Microbial agricultural compounds under the ACVM Act
ACVM position statement: October 2015
IN THIS DOCUMENT
Background
Agricultural compounds that include organisms as they relate to the ACVM Act
Appendix: ACVM registration decision tree for organisms
Background
Agricultural compounds are subject to regulatory control under the Agricultural Compounds and
Veterinary Medicines (ACVM) Act 1997(authorisation and post-authorisation verification of
compliance, and investigation of non-compliance covering import, manufacture, sale and use).
However, the ACVM Act is limited in its relevance to organisms. The definition of an agricultural
compound refers to “any substance, mixture of substances or biological compound”. The definition
does not explicitly refer to organisms. However, it does provide this definition of a biological
compound:
any agricultural compound that is—
a) a preparation of animal origin; or
b) a bacterial or viral vaccine, whether living or not; or
c) a virus, mycoplasma, or other micro-organism, whether living or not; or
d) a product of a virus, mycoplasma, or other micro-organism, or any substance
manufactured for the purpose of having the same action as a product of a virus,
mycoplasma, or other micro-organism.
Therefore, for the purposes of ACVM registration, microbial agricultural compounds are trade name
products that contain micro-organisms. Micro-organisms are here defined as any living organisms
classified as a micro-organism, including but not limited to bacteria, protozoa, Rickettsia, fungi and
viruses, or the genetically modified or naturally occurring mutants of any of these micro-organisms.
According to the definition of micro-organisms above, some organisms could be defined as
agricultural compounds, depending on their use. By implication, other organisms are not agricultural
compounds. There is nothing in the law that supports the view that those other organisms can be
considered as substances or mixtures of substances.
In fact, the only reasonable conclusion is that organisms that are not microbial agricultural
compounds are not agricultural compounds. The view that the ACVM Act is not designed to regulate
organisms per se is reinforced by the fact that subsection 2(2) does not expressly allow the Director
General to make an Order-in-Council to declare an organism itself an agricultural compound (ref
section 2(2)(a)).
Agricultural compounds that include organisms as they relate to the
ACVM Act
Macro-organisms
Macro-organisms are not agricultural compounds and, therefore, are not regulated under the ACVM
Act. Macro-organisms include insects, mites, nematodes, plants, and any other organisms that as a
rule are not defined as microbial agricultural compounds.
Metabolites (e.g. toxins, venoms, enzymes or other biochemical substances) naturally produced by
macro-organisms are not considered separate from the macro-organism unless the metabolite is
isolated from the macro-organism and developed into an agricultural compound in its own right.
Micro-organisms that are part of a naturally occurring macro-organism/micro-organism complex (e.g.
entomopathogenic nematode associated with a symbiotic adventitious bacterium or fungus) are not
considered separate from the complex; and the complex is considered to be a macro-organism.
The complex is not an agricultural compound. However, if the micro-organism is separated from the
macro-organism and developed as an agricultural compound in its own right, then it would be an
agricultural compound if the organism fits the definition of microbial agricultural compounds.
Micro-organisms
Micro-organisms are agricultural compounds if they fit the definition of microbial agricultural
compounds. Micro-organisms that are used with the intention of creating a sustainable, selfperpetuating population in the environment are considered to be biological control agents, not
agricultural compounds.
For biological control agents, an initial release (or series of releases) is required, but little or no
intervention should be necessary after initial establishment of the biological agent in the
environment. Therefore, biological control agents are not considered within the definition of an
agricultural compound.
Metabolites of biological control agents can be agricultural compounds in their own right if they are
isolated from the biological control agent and developed into an agricultural compound in their own
right. Conversely, if the biological control agent is the agent effecting an agricultural benefit via a
naturally produced metabolite, then the metabolite itself will not be considered separate from the
biological control agent.
Macro-organisms as carriers/applicator for agricultural compounds
Macro-organisms that are artificially induced to be carriers or applicators of agricultural compounds
(chemical or microbiological) are not agricultural compounds themselves. The chemical or
microbiological entity effecting an agricultural benefit will be the agricultural compound.
Ministry for Primary Industries
Microbial agricultural compounds October 2015 • 2
Appendix: ACVM registration decision tree for organisms
ACVM registration decision tree for organisms
Is the organism being used for one of the purposes
listed in the definition of an agricultural compound?
Yes
No
Not an agricultural compound
Is the organism a micro-organism (see microorganism definition)?
Yes
No
Not an agricultural compound
Is the intention to create a self-sustaining population in
the environment (i.e. once established, repeat
applications will not be required)?
No
ACVM registration
required
Ministry for Primary Industries
Yes
Not an agricultural compound
Microbial agricultural compounds October 2015 • 3