Adverse Experience Reporting Program (AERP)
The AERP is a quality assurance program established by the APVMA to facilitate responsible management of agricultural chemicals throughout their lifecycle. The aim of the AERP Ag is to ensure that products on the market remain safe, effective, are of acceptable quality, and that instructions and warnings on labels are appropriate.
Agricultural Chemical Products
Agricultural chemical products' includes any substance or organism used to:
- destroy, stupefy, repel, inhibit the feeding of, or prevent pests on plants or other things;
- destroy a plant or to modify its physiology;
- modify the effect of another agricultural chemical product; or
- attract a pest for the purpose of destroying it.
This encompasses all herbicides, insecticides and fungicides. Fertilisers are not considered agricultural chemical products for the purposes of registration unless they modify the physiology of a plant.
Dairy cleansers for on-farm use, crop markers, insect repellents for use on humans, swimming pool disinfectants and algaecides, rodenticides, antifouling paints, timber preservatives and household and home garden products for pest and weed control have been deemed to be agricultural chemical products. Some pest traps and barriers using chemical attractants also require registration.
For a complete definition see the Agricultural and Veterinary Chemicals Code (the Agvet Code) (external site), scheduled to Agricultural and Veterinary Chemicals Act 1994, and the Agricultural and Veterinary Chemicals Code Regulations (external site), (no. 27 of 1995). These instruments legally define both what constitutes and what does not constitute an agricultural chemical product.
Australian Pesticides and Veterinary Medicines Authority (APVMA)
The APVMA is an Australian government statutory authority established in 1993 to centralise the registration of all agricultural and veterinary chemical products into the Australian marketplace.
Category of Manufacture/Product
Type of manufacture for example, sterile products, immunobiologicals, non-sterile products, ectoparasiticides, premixes and supplements.
- Category 1 - Immunobiologicals and sterile veterinary preparations
- Category 2 - Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements
- Category 3 - Ectoparasiticides
- Category 4 - Premixes and supplements
- Category 6 - Single step manufacture
(Note: Category 5 not used)
Electronic Application and Registration System (EARS)
EARS is computer software that provides a secure means of submitting applications and supporting data to the APVMA via the Internet.
Extraneous Residue Limit (ERL)
Extraneous residue limit (ERL) refers to a pesticide residue arising from environmental sources (including former agricultural uses) other than the use of the pesticide directly or indirectly on the commodity. ERL is defined as the maximum concentration of the pesticide residue that is recommended to be legally permitted or recognised as acceptable in or on a food, agricultural commodity or animal feed. The concentration is expressed in milligrams per kilogram of the commodity (or milligrams per litre for liquid commodities).
Feed additive is defined as any substance or agent added to the basic feed mix for continuous long-term administration to livestock for specific purposes, for example, enhancing production or maintenance or health above the levels obtained from the basic feed, improvement of storage qualities and/or the palatability of the basic feed mix.
A completed product which has undergone all stages of production, and which is 'bottled' or packaged, sealed and labeled as required for registration purposes.
Australian Code of Good Manufacturing Practice for Veterinary Chemical Products.
Good Agricultural Practice
The nationally recommended, authorised or registered use-pattern of chemicals, that is necessary for effective and reliable pest control under actual conditions at any stage of production, storage, transport, distribution and processing of food commodities and animal feed.
All operations (steps) involved in the manufacture of veterinary chemical products, including purchase and quality assurance of raw materials, processing and blending or assembly, quality control, packaging, labeling, sterilising and microbiological reduction, analysis and testing, in-process storage, and releasing from manufacture for supply.
Maximum residue limit (MRL)
The maximum residue limit (MRL) is defined as the maximum concentration of a residue, resulting from the registered use of an agricultural or veterinary chemical, that is recommended to be legally permitted or recognized as acceptable in or on a food, agricultural commodity, or animal feed. The concentration is expressed in milligrams per kilogram of the commodity (or milligrams per litre in the case of a liquid commodity).
Meat(s) and Milk(s) [in the fat]
Where consideration has been given to an MRL for meat or milk, and the chemical concerned is fat soluble, the commodity is designated with the qualification '[in the fat]'. 'Meat' MRLs are expressed on a fat basis rather than on a whole product basis. The approach followed in the MRL Standard is that a portion of adhering fat is analysed and the MRLs apply to the clean, dry fat. In the MRL Standard, when an MRL for cattle milk or milks is qualified by '[in the fat]', the MRL applies to the fat portion of the milk. Thus, MRLs are expressed on a fat basis. In the case of a derived or a manufactured milk: product with a fat content of 2% or more, the MRL also applies to the fat portion. For a milk product with fat content less than 2%, the MRL applied should be 1/50 of that for `milk [in the fat]' and should apply to the whole product.
The Agricultural and Veterinary Code Regulations 1995 state that a minor use "in relation to a chemical product or an active constituent, means a use of the product or constituent that would not produce sufficient economic return to an applicant for registration of the product to meet cost of registration of the product, or the cost of registration of the product for that use, as the case requires (including, in particular, the cost of providing the data required for that purpose).
Manual of Requirements and Guidelines (MORAG)
MORAG sets out the requirements and guidelines for registering veterinary and agricultural products in Australia.
In most States, registered products must only be used for purposes that are specified on the label. In practice, situations often arise where chemicals are needed for a use not specified on the label, these are often termed ‘off-label’ uses. The APVMA can consider applications for permits that allow for the legal use of chemicals in ways different to the uses set out on the product label. In certain circumstances, the limited use of an unregistered chemical may also be allowed by permit.
Primary Feed Commodity
A primary feed commodity such as pastures, grains, forages and fodder, for the purpose of this standard, is defined as the product in, or nearly in, its natural state intended for use by:
- (a) the farmers as stockfeed which is used without further processing for livestock animals, or after silaging or similar farm processes, or
- (b) stockfeed manufacturers as a raw material for preparing compounded feeds.
Other definitions can be found in the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 and related legislation.
The PUBCRIS database, which is updated nightly, contains details of agricultural and veterinary chemical products which are registered for use in Australia.
Before an agricultural and veterinary chemical product can be legally supplied, sold, or used in Australia it must be registered by the APVMA.
Step of Manufacture
A single, discrete manufacturing activity, e.g. sterilisation, testing, packaging, labeling, etc.
Sterile or Sterility
Freedom from viable contaminating micro-organisms as described in European Pharmacopoeia (external website) or other contemporary standards. The level of assurance provided by the absence of contamination in the sample as applied to the quality of the batch is a function of both the efficiency of the sampling plan adopted as well as the rigour of the methods employed.
Veterinary Chemical Product
'Veterinary chemical product' includes any substance administered or applied to an animal to:
- prevent, diagnose, cure or alleviate a disease, condition or pest infestation;
- cure or alleviate an injury; or
- modify the physiology.
It also includes:
- any substance that modifies the effect of another veterinary chemical product;
- vitamins, minerals and additives if they are used for any of the purposes mentioned above;
- allergenic substances, medicated blocks and licks, enzymes for animals, direct-fed microbial products and sheep branding substances, and
- stockfeed non-active constituents unless those non-active constituents are included in an Order (‘The Stockfood Non-active Constituents Order’) in the Regulations to the Agvet Code.
- even if a stockfeed constituent is listed in the above Order, it cannot be regarded as a non-active constituent if it is included at a level that has biological or other effects; in these cases the constituent is an active constituent and the product is a veterinary chemical product.
It does not include a substance or mixture of substances prepared by a veterinary surgeon under veterinary prescribing rights.
Non-medicated licks and blocks, stockfoods and stockfood additives must be registered if they carry claims about therapeutic effect, performance or productivity enhancement.
For a complete definition see the Agricultural and Veterinary Chemicals Code (the Agvet Code) (external site), scheduled to Agricultural and Veterinary Chemicals Act 1994, and the Agricultural and Veterinary Chemicals Code Regulations (external site), (no. 27 of 1995). These instruments legally define both what constitutes and what does not constitute a veterinary chemical product.