UN ITE D S T ATES ENV IRONMEN T AL PROT E C T IO N AGENCY W AS HI NGT O N , D . C. 20 460

DECISION MEMORANDUM O F F ICE O F CI I D II C \1. S AF E f\ A N I> I' O L LI IT I O:'I' l'l{ f.\' ENT I O

SUBJECT: Registration of th e New Act ive Ingredient Oxathiapiprolin TO:
FROM: Jack Housenger, Director Office of Pesti c ide Programs Susan Lewis Director, Registration Division Office of Pesticide Programs This memorandum recommends that yo u co nc ur o n the reg istr atio n of the new active ingredient oxat hi apip rolin , a broad

- spectrum fungicide fo r foliar or soil use o n brassica, head and stem. crop subgroup SA ; bu lb onion crop subgroup 3-07A; c ucurbit vegetables, crop g roup 9; f ru iting vegetables , crop g r oup 8-10: g rap es ( imp o rt only): g re e n onion, crop s ub g roup 3-07 8 ; leafy greens , crop subgroup 4A: peas , edib le-podded; peas, succu lent. s hell ed; g in se ng root; tuberous and conn vege tab l es , s ubgroup I C; Tob acco; and go lf co urse tur f. It is al so for u se o n ornamental p lants g rown in greenhouses , shade houses. lath houses. hoop houses , nurseries , and commerc ial landsca p es. A summary of th e human hea lth and envi r onme nta l fa te a nd effects r isk assessme nt s and the final regu latory dec is i on are in the attached Fin al Decision D ocume nt. The Science Di vis ions have reviewed all availab l e data and the Re g istrat io n Di vision has concl uded that th e crite ria for registration under FlFRA section 3(c)(5) have been met. RECOMMENDATIONS: I reco mme nd for the r egistrati o n of oxathia its m etabo li tes and degradates under F IFRA section 3(c)(5).

onconcurr

_______________________________ ___ Jack Housenger. D irecto r Oftice of P es tic ide Prog ram s Attac hment: Final D ec is io n D oc ume nt

# Registration Decision for the New Active Ingredient Oxathiapiprolin

ckj:. ousenger , Directo r Office of Pesticid e Programs Date: 

# "B'[J.-1 

# i i{ -----+--+,--------------

### SUMMARY This document announces that the Environmental Protection Agency (EPA) has comp l eted it s evaluation of the data/information submitted to support the new fungicide oxathiapiprolin. The Agency has determined that it meets the regulatory and safety standards under the Fede ral In secticide, Fungicide and Rodenticide Act (FIFRA) and the Fede r al Food , Drug and Cosmet ic Act (FFDCA)

. The dataset for this application is complete

. Oxathiapiprolin is a fungicide for contr o l of downy mildew (caused by Pythium spp) and late blight (caused by Phytophthora spp.) diseases on food, ornamental crops and golf course turf. Five products are being unconditiona ll y registered under Section 3(c)(5) of FIFRA

- a technical and two end-use products by E
. I. de Pont de Nemours & Company (Du P ont): " DuPont Zorvec Technical ," " DuPont Zorvec Enicade Fungicide ," and " DuPont Zorvec Epicaltrin Fungicide "

. Syngenta Crop Protection has two end

- use products being registered: " Oxathiapiprolin FHG OD " and "Oxathiapipro lin FHG SC

. " DuPont applied for the fo ll owing food crops: Brassica , Head and Stem , Crop Subgroup SA; Bulb On ion Crop Subgroup 3-07A; Cucurbit Vegetables , Crop Group 9; Fruiting Vegetables, Crop Group 8-1 0; Grapes (import only); Green Onion, Crop Subgroup 3-07B; Leafy Greens , C r op Subgroup 4A; Dried Fru itin g Vegetab l es; Peas , edible-podded; Peas, succulent, she ll ed; Ginseng Root; Tuberous and Corm Vegetables, Subgroup 1C and non-food use for Tobacco. The approved labeling contains maximum applicat ion rates of oxathiapiprolin on crops ranging between 0.1245 lb. a.i ./A/year for most fo li ar app li cations and 0

. 5006 lb. a.i ./ A/ye ar for soil applications with 2 to 5 retreatments (12 drench treatments for ornamental use) at a range of minimum intervals between 3 to 14 days. The pre-harvest interva l ranges from 0 to 14 days

. Syngenta applied for the follow ing non-food uses: ornamental plants grown in greenhouses, shade houses , lath houses , hoop houses , nurseries , commercia l landscapes and golf course turf. For DuPont and Syngenta, the approved oxathiapiprolin label directions a ll ow thi s pesticide to be applied to either plant foliage or to the soi l but not both. Product appl ic ation methods are by ground and air sprays, aerial, chemigat ion , so il drench/ spray, drip irrigation , and hand sprayer (greenhouse use only)

. The approved end-use product label directions are for use by professional app li cators (not intended for homeowner application)

. Oxathiapiprolin is approved for use on brassica , head and stem, crop subgroup 

### SA; bulb onion crop subgroup 3 -07A; cucurbit vegetables, crop Group 9; fruiting vegetables, crop group 8- 1 0 ; grapes (import only); green onion, crop subgroup 3-07B; leafy greens, crop subgroup 4A; peas , ed ibl e-podded; peas , succulent, shelled; g in seng root; tuberous and conn vegetables , subgroup 1 C; T obacco; and turf. In add iti onal, oxathiapiprolin is approved for uses in greenhouses on ornamental plants , tomatoes, cucumbers , summer squash, bell peppers, and non-bell peppers . All other food uses on the labels will have a restriction s tatement against applications in a greenhouse because they were not requested and thus not assessed

.

Page 2 of12EPA determined that oxathiap i pro lin met the criteria for r educed risk status for a ll food and nonfood uses. The toxico logy database is cons id ere d complete. For human health, EPA conducted a qualitative risk assessment, in which toxicological endpoints and points of departure (POD) were not evident for oxathiap ipro lin

. Currently , there are no maximum residue levels (MRLs) established in other countries for oxathiapiprolin. Numerical tolerances were not needed but establis hed only to support future international harmonization purposes. Therefore, when MRLs are establ i shed by other regulatory agencies , it is expected that those MRLs will be harmonized with the U
. S. tolerance. Oxathiapiprolin is a broad-spectrum fungicide with preventative, residual, system ic , erad i cative , and antisporu l ant properties fo r foliar and soil -b orne fungal d i seases. It provides a different mode of action than other fungicides and thus cou ld minimize disease resistance. As approved , it is applied in a sched ul ed protect ive program and used in an applicatio n r otat io n program with products with a different mode of action

. 

### BACKGROUND
EP A received DuPont's three product applications on 12/ 3/2013 and received Syngenta's two product app li cat ions on 113 /2014. DuPont's applicat ions were also submitted for simultaneous review to the Pest Management Regulatory Agency (PMRA) of Canada. Synge n ta ' s non -food ornamenta l plant app lications were only s ubmitted to EPA because registration for these uses is not being requested for use in Canada. EPA and PMRA conducted a globa l joint review of oxathiapiprolin food uses with participation from Australia, Mexico and Japan. Regulatory observers from Sou th Korea , China , and the Philippines a lso part icipated. Each country conducted primary or secondary review for the 411 studi es sub mitted. Human health and ecological risk assessments were developed by EP A and PM RA in d iv idu ally

. DuPont petitioned EPA under the FFDCA to estab li s h tolerances for the food c rops li sted above. At this time, there are no established maximum residue limit s (MRLs) for oxathi apipro lin by Codex or PMRA. 

### EVALUATION OF RISK TO HUMAN HEALTH AND THE ENVIRONMENT In evaluating a pesticide registration application , the EPA assesses a wide variety of pesticide spec ific in fo rm at io n includ in g where and how the pesticide is used, environme nt a l fate (i.e. , what happens to the pesticide once it ' s applied), and toxicity studies 

### (i.e. , hazards) to determine the like lih ood of adve rse effects 

### (i. e . , risk) from expos ures associated with the proposed use of the product. The environmental fate properties of the pesticide are characterized by EPA. Also, risk assessments are developed to evaluate the compound as to how it might affect a wide ran ge of non-target organ isms including humans and terrestrial and aquatic wild li fe (plants and animals). On the basis of these assessments, EPA evaluates and develops language for each P age 3 of 12pestic ide labe l to e n sure the directions fo r u se and safety measures are appropriate t o mitigate any risks of concern. In this way , the pesticide labe l commun ic ates to the user the essenti al limitations and mitigation measures to ensu re no unreasonab le adverse effects on human health o r the e nv ironment. Add it iona ll y , i t is a F IFRA v iolati o n to use a pesticide in a way that is inconsistent with the labe l. 

### Assessment of Risk to Human Health The toxicology database for oxathi apipro lin is comp lete. In the ora l and dermal gui d eli n e tox ic ity stud ies , includin g subc h ronic, chronic, neurotoxicity , and immuno tox i c ity stu die s, no treatmen t re lated effec t s were seen at doses up to the limit dose. No treatment related effects were observed in mate rnal or fetal anim als in rat or rabb it developmental to xic ity s tudi es. Treatment related effects were observed in offspri n g animals in rat reproduction st udi es. However , these effec t s we re onl y observed at doses above the limit dose

. S uc h high doses are not re levant fo r human health risk because human expos ure at this level i s n ot anticipated in conjunction w i t h the use directions o n the approved product lab els. Th ere was no ev idence of carcinogenicity in cancer studi es with rats or mice. Oxathiapiprolin is classified as "no t likely to be carcinogenic to hum ans." Th ere is no mutagenic conce rn for oxathi apipro lin including its metabolites. An inhal ation toxicity s t udy was not subm i tte d. However , 

### in consideratio n of a ll o th e r available data and through a weight of evi d ence (W O E) approach , EP A co ncluded that the inh alation study is not required for oxathiapipro lin

. B ased on the lack of tox icity for oxathi apipro lin across the database , the inh al ation tox i c i ty study has therefo re been waived. Due to the lac k of toxicity observed in the oxathiap ip rol in database, toxicological endpo int s and POD were not evident in th e data for oxathiapipro lin. Therefore , a q uan t itat ive risk assess me nt approach w hi ch uses endpo int s was not needed and, instead a qual it ati ve hum an health risk assessment was conducted to s u pport the u ses. This includes assessment of dietary, res ident ial, and occupational (handler and post-application) risk estim ates. In acute tox icity st udi es, expos ure to oxat hi ap i prol in r es ul te d in low toxicity via the oral, dem1al , and inh alation routes of ex pos ure (T oxicity Category IV ). Oxathiap ipro li n was not a dermal o r eye irritant, o r a sk in sensitizer. B ased on the acute toxicity of the technical acti ve ingredient the R e-Entry In te r val (REI ) wo uld be 12 -h ou rs based on the Worker Protection Sta ndard. The company proposed a 4-hour REI which is the lowest RE I a ll owe d on any l abel. Th e Agency agreed that a 4-hour REI i s appropriate here because this acti ve in g redi e n t meets the criteria of 1) an active in g redie nt with lo w tox i city for acu te dermal , inha lati on toxicity , primary sk in irritation, and primary eye irritation; 2) the acti ve in gre di e nt is not a dennal sens iti ze r ; 3) th e acti ve ingredient is not a cholinesterase inhibitor; 4) there are no known reprodu ct ive, developmental, carc inogenic, or neurotoxic effects known; and 5) there i s no adve rse incident inf ormati o n ( illn ess or injury reports) related to pos t- app li cation exposures. The Perso n a l Protective Eq ui p me nt ( PP E) statement s on the approved label s r equi re handlers to wear baseline cloth ing ( i. e., long sleeved shirt , l ong pants , s hoes plus socks)

. The residue chemistry database is complete , including adequate anal yt ica l methods; me taboli s m in target crops , rotati onal crops, and liv es t ock; sto r age stab ili ty ; residues from field tria ls; and Page 4 of12residues in processed commod it i es. A ll residue study results are supported by adequate sto ra ge stability data

. The fie ld tr ial stud ies were co ndu cted using the proposed ana lytical enforcement method. 

### Assessment of Risks to the E nvironment E nvironmental Fate Oxathiap i prol i n is characterized by a relatively low water solub ili ty with l ow potenti al for volati li zation from dry / we t and water s urfaces

. The octanol/wate r partition coef fi c i ent suggests that the chemical has the potential to bio-concentrate in aquatic o r gani sms suc h as fish. Oxathiapipro lin is not expected to be affected by hydrolysis , aqueous photolysis , and photolysis in soi l and anaerobic so il metabol ism. The chemic al i s expected to be relatively persistent in the soil and water sed iment systems. In these soil and water sed i ment systems , b io-tran sfo rm atio n/biodegradation a re th e major processes that are expected to affect the fate of oxathiapiprolin. 

### Ecologica l E ffects Because of its l ow solubility , oxathi ap ip r o li n d id not demonstrate acute or chronic effects of conce rn to freshwat er and estuarine/ marine fish. Chronic Risk Quotients ( RQ) to fres hwater sed iment-dwe llin g invertebrates were estimated to be 2. 72 whic h exceeded the L evel of Concern (LOC) of 1.0 when calculated from sediment based t ox icity e ndp oints

. H owever, the chronic LOC was not exceeded for any of the approved uses w hen the RQs were estimated using pore water or water co lumn based tox ic ity endpo int s. To further characterize these findings, i t i s n ote d th at separate sp i ked-water and spiked

- sediment system sed ime nt toxic ity studi es yielded sediment and pore water-based toxicity endpo i nts. Th e endpoints from the sp iked sedi ment system a r e approximate l y an o rd e r of m agnitude less than those determ in ed fro m th e spi ked water syste m . Consequent ly , there were chron ic risk estimates above the level of concern to sediment-dwellin g invertebrates when using endpoi nts derived from the sp iked sediment system. Although no study i s availabl e to c haracterize the toxic ity to estuar in e/ marine organisms , the curre nt suite of data for water co lu mn invertebrates indi cate th at es tu arin e/ marin e o r gan isms are not disproportionately more sensitive than freshwater organ isms . Ad di ti ona ll y , as i nd icated above, the two c hro ni c f reshwate r sed im ent toxicity stud ies ind icate a leve l of ri sk below the level of concern for most of the uses. For the uses that do exceed the chronic leve l of co n cern, th e exceedances a r e m a rgi na l. Longer term 21 -d ay freshwater in verteb rate sed im e nt toxicity stud ies, as opposed to the shorter guide lin e subchronic l 0 -d ay toxicity stud ies, we re s ubm itted and classified as suppleme nt a l. The Agency assumes a s imil ar level of risk to estuarine / marine sedi me nt-d welli ng o rgani sms. The r efo r e, no further studies characterizi ng t he toxic i ty to fres hwater or estuari n e/ marine se dim ent -d we llin g invertebrates are needed as they are determ i ned to have li tt le overall added val ue to the cunent risk picture. There were no LOC exceedances of listed a nd non-listed spec ies of aquatic plants for the u ses of oxath iapipro lin

. No acute and chroni c avian and mammal LOCs are excee ded, thus , risk to b irds (and their surrogates) a nd mammals are not expected

. Despite the environmental fate data indicating that oxathiap iprolin has the potential to b io- conce ntr ate in aq uatic organisms such as fish , the r e was no ac ute o r c hronic risk above the LOC indicated for birds and mamma ls consum ing

Page 5 of 12oxathiapiprolin-containing aquatic taxa. This is due primarily to oxathiapiprolin's low acute and chronic toxicity to birds and mammals. No ri sk above the LOC to terrestrial plants are expected. The highest application rates tested on plants, which was more than twice the highest approved label application rate for all uses of oxathiapiprolin, did not elicit a tox icity endpoint at or above the 25% trigger level. The no-adverse effect concentrati on (NOAEC) also exceeded the maximum application rate, reinforcing the conclusion of no risk expected for both listed and non-listed spec ies of terrest ri al plants. The results of the Tier I risk assessment to adult honeybees via direct contact and ora l exposure resulting from fo li ar and soil applicat ions , respectively , indicate all RQs fa ll below the terrestrial invertebrate acute LOC of 0.4. A Tier II se mi-field bee study was conducted which examines effects from the larvae stage through pupation , to adults in an outdoor flight cage where bees are exposed to oxathiapiprolin -tr eated blooming plants. This study indicates that while there were reductions in surv ival at Days 12 and 13 after applicat ion, as we ll as reductions in flight intensity on the day of application , the bees recovered from these effects during the course of the 25 day study. This is indicated when the entire study interval was considered , all response vari ables related to colony health , survival, and foraging behavior were s imilar to controls. Based on the result s of the Tier I hon ey bee assessment which indicated no LOC exceedances 

### (i.e. acute contact and oral risk to adult honey bees), and Tier II semi-field study which indicated honey bee co lonies showed recovery in multip le response variables , the proposed uses of oxathiap iprolin are n ot expected to significantly impact honey bees at the colony level. Therefore , at this time , no additional bee studies are needed. The ecological risk assessment determined that for brassica vegetables , bulb vegetables , leafy vegetables, peas, tobacco and turf , there were no acute or chronic LOC exceedances of any taxa assessed. Thus , a " no effect finding" can be made for liste d species. Fo r all other uses that include cucurb i t vegetables, fru i ting vegetab les , ginseng , tuberous vegetables, and ornamentals , there was at least one scena ri o assessed fo r which there was an exceedance of LOC (RQs range from 

### 1.0 I to 2

. 72) and the taxa of concern were freshwater sediment dwelling invertebrates exposed to oxathiap iprolin on a chronic basis. It is noted that for the tuberous vegetab le use scenarios that were assessed, the highest RQ estimated was 

### l.O 1 , negligibly above the chronic LOC of 1. For the fruiting vegetab les use scenarios , the highest RQ est im ated was 2.72, marginally above th e chronic LOC of I. 

### A lte rnative s According to information provided by the registrant s, use of oxathiapipro lin could be expected to be an alternative, based on the pest spectrum , to existing pesticides which contain Chlorotha lonil , Mancozeb, Zox amide, Mandipropamid , Difenoconazole , Dimethomorph , Cyazofamid, Fluazinam , Fluopicolide, and Cymoxanil. 

### Benefits Oxathiapiprolin met the criteria for reduced risk status for a ll the approved food and non-food uses. It is a broad-spectrum fungicide w ith preventative , res idual , systemic, eradicative , and Pag e 6 of 12antisporulant properties for foliar and soil-borne fungal diseases. Oxathiapiprolin exhibits a unique mode of action

. lts unique mode of action suggests that it may play a role in resistance management. It can be used as part of an i ntegrated disease contro l program with fungicides of other modes of action that can be part of a resistance management strategy for the approved crops. Resistance management directions on the agricu l tural labels include the limitation of no more than two sequential applications and use of effective chemical alternatives in rotation programs. Utilization of integrated pest management programs is also encouraged on the approved labeling. It is registe r ed for use as a fungicide for protection of crops against difficult to control diseases caused by Oomycetes group of fungi (i

. e. downy mildew and late blight). The maximum yearly application rate is 0

. 5 lbs ./ A , which could resu lt in a reduction of the pesticide loading in the environment compared to certain registered alternatives. Benefits might also be recognized for oxathiapiprolin treatments on registered crops with minor pesticide uses (suc h as ginseng and yams)

. The use of oxathiap ipro li n cou l d offer benefits as a tool in integrated fungicide program to faci li tate the season-long contro l of specific fungal pest and extending the li fespan of many current ly registered fungicides. From a worker safety standpoint , and based on the toxic ity of the pesticide , agricultural products will have a 4 hour REI , which is the shortest period for any agricultural pesticides

. ln consideration of the toxicolog ica l information on oxathiapiprolin compared to several registered alternatives , oxathiapipro lin presents a favorable human health and ecological hazard profi le. 

### Public C omm e nts The Noti ce of Receipt for this new chemica l was pub lished in the Federal Register on April 18, 2014 with a non-substantive correct ion published J une I L 2014 for registration of oxathiapipro lin products and a public comment period of 30 days was announced

. No comments were received specifically pertaining to oxathiap iprolin. On May 23 , 2014 , the EPA published a Notice of fi ling in the Federal Reg ister announcing the receipt of the initial fi li ng ofthe oxathiap i prolin petition DuPont submitted under the FFDCA requesting the establishment of regu lations for tolerances of oxathiapiprolin on various commodities. On July 17, 2015 , a correct ion to this Notice of F il ing was published by adding the missing requested entry for dried fruiting vegetable. Both publicat ions also announced a pub li c comment period of 30 days and no comments were received. The EPA announced the proposed decision of the unconditional registration of oxathiapipro lin on June 10 , 2015 , and held a public comment period for 30 days , closing on August 9 , 2015

. The Agency received two comments to the docket (EPA-HQ

- OPP-2014-0114)

. These comments and the Agency's response are summarized later in this document. 

### R eg ul a to ry D e ci s ion EPA reviewed 411 studies as well as other infonnation submitted to support the approved uses for oxathiapiprolin

. Because no toxicological endpoints were evident after reviewing the complete database, a qualitative (no endpoints generated) human health ri sk assessment was conducted. The assessment concluded that the requested uses pose no human health risks. For Page 7 of 

### 12future MRL global hannonization purposes. the Agency is setting tolerances for the approved use s. Oxathiapiprolin received a reduced risk classification an d meets the low toxicity criteria publi s hed in the Federal Register on May 3. 1995. stated in Pe s ticide Registration Notice 95-3 , and provided in EPA Label Rev iew Man u al (revised April2015). Therefore it is qualified for a 4-hour REI. which is the lowest REI allowed on any lab e l. A quantitative eco lo gical risk assessment was conducted a nd found that no acute and chronic LO C were exceeded for all taxa assessed with the exceptio n of ch ronic ri sk to freshwater sed imen t-dwe llin g invertebrates for some regi ste red uses. In addition to the reduced r isk c lassificat ion rece ived for thi s c la ss of chemistry, EPA believes th at th e benefit of adding a novel mode of action to the ex ist in g class of fungicides is important as part of a resistance m a nagement progran1 for foliar and soil-bo rn e fungal diseases ; refer to th e Benefits sec tion for additional information. Therefore , the Agency has approved the r egistrat i on of the five products which met the FIFRA safe t y s tandard and the minimal risk found (ie. sediment dwelling invertebrates) associated with certain u ses is o utweighed by the benefits of the u se of the se products. No additional data are being re quired for registration. Therefore, E PA unconditionall y reg is tered five oxathiapipro lin product s under Section 3(c)(5) of FIFRA. The human hea lth and envi ronmental risk assessments s upporting thi s decision as well as the Re g is tration Notices and final labeling can be found in the regulatory docket (Document T O: EPA-HQ-OPP-2014-0114). 

### Co mm e nt s to th e Agen c y's Pro p ose d R eg ul a t o r ·y D ecis io n S umm a r y of Co mm en ts S upporting th e Ag en cy's Pro p ose d Deci s i on Two co mmen t s were received from members of the public regarding the regis tration of oxa thiapipro lin

. The se two comments can be found in the docket. 

### S umm arv of Co mm e n ts s ubmi tte d b v Ce n te r f o r B io log ica l Di ve r s ity (CB D); co mm e nt # E PA- H Q-O P P-2 0 14- 0 114- 001 7. Th e foll owin g a r e exce rpt s o f th e co mm en ts s ubmi tte d b y CB D
. Th e full s u b mi ss io n c a n be fo und in th e doc k et.

"The reg is trati o n of Oxath iapiprolin prior to consultat ions with the U.S

. Fish and W i ldlife Service and National Marine Fisheries Service repre se nt s a clear violati on of the ESA. According to EPA. ' ·taxa of concern were freshwater se diment dwelling invertebrates exposed to oxathiapiprolin on a chronic basis. " A decision to regi s ter Oxathiapiprolin prior to the comp letion of consultat ion s would be arbitrary and capricious. a v iolation of the Federal In secticide, Fungic id e, and R odenticide Act , and a vio lation of the Endangered Species Act. Accordingly. the Ce nte r opposes the registration of Oxathiapiprolin at this time.
Page 8 of 12"EPA has an independ e nt duty Under the Endan g ered Species Act to Con s ult with the U.S. Fish and Wildlife Ser v ice and National Marine Fi s he ri es Service on the Regi s tration of any New Active In gredient o r approval of any end-usc product that May Affect Protected Species

. "

' ' Section 7(a)(2) of th e E ndangered Species Act ( "E SA") requires that '" e ach federal agency s hall, in consultation with and with the as s is tance of the Secretary , in s ure that any action a uth o rized , funded , o r c arried out by such a ge nc y is no t likely to jeopardi ze the continued ex is tence of an y end a n ge r e d s pecies or threate ned s pecie s or result in th e d es truction or ad v ers e m o dification of habit a t o f s uch s pecie s which i s d e te rmined b y th e S e cr e tary ... to be critical.·· Under Section 7 ( a )(2), the EPA must con s ult with the U .S. Fish and Wildlif e Service and National Marin e Fi s he rie s Service ( collectivel y the · ' Services " ) to d e termin e whether its action s will jeopardize listed species ' survival or adverse ly modify designated critical habitat , and if so , to identify ways to modify th e actio n to avoid that re s u lt. Under the Services ' joint regulations implementing the ESA , a n action agency such a s the E PA must initiate con s u l tation under S ection 7 when e ver it s action · ' may affect'' a li s ted s pecies or critical habitat. Only where the a ction agency dete rmin es that it s action will ha ve ..n o e ffect " on listed s peci es or designated critical habitat is the c on s ultati o n obligation lifte d

. Th e consultation require m e nt applies to an y di s cretionary agenc y action that may aff e ct li s te d s p ecies. The EPA may d e cline to register a pe s ticide acti v e ingredient or end-use product if'"when used in accordanc e with widespread and commonly recogni ze d practice ' · the pesticide would re s ult in " unreas on ab le adverse effects on the environment. '

. Accordingly , the EPA ' s re g is tration of any pesticide repre s ents a discretionary action that clearly falls within the E SA ' s consultation requi r ement. " ··Gi ve n the re s ult s o f it s eco l og ical ri s k assess me nt f o r O x athiapipro lin

. th e E PA mu s t begin th e in fo rm a l c o n s ult a ti o n p r ocess w ith th e Serv ices a nd wo rk to w a rd s th e pre p a ra ti o n o f a n a ti o nwid e bi o log ica l assess m e nt of Ox athi api pro lin. Sec ti o n 7( d ) o f th e ESA prov ides that o n ce a l e dera l a g e n cy initi a tes co n s ult a ti o n o n a n ac ti o n und e r the ESA

. th e age ncy .. s h a ll not make a n y irrev er s ibl e o r irre tri evabl e co mmitm e nt o r reso urc es with r es p ec t to th e age nc y action w hi c h h as the e tTect o f f o rec los in g the f 01mulati o n o r impl e m e ntation of a n y reaso nabl e and prudent a lte rnati v e m eas ure s whi c h would not v io late s ub sec ti o n (a )(2 ) of thi s sec ti o n .' · Th e purpose or Sec ti o n 7(d) i s to maint a in the e nvironmental s ta tu s quo pending th e compl e tion of consultation. Sec ti o n 7(d ) pro hibiti o n s remain in effect thro u g h o ut th e consultation p e ri o d and until the EPA h as sati s fied it s o bli ga ti o n s und e r S e cti o n 7(a)(2) th a t th e action w ill n o t r es ult in j e opard y to the spec i es o r a d ve rse m o dificati o n of it s c riti ca l hab it a t. A n a cti ve in g r e di e nt cann o t be regi s te re d fo r u se prior to th e co m p l e ti o n of the co n s ult a ti o n process . The r eg is tra ti o n o f a n ac ti v e in g r e di e nt pri o r to th e co mpl e ti o n o f con s ult a ti o n s would re pre se nt an irreve rs ible a nd irre tri ev abl e co mmitm e nt o f reso urce s . a nd v lo uld v io la te th e ba s ic re quire n1 e nt of the E SA th a t each ag enc y o f th e f e d e ra l g o ve rnm e nt in s ure that th e ir action s d o not j eo p a rdi ze li s ted speci es o r a d v ersely modif y criti ca l habitat.· •

· · Furthe rm o re , th e pro p ose d lab e ls fo r Oxathi a pipro lin all o w appli c ato rs to mix the Oxa th ia pipro lin e nd-u se pro duct s w ith o th e r p es ti c ide pro duct s . Gi ve n th e p o te ntial syne rg ist ic a nd a d d iti ve ef f ects o f mi x in g p es t ic i des

. a n d the la rge ra n ge of unc e rtain ty rega rd in g th e cfTec t s of mi x ing O x athi a pipro li n w ith a n e n o rm o u s s uit e o r o th e r p es ticid e p r o duct s a lre ady o n th e mark e t. s u c h a pe rmi ss i ve labe l cle a rl y re pr ese nt s a failure o f th e
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### 12EPA to insure its actions will not jeopardize listed species. " EPA/Agency response: The Agency has been worki ng collaborati vely and actively with the United States Fish and Wildlife Service (USFWS) and the Nationa l Marine Fisheries Service (NMFS o r "Servi ces") to design a framework for efficiently completing the consultation process for pesticide actions in accordance with the Endangered Species Act (ESA)

. The Agency is focusing most of its resources for assessing impacts to listed species on the Agency's registration review program for cun·ently registered or existing pesticides. This allows the Agency to focus on c hemica ls w ith higher risk , i.e., the "wo rst first ", resulting in the greatest potential benefits for listed spec ies. The EPA believes that, as a general matter , currently registered and existing pesticides may present a greater degree of risk to listed species than most new chem istries coming to market, and that it is therefore env ironmentally preferable in most circumstances for the EPA to assess the impacts of existing pesticides sooner in th e process than newer pest ic ides that are designed to compete with more risky alternatives

. The Agency does not bel ieve the environment or the public would be best served by delaying the registration of oxathiapiprolin to complete consultation. In fact, EPA has made a "no-effects" determination for most of the uses approved in this registration decision and reached the conclusion that the overall ecological risks of oxathiapiprolin are generally low when compared to the LOCs and other fungicides. Additionally, the EPA has a lso negotiated with ou r partner agencies to phase-in interim scientific approaches over t ime . In November 2013, EPA , USF WS , NMFS, and the US Department of Agri culture (USDA) released a w hi te paper containing a summary of their joint interim approaches for assess ing risks to li sted species from pesticides. These interim approaches were developed jointly by the agencies in response to the National Academy of Sciences (NAS) recommendations , and reflect a conunon approach to risk assessment shared by the agenc ies as a way of addressing scient ific differences between the EPA and the Services. Details of the jo int interim approaches are contained in the November 1, 2013 wh ite paper , Interim Approaches for Nat ional-Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences Apri l 2013 Report. The E PA , US FWS and NMFS are cont inuin g to develop and work toward implementation of the interim approaches to assess the potential risks of pest icides to listed s pecies and their designated critical habitat , and wi ll apply these approaches to initial consultations and, based upon the experience gain ed with these approaches as well as any new science that may develop , modify procedures as appropriate. With respect to the eva lu at i on of oxathiapiprolin spec ifi cally and as explained in this document , current data indicate that the eco log ical risks presented by uses of oxathiapipro lin are generally low. A "no effect" determination was reached for the Iisted species for most of the assessed crop uses . For the uses that include cucurbit vegetable , fruiting vegetab l es, ginseng, tuberous vegetables, and ornamental, there was at l east one scenario assessed (freshwater sed iment dwelling invertebrates) for which there was a marginal risk. Therefore, there are potentia l risks of direct effects to listed freshwater sediment dwelling invertebrates and potential indirect effects to fish and other aquatic taxa that consume freshwater benthic in vertebrates. Potential direct effects on freshwater sediment dwelling invertebrates from the uses of oxathiap iprolin may be associated with the modification of Primary Constituent E l ements of designed critical habit ats, where such designations have been made. However, it is premature to make an effects Page 10 

### of 12determinations for listed s pecies of concern until further scientific analysis a nd refinements are conducted, based on reco mmendations receiv ed from th e National Academy of Science's National Research Counci l April 2013 report , available at http ://wwvv.nap . edu/cata log .php ?record id = 18344 To the extent that the E PA receives new inform a ti o n indicating that oxathiapiprolin may pose a greater risk to li s t ed species than indicated by th e existing sc ientific database for this pesticide, the EPA wi ll re- evaluate th e tern1s of registration and detern1ine whethe r use restrictions to protect listed species are necessary. The Agency is currently worki ng to priori tize its consultation activities with the Services and will eva luate the appropriate timing and scope of any necessary consultation on oxathiapiprolin in connection with those efforts. Additiona ll y, if evi dence from incident s or field observations s u ggest that current label la n g uage is not prov iding adequate protect ion to non-target o rganisms, co u nty use l imi tatio n s cou l d be required. To the ex tent that county-specific label mit igation is need ed, the E P A would u se the web application

.. Bulletins Live Two " (B LT)" to set fourth geog raphically-specific pesticide use limitations for the protection of threatened and endangered species and their designated critical habitat. BL T can be found at hnp: l/ww"'

. cpa.gov/oppfead I /cndanger/bulletins.htm Regarding synergistic effects, the Agency does not ro ut i nely include a separate evaluation of mixtures of active ingredi en ts , rather the EPA risk assessments focus on individual chemicals. The oxathiapiprolin end-use products do not contain multiple active ingre dients. However , tank m ixing is a common practice in agri culture. In an ins tance w here a u se r is tank mixing products , the pesticide applicators must follow the require ments of each label. If th e re is any unique requirement more (most) re s trictive oflab e l limitation s and precaution s, the more re s trictive label must be foll owed. S umm arv of Co mm e nts s ubmitte d by priva te citiz e n; comm e nt # E PA- HQ-O PP-2014- 0114-0005 . Th e foll o win g a re exc e rpts of th e co mm e nts s ubmitte d by a private ci tizen . T h e full s ubmi ss i o n can b e found on the dock e t. 

### ··1 hope you w i ll recons ider before loosening tol e r ances on any food item s, imported or domestic , or agricu ltural product s destined fo r food anima ls . You list those concerned as be ing involved in crop or animal production , food or pesticide manufacturing, but you see m to forget the most important party concerned: the American citizens yo u are supposed to be protecting." and "

. .. These petitions address many different pesticides (a term that includes in sec ticid es, herbicides , fung icides, etc.) and many d i fferent products. I am making an argument that regulations of these dangerous chemica ls - a ll of them- should be significant ly tightened. It is an i ssue of enviro nmental justice th at our you ngest citizens

- our children- are disproportionately exposed to health risks." ' "The P res ident's Cancer Panel (PCP) Report of20 10 and the American Academy ofPediatr ics (AA P) in 2013 assign much ofthe blame for ri si ng cancer rates in children to virtually unregulated pesticide exposures. The CDC Biomonitoring Project shows th at every American is contami nated wit h hundreds of toxic chemicals. even before birth (C DC , 2005). It woul d be unconscionable to continue ignoring the epidemio logic data. w hich is superior to animal studies in assessing harm. The Pr es iden t' s Cancer Panel is even more exp licit. The Pre s ident's Cancer Panel, appointed by Pre s id ent Bush, whose 2008-2009 Annual Report Page 11 of 12reviewed 454 so urces and found that man y cancers. perhaps mo s t , could be prevented by cleaning up th e e n vi ro nment in ju s t a few hi g h-imp act ways. In the letter to the Pre s ident that precedes the report , they could scarce ly ha ve s tate d the a larm their findin gs rai s ed more s t r ongly : " E P A/ A g e nc y r es pon se : The existin g lega l f ra m ewo rk pro vided b y sect io n 408 of FFDCA s tates th a t tolerances may b e set w he n p e rso n s seek in g s uch tolerances or exempt io n s have d e m o n s trated that the pesticide meets the s afety s tandard imposed by that s tatu e. When new or amended to leranc es are requested for residues of a pesticide in food o r feed. th e Agency, as is required by Section 408 of FFD CA, estimates th e ri s k of the potenti al ex p os ure to these residu es by p e rforming an aggregate risk assessment. S uch a risk assessment integrates the i ndividual assessme nts t h at ar e co nducted fo r food , d ri nk ing water, and r es ide ntial exposur es . Additionally , th e Age ncy , as is f UJth e r requ ired b y Sec tion 408 of the FFD CA, cons i ders availab le i nform at ion concerning what a re termed cumulative toxicological effects of th e residues of that p es ti c id e a nd of other s ub stances ha v in g a commo n m echani sm of t oxicity. Pur s uant to it s a uth o rity under the FFDCA , the Agency conducted a co mpre he nsi ve asses s ment of oxathiapiprolin. w hich co n si d e re d both ex p os ure and toxicological effects-including an assess m e nt on the carcinogenic potential of oxa thiapiprolin-in reaching a conclusion as to w he th er or not the re asonab le certainty of no harm decision can be mad e . Based on its ass ess m e nt of the available data , the Age nc y has found that the re is a reasonabl e certainty of no harm to human s, with spec i al emphases o n i nfants and children se n sitiv ity, fr om aggregate expos ure to ox athiapiproli n based on a complete toxicological data ba se and th e potentia l exposure leve ls

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