UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASH INGTON 0 C • 2046 0 

### A

UG 

# 31 20 10 OfFICE Of CHEMlCf.l. SAFETY AND POlLUTION PREVENT ION M EMO RANDU M 

### S UBJECT : F ROM : THRU: TO : Evaluation of a Request for a Pub lic Interest Findi ng for the Conditional Registra tion of Fluopyram (DP#37768 4) Car) Chen. Plant Pathologist 

## c.-J CJ,v.. Biological Analysis Branch /':) Arnet J ones, Chief

# Uf.<**:tt'~** Biolog ical A nalysi s Branc h B iological and Economic Analysis Di . o n (7503P) Erik Kraft. Risk M anager Fungicide Branch Registration Division (7505 P) Office of Pesticide Programs Product Review Panel : August 25, 2010 

### SUMMARY Bayer CropScience LP has submitted documentation supporting a pub lic interes t finding for the condi tional registration of fluopyram . It is a fungicide that wo u ld be used for the control of a wide spectrum of econom ically important fungal pathogens. The labeled use sites would include almonds. po mes. leafy greens. and other tree nut . fru it. ve geta ble and fie ld crops. The registrant claims that the use of fluopyram is 

### in the public interest and the re are multiple advantages that stro ngly suppo rt the timely registration of fluopyram to control s ignificant d isease pro blems . The ana lysis i n this memo sho ws that there is a need f or fluopyram tha t is not bei ng met by other currently reg istered fungicides for co ntrol o f huH rot. In add ition , this analys is ind icates that Fl uopyram may have som e use ful c haracteristics as a viable alternative to c urrent fru it and vegetable crop d isease mana gement options . There also cou ld be a need for fluopyram that is not being met by other current ly reg istered fung icides or non -pe stic idal alternatives under certain situa t ions w here fluopyram shows potential in crop saf ety. early season control. and storage rot contro l. BEA D concludes that fl uopyram meets the criterion for a public interes t find ing .

1BACKGROUND Bayer CropScience LP has submitted information showing that the registration offluopyram is in the public interest to the U.S. Environmental Protection Agency (EPA). Fluopyram is labeled to control a broad spectrum of plant diseases on a wide variety of sites including tree nuts, fruits, vegetables, and field crops . The fungicide functions through "SDH inhibition ", which acts on succinate dehydrogenase at protein complex II in the mitochondrial respiration cha in (Group 7) (FRAC, 2006/2010) . The registrant claims the use of fluopyram is in the public interest. In the executive summary of its submission , the registrant has made several claims that there are multiple advantages that strongly support the timely registration of fluopyram to control economically important diseases i n a wide variety of crops. Data and other relevant information were submitted in the public intere st finding document to support the registrant's claims (Nelson et al ., 2009) . P UBLIC INTE RE ST F IN DING P O LI CY The use of a new pesticide shall be in the public interest for its conditional registration under section 3(c)(7)(C) of the Federal Insecticide , Fungicide, and Rodenticide Act (FIFRA) . A new pe sticide is presumed to be in the public interest if it is 1) a replacement for another pesticide that is of continuing concern to EPA, 2) a use for which a FIFRA section 18 has been granted. if the basis for the emergency exemption was the lack o f a s uitable alternative , and/or 3) a use against a pest of public health s ignificance . For a public interest finding , issues of consideration defined in 51 FR 7632 include: 1) there is a need for the new pesticide that is not being met by other currently regis tered pesticides or nonpesticidal alternatives; 2) the new pesticide is comparatively less risky than curren tly registered pesticides; and/or 3) the benefits from use ofthe new pesticide exceed those of alternative registered pesticides and other available non-chemical alternatives. The Biological and Economic Analy sis Division (BEAD) examines the first and/or third issue , and defers the second is sue to the Registration D ivision, Environmental Fate and Effects Division, and/or Health Effects Division . ANAL YSIS This analysis is to evaluate whether the registration of tluopyram is in the public interest. In particular, it focuses on whether there is a need for fluopyram that is not being met by other currently registered fungicides or non-pe sticidal alternatives. The areas of consideration do not include the presumption of public interest, which is not c laimed for fluopyram in Nelson et al. (2009). 

### It is also noted that o n ly the claims and analyses related to the specific conclusion are presented in this memo, organized as " Registrant's Claim" and "B EAD's Evaluation". R e gistrant ' s C laim:



### • Fluopyram will suppress hull rot on almond , a disease for which growers have no good fungicid e control options. 2

### BEAD's Evalu ation: Almond hull rot is caused by 

### Rhizopus stolontfer and 

### Monilinia spp . , which has spread throughout the California almond growing area since its discovery in the 19505 (Nelson et al ., 2009). The fungal disease is considered to be a somewhat sporadic, but potentially serious problem (Almond Growers. 1996) . Almond hulls are susceptible to hulJ rot fungi from the beginning of hull split until the hulls dry, which will also cause diebac k of shoots and fruiting wood that reduce productivity in future years (UC IPM, 2009) . Approximately 5·10% of Califomi a almonds are infested with an economic level of hull rot with average yield l osses ranging from 100 to 200 pounds per acre (lb /A) (Duncan, 2009) . The disease is beli eved to 

### be 1 ) a more serious problem of almonds than brown rot blossom blight, shot hole or scab because fruiting SplU'S die on infected twigs resulting t hat production on those branches is lost forever ; and 2) more common and more severe in the Southern San Joaquin Valley where approximately 80% of California almond s are grown, and yield losses were observed as high as 500 Ib /A in heavily infested, over irrigated orchards (H oltz, 2009). Based on the infonnation above, Nelson et al . (2009) estimate that almond growers lose appro ximately $36 million annually to hull rot. However, no fungicides are registered for the control of hull rot (Nelson et al., 2009 ; NPRlS, 2010) . No fungicides are suggested for almond hull rot in the University of California Integrated Pe st Management Program (UC IPM , 2009) . Fluopyram as a s ingle active ingredient product and a combi nation product with other fungicides such as trifloxystrobin has been tested for control of almond hull rot. In a study , fluopyram was shown to be responsible for the majority of hull rot suppression (Nelson et aI. , 2009) . In summary , f1uopyram would be the only fungicide tool for almond growers to control hull rot that cou ld bec om e a seriou s problem . It i s a need that is not being met by other currently regi stered fun gicides. Additionally , i nf

ormation on the role of other means for control of alm ond hull rot is submitted in support of the regi strant 's claim. Thus , BEAD evaluates whether fluopyram is a viable alternative to other control means , and the analysis follows. Although no biological control is commercially effective against almond hull rot (Nelson e t aI. , 2009), there i s a cultural method , " Regulated Defici t Irrigation" (U C IPM, 2009 , Duncan 2010 ) for c ontrol of t his disease . This method works by reducing the am ount of watering during almond hull d evelopment when almond s are mo st susceptible to almond hull ro t. The grow er can use a "pressure bomb " as an ideal tool to monitor stres s levels in almond trees or use a technique call ed "shoot from the hip " instead of a pres sure bomb (Duncan , 2010) . In a 2008 survey , the method of using plant moisture sensing device to dec ide when to irrigate was used in 1,419 farms among 4 5 , 136 C alifornia farms (Cen sus of Agriculture Publication , 2008) , where it is estimated that there are 6 ,000 almond growers in C alifornia (Almond Orchards, 2010) .

3Irrigation i s a big factor i nfluencing the hull rot s everity (Duncan , 2010). Although virtually all almond s are irrigated (NA SS , 2009 ; Census of Agriculture Publication, 2008), ther e is no data indicating that regulated deficit irrigation has been used widely by growers. Careful monitoring and measurements of tree stress levels are required to properly use this method . If the method is not carefully done and tree s become stressed from lack of adequate irrigation during almond hull development , yield losses will occur . Duncan and Holtz (2009) i ndicate that many growers would rather u se fungici des to control the disease than fully implement 

### a deficit irr igatio n program due to the risks and difficultie s associated with proper implementation . In summary, fluopyram would be the only viable alternative f or many alm ond gro wers in hull rot management. Registrant' s Cl a imj

• Fluopyram will provide superior or equivalent control of economically important and difficult-to-control dis eases c om pared to current s tandards without phytotoxicity 10 the crop . 

### BEAD 's Ev alu a tion: C rop safety is a serious concern to orchard growers . For example, azoxystrobin fungicides could be phytotoxic to certain varieties of apples (Lalancette et el. , 2000). Based on a substantial database of over 1,000 U .S. trials and over 10,000 non-U .S. trials , the registrant states that fluopyram provides excellent crop safety in nearly all field trials and poses no risk o f injury to labeled crops. For example, in the fungicide trials against scab , powdery mildew, and summer disea ses s uch as s ooty blotch and flyspeck on apples , fluopyram based products di d not in jure the crop and offered crop saf ety equa l to the standard s (Nelson et aI., 2009; Travis and Halbrendt , 20(8). Thus , fluopy ram c ould be an option und er certain situations where there is concern on crop safety with use of other fungicide( s}. Note that this is a relatively general ass essment. Incidents of crop injury by fluopyram based products were observed and due to the other chemical in the combination product (Ne lson et al., 2009). The evaluation could be specific if data on individual cases that aim to directly compare phytotoxicity of other fungicides to fluopyram had been provided by N elson et al. (2009) . R eg istrant' s Cl aim :

• in -season use of jIuopyram will increase orchard productivity and lon gevity through improved tree health. B EAD ' s Ev alu ation : Data and information submitted by the registrant on this subject include the role of early season control in orchard manag ement, which is supplied and analyzed below .

4Fluopyram based products have been sho wn to be superior to other fun g icides in reduc ing the primary infection. as well as the secondary infection. on certain crops (N elson et aL 2009) . For example. Luna S ense non ". a fluo pyram based product. w as effective under s ustained mild ew pressure with 27 da ys favorable i n the earl y apple grov .. -ing season . April and May. A s 

### few as two or three Il uopyram app lications can reduce the amount of primary inoculums i n app le trees. P

rimary shoot sup pression following appl ications of flu opy ram/tri floxystrobi n was s ignificantly better than m ost of other fungic ides tested app le trees in a study (Nelson et al. . 20 09). The ex ceptions were fIutri afol that is a Group 

### 3 fungicide and mancozeb. z iram and ca ptan that are 

### M3 or 

### M4 fung icides . w here fluopyram is 

### a Group 

### 7 fungicide (FRAC . 2006/2010). In a test of an early 

### seaso n spray program on apples reported in Plant Disease Management Reports (PDMR , 2009), Halbrendt et 

### aI. found that Luna Sensation « was among the fungicides that provided the best scab and po wdery mildew control. The above informatio n suggests that fluopyram could be an option for e arly season control on orchard crops where other fungicid es that also are good for early seaso n control are not availab le due to reasons like logistic restraint. phytotoxicity management , and pesticide-rotation arrang ement. BEAD agrees that , in general, an early 

### season control of fungal d iseases reduces not only pri mary infection bu t also the secondary infection. and therefo re helps red uce the negat ive 

### impact of diseases on orchard produc tivity.**Registra nt~1**  C laim :

• In- season and pr eharvest applications of fluopyram will reduce apple. grape. stone f r ui t . t

oma to and stra wberry postharves t decay l osses during tra nsportation. storage. and in-sto re by controlling common s torage rot dis eases . 

### B EAD's Evaluation : The re gistrant states that data submitted sho w apples. grapes, stone fruit . tomato. and strawberries clearly develop less storage rot damage following in-season or pre-harvest applications of fluopyram based products . Most other in-season fungicides do not provide this postharvest benefit (Nel son , et al .• 2009) . The registrant also states that some of these commodities do not tend themselves to postharvest dips, an additional advantage of in-season fluopyram use . In a PD MR report on the control of field and storage rot of cranberries. all th ree fl uopyram based Luna products res ulted in a s ignificant rot reduction compared to untreated chec k. although chl orothalonil provided the bes t contro l (Garuso. 2009) . In another P DMR repo rt on apricot that w as inc ubated at 28 "C and over 75% o f re lative hum idity for 14 days after harvest. bo th Luna Sensation I an d Luna Experience '[ provided the highest l evel of contro l o n latent bro wn rots and post harvest 

### fruit rots (Cox e t 

### aJ . • 2009) . Postharve st decay lo sses during transportation . storage. and in-store are a seri ous c oncern to growers . sh ippers. and retailers of perishable fru its and vegetables. Flu opyram could 

### be an interesting alt ernative under certain situations where other in-season fungicides that can provide

5storage rot control are not available due to whatever reasons and postharvest fungicide uses are limited on certain commodities . 

### CON CL USION The use of registered and/or generally recommended fungicide(s) sometimes is limited by rotating fungicides, phytotoxicity concern, emphasis on early season control, commitment to storage rot control , maximum amount/sprays allowed 

### in a season, logistic restraint, and/or some other considerations . For example, 73% ofV.S. 

### fruit and tree nut acreage treated with pesticides has been applied with ones that have different mechanisms of action used to keep pest from becoming resistant to pes ticides (NASS, 2009), which could suggest a demand for more effective fungicides to be available for rotation schemes . Therefore , even though there are other fungicides registered. and/or recommended for the same target disease( s) , fluopyram sometimes still could be the only option or alternative to other currently registered fungicides or nonpesticidal alternatives under certain situations. In conclusion , there is a need for fluopyram that is not being met by other currently registered fungicides for control of the almond hull rot disease . Thus, the criterion for a public interest finding is met. In additio n, there is a need under some situations for fluopyram to 

### be a viable alternative to other currently registered fungicide s or non-pesticidal alternatives in p hytotoxicity management , early season control , and storage rot control on fruit and vegetable crops. BEAD concludes that the use of fluopyram fulfills the crit erion f or a public intere st finding . 

### RE F ERENCES A lmond Growers . 1996 . How to Minimize Hull Rot. Blue Diamond Growers . Accessed on August 1 6, 2010 hnp :l/ww w .bluedi uffiond .comljndex .cfm ?n a\ ·id=18 6 Almond O rchards. 2010. ARTICLEBAS E

- California's Almond Orchards. Acces sed. on August 25 , 20 I 0**http //v..~w** **.artic** I cs base .com' gardcni ng - artiele slcalifomias -almond -orchards



### 23 42984 . hlml C ensus of Agriculture. 2008 Farm and Ranch Irrigation Survey . U nited States Department of Agriculture N ational Agricultural Statistics Service . Accessed on August 25. 2010. http :/ /www . agcensus.usda .gov /Pub lication s12 00 7/0nline

_ Highlights/F arm_and_Ranch

_ I rrig ation _Surve y /inde x.asp C ox KD, Villani SM , Rae s 

### JJ . 2009 . Evaluation of fungicides and bactericides for control of bacter ial spot and brown rot of apricot . Plant Disease Management Reports 4:STFOIl . Duncan R. 2009 . Information cited in Nelson et al . , 2009, which is provided by Dr. Roger Duncan , University of California Co operative Extension Service Crop Advisor for Stanislaus County . Duncan R. 2010. Managing Bull Rot and Stick Tights with Regulated Deficit Irrig ation . Univers ity of California Extension Serv ice. Accessed on August 16,2010 

### http: //ce stanislaus .ucdavis .ed ulfi les/403 46 .rdf FRA C . 200612010. Fungicide Mode of Action . Fungici de Resistance Action C ommittee. The latter accessed on August 16,2010 http ://wv..w .frac . info/frac/i ndex .htm

6Garuso FL. 2009 . Evaluation of fungicides for control of field and storage rot of c ranberries . Plant 

### Disease Management Reports 4 :SMF002 . Halbrendt NO, Travis J W. Jarj our 

### B. 2009 . Early season spra y programs f or scab and po wdery milde w on a pples. Plant Disease management Report s 4: PFOI2 . Holtz B . 200 9 . Information cited 

### in Nelson et aI., 2009 , which is provi ded b y Dr . Brent Holtz , University of Ca lifornia C ooperative Extension Service Crop Advisor for Madera C ounty. Lalancette N , Co wgill W, C ompton J . F oster K. 2000. S ensitivity o f appl e culti vars to azoxy strobin fungicide . Page 141-146, Proc . ofthe 76th C umberland S henandoah Fruit Workers C onference, N ovember 16-1 7. Wi nchester, VA. N ASS. 20 09. Fruit and T ree N ut Pest Management. United S tates Department of Agriculture National Agricultural S tatistics S ervice. Ne lson J E, Musson 

### GH. Kelly ID . 

### YOWlg HS . 20 09 . A public interest proposal supporting the re gis tration o f fluop yram to control economically important an d difficult-to-control disease s o n almonds , apples, cu curbits , grape s, lettuce , potato. strawberry. sto ne fruit and tomato . B ayer Crop S cience . NPIRS. 2010 . National Pe sticide Information Retrieval S ystem - Almonds . Purdue University. ht to : 11 wv,"\v .t cDs . purdue . 

### roo/nri rs PDMR . 2000·2010 . P lant Disease Management Report s (V olumes 1· 3, 200 7 ·2009 o nline); F

ungicide and N ematicide T ests (F& N T ests : Volume s 55·61 , 2000·2006 online); Bio logical and C ultural Test s (B& C Tes ts: Volumes 16-21,2001-2006 on line) . http : //www .plantmanagementnctwork .orglpub/triallpdmr / Travis 

### JW , Halbrendt NO . 2008 . Inf ormation cited 

### in N el s on et 

### al ., 2009 , which i s provided by Drs . Trav is and Halbrendt, P ennsylvania St ate University. FRE C 2008 . UC IPM . 2009 . UC Pe st Management G uidelines

- Almond Hull Rot. Univer s ity of C alifornia S tatewide Integrated Pest mana gement Program

- UC IPM Onl ine. A cc ess ed on August 16 .20 

# to http ://v,,w\Ij ' .ipm.ucdav is .eduIPMG/r3101811 .htm l

7