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Biotech News APVMA Guidelines for the Registration of Biological Agricultural Products In brief: Senior Associate Caroline Ryan provides an overview of the APVMA's Guidelines for the Registration of Biological Agricultural Products that have been issued to assist Applicants in understanding the additional data requirements to be addressed when applying to register an agricultural chemical product with an active constituent that comprises or is derived from a living organism. |
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- Background
- Biological Agricultural Products
- Data Requirements – Biological Agricultural Products
- Genetically Modified Products
- Conclusion
Background
As reported in an earlier edition of Biotech News, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is the Australian Government agency responsible for the assessment, registration and regulation of pesticides and veterinary medicines, up to and including the point of retail sale.
A number of products of biological origin are encompassed by the definition of Agricultural Chemical Product in the Agricultural and Veterinary Chemicals Code (the Code), and are therefore subject to regulation by the APVMA. As biological products can have different properties to conventional chemical products, the APVMA has recently published separate Guidelines for the Registration of Biological Agricultural Products (the Guidelines) to assist Applicants in understanding the additional requirements to be addressed when applying to register a Biological Agricultural Product.
Biological Agricultural Products
The Guidelines define a Biological Agricultural Product as an agricultural chemical product with an active constituent that comprises or is derived from a living organism, with or without modification. This definition encompasses a number of chemicals that are commonly referred to by manufacturers as being 'herbal', 'organic' or 'botanical' products.
The Guidelines identifies the following 4 groups of Biological Agricultural Products as being subject to additional requirements.
Group 1 – Biologically Derived Chemicals (including pheromones, hormones, growth regulators, enzymes and vitamins).
Group 2 – Unpurified or Partially Purified Extracts (such as plant and some food product extracts, oils).
Group 3 – Microbial Agents (such as fungi, viruses, and bacteria).
Group 4 – Other Living Organisms (such as microscopic insects, plants and animals, including some organisms that have been genetically modified).
The Guidelines identifies the following as categories of products that are not considered to be Biological Agricultural Products.
Products categorised as conventional agricultural chemical products
Products where the active constituent is a biologically derived chemical that has direct toxicity to the target species and can be purified, fully identified and has a residue detection method applied, are not considered to be Biological Agricultural Products for the purpose of the Guidelines. An example of this category includes nicotine and strychnine-based products.
Exempt Products
Schedule 3 of the Code Regulations specifically exempts certain classes of products from registration. These include soil ameliorants, fertilisers and domestic disinfectants. More detailed information on what is considered to be an exempt product can be obtained directly from the APVMA.
Plant Growth Stimulating Products
Plant growth stimulating products that are not for pest control or specific growth regulation are dealt with under State and Territory regulation and are not administered by the APVMA. Products based on plant hormones are required to be registered with the APVMA.
Higher Plants
Higher plants are not required to be registered with the APVMA. However, certain categories of genes inserted in the genome of plants may require registration. For example, genes that code for the production of pesticidal substances are considered to be a pesticide and require regulatory approval and registration.
Data Requirements – Biological Agricultural Products
During the evaluation process for registration of a new product, the APVMA takes full account of the nature of the product on a case by case basis, including a review of the data supplied by the Applicant. This process requires the Applicant to supply data to the APVMA in relation to the following categories:
a) Chemistry & Manufacture;
b) Toxicology;
c) Metabolism and Toxicokenitics;
d) Residues;
e) Overseas Trade Aspects;
f) Occupational Health & Safety;
g) Environmental Aspects;
h) Efficacy and Safety; and
i) Any Special Data Requirements.
Chapter 4 of the Guidelines discusses in detail the additional data requirements for Biological Agricultural Products categorised in Group 1 and 2. This includes additional information such as the biological properties of the active constituent, and the likely biological effects arising from use of the Biological Agricultural Product.
Chapter 5 of the Guidelines discusses in detail the additional data requirements for Biological Agricultural Products categorised in Group 3 and 4. This Chapter includes important information such as what details are required to be given during the Application process for the purpose of identifying the active agent (being either a microbial agents or some other living organism).
Genetically Modified Products
The Guidelines recognise that products from any of the Groups outlined above can consist of or be derived from genetically modified organisms (GMOs). Products based on GMOs are identified in the Guidelines as having additional data requirements concerning genetic manipulation.
Applicants will be required to provide additional information on the following items:
1. the host organism;
2. the donor organism;
3. genetic engineering techniques used;
4. identity of the inserted or deleted gene segment;
5. information on the control region of the gene;
6. description of the new traits or characteristics that are intended to be expressed;
7. tests to evaluate genetic stability and exchange; and
8. environmental expression and toxicology tests.
In addition to complying with the requirements of the APVMA, such products are also likely to be subject to regulation by the Gene Technology Regulator under the Gene Technology Act 2000 (Cth).
Conclusion
In most cases, before agricultural and veterinary chemical products can be sold, supplied, distributed or used in Australia, they must be registered by the APVMA. In many cases, such products are based on an active constituent that comprises or is derived from a living organism, and will therefore be required to meet additional data requirements during the Application process. The Guidelines have been issued by the APVMA to assist Applicants in understanding the additional requirements to be addressed when applying to register a Biological Agricultural Product.
The APVMA welcomes comments and suggestions for improvement on the usefulness of the Guidelines. Comments can be submitted to the Program Manager Pesticides, APVMA PO Box E240, Kingston, ACT, 2604.
For further information please contact Dr Trevor Davies on +61 2 9230 4007.
