### Docket Number E P A-HQ -OPP- 20 15-0571 www.regulations.gov



# Acrolein Final Work Plan Registration Review

Case Number 2005
March 2016

Approved by: Director Pesticide Re- evaluation D ivision Approved by:

# -~ steVeKniZl1ef Director Anti mic robials Divis i o n
Date:

### INTRODUCTION This i s the Environmental Protec ti o n Age nc y's (EPA or th e Agency) Final Wo rk Plan (FWP) for the registration review of acrolein. Thi s work plan addresses public comments received concerning th e Preliminary Work Plan ( PWP) , w hich was posted in the acrolein r eg i s trati o n review docket (E PA-HQ-OPP -20 15-0 57 1 ). Acrolein is a restricted use herbic id e and algicide used for the contro l of s ubmerge d and floating aquatic weeds and algae in irrigation canals and irri gati o n re se r vo irs. Acrolein is also a restricted u se br oad

- s pectrum microb iocid e used to cont rol bacteria and fungi in oilfie ld water inje ctio n systems , and to rem ove h y droge n sulfide in o ilfi e ld operations. The Agenc y is impl e me nting th e reg i stration review program pursuant to Section 3(g) of the Federa l Insectic id e, Fungicide, a nd Rod e nticide Ac t (F I FRA), and w ill rev iew each registere d pesticide every 15 years to d ete rmine wh e ther it continues to mee t the FIFRA standard for regi s trati o n. C hanges in sc i ence , public policy , and pesticide u se practices occur over time. The regi stration rev i ew pro g ram is intended to make s ure that , as the abi lity to assess ri s k evolves and as p o licies and practices change , all re g is t e red p estic id es co ntinu e to me et the statutory standard

. The public phase of registration review beg in s when th e initial docket is ope ned for ea ch case. Information on this pro g ram is prov ided on the Age nc y ' s webs it e. ' The FW P begins with any updates since the PWP was issued. Nex t is a sum mary of s ub stantive comments rec e ived during the public comment p e riod for the PWP co ncern ing ant ic ip ated data need s. ex pe cted risk assess me nt s , or th e est im a t ed timeline identifi ed in th e PWP , and a s umm ary of th e Agency ' s re spo n ses to those comments. T hi s sect ion is followed by reg istrat io n revi ew planned data n ee ds, ri s k assessments exp ec ted to b e co ndu cted, and the proj ec ted regi s tr ation review timeline for ac rol ein. Las tl y . th e re is a discussion of n ex t step s. UPDATE S S IN CE THE PWP WAS ISSUE D Si n ce the P W P was i ssued, th e re have been two minor c ha nges to the registration review of acrolei n . Firs t , a data re quirem e nt was added to the Plann e d Data N eeds table , guideli ne number 860.1400 , a residue s tud y for fish and s he llfish , that is required based on th e us e of acrolein in reservoirs. Thi s was previously reference d in th e PWP as part of th e Anticipated Ri sk Asses s ments tab le und e r the Tole ranc es sec tion

. Second , the te st material for guide line 850.3020 , the honey bee ac ute contact t ox ici ty s tud y , ha s been changed from typical e nd use product (TE P ) to technic al grade active in g redi e nt (TGA I). Bo th c han ges have been reflected in th e Planned Data Needs tab le b e low. SUMMA RY OF COMMENTS AN D AGENCY RESPONSES Durin g the 60

- day public comment period fo r th e acrolein PWP , which opened on October 2 , 20 15 and clo sed o n D ecember I , 2015, th e Agency received one public comment. T h e comm e nt was s ubmitted by the Ce nter for Biolo g ica l Div e rs ity (CBD).

1 hnp : //www . epa.gov / oppsrrd 1 / registration

_ revicw/ 2

### CB D 's co mm ent d oes not address the ant icipated data requirements nor the timel in e described in the PWP. In th e PWP , E PA al so so licite d comments on the s pec i fic topics of e nviro nm ental justice. water quality conce rn s , and trade irritants , but no co mm ents or information were rece ived on those issues

. This section summarizes the public comment and provides the Age nc y ' s respo n se . T h e public comment in it s entirety i s located in the docket , EP A -HQ- O PP- 20 15- 0571. 

### C omm e nt s ubmitte d by C BD i n EPA -HQ -O PP - 201 5 -0 57 1-000 7 . Co mm e nt : 

### CBD ' s co mm en tsfocus on th e EPA's duty to co nsult w ith th e 

### U.S. Fish and Wildlife Service and th e National Marine Fisheries Service (the Se r vices) on the regis tration review of acrolein in acco rd ance w ith th e Endangered S p e ci es Act (ESA). C BD ' s co mm en ts mention various aspects of th e risk assessment process , including use of the best available data to develop endangered spec ies risk assessmen t s, and evaluat ion of effects on endange red and threatened (listed) species and their designated critical habi tat. C BD also expresses concern regarding the rigor of the Agency ' s prelim inmy dete rminations r egarding th e effects of acrolein on list ed spec i es and their des i gnated cri tical habitat. R es pon se: E PA h as rev iewe d th e comments from C BD o n th e registrati on review docket opening for acrolein and p lans to add ress many of the concerns raised by CBD as part of the impl eme ntati o n plan for assessing th e ri s ks of pesticides to lis te d s p ec i es ba se d on the recomme nd at io n s of the Ap ril 2013 National Academy of Sciences (NAS) report. E PA will add ress concerns spec ifi c to acrolein in c onn ectio n w ith the development of it s fina l re g i stration rev iew dec i sion for ac ro l ein. ln Nove mb e r 2013, th e EPA, al o ng with th e Serv i ces and the USDA, re leased a summary of their joint Interim Approaches for assess in g risks to listed species from pesticides. The Interim A ppr oac he s were developed jointly by th e agencies in respo n se t o th e NAS report recommendations , and reflect a com mon approach to risk assessment s hared by the agencies as a way of a ddress in g sc ientifi c di ffe renc es betw ee n th e EPA and the Services. T he NAS report2 

### outlines recommendation s on spec i fic scientific and technical issues related to the development of pesticide ri sk assessments that E P A a nd the Services mu s t conduct in connection w ith their obligations under the ESA and FIFRA. The jo int Int eri m App roaches were r e leased prior to a stakeho ld e r workshop held on November 15, 2013. In add iti on, the EPA presented the joint In teri m Approac hes at the December 20 1 3 P es tic ide Pro gram Dialogue Commi ttee (PPD C) and State-FIFRA Is s ues Resea rch and Eva luation Group (S FIR EG) meeting s. The agencies also held s tak eho ld e r work s hops in Apri l a nd October 20 14 , and in Ap ril 20 15 , a llowin g additional opportunities for stake hold ers to comment on the Interim Approaches. Additional workshops are planned to enhance stakeholde r involvement. As p a rt of a pha sed, ite ra tive process for deve lopin g th e Interim App roaches, the agencies w ill also cons id er public comment s o n the Int erim Approaches in connection with the development of upcoming Registration Rev i ew decisions. The deta i ls of th e joint Inter im App roac he s are contained in the w hi te pap er "Interim Approaches for Nationa l- Leve l P estic id e

2 http: // www.nap.edu/catalog.php?record

_ id = I8344 

### 3E ndan gere d Species Act Assessments Based o n the Recommendations of the Nat ional Academy of Sciences April20 1 3 Re port
.. 3
, dated Nove mber I , 2013
. Given that the age nci es are continuing to develop and work toward implementat ion of the Int e rim Approaches to assess the potential risk s of p esticides to li sted s p ecies and their designated c ritic a l habit at, th e eco lo g i ca l probl e m fonnulation supp o rtin g t hi s FWP fo r acrolein does not describe the speci fi c ESA anal ys is , in clu din g e ffects determinatio n s for spec ific listed s p ec i es or designated c ritical habitat , to be conducted durin g regis tration rev i ew . ln the ecological problem formulation document for acro le in , E P A described the scre ening-level risk assessment to dete rmine the potential effects of ac rol ein o n all taxa of non -targe t w ildlif e and plants , whi c h will assume that li ste d s p ec ies and th e ir d es i gnate d critical habitats may b e present in the v icinity of the app li cati on of acro le in

. This sc reen in g-level assessment will allow EPA to focus i ts future eva lua ti o n s on th e typ es of species where the potential for effec ts ex i s ts once th e scie ntific method s being developed by the agencies have be en fully vetted

. While the agenc ies continue to develop a common method for ESA analysis, the planned sc ree nin g -l evel risk as sess m en t for th e r eg i s tr at ion rev iew of ac rol e in will de scribe the leve l of ESA a n a l ys i s completed for thi s particular registration review case. Once th e agencies h ave full y deve loped and impl e m e nt ed the sc ie ntifi c m ethod s necessa ry to co mplet e risk ass essm e nt s for li s ted spe cie s and their des i g n ated critica l h abi t a t s, th ese methods will be app li ed to s ub sequent analyses for ac ro lein as part of comple tin g thi s regi s tration rev iew. 

### PLANN E D DATA NEEDS The table below s ummari ze s planned data n eeds for ac rol ein based o n the 

### R eg istration R eview: PreliminGJy Pro ble m Fo n nufationfor Env ironm e ntal Fate, Eco logical Risk , E ndan ge red Spec ies, and Drinking Water Assessm e nt sfor Acrole in (8 / 11/1 5) and the 

### Acrole in. Human Hea lth Assessment Scoping D ocu m en t in Support of R egis tration R eview (9/ 9114) documents

. Th e plann ed data ne ed s h a d two changes. Fir st, a data requirement was added, g uid e line number 860.1400 , a re s idu e stud y for fi s h and s he llfi sh , that i s required based o n the u se of ac ro l ein in re se rvo ir s . Th i s was p rev iousl y refe re nced in the P W P as part o f th e Antic ipated Ri sk Assessments table under the Tolerance s se ction

. Second , th e test m ate rial for guideline 850 .3 020 , the h o ney bee ac ut e contact toxicity s tudy , has been ch an ge d from typ ical e nd u se product (TE P) to technical grade active ingredie nt (TGA I )
. Both changes have b ee n refl ec t e d in the Pl anne d D ata Needs tab l e b e low . The ant ic ipated timelin e for acrolein h ave not c han ge d from what was id e ntifi e d in the PWP.

3 hnp :// www. e pa.gov/es pp/ 20 I 3/ n as. htm l
4Planned Data Needs for Acrolein Registration Review for Conventional U ses Es timated Guide line Study T itle T i meframe Number Test Material (Month s from receipt of DCI) 835.4100 Aerobic S o il Metabolism TGAI 24 850. 22 00 Av i a n Dietar y S ubacu t e Tox i city TGA I 12 850.4100 Seedling Em e rgen ce T EP 12 850 .4 150 Vege tat i ve V i go r TEP 12 850. 3020 Hon ey Bee Acute Con tact Toxicity TG A I 12 850 .3 030 Honey Bee Residue On Fo li age TEP 12 850 .3040 Field Te s tin g F o r P o llinat o rs TEP 24 860.1 4 00 Resid ue Study fo r f-i s h a nd S he ll fi s h TE P 24

Special Pollinato r Acute Oral Tox i city, Adult TGA I 12 S tud y Special Pollinator Acu te Oral T ox i c ity, Larvae TG A I 12 Study Sp ec i al Pollinator C hr o ni c Oral Tox ic it y. Ad ult TGA I 12 Study Spec i al Pollinator C hronic Oral T oxic ity. Larva e TG AI 12 Study P l anned Data Needs for Acro l ein Registration Review for Antimicrobial Uses
Guid e line Number Study Title

875.2500 Inhalati o n P os t-applicati o n Monito ring Data TGA I = technic a l g rad e acllve mgred1 e nt T EP = typical end usc product 

### RISK AS S ESSMEN T S FOR REGI S TRAT ION REVIEW Estimated T i meframe T est Material (Months from receipt ofDCI) T EP 24

Durin g registration review. the Age nc y a nticipate s the ne ed to conduct a comprehensive eco lo g ica l ri sk assessment, including an endangered s peci es a ssess ment , for all use s of acrolein. For human hea lth , E PA ant ic i pat es the need to conduct revised dietary ( drinking water). residen t ial post-application (vo la tilizati o n ), and occupational ( p ost
- application ) risk assessments dur ing registration rev iew. T he table below summarizes th e planned risk assessmen ts for the r egistration review of acro lein

. T he planned assess m e nt s for acrolein h ave n o t changed from w h a t was includ ed in the PWP.

5

### P l a nned Ri s k Assess m e n ts f o r Acro l ein R eg i str a ti o n R ev i ew Ty p e of Ri s k Assess m e nt Co nduct ? Notes 

### Ecological and Environmental Fate Comprehensive ecological 

### y risk a ss essment , including e ndangered s p e cies Ecological Incidents Will ch e ck For a di s cussion of reported ecological incidents for f o r update s acrolein , see the 

### Proble m Formulation. 

### Human Health Dietary Food y The ne e d for a drinkin g water assessment will be Drinking water considere d during regi s trat ion review. If a drinking w ater a sses sment is conducte d , the A g ency may al s o re vise th e dietary asse ss ment. Occupational Handl e rs ( mi x ers , loaders , y An updat ed quantitativ e occupational handler expo s ure applicators) a s sessm e nt may be needed to incorporate air monitoring data. Post-application 

### y An updated quant itative post-application occupationa l e xposure asse ss ment i s anticip a ted f o r both the aqu a tic he rbicid e use a s well a s the bacteriocide use to incorporate po s t-application air monitoring data. Residential Handl e rs N There are no proposed or curre nt residential uses for acrolein ; theref o re , a quantitative re s idential handler exposure asses s ment i s not anticipated to be needed for re gistration review. Po st-applicati o n y T he ne e d for a post-applicati o n resid e ntial a ss essm e nt (from vo latilization) will be considered for registration re view. Other Aggre g ate 

### N The need for an aggre g ate ass es sment will b e c onside re d during regi s tration r ev iew , contin ge nt up o n the determination on a drinking water analysis and / or a re s idential po s t-application anal y si s . C umul a ti v e 

### N E PA ha s not made a c o mmon mechanism of toxicity finding for acrolein and any other sub s tance ; and acrolein does n o t app e ar to pro duce a toxic m e tabolite produced by other sub s tances.



### 6Tolerances 

### y The n eed for to l e rance s in crops will be r e - evaluated once th e natur e of the residue study in a root a nd tuber crop i s subm it ted, which was requir e d as part ofthe regi s tration eligibility document (RE D ) and was included in the Data Call-In Not i ce (G DCI-00070 1- 28207) as a resu lt ofthe RED. Thi s res idu e s tud y is currently being conducted and w ill be subm itted to the agenc y in 2016. In addition , ba se d on th e u sc of ac ro le in in reservo irs, the agency will eva luate th e need f o r tolerance s for acrol e in in/o n fi s h and s h e llfish. Human Health Incident s Wi ll check Fo r a discussion of report e d human health incidents for for updat es acrolein. see the 

### Sco ping Doc um en t and the 

### Acro lein : Tier I R ev i e ll · of Human In c id en t s and Epidemiology document. 

### T I MEL I NE EPA h as created the following es timat ed timelin e for the completion of the acro le in registration revtew.
R eg i st rati o n Review for Acro le in- Projected Re g i s tration Review Timeline Activ iti es Estim ate d Date Opening the Docket Open D oc ket and Public Comme nt Period 20 15

- September

- Completed C lose Public Comment 2015

- Nov emb e rCompleted Case D eve lopment Final Work Plan 2016

- March

- Completed Issue D C I 2016

- Aprii

- Jun e Data Submission 2018

- April

- June 60 -Day Public Comment Peri o d for Draft Risk Assessments 4 2019

- October

- Decemb e r Registration Review Decision 60- D ay Public Comment Period for Propos ed Re g i strat ion R ev iew 2020

- Jul y - Decisi on August Registration Review Decision and Begin Pos t- D ecision Follow-up 2021 Total (years) 

### 6**The** r eg ulation s governing Re g is tration Revi ew ge nerall y require the agency to provid e a public comment period of ar le ast 30 calenda r days fo r draft risk assessments: see 40 cr: R Part 15S.S3 ( c). Fo r conventiona l pesticide s . the agency plan s to provide a 60 ca lend ar day public com ment period ge ne ra ll y for draft ri s k assessmen ts. 7

### N EXT ST E PS As n oted p r ev io u s ly, th e Agency p lans to req ui re studies fo r ac ro lein through a D ata Call- In Notice. expected to be issued in Apri I to June 20 1 6
.



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