Definition of terms

A genetically, and as a rule geographically, distinct mating group within a species.

Equimolar mixtures of enantiomers.

A composite (solid, liquid, gaseous or in solution) of equimolar quantities of two enantiomeric species. It is devoid of optical activity.

The ability of an agvet chemical product to remain on a treated surface after exposure to a specified spray of water (reflecting exposure to rainfall after application).

A seedbed raised above ground level to provide better management options, including improved (targeted) fertiliser use and water management. Raised beds also improve soil physical conditions, resulting in better—drained and aerated soil. Permanent raised bed cropping systems are used under a wide range of irrigated and dry-land farming conditions, and are especially beneficial in heavy soils where waterlogging and soil compaction are problems.

The process of assigning study animals, groups of study animals, plants or areas of crops to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

The arrangement of experimental units in groups (blocks) that are similar to one another. The blocking factor is typically a source of variability that is not of interest in the experiment and thus can be used to control that source of variability.

Land producing forage crops for annual consumption to be harvested by grazing and which is not cultivated, seeded, fertilised, irrigated or treated with pesticides or other such similar practices on an annual basis. Fence rows enclosing range areas are included as part of the range.

Low prevalence parasite species that may or may not be able to produce significant morbidity and clinical symptoms, usually limited to certain geographic locations.

The amount of an agvet chemical that is being delivered to a plant, animal or area—a measurement of the volume that is being applied. Rates are expressed in metric units to suit the particular type of application, eg litres per hectare (L/ha), litres per minute (L/min), milligrams per kilogram of body weight (g/kg bw).

The amount of an active constituent applied to a unit area.

From s. 3 of the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994(Opens in a new tab/window):

Has the meaning given by section 12C [of the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994(Opens in a new tab/window) ].

New plants that grow from stubble that remains after the harvesting of a crop. In several crops (eg sorghum, sugar cane), a ratoon crop provides an opportunity to harvest a second crop without the need to replant. Stubble-strewn crops are either sprayed out or burnt after harvest in a minimal tillage situation, or mechanical cultivation is used to minimise the emergence of a ratoon crop.

Any plant or part of a plant, animal or animal product that is to be bought or sold in the raw (unprocessed) form. For the purpose of establishing or enforcing maximum residue limits, the term means the commodity in, or nearly in, its natural state, intended for processing into food for sale to the consumer or intended for sale to the consumer as a food without further processing. It includes, among other things:

• fresh fruits, whether or not they have been washed, waxed or otherwise treated in their unpeeled or natural form
• vegetables in their raw or natural state, whether or not they have been stripped of their outer leaves, washed, waxed or otherwise treated in their unpeeled form
• cereal grains
• nuts
• eggs
• raw whole milk
• meats
• other similar agricultural products.

Any original worksheets, calibration data, records, memoranda and notes of first-hand observations and activities of a study that are necessary for the reconstruction and evaluation of the study. Raw data may include, but are not limited to, photographic materials, magnetic, electronic or optical media, information recorded from automated instruments and hand-recorded datasheets. Raw data may also be verified copies of original data, but facsimile transmissions and transcribed data are not considered raw data.

In terms of manufacturing, any chemical or physical substance used in the manufacture of a product, but not including packaging materials.

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

In relation to the use of a chemical product in a particular place (including the use of a product in relation to a crop or pasture in that place), means the period after that use during which it is unsafe for a person to enter the place without wearing appropriate protective clothing or equipment, or both.

One or more administrations of a vaccine used to maintain the initial protective effects induced by the primary vaccination schedule. The first (or only) dose of the re-vaccination is given a relatively long time (eg three months or more, depending on the species and the disease) after the primary vaccination schedule.

A product arising from the reaction of a substance with an excipient in an agvet product or immediate container or closure system.

A substance, other than a starting material or solvent, that is used in the manufacture of an agvet chemical.

Testing on the product stored in the container and closure system intended for marketing, under proposed storage conditions that support a proposed shelf life for that product.

An action taken by a registration holder (either voluntarily or compulsorily as directed by the APVMA) to reduce the harmful effect of non-compliant agvet chemical products or non-compliant batch(es) of an agvet chemical product. This may include stopping supply or publishing product alert notices to locate, retrieve and destroy all non-compliant product within the supply chain or distribution network.

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

A notice published under section 101, 102 or 103 [of Part 6 [of the Agvet Code(Opens in a new tab/window) ].

A recall notice requires persons who have (or have had) stocks of agvet chemical products in their possession to stop supplying the products(s) and take whatever actions the APVMA requires to result in an effective recall.

A sprayer system with the nozzle aimed at a catchment device that recovers and recirculates herbicide that is not intercepted by plants.

In terms of manufacturing, the process of comparing, after making due allowance for normal variation, the amount of product or in-process materials actually produced with the amount of starting materials used, and the theoretical or expected amount.

A reconsideration of an active constituent or label approval or chemical product registration.

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

Means the [APVMA's] Record of Approved Active Constituents for Chemical Products kept under section 17 [of the Agvet Code(Opens in a new tab/window) ].

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

Means the record of permits kept under section 113 [of the Agvet Code(Opens in a new tab/window) ].

In terms of manufacturing, the documentation that confirms that a particular process has been carried out correctly. Collectively, records provide a history of each batch of product, including its distribution and all other relevant circumstances pertinent to the quality of the final product.

A practice that involves grazing of stubble and weed growth after harvest, followed by seedbed preparation involving substantially less cultivation than for a conventional system. This may be the only cultivation followed by sowing, with an appropriate application of contact herbicide before or after sowing.

Crop management practices that enable a crop to be grown with less tillage operations than would be the case for conventional cultivation. Herbicides are used for fallow weed control. There are four such systems: reduced cultivation, direct drilling, minimum tillage and no-tillage.

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

Has the meaning given by regulation 3A [of the Agvet Code Regulations(Opens in a new tab/window) ].

For an application mentioned in section 11B or 28B of the [Agvet] Code(Opens in a new tab/window) (the primary application), means an active constituent that:

1. is the subject of another application, being an application under section 10 or 27 of the [Agvet ] Code that was lodged before the primary application, and
2. is referred to in the primary application because information that is relevant to the active constituent is also relevant to the primary application.

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

Has the meaning given by regulation 3B [of the Agvet Code Regulations(Opens in a new tab/window) ].

For an application mentioned in section 11B or 28B of the [Agvet] Code(Opens in a new tab/window) (the primary application), means a chemical product that:

1. is the subject of another application, being an application under section 10 or 27 of the [Agvet] Code(Opens in a new tab/window) that was lodged before the primary application, and
2. is referred to in the primary application because information that is relevant to the chemical product is also relevant to the primary application.

In certain circumstances, an applicant may nominate a reference product to support their application to register an agvet chemical product in order to assist the APVMA to be satisfied against the statutory criteria.

An area within a geographic location defined by a combination of factors that may include things such as climatic conditions, target animal husbandry, soil type, land use patterns and pest prevalence.

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

From s. 3 of the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994(Opens in a new tab/window):

In relation to a jurisdiction, means registered under a registration law of the jurisdiction.

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

Means a chemical product that complies with the relevant particulars set out in the Register [of Agricultural and Veterinary Chemical Products] for the product.

From s. 3 of the Agvet Code(Opens in a new tab/window): Means registration under Part 2 [of the Agvet Code(Opens in a new tab/window) ] of a chemical product.

In summary, registration is the process whereby the APVMA approves the supply of a formulated product in Australia, after the process of evaluation and assessment of appropriate scientific data and/or argument demonstrates that the product is efficacious and not unduly hazardous to human health or to the environment, and that it will not adversely affect trade.

From s. 3 of the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994(Opens in a new tab/window):

In relation to a jurisdiction, means:

1. if there is an Agvet Code(Opens in a new tab/window) of the jurisdiction that is in force—Part 2 of that Code(Opens in a new tab/window), including (to avoid doubt) Part 2 of that Code(Opens in a new tab/window) as it has effect because of the operation of Part 11 of that Code(Opens in a new tab/window), or
2. otherwise—a prescribed law of the jurisdiction

and also has an extended meaning as mentioned in subsections (2) and (2A) of s. 3 of the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994(Opens in a new tab/window) .

The main consultative forum between the APVMA, the states, territories and Australian Government agencies, relating to operational management of the National Registration Scheme.

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

Means the Agvet Code Regulations(Opens in a new tab/window) [related to the agvet legislation].

A forum for the coordination and exchange of information, ideas and expertise between the Australia Government agencies that regulate therapeutic goods, pesticides and veterinary medicines, food safety, biosecurity, gene technology, industrial chemicals and radiation protection.

The primarily administrative actions required by the APVMA to return a non-compliant system to compliance, and ensure continued compliance in the future. While not punitive in nature, costs may be associated with addressing APVMA requirements.

An online collection of published documents made by the APVMA under s 6A of the Agvet Code(Opens in a new tab/window) that includes technical and supporting information to assist stakeholders in their interactions with the APVMA and describes how the APVMA makes risk-related regulatory decisions about agvet chemicals.

The regulatory guidelines describe how the APVMA aligns regulatory effort with risk and improve the transparency and consistency of APVMA processes and decisions. The regulatory guidelines replace the APVMA's Manual of requirements and guidelines (MORAG). During their development, the regulatory guidelines were referred to as the Risk compendium.

Punitive measures intended as a response to non-compliant action or behaviour for the purpose of deterrence. Usually applied in conjunction with regulatory action.

A high-level internal forum that considers and provides advice on the resolution of strategic regulatory issues. The RSG promotes cooperation, collaboration and communication between the different program areas within the APVMA.

for ectoparasiticide dips

The addition of undiluted product to the dip without the addition of water to ensure that stripping is compensated for and the concentration of the dip remains above the minimum effective concentration as the dip volume decreases, especially during dipping out.

The combination of physical, chemical, biological and microbiological test requirements that a product (generally a veterinary chemical product) must meet to be declared suitable for release for supply or sale at the conclusion of the manufacturing process.

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

Means the file in which information about approved labels is recorded, as mentioned in paragraph 21(c) [of the Agvet Code(Opens in a new tab/window) ].

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

Means information relevant to determining whether:

• an agvet law has been, or is being, complied with, or
• information provided under an agvet law is correct.

From s. 3 of the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994(Opens in a new tab/window):Means the financial year in which the leviable disposals in respect of which the levy is payable took place.

A ‘relevant person’ has been convicted of a relevant offence if they have been:

• convicted of an offence against an agvet law or a law of this or another jurisdiction relating to chemical products, or
• held a permit that was cancelled under subsection 119(2) or section 119B of the Agvet Code(Opens in a new tab/window) or under a corresponding provision of the Agvet Code(Opens in a new tab/window) of another jurisdiction, or
• held a manufacturing licence or permit that was cancelled for any reason other than under subsection 127(1)(d) or (e) of the code or a corresponding provision of the Agvet Code(Opens in a new tab/window) of another jurisdiction, or
• ordered to pay a pecuniary penalty for the contravention of an
  • agvet law
  • a law of this or another jurisdiction relating to chemical products
  • a law of the Commonwealth or of a state or territory involving fraud or dishonesty, even if a court has decided not to record a conviction, or the relevant person was convicted of a relevant offence while a manager or interest holder in relation to another entity at the time of the offence.

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

Means:

• in relation to the approval of an active constituent—the distinguishing number, any instructions for use and any other particulars required by paragraph 19(1)(c) [of the Agvet Code(Opens in a new tab/window)] to be entered in the Record [of Approved Active Constituents for Chemical Products]
• in relation to the registration of a chemical product—the distinguishing number, any instructions for use and any other particulars required by paragraph 20(1)(c) [of the Agvet Code(Opens in a new tab/window) ] to be entered in the Register [of Agricultural and Veterinary Chemical Products], and
• in relation to the approval of a label—the information required to be recorded in the relevant APVMA file by subparagraphs paragraph 21(c)(i) to (iva) [of the Agvet Code(Opens in a new tab/window)]
• and includes particulars of variations of relevant particulars made under sections 26, 26C, 29, 29A, 29G, 34A or 34AF [of the Agvet Code(Opens in a new tab/window) ].

in relation to the suitable person test

The relevant person is:

• the applicant, or
• any person who makes or participates in making decisions that affect the whole, or a substantial part of, the applicant's affairs, or
• if the applicant is a body corporate holder, a major interest holder in the body corporate.

'Relevant' means related to the active constituent in that product or related to the claims and use patterns in that product. 

'Scientific argument' includes arguments based on data published in peer reviewed journals, texts, relevant case studies/trial data, or accepted scientific principles.

A product that is identical in all respects to another registered product (the reference product) except for the product name, product number or the registration holder details.

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

Means the Agricultural and Veterinary Chemicals Act 1988.

A treatment that follows an identical treatment on the same site or on the same animal.

The precision under the same operating conditions over a short interval.

A pesticide that makes pests leave or avoid a treated area, surface, animal or plant.

A chemical which drives insects or other pests away from a treated person, animal, object or area.

The reworking from a defined stage of production of all or part of a batch of product of an unacceptable quality so that its quality may be rendered acceptable by one or more additional operations.

Investigations into the effect of a chemical or drug on the capacity of both male and female reproductive systems.

Adverse effects or abnormalities in, for example, gamete production, reproductive cycle (eg menstrual disorders), sexual behaviour (as seen in animals), fertility, gestation, parturition and/or lactation, pregnancy outcomes (spontaneous abortion, stillbirth, etc.) and premature reproductive senescence (ie early menopause).

A permit issued by the APVMA that allows research and development of registered and unregistered agvet chemical products.

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

Means reserved by being a chemical product that is, or is included in a class of chemical products that is specified in the Reserved Schedule.

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

A chemical that is, or is included in, a class of chemical products that is specified in the Reserved Schedule (Schedule 3C of the Agvet Code Regulations(Opens in a new tab/window)).

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

Means the schedule contained in the regulations under section 56ZU [of the Agvet Code(Opens in a new tab/window) ].

A term applied to a herbicide, insecticide or fungicide that refers to the persistent effectiveness of its residue. Some pesticides have long residual action if they are effective for some time after application, whereas others may have short residual action.

Poisons that have a similar uptake mechanism to contact poisons, but will remain active for a longer period, depending on the method of application.

The potential of viruses or bacteria that have been attenuated for specific target animal species and for specific routes of administration to retain different levels of pathogenicity (eg induction of clinical signs or lesions of disease, or persistence or latency of the microorganism in the body of vaccinated animals) under certain conditions of use (eg in animals of a certain age or class), as demonstrated in a passage test.

The total amount of residues that have relevance to the acceptable daily intake established for an active constituent.

A scientific investigation to determine the nature, level and fate of chemicals on crops, animals, food and other environmental components, following the proposed use of an agvet chemical product.

The amount (usually expressed in parts per million—ppm) of pesticide that may legally and safely remain in, or on, raw farm products at the time of sale (if the food or feed or plant or animal is to be eaten by livestock or people).

A term used in United States and by some other trading partners to mean the legally tolerated or legally permitted (maximum) residue limit.

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

In relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product, means:

1. subject to paragraph (b), any remains, persisting in or on a protected commodity, of
   1. the active constituent, or the active constituents in the chemical product, or
   2. any derivatives, metabolites, or degradation products, of the active constituent or of the active constituents in the chemical product, or
2. if the APVMA has published a notice in the Gazette for the purposes of this paragraph that applies to the active constituent or chemical product—only such of the remains referred to in paragraph (a) as are specified in the notice to be remains that constitute residues of the active constituent or of the chemical product for the purposes of [the Agvet] Code(Opens in a new tab/window).

In summary, ‘residue(s)’ are any remains persisting in or on a commodity, of the active constituent(s) in the chemical product or any derivatives, metabolites or degradation products of the active constituent(s) in an agvet chemical product, arising from the direct use of the product or indirect exposure to the product or its residues. Residues may occur in plants, animals, soil, water or other environmental components. Residues are normally measured in units mg/kg.

The APVMA may publish a notice that specifies those remains of the active constituent(s) in an agvet chemical product that are considered to be residues for the purposes of the Agvet Code(Opens in a new tab/window). Specific definitions for residues for individual chemicals are found in Table 3 of the maximum residue limit standard.

The inherited ability of a pest or pest population to tolerate the label rate of application of an agricultural or veterinary chemical product. May also be applied to describing the tolerance of an environmental factor by an organism. Survivors of a treatment or environmental condition will pass on their tolerance or resistance to their progeny, resulting in changes in the population-wide level of resistance. Resistance may be influenced by a single gene or multiple genes, and may develop very quickly if a single gene is involved. Resistance can be an important factor in the useful lifespan of a chemical and may be managed by the careful rotation of products with active constituents that have different modes of action.

The use of pesticides and alternate pest control measures so as to minimise or delay the development of resistance in the target pest.

A term used to describe insects, fungi, bacteria, weeds or any other living organisms that are able, because of their genetic make-up, to survive the disruption of life processes brought about by pesticides that normally cause the death of the organism.

The antibiotic concentration, at the site of action within the target species, at which organisms whose minimum inhibitory concentrations (MICs) are above this concentration are unlikely to respond to treatment with that antibiotic.

Plants produced through selective breeding to possess a genetic make-up that improves their ability to withstand attacks by pests.

A species that is difficult to kill or control with a particular pesticide, generally due to possession of resistance genes in its genetic make-up.

Breathing; inhalation and exhalation.

A facemask that removes toxic gases and particles from the air, enabling a person to breathe and work safely in a toxic atmosphere.

Having to do with the breathing of the lungs, the nose and mouth and the oxygen supply to an animal.

Label statements that place an absolute limitation or restriction on the approved use of the product. Restraint statements usually start with the words 'DO NOT…'. Restraint statements are enforceable under law.

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

Means a chemical product declared by the [Agvet Code] regulations(Opens in a new tab/window) made for the purposes of section 93 [of the Agvet Code(Opens in a new tab/window) ] to be a restricted chemical product.

Restricted chemical products may only be supplied to authorised persons and there are offences and civil penalties for the supply of restricted chemical products to unauthorised persons.

Restricted chemical products may only be supplied to authorised persons and there are offences and civil penalties for the supply of restricted chemical products to unauthorised persons.

Limitations under the law.

The occurrence of harmful effects—caused by a substance—that disappear after the exposure to the substance ends.

An underground stem, bearing buds in the axils of reduced scale-like leaves, as seen in mint, couch grass and bracken fern.

Roads, stock routes, pathways, railways, power lines, telephone lines, fuel and water pipelines.

The management of riparian zones, which includes that part of the landscape that exerts a direct influence on stream channels or lake margins, and on the water and aquatic ecosystems contained within them.

Any land that adjoins, directly influences, or is influenced by, a body of water. It includes the land immediately alongside small creeks and rivers, including the riverbank itself, gullies and dips that sometimes run with surface water, areas surrounding lakes, and wetlands on river floodplains that interact with the river in times of flood.

Some state and territory legislation includes definitions of riparian lands, which normally refer to a strip of a set width (usually 20 to 40 metres) along the banks of designated rivers and streams.

The probability of an adverse effect in an organism, system or (sub) population caused under specified circumstances by exposure to an agent.

With respect to antibiotic resistance, the risk being assessed is the probability of disease due to infection of susceptible humans with antibiotic-resistant pathogens arising from the use of antibiotics in animals and the consequences of infections caused by such pathogens in susceptible humans.

A process consisting of three components: risk assessment, risk management and risk communication.

A scientifically based process, generally consisting of a series of steps identifying and characterising hazard, exposure and risk.

The qualitative and/or quantitative evaluation, including related uncertainties, of the probability of exposure and severity of susceptible organisms (including humans) or hazards to the environment.

An interactive process involving the exchange of information and opinion about the nature, severity and acceptability of risks and decisions taken to manage them.

The process of evaluating alternative actions, selecting options and implementing them in response to risk assessments and seeking to minimise or eliminate risks. A risk management strategy is selected after an analysis of all available options.

Phrases that describe the hazards associated with the normal, or reasonably foreseeable, handling or use of a substance. Phrases may be set that include effects of overexposure or any likely chronic effects following multiple low-level exposures.

The potential hazard of a chemical to the environment that can be determined by dividing the estimated environmental concentration by the relevant toxicity concentration. The resulting score (the risk quotient) then provides a measure of the risk to the organism concerned.

of an analytical procedure

A measure of the capacity of the analytical procedure to remain unaffected by small variations in method parameters. The robustness measure provides an indication of the procedure's reliability during normal usage.

A cylindrical solid, with a minimum diameter of 2 millimetres (mm) and a length greater than its diameter.

Any animal of the order Rodentia, including but not limited to rats, mice and hamsters. It does not include rabbits, which are members of the Lagomorpha.

Any substance or mixture of substances intended for preventing, destroying, repelling or controlling rodents declared to be pests.

A pump in which liquid is transferred between vanes formed by rollers that are bedded in the surface of the rotor.

A nematode-caused disease characterised by galls on the roots. The disease is most commonly found in sandy soils, where it attacks hundreds of different kinds of plants.

The common name of several species of nematodes.

The fleshy root of a herbaceous perennial plant with buds and eyes.

The plant variety used to provide vigorous, disease-free roots onto which a scion of a perennial crop is budded or grafted.

A flat circlet of leaves spreading from a very short stem and pressed close to the ground (eg as in plantains, dandelions and young stages of variegated and scotch thistle).

A state of decomposition and putrefaction. It may range from dry and firm to mushy and slimy and is caused by the disintegration of a large number of living cells. Rot is caused by fungi and bacteria.

The excess of a spray solution that runs off a surface after it has been thoroughly wetted.

Brownish, roughened or corky areas on the skin of leaves, fruit or tubers, caused by disease, insects or spray injury.