## Proposed Registration Decision for the New Active Ingredient Choline Chloride

l : 

### J a E.**ci senge** **~** 

### D irector 0 fice of ' Pesticide 'Programs D ate: 

# //- 13 -1 

# S

### S umm a r y This document announces that the Environmental Protection Age n cy (E PA ) ha s completed its initial eval uation o f the proposed new plant growth reg ul ator (PGR) Cho line Chlo rid e and has concluded that it meets the r egu latory a nd safety standa rd s unde r the Federal In sect icide
. Fungicide and Rodentic ide Act ( FIFR A). Two products a re proposed to be re gistered under ect ion 3(c)(5) ofT IFRA: a Manufacturing

use Produ ct (M P ), Choline Chloride Technical; and a n End-use P rod uct (E P ). Choli ne Chloride S P 20%. T he E P is inten ded for fo li a r application to grow in g c rops, inc lud ing food crops, and is L o be s upp o rt ed by an exe mption from th e r equirement o r a to lera nc e . allowing fo r the us e of Choline C hl o rid e "in or on all food commod iti es whe n applied/ u sed prehar ves t a nd used in acco rd ance w ith labe l d ir ect io n s and good agr ic ultura l prac ti ces". C ho lin e C hlo ri de is a qu ate rn ary a mm o nium sa lt co n s is tin g o r a c ho lin e cat io n with a chloride a ni o n. /\s wit h man y sa lts, it pr ese nt s as a wh it e c rys ta llin e so li d that is o dorless. It r ea dil y dissocia tes into two co n s tituent s - Choline and C hl oride

- particularl y in wate r . Eac h const itu ent is ubiquitou s in th e e nv ironment , constitutes a r eg ular part or th e human diet , and se rves many c riti ca l functions in th e hum an body
. Cho lin e is found in vegetab les, anima l fa t a n d egg yo lk s; it is a precurso r fo r the production of the neurotransmitter ace ty l choline. is important for the structural int eg rit y of ce ll m e mbrane s a nd is imp o rta nt in multiple physiological pathways s uch as methylation metabolism. transmembrane s igna lin g and lipid and cho lesterol transpo rt and metaboli s m. Chloride is a major constituent of edibl e sa lt ; it is an essen tial electro l yte l ocated in all bod y fluid s and is responsible for maintaining acid/base balance. tran s m itt ing nerve impul ses and regulating fluid in and out of cells. As a b iopest icide
. Choline Chloride is classified as a plant growt h reg ul ato r ( PGR ). F IFRA Sec 2 ( 1 36) (v) estab li s hes th e definition of plant r eg ulat ors and car ves o ut t erm s of excl usion: "T he t e rm "p la nt regu lato r.. mea n s any s ub s ta nce o r mix lure of s ub s tanc es in tended, through physio log ica l act io n. for acce lerati ng o r r etard in g th e ra t e of growt h or rat e of ma turati o n o r for o th e rw ise a lt e rin g th e behavior of p lant s thereof , but s ha ll no t include s ub s tances to the ex t en t th at th ey arc int e nded as plant nutri e nt s, trace e l eme nt s, nu tr iti ona l chemical s, plant inocu lan t s, and so il a mendm e nt s . " In makin g it s determinati o n that C holine C hl o ride is a b iopesticide , th e /\gency, based o n in format io n reviewed , co nc lud e d th at th e propose d u se of Cho lin e C hl o rid e docs no t meet the terms of exc lu s io n a nd r equ ires r egistra ti o n because it s direct app li cat ion to p la nt s c ha n ges th e behavior (phys iology) of th e plant. a nd because it is inte nd ed fo r u se o n food crops. ' pecifica ll y. th e C ho lin e Chl oride 

### EP is to be app li ed as a fo liar spray directly to the fo li age of grow in g plants at application rate s ranging from 0.0004 t o 0.282 lb a i /A wit h a maximum of 4 app licati o n s per seaso n. It s app li cation is int e nd ed t o in c rea se p l ant grow th and decrea se s tre ss in growing crops. The crops listed on the labe lin g fo r thi s new ac ti ve ingred ie nt include fruit in g vege tab les . ce real gra in s. stone fruit. tree nut s an d cotto n. Th e mo st act i ve constituent 

## or the active ingredient is considered to be Cho lin e but the C hl o rid e Salt of C h o lin e compound (Cho lin e C hl o rid e) provides join t ac ti vit y as the sa lt compou nd is more stab le and effective as a de li very vehic le. As with m os t PG R s. C h o lin e Ch l orid e is necessarily appl ied a t low concen trati ons because use at hi g h concentrations resu lt s in detrimental effec t s to the plant. Choline Ch lo rid e is al r eady approved for u se by EPA as an in e rt in g r edient in pesticide product s w ith o ut nume ri cal limit a ti on fo r preharvest food (as a so lv e nt und e r 40 CFR 1 80.920) and
Pa ge 2of7

### nonfood uses . Furthermore , Choline Chlo ri de is desi g nated as GRAS (Genera ll y R ecog ni ze d as Sa fe) and is approved by the Food and Drug Admini s tration ( FDA) as a human nutri ent under 2 l C FR 18 2 .8 252 and as a nutrient in animal feed under 2 1 CF R 582.525 2
. 

### Background C holin e Ch loride was cla ss ified as a bi oc hemical p es ticid e by th e Bio chemica l Classif icati on Co mmittee (BCC) on April I 0. 2 014 , due to it s natur a l occurrenc e . hi sto ry of expos ur e to human s and the en v ironment w ith out t ox icity and it s nont ox ic mo de o f action. The C holine C hlorid e EP is s imilar to previously r eg is tered PGR EPs: It is a foliar spray appl ied d irectly to plant s at very low concentrations, app li cat ions are infrequ e nt and tar ge t e d. and int ended to acc elerate plant growth at c ritic a l s ta ges of th e plant' s d eve lopm e nt. On Jun e 4, 20 14, th e U
. S. Enviro nment a l Prot e ction Agency C-EPA ") received an application from Sp rin g Tra din g Company on beh a lf of C P Bi o. Inc. fo r the r eg istrati o n o r a new active ingredi e nt Choli ne C hlorid e with a fir s t food u se . On Feb ru ary 4 , 2 015. EPA a nnounced r ec eipt of an app l ication to reg is te r products conta inin g a new active in g red ien t
- Cho li ne C hl oride (Vo lum e 80
. umb e r 23. FR pa ge numbers 6085

- 60 86 )
. On March 4 , 20 15
. E PA iss ued a notice pursuant to f-FDCJ\ s ect io n 408( d)(J ), 2 1 U.S.C
. 346a( d)(J ), announcing the ti lin g of a pesticide tolerance pet iti o n ( PP 4F8287) by C P Bi o. In c. (Vo lum e 80. N umb e r 42
. fR pa ge numb e rs 11611 -11614). T hat doc um e nt referenced 

### a s ummar y o r the pet ition prepared by th e pet iti oner 

### CP Bio. In c .. which is available in Dock e t 

### ID umber EPA- 1IQ-OPP- 20 15

- 0023 via h11p: 11 · 1nr

. r e<s 11/atio11s. !!OI'

. No s ub s tant ive co mm ents were s ubmitted in re spo ns e t o e ith e r a nnouncem e nt. 

### Eva lu at ion In C\ ' al umin g a pe s ticid e reg i st rati o n app li cati o n. the EP /\ assesses a w id e variety orpcs ti cide- -;pccilic information in cluding where and ho\\' the pc s ti ciue is use d. e1wiro n1m :n tal fotc (ie
.. \\.hat h a ppen s to th e pe s ti c ide o nc e it" s app l ied). and toxi c it y s tu dies (i. e .. effects on hum a n s a nd other nontargct o rganisms) to determine the likclihoou or aun::rsc effec ts (i.e
.. ri sk) from c:-:posurcs as s oc ia ted 'vvith the proposed u se 

# or the product. Ri sk assessrnents arc dev e loped to eva luate the Cll\' i ronmenta l fate or the compound as we ll as he)\\ it mi g ht affect a\\ idc range 

## or no nt argct organ isms includin g humans and t e rre s trial and aquatic w ilclli l"e (plants a nd ani mals)
. On th e basi s 

## or the se a ssess ment s . EPJ\ evaluate s and approve s langua ge l \.) 1

· eac h pesticide label tn ensu re th e directions fo r use and snlc ty measures arc appropr iate t o mitigntc potential ri sk. In thi s \\H). the pcstieidc·s labe l helps to co mmunicat e esse nti al l imitations and mitigations that an: neccss<iry for pub li c s af'ct). It is a F IFR 1 \ 'iolation to u se a pesticide in a \\U) that is inconsistent \\'i th th e label. The human hea lth and e nvironm e nta l ri s k assessments (including an e ndange red s pec ie s assess me nt ) s upporting thi s deci s ion as we ll as the draft lab e lin g ca n be found in th e re g ul ato ry docket ( Do cume nt ID: EPJ\ -HQ -O PP -20 15-00 23)
. 

### Assess m e nt o f Ri s k to Hum a n Health EPA req uires a wide ran ge o f s tudie s in o rd e r to a ssess a p es ti cide. For C holin e Ch l o rid e. th e database or s tudie s s upp o rtin g the assess ment of ri s k to hum a n hea lth is particularl y robu s t. A s a Pa ge 3 o r7Jon g - s tandin g FDA approved food supplement and an oil-studied PGR , there i s a voluminous a mo unt o f peer-reviewed sc ientific literature indicatin g that C h o line Chloride is nontoxic and th a t it docs no t pose a di e tary risk or a ri s k throu g h any o th e r ro ut e of ex po s ure. The sc icn tili c l iterature notw ith s tanding. all Ti e r I m a mm a li a n acu t e t ox icol ogy data requ ire me nt s we re sa ti s fi e d by OCSPP g uid e lin e s tudi es. A ll ac ut e t ox ic it y s tudi es indicate that Cho lin e C hl orid e is n o t acutely t o xic for an y rout es o f ex p os ure: it is classified as Toxicity Catego ry 111 f o r ac ut e o ral exposure; Toxicity Category IV fo r dermal and inhalation exposure: and it is no t a de rmal or eye irritant. Specifically, C holine C hlorid e had: a LD so > 1 ,7 50 mg/ kg ( rat ) for ac ut e o ral toxicit y; a LD so> 5.050 mg/ kg ( rat) for acute dermal toxicity ; and a LC so > 2.03 mg/L (ra t) for acute inhalation toxicity. o toxic e ndp o int s were es tab li shed for any ex p os ure . Eye irritation was determined to be minimal ; no dermal irritation was noted; and th e s ub s ta nce is not a dermal se n s iti zer. The Si g nal Word for both th e Manufacturing-use Product (M P) and th e End-u se Product (E P) is "Caut ion .'' Th e information s ubmitted in s upport or the application 

### fo r th e ac tiv e in gred ie nt Choline C hlorid e indicat e that it is not subc hronicall y t oxic. Subc hro nic ora l toxicit y data re quirement s we re sa ti s fi e d throu g h th e open scientific literature. Two s tudi es, a 2 1-d ay study and a 28-day o ral t ox icit y s tud y, were assessed and found to collec ti ve l y sa ti sfy the s ubchronic oral data requirement. B o th s tudi es confi rm a lack of adverse effects throu g h th e oral exposure. In th e 21-day o ral to x icity s tud y (rat ), bod y weight and food co n s umpti o n were unaffected in the tes t a nim a ls . A sma ll beneficial effect was ob se r ve d rel a ti ve to th e ge n e ration of me mbranou s pho s pholipid s . /\. no-observed-adverse

- effect- level (NOAEL) for the s tud y is 1 , 000 mg/kg , th e highe s t do se t es t ed
. In a 28 -d ay o ral toxicit y s tud y (m ice), th e r es ult s o f th e s tud y indicated no adve rse effec t s 

### for any 

## o r the parame te rs te s ted. The NOA 

### EL fo r th e st ud y i s 200 mg/kg/ d ay . which was th e hi g hes t dose te s ted. S ub c hr o ni c dermal and inhalation toxicit y data r eq uir e ment s were waived. Per 40 CFR 1 58.2050. th ese re quir e ments are 'Condi ti onally Require d' (C R ) ba se d on exposure . In the case of th e s ub c h ro ni c dermal toxicity data r eq uir emen t , the r e quir e me nt wa s waived because ther e is no ' purpo se ful app li ca tion ' to hum ans and ' prolon ge d exposu r e to th e human sk in ' is not a nti cipated. C holine C hl o rid e is a PGR that \Viii be app li e d t o grow in g crops infrequentl y and at low conce ntr ation s . The s ubchronic inhalation toxic it y da ta r e quirement was wa i ved becaus e no 's ig nili ca nt r e pea t inhalation expos ure to th e act ive in g r edie nt as a gas, vapor or aerosol' i s anticipa t e d . C ho lin e is a salt w ith a lo w vapor pres s ure and vo latilit y; and again , it will be ap pli ed inl"req ue ntl y and at lo\ v concentrations. Mutagenicity data fr o m th e open scientific lit e rature sa ti sfy th e muta ge nicity data requirement s 

### fo r ho lin e C hl o rid e. In thre e separate Ames assays, s tr ains o f Salmon e lla t yp himurium we re exposed t o C ho lin e C hl o ride at up to I 0,000 μg / plate wi th or w ith o ut me tabolic acti vation. Cho lin e C hl o ride was not considered muta ge ni c in any o f the assays . /\.develop me ntal t ox icit y s tud y on mic e fr o m th e o pen sc ie ntifi c lit e rature sati s fies the deve lopmenta l tox icit y data requirement for C h o lin e C hl o rid e. In th e s tud y, n o adverse effec ts were obse rved at th e limit do se of 1250 m g

/ kg, es tab li s hin g a NOAE L for maternal and developmental tox icit y at 1250 mg / kg.

Page 4 of7Add iti o na ll y. EPA has not found C ho lin e Chloride to s h a re a co mm o n m ec hani s m of to x i c it y w ith a ny o th e r s ubstanc es; and C holin e Chlorid e doe s not appear 

### to produce a toxic metabolite produced by o th er s ub s t ances. Gi ve n th e demo n s trated lac k of ad ve rse e ffect s o n hum an s . a qualitative asse ss me nt of C ho lin e C hl o ride is co n s idered s uflicient. Hum a n s are a lready r eg ul a rl y expose d t o C ho lin e C hl o rid e. T he s ub s t a nce is produc e d e nd ogenous ly, and is a regula r part of the human diet. Mor e ove r . di e t a ry expos ure to th e r es idu es of Choline Chloride is ex pec te d to be neg li g ibl e . T he ac ti ve in g r ed ie nt w ill be u se d a t low co ncentration s beca u se u se at hi g h concentrations res ults in detrimental e ffect s to pl a nt s (as is the case with mo s t PGR s). /\!so. C holin e C hlorid e is expected to b iodeg rade r ap idl y o nce app li ed. In a MITI-1 test. th e subs tance degraded 93 % w i thin 14 day s. Finally , a s a sa lt. C holin e C hlorid e dis soc iate s readil y when in wate r, makin g it s pe rs i s tenc e as a re s idue even mo re unlikel y . (It has a meas ured wa te r so lubilit y o f 650 g/L. ) Due to the infre quent app licati ons, low a pplic a ti o n rate. hi g h so lubilit y and biodegradab ilit y . th e pes ticid a l u se o r Ch o lin e C hl oride is not a nticipat e d to co ntribut e s ig nifi ca ntl y to human expo s ure bey ond exis tin g background leve ls. Choline C hl o rid e is int e nd e d for food u se . and is to be s upp ort ed by a n exe mption from th e r equi re me nt of a t o leran ce. Accordingl y, the human h ea lth a ssess ment for C holin e C hlorid e s pec ificall y conside r s di e tar y ri s k, wh ic h is al so largely pre mi se d on th e overa ll no nt ox icity and la c k of hum a n expos ur e d iscussed above. H oweve r, add iti o nal dietary ri sk co n s id e ration s ca n be found in deta il in the ac co mpan y ing rul e for Choli ne C h lorid e . In bri e f, the di e tary assess m e nt makes th e fo ll ow in g di e t a ry ri s k- s pecific findin gs . whi c h are r e leva nt t o th e ge neral human he a lth as sess me nt: C ho lin e Chloride po ses n o agg r ega t e ri sk ( includin g, food ex po s ure, drinkin g water ex pos ure, and non- occ up ational ex posur e): it po ses no c umul ativ e ri s k r e lati ve to sub lanc es w ith co mmon mech a ni s m s o f toxicit y: and data ha ve been de te rmin ed to be s upp o rti ve of a safoty finding , protectiv e of s pec ial po pulation s, including infant s and child re n. De ta il s o r th e di e tar y ri sk assess me nt ca n be fo und in th e rul e es tabli s hin g a n exemp ti o n o f the requirem e nt of a t o le ran ce fo r C ho lin e C hl o rid e, and it s associa t e d document s . Tho se d oc um e nt s can be found in th e regulatory docket

- Docket ID Number EP A-HQ -O PP- 2 0 1 5-00 23. 

### Assessment of Eco logica l Risk E n v ironm e ntal Fa te E

n v ironm e ntal fa t e and g r o undwater data a r e not r equ ir ed at thi s tim e becau se the res ult s of th e no ntarg e t o rga ni s m toxi c it y asse ss me nt (T ier I data r e quirem e nt s) did not tri gge r th ese Ti e r 11 data r equ ir e m en t s. Howeve r , as referred to abo ve . C ho lin e Chl o rid e is not expec t ed to per s i s t in th e e n v ironm ent. C holin e Chloride i s hi ghl y so luble, di sso ciating int o nont oxic con s titu e nt s upon contact with moi s ture ; and it biodegracle s rapidl y , degrad in g 93% within 1 4 days. Envi ronm e ntal E ffects Th e ava il ab le batte ry of t es t s r equi red t o assess rh e eco l og ica l e ffect s of Ch o line C hl o rid e is adequate t o conduct an ec o logic a l ri s k assess m e nt. A lI nont arge t toxi co logy d a ta r cq ui rem e nt s ( pe r 40 Cf R 158. 2060) have been sa ti s fi ed from th e o pe n scien tifi c lit erature. Both gu id e lin e and n on-g uid e ! in e fres hwate r fi s h s tu dies were c ited from th e op e n sc i en ti fie lit e ra ture. The s tudie s indi cate th a t C ho line C hl o ride is practi ca ll y no nt ox ic to fr es hwa ter fi s h. and es tabli s h a 96

- ho ur Pa ge 5of7LC so 

### > 10000 mg/ I. Likewise, both gu id e lin e and non-guideline studies were cited from the open scientific literature to satisfy the data requirement for aquat ic invertebrate toxicity. The studies indicate that Cho lin e Chloride is practically nontoxic to aquat ic in vertebrates, and establish a 48-hour EC so 

### > 500 mg/I and a NOEC of 125 mg/ I. With regard to avian acute oral toxicity and avian dietary toxicity, severa l non-guideline studies demonstrate Cho lin e C hl oride's nontoxicity through the ora l route of exposure. Indeed, the s tudie s actua lly indic ate that Choli ne Chloride can have beneficial effects for birds: increases in body weights and growth; decreases in the incidence of perosis ( l eg deformity); and increases in egg weigh t s and egg production. The data requirements for te1Testrial plant toxicity-seedling emergence and terrestrial plant toxicityvegetative vigor were satisfied by several non-guideline studies from the open sc ient ific literature. Those stud ies demonstrate that Choline Chlo rid e , as a PGR , can confer beneficial effects to plants by increasing shoot height , leaf area , leaf ratio, chlorop hyll co nt ent and root elongation. Fin a ll y , with r egard to nontarget insect data requirements, adequate non-guideline s tudies from the ope n scientific lit erature were cited, demonstrating that Chol in e Chloride is practical l y nontoxic to nontarget insects, includin g honey bees. An acute contact honey bee toxicity study estab li shed a LOSO of > 89 μg a.i./bee. An endangered species assessment on Choline Ch lor id e further quantifies Choline Ch lor id e's nontoxicity to nontarget orga ni sms and makes clear that sign ific ant exposure to nontarget organisms is not antic ip ated
. Per label directions, Cho lin e C hl orid e is used infrequently and at low rates ; furthermore , Choline Ch loride ' s high so lubility and rapid biodegradation preclude any prolonged expos ure. The assessment also demonstrates that nontarget expos ure s will effec tiv ely be de minimus and that no effects are anticipated. The T-REX model produced low dose-based values and risk quotients (RQs) that were at least one to two orders of magnitude (0.00

- 0.06) below the EPA Levels of Concern (LOC) ofO.l for avian and mammalian endangered species. For aquatic spec ies. the F IR ST Ver 1.1.1 model ca lculated RQ va lu es at 0.00 , showing no acute toxicity risk. With regard to nontarget plants , the endangered species assessment calculat es drift residues of 0.63

- I 0.15 ppm on adjacent vegetative s ites , a conce ntration a t or below background levels (28

- 589 ppm), and considered to be effect i vely in conseque nti al. Due to Choline Ch lor id e ' s nontoxic mode of action (as a PGR), rapid rate of biodegradability (7 day half-life). r apid rate of photo-degradation (6.9 hours), low rate of bioaccumulation (Log Koc = 0.37) and low potential for exposure (maximum application of 0.282 lb s ai / A 4 tim es / season), the Agency has made a "No Effect " determ in ation for direct and indirect effects to a ll listed s pecies and their hab it ats. 

### A lt ernat ives While there are other PGRs, they are not all functionally equivalent , nor directly interchangeable with Choline Chlo rid e. However , as with most P GRs, Cho lin e Ch lorid e is expected to genera ll y reduce the amount of conventional fungicides and insecticides required for commercial crop production. By producing st r onger and healthier plants , this act ive ingredient will allow the target plant/ crop to better resist in sects and disease , th ereby diminishing the need for conventional pesticide app li cations. 

### Benefits By definition , biochemicals are favorable when compared to curr ently registered convent ional alternatives because biochemicals are naturally-occurring substances (o r s ub stances struc turall yPage 6 of7similar and functionally identical lo natu ra ll y - occur r ing substa nces) w ith a his t ory of exposure to hu mans a nd th e e n v ironm e nt d e mo n s tra tin g minim a l toxicit y an d a no ntoxi c mode o r act i on to the target pest(s). Benefits o f biochemical pesticides as compared t o conven ti ona l pestic i des typically include lower toxicity profiles for hum a n s and nontar ge t organ isms, a nd fas le r degradat ion in the e nviro nment. And as outlin ed a bo ve. Cho lin e Chloride has Lhe potential to reduce the amount of more toxic conventional pesticide applicatio n s by produci ng more robust s tress- r esis t a nt plants. 

### Pu b li c Co mm e nts On r:ebruary 4, 20 1 5
. EPA announced receipt of an application in the Federal ReKister to reg is te r a Manufa c tu rin g-use Pro duct (C hol in e Chl o rid e T echn ica l ) and a n E nd-us e Produ c t (Choli ne Chlo rid e EUP 20%) contain i ng a new active ingredient. Cho l ine Chloride (Vo lum e 80,

umber 23, FR page numb e rs 6085

- 6086). o s ub s t anti ve co mm e nt s we r e received in re spo n se to this Notice of R ece ipt. On March 4, 20 1 5, the E PA iss u e d a no ti ce purs ua nt l o FF DCA sect io n 408(d)(3 )
. 2 1 U.S.C. 346a(d)(3). a nn ounc in g the filing of 

### a pesticide tolerance petition ( P P 4F8287) by C P Bio, I nc. (Volume 80, umber42, FR page numbers 11 6 11 -11 6 14)
. The petiti o n re qu es ted that 40 C FR part 1 80 be amended by estab li s hin g an exe mpti on fr om th e requ irement of a t o lerance for residues of Choline Chloride in or on all food commodities (when applied preharvest). That document refe r enced a s ummar y of the pet ition prepar ed by th e petitioner C P Bi o, I nc., wh ic h is ava il ab le in D ocke t ID umber EP A -HQ-OPP -2015-0023 v i a '1110 : 11 · 1nr
. rc: g11/utiom
. <;0L o subs t ant i ve co mm e nt s we r e received in response to thi s otice of r:ilin g. 

### Propo se d R eg ul atory Dec is io n The Cho lin e C hl oride database is co ns idered to be complete, and suppo rt s a pesticidal food use. In conside rin g the assessed risk t o hum a n h ea lth and the e n viro nment . the Age nc y co nclud es that Cho lin e C hl o rid e m eets th e re g ul a tor y s tandard under th e Federa l In sec ticid e. fung icide and Rodent icide Act (FIFRA). There are no o ut standing data requi remen t s for this biochemical. The r efo r e. the E P A is proposi ng t o gra nt the unc o ndi tiona l r eg istrat io n of Cho lin e C hl o rid e as a new act i ve ingredient food use under Section 3(c)(5) of F I FRA. Two prod uc ts are proposed t o be reg is t ered: Chol in e Chl o rid e Tec hn ical is a Manul ac curin g- u se Product (MP) and Cho lin e C hl oride S P 20% is an End-use Product (EP)
. App li cat i ons of the EP can be m ade 3-4 t im es per seaso n. The EP is form ul ate d as a so luble powde r and co n ta in s 20% Cho l ine C hl o rid e. The powder is mixed wi th wa ter and app li ed by folia r spray. T he EP is proposed to be labelled fo r use on fruiting vegetab l es. cerea l gra in s, stone fruit, tree nut s and cotton. Th e E P is t o be app li ed at applica ti on rates rang in g fr o m 0.0004 t o 0.282 lb a i / A. The hum an h ea lth a nd ecological risk assess m e nt s s upportin g thi s d ec is ion as we !I as the draft labeling can be fou nd in the regu lator y docket (Docket ID EPA- HQ-OPP

- 20 1 5-0023).

Page 7 of 7