Aspergillus jlavus 

(PC Codes: 006456 and 006500) 

Preliminary Work Plan and Summary Document 

Registration Review: Initial Docket 

June 2015 

Case 6008 

Approved by: 

Robert McNall y, Director 

Biopesticides and 

Pollution Prevention Division 

Date: 
Aspergillus flavus 

TABLE OF CONTENTS 

EPA-HQ-OPP-20 15-028 1 

www.regulations.gov 

I. PRELIMINARY WORK PLAN ...................................................................................................... 4 

A. Overview ............................................................................ ..................................................................................... 4 

B. Statutory and Regulatory Authority ..................................................................................................................... 4 C. Background and Regulatory Information ............................................................................................................ 5 

D. Anticipated Data Needs and Risk Assessments .................................................................................................... 7 

E. Risk to Threatened and Endangered Species ..................................................................................................... 14 

F. Endocrine Effects ................................................................................................................................................. 15 

G. Jncidents ................................................................................................................................................................ 15 

H. Timeline ................................................................................................................................................................. 16 

r. G uidance for Commenters ......................................... .......................................................................................... 16 

J. NextSteps .............................................................................................................................................................. l8 

II. BIBLIOGRAPHY ........................................................................................................................... 19 

A. Studies Supporting Registration Review of Aspergillus jlavus strain AF36 .................................................. 19 

B. U.S. Environmental Protection Agency Risk Assessment Memoranda ........................................................... 24 

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Aspergillus flavus EPA-HQ-OPP-20 15-0281 

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ACRONYMS AND ABBREVIATIONS 

BPPD The EPA's Biopesticides and Pollution Prevention Division 

CFR Code of Federal Regulations 

DCI Data Call-In 

EDSP Endocrine Disruptor Screening Program 

EPA U.S. Environmental Protection Agency 

FFDCA Federal Food, Drug, and Cosmetic Act 

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 

FQPA Food Quality Protection Act 

FR Federal Register 

FWP Final Work Plan 

IDS Incident Data System 

MRID No. Master Record Identification Number: The EPA's system of recording and tracking studies submitted to the 

Office of Pesticide Programs. 

MRL Maximum Residue Limit 

OPP The EPA ·s Office of Pesticide Programs 

PC Code Pesticide chemical code: a six-digit number assigned by OPP to identify pesticide chemicals. 

PMRA Health Canada's Pest Management Regulatory Agency 

PWP Preliminary Work Plan 

TGAI Technical grade ofthe active ingredient 

TMDL Total Maximum Daily Load 

us United States 

3 
Aspergilfus jlavus 

I. PRELIMINARY WORK PLAN 

A. Overview 

EPA-HQ-OPP-20 15-0281 

www. regulations. gov 

The docket for Aspergillus jlavus (Case 6008) is now open, thereby initiating the first public comment 

period for this Registration Review case (docket number EPA-HQ-OPP-2015-0281). Aspergilfusjlavus, 

a species of fungus, comprises two active ingredients contained individually in three registered products 

(one manufacturing-use product and two end-use products) for use as fungicides to control aflatoxinproducing fungi on cotton, com, pistachios, and peanuts. Aflatoxins are naturally occurring mycotoxins 

produced by some strains of Aspergillus jlavus and are among the most carcinogenic substances known. 

Two of the non-aflatoxin-producing strains are Aspergillus jlavus AF36 and Aspergillus jlavus NRRL 

21882. AF36 was isolated in Arizona and is also found in Texas, while NRRL 2 1882 was isolated from 

a peanut seed in Georgia. When applied to cotton, corn, pistachio, and peanut at the right time 

(pre bloom), these strains of Aspergillus jlavus are expected to displace the aflatoxin-producing strains of 

Aspe1gillusjlavus from the crop and field. This Preliminary Work Plan (PWP) explains what the U.S. 

Environmental Protection Agency's (EPA) Office of Pesticide Programs knows about Aspergillus jlavus, 

highlights its anticipated data and assessment needs, identifies types of information that would be 

especially useful in conducting the review, and provides an anticipated timeline for completing the 

Registration Review process for this biopesticide. 

The Registration Review process was designed to include a public participation component and by 

sharing this information in the docket, the EPA intends to inform the public of what it knows about 

Aspe1gillusjlavus and what types of new data or other information would be helpful to receive as the 

Agency moves toward a decision on Aspergillus jlavus. The EPA encourages all interested stakeholders 

to review the PWP and to provide comments and additional information that will help the EPA's 

decision-making process for this microbial pesticide. In addition to general areas on which persons may 

wish to comment, there are some areas identified in the PWP about which the EPA specifically seeks 

comments and information. Interested stakeholders could include the following: environmental 

nonprofit or interest groups; pesticide manufacturers; agricultural labor or commodity groups; 

commercial, institutional, residential, and other users of pesticides; or the public at large. 

The PWP begins by describing the statutory and regulatory authorities for Registration Review. Next, it 

provides background on Aspe1gillus jlavus, including a description of its mode of action, the currently 

registered pesticide products, application rates and methods, use sites, and tolerance exemption 

information. Then, it lists the anticipated data needs, risk assessments, and a projected Registration 

Review timeline for this case. Finally, the PWP provides guidance for commenters, explains the next 

steps EPA will be taking, summarizes background infonnation, and lists supporting studies, risk 

assessments, and other documents available for the Registration Review of Aspergiflusjlavus. 

Further information about this case. including background and supporting documents, is available at 

hllp:llwww.regulations. gov (under '·SEARCH for: Rules, Comments, Adjudications or Supporting 

Documents,'· enter the docket identification number, which is indicated above). 

B. Statutory and Regulatory Authority 

The Food Quality Protection Act (FQPA) of 1996 mandated a Registration Review program. All 

pesticides distributed or sold in the United States (US) must generally be registered by the EPA. based 

on scientific data showing that they will not cause unreasonable risks to human health or the 

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Aspergillus Jlavus EPA-HQ-OPP-20 15-0281 

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environment when used as directed on the product labeling. The Registration Review program is 

intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all 

registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human 

health or the environment. Changes in science, public policy, and pesticide use practices will occur over 

time. Through the Registration Review program, the EPA periodically reevaluates pesticides to make 

sure that, as change occurs, products in the marketplace can continue to be used safely. Information on 

this program is provided on the EPA's website. 1 

The EPA is implementing the Registration Review program pursuant to Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA) section 3(g) and will review each registered pesticide every 15 years to 

determine whether it continues to meet the FIFRA standard for registration. The regulations governing 

Registration Review begin at 40 C.F.R. § 155.40. The EPA will consider benefits information and data as 

required by FIFRA. The public phase of Registration Review begins when the initial docket is opened 

for each case. The docket is the EPA's opportunity to state what it knows about the pesticide and what 

additional risk analyses and data or information it believes are needed to make a Registration Review 

decision. After reviewing and responding to comments and data received in the docket during this initial 

comment period, the EPA will develop a Final Work Plan (FWP) and the anticipated schedule for the 

Registration Review of Aspergillusjlavus. 

C. Background and Regulatory Information 

i. Summary of the Active Ingredient, Usage and the Associated Pesticide Product 

Aspergillusjlavus strains AF36 and NRRL 2 1882 are contained in registered microbial pesticides. 

Aspergillusjlavus strain AF36 is the active ingredient in the product, Aspergillusjlavus AF36, a 

fungicide applied to cotton just prior to first bloom in Arizona, Texas, and three California counties, to 

corn from the 7 leaf stage until silking in Arizona and Texas, and to pistachio from late May through 

early July in California, Arizona, Texas, and New Mexico. Aspergillus jlavus NRRL2 1882 is the active 

ingredient in the product, Alfa-Guard GR, wruch is applied to peanuts. and corn (field corn and popcorn). 

Both products are intended to compete with strains of Aspergillus jlavus that produce large amounts of 

aflatoxin and, in doing so, limit the amount of these rugh aflatoxin producers that become associated 

with the crop. Both strains of Aspe1gillus jlavus belong to a naturally occurring genus of fungi, 

Aspe1gillus, which is ubiquitous in the environment. The acute toxicity data performed resulted in a 

classification ofToxicity Category IV for acute oral toxicity/pathogenicity and Toxicity Category III for 

acute inhalation. (U.S. EPA. Biopesticides Registration Action Document: Aspergillus jlavus strain 

AF36 (PC Code 006456), July 3, 2003). Further information regarding the products appears in Table 3, 

below. Tables I and 2 provide summaries of the chemical facts for Aspergillus jlavus strain AF36 and 

NRRL21882. 

TABLE 1. Chemica l Facts for Aspergillusjlavus strain AF36 

PC code 006456 

Case Number 6008 

CAS Number NA 

Year first re.ltistered 2003 

Pesticide Type Fungicide 

Chemical class Microbial 

1 See hup: www.epa.gm· opnsrrd/;registration re1·iew. 

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Aspergillus jlavus EPA-HQ-OPP-20 15-028 1 

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TABLE I. Chemical Facts for Aspergillusjlavus strain AF36 

Reregistration Eligibility Not applicable. Because it was registered after November 1984, Aspergillus jlavus 

Decision (RED) strain AF36 was not subject to rere_gistration. 

Tolerance Reassessment Not applicable. This pesticide is exempt from the requirement of a tolerance for Eligibility Decision (TREDl residues on cotton, pistachio, and com. 

Cumulative group Not applicable. Aspergillusjlavus strain AF36 has not been identified as a member of 

a cumulative group that shares a common mechanism of toxicity. 

40 CFR Citation 180.1206 

Non-pesticidal uses NA 

TABLE2. Chern ical Facts for Aspergillus jlavus NRRL 21882 

PC code 006500 

Case Number 6008 

CAS Number NA 

Year first registered 2004 

Pesticide Type Fungicide 

Chemical class Microbial 

Reregistration Eligibility Not applicable. Because it was registered after November 1984. Aspergillus jlavus 

Decision (RED) strain AF36 was not subject to reregistration. 

Tolerance Reassessment Not applicable. This pesticide is exempt from the requirement of a tolerance for Eligibility Decision (TRED) residues on peanuts and corn. 

Cumulative group Not applicable. Aspergillus jlavus. NRRL 2 1882 has not been identified as a 

member of a cumulative group that shares a common mechanism of toxicity. 

40 CFR Citation 180.1206 

Non-pesticidal uses NA 

TABLE 3. Information About the Currently Registered Aspergillusjlavus Pesticide Products 

EPA Product Name 

Registration (%Active Date Application Application 

Numbe Use Sites r Ingredient; Registered Rates Methods 

Formulation Type) 

Cotton in Arizona. 

The fungus is Texas, and 

grown on sterile California 

I 0 pounds per wheat seed. which (Imperial, 

acre of cotton: is applied to the Riverside, and San 

Aspergillus jlavus July 23, I 0 pounds per surface of the soil Bernardino 

7 1693-1 AF36 (0.0008% AI; acre of com; under the plant counties only): 

granular) 2003 and I 0 pounds canopy with a com in Arizona 

per acre of tractor-mounted. and Texas: and 

pistachio granular applicator pistachio in 

or by aerial California, 

application. Arizona. Texas, 

and New Mexico. 

6 
Aspergillus jlavus 

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

Alfa Guard GR September I 00-1 469 (0.0094% AI: 

granular) 17,2004 

ii. Tolerance Actions 

NA 

I 0-20 pounds 

per acre of 

com: and 20 

pounds per acre 

of peanuts 

EPA-HQ-OPP-20 15-0281 

www. regulat ions.gov 

For manufacturing 

NA or formulating use 

only 

Ground or aerial Peanuts: com 

(field com and application popcorn) 

An exemption from the requirement of a tolerance is established for residues of the microbial pesticide 

Aspe1gillusjlavus AF36 in or on cotton, gin byproducts; cotton, hulls; cotton, meal; cotton, refined oil; 

and cotton, undelinted seed. 

An exemption from the requirement of a tolerance is established for residues of Aspergillus flavus 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 removed; corn, sweet, forage; com, sweet, stover; com, pop, 

grain; and com, pop, stover, when applied/used as an antifungal agent. 

An exemption from the requirement of a tolerance is established for residues of Aspe,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 Aspergillus flavus AF36; exemption from the requirement of a tolerance) 

An exemption from the requirement of a tolerance is established for residues of Aspe1gillus jlavus 

NRRL 21882 on peanut; peanut, hay; peanut, meal; and peanut, refined oil. 

An exemption from the requirement of a tolerance is established for residues of Aspetgillus jlavus 

NRRL 2 1882 on corn, field, forage ; corn, field, strover; corn, field, aspirated grain fractions; corn, 

sweet, kernel plus cob with husk removed; corn, sweet forage; com, sweet, strover; corn, pop, grain; and 

corn, pop, strover. 

(40 CfR § 180.1254 Aspergillus tlavus NRRL 21882; exemption from the requirement of a tolerance) 

D. Anticipated Data Needs and Risk Assessments 

Provided below are tables of the current data requirements for microbial pesticides as set forth in 40 

CFR § 158, subpart U. They are arrayed by scientific discipline (i.e., product chemistry, human health 

assessment, and nontarget organisms and environmental fate), and descriptions are included regarding 

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Aspergillus flavus EPA-HQ-OPP-20 15-028 1 

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how the data requirements have been fulfilled or where data have been waived. At this time, no data 

gaps (anticipated data needs) for Aspergillusjlavus have been identified. 

The most recent comprehensive risk assessment for Aspergillus jlavus strain AF36 was completed on 

July 3, 2003, in support of the first registration of Aspergiffusjlavus strain AF36, which occurred on July 

23, 2003, allowing its usc on cotton in specific states and California counties. Additional data were 

submitted to support the use of Aspe1gillus jlavus strain AF36 on corn and pistachio. An amendment to 

the registration to allow its use on pistachio in certain states 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 strain AD6, the Agency does not anticipate the 

need to conduct a new risk assessment during registration review. Nevertheless, the EPA plans to 

conduct a literature search to update its understanding ofthe current state of the science on this pesticide 

and will consider the need to conduct a new risk assessment depending on the findings. 

Product Chemistry (40 C.F.R. § 158.21201 

TABLE 4. Summa ry of Product Chemistry Data for Aspergillus jlavus stra in AF36 

Has Data 

Ha rmonized Requirement 

G uideline Da MRID/ Accession Number or Other ta Requirement Been , Source 

Number Addr Reference essed? 

How? 

885.1100 Product Identity Yes: Study U.S. EPA (2003) 4376634-0 I 

U.S. EPA (2003) 437634-0 I 

885.1200 Manufacturing Process Yes: Study 445970-01 

447137-01 

Deposition of a Sample 

885. 1250 in a Nationally 

Reco Yes: ATTC U.S. EPA (20 13) Deposit No. 96045 gnized Culture 

Collection 

Discussion of Formation U.S. EPA (2006) 437634-02 

885.1300 of Unintentional Yes; Study 44626 1-0 I 

Ingredients 468595-0 I 

446261-01 

885. 1400 Analysis of Samples Yes: Study U.S. EPA (2006) 439724-03 

468595-0 1 

885.1500 Certification of Limits Yes: Study U.S. EPA (2006) 446261-01 

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Aspergillus jlavus EPA-HQ-OPP-20 15-0281 

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TABLE 5. Summary of Physical and Chemical Characteristics for Aspergillusjlavus strain AF36 

Has Data 

Harmonized Requirement 

Guideline Data Requirement Been MRlD/ Accession Number or Source 

Number Other Reference Addressed? 

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 Stability Yes; Study U.S. EPA (2007) 468595-0 I 

830.6319 Miscibility Yes: Study U.S. EPA (2007) 468595-0 I 

830.6320 Corrosion Yes; Study 

C U.S. EPA (2007) 468595-0 I haracteristics 

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 Density/relative 

den Yes; Study U.S. EPA (2007) 468595-0 I sity/bulk density 

Toxicology (40 C.F.R. § 158.2050) 

TABLE 6. Summary of Toxicology Data for Aspergillusjlavus strain AF36 

Harmonized Has Data 

Guideline Data Requirement Requirement Source 

MRJD/ Accession Number or 

Number Been Addressed? Other Reference 

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/Pathogenicity 457982-01 

Yes; Data waived 439724-03 

Acute Intravenous 457391-0 I 885.3200 Toxicity/ Pathogenicity based on scientific U.S. EPA (2003) 457981-01 rationale 457982-0 I 

Hypersensitivity Yes; Data waived based on scientific 

885.3400 BPPD Review of Data Waiver rationale. Any future hypersensitivity Incidents incidents should be reported per OCSPP Requests ... May 22, 2003 

Guideline 885.3400. 

885.3500 Cell Culture Not applicable. 

9 
Aspergillus jlavus 

Harmonized 

Guideline 

Number 

870.1100 

885.3100 

870. 1300 

870.2400 

870.2500 

Harmonized 

Guideline 

Number 

885.4050 

885.4 100 

885.4150 

885.4200 

885.4240 

885.4280 

EPA-HQ-OPP-20 15-0281 

www. regulations.gov 

TABLE 6. Summary of Toxicology Data for Aspergillusjlavus strain AF36 

Has Data 

Data Requirement Requirement Source 

MRID/ Accession Number or 

Been Addressed? Other Reference 

How? 

Yes: Data waived 

Ac BPPD Review of Data Waiver ute Oral Toxicity based on scientific U.S. EPA (2003) Requests ... May 22, 2003 rationale 

Yes: Data waived 

Acute Dennal BPPD Review of Data Waiver Toxicity based on scientific U.S. EPA (2003) Requests ... May 22, 2003 rationale 

Acute Inhalation 

Yes; Data waived 

BPPD Review of Data Waiver 

Toxicity based on scientific U.S. EPA (2003) Requests ... May 22, 2003 rationale 

Yes: Data waived 

Acute E BPPD Review of Data Waiver ye Irritation based on scientific U.S. EPA (2003) Requests ... May 22, 2003 rationale 

Primary Dermal Yes; Data waived 

BPPD Review of Data Waiver 

Irritation 

based on scientific U.S. EPA (2003) Requests ... May 22. 2003 rationale 

Nontarget Organisms and Environmental Fate (40 C.F.R. § 158.2060) 

TABLE 7. Summary of Nontarget Organisms Data for Aspergillus jlavus strain AF36 

Bas Data Requirement MRJD/ Accession 

Data Requirement Been Addressed? Source Number or Other 

Bow? Reference 

437634-03 

437634-05 

444642-02 

A vi an Oral Toxicity 

Yes: Data waived based U.S. EPA (2003) 444526-1 5 

on scientific rationale . 457391-03 

453072-0 I 

453072-01 

45798 1-02 

Avian Inhalation Yes; Study U.S. EPA (2003) 45798 1-02 Tox iciry/Pathogen iciry 

Wild Mammal Toxicity/ Not applicable: No testing expected to be required. Results of the Tier I 

toxicity tests required by 40 CFR § 158.2140 (Table 5) are adequate and Pathogenicity appropriate for assessment of hazards. 

Freshwater Fish Toxicity/ Yes: Data waiver based 437634-03 

Pathogenicity on scientific rationale U.S. EPA (2003) 437634-05 

453072-01 

453072-02 Freshwater Invertebrate Yes: Data waiver based BPPD Review of Toxicity/ Pathogenicity on scientific rationale U.S. EPA (2003) Data Waiver 

Requests ... May 15. 

Estuarine And Marine Yes: Data waiver based U.S. EPA (2003) 2003 

Invertebrate Testing on scientific rationale 

10 
Aspergillus jlavus 

Harmonized 

Guideline 

Number 

885.4300 

885.4340 

885.4380 

EPA-HQ-OPP-20 15-0281 

w1vw. regul at ions.gov 

TABLE 7. Summary of Nonta rget Organisms Data for Aspergillusjlavus strain A.F36 

Has Data Requirement M RID/ Accession Data Requirement Been Addressed? Source Number or Other 

How? Reference 

BPPD Review of 

Nontarget plant Yes: Data waiver based 

U.S. EPA (2003) Data Waiver 

Testing on scientific rationale Requests ... May 15. 

2003 

437634-03 

437640-05 

ontarget insect testing Yes; Data waiver based 

U.S. EPA (2003) BPPD Review of 

on scientific rationale Data Waiver 

Requests ... April 

29.2003 

Honey bee testing Yes; Study U.S. EPA (2003) 457391 -02 

The most recent comprehensive risk assessment for Aspe1gillus jlavus NRRL21882 was completed on 

May 24, 2004, in support of the first registration of A.spergillus jlavus NRRL21882, which occurred on 

September 17, 2004. The end-use product, Alfa-Guard GR, was conditionally registered on September 

17, 2004, allowing its usc on peanuts. 

Because there are no data gaps for Aspergillusjlavus NRRL21882, the Agency does not anticipate the 

need to conduct a new risk assessment during registration review. Nevertheless, the EPA plans to 

conduct a literature search to update its understanding of the current state of the science on this pesticide 

and will consider the need to conduct a new risk assessment depending on the findings. 

Product Chemistry (40 C.F.R. § 158.2120} 

TABLE 8. Summary of Product Chemistry Data fo r Aspergil/usjlavus NRRL 21882 

Has Data 

Harmonized Requirement 

Guide MRID/ Accession Number or Other line Data Requirement Been Source 

Numb Reference er Addressed? 

How? 

885.1 100 Product Identity Yes; Study U.S. EPA (2004) 458840-0 I 

46 1968-0 I 

885.1200 Manufacturing Process Yes: Study U.S. EPA (2004) 458840-01 

461968-0 1 

Deposition of a Sample 

885.1250 in a Nationally 

Reco Yes: RRL U.S. EPA (2004) Deposit 0.21882 gnized Culrure 

Collection 

Discussion of Formation U.S. EPA (2004) 458840-0 1 

885.1300 of Unintentional Yes: Study 461968-01 

Ingredients 

I I 
Aspergillus flm,us EPA-HQ-OPP-20 15-0281 

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TABLE 8. Summary ofProduct Chemistry Data for Aspergillusjlavus NRRL 21882 

Has Data 

Harmonized Requirement 

Guide MRID/ Accession Number or Other line Data Requirement Been Source 

Numb Reference er Addressed? 

How? 

458840-0 I 

885.1400 Analysis of Samples Yes: Study U.S. EPA (2004) 461968-0 I 

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

TABLE 9. Summary of Physical and Chemica l Characteristics for Aspergillusjlavus NRRL 21882 

Bas Da ta 

Harmonized Requirement MRID/ Accession Number or 

Guideline Number Data Requirement Been Source Other Reference Addressed? 

Bow? 

830.6302 Color Yes; Study U.S. EPA (2004) I 461968-01 

830.6303 Physical State Yes: 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 

830.63 17 Storage Stability Yes; Study U.S. EPA (2004) 458840-0 I 

46 1968-0 I 

830.6319 Miscibility Yes: Study U.S. EPA (2004) 46 1968-0 I 

830.6320 Corrosion Yes: Study U.S. EPA (2004) 461968-01 Characteristics 

830.7000 pH Yes; Study U.S. EPA (2004) 461968-01 

830.7100 Viscosity Yes; Study U.S. EPA (2004) 46 1968-0 I 

830.7300 Density/relative Yes; Study U.S. EPA (2004) 461968-01 density/bulk density 

12 
Aspergillus flavus 

Harmonized 

Guideline 

Number 

885.3050 

885.3 150 

885.3200 

885.3400 

885.3500 

870.1100 

885.3100 

870.1300 

870.2400 

870.2500 

Harmonized 

Guideline 

Number 

885.4050 

885.4100 

EPA-HQ-OPP-201 5-028 I 

www. regul at ions.gov 

Toxicology (40 C.F.R. § 158.2050) 

TABLE 10. Summary of Toxicology Data for Aspergillusjlavus NRRL 21882 

Has Data 

Data Requirement Requirement Source 

MRID/ Accession Number or 

Been Addressed? Other Reference 

How? 

Acute Oral Toxicity/ 

Pathogenicity Yes, Study U.S. EPA (2004) 461968-02 

Acute Pulmonary 

Tox Yes: Study U.S. EPA (2004) 455840-03 icity/Pathogenicity 

Acute Intravenous Yes: Study U.S. EPA (2004) 458840-04 

Toxicity/ Pathogenicity 462239-0 I 

Yes; Data waived based on scientific 

Hypersensitivity rationale. Any future hypersensiti vity 461968-04 Incidents incidents should be reported per OCSPP 

Guideline 885.3400. 

Cell Culture Not applicable. 

Acute Oral Toxicity Yes; Study U.S. EPA (2004) 458840-03 

Yes; Data waived 458840-02 

Acute Dermal Toxicity based on scienti fie U.S. EPA (2004) 458840-03 

rationale 461968-02 

Acute Inhalation Yes; Data waived 

Toxicity based on scientific U.S. EPA (2004) 458840-03 

rationale 

Yes; Data waived 458840-02 

Acute Eye Irritation based on scientific U.S. EPA (2004) 458840-03 

rationale 461968-02 

Primary Dermal Yes: Data waived 458840-02 

based on scientific U.S. EPA (2004) 458840-03 Irritation 

rationale 461968-02 

Nontarget Organisms and Environmental Fate (40 C.F.R. § 158.2060) 

TABLE 11. Summary of Nontarget Organisms Data for Aspergi/lusjlavus NRRL 21882 

Has Data Requirement MRID/ Accession 

Data Requirement Been Addressed? Source Number or Other 

How? Reference 

A vi an Oral Toxicity Yes: Study U.S. EPA (2004) 462407-01 

Avian Inhalation Yes; Study I U.S. EPA (2004) I Toxicity/Pathogenicity 458840-05 

13 
Aspergillus jlavus 

Harmonized 

Guideline 

Number 

885.4150 

885.4200 

885.4240 

885.4280 

885.4300 

885.4340 

885.4380 

E. 

EPA-HQ-OPP-20 I 5-028 I 

www.regulations.gov 

TABLE 11. Summary of Nontarget Organisms Data for Aspergillus jlavus NRRL 21882 

Has Data Requirement MRID/ Accession 

Data Requirement Been Addressed? Source Number or Other 

How? Reference 

Wild Mammal Toxicity/ Not applicable: No testing expected to be required. Results of the Tier I 

Pathogenicity toxicity tests required by 40 CFR § I 58.2 I 40 (Table 5) are adequate and 

appropriate for assessment of hazards. 

Freshwater Fish Toxicity/ Yes: Data waiver based 

U.S. EPA (2004) Pathogenicity on scientific rationale 

BPPD Review of 

Data Waiver Freshwater Invertebrate Yes: Data waiver based Requests ... May 6. Toxicity/ Pathogenicity on scientific rationale U.S. EPA (2004) 2004 

Estuari ne And Marine Yes: Data waiver based U.S. EPA (2004) Invertebrate Testing on scientific rationale 

BPPD Review of 

Nontarget plant Yes; Data waiver based U.S. EPA (2004) Data Waiver 

Testing on scientific rationale Requests ... May 6, 

2004 

BPPD Review of 

Nontarget insect testing Yes; Data waiver based U.S. EPA (2004) Data Waiver 

on scienti fie rationale Requests ... May 6. 

2004 

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

46196806 

Risk to Threatened and Endangered Species 

One non-aflatoxin-producing strain of Aspergillus jlavus, AF36, was isolated in Arizona and is also 

found in Texas. When applied to cotton, corn, or pistachio at the ri ght time (prebloom), Aspergillus 

jlavus strain AF36 is expected to displace the aflatoxin-producing strains of A. jlavus from the crop and 

field. Data submitted, either as studies or as scientific rationale in support of the ecological risk 

assessment at the time of registration, demonstrated that adverse effects to terrestrial and aquatic 

nontarget organisms are not expected. 

The second strain, NRRL 2 1882, was isolated in Georgia. When applied to peanuts or corn, Aspergillus 

jlavus NRRL 2 1882 also is expected to displace the aflatoxin-producing strains of A. jlavus from the 

crop and field. Published literature searches conducted by the registrant for data waiver justifications 

found no relevant reports of adverse effects on wildlife. The combined evidence of literature citations 

provided by the registrant, product formulation, application, usage on peanuts, and a lack of published 

reports of adverse effects on wildlife indicate that exposure to Alfa-Guard GR should have no 

measurable adverse effects on endangered species. 

The EPA anticipates no effects to federally-listed threatened or endangered species; however, the EPA 

plans to conduct a literature search to determine whether any additional nontarget effects of Aspergillus 

jlavus may have been reported since they were previously assessed at the times of registration. Based on 

14 
A:!!pergillus jlavus EPA-HQ-OPP-20 15-0281 

www.regulations.gov 

the data submitted to support the registrations and additional findings from the literature, if any. the EPA 

will conduct an assessment and make a determination on potential effects to listed species and 

designated critical habitat during Registration Review. 

F. Endocrine Effects 

As required by the Administrator under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 

408(p), the EPA has developed the Endocrine Disrupter Screening Program (EDSP) and has begun to 

implement the screening program that is to be used to test all pesticides in order to determine 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 Administrator may designate."' 

FFDCA section 408(p)(4) authorizes the Administrator, by order, to exempt from the requirements of 

the Estrogenic Substances Screening Program a biologic substance or other substance if a determination 

is made that the substance is not anticipated to produce any effect in humans similar to an effect 

produced by a naturally occurring estrogenic substance. 

Between October 2009 and February 2010, the EPA issued test orders/data call-ins for the first group of 

67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of 

chemicals identified for EDSP screening was published on June 14, 20 13,2 and includes some pesticides 

scheduled for registration review and chemicals found in water. Aspergillusjlavus strain AF36 and 

Aspergillusjlavus NRRL 21882 are not among the group of pesticide active ingredients on the lists to be 

screened under the EDSP. 

The EPA, as part of this Preliminary Work Plan, believes that Aspergillus jlavus is a substance that 

would not likely produce any effect in humans similar to an effect produced by a naturally occurring 

estrogenic substance. As such, pursuant to Section 408(p)(4), the EPA will determine in the future 

whether it can exempt Aspergillusjlavus from the requirements of the Section 408(p) EDSP. In the 

event the EPA does determine to exempt this substance from the EDSP. an order will be issued. 

For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, 

future lists, the test guidelines and the Tier 1 screening battery, please visit our website at 

http://wwll'.epa.gov/endol. 

G. Incidents 

From July 23, 2003 through April 20, 2015, the Office of Pesticide Programs' Incident Data System and 

Ecological Incident Information System indicate that there were no reports of adverse effects to humans 

or the environment from use of the pesticide product containing Aspergillus jlavus strain AF36 as its 

active ingredient. There were reports of three incidents of minor exposure to humans who came into 

contact with Alfa Guard GR, which contains Aspetgillus jlavus NRRL 2 1882 as an active ingredient. 

The EPA will consider any additional incident data or comments submitted in response to this 

Preliminary Work Plan. 

2 Sec http://w\\ \\".rcgulations.gov/#!documcntDctaii:D=EPA-IIQ-OPPT-2009-0.J77-0074 for the second list of chemicals. 

15 
Aspergillus jlavus 

H. Timeline 

EPA-HQ-OPP-20 15-0281 

www.regulations.gov 

Below is the projected timeline for Registration Review case 6008: Aspergillus jlavus. 

Activities Estimated Month/Year 

Opening the Docket - Open Docket and 60-Day Public Comment Period for Aspergillus jlavus June 2015 

strain AF36 

Close Public Comment Period August 2015 

Case Development , . ·• 

Issue Final Work Plan November 2015 

Issue Data Call-in N/A 

Data Submission N/A 

Open 30-Day Public Comment Period for Draft Risk Assessments N/A 

Close Public Comment Period NIA 

Registration Review Decision ., 

Open 60-Day Public Comment Period for Proposed Registration Review January 2016 

Decision 

Close Public Comment Period March 2016 

Final Decision May 2016 

•Estimated Total (years) 1 year .. * Th1s schedule IS subject to rev1s1on should unforeseen 1ssues anse durmg the reg1strat1on rev1ew process. In the event that 

an issue arises, such as the failure to acquire an EDSP exemption or the need to further analyze ecological risk based on an updated literature review, then the EPA would issue an amended Final Work Plan. That Final Work Plan would identify any newly anticipated data needs and set forth a new timeline. 

I. Guidance for Commenters 

The public is invited to comment on the EPA"s Preliminary Work Plan and rationale. The areas below 

highlight topics of special interest to the EPA where comments, infonnation and data, or reference to 

sources of additional information could be of particular use. The EPA will consider all comments, as 

well as any additional information or data provided in a timely manner, prior to issuing a Final Work 

Plan for this case. 

i. Environmental Justice 

The EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, 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 other factors, may have unusually hjgh exposure to the pesticidal use 

of Aspergillus jlavus compared to the general population. Please comment if you are aware of any 

subpopulations that may have atypical, unusually high exposure compared to the general 

population. 

16 
Aspergillus Jlavus 

ii. Water Quality 

EPA-HQ-OPP-20 15-028 1 

www.regulations.gov 

Aspe1gillus jlavus is not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act.3 In addition, no Total Maximum Daily Loads (TMDLs) 

have been developed for Aspe1g illusjlavus.

4 More information on impaired water bodies and TMDLs 

can be found at the EPA's website. 5 The EPA invites submission of water quality data for this 

pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the 

Office of Pesticide Programs (OP P) Standard Operating Procedure: Inclusion of Impaired Water Body 

and Other Water Quality Data in OP P 's Registration Review Risk Assessment and Management 

Process6 to ensure they can be used quantitatively or qualitatively in pesticide risk assessments. 

iii. Trade Irritants 

Through the Registration Review process, the EPA intends to solicit information on trade irritants and, to 

the extent feasible, take steps toward facilitating irritant resolution. The EPA will work to harmonize 

tolerance and international Maximum Residue Limits (MRLs) and, if necessary, may modify tolerance 

levels to do so. Growers and other stakeholders are asked to comment on any trade irritant issues 

resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export markets, 

providing as much specificity as possible regarding the nature of the concern. 

Pesticidal food-use is not allowed. as explicitly stated on the subject product labels, and there is no 

approved tolerance or exemption from the requirement of a tolerance for residues of this pesticide found 

in or on food or animal feed. Moreover, there are no known MRLs for Aspergillus jlavus. Therefore, the 

EPA does not anticipate that current uses of Aspergillus jlavus will pose concerns as trade irritants. 

iv. Additional Information 

Stakeholders are also specifically asked to provide information and data that will assist the EPA in 

refining the risk assessments. The EPA is interested in obtaining the following information regarding 

Aspergillus jlavus: 

}> Additional incident data . 

.,.. Confirmation on the following label information: 

- Sites of application 

-Formulations 

-Application methods and equipment 

- Maximum application rates 

-Frequency of application, application intervals, and maximum number of applications 

- Geographic limitations on use 

.,.. Use or potential use distribution (e.g., acreage and geographical distribution of relevant use 

sites) 

3 Based on 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 TI1is document can be found at h11p: Wll'w.ena.gov O(Jpsrrdl registratio11 re1·iew wafer qualitv soo.hrm. 

17 
Aspergillus jlavus EPA-HQ-OPP-2015-028 I 

www.regulations.gov 

.,.. Median and 901

h percentile reported use rates (lbs active ingredient/! ,000 square feet) from 

usage data - national, state, and county 

.,.. Application timing (date offrrst application and application intervals)- national, state, and 

county 

.,.. Usage/use information for nonagricultural uses 

.,.. Typical application interval (days) 

.,.. State or local use restrictions 

.,.. Monitoring data 

J. Next Steps 

After the 60-day comment period closes, the EPA will review and respond to any comments received in 

a timely manner and then issue a Final Work Plan for case 6008: Aspergillus.flavus. 

18 
Aspergillus jlavus 

ll. BIBLIOGRAPHY 

EPA-HQ-OPP-20 15-0281 

www.regulations.gov 

A. Studies Supporting Registration Review of Aspergillus jlavus 

43763400 USDA/ARS and IR-4 (1995) Submission of Product Chemistry, Toxicity, and Risk Data in Support of 

an Experimental 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 Ingredient 

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) Submission of Product Analysis and Toxicology Data in 

Support of an Experimental 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 Certified 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: (Aspergillus flavus AF36): Final Report: Lab 

Project Number: M96AG84.6G31 : MA M96AG84.6G31 . Unpublished study prepared by 

Microbiological Associates, Inc. 59 p. 

43990000 Interregional Research Project No. 4 ( 1996) Submission of Product Chemistry Data in Support of the 

Application for Experimental 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, Southern Regional Research Center. 6 p. 

44597000 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 Wheat. Transmittal of 1 Study. 

44597001 Cotty, P.; Antilla, L. (1998) Aspergillus flavus Isolate AF36 Manufacturing Process and Discussion 

on the Formation of Unintentional Ingredients. Amendment No. 2 MRID 43763401 : Lab Project 

Number: 528. Unpublished study prepared by USDA/ARS, Arizona Cotton Research and Protection 

Council and Rutgers Univ. 38 p. 

19 
Aspergillus jlavus EPA-HQ-OPP-20 15-0281 

ww1v. regul 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 (1998) Submission of Product Chemistry Data in Support of the 

Petition for Tolerances of Aspergillus flavus in/on Cotton. Transmittal of 1 Study. 

44 713701 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 (2001) 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 Environmental 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. 

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 Studies. 

45739101 Blanchard, E.; Carter, J. (2002) Aspergillus flavus AF36: Acute Pulmonary Toxicity and 

Pathogenicity to the Rat: Interim Report: Lab Project Number: UAR/006. Unpublished study 

prepared by Huntingdon Life Sciences, Ltd. 86 p. {OPPTS 885.3150} 

45739102 Mayer, D. (2001) Honey Bee Field 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 N0.52B: 

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. (2002) 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 (2002) Submission of Toxicity 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 Toxicity 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 Petition for Tolerance of Aspergillus flavus Isolate AF36 

in/on Cotton. Transmittal of 1 Study. 

20 
Aspergillus jlavus EPA-HQ-OPP-20 15-0281 

www.regulations.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 Arizona Cotton Research and Protection Council (2006) Submission of Product Chemistry and 

Efficacy Data in Support of the Amended Registration of Aspergillus Flavus AF36. Transmittal of 2 Studies. 

46859501 Cotty, P. (2006) Product Analysis, Limits, Identification, Determination of Unintentional Ingredients, 

Quality Control, Storage Stability and Viability: Aspergillus flavus AF36. Project Number: 0052B. Unpublished study prepared 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 Data 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/4PRN0/0327B. Unpublished study prepared by Interregional 

Research Project No. 4. 106 p. 

46956402 Braverman, M. (2006) Aspergillus Flavus AF 36 Health Effects Waiver Requests. Project Number: 

IR/4PRN00327B. Unpublished study prepared by Interregional Research Project 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 

Number: 0327B. Unpublished study prepared by Interregional Research Project No. 4. 41 p. 

47935100 IR-4 Project (2009) Submission of Efficacy Data in Support of the Petition for Tolerance 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 

Arizona, Wakelyn Associates. LLC and Interregional Research Project No. 4. 233 p. 

48330100 Arizona Cotton Research and Protection Council (201 0) Submission of Efficacy Data in Support of 

the Amended Registration of Aspergillus Flavus AF36 and the Petition for Tolerance of Aspergillus 

Flavus AF36 for Use on Corn. Transmittal of 1 Study. 

48330101 Cotty, P.; Wakelyn, P.; Braverman, M. (2010) 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 Michilides, T.; Doster, M.; Cotty, P.; et al. (2010) Efficacy Data for Aspergillus flavus- AG36 in 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 Pistachio Amendment #1 to MRID 48363701 . Project 

Number: 0327B. Unpublished study prepared by Interregional Research Project No. 4. 60p. 

21 
Aspergillus jlavus EPA-HQ-OPP-20 15-0281 

www.regulations.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 Circle 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 Ingredients; Analysis of Samples; Certification 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 Sciences ltd. 43 p. {OPPTS 885.3150} 

45884004 Blanchard, E. (2002) Aspergillus flavus NRRL 21882: Acute Intraperitoneal Toxicity 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: 

Avian Inhalation Test Tier 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 Global, 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 Studies. 

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. Unpublished study prepared by Huntingdon Life 

Sciences, Ltd. 53 p. 

46196804 Dorner, J. (2004) Occupational 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. 

22 
Aspergillus jlavus EPA-HQ-OPP-20 I 5-028 I 

www.regulat ions.gov 

46223900 Circle One Global, Inc. (2004) Submission 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 Intraperitoneal 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 Petition 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. Transmittal 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/001/042068. Unpublished study prepared by 

Huntingdon Life Sciences, Ltd .. 26 p. 

47008700 Circle One Global, Inc. (2006) Submission 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 Flavus NRRL 21882. Project Number: 

980/01/53. Unpublished study prepared by Acta Group, L.L.C. 29 p. 

47189200 Circle 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 Study: 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) Supplemental Information to Group A: Product Analysis: Aspergillus flavus NRRL 

21882. Project Number: 980/01/56. Unpublished study prepared by Circle One Global Inc. 30 p. 

47299400 Circle One Global, Inc. (2007) Submission of Efficacy Data in Support of the Amended Registrations 

of Aspergillus flavus 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. Transmittal 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) Submission of Product Chemistry Data in Support of the Registrations of Aspergillus flavus NRRL21882 and Afla-Guard. Transmittal of 1 Study. 

47364501 Dorner, J.; Jacoby, H.; Dolan, S. (2008) Submission of Data to Meet Conditions of Registration 

Product Chemistry Supplementing MRID Nos.: 47008702 and 47189202. Project Number: 

980/001/71 . Unpublished study prepared by U.S. Dept. of Agriculture and Acta Group, L.L.C. 78 p. 

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Aspergillus flavus EPA-HQ-OPP-20 15-0281 

www.regulations.gov 

47416000 Circle One Global, Inc. (2008) Submission of Efficacy Data in Support of the Experimental Use of Afla-Guard on Corn. Transmittal of 1 Study. 

47416001 Dorner, J; Jacoby, H.; Lindros Dolan, S. (2008) Annual Report for Experimental Use Permit No. 

75625-EUP-2, 2007 Season. Project Number: 980/001/81 . Unpublished study prepared by U.S. 

Dept. of Agriculture and Acta Group, L. L. C. 18 p. 

47490100 Circle One Global, Inc. (2008) Submission of Efficacy Data in Support of the Registration of 

Aspergillus flavus NRRL 21882 and the Petition for Tolerance of Aspergillus flavus NRRL 21882 for 

Use on Corn. Transmittal of 1 Study. 

47490101 Jacoby, H.; Dolan, S. (2008) Additional Information in Support of the Tolerance Exempton 

Amendment Petition for Aspergillus flavus NRRL 21882 and Registration Amendments for 

Aspergillus flavus NRRL 21882 and afla-guard to Add the Food and Feed Commodity Corn. Project 

Number: 980/001/091 . Unpublished study prepared by Acta Group, L.L.C. 24 p. 

47904500 Circle One Global, Inc. (2009) Submission of Efficacy Data in Support of the Amended Registration of Afla-Guard. Transmittal of 1 Study. 

47904501 Dorner, J. ; Jacoby, H. ; Dolan, S. (2009) Afla-Guard 2008 Annual and Final Report for Experimental 

Use Permit: Efficacy for Use of Afla-Guard on Field Corn to Reduce Aflatoxin 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. (2010) Submission of Product Chemistry Data in Support of the Amended 

Registration of Afla-Guard. Transmittal of 1 Study. 

48289501 Hipps, A. (201 0) Afla-Guard (A 17798A) - Manufacturing Process Description and Supporting Data. 

Project Number: PC/1 0/102. Unpublished study prepared by Syngenta Crop Protection, Inc. 34 p. 

48557501 Ross, D.; Strader, C. (2011) Aspergillus flavus NRRL 21882: 2010 Efficacy Data for Use of AflaGuard on Popcorn to Reduce Aflatoxin Contamination: Final Report. Project Number: TK0028467. Unpublished study prepared by Vernon G. James Research and Extension Center. 1 Op. 

48557502 Durando, J. (201 1) Aspergillus flavus NRRL 21882 (ASF1084A)- Acute Dermal Toxicity in Rats: 

Final Report. Project Number: 28793 TK0014180. Unpublished study prepared by Eurofins/Product 

Safety Laboratories. 16p. 

48557503 Durando, J. (2011) Aspergillus flavus NRRL 21882 (ASF1084A) - Acute Eye Irritation in Rabbits: 

Final Report. Project Number: 28794 TK0014848. Unpublished study prepared by Eurofins/Product 

Safety Laboratories. 19p. 

B. U.S. Environmental Protection Agency Risk Assessment Memoranda 

BPPD Review of Data Waiver Requests Submitted by IR-4 on behalf of the Arizona Cotton and 

Research Council in support of the Health Effects of Aspergillusjlavus AF36 for use on cotton food/feed 

commodity, May 22,2003 . 

BPPD Review of Product Chemistry and Efficacy Data to satisfy conditions of Registration for 

aspergillus tlavus AF36 [EPA Reg. No. 71693-1 ], September 13, 2007. 

BPPD Review of Soil and Air Monitoring Studies and Product Performance Testing (Efficacy) 

Submitted by USDA Southern Regional Research Center/IR-4 as a Condition of Registration and EUP 

Extension (Texas) for Aspergillusjlavus AF36, May15, 2003. 

Ecological Risk Assessment Aspergillusjlavus NRRL 2 1882. Memorandum from Hilary Hill and 

Zigfridas Vaituzis to Shanaz Bacchus, May 6, 2004. 

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Aspergillus jlavus EPA-HQ-OPP-20 15-028 I 

www. regulations. gov 

U.S. EPA. 2003. Biopesticides Registration Action Document: Aspergillusjlavus strain AF36 (PC Code 

006456), July 3, 2003. 

U.S. EPA. 2004. Biopesticides Registration Action Document: Aspetgillusjlavus NRRL 21882 (PC 

Code 006500), March 24, 2004. 

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