Definitions
3 Definitions
In this Code, unless the contrary intention appears:
active constituent, in relation to a proposed or existing agricultural chemical product or veterinary chemical product, means the substance that is, or one of the substances that together are, primarily responsible for the biological or other effect identifying the product as an agricultural chemical product or a veterinary chemical product, as the case may be.
adequate, in relation to instructions on a label for containers for a chemical product, means adequate to ensure, as far as reasonably practicable, that the product meets the safety criteria and the trade criteria.
agricultural chemical product has the meaning given by section 4.
agvet law means:
the Agvet Code or the Agvet Regulations of this, or another, jurisdiction; or
the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994; or
the Agricultural and Veterinary Chemicals (Administration) Act 1992.
agvet penalty provision means:
a civil penalty provision of the Agvet Code or the Agvet Regulations of this, or another, jurisdiction; or
a civil penalty provision of the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994; or
a civil penalty provision of the Agricultural and Veterinary Chemicals (Administration) Act 1992.
animal means any animal (other than a human being), whether vertebrate or not, and whether a food‑producing species or not, and includes:
mammals, birds, bees, reptiles, amphibians, fish, crustaceans and molluscs; and
the semen, ova or embryo of an animal (other than a human being) or any other substance or thing directly relevant to the reproduction of an animal (other than a human being); and
any other prescribed form of animal life, whether prescribed by reference to a species or in any other way.
application means an application under this Code.
approval means approval under Part 2 of:
an active constituent for a proposed or existing chemical product; or
a label for containers for a chemical product.
approved active constituent means an active constituent that is approved and complies with the relevant particulars entered in the Record for the constituent.
approved analyst means a person appointed under subsection 69G(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 to be an approved analyst for the purposes of this Code.
approved form means a form approved by the APVMA or prescribed by the regulations.
approved label means a label that is approved and complies with the relevant particulars recorded in the relevant APVMA file for the label.
APVMA means the Australian Pesticides and Veterinary Medicines Authority continued in existence by section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992.
Australia includes any external Territories that are participating Territories.
authorising party for information means a person who would be entitled to bring an action for breach of an obligation of confidence if the information were disclosed by someone else to the APVMA for the purposes of this Code without the person’s permission.
chemical product means an agricultural chemical product or a veterinary chemical product, or both.
Chief Executive Officer, in relation to the APVMA, includes a person acting as the Chief Executive Officer of the APVMA.
civil penalty order has the meaning given by section 145A.
civil penalty provision means a provision declared by this Code to be a civil penalty provision.
claim includes any statement.
confidential commercial information, in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product or a constituent of a chemical product, means:
a trade secret relating to the constituent or product; or
any other information relating to the constituent or product that has a commercial value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed; or
information (other than trade secrets to which paragraph (a) applies or information to which paragraph (b) applies) that:
concerns the lawful commercial or financial affairs of a person, organisation or undertaking; and
relates to the manufacture, distribution or supply of the constituent or product; and
if it were disclosed, could unreasonably affect the person, organisation or undertaking in an adverse manner;
but does not include:
the making of an application for a permit for the use of an active constituent for a proposed or existing chemical product or for the use of a chemical product, if the use of the product proposed in the application is:
a minor use; or
an emergency use; or
any prescribed information relating to the making of an application for a permit, as mentioned in paragraph (d).
constituent, in relation to a chemical product, means any constituent of the product, whether an active constituent or not.
container includes anything by which or in which a chemical product is, or is to be, covered, enclosed, contained or packaged, but does not include a container (such as a shipping container) in which other containers of chemical products are, or are to be, placed for the purpose of being transported.
continue, in relation to an approval or registration, has, for the purposes of Part 3, the meaning given by subsection 59(6).
co‑ordinator, in relation to a jurisdiction, means a person designated:
if the jurisdiction is a State—by a Minister of the State; or
if the jurisdiction is the participating Territories:
if the Australian Capital Territory is the only participating Territory—by a Minister of the Australian Capital Territory; or
if there is more than one participating Territory—jointly by a Minister of the Commonwealth and a Minister of the Australian Capital Territory;
to perform the functions of a co‑ordinator under this Code.
copy, in relation to a warrant issued under section 143 or 143A (or a form of warrant completed under subsection 143B(6)), includes:
a copy sent by fax or other electronic means; or
a copy of a copy so sent.
corresponding previous law means a previous law of this jurisdiction that corresponds wholly or partly to this Code, to the extent that it so corresponds.
criteria includes standards.
damage, in relation to data, includes damage by erasure of data or addition of other data.
data includes:
information in any form; and
any program (or part of a program).
date‑controlled chemical product means a chemical product declared by the regulations to be a date‑controlled chemical product.
date of manufacture, in relation to a chemical product, means the date on which formulation of the product was completed.
deal with, in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product, includes supply or otherwise dispose of the constituent or product.
determine, in relation to an application, means:
approve, register, renew, vary or issue upon the application; or
refuse the application.
director, in relation to a body corporate incorporated for a public purpose by a law of the Commonwealth, of a State or of a Territory, means:
a constituent member of the body; or
if the body does not have any members—a member of the board or other group of persons responsible for the administration or management of the affairs of the body.
distinguishing number includes a distinguishing number together with one or more letters or symbols, or both.
electronic signature of a person means the unique identification of the person in an electronic form approved by the APVMA.
eligible law, in relation to a jurisdiction, means a law, or a provision of a law, of that jurisdiction that is declared by a law of that jurisdiction to be an eligible law for the purposes of this Code.
emergency use has the same meaning as in the regulations.
environment includes all aspects of the surroundings of human beings, whether affecting them as individuals or in their social groupings.
established standard has the meaning given by subsection 8U(7).
evidential burden, in relation to a matter, means the burden of adducing or pointing to evidence that suggests a reasonable possibility that the matter exists or does not exist.
evidential material means any of the following:
a thing with respect to which an offence against an agvet law has been committed or is suspected, on reasonable grounds, to have been committed;
a thing with respect to which an agvet penalty provision has been contravened or is suspected, on reasonable grounds, to have been contravened;
a thing that there are reasonable grounds for suspecting will afford evidence as to the commission of such an offence or contravention of such an agvet penalty provision;
a thing that there are reasonable grounds for suspecting is intended to be used for the purpose of committing such an offence or contravening such an agvet penalty provision.
excluded organism means an organism that is declared by the regulations to be an excluded organism.
executive officer of a body corporate means a person, by whatever name called and whether or not a director of the body, who is concerned in, or takes part in, the management of the body.
expiry date, in relation to the contents of a container, means the month and year after which the contents must not be used.
fee includes a fee that is a tax.
file includes a file of information stored or recorded by means of a computer.
food‑producing species means an animal that produces food for human consumption or is used as food for human beings, and includes:
any buffalo, cattle, deer, fish (other than ornamental fish), goat, kangaroo, pig, poultry, rabbit, sheep, bee, crustacean or mollusc; or
any animal declared by the regulations to be a food‑producing species.
give information includes make a statement.
handling includes transportation, storage, processing, use or disposal.
holder:
in relation to an approval or registration, means:
the person entered in the Record, Register or relevant APVMA file as the holder of the approval or registration; or
if the holder was an individual who has died or is an individual whose affairs are being lawfully administered by another person—the legal personal representative of the individual or the person administering the individual’s affairs; or
if the holder was a body corporate—a successor in law of the body corporate; or
in relation to a permit or licence, means the person to whom the permit or licence was issued.
inspector means:
a person appointed as an inspector for the purposes of this Code under subsection 69F(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992; or
a person to whom an authorisation referred to in subsection 69F(2) of that Act applies for the purposes of this Code.
instruction includes direction, caution, warning or recommendation.
instructions approved by the APVMA includes authorisations and requirements (however described) set out in a permit.
investigation powers has the meaning given by sections 132A, 132B and 132C.
investigation warrant means:
a warrant issued under section 143A; or
a warrant signed by a magistrate under section 143B, being a warrant of the same kind as would have been issued under section 143A.
jurisdiction means:
a State; or
the participating Territories.
label includes tag, leaflet, brand, stamp, mark, stencil or written statement.
licence means a licence under Part 8.
limitation period has the meanings given by section 34M.
See also section 34MA (which deals with extensions of limitation periods).
listed chemical product means a chemical product that:
is, or is included in a class of chemical products that is, listed by regulations under section 8T; and
complies with the established standard for the product.
lodged, in relation to an application under this Code or a notice under Division 2AA of Part 2, has the meaning prescribed by the regulations.
manufacture, in relation to a chemical product, means:
to produce the chemical product; or
to engage in any part of the process of producing the chemical product, or any component or ingredient of the chemical product as part of that process, or of bringing the chemical product to its final state, including by formulating, processing, assembling, packaging, labelling, storing, sterilising, testing, supplying or releasing for supply.
manufacturing principles means principles that the APVMA has determined under section 23 of the Agricultural and Veterinary Chemicals Act 1994 to be principles to be observed in the manufacture of chemical products.
Maximum Residue Limits Standard means the Maximum Residue Limits Standard, made under the Food Standards Australia New Zealand Act 1991, as in force from time to time, or any standard in force in substitution for that standard.
meets the application requirements has the meaning given by section 8A.
meets the efficacy criteria has the meaning given by subsection 5B(1).
meets the labelling criteria has the meaning given by subsection 5D(1).
meets the notice requirements has the meaning given by subsection 26AD(1).
meets the safety criteria has the meaning given by subsection 5A(1).
meets the trade criteria has the meaning given by subsection 5C(1).
member of the staff, in relation to the APVMA, has the same meaning as in the Agricultural and Veterinary Chemicals (Administration) Act 1992.
minor use has the same meaning as in the regulations.
monitoring powers has the meaning given by sections 131A, 131B and 131C.
monitoring warrant means:
a warrant issued under section 143; or
a warrant signed by a magistrate under section 143B, being a warrant of the same kind as would have been issued under section 143.
nominated agent, for an approval or registration, means the person entered in the Record, Register or relevant APVMA file as the nominated agent for the approval or registration.
notifiable variation, of the relevant particulars of an approval or registration, has the meaning given by subsection 26AB(3).
occupier, in relation to any premises or a part of any premises, means the person in occupation, charge or control of the premises or of that part of the premises, as the case may be.
ordinary office hours means the hours when the office of the APVMA is open to members of the public.
participating Territory has the same meaning as in the Agricultural and Veterinary Chemicals Act 1994.
penalty unit has the same meaning as in section 4AA of the Crimes Act 1914.
permit means a permit under Part 7.
person assisting an inspector:
in relation to the exercise of monitoring powers—has the meaning given by section 131D; and
in relation to the exercise of investigation powers—has the meaning given by section 132E.
pest means:
in relation to an animal, plant or thing—any animal, plant or other biological entity that injuriously affects the physical condition, worth or utility of the first‑mentioned animal or plant or of that thing; or
in relation to a place—an animal, plant or other biological entity that injuriously affects the use or enjoyment of that place.
place of residence, in relation to a body corporate that is incorporated in Australia, means its registered office in Australia.
plant means any vegetation or fungus and includes a seed or cutting of a plant, or any other part or product of a plant.
premises includes any place (whether enclosed or built on or not), including a place situated under ground or under water, and, in particular, includes:
a building, aircraft, vehicle or vessel; and
any structure, whether a fixed structure, or a moveable structure such as a tent, and whether on land or the bed of any waters or floating on any waters; and
a part of premises (including a part of premises of a kind referred to in paragraph (a) or (b)).
prescribed means prescribed by the Agvet Code of this jurisdiction or by the regulations.
prescribed active constituent has the meaning given by subsection 14C(4).
prescribed chemical product has the meaning given by subsection 14D(4).
prescribed civil penalty provision means a civil penalty provision that is prescribed by the regulations.
prescribed label for containers for a chemical product has the meaning given by subsection 14E(4).
prescribed variation, of the relevant particulars of an approval or registration, has the meaning given by subsection 26B(4).
previous registering authority means a registering authority under a corresponding previous law.
previously endorsed active constituent for a chemical product at a particular time means a substance that:
before that time, had been approved or registered (however described) under a law of the Commonwealth or a State or Territory as an active constituent for a chemical product; or
was an active constituent for a chemical product that, before that time, had been approved or registered (however described) under a law of the Commonwealth or a State or Territory as a chemical product;
whether or not the approval or registration was a result of an application by a particular person.
primary active constituent has the meaning given in section 59.
primary chemical product has the meaning given in section 59.
primary holder means:
in relation to a primary active constituent—the holder by whom, or on whose behalf, protected information was given to the APVMA in respect of the constituent; or
in relation to a primary chemical product—the holder by whom, or on whose behalf, protected information was given to the APVMA in respect of the product.
prohibited chemical product means a chemical product that is declared by the regulations to be a prohibited chemical product.
protected active constituent means an active constituent for a proposed or existing chemical product, being an active constituent to which each of the following paragraphs apply:
the constituent is or includes an invention in respect of which letters patent were granted under the Patents Act 1952 or the Patents Act 1990;
the term of the letters patent (including any extension of that term):
has ended; or
will end during the protection period (including that period as extended) that applies to protected information about that constituent;
the constituent is approved under Part 2.
protected chemical product means a chemical product to which each of the following paragraphs apply:
the product is or includes an invention in respect of which letters patent were granted under the Patents Act 1952 or the Patents Act 1990;
the term of the letters patent (including any extension of that term):
has ended; or
will end during the protection period (including that period as extended) that applies to protected information about that product;
the product is registered under Part 2.
protected commodity means:
any substance or thing of a kind used, or capable of being used, as food or drink by human beings; or
any substance or thing of a kind used, or capable of being used, as an ingredient or additive in, or any substance used in the preparation of, a substance or thing referred to in paragraph (a); or
any plant or animal; or
any soil, water or other environmental component; or
any other agricultural commodity; or
any animal feed; or
any other prescribed substance or thing; or
any substance or thing that is capable of being made into anything referred to in any of the above paragraphs;
but does not include a therapeutic good within the meaning of the Therapeutic Goods Act 1989.
protected information means information or results given to the APVMA as required under paragraph 32(1)(b) or 33(1)(a) or (c), or subparagraph 159(1)(d)(i), (ii) or (iii), that:
have been obtained because of a trial or laboratory experiment; and
relate to:
an active constituent that has been approved; or
a chemical product that has been registered.
protection period, in relation to protected information, means the period that:
begins when the information is first given to the APVMA in relation to a reconsideration; and
ends 8 years after the APVMA makes its decision on the reconsideration.
See also section 34KA (which deals with extensions of the protection period).
published literature, in relation to a particular matter, means all documents that relate to that matter and are accessible to the public.
recall notice means a notice issued under section 101, 102 or 103.
Record means the Record of Approved Active Constituents for Chemical Products kept under section 17.
Record of Permits means the Record of Permits kept under section 113.
re‑entry period, in relation to the use of a chemical product in a particular place (including a use of the 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.
Register means the Register of Agricultural and Veterinary Chemical Products kept under section 18.
registered chemical product has the meaning given by section 5AA.
registration means registration under Part 2 of a chemical product.
regulations means the Agvet Regulations of this jurisdiction.
relevant APVMA file means the file in which information about approved labels is recorded as mentioned in paragraph 21(c).
relevant data 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.
relevant particulars 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(c) to be entered in the Record; and
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) to be entered in the Register; and
in relation to the approval of a label—the information required to be recorded in the relevant APVMA file by subparagraphs 21(c)(i) to (iva);
and includes particulars of variations of relevant particulars made under section 26, 26AC, 26C, 29, 29A, 34A or 34AF.
repealed Act means the Agricultural and Veterinary Chemicals Act 1988.
reserved 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.
reserved chemical product means a chemical product that is, or is included in a class of chemical products that is, specified in the Reserved Schedule.
Reserved Schedule means the schedule contained in the regulations under section 56ZU.
residues, in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product, means:
subject to paragraph (b), any remains, persisting in or on a protected commodity, of:
the active constituent, or the active constituents in the chemical product; or
any derivatives, metabolites, or degradation products, of the active constituent or of the active constituents in the chemical product; or
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 this Code.
restricted chemical product means a chemical product declared by regulations made for the purposes of section 93 to be a restricted chemical product.
sample includes specimen.
secondary active constituent has the meaning given in section 59.
secondary chemical product has the meaning given in section 59.
secondary holder, in relation to a secondary active constituent for a proposed or existing chemical product, means:
if the APVMA is considering an application for the approval of that constituent—the person who made the application; or
if the APVMA has reconsidered or is reconsidering the approval of that constituent:
the person entered in the Record as the holder of the approval; or
if the holder was an individual who has died or is an individual whose affairs are being lawfully administered by another person—the legal personal representative of the individual or the person administering the individual’s affairs; or
if the holder was a body corporate—a successor in law of the body corporate.
secondary holder, in relation to a secondary chemical product, means:
if the APVMA is considering an application for the registration of that product—the person who made the application; or
if the APVMA has reconsidered or is reconsidering the registration of that product:
the person entered in the Register as the holder of the registration; or
if the holder was an individual who has died or is an individual whose affairs are being lawfully administered by another person—the legal personal representative of the individual or the person administering the individual’s affairs; or
if the holder was a body corporate—a successor in law of the body corporate.
State includes the Northern Territory.
substance includes:
any gas, liquid, mixture or compound of gases, or mixture or compound of liquids; and
an organism or part of an organism, including a genetically manipulated organism or part of a genetically manipulated organism; and
material that is produced from an organism; and
matter whose production involves the use of an organism;
but does not include an excluded organism or part of an excluded organism, or material that is produced from, or matter whose production involves the use of, an excluded organism.
supply includes do, or cause or permit the doing of, any of the following:
sell;
expose for sale;
send or deliver for sale or on sale;
dispose of under a hire purchase agreement;
exchange;
give;
offer to do an act that would be a supply (including an act referred to in any of the above paragraphs);
and, for example, includes supply under a contract for work or labour that also involves the supply of any thing.
Territory does not include the Northern Territory;
thing, except where used as an object of the verb “to do”, includes:
an animal; and
information; and
a document; and
a substance.
this Code means the Agvet Code of this jurisdiction and includes the Agvet Regulations of this jurisdiction.
use, in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product, includes deal with the constituent or product.
variations includes additions, omissions, substitutions and modifications.
veterinary chemical product has the meaning given by section 5.
veterinary surgeon means a person who is registered as a veterinary surgeon under the law of a State or Territory.
warrant means a monitoring warrant or an investigation warrant.
withholding period, in relation to the use of a chemical product, means the minimum period that needs to elapse between:
the last use of the product in relation to a crop, pasture or animal; and
the harvesting or cutting of, or the grazing of animals on, the crop or pasture, the shearing or slaughtering of the animal, or the collection of milk or eggs from the animal for human consumption, as the case may be;
in order to ensure that the product’s residues fall to or below the maximum limit that the APVMA permits.
working day means a day other than a Saturday, a Sunday or a day that is a public holiday in the place where the office of the APVMA is situated.
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