Definition of terms

A pronounced localised swelling on a plant.

An outgrowth—often more or less spherical—of unorganised cells.

A gas packed in a pressure bottle or pressure tank

A product that generates a gas by a chemical reaction

Pump in which liquid is transferred from inlet to outlet in spaces between teeth on two meshing gears and casting.

The unit of inheritance that is transmitted from parent to offspring and controls the development in the offspring of a characteristic of the parent.

A detectable permanent change within a single gene or its regulating sequences. The change may be a point mutation, insertion, deletion, etc.

From s. 3 of the Agvet Code(Opens in a new tab/window):Gene Technology Act 2000.

Any technique for the modification of genes or other genetic material but does not include sexual reproduction, homologous recombination or any other techniques that may be specified as gene technology in the Gene Technology Act 2000(Opens in a new tab/window) and the Gene Technology Regulations 2001(Opens in a new tab/window).

An agvet chemical product that is not manufactured by the innovator (pioneer) of the product, but rather is a copy (or image) of the pioneer product. A generic product will contain the same active constituent at the same concentration as the pioneer product, but may differ slightly from the pioneer product in its excipient profile. A generic product would be required to have similar levels of efficacy and safety to the pioneer product when applied or administered in the same way as for the pioneer product (ie be bioequivalent to the pioneer product). Generic products are generally registered through demonstration of their similarity to the pioneer product, and are typically presented with a smaller dataset than the pioneer product.

From s. 3 of the Agvet Code(Opens in a new tab/window):Gene Technology Act 2000.

A genetically modified organism is:

1. an organism that has been modified by gene technology
2. an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, or
3. anything declared by the Gene Technology Regulations 2001(Opens in a new tab/window) to be a genetically modified organism, or that belongs to a class of things declared by the regulations to be genetically modified organisms;
   
   but does not include:
    
4. a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy, or
5. an organism declared by the Gene Technology Regulations 2001(Opens in a new tab/window) not to be a genetically modified organism, or that belongs to a class of organisms declared by the regulations not to be genetically modified organisms.

A genetically modified product is a thing (other than a genetically modified organism) that is derived or produced from a genetically modified organism.

A damaging or toxic effect on the genetic material, such as a mutation.

A chemical that induces tumours via a mechanism involving direct damage to DNA.

Carcinogens that produce cancer by directly damaging genetic material.

A broad term that refers to any deleterious change in the genetic material, regardless of the mechanism by which the change is induced.

The genetic make-up of a cell or an organism, usually with reference to a single trait.

A type of average that indicates the central tendency or typical value of a set of figures. Calculated by multiplying the values and then taking the nth root (where n is the number of values in the set) of the resulting product. This mean is more robust than the arithmetic mean, as it is less susceptible to the effects of outliers and better suited to skewed distributions (typical of parasite distributions in populations).

A substance that kills microorganisms.

From s. 3 of the Agvet Code(Opens in a new tab/window): Includes make a statement.

A small, dry, light leaf or bract surrounding the flower or seed of a grass.

A written agreement between the primary manufacturer or registration holder of a veterinary chemical product (the contract giver) and another manufacturer or laboratory that carries out a step in the manufacture of that product (the contract acceptor). The agreement must clearly specify each party's responsibility in relation to every aspect of the manufacturing process, and give assurance of the product quality and product registration particulars.

From r. 3 and r. 61(8) of the Agvet Code Regulations(Opens in a new tab/window) (unless the contrary intention appears):

If directed by the APVMA CEO, the holder of a licence must:

1. undergo an audit by an APVMA inspector, or another person authorised in writing by the APVMA (an auditor), of the facilities, equipment, systems, processes, procedures and personnel used in the manufacture of the chemical products (a GMP audit), and
2. demonstrate to the satisfaction of the APVMA that the holder is complying with the following conditions of the licence:
   1. any conditions imposed on the licence under subsections 126(1) and (2) of the [Agvet] Code(Opens in a new tab/window)
   2. the condition mentioned in paragraph 126(4)(a) of the [Agvet] Code(Opens in a new tab/window) , if the licence is subject to that condition
   3. any of the conditions mentioned in subregulations (3) to (7A) [of r. 61 of the Agvet Code Regulations(Opens in a new tab/window) ] to which the licence is subject.

From r. 3 of the Agvet Code Regulations(Opens in a new tab/window) (unless the contrary intention appears):

Means the Australian Code of Good Manufacturing Practice for Veterinary Chemical Products, published by the APVMA.

The officially recommended or authorised usage of pesticides under practical conditions at any stage of production, storage, transport, distribution and processing of food and other agricultural commodities. This includes accepting the variations in requirements within and between regions, taking into account the minimum quantities necessary to achieve adequate control, and ensuring that the pesticides are being applied in such a manner as to leave a residue that is the smallest amount practicable and that is toxicologically acceptable.

A set of recommendations intended to promote the quality and validity of test data. It covers the organisational processes and conditions under which studies are planned, performed, monitored, recorded, analysed and reported.

Practices utilised in the performance of laboratory investigations that assure the integrity and reliability of the data, and provide a complete and accurate description of the methods employed and the results obtained.

A means of ensuring that veterinary chemical products are consistently manufactured in a safe and clean environment, by specified methods, under adequate supervision, with effective quality control procedures. This ensures that the finished product meets the standards of safety, identity, strength, quality and purity that it is represented to possess.

A program initiated by a company to promote responsible manufacture, use and disposal of their product(s).

In the use of veterinary chemical products, the careful use of registered veterinary chemical products according to the instructions on the label and in the recommended manner so as to achieve the desired effect and leave the minimum amount of residue that is practical.

The small seed or fruit of cereal plants such as wheat, oats, rye, triticale, rice, maize (corn), millet and sorghum.

Bacteria that are not stained by the crystal violet dye (Gram stain) used to classify bacteria.

Bacteria that retain the stain caused by the crystal violet dye (Gram stain) used to classify bacteria.

Ready-to-use active constituent and inert ingredients either in the form of grains or pressed or extruded pellets.

The process whereby a powder is formulated into the form of granules. This assists greatly with accurate application from the air.

A pesticide formulation in the form of discrete, free-flowing dry particles of uniform size for application as a dry dressing without further preparation or dilution. The active constituent is generally mixed homogeneously with the carrier.

The APVMA formulation type code for granule is GR.

A group of monocotyledonous plants that include cereals, sugar cane and pastures.

The vegetative material produced by chlorophyll in plants. 'Green matter' can be used to describe pastures and forage crops, other herbage and grasses, or the leaves of plants, shrubs and trees.

greenhouse

A glass building in which plants that need protection from cold weather are grown.

greenhouse

A glass building in which plants that need protection from cold weather are grown.

The ease with which a material may be broken down by mechanical means under stated conditions.

The hard, non-friable particles present in a material.

The period between commencing of growth in the spring to cessation of growth in the winter.

From the germination of seed to the ripening of the fruit.

Chemical substances (often natural or synthetic hormones) capable, at low concentrations, of modifying plant or animal growth patterns (either accelerating or retarding) or inducing developmental changes. Growth regulators may accelerate or retard the rate or growth or maturation or otherwise change the physiology or behaviour of the organism.

The four growth stages of cereal crops are:

• Tiller or tillering – when additional shoots are developing from the crown
• Joint or jointing – when the stem internodes begin elongating
• Boot or booting – when the upper leaf sheath swells due to the growth of the developing spike or panicle
• Head or heading – when the seed is emerging from the sheath.

good regulatory science practice

A plant disease that has secretion of gum as a well-marked symptom.