# Registration Decision for New Use Based on Method of Delivery of Lavandulyl Senecioate Update to the Lavandulyl Senecioate Biopesticides Registration Action Document (BRAD)

Approved by:



### Ro bert McNa ll y, Director B iopes tic id es a nd Po llutio n Preve n tio n Di vis io n Date:

### 1 . B a ck g round On June 12 , 2014 , th e U.S. Env ironmental Protection Agency ( " EPA " ) received an application from Suterra LLC for the registrat io n of a ne w use based on method o f delivery of 5-methyl-2- ( 1-methylethe nyl)-4- he xenyl 3-methyl

- 2 -butonate (common name: lavandu ly l senec ioate ; CAS Number 23960

- 07-8) , an arthro pod pheromon e first registered on January 29,20 10. There will be one new product so ld under the trade nam e "C heckMate YMB-F " (EPA File Symbol No. 56336-A T). Lavandulyl senec ioate is classified as a biochemical pesticide based on its history of expos ure to human s and the e nv ironment demonstrating minimal tox icity and its non-toxic mod e of action to the target pest(s). Lavandulyl se necioate ha s been previously s ummarized in th e B iopesticides R eg i s tration Act ion Document (BRA D ) d a ted January 20, 2010 available in Dock e t ID E PA-I

- IQ-OPP-2009-0044 v ia http : //www. r eg ul a ti ons.gov . Lava ndul y l se nec io ate is a teclmical grade synthetic arthropod pheromo ne . This arthropod ph e romon e is st ructura ll y s imilar to and mimic s a naturally occ urrin g pheromone produced by the fe m a l e v ine mea l y bug 

### (P lanococcus ficus) to attract m a les for m at in g. Thi s pheromone is used to disrupt th e n o rmal mating cycle of the v in e mealybug in rais in , table and wine grapes and has a non-toxic mode of actio n. As an arthropod pheromone , lavandu l y l senecioate i s exe mpt from the requirement of a tolerance w hen u sed in retrievably sized polymeric matrix dispensers in or on all raw ag ri cult ural commodities w hen app li ed to growi n g crops only at a rate not to exceed 150 gram s active ingredient/acre / yea r in accordance wi th good ag r ic ultural practices (40 CFR 1 80. 11 24). T he one new prod uct , CheckMate VMB-F ( EP A F il e Symbol No. 56636-AT) , put forth by Suterra LLC is intended to be applied in a n aqueous mic ro-bead/dispe n sers v ia normal s pr ay equ ipment. The proposed n ew u se based o n method of delivery of lavandulyl senecioate is n o t cove re d und e r th e ex is tin g arthropod ph e romo n e tole ra nc e exe mpti o n li s ted in 40 C FR 1 80. 1 1 24

. Therefore, S ute rra LLC h as requested that 40 CF R part 180 be amended by es t ab li sh in g a n exe mption from the requirement of a to lerance fo r residues of the arthropod pheromone , l ava ndu lyl se nec ioate , in or on all ra w agricu ltur a l co mmoditi es when applied or u se d in m icrobeads/dispensers at a rate not to exceed 1 50 g ra m s act ive in g re dient / acre/ year. A copy of th e p e tit ion is ava il able in Docket ID E P A-HQ-OPP-20 1 5-00 17 via http: //www .reg u lat io n s.gov.


### 2 . E valuati o n In evaluating a pest i c id e r eg istrati o n app li cation, th e EPA asses s es a wide var i ety of envi ronme ntal fate 

### (i.e. , how the chemical will move in the environment) and toxicity studies 

### (i. e . , effects o n n on- t arget o rganis m s) to determine th e lik elihood of adverse effects 

### (i.e. , risk ) from exposures assoc iated with the proposed use of the product. Risk assessmen t s are developed to evaluate the e n v ironmenta l fate o f the compound as well as how it might af f ect a w id e range of non-target organisms including humans, terrestrial and aquati c wildl i fe (plants and animals), On the basis of these assessmen t s, EPA eva lu ates and approves lan guage for each pesticide label to ensu re the di rections for use and safe ty measures are appropri ate to mitigate any potential risk. In thi s way , the pesticide's l abel he lp s to commun icate essen ti a l limitations and mitigations that are necessa ry fo r public safe ty . In fact, the p es ti c id e law h as a provision whic h indicate s th at it is a v io la ti on to u se a pesticide in a way that conflicts w ith th e labe l. Page 2 of S

### 2 . 1 Assessment of Risk to Human Health EPA requires a wide range of stud ies in o rd er to assess a pesticide. For l avanduly l senecioate, adequate data/ inf ormation has been received by the Age n cy to suppo r t the assessment of risk to human health for the use of this arthropod pheromone in or on all raw agricultural commod iti es when app li ed/used at a rate not to exceed 150 grams ac ti ve ingredien t/a cre/year (new use based on method of delivery). The acute toxicity for lavandulyl senec ioate is low for all routes of exposure (ora l, dermal, inhalation) , with the except ion of skin irritation ( moderately irri tating)

. The lab e lin g precautionary s ig n al word is "CAUTION. " · The evaluatio n of the data a nd inf ormation submitted indicate that lavanduly l senec ioate is not genotoxic. There are no known effects of l avanduly l senecioate on endocrin e systems via oral, dermal, o r inhalation routes of exposure. T o addres s the subchro nic a nd prenatal developmental toxicity data requirements for this exemption from the requirement of a tolerance for this arthropod pheromone , lavanduly l senecioate, th e petitioner subm i tted scientific rationales that demonstrate that it i s highly unlikely that there wi ll be s i gnifican t repeated exposure, including dietary exposure and exposure to femal e humans , to this pheromone when used as proposed based on the extreme l y l ow app li cation rate , l ow e mi ss ion rate , rapid vo latilizat ion after e mi ss ion from the microbeads , and rapid biodegradation. T ak in g into acco unt the petitioner 's rationale, EPA has concluded that t here is unlikely to be expos ure that co uld res ul t in s ub chr on i c and developmental effects and so has waived the requireme nts for subchronic and prenatal developmental testing. Furthem1ore, E PA has not fou nd lavandul yl senec ioate to share a common mechanism of toxicity with any other substances, and lavandu lyl senecioate does not appear to produce a toxic metabolite produced by other s ub stances. Given the low likelihood of adverse effects o n humans, more refined estimates of acute and chronic dietary risk we re not necessary for lavandulyl senecioate

. Lavandulyl senec i oate is already present in the environment wherever vine mealybugs are present and mating, and humans are a lready exposed o n a repeated basis. Furthermore, human exposu re to lavandu lyl senec ioate via dietary exposure to pesticide-treated commod iti es, such as raisin , table and wine grapes, is highly unlikely. Residues on food commod iti es are not anticipated as arthropod phe romones, including lavandu lyl senecioate, ar e hi ghly volatile and rapidly biodegrade. Exposure of humans to lavandulyl se necioate in drinking water i s not expected because lavandulyl senecioate is highly vo lat il e and degrades rapid l y in the environment and it is not to be appl ied directly to water. For more information , please ref e r to the document en titl ed, " Federal Food , Drug , and Cosmetic Act (FFDCA) Considerations fo r Lavandulyl Senecioate (June 30, 2015)," wh i ch can be found in Docket ID EPA-HQ-OPP-20 15-0 017 (Document ID: EPA -HQ-OPP- 20 1 5

- 00 17-0007).



### 2.2 Assessment of Eco logica l Risk
Page 

### 3 of SAcco rding to 40 C FR 1 58.2060( a)(2) , arthropod pheromones when ap pli ed at up to a max imum u se rate of 150 gra m s active in g redien t/a cr e / yea r , an d that are not ex p ec t ed to be available to av ian species, are not re quired to provide n o n-t a rge t toxicity and environmental fate data. Lavanduly l se n ecioate i s a sy nthetic arthropod pheromone that i s struct ura ll y s imi lar to and mimic s the pheromone produced by the femal e vine mealybug

. This compound acts on a se lect g r

o up of insect s and h as a non-toxic mod e of ac ti o n. The e nd-u se product s (E P s) , in retri evab le sized polymeric d i spe n ser s and sp rayab l e microbeads , ar e not ex pected to be ava ilable to avian spec1es.


### 3. A lte rnatives Lavandulyl se n ecioate can be u sed a l one or a lo n gs id e cur rently reg i stered biochemica l or conventional pe s ticid es and can be an import a nt component of an I nte g rat e d Pes t Manageme nt ( IPM ) sys tem. According to the petition e r , Suterra LLC , the propose d prod u c t , C h ec kMate VMB -F , containing I avand ul y l se necio a te in a n aqueous micro-b ead/dispenser s th at can be app l ied via n o rmal spray , i s: 1 ) an impro vement in some s itu ation s over Su te rra ' s currently registered v in e mealybug (VM B ) hand- app li ed dispenser s uch as when large fa rm s experience problems in d ep l oyme nt costs and crew man age m en t i ssues , and 2) a t o th er times i s fo re see n to co mpl e ment the currently reg i s te red VMB hand- a ppli ed di s penser in sce n a ri os with longer g rowing seasons( > 150 d ays)

. The u s e of thi s arthropod pheromone i s expec te d to di s p lace and / or reduce the amou nt of in sec ticid es u se d against the target pe s t , vi n e m ea lyb u g, that contain more toxic conv e nti o na l active ingredi e nt s s u c h as imid a cloprid , buprof ez in , acetam iprid , c lo thi anidin , chlorpyrifos , s piro tetramat , thiamethoxam , and dinotefuran. Growers may pr e f

e r to use lavandulyl senec ioate as a v iable alternative to conventi onal in sec ti c id e s because lavandu l y l s enecioate h as an establis h e d exe mpti o n from the requi re m e nt of a tole rance for all raw agricu ltural commodities , indi catin g th a t it is s afe. Conve ntion a l in sec ti cides ge n e ra ll y h ave tolerances and m ay result in residues of concern o n food commodities.


### 4. Benefits and Public Comments By definjtion alone , biochemicals are favorable w hen compared to currently registered convent ion a l alternatives because biochemicals are naturally-occurring substances (o r s ub s t an ces structurall y - s imil ar a nd functio n a ll y id en ti ca l to n at urally

- occurri n g subs tan ces) with a history of exposure to hum a n s and the env ironme nt demonstrating minimal tox icity and a n o n - toxic mode of actio n to the target p est(s). Benefits of biochemical pesticides as co mp ared to co n ve ntional pestic id es typically include lower toxicity profil es fo r humans and n o n-t a rge t o rganis ms , and faster degradation in th e e n v ironm e nt. As out lin e d above, the arthropod ph e ro mone , lavandulyl se necioate i s a v i able a lternative to convent io n a l in sec ticid es contain in g a low toxicity profi le, hi g h vo latili ty, and rap id d eg radation in th e e nvironm e nt. On March 4 , 2015 , EPA published a Not ic e of F ilin g in th e Federal Register announci n g the receipt of th e initi a l filing of the lavan du l yl se n ccioate petit io n by Suterra L LC , under the Federa l Food , Dru g and Cosmeti c Act ( FFD CA) requesting the estab li s hm e n t of an exe mpti o n f rom the require m e nt of a to lerance for residues of th e arthropod pheromone , lavand ul y l se neci oa te , in o r o n a ll raw ag ri cultural commodities when applied/ u sed at a rate not to exceed Page 

### 4 of S150 grams active ingredient / acre/ year. This publication a lso announced a public comment period of30 days. No comments were received on the notice of filing. EPA announced (in Docket ID: EPA -HQ-OPP- 2015 -0017 ) the proposed decision of the unconditional registration of the new use based on method of delivery of the arthropod pheromone , lavandulyl senecioate , on July 9, 20 1 5 , and held a public comment period for 15 days , closing July 24 , 2015 , at 11 :59 PM EST

. The announcement included the draft Decision Document and the draft product label for "CheckMate VMB -F " (EPA File Symbol No. 56336- AT). No comments were received during this public comment period.


### 5. Regulatory Decision The lavandulyl senecioate database is considered to be complete. The proposed new use based on method of delivery of lavandulyl senecioate is well supported by this database. In considering the assessed risk to human health and the environment , the Agency concludes that lavandulyl senecioate meets the regulatory standard under the Federal Insecticide, Fung icide and Rodenticide Act (FIFRA)

. There are no outstanding data requirements for this biochemical. Therefore, the EPA is grant in g the unconditional registration of the lavanduly l senecioate new use based on method of delivery under Section 3(c)(5) of F IFRA. One product will be registered

. "CheckMate VMB-F" is an EP that contains lavandulyl senecioate as its sole active ingredient. App li cation of this product contai ning an aqueous solution of microbeads /dispsensers can be made any time prior to crop h arvest. The product will only affect adult vine mealybug males and has no effect on females, eggs , or immatures. The application rate is 5-10 grams of active ingredient per acre and the user cannot exceed 150 grams active ingredient per acre per year. Raisin, table and wine grape crops may be retreated via normal ground and aerial spray equipment as needed based on insect monitoring and field scouting programs. The risk assessment support ing this dec ision can be found in the regulatory docket (Document 10: EPA-HQ-OPP-20 15-00 17-0005).

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