s.gov



# Sabadilla Alkaloids Final Work Plan Registration Review

Case Number 3128
March 2016

Approved by: Director Pesticide Re-evaluation Division

Date :

### INTRODUCTION This i s the Environmental Protection Agency ' s (EPA or the Agency) Fina l Work Plan (FWP) for the registration review of sabadilla alkaloids. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP) , which was posted in the sabadilla a l kaloids registration re v iew docket (EPA-HQ

- OPP

- 2015-0063). Sabadilla a lkal oids is registered as an in sec ticide for the control of thrip s on citrus , avocados, and mango s. There are no product s registered explicitly for non-agricultural (residential) use s. The active ingredient is obtained as an extract from the ground see ds of the sabadi ll a plant. It 

### is a comp lex mixture , with the two primar y components being the alka loids cevadine (crystalline veratrine) and veratrid in e (amorphous veratrine). The remainder of the mixture include s smaller amounts of alkaloids s uch as sa badine , sabadinine, and sabadilline. The Agency i s implementin g the registration review program pur s uant to Section 3(g) of the Federal Insecticide , Fungicide , and Rodenticide Act (FIFRA) , and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA sta ndard for registration. Changes in sc ienc e, public polic y, and pesticide use practices occur over time. The registration review program is intended to make sure that , as the ability to assess risk evolves and as policies and practices change , all regi ste red pesticides continue to meet the s tatutor y stan dard. The public phase of re g istration review begins when the initial docket is opened for each case. Information on this program is pro v id ed on the Agency's webs ite . 1 

### The FWP begins with any updates s ince the PWP was is s ued. Nex t i s a s ummary of su b stantive comments recei ve d during the public co mment period for the PWP co nc erni n g anticipated data need s, expected risk assessments , or the es timated timeline identified in the PWP , and a summary of th e Agency 's responses to those comments. This sec tion i s followed by regi stration review p lanned data needs , risk assessments expected to be conducted , and the projected reg i stration re v iew timeline for sa badilla a lkal oids. Lastly , there is a discu ss ion of n ex t steps. 

### UPDATES SINCE THE PWP WAS ISSUED There are no updates on sabadilla a lka loids s ince the PWP , aside from the inclu s ion in this document of so me anticipated data requirements inad verte ntly omitted from the PWP. 

### SUMMARY OF COMMENTS AND AGENCY RESPONSES During the 60-day pub li c comment period on the Sabadilla A lkal oids Preliminary Work Plan, which opened on October 2, 20 1 5 and closed on December 1 , 

### 2015 , the Agency recei ved two public comments
. Comments were submitted by FIFRA Endangered Species Taskforce (FESTF) and McLaugh li n Gormley King Company (MGK). The comments do not address the time line d esc ribed in the PWP , but the y do address the planned eco logica l and human health risk assessments and data requirements. In the PWP , EPA also so li cited comments on the specific topics of e n vironmen tal ju s tic e, water quality concerns, and trade irritants , but no comments or information we re received on tho se is s ues.

1 http: // www2
. epa .go v / pes ti c id e-reeva l uation 

### 2

### This section does not capture every comment made about the PWP nor all of the Agenc y' s re spo n ses . No comments resu lted in changes to the ant icipa t ed regi s tration review data needs, ri s k assessments o r timeline. Public co mm ents are located in the public docket.
Comments s ubmitted by FESTF in EPA-HQ-OPP-2015-0063-0008. 

### Co mme nt: 

### FESTF noted that MGK is m ember of th e ta sk force and is e ntitled to mak e use of the FESTF database on species proximity to use s it es. Re s pon s e: T he Age nc y is aware of th e data d eve lope d by FESTF and will u s e those data to eva lu ate ri sks to li sted spec ies, as appropriate. Comments submitted by MGK in EPA-HQ -OPP-2015-0063- 0009. 

### Comme nt: 

### MGK noted the value of sabadilla alkaloids products to organic g rowers. Additionall y, th e registrant indicated that their in tent to develop th e data that EPA requires and, furthermor e, that they express interest in adding additional uses to th eir produc t s in thefutu re . R espo n se: E PA thank s MGK for the se co mm ent s and w ill take them into co n sideration. PLANNED DATA NEEDS 

### Table 1 below s ummari zes th e plann ed data needs for sabadilla alka l oids based on the 

### Problem Formula t ion or th e Environmental Fate, Ecological Risk, Endangered Specie s, and Drinking Water Assessments for Sabadilla Alkaloids, and the 

### Human H ealth A sses s me nt Sco ping Do cu m ent in Support of R eg i stration Review
. The planned data need s have changed from what was inclu ded in the PWP. The followi ng guideline numbers were inad vertently omitted from the PWP however , they h ave been includ ed i n the FWP : 860 .1 850, 860 .1 900 , and 875.2000. Tab l e 1 : Planned Data Needs for the Sabad ill a Alkaloid s Regi s tration Review
Guideline Number2

835 .61 00 St udy Title

850
. 10 I 0 Fres hwater invertebrate acu t e toxicity Estimated Timeframe Test Material (Months from receipt of DCI)

TGA l 3 12

2 On June 27 , 20 12 , EPA ann o un ced ce rt a in r ev is ion s in h armonized g uideline se ri es 85 0

- Ecological Effec t s Tests

- including renumbe ri ng and oth e r de s igna t ion s or changes fo r so m e g uid e li ne s tudie s. See · ·Final Test Gu ide lines; OCSPP 8 5 0 Series: N oti ce of Avail ability '" 77 FR 38282 , June 27, 2012. hnp : //www .regulation s .g ov/ # !documentDetail;D = EPA

- HO

- O PPT-2 009

- 0 1 54

- 0028 3 T GA I r e f

e r

s to a mi xtu r e of sabad ill a a lkalo id s that would be r e prese nt at ive of the ac ti ve ing r ed ient fou n d in the r egistered pro duct. It h as been reported t hat there is s i g nifi cant vari at ion i n the co ncentration s of ind ividual component s of th e active ingredi e nt am o ng s amp les of sa badi ll a a l kaloid s. As a re s ult , all TGA I s hould inc lude a co nfirm a ti on that the ma t erial co nta in s th e sam e re lativ e proport ion s of ve ratridin e, cevadi ne, sa badin ine , and sabadine
. 3Table 1: Planned Data Needs for the Sabadilla A l ka loids Registration Review Estimated Guideline Study Title Timeframe Number2 Test Material (Months from receipt ofDCI) 850. I 025 Estuarine/ marine in verte brate acute to x icity TGAI 12 (ea ste rn o ys ter i s the preferred te st s pecie s) 850. I 035 Estuarine/ marine invertebrate acute toxicity TGAI 12 (mysid s hrimp) 850.1075 Freshwater fi s h acute toxicity TGAJ 12 (cold water and warm water s pecie s) 850.10 75 Estuarine/ m a rine fi s h acute toxicity TGAI 12 850.1300 Fre s hwater inve1tebrate life cycle TGAI 12 850.1350 Estuarine/ marine inve11ebrate life cycle TGAI 12 850.1400 Fres hwater fish early-life s tage TGAI (co ld water o r warm water s pecie s , using the 12 sa me s p ec ie s as GDL# 850. l 075) 850.1400 Es tuarine/ marine fi s h early-life s tage TGAI 12 Whol e s ediment: in ve rtebrate s s ubchr o nic: 850.1735 fre s hwate r amphipod, H ya le lla azteca, and TGAI 12 mid ge , C hironomus dilutus Who le se dim e nt in ve rtebrates s ubchronic : 850.1740 Estuarine/ m ar in e amphipod, L e ptoch e irus TGAI 1 2 plumulosus Non- Who l e se dim e nt chronic ( te st in g w ith the mo s t GDLN 4 se n s itive spec ie s id e ntifi ed fr o m the s ubchronic TGAI 24 s tudie s) 850.2 1 00 Avian acute ora l toxicity (bo bwhite quai l or TGAI 12 mal l ard du c k ) 850.2100 Avian ac ute ora l to x ic ity (passerine s pecie s) TGA I 1 2 850.2200 Avian Dieta ry To x ic ity (bobwhite quail a nd TGAJ 12 mallard duck) 850.2300 Avian rep roduction ( bob w hite qu a il a nd mallard TGAI 24 du ck)

4 A ti e r e d te s tin g s trategy m ay be con s idered for the data reco mm ended to be r eq uire d for se diment toxicity. Under this s trategy, I 0-day sed im e nt to x ici ty te s tin g i s fir s t co ndu cted w ith H yale /la a z teca , Chironom us d ilutus , and l e

pt oc h e irus p/umulosus und e r OS C PP Guid e lin es 85 0 .1735 and 85 0
. 1 740. After s ubmi ss ion and r ev ie w of data from the se s tudie s (including a co mp ariso n of e s timated env ironm enta l co n ce ntrati o n s in se diment and pore water w ith to x ic i ty res u l t s from the I 0-d ay s tudie s), the Agency w i ll advis e th e reg is trant o n the ne ed for o ne or more c hroni c sed im e nt toxicity s tudie s


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### Tab l e 1: P lanned Da t a Needs for the Sabad ill a A l ka l o i ds Reg i stra t io n Review Estimated G u ideline Timeframe Number2 St udy Title Test Material (Months from receipt of DCI) No n- Honey b ee ad ult ac ute o ra l t ox ic ity (T ie r I) TGA I 1 2 G uid e lin e s No n- Ho n ey b ee a dult c h ro ni c o ra l tox ic ity (T ie r I ) TGA I 1 2 G ui de lin e s No n- H o n ey b ee larva l ac ute and c hro ni c ora l tox ic ity TGA I 1 2 G ui de lin e 5 ( T ier I) No n- Nec ta r a nd po ll e n res idue s tud y fo r in sect T E P 24 G uid e lin e 5 p o l lin ato r s (T i e r II) No n - Se mi

- fi e ld t es tin g fo r h o ney b ees (T i e r II ) TE P 24 G u i d e l in e 5 85 0 .3 040 5 F ie ld t es tin g fo r p o llin ato rs (T i e r III ) TE P 2 4 85 0 .4 100 See dlin g eme rge nce (T ie r I) TE P 1 2 85 0 .4 1 5 0 V ege t ati ve v igo r (T i e r II ) TE P 1 2 85 0.4 4 00 A qu a t i c vasc ul a r p l a nt growt h (Lemna spp.) T GA I 1 2 8 5 0 .45 00 A lga l tox i c i

ty (Pseudokirchnerie ll a sub capitata) T G AI 12 85 0 .45 00 Marin e d iat om (Ske leto n ema cos tatum) TGA I 1 2 850.45 00 F r es h wate r di a t o m (Navic ul a pe lliculosa) TGA I 1 2 85 0 .455 0 Cyano b acte rium (Anabaenajl.os-aquae) toxic ity TGA I 1 2 860
. 1 100 C he mi ca l id e nti ty TGA I 6 860. 1 300 Natur e of th e res idu e in p la nt s TGA I 24 860. 1 3 00 Natu re of th e res idu e in li vestock TG AI 24 8 60
. 1 34 0 R es idu e a na lyt i ca l me th o d s R es idu es o f 24 co n cern 86 0
. 1 36 0 Mul t ires idu e m et ho d R es idue s o f 24 co n cern 8 6 0
. 1 3 80 Storage sta bili ty Re s idu es of 24 co n cern 86 0
. 148 0 M ag nitud e of th e res idu es-- TGA I o r pl a nt 24 meat/mil k/ po ul try/ e ggs me t abo l i te(s) 8 6 0
. 1 5 00 M ag nitud e o f th e r es idu es--cro p fie l d tria ls TEP 24 8 60 .1 52 0 M ag ni t u de of t he r es idu es-- p rocesse d foo d/ fee d TEP 24 TGA I a n d 8 60. 1 650 S ubmi tta l of a n a l y t ica l r efe re nce stan da rd s r es idu es of 1 2 co n ce rn 8 6 0
. 1 850 Co n fi ne d a cc umul a ti o n in rota ti o n a l crops TEP 24 860. 1900 F i e ld acc umu lat i on in rota ti o na l cro p s TE P 24 8 70.3 15 0 90-d a y ora l , d og TGA I 24 870.3200 21/28 -d ay d e rm a l TGA l 24

5 T he need fo r T i er II and Tier III po ll in ato r data is co ntingent upo n the res ul ts o f the l owe r ti er tes tin g. 

### 5

### Table 1: Planned Data Needs for the Sabadilla Alka loids Registration Rev iew Estimated G uideline Timeframe Number St udy Title Test Material (Months from receipt of DCI) 870.3465 2 1 / 28

- or 90-day inh a lati o n , rat T GA I 24 870.3700 Pre-nat a l developmental toxicity , rabbit TGAI 24 870.3800 R e producti o n , rat TGAI 48 870.4200 Ca rcino ge n ic ity , m o u se and co mbin e d TGA I 48 chronic/ carc ino ge ni c ity , rat 870.6200 Neurotoxicity batte1 y: ac ute and s ub c hroni c, rat TGAI 12 870.7485 Ge n e r a l m e tab o lis m TGAI 24 8 7 0. 78 00 Immun o t ox icity TGAI 12 875.2000 Background for po st a pplic a ti o n ex p os ure TGA I 24 m o nitorin g tes t g uidelin es 875.2100 Di s lodgeab l e foliar dis s ipati o n TGAI 24 Planned Data Needs for the Veratridine Component 835.1230 / Leachin g and ad so rpti o n / de s orption 1 2 835.1240 835. 2 1 20 H y dro l ys i s 1 2 835.2240 Aqueou s photol ys is 1 2 835.2410 So il ph o t o l ys i s 1 2 835.4100 Aerobic s oil m etabo lism Veratridine 24 835.4 3 00 Aerobic a quatic m eta b o l is m 24 835.4400 A n aerob i c aquati c metab o li s m 12 8 5 0.1 73 0 Ac c umulati o n in fi s h 12 850.6100 Environmental c hemi stry method s & ind epe nde nt 24 lab o ratory va lid ati o n (so il an d water) Planned Data Needs for the 

### Cevadine Component 835.2120 H y drol ys is 12 835.4 1 00 Aerobic so il m etabo li s m Cevadine 24 835.4300 Aerobic aquatic met a bo l is m 2 4 

### TOAi = technical grade ac tive in gre dient ; TEP = typical end-u se product RISK ASSESSMENTS FOR REGISTRATION REVIEW Durin g reg i strat io n re v i ew, the Agency w ill conduct a comprehen s ive eco l og i cal ri s k as sess ment , includin g an e nd ange red s p ec i es assess ment, for a ll u ses of s abadilla alka loid s. For human h ealth , E PA will co nduct rev ise d dietary, re s id ent i a l , and occ up at ion a l ri sk a ssess ment s durin g reg i s tration review
. 

### If tox icolo g ic a l endp o int s or points of departure are rev i sed ba s ed on th e d a ta th at are r e quired for regi s tration r ev i ew, they w ill be cons id ere d in the new assessme nt s, as w ill a n y c han ges to the s tandard op eratin g procedures or default exposure assum pti o n s .

6Table 2 below s ummari zes the planned registration review ri s k assess m ents based on the EFED Problem Formulation and the HED Scop in g Document. The planned assessments h ave not changed from w hat was included in the PWP. 

### Table 2: Planned Risk Assessments for the Sabadilla Alkaloids Registration Review Type of Risk Assessment Comp rehe n s i ve ecological (spec i es to be assessed includ e terrestrial and aquatic organisms) , includin g endangered s ec1es Incidents 

### Conduct? Notes The Agency wi ll conduct a comprehensive eco log i cal a ssess ment including an endangered Y spec ie s assessmen t. Specie s to be assesse d include terrestrial and aq u ati c organisms. W ill c h eck for T here were n o reported eco logical incidents for updates sabad illa a lka lo id s. See page 1 3 of th e Problem Formulation for additional information.

### ~~**~~~~gz~ii] ~~~** 
Drinking water Occu ational Handler s (m i xers , l oaders , app li cators) Y The dietary risk a ssess ment may be revisited , as needed , to reflect new data and c urrent policy. Y Drinking water wi ll be reevaluated as part of registration re view
.


### y**t--~~~~~~ ~~~~** **+- ~~~~~** **---1** Occupationa l handler and post-application derm a l and inh al ati on assessments w ill be revisited to reflect all potential exposure scenarios , upd ated policie s, and Post-a li cat i on 

### y Residential Handlers 

### N

Post-app li ca ti on N

Other Aggregate 

### y Cumu l at ive 

### N new data. The labe l doe s not pro hibi t th e u se of sabadilla a lkal oids in res identia l sett ings, but given the u ses are c itru s , avocado , and mango , it does not appear that a re s i denti a l handler assessment wi ll be n eeded
. A conventi ona l residential post-application assessmen t i s n ot needed. T h e n eed for drift and vo l ati li ty assessments w ill be co n sidered during re a i s tration revi ew . As needed to re fl ect new data and c u rrent policy , for a re atin food and drinkin water ex osures. Sabadi ll a al kalo id s have not been identified as a member of a cumu l ative group th at shares a common mechani s m of to x i ci t
.

7

### Tolerances 

### y New data anticipated to be required will be used to establish tolerances as neces sary . Incidents Will check for There we re three incidents reported and classified as update s minor severity. For a discussion of reported human incidents for sabadilla alkaloids , see page 2 of the Sabadilla alkaloids: Tier I (Scoping) Review of Human Incidents. TIMELINE EPA ha s created the following estimated timeline for the completion of the sabadilla alka loids registration review in Tab l e 3 be low. The projected timeline ha s been updated to reflect impact s of public comment s received , changes to th e p lanned data need s , and/or recent actions. Table 3: Registra tion Review for Sabad ill a A lka loids - Projected Registration Review Timeline Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period 2015 October (completed) Close Public Comment 2015 December (comp leted) Case Development F in a l Work Plan 20 16 March I ss ue DCI 2016 Apri l -June Data Submission 2 0 2 0 April-June 60-day Public Comment Period for Draft Risk Assessments 6 

### 2021 OctoberD ece mber Registration Review Decision 60-day Public Comment Period for Proposed Registration Re v iew 2022 Ju lyDecision September Registration Review Decision and Begin Po s t-Deci s ion Follow-up 2022 Total (years) 

### 7 NEXT STEPS Ba se d on the sc hedu l e above , which include s stan dard timeframes for data development and the pub li c proce ss for re gistration review , the projected date for comp leting the sa badilla alkal oids regi stra tion review comes clo se to the deadline for completing all registration rev iew s b y October 1 , 2022. The Agency wi ll wo rk with the registrant to deve lop an expe dited plan for regi s tration review.

6 The re g u l ation s g overnin g Re g istration Review genera ll y require the Age n cy to provide a pub l ic comment period

of at lea s t 30 ca le nd ar day s for draft ri s k a sse ss ment s; s ee 40 CFR Part 155.53(c). For conventiona l pe s ticides , the Agency pl a n s to provide a 60 ca l endar day public comme nt period ge n era ll y for draft r i sk a s se s sments. 

### 8

### As noted prev i o u s l y, the Age ncy plan s to require e nvironmen ta l fate, ecologica l effects , and human hea lth ( r es idue , expos ure , and to x i co logy) data for sa badill a a lk a lo id s through a Data Ca ll-In Notice, expected to be issued April-J une 2 016
.



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