EPA Petition File 7F7252
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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. 
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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.gov. 

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 
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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 

"safelJ 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 
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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 resi.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 cJ.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 toxico1.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 
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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 acutet 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:,dlJ, 

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 ingr'( ,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 
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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 Leso 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 rEu1: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"' L (:1;, i'111E t. " (" ,S.i!\... "I" L' ~t".::"J", '" "T" 'l -',),) "f') • ..tYt,.L1;::' "'I'''''''' .,-:,-,t,,, W t 'J v 1 ~ 'wo 

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 
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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(' .;)",l'~' '" ' ,', Ie c."' L,I, of ':II" i '" ,., " .•. ,,1,'" "-.J.",'(" •• " C' /L V ,'c'· '_., 1\; and 

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, .·.Le '.,.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 
8

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''''' ,', "'/'" 7o l'l s u y ase on 1e a~,Y LXptj-:O,-,-yg,:. \',. _, -,-,,) :.:> v. 0 f '" "P,', ,IV_,'_,___ 7 J.-'-'> "'J901) , 

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 v."',, oVI10" '~c' '-"i"1'1""'-"1'- v l'U6l;' ;1('.1.--, 'i'-'" B' ,,)0' ('L"O~ r'" Vi; --l' 

~ i:j (i ~ __ t '-' i'-"j" - :<, "l'~ ;,,_ D 

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 Xh 'nD Zl.Ilv"." '"'j",,,,_e,,,,,,,, U",.-!L,), ',', "j'l')""'1 ,e":l '" ,d 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 
9

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:ti118, 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 marnmQ .li8.r diei:>=c'v dfEiCtS. 
10

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 1j8ble 

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 zincL 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",<' 
11

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:'" .• , tC1_1-" Y1'-',,·!,· v· 1"'-'r-l'-~~;'-'o ___ {,~ •.. b tn -' l'rr'J--~'" _, I,,, " ~1 r1, ,_ ,;1(;"pn ., '.'_ • c 'Ina' 

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:: ,:;umpti [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 "'~':. ' . ·ut,(\ 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 :\"rl' 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\'\-, 2'11 ' 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 . II " , _".~ __ , ,_".j~_,_ .. ·IIJd "J. Q'-I, . __ ,,~ ',' 1'J',-' l_'J. . ~'J'\):-t 

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 
12

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"::/ 
13

.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 1l! 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

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

. , 

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 
16

. 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, 

Front 

7'.f./WJA 

End Processing 

~ 

Staff 

Information Technology & Resources Management Division 
17

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 
18

.. . 

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",~, [": 
19

, 

! 

FEE F'OR SERVICE 
20

,,-' " 

DATE: AUG! 02007 " ',- ," ,,"" "- ' -" 

,--" .. _. ." i' 

FILE NUMB$~:i . 1 (' 1:)5?- ', .. ,","-"-::. "', '-, 

FEP (OPPIN~~A7JA1~);,17 .·g(to(~OJ) 

. .... ..'i?i:i)r\;"i!(Xp;J~i~l~;;:t1,~t¢) ... 

FILE- ROOM;:~/,;:; •.• ' .. ··.tX!U:~~ijt·'i~ij3t~) .. ' . 

SIG: 

FILE ROOM; '·~'·Hi':"";""i."'i·· .. """,·· .. ",,:...,' """," ~."......,....._ 

/ . . ••• )~~I(~~~) .•. , . _ ASSIG]N')a;\~~II.!i~:'''i'~/ ii. '.' (NQiiQAT A) , .. '.,'- '-, '."~,~':\·~'V;"::~'}<':',:;' '_, ", -. ",'_' _, - ",", 

__ JACKET,rt1.~~·I_~~F,.(nATA)· 
21

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 

" ) , , , , 

" , , , , , 

, , , , , , , , , , , 
22

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 

" , , )) 

, , 

, , , > , , " , , . 
23

~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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•••••• 

, " , , , " , » ) 

'" , 

'" , j" , 

'" , ) 

, 

" 

" , " , 

, , 

, " 
24

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 .................................................................. ,.'.:.,.3.9 " , .. ~ ~ .. , .. , . , ) " } , , , .. , .', , , " , , >. 

"" "'S' 

"; , 

" . ", , , , 

" 

Arysta UfeScience North America Corporation 

Polyoxin 0 Zinc Salt 

Page 2 

, . • • • • • 
25

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 
26

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 
27

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. 

Pro d 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 7 
28

OPPTS 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/cm3 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 8 
29

OPPTS 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 
30

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 
31

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 11 
32

FIRST 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. 

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STORAGE 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 

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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) 

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FIRST 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. 

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USER 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 

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Worker 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 

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5 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. 

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CUCURBIT 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. 

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FRUITING 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. 

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GRAPES 

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. 

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POME 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. 

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STRAWBERRIES 

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. 

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Disease 

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 

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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 

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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. 

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SECTION C: SAFETY DATA 

1. TOXICOLOGICAL DATA 

A cu t e T OXIC!tV ··t 

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 

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Guideline 

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 

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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 

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Guideline 

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 

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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 

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) 

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 LCso - Rainbow 5.1 mgll Moderately toxic 3 

Trout 

154-9 Freshwater invertebrate ECso - 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 

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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 

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SECTION E: PROPOSED TOLERANCES 

No tolerances are propose 

Arysta UfeScience North America Corporation 

Polyoxin 0 Zinc Salt 

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55

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 

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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 

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57

\ 

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 
58

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 
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Attachment: Data Matrix 

Arysta LifeScience North America Corporation 

Po!yoxin 0 Zinc Salt 

Page 39 
60

0 UNITED STATES ENVIRONMENTAL PRL .':TION AGENCY Form App

401 M Street, S.W. "" WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registraflon activities 

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate 

of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2t37), U.S. Environmental Protection Agency, 401 M 

Do not send the form to this address. 

DATA MATRIX 

Date April 30, 2007 EPA Reg. No.lFile Symbol 68 t73-t 

Applicanj'sfRegistrant's Name & Address: Product 

Arysta LifeScience North America Corporaflon, 1540t Weston Pkwy., Suite 150, Cary, NC 27513 Polyoxin 0 Zinc Salt as§lgent for Kaken Pharmaceutical Co., Ltd. 

Ingredient(s): Captan, CAS # 146659-78-t 

Guideline Reference Number Guideline Study Name I MRID Number Submitter Status 

Product Chemistry EndMUse Product 

830.1700 Preliminary analysis 43261811 KAKEN OWN 

44249701 

! 

Manufacturing I rocess 44249801 KAKEN OWN 

830.1750 Certified limits 43261809 KAKEN OWN 830.1800 Enforcement analytical method 43261811 KAKEN OWN 

830.1800 Enforcement analytical method 43261812 KAKEN OWN 

830.1800 Enforcement analytical method 43261813 KAKEN OWN 

830.1800 Enforcement analytical method 43261814 KAKEN OWN 

830.1800 Enforcement analytical method 43261815 KAKEN OWN 

830.6302 Color 43261816 KAKEN OWN 

830.6303 Physical state 43261816 KAKEN OWN 

830.6304 Odor 43261816 KAKEN OWN 830.6313 Stability to normal and elevated 43261819 KAKEN OWN 

S;gnatu,. /4:.- ,. Name and Title: 

V 7. c7Z---. Dolna Bujor I Regulatory Manager 

J'PA ."om R,,,n."S p" ,,,,,,,,10M 3"",;13 "'unm;! ""Iv v",.;on 
61

0 UNITED STATES ENVIRONMENTAL PRe. cTION AGENCY Form Ap

--.. 401 M Street, S.W. " WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The reporting burden for this collection of infotmation is estimated to average 0.25 hours per response for registration activities 

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimat

of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M 

Do not send the form to this address. 

DATA MATRIX 

Date April 30, 2007 EPA Reg, No.lFile Symbol 

Applicant'slRegistrant's Name & Address: Produc1 

Arysta LifeScience North America Corporation, 15401 Wes10n Pkwy., Suite 150, Cary, NC 27513 Polyoxin 0 Zinc Salt as aQent for Kaken Pharmaceutical Co., Ltd. 

lngredienl{s): Caplan, CAS # 

Guideline Reference Number Guideline Study Name MRID Number Submitter Status 

temperatures, metals, and metal 'Ions 

830.6317 stability 43261821 KAKEN OWN 830.7000 , pH 43261816 KAKEN OWN 

830.7200 Melting point/melting range 43261816 KAKEN OWN 830.7300 Density/relative density/bulk density 43261816 KAKEN OWN 

830.7370 Dissociation constants in water 43261816 KAKEN OWN 

830,7840 Solubility 43261816 KAKEN OWN 

830.7860 

850.1010 Aquatic invertebrate acute toxicity test, 43261843 KAKEN OWN 

freshwater d§!phnids 

850,1075 Fish acute toxicity test, freshwater and 43261842 KAKEN OWN 

marine 

! 850.2100 Avian acute oral toxicity Jest 43261840 KAKEN OWN 

850.2200 Avian dietary toxicity test 43261841 KAKEN OWN 

1870.1100 Acute oral toxicity_ 43261823 KAKEN OWN 

Signature Name and TitIe: 

/ ,0 a "C2:----. Doina Bujor 1 Regulatory Manager 

/ 

EPA Fo,m 8570-35 {9·9 Elac1lonic and Paper .erslonIf"QvQII"bl". Subn"j>l'"onlv Papet version. 

/ 
62

0 UNITED STATES ENVIRONMENTAL PRl ;TION AGENCY Fonn Ap

401 M Street, S.W. " WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities 

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimat

of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M 

Do not send the form to this address. 

DATA MATRIX 

Date April 30, 2007 EPA Reg. No.lFile Symbol 68173-1 

Applicant's/Registranfs Name & Address: Product 

Arysta LifeScience North America Corporation, 15401 Weston Pkwy., Suite 150, Cary, NC 27513 

as· agent for Kaken Phannaceutica! Co., Ltd. Polyoxin D Zinc Salt 

Ingredient(s): Caplan, CAS # 146659-78-1 

Guideline Reference Number Guideline Study Name MRID Number Submitter Status 

870.1200 Acute derma! toxicity 43261825 KAKEN OWN 

870.1300 Acute inhalation toxicilll 43261827 KAKEN OWN 870.2400 Acute eye irritation 43261829 KAKEN OWN 

870.2500 Acute dermal irritation 43261831 KAKEN OWN 

870.2600 Skin senSitization 43261833 KAKEN OWN 870.3700 TeratoQenicity 43261837 KAKEN OWN 

870.7800 Immunotoxicity Arysta PER 

870.3100 gO-day oral toxicity Kaken Own 

870.4100 Chronic toxicity_ 43261838 KAKEN OWN 

870.4100 Chronic toxicity 43261839 KAKEN OWN 

870.4200 Carcino enicity 43261838 KAKEN OWN 

870.4200 Carcinoaenicitv 43261839 KAKEN OWN 870.5100 Bacteria! reverse mutation test 43323001 KAKEN OWN 870.5100 Bacteria! reverse mutation test 43261836 KAKEN OWN 

Signature , Name and TItle: 

"'C..... Daina Bujor I Regulatory Manager 

\ "'oM,nn'" "ono, ... , < nn" "",-,,,,n 
63

0 UNITED STATES ENVIRONMENTAL PRl ;TION AGENCY Form Ap

401 M Street, S.W. 

- WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of infOrmation is estimated to average 0.25 hours per response for registration adiviUe

reregistration and special review activities, including lime for reading the instructions and completing the necessary forms. Send comments regarding the burden estima

of information, including suggestions for reducing the burden 10: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M 

Do not send the form to this address. 

DATA MATRIX 

Date April 30, 2007 EPA Reg. No.lFile Symbol 68173-1 

Applicant's/Registranfs Name & Address: Product 

Arysta lifeScience North America Corporation, 15401 Weston Pkwy., Suite 150, Cary, NC 27513 Polyoxin D Zinc Salt as aoent for Kaken Pharmaceutical Co., ltd. 

Ingredient(s): Captan, CAS # 146659-78-1 

Guideline Reference Number Guideline Study Name MRID Number Submitter Status 

870.5265 The Salmonella typhimurium reverse 43261836 KAKEN OWN 

mutation assail 

870.5395 In vivo mammalian cytogenetics test KAKEN 

Erythrocvte micronucleus assay 

! 870.5375 In vitro mammalian chromosome 43261835 KAKEN OWN 

aberration test 

880.1100 Product identity and composition 43261809 KAKEN OWN 

.880.1100 Product identitll and composition 43261810 KAKEN OWN 

, 880.1200 Description of starting materials, 43261809 KAKEN OWN 

production and formulaflon process 

880.1400 Discussion of formation of impurities 43261809 KAKEN OWN 

880.4350 Nontarget insect testin 43261844 KAKEN OWN 

NfA T oxicoloQV Summary 43261822 KAKEN OWN 

NfA Mode of action 43372101 KAKEN OWN 

NfA Mode of action 43372102 KAKEN OWN 

" 

Signature ' Name and Title: 

Doina Bujor I Regulatory Manager 

EPA Form 8571l-3S 19·971 Eletlronicand P""ervaWons available. onlv Paper"" .. ion 
64

, 

0 . UNITED STATES ENVIRONMENTAL PRl ;TION AGENCY Fo"" A

" 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activitie

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estima

of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M 

Do not send the form to this address. 

DATA MATRIX 

Date April 30, 2007 

Applicant'siRegistrant's Name & Address: 

Arysta UfeScience North America Corporation, 15401 Weston Pkwy., Suite 150, Cary, NC 27513 

as aQent for Kaken Pharmaceutical Co., ltd. 

Ingredient(s): Captan, CAS # 146659-78-1 

Guideline Reference Number Guideline Study Name MRID Number 

N/A Aerobic soil metabolism 43372103 N/A Efficac'j 43261802 

N/A Mode of action (for classification as a 

b'lochemical pestic"lde) -

43261803 

N/A Mode of action (for classification as a 43261804 

N/A Mode of action (for classification as a 43261805 

biochemical pestic"lde) 

N/A Mode of action (for classification as a 43261806 

biochemical pesticide) 

N/A Mode of action (for classification as a 43261807 

biochemical pesticide) 

N/A Mode of action (for classification as a 43261808 

biochemical 

Signature w.z, 

EPA Fo;:m 557().35 (s·;iijE.eelronic vernlons submi! only Pap ... WSion_ 

EPA Reg. No.lFile Symbol 68173-1 

Product Polyoxin D Zinc Salt 

Submitter 

KAKEN KAKEN KAKEN KAKEN KAKEN 

KAKEN 

KAKEN KAKEN 

Name and Title: Doina Bujor 1 Regulatory Manager 

Status 

OWN 

OWN 

OWN OWN OWN 

OWN 

OWN 

OWN 
65

AD 

" 

UNITED STATES ENVIRONMENTAL PRC.;TION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Form Ap

for reading the instructions and completing the necessary forms. Send comments regarding the burden estimat

for reducing the burden to: Director, OPPE Information Management Division (2 t37), U.S. Environmental Protection Agency, 401 M 

DATA MATRIX 

EPA Reg. No.lRle Symbol 68173-1 

Product 

15401 Weston Pkwy., Suite 150, Cary, NC 27513 1 Polyoxin 0 Zinc Salt 
66

o 

-

North 

UNITED STATES ENVIRONMENTAL PRe .... AGENCY 

401 M Slree!, S,W. 

WASHINGTON, D.C. 20460 

Form App

average 0.25 hours per response for registration activities 

completing the necessary forms. Send comments regarding the burden estimate 

OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M 

DATA MATRIX 

68173-1 

15401 Wes10n Pkwy., Suite 150, Cary, NC 27513 

Doina Bujor 1 Regulatory Manager 
67

o 

" 

UNITED STATES ENVIRONMENTAL PRe. .. "TION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Form Ap

time for !eadiog the' comments regarding the burden estimat

the burden to: Director, U.S. Environmental Protection Agency, 401 M 

DATA MATRIX 

Product 

15401 Weston Pkwy., Suite 150, Cary, NC 27513 ! Polyoxin 0 Zinc Salt 

Doina Bujor { Regulatory Manager 
68

o 

" 

North America 

UNITED STATES ENVIRONMENTAL PRL AGENCY Form Ap

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

average 0.25 hours per response 

for reading the instructions and completing the necessary forms. Send comments regarding the burden estimat

burden to: Director, OPPE Information Management Division (2137), U.S, Environmental Protection Agency, 40t M 

DATA MATRIX 

EPA Reg. No.fFlle Symbol 68173-1 

Product 

15401 Weston Pkwy., Suite 150, Cary, NC 27513 I Polyoxin D Zinc Salt 

i>c:. 
69

o 

" 

UNITED STATES ENVIRONMENTAL PRl ;TlON AGENCY 

401 M Street, S.W. 

D.C. 20460 

and completing the necessary 

Information Management Division (2137), U.S. 

DATA MATRIX 

15401 Weston Pkwy., Suite 150, Cary, NC 27513 I Polyoxin D Zinc Salt 

Signature " Name and Title: 

Form Ap

burden estimat

Agency, 401 M 

Doina Bujor I Regulatory Manager 

EPA FOm. S570-35 wersion. aVailah"swbmil only Papor versicm. 

,