Bicyclopyrone : Response to Public Comme nt s on EPA's "Pro p osed Registration of the New Active Ingredient Bicyclopyrone" (Docket ID: EPA -HQ-O PP

- 2014 -0355) Su mm ary This document summarizes the U.S. Env ironmental Protection Agency ' s (the agency , EPA) responses to public comments received through the public notification ofthe receipt ofthe application for registration of the new active ingredient bicyclopryone , and the announcement of the proposed decision to conditionally register bicyclopyrone under Sect ion 3(c)(7)(C) of the Federal Insecticide , Fungicide , Rodenticide Act (FIFRA)

. On 8113114 , EPA published a notice of receipt in the Federal Register of an application for registration of bicyclopyrone and announced a public comment per iod of 30 days

. No comments were received. On 9/ 5114 , the E PA published a notice of filing in the Federal Reg i ster announc in g the receipt of the initial filing of the bicyclopyrone petition by Syngenta under the Federal Food , Drug , and Cosmet ic Act (FFDCA) requesting the establishment of regulations for re s idues of bicyclopyrone on various commodities. This publication also announced a public comment period of 30 days; seven comments were received on th e FFDCA notice of filing. Three of the comments were relevant to bicyclopyrone, the other four comments were relevant to other actions that were batched together with bicyclopryone in the same Federal Register document. The commenters noted that pesticides and bicyclopyrone pose a risk to pollinators. T he agency has d e termined that bicyclopyrone is moderately to practically non-toxic to young adult honey bees (Apis mellifera) on an acute exposure basis

. On 2 / 11 / 2015 , the E PA published an additiona l notice of filing in the Fede ra l Register for the imp ort tolerance on sugarcane petition and no rel evant comments were received. The E PA announced the proposed decision of the unconditional registration of bicyclopyrone on 3113115 , and held a public comment period for 30 days , closing 4 / 1 3 / 1 5

. Forty four submiss ion s were received in response to the public commenting per iod. Forty one subm i ss ion s were in favor of and supported the registration of bicyclopyrone and three submissions were in opposition to the agency's proposed decision to register bicyclopyrone. One of the subm i ssions in oppos iti on to regi s tration was a mail campaign submission conta inin g 5 , 558 indiv idual letters

. The agency ' s review and responses are summarized in this document. Su mm ary of Comments Supporti n g the Agency's Proposed DecisionForty one submissions were rece ived f rom var ious u ni ve r sities, state corn grower associat ions , sta te agri

- bus iness assoc i ations, state farm bureaus , s ta te food processo r s associations , IR-4 , Syngenta, a n d the public in favor of and supported the r eg i strat io n of bicyclopyrone noting its benefits of controlling hard to cont rol weeds such as cock l e b u n· , ragweed, etc., h e lpi n g wit h herbicide resistance managemen t , its ability to be used as par t of a one - pass sp r ay system, a n d reduction of th e use of atrazine, S

- metolachlor, and mesotri one. Comment: C hri s toph e r L is h (Document ID: EPA-HQ-OPP-2014-0355-0060), Mail Ca mpai g n s ubmitted b y Jonath a n Ev a ns , Center for Biolo g ical Div e rs ity ( Document ID : E PA- HQ-OPP-2014-0355-0063 , 5558 indiv idual comments) , and C ent e r for Biological Di ve rs ity, Brett H a rtl, Dir e ctor (Document ID: E PA-HQ-OPP-2014-0355-57). A number of comments were submitted re lated to no n -target species and po li c ies for pro t ecting endange red species. Specific areas c ited by th e p u b l ic inc l uded:

" l'm ·writing to you with a simple request: When considering approval for new and potentially harmfulpesticides like bicyclopyrone and AcuronTM , follow the law and first consult w i th wildlife experts. The Endangered Species Act requ i res federal agencies--including the Environmental Protection Agency (EPA)--to consult with the 

### U.S. Fish and Wildlife Serv i ce (USFWS) and National Marine Fisheries Service (NMFS) before taking any action that could potentially harm wildlife protected under the Act. And ye t , too often, this rule is ignored or not followed and harmfulpesticides are rubber s t amped for approval." ''The National Academy a/Sciences has prov i ded clear guidance to the EPA on the importance of a rigorous analysis of pesticide impacts to endangered species, and the requirement to consult with the FWS and the NMFS is written directly into the Endangered Species Act. I demand that this consultat ion be pe1jormed before bicyc/opyrone, AcuronTM, or any other such pesticide earns y our agency's approval. " "EPA has an ind e pendent duty under the Endange red Species Act to consult with the 

### U.S. Fish and Wildlife Service and Na t ional Marine Fisheries Service on the reg istration of any new active ingredie nt I end-use product/hat may affec t pro t ected species. "

" Th e ne w corn herbic i de bicyc!opyrone,fo r instance, has po t ent ial to harm endangered species, both on its own or mixed with other pest i cides like atrazine, a known endocrine disruptor to amphibians. Millions of pounds of atrazine are used in this count1 y and have been found in s wface water in concentrat i ons far exceeding the threshold/or harming wildlife. Studies have also shown that pesticides can have synergistic effects when mixed w i th othe r chemicals, caus i ng greater harm to species than e i ther chemical would alone. Fast- t racking bicyclopyrone's approval for us e on millions of acres of corn would be an unthinkably irrespons i ble move."

"Label and use restrictions requ ired to protec t listed spec i es ... "EPA Resp o nse: The age ncy has been working co ll abo rat ivel y and actively with the USFWS and the NMFS (Se r v ices ) to desi g n a framework fo r e fficiently completing the con sultation proce ss for pe s ticide actions in accordance with the Endan ge r ed Species Act (ESA). The agency is focusing mo st of it s r eso urces for assessing impact s to li s ted species on the agenc y's registration review pro g r am for currently re gistered or existing pesticides. EPA believes that , as a general matter , currently re g is tered and existi ng pe s ticide s may present a g reater degr ee of ri sk to li s t ed species than most new chemistries co ming t o marke t , and that it i s therefore environmentally preferable in mos t circumstances for EPA to assess the impacts of ex istin g pe st icides soo ner in the process than newe r pe s ticid es that are designed to compete with more risk y alternatives. EPA doe s not beli eve the env ironment or the public would be best served by dela y ing the registration of bic yc lopyrone to comp lete consultation. EPA received numerou s comments from vario us univ e rs itie s, s tate com g rower association s, state agri-business associations, s tate farm bureaus , state food proce ss ors as soc iations , IR-4 , Syngenta, and th e pub li c requesting an ex pedited regi s tration of bicyclopyrone noting its benefits of contro llin g hard to control weeds such as cockle burr , ragweed , etc., helpin g with herbicide re s ista nce mana ge ment , it s ability to be used as part of a one - pass spray system, and reduction of the use of atrazine, S-meto lachlor, and mesotrione. AcuronTM can provide it s most effective weed mana ge ment with a s ingle pre-eme rgent app lic ation that may not require additional postemergent ap plic a ti ons. Ac uronTM can provide higher ef fica cy o n difficult to control weeds with a lowe r rate of atra z ine , S-metolac hlor , and me sotr ion e; r esu ltin g in decreases in the amoun t of atrazine that will be applied to co rn as well as s maller reductions in S-metolachlor a nd meso trion e. AcuronTM 's introduction will result in r eduction in the use of other Syngenta prod ucts , re s ultin g in a r e duction of 3.6 million pound s of atra z ine per yea r on acre s that would of have been tre ated vvith those products. The agency i s requiring Syngenta to achie ve thi s reduction no later than the 2020 growi ng seaso n. In th e eve nt that the se reduction s are not achieved, E PA has a me c hani s m in place to ensure future at razine reduction s . Foc u s ing E PA 's, f'WS', and NMFS' limited

**resou~ces** on completin g a consultat ion on th e effects of bicyclopyrone wo uld by nec ess ity come at th e expense of putt in g more re so urces into eva lu at in g - and co nsequ e ntly r eg ulatin g, where appropriate

- what EPA believes to be more toxi c compounds. EPA currently emp loys a 3-pronged strategy in managing pesticide registration actions. This is int ende d to protect li s ted spe cie s and th e ir desi gnated critical habitat by focu s ing re so urce s o n are as where we can achi ev e th e most important protections. First , EP 1\ will undertake the maj o rity of its ES/\ consultation work through r eg istration review. This allows EPA to focus on ch emical s with hi gher ri s k , i.e. , the · 'wo rs t first ", resulting in the greatest pot ential benefit s for li s ted spec ies. EPA ha s a lso negotiated with our pru1er age nci es to phase in the interim scientific approaches over time. I n 1 ovembe r 20 I 3

. EP A. USPWS

. MFS, and US Department of Agricultmc (USDA) rele ase d a white paper cont a inin g a s ummary of th e ir j o int int e rim approaches for assess in g risks t o li s t ed spec ies from pesticides. The se inte rim approaches were developed jointly by th e agenc ie s in re spo ns e to th e a ti o nal/\ cademy of Sc ie nce s (NAS) r ecom mend a tion s. and r c f1 ec t a co mmon approach t o ri s k assessmen t s hared by the age nci es as away of address i ng sc i entif i c differences between th e E PA a nd th e Se r v ices . D eta il s of th e j oi nt int er im approaches ar e co nt a in ed in the ovember I , 2 013 wh it e paper, I nte rim App roa c hes for N

ational-L e vel Pes ticid e Endange re d Sp e cie s Act Asse ssm e nts Based on th e Re commendations

o f the N ational Academy

**(~(Sciences** April 2013 Report. EPA , FWS , and NMFS are cont inuing to deve lop a nd "vo r l toward impl ementatio n or th e inte ri m approaches to a ss es s the potential ri s ks o r pe s ticides t o li s t e d s peci es and their des ignated criti ca l habi t at , and will a ppl y th ese approaches to initi a l consu lt a ti ons and , based upon th e experience g ain ed w ith thes e app r oaches
as well as a ny new sc ience that ma y develop, mod ify procedures as appropriate. Secondly , EPA int en d s to complete a n endange r ed species assessment for ne w herbicid e tol erant
cro p u ses. T he age nc y believes this is appropriate since th ese registrations wou ld be expected to g r

eat ly increase th e number of ac re s treated fo r a curre ntl y re gis ter ed pesticide. Thi s current action does not invo l ve tr ansgen ic seeds. Thirdly , EPA will provide information that compares the potential hazards of the new ac ti ve in gredie nts to a lr eady r eg istered pesticides w ith s imilar u se patterns. This will a llow
s t

ake h o ld ers to compa r e th e relative toxi c ity of th e pro po sed r eg i st ration to ava ilabl e alternatives. The agency w ill proceed wit h r egistration in those in stances w her e th e re wo uld be a favorable shift to the new act ive ingredient and could c ho se t o conduct a n ESA assessment for th ose in s tanc es where th e new act i ve in gredi ent pos e s g r eater ri s ks to no n-t arg e t organisms prior to making a r eg is tration decision. EPA concludes the overa ll enviro nm e ntal b ene fit for this
ac ti on is consistent wi th these policy priorities. For the rea so ns exp la in ed above , EPA has not d ete 1mined whet h e r co n su lt ation with the Services under section 7 of th e ESA for bicyclopyrone wou ld b e necessary. Th e agency beli eves that the

r ed uct io n in th e amou nt of at r az in e and the other pesticides wo uld provide an environmental benefit and s upp o rt th e r eg istratio n of this new active ingredient. However , E P A is c urre ntl y work in g to prioritize it s co nsulta tion ac ti v iti es with th e Services and will eva lu ate the appropriate timin g an d scope of any nec essa ry cons ul tat io n on bic yc lop yro ne in connection with th ose efforts

. In addi ti on , to the ex tent EPA r ece ives new inf ormation in dicat in g that bicyclopyrone may pose a greater ri sk to li sted s pecies than indicated by the ex i s ting sc ientific database for this pes ticid e , E PA will r e - eva lu ate the t e rm s of r eg istrat ion and d ete nnin e whether addition al u se
r es triction s t o protec t li sted species are necessa ry. Concerning sy nerg is tic e ffe cts, the agency do es not r out in e l y includ e a se p arate evaluation of mi x tures of act ive in gredie nt s. However , there are some data ava il ab l e to the agency r ega rding sy ne r gist ic effects and E P A beli eves it adequate l y addres sed th e iss ue of synergism between bicyclopyrone a nd a tra z in e. Although th e subm itted data and EPA risk assessments tend to focus on individual chemical s, fo r AcuronTM, a formulation where th ere ar e multipl e ac ti ve in gredie nt s , each is subject to a n indi v idu a l ri sk assessment for a re gul ato ry deci s i o n re ga rdin g the ac ti ve ingredient on a particu l ar use s ite . In the ca se o f Acu r onTM, this would be for eac h active in gr edi ent s co nt a ined in th e fo rmul ati on ( i .e . , bicyclopyrone , mesot ri o ne , atrazine , and S

metolachlor). I f effects data are avail ab l e fo r a formulated product for no n-t a rg e t o r gani s ms contai nin g more th an one active ingr edient , th ey may be use d qua litative ly o r quantitati ve ly in accordance w i th th e age nc y ' s Overview D ocumen t and the Services ' Eva lu ati on Memora ndum (USEP A 2004; USFWS/NMFS/N O AA 2004).Additiona ll y , for atrazine and b icyclopyrone specifica ll y, the agency compared th e AcuronTM (a mixture of bicyclopyrone , mesotrione , atrazine and S-meto lachlor) formulation-specific acute toxicity data with atra z ine only and bicyclopyrone only active ingredient specific acute toxicity data. All thr ee formulations demonstrated low acute toxicity for mamm a ls. The acute toxicit y effects for all three formulations are simi l ar and do not indicate a synergistic effect fo r atrazine a nd bic ycl o pryone f o r mammal s. If evidence from incid e nts or fie ld observat ions suggest that cutTcnt labe l language is not providing adequate protection t o non-target organisms , county s pecific use limit ati o ns may be r e quired. To the extent that county-specific label mitigation is needed, E PA would use the web application " Bulletin s Live Two " (BLT)" to set fourth geographically-specific pe s ticide use limitations fo r the p ro t ection of threatened and endangered spec ies and their designated critical habitat. BLT can be found at http: / /\ n\" .cpa.uov/ oppfeacll /cndanuer /hulletins.htm. Co mm e nt: Sy nge nta C rop Protection, LLC, (Document ID : E PA-HQ - OPP-2014-0355-66)

' "In th e document " Proposed Reg istration ofthe Ne w Active Ing re dient Bic y c/op y ron e" (EPAHQ-OPP- 20 1-1-0355-0024), on page 6 (2 nd Paragraph and associated tables ), th e L e mna gibba EC50 (mg /

L) li s ted for bicyclopyrone con tained a typographica l error of0.003 mg /

L instead of th e c orr ect EC 50 value of0.0/3 mg /

L. See page 32 in EPA-HQ-OPP-20/.f-0355-0015 for th e EC50 and NOECfo r L. gibba (0. 0 13 mg /L and 0. 003 mg /

L, res p ective l y). The correct EC5 0 value was us e d in th e risk assess ment conducted by EFEp, and the typo g raphical correct ion s u gges ted h e re isfor th e tables in the Proposed R egis tration document on l y. The updated compariso n table s are provided below. Additionally , we ha ve added is ox ajlutole to the tables below for additional co mparison s ince it i s also a preeme r gence HPPD inhibitor r eg is feJ·ed in co rn. EPA in c lud ed comparative tabl es for three taxa (terrestrial plants , mammals, and vascular aquatic plants), bas ed on the screen ing level assessment , stating " Only groups of organisms for which LO Cs are exceeded/o r bicyclopyrone are lis te d. " (EPA-HQ-OPP-2014-0355-0024 , page 6). Add itionall y, bicyclopyrone ha s a favorable toxic ity profil e for all oth e r taxa for which EPA ' s sc ree ning lev e l assessment showed no LOC excee dan ces. Forfutur e analy s i

s of bicyclopyrone, th e tables in Allachment I provide a co mparison ofthe toxicity o.fbicyclopyrone re lativ e to alternative h e rbicid es .for additional environmental e ndpoint s. We sug ges t that jillure co mparati ve analyses sho uld also utiliz e ove rall risk co mpari sons (exp os ure as well as toxic it y). Th ese additional comparisons s how that this new h e rbicide provides a hig hly favorable e nvironm e ntal profile. EPA conducted sc r een ing l eve l assessm ent s in th e document " Envi ronm e ntal Fat e and Ecolog ic al Risk Ass ess ment for Use of th e New H e rbicide Bicyclopyrone (NOA4-19280)" (EPAHQ-OPP -20 1-1-0355 -00 15 ). Additional data and m e thodolo g ies are available for use in future a ssess m en t s to ji trth e r refine th e highl y co n se rvati ve a ss umptions implic it in th e screening l eve l assessments. Such ref inements includ e use of foliar degradation data and residu e decl in e, ref inement ofrunoffscreen in g es timat es using established mod e ls such as PRZM edge of field fl ux data with chemical specific e n vironm ental fat e data , terrestrial and aquatic plant recove tydata, and other best available data and m e thodologies. In addition , label mitigations add ed by E

PA to minimiz e drift and runo ff( 25 foo l downwind buffer , drople l size requiremen l s, wind speed , e lc.} co uld be us ed to refin e !he screen ing leve l a ssessmem. Use oflhese refin e menl s resu lt s in risk and exposure conclusions that are below leve ls of co ncern for listed and non-lis!ed species." 

### EPA R es pon se: The agency ack now led ges the t ypog raphi ca l error a nd ha s revised the tabl e with the correct EC50 value of 0.0 13 m g/L in the decision document. I soxatl utol e was not included in th e tables because it was no t identified among th e to p alternatives to bicyclopyrone in corn. The agen cy will use a ll available inf o rmati on and m e thods as appropri ate , in eva luatin g an y future bicycl o pyrone actio ns.