# Aspergillus jlavus (PC Codes: 006456 and 006500) Preliminary Work Plan and Summary Document Registration Review: Initial Docket 

# June 2 015 Case 6008

Approved b y :

Rob e rt McNall y, Director Bi opes ticides and Pollution Prevention Division 

### D ate:Aspergill u sflavus 

### TABLE 

## OF CONTENTS EPA-HQ-OPP- 2 0 15-0 28 1 www.regu lations.gov



### I. PRELIMI NA RY WORK PLAN ......................................... ..... ........................................................ 4 A. Overview ... .............. ...... ............... .... ................... .. ........... .. .. ....... ........... . .. ...... ............ ....... ............ ....... ............. ... .. 4 B. Statutory and Re g ulatory Authority ..................................................................................................................... 4 C. Backg r o und and Regulatory Inf ormation ..... .... ................................ ... . . ..................... . ........................................ 5 D . Ant ic ip ated Data Needs and Risk As sess ments.................................................................................................... 7 E. Ri s k to Threa ten e d a nd En d ange red S p ec ies ......... ........ ......... ........... ...... ............ ........ ............. ......... ........... ..... 14 F. E n doc rin e Effect s ................................................................................................................... . ............................. 15 G. Jn ciden t s .............................................................................................................. . ................................................. 15 H . Tim e lin e .. .. .................................... ..... ............. ....... ............... ... ........ . ..... .. .................. .. ........ . ........... ... ............... .... 16 

## r. G uid ance for Com mente r s ... .... ......... ...... ................. .. .................................................................. .... .................... 16 J . NextSteps ................................................. . ....... .. ........ . ......... ... ................ ..... ..... . ....... .... .................. .... .............. .... l8 

### II. BIBLIOGRAPHY . . ... ...... .. .. .. . .... ....... . ... .. . .... ....... .. ... ...... ... . ... . ... . . .. ........ .. .. . ... .. ........... ... ...... . .. .. . ... ... 1 9 A. Studi es S upp o rtin g Registration Review o f Aspergillus jlavus st rain AF36 .................................................. 19 B. U.S. E n v ir o nm e n ta l Protec ti o n Agency Ri sk Assessme nt Me mo r an d a ........................................................... 24

2Aspergillus flavus EPA-HQ-OPP-20 15-0281 www.reg ulations .gov 

## ACRO NYMS A ND ABBREVIATIO NS BPPD The EPA 's Biopesticides and Pollution Prevention Division CFR Code of Federal Regulation s DCI Data Call- I n EDSP Endocrine Di srup tor Screening Progra m EPA U.S. Environmental Protection Agency FFDCA Federal Food, Drug, and Cos metic Act FIFRA Federal Insecticide , Fungicide , and Rodenticide Act FQPA Food Quality Protection Act FR Federal Regi ster FWP Final Work Plan IDS Incident Data System MRID No. Master Record Identification Number: The EPA's sys tem of recordi ng and tracking studies submitted to the Office of Pesticide Pro grams. MRL Maxim um Re s idue L imit OPP The EPA · s Office of Pesticide Program s PC Code Pe s ticide chemical code: a six-digi t number assigned by OPP to identify pesticide chemicals. PMRA He alth Canada 's Pest Man age ment Re gu latory Agency PWP Preliminary Work Plan TGA I Technical grad e ofthe active ingredient TMDL Total Maximum Daily Load 

# us United S t ates

3Asp ergilfusjlav us 

### I. 

### PREL IM I

NA R Y WORK PL AN A. O v ervi ew E PA-HQ-OPP-20 15 -0 2 81 www. r eg ulation s. gov



### The docket for 

### Aspergillus jlavus (C ase 6008) is no w open , thereby initiatin g the first public comment period for this Reg i stration Review case (docket numb e r EPA - HQ-OPP-2015-0281). 

### Aspergilfusjlavus, a spec ies of fungus , comprises tw o ac tive in gre dients con tained individually in three reg is tere d products (one manufacturing-use product and t wo end -u se products) for u se as fungicides to control aflatoxinproducing fun g i o n cotton , com , pi stac hio s, a nd peanut s. Aflatoxins are naturall y occ urring mycotoxin s produced by so me strains of 

### Aspergillus jlavus and are a mong th e most carc inogenic s ub stance s known. Two of the non-aflatoxin-producing stra in s a re 

### Aspergillus jlavus AF36 and 

### Aspergillus jlavus N RRL 21882. AF36 was isolated in A ri zo na and is also found in Texas, w hi le NRRL 2 188 2 was i solated from a peanut seed in Georg ia. When applied to cotton, corn , pistachio , and peanut at the r ig ht t ime (pr e bloom) , th ese strains o f 

### Aspe r g illus jlavus are expected to di sp lace the aflatoxi n-produ cin g s trains of 

### Aspe1 gillusjlavus from th e crop and field. This Prelimin ary Work Plan ( P WP) exp lains w hat the U .S. Env ironmen tal Protection Age ncy's (EPA) Office of Pe s ticide Pro g rams kn ows about 

### Aspe r g illus jl avus, hi g h li g hts it s anticipated da t a and assessment needs , ide ntifies typ es of information th at wou ld be especia ll y u seful in conducting the review, and pro v ides an anticipated tim e line for co mpl e tin g th e Regi s tration Rev iew proc ess for thi s biopesticide. Th e Regi strat io n Revi ew pro ces s was desi g ne d to include a publi c particip ation component and by s haring this information in the docke t , the EPA intend s to inform the publi c of w hat it knows about 

### Aspe1gillusjlavus and w hat types of new data o r other information would be helpful to receive as the Agency mov es toward a dec ision on 

### Aspergillus jlavus. The EPA e ncourage s all i nteres ted stakeholders to rev iew the PWP and to provide co mments and additional inf ormatio n that will help th e E PA's deci s ion -making proc ess for this mi crob ial pe s t icide. In add iti on to ge neral areas o n whic h per so n s may wi s h to comment, there a re so m e areas ide ntified in the PWP about which the EPA specifically seeks comments and information . Intere s te d stakeho lders could include th e fo ll owing: environmental nonprofit or inte rest grou p s; pesticide manu fac turers; ag ri cu ltural labo r or commodity groups; commercial , in s tituti o na l , re s ide nti a l, and othe r users of pesticide s; or th e publi c at la rge. The PWP be g in s by desc ribing th e s tatutory and regulatory auth oritie s for Reg i s tration Rev iew. Next, it pro v ides back g round on 

### Aspe1gillus jlavus , including a descripti o n o f it s mode o f actio n , the currently r egistered pe s ticide prod uct s, application rates and met hods , u se s ite s, and toleranc e exe mption info rmat ion. Th e n , it li s ts the anticipated data needs , ri sk assess me n ts , and a projected Registrati o n Review timeline for thi s cas e. Finally, the PWP provide s g uidan ce fo r commenters , explains the next s teps EPA w ill be taking , summarizes background infonnation , and lists s upp orting studi es, risk assess ment s, and other doc ument s ava il abl e fo r the Reg is tration Rev iew of 

### Aspergiflus jlavus . Further inf o rmation about this ca se. includin g background and s upporting d oc ument s, i s av ailabl e at 

### hllp :ll www . r

e gulations. gov (und er ' ·SEARCH for: Rul es, Comm e nts, Adjudications o r S upport in g D oc ument s,' · e nter th e do c ket ident ification number, wh ich is indicated above). B. S ta tutory a nd Re g ul a tory A u thori ty 

### Th e Food Quality Protec tion Act (FQPA) of 1 996 mandat e d a R eg istrat ion Review pro gram . All pe s ticides distributed or sold in the U nited S t ates (US) must generally be re gis tered by the EP A. base d on sc ientific data s ho wi ng that the y will not cause unreaso nabl e ri s ks to hum an health o r the 4

### Asp er g illus Jlavus EPA-H Q-OP P- 20 15 - 0281 

### IVH' IV.r e g ul a ti o n

s . gov 

### env ironment when u se d as direc ted o n the prod uct labelin g. The Registration Re v i ew program i s intended to mak e sure that, as the ab ili ty to assess ri sk evolves and as policies and p rac tices change , a ll regi stered pesticides co ntinue to meet the statutory standard of no unreaso nable adverse effects to human health or the environment. Changes in scienc e , public po li cy, and pesticide u se pract ices will occur over time . Through th e R eg i s tration Rev iew pro g ram , the EPA periodically r eevaluate s pesticides to make sure th at , as change occurs , products in th e marketplace can co ntinue to be used safe ly. Informati on o n thi s program is provided on the E P A ' s webs ite. 1 

### The EPA is implem e ntin g the R eg is trat i on Rev ie w program pursuant to Federa l In sec ticide , Fun g ic ide , and R ode nticide Ac t (F IFRA ) sec ti o n 3(g) and w ill revi e w eac h registered pesticide eve ry 15 year s to determine whether it cont inu es to meet th e FIFRA st andard for regi strat io n. The regu lat ion s governing Regis trati o n Re v iew begin at 40 C .F.R . 

### § 155.40. The EPA will consider be nefit s in fo rmation and data as require d by FIFRA. The public phase of R eg is tration Revi e w be gins wh e n the initial docket is opened fo r eac h case. The docket is th e EPA' s opportunity to state what it know s about th e pest icide and w h at additional risk analyses a nd data or informat ion it beli eves are need ed to make a Reg i s tra tion Rev iew decision. After reviewi ng and respond in g to comme nt s and data recei ve d in the docket during this initial comment period, th e E PA will deve lop a Final Work Plan (F WP) and the ant icip ated sc hed ul e for the Regi s tra tion Rev iew of

### Aspergillusjlavus. 

### C. B ac k g r o und a nd R egu lato ry Information i . S umm ary of th e A ctiv e Ingredient , Usage and th e Associated P es ticide Product 

### Aspergillusjlavus stra in s AF36 an d N RRL 2 188 2 are contained in r eg i s tere d microbial pesticides. 

### Aspergillusjlavus s trai n AF36 is the active ingredient in the product , 

### Asperg ill usjlavus AF36 , a fungicide applied to co tton ju s t prior to first bloom in Arizona, Texa s, and three California countie s, to corn from the 7 leaf stag e unti l s ilkin g in Arizo na and Texa s , and to pi s tach io from late May thr o ug h early Jul y in California , Arizona , Texas, and New Mexico. 

### Asperg illusjlavus N RRL 2 1882 is th e ac ti ve in gredi e nt in the product, Alfa-Guard GR , wruch is applied t o peanuts. and corn (field corn and popco rn ) . Both products are intended to compete with s trai n s of

### Aspe r gillus jlavus th at produ ce larg e am o unt s of aflatoxin and, in doin g s o , limit the amount of these rugh aflatoxin produ cers that beco me associate d with th e crop. Both strains of 

### Aspe1gillus jlavus be long to a naturall y occurri ng g enu s of fungi, 

### Aspe1gillus , w hi c h is ubiquit ous in the envi ronment. The acute toxicity data p e rformed resulted in a classification ofToxicity Category IV for ac ute oral to x ic ity/ pathogenicity and Tox ic ity Ca tego ry III for acute inh a lation. (U.S . E PA. Biop es ticid es Reg i s tration Action Docum e nt: 

### Aspe r g illusjlavus s train AF36 (PC Code 006456) , Ju ly 3, 2003) . Furthe r in formati o n regardin g th e product s appears in Tab l e 3, below. Tab les I and 2 pro v id e summarie s of th e chemical facts for 

### Aspergillus jlavus s train AF36 an d N RRL 21882 . TABLE 1. C h e mic a l Fact s f o r 

### Asper gill u sjla vus s tr a in AF36 PC code 006456 Case Number 6008 CAS Numbe r NA Year first re.ltistered 2003 Pesticide Type Fun g icid e Chemical class Microbial

1 See hup: www.epa . gm· opnsrrd/ ; registration re1·iew. 5Asp e r g illus jlavus EPA-HQ-OPP- 2 0 15-028 1 IVIvw. r eg ulations.gov TABLE I. C hem ical Fac ts for Aspe rgillusjla vu s str ain AF36 Reregistration Eligibility Not applicable. Because it wa s reg is t e red afte r Novembe r 1984 , Asp e r g illusjlavus D ec is ion (RED) strain AF36 wa s not subject to rere_gistrati o n. Tol erance Reassessment Not applicable. Th is pesticid e is exempt from the require m e nt of a t o l

e rance for Eligibility Dec is ion (TREDl re sidues on cotton , pistachio, and com. Cumulative gro up Not applicab l e. Asperg illusjlav u s s train AF36 ha s not been id entifi ed as a m e mb er of a cumul at ive group that shares a common mechanism of toxicity. 40 CFR Citation 180.1206 No n-p es ticid a l uses NA TABLE2. C he rn ica l Fa cts for Asp e r gillus jla vu s NRRL 21882 PC code 006500 Case Number 6008 CAS Number NA Year first regi stered 2004 Pes ticide Type Fungicide Ch e mical class Microbial Reregistration Eligibili ty No t applicable . Because it wa s regi stered after Novembe r 198 4. Aspergillus jlavus D

ec i s ion (RED) s train AF36 wa s not subj ect to reregistration. To l erance Reassess ment Not ap plicabl e. T hi s p es ticid e is exempt from the r eq uire ment of a tol eran ce for Eli gibility Decision (TRED) re sidues on p eanuts and corn. Cumulative group Not applicable. Asper gill u sjlav u s. NR RL 2 1882 ha s not been identified as a member of a cumulati ve grou p that shares a common mechanism of toxicit y. 40 CFR Citation 180.120 6 Non-pesticidal u ses NA TABLE 3. Information About the Currently Regi s tered Aspergillusjlavus Pes t icide Product s EPA Product Name Registr atio n (%Active Date Application Application Use Sites

Numbe r Ing r edient; R egistered Rates Methods Formu lation Type) Cotton in Ari zo na. The fungus is Texas, and grown on s t e rile Californi a I0 pounds per wheat see d. which (Imperial , acre of cotton: is applied to the Ri ve rs id e, and San Aspergillus jlavus Jul y 23, I0 p ounds per surface of th e soil Bernardino 7 169 3 -1 AF36 (0.0008% AI ; acre of com ; und e r the plant co unti es only): g ranular) 2003 and I0 pound s canopy with a com in Ar i zo na per acre of tractor-mounted . and Texas: and pi s t ach io g ranular app licator pis ta chio in o r by ae rial Calif o rni a , application. Arizona. Texas, a nd New Mex ico.

6Aspergillus jlavus

Aspergillus jlavus May 28, I 00-1468 NRRL21882 2004 (94% A I )

Alfa Guard GR September I 00 -1 469 (0.0094% A I: g ranular) 17,2004



### ii. To l e ranc e Ac ti ons NA

I0-20 pounds

per acre of com: and 20 pound s per acre of peanuts EPA-HQ-OPP-20 15 -0281 www. r eg ulations.gov

For manufacturing NA or formulating use only

Ground or aerial Peanuts: com (fie ld com and application popcorn)



### An exemption from the r equirement of a tolerance is established for re sid ues of the m icrobial pesticide 

### Aspe1gillusjlavus AF36 in or on cotton , gin byproducts; cotton , hulls ; cotton , meal ; cotton , refin ed oil; and cotton , undelinted seed. An exemption from the requirement of a to l erance is estab l ished for residues of Aspergillus flavu s AF36 in or on com, field , forage; corn , field , grain ; com , field , stover; corn , fiel? , aspirated grain fractions; com, sweet, kernel plus cob with husk remov ed; corn , swee t , forage ; com , sweet, stover; com , pop , grai n ; and com , pop , stover, when applied/used as an antifungal agent. An exemption from the requ i rement of a to lerance is established for re s idues of

### Asp e, g illusjlavus AF36 in or on pistachio when applied as an antifungal agent and used in accordance with good agricultural practices. (40 CFR § 180 . 1206 Asperg ill us flavus AF36 ; exe mption from the requi r ement of a to lerance) An exemption from the requirement of a tolerance is established for residues of

### Aspe1gillus jla v us NRRL 21882 on peanut; peanut , hay ; peanut , meal ; and peanut , refined oil. An exemption from the requirem ent of a tolerance is established for re s idues of

### Aspetgillus jlavus NRRL 2 1882 on corn , field , forage ; corn , field, strover ; corn , field , aspirated grain fractions; corn , sweet , kernel plus cob w ith husk removed ; corn, sweet forage; com , sweet, st ro ver; corn, pop , grain; and corn, pop , strover. (40 CfR 

### § 180 . 1254 Aspergillus tlavus NRRL 21882; exemption from the requirement of a tolerance) 

## D. A nti c i pa te d D ata Nee ds and Ri s k Assess m e nt s Provided be l ow are tab les of the current data requirements for microb ia l pesticides as se t forth in 40 CFR 

### § 158 , subpart U. They are arrayed by scientific discipline ( i.e. , product chemistry, human health assessment , and nontarget organi s ms and environmental fate ), and descriptions are included regarding 7Asp e rgillus flavus EPA-HQ-OPP-20 15-028 1 www. regulations.gov 

### how the data requirements have been fulfilled or where data have been waived. At this t ime, no data gaps (anticipated data needs) for 

### Aspergi llusjlavus have been ide nt i fied. The most rec en t comprehensive r isk assessment for 

### Aspe r gillus jlavus strain AF36 was comp leted on July 3 , 2003, in support of the first registration of 

### Aspergiffusjlavus strain AF36, which occurred on July 23, 2003, all owing i t s u sc on cotton i n specific s t ates and Ca lifornia counti es. Additi o nal data were submitted to s upport the use of

### Aspe 1 gillus jlavus strain AF36 on corn and pistachio. An 

### amendment to the registration to allow its use o n pistachio in certain s t ates was granted on October 10. 2006, and an amendment to allow its use on corn in specific states was granted on March 9 , 201 1 . Because there are no data gaps for 

### Aspergillusjlavus s train AD6 , the Agency does not anticipate the need to conduct a new risk assessment during registration review. Nevertheless, the EPA plans to conduct a literatur e searc h to update its unde r stan d ing ofthe c urrent state of the science o n thi s pesti c i de and will consider the need to conduct a new risk assessment depending on the findings. 

### Prod uct Ch e mistry (40 C. F.R. 

### § 158.2120 1 TABLE 4 . Summ a ry of Produ ct Ch e mi s t ry Data f o r As p e r g illus jl

av

u s st r a in AF3 6 H as D ata H a rmonized R equ ire ment MRID / Access io n N umb e r o r Other G u id e lin e D a ta R equirem e nt B ee n , S ou r ce R e fere n ce Numb e r Addresse d? How ? 885.1100 Produ c t Identity Yes: Study U.S. EPA (2003) 4376634 -0 I U.S. EPA (2003) 437634-0 I 885.1200 Manufacturing Proc ess Yes: Study 445970-01 447137-01 Deposition of a Sample 885. 1250 in a Nationally Ye s : ATTC U.S. EPA (20 1 3) Depo s it No. 96045 Reco gn ized Culture Collection Discussion of Formation U.S . EPA (2006) 437634-02 885.1300 of U nintentiona l Ye s; S tudy 44626 1 -0 I Ing redient s 468595-0 I 446261-01 885. 1 400 Analysi s of Sample s Yes: Study U.S. EPA (2006) 439724-03 468595-0 1 885.1500 Ce rtifi cation of Limits Ye s: Study U .S. EPA (20 06) 446261-01



### 8Aspergillus jlavus EPA - HQ-OPP-20 15-0281 www. r egul at ions .gov TABLE 5. Summary of Ph ysica l and Chemical Characteristi cs for Aspergillus jla vu s strain AF36 Has Data Harmonized Requirement MRlD/ A ccession Number or

Guideline Data R e quirement Been Source Other Reference Number Address ed? How? 830.6302 

# I Color Yes; Study 

# I U.S. EPA (2003) 437634-0 I 830.6303 Physical State Yes: Study U.S. EPA (2003) 437634-0 I 830.6304 Odor Yes; Study U.S. EPA (2003) 437634-01 830.6317 Storage Stabi l ity Yes; Study U . S. EPA (2007) 468595-0 I 830.6319 Miscibility Yes: Study U.S. E PA (2007) 468595-0 I 830.6320 Corrosion Yes ; Study U.S. EPA (2007) 468595-0 I C haracte r istics 830.7000 pH Yes: Study U.S. EPA (2007) 468595-0 I 830.7100 Viscosity Yes ; Study U.S. EPA (2007) 468595-01 830.7300 Dens ity/ r elative Yes ; Study U.S. EPA (2007) 468595-0 I den si t y/b ulk den si ty 

### Toxicolo gy (40 C. F. R. § 

### 158 .2050) TABL E 6. Summary of Toxicology Data for A spergillusjlavus strain AF36 Harmonized Ha s D ata

Guideline D a ta Requirement R e quirement S ourc e MRJD/ Acc ession Numb e r or Been Address ed? Other Reference Number How? 885.3050 Acute Oral Toxicity / Yes , Study U.S. EPA (2003) 439724-03 Pathogenicity Acute Pulmonary 457391-0 1 885.3150 Yes; Study U.S. EPA (2003) 457981-01 Toxicity / Pathogenic ity 457982-01 Yes; Data wa ived 439724-03 Acute Intravenous 457391-0 I 885.3200 Toxicity / Pathogenicity based on scientific U.S. EPA (2003) 457981-01 rational e 457982-0 I Hypersensitivity Yes; Data waived based on sc ienti fic BPPD Review of Data Waiver 885.3400 rat ionale. Any futu re hypersensitivity Incidents incidents should be reported per OCSPP Requests ... May 22 , 2003 Guideline 885.3400. 885.3500 Cell Culture Not applicable. 9Aspergillus jlavus

Harmon ized

Guideline N umb er 870 .11 00 885. 3 100 870. 130 0 870. 2400 870.2500

H a rmoni zed

Guideline N umb e r 885.4050

885.4 1 00 885.4150 885.4 200 8 85.4240 885.4 280 EPA -H Q-OPP-20 15 -0281 www. reg ulations.gov TABLE 6 . S umm ary of T ox i cology D ata for As p e rgillusjlavus st r ain AF36 Ha s Data D a ta Requirement Requirement So urce MRID/ Accession N umber or Been A ddressed? Other Reference H ow? Yes: Data wai ved BP PD Re v iew of Dat a Wa iver Ac u te Oral Tox icity base d o n sc ienti fic U.S . EPA (2003) R equ es ts . . . May 22, 2 003 r ati onal e Yes: Data waived B PPD Review of Data Waiver Acute Dennal Toxicity ba se d on s cientific U .S. EPA (2003) Requests ... May 22, 2003 rationale Ac ute Inh alati on Y es; Data wai ved B PP D R ev iew o f Dat a W a ive r Tox ic i ty base d o n s ci entifi c U.S . EP A (20 03) R eq ues ts . .. May 22, 2003 ration ale Ye s: Data waived BPPD Review of Data Waiver Acute E ye I rritation ba sed on scien t ific U.S. EPA (2003) Requests ... May 22, 2003 r ationa l e Prim ar y D e rm al Y es; Data wai ve d B PP D R ev iew of Dat a W aiver Irritation ba s ed on sc ient ifi c U.S . EP A (2003) R e que s ts . .. May 22. 2003 rationale 

### No ntarg et Organisms a nd E nvironment a l Fate (40 C .F . R. 

### § 158 .2 060 ) TABLE 7. Summary of Nonta r ge t Organisms Data for Aspe r gillu s jlavus st r a in AF36 Bas Data R e quire me nt MRJD/ Accession D a t a Requirement B een Addressed? So urce Number or Other Bow ? Reference 437634-03 437634 - 05 444642-02 A v i a n Oral Tox ic it y Y es: Data wa ived based U.S. E P

A (2003) 444526 -1 5 on s c ien t ifi c rationa l e 

# . 457391-03 453072-0 I 453072 - 01 45798 1 -02 Avi an Inh alatio n Yes; S tu dy U.S . E PA (2003) 45798 1- 02 Tox iciry/Patho ge niciry Wild Mammal Toxicity/ Not applicable: No testi ng expected to be required. Results of the Tier I toxicity tes ts required by 40 CFR § 158.2140 (Tab l e 5) are adequate and Pathoge ni c i ty a ppropriate f o r assess m e nt of hazard s. Fres hwate r Fish Toxic i ty

/ Ye s : Data wa iver ba s ed 437634-03 Pathogenicity on sc ientific rationale U.S. E P

A (2003) 437634-05 453072 - 01 453072 -02 F

resh w at

e r I nve rt ebrate Yes: Da t a wa iver based B PP D R ev ie w of Tox ic ity / Pathoge ni c i ty on scie nti fic r ati o nal e U.S. EP A (2003) Dat a W aive r Reque s ts ... May 15 . Es tuarine And Marine Y es: Data waiver based U.S. EPA (2003) 2003 Inverteb rate Tes ting on scie ntific rationale 10Aspergillus jlavus

H a rm o niz e d G uid elin e N umbe r 885.4300

885.4340 885.4380 EPA - HQ-OPP-20 1 5 - 0281 w 1

vw. r egul at ions .gov T ABL E 7 . S umm a r y o f Nonta r ge t Or ga ni s ms D a ta f or As p e r g illusjl a v

u s s t ra in A.F36 Ha s Dat a R equire me nt M RID / Acc ess io n D ata Require m e nt B ee n Addres s e d ? So ur ce Numb e r o r O t h er Ho w ? R e f e ren ce BPPD Review of Nontarget plant Ye s: Data waiver based U.S. E PA (2 00 3) Data Waiver Tes ting on scientific rationale Requ es t s ... Ma y 15. 2003 437634 -03 437640 -05 ontarget in sect te s tin g Yes; Data waiver based U.S. E PA (2003) BPPD Review of on scientific ratio n ale Data Waiver R

equests ... Apri l 29 .2003 Hone y bee te s tin g Yes ; S tud y U.S. E PA (2 003 ) 457391 - 02 

### The most recent comprehensive risk assessment fo r Aspe1gillus jlavus 

### NRRL21882 was co m pleted on May 24, 2004 , in support of the fi rs t reg istration of A .

spergillus jlavus 

### NRRL21882, which occurred on Septe mber 17 , 2004. The end - use pro d uct, Alfa - Guard G R , was co nd iti o na ll y reg i ste red o n Sep te mb er 17 , 2004 , all ow ing its u sc on pea nuts. Because there are no data gaps for Asper gillusjlavus 

### N RRL21882 , the Agency does not antic ipate t he need to condu ct a new ri sk assess me nt duri ng r eg i strat io n review. Neve rth e l ess, th e E P A pl an s t o conduct a literature search to u pdate its under stand i ng of the c urrent state of the sc ience on th is pes ticide and will con s ider the need to conduct a new risk asses s ment d ep ending on the fi ndin gs . 

### Produ ct C hemi s try (40 C.F. R. 

### § 158 . 2120} TABLE 8 . S umm a r y o f P rod u ct Ch emi s try D ata fo r A s p e r gi

l / u sjla v u s NRRL 2 1 8 8 2 H a s Data Ha rm o nized R eq u ir e me nt MRID/ Ac ces s io n Nu mb e r o r O t he r G uid elin e D a ta Require m e nt Be e n Sour ce Re f e r e n ce Numb er Addr ess ed ? H ow ? 885.1 1 00 Product Iden ti ty Ye s; S tu dy U.S . EPA (2004) 458840-0 I 46 1968-0 I 885.1200 Manufacturing Process Yes: Study U.S. E PA (2004) 458840-01 461968-0 1 Deposition of a Samp le 885.1250 in a Nationally Yes: RRL U. S. EPA (2004) Dep os it 0.21882 Recogn ized Culrure Collection Disc u ss io n of Fo rm ation U.S. EPA (20 04) 458840-0 1 885.1300 of Unintentional Ye s: S tudy 461968-01 Ing red ients I IAspergillus flm , us EPA - HQ-OPP-20 15-0281 www.regulations.gov TABLE 8. Summ a ry ofPr odu ct C hemi s t ry D a ta for 

### A s p e r g illusjla v u s NRRL 21 8 82 Has Data Harmoni ze d Requirement MRID/ Access ion Numb e r or Other

Guid elin e Data Require ment B ee n S ource R e ference Numb e r Addresse d ? How? 458840-0 I 885.1400 Ana lysis of Samp les Yes: Study U.S. EPA (2004) 461968-0 I

885.1500 Cer1ification of Limit s Yes ; Study U.S. EPA (2004) 461968-0 I

TABLE 9. S ummary of Ph ys ical and C he mica l C haract e risti cs for 

### As p e r g illusjl av

u s NRRL 2 1 882 Ba s D a ta H a rm o nized R e q u irement MRID/ Accession Number or Guideline Number D a ta Requir eme nt Be en Source Other Reference Addres sed? Bow? 830.6302 Color Yes; Study U.S . EPA (2004) 

# I 461968-01 8 30.63 03 Physica l State Ye s : Study U.S. EPA (2004) 458840 -0 I 461968-01 830.6304 Odor Yes: Study U.S. EPA (2004) 458840-0 I 461968-0 I 8 30.63 1 7 Storage Stability Ye s; Study U.S. EPA (2004) 458840-0 I 46 1968-0 I 830.6319 Miscibi l ity Yes: Study U.S. EPA (2004) 46 1968-0 I 830.6320 Corrosion Yes: Study U.S. EPA (2004) 461968-01 Characte ri stics 8 30.70 00 pH Y es; S tu dy U.S. E PA (2004) 461968-01 830.7100 Visco sity Yes; Study U.S. EPA (2004) 46 1968 - 0 I 830.7300 Densit y

/ relative Yes; Study U.S. E PA (2004) 461968-01 density/bulk density

12Asper gillus flavus

Ha rm o ni zed

G uide lin e N umb e r 885.3050 885.3 150 885.3200 885.3400 885.3500 870.1100 885.3100 870.1300 870.2400 870.2500

H ar mo nized

G uid e lin e N um be r 885.4050 885.4100 EPA-HQ-OPP-201 5-028 I www. r eg ul a tions.gov 

### To xic o l ogy (40 C. F. R. 

### § 158.2050 ) TABLE 10 . S umm a ry of Toxico logy Da t a for As p er gillu sjla v us NRRL 2 1882 H as D ata D ata Re quirement R e quirem e nt So urce M RID/ Accessio n N umb er or B ee n Addresse d ? O the r R ef e re nce Ho w? Acute Oral Toxicity / Ye s, St ud y U.S. EPA (2004) 461968-02 Pathogenicity Acute Pulmonary Ye s: S tud y U.S . EP A (2004) 455840-03 Tox ic it y/Pa tho ge ni city Acute Intr avenous Yes: Study U.S. EPA (2004) 458840-04 Toxicity/ Patho genicity 462239-0 I Y

es; Data waive d ba se d on scien tifi c H

yp erse ns itivity rati o nal e . Any future h yp ersens iti vity 461968-04 Incident s incident s should be reported per OCSPP Guideline 885.3400. Ce ll Culture No t app licabl e. Acute Oral Toxicit y Yes; Study U.S. EPA (2004) 458840-03 Ye s; Data waived 45 884 0 -02 Acute Dermal Tox ic i ty based o n scie nti fie U.S . EPA (2004) 458840-03 ra t ionale 461968-02 Acute Inhalation Ye s; Data waived Toxicity based on scientific U.S. EPA (2004) 458840-03 rationale Ye s; Data wa iv ed 45 88 40-02 Acute Eye I rri t ati o n based on sc ientifi c U.S. EPA (2004) 458840-03 rationale 461968-0 2 Primary Dermal Ye s : Data waived 458840-02 based on scientific U.S. EPA (2004) 458840-03 Irritation ration ale 461968-0 2 

### No nta r ge t Or ga ni s m s a nd E nv i ro nm e n tal F ate (4 0 C.F. R. 

### § 158 . 2 0 6 0 ) T AB L E 11 . S umm a r y o f No nt a r

get O r ga ni s ms Da t a f o r As p er g i/l us

jl

av

us N RRL 21 882 H as Data Re quire me nt MRID/ A ccess i on D ata Req uirement Bee n A dd ressed ? S ource N umb e r o r Other Ho w? Re f e r

e nce Avi an Oral Toxicity Yes : Study U.S. EPA (2004) 462407-01

Av ian Inhalation Yes; Study 

# I U.S. EPA (2004) 

# I Tox icity/Pathoge nicit y 458840-05 1 3Aspergillus jlavus

H ar monized

Guideline Number 885.4150 885.4200 885.4240 885.4280 885.4300 885.4340 885.4380 

## E. E PA-HQ- OPP-20 I 5 - 028 I www.regulations.gov TABLE 11. Summary of Nontarget Organi s m s Data for 

### Aspergillus jlavus NRRL 21882 Ha s Data Requirement MRID/Accession Data Requi r ement Been Addre ssed? Source Number or Oth e r How? Reference Wild Mammal Toxicity / Not applicable: No te s ting expected to be required. Results of the Tier I Pathogenicity toxicity test s required by 40 CFR § I58.2 I40 (Table 5) are adequate and appropriate for assessment of hazards. Freshwater Fish Toxicity / Yes: Data waiver based U.S. EPA (2004) Pathogenicity on scie ntific rationale BPPD Review of Data Waiver Fre shwater Invertebrate Yes: Data waiver based Reque sts ... May 6. Toxicity / Pathogenicit y on scientific rationale U.S. EPA (2004) 2004 Estuari n e And Marine Yes: Data waiver based U.S. EPA (2004) In vertebrate Testing on sc ientific rationa le BPPD Review of

Nontarget plant Yes; Data waiver based U.S. E PA (2004) Data Waiver Testing o n sc ie ntifi c r a ti o nal e R eq uests ... May 6 , 2004 BP PD Review of Nontarget insect te s ting Yes; Data waiver based U.S. E PA (2004) Data Waiver o n scienti fie rationale R eq u ests ... Ma y 6.

2004 Honey bee testing Yes: Study U.S. EPA (2004) 45884006 46196806 

### Ri s k to Threatened and Endangered S p ec ies One no n-afl atox in -produc in g stra in of

### Aspergillus jlavus, AF36, was isolated in Ar izo na and i s a lso found in Texas. When applied to cotto n , corn , or pi stac hi o at the ri ght time (preb l oom) , 

### Aspergillus jlavus strain AF36 is expected to disp lace the aflatox in-producing strains of

### A. jlavus from the crop and field. Data submitted, either as studies or as scientifi c rationale in support of the eco log ical ri sk assessment at the time of r egistra tion , demon strated that adverse ef fects to t e rrestrial and aquatic nontarget organisms are not expected. The second stra in , NRRL 2 188 2, was isolated in G eorg i a. When app lied to peanuts o r corn, 

### Aspergillus jlavus N RRL 2 1882 also is expecte d to di sp lace the aflatoxin-produc ing strain s of 

### A. jlavus from the crop and field. Published literature searches conducted by the reg is trant for data waiver justifications found no relevant reports of adverse effects on wildlife. The combined evidence of literature ci tations provided by th e reg is tra nt , produ ct formu lat io n , appl icat ion, u sage on peanut s, and a lack of publi s hed reports of adverse effects on wi ldli fe indi cate that exposure to A l fa- Guard G R s h o uld have no measurable adverse effects on endangered spec ies . The EPA anticipates n o effects to federally-listed threatened or en dangered sp ec ies; however, th e EPA plans to conduct a literature search to determine whether any additional nontarget effects of

### Aspergillus jlavus may have been reported s in ce they were previousl y assessed at the times of registration. Based on 14A:!!p e r g illusjlavus 

### EPA -HQ- OPP-20 15-0281 www.r e gulations. gov 

### the data submitted to support the registrat ion s and additional findings from the literature , if any. the EPA will conduct an assessment and make a determination o n potential effects to listed spec ies and designated critical habitat during Registration Review. 

### F. Endocrine Effects As required by the Administrator under the Federal Food , Drug , and Cosmetic Act (FF DCA) section 408(p) , the EPA has developed the Endocrin e Disrupter Sc reen ing Pro g r a m (EDSP ) and has begun to impl e me nt the screening program that is to be used to test all pesticide s in order to determ ine whether certain substances ( including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a · ' naturally occurring estrogen. or other such endocrine effects as the Adm inistrato r may designate." ' FFDC A sec tion 408(p)(4) authorizes the Administrator, by order, to exempt from the r equ ir ements of the Estrogenic Substances Screening Program a biologic substance or other substance if a determination is made that the substance is not ant ic ip ated to produce any effect in humans sim ilar to an effect produced by a naturally occurring estrogenic substance. Betwee n October 2009 and February 2010, the E PA issu ed te st orders/ data call-ins for the first g roup of 67 chemicals , which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified for E D SP screening was published o n June 14 , 20 13 ,2 and includes some pesticides scheduled for registration review and chemicals found in water. 

### Aspe r gillusjlavus stra in AF36 and 

### Aspe r gillusjlavus 

### NRRL 21882 are not among the group of pesti c id e active ingredi e nts on the li sts to be sc re ened under the EDSP. The EPA , as part of thi s Preliminary Work Plan , believes that 

### Aspergillus jlavus is a substance that wou ld not likely produce any effect in humans s imilar to an effec t produced by a natura lly occurring es tro ge ni c substance. As such , pursuant to Sect io n 408(p)(4) , the E PA will determin e in the future w hether it can exempt 

### Aspergillusjlavus from the requirements of the Section 408(p) EDSP. In the event the EPA does determine to exempt this subs tan ce from the EDSP. an order will be issued. For further information on the statu s of the EDS P , the policies and procedures, the li sts of chemicals, future li sts , the test guide l ines and the Tier 1 sc r ee ning battery, p l ease visit our website at 

### h tt p:

//

wwll'.e pa.gov /

endo l. G. Incident s From Jul y 23, 2003 through April 20 , 2015 , the Office of Pesticide Programs' Incid ent Data System and Ecological Incident I nformation System indicate that there were no reports of adver s e effects to humans or the environment from use of the pesticide p roduct containing 

### Aspergillus jlavus strain AF36 as its active ingredient. There were reports of three inc idents of minor exposure to humans who came into contact with A l fa Guard GR , which contains 

### Aspetgillus jlavus NRRL 2 1882 as an ac tiv e ingredient. The EPA will consider any additional incident data or comments submitted in response to this Preliminary Work Pl an.

2 Sec http : //w\\ \\ " .rcgulation s. gov/# !documcntDc t aii:D = EPA-IIQ-OPPT- 2009-0.J77-0074 for the s econd li s t of chemica ls. 15Asp erg illusjlavus 

### H. Timelin e EPA-HQ-OPP-20 15-0281 www. reg ulations.gov 

### Below is the projected timeline for Reg istrat ion Review case 6008: 

### Aspergillus jlavus. Activities Es tim ate d Month/Year Opening the Docket 

# - Open Docket and 60-Day Public Comment Period for 

### Aspergillus jlavus Jun e 2015 strain AF36 Close Public Comment Period August 2015 

### Case Development , 

# . ·• 

### Issue Fina l Work P lan November 2015 Issue Data Call-in N/ A Data Submission N/ A Open 30- Day Public Comment Period for Draft Ri sk Assessments N/A Close Public Comment Period N IA 

### Registration Review Decision 

## ., Open 60-Day Public Comment P eriod for Pr oposed Registration Review January 2016 Deci s ion Close Public Comment Period March 2016 Final Decision May 2016 

## •Es timated Total (years) 1 year

.. 

## * Th1s sc hedule IS s ubject to rev1s1on should unforeseen 1ssues anse durmg th e reg1strat1on rev1ew proce ss. In the event that an iss ue arises , such as the failure to acquire an EDSP exemption or the need to further analyze ecologica l risk ba sed on an updated literature review , then the EPA would issue an amended Fina l Work Plan. That Final Work Plan would iden t ify any newl y anticipated data needs and set forth a new timeline. 

### I. 

### G uidanc e for Commenters The public i s in v ited to comment on the E PA" s Preliminary Work Plan and rationale. The areas be low highl ight topic s of special interest to the EPA whe re comments, infonnation and data, or reference to sources of additional inf ormati on cou ld be of particu lar use. The EPA will cons ider all comments , as well as any additional information or data pro v ided in a timely manner , prior to issuing a Final Work Plan for this case. i. 

### E nvironmental Justice The EPA seeks to achieve environmental justice , the fair treatment and meaningful involvement of all people , regardless of race , color , n at ional ori g in , or income, in the development , implementation , and enforcement of environmental laws , regulations , and policies. To help address potential environmental justice issues , the EPA seeks information on any groups or segments of the population who, as a result of their location , cultural practices , or othe r factors, may have unusually hjgh exposure to the pesticidal u se of

### Aspergillus jlavus compared to the gene ra l population. 

### Please co mment if yo u are awa re of a ny s ubpopul ati o ns th at may h ave aty pical , unu s uall y hi g h ex po s ure compared to the ge n e ral population . 16Aspergillus Jlavus



### ii. Water Quality E PA-HQ-OPP- 20 15-0 28 1 www.regulations.gov 

### Aspe1gillus jlavus is not identified as a cause of impai rment for any water bodies listed as impaired under sectio n 303(d ) of the Clean Water Act. 3 

### In addition , no T o tal Maximu m Daily Loads (TM DLs) have been d eve loped fo r 

### Aspe 1 g illusjlav us . 4 

### More info rm ati on on impaired water bodi es and TMD Ls can be found at the EPA's we b si te. 5 

### The EPA in v ite s s ubmi ss ion o f water quality d ata for this p es ti c id e. To th e extent possib le , data should co nf orm to the quality standards in A p pe ndix A of the 

### Office of Pestic ide Pr ograms (OP P) Standard Operating Procedure: Inclu sion of Im pa ir e d Wa te r Bod y and Other Water Quality Data in OPP 

### 's Reg i s tration R ev i ew Risk Assessment and Management Proc ess6 

### to ensure th ey can be u sed quanti tative ly o r qualitatively in p esti c id e risk assessme nt s. 

### iii. Trade Irritant s Throug h the Registration R ev iew process, th e E PA intends t o solicit information on trade irritants and , to the ex te nt feasible, take step s toward facilitating irritant resolution. Th e EP A w ill work to harm o ni ze tolerance and inte rn ational Maximum Residue L imit s ( MRLs) and , if nec essary , may modify t o le rance levels to do so. 

### G row e rs and other s takeho ld e rs are as ked to co mment on any trad e irritant i ss ues resu lting from lack of MRLs o r dispa riti es between U.S. tolerances and MRLs in key ex p ort m arkets, providing as much specific it y as possible regarding the nature of th e conc e rn. P estici d al food-use is not a llo wed. as exp li c itl y stated on the subject product labels, and there is no approved tolerance or exemption from the requ ireme nt of a tolerance for re s idues of th is pesticide found in o r o n food o r animal feed. Mor eover, th e re a re no known MRL s fo r 

### Aspe r gillus jlavus. Therefore , th e E P A doe s n o t anticip ate th at current uses of 

### Aspe r g illusjlavus w ill pose concerns as trade irritant s. 

### iv . Add iti o na l Information Stakeho lde r s are a lso spec ific all y aske d to p r ovide info rmati o n and data that w ill ass is t the EPA in refining the ri sk assessmen t s . The E P A is int erested in obtaining the following information regarding 

### Aspergillus jlavus : }> 

### Additional incident data .

.,.. Confirmation on the follow in g labe l inform atio n :



### - S ites of appli ca tion -Fo rmulat ions -Application m ethods and eq ui pment

- Maximum appli cation rates -Frequency of appli ca tion, appli cation interv als, a nd ma x imum numb e r of appli cation s

- Geograph i c limitations on use

.,.. Use or potential use distribution (e.g., ac reage and geograp hic al d istrib ution of relevant use s it es)

3 Based o n information provided at ltup: ' lfii ' W . epa . gov owow tmd/ . 4 Based on information provided at ltup:

**iasrmh epa**  **go~·tmdl** waters/0 text searclumd/ search form . 5 Sec l111p : ,, · ww. epa . gm· ow ow tmdl . 6 TI1i s document can be found at h11p: Wll'w . ena.gov O(Jpsrrdl registratio11 re1·iew wafer qualitv soo.hrm. 1 7Asp ergillusjlavus 

### E PA-HQ-OPP-2015-0 28 I www. reg ulations.go v



### .,.. Median and 90 1 h 

### percentil e reported use rates ( lbs active ingredient/! , 000 square feet) from usage data - national , state, and county

.,.. App li ca tion timing (date of frr st app li ca ti o n and application inte rva ls)- national , s tate , and coun ty

.,.. Usage/ us e information fo r nona gric ultur al u ses

.,.. Typical application inter val ( days)

.,.. S ta t e or local u se re s triction s

.,.. Monitorin g d ata J. 

### Next Steps A ft er the 60-day comment peri od closes , the EPA wi ll rev iew and respond to any comments r eceived in a tim e ly mann e r and then issue a Final Work Plan for case 6008: 

### Aspergillu s.fl avu s.

18As p erg illusjla vus 

### ll. BIBLIOGRAPHY EPA-HQ-OPP-20 15-02 81 www. reg ulations.go v 

### A. Studies S upportin g Regi stration Review of

### Aspergillus jlavus 43763400 USDA/ARS and IR-4 (1995) Submission of Product Chemistry , Toxicity , and Risk Data in Support of an Expe rimental Use Permit for Aspergillus flavus AF36 . Transmittal of 5 Studies . 43763401 Cotty , P . (1995) Aspergillus flavus Isolate AF36 --Product Identity and Disclosure of Ingredients. Manufacturing Process and Discussion on the Formation of Unintentional Ingredients: Lab Project Number : PR 528. Unpublished study prepared by USDA/ARS . 85 p. 43763402 Cotty , P . ( 1995) Aspergillus flavus Isolate AF36--Analysis of Samples , Certification of Ingredien t Limits , Analytical Methods for Certified Limits , and Physical and Chemical Properties : Lab Project Number : PR 528. Unpublished study prepared by USDA/ARS. 8 p . 43763403 Cotty , P .; Hartman , C . (1995) Aspergillus flavus Isolate AF36--Safety Data in Support of Petition Proposing a Temporary Exemption from the Requirements of a Tolerance for Aspergillus flavus for Use in Cotton Production : Lab Project Number : PR 528 . Unpublished study prepared by USDA/ARS and IR-4 . 882 p . 43763404 Cotty , P . (1995) Aspergillus flavus Isolate AF36 : Hypersensitivity Incidents with Microbial Pest Control Agents : Statement of Finding No Hypersensitivity: Lab Project Number : PR 528 . Unpublished study prepared by USDA/ARS . 4 p . 43763405 Cotty , P .; Hartman , C . (1995) Aspergillus flavus Isolate AF36 : Product Performance Data : Lab Project Number: PR 528 . Unpublished study prepared by USDA/ARS and IR-4 . 145 p. 43972400 Interregional Research Project No . 4 (1996) Subm ission of Product Analysis and Toxicology Data in Support of an Exper imen tal Use Permit for Aspergillus flavus AF36 . Transmittal of 3 Studies . 43972401 Cotty , P . (1996) Aspergillus flavus Isolate AF36--Analysis of Samples , Certification of Ingredient Limits , Analytical Methods for Cert ified Limits: Amendment No . 1 to MRID No . 43763404 : Lab Project Number : PR 528: 528. Unpublished study prepared by Southern Regional Research Center , USDA/ARS . 6 p. 43972402 Cotty , P . (1996) Aspergillus flavus Isolate AF36 : Hypersensitivity Incidents with Microbial Pest Control Agents : Statement of Finding of No Hypersensitivity: Amendment No . 1 to MRID No . 43763404 : Lab Project Number: 528 : PR 528. Unpublished study prepared by Southern Regional Research Center , USDA/ARS . 4 p . 43972403 Shelton , L. ( 1996) Acute Oral Toxicity Study in Rats : (Asp erg illus flavus AF36 ): Final Report : Lab Project Number : M96AG84 . 6G31 : MA M96AG84 . 6G31 . Unpublished study prepared by Microb iologica l Associates , Inc. 59 p . 43990000 Interregional Research Project No . 4 ( 1996) Submission of Product Chemistry Data in Support of the Application for Exper imental Use Permit for Aspergillus flavus AF36 . Transmittal of 1 Study . 43990001 Cotty , P . (1996 ) Aspergillus flavus Isolate AF36--Product Identity and Disclosure of Ingredients , Manufacturing Process , and Discussion on the Formation of Unintentional Ingredients : Amendment No . 1 to MRID 43763401 : Lab Project Number : PR 528 . Unpublished study prepared by USDA/ARS , Sou t hern Regional Research Center . 6 p . 44597000 Interreg i onal Research Project No.4 ( 1998) Submission of Product Chemistry Data in Support of the Petition for Tolerance of Aspergillus flavus isola te AF36 in/on Wheat. Transmittal of 1 Study . 44597001 Cotty , P .; Antilla, L. (1998) Aspergillus f l avus Is olate AF36 Manufacturing Process and Discussion on the Formation of Unintentional Ingredients. Amendment No . 2 MRID 43763401 : Lab Proj ect Number : 528 . Unpublished study prepared by USDA/ARS , Arizona Cotton Research and Protection Counc i l and Rutgers Univ . 38 p . 19Aspergillus jlavus EPA -HQ-OPP-20 15-0281 ww1v. r eg ul at ions.gov 44626100 Interregional Research Project No . 4 (1998) Submission of Product Chemistry Data in Support of the Petition for Tolerance of Aspergillus flavus isolate AF36 in/on Cotton . Transmittal of 1 Study . 44626101 Cotty , P .; Antilla , 

### L. (1998) Aspergillus flavus isolate AF36-Analysis of Samples , Certification of Ingredient Limits, Analytical Methods for Certified Limits : Amendment No . 2 to MRID No . 43763402 : Lab Project Number : 52B . Unpublished study prepared by USDA/ARS , and Arizona Cotton Research and Protection Council. 33 p . 44 713700 Interregional Research Project No.4 (199 8 ) Submission of Product Chemistry Data in Support of the Petition for Tolerances of Aspergillus flavus in/on Cotton . Transmittal of 1 Study . 44713701 Cotty , P. ; Antilla , 

### L. ( 1998) Aspergillus Flavus isolate AF36--Amended Manufacturing Process-- Amendment No . 3: Lab Project Number : 52B . Unpublished study prepared by IR-4 . 21 p . 45307200 USDA/ARS Southern Regional Research Center (200 1 ) Submission of Environmental Fate Data in Support of the Petition for Tolerance of Aspergillus flavus Isolate AF36/Cotton in/on Cotton . Transmittal of 2 Studies . 45307201 Cotty , P . (2001) Aspergillus flavus Isolate AF36 : Safety Information (Soil and Air Monitoring of Populations of A. flavus) : Lab Project Number : 52B. Unpublished study prepared by Interregional Research Project No.4 . 130 p. 45307202 Cotty , P . (2001) Aspergillus flavus Isolate AF36 Non-target Organism and Env ironment al Safety Information (Soil and Air Monitor ing of Populations of A. flavus): Lab Project Number : 52B . Unpublished study prepared by Interregional Research Project No.4. 130 p . 45739100 Interregional Research Project No . 4 (2002) Submission of Toxicity and Exposure Data in Support of the Petition for Tolerance of Aspergillus flavus on Cotton . Transmittal of 4 Stud ies . 45739101 Blanchard , E .; Carter , J . (2002) Aspergillus flavus AF36 : Acute Pulmonary Toxicity and Pathogenicity to the Rat: Interim Report : Lab Project Nu mber : UAR/006 . Unpublished study prepared by Huntingdon Life Sciences , Ltd . 86 p . {OPPTS 885 . 3150} 45739102 Mayer, D . (2001) Honey Bee F i eld Study of Aspergillus flavus AF36 in Cotton : Lab Project Number : WSU 00-011 . Unpublished study prepared by the Bee Group , Washington State University . 30 p . {OPPTS 850 . 3040 , 885 . 4380} 45739103 Smith , D .; Cotty , P .; Braverman , M .; et al. (2002) Aspergillus flavus Isolate AF36 : Non-Target Organism and Environmental Safety Information : Lab Project Number : IR-4 PR N0 .5 2B : Unpublished study prepared by Soil & Crop Sciences, Southern Regional Research Center USDA/ARS , Rutgers University and Arizona Cotton Research and Protection Counsil. 57 p . 45739104 Antilla , 

### L. ; Cotty , P .; Braverman , M . (200 2 ) Aspergillus flavus Isolate AF36 : Hypersensitivity Incidents : Lab Project Number : 528 . Unpublished study prepared by Arizona Cotton Research and Protection Council , USDA Southern Regional Research Center and Rutgers University . 18 p . 45798100 Southern Regional Research Center (200 2 ) Submission of Tox icity Data in Support of the Registration of Aspergillus flavus AF-36 and the Petition for Tolerance of Aspergillus flavus isolate AF-36 in /on Cotton. Transmittal of 2 Studies. 45798101 Blanchard , E . (2002) Aspergillus flavus AF36 : Acute Pulmonary Toxic ity and Pathogenicity to the Rat: Lab Project Number : UAR/004 : UAR004 / 014519/AC : PR 528 . Unpublished study prepared by Huntingdon Life Sciences Ltd . 53 p . {OPPTS 885 . 3150} 45798102 Rodgers , M. (2002) Toxicity/Pathogenicity to the Bobwhite Quail : Avian Inhalation Test Tier 1 : Aspergillus flavus AF36 : Lab Project Number : UAR 005 : UAR 005/022336: PR 528 . Unpublished study prepared by Huntingdon Life Sciences Ltd . 21 p . {OPPTS 885.41 00} 45798200 Southern Regional Research Center (2002) Submission of Toxicity Data in Support of the Registration of Aspergillus flavus and the Pet ition for Tolerance of Aspergillus flavus Isolate AF36 in/on Cotton . Transmittal of 1 Stud y . 20Aspe r g illusjlav us 

### EPA-HQ-OPP-20 15-0 281 www. reg ulati ons.gov 45798201 Blanchard , E . (2002) Aspergillus flavus AF36 : Acute Pulmonary Toxicity and Pathogenicity to the Rat: Lab Project Number : UAR/006 : UAR 006/023279/AC . Unpublished study prepared by Huntingdon Life Sciences Ltd . 61 p . {OPPTS 885 . 3150} 46859500 Ar i zona Cotton Research and Protection Counc i l (2006 ) Submission of Product Chemistry and Efficacy Data in Support of the Amended Reg is trat ion of Aspergillus Flavus AF36 . Transmittal of 2 Studies. 46859501 Cotty , P . (2006 ) Product Analysis , Lim i ts , Ident i fication , Determination of Un i ntent i on a l Ingredients , Qual i ty Contro l , S to rage Stability and Viabil i ty : Aspergillus flavus AF36 . Project Number : 0052B . Unpublished study prep ared by U . S . Dept. of Agriculture , Agr . Res . Serv . and U . S . Dept. of Agriculture , Agric . Res . Serv . 112 p . 46859502 Cotty , P . (2006 ) Product Performance Data : Aspergillus flavus AF36 . Project Number : 0052B . Unpublished study prepared by U . S . Dept. of Agriculture , Agr . Res . Serv . 38 p . 46956400 IR-4 Project (2006) Submission of Toxicity Dat a in Support of the Experimental Use Permit of AF 36 . Transmittal of 2 Studies . 46956401 Braverman , M . (2006) Aspergillus Flavus - AF36- Non-Target Organism and Environmental Fate Waiver Requests. Project Number: IR/4PRN0 /0327 B. Unpublished study prepared by Interregio nal Research Project No . 4 . 106 p. 46956402 Braverman , M . (2006 ) Aspergillus Flavus AF 36 Health Effects Wa i ver Requests . Project Number: IR/4PRN00327B . Unpublished study prepared by Interregional Re sea rch Proj ect No.4. 125 p . 47108900 IR-4 Project (2007) Submission of Toxicity and Fate Data in Support of the Experimental Use of Aspergillus flavus and the Petition for Tolerance of Aspergillus flavus on Corn . Transmittal of 2 Studies . 47108901 Braverman , M . (2007) Aspergillus flavus- AF36 on Corn : Non-Target Organism and Environmental Fate Waiver Requests . Project Number : 03278 . Unpublished study prepared by Interregional Research Project No . 4 . 29 p . 47108902 Braverman , M . (2007) Aspergillus flavus AF36 Corn- Health Effects Waiver Requests. Project Nu mber: 0327B . Unpublished study prepared by Interregional Research Project No . 4 . 41 p . 47935100 IR-4 Project (2009 ) Submiss i on of Efficacy Data in Support of the Peti t i on for T olerance of Aspergillus flavus AF36 for Use on Corn . Transmittal of 1 Study . 47935101 Cotty , P .; Wakelyn , P .; Braverman , M . (2009) Aspergillus flavus AF36 : Product Performance Data: Efficacy of AF36 in Corn . Project Number: PR# /0378/B . Unpublished study prepared by University of Ar i zona , Wakelyn Associates . LLC and Interregional Research Project No . 4 . 233 p . 48330100 Arizona Cotton Research and Protection Coun ci l (20 1 0) Submission of Efficacy Data in Support of the Amended Registration of Aspergillus Fla vus AF36 and the Petition for Tolerance of Aspergillus Flavus AF36 for Use on Corn . Transm i ttal of 1 Study . 48330101 Cotty , P. ; Wakelyn , P .; Braverman , M . (20 10 ) Product Performance Data : Efficacy of AF36 in Corn 2009 Commercial Field Tests: Amendment#1 to MRID 47935101. Project Number : 0378B . Unpublished study prepared by U . S . Dept. of Agriculture , Agr . Res . Serv ., Wakelyn Associates , LLC and Interregional Research Project No . 4 . 58 p . 48363700 Arizona Cotton Research and Protection Council (201 0) Submission of Efficacy Data in Support of the Petition for Tolerance of Aspergillus Flavus AF36 for Use on Pistachio . Transmittal of 1 Study . 48363701 Mich i l i des , T. ; Doster , M .; Cotty , P .; et al. ( 2010 ) Efficacy Data for Aspergillus flavus- AG36 i n or on Pistachio . Project Number : 03278 . Unpublished study prepared by Interregional Research Project No . 4 , USDA-ARS and University of California Kearney Agricultural Center . 99 p . 48567201 Braverman , M . (2011 ) Aspergillus flavus AF36 P i stachio Amendment #1 to MRID 48363701 . Project Number : 0327B . Unpublished study prepared by Interregional Research Project No . 4 . 60p . 2 1Aspe rg illus jla v us EPA-HQ-OPP-20 15-0 2 81 ww w. r eg ulation s.gov 49256300 Arizona Cotton Research and Protection Council (2013) Submission of Product Chemistry and Efficacy Data in Support of the Application for Registration of Aspergillus flavus AF36 Prevail. Transmittal of 2 Studies. 49256301 Cotty , P . ( 2013 ) Product Chemistry for Asperfillus flavus AF36 End Use Product. Project Number : IR

/4/PR/0052B . Unpublished study prepared by U . S . Dept. of Agriculture , Agr. Res . Serv . 34p. 49256302 Cotty , P. (2013) Product Performance for Aspergillus flavus AF36 Prevail End Use Product. Project Number: IR/4 / PR/0052B . Unpublished study prepared by U . S . Dept. of Agriculture , Agr . Res . Serv . 41p . 45884000 C i rc l e One Global , Inc . (2003) Submission of Product Chemistry and Toxicity Data in Support of the Experimental Use of Afla-Guard on 5 , 000 Acres and the Petition for a Temporary Tolerance of Aspergillus flavus NRRL 21882 on Peanuts . Transmittal of 6 Studies . 45884001 Dorner , J. (2003) Afla-Guard : Product Identity ; Manufacturing Process ; Discussion of Formation of Unintentional I ngredients ; Analysis of Samples ; Cert i fication of Limits ; and Physical and Chemical Properties : Lab Project Number: NPRL-2003-01 . Unpublished study prepared by USDA National Peanut Research Laboratory . 11 p . {OPPTS 885 . 1100 , 885 . 1200 , 885 . 1300 , 885 . 1400 , 885 . 1500} 45884002 Freeman , D . ; Watson , M . (2000) Acute Oral Toxicity in Albino Rats with Alfaguard (sic): Lab Project Number: 012685-1 . Unpublished study prepared by Ricerca , LLC . 21 p . {OPPTS 870.1100} 45884003 Blanchard , E . ( 2002 ) Aspergillus flavus NRRL 21882 : Acute Pulmonary Toxicity and Pathogenicity to the Rat: Lab Project Number : UAR/003: UAR 003/014451/AC. Unpublished study prepared by Huntingdon Life Sc i ences ltd. 43 p . {OPPTS 885 . 3150} 45884004 Blanchard , E. ( 2002 ) Aspergillus flavus NRRL 21882 : Acute Intraperitoneal Toxic i ty and Pathogenicity to the Rat: Lab Project Number : UAR/002 : UAR 002/014454/AC . Unpublished study prepared by Huntingdon Life Sciences ltd. 35 p. {OPPTS 885 . 3200} 45884005 Rodgers , M . (2002) Aspergillus flavus NRRL 21882 : Toxicity/Pathogenicity to the Bobwhite Quail : Av i an Inhalat i on Test T i er 

### 1 : Lab Project Number : UAR 001 : UAR 001 / 022259 . Unpublished study prepared by Huntingdon Life Sciences ltd. 22 p . {OPPTS 885.41 00} 45884006 Dorner, J . (2001) Honey Bee Field Study of Aflaguard (Aspergillus flavus) in Alfalfa : Final Report : Lab Project Number : WSU 01-006 . Unpublished study prepared by The Bee Group . 43 p . {OPPTS 850 . 3040 , 885 . 4380} 46196800 Circle One G l obal , Inc . (2004) Submission of Product Chemistry , Toxicity , Efficacy and Risk and Exposure Data in Support of the Application for Registrations of Aspergillus flavus NRRL 21882 , and Afla-Guard . Transmittal of 5 Stud i es . 46196801 Dorner , J. (2004) Group A--Product Analysis : Aspergillus flavus NRRL 21882. Project Number : NPRL/2004/01 . Unpublished study prepared by U.S. Dept. of Agriculture and Japan Food Research Laboratories . 171 p . 46196802 Chandler, P . (2004) Acute Oral and Pathogenicity Study to the Rat: Aspergillus flavus NRRL 21882 . Project Number : WZY/003 , WZY/003/033960/AC . Unpub l ished study prepared by Huntingdon Life Sciences , Ltd . 53 p . 46196804 Dorner , J . (2004 ) Occupat i ona l Exposure and Risk Characterization : Use of Afla-Guard on Peanuts . Project Number : NPRL/2004/02 . Unpublished study prepared by U . S . Dept. of Agriculture . 6 p . 46196805 Dorner , J . (2004) Compilation of Multi-year Efficacy Studies Conducted with Aspergillus flavus NRRL 21882 . Project Number : NPRL/2004 / 03 . Unpublished study prepared by U . S . Dept. of Agriculture. 6 p . 46196806 Dorner , J. (2004) Supplement to MRID 458840-06 , Honey Bee Field Study of Aflaguard (Aspergillus flavus) in Alfalfa . Project Number : NPRL/2004/04 , JD04/2004 . Unpublished study prepared by U . S . Dept. of Agriculture . 6 p . 2 2As p e r g illus jlav us EPA -HQ-OPP-20 I 5-02 8 I www. r egulat ions. gov 46223900 Circle One Global , Inc. (200 4) Subm is sion of Toxicity Data in Support of the Applications for Registration for Aspergillus flavus NRRL 21882 and Alfa-Guard and the Petition for Tolerance of Aspergillus flavus NRRL 21882. Transmittal of 1 Study . 46223901 Chandler , P . ( 2004) Aspergillus flavus NRRL 21882 : Acute Intraperi toneal and Pathogenicity Study to the Rat. Project Number : WZY/004 , WZY/004/042013/AC . Unpublished study prepared by Huntingdon Life Sciences , Ltd . 55 p . 46232500 Circle One Global Inc . (2004) Submission of Product Chemistry Data in Support of the Applications for Registration of Alfa Guard and Aspergillus flavus NRRL 2188 and the Pet ition for Tolerance Aspergillus flavus NRRL 2188 for Use on Peanuts . Transmittal of 1 Study. 46232501 Dorner, J. (2004) Pesticide Product Analysis : Afla-Guard . Project Number : NPRU2004/05 . Unpublished study prepared by U . S . Dept. of Agriculture . 21 p . 46240700 Circle One Global Inc . (2004) Submission of Toxicity Data in Support of the Application for Registration of Aspergillus flavus NRRL 21882 . Transmitta l of 1 Study . 46240701 Cameron , D . (2004) Aspergillus flavus NRRL 21882 : Oral Toxicity/Pathogenicity to the Bobwhite Quail Tier I. Project Number : WZY/001 , WZY /001/04 2068 . Unpublished study prepared by Huntingdon Life Sciences , Ltd .. 26 p . 47008700 Circle One Global , Inc . (2006) Subm is sion of Efficacy and Product Chemistry Data in Support of the Registrations of Aspergillus Flavus NRRL 21882 and Afla-Guard . Transmittal of 2 Studies . 47008701 Dorner , J . (2006) Efficacy Study: Field Trial with Afla-guard . Project Number : 980/01/52. Unpublished study prepared by U . S . Dept. of Agriculture . 54 p . 47008702 Gaughan , R . ( 2006 ) Group A- Product Analysis : Aspergillus F l avus NRRL 21882 . Project Number : 980/01/53 . Unpublished study prepared by Acta Group, L.L.C . 29 p . 47189200 Circ l e One Global (2007) Submission of Efficacy and Product Chemistry Data in Support of the Registration of Afla-Guard and Aspergillus Flavus NRRL 21882 . Transmittal of 2 Studies . 47189201 Dorner, J . (2007) Supplemental Information to Efficacy S t udy: Field Trial with Afla-guard . Project Number: 980/01/55 , 0/001/6/00006911/DOC . Unpublished study prepared by U . S . Dept. of Agriculture . 32 p . 47189202 Dorner, J . (2007) Supp lemental Information to Group A: Product Analysis : Asperg i llus flavus NRRL 21882 . Project Number : 980/01/56 . Unpublished study prepared by Circle One Global Inc . 30 p . 47299400 Circle One Global , Inc . (2007) Submiss ion of Efficacy Data in Support of the Amended Registrations of Aspergillus flavu s NRRL 21882 and Afla-Guard and the Petition for Tolerance of Aspergillus flavus NRRL 21882 for Use on Corn . Transmittal of 1 Study. 47299401 Jacoby , H .; Dolan , 

# s : (2007) Efficacy Study for Use of afla-guard on the Food and Feed Commodity Corn to Reduce Aflatoxin Contamination . Project Number : 980/001 / 64 . Unpublished study prepared by Acta Group , L.L.C . 336 p . 47349300 Circle One Global , Inc. (2008) Submission of Product Chemistry Data in Support of the Registrations of Aspergillus flavus NRRL 21882 and Afla-Guard . Transm ittal of 1 Study . 47349302 Dorner , J . (2008 ) Storage Stability of Afla-Guard . Project Number: 980/001 / 72 . Unpublished study prepared by U . S . Dept. of Agriculture . 6 p . 47364500 Circle One Global , Inc . (2008) Subm issio n of Product Chemis t ry Data in Support of the Reg istra tions of Aspergillus flavus NRRL21882 and Afla-Guard . Transm i ttal of 1 Study . 47364501 Dorner , J. ; Jacoby , H .; Dolan , S . (2008) Subm issio n of Data to Meet Conditions of Registration Product Chemistry Supplementing MRID Nos .: 47008702 and 47189202 . Project Nu mber : 980/001/71 . Unpublished study prepared by U . S . Dept. of Agriculture and Acta Group , L.L.C . 78 p . 23A s p erg illus flavu s E PA-HQ- O PP- 20 15-0281 www . reg ulations.go v 47416000 Circle One G lo bal , Inc . (200 8) Submiss i on of Efficacy Data in Support of the Exper i mental Use of Afla - Guard on Corn. Transmittal of 1 Study . 47416001 Dorner , J ; Jacoby , H .; Lindros Dolan , S . (2008 ) Annual Report for Exper i mental Use Permit No . 75625- EUP-2 , 2007 Season . Pro ject Numbe r : 980/001/81 . Unpublished study prepared by U . S . Dept. of Agriculture and Acta Group , L. L. C . 18 p . 47490100 Circle One Global , I nc . (2008) Submission of Efficacy Data in Support of the Registration of Aspergillus flavus NRRL 21882 and the Petit ion for Tolerance of Asperg ill us flavus NRRL 21882 for Use on Corn . Transmittal of 1 Study . 47490101 Jacoby , H .; Do l an , S . (2008) Additional Information in Support of the Tolerance Exemp t on Amendment Petition for Aspergillus flavus NRRL 21882 and Registration Amendments for Aspergillus flavus NRRL 218 82 and afla-guard to Add the Food and Feed Com modity Corn . Pro j ect Number: 980/001/091 . Unpublished study prepared by Acta Group , L.L.C . 24 p . 47904500 Circ l e One Globa l , Inc . (2009) Submission of Efficacy Data in Support of the Amended Regi stra t ion of Af la-Gua rd . Transm i ttal of 1 Study . 47904501 Dorner , J . ; Jacoby , H . ; Dolan , S . (2009) Afla -Guard 2008 Annual and Final Report for Experimenta l Use Permit: Efficacy for Use of Afla - Guard on Fie l d Corn to Reduce Af l atoxin Contamination . Project Number: 980/001 / 101 , TK0021333 . Unpublished study prepared by U . S . Dept. of Agriculture and Acta Group , L.L.C .. 684 p . 48289500 Circle One Global , Inc . (201 0 ) Subm is sion of Product Chemistry Data in Support of the Amended Regist ra tion of Afla-Guard . Transmittal of 1 Study . 48289501 Hipps , A. (20 10) Afla-Guard ( A 17798A) - Manufactur ing Process Descr ipti on and Supporting Data . Project Number : PC / 1 0/102 . Unpub lishe d study prepared by Syngenta Crop Protect i on , Inc . 34 p . 48557501 Ross , D .; Strader, C . (2011) Aspergillus f l avus NRRL 21882 : 2010 Efficacy Data for Use of AflaGuard on Popcorn to Reduce Aflatox i n Contam i nation : F inal Report . Project Number : TK0028467 . Unpublished study prepared by Vernon G . James Research and Ex tension Center . 1 Op . 48557502 Durando , J . (201 1) Asperg i llus flavus NRRL 2 18 82 (ASF1084A)- Acute Dermal Toxicity in Rats : Final Report . Project N umber : 28 793 TK0014180 . Unpublished study prepared by Eurofins/Product Safety Laborato rie s . 16p . 48557503 Durando , J . (2011) Asperg ill us flavus NRRL 21882 (ASF1084A) - Acute Eye Irritation in Rabbits : Final Report . Project Number : 28794 TK0014848 . Unpubl i shed study prepa red by Eurofins/Product Safety Laborator ie s . 19p . 

### B. U.S. E nvironme nt a l Protection Agency Ri s k Assessme nt Mem ora nd a BPPD R eview of D ata Waiver Requests Submitted by IR-4 on behalf of the Arizona Cotton and Research Counc il in support of the Health Effects of

### A s pergillusjlavus AF36 for use o n cotton food/ feed commodity, May 22,2003 . BPPD Review of Pr oduct C hemis try and E fficacy D ata to satisfy conditi on s of Regis tr atio n for aspe rgillus tlavus AF36 [EPA Reg. No . 71693-1 ] , September 13 , 2007 . BPPD Review of Soi l and Ai r Mon itori ng Stud ies and Product P erformance Tes tin g ( Efficacy) Submitted by US D A Southern Regional Research Cent er/I R-4 as a Con diti on of R egistrati o n and EU P Ex t e n s ion (Texas) for 

### Aspergillusjlavus AF36, May15 , 2003. Ecological Ri sk Assessment 

### Asper g illusjlavus NRRL 2 1 882. Me morandum from Hil ary Hill and Zigfridas Vaituzis to S hanaz Bacchus , May 6 , 2004. 24Aspergillus jlavus 

### EPA-HQ- OPP - 20 15-0 28 I www. r egulatio ns . gov 

### U.S. EPA. 2003. Bi o pe s ticide s Re g i stration Action D ocume nt: 

### Aspergillusjlavus st rain A F 36 ( P C Code 006456) , July 3, 2003 . U . S. EPA. 2004. Biopesticides R eg istration Ac ti on Do cument: 

### Aspetgillusjlavus NRRL 21882 ( PC Code 006500), March 24, 2004.

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