# Registration Decision for the New Active Ingredient California Red Scale Pheromone
PC Code 017705

### Summary
Thi s document announces that th e Envi ronmental Protec tion Agency (EPA) h as completed its initial evaluation of the proposed new bioch e mic a l pheromon e Californ ia Red Scale (C R S) Pheromone and has concl ud ed that it meets th e regulator y and safety standards und e r the Federal Ins ec ticid e, Fun g ic id e and Rodenticid e Act (F lF RA). C alif o rnia Red Scale i s a major p es t to citrus crops; and CRS populations have i ncreased dramatically over the last few years due to wa rm e r w in ters and reduced w int er morta lity

. Ca li fornia Red Scale infe s tation s hav e been h istorically treat e d with conventional pestic id es; however, th e pest is developing resistance to man y of these conventional treatm e nt s, w hich are relatively mor e toxic than thi s bio c he mical ph e romone
. It i s for th ese re aso n s that EPA i s exped itin g this registration of Californi a Red Sca le Ph ero mon e. The Agency no rmall y has a 1 5- day public comment p e riod on it s propo se d reg i stra tion decision as part of it s Public Parti c ipati o n Pr ocess. Fo r Calif orn ia Red Scale , we are i ss uin g the final decision and takin g publi c comment s ub seq uently. H owever , if th e Agency rece i ves s ub s tantive comments , EPA w ill address those comme nt s, revise thi s decision appropriately, and r e-iss ue a fin a l d ecis ion memorandum

. The Agency w ill a lso includ e a term i n th e re g i s tration notice , requi rin g the registrant to s u bmit revised labeling consistent with EPA reco mm e ndation s th at may re s ult from any s ubstantive co mm e nt s receiv ed during the Public Particip a tion Proc ess. If no comme nt s are received , th e Agency w ill no te th at and af firm this dec i s io n d oc ume nt as our final d ec ision and the registration will sta nd unchan ge d

. Two produ c ts are b e in g reg is tered und e r Section 3(c)(5) of FIFRA: a Manufacturing-use Produ ct (MP) , CheckMate CRS Teclmical Phe ro m one; and an E nd-u se Product (E P) , C hec kMate C RS. Th e reg is trant f o r th ese product s i s Suterra , LLC

. The new act i ve in gre di ent will be used as a matin g disruptor for Cali fornia Red Scale (Aonidi e !la auranti) in c itru s c rop s and oth e r orchards where Cal i forn ia Red Scale are pr esen t. Th e new active ingredi e nt Ca lif o rnia Red Scale Ph e rom one , c hemi ca ll y known as (3S, 6R) (3S , 6S)-3-Me th y l- 6-iso pr ope ny l -9- d ecen- l -y l acetate, i s a technica l grade sy ntheti c arthropod ph e ro mon e . Thi s ph e romone is structur a ll y id e nti cal to an d mimi cs a naturall y occ urrin g pheromone produ ced by th e fema le Ca li fornia Red Scale to attract th e m a les for mating. Cali fornia Red Scale Pheromon e i s int e nd e d for u se in p o l y meric di s pen se rs to disrupt the norm al m ating cycle o f Cali fornia R ed Scale in orchards. The disp e n se rs are ty pically deployed s hortl y b efo re th e mal es actively tak e (ge nera tional ) fli g ht. Mating disruption res ult s w h e n a dul t mal e s , ha v ing o nl y about s i x hours to m a te before dyin g, are attracted to th e p es ticid e product in the tree tops, and the di s trac tion reduces the c hanc e of th e ir l oc atin g act u a l fem a les , w hi ch are immobi le. Applications are infr eque nt because they corre la te d ir ectly wi th California Red Scale matin g cycles, w hich norm a ll y occ ur just o nce a year. The ph ero m one will b e appli ed at an effective ra te of 12 .6 g/ac re / year ( 180 di s p e n se rs/ acre/ ye ar) ; and the concentration of California Red Scal e Ph e ro mone rese mble s natura ll y-occ urrin g b ackgro und leve l s. L ik e most pheromones, Cali fo rni a Red Scal e Pheromone biod egr ad es rapidl y. As an arthropod ph e romon e appli ed v ia di s p e n se r a t low application rat es , Cali fornia Red Scale Pher o mon e i s exempt from the requirement of a to le ran ce. P e r 40 CF R § 180

. 11 24, art hr opo d pheromones are exe mpt when u se d in re trievable p o l y m e ric dispensers and wh e n applied to g rowin g c ro p s at rat es below 1 50 g ram s / ac r e / year. P age 2 of7The Biopesticides and Pollution Preventio n Division (BPPD) ha s reviewed the data required to su pp ort the reg i strat ion of this art hropo d pheromone, under Secti on 3(c)(5) of th e Federal In sec ti c ide, Fungicide and Rod en ticid e Act (F IFRA). D ata requi rements for arthropod pheromones are red u ced w he n the ph e romo ne i s to be applied in retr ieva bl e po ly m eri c dispen se rs and when app li cation rates are bel ow 150 grams/ ac re / year. A ll product chemistry data requirements for CRS Pheromone were sa tisfied by accept ab le g ui de lin e s tudi es. Ac ut e tox ic ity data requirem e nts were satisfied by guidel in e stud ies; all other h uman health data req uirem e nts were sati sfied throug h rationale s. Nontarget organism data requirements are not req ui red for ar

thr opo d pheromones pe r 40 C.F

. R

. § 158.2060(a)( 2). 

### Background
Calif o rni a Red Scal e Ph eromo ne i s a we 11 -known arthropod p he romon e w ith a histor y of u se as a b iochemica l active i ngred ien t. The active in g red ie nt i s a sy nthetic compound that i s identical in s tructure and function to a natura11y occurring s ub stance of insect orig in and functio n s by a nontoxic mode of ac t ion on it s target pest. Therefore, this compound h as bee n classi fi ed as a bioc h e mical pestic id e. Thi s D ec i si on Docum e nt m arks th e seco nd tim e that thi s active in g re di e nt h as b een assessed and approved for pe sticidal use. On September 9 , 2002, E PA received an application f rom HBB Partner s hip to reg i ster two p roduc t s conta ining Califo rni a Red Scale Ph e romon e. On Augus t 11 ,200 4 , E PA published a not ice in the Fe d era l Regi ste r ann ounci n g receipt of those Section 3 applications (69 FR 48867)

. No comments we re rece i ved rega rding that notice. T he product s were registe red on March 10 , 2005. Howeve r , on Jul y 24, 2009, E PA announced cance ll ation of tho se products du e to nonpayme n t of fees (74 FR 36699). On Marc h 1 6, 2016 , EPA a nnoun ced receipt of a Section 3 application from Su terra LLC to reg i ster two new prod u cts- C heckMate C RS Tec hni ca l Ph e rom one and C heckMate C R Sreviving t h e act i ve ingredi e nt Californ ia Red Scale Phe romone (Vo l ume 8 1 , Number 51, FR page n umbers 14103- 14 104). A copy ofthat notice i s availabl e in D ocket ID N umb er EPA- H QO PP -20 16 -0095 v i a 

### http : //

www . regulations

. gov . No s ubst a ntive comments were submitted in res pon se to the announceme nt. 

### Eva luation
In evaluating a pesticide reg istration application, the EPA assesses a w id e va ri ety of pesticidespecific inf orma ti on including where a nd how the pestic ide i s u se d , env ironn1ental fate 

### (i.e., what happens to the pesticide once it ' s applied) , and toxi city studies 

### (i. e . , effects on human s and other nontarg et organi sms) to d ete rmin e the li ke lih ood of a dv e r se effects 

### (i.e., r i sk) from expos ures assoc iated with the proposed use of th e product. Risk assessments are developed to eva luat e the enviro n mental fate of the co mpound as we ll as how it mig h t affect a w ide ra n ge of nontarget o rganism s including human s and terrestr ia l and aquatic w ildli fe (pla nt s and animals). On the basis of these assessments, EPA evaluates and a pproves language for eac h p esticid e label to ensure the directions for us e and safety me as ure s are appropria te to mitigat e potential risk. In this way , the pesticide ' s l abe l helps to communicate essen t ial li mitations and mitig at ions that are

Page 3 of7necessar y for publi c safe ty. It i s a FIFRA vio lation to use a p estici de in a way that i s incon s i s t e nt with the l abe l.
T h e human health and e nvironm e ntal risk assess m e nt s s up port in g this dec i s ion as we ll as th e product lab e lin g can be found in the regu latory docket ( D ocument ID : EPA- HQ -OPP-20 16- 0095). 

### Assessment of Risk to Human Health
E PA re quires a wide r a nge of s tudie s in o rd e r to assess a pe s ti c ide. For Ca liforni a R e d Scal e Ph ero m o n e, th e datab ase of st udi es and inform a tion s upportin g th e assessment of ri sk t o hum an h ea lth i s s ufficient t o s upport regist r ation of this n on-food use pheromon e. There i s ample informatio n indicating that th e u se of Ca lif o rnia R ed Sca le Ph e romon e will not result in any meaningful n e w exposure, and that , exposure notwith s tandin g , th e compound i s v irtually n o ntox ic a n d d oes not pose a ri s k throu g h any route of expos ure. Wit h regard to th e T ie r I Acute Tox icity d a ta re quire m e nt s , g uid e line st udi es w e re s ubmitted in s upp o rt of a ll tho se data requir e m e nt s, exce pt for Ac ut e Inh alation and Sk in S e n s iti zat ion , whic h we re wa i ved

. In the ac ute o r a l toxic ity st ud y, the acute o r a l LD so valu e was d etermi n e d to be greater than the do se r a te of 5000 m glkg ; and no m o rt a lit y occurred as p a rt of th e s tud y . Ca liforni a R e d Sca le Ph e romon e is To x ic it y Cat ego ry I V for ac ute o ral toxicity. A st ud y for acu t e dermal toxicity es t ab li shed an LD so > 5050 m g/kg ; and i s Tox ic i ty Ca t ego ry lV

. Th ere was no observed d ermal i rritation throughout the study. A study for acu te eye irrita ti o n determin e d th a t California R ed Sca le Ph e ro mone was a mild irrit a nt. No irri ta tion was observed b y Da y l 0. In the acute d erma l irrit a tion stud y , no irrita tion wa s o b serve d ; a nd th e p h e rom o n e was assigned a Toxic it y Ca tegory I V. Wit h rega rd t o ac ut e inh alation and skin se n s iti za ti on, th e data requi reme nt s were wa i ve d ba se d on th e following: Ca liforni a R ed Scal e Ph e rom o n e d e mon s trat es l ow ac ut e t oxicity in the s tudie s conducted; there i s minim a l pulmonar y exposure pote nti a l ; th e compou nd has lo w va p o r pre ss ure; th e re h ave been no reported adverse e ffec t s in California Red Scale habitat ; and minim a l ex p osur e i s exp ected due to th e pheromone 's u se in dispensers , f rom w hi c h th e ph e romone i s released in ve ry s m a ll quantiti es. Altogether, Californ i a Red Scale Ph e romon e expo s ures are expected to b e minimal an d the phe romone i s co n s id ere d v irtu ally nonto xi c for ac ut e to x ic ity.
T h e hum an health data requ ir e ment s for s ubchronic tox icit y , d eve l opme nt a l toxicit y and mutagenicit y we re wa ived

. T h e r a tion a l es for th e wa i ve r r eq u es t included the following information: 1 ) California R ed Scale Ph eromone ha s a low ac ut e toxic it y profile ; 2) there i s l ow ex p os ure t o Ca li fo rni a Red Sca le Phero m o n e when it i s appli e d in s low- relea se polymeric di s pen se r s; 3) exposure to Ca li fornia R ed Scale Phe romon e a pproxim a t es th e natura ll y occ urrin g pheromone co n cen trat ion produced by C alifornia Red Scale fema les , t o w hi ch humans are al read y ex po sed w i tho ut known hazard ; and 4) Ca li fornia R ed Scal e Ph eromo n e h as a nontoxic m o de of act io n , which i s targ e t

- p es t s p eci fi c. With spec ifi c regard to the s ub c hr onic t ox ic ity data requirement s, th e data requirement is qualified for bi o pe s ticides ; and th ese d a ta can be waived whe n the u se patt e rn of th e produ c t precludes th e potential for long tern1 or repet iti ve ex p os ure to the ph e ro mone. In thi s case , l ac k of ex p osure is s upp o rt ed b y the fac t that th e Cal i fornia Red Scale Pheromone w ill b e f ormu l a ted exclus i vely into p o ly meric dispensers that present minimal ri sk from ex p osure to human s or Pag e 4 of 7nontarget o rg ani s m s. The app li ca tion ra tes of th ese arthropod pheromone di s p e n sers are b y necessity low because their act ivity on the target p est d e p ends o n their olfactory r ecepto r s being tuned to n a tura ll y occ urrin g ba ckgro und levels , to w hi ch we a re a l ready exposed. Furthermore, the effecti ve appl ica tion rate of Cali fornia Red Scale Pheromone at 1 2.6 g ram/acre / year is a n orde r o f measure lower than the a ll owab le maximum rate of 150 gram/acre / year, and does no t constitute s ig nifi ca nt exposure. Accordingly, ri s k s to ap plic ato rs, mi xe r s, l oaders, and b ystan de r s , from long te rm , r e p et it i ve expos ur e to Ca li fo rni a Red Scale Ph eromone i s negligible or unl ike ly; a nd the rati ona le s s upportin g the waiver r eques t are thereby furth e r s upp o rted. L as tl y , EPA has n ot found Calif o rn ia R ed Scale Pheromo ne to s hare a common mechanism of toxicity with any other s ub stances. In addition , Ca lifornia Red Sca le Ph e romon e do es not appear to pr od u ce a to x ic metabolite prod u ced b y other substa n ces. Gi ve n the d e mon s tra te d l ac k of adve r se ef fect s o n hum a n s , a qual it ative a ssess ment of California Red Scal e Ph e ro m o ne i s considered s u fficient. Humans are rarely exposed to this n o ntox ic ph ero mon e; and the r e h ave been n o observed or reported adverse effects on human s who are regularly present in and around Cali fornia R ed Scal e h abitat. The act i ve in gred ien t w ill be u sed at low r ates in agric ultura l setti ngs , and its u se wi ll r esult in concentrati o n s rese mblin g n atura l ba ckg round leve l s. Al so , the EP w ill only be u sed once a season. Du e to the infr e qu e nt applications, low app li cat io n r a te , and hi g h biodegradability , the pesticidal u se of Califo rni a Red Scale Pheromone i s not a nti c ip a ted to co ntribut e s i gnifi cantly to hum a n exposure b eyo nd ex i st ing (but tempo ral) background l eve l s. 

### Assessment of Ecological Risk Acco rdin g t o 40 CF R I 58.2060(a)(2), arthropod ph ero mon es when app lied a t up to a maximum use rate of 1 50 g rams act i ve in gred ien t/acre / yea r , and th at are n ot expec te d to be ava il ab l e to av ia n s p ec ies , are not required t o provide non targe t toxicity and environmental fate data. Cal if ornia Re d Sca le Ph e romone i s a sy nthetic arthro pod ph e ro mon e that i s structura ll y s imilar to and mimics the ph eromo ne produced by the fe m a l e Califo rni a Red Scale. The pheromone acts spec ifi ca ll y on male California Red Scale and ha s a non-toxic mode o f action. California Red Scale Ph eromone w ill be applied v ia retrievable polymeric dispensers at an effecti ve ra te of 1 2.6 g/acre / year. B eca u se the po lymer ic di s p ensers preclude av ia n expos ure, n o signifi cant am ou nt of Ca lif ornia Re d Scale Pheromon e i s expected to b e avai lable to avian s pecie s. 

### Endangered/Threatened Species With regard to (a ll) arthropod pheromones, th e Agency has concluded a No Effect for endangered or thr eate n ed s peci es and d es ignated cr iti ca l habitat. Foremost, arthropod phe romon es hav e a nont ox ic m o d e of action and are highl y s p ec ifi c to target p ests

. As attractants and confusants , no mortality i s associated wi th these co mp ounds; and these unique se mi ochem ica l compounds only react w ith the hi g hl y a ttun ed se n sors of th e t arget s p ec ie s. Seco ndl y , n o s ig nificant expos ur es are an ticipat e d with a rthropo d ph eromone u se. App l ications r ates are low; and they resemble natura ll y occur ring background l eve l s. Mo reove r , a rthropo d ph e ro mon es ar e hi g hly volatile a nd biod eg rad able ; and as a res ult , do not p e r s i s t in e ither terrestrial or aqua t ic habitats. Finally, art hropod pheromones a re virtua ll y nontoxic ; a nd there have been n o known effects associated w ith o ur natural ex p os ure to these co mpound s. Altogether, it i s for these reaso n s that arthropod pher omo nes are both exe mp t from a ny nontarg et

P age 5 of 7organism data requirements and that the u se of arthropod ph ero m o nes are deem e d to have n o effect on threa te ned and endangered spec ie s . 

### Alternatives Organophosphates, carbamates , py ri proxyfen , buprofezin , sp irotetra m at and horticultural o il s (primaril y min e ral oils) are a ll u sed to co mb at Ca li fo rni a Re d Sc al e infe s t ations. T hese conventiona l active in gredients a ll ha ve a m o re toxic profil e than Ca li fo rni a Re d Scale Pherom o n e a nd the ir u se wo uld lik e ly be diminished with this r eg i s tr at ion

. Notab ly , the toxic profil es o f the o rgan oph osphat e c hlorp yr i fos and th e carbamate carbary l ha ve b een s ubject t o s peci a l cons id e rat io n b y the Agency du e to the i r to x ic i ty. Additi o nall y , the i nsect g rowth regulato r s, pyriproxyfen and buprof ez in , and the lipid sy nth es i s i n hi bitor spi rotetra m at all ha ve syste mi c m o d es of action assoc iated wit h n o nta rg e t effects. A nd with regard t o th e horticultur a l o il s , man y of tho se activ e in g re di e nt s conta in p e troleum di s tillat es and can h ave p h y t otoxic e ff ec t s. The u se of Ca li fornia Re d Scal e Ph e romo n e as an a dditi o n a l tool to combat Ca lifornia Red Scale infestations offers su b s t ant ial benefits b y p o te nti a ll y reduc ing the use of mo re toxic a ltern atives. 

### Benefits
Californ i a Red Scal e i s a m a j o r p est to c itru s c ro p s and i s t y pi ca ll y co ntroll ed through the u se of co n ve nti o n a l insecticides. Fo r the past seve ra l years , Ca li fornia citru s g ro we r s h ave expe ri enced reduced e ffi cacy of th ese conven tional in sectic id es due to g row in g p est ic id e res i stance. At the same tim e, Ca lifornia R ed Sca le popul at ion s h ave in c rease d because wanner winters have reduc e d w inte r morta lit y and e n ab l e d the g rowth of more generat ion s . U nfortun a te ly, in response to the se co n dit io n s, growers have had to u se m o re of th ese co n ve nti o n a l in sec ticid es to control C alifornia Red Scale over the p ast few yea r s. B y reg i sterin g Ca lifornia Re d Scale Ph e rom one , growers will h ave another e ff ect i ve t oo l to co ntro l Ca li fornia R ed Scale, forestalling res i stance and reducing th e numb e r of co n ve ntional p es ti cide applicatio n s. And as di scussed , these conventio n a l p est icid es ge ne r a ll y hav e a more toxic profile an d the reductio n of th e ir u se will directl y b e ne fit both hum ans and nontarg et o rga ni s ms. Conver se ly, Ca liforni a R e d Scale Ph ero m o ne i s v irtually nontoxic and i s app li e d at a ve ry low rat e , at concentration s that re se mbl e naturally occ urrin g back gro und leve ls

. Secondarily, it should be note d that man y co n ve ntion a l in sectic id es are a l so toxic to th e natural enem ies o f California R e d Sc ale , s u c h as was p s and beetles , w hil e Ca lifornia Red Sca le Phero m o n e is s pecifi c t o Ca lifornia R ed Scale. And thu s , b y reducing th e u se of the se conven ti onal in sectic id es, the u se of Ca lifornia Re d Sca le Ph e romon e r e -op ens thi s n atural ave nu e of co ntrol , allowing for addit ion a l co ntro l beyond th e ma tin g disruption. Fin a ll y, Californ i a Red Scale Ph e ro mone propiti o u s ly offe r s another too l at a tim e wh en Ca lif o rnia Re d Scal e are d eve loping resistance to man y co n ve ntional in sect ic id es. In s h ort , the use of Ca lif o rnia Red Scal e Ph e romon e w ill a ll ow g rowe r s another effective tool to contro l Ca li fornia Red Sca le , re du ci n g th e number of mo re harmful co n ven t ional insecticide applications. 

### Public Comments
On March 1 6 , 2 016 , EP A announced recei pt o f a Section 3 application t o register two new products

- C heckMa t e CRS Technical Pheromone an d C hec kMate C RS

- co nt a inin g the ne w
Pa ge 6 of 7active ingredient California Red Scale Pherom one (Volume 8 1 , Number 51 , F R page numbers 1410 3- 14104). A copy of that notice is available in Docket ID Number EPA-HQ-OPP-2016- 0095 via http :// www. regulat ions. gov . No substantive comme nts were su bmitt ed in respons e to the announcement. 

### Regulatory Decision
The Ca l ifornia Red Scale Pheromon e database i s considered to be comp lete. The u se of this new act i ve ingredient in polyme ric dispensers , at rates we ll below 150 mg/acre /year , are well supported by thi s datab ase. In cons idering the assessed ri s k to human health and the env ironment , the Agency concludes that California Red Scale Ph eromone m eets the regulatory standard under the Federa l In secticide , Fungic ide and Rodenticide Act (FIFRA). There are no outstanding data requir e m e nt s for this biochem ica l. The refore, the EPA i s grant in g th e un co nditional regi strat ion of the new active ingred ie nt Ca lif orn ia Red Scal e Ph ero mone under Section 3(c)(5) of FIFRA. Two products wi ll be registered- a Manufacturing-use Product , CheckMate C RS Technical Pheromone; and an E nd-u se Product , CheckMate CRS. The End-use Product is applied as a retr i evab le po lymeric dispenser, and i s intended f o r u se in o rchard s w here Ca li fornia Red Scale are present, which are primarily citrus orchards. Ca lif ornia R e d Scale Pheromone mimics the n atura l pheromon e em itted by the female Ca lif o rnia R ed Scale. Mating disruption results when adult males , having on ly about s ix hours to mate before dying, are attracted to the pesticide product in the tree top s . Thi s distraction reduce s the c hance of their locating actua l females (which are immobile) with which to mate. Applications of the disp ensers can b e mad e any tim e prior to crop harvest. The pheromone will only affect adu lt California Red Sca le males and has n o effect on females o r eggs. The application rate is 1 2.6 grams of act ive in gredient/ac re and cannot exceed 15 0 grams active in g re di ent/ac re / year. Due to the compelling n eed for a new tool to combat Ca li fornia R ed Scale a nd the s ub stantia l benefits conferred by Ca liforni a Red Scale Ph e romone , the registration of thi s n ew active ingredient is b e in g i ss u ed concurrent with EPA's Pub I ic Participation Proc ess . While the final decision on registration typica ll y a ll ows a 1 5-day co mment period on the complete risk assessment prior to issuing the decis ion , th e Agency b e li eves that it is in the best interest of the public and the environment t o issue the registration of California Red Sca le Ph eromone without delay. Notab ly , this act i ve in gredient was previou s ly registered until recently; and it was not assoc iated with any known hazard. Moreover, this m ost recent risk assessment for California Red Sca le Pheromone o nl y affi rm s its negligible toxicity. Fina ll y, it is noted that the Federal Register comment period for California Red Scale recently ended on Apri l 1 5 , 2016 without substantive comment , a nd that any s ub stantive comments recei ved through this additional comment period will s till be addressed in a respo n se for th e record. T he human health and eco lo g ical risk assessments s upportin g this d ec i s ion as well as the draft labeling can be found in the regulatory docket (Docket ID E PA-HQ-OPP -20 16 -0095).

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