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

1 of 8

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

		Date: April 29, 2015

			Susan MacIntosh

			President

			MacIntosh & Associates, Inc.

			Regulatory Agent On behalf of Pasteuria Bioscience, Inc.

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.

				29 April 2015

			Susan MacIntosh	   ASK StudyDirector "Study Director's Name?"  Study
Director, Degree 				Date

			Regulatory Agent to AgBiTech

				29 April 2015

	Anthony Hawes	Date

CEO

				29 April 2015

	Susan MacIntosh	Date

Regulatory Agent to AgBiTech

APPROVALS PAGE

We, the undersigned, declare that this report accurately represents the
results observed during the course of this study.

			29 April 2015

	 Susan MacIntosh	Date

	       Agent on behalf of AgBiTech

			29 April 2015

	         ASK CoAuthor "Co-Author?"  Coauthor Anthony Hawes	Date

	       CEO, AgBiTech

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,<PHONE_NUMBER>

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 [SD-6840].

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 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-of-action 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 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 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.

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