### Docket Number EPA- H Q-OPP-20 14-0 I 08 www.regulations
. gov



## Pol yoxin D Zinc Salt Amended Final Work Plan Registration Review C a se Numb e r 607 6 PC C ode: 230000 M a rch 2016

Approved by: ____ 

# /Z

__ {!l ___ c ___ _ Robert McNally, Director Biopes ticide and Pollution P reve n tion Divi s ion D ate: 

# _ 3 ---=--- {5 __._

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### I NT ROD UC TIO N This is the Env i ronmental Protection Agency's (EPA or the Agency) 

### Amended Final Work Plan (FWP) for the registration review of Polyoxin D Zinc Salt. Following the publication of the June 2015 

### Final Work Plan, the Agency identi fied tw o comments submitted in respo n se to the Pol yoxin D Z in c Salt 

### PreliminCIIy Work Plan and SummCIIy Do c ument (PWP). One submission was s ubmitted on behalf of Kaken Pharm ace uti ca l Co., Ltd. (Kaken), and included comment s regard i ng technical corrections, use and usage inf01mation , corrections to registered Polyoxin D Zinc Salt pesticide product information, and corrections to MR JD citations. The second sub mi ssio n was subm itt ed b y the Center for Bio l ogica l Div ersity. These comments did not change the Agency' s work plan as established in the PWP, and did n o t estab li sh the need for a n ew risk assessment on Po l yoxin D Z inc Salt. The specific comments submitted by Kaken and the Center for Biological Diver s ity are addressed below. Thi s 

### Amended Fina l Work Plan (FW P) document makes final the work plan for the P olyoxin D Zinc Salt registration review process. BA C KGROUND The Agency i s impl ementing the registration review program pursuant to Section 3(g) of the Federa l In sec ticid e, F ungi c ide , and Rodenticide Act (F I FRA), and will r ev iew eac h registered pesticide every 15 years to detennine whet h er it continues to meet the FlFRA standard for registrati o n. C hang es in science, public policy, and pesticide u se practices wi ll occu r over time. Th e registration review program is int e nd ed to make su r e that , as the ab ilit y to assess ti sk evolves and as policies and practices change, all registered pesticides continue t o meet the stat utory sta ndard. Th e public phase of registrat ion rev iew begins when th e initial docket i s ope n ed for each case . Information on this program i s provided on the Agency's website. 1 

### Polyoxin D Zinc Salt is a biochemical derived from 

### Streptomyces cacaoi var. 

### aso e nsis, a soil-borne actinomycete origin ally isolated in J apan. T hi s active ingredient is currentl y registered for u se on food crops , turf, a nd ornamentals to control and/ or s uppre ss fungal diseases of plants. The mode of action of polyoxin D z inc salt i s to prevent the binding of uridine diphosphate-N-acetylglucosamine to fu ngal c h itin synthetase and inhibit th e normal biosynthesi s of ch itin in fungi. In suscept ibl e fungi , po l yoxin D competes with uridine d i s pho s phate-Nacetylglucosamine for the chitin synthetase binding sites, resulting i n insufficient chitin for n ormal ce ll wa ll grow th and m aki ng th e fun gus unabl e to express it s p athogenicity again s t the pl a nt. Polyoxin D Zinc Salt is not used as a drug in human or veterinary medicine.

1 http: //www.epa.gov / op p srrd 1 /registration_review / 

### 2

### Agency's Re s pon se to Public C omments on the Pre li minary Workp l an and Summarv Docum e nt COMMENT#! 

### Agenc y's response to comment s s ubmitt e d on be half of Kak e n Pharma ce uti cal Co., Ltd.

1 3 

### 4 5 

### 6 8 

### 9 10 11 12 13 

### 14 1. Kaken Pharma ce utica l Co. , Ltd. noted that pa ge 5 

### of the Pre l iminary Work P l an and Summar y Do c ume nt co rr ectly notes that us es of Pol yox in D Zin c Salt we re exp anded in 2008 to includ e th e li s t e d food us es. How eve r, th e Pr e liminar y Work Plan and S u mmar y Document omits the S e pt ember 12, 2012 s ignifi c ant lab e l expansion t o includ e additiona l {ood c rop uses. Crop Group No. Crop Group Name Comments Root and tub e r vegetables Carrots, ginseng , par s nips, potatoes and suf!ar beets Bu lb

**ve~te tabl**  **es** 

### All crop f!roup m e mbers. Leaf y

**ve~tetab es**  

### All c rop

**~t oup**  

### m e mber s. Brass i c a (co le) leafy A ll c rop group m e mbers.

**ve~te tabl**  **es**

**Le~tum**

**e** 

### vef!elables A ll c rop f!roup m e mber s.

**Fruitin~t** 

### vef!etab les All c rop f!roup m e mber s. C u c urbit

**ve~t tahles**  

### All c rop f!roup m e mbe r s . Citrus fruits All c rop f!roup m e mbers. Po m e fruits All c rop

**~troup** 

### m e mbers. Stone fruits A ll crop

**~troup** 

### m e mber s. B e rri es and s mall fruits A ll crop

**~troup** 

### m e mb e r s . Tree nuts A lmonds and pi s ta chios. Crops not assign e d to a crop A rtichokes andpomegranates.

**~troup** 

### E PA Re s pon se : EPA c oncurs w ith including the mi ss ing information from the Septemb e r, 

### 201 2 , l ab e l expansion , w hich included a dditi ona l food crop uses. 

### Trade irritant s : C anada is a significant trading partn e r for food cro ps grown in th e U nit e d States . Currently, ther e ar e no Ca nadian MRLs for p o l yoxin D zi n c s alt . On September 18 , 2014, Kak en submitted an appli cation for Canadian MRLs (PMRA Submission No. 2014- 3 908). Expedited review has been re quested based upon th e inclusion of th e U . S . EPA d ecis ion do c ume nt s . EPA Re s pon se : E PA i s a w are o fKak e n ' s s ubmitted application for C anadian MRL s 

### ( PMRA Subm i ssion No. 

### 2014-390 8 ) . EPA ' s sc hed ul ed date fo r comp let ion of its r eg i stra ti o n re view d ec i s ion i s D ecember 

### 2016. Th e Agenc y will e xplor e o pportunitie s to comple te i t s decisi o n soo ner if poss i bl e .



### 3

### Comments 011 Table 2 regarding use a11d usage information: Tabl e 2 . P o l y oxin D Z inc S alt Use and Us a ge In f o rm a ti o n 

### Kaken Pharma ce u ti c al Comme11ts 

### EPA Respon se S ummary o f Us e 

### Polyoxin D Zinc Salt is r egist e red for The A g enc y c on c urs with the use 65 afeliHF SfJHIJ' 

### on food c rop s, turf, co rre c ti o n of us e informati o n. and ornamentals to con trol ami/or suppress {unxal diseases of plants. Us e Site s 

### C omme rcial agric ultur e 1 

### g o({ co urs es, The A g enc y concurs with the h om e lawn s and gardens, parks , tmd additional s ite u se commercial lmd industrial groumls 1 

### information. nurs e ri es, gr eenh o uses and s imilar structur es . S umm ary o f Usag e 

### 1) Sod for sale and oth er commercial Th e Ag enc y c on c urs w ith th e use; 2) comm e rcia l see d produ ction; 3) addition of u s ag e resear ch

j 4l comme r ci

al ag,ricullurej 5l information . h om e am/ earden. A ppli c ati o n m e thod (s) Pffld-ttefs CHJI be ttppf.ied by ltamllteld

**e~** 

### The Age ncy c on c urs w ith the medumiea!

**SfJFfiJ'e~s .**  

### Hmul
- h eld1 

### addition me thod s of ground1 

### and ae rial (pliar sera'(.. Band e d applic ation information. (in-{wrowl se.raf. . Ch e migation (sorink/ e r am/ drio) . Soil dr e n ch . T e chnical R e gi s trant lffH:e.H 

### Kaken Pharma ce utical CO. LT». All typographica l errors ha s Co . 1 

### Lid . b ee n no te d a nd addresse d . No. o f Reg i s tra ti o n s 

### 8 (681 73 -5. R egi s t

e red on D ecemb e r 11 1 

### 2 014.)_ Please not e that footnote 2 to Table 2 of the Preliminary Work Plan and Summary Do c um e nt s tat es, " Ref e r to th e Usage Report in Support of a Registration Review for Polyoxin D z in c salt (23000) in th e registration review docket for m o re details. " How ever, the referenced Us age Report is not included in th e docke t. 

### E PA Response: EP A note s the o mi ss ion o fth e abo ve me ntion e d ref e ren c e; addition of the reference w ill b e added to the docket.

The fo ll owing was omitted from EPA's bibliograph y and that are ref ere nc e d in Tables, 4, 6 , 7, 8 and 9.U.S. EPA 2012, Memorandumfrom Manying Xue, Ch emis t , U.S. Environmental Protection Agency to Colin Walsh, R eg ulatory Action Lead e r: "Polyoxin D Zinc Sa l t (EPA Reg. NO. 68173-1) Sci e nc e Review of Product Chemistry, Residu e Chemistr y, No n-targe t Organi s m and Toxicit y Data in Support of a Label A mendment , " May, 11 , 2012. U.S. EPA 2014, L e tter from Linda A. Hollis , Chief, U.S. Environmental Prot ectio11 Agency to Kake n Pharmaceutical Co., Ltd . regarding "Submission of data under F e d e ral Ins ecticid e, Fungicide, ami Rod en ticid e Act (F IFRA ) section 6(a)(2) that 4

### id e ntify impuri ti es notpr e vious l y li s te d 011 

### th e c urr e nt applicable C onfid e ntial St a tem e n t of Fo rmu la (C SF ) a11d imp u rities f o t md o ut s id e th e pr e vious l y a ppro ved ce rtifie d limit s," Mar ch 6, 2 014 . E P A Re s pon se: The Agency concurs with the correction to the omitted bib l iography . The bib l iograp hy w ill be inc l uded in the Final Decision document. 

### T

a b l e 3 o n pa ge 7 

### o ftlt e P re li m inar y W ork P lan ami Summa r y Do c u m e11t includ es ma n y e rrors ami omi ss ion s . P le ase see th e co rr ect e d tab le bel o w . T a b l e 3. In f or m at io n Abo u t t h e C u rre ntly R eg i ste r e d P o l yoxi n 0 Z in c Sa lt Pest ici d e P roduc ts EP A R eg. P ro du ct Dat e A ppli ca ti o n A pp li c ati o n Use S it es EP A R es 12 o n se No. Na m e R eg i s t e r ed " R a t es M e tho ds (%Ac ti ve i n g r e d i e n t ; F o rmu l at io n T y p e) 66330-41

**~tem9ef** Turf : 0.275 lb

**Foliar ~**  Turf(go lf The Agency notes 24 . 2002 a. i ./ A dren c h courses, that the column Fc bru!!fY 2 7, Gin se ng: 0 . 0 3 re s idential entitled D ate 2007

- 0 . 06 lb lawn s, Regi s tered ha s been a. i./ 10 0 gal /A parks , modified by adding Orn a mental s: commercial the qualifier 0.6-0 . 12 lb and s upersc ript A which a. i ./ 100 gal in sti tutional refers to the date of grounds 1 the most recently non-food accepted label. gin s eng; The product (66330- ornamental s 41) was federally ENDORS£TM registered on September 24 , 2002. (2.5% a.i.: The product label wettable was amended and powder) stamped accepted on 2

/ 27 /2007. The product label (storage & disposal) statement was updated via notification on 8 / 31 /2009. The Agency concurs with the additional application rates , methods and use site information. 66330

- 56 ENDORS ETM

**~eBFI:Ia~** ;; Up t o ;; 6 Foliar S (;!ra v, Outdoor The product was Water Jun e 5 , 2014 applications drench . agricultu r al registe red (66330- Di spe rsible Jul y 23, 20 15

**~** 4 . 2 oz · £hcmigation crops , 56) October 27, Granules a. i./ A) per (sprinklers greenhouse , 2005. June 5 th , ( 11.3 % a . i . ; season or drip nurse ries , 2014 & July 23, granular) irrig at ion ) turf, 20 15 constitute the 

### 5T a b l e 3. Inf ormati o n A b o ut th e C urr entl y Reg is te r ed P o l

yox in D Zin c Sa lt P es ticid e P rod u c t s EPA R eg. Produ c t D a t e Ap p li ca ti o n Ap p lica ti on Use S i tes EP A Res 12 o n se No. Nam e R eg is t e r ed " Rat es Me t h o d s (%Ac tiv e in g r e di e nt ; F

ormul a ti o n

T y p e) ornamentals mo s t recent stamped ' accepted label s. The Agency concurs with the additional application rate s , m

ethod s and use s it e inf o rmation. 68 17 3- 1 Pol yoxi n D August 29 , Not Not All food and The Agency concu r s Zinc Salt 20 12 applicable; a ppli cab le feed crO(! S with the a dditi onal Teclmical product is (Qre-harvest use s ite infonnation. (23. 8 % a.i.) for p esticide and manufacturing (!Ostharvcst). use only ornamentals , golf course s, re s identi a l lawns , pa rk s and commercial and in s tituti o na l gro und s 68 173-2 ENDORSE April 2 8 , Turf : 0.03-

**Fol iar**  **~** Golf courses, Th e Agency concurs W

ettabl e 2009 0.275 lb drench r es i dential with th e a ddit ional P

ow der a. i./A lawn , parks percentage of active Fungicide Gin seng : 0 .0 3 and ingred i ent , (2.5% a.i. ; - 0 .06 lb com mer cial app lication rate s . wettable a . i ./ 100 gal/ A and methods and use s ite Q

O

wder) Ornamental s : in s titutional information. 0 . 6-0 . 12 lb grounds , a . i./ 100 gal non- f oo d gin s eng , ornamentals 68 173-3 ENDORSE February 1 2 , **~** Ol: a . i . ! A

**~** F o liar

**(!ra~ .**  Co mm e rcial Th e Agency concur s Water 2014 ,) drench . outdoor with th e add iti o n al Di spe r sib le lilfles t seasen c hemi ga tion and ind oo r perc e nta ge of active Granules Food : Max (sp rinklers food use, in g r edient , ( I 1.3 %

**a.i. ~**  4 . 2 oz or drip turf , application rat es and , water a . i .A / s easo n . irrigation) o rnam ental s m etho d s and use si te di s Qersible Ornamental s : i n formation. granule s ) 0 . 03 -0 .06 lb a . i .LI 00 gal Th e Agen cy also Turf : 0 . 27 lb concurs with th e a.i.! A correction to th e application rate s . 

### 6Tabl e 3 . Informa t ion Ab o ut th e C urr en t l y Reg is t ered P o l y o x in D Zin c Sa l t Pest i c id e Pr o ducts E PA R eg. Pr odu ct D a t e Appli c a t ion Applic a ti o n Use S it es E PA

**es ~on**  **se** No. Na m e Reg i s t ere d " R ates Meth o d s ( % Act i ve in g r e di e nt ; Fo rmul a ti o n T y p e) 68173-4 Vegg i eturbo Ap ril 26 , Max . 4 . 2 oz Gro und or C omm e r cial The Agency concurs 

## sse 201 3 a. i./ A

/s easo n . aerial s pra y , emEioor with th e additional Sus pen s ion 3. 7S

- 6.S fl soi l drench , foo d u s e perc e ntage of acti ve Co n centrate oz pr oduct!A or in gred i ent , Fungicide (prot ec ti ve); ch emigati on app li ca tion rate s a nd ( S% a.i .: 6.S to 13.0 ( sprinkle rs methods

**~en**

**n** fl oz/A (high or drip information . concentrate) disease irrigation) , 

### ill pressur e or f urrow Th e Agenc y also s tand-alone co n c urs with th e app li catio ns . correction to the u se site inform at ion. 700S I- Nove l O.S % March S , Food and Foliar spra y Gen=uf!ereial The Agenc y concurs 11 6 SC Fungicide 2014 o rn am ent a ls : (hand outeeor with the addit i onal ( O

. S% a . i . ; Max. 2 pump

**~ee** lise percentage of active s us Q en s io n t easQOOn S spraye r, R es id e nti al ingredient , co nc e ntra te) Q rod uct I garde n h o m e an d application rates , an d guart water. s pra y e r, ga rde n , use s ite infom1ation. T ur f : I .S
- 3.0 mi s t e r, or res identi a l fl o z/ga l oth er s praye r turf. The Agency a lso water ; in a res id enti a l concurs with th e minimum of 2 indoor correc ti on to th e us e g a l mix / 1 , 000 and o ut door s it e infonnation. ft 2 of orna m e ntal s . trea tm e nt area. 6 81 73 -L P o l

voxin D C o mm e rcial Th e Agen cy' s PWP Zinc Salt gos t-h arves t for Polyoxin D Z inc 

## sse Salt addr e sse d Po s t- H a r

v e s t current registe red F

ungi c id e products containing Pol yoxin D Zinc Sal t a

t th e time when th e regi s trati on review pr

ocess began. The PWP do e s not addre s s pendin g a

pplicati ons at the tim e of document producti on. A Da te of most recently acce pt ed label.



### 7

### E P A R es pon se: The Agency concur s wit h the corrected tabl es . The updat e d tables will be included in th e Final Decision document.
Tabl e 4. S umm a r y o f Pr o du c t A n a lys i s D a t a f o r Pol yoxi n D Zi n c Sa lt H a rm o ni zed D ata Req u i r e m e nt H as D a t a R e quir e m e n t MRID No. or G u ide lin e Bee n Addresse d ? H ow? Oth er So u rce N umb e r 880.1100 Produ c t I dentity and Composition Yes- St ud y 43261809 44 2 14601 " 880.1200 D esc ript i on of Starting Materials , Yes- St udy 43261809 Pr

oduction, and Fonnulation Proc ess 432 6 1810 A 44214601 " 4922 77 01 8 880.1400 Discu ss ion of Fonnation of impurities Yes- S tudy 43261809 44 2 14601 " 44 2 49801 " 491 25 501 ° 49 2 27701 ° 830.1700 Preliminary Analy s i s Yes- S tud y 43261811 44 2 49701 ' ' 44 2 49801 \ 49277301 8 830.1750 Ce rtifi ed Limits Y es - Study 43291809 44 2 14601 " 49 277 301 ° 830 . 1800 E nforcement Anal y tic a l Method Yes- St ud y 43261811 43 26 1812 43261813 4326 181 4 43261815 4912 5 501 8 49 2 2770 3 13

A . U.S . E PA. 2 008 . B . U.S . E PA. 20 14 . 

### E P A Re s pon se : The Agency concurs with the corrected tab le. The updated tables wi ll be i nc lu ded in the Final Decision document.

**~** 

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### ogy D S b . d EP A 

### at

a u m rtt e 

### t o T a bl e 6 . S u m m a r y o f H u m an H ea lth Assess m e nt D a t a f o r Po lyox in D Z in c S alt H a rm o ni ze d Data R e q u ir e m e n t H as Da t a R e q u ir e m e nt MRID No. o r G ui de lin e B ee n Ad dresse d '? H ow? Oth er So ur ce

Num be r 8 7 0 .3 10 0 90-da v Oral (I Socc i es ) Ye s - Stud v

**4714 101**  **"** 870. 3 700 Pr e nat !J I Dev e logm e ntal (2"d Y es - S tud v 486 533 1 5 II Soc ci es) 870 .3 800 Rcgroduction and Fertility Ye s - Stud y 471 2 0904 \ E ffect s 870.5100 Bacterial Reverse Mutation Test Yes- Study 433 23 001 

### 8Ta bl e 6. S umma ry o f Hum a n H ea lth Assess m e nt Da ta f o r P o l yox in D Zin c Sa lt Ha rm o ni zed Data Req u ir e m en t Has Dat a Requir e m en t MRID No. or Gui de lin e Bee n Addr esse d ? Ho w ? O th e r So ur ce Numb e r 48653313 I) 870.5 3 00 In Vitro Mamma lian Ce ll A ssay Y es - Stud y 43 26 1835 8 7 0. 537 5 48653314 9 870.5395 In Vivo Mammalian Yes- Study 47145102 " C vtoe..enetics 880 . 3550 lmmunotoxicitv Ye s - Stud v 47120901 \ A . U . S . EPA. 2008. B . U . S . E P

A . 2012 . 

### E P A Respon s e: The A g ency concurs with the corrected table. The updated t able will be included 

### in the F in al D ec i s io n doc um ent. 

### Table 7: No n - Tar ge t Or g ani sm and Environmental Fate Data Table 7. Summary o f Non-Target Organi s m and Environmental Fate Data for P ol oxin D Zinc Salt Ha rm o ni ze d Da ta R eq uir e m e nt H as Da t a Req uir e m ent MRID No . or G u ide lin e B ee n Ad d r esse d ? How? O t h e r S our ce Numb er 835 . 2120 Hvdrolvsi s Ye s - Studv 48653304 A 8 35.2 240 Photodee.radation in Water Ye s - Stud v 48653305 , , 835.4100 Aerobic Soil Metabol ism Ye s - Studv 48653306 A 8 70 . 2 100 Avi an Acut e Oral Toxi c it y Y es - Stud y 43 26 1840 1;261841 870.2200 Av ian Dietary Toxicity Y es - f>ata Wai .. • eF Stud y 43261841 B 85 0 .4100 T e rres trial Plant T ox icity , Seedlin g Y es - Data Waiver U.S. EPA , **2008** Emergenc e 850.4150 T e rres trial Plant To x icity , V e getati ve Vi go r Y es - Data Wai ve r U . S .

**PA ~**  20 0 8 850.5400 Ah.tal Toxicitv Ye s - Studv 48660403 A 880.4350 Nontarget I nsect T e sting Ye s - Study 43261844 48660404 A A . U . S. EPA . 2012 . B . U . S . EPA. 1997. 

### E P A Re s p o n s e: The Age ncy concur s with the corrected table. The updat e d table will be incl u ded in the Fina l Dec is ion docume nt.



### 9

### Tabl e 8: Residu e Ch e mistr y Data Table 8 . Summarv of Residue ChemistrY Data for Polvoxin D Zinc Salt H

arm o nized Data R e quir e ment H as Da ta Requir e m ent MRID No. o r Guid e lin e Bee n Add r es se d ? How ? Oth er So urce N umb e r 860.1100 Chemical

**denti~** Ye s - Studv 48653307 " 860 . 1 2 00 Directions for U se Ye s - Study 4865 33 07 " 48653308 " 860 . 1 3 00 Nature of the Re s idue in Plants Y es - Stud y 48653309 A 48653310 " 48653311 " 860.1300 Nature of the Residue in Livestock Ye s - data waiver 48653307 " 860.1 340 Residue Analvtical Method Yes- data waiver 48653307 " 860 . 1360 Multiresidue Method Ye s- data waiver 48653307 " 860.1400 Magnitude of the Re s idue in Potable Water, Ye s - data waiver 48653307 " Fish and I rrigated Cro_g_s 860 . 1460 Food Handling Ye s - data waiver 4865 33 0 7 ' 860 . 1480 Magnitude of the Re s idue in Meat, Milk , Ye s - data waiver 48653307 ' ' PoultrY and E!!J?.S 860.1500 Croo Field Trials Ye s - data waiver 48653307 " 860.1520 Processed Food/feed Ye s - data waiver 48653307 " 860.1540 Anticioated Residue s Ye s - data waiver 48653307 " 860 . 1550 Propo s ed Tolerance s Ye s - Stud y 48653307 " 860 . 1560 Reasonable Ground s in

**Sum~ort** of the Ye s - Stud v 48653307 " Petition A . U . S . EPA , 2012 . 

### EPA Response: T h e Agency co ncu rs w ith the corr ec ted tab l e. Th e up d at e d table w i ll be in cl ud e d in the F inal Deci s ion d ocum e nt. 

### Tab le 9. regarding efficacy am/ mode of action data is n e w and is provid e d below. P le ase note that: 

### 1. Efficac y (maximum inhibitor y concentration) data were required by EPA to confirm thatpolyoxin D z in c salt is not an antibiotic; am/ 

### 2. Mod e of a c tion data we re r e quir e d by EPA to support the classification of po l yoxin D z inc sa lt as a biochemical p esticide. Table 9 . Summary of Efficacy and Mode of Action Data for Polyoxin D Zinc Salt Harm o nized Da ta R eq uire men t Ha s Da ta R eq uire m ent MRID No. or Gu i de li n

e Been A ddres s ed ? H o w ? Oth e r So urce Num be r 810 . 0000 Efficacy (to confirm not an antibiotic) Ye s - Study 4 32 61802 " 48653308B 810 . 0000 Mode of Action Yes- Study 4326180 3" 43261804 " 4 32 61805'' 43261806 " 4 3 26180 7" 4326J808 A 

### 10A. U.S. EPA. 1997 . B. U.S . EPA. 2012 . 1 43372101 ,\ 43372102 :\ 

### E PA Re s pon se: The Agency concurs with the co rrected table. The upd ated tab l e wi ll b e included in th e Final Deci s ion document. 

### COMM E NT #2 Agen cy ' s res ponse to co mme nt s submitted by The CENT ER for BIOLOGIC A L DIVE RSIT Y Th e Cent e r

for Biological Di vers i ty's (CBD) co mme nt s

fo c u s on th e EPA's du ty t o c onsult with th e U .S. F i s h and Wildlif e Service and th e Na tional Marine Fish eries Service (th e Services) 0 11 

### th e reg i s tration r ev i ew of P

o l

y oxin D Zin c Salt in accordanc e with th e Endang e red Species Ac t (ESA). Th e C BD co mme nts menti o n variou s asp ects of the risk ass essment pr ocess, including use of th e bes t available data to deve lop en dan ge re d species risk ass ess m e nt s, and evaluation of ef ects on e ndange red and threat e n e d s p ecies and th e ir des ignat ed c ritical habit at. CBD also exp resses c on ce rn reg arding th e rigor of th e Agen cy's pr e liminary de te rmination s r ega rding th e effect s of Polyoxin D Zinc Sa lt 011 

### endanger e d and threatened (liste d) species and th ei r des i g nat ed critical habitat for the Polyo x in D Zin c Salt reg i s tration r ev i ew . EPA R es pon se: E P A has r eviewed the comment s from CBD on the 

### Polyoxin D Zinc Sai l

**Prelimina~y** 

### Work Plan and Summary Document and plans to address m any of t h e co nc erns rai sed by C BD as p art of th e impl ementation plan for assessing th e risk s of p est ic ides to li s ted spec ies based on the recommendations of the April 2013 Natio n a l Academy of Sc ie nces (NAS) report. E P A wi ll address co nc e rns spec i fic t o Polyoxin D Z inc Sa lt in connection w i th the development of its final registrati on review decision for this pesticide.



### 11

### AMENDED TIMELJNE 

### Table 1: Registration Review for Polyoxin D Zinc Salt- Projected Registration Review Timeline Ac tivitie s Estimated Date Opening the Docket Open Docke t and 60-day Public Comment Pe riod for PWP Se ptember 2014 - Co mpl e ted C lo se Publi c Comme nt November 20 14 - Comp leted 

### Case Development Final Work Plan June 20 1 5 - Co mpl e ted A mended Fina l Work Pl an February 20 16 - Compl e te d 60-day Public Comment Pe riod for Draft Ri s k Asses s me nt NA 

### Registration Review Decision Open 60-Day Publi c Co mment Period for Pr o po sed June 2 016 Reg istration R eview De c isio n Close Public Comm e nt P e riod August 20 1 6 Final Deci s ion D ece mber 20 1 6 *Estim ated Total (years) 2 years and 

### 3 month s



### .. • Th1s schedule IS sub j ect to rev1s1on should unforeseen 1ssu es ans e dunng th e reg1 s trat1 on rev 1 ew proces s . In the eve nt an iss u e arises , s uch as th e fa il ure to acqu ir e an EDSP exemption , another amended Final Work Plan will be issued a t that time th a t will set forth a new timeline an d, if ap pli cable, a n y new data req uireme nts wi ll be in c luded in the amended document a nd a Data Ca ll - In Noti ce wil l be issu e d.



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