UNITED STATES ENVIRONMENTAL PROTE C TION AGENCY WASHINGTON , D .C. 20460 OFF I CE OF C HEMI CAL SAFETY A ND POLL UTI O N PRE V ENTI O N MEMORANDUM D A T E: July 28, 20 1 5 SU BJECT: Cyazofa mi d

. Re spo nse to ISK Biosciences Corporation Comme nt s Submitted t o Cyazofamid D oc ket ( Docket No. E PA-HQ-OPP-2015-01 28). PC Co d e : 085651 Deci s i o n No.: 505936 P e titio n No.: NA DP Ba r co d e: 0 427776 Reg i s t r at i o n No.: NA Reg ul atory Act i on: R eg i stra ti o n Rev iew Case No. : 7056 R i s k Assessment Type : NA TXR No. : NA CAS No. : 120116-88-3 40 CF R : § 180.6 0 I MRJD No.: NA FROM: Kristin Rury, Biologist

# ~**~** /".:) Whan g Ph a n g, Senior

### ox**c; og** **~D** Nancy Dodd, Chemis t**~~** Risk Assessment Branch Ill**~B** III ) He alth Effects Div i sion (7509P) Office of Pest ic ide Programs THROUGH: C

. Ju·istine Olinger, Branch Ch ief

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TO : Risk Assessment Branc h Ill (RAB3 _,. Health Effects Division (7509P) Office of P est ic id e Pro grams Jose Gayoso, C hemical R eview Manager Cathryn Britton, Team L eader Pestic ide Re-Eva l uatio n Di vision 

### (PRO) (7508 P ) Office of Pesticide P rograms E xec ut ive S umm ary
Detai l e d Res p o n se t o Com m e n t s I. Cyazofamid PreliminG1y Work Plan Registration R eview: Initial Docket C a se Number 7

056 March 2015). a. Page -I. Table 1: Anticipated Data Needs for Cyazofamid Registration R eview. !SK Response: The s torage stability data were submitted on November 20, 2006 ( 1 \1/RID # -16989701). P age I of 4H ED R es pon se: The storage stabilty data have been reviewed and the review i s now finali zed (N. Dodd , 0425460 , 05 / 05 / 20 15 )

. Therefore, t h e Agency agree s with the Re g i strant that thi s data gap is re solved. b. Page 6, Table 3: Under USE AND USAGE INFORMATION. Formulat i on Type(s) listed is emulsifiable concentrate. / S K R es pon se : The only formulation type available is suspension concentrat e. HED Re s pon se : HED ag r ees w ith the Reg i strant th a t the only reg i ste r ed form ul a t ion typ e ava il able is suspension concentr ate.

c. Page 6, Table 3: Under USE AND USAGE**NFORM ATION.**  Application Me thod (s) listed include g round, aerial, chem i ga tion, and hand h e ld spray equ ipment. / SK R espon se: Currently u sed application methods include only broadcast (gro und and aerial), chemigation, and soil /

g rowth media drench treatment. H E D R es p o n se: Th e r eg i ste red cyazofamid lab e l s (EPA R eg. Nos. 071512-2 , 07 1 5 12-3, 071515-13) do not restrict the use of handheld application equipment. It is HED policy to assess occupa tional exposure usin g handheld equ i pment for crops H ED classifies as '· t ypica l field crops" and crops grown in g reenhouses. If the Regi s trant wishes to restrict th e use of handheld eq uipm e nt , l anguage shou ld be ad d e d to the r eg i stered l abe l s restricting these app lic at i o n methods. 2. Cyazofamid. Human Health Assessm ent Scoping Document in Support of Registration R eview November 21, 2014 (EPA-HQ-OPP-2015-0128-0006).

a. Page 2 , Executive Summary , second paragraph sta tes that "on .January 8, 2015 , !-!ED ' s Hazard and Science Polic y Council (HASPOC) , based on a weight of ev idence approach considering all th e available hazard and exposure information g ranted a waiver/or th e .rnbc hronic n e urotoxicity and immunotoxicity s tu dies that are required under th e 200 7 40 CFR tox icology data requirements (TXR No. 00563-1 1 ). ! SK R espo n se : We are un s ur e wil y a waiver was co n side red for tll ese tw o s tudi es in 20 15 sin ce we llad submitt e d botll of tllese s tudi es to til e Ag e n cy 011Jul y2 5 , 2 015 (MRID Nos
. 48891 7 02 & 48891 7 01 , respec ti ve l y) in res p o n se t o til e co 11d itio11a l regis tration l ette r s of July 29 , 2 009 (Decis i o n Nos. 469061, 4 69 062 , 46906 5) and th e co 11ditio11al reg is tratio 11 l etters of A ugust 1 3, 20 10 (D ecis i on Nos
. 420978, 4 2 0980). Bot h of these studies wer e s ub se qu e ntl y rev i ewe d mulfountl Acce ptable/ Guid e lin e by th e Age n cy in tll e ir DER dated July 26 , 2013, DP# D405012. Ple ase co rrect yo ur re co rd s. H E D Re s pon se : HED w ill co n-ect the records to reflect that both immunotoxic i ty a n d subchronic neurotoxicity studies have been s ubmitted and reviewed. These two study req uire m ents are met.

P age 2 

# o r 4b. P age 2 , Executive Sum mar y. fifth paragraph, and Page 4 , Diel01y Exposure, third paragraph state " The storage stabilty data are (currently ) under review. " /SK R es pons e : This data was a condition of reg is tration in 2004. We s ubmitt e d thi s data 011 November 20, 2006. Since thi s i ss u e llas not been rais e d in A gency re views s in ce that tim e for seve ral n ew c ro p reg is trations, we a ss um e d til e Age n cy ll ad rev i ewed til e data am/ found it acceptable. H E D Respon se : Th e storage s t a bilty data h ave been r ev iewe d and th e r ev i ew i s n ow fi n ali ze d (N. D o dd , 

### 0 425460, 05 105 1 2 01 5). Th erefore, the Agency ag re es wit h the Regi str a nt that thi s data gap i s resolved.

c. Page 3, Introdu c tion, second paragraph, third se ntence s tal es " HomeoHmers m ay apply cyazofamid to resid en tia l twf and ornamental plant s." (A l so m e ntion ed on Page 5). /SK R es ponse: S in ce we have n eve r int e nd e d for this product to b e sold t o til e '1 0111 eo w11er , we s p ec ific all y s tate 0 11 o ur tu rf lab e l that "Applic ation by h ome -o wn e rs to reside ntial turf is prohibited. " As we were in s tru c ted by til e E PA wlle11 til e turf u se wasfirst r eg is te re d. Pl e a se advi se 

## if a diff e re nt st

ate m e nt is now re quir ed to pr event u se 0 11 lawn s by til e llom eown er. H E D R es pon se: It i s n ow H ED po li cy to co n duc t a res id e ntial assessmen t for products registered on tur f a nd ornamenta l s unle ss th e u se site i s res tri cted on the l abe l. 

### IS K s h o uld consu l t w ith th e R eg i s tration Div i s i o n (RO) on the approp ri ate label lang u age to d e li neate th e intended u se si t es and spec ific a ll y restrict app lic at ion to res identi a l turf. Fo r examp le:

.. For use on sod far m s , seed fa rm s , g o(f courses , professionally mana ged coll ege and profess ion al spo rtsfields, industrial and commercial lawn s and other s imilar nonresidential areas. Do not apply to r esident ial tw f o r twf in residential a r eas". d. Pag e 3 , Hazard I de nt ification/Tox icology ,firs t paragraph, first s e ntence s ta tes " The toxi co lo gy da taba se for Cyazofa mid is adequatefo r risk assessment, excep t for th e immunotox ic it y and s ub ch roni c neurotox i c it y s tudi es." /SK R es pon se : As n o te d in 2 a. above, both of th ese s tudi es we re s ub seq u e ntl y found a cce ptable by th e Agen cy in th e i r revi ew date d Jul y 26 , 2013, DP# D405012. Til e N OA EL and LO AEL were determin e d to b e 6000 ppm (1381 m g/ kg /day) and > 6000 ppm , res pectively in til e imnwnotoxicity study. Tile NOA E L and LO A EL were dete rmin ed to b e 20,000 ppm ( 1356 m g/ kg /da y) and >2 0,000 ppm, res p ec tiv e l y in til e s ub c hr o uic n e urot oxi city s tud y . Please co rrec t y our reco rds

. HED Response: HED will correct the reco rd to reflect th e immunotoxicity and s ub c hronic neuroto x ici t y s tudi es req uire ment s are met. In a ddition , a se nt e nce indicatin g "the toxicology database for cyazofamid is cons id e red co mpl e t e " w ill replace th e first sentence on page 3 , Hazard Id e nti fica ti onffoxicology section.

e. Page 9, Tolerance Assessm en/ and fn/e rnalional Harmonization ,firs ! para g r aph, th e discuss i on on th e tole rances, .. . " inc/11cle permanen t Sec tion 3 to l erances, a S e ction 18 em e rg e ncy exemption toleranc e, and a tole rance with regional
P age 3 of 4registration. The plant tolerance levels range from 0. 02 ppm lo 1././ppm. ·· /S K R es p o n se : A ltltoug lt th e Sec tion 18 tolera n ce exe mptio n 011 basil (1 44 ppm ) didn 't ex pir e until D ece mb er 3 1 , 2 014 , it was replaced by Section 3 to l e ran ces (30 ppm/or fr es h , 90 ppm for dried basil) and reg ist ratio n s for b a si l that were g rante d 011 Septem b er14, 2012

. Titus, tlte hi g h es t tolerance c urr e ntl y in ef ect is 90 ppm. Ple ase updat e th e do c um ent. H E D R e s pon se: The Section 18 tol erance expired on 1 2/ 31 /14. The hi g he st tolerance is n ow 90 ppm. 

## f Page 12, Ref e re nces, Toxicology / SK Response: Pleas e a dd tlt efo llo w in g refere n ce : V. Ch e n ; D405012; 7126 1 13; Cyazofa mid: Ne ur otoxi city and lmm11110to x icit y Data R ev i ew. H E D Re s ponse: HED wi ll add the reference. 

### g. Page 23, Toxicity Profile Table, seco nd to th e la s t e ntr y, "Study not available' '
. lSK R espon se: As n oted above ill 2a and 2 d , a 90-day n e ur o toxicity and immun otoxicity s tudy we re s ubmitt ed a nd a cce pted by th e Agency, and th e table s h o uld be co rr ec t e d asfollows: 860

. 6200 b Subchronic n e u rotoxici t y : M RID No. 48891 702 (2 012): Acce ptablelg uid e li11 e; 0, 500, 2000, 20000 ppm (0, 3 4 13 9 , 1 341 156, & 1356 1 1539 mg /kg/d a

y males/fe mal es respec tiv e l y),· sys te mic tox icit y and 11 e ur otoxi c it y NOAE L 

## = 20 , 000 ppm, (1356 m g/kg/day); sys te mic toxicity and 11 e u rotox i city LOA EL > 20,000 ppm (1356 m g/kg/day) 870

. 7800 28 -da y Dietary Immun o t oxici t y Study: MRID No
. 48891701 (2 01 2); Accep tab l e/g u idel in e; 0, 600 , 3000, 6000 ppm (0 , 136 , 599, & 138 1 m glkg/day); Sys te mic toxi c it y and im1111111 o t ox i city NOAE L is 6000 ppm (138 1 m g /

kg /

da y) and LO AEL is > 6000 pprn (1381 mg/k g/d a

y). H E D R espo n se : HED ha s cor r ected this e ntr y. We will co rrect our records accord in g to th e data eva lu ation report ( D E R). HED w ill co rrec t th e hazard and exposure reco rd s fo r cyazofam id during risk assess m e nt phase of Re g i stratio n R eview

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