99Information and documents about, and analysis of, substances supplied as active constituents or chemical products

#### 99 Information and documents about, and analysis of, substances supplied as active constituents or chemical products (1) This section applies if the APVMA reasonably believes that it is necessary to exercise powers under this section: (a) to protect the health and safety of human beings; or (b) to protect animals, plants or things, or the environment; or (c) to prevent significant prejudice to trade or commerce between Australia and places outside Australia. (2) The APVMA may give written notice to a person who has, has had or will have, possession or custody of a substance or mixture of substances that is or was intended for supply by the person: (a) as a chemical product; or (b) as an active constituent for a proposed or existing chemical product; requiring the person to give the APVMA information or documents specified in the notice or to take the steps specified in the notice. (3) The notice may require the person to give to the APVMA, within such reasonable period as is specified in the notice, information or documents required by the notice about the following: (a) the constituents of the substance or mixture; (b) the concentration of the constituents of the substance or mixture; (c) the formulation type of the substance or mixture; (d) the composition or purity of a constituent of the substance or mixture; (e) the name of each manufacturer of the substance or mixture; (f) the address of each site at which the substance or mixture is manufactured; (g) the packaging or labelling of the substance or mixture; (h) advertising material related to the substance or mixture; (j) if the substance or mixture is intended to be supplied, or has been supplied, as an active constituent for a chemical product, or as a chemical product, under a particular name—the name of the constituent or product and whether: (i) the substance or mixture conforms to any standard prescribed in respect of the constituent or product with that name, any established standard or any other prescribed requirement; or (ii) the supply of the substance or mixture is or was in accordance with any conditions applying to the approval or registration of the constituent or product with that name; (k) any other prescribed information or documents. (4) The notice may also require the person, within such reasonable period as is specified in the notice: (a) to have the substance or mixture analysed to find out about the matters mentioned in paragraphs (3)(a) to (d) and paragraphs (3)(j) and (k); and (b) to give the results of the analysis to the APVMA; and (c) to give the analyst’s certificate to the APVMA. (4A) Without limiting subsection (4), the notice may require any one or more of the following: (a) that samples of the substance or mixture are taken: (i) under the supervision of an inspector; or (ii) in the manner stated in the notice; (b) that the analysis is carried out: (i) under the supervision of an approved analyst; or (ii) in the manner stated in the notice; (c) that the analysis is carried out at a prescribed laboratory; (d) that the analysis is carried out within a period stated in the notice; (e) that the analysis is carried out at the expense of the person. (4B) Information or results required to be given to the APVMA must be given in writing. > Note: For giving information electronically, see section 156A. (5) A person to whom a notice is given under subsection (2) must not fail to comply with the notice. (5AA) A person commits an offence of strict liability if the person contravenes subsection (5). Penalty: 120 penalty units. > Note: For strict liability, see section 6.1 of the Criminal Code. (5A) Subsection (5AA) does not apply if the person has a reasonable excuse. > Note: The defendant bears an evidential burden in relation to the matter in subsection (5A). See subsection 13.3(3) of the Criminal Code. (5B) Subsection (5) is a civil penalty provision. > Note: Division 2 of Part 9A provides for pecuniary penalties for contraventions of civil penalty provisions. (6) The APVMA may publish in a manner that it thinks appropriate: (a) the name, and the address of the place of business, of: (i) the person who had possession or custody of the substance or mixture; and (ii) if the substance or mixture is intended for supply as a chemical product and the person referred to in subparagraph (i) is not the holder of the registration—the holder; and (b) the result of the analysis of the substance or mixture. (7) If a requirement made under this section is inconsistent with an earlier requirement made under this section, the earlier requirement is, to the extent of the inconsistency, of no effect.