TITLE

PETITION FOR AN EXEMPTION FROM THE 

REQUIREMENT OF A TOLERANCE FOR 

SPODOPTERA FRUGIPERDA

MULTIPLE NUCLEOPOLYHEDROVIRUS – 3AP2

NOTICE OF FILING

AUTHORS

Susan MacIntosh

MacIntosh & Associates, Inc.

1203 Hartford Avenue

Saint Paul, MN 55116

TEST GUIDELINE

Not Applicable

COMPLETED ON

April 29, 2015

SPONSOR

AgBiTech Pty Ltd

TESTING FACILITY

Not Applicable

Total Number of Pages: 10

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STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS

Compound: Spodoptera frugiperda Multiple Nucleopolyhedrovirus

Title: PETITION FOR AN EXEMPTION FROM THE REQUIREMENT OF A TOLERANCE FOR 

SPODOPTERA FRUGIPERDA MULTIPLE NUCLEOPOLYHEDROVIRUS – 3AP2

NOTICE OF FILING

No claim of confidentiality is made for any information contained in this study on the 

basis of its falling within the scope of FIFRA §10(d)(1)(A), (B), or (C).

Company: AgBiTech Pty Ltd

8 Rocla Court

Glenvale, Queensland, 4350

Australia

Company Agent: Date: April 29, 2015

Susan MacIntosh

President

MacIntosh & Associates, Inc.

Regulatory Agent On behalf of Pasteuria Bioscience, Inc.
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GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT

This study was not conducted in accordance with the requirements for the U.S. EPA 

Good Laboratory Practice (GLP) Standards, 40 CFR 160, 1989. 

Study Director 29 April 2015

Susan MacIntosh Date

Regulatory Agent to AgBiTech

Sponsor 29 April 2015

Anthony Hawes Date 

CEO

Submitter 29 April 2015

Susan MacIntosh Date

Regulatory Agent to AgBiTech
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APPROVALS PAGE

We, the undersigned, declare that this report accurately represents the results observed 

during the course of this study.

Study Director/Author 29 April 2015

Susan MacIntosh Date

 Agent on behalf of AgBiTech

Co-Author 29 April 2015

 Anthony Hawes Date

 CEO, AgBiTech
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EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION 

COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN 

THE FEDERAL REGISTER 

EPA Biopesticides and Pollution Prevention Division contact: Robert McNally, 703-

308-8085

MacIntosh and Associates, Inc, 1203 Hartford Avenue, St. Paul, MN 55116-1622, on 

behalf of AgBiTech Pty Ltd, 8 Rocla Court, Glenvale, Queensland, 4350, Australia

5F8361

EPA has received a pesticide petition (5F8361) from MacIntosh and Associates, Inc, 

1203 Hartford Avenue, St. Paul, MN 55116-1622, on behalf of AgBiTech Pty Ltd, 8 

Rocla Court; Glenvale, Queensland, 4350, Australia proposing, pursuant to section 

408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to 

amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for

microbial pesticide Spodoptera frugiperda Multiple Nucleopolyhedrovirus – 3AP2 [SD6840].

Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, MacIntosh and Associates, 

Inc, 1203 Hartford Avenue, St. Paul, MN 55116-1622, on behalf of AgBiTech Pty Ltd

has submitted the following summary of information, data, and arguments in support of 

their pesticide petition. This summary was prepared by MacIntosh and Associates, Inc, 

1203 Hartford Avenue, St. Paul, MN 55116-1622, on behalf of AgBiTech Pty Ltd and

EPA has not fully evaluated the merits of the pesticide petition. The summary may have 

been edited by EPA if the terminology used was unclear, the summary contained 

extraneous material, or the summary unintentionally made the reader conclude that the 

findings reflected EPA’s position and not the position of the petitioner.

I. MacIntosh and Associates, Inc, 1203 Hartford Avenue, St. Paul, MN 55116-1622, on 

behalf of AgBiTech Pty Ltd Petition Summary 5F8361

A. Product Name and Proposed Use Practices

Spodoptera frugiperda Mulitple Nucleopolyhedrovirus (SfMNPV) is a baculovirus 

characterized by rod-like nucleocapsids contained within a viral envelope. Baculoviridae 

genomes are supercoiled circular double stranded DNA ranging from 90-230 kbp in size. 

Baculoviruses are ancient organisms, likely discovered as early as 5000 years ago as a 

disease impacting the silk industry in Asia. They have been exclusively isolated from 
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arthropods, specifically from Lepidoptera, Hymenoptera and Diptera, and usually 

identified by the species that they infect along with the type of occlusion body that they 

form. SfMNPV has a relatively narrow host range specific for Noctuidae Lepidoptera.

The target pests are Spodoptera frugiperda and Spodoptera exigua.

SfMNPV and NPVs in general are ubiquitous in nature, found in nearly every location 

where investigated. This natural product will be an excellent addition to growers’ options 

for Spodoptera spp. control that reduces or eliminates the need for chemical inputs and 

fits well within an integrated pest management program for organic or conventional 

production.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. The insect viral strain, 

Spodoptera frugiperda Multiple Nucleopolyhedrovirus – 3AP2 [SD-6840] was isolated 

from insect cadavers collected in Missouri (USA). The strain is a natural insect viral

strain that has not been modified in any way and is identical to SfMNPV that are 

ubiquitous in nature. NPVs are known for their ability to control their Spodoptera spp.

hosts and have been shown to reduce larval damage below economic levels leading to 

improved crop production.

2. Magnitude of residues at the time of harvest and method used to determine the 

residue. NA. See 1. Above.

3. A statement of why an analytical method of detecting and measuring the levels 

of the pesticide residue are not needed. No analytical method is included since this 

petition requests an exemption from the requirement of a tolerance.

C. Mammalian Toxicological Profile

Baculoviruses in general have a long history of safe use as microbial pesticides in the 

USA. Baculoviruses have narrow host ranges and virtually no adverse effects in people, 

wildlife, or non-target insects. The active ingredient for all baculoviruses, including 

SfMNPV, is the occlusion bodies (OBs) that are formed in the nuclei of infected cells. 

Target larvae ingest OBs and until about day 4 post-infection, no symptoms are observed. 

From 4-6 days post-infection, the larvae begin to appear diseased and typically stop 

eating at day 6-7 with death occurring between 7-10 days post-infection. This mode-ofaction occurs across all baculoviruses demonstrating the similarity of this group of insect 

control viruses.

The body of toxicology data is quite extensive for NPVs, addressing different routes of 

exposure – oral, pulmonary, dermal and injection – with many different species, rodents, 

dogs, monkeys and even humans for Helicoverpa zea NPV (EPA, 1990). Since the 

reregistration actions completed in 1990, other NPV and GV strains have been registered, 

beet armyworm, Indian Meal Moth, etc. In addition, a full set of toxicology results are 

available from other less related NPVs (e.g., OpNPV, LdNPV) addressing the same 
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routes of exposure but limited to rodent and a dog study. 

The last re-registration documents prepared by EPA that provide detailed historical 

regulatory data and extensive review of health and safety data on NPVs were published in 

1990s (EPA, 1990; EPA, 1996). The full body of toxicology data regardless of the 

baculovirus species is important to cite given the close relatedness of all baculoviruses 

and their common mode of action (see Figure 2, Harrison et al., 2008). An extensive 

genetic analysis of all open reading frames of the SfMNPV as compared to SeMNPV and 

other related insect viruses, demonstrates that these two Spodoptera spp. MNPVs are 

very similar. However they are different species. What makes each strain unique is the 

pest complex that they control.

Perhaps one of the best description of the lack of human toxicity is provided in by OECD 

(2002): 

‘Baculoviruses are naturally occurring pathogens of arthropods. Their 

host range is exclusively restricted to arthropods. No member of this 

virus family is infective to plants or vertebrates. Baculoviruses are 

ubiquitously resent in the environment and have been used for biological 

insect control for more than 100 years. Circumstantial evidence for the 

safety of baculoviruses emerges from the history of contact between 

baculoviruses and humans without any detrimental effect.’

As part of the scientific rationale a bridging study was conducted using mammalian cell 

lines to characterize any mammalian cell effects from SfMNPV. Non-occluded SfMNPV 

isolates, control insect medium (NPV control), spent medium, inactivated virus as 

appropriate and a commercial H. zea NPV product were included in the tests. 

In this study, no cytopathic effects or replication of SfMNPV exposed to any of the 

mammalian cell lines were observed. If NPV nucleic acid had been detected in the cells, 

then viral antigen would have been assayed; and, the presence of infectious virus in the 

supernatant at the same days of incubation would also have been assayed in a sensitive 

insect bioassay. However, since no SfMNPV nucleic acid was detected, no further testing 

was necessary.

The results of this cell culture study, demonstrating a total lack of infectivity or toxicity

of SfMNPV to mammalian cells, allows for a bridge to the many different types of 

mammalian toxicology studies conducted with commercial NPV strains. The common 

mode of action shared by all NPV adds to the weight of evidence that NPVs as a group,

and specifically SfMNPV, will not cause mammalian toxicity. Therefore, SfMNPV 

should be considered as safe as any baculovirus used in past and current commercial end 

products. 

D. Aggregate Exposure

1. Dietary exposure. Since SfMNPV is applied to the crop, there will be 

negligible to non-existent dietary, dermal or inhalation exposure. Use of this baculovirus
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in pesticide products will not increase the exposure of humans beyond normal 

background levels.

i. Food. There will be no accumulation of the insect virus or this SfMNPV

product in any plant tissues or food.

ii. Drinking water. Drinking water is unlikely to be contaminated with SfMNPV, 

because SfMNPV only grows and replicates within it’s Spodoptera spp. host, which are 

limited to plant and soil habitats and do not live in water environments.

2. Non-dietary exposure. Non-dietary exposure of infants, children or the US 

population in general, to SfMNPV are not expected due to the uses of this product within 

agricultural settings.

E. Cumulative Effects

The unique mode-of-action and narrow host range SfMNPV, and of NPV occlusion 

bodies in general, coupled with the lack of mammalian toxicity provides no basis for the 

expectation of cumulative exposure with other compounds.

F. Safety Determination

1. U.S. population. The lack of mammalian toxicity to the insect virus SfMNPV

provides support for our request of an exemption from the requirement of a tolerance set 

forth in this petition, including infants and children. 

2. Infants and children. (See F.1. above)

G. Effects on the Immune and Endocrine Systems

The unique mode-of-action and narrow host range SfMNPV, and of NPV occlusion 

bodies in general, coupled with the lack of mammalian toxicity provides no basis for the 

expectation of effects on the immune or endocrine systems.

H. Existing Tolerances

No tolerances or tolerance exemptions have been granted for SfMNPV. However, these 

naturally occurring insect viruses have all been granted exemptions from the requirement 

of a tolerance; Heliocoverpa zea NPV (§180.1027), Spodoptera exigua NPV 

(§180.1118), Anagrapha falcifera MNPV (§180.1149) and Cydia pomenella GV 

(§180.1148) and Indian Meal Moth GV (§180.1218). 

I. International Tolerances

No international tolerances or tolerance exemptions have been granted for SfMNPV.