# EPA Petition File 7F7252

# · '



### ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180**[EPA-H~PP-2008-0417;** 

### FRl-8389-5]
Polyoxin 0 Zinc Salt; Exemption 

### from the RequiremE!I1t 

### of a Tolerance

AGENCY: 

## Environmental Protection Agency (EPA),

ACTION: 

## Final rule.

SUMMARY: 

## This regulation establishes an exemption from the requirement of a tolerance for residues of the polyoxin D zinc salt (zinc 5 -[ [2·amino·5 '0-( aminocarbony l)-2-d eoxy- L· xy lonoy I]amino ]·1-( 5- carboxy·3 ,4-dih ydro-2 ,4 -dioxo-1 (2H)

- pyrimidiny 1)-1,5 -dideoxy 

# -p-o.- allofuranuronatein) on almonds, cucurbit vegetables, fruiting vegetables, ginseng, grapes, pistachios, pome fruits, potatoes and strawberries when applied/used as a biochemical pesticide to control and suppress fungal diseases. Arysta LifeScience North America Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of polyoxin D zinc salt (zinc 5-[[2-amino-5-0-(aminocarbonyl)-2-deoxy-L-xylor;oyl]amino]- 1-(5-carboxy -3, 4-dih ydro- 2,4-di oxo-1 (2H)- pyrimi di ny I) -1,5 -di.deoxy 

# -pD-allofuranuronatein).

DATES: 

## This regulation is effective 

## [imer.t date of pl.lblication in the Federal Register). Objections and requests for hearings must be received

on or before 

## [insert dale 60 

## days after date of publication in the Federal Register], and.mus\.be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit 

# I.e. of the SlJPPLflMENTARY 

### INFORMATION).

ADDRESSES: 

## EPA has established a docket for this action nnder docket identification (ID) number EPA-HQ-OPP-2008-0417. All documents in the docket are listed in the docket index available at 

## http:// www.regulations.gov. Although listed in the index, some information is not pnblicly available, e.g., Confidential Bnsiness Information (CBI)

or other information whose disclosure is restricted by statute. Certain other material, sllch as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form, Publicly available docket materials are available in the electronic docket at 

## http:/ /www.regulations.gov, or, if only available in 

## hard copy, at the opp 

## Regnlatory Public Docket in Rm. S-440[J, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, V A. 

## The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday throngh Friday, excluding legal holidays. The Docket Facility telephone number is (703) :10S-·5805.

## 2

FOR FURTHER INFORMATiON CONTACT: 

## Chris Pfeifer. Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs. Environmental Protection Agency. 1200 Pennsylvania Ave .• NW., Wa.shington, DC 20460-0001; telephone number: (703) 308·-0D:ll; emaIl address: 

## pfeifer.c1ms@epa.go v

.

SUPPLEMENTARY INFORMATION:



### I. 

## General Information


## A. Does this Action Apply to Me?
You mal' be potentially affected by this action if you ar9 an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities mal' include, but are not limited to:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufe.cturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive. but rachel' 

## provides

a guide for readers regarding entitie" likely to be affected by 

## this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Cls.ssification System (NA.l.CS) codes have been provided to assist you and others in determini.ng whether this action might apply to certain entities. If 

## you have any questions regarding the applicability of this action to a particular entity. consult the person listed under FOR FURTHER INFORMATION CONTJler.



## B. 

## How Can I 

## Access Electronic Copies of this Document'
In addition to accessing electronicaliy available dOC'ifrients at 

## http:/ /www.regulations.gov, you m.ay access this Federal**Reg:~s1m:** 

## document 

## electronically through the EPA Internet under the "FBdoral Register" listings at 

## http://www.epa.govlfedlgstl'. You may also access a frequently updated electronic version of 4,0 CFR part 180 through the Government Printing Office's e-CFR site at 

## lJttp://www.gpmccess.gov/ ecfr.

C. Can 

## I File an 

## Objection 01' 

## Hearing Request? Under section 408(g) of FFDCA, 21 U.S.c. 3468, 

## any DE-'son 

## may file an objection to any aspect of t"lis 

## regulation and may Eliso 

## request

a hearing on those objections. The EPA procedural regtL;atiuns 

## which
govern the submission of objections and requests fm' hearings appear 

## in 40 CFR part 178. You must file your objection or re'll'est a hearing

on this regulation in accordance witle. the instructions provided in 40 CFR part 178. To ensure proper receipt by 

## EP!l. yon must itientify docket ID number EPA-HQ-OPP-2008-'041.7 in the subject line on the first page of your submission. All requests must be in writing, and must

## 3

be mailed or delivered to th" Hearing Clerk on OJ' 

## befo]'(, limer! 

## date 60 

## days after date of publication in 

## tlie Federal Regist""J.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit 

## a copy of the filing that does IC.Ot contain any 

# eEl for inclusion in 

## the public docket that is described in ADDRESSES. 

## lnformatioI'. not marked confidential pursuant to 40 CFR pert 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID 

## number EP A-HQ-OPP-2008-0417, 

## by Olle of the follo1Ning mpthods.



## • FedemJ eRu1emaking Portol: 

## http://ww,,,;.mglllo'Jons.gov, Follow the on-line instructions for submHting comments.

• Mail: 

## Office of PHsticide Programs (OPPJ Regulator) Public Docket (7502P), Environmental Protect'on Agency, 1200 P8'lnsylvania Ave., NW., Washington, DC 204(,0

.. ·OD01.



## • Delivery: opp 

## Regulatory Public Docke'·: (7502P), Environmental Protection Agency, Rill. 05-4.400, ODe 

## Potomac Yard 

## (South Bldg.), 2777 S. Crystal Dr" Arlington, VA. 

## Deliver:;es are only ","cepted during 

## the Docket Facility's normal hO'llfS 

## of opmation (B:30 -"I.m. 

## to**(~,** 

## p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed informati.on. The Docket Facility telepho;1e n:.;mber is (703) 305-·580.3.



## II. Background and**StalutorJ'FindiTl~'** 

## In the Federal Register oOuiy 31. 

## 200S (73 FR 44?19) (FRL-8374- 3), EPA issued a notice pursuant to s6cti"n 408(d)(3) of FFDCA. 21 U.S.C. 346a(d)(3), announcing the filing of a pestic:,de 

## t,,,,,m'1rter. petition (PP 7F7252) by ArystB LifeScisllC8 North America Gorpo''ol!ioll, 

## 15401 Weston Parkway, Suit<5150, Cary, NC ?7b13, 

## Th8 

## petitii>.'J.**r,·~ql:,ested** 

## that 40 CFR part 180 be amended 0]' r.slablishing an exemption from the requirement of a tolerance for fBGiduer.:: 

## of pO 

## lynx in D zinc balt (zinc 5 -[ [2-amino-5 -0-( 

## arrjnocarbo n y 

## 1)- 2· deoxy L- xl" lonoy 

## I jaminG 1·1·(5- carboxy-3,4-dih ydro· 2 ,4-dioxo

.. 1 (2H)· 

## pyrimid,in y 

# 1:: -1 ,5 ·dideoxy. 

# 13· Dallofuranuronatein). This notice incLcl"d a summary of [he petition prepared by the petitioner Arysta LifeScience North America Corporation. There wel'e no 

## cmnn18nts received in**~espons€** 

## to the notice of filing.

Section 408(c)(2.)(A)(i) 0;' 

## FFDC!, ailows EPA· ,', 

## est"b;L h 6:, 

## exemption from the**req~irement** 

## fc:J' a tolerance (thE**.~eg2~** 

### li:nit 

## for a 

## pesticide chemical resie,u8 

## in or on 8. 

## foodJ only iT EPA. de[onnillHs 

## that the exemption is "safe, ' Section 408(c](2](A](ii) 

## 01 FFDCA ,'d,nes "safe lJ 

## to mean that "thera is a 

## TSB.sJl1abla certaint'l that IW 

## harm will result from aggregate exposure to the p'esticide chemical residue, including all anticipa.ted dietary 8ZpOSafGs 

## and. all**othl.~r** 

## exposures for which there is reliable inforrnatio:n "**Tl~L** 

## includes**expo~m.::e** 

## through 

## drinking water and in residential sHttings, 

## but does not J.nc1 '.ale

## 4


## occupational exposure. Pursuant to s"cli.nD. 408(c)( 2)(B\ 

## 00" 

## iFOCA, in establishing or maintaining in effect HIl.**8J~8mption** 

## from**t~~f~** 

### IBqyirement 

## of a tolerance, EPA must take into aCCmlG 

### t 

## the factors set ,-(Y'th**~n** 

## section 408(b)(2)(C) of 

## FFOCA, which require EP.'I. 

## to givE c?8cial consideration to 8XDosure 

## of infants and childre}.; to the**P8~:ticicl8** 

## chemical residue 

# jn establishing a tolerance and to**"tm~~ln'3** 

## that there is a reasonable certainty that no harm 1NUI 

## result to infantE end children from aggregate exposure to 

## the peshcidechernics.l:esi{b.e " Additionally, section 408(b)(2)(0) 

## ()f FFOCA requires that t'le_Agency consider "available. information concerning the cumulatiVE 

## etfects of a particular pesticide's residuHs " and "0 

### the)' substHllC8:,; 

## i.t,.at ha'h8 

## a comllon 

## mechanism of toxicity."

EPA 

## performs a DUDlber of**8.naly!:jef~** 

## to 

## deterrcine :'Le**r~:)ks** 

## from aggregate exposure to pr3sticide res1dues, Fi.rst, EPA d,:::trrm 

### D.es 

## the toxicity of pesticides. Second, EPA. 

## Hxc,:rc':'nes exposure**'~O** 

## +he. p(;!stic:ide through food, drinking wat8I', 

## and through oth.er exposures that occur

as a result of pesticide llse in res i 

## .d,;:mti!11 ';;ettings

III, 

## Toxicological Profile Consistent with sec; ion. 408(b)(2)(0) 

## of FFOei'" EP",. h:,s 

## reviewed the available scientific data and other relevant infolTQrltion :n support ofthis action and considered its validity, comp],skness. 

# ","J reliability and the relationship of this 

## inforr:W':ction i:n**huma~l** 

## risk. ,'::;Pi\ has 81so considered available in2ormation concGrning the variaul1itj of t.he sensitivities of major 

## identifiable**sJ.bgn>l.~ps** 

## of**GGrLsu.r~H:'::"5,** 

## illcLlding infants and children.
Polyoxin 0 zinc salt is a brown musty smellil'.r, powder derived through the fermentation of the mjcrobe Streptomyces cacaoi val', 

## asoensis, which was iso:ated from a soil sample cr.llected in Ja:;Jan. It 

## is registered with EPA. 's BiopesUcidet; cmd. 

## Pollutisn**P~Fvr1utioJl** 

## Division (BPPD) 

## as a biochemical active ingredient intend,d br 

## incorporation into spm.yable fungiddes**~~C'T** tUEf.**A~~** 

## an**gC'~>V'3** 

## ingredient, it has a**non~toxic** 

## nlOdD 

## 'Jf action,**wh~ch** 

## acts against**fl~.ug~;** 

## not by 

## killing it, but by inhibiting chitin growth il'. the cd! 

## "dis. ,:ild 'hus precluding the development of fungal mloHi"s. liE 

## effects are considered**fungi~exclusj.v8** 

## in that it has '"0 

## mode of action relative to mammals. Polyoxin D zinc salt does not persist in.**,~he** 

## 811V.lrOaE1ent, biodegrading readily w,thin 2 to 3 days. Finally, polyoxin D ZiIlC salt has a well understood lcN, 

## toxicity prom".
Polyoxin-D zinc sal: was first f1ss2sseJ 

## by EPA in '1**~)P7** 

## ,."'ith regard
to the human health ri:;xs**associn~,')d** 

### wif:i 

## its fllrq),::::idnl U.:C

### Uj~ 

### 'lcrf. 

## The risk assessment**cl,~,n:::luded** 

### th2t 

## the c J 

## .lIl1rcerrj:.d tll

,. -**!,:::~.** 

## s T[ 

## polyoxin D zinc salt pns(Hl }flt) 

## heal.h r:s}:.!:: to f.it:_ll': OC:'1

### ~ 

### ;JfL.:: 

## and users

or to any**non~occupaUoilal** 

## populations**~b.8.t** 

## migh:: 1]8 

## c)()osed. A battery of acute and chro:;1Jc toxico 1 

### .ogics.! 

## studisf;,**s'J.bmitt(~d** 

## in support of this non-food use, showed that poJyoxin 0 

## zinc :sal:**ind~cEld** 

## "minimal toxic affects tl) 

## humans through oraL 

## del mal, 

## oClLlar or

## inhalation routes of exposure."**Th(~s(J** 

## studies included all acute toxicity studies, mutagenicity studies, develop:meutal stL:..dws, 8Tlct 

## t;xposure and oncogenicity studies. Additionally, EPA's 

## risk 8:;S8SSIr,-em: 

## considered the active ingredient in 

## light of the requirements of 

## the**i-'~ood** 

## Quality Protection Act (FQPA) and made a determinaUoc, of "e'casoD,able certainty of no harm to human health," Altogethe::', the Agency's 1997 risk assessment of polyoxin D zinc salt c()ncludEJd that them are no risks expected for acute t 

## subchronic, chronic, immune, nndocrine, or nondietary cumulative exposures due to the negligible toxicity associated with the active ingredient.

New toxicity data 

## h-3.ve since 

## beer:. submitted 

## In sur'}.,.J- L 

## of**~"he** 

## request by the applicart to allow food ,lS\'S

### (d9t;;j~fd Ll

### t;~i~. f'ki,U) 

## of 

## this registered non··foc,d use active ingrechent. Th:':;G8 

### oal.a f..-{'v·e 

## been incorporated into a 

## comprehensivE l'L:;k**c:1jSes~:mont** 

## on F'Jl,yo:dr: D 

## zinc salt and provide sufficient grounds fur 

## this 8xernption f:';)r':\ 

### tIw 

## requirement of a 

## toleraoce. The new dat2 inc: lIds- a new 

## rnutagmlicity study, a gO-day subchronic oral**to){ici~Y':3tudy,** 

### a 2·--g8EBL'3tion 

## developmental toxicity study, an iml1UulOtoxicty**~;tlJdy,** 

## and calculations for terrestrial residues, 

## 11.11 new data confirm a 

## lack of human health hazard associated 1Nlth dietary exposurw:, 'l'1188e 

## new toxicity data, coupled with tho dauJ. 

## to suupOrl1fJ.EJ Dl'ig:nal 

## :wn-·food
uses, allow for a com.plehensivl;:! dletary Ilsk analysis, au:i 

## j:,dl J , 

## demonstrate polyoxin. D zinc sah slack ot' 

## acnte. subchIUIlic, and/or chronic toxicity with rebaI'd to 

## dietary 8ApOSlr.i'EL 

## ldl da .i:: 

## substf1ntiate the lack of dietary risk**associate(~** 

## vyjJh t'he fOlJd USG 01 

## !=·c.l:,/oxin D 

## zinc salt.

All data supporting the use of pol)'oJ:in D 

## "in: sa]' on :he 

## food crops mentioned in**thi~,** 

## rule confirm that the dietary**ris]~s** 

## to b .l,nlans

are negligible for the foj ;owing re2"OIlS:

i. 

## The fungistatic r'locie of 

## fiction ,Jf this activp ing r '( ,dlf'JI 

## i:; 

## specific
to fungi and poses no eisk 

## to**.~nam'I18Js,** 

## ii. Polyoxin 

## D zinc salt is not c5.8,(-'!stiUe 

## by m';:l,m.Inf:

..**~,** 

## BP.O passes through the digest;,ve s)'stem,

iii. Theoretical (potential) resioues are subsl.actially 

# 1,,[;" than the doses that were actually llsed in pclyo,,jn D 

## z:.nc baIts' toxicity studies. which showed virtual**n\}n~toxicit\i. ~**  

## iv. A 

## complete ba.ttery 

## of toxkolugical studi8<; she,," nc 

## toxicological enapoints and cOllHnn 

## the c.ctive ing.<'ed18(li 

## 's very low toxicity. For the**re~iSOllE** 

## listed in this i.'lui

_, 

## any**pCLGnt;E~** 

## re:;idu'i3S 

## of polyoxin D 

## zinc salt fF8 

## conside:red 

## tu hE 

## -;afe 'Njt:h 

## reg-?**'~ll·)** 

## dir:tary risk. Summaries oftbe**~dPporting** 

## Dxicological**:-..1:fonnc.tLl~** 

## nff\; found in this unit.



## 1. Acute toxicity. i.cute toxiCity ,::tqdies 

## v':ere**3nb::::.ljUr;'i".~:0** 

## support the initial registration of polyoxin. D 

## zinc**s~Jlt.** 

## TheE8 studies ShOV'i 

## a

### 6



## lack of significant aClltH 

## toxicologj_cal endpoints, 8.:"ld :;"i.i.pp!.Jrt 1"he, 

## finding that polyoxin D zinc sal,: pc)S"S 

## ne signifiu,:tLIC.cEl health risk with regard to food. uses listeclin the**s"J:n~,mary** SOI':.tlOL 

## or**,~;** IS**,~tocument.** 

### A 

## precis of the acute toxicity StUd;8S 

### fol1c.ws:

i. 

## The acute oral LD50 

## is greater than 10,000 milligrams/kilograms (mg/kgJ in rats, a result that confirms acule non-toxicity tLwugb 

## the oral route, and undergirds the risk aS38ssmen'l 

## fin.-:i.ing th,ji 

## o.nyamount 

## of residues of polyoxin D zinc salt, if cnl1sulTIl3d, i:?, 

## not d. 

## health concern.

ii. 

## The acute derma: LD;"o in n1ts 

## is greater thaE 2,000 rng/kg in rats. and demonstrates very low toxic 

## ity through dm'Tra i**:~;::( PG~!_lre.**  

## While no significant**d':~rmal** expo,;;,uTO 

### !B 

## expected as 

## a.**J\~I;ll!'\** (1j 

## pesticidal applications assoc:iatecl with tl'ese new fooel :.1se:". tbose data substantiate polyoxin D 

## zinc salt's**r81atiw~ non~iuxiciJ:y**  iT 

## Loth occupational users and**'~he** 

## general public.

iii. 

## The acute**inha~ation** 

# Le so JS 

## great.er than 2,,:P .mg/L in rats, and shows no significant inhalatjon toxiclty. Again, nu signitJcrwt Dew 

## inhalation exposure is expected; and relatedly, 110 

## risks me expected for occupational**user~;** 

### OT 

## the gene.:al ")ubHc m; a l'o.'1ult of**th~Ge** 

## new 

## food uses.


## iv. Primary dermEd l,rritatjon l:C rahL}:::s \V[',$

### cc..,_\Si('8~i:;{1 

### :;jqht. 

### which finding bolsters 

## thE1 infe·rmatioD**pll~~;er;** 

### Led in tho acutE.' 1-

### Ar~';}aC 

## toxicity study,

v. A 

## hypersensitivity study 011 

## guinea pigs fmth.er (,eDWTlstrated 

## that the active ingredi13nt was Ilot p, 

## donnal sensiti"2:m.**T~'8** LcutG 

## toxicity studies demonstrate tha:.: even 

## if th9r-a 

## weT'e**rEl~;id.U8S** 

## preSGi)'( oil 

## food, 

## there would be negligible toxic e:ff(,cts aseociated with pobnxin [) zinc salt.


## 2, Mutagenicity. DT:a demons 'Btelb,t polyOJuD D ,-" sni.' is nonmutagenic. Acco:,dingj.v. rm;iduBs**FiSl~,:;dwed** 

## lvith L:18

### H(~h 

## :fist 

## .cidal food uses of polyoxin D 

## zinc salt are 11()t, 

## c.xpectE'c ':0 

## pmw Bliy 

## nsk to 

## humans with regard to mutagenicity, Studies submitted in support of the original 1997**regi-2t1."£t~oli** 

## of polYDxin 

## D zinc f,;ilt fint**,"hilVi;,~d** 

## the active ingredient to be 

## 1Nithout ll1u::2,gel1ic. effHct. 

## 1/\"hile Hi 

### ,\rnE;', 

## Assay (Master Record IdentiHcation NUTI:!.h:;:T 'i\1IUD 

### 433230--01); dlOV.-od 

## polyoxin 

## D to be weakly mutagenic, 

## a batl:ery I)f 

## '(l:'ee**com~dementary** 

## mutagenicity tests supported**neg~tu:vG** 

## cOi-cclusioHb for rEu 1 :cgen,cHy. In further support of that finding of 

## non· ilJu.,agenicity, DC 

## P!.o1't--;rna!. toxicity

or developlnental toxidi:j**~vVfll'e** 

## ob:;e: 1 

### 'ed 

## .n a de\i,;:'- 

## '.:prn

.. .i'i

.. 

## :Ll**~c}** 

## ,deity 

## study subml 'tted at 11'1"' i'111E (" 

## "I" '" "T" 

## 'l "f') "'I'''''''' W 

## t v 

## 'wo

L (:1;, t. " ,S.i!\... L'**~t".::"J",** -',),) • ..tYt,.L1;::' .,-:,-,t,,, 'J 1**~** 

## additional studies vverB submitted ifJ. 

### sup.f;ort 

## of :

..**l(Jn~IEuLagA:dcity** 

## with regard to a food use. A Tier II MaulInaUan ErythI0cyte lvticronncleus Study (OPPTS 870.5390; !vIR1D**471L~5102)** 

## showod no i),}'L,I.dl-,en.lC 

## effect. The test material was II rJ1 

## toxic to male -,'-l:l;,Ce aL 

### all '. 

## dcse ,bs!sd, dud 

## there were no reported 38X c],i[fel'e:uDGS 

### 1-0.**,.'espon~j(~ ~o**  

### chl;- tfJ;:"L, 

## In a second study, polyoxin D zinc so.It was !:e-sted cO**i:Jd~** 

### 1nl;-[1 C ():;·3 

## of 2,000

### mg/kg on mice. The I(tic8 Si1(lvvecJ. :.10 

### diLI.cal si.g:;';- OT

### .;rn,~'L-j:~y, 

### and there was no significant increase ill 

## Lw frequrHlC) of**m~ci'on1ic~eated** 

### peEs, further indicating no mutagenic effect. The**mL't:3.3!;-3.n!clt~,** 

### studies

are sufficient to confirm tha.t there 

## are no 

## expected diHl-lty. 

### occupational, or non-uu:upationai risks c,f IDlltag('.nir::] 

## t>' \\':i.h 

### n-,gard to



## new food uses,



## 3. Subchronic toxicity. Polyoxin D 

### zinc 

## salt**b~iS** 

### very l:-)1.,\1 

### subchronic oral toxidty, 

## and dem lD:-;trat8s a lack 

### Clf cii.er2.I'· risl( Ht the subchronic leveL In a fJO-Day Oral ToxiCity Btuciy 

### ,)n I'f!' : 

# t ---pp rs 

### 870.3100; MRID 4714L·101), '::Jo,l'y'u::ln L; L'De 

### sal: t;"c;l:mi.""Ji. ,vas



## d " d j. ,'- 

## 'fl"·-'.,

, , --" '"**,'~.-'",** --.",,1;

..**<.;~.' .~'(,,-,**  

## t 

## a IDlnlstere to len rdl.).**~dlH** WGJ8 J.,.'J

.. u),h."OLt..,g.,_<,,:d,., "_b L 'Ll,--,d_1. 

### treatment-related**effect~,** 

## on f:;lOctHl.l[y,**·'~(--,!Jlrolog:';~8.'** .:Jr.:;: :r,'::f\'Bl1tG, 

### urinalysis, ophthalmc.lclgYl**heillaw~,Jgy,** 

### clinic:al**c~'le~T.lisi,::y** 

### and gross and histologic pathology found nD C;.illict.i. 

### signs**'~'ftO';-:i:.~Gl.Lslcully** 

### significant treatment-f818.ted effects. 

## The no·,obsHrvr3d-adv(J] se··i3ffect 

## level (NOAEL) in this study is 20.')00 

## parts per IYl.!liol] (0]!.11) 

## (1.,333 mg/kg/day) in females and 2,000 fern; In9 lTl:s/k8/day) C<1 

### ",al0S, 

## The lowest-observed-adv812s-eE'"clle',dj 

## fL:Jc\EL) in n ,let< 

## ,>WCO ppm (1,166 mg/kg/day) ba

.. iE3L( 

### on 

## decJ'8n.seu hcdy ,!\'eig;':I: 

## Cu';!\,**~,~<' (~,**  

### loud consumption and fOCkt efficienc1', q 

### LO/l.'-:1, 

### was lhot 

### aG:;",-;:,\;

.. 

### ,(i i "t 

### females. Based on the i.ack oE**lIl8ahingnIl3ubch1'~)[itc U),.;.~;t**  

### lUgJcal endpoints for the tech.T:jcal 

## graoe i:.'.cti\ll:J

__ llgredii;)Itl. 

## (Te,.L !.\El 

## ilmgiexclusive mode 

## of actiOu as 

## a chiun. synb.stase hJI.LOilIJL. d 

## d Ul8 

### related lack of toxic o;·'.d effec[ in rn';:;lTliildis, 

### thel'f;**dn~** '10 ;',;, 

### Jchronic oral toxicity concerns 'VI'I.th 

### polyox:.n 

## D Zi:lC salt.**:~I'** i5 

## fr:.,·JE'! 

## 'Qu:.e.d that the proposed use**pRtteJ'r~s** 

## fOJ this '::ICL.iye .lngrerli.G::. j 

### 8.l'b :,)):. 

### ");pc:cted
to result in any repeated and/or 

## lOj',g-tHrnJ expDsdr,:: 

## b)i**'~,iJ,,~J** 

## the dermal

or inhalation routes; and as 

## a. L'8SlJ.ci, I 0**(k~l'mBI** (j-f 

### l:lh;:d_LI,11/

,**~i)'-.lchronic** 

## studies are required to ""lalIEs!: k " ['y.ciJSL



## 4. Developmen16i .'oxicily, T'JC:",1**d~~:'-nc,ns[l'atu** 

### .. 

## Lat**'p~)i>[)L~n;J** 

### zinc salt is not a**developJ!le~:.tal** 

### or rE;pr<,dl!.::d'" I;; toXt('tl[;L**T.H'~,~)** :lLi.C 

### iugs 

## further confl 'rm pol'j 0'"'' 

## D Z I 11(' '" ' ,', 

## Ie L,I, 

## of ':II"

,., 

### ,,1,'" " V 

## ,'c'· 1\; 

## and
_'"

__**~** _,**.;)",l'~'** c."' i '" " .•. "-.J.",'(" •• C' /L '_., 

### demonstrate a lack of Cilotmy effect**I.Gr-;.si.~.t8Ilt** w\ilj 1

### ~s ,:'.J.Hgi 

### --oxclusive mode of action. A Tier 

### iiI TIVQ**G8[1.E.J:'~itLm RGprOCl~:.;~:·Cl,OL**  

### 'L;x:,cj;·::'-' 

### Study (OPPTS 870.3800j tv.m

.. ljj '1?12D9G.Q} DE 

### raJ::**ShOW~j:i** 

### HOI_Hi?' ltal 

### systemic toxicity or 

## dH'fol'ences in ;}\\.**~:un.** 

### of**Bi.tl.:~: g(~:IL**  

### '8 1 

### efG 

### llJo abnormal' clinic,,=,l SI'gr," 'VP'TP**('I"''-'er'Tf·'I'·:--:''ll;''l·l~O** [1'-,·" ,.,:.;,.**;,~,'** "),,,: 'I" 

### any ,-'--

...**~'-'** ,.'-" ,.",' ,,<:''--'

... L, .·.L e '.,.l '--''-'-r ",-,,

__ , '''''' 

### generation. No signifi;,!'l, ,,t 

### d:ff8!8:::_,:..:es**Vd:!_".~** 

### fo'tmd b3tv';'EiIC,:':. 

### ,:'uHtod and control groups with regard**tc~** 

### thE: averap:e number 0'S 

### liFe**!J:~** 

### 11lS 

### per litter) average bw of liv(!i PUP,3,**(;~;SULC<ilL:n.'** 

### fdi.lnI'e 1.',rr}'L3 L.,lL·:;, 

### ossification center, or i)0.ne 

### \'ari::dic)Ll

. .l',Jo**~;,lfforfxl** /:;<S**\'1i'.~;** I': ,'_·",ullri. 

### in the number of stillbirths**<-l~** H.1. W8S111.11g ,;:lit"!. l\](' 

### spfJci**~i,:** 

### e.bn(.l'Ll<·**'11l-h'~** 

### in postnatal growth or geliELral behavlClf 1!'II68 

### .:ound !)':::[Ti\':D;;)t**lr~.::)Jed** 

### and control groups. No chf£:r::-aTlc(:Js Vv'81'1' 

### d.8'luc;ed 

## -,n IllHting,**f'l~'(~,:_'fJ.5,LCy,** 

### delivery> or nursing faL8 

### bV gell 

### 8ral;on bmwBE:H 

### tt**~-: ;:rt:.klt\.~;::;.**  ell) 

### ,d ':':Olltrol
groups. No chemical 8iL,'Sts ';}sre 

## f- 'L.t>,::: 

### h**maJE:!~1** 

### U: 

### fen'", 8-', 

### rlr:: 

### reproductive NOAEL '(;"**po~:-'uxm** 

### ], 'i'1**,~,** 

### ·;alt is -j**1~,,:** H 

### :_,t')/\ 

### :L (f"a:} 

### not

### identified. Again, the dElta**indicaL~** 

### tr 8 

### fT,ngistatic**'lat-.l,:;~ :~'**  

### deLve 

## ingredient and the ca:'ecity "f**pO,~,<»il** 

# r: ziac 

## sd tG:1,,' ti'rc Igh mammalian digestive :',ystems, In .'hlil1,

, 

## t1 8 

### stnd> dmn ,t, ;;l 

### bel a olear lack of reproducti'v8 

## to)jcity regard ing**d.'i,,~tary e;q)cml~;r,**  

## roil l, 31, 

### ppOlts the Agency's conclus;,:Y:' that there is. flO: 

### 18k 

## of dn'i8J.n[-,Tcf'· 

### ;ial**~.oxicity** 

### associated with the rw,'v 

### food uses

5 J 

### t**·,·-<--,-~·ll·** v:**"'~,-** ,.,'it·,-, ,';'··"·-l;-'·-.··

..**~ona**



### .. mmuno OX1C.l!.y_ xa**'yO~'-lll!J** ,;.Hl,**~a,t** b 

### ro -,-,"ILl' ';-'

, ·,lIJ'. L 

### dietary basis. No 

## meaningfuJ imnFw:'(\:Ux.i.c:ity**endl)oi:Lt~:** (j.'-., 

### dietarily possible) for polyoxiD. 

## D zinc salt '\,VBr8 

## lch:mEfied. ':n ali 

## 1m L'Jrotoxicity



## t d b d d ' t',' " """**'~'JJ'''''** 

## ,', "'/'" 7 o l'l f 

### "P,', 7 

### "'J901) 

### s u y ase on 1e**a~,Y** LXptj-:O,-,-yg,:. \',.

_, -,-,,) :.:> v. 0 '" ,IV_,'_,___ J.-'-'>

, 

### polyoxin D 

### zinc salt 'C13c;.rnical "1)"

### 0.~ 

### nd m 

### iI"**i~ltered_ ~(**  

### :;:n i :, 

### in \ li.t:;',r 

### diet for 28 

### days at variou:, CffllCtnlTaticJJ$.

### r_~'J:-, ;m 1:'!6',,{, ,';:; 'l:,;:.',1: 

### p _;,**~l** 

### _i,"related deaths or effects 

## on**cUli~cal** 

## olX,el't,:dth;;_d" bw 

## Or 

## :iWG. ': c '1' j '_ 

### ,:n;;;:"Jn. 

### There were no**COn:~pOll;'ld"'rejated** ,;nacl'Gs:=:up_i_,:.;

### L_lnlIlg~ 'J.tj 

# ';c1, ,md
organ weights were Lllidile-ci::,d, n."31'E:

### \\'e~re 

### no**(;.~);'r;,p(r·_!r** 

### :l'r'-,;au\d effects

on the humoral imlnunl' respouse _c**'~-}-)8 ':"~de'Je:'idr:dY~**  

### '-Ui. 

### 'tm, ,RBC. 

### This study shows 

## the ; ,';[ck**iJ~** diBtE 

### 'Y '1::')(

### ()03U~'.i ;):)' 

## i..1J.8 1:;ll.

### _~!lU; 

### oxicity of poly ox in D 

### zinc 

## salt IBSid1.l8S, C'lL(.(**i~}pport.s** 

## cne --xelr'il;"Ul h\HU 

### the requirement of 

## a tolere.'f)_ce 

## by Iurt1..er d.n:mons1.f8.th11-6 

## a 

## Ide L.-.f t(,xic endpoints,

6 Cl1ronl 'c oVI10" '-"i"1'1""'-"1'- 'i'-'" 

## B'**('L"O~** r'" 

## --l' (i

-**"l'~** 

## D

. , v."',,**'~c'** v l'U6l;' ;1('.1.--, ,,)0' Vi;**~** i:j**~** __ t '-' i'-"j" :<, ;,,_ 

### zinc salt.is not a**chrOJi._'l~ to~,;j.,--:aHL**  ':u Glll;mjtW_,**R(~~** o.-l;_L3 ij**~** 

### <**U;~\** - t, 

## toxicity/oncogenic,:t} studies (MRU, ,13;,')18

.. 31'. 

## cud l)'"" 

### ,Ltkclted 

## that there were 

### no**sign~fic::-.** 

### __**.~ tox~dty**  

### u r 'JQl'() 

### 4BIl1;'" l>;,,'JpC'l.\.:>i.: c 

### .t" L'_,] I' 

### e 

### dosed 

## wl 'thpolyo 'nD '"'j",,,,_e,,,,,,,, ',', "j'l')""'1 ,e":l '" 

## ,d Xh Zl.Ilv"." U",.-!L,), c.l", :.t,8 '\_h,

..**~** ...**,\i'-i~ ('A~L~nv**  

### to be 2,058.7 

### Ing**TG.(~J/J-.;g** 

### L'-f,;/daji .l1**~'n,:.IJ-:'S** 

### c1.I;,d 

### ;J,,-:l:lhi-,G 

### ,'t,**l.·~i** 

### .lJkg 

### bw/day in fenlales. ThH data show LilH 

### .tat**i:~_** 

### of chrG_'tic**CD:,j,~** ;'i,,! 

### oncogenicity posed by .::detcu'y eXF'_-"::;LF' jlJ pc,YOX:.!l

### ~!**~'i':'.':'** :;,:Hi:, 

### and further demonstrate the runglstGtic**nf,tl~.rE'** 

### of 

## t:'n9 He 

### tl 

## VE' "**'-~':;!1_** 

### )-,d 

## i",nt

- i.e. polyoxin D zinc sal;-_ can paGB 

### thrmlgh the nlam_wa.J 

### ian C' '?3"-:i\;f' 

### system regularly without tOX1L. 

### l--!uet",.



## 7. Effects on iI.1lE.1Li.1W 

## a.lld 6{l.do(.{'id0 ys"efl15,**'~-J.15£C** ;.,; .,_-<; 

### ,;Lailable evidence**demonstra~lL:~** 

### thal**polyO~(;.ll** 

### D ;;,;.l1C 

### .:;all**,-.:".L~';** 

### ie' .}:_ 

### -_::'lc.hcrine disruptor in hUnl8.;]s. 

### ;,;;_,38d '_in**n(·:'i~'.:Li** Vt:'! 

### r ,SPC,I'J.8,-: 

### s**Jb~<;d'** 

### -- _i,\J 

### developmental**toxicit~, ·:~nd18s~** **-...~h,« -LL'~**  

### ',J**,_p:):J'Ur~! >~lldie:;**  ';j 

## Ji.l

_ oncogenicity studies**(lvl}j~[;~** 

### 432G'J [\,"-3,). 38 2IHJ

.. ,;U), 1](, ;::-' i\'0n:'8 

### effects
to the endocrine or iff 111 

### u.n!: 

## fey**<,:t8_:l_'~, ;'T~;** **~JIJ\'v** 

### n "r ;X 

## 1- 0; ,-J '1.':;;8 

### 'tack of evidence of endocrIne dis:"uptLm**i~:** (0;**s.is~l3nt** 

### ,dth r**~** 

### -, ';-en 

### D zinc salt's**non~toxic** 

### profi;_(;, Hnd**snp1Ju_~iS** 

## ':1:;,. -3xunpt':,(**_~:!.** 

### fl'(;'l;' 

### requirement of a tolan .:1(;fJ.



### IV. Aggregate EXPD'W"':
In examining**aggH:[~;9te 8~.{pOS1.l**  '"(), 50C' 

### tOn**40:~** 

### :If**l~'r"-)y'-:** 'C, 

### rtJ.:':3cts 

### EPA to consider aVc\l_:2 -He**in1Drmc!'~'_Cf'.** 

### CIJI ceGI:_l1:_:**ey,n('r'~,':'," :~\I,**  [11. 

### the pesticide residue in :fo;.)':, ('I,ni 

### all**()~** 'l'..H' )"'_':; '-, 

### ·occn 

# r:a.
t (ID,';l,

### ;;.;~, .CS 

### liTes J 

### including drinking wah",' 

### :from gro-,. no ,-'f,?t::er OJ' sur·d.ci:)**'~1".[,-'t-:' 2.',~,.d** 

### exposure through pes',.icicle use 

## :_11 gardnlll;, law!:'s, Dr 

## r'l.'-dd ;1gS (residential and other indoor 

## uses'



## A. 

## Dietary bxposure Dietary risks to hll.fLanS are**cO:'1;)jdHT~'d** 

### negligi!1:_f'.**t,I~;i::** ;:;1, 

### th8lack of dietary toxicological (mcipoints 

## far**po~** 

## .. ,o:xin [J

### :~inr. 

## '; '(."**'.r~d** 

## :ts n,ontoxic mode of action a5 :::\ fu.ngi-sprc:!i.c 

## ch.tin**Bynl'H~Ut5/'** 11'

### r-1.~b:_::l)r 

### that
passes through mammalian digest1vEJ**:3y~;tems,** 

### No ;:cute, 

### f',lLo(hronic, mutagenic, immunotoxJc, reprOdl.lc:ti 11 

### 8, 

### or chronic diHLry 

### IO;'ddty hazards were identified in fmy 

## of the stue.ies llsed 1:0 S-,ll)Pf'Cl 

### tbis exemption from the l'!3quirement 

## oi' a tolenmce. "cia,;;ed [L 

### j}u).)TDdn 

## D zinc salt's virtual diet:·lTY nOJl-toxk:ity 

## for mamm.ab, n'J ;J:gg ,-egnte 

### dietary exposure COnC8TJJ.8 are 

### expected.,

1. 

## Food. A Terre'Erial Exposur', Mo,L 1 (T·Rf'o(. '1.1.:

... 1, 

### [\1'.".,2005) 

### used to calculate**te:"TG~:trial resid~w**  

### -=latH::: Jnfil'm;:;**i'h~lt** 

### '. :.3 

## ._13.h:y unlikely that there will De 

## adverse Hffeet::-**Tesnlti~\j** 

## f.,:'om \':'.: us!'; of polyoxin 

## D zinc salt via 

## the oral :':'OlJ.te 

## of ,e;XpOSLUG. 

## EPA';;. T**·R8:-~** 

### calculations delimit aggregate COl.t:;;UIIl.pti..::Jll 

## c(rf':;iJues**~-C:** 1:,,:., 

## n-

.. ore than 

## 40 ppm polyoxin 

## D zin-:=: salt, 

## a levd**':h~!t** 

## ... ; feT 

## tdcw**t.b:~ Ll:~hc):jt**  

### doses used in any of the**tox.i.;::i'~y** 

### tSGting. T··l<EX**~'esidu0** 

## n,od(:.i.lJJi:;'**r~,-dings** 

### of negligible toxicity.**i::.~ld iL:o.~r:!l<j,**  

### .. on**(:Ql:firmir~g** 

### ,Joly:: :i' Li**,~~ :~'~nc**  

### salt's fungi-specific mode oLv:::tion dl3mC::"HBtratI3 

### a lack. of**aggl:~~gr>Ei** 

### dietary risk sufficient to support this exemption hom the reqccl"mro,,,'t 

### cf 

### a tolerance.



## 2. Drinking water /};cposure_ T'} ;(j\;**;'"~,** d. 

## sma]**~** 

### f .'_! tEl" 

### L . 

## a .

. J.:**t~"2.ce** 

### amounts ofpolyoxiIl 

### D zinc salt to 13!ltcr p·G

. 

### 1n,d 'IV;Ltfl';); ,,/.i-:fJI' 

### rJrjnking
water sources after a S:!9,·:1)Ji.cunt .i:[i,:1l**;:~ll.l** ;'i[ld**$u~'f,-c' W;i,-~,l**  : 

### 'Jfwff, 

### and from incidental spray drift.**VVhi~8** 

## :.1

.. 0**E~d;ve :'.ng~';;]":.~GLt** **:;~;:** 

### :**dt~I'srad8** 

### in water over days, it**~:;titl** 

## har. the .\3H.'OuJ 

### pot8D.t:'-El**~8 r":;d~_:"·**  

### cdiuking
water sources.**NOlletl:.',~13ss,** 3.1!.y 

## H

.. :,:iduus**"8sulti-:~g** 

## ::rO;Tj ,,',- s::;<:carios in this 

## unit are expected to 

## be so**di:-'..l~G.i** 

### ,,-S to 

## be**:~;,agli,:~~-0'1;-,., L\~**  11 

### result,

even if there is drinking 

## water f}:;C':"JSl'!Te, ,-1.**heHlt1~~** 

### risk: 

## tc t·,. _31**~'.P;:;** 

### is considered negligible. Again, based on 

### tlt-3 lack (jl 

### toxic[J\)k[J.Ca; endpoints for pOlyoxlf: 

### JJ zinc salt 

## and it -; 

### non-tux C IUHg' 

### ,specIfic mode 

## of action as 

## a chittn sYl1thC3'u-:.aH**~nhlbitof,** 

### HG 

## dhlt.a

.. ' 'j 

## "sks ,S_1'e 

### expected with regard Ie dri.nking W8i:8r 8> pc-surE'.



## B. Other**Non-OccuPQti:~nol** ExP,'::',:",!l\i


### No new non--occu)JHtiOllal. expnS\ll'H i::; 

### expeUeJ fa ,'B:;'li'l: 

### fru:m the

new agricultural uses 

## oJ polyoxiu ,,) zinc salt

.. l+J\:.j·JVH,'.> I:i'f: 

### hgency
notes that no hea.lth riSK'S 

### are expected 11'CHl 

### any expus,_tf'" Ll tir,') 

### active ingredient in any evelli. 

### A 1997**r:Gl.~** 

### asser-;nnent ci"**:~JOlv :~,.'**  

### D 

### ?inc**~;alt** 

### makes clear that even th3 

### expected**nOIHl:'J'ic~lJltl:'C1"** 

### rtOr "{lv:1:pF,lional
exposures that a.re**8Ssi~'c:ater3** 

### with**dt'i'~** '-'.r' 

### iv,':} in::;·",,!Y_e;'· 

## :_:11'"::: 

## i:. igligible risks. Polyoxin D zinc 

## "edt is**:::ttara·~-"h:+7,el~i.** 

### oy it:::**!:"'~g.tig,-;'h** 

### 'yd'::.lty; 

### it 

### has a non-toxic, fungistRtic**fungi~:',r'-;dnc:** 

### mode or**a.ct~.cll,** ;"'j.1 

### I demonstrates no marnm Q 

### .li8.r 

### diei:>=c'v dfEiCtS.

## 1. Dermal exposure. No 

### IleW 'lOJi-(lCcupa::iol1i1J**d8i':'["~!'** 

### ,:;xp0sures



## are expected to result from the ne N 

## agr;.cultul'al**-,_'~** I':'S ()f 

# r'-' :, JX>J1 

## D zinc salt. Any new derrrlal 

## 8.r::.po:ure assoc-;aLej with tl-L')L 

## n'JW ,='!:;:ccultural



## use pattern is expected to be occnpaUollE 

## 1 in ilc.l '.,_T'G.



## 2. Inhalation exposure. No new non-occllpafj\.mal )Lln';-.ati'.-·n 

## exposures are expected to H:,3Ult 

## from the new**a;s~'icnLc** 

## :;:r,**J~,e:~** 

## of polyoxin D zinc salt

... hny new inhaJatioI exposun-;; e.S5UC",d:Jd Vtdth this



## new agricultural use p8Itern 

## is**eXJJ5.C'~8d** 

## to bo oCC1:pat;,cl.1c,: 

## in nature.

, V. Cumulative Effeets Pursuant to secHT:"**40afb)(2)(D)~** 

### /' 

### DJ' 

## FFDC/i,**;~~PA** 

## }-; :;. UiF.lGidered 

## available infornlation**8(mcE]'ni~Jg** 

## }18 G-'llT_ulativv S!'t8Ct:·:

### ,~",: tJ 

## -::1; oxin D zinc salt residues and other**:;:Jbst.~-iT1cr:~** 

### tl].t have ;j 

## cov.r'n_:] : -mer.,:hac"lism of toxicity. These considerations i:nc1udcl the cu!({ulaU.,.:;**(.~dec:tE** 

### OIl infants and childrell G_; 

### polyoxin :;] zinc 

## s 

## tIt resi,**;~'_I,'_~S** Ell- 

## c: \) !E:I' 

### substances with a (01):1;.llon 

### lllechan;srJ.J 0'. 

### toxici -."**;:"f>_,,-:,l:)~:** 

### tljLF''''o is no 

### indication oflnamrna.'"an. tm.:icity, 

## tl:..c,**i~'.g'3nc-y** 

### cundL.dt)·,**!!:,_~i\** 

## t1',81'8 are

no cumulative effects 

## ,::"I'ising from**~:..u** 

## ym_in D Zi.\L 

### s&l!:**~'(~~i.d;,,18:.** 

### in 

## or

on almonds. cucurbit H;getables. L'uit.ing vegeta:Jles, gim;fl.g, grapes, pistachios, pome fruits, 

### potatoes :;Eld, 

### Btr;::'Lwbcn:lf)s



### VI. 

## Determ.ination of**~nfpt::,** 

## for U 'S, I \r:.nd;.d:\1.Jllt'1; f},**t~2:r** 

### [" oJ 

## L'rHdren 

## Health .risks to h'l::' \1EL.W, 

### im-J\l< : 

## ;,n;s : n'an-rs**s.):~_d** '.:11i1, ,:'**;'~_'** i**2.'\-{~** 

### considered negligible.**T~'lerD** 

### is 8 

## la,:.:k of**r::~eaning :,~** **~ ~G'X**  ,C t, 

## :Jgi.->3.1 endpoints for**polyoxi',~_** 

### ') zinc salt. 

## ;'IloreL vel', 

## plIJ',',Vx;_**~) -~_**  £1C**~~c;Jt** 

### is defined by its**fung~stfl:jC** 

### nOfl-to:{.I,C lLGdEJ 

## -of acti<:;l. ':iU:""j 1.l.,::;- 

### :OG:,(fHtes

no mammalian effect.

...**\ccording~y,** 

### tL is r:JIlsid,0rm,l to dF:\' : 

### 118gligible toxicity, and 

## there am 1:,(] 

### aCtltE- 

## or dj

.. ,JrllC 

## di(:,cmy 

## risk**,~(;n** _.'m.1S 

## for sensitive subpopula,iow;,

1. 

## U.S. population. rh.e _AgeD::')' ,;as**~BtE:1i'ml!** 

# '-vi th(l:t '.-., J'_,H}**~ ~**  

### reasonable certainty**t~'lG'** l:"C lWIL";

### .,''Ji~; 

### _' 

## _,s.lll tJ 

## t1L, ..J.L 

# r :"',:Ldoll {'Tom 

### aggregated exposurE:" 1'-) 

### L':Jid.'.tE1S 

## ere**;I~'\''')** 

## '::} D ?,,;r) 

## ,sal ',',- '; '.I

_, .. 

### Judes all dietary**exposur8~3** a1',u 

### .other**E.\Y})U8~,_~e-L** for**wHt~",** 

### :.h" ','**~'-** 

### , n 1 

### j8ble information. 

## The AgFJu.::_)**hm~** 

## arrived at f**~s** 

## con:' ,,::;lCJi;; ", d 

## u 1 

### polyoxin D 

### zinc 

## salt's**Jil)n-~(','(ic** 

### f:!lgj**-.~)xcifi.c** 

## n> ',:(' (,; ,.tt: 

## uL ,Hd 

## its observed**non~toxic** 

### erk,:t: 0.:1 

### rnarnnu-{L, T '1.!3 

### AglE; 

# <; ;',; 1.1:) Ir't tito 

### combination of**re8istol'~)(i** 

### tnT 

## f w',c; :/J ,u 

### I-hE 

### pI'!.:**p~n:'~,** 

### 1 ':;1"0,' ' :- 

### os 

### cE polyoxin 

## D zinc L 

### salt 

## h"H.'**::~** 

### reasonable certaint.y 

## of no 

## harm**~'~"** 

## tho U.S. population.



## 2. Infants aEd 

## cbi'h ',,:·n.**:~,CGlio.~** 

### 'tJ

__ :_ 

# r FrOc. _', lL'C, ,,' ,'.' !l;**,~1:~1?A** 

### shall apply an additlc!'""',:,'**~e-':f(}ld** 

### 7.'(1f'.xLl n**,~~f** 

### e"'(po::;.: ;';:, (H !;,-, .\ 

## L,-- infants and children in the ca:,t,**')f~_:~~n12!1,--:\l** 

### DEfer**t;;~** 

## tc 8..'Y",j.:-:C' ':1 f:;;"

.. 

### l{:al and postnatal toxiclLy**u:,J,~** 

## :ly-:-**C<Jmp~13~()n(!** ',f( t'

### ~_he ,l.-,_l,,"'ilf:! ,'J::' ,;-'-'_8 

### EPA determines that 

## a. d-;Jf.-= ,," 

## _it :rn.J.rgir ./'**,::~(")** ;')_1"::-**t:~,** 

## ;'1' t 

## Y j ",:;: ,:.::;.**I't~** 

## br infants and chHdI'8Il. lLsecl v. 

# Rn t;}(' t6li.'lhlo ,:n:- 

### h';') l-', 'it( 

### r·'.i· ion 

### the Agency reviewed 

## on 1";1 

## }oxin D /,hl.:**~,,<ii'-** 

### tlw**~,.gu** I;'j 

## c-: l. ; <::<?:; 

### that there are nD 

### residur:d 11

### <:~~rtEHlti.i()S**~o~ pr(~'1.,5.tal!p::':-,,_nfi_ud** **:,'~** 

### ), ;_e).1",<'

## resulting from polyoxh D zbc sa]',::' 1,.-1 !" 

## at**po!"o·:~.n** 

### r' ;.;**~c** 

## snt has relatively low tOXiClt}**~'";** 

## m"mrrl9. 1

. 

## fi"!1n" 

## dimar:.**~** 

### :l3nd ):'); ·'t 

### j;lcluding infants and children, :' <**cordinp.~,** 

### t1:.**~-,'C':** t r8 

### no'+hr :;::tl().**~]** 

# ·;/'r**,~j** 3 

### of



## concern and an add:itir;nal nargir'**!")~:** 

## sr:r"c::; is**nc~** 

## .**:;';C~; ~_,**  "', 

### t:' 

## 'TDtect infants and children. »:leed, th-J**F",-',~,i~ai>:** 

### '; 

### deJa: 

## tc;:;;; j-') ,-, 

## p-:Jyoxin D 

## z, 'nc salt has very I:'" 

## tC Y 1'-',,·!,·**1"'-'r-l'-~~;'-'o** 

### tn**l'rr'J--~'" ~1**  

### r1, ,;1(;"pn 

## 'Ina'

.• , 1_1-" v·

___**{,~** •.. b -'

_, I,,, "

,_ ., '.'_ • c


### no increased 

### sensiUviL'i of iLfants .lr chdd

.. fell W,F indic;:;J,:-[ in :lny of 

## the laboratory studins, 'In 

## sum, theT8 ,tS 

## a reasonabi.8 C'3rtaiclY 

## of no harm
to infants and children -Nith 

## regHrd Li 

### tils proposI3cl fOGd. -\ '",d!:i 0 ' 

## polyoxin D zinc salt.

VII. Other 

## Considerai 1D' liJ 

## A. Endocrine Disruotu_,",s


## Ba.sed on**avaj1ab]I-~** 

## data

.. no

### 8:';<}(JcnT~**~ SVf;te:'~"·"**  

### "':' [::1

, 

## ct :-' -t;:,c '; 

## have been identified with tl-'c: cor:: ,:;umpt i [11" r:'j" 

## ,of yo xi " .1-) Z!)-- ---; '-::'- Ii' .,' 0 

## evidence of endocrirg ,;'yste:El e£±8{'h; 'N,l'; nbSertlf'r1.**~n** '!:-'f; 

## immunotoxicity.**n~bchronic** Chrt)ll._;.C.**L:r~t(llogy** (T**r3~-':-;J:)-\** 

### ,::::tiun 

## studies.



## B. Analytjcal Method Through this ac-j0:1" Lh'J Agen;;y il-',JI-.OS8-::: RJ.- 1;::\:8[;'1; 

### d.:, :i**"r~** 

### In the 

## requirement of a 

## .tole:r:::-,:I:.::e 0::' 

## pc.'): _;,xi: J.:J 

## jnc**sa:~_ .'~'jE-l:**  :.: 0 i I 

## almonds, cucurbit \/8[lJ:Lablul,**f~·;.11L_!lb 'j:~,:~,i~t0:b18:;**  e1l'_S; --F, 

### --.-,'If**'~R,** 

## pistachios, pOlne frU?,lt.>" ,t1ot,:'l.toes**a,I~,':-li1** J 

### raVl,Le(,**;'.~,** 

### ,\. ',h,.I i ','ly 

## numericallirnitatioll8 ,'"fC**reHldll(~~-j, !~,:t'/'L**  

## 1I.J3 dGh:-" ,:-

.. ,1(('. 

## tiL.

_ 18 

## :idues 

## resulting from the P8t:>::, 

## ciual uses cf 

## p.c),i;, l::xin D**,_J_~.i..C "'~':.**  

### ' . 

## ·u t ,(\ 

## as Pi 

## matter of viable appL.ccldoll 

## be-lo\-'\., 2_HO tJat**d::'GF;~ u,,~~**  

## ill!**~.:':?nit](;ant** 

## toxicity concerns regaj:'G.ing this ac:i va**y.t~ced_;,l~n;_** /'

... 5 2.**:8,_;,~** 

## It, t**',lf~** 

## Agency has concluded that an anEwtiCi'J -r::D.eU,ozL**:~~,** 

## not 1'81,; 

### lit'ad 

## for enforcement purpose::;, for this prDf'cw::?;() ':..cse oJ pJJ)«Odl! 1)' 

### dile 

## 3alt.



## C. Codex MaximuJ1: FL"; 'due Le/el 

## Throngh this acthlD" 

## tho AgBHC,v**::'H"~L,'(J88~'** fL.' :--'::!i',t'li" i'.:'l 

### m 

## the requirement of a tOleH11lc8 

## 01 p01.Y';':O:- jll**;-~;** /,tnc 

### sal**',/llf~I--** 1 ,''':, '\j [;:' 

## almonds, cucurbit**\J8~:(:ltablef,** 

### fruitine**yc',~,;gtabhw, ~5i,ns'_~I?/,:o**  

### rapr.-;s, 

## pistachios, POTI18 fI'll 

### it:: 

## 'Jotatoes 3! ,J 

### diu;, s:_I'FnIl.'(m,' "(BE, \"', l; (", h ;;.'11 

### y 

## numerical limitations :\"r 

### l ' 

## resJ.duet:" E'F-P, has ciei:erlnin.f;!). 

### 1::1::' 

## cR'-idues resulting ITOn1 the 

## p8s:.i_cid.al uses if 

## pot,yuxin D**,~iLG** 

## sidi Ii' 

## ndc 

## as a matter of viable-**applf'(~2.(ion** 

### be lO\'\-, 2'1 1 ' 1'\8t (,'lEU'€'- ,:il'H 

### n ,:' ,,' 

## ;:L:,hGant toxicity concerns 

## regr:r":1mg thL; CI,:.:,i'lJP 

## ilPrecie::n.

.. :,'; 8 '8":'t1t:, 1-1"!.0 

## Agency has**concll1d~,;:l** 

### th_at**;:;~n rnV1!:ltiG~t1**  

### -net}:,[Jc:]: no!- ""( 'lirl3"1 for 

## enforcement purposp." f(1f 

### thLs**p),0',xJs'~d** 

### r se n': po: 'oX': \' i-i ';-,lC**~alt** 

## VIll. 

## Conclusions
Based on ICe**;rJt~(:"-,;~a'l'I~I'- Sl"(),~**  '!"\'I- l ·IIJd Q'-I, ',' 1'J',-'

.**~'J'\):-t** . II " ,**_".~** __ ,**,_".j~_,_** .. "J.

. __**,,~** l_'J. 

## available to the Ag8IL::" 

### EPf', 

## is**e~;r<1bjj':}--!.:ng** 2]1 C):YI'Lpf 

## 1 '''-:' 1-**~1'C'::l'l** 

## i_he tolerance requireU'--,-Hnts**nl),rSl'a~'J.L** t-{l 

## :F'C-l(;-C**"~Jg(,:'l** 

### (E Ft'TK 

## io_ residues of poly ox in D 7;inc**~:-,:lli ''"~!**  

## or on**8h,;nIl(~:';, :::uc'Jrb~t**  <, 

## r::gtLd" ",S. 

# r d,Jing

## vegetables, ginseng,**~)'2,peS,** 

## pistal_::JiLs, p.Jlne 

### fn'.!!':, 

## PI} .]'.<.:.2.:; a,;',d, 

## strawberries.

IX. Statutory and EJikC"utiva**Onlf)~ l-t~vi'i~**  

## ws 

## This final 

## rule Bs\.(-lJishes r} 

### tDhnl

. 

## .-,c!; undrr**~<;(:'::>:** ; j.{ 

## 3',d: 

## of FFDCA in respons':'J .f.: 

## pei:'LLi.oo :3·Jl)rril·.:., 

## ,d.**:~o tL;~**  

## /\3e \ :., 'j'lt

### '~)ffice 

## of Management 

## and B'u.,j.get fOlvH3i has H);e,mptft,_,:. t!w:SF!**~},** 

### ,S (J" 

## actions frOlll review under**Ex~~UnTV{;** 

### Order -iZ,S\YJ, 8'.lht --6**.h.'~,}.;,** 

### 0':/ 

## Planning and Review (SH FR

### 5~i 'l ,15, Octobp: !'" ]

### '~:l:B'). B8caa.<;,e

### ::_ii:~; 

## ;"**l~1.1** 'HIe 

## has been exempted from rE:l/18'V\o'

### und8~ 

### E)(e':-J.!:iv8 C1rdm' 1 ?B_C-"h 

## Lhis Hnal rule is not subject to J::xncllTive CIrcle:.:' 1'3:2.11, nnti-l.l'3d .Ad'''.'');; 

## Concerning Regulation? That 

## Sig;.--,.ojJcO:lt-J,v Ajfect J"nerg'i' 

## '::uj;piy, Distribution, oj: 

## Us-e1 r \!) 

### foR

### :zn?S~~, [\1HI' 

### 7!?', 2001)

### c"E:~:_':'!,:_,v·'0 

### ')l'der 13045, 

## entitled Protection o( 

### ClIJldreu'flV/T1 Envn{). I.m,-!<;,',';/ Pt";, 

## ilth 

## ilisks and Safety Risks [62**F;~.** 

### 19{3;3-5,**Alji<~** 

## :.n.**lS9~:J** 

### T:,t", 

## r.;

.**t~::j** 

### does 

## not contain any in1\)f.,lation COhE-;( ;'**OI1~** ',lojec:t ;-,) 

### (':,1,,! i,

,. 1. CI,.eli 

## under the Paperwork Re-dm:uun 

## Act {PRH,I. 

## 44 l J.S.c,. :<';0! f> He 

## does it require any sp8ciul,

.. 

## :!.1s.tcil'.!ralio: ,f; 

## ,,;,<1, 11**-Cr~I::!-C~_** :i\7(;; :," 

## ,'< i:! ',S8, 

## entitled FederCil Action.;) to**il.ddn~;_s l~'rc;:il**  O11J;::·6'i,:U.J.! 

### jw,L,>- 1".' 

### iV)nority 

## Populations and Low·':'!'**:::-011/{~** 

## Por.1**)r~~i,:'n;** 

### (Elf) FE**7-3::~n)** 

### I: ,1')'-.lb·1,.' 

### 16, 

### 1994).



## Since toleranc88 ".'rd**E:D;Gm'lj~:** 

### H".>**tt;a~** 

## an} estHl 1:.s:i;,_ 

## d of a petition under ser :iun 'L08eD

.. 

### i 

## 1'F**~)CA,** 

## sueL**~:tj** ','-I

, 

## this final Iule, do l).ot 

### i".-,q**a~J.'E;** 

## tho j**I"~** ,:U"C, ;"1 ':-'(-; 

## e:' tf 

## P--- jA;E:t ;' 

## requirements ofthr;**F,~,,~,datu:,'y** 

### Vl!:-;:ibL., I 

## l-l.si 

## 0·: /'1**~** 

### seq.) 

## do not apply.**~"i:,** .c8 III

l."., : 

### .01 

## ut

This final :"1.111.1 

## Ji."',,'1**~tty ::\':.gu_~;~~;_·:~.s**  :y"h 

## ;O-rs, 'Cd---,! \ 

## i"1 r (

... : :.; , 'fS**~** 

## ',:').Jd handlers, and food TLt,'li-rex:_;, l10C 

### S :tI,,> ,)[**trr:JIj~',** '1"" 

## dUt> 

# i'::: ;,r.tion alter the relationships {jJ' 

## distI'lbut,JU 

## oi' powe:" add**[eSp'~'D** 

## ,_,L,i.li(ies established by Congres.':J in the**pI'fJ2nl~)tjOn** 

### pTovisic.ns 

## )C**:'~,A** 

### tiD;" 408(n)(4) 

### ofFFDCf," 1._,')**,",l,C.:~,** 1;,.1:: -"-{J,;,tl"-j 

## b,:..S**d8~,~:",-nlL',_,(:_** 

### "dLl:,tis 

## action will 

## not havE. 8.**~'~'lost:lntid** 

### d".ru>,**t~rf8ct** 

## Of' ,,;, do'; ,I**·i,~:n;** 

## governments, o.n the f,,::**:.'_tio.:.~:~.hi!) :~,**  

## ;. v, \:'_'1 ' .;**~_~e.** L;:c:**~;j** .. :;.. 1 ,l. ,1 ','G\ 

## snt and the States or tl'ihal \",tj", ,;-,.l:I(,lents, (' l ;)1','**_~t,** 

## dis**ri~~ :~,Ul"'**  

### d I,",'t: 

## and

## responsibilitie~:**(r'.11';I;f.~** lile 

### vari(;u,;; 

# leo,,: 8 i t' 

### ,)f gOVE.' i l.L:eI, 

### i L ! HI 

## v 88fl 

## the Federal Government an,;: Ind 

## ian tl.'l }13-,' • 'ri-, 

## us, 1,11[;**,:'\Wj~** 

### _>! 

### d 

## t . d 

## tl·· t E U-'

. ",

.,. . - ,- .. ',

8 

## ermIne .la Xt;0Li:J,re**~'Q81 ~_;-,.:;<~,e!.!.nl.if;:J.j-e):',,~d,'.)**  l.t>:, rh 

### 43255, 

## August 10, 

### 180:; J 

### d,11d 

### EXDCi_ '.'**d~ ~~~;**  

## (leI 13 

### ,_:'"r, 8-'1 

## r,**L,~'** 

## \ Consultation and Coo.rd,nation H'iJ'h ;'.!lrhcm Trib.J,1**~;0'V'3i"(Lnl'5!nt·,** 

### (65 FR 

## 67249, November 9, 2iJUO) 

## do ll'.Jt 

## aPt:;:Y to 

## this Enc' HLB ;'r 

## ::ldcltton, this final rule does no:**jlilp(I~)e** {In.} PTI

### 'l':'\_""·8.h~n 

### dlli" OJ' : 

## ,u:· "r), oUlY 

## unfunded mandate tl:-.r -:;('3cr: 

## bE:d U" }8:' 

## ft: 

## io 

# n of th;- 'l)

. 'II**~** ,::(i 

## Mandates Reforrn f"c': 

## <;I.'19W., {l'jHtJJ 

## r',Jdic**1.:;,~** J., -,:,



## This aetiaL 

### UO-(,;) 1,", 

## inv(Jl \/;-; <IT:)' 

### ::{i,::_b 

## ]intl ,):! '1.i,,-,-:_ 

### :J;, '-,**~;,11d** 

## require Agency c01(sh;,:j ltlGr 

## ofvn ::: (';lr!

### GGL38,~'i1 :-; ,,;';-1 

## :'ds pursuant to sec dOL 12,:" ui'L18 

### t\lc::**l(:'~I...:i** 6G,"}.:':"D**\J1~',j** 

### I,. ", ,; ,:,:t"::/

## .Advancement .Act of ;;>"5 

### (NTT,",,,' F, '" 

## "r L",'N ")4,i," ,;";,, 

## 'on n(d) (15 U.S.C. 272 

## note),

X. 

## Congression,aJ Re:,**~;-'W** 

## Ad 

## The Congl'HssioI1 

## 1 l! Re1r,9w**A~ ~,i**  

### f 

## (':.C. 30-1 S'i 5':'q

, 

### 1..:;]', 

## Hy provides that befo18: "',.18 rnay 

## tr,:',';-" '::-., the**di~,"!l;(:Y Il!~** **~~** 

## lUng 

## the rule must suhmit :, :ule T8Der! -{I 

### .::!Fe::' 

## Heusc' 'l,: 

## ,J

-**:,~J'r;'-** 

## sand
to the Comptroller Ct'-' 

## '3wl Gftlw 

## :.L:'**~nc1 ,~;tat8f,_** **E'-~fL** ." 

## 'Jr, it 

## a report containing this**~'i** 

## Je 8.nd otin,- .'ftJ.t'ired ir: f!'J"I.IE.l\}**U-i~** ! ,; 

## tl:e U.S. 

## Senate, the U.S. House of R9presBr;.ta .h'f8, 

## and**tlJ,~ CO''-~-Jj:'t**  'I 

### )Ue" 

## General of the United States p.;t r- 

## tu puerl L' ,'L: l..;' i 

## of th:.s ;'l'l; 

## -d**ril.>~** :Ji I ill:: 

### ,F'Eueral 

### Register. 

## This fiIlc!l Ill)(! 

## is nnt ;:,- '·:-'i.::V)' 

## rJle" <1E C"**~i::\·** 

### :r'**·~.I** ", 

## -S.C. 804(2).

## 14

List of Subjects in 40 CFR Part Hl(l
Environmental 

## protection, Acilni.nistrativ8 pl'Hctice aId 

## procedure, Agricultural commodities, Pesticides and pests. F"'portiDg and recordkeeping requirements,

Director, Office of Pestidde Programs.

# . , 

## 15

• Therefore, 40 CFR chapter I is amended as follows:

PART 

### 180-[AMENDEDJ

.1. 

## The authority citation for part 180 continues jc read ".0 

## follows:

Authority: 21 U.S ,C. 321(q), 346a and 371,


## .2. Section 180.1285 is added to s'":Jpart D to read af, 

## raJo'//,,:

§ 

### 180.1285 

## tolerance. An exemption from the requirement of a tolerance is Established for the residues of thd 110chemical 

## pesticide polyoxin D zillc 

## when used

as a fungicide on almonds, cucurbit 'regetables,**fndtj~,£,** 

## v838t-Rhles, ginseng, grapes, 

## pistachiOS, pOlJl8 fruits, potatoes 8nd stra'HJberries.

[FR Doc. 08-???'! Filed 77-?7-08; 8:45 am]

BILLING CODE 6560-50--3. uNITED STATES ENVIRONMENTAL PROlt;;\".'TION AGENCY WASHINGTON, D.C. 20460



### August 13, 2007

PLEASE RETURN A COPY OF THIS LETTER WITH PAYMENT Or Pay On-Line at www.Pay.Gov (See Below for Details)

OPP Decision Number: D-38235I EPA File Symbol or Registration Number: 7F7252 Product Name: Endorse WDG EPA Receipt Date: IS-Jun-2007
EPA Company Number: 66330 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Company Name: ARYSTA LIFESCIENCE NORTH AMERICA CORPORATION

MS. BECKY RHODES ARYSTA LIFESCIENCE NORTH AMERICA CORPORATION 15401 WESTON PARKWAY, SUITE 150 CARY, NC 27513-

SUBJECT: Receipt of Registration Application Subject to Registration Service Fee

Dear Registrant:

The Office of Pesticide Programs has received your application for registration. If you submitted data with this application, the results of the PRN-86-5 screen will be communicated separately. During the administrative screen, the Office of Pesticide Programs has determined that this Action is subject to a Pesticide Registration Service Fee as defined in the Pesticide Registration Improvement Act.

The Action has been identified as Action Code: B63.0 NEW USE;FIRST FOOD USE;MICROBIALIBIOCHEMICAL WITH EXEMPTION;

Please note that there is no fee associated with this action. If you have any questions, please

contact the Pesticide Registration Service Fee Ombudsman at (703) 308-8260.

Sincerely,



# 7'.f./WJA**~** Front End Processing Staff Information Technology & 

### Resources Management Division

# I 

# f

IFee for Servicel 

# {814719A-

, 

## This package includes the following for Division



# , New Registration :: AD

Amendment**~')** 

# BPPD

:RD Studies? Fee Waiver? 

# [IT] volpay 

# % Reduction: 

# I Risk Mgr.

i


# Receipt No. 

# s-I 814719 

# I

EPA File Symbol/Reg. No. 

# I 7F7252 

# I

Pin-Punch Date: 

# I 8/10/2007 

# I



# o This item is NOT subject to FFS action.

Action Code: 

# I Parent/Child Decisions:

Requested: 

# I Bit?;; 0 i 

# I.e/;; T3:V-b7,o

Granted:

LI _----,,--' 

## Amount Due: 

# $-FInert Cleared for Intended Use

Reviewer: 

# L. /Jol/l·.\.

Remarks: 

# /}M 

# h. COW 

# ·stt 'bE'

... 1 

# cr

,\,AJl+h. 

# &/;;>;3 0 J:; 

# (p

. Uncleared Inert in Product

Date:

# ~ / 10 

# /tXl



# , , 

# k''''-'f"**~** OSSc!ClOtrQ.. .


# Applioooioo

# Dm~**·.~8-J"02007·····.IirJJ** •. •••··· •• 

# ····?··'·!'·/'!

Fro'nt_Erui Date:

### JiO~:£Wg:2007liaf 

# Iji,***~,,"i,** Ff$ Due Date: 

# I -- -**~** 

# \- --'--

opp Target Pede;

_ 

## j "_ <,,",

_A _,_- _ - - ,NeW

### i"'fiiero",~, 

### [":

### , !



# FEE F'OR 

# SERVICE,,-' "



# DATE: AUG! 02007

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### ..

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# FILE**NUMB$~:i** 

# . 

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# JACKET,rt1.~~·I_~~F,.(nATA)·April 30, 2007

Denise Greenway Biopesticide and Pollution Prevention Division Office of Pesticide Programs (7511C) U.S. Environmental Protection Agency One Potomac Yard 2777 S Crystal Drive Arlington, VA 22202 703-308-8733



### RE: ENDORSE WDG

- Label expansion (EPA Reg, No, 68173-3 and EPA Reg. No, 66330-56)

Dear Ms. Greenway: 

### '"

) 

### ",



# .

, -, ) )



### , ,

,

Arysta LifeScience North America Corporation (Arysta), as an agent for Kaken Pharmaceutical Co., Ltd (Kaken) and on its own behalf is submitting the present labels expansion request for the following products: Polyoxin 0 Zinc Salt Technical (EPA Reg. No. 68173-1) and Endorse Water Dispersible Granules (EPA Reg. No. 68173-3 and 66330-56) to add first food crops uses.

On September 28, 2005 Arysta met with BPPD-EPA to discuss to possibility and the requirements to expand the Endorse WDG label by adding food crops. We were recommended to conduct additional toxicity studies to confirm the low toxicological effects of Polyoxin D zinc salt. The additional studies are incorporated in the present submission and are listed in the Data Transmittal Document.

Arysta believes that Polyoxin D zinc salt qualifies for exemption from tolerances based on the requirements listed in 40 CFR §158.690 (b) (i) (A) (S) (C) and (xiv).

The present submission contains:

ADMINISTRATIVE DOCUMENTS Present cover letter Data Transmittal Document EPA form 8570-1 for Polyoxin 0 Zinc Salt Technical, EPA Reg. No 68173-1 EPA form 8570-1 for Endorse WDG, EPA Reg. No. 66330-56 EPA fonm 8570-1 for Endorse WDG, EPA Reg. No 68173-3 EPA form 8570-34 for Polyoxin 0 Zinc Salt Technical, EPA Reg. No 68173-1 EPA form 8570-34 for Endorse WDG, EPA Reg. No. 66330-56 EPA form 8570-34 for Endorse WDG, EPA Reg. No 68173-3 Data Matrix for Polyoxin D Zinc Salt Technical, EPA Reg. No 68173-1 Data Matrix for Endorse WDG, EPA Reg. No. 66330-56 Data Matrix for Endorse WDG, EPA Reg. No. 68173-3 Five (5) copies of the Polyoxin D Zinc Salt label

Arysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 3 

### "
) 

### , , , , 

### "

, , , , 

### ,

, , , , , , , , , , ,Five (5) copies of the Endorse WDG label (Arysta) Five (5) copies of the Endorse WDG label (Kaken)

SUPPORTING DATA Three (3) copies of each report as listed in the Data Transmittal Document Summary of the data submitted , " , '

Arysta believes that this action qualifies as PRIA Cat. 8-63

- New use; First food use, with) , ) ) , ' exemption.

)') , 

### , , Please notify Arysta of the receipt of these documents and the MRID number assigned to them', 

## 'We
would greatly appreciate receiving the Agency reviewer's comments as soon as they

### becom~ available. If you have any questions or need more information please contact me at (919) 678-4879

or bye-mail atdoina.bujor@arystalifescience.com.

Sincerely,

Doina Bujor Regulatory Manager

- Polyoxin Arysta UfeScience North America

Arysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 4 

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# ~TION PROPOSING EXEMPTION FROM TOLERANCES FOR POL YOXY D ZINC ( SALT USE IN ALMONDS, CUCURBIT VEGETABLES, FRUITING VEgiJ:'fABLES, GINSENG, GRAPES, PISTACHIOS, POME FRUITS, POTAT9ES, AND STRAWBERRY PRODUCTION /

SUPPLEMENTAL INFORMATION ADMINISTRATIVE VOLUME

DATE: June 11, 2007

AUTHOR

Doina Bujor Arysta LifeSvcience North America Corporation 15401 Weston Parkway, Suite 150 Cary, NC 27513

Page 1 of 49 )" ) ") 

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### TABLE OF CONTENTS

TITLE PAGE

................................................................................................................... 1 TABLE OF CONTENT

.................................... "

... '"

............. "

........................... 2 COVER LETTER.

............................................... '"

.......................................... 3 EXECUTIVE SUMMARy

...................... '" '"

.......................... '

............................ 5 SECTION 

### A: NAME, CHEMICAL IDENTITY, AND COMPOSITION

.......................... 7 SECTION B: AMOUNT, FREQUENCY, AND TIMING OF APPLICATION

................. 10 SECTION C: SAFETY DATA

......................................................................... 27 SECTION D: RESIDUE DATA

...................................................................... 33 SECTION 

### E: PROPOSED TOLERANCES

......................................................... 34 SECTION F: PROPOSED METHODS FOR REMOVING THE RESiDUES

................ 35 SECTION G: REASONABLE GOUNDS IN SUPPORT OF PETITION FOR POLYOXIN D ZINC SALT IN ALMONDS, CUCURBIT VEGETABLES, FRUITING VEGETABLES, GINSENG, GRAPES, PISTACHIOS, POME .". FRUITS, POTATOES, AND STRAWBERRy

.................................................. .'.·.:.86 ATTACHMENT: DATA MATRIX

.................................................................. 

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Arysta UfeScience North America Corporation Polyoxin 0 Zinc Salt Page 2 

## , 

# . • 

### • 

## • • •

## EXECUTIVE SUMMARY

Arysta LifeScience North America Corporation is petitioning the Agency to exempt from the tolerances Polyoxin 

### 0 Zinc Salt (zinc 5-[[2-amino-5-0-(aminocarbonyl)-2-deoxy-Lxylonoyljamino j-1-(5-carboxy-3,4-dihydro-2, 4-dioxo-1 

### (2H)-pyrimidinyl)-1 ,5-dideoxy-/J-Dallofuranuronate) used in almonds, cucurbit vegetables, fruiting vegetables, ginseng, grapes, pistachios, po me fruits, potatoes, and strawberry production

Polyoxins are a family of chemicals produced by a specific bacterium naturally found in
soil. The bacteria are grown commercially, and the polyoxins are then purified in the
fonn of Polyoxin 

### 0 zinc salt. This active ingredient inhibits the action of the enzymes needed by the target fungi for making chitin, a component of the cell wall. Without chitin, susceptible fungi are unable to continue growing and infecting plant cells.

Polyoxin 

### 0 Zinc Salt fonnulations are applied as foliar spray. It has preventative or 

### curative activity at low use rates. Polyoxin 0 

### linc Salt is registered for uses on ornamentals, golf courses, residential lawns, 

### parks, and commercial and institutional grounds composed of cool and warm season grasses such as Bluegrass, Bentgrass, Fescue, Ryegrass, Zoysiagrass, or their mixtures and has proposed uses in controlling



### or suppressing certain diseases on almonds, cucurbit vegetables, fruiting vegetables, ginseng, grapes, pistachios, pome fruits, potatoes, strawberries

Based on required toxicity tests, no risk to humans are expected when products 

### containing this active ingredient are used according to label directions.

There was no toxicity to land mammals, insects, or birds in various tests. The product label reflects the concern for possible harm to freshwater invertebrates and fish by prohibiting the use or disposal of Polyoxin 

### 0 Zinc Salt in bodies of water.



### Polyoxin is used in Japan on rice and turf, in Korea on rice, ginseng, persimmon, watermelon, melon Welsh onion, chili pepper, cucumber, and tomato and in Taiwan on asparagus and rice.

Arysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 5

### Arysta LifeScience North America Corporation is requesting exemption form tolerances
for the following uses: almonds, cucurbit vegetables, fruiting vegetables, ginseng.
grapes, pistachio, pome fruils potato, and strawberry.

Arysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 6

## SECTION A: NAME, CHEMICAL IDENTITY, AND COMPOSITION

Trade Name

CAS Name:

CAS Number:

Molecular Weight:

Empirical Formula:

Structure: Polyoxin D Zinc Salt

zinc 5-[[2-amino-5-0-( aminocarbonyl)-2-deoxy-L -xylonoyl]-1- (5-carboxy-3,4-dihYdro-2,4-dioxo-1 (2H)-pyrimidinyl)-1 ,5- dideoxy-p-D-allofuranuronate

146659-78-1

586.76 to 586.78

C17H21N,014.Zn (1:1 zinc salt)

Tables below lists applicable product chemistry data requirements for Polyoxin D Zinc Salt Technical Grade Active Ingredient and end-use product (Endorse WDG Fungicide),


### and indicates the document in which each requirement is addressed.



### d Pro uct Chemistry Data Requirements
QPPTS Guideline Title Guideline

Technical Grade Active Ingredient



### 830.1550 Product Identity



### 830.1600 Description of Manufacturing Process 

### 830.1620 Results Ref. No.

Confidential information 

### 1,2

Confidential information 

### 1

Arysta LlfeScience North America Corporation Polyoxin 0 Zinc Salt Page 7OPPTS Guideline Title Guideline



### 830.6303 Physical State



### 830.6304 Odor



### 830.7200 Melting Point



### 830.7220 Boiling Point



### 830.7300 Density



### 830.7840 830.7860 Water Solubility



### 830.7370 Dissociation Constant



### 830. 7000 pH

830.6313 Stability to normal and elevated temperatures, metals, and metal ions



### 830.6317 Storage Stability

OPPTS Guideline Title Guideline

Formulated Product



### 830.6302 Color



### 830.6303 Physical State



### 830.6304 Odor


### 830.6314 Oxidation/Reduction



### 830.6316 Explodability


### 830.7300 Density Results Ref. No.

Powder 

### 4
Musty 

### 4

122.S±O.1°C decomposes at 170°C 

### 4


### NA 4

1.8391 g/cm 3 

### at 26.9°C 

### 4

Water 1.0 g/100ml at 25°C 

### 4 Methanol and octanol- not reliable, chanaes with time 

### 3.25,4.16,8.0,9.56, and 

### 10.5 4

7.19 

### at 23.2°C, 1% solution 

### 4

Stable at a and 12°C (96 hours); 

### 4 complete degradation (95.8%) at 54°C for 14 days; no change to metals zinc and iron foil; unstable in sunlight 39.3% degradation in 24 hours

Stable 

### 5

Results Ref. No.

Dusty sable brown 

### 6

Fine granules 

### 6

Clay like, earthy 

### 6

Chemical incompatibility: no 

### 6 significant temperature increase, evolution of gases, noxious fumes, splattering, or evolution of flame were

seen when the test substance was placed in contact with water, zinc powder or monoammonium phosphate for 24 hours. Significant temperature increase and evolution of bubbles were seen when the test substance was placed in contact with household bleach for 24 hours No explosive properties 

### 6

Pour density: 0.561 g/ml (23.5°C) 

### 6 Tap denSity: 

### 0.576 g/ml 

### i23.5'Cj

Arysta LifeScience North America Corporation Polyoxin D Zinc Salt Page 8OPPTS Guideline Title Results Ref. No. Guideline

830. 7000 pH 7.07 

### at 22°C, 1 % solution 6

830.6317 Storage Stability Stable 7



### References: 

### 1. Polyoxin 0 Zinc Salt Technical and Polyoxin Z Wettable Powder: Product Identity, Manufacturing Process, Unintentional Ingredients and Certification of Limits, M. Hori, 1994 2. Studies on Polyoxin, Antifungal Antibiotics Part 

### VII: The Structure of Polyoxins, (JACS Dec.1969 pp 63-78) K. Isono, 

### K. Asahi, S. Suziki, 1969 3. Contamination Test and Quality Control Examination and Method in Fermentation of Polyoxin 0, M. Hashimura, 1997 4. Physical and Chemical Properties of Polyoxin 0 Zinc Salt Technical grade Active Ingredient (Color, Physical State, odor, Melting Point, Density, Solubility, Dissociation Constant, pH, and Stability), Jim Blasberg, 1994 5. Storage Stability of Polyoxin 0 Zinc Salt Technical Grade Active Ingredient and Polyoxin Z Wettable Powder, J. Maramatsu, 1994 6. TM-43802: Determination of Some Physical and Chemical Characteristics, Y. 

### Li, K. Baldwin, 2003 7. TM-43802: Detemnination of Storage Stability and Corrosion Characteristics, Y. 

### Li, K. Baldwin, 2005

Arysta UfeScience North America Corporation Polyoxin 0 Zinc Salt Page 9

## SECTION 8: AMOUNT, FREQUENCY, AND TIMING OF APPLICATION

The proposed label will provide instructions for application of Polyoxin D Zinc Salt formulations to almonds, cucurbit vegetables, fruiting vegetables, ginseng, grapes, 

### pistachios, porne fruits, potatoes, strawberries, ornamentals, golf courses, residential lawns, parks, and commercial and institutional grounds composed of cool and warm
season grasses such as Bluegrass, Bentgrass, Fescue, Ryegrass, Zoysiagrass, or their mixtures. Forthe food uses the maximum application rate is 0.7 oz a.i.lAiapplication with maximum 3 applications per season at 10-14 day interval and 0 day pre-harvest interval (PHI).

Arysta Life8cience North America Corporation Polyoxin D Zinc Salt Page 10

## Polyoxin D Zinc Salt Technical

For Manufacturing Use Only 

# I GROUP 

## M!jII FUNGICIDE 

# I

Active Ingredient: Polyoxin D zinc salt (1:1)1, 

### Zi 

### nc 5-[[2 

### -amin 0-5-0-( 

### am inoca rbony!)- 2 -d eoxy-L -xylon oyl] amino J-1-(5-ca rboxy-3, 4- dihydro-2,4-dioxo-1 (2H)-pyrimidinyJ)-1 ,5-dideoxy-B-D-aUofuranuronate

............................... 23.8% Inert Ingredients:

.................................................................... "

........................................ 76.20/0 

### Total:

................................. , ................................................................................................. 100.00/0

1 Equivalent to 21.1% polyoxorim and 2.65% metallic zinc.



## KEEP OUT OF REACH OF CHILDREN

CAUTION

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS AND DOMESTIC ANIMALS CAUTION. Causes moderate eye irritation. Harmful 

### if absorbed through the skin. AVoid contact with skin, eyes or clothing. Wash thoroughly with soap and water after handling.

Arysta LifeScience North America Corporation Polyoxin D Zinc Salt Page 11FIRST AID 

### If on skin or 

## • Take off contaminated clothing. 

### clothing 

## • Rinse skin immediately with plenty of water for 15-20 minutes.


## • Call a poison control center or doctor for treatment advice. 

### If in eyes 

## • Hold eye open and rinse slowly and gently with water for 15-20 minutes.



## • Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye.


## • Call a 

### Doison control center or doctor for treatment advice. 

### If swallowed 

# • Call poison control center or doctor immediately for treatment advice.



## • Have person sip a glass of water if able to swallow.



## • Do not induce vomiting unless told to do so by the poison control
center or doctor.


## • Do not give anything by mouth to an unconscious person. 

### If 

### inhaled 

## • Move person to fresh air.


# • If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably by mouth-to-mouth, if possible.


# • Call a poison control center or doctor for further treatment advice.

HDTLINE NUMBER Have the product container or label with you when calling a poison control center or doctor, or going for treatment.

FOR 24-HOUR EMERGENCY MEDICAL ASSISTANCE: Call PROSAR at 1-866-303-6952 or 1-651-632-8946 if callinq from outside of the U.S.

ENVIRONMENTAL HAZARDS This pesticide is moderately toxic to aquatic invertebrates and fish. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing priorto discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office of the EPA.

DIRECTIONS FOR USE

It is a violation of Federal law to use this product in a manner inconsistent with its labeling.

Polyoxin 0 Zinc Salt Technical is for manufacturing use only for the production of fungicide formulations for use on almonds, cucurbit vegetables, fruiting vegetables, ginseng, grapes, pistachios, pome fruits, potatoes, strawberries, ornamentals, golf courses, residential lawns, parks, and commercial and institutional grounds.

Arysta UfeScience North America Corporation Polyoxin 0 Zinc Salt Page 12STORAGE AND DISPOSAL 

### Do not contaminate water, food or feed 

### by storage or disposal. PESTICIDE STORAGE: Siore in dry place away from food or feed. 

### PESTICIDE DISPOSAL: Wastes resulting from the use of this product may be disposed of on site

or at an approved waste disposal facility. CONTAINER DISPOSAL: Completely empty bag into manufacturing equipment. Then dispose of 

### empty bag in a sanitary landfill or by incineration, or, 

### if allowed by State and local authorities, 

### by burning. If burned, stay out of smoke.

FOR 24-HOUR CHEMICAL EMERGENCY ASSISTANCE: Spill, leak, fire, exposure or accident), call CHEMTREC 1-800-424-9300

or 1-703-527-3887 if calling from outside of the U.S.

Warranty and Disclaimer Statement 1. Kaken Pharmaceutical Co., Ltd. ("Kaken") warrants that this product conforms to the chemical description on the label and is reasonablyfitforthe purposes stated in the Directions for Use, subject to the inherent risks described above, when used in accordance with the Directions for Use under normal conditions. 2. This warranty does not extend to the use of this product contrary to label instructions or under conditions not reasonably foreseeable to Kaken, and is subject to the inherent risks descr'lbed above. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, KAKEN DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, KAKEN, MANUFACTURER, AND SELLER DISCLAIM AND SHALL NOT BE LIABLE FOR ANY SPECIAL, INCIDENTAL, INDIRECT, OR CONSEQUENTIAL DAMAGES RESULTING FROM THE USE, HANDLING, APPLICATION, STORAGE, OR DISPOSAL OF THIS PRODUCT OR FOR DAMAGES IN THE NATURE OF PENALTIES, AND THE USER AND BUYER WAIVE ANY RIGHT THAT THEY MAY HAVE TO SUCH DAMAGES. NO AGENT, REPRESENTATIVE OR EMPLOYEE OF KAKEN IS AUTHORIZED TO MAKE ANY WARRANTY, GUARANTEE OR REPRESENTATION BEYOND THOSE CONTAINED HEREIN OR TO MODIFY THE WARRANTIES CONTAINED HEREIN. 3. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, THE EXCLUSIVE REMEDY OF THE USER OR BUYER, AND THE TOTAL LIABILITY OF KAKEN, MANUFACTURER, AND SELLER, SHALL BE LIMITED TO THE PURCHASE PRICE PAID, OR AT KAKEN'S ELECTION, THE REPLACEMENT OF THE PRODUCT,

EPA Reg. No: 68173-1 EPA Est. No: 68173-JP·001

Net Content:

Produced by: Kaken Pharmaceutical Co., Ltd. Agrochemicals & Animal Health Products Division**28~8** Honkomagome**2~chome** Bunkyo, Tokyo**113~8650,** Japan

Arysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 13

### Alternate Brand Name for ENDORSE Water Dispersible Granules:

• VERANDA 

### TM Water Dispersible Granules



## ENDORSE® Water Dispersible Granules

For use on Turf, Ornamentals, and Various Crops


# I GROUP 

# IV' FUNGICIDE

ACTIVE INGREDIENT: Polyoxin D zinc salt

................ , ...................................................... . OTHER INGREDIENTS:

................................................................... . 

## TOTAL

............................................................................................ .

KEEP OUT OF REACH OF CHILDREN


# CAUTION 11.3% 88.7% 100.0%

SEE SIDE OR BACK PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS

EPA Reg. No. 68173-3 EPA Est. No.

__

Produced for: 

### Kaken Pharmaceutical Co. Ltd. Agro Chemicals and Animal Health Products Department 28-8, Honkomagome 2-chome Bunkyo-ku, Tokyo 113-8650, Japan

For Product Information Call 1-866-761-9397

Net Content: 1 Ib 

### 2 Ibs 6.4 oz (2.4lb)

Arysta UfeScience North America Corporation Po!yoxin 0 Zinc Salt Page 14FIRST AID



### If on skin or 

## • Take off contaminated clothing. 

### clothing 

# • Rinse skin immediately with plenty of water for 15-20 minutes.



## • Call a poison control center or doctor for treatment advice.



### If in eyes 

## • Hold eye open and rinse slowly and gently with water for 15-20 minutes.


# • Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye.


## • Call a poison control center or doctor for treatment advice.



### If swallowed 

## • Call poison control center or doctor immediately for treatment advice.



## • Have person sip a glass of water 

### if able to swallow.



## • Do not induce vomiting unless told to do so by the poison control center

Of doctor.


## • Do not Qive anything by mouth to an unconscious person.

If 

### inhaled 

## • Move person to fresh air.


## • If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably by mouth·to-mouth, if possible.


## • Call a poison control center or doctor for further treatment advice.

HOTLINE NUMBERS H ave the product container or label with you when calling a poison control center or doctor, or going for treatment.

FOR 24·HOUR EMERGENCY MEDICAL ASSISTANCE Call PROSAR at 1·866·303·6952 or 1·651·632·8946 

### if calling from outside of the U.S.

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS AND DOMESTIC ANIMALS CAUTION. Harmful if absorbed through the skin, swallowed or inhaled. Causes moderate eye irritation. Avoid contact with skin, eyes or clothing. Avoid breathing dust or spray mist. Wash thoroughly with soap and water after handling. Remove and wash contaminated clothing before

reuse.

PERSONAL PROTECTIVE EQUIPMENT (PPE) All mixers, loaders, applicators and other handlers must wear:

• Long·sleeved shirt and long pants

• Socks

• Shoes

• Chemical-Resistant gloves

User Safety Requirements Follow the manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables are available, use detergent and hot water. Keep and wash PPE separately from other laundry.

Arysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 15USER SAFETY RECOMMENDATIONS

• Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the

toilet.

• Users should remove clothing/PPE immediately 

### if pesticide gets inside. Then wash thoroughly

and put on clean clothing.

• Users should remove PPE immediately after handling this product. Wash the outside of



### gloves before removing. As soon as possible, wash thoroughly and change into clean 

### clothing.

ENVIRONMENTAL HAZARDS This pesticide is moderately toxic to aquatic invertebrates and fish. Do not apply directly to water, or to areas Vlihere surface water is present orto intertidal areas below the mean high water mark. Do
not contaminate water when disposing of equipment washwater or rinsate. Do not allow runoff into lakes, streams, ponds or public waterways. Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas.

Granules exposed on soil surface may be hazardous to fish and aquatic invertebrates. Collect granules spilled during loading.

Observe the most restrictive of the labeling /imitations and precautions of all products used in mixtures. DIRECTIONS FOR USE 

### It is a violation of Federal law to use this product in a manner inconsistent with its labeling.

For any requirements specific to your State or Tribe, consult the State or Tribal agency responsible for pestiCide regulation.

AGRICULTURAL USE REQUIREMENTS Use this product only in accordance with its labeling and the Worker Protection Standard, 40 CFR part 170. This Standard contains reqUirements for the protection of agricultural workers on farms, forests, nurseries, and greenhouses, and handlers of agricultural pesticides. 

### It contains requirements fortraining, decontamination, notification, and emergency assistance. 

### It also contains specific instructions on this label about personal protective equipment (PPE), notification to workers, and restricted-entry interval. The requirements in this box only apply to uses of this product that are covered by the Worker Protection Standard.

Do not enter or allow entry into treated areas during the restricted entry interval (REI) of 4 hours unless wearing appropriate PPE.

PPE required for early entry into treated areas that is permitted under the Worker Protection Standard and that involves contact with anything that has been treated, such as plants, soil. or water is: coveralls, socks, shoes, chemical resistant gloves.

NON-AGRICULTURAL USE REQUIREMENTS The requirements in the box apply to uses of this product that are NOT within the scope of the

Arysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 16Worker Protection Standard for agricultural pesticides (40 CFR part 170). The WPS applies when this product is used to produce agricultural plants on farms, forests, nurseries or greenhouses. Keep children and pets out of treated area until sprays have dried.

GENERAL INFORMATION ENDORSE Water Dispersible Granules is not for use on turf being grown for commercial seed production.

ENDORSE Water Dispersible Granules is not for homeowner use to treat food crops.

ENDORSE Water Dispersible Granules is for use in controlling or suppressing certain diseases on almonds, cucurbit vegetables, fruiting vegetables, ginseng, grapes, pistachios, pome fruits, potatoes, strawberries, ornamentals, golf courses, residential lawns, parks, and commercial and institutional grounds composed of cool and warm season grasses such as Bluegrass, Bentgrass, Fescue, Ryegrass, Zoysiagrass, or their mixtures.

Apply ENDORSE Water Dispersible Granules as a preventative or curative treatment in conjunction with good management practices.

RESISTANCE MANAGEMENT RECOMMENDATIONS ENDORSE Water Dispersible Granules contains a Group 19 fungicide. Fungal isolates with acquired resistance to Group 19 may eventually dominate the fungal population if Group 19 fungicides are used repeatedly in the same field or in successive years as the primary method of control for targeted species. This may result in partial or total loss of control of those species by ENDORSE Water Dispersible Granules or other Group 19 Fungicides. To delay fungicide resistance, consider:

• Avoiding the consecutive use of ENDORSE Water Dispersible Granules or other target site of action Group 19 fungicides that have a similar target site of action, on the same pathogens.

• Using**tank~mixtures** or premixes with fungicides from different target site of action Groups

as long as the involved products are an registered for the same use and are both effective at the tank mix or prepack rate on the pathogen(s) of concern.

• Basing fungicide use on a comprehensive IPM program.

• Monitoring treated fungal populations for loss of field efficacy.

• Contacting your local extension specialist, certified crop advisors, and/or manufacturer for fungicide resistance management and/or IPM recommendations for specific crops and resistant pathoQens.

MIXING AND APPLICATION When diseases not specified on this label are present or expected, it is appropriate to mix ENDORSE Water Dispersible Granules with appropriately labeled fungicides. When tank mixing ENDORSE Water Dispersible Granules with other products, observe all precautions and limitations

on each separate product label. It is always advisable to conduct a tank mix compatibility test when you plan to mix this product with other products. To determine the physical compatibility of this product with other products, use a jar test. Using a quart jar, add the proportionate amounts of the products to approximately one quart of water with agitation. Add dry formulations first, then flowables, then emulsifrable concentrates last. After thorough m'lxing, allow this mixture to stand for

Arysta LifeScience North America Corporation Poryoxin 0 Zinc Sart Page 175 minutes. If the combination remains mixed or can be readily remixed, it is physically compatible. Once compatibility has been proven, use the same procedure for adding required ingredients to the spray tank. To assess the potential for phytotoxicity, test tank mixtures on a small number of plants prior to more widespread application.

Do not apply this product through any type of irrigation system.

Mixing instructions for ENDORSE Water Dispersible Granules:

• Fill spray tank with water to % of the intended final volume.

• Start spray tank agitation.

• Add the appropriate amount of product to the tank according to the rates in the following tables. Follow the directions above for mixing other products in the spray tank.

• Agitate to ensure thorough mixing while adding the rema'lning required water.

• DO NOT allow the spray mixture to stand without agitation.

Mix only the amount of spray solution needed to treat the desired area.

For optimum control of labeled diseases, apply ENDORSE Water Dispers'lble Granules with sufficient water to provide a thorough coverage.

ALMONDS

Disease Control Rate Application Notes

Alternaria 6.20zfacre • Mix in appropriate spray volume (Alternaria alternata) 

### (0.7 oz ai/acre) appropriate for sufficient coverage (Spray
every row to ensure coverage [avoid every other row applications]).

• Begin sprays preventatively and repeat

on a 

### 10-14 day interval.



### • 0 day Preharvest Interval.

• May be applied by air or ground.

• Use of an adjuvant may enhance

coverage. Notes:


## • Use in alternation with fungicides that have different modes of action

. 

## • Do not apply more than 3 applications of ENDORSE Water Dispersible Granules (2.1 oz ai/acre) per season.

Arysta LifeScience North America Corporation Polyoxin 

### 0 Zinc Salt Page 18CUCURBIT VEGETABLES lChayote (fruit), Chinese waxgourd (Chinese preserving melon), Citron melon, Cucumber, Gherkin, Gourd, edible (includes hyotan, cucuzza, hechima, Chinese okra), Momordica spp. (includes balsam apple, balsam pear, bitter melon, Chinese cucumber), Muskmelon (includes true cantaloupe, cantaloupe, casaba, crenshaw melon, golden pershaw melon, honeydew melon, honey balls, mango

melon, Persian melon, pineapple melon, Santa Claus melon, and snake melon), Pumpkin, Squash,

summer (includes crookneck squash, scallop squash, straightneck squash, vegetable marrow, zucchini), Squash, winter (includes butternut squash, calabaza, hubbard squash, acorn squash, spaghetti squash), Watermelon]

Disease Control Rate Application Notes

Powdery Mildew 6.2 oz/acre • Mix in appropriate spray volume (Spthaerotheca sp.) (0.7 oz aVacre) appropriate for sufficient coverage. Gummy Stem Blight • For all diseases, spray product (Didymella bryoniae) preventatively and continue as needed Gray Mold on a**10~14** day interval. (Botrytis sp.) 

### • 0 day Preharvest Interval. Corynespora leaf spot (Corynespora cassicola)

Scab (Cladosporium sp.)
Early Blight (Alternaria sp.)
Notes:



## • Use in alternation with fungicides that have different modes of action

. 

## • Do not apply more than 5 applications of ENDORSE Water Dispersible Granules (3.5 oz ai/acre) per season.

Arysta LifeScience North America Corporation Polyoxin D Zinc Salt Page 19FRUITING VEGETABLES (Except Cucurbits) [Eggplant, Groundcherry, Pepino, Pepper**(inCI~~es** bell pepper,**Ch!~i** pepper, cooking pepper, ·oimento, sweet oeooer Tomatillo, Tomato
Disease Control Rate Application Notes

Powdery Mildew 6.2oz/acre • Mix in appropriate spray volume (Leveillula taurica, Oidiopsus 

### (0.7 oz ai/acre) appropriate for sufficient coverage. sipula) • For all diseases, spray product Botrytis Rot preventatively and continue as needed (Botrytis sp.) on a**10~14** day interval.
Early Blight • 0 day Preharvest Interval. 

### (Alternaria solanO

Disease Sunnression

Anthracnose (Colletotrfcum coccodes)

Notes:



## • Use in alternation with fungicides that have different modes of action.



## • Do not apply more than 5 applications of ENDORSE Water Dispersible Granules (3.5 oz ai/acre) per season.

GINSENG (Except California)

Foliar Disease Control Rate Application Notes

Alternaria blight 6.20zlacre • Apply as a foliar spray every 7-10 days. (A/ternaria panax) (0.7 oz ai/acre)
• Apply prior to disease development and Botrytis blight when conditions are conducive for (Botrytis cinerea) disease. 1

Root and Crown Disease Control Rate Application Notes

Cylindrocarpon root rot 6.20z/acre • Apply as a drench every 14 days. (Cylindrocarpon destructans) (0.7 oz ai/acre)

Rhizoctonia root and crown rot • Apply as a drench every 14-28 days. (Rhizocfonia so/ani)

Notes:


## • Apply within 2 weeks following plant emergence and continue throughout the season.


## •

• • 1Consult your local extension agent or local recommendations for information relating to proper timing for control of these diseases. Use in alternation with fungicides that have different modes of action. Do not apply more than 3 applications of ENDORSE Water Dispersible Granules (2.1 oz ai/acre) per season.

Arysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 20GRAPES



### Disease Control Rate 

### Application Notes

Botrytis Bunch Rot 

### 6.2 oz/acre • Mix in appropriate spray volume 

### (Bolrylis cinerea) 

### (0.7 oz ai/acre) appropriate for sufficient coverage. Powdery Mildew • For Botrytis Bunch Rot control, spray (Uncinula necator) product at veraisicn and 7 days prior to harvest.

• For Powdery Mildew control, begin

sprays preventatively and continue as needed on a 14 day interval.

• 0 day Preharvest Interval.

• Do not apply by aiL

Notes: 

# • Use in alternation with fungicides that have different modes of action.



## • Do not apply more than 3 applications of ENDORSE Water Dispersible Granules (2.1 oz ai/acre) per season.

PISTACHIOS



### Disease Control Rate 

### Application Notes

Alternaria 

### 6.2 oz/acre • Mix in appropriate spray volume 

### (Allernaria sp.) (0.7 oz ai/acre) appropriate for sufficient coverage

Disease Suppression (Spray every row to ensure coverage (avoid every other row applications))
Botryosphaeria blight • For both diseases, begin sprays (Botryosphaeria sp.) preventatively and continue as needed

on a 10-14 day interval.

• 0 day Preharvest Interval.

• Do not apply by air.

• Use of an adjuvant may enhance

coveraae. Notes: 

# • Use in alternation with fungicides that have different modes of action.



## • Do not apply more than 3 applications of ENDORSE Water Dispersible Granules (2.1 oz ai/acre) per season.

Arysta LifeScience North America Corporation Polyoxin D Zinc Salt Page 21POME FRUITS [Apple, Crabapple, Loquat, Mayhaw, Pear, Oriental Pear, Quince]



### Disease Control Rate 

### Application Notes

Powdery Mildew 

### 6.2 oz/acre • Mix in approprlate spray volume (Apple: Podosphaera /eucotricha 

### (0.7 oz ai/acre) appropriate for sufficient coverage. Pear: Phyllactinia mali) • Start sprays for scab control at green tip Alternaria Leaf Spot and continue as needed on a 7-10 day (Alternaria mail) interval.

Blotch • For Powdery Mildew control, begin (Oip/ocarpon mall) preventatively and repeat as necessary


### Disease Suppression on a 

### 10-14 day interval. Use of an alternation program with a sterol
Scab inhibiting fungicide is recommended. (Venturia sp.) 

# • a day Preharvest Interval.
Notes: 

# • Use in alternation with fungicides that have different modes of action.



## • Do not apply more than 6 applications of ENDORSE Water Dispersible Granules (4.2 oz ai/acre) per season.

POTATOES

Disease Control Rate Application Notes

Early Blight 6.2ozfacre • Mix in appropriate spray volume (Alternaria so/ani) (0.7 oz ai/acre) appropriate for sufficient coverage.

• For all diseases, spray product

preventaflvely and continue as needed

on a 

### 10-14 day interval.



### • 0 day Preharvest Interval. Notes:


## • Use in alternation with fungicides that have different modes of action.



## • Do not apply more than 

### 5 applications of ENDORSE Water Dispersible Granules 

### (3.5 oz ai/acre) per season.

Arysta UfeScience North America Corporation Polyoxin D Zinc Salt Page 22STRAWBERRIES



### Disease Control Rate Application Notes

Anthracnose Leaf and Fruit Rot 

### 6.2ozlacre • Mix in appropriate spray volume (Colletotricum sp.) (0.7 oz ai/acre) appropriate for sufficient coverage. Botrytis Fruit Rot • Begin applications preventatively and (Botrytis cinerea) continue as needed on a 7-10 day
Powdery Mildew interval. (Sphraerotheca macularis) • 0 day Preharvest Interval.

• Do not apply by air.

• Use of adjuvant may enhance coverage.
Notes:


## • Use in alternation WITh tungicides that have difterent modes of action.


## • Do not apply more than 3 applications of ENDORSE Water Dispersible Granules (2.1 oz ai/acre) per season.

ORNAMENTALS

Foliar Disease Control Rate Application Notes

Botrytis blight 0.25

- 

### 0.51b/100 gaVacre • Apply as a foliar spray every 7 - (Botrytis cinerea) (0.03

- 0.061b 

### ai/100 10 days. gal/acre) • Apply prior to disease

Alternaria blight 

### 0.5 Ib/100 gaVacre development and when conditions are conducive to (Alternaria panax) (0.06Ib ail100 gallacre) disease development. 1

Root and Crown Disease Rate Application Notes Control

Rhizoctonia root and crown rot 0.25

- 0.5 

### Ib/1 00 gal/acre • Apply as a soil drench every 

### 14- (Rhizoctonia so/am) (0.03

- 0.061b 

### ai/100 28 days. 

# I gal/acre)

Notes:


## • 1Consult your local extension agent or local recommendations for information relating to proper



# • timing for control of these diseases. Use in alternation with fungicides that have different modes of action.

Arysta UfeScience North America Corporation Polyoxin D Zinc Salt Page 23Disease

Control

Brown Patch
Large Patch



### Aids in Control (Except California)

Cool Weather Brown Patch (Yellow Patch) (Rhizoctonia cerea/is)

Foliar and Basal Anthracnose (Collectotrichum graminicola)
Gray Snow Mold (Typhula ;shikariens;s and Typhula incarnate)

Leaf SpoUMelting Out (Dresch/era pcae)

Pink Snow Mold (Microdochium so/anI)

Red Thread (Laetisaria fuciformis)

Rhizoctonia Damping Off (Rhizoctonia solanl)
Zoysia Patch 

# I (Rhizocfonia so/am)

Aids in Suppression (Except Califomia)

Gray Laaf Spot (Pyricularia grisea)

Suppression and Short Term Control:
Fairy Ring (including Marasmius spp., Lepiota, spp. and Agan'us spp.) TURF GRASSES



### Rate Application Notes

2.4 Ibs lacre • Repeat treatment on a 7-14 day (0.27 Ib ai/acre in a schedule where environmental
minimum of 

### 88 gallons of conditions are conducive to water) development of diseases. 1

• When symptoms are present,

best control will be achieved 

### by using a shorter interval.

• For best results apply after

mowing.

1 ozl1000 sq 

### It in • Make two-three applications on a minimum of 2 gallons of 7-day interval schedule. water • Use a penetrating wetting agent. (0.27 Ib ai/acre in 88 • Immediately following application,

gallons of water) water in the treatment with sufficient irrigation (0.5_1n) to wet

Arysta LifeScience North America Corporation Polyoxin D Zinc Salt Page 24 

## ,TURF GRASSES

Disease Rate 

### Application Notes
the active root zone.

Notes:


## • With the exception for treatment of Fairy Ring, irrigation or rainfall soon after treatment with ENDORSE Water Dispersible Granules will decrease disease control. For best control, do not irrigate for 

### 12 hours after treatment.



# • 1Consult your local extension agent or local recommendations for information relating to proper timing for control of these diseases.



## • Use in altemation with fungicides that have different modes of action.

STORAGE AND DISPOSAL Do not contaminate water, food or feed 

### by storage or disposal. PESTICIDE STORAGE: Store in 

### dry place away from food or feed. PESTICIDE DISPOSAL: Wastes resulting from the use of this product may be disposed of on site

or at an approved waste disposal facility. CONTAINER DISPOSAL: Completely empty bag into application equipment. Then dispose of empty bag in a sanitary landfill or by incineration, or, if allowed, by State and local authorities, by burning. 

### If burned, stay out of smoke.

FOR 24·HOUR CHEMICAL EMERGENCY (Spill, Leak, Fire or Accident) ASSISTANCE: CALL CHEMTREC 1 ·800·424·9300



### Warranty and Disclaimer Statement
4. The directions for use of this product are believed to be adequate and must be followed carefully. However, it is impossible to eliminate all risks associated with the use of this product. Such risks may arise from weather conditions, soil factors, ofHarget movement, unconventional farming techniques, the presence of other materials, the manner of use or application, or other unknown factors, all of which are beyond the control of Kaken Pharmaceutical Co. Ltd. (UKaken"), and can cause crop injury, injury to**non~target** crops or plants, ineffectiveness of the product, or other unintended consequences. All such risks shall be assumed by the user or buyer. 5. Kaken warrants that this product conforms to the chemical description on the label and is reasonably fit for the purposes stated in the Directions for Use, subject to the inherent risks described above, when used in accordance with the Directions for Use under normal conditions. 6. This warranty does not extend to the use of this product contrary to label instructions or under conditions not reasonably foreseeable to Kaken, and is subject to the inherent risks described above. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, KAKEN DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. TO THE EXTENT

Arysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 25

### CONSISTENT WITH APPLICABLE LAW, KAKEN, MANUFACTURER, AND SELLER DISCLAIM AND SHALL NOT BE LIABLE FORANYSPECIAL, INCIDENTAL, INDIRECT, OR CONSEQUENTIAL DAMAGES RESULTING FROM THE USE, HANDLlNG,APPLICATION, STORAGE, OR DISPOSAL OF THIS PRODUCT OR FOR DAMAGES IN THE NATURE OF PENALTIES, AND THE USER AND BUYER WAIVE ANY RIGHT THAT THEY MAY HAVE TO SUCH DAMAGES. NO AGENT, REPRESENTATIVE OR EMPLOYEE OF KAKEN IS AUTHORIZED TO MAKE ANY WARRANTY, GUARANTEE OR REPRESENTATION BEYOND THOSE CONTAINED HEREIN OR TO MODIFY THE WARRANTIES CONTAINED HEREIN. 7. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, THE EXCLUSIVE REMEDY OF THE USER OR BUYER, AND THE TOTAL LIABILITY OF KAKEN, MANUFACTURER, AND SELLER, SHALL BE LIMITED TO THE PURCHASE PRICE PAID, OR AT KAKEN'S ELECTION, THE REPLACEMENT OF THE PRODUCT.

ENDORSE® is a registered trademark of Arysta UfeScience North America Corporation.

Arysta Life8cience North America Corporation Polyoxin 0 Zinc Salt Page 26

## SECTION C: SAFETY DATA

1. TOXICOLOGICAL DATA

A 

### t T 

### ··t

cu e OXIC!tV 

### Guideline Results Reference Data 

### LD501lCso 

### Toxicity Category Ref. No

Number Technical Grade Active Ingredient 870.1100 Acute oral toxicity Male >15,000 mglkg IV 1 

## I (rat) Female 

# = 10,000·15,000 mg/kg 870.1200 Acute dermal >2000 mg/kg III 2 toxicity (rat) 870.1300 Acute inhalation Male >2.44 mg/L IV 3 Toxicity (rat) Female >2.17 mg/L 870.2400 Acute eye irritation 

## I (rabbit)**Slight~moderate** III 4

870.2500 Acute dermal Slight irritation IV 5 irritation (rabbit) 870.2600 Skin sensitization Mild @ 5% dose 6 Formulated Product 870.1100**A~~te** oral toxicity 4916 mg/kg III 7 

## I (rat 870.1200 Acute dermal >2000 mg/kg III 8 toxicity (rat) 870.1300 Acute**i~~ralation** >2.41 mg/L IV 9 Toxicitv rat) '870.2400 

# I**~ut~t~ye** irritation Mildly irritating III 10 rabbit 870.2500 Acute dermal irritation -(rabbit) Non irritant IV 11

870.2600 Skin sensitization No skin sensitizer 12**Mutagenici~** 

### Studies
Guideline Ref. Reference Data Results Conclusion

Number No.

870.5375 In vitro mammalian Slight increase in the frequency of the Equivocal 13 chromosome al chromosomal aberration was aberration test observed in Chinese hamster**fibrob~~~t** cells at**~~e** highest dose tested 0.05 mq/ml 152·17 Rec-assay with Bacillus Polyoxln D Z'lnc Salt showed little Negaflve 14 subti/is H-17 add M-45 differences in growth inhibition between H-17 and M-45 strains, Mitomycin was used as positive control causing a significant difference between the size of the

Arysta UfeSdence North America Corporation Polyoxin 0 Zinc Salt Page 27Guideline Reference Data

Number

152-17 Reverse mutation test with and without liver metabolic activation systems using 2 strains of Esheruchia coli

152-17 Reverse mutation test with liver metabolic activation systems using 2 strains of Esheruchia coli

152-17 Host mediated assay with s. typhimurium G46 in mice

870.5395 Mammalian erythrocyte micronucleus test

152-17 Reverse mutation Ref. Results Conclusion No.
inhibitory zone of the two strains Polyoxin 0 Zinc Salt did not increase Negative 14 the number of revertant colonies of any strains compared with the control unlike the AF-2, f3-propiolactone, 9- aminoacridine and NBT used as positive controls induced clearly the increased numbers of revertant colonies of any strains compared with those of the controls. 2-aminoantracene used as a positive Negative 14 control was activated by S-9 Mix and it was strongly mutagenic for TA1535, TA1527 and TA1536 strains. The Polyoxin 0 Zinc Salt did not increase the number of revertant colonies of any strain compared with those of the controls. The results of in vifro reverse Negative 14 mutation using G-46 strain were negative compared with the control I arouo and positive aro.!:!.2:.

Polyoxin 0 Zinc Salt Technical did not Negative 15 show a significant increase in the incidence of micronuclei in polychromatic erythrocytes as compared to controls at any dose level. Based on the results obselVed, Polyoxin 0 Zinc Salt Technical was negative in the In vivo mouse micronucleus test under the conditions of this study The mutagenicity was investigated Negative 16 using the induction of the gene mutation in Salmonefla fyphimurium and Escherichia coli as the testing index. The solutions of PSB at the dose levels of 156-5000!-lgfplate were tested by the plate method using 5 different bacteria: S. typhimurium TA100. TA1535, TA98, TA1537 and E. co{l WP2uvrA. After treatment with the positive control, clear mutagenicity was obselVed. Both in the test by the direct method and the metabolic act"wation method, PSB

was found to cause no clear increase of the numbers of the revertant colonies.

Arysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 28

### Sub-chronic, Chronic Toxicity and Teratology Studies
Guideline Reference Data

Number 152-23 Teratogenicity

870.7800 Immunotoxiclty Ref. Results NOEL No.

Administration of Polyoxin 0 Zinc Salt Maternal 17 induced neither mortality nor changes in NOEL =200 general signs or autopsy findings of dams. mg/kg/day One dam was not treatment related. Fetuses Observed signs were decreased body weight NOEL = 800 followed by recovery at 800 mo/ko/day

.. mo/ko/day There were no test-related effects on clinical NOEL -1687 18 observations, body weights, or food mg/kg/day consumption. Neither were there any testrelated effects on both macroscopic findings and organ weights. Polyoxin 0 Zinc Salt Technical did not have an effect on the humoral immune response to T -dependent**~ntigen,** sRBC. For the cyclophosphamidetreated group, the T -dependent antigen, sRBC,

was decreased (100%) when compared to the control group. These changes are consistent with the expected immunological effects of cyclophosphamide treatment.

2°1000 QQm dose leve!: for males only, lower NOEL 2000 19 body weights were seen in males and during Mg/kg/day weeks**7~13** the body weights were statistically significant. Associated with the lower body weights, food consumption and food efficiency

were also decreased, but not statistically. Females were unaffected by treatment for these parameters. For hematology and clinical chemistry parameter the following statistical significant effects for male and female parameters were observed: decreased erythrocyte, increased mean corpuscular volume, increased mean corpuscular hemoglobin, decreased total protein, decreased albumin, and increased blood urea n·ltrogen, respectively. Statistically significant decreases in absolute weights of the liver and spleen were observed in both male and females rats. In males only, relative liver weights were decreased. In addition, males showed statistically significant increases in relative weights of the brain, kidney, and adrenal and statistically significant decrease in absolute heart weight.

Arysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 29Guideline Reference Data Results 

### NOEL

Number 152-26 Chronic No dose related effects were observed in Male NOEL 3591 152-29 Toxicity**~** Mice mice fed diet containing 0, 0.04, 0.4, and 4% mglkglday Female NOEL Polyoxin 0 Zinc Salt TGAI ad libitum for 24 4177 mg/kglday 

### months (Non-GLP study) 152-26 Chronic No dose related effects were observed in Male NOEL 2058 152-29 T oxicity**~** Rats Wister rats fed diet containing 0, 0.01, 0.1, 1 mg/kglday Female NOEL and 5% Polyoxin 0 Zinc Salt TGAI ad libitum 2469 mg/kg/day for 24 months



### References:

1. Acute Oral Toxicity Study in Rats with Polyoxin D Zinc Salt Technical Grade Material, S.K. Shultz, AW. Brock, J. Lavegia, 1992 Ref. 

### No.

20

21



### 2. Acute Dermal Toxicity Study of Polyoxin D Zinc**Sa~** 

### in rats, K. Maruyama, 1989 3. Polyoxin D Zinc Salt Acute Inhalation Toxicity in rats: 4-Hour Exposure, C.J. Hardy, G.C Jackson, 1988, amended 1988 and 1994 4. Primary Eye Irritation Study in Albino Rabbits with Polyoxin D Zinc Salt Technical Grade Material, S.K. Shultz, AW Brock, J. Lavegia, 1992 5. Primary Dermal Irritation Study in Albino Rabbits with Polyoxin D Zinc salt Technical Grade Material, SK Shultz, AW. Brock, J. Lavegia, 1992 6. Skin Sensitization Study of Polyoxin D Zinc Salt in the Guinea Pig, T. Tanigaki, 1988 7. An Acute Oral Toxicity Study of Polyoxin Z Dry Flowable in Rats: (Endorse Water Dispersible Granules), S. Oda, 1996 8. A Dermal Acute Toxicity Study of Polyoxin Z Dry Flowable in Rats: (Endorse Water Dispersible Granules), S. Oda, 1996 9. An Acute Nose-Only Inhalation Toxicity Study in Rats with Endorse WDG, J. Smedley, 2005 10. A Primary Eye Irritation Study of Polyoxin Z Dry Flowable in Rabbits, R. Shibata, 1996 11.A Primary Derrnallrritation Study of Polyoxin Z Dry Flowable in Rabbits, 

### R. Shibata, 1996 12.A Skin Sensitization Study of Polyoxin Z Dry Flowable in Guinea Pigs, 

### R. Shibata, 1996 13. Studies on Chromosomal Aberration by Polyoxin D Zinc Salt in CHL cells, J. Yoshida, K. Kubo, 1987 14. Mutagenicity Testing on Polyoxin D Zinc Salt in Microbial Systems: (1) RecAssay with Bacillus subtilis H-17 and M-45 (2) Reverse Mutation Tests with and without a Liver Metabolic Activation Systems Using Two Strains of Escherichia coli and Four Strands of Salmonella typhimurium, and (3) Host-Mediated Assay with S. typhimurium G-64 in mice, Y. Shirasu, M. Moriya, 

### K. Kato, 1976

Arysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 30

### 15. Micronucleus Test of Polyoxin D Zinc Salt Technical in Mice, K. Matsumoto, 2003 16.Reverse Mutation Test of PSB with Bacteria, 

### J. Yoshida, 1994 17. Teratology Study on Polyoxin D Zinc Salt (PSB) in Rabbits, M. Yoshida, 1991 18.A Splenic Antibody Study Following Dietary Exposure to Polyoxin D Zinc Salt Technical in Female Mice for 28 Days, 

### E.L. Padgett, 2006 19. Polyoxin D Zinc Salt Technical: Repeated Dose 90-Day Oral Toxicity Study in Rats, N. Takahashi, 2006 20. Summary of Chronic Toxicology Study of Polyoxin D Zinc Salt in Mice, M. Hori, 1976 21. Summary of Chronic Toxicity Study of Polyoxin D Zinc Salt in Rats, M. Hori, 1976

Arysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 31) 

### 2. ECOTOXICOLOGICAL DATA

Guideline 

### Studv Results Conclusion Ref. No. 154-6 Avian acute oral

- Mallard >2150 mg/kg Practically**non~toxic** 1 Ducks 154-7 Avian dieta

- Mallard Ducks >5000 ppm Practically non-toxic 2 154-8 Freshwater fish LC so - Rainbow 5.1 mgll Moderately toxic 

### 3 Trout 154-9 Freshwater invertebrate EC so - 1.4 mgll Moderately toxic 4 Daohnia maana 154-11 Effects on Two-Spotted Spider No effects Practically non-toxic 5 mite, Brown Plant Hopper, and observed following Diamond Back Moth application of 400 "Q/ml



### References:

1. Polyoxin D Zinc Salt Technical Grade Material: 21-Day Acute Oral LD50 Study in Mallard Ducks, C. Pedersen, 1992 2. Polyoxin D Zinc Salt Technical Grade Material: 8-Day Acute Dietary LD50 Study in Mallard Ducklings, C. Pedersen, 1992 3. Polyoxin D Zinc Salt Technical Grade Active Ingredient: Acute LC50 to Rainbow Trout (Oncorhynchus mykiss), 

### J. Bowman, 

### R. Herzig, 1994 4. Polyoxin D Zinc Salt Technical Grade Active Ingredient: Acute EC50 to Daphnia magna, 

### Bowman, 

### R. Herzig, 1994 5. Effects of Polyoxin D on Two-Spotted Spider Mite, Brown Plant Hopper and Diamond Back Moth, 

### J. Tokumura, 1990

Arysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 32

## SECTION D: RESIDUE DATA

Polyoxin 0 Zinc Salt is registered as a biochemical-like pesticide. Based on 40 CFR §158.690(b) no residue data is required if the product use rate is 20 grams (0.7 ounces)

or less active ingredient per acre per application and Tier II or III toxicology data is not required. The product is not intended for outdoor residential uses.

Arysta UfeScience North America Corporation Potyoxin 0 Zinc Salt Page 33

## SECTION E: PROPOSED TOLERANCES

No tolerances are propose

Arysta UfeScience North America Corporation Polyoxin 0 Zinc Salt Page 34

## SECTION F : PROPOSED METHODS FOR REMOVING THE RESIDUES

Since exempt from tolerance is requested methods for removing the residues are not necessary.

Arysta UfeScience North America Corporation Polyoxin 0 Zinc Salt 

### Page 35

## SECTION G: REASONABLE GOUNDS IN SUPPORT OF PETITION FOR POL YOXIN D ZINC SALT IN ALMONDS, CUCURBIT VEGETABLES, FRUITING VEGETABLES, GINSENG, GRAPES, PISTACHIOS, POME FRUITS, POTATOES, AND STRAWBERRY

Arysta LifeScience North America Corporation as Agent for Kaken Pharmaceuticals is requesting exemption from tolerances on the basis of 40 CFR conditions for biochemical-like pesticide. Some of the supporting data was submitted and accepted. Additional data is submitted with now to support food uses.

SUMMARY



### Polyoxin D (also known as polyoxin), the active portion of the polyoxin D zinc salt compound, is an antibiotic and acts to inhibit the growth of phytopathogenic fungal cell wall chitin by competitively inhibiting chitin synthetase. Polyoxin D is produced via a 

### fermentation process using 

### Streptomyces cacao! var. asoensis, which was isolated from a soil sample collected in Japan. Polyoxin D is very water soluble so it is formulated as the zinc salt to give longer residence time on plant surfaces. The compound is fungi static and reportedly has no residual effects after the compound has degraded or washed off surfaces.

The technical product, Polyoxin D Zinc Salt Technical, is used for the manufacture of the end-use product and contains 23.8% polyoxin D zinc salt. The end-use product, ENDORSE Water Dispersibel Granules, contains 11.3% polyoxin D zinc salt active ingredient.



### 1. Use Sites/Usage

The proposed added end-use involves ground spray foliar applications of water dispersible granules to almonds, cucurbit vegetables, fruiting vegetables, ginseng, grapes, pistachios, pome fruits, potatoes and strawberries. ENDORSE WDG is not for 

### homeowner use to treat food crops.

2. Human Health Risk Assessment

(a) Human Exposure

All data requirements have been fulfilled for the active ingredient. Exemption from the

Arysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 36

### \



### requirement of a tolerance is needed since polyoxin 0 zinc salt will be registered for

uses on food.

The acute oral toxicity, acute inhalation toxicity and primary dermal irritation studies indicated Toxicity Category IV for Polyoxin 0 Zinc Salt Technical. The acute inhalation toxicity and primary dermal irritation studies indicated Toxicity Category IV for Endorse WDG. The acute dermal toxicity and acute 

## eye irritation studies indicated Toxicity Category III for Polyoxin 0 Zinc Salt Technical. The acute oral toxicity, acute dermal toxicity and acute 

## eye irritation studies indicated Toxicity Category III for Endorse WDG. The hypersensitivity study indicated Polyoxin 0 Zinc Salt Technical was a mild 

### sensitizer at a 5% dose, and that the end-use product was a non-sensitizer. To date, there have been no hypersensitivity incidents reported in handlers of the technical or end-use product.

(b) Risk Assessment

The battery of acute and chronic toxicological studies indicates polyoxin 0 zinc salt 

### induces minimal toxic affects to humans through oral, dermal, ocular or inhalation exposure. We have also considered polyoxin 0 zinc salt in light of the nine safety factors listed in the Food Quality Protection Act (FQPA) and have made a determination 

### of reasonable certainty of no harm.

3. Ecological Risk Assessment

(a) Ecological Toxicity Endpoints



### No unreasonable adverse ecological or environmental fate effects on avian, aquatic or other nontarget organisms were identified.

(b) Ecological Exposure



### Potential exposure to freshwater invertebrates and fish, via runoff after application, 

### will be minimized by mitigating Environmental Hazards label 

### text.

(c) Risk Assessment



### Ecological effects studies were performed on mallard duck, freshwater invertebrates and rainbow trout and non-target insects including two-spotted spider mites, brown plant hopers, and diamond back moths. Toxicological studies indicated that there is no significant toxicity to rodents from acute oral testing at the maximum hazed dose. 

### Therefore, risk to mammalian wildlife is expected to be minimal to nonexistent. Polyoxin 0 zinc salt was found to be practically non-toxic to the mallard duck, which is a 

### representative species for avian risk assessment. Based on the results of the nonArysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 37

### target insect study, exposure to polyoxin D zinc salt is not expected to pose significant increased risks to terrestrial insects. Moderate toxicity to aquatic species (freshwater invertebrates and rainbow trout) was observed. No unreasonable adverse ecological or environmental fate effects were identified by the duck, mite and insect testing. Potential exposure to freshwater invertebrates and fish will be minimized by appropriate precautionary labeling.

Arysta LifeScience North America Corporation Polyoxin 0 Zinc Salt Page 38

## Attachment: Data Matrix

Arysta LifeScience North America Corporation Po!yoxin 0 Zinc Salt Page 390UNITEDSTATESENVIRONMENTALPRL.':TIONAGENCYFormApprovedOMSNo.k,_.-0060401MStreet,S.W.""WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistraflonactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2t37),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateApril30,2007EPAReg.No.lFileSymbol68t73-tJPage1of5Applicanj'sfRegistrant'sName&Address:ProductArystaLifeScienceNorthAmericaCorporaflon,1540tWestonPkwy.,Suite150,Cary,NC27513Polyoxin0ZincSaltas§lgentforKakenPharmaceuticalCo.,Ltd.Ingredient(s):Captan,CAS#146659-78-tGuidelineReferenceNumberGuidelineStudyNameIMRIDNumberSubmitterStatusNote'._.."ProductChemistryEndMUseProduct830.1700Preliminaryanalysis43261811KAKENOWN44249701!ManufacturingIrocess44249801KAKENOWN830.1750Certifiedlimits43261809KAKENOWN830.1800Enforcementanalyticalmethod43261811KAKENOWN830.1800Enforcementanalyticalmethod43261812KAKENOWN-830.1800Enforcementanalyticalmethod43261813KAKENOWNj-830.1800Enforcementanalyticalmethod43261814KAKENOWN830.1800Enforcementanalyticalmethod43261815KAKENOWN830.6302Color43261816KAKENOWN830.6303Physicalstate43261816KAKENOWN830.6304Odor43261816KAKENOWN830.6313Stabilitytonormalandelevated43261819KAKENOWNS;gnatu,./4:.-,.NameandTitle:DateV7.c7Z---.DolnaBujorIRegulatoryManager04/3012007J'PA."omR,,,n."Sp",,,,,,,,10M3"",;13"'unm;!""Ivv",.;on0UNITEDSTATESENVIRONMENTALPRe.cTIONAGENCYFormApprovedOMSNo..J060--..401MStreet,S.W."WASHINGTON,D.C.20460PaperworkReductionActNotice:Thereportingburdenforthiscollectionofinfotmationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateApril30,2007EPAReg,No.lFileSymbolIPage2of5Applicant'slRegistrant'sName&Address:Produc1ArystaLifeScienceNorthAmericaCorporation,15401Wes10nPkwy.,Suite150,Cary,NC27513Polyoxin0ZincSaltasaQentforKakenPharmaceuticalCo.,Ltd.lngredienl{s):Caplan,CAS#GuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNotetemperatures,metals,andmetal'Ions830.6317stability43261821KAKENOWN830.7000,pH43261816KAKENOWN830.7200Meltingpoint/meltingrange43261816KAKENOWN830.7300Density/relativedensity/bulkdensity43261816KAKENOWN830.7370Dissociationconstantsinwater43261816KAKENOWN830,7840Solubility43261816KAKENOWN830.7860r850.1010Aquaticinvertebrateacutetoxicitytest,43261843KAKENOWN..ifreshwaterd§!phnids850,1075Fishacutetoxicitytest,freshwaterand43261842KAKENOWNmarine!850.2100AvianacuteoraltoxicityJest43261840KAKENOWN850.2200Aviandietarytoxicitytest43261841KAKENOWN1870.1100Acuteoraltoxicity_43261823KAKENOWNSignatureNameandTitIe:Date/,0a"C2:----.DoinaBujor1RegulatoryManager04/3012007/EPAFo,m8570-35{9·9Elac1lonicandPaper.erslonIf"QvQII"bl".Subn"j>l'"onlvPapetversion.Aaenc.InternalUseConv/0UNITEDSTATESENVIRONMENTALPRl;TIONAGENCYFonnApprovedOMSNo.•__.________J060401MStreet,S.W."WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet.S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateApril30,2007EPAReg.No.lFileSymbol68173-1IPage30fSApplicant's/RegistranfsName&Address:ProductArystaLifeScienceNorthAmericaCorporation,15401WestonPkwy.,Suite150,Cary,NC27513as·agentforKakenPhannaceutica!Co.,Ltd.PolyoxinDZincSaltIngredient(s):Caplan,CAS#146659-78-1GuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNote870.1200Acutederma!toxicity43261825KAKENOWN870.1300Acuteinhalationtoxicilll43261827KAKENOWN870.2400Acuteeyeirritation43261829KAKENOWN870.2500Acutedermalirritation43261831KAKENOWN870.2600SkinsenSitization43261833KAKENOWN870.3700TeratoQenicity43261837KAKENOWN870.7800ImmunotoxicityArystaPERI-870.3100gO-dayoraltoxicityKakenOwn..I870.4100Chronictoxicity_43261838KAKENOWN870.4100Chronictoxicity43261839KAKENOWN870.4200Carcinoenicity43261838KAKENOWN870.4200Carcinoaenicitv43261839KAKENOWN870.5100Bacteria!reversemutationtest43323001KAKENOWN870.5100Bacteria!reversemutationtest43261836KAKENOWNSignature,NameandTItle:Date"'C.....DainaBujorIRegulatoryManager04130/2007\"'oM,nn'""ono,...,<nn""",-,,,,nJI".nru....'""nu0UNITEDSTATESENVIRONMENTALPRl;TIONAGENCYFormApprovedOMBNo.J060401MStreet,S.W.-WASHINGTON,D.C.20460PaperworkReductionActNotice:ThepublicreportingburdenforthiscollectionofinfOrmationisestimatedtoaverage0.25hoursperresponseforregistrationadiviUesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includinglimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburden10:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateApril30,2007EPAReg.No.lFileSymbol68173-1IPage4of5Applicant's/RegistranfsName&Address:ProductArystalifeScienceNorthAmericaCorporation,15401WestonPkwy.,Suite150,Cary,NC27513PolyoxinDZincSaltasaoentforKakenPharmaceuticalCo.,ltd.Ingredient(s):Captan,CAS#146659-78-1GuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNote870.5265TheSalmonellatyphimuriumreverse43261836KAKENOWNmutationassail870.5395InvivomammaliancytogeneticstestKAKENErythrocvtemicronucleusassay!870.5375Invitromammalianchromosome43261835KAKENOWNaberrationtest880.1100Productidentityandcomposition43261809KAKENOWN.880.1100Productidentitllandcomposition43261810KAKENOWN--,880.1200Descriptionofstartingmaterials,43261809KAKENOWNproductionandformulaflonprocess880.1400Discussionofformationofimpurities43261809KAKENOWN880.4350Nontargetinsecttestin43261844KAKENOWNNfAToxicoloQVSummary43261822KAKENOWNNfAModeofaction43372101KAKENOWNNfAModeofaction43372102KAKENOWN"Signature'NameandTitle:DateDoinaBujorIRegulatoryManager04130/2007EPAForm8571l-3S19·971EletlronicandP""ervaWonsavailable.onlvPaper""..ionAaencvIn!ema!UseCODV,0UNITEDSTATESENVIRONMENTALPRl;TIONAGENCYFo""App'"''OMBNo,.'I."401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington.DC20460.IDonotsendtheformtothisaddress.IDATAMATRIXDateApril30,2007Applicant'siRegistrant'sName&Address:ArystaUfeScienceNorthAmericaCorporation,15401WestonPkwy.,Suite150,Cary,NC27513asaQentforKakenPharmaceuticalCo.,ltd.Ingredient(s):Captan,CAS#146659-78-1GuidelineReferenceNumberGuidelineStudyNameMRIDNumberN/AAerobicsoilmetabolism43372103N/AEfficac'j43261802N/AModeofaction(forclassificationasab'lochemicalpestic"lde)-43261803N/AModeofaction(forclassificationasa43261804N/AModeofaction(forclassificationasa43261805biochemicalpestic"lde)N/AModeofaction(forclassificationasa43261806biochemicalpesticide)N/AModeofaction(forclassificationasa43261807biochemicalpesticide)N/AModeofaction(forclassificationasa43261808biochemicalSignaturew.z,EPAFo;:m557().35(s·;iijE.eelronicvernlonssubmi!onlyPap...WSion_EPAReg.No.lFileSymbol68173-1ProductPolyoxinDZincSaltSubmitterKAKENKAKENKAKENKAKENKAKENKAKENKAKENKAKENNameandTitle:DoinaBujor1RegulatoryManagerStatusOWNOWNOWNOWNOWNOWNOWNOWN\Page5of5NoteDate04/30/2007AgencyIn!eme!UseCopy-._/"--"AD"UNITEDSTATESENVIRONMENTALPRC.;TIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460FormApprovedOMSNo.:<..J060forreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionforreducingtheburdento:Director,OPPEInformationManagementDivision(2t37),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.DATAMATRIXEPAReg.No.lRleSymbol68173-1Product15401WestonPkwy.,Suite150,Cary,NC275131Polyoxin0ZincSalt04/30/2007o-NorthUNITEDSTATESENVIRONMENTALPRe....AGENCY401MSlree!,S,W.WASHINGTON,D.C.20460FormApprovedOMBNo.:....0060average0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponsecompletingthenecessaryforms.SendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionOPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.DATAMATRIX68173-1Page2of515401Wes10nPkwy.,Suite150,Cary,NC27513DoinaBujor1RegulatoryManager04/30/2007o"UNITEDSTATESENVIRONMENTALPRe..."TIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460FormApprovedOMSNo.:C.___J060timefor!eadiogthe'commentsregardingtheburden estimateoranyetheraspectofthiscollectiontheburdento:Director,U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.DATAMATRIXProduct15401WestonPkwy.,Suite150,Cary,NC27513!Polyoxin0ZincSaltDoinaBujor{RegulatoryManager04130/2007o"NorthAmericaUNITEDSTATESENVIRONMENTALPRLAGENCYFormApprovedOMSNo.:",J060401MStreet,S.W.WASHINGTON,D.C.20460average0.25hoursperresponseforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionburdento:Director,OPPEInformationManagementDivision(2137),U.S,EnvironmentalProtectionAgency,40tMStreet,S.W.,Washington,DC20460.DATAMATRIXEPAReg.No.fFlleSymbol68173-1Product15401WestonPkwy.,Suite150,Cary,NC27513IPolyoxinDZincSalti>c:.Date04/30/2007o"UNITEDSTATESENVIRONMENTALPRl;TlONAGENCY401MStreet,S.W.D.C.20460andcompletingthenecessaryInformationManagementDivision(2137),U.S.DATAMATRIX15401WestonPkwy.,Suite150,Cary,NC27513IPolyoxinDZincSaltSignature"NameandTitle:FormApprovedOMBNo.,J060burdenestimateorAgency,401MStreet,collectionDC20460.DoinaBujorIRegulatoryManagerDate04/30/2007EPAFOm.S570-35wersion.aVailah"swbmilonlyPaporversicm.,AgencyIniernalUsee'apy