D ocke t Numbe r E P A -HQ-OPP- 20 1 4-0199 wwv .r . r eg ul a ti o n s.gov



# Boscalid Final Work Plan Registration Review

Case Number 7039
June 2015

Approved b y :



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**~:JD** Richard P
. Keig w in , 

## Jr. D irector Pe st ic id e R e -e va lu ation Di v i s ion

D ate:

### I NT ROD UCT IO N This i s the Env ironmental Protection Age n cy's (EPA or the Agency) Final Work Plan (FWP) for the reg istration revi e w of boscalid. Thi s work p lan addresses public com m e nt s received concerning the Pr e limin a r y Work Plan (PW P ) , which was posted in th e bosca lid registration r ev iew docket (E P A -HQ-OPP-2014-0199 )
. Boscalid, 3 -p y ridin eca rb oxa mid e, 2 -chloro- N

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- c hl oro[ I , 1'-bipheny l)- 2-y l ) , i s a carboxamide fungicide registered for th e co ntro l of several econom ic ally imp ortant d i se a ses, inc l uding gray mo ld o n seve ral crops , wh ite m o ld o n potato and beans, a nd lettuce drop. It is regis te red o n numerous agricultural and orchard crops, and as a seed treatment. It is a l so registered for u se o n go lf course turf , ga rd e n s , residential fru it and nut trees, ornamenta l s , includin g s hrubs and bu s h es, and on tomato plant s m ea nt to be transpl a nted into home gardens. The Age nc y is impl e m e ntin g the registration r eview program pur s u a nt to Sec ti on 3(g) of the Federal Insecticid e, Fungicide , and Rodenticide Ac t (F I FRA) , and will r eview eac h regis tered pesticide every 15 ye ars to detern1ine whether it con tinu es to meet the FT FRA s tandard for registrat io n. Changes in scie n ce, public policy , and p estici d e u se practices occ ur ove r time. The registration review program is intended t o m ake s ur e that, as the ab ilit y t o assess ri sk evolves and as polic ies and practices c h ange, all regi stered pesticides continue t o m ee t th e s tatutory s tand a rd. The public pha se of r eg i s tr at ion rev iew b eg in s when th e initial d oc ke t i s ope ned for each case. Information on thi s pro g ram i s provided on th e Agency's website. 1 The F WP be g in s with a ny updates sinc e th e PWP was i ssued. Next i s a su mmary of substantive co mments re ce ive d during the public comment p er io d for the PWP concerning anticipated dat a needs , ex pected risk assessments, o r the es tim a t ed tim e line identifi ed in th e PWP , and a summary of the Age n cy ' s r espo n ses to th ose com m ents. T hi s sec ti o n is followed by registration review planned data needs , ri sk assess m ents expec t ed to be conducted , and the projected registration re view tim e lin e for bosca lid. Lastly, there i s a discu ss io n of n ex t s te p s. 

### UPDATE S SINCE THE PWP WAS IS SUE D There are no additional updates on bo s calid s in ce the PWP (November 20 14)
. 

### SUMMARY OF COMMENTS AND AGENCY RESPONSES During the 60-day pu blic com ment period o n the boscal id P W P , wh ic h ope n ed o n D ece mb e r 19 , 20 14 a nd closed on February 17 , 20 1 5, the Agency received pub li c comments f ro m s ix stakeho ld e r s . Co mments were s ubmitt e d by the Nort h west Horticultural Counc il , FIFRA Endangered S p ec ie s Task Force , BASF Co rp ora tion , National A l falfa and Forage A lli ance, Ce n te r for Bi o logica l Diver s ity, and A l mond Boa rd of Calif ornia. The co mm e nt s do n ot a ddress the tim e li nc described in th e PWP , but th ey do address th e pl a nn e d eco logical and human health risk assess m e nt s and data require m e nt s . Consideration of th ese co mments did n o t result in a n y changes to the data th e Age n cy an ti cipates requiring for th e boscal id r eg i s tration review. The Agency w ill h oweve r consider waiver requests s ubmitt ed in response t o th e D C I. In the PWP , EPA a l so solici ted comments o n the s p ec i fic t o pic s of envi ron m e nt a l ju s tic e, water

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cw/ 2qual i ty concerns, and trade irritan t s, but no comments or information were received on those ISSUeS. Summa ri zed below a re s ign ifi cant pu blic com m e n ts th a t do not r es ul t in c h anges to th e anticipated regist ration review data needs , risk assessments, or time li ne. They are of a broader regulatory nature. Public comments in their entirety are located in the docke t , E P A

- HQ-OPP

### 20 14 - 0199. Co mment s s ubmitte d b y N orthwe s t Horti c ultur a l C ouncil in EP A -H Q -OPP-2014-0199 - 0015 I. Comment: 

### The Northwest Hort i cultural Co uncil commented on the importance of boscalid in the dec iduous tree fru i t indust1y in t he Northwest and also provided information on usage and resis tance development. Response: The Agency thanks the Northwest Horticultural Council for its comment and will take this infonnati o n into consideration. Co mment s s ubmitte d b y FIFRA E ndan ge r e d S p e ci es Task Forc e ( F ES T F) in E PA-HQOPP-2014-0199-001 . 1 2. Comment: 

### FESTF subm i lled a comment inform ing the Agency that th e tech n i cal registrant ofboscalid is a m e mb e r of the FESTF (or a company having met it s da ta compensation obligations) and is ent itled to rely on FESTF data. Response: The Agency thanks FESTF for its comment and looks forward to reviewing the FESTF data in th e context of the endangered spec ies assessment for boscal id. C omments s ubmitte d b y BA S F Corporation in EPA-HQ-OPP-2014 - 0199-0012 3. Comment: 

### BASF Co rpora t ion ind i ca ted that it intends to reques t waive rsfor some of the data EPA plans to ca ll-in for the registration rev iew ofboscalid. BASF also suggests alternative approaches to developing so me of the data th e Agency has indicated it im ends to require. Response: EPA will consider the waiver requests when B ASF responds to the boscal id registrat ion review DCI and provides a detailed justification for each data requ iremen t the company wishes to have waived. Likewise, E PA will take the alternative proposa l for deve loping ce rtain data into co n s ide ration at that t ime. C omments s ubmitted b y National Alf a lfa and For ag e Alliance in E J> A-HQ-OPP-2014-0199- 0013 4. Commenr: 

### The Na tional Alfalf a and Forage Alliance commented on the importance of boscalid in managing white mold and spring black stem and leaf spot in alfalfa seed and hay production areas.

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### Response: EPA thanks the Nationa l A l fa l fa and Forage Allia nce for its comme nt a nd w ill take this in format ion into considerat io n. Comments submitted by the Center for Biological Diversity (CBD) in EPA-HQ-OPP-2014- 0199-0010 5. Comment: 

### The CBD commentsfocus on the EPA 's duty unde r the Endangered Species Act (ESA) to consult w ith th e U.S. 

### Fish and W i ldlife Service and th e Na tional Marine Fisheries Service (the Servkes) on th e registra t ion revie·w of boscalid. Habitat data, including life h isto 1 y and spatial dis tribution, are provided for severa l listed spec i es. Response: EPA plans to address many of the concerns raised by CBD as part of th e implementation plan fo r assessing th e ri sks of pes ti cides to listed spec ies based on the recommendations of the Apr il 20 1 3 Nationa l Acade m y of Sc i ences (NAS) r eport, ava il able at http: // www .n ap . edu / catalog
. php?record

_ id = 18344. EPA w ill address concerns specific to boscalid in connection with th e d eve lopment of its r eg i stration review dec i sion fo r bosca lid
. The NAS report out lin es recommendations o n spec i fic scien t ific and techn ical i ss u es related to the deve lopment of p esticide risk assessments tha t EPA and the Services must conduct in connec t ion wi th th ei r obl igations under the ESA and FIFRA. At th i s t im e, EPA has not fu ll y developed its ri sk assessment process for listed spec ies. In November 2013 , the E PA , a long w ith the Services and the U.S
. Department of Agri culture, released a summary of their joint Int erim Approac hes fo r assess in g risks to li sted species from pesticides (see the whi te paper "Interim Approac hes fo r National- L eve l Pesticide Endangered Species Act Assessments Based on the Recommendations of the Nationa l Academy of Sc ie nces Ap ril 20 1 3 Report ," avai lable at http: // www.epa.gov/ espp/ 20 13 / na s . html)
. The In ter im Approaches were deve loped by the Agenc ies in response to the NAS recommendations , and reflect a common approach to risk assessment shared by th e Agencies as a way of addressing scient ific differences between the EPA and the Se rv ices. T he joint Interim Approaches were released prior to a s t a ke holder workshop h e ld on November 15 , 20 1 3
. In add i ti on, the EP A presented the jo int Interim Approac hes at the Decembe r 2013 Pesticide Program Di a logue Comm ittee and State

- F IFRA Issues Research and Evaluation Group meetings , a ll owing additional opportu ni ties for stakeho ld e rs to comment. As part of a p h ased, iterative process for furt her development of the In ter im Approaches , the Age ncies w ill a lso consider public comments on the Interim Approaches in the context of upcoming registration review dec i sions
. Comm e nt s s ubmitted by Almond Board of California in EPA-HQ-OPP -2014-0199-0014 6. Comment: 

### The Almond Board of Californ i a addressed the im portance ofboscalid i n almond production and th e need for con tinu ed s take hold er involvement in th e registration review process. Response: The Agency th anks th e Almond Board of California for its comment and will take thi s information in to considerat ion.



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### PLA NN E D DATA N EE DS Table I be low summa ri zes th e p l an n e d data n ee d s for bosca lid ba s ed on th e 

### R eg istration R ev i ew: P r oblem For m u l a t ion fo r Env ironmen tal Fat e, Ecologica l Ri sk

, Endan ge r e d Species, and Human H ealth Drinking Water Exposure Assessmen t sfor Boscalid ; and 

### B osc alid. Human H ea l t h Assess m e nt Scop ing Document in Support of Reg is tration R ev iew. T h e pl a nn e d data needs ha ve not changed from w ha t was included in the PWP. Tab le 1 : P l a nn e d D ata Nee d s f o r th e Bo s ca lid R eg is t r atio n R e v i ew Estimated G uid e lin e St udy T i t l e 1 T i mef r

ame N u m be r • Test Mate ri a l (Mo nths fro m rece ipt of DC I) Pl a n ned Data Nee ds for Bos ca li d 835.4100 Ae r obic so il m etab o li s m T GA I 24 835.4400 Anaerobic aqua tic metab o li s m T GA I 24 Ac ut e t ox i ci t y freshwater inv e rtebrat es - 850.1010 daphnid s (with bo sc alid alone and r e pr ese nta ti ve T GAI , TEP 2 24 e nd- use pr o duct s) 850. 1 035 Ac u te toxici t y es tuarine a nd ma r ine organ i s ms TGA I 12 ( m ys i d ) 850.1350 Aquatic in ve rteb rate life cycle (sa ltwate r ) TGA I 12 850.1400 Fi s h e arl y- lif e (est uarine / marin e) TG A I 12 8 50 .15 00 Fish li fe cyc l e (f re s hwater) TGJ\1 24 850.4150 Vegetative v i go r (c abbage o n l y) T EP 12 Envir o nme ntal C hem istry Me th o ds and 850
. 6 1 00 Indep e nd e nt Labo r atory val i dation f o r wa ter, TGA I 12 se d im e nt , a nd s o il fo r an a l ys is ofboscal i d Non- C hro nic s edime nt tox i city w i th Chir on o m us G DLN dilutus , H ya le lla azteca, a n d L e ptoc h e iru s TGA I 

### 24 plumulos u s 870.34 65 90- D ay inhalati on T GA I 24 fGAI = techmcal grade acuvc mgredrcrll. TEP = typrcal end-usc product
1 On June 27.20 12. EPA annou n ced certa i n r

e vi sions in harm on ized g uideline series 850- Ecological EITcc l s Tes t s - including renumberin g and ot h er designa ti on s o r c han ges for so m e g uid eli n e studies
. Sec "Fi n al Tes t G ui de l ines ; OCSPP 850 Series : No tice of Availability" 77 FR 38282. Ju ne 27, 2012
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s is n eede d f o r t he boscal i d pr od u c t

s th a i arc f o rmulat ed with o ther ac tive in gre di e nts. i

. e . • boscalid + p yrac l os trobin. bosca lid +p yraclos trobi n + lamhda cy h alo thr in, and boscal id +c hl o r o th al o n

i l.

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### R ISK ASSESSMENTS FOR REG I STRATION REV IEW 

### The most recent aggrega te r isk assessment was co mpl eted by B E D o n Septembe r 30, 2014 (0416695). The most r ece nt d ietary assessment that was included in that agg rega te risk assessment was comp leted on J u ly 16, 2014 (042 1151 ). R es idential and occ upational handler and post
- application risk assessme nt s were conducted around the same time. Th e most r ece nt ecological and environmental fate risk assessment was completed in 2003 (USEPA, 2003, 0278387). Findings and conclusions from th ese risk assess m ents are summarized in Regisrrarion Revie w : Pr e liminmy Problem Formularionfor Environmental Fare , Ecological Risk , Endangered Sp ec ies, and Human Heal1h Drinking Water Exposu re Assessments for Boscalid and Boscalicl. Human Health Assessment Scoping Documenl in Suppor r of Regis/ration Review, 

### wh ich can be fou nd in the docket fo r r eg is tration r eview
. During r egistration review, th e Agency will conduct a comprehensive eco logica l risk assessment , including an endangered species assessment , for all uses of boscalid. The Agency intend s to consider the need for bystander drift and volatilization human health risk assessments. I n add iti on , if toxicological endpoints or points of departu r e are revised based on the data that are required for registration r eview , they will be considered i n the new assessments , as well as any changes to the standard operat in g procedures or default exposure assumptions.



### 6Table 2 below summarizes the planned regis tra t ion rev iew risk assessments. The planned assessments have not changed from what was included in the PWP.
T a ble 2: Plann e d Risk A ss e ss ment s for the Boscalid Regi s tt· ation Review T y p e of Ri s k A ssess m e nt C onduct ? N ote s E cological and Environmental Fate Comprehensive ecological 

### y The Agency will conduct a comp rehensive ecological (s pecies to be assessed risk assessment for the parent boscalid , including an include terrestrial and aquatic endangered species assessment. organisms), including endangered spec ies Incidents Wi ll c heck for For a d i sc u ss i o n of r eported eco logical inc idents for updates boscalid, see page 21 of the Problem Formu lation. Hum a n Health **~** Dietar y Foo d 

### N Drinking water 

### N Occupatio n a l ll and lers ( m ixe r s, loaders , 

### N app l icato r s) Pos t -app l icat io n 

### N Reside ntia l Handlers 

### N Po s t
- application 

### y During registrat ion revievv, the Agency inte n ds to con s ider the need for b ys tande r d r ift and vo la tili z ation ri s k assessments. Other Aggregate 

### N Eva luates the combined risk from d ietary a n d r eside nti a l ex p os ures. Cumulat i ve 

### N Tolerances 

### N Incidents Will check for For a discussion of reported human incidents for upda tes boscalid , see pages 1 1 - 12 of the Seep i ng Docume n t and the 

### Boscalid: Ti e r I R e view of Human In c idents report.



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### TIMELINE 

### EPA has created the following es t imated timeline for th e completion of th e bosca li d registration rev i ew in Table 3 below. Th e projected timeline h as not c han ged since the PWP. Tab l e 3: Registration Review for Boscalid -Projected Registration Review Timeline Activities Esti mated Date 

### Opening the D oc k e t Open Docket a nd 60-day Publi c Comment Pe ri od D ece mber 20 14

- Completed C lose Public Co mm ent February 20 15

- Co mpl eted Case De velopment Final Work P lan Jun e 2015- Co mpl ete d I s sue D C I July

- September 20 15 Data Submiss ion July

- September 2017 60

-day Publi c Comme nt Per iod for Draft Risk Assessments 2 

### J anuary- March 20 19 Registration Review Dec i sio n 60-day Public Comment Pe ri o d for Pr opose d Reg i strat ion Rev iew October

- D ece mb er D e cision 20 19 Registration Rev iew De c i s i o n and B egin Post-Decision Follow-up 2020 Tota l (years) 6 NEXT STEPS 

### As noted previous ly, the Agency plans to re quire several env ironm en ta l fate, ecological effects , and human hea lth stud ies fo r bosca lid throu gh a D ata Call-In Notice, expec ted t o be i ssued in July

- Sep temb er 20 1 5
.

2 T h e r

egul at io ns governin g Regis trat io n R e v iew ge n e rall y require the Ag enc y t o pro vide a publi c co mme nt p e ri o d o f at le as t 3 0 cal e ndar da ys f or dra ft ri s k assess ment s; s ec 40 C FR Pan 155
. 5J( c)
. Fo r conventi o na l pes ti c id es , th e Ag ency plan s to pr o vid e a 60 calendar da y publi c co mm e n t p e ri o d gen e r all y f or dra ft risk ass e ss m ent s . 

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