UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASH INGTON 0 C • 20460

AUG31 2010

OfFICEOf CHEMlCf.l. SAFETY

AND POlLUTION PREVENTION

M EMORANDUM

SUBJECT:

FROM:

THRU:

TO:

Evaluation of a Request for a Public Interest Finding for the Conditional

Registra tion of Fluopyram (DP#377684)

Car) Chen. Plant Pathologist c.-J CJ,v..

Biological Analysis Branch /':)

Biolog

Arnet J

ical A

ones,

nalys

Chief

is Branch

Uf.<:tt'~ Biological and Economic Analysis Di . on (7503P)

Erik Kraft. Risk Manager

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 interest finding for the

conditional registration of fluopyram . It is a fungicide that would be used for the control of a

wide spectrum ofeconomically important fungal pathogens. The labeled use sites would include

almonds. pomes. leafy greens. and other tree nut. fruit. vegetable and field crops. The registrant

claims that the use offluopyram is in the public interest and there are multiple advantages that

strongly support the timely registration of fluopyram to control significant disease problems .

The analysis in this memo shows that there is a need for fluopyram that is not being met by other

currently registered fungicides for control of huH rot. In addition, this analysis indicates that

Fluopyram may have some useful characteristics as a viable alternative to current fruit and

vegetable crop disease management options. There also could be a need for fluopyram that is

not being met by other current ly registered fungicides or non-pesticidal alternatives under certain

situations where fluopyram shows potential in crop safety. early season control. and storage rot

control. BEAD concludes that fluopyram meets the criterion for a public interest finding.

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BACKGROUND

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 ofsites 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 chain (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 offluopyram to control economically important diseases

in a wide variety of crops. Data and other relevant information were submitted in the public

interest finding document to support the registrant's claims (Nelson et al., 2009).

PUBLIC INTEREST FIN DING POLICY

The use of a new pesticide shall be in the public interest for its conditional registration under

section 3(c)(7)(C) ofthe Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). A new

pesticide 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. ifthe

basis for the emergency exemption was the lack of a suitable alternative, and/or 3) a use against a

pest of public health significance.

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 registered pesticides or nonpesticidal alternatives; 2) the new pesticide is comparatively less risky than currently registered

pesticides; and/or 3) the benefits from use ofthe new pesticide exceed those ofalternative

registered pesticides and other available non-chemical alternatives. The Biological and

Economic Analysis Division (BEAD) examines the first and/or third issue, and defers the second

issue to the Registration Division, 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-pesticidal alternatives. The areas of consideration do not

include the presumption of public interest, which is not claimed for fluopyram in Nelson et al.

(2009). It is also noted that only the claims and analyses related to the specific conclusion are

presented in this memo, organized as "Registrant's Claim" and "BEAD's Evaluation".

Registrant's Claim:

• Fluopyram will suppress hull rot on almond, a disease for which growers have no

goodfungicide control options.

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BEAD's Evaluation:

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 dieback ofshoots and fruiting

wood that reduce productivity in future years (UC IPM, 2009).

Approximately 5·10% ofCalifomi a almonds are infested with an economic level of hull rot with

average yield losses ranging from 100 to 200 pounds per acre (lb/A) (Duncan, 2009). The

disease is believed 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 that production on those

branches is lost forever; and 2) more common and more severe in the Southern San Joaquin

Valley where approximately 80% ofCalifornia almonds are grown, and yield losses were

observed as high as 500 Ib/A in heavily infested, over irrigated orchards (Holtz, 2009). Based on

the infonnation above, Nelson et al. (2009) estimate that almond growers lose approximately $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 ofCalifornia Integrated

Pest Management Program (UC IPM, 2009). Fluopyram as a single active ingredient product

and a combination 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 could become a serious problem. It is a need that is not being met by other currently

registered fungicides.

Additionally, information on the role of other means for control of almond hull rot is submitted

in support ofthe registrant'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 et aI.,

2009), there is a cultural method, "Regulated Deficit Irrigation" (UC IPM, 2009, Duncan 2010)

for control ofthis disease. This method works by reducing the amount of watering during

almond hull development when almonds are most susceptible to almond hull rot. The grower

can use a "pressure bomb" as an ideal tool to monitor stress levels in almond trees or use a

technique called "shoot from the hip" instead of a pressure bomb (Duncan, 2010). In a 2008

survey, the method of using plant moisture sensing device to decide when to irrigate was used in

1,419 farms among 45,136 California farms (Census of Agriculture Publication, 2008), where it

is estimated that there are 6,000 almond growers in California (Almond Orchards, 2010).

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Irrigation is a big factor influencing the hull rot severity (Duncan, 2010). Although virtually all

almonds are irrigated (NA SS, 2009 ; Census of Agriculture Publication, 2008), there is no data

indicating that regulated deficit irrigation has been used widely by growers. Careful monitoring

and measurements oftree stress levels are required to properly use this method. Ifthe 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) indicate that many growers

would rather use fungicides to control the disease than fully implement a deficit irrigation

program due to the risks and difficulties associated with proper implementation.

In summary, fluopyram would be the only viable alternative for many almond growers in hull rot

management.

Registrant's Cla imj

• Fluopyram will provide superior or equivalent control ofeconomically important and

difficult-to-control diseases compared to current standards without phytotoxicity 10

the crop.

BEAD's Ev aluation:

Crop 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 of injury to

labeled crops. For example, in the fungicide trials against scab, powdery mildew, and summer

diseases such as sooty blotch and flyspeck on apples, fluopyram based products did not injure the

crop and offered crop safety equal to the standards (Nelson et aI., 2009; Travis and Halbrendt,

20(8).

Thus, fluopyram could be an option under certain situations where there is concern on crop

safety with use of other fungicide(s}. Note that this is a relatively general assessment. 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 ifdata on individual

cases that aim to directly compare phytotoxicity of other fungicides to fluopyram had been

provided by Nelson et al. (2009).

Registrant' s Claim:

• in -season use ofjIuopyram will increase orchard productivity and longevity through

improved tree health.

BEAD ' s Ev aluation:

Data and information submitted by the registrant on this subject include the role of early season

control in orchard management, which is supplied and analyzed below.

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Fluopyram based products have been shown to be superior to other fungicides in reduc ing the

primary infection. as well as the secondary infection. on certain crops (Nelson et aL 2009). For

example. Luna Sensenon". a fluopyram based product. was effective under sustained mildew

pressure with 27 days favorable in the earl y apple grov..-ing season. April and May. As few as

two or three Iluopyram app lications can reduce the amount of primary inoculums in apple trees.

Primary shoot suppression following applications of fluopyram/trifloxystrobi n was significantly

better than most of other fungic ides tested apple trees in a study (Nelson et al.. 2009). The

exceptions were fIutriafol that is a Group 3 fungicide and mancozeb. ziram and captan that are

M3 or M4 fungicides. where fluopyram is a Group 7 fungicide (FRAC. 2006/2010). In a test of

an early season 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 powdery mildew control.

The above information suggests that fluopyram could be an option for early season control on

orchard crops where other fungicides that also are good for early season control are not available

due to reasons like logistic restraint. phytotoxicity management, and pesticide-rotation

arrangement. BEAD agrees that, in general, an early season control of fungal diseases reduces

not only primary infection but also the secondary infection. and therefore helps reduce the

negative impact of diseases on orchard productivity.

Registrant~1 Claim:

• In-season and preharvest applications offluopyram will reduce apple. grape. stone

fr uit. tomato and strawberry postharvest decay losses during transportation. storage.

and in-store by controlling common storage rot diseases.

BEAD's Evaluation:

The registrant states that data submitted show 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 (Nelson, et al.• 2009). The registrant also states that some ofthese

commodities do not tend themselves to postharvest dips, an additional advantage of in-season

fluopyram use.

In a PDMR report on the control offield and storage rot ofcranberries. all three fluopyram based

Luna products resulted in a significant rot reduction compared to untreated chec k. although

chlorothalonil provided the best control (Garuso. 2009). In another PDMR report on apricot that

was incubated at 28 "C and over 75% of relative humidity for 14 days after harvest. both Luna

SensationI and Luna Experience'[ provided the highest level ofcontrol on latent brown rots and

post harvest fruit rots (Cox et aJ.• 2009).

Postharvest decay losses during transportation. storage. and in-store are a serious concern to

growers. shippers. and retailers of perishable fruits and vegetables. Fluopyram could be an

interesting alternative under certain situations where other in-season fungicides that can provide

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storage rot control are not available due to whatever reasons and postharvest fungicide uses are

limited on certain commodities.

CONCLUSION

The use ofregistered 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 pesticides (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 ofthe almond hull rot disease. Thus, the criterion for a public interest

finding is met. In addition, 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 phytotoxicity

management, early season control, and storage rot control on fruit and vegetable crops. BEAD

concludes that the use of fluopyram fulfills the criterion for a public interest finding.

REFERENCES

Almond Growers. 1996. How to Minimize Hull Rot. Blue Diamond Growers. Accessed on

August 16, 2010 hnp:l/www.bluediuffiond.comljndex.cfm?na\·id=186

Almond Orchards. 2010. ARTICLEBASE - California's Almond Orchards. Accessed. on August

25, 20 I0 http //v..~w .artic Icsbase.com'gardcni ng-artieleslcalifomias-almond -orchards2342984.hlml

Census of Agriculture. 2008 Farm and Ranch Irrigation Survey. United States Department of

Agriculture National Agricultural Statistics Service. Accessed on August 25. 2010.

http://www.agcensus.usda .gov/Pub lications12007/0nline_Highlights/Farm_and_Ranch_I

rrigation_Survey/index.asp

Cox KD, Villani SM, Raes JJ. 2009. Evaluation offungicides and bactericides for control of

bacterial spot and brown rot ofapricot. Plant Disease Management Reports 4:STFOIl .

Duncan R. 2009. Information cited in Nelson et al., 2009, which is provided by Dr. Roger

Duncan, University ofCalifornia Cooperative Extension Service Crop Advisor for

Stanislaus County.

Duncan R. 2010. Managing Bull Rot and Stick Tights with Regulated Deficit Irrigation.

University of California Extension Service. Accessed on August 16,2010

http://cestanislaus.ucdavis.edulfiles/40346.rdf

FRAC. 200612010. Fungicide Mode of Action. Fungicide Resistance Action Committee. The

latter accessed on August 16,2010 http://wv..w.frac.info/frac/index.htm

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Garuso FL. 2009 . Evaluation of fungicides for control of field and storage rot of cranberries.

Plant Disease Management Reports 4:SMF002.

Halbrendt NO, Travis JW. Jarjour B. 2009. Early season spray programs for scab and powdery

mildew on apples. Plant Disease management Reports 4:PFOI2.

Holtz B. 2009. Information cited in Nelson et aI., 2009, which is provided by Dr. Brent Holtz,

University of California Cooperative Extension Service Crop Advisor for Madera

County.

Lalancette N, Cowgill W, Compton J. Foster K. 2000. Sensitivity of apple culti vars to

azoxystrobin fungicide. Page 141-146, Proc. ofthe 76th Cumberland Shenandoah Fruit

Workers Conference, November 16-17. Winchester, VA.

NASS. 2009. Fruit and Tree Nut Pest Management. United States Department of Agriculture

National Agricultural Statistics Service.

Ne lson JE, Musson GH. Kelly ID. YOWlg HS. 2009. A public interest proposal supporting the

registration of fluopyram to control economically important and difficult-to-control

diseases on almonds, apples, cucurbits, grapes, lettuce, potato. strawberry. stone fruit and

tomato. Bayer CropScience.

NPIRS. 2010. National Pesticide Information Retrieval System - Almonds. Purdue University.

htto:11wv,"\v.t cDs.purdue.roo/nrirs

PDMR. 2000·2010. Plant Disease Management Reports (Volumes 1·3, 2007·2009 online);

Fungicide and Nematicide Tests (F&N Tests: Volumes 55·61 , 2000·2006 online);

Biological and Cultural Tests (B&C Tests: Volumes 16-21,2001-2006 online).

http://www .plantmanagementnctwork.orglpub/triallpdmr/

Travis JW, Halbrendt NO. 2008 . Information cited in Nelson et al., 2009 , which is provided by

Drs. Travis and Halbrendt, Pennsylvania State University. FREC 2008.

UC IPM. 2009. UC Pest Management Guidelines - Almond Hull Rot. University ofCalifornia

Statewide Integrated Pest management Program - UC IPM Online. Accessed on August

16.20 to http://v,,w\Ij'.ipm.ucdav is.eduIPMG/r3101811 .html

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