Commonwealth: Industrial Chemicals (Notification and Assessment) Amendment (Low Regulatory Concern Chemicals) Act 2004 (Cth)

Industrial Chemicals (Notification and Assessment) Amendment (Low Regulatory Concern Chemicals) Act 2004 No. 110, 2004 An Act to amend the Industrial Chemicals (Notification and Assessment) Act 1989, and for related purposes Contents 1 Short title 2 Commencement 3 Schedule(s) Schedule 1—Amendment of the Industrial Chemicals (Notification and Assessment) Act 1989 Part 1—Amendments Part 2—Application provisions Industrial Chemicals (Notification and Assessment) Amendment (Low Regulatory Concern Chemicals) Act 2004 No. 110, 2004 An Act to amend the Industrial Chemicals (Notification and Assessment) Act 1989, and for related purposes [Assented to 13 July 2004] The Parliament of Australia enacts: 1 Short title This Act may be cited as the Industrial Chemicals (Notification and Assessment) Amendment (Low Regulatory Concern Chemicals) Act 2004. 2 Commencement (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms. Commencement information Column 1 Column 2 Column 3 Provision(s) Commencement Date/Details 1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table The day on which this Act receives the Royal Assent. 13 July 2004 2. Schedule 1 A single day to be fixed by Proclamation. 9 August 2004 (Gazette 2004, No. S320) However, if any of the provision(s) do not commence within the period of 6 months beginning on the day on which this Act receives the Royal Assent, they commence on the first day after the end of that period. Note: This table relates only to the provisions of this Act as originally passed by the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent. (2) Column 3 of the table contains additional information that is not part of this Act. Information in this column may be added to or edited in any published version of this Act. 3 Schedule(s) Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms. Schedule 1—Amendment of the Industrial Chemicals (Notification and Assessment) Act 1989 Part 1—Amendments 1 Section 5 Insert: chargeable person, in relation to a registration year, means: (a) a person who proposes to introduce relevant industrial chemicals in that registration year of a value that equals or exceeds the threshold value if that person: (i) did not introduce relevant industrial chemicals in the previous financial year; or (ii) introduced relevant industrial chemicals in the previous financial year of a value less than the threshold value; or (b) a person who proposes to introduce relevant industrial chemicals in that registration year of any value if that person introduced relevant industrial chemicals in the previous financial year of a value that equalled or exceeded the threshold value. 2 Section 5 (definition of confidential section) Omit "subsection 12(4)", substitute "subsections 12(4) and (4A)". 3 Section 5 (definition of confidentiality request) Repeal the definition. 4 Section 5 Insert: controlled use permit means a permit under section 22F. 5 Section 5 (definition of cosmetic) Repeal the definition, substitute: cosmetic has the same meaning as cosmetic product has in the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991. 6 Section 5 Insert: hazardous chemical has the meaning prescribed by the regulations. 7 Section 5 (definition of hazardous substance) Repeal the definition. 8 Section 5 (definition of holder) Repeal the definition, substitute: holder, in relation to a permit or an assessment certificate, means a person in respect of whom the permit or certificate is issued. 9 Section 5 (definition of low volume permit) After "subsection 21U(2)", insert "or (2A)". 10 Section 5 (definition of new industrial chemical) Repeal the definition, substitute: new industrial chemical means: (a) either: (i) if the chemical is a listed industrial chemical whose introduction is subject to a condition of use under section 13—the chemical but only to the extent that the manufacturer or importer of the chemical introduces, or proposes to introduce, the chemical for any other use; or (ii) otherwise—an industrial chemical that is not a listed industrial chemical; and (b) in the case of a synthetic polymer—a chemical that is a new synthetic polymer; but does not include the following: (c) a reaction intermediate; (d) an incidentally‑produced chemical. 11 Section 5 (definition of non‑confidential section) Omit "subsection 12(2)", substitute "subsection 12(3)". 12 Section 5 Insert: non‑hazardous chemical has the meaning given by subsection (2). 13 Section 5 Insert: permit means: (a) a commercial evaluation permit; or (b) a low volume permit; or (c) a controlled use permit; or (d) an introduction permit. 14 Section 5 Insert: polymer of low concern means a polymer that: (a) either: (i) has a number average molecular weight, as defined by the regulations, that is greater than 1,000; or (ii) has a number average molecular weight, as defined by the regulations, that is less than or equal to 1,000, and has such other characteristics as are prescribed by the regulations; and (b) has a low charge density, as so defined; and (c) is not a hazardous chemical; and (d) does not dissociate readily, as so defined; and (e) under the conditions in which it is used is stable, as so defined; and (f) has such other characteristics as are prescribed by the regulations. 15 Section 5 (definition of registrable person) Repeal the definition. 16 Section 5 (definition of registration charge) Omit "registrable person", substitute "chargeable person". 17 Section 5 Insert: self‑assessed assessment certificate means an assessment certificate given under subsection 39(1A). 18 Section 5 (definition of synthetic polymer of low concern) Repeal the definition. 19 At the end of section 5 Add: (2) In this Act: non‑hazardous chemical means a chemical in respect of which the following conditions are met: (a) the chemical is not a hazardous chemical; (b) the chemical is not a dangerous good; (c) the prescribed criteria relating to the environmental effect of the chemical have been met; (d) any other prescribed conditions have been met; (e) the introduction of the chemical is consistent with the reasonable protection of occupational health and safety, public health and the environment. (3) The Director must take account of the following matters in deciding whether he or she is satisfied that the condition referred to in paragraph (e) of the definition of non‑hazardous chemical is met: (a) the proposed nature of the use of the chemical; (b) the extent of the proposed use of the chemical; (c) the effect of the chemical on the environment; (d) the effect of the chemical on occupational health and safety and public health; (e) the structure and activity of the chemical; (f) whether, in Australia or overseas, the chemical is the subject of: (i) investigations initiated by a person because of concerns about a possible adverse effect on occupational health and safety, public health or the environment; or (ii) action taken by a person to control the use of, or access to, the chemical; (g) any other prescribed matter. 20 Subsection 11(3) (note) Repeal the note. 21 At the end of section 11 Add: (4) However, if the importation or manufacture of the chemical is subject to a condition included in the Inventory under section 13, the chemical may only be imported or manufactured without obtaining an assessment certificate or permit if the importation or manufacture is in accordance with the condition. Note: Subsections (3) and (4) are not intended to be an exhaustive description of the effects or consequences of including a chemical, or a condition on the importation or manufacture of a chemical, in the Inventory. There may be other consequences, express or implied, because of other provisions of the Act. 22 At the end of subsection 12(3) Add: ; and (f) any condition of use, or any other condition, to which the importation or manufacture of a chemical referred to in paragraph (d) or (e) is subject under section 13; and (g) any other matter included under section 13 in respect of a chemical referred to in paragraph (d) or (e). 23 After subsection 12(4) Insert: (4A) The confidential section is also to contain approved particulars of: (a) any condition of use, or any other condition, to which the importation or manufacture of a chemical referred to in paragraph (4)(a) or (c) is subject under section 13; and (b) any other matter included under section 13 in respect of a chemical referred to in paragraph (4)(a) or (c). 24 After section 12 Insert: 13 Conditions of use etc. of, and other information about, chemicals (1) The Director may include in the Inventory the following particulars in respect of a chemical included in the Inventory: (a) particulars of any condition of use to which the importation or manufacture of the chemical is subject; (b) particulars of any other condition to which the importation or manufacture of the chemical is subject; (c) any particulars about the assessment of the chemical under Division 3 of Part 3; (d) any other particulars in respect of the chemical that are prescribed by regulations for the purposes of this section. Note 1: For example, the Director may include particulars recommending the secondary notification of a chemical in particular circumstances. Note 2: The Director is required to give notice in the Chemical Gazette if the Director proposes to include particulars in the Inventory (see section 13A). Note 3: A person who breaches a condition on the importation or manufacture of a chemical in the Inventory might commit an offence (see section 15A). (2) The Director may: (a) include particulars at the time a chemical is included in the Inventory or at a later time; and (b) vary particulars already included in the Inventory in respect of a chemical; and (c) remove particulars already included in the Inventory in respect of a chemical. Note: The Director is required to give notice in the Chemical Gazette if the Director proposes to include or vary particulars in the Inventory (see section 13A). 13A Director to notify of inclusion or variation of particulars (1) If at any time the Director proposes, under section 13, to include or vary particulars in the Inventory in respect of a chemical, the Director must give notice in the Chemical Gazette that he or she proposes to include or vary the particulars in respect of the chemical. (2) The notice must state: (a) the name under which the chemical has been or is to be included in the Inventory; and (b) any name by which the chemical is commonly known; and (c) that the Director proposes to include or vary the particulars in the Inventory in respect of the chemical; and (d) that a person may give a statement to the Director, within 28 days of the date of publication of the notice, giving reasons why the particulars should not be included or varied. (3) If the Director knows the name and address of a person who is introducing or proposes to introduce the chemical, the Director must send a copy of the notice to the person. (4) If the Director receives a statement from a person giving reasons why the particulars should not be included or varied, the Director must reconsider the proposed inclusion or variation in the light of the statement. (5) If the Director accepts the reasons why the particulars should not be included or varied, the Director must: (a) publish a notice in the Chemical Gazette that the particulars are not going to be included or varied in respect of the chemical; and (b) give a copy of the notice to the person who gave the statement. (6) If the Director rejects the reasons why the particulars should not be included or varied, the Director must: (a) give the person who made the statement notice of the decision to reject the reasons; but (b) not include or vary the particulars until 28 days after the date of the giving of the notice or, if the person applies to the Tribunal for review of the decision, until the review has been finalised. (7) A notice under this section may be included with a notice under another section under this Act. 25 Before section 14 Insert: 13B Inclusion of new industrial chemical in non‑confidential section of Inventory before 5 years (1) This section applies if: (a) an assessment certificate (other than an extension of an original certificate) for an industrial chemical is in force; and (b) the period of 5 years from the giving of the certificate has not yet ended; and (c) the holder or each holder of the certificate applies in the approved form to the Director for the inclusion of the chemical in the non‑confidential section of the Inventory; and (d) if the application is made after 28 days of the giving of the certificate—the fee prescribed under section 110 is paid. (2) If there are any other assessment certificates in force in respect of the new industrial chemical, the Director must give each holder or holders of those assessment certificates (including each holder of an extension of such a certificate) written notice: (a) informing them of the proposed inclusion; and (b) setting out the terms of subsections (3) and (4). (3) The holder or each holder of any of those other assessment certificates may apply to the Director in the approved form, within 28 days of the giving of the notice, for the chemical not to be included in the non‑confidential section of the Inventory. (4) If an application is made under subsection (3) within the 28 days, the Director: (a) must not include the chemical in the non‑confidential section of the Inventory; and (b) must give a written notice to the applicant or applicants under subsection (1) stating that the chemical is not going to be included in that section of the Inventory; and (c) must repay any fee paid in respect of the application made under subsection (1). (5) If an application is not made under subsection (3) within the 28 days, the Director: (a) must include the chemical in the non‑confidential section of the Inventory; and (b) must give notice in the Chemical Gazette that he or she has included the chemical in the non‑confidential section of the Inventory. Note: Under section 13, the Director can include conditions and other particulars in respect of a chemical that is included in the Inventory under this section. 26 At the end of subsection 14(1) Add: Note: The Director can include conditions and other particulars in respect of a chemical that is included in the Inventory under this section (see section 13). 27 At the end of Division 1 of Part 2 Add: 15A Offence for failing to comply with conditions of use etc. A person commits an offence if: (a) the person imports or manufactures an industrial chemical at a particular time; and (b) at that time, the importation or manufacture of the chemical is subject to a condition under section 13; and (c) the importation or manufacture breaches the condition. Penalty: 120 penalty units. 28 Paragraph 18(1)(a) Omit "subsection (2)", substitute "this section". 29 At the end of section 18 Add: (3) However, if the introduction of the chemical is subject to a condition of use included in the confidential section under section 13, then the Director may only disclose the condition if: (a) the Director has asked the person the use for which the person intends to introduce the chemical; and (b) the Director is satisfied that the person intends to introduce the chemical for that use. (4) If the Director discloses a condition under subsection (3) to a person, then the Director may also disclose to the person any other conditions in the confidential section to which the introduction of the chemical is subject. 30 Subsection 18A(2) After "transfer the chemical", insert ", and any particulars in respect of the chemical,". 31 Subsection 19(2) After "industrial chemical", insert ", and any particulars in respect of the chemical,". 32 Paragraph 19(7)(b) Omit "the transfer:", substitute "transferring the chemical and any particulars in respect of the chemical:". 33 Division 3 of Part 2 (heading) Repeal the heading, substitute: Division 3—Amendment of Inventory 34 At the end of section 20 Add: Note: The Director can also add or vary information under section 13 about chemicals already in the Inventory. 35 Paragraph 20AA(5)(a) After "leave the chemical", insert ", and any particulars in respect of the chemical,". 36 Paragraph 20AA(6)(b) After "remove the chemical", insert ", or any particulars in respect of the chemical,". 37 At the end of subsection 20AB(4A) Add: Note: The Director can include conditions and other particulars in respect of a chemical that is included in the Inventory under this subsection (see section 13). 38 At the end of subsection 20AB(4B) Add: Note: The Director can include conditions and other particulars in respect of a chemical that is included in the Inventory under this subsection (see section 13). 39 Paragraphs 21(2)(aa) to (b) Repeal the paragraphs, substitute: (a) a commercial evaluation permit; or (b) a low volume permit; or (c) a controlled use permit; or (d) an introduction permit. 40 Paragraph 21(3)(d) Repeal the paragraph. 41 Subsection 21(4) Omit "10 kilograms", substitute "100 kilograms". 42 Paragraph 21(4)(b) Repeal the paragraph, substitute: (b) either: (i) if the chemical is introduced in a cosmetic—if requirements (if any), prescribed in regulations made for the purpose of this subparagraph, relating to its introduction are met (including requirements relating to its use, packaging or labelling); or (ii) otherwise—if requirements (if any), prescribed in regulations made for the purpose of this subparagraph, relating to its introduction are met (including requirements relating to its use, packaging or labelling). 43 At the end of section 21 Add: (5) For the purposes of subparagraph (4)(b)(i) or (ii), different requirements may be prescribed in respect of different volumes of a particular chemical. (6) Subsection (1) does not prohibit the introduction of the following: (a) a new industrial chemical introduced by a person: (i) solely for the purpose of research, development or analysis; and (ii) in a quantity of not more than 100 kilograms in any 12 month period; (b) a new industrial chemical: (i) that is introduced by a person at a port or airport in Australia; and (ii) that remains subject to the control of Customs (within the meaning of the Customs Act 1901) at the port or airport at all times before leaving Australia; and (iii) that leaves Australia less than 30 days after the day of introduction; (c) a new industrial chemical: (i) that is a non‑hazardous chemical; and (ii) that is introduced in a cosmetic; and (iii) whose concentration in the cosmetic is 1% or less; and (iv) whose introduction meets any requirements, prescribed in regulations for the purposes of this subparagraph, relating to its introduction. Note 1: A defendant bears an evidential burden in relation to the matters in subsection (6) (see subsection 13.3(3) of the Criminal Code). Note 2: A person who introduces a new industrial chemical under subsection (6) is required to provide an annual report (see section 21AA). 44 At the end of Division 1 of Part 3 Add: 21AA Annual reporting obligations for introductions under section 21 (1) A person who introduces a new industrial chemical in a registration year under subsection 21(4) or (6) must provide a report to the Director stating: (a) the name of the chemical that was introduced in the year; and (b) the volume of the chemical that was introduced in the year. (2) The report must be provided before or on 28 September of the following registration year. (3) The report must be provided in the approved form. (4) A person commits an offence if: (a) the person is required to provide a report in accordance with subsections (1) and (2); and (b) the person fails to do so. Penalty: 10 penalty units. Note 1: A person does not commit an offence if the person fails to provide the report in the approved form. Note 2: If a person does not provide the report in accordance with subsection (1) before or on 28 September, the obligation to do so continues after that date, with daily offences being committed until the obligation is complied with (see section 4K of the Crimes Act 1914). (5) Subsection 4K(2) of the Crimes Act 1914 ceases to apply in relation to an offence against subsection (4) of this section at the end of the 12th day after 28 September (being 10 October). Note: Because of this subsection, 120 penalty units is the maximum penalty that can be imposed for offences against subsection (4). 21AB List of chemicals exempt under subsections 21(4) and (6) (1) The Director must maintain a list of: (a) the names of the chemicals provided in each report under section 21AA for a registration year; and (b) the volume of such chemicals. (2) At least once during the next registration year, the Director must publish the list in the Chemical Gazette. 45 At the end of section 21B Add: (2) A manufacturer or importer whose commercial evaluation permit relating to a new industrial chemical is still in force may apply for the permit to be renewed if the following conditions are met: (a) the function or use of the chemical has not changed, and is not likely to change, significantly; (b) the amount of the chemical being introduced has not increased, and is not likely to increase, significantly; (c) in the case of a chemical that was not manufactured, or proposed to be manufactured, in Australia at the time the permit was issued—it continues not to be manufactured in Australia; (d) the method of manufacture of the chemical in Australia has not changed, and is not likely to change, in a way that may result in an increased risk of an adverse effect on occupational health and safety, public health or the environment; (e) no additional information has become available to the manufacturer or importer as to any adverse effects of the chemical on occupational health and safety, public health or the environment; (f) no event prescribed for the purposes of section 64 has happened; (g) any conditions of the permit imposed by or under section 21L were complied with during the period of the current permit; (h) no changes are required to any conditions of the permit. (3) A manufacturer or importer may only apply for a commercial evaluation permit to be renewed once. Note: The heading to section 21B is altered by adding at the end "or renewal of permit". 46 Subsection 21D(1) Repeal the subsection, substitute: Form of application (1) An application for a commercial evaluation permit, or a renewal of a commercial evaluation permit, must: (a) be in writing; and (b) be in an approved form; and (c) be given to the Director. 47 Subsection 21D(2) Omit "The application", substitute "An application for a commercial evaluation permit". Note: The heading to subsection 21D(2) is replaced by the heading "Material to accompany application for permit". 48 Subsection 21D(3) Omit "paragraph 21B(b)", substitute "paragraph 21B(1)(b)". Note: The heading to subsection 21D(3) is replaced by the heading "Form of paragraph 21B(1)(b) agreement". 49 Subsection 21E(1) Omit "the application", substitute "an application". 50 Subsection 21E(2) Omit "in the application", substitute "in an application". 51 Subsection 21E(3) After "commercial evaluation permit" (first occurring), insert ", or an application for a renewal of a commercial evaluation permit,". 52 Section 21F Omit "consider the application", substitute "consider an application". 53 Subsection 21G(1) Omit "considering the application", substitute "considering an application". 54 Subsection 21H(1) Omit "the application", substitute "an application". 55 Subsection 21H(2) Omit "the applicant" (first occurring), substitute "an applicant". 56 Subsection 21H(3) Omit "the application" (first occurring), substitute "an application". 57 Subparagraph 21H(3)(c)(i) After "commercial evaluation permit", insert "or an application for a renewal of a commercial evaluation permit". 58 After subsection 21H(3) Insert: (3A) The Director may refuse an application for a renewal of a commercial evaluation permit if the Director is satisfied that the conditions in subsection 21B(2) have not been met. 59 At the end of subsection 21L(1) Add: Note: A person who holds a commercial evaluation permit must also provide an annual report (see section 40N). 60 Subparagraph 21N(1)(b)(i) After "the permit", insert "or the application for the renewal of the permit". 61 Subsection 21P(1) After "commercial evaluation permit", insert ", or an application for a renewal of a commercial evaluation permit,". 62 Paragraph 21Q(a) Omit "any person or persons", substitute "the person". 63 Paragraph 21Q(a) After "100 kilograms", insert "(or 1,000 kilograms in certain cases)". 64 After subsection 21R(1) Insert: (1A) A manufacturer or importer whose low volume permit in respect of a new industrial chemical is still in force may apply for the permit to be renewed if the following conditions are met: (a) the function or use of the chemical has not changed, and is not likely to change, significantly; (b) the amount of the chemical being introduced has not increased, and is not likely to increase, significantly; (c) in the case of a chemical that was not manufactured, or proposed to be manufactured, in Australia at the time the permit was last issued—it continues not to be manufactured in Australia; (d) the method of manufacture of the chemical in Australia has not changed, and is not likely to change, in a way that may result in an increased risk of an adverse effect on occupational health and safety, public health or the environment; (e) no additional information has become available to the manufacturer or importer as to any adverse effects of the chemical on occupational health and safety, public health or the environment; (f) no event prescribed for the purposes of section 64 has happened; (g) any conditions of the permit imposed by or under section 21W were complied with during the period of the current permit; (h) no changes are required to any conditions of the permit. (1B) A manufacturer or importer may apply for a low volume permit to be renewed any number of times. Note: The heading to section 21R is altered by adding at the end "or renewal of permit". 65 Subsection 21R(2) After "subsection (1)", insert "or (1A)". 66 Subsection 21S(1) Repeal the subsection, substitute: (1) An application for a low volume permit, or a renewal of a low volume permit, must: (a) be in writing; and (b) be in an approved form; and (c) be given to the Director. 67 Subsection 21S(2) Omit "The application", substitute "An application for a low volume permit". 68 At the end of section 21S Add: (3) An application for a renewal of a low volume permit is taken not to be duly made unless the applicant has paid the prescribed fee. 69 Subsection 21SA(1) Omit "the applicant" (first occurring), substitute "an applicant". 70 Subsection 21SA(1) After "paragraph 21S(2)(a)", insert ", or a matter referred to in the application for the renewal of the permit,". 71 Subsection 21U(1) Omit "the application" (first occurring), substitute "an application". 72 Subsection 21U(2) Repeal the subsection, substitute: (2) The Director must grant an application for a low volume permit in respect of a chemical and issue the permit to the applicant if the Director is satisfied of the following: (a) section 21S has been complied with in respect of the application; (b) the intended use of the chemical does not pose an unreasonable risk to occupational health and safety, public health or the environment, having regard to the following: (i) the inherent nature of the chemical; (ii) any guidelines prescribed for the purposes of this section; (iii) any other matters that the Director considers relevant; (c) the total quantity of the chemical that is proposed to be introduced by the applicant during any calendar year does not exceed: (i) if guidelines prescribed for the purposes of this section apply to the chemical—1,000 kilograms; or (ii) otherwise—100 kilograms. 73 After subsection 21U(2) Insert: (2A) The Director must grant an application for a renewal of a low volume permit in respect of a chemical and issue the permit to the applicant if the Director is satisfied of the following: (a) section 21S has been complied with in respect of the application; (b) the conditions referred to in subsection 21R(1A) have been met. 74 Subsection 21U(3) Omit "so satisfied", substitute "satisfied under subsection (2) or (2A)". 75 Subsection 21W(1) Omit "since the permit was issued", substitute "since the permit was last issued". 76 Paragraph 21W(1)(b) After "subsection 21S(2)", insert "or the application for the renewal of the permit". 77 Paragraph 21W(1)(c) After "the permit was", insert "last". 78 Paragraph 21W(1)(d) Omit "adverse health effects or adverse environmental effects", substitute "an adverse effect of the chemical on occupational health and safety, public health or the environment". 79 Paragraph 21W(1)(e) Omit "the adverse health effects or adverse environmental effects of the chemical", substitute "an adverse effect of the chemical on occupational health and safety, public health or the environment". 80 At the end of subsection 21W(1) Add: Note: A person who holds a low volume permit must also comply with the obligations in Division 3B of this Part. 81 Subsection 21W(3) Omit "to health or to the environment", substitute "to occupational health and safety, public health or the environment". 82 Subparagraph 21W(6)(b)(i) After "the permit", insert "or any application for a renewal of the permit". 83 Subsection 21ZB(1) After "low volume permit", insert ", or an application for a renewal of a low volume permit,". 84 After Division 1B of Part 3 Insert: Division 1C—Controlled use permit system 22A Object of controlled use permit system The object of the controlled use permit system is: (a) to provide an alternative to the assessment certificate system in respect of a new industrial chemical that is a low risk to occupational health and safety, public health and the environment because its use, handling and disposal are highly controlled; and (b) to ensure that this alternative is subject to adequate safeguards. 22B Who may apply for permit or renewal of permit (1) A manufacturer or importer of a new industrial chemical may apply for a controlled use permit in respect of the chemical. (2) A manufacturer or importer whose controlled use permit in respect of a new industrial chemical is still in force may apply for the permit to be renewed if the following conditions are met: (a) the function or use of the chemical has not changed, and is not likely to change, significantly; (b) the amount of the chemical being introduced has not increased, and is not likely to increase, significantly; (c) in the case of a chemical that was not manufactured, or proposed to be manufactured, in Australia at the time the permit was last issued—it continues not to be manufactured in Australia; (d) the method of manufacture of the chemical in Australia has not changed, and is not likely to change, in a way that may result in an increased risk of an adverse effect on occupational health and safety, public health or the environment; (e) no additional information has become available to the manufacturer or importer as to any adverse effects of the chemical on occupational health and safety, public health or the environment; (f) no event prescribed for the purposes of section 64 has happened; (g) any conditions of the permit imposed by or under section 22H were complied with during the period of the current permit; (h) no changes are required to any conditions of the permit. (3) A manufacturer or importer may apply for a controlled use permit to be renewed any number of times. (4) 2 or more persons, each of whom is a manufacturer or importer of a new industrial chemical, may make a joint application under subsection (1) or (2). (5) If a joint application is made, then, unless the contrary intention appears, a reference in this Division to the applicant is a reference to the joint applicants. 22C How application is to be made (1) An application for a controlled use permit, or a renewal of a controlled use permit, must: (a) be in writing; and (b) be in an approved form; and (c) be given to the Director. (2) An application for a controlled use permit is taken not to be duly made unless the applicant has provided a written statement about the chemical that: (a) states the use for which the chemical is to be introduced; and (b) contains a summary of the chemical's effects on occupational health and safety, public health and the environment; and (c) states the quantity of the chemical proposed to be introduced by the applicant in the period beginning on the date on which the application is made and ending at the end of the calendar year in which that date occurs; and (d) states the quantity of the chemical proposed to be introduced by the applicant in each of the next 3 calendar years; and (e) contains such other information as is prescribed in the regulations. (3) An application for a controlled use permit, or a renewal of a controlled use permit, is taken not to be duly made unless the applicant has paid the prescribed fee. 22D Director may request further information about application (1) The Director may give an applicant a written notice requiring the applicant to give the Director further information about a matter referred to in subsection 22C(2), or a matter referred to in the application for the renewal of the controlled use permit, within the period specified in the notice. (2) The notice must specify a period of at least 14 days. 22E Applicant may withdraw or amend application An applicant may, at any time before the application has been determined, by written notice to the Director, withdraw the application or amend the application or any document that accompanied the application. 22F Determination of application (1) The Director must grant an application for a controlled use permit in respect of a chemical and issue the permit to the applicant if the Director is satisfied of the following: (a) section 22C has been complied with in respect of the application; (b) the intended use of the chemical does not pose an unreasonable risk to occupational health and safety, public health or the environment, having regard to the following: (i) the inherent nature of the chemical; (ii) any guidelines prescribed for the purposes of this section; (iii) any other matters that the Director considers relevant. (2) The Director must grant an application for a renewal of a controlled use permit in respect of a chemical and issue the permit to the applicant if the Director is satisfied of the following: (a) section 22C has been complied with in respect of the application; (b) the conditions referred to in subsection 22B(2) have been met. (3) If any further information required by the Director under section 22D is not given to the Director within the period specified in the notice requiring that further information, the application is taken to have been withdrawn. (4) If the Director is not satisfied under subsection (1) or (2), the Director must refuse the application. 22G Duration of permit A controlled use permit: (a) comes into force at the beginning of the period of not more than 36 months that is stated in the permit; and (b) remains in force until the end of that period. 22H Permit may be subject to conditions (1) A controlled use permit is granted subject to a condition that the chemical in respect of which the permit is issued is only imported or manufactured for the use stated in the permit. Note: A person who holds a controlled use permit must also comply with the obligations in Division 3B of this Part. (2) A controlled use permit is granted subject to a condition that, if the holder of the permit becomes aware of any of the circumstances referred to in subsection (3) happening since the permit was last issued, the holder will, within 28 days, give written notice to the Director of the circumstances. (3) These are the circumstances: (a) the function or use of the chemical has changed, or is likely to change, significantly; or (b) in the case of a chemical not manufactured, or proposed to be manufactured, in Australia when the permit was last issued—it has begun to be manufactured in Australia; or (c) the method of manufacture of the chemical in Australia has changed, or is likely to change, in a way that may result in an increased risk of an adverse effect on occupational health and safety, public health or the environment; or (d) additional information has become available to the holder as to an adverse effect of the chemical on occupational health and safety, public health or the environment; or (e) a prescribed circumstance has happened. (4) For the purposes of subsection (2), the holder of a permit is taken to have become aware of circumstances if the holder ought reasonably to have become aware of the circumstances, having regard to: (a) the holder's abilities, experience, qualifications and other attributes; and (b) the nature of the circumstances. (5) A controlled use permit may be expressed to be granted subject to such other conditions as the Director considers necessary or desirable to ensure that use of the chemical will not constitute an unreasonable risk to occupational health and safety, public health or the environment. (6) If the Director considers it necessary or desirable to ensure that use of a chemical will not constitute an unreasonable risk to occupational health and safety, public health or the environment, the Director may, by written notice given to the holder of a controlled use permit issued in respect of the chemical: (a) impose one or more further conditions to which the permit is to be subject; or (b) revoke or vary a condition: (i) imposed under paragraph (a); or (ii) stated in the permit. (7) The notice under subsection (6) must specify a day on which the permit: (a) becomes subject to the condition imposed, or the condition as varied, under that subsection; or (b) ceases to be subject to the condition revoked under that subsection. The day must be at least 28 days after the giving of the notice. 22I Offence for contravention of permit A person commits an offence if: (a) the person is or was the holder, or any of the holders, of a controlled use permit; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition to which the permit is subject. Penalty: 300 penalty units. 22J Cancellation of permit The Director may, by written notice given to the holder of a controlled use permit, cancel the permit if: (a) a condition to which the permit is subject has been breached; or (b) a written statement provided or any information given: (i) in or in connection with the application for the permit or any application for a renewal of the permit; or (ii) in accordance with a condition to which the permit was subject; was false or misleading in a material particular. 22K Form of permit A controlled use permit must be in an approved form. 22L Notice of permit to be published in Chemical Gazette As soon as practicable after a controlled use permit is issued, the Director must cause to be published in the Chemical Gazette a notice stating that the permit has been issued and setting out: (a) the name of the holder of the permit; and (b) the trade name of the chemical; and (c) the use for which the chemical may be imported or manufactured; and (d) the period of the permit. 22M Notice of refusal of application If the Director decides to refuse an application, he or she must, as soon as practicable, give to the applicant a written notice of the decision that sets out: (a) the findings on material questions of fact; and (b) the evidence or other material on which those findings were based; and (c) the reasons for the decision. 22N List of controlled use chemicals (1) The Director must maintain a list of the following: (a) the chemicals in respect of which controlled use permits are in force; (b) the conditions of use to which those permits are subject. (2) At least once a year, the Director must publish the list in the Chemical Gazette. 22O Exempt information (1) An application for a controlled use permit, or an application for a renewal of a controlled use permit, may include an application that certain information given in accordance with section 22D be treated as exempt information under section 75. (2) The giving of information about a chemical in accordance with a condition of a kind referred to in subsection 22H(2) may be accompanied by an application in the approved form that some or all of the information be treated as exempt information under section 75. 85 Before section 23 (at the beginning of Division 2 of Part 3) Insert: 22P Object and overview of assessment certificates (1) The object of the assessment certificate system under this Division and Division 3 of this Part is to allow a new industrial chemical to be assessed before a manufacturer or importer introduces the chemical. (2) There are 2 main assessment systems set out in this Division and Division 3. In the self‑assessed system, a manufacturer or importer of certain chemicals of low concern does most of the assessment himself or herself and the application form is adopted as the assessment report. However, the manufacturer or importer is subject to additional obligations under Division 3B of this Part. (3) Otherwise, an officer assesses the chemical and prepares an assessment report. 86 Subsections 23(4) to (9) Repeal the subsections, substitute: Notification statement for chemicals other than polymers (4) A notification statement about the following new industrial chemicals must contain the matters specified in Parts A and B of the Schedule: (a) a new industrial chemical (other than a polymer) that is to be introduced by the applicant in a quantity of not more than one tonne in any 12 month period; (b) a new industrial chemical (other than a polymer) that is to be manufactured in Australia by the applicant: (i) solely for the purposes of further manufacture at the site of its manufacture; and (ii) in a quantity of not more than 10 tonnes in any 12 month period. Note: Polymers are dealt with in subsections (6), (7) and (8). (5) A notification statement about any other chemical (other than a polymer) must contain the matters specified in Parts A, B and C of the Schedule. Note: Polymers are dealt with in subsections (6), (7) and (8). Notification statement for polymers (6) A notification statement about a polymer (other than a polymer of low concern) must contain the matters specified in Parts A, B and D of the Schedule. Note: Section 24A describes the contents of the document that needs to accompany an application in respect of a polymer of low concern. (7) A notification statement about the following polymers (other than one referred to in subsection (8)) must also contain the matters specified in Part C of the Schedule: (a) a biopolymer; and (b) a synthetic polymer having a number‑average molecular weight of less than 1,000. (8) A notification statement about the following polymers does not need to contain the matters specified in Part C of the Schedule: (a) a biopolymer that is to be introduced by the applicant in a quantity of not more than one tonne in any 12 month period; (b) a biopolymer that is to be manufactured in Australia by or on behalf of the applicant: (i) solely for the purposes of further manufacture at the site of its manufacture; and (ii) in a quantity of not more than 10 tonnes in any 12 month period; (c) a polymer of low concern. Note 1: The heading to section 23 is replaced by the heading "Application for a non‑self‑assessed assessment certificate for any chemical". Note 2: The following heading to subsection 23(1) is inserted "Who may make an application for a non‑self‑assessed assessment certificate". Note 3: The following heading to subsection 23(2) is inserted "Requirements for the application". Note 4: The following heading to subsection 23(10) is inserted "Other requirements for the application". 87 After section 23 Insert: 23A Application for a self‑assessed assessment certificate for certain chemicals (1) A manufacturer or importer of any of the following new industrial chemicals may apply for a self‑assessed assessment certificate for the chemical: (a) a polymer of low concern; (b) a non‑hazardous chemical; (c) any other chemical, or class of chemical, the criteria for which are prescribed by the regulations. Note: A manufacturer or importer of any of those new industrial chemicals can still apply under section 23 for a non‑self‑assessed assessment certificate. (2) The application must be in writing in the approved form. (3) The application must be given to the Director, together with a statement signed by the applicant that the information provided in the form is correct. 88 Section 24A Omit "synthetic". Note: The heading to section 24A is altered by omitting "synthetic". 89 Section 24A Omit "prescribed", substitute "approved". 90 Section 25 After "An application", insert "under section 23 or 23A". 91 Section 25 After "notification statement", insert "or approved form". 92 Subsection 26(1) After "An applicant", insert "under section 23 or 23A". 93 Paragraph 27(1)(a) After "been made", insert "under section 23 or 23A". 94 Paragraph 27(1)(b) Repeal the paragraph, substitute: (b) either: (i) the notification statement accompanying the application does not contain sufficient information about a matter required under section 23; or (ii) the applicant has not included sufficient information about a matter referred to in the approved form under section 23A or 24A; 95 Paragraph 27(2)(a) After "has been made", insert "under section 23". 96 Subsection 27(4) Omit "subsection 31 (2)", substitute "subsection 31A(1)". 97 Subsection 28(1) After "has been made", insert "under section 23 or 23A". 98 Subsection 30A(1) Omit "under section 23 for an assessment certificate for a chemical", substitute "under section 23 or 23A for an assessment certificate for a chemical of a kind mentioned in subsection (1A)". 99 After subsection 30A(1) Insert: (1A) An application may be made under subsection (1) in respect of the following chemicals: (a) a polymer of low concern; (b) a non‑hazardous chemical; (c) any other chemical, or class of chemical, the criteria for which are prescribed by the regulations. 100 Subsection 30A(3) Repeal the subsection, substitute: (3) The Director may grant the permit if he or she is satisfied that the chemical is a chemical of a kind mentioned in subsection (1A). 101 Subsection 30A(4) Repeal the subsection. 102 Subsection 30A(6) Omit "satisfied as to the matters mentioned in subsection (3)", substitute "able to determine whether the chemical is a chemical of a kind mentioned in subsection (1A)". 103 Paragraph 30A(6)(a) Omit "on those matters", substitute "on whether the chemical is a chemical of a kind mentioned in subsection (1A)". 104 Paragraph 30C(1)(b) Omit "any of the matters mentioned in subsection 30A(3) or (4)", substitute "whether the chemical is a chemical of a kind mentioned in subsection 30A(1A)". 105 Division 3 of Part 3 (heading) Repeal the heading, substitute: Division 3—Assessment, self‑assessment and reports 106 Paragraph 31(1)(a) After "section 23", insert "or 23A". 107 Subsection 31(1) After "section 32", insert "or 33A". 108 At the end of subsection 31(1) Add: Note: The report of the assessment for polymers of low concern and other chemicals referred to in section 23A might be the application form under that section (see sections 33A and 33B). 109 Subsections 31(2) to (4) Repeal the subsections. 110 After section 31 Insert: 31A Time periods for applications for non‑self‑assessed assessment certificates under section 23 Time periods for applications for non‑self‑assessed assessment certificates under section 23 (1) An assessment of an application under section 23 is to be made and the assessment report, the full public report and the summary report completed within: (a) if a notice or notices requiring additional information were given under section 27—90 days after the day on which the information was provided; and (b) otherwise—90 days after the day on which the application was made. Note: The Minister may extend the 90 day period under subsection (3). Time periods to exclude time taken to provide requested information (2) If: (a) the applicant for the assessment certificate also applies under section 30A for a permit to introduce the chemical before the assessment report is complete; and (b) the Director requests further information to be given by the applicant under subsection 30A(6); then, the period starting on the date of that request and ending when the further information is received is not to be taken into account in determining the period of 90 days referred to in subsection (1). Minister may extend time period (3) If it is not reasonably practicable for the assessment to be carried out thoroughly, and the reports completed, within the period, the Minister may extend the period by up to 90 days. (4) The Minister must immediately notify the applicant of any extension under subsection (3). 31B Time periods for applications for self‑assessed assessment certificates under section 23A Time periods for applications for self‑assessed assessment certificates under section 23A (1) An assessment of an application under section 23A is to be made and either: (a) the assessment report, the full public report and the summary report completed; or (b) a notice given under subsection 33C(2); within: (c) if a notice or notices requiring additional information were given under section 27—28 days after the day on which the information was provided; and (d) otherwise—28 days after the day on which the application was made. Note: The Minister may extend the 28 day period under subsection (3). Time periods to exclude time taken to provide requested information (2) If: (a) the applicant for the assessment certificate also applies under section 30A for a permit to introduce the chemical before the assessment report is complete; and (b) the Director requests further information to be given by the applicant under subsection 30A(6); then, the period starting on the date of that request and ending when the further information is received is not to be taken into account in determining the period of 28 days referred to in subsection (1). Minister may extend time period (3) If it is not reasonably practicable for subsection (1) to be complied with within the period, the Minister may extend the period by up to 28 days. (4) The Minister must immediately notify the applicant of any extension under subsection (3). Deemed refusal of application for self‑assessed assessment certificate (5) An application for a self‑assessed assessment certificate is taken to have been refused if subsection (1) is not complied with within the period required by this section. 111 Subsection 32(1) After "an assessment of", insert "an application under section 23 for". Note: The heading to section 32 is altered by omitting "assessment" and substituting "non‑self‑assessed assessment". 112 Section 33 After "assessment report", insert "(other than an assessment report referred to in section 33B (self‑assessment))". Note: The heading to section 33 is altered by omitting "assessment report" and substituting "non‑self‑assessed assessment report". 113 After section 33 Insert: 33A Nature of self‑assessed assessment An officer assessing an application under section 23A for an industrial chemical must: (a) determine whether the chemical is a chemical of a kind referred to in subsection 23A(1); and (b) determine the risk (if any) of the adverse effects referred to in section 32. 33B Contents of self‑assessed assessment report (1) If the officer determines: (a) that the chemical is a chemical of a kind referred to in subsection 23A(1); and (b) that there is no possibility of an unreasonable risk of any of the adverse effects referred to in section 32 occurring; then the officer must adopt the application made under section 23A for the chemical as the assessment report under section 31. (2) However, the officer may include in the assessment report additional information or recommendations in respect of the chemical. Note: For example, the officer may adopt the application as the assessment report but also recommend in the report the secondary notification of the chemical in particular circumstances. 33C Moving from the self‑assessed system to the non‑self‑assessed system Persons can be moved from the self‑assessed to the non‑self‑assessed system (1) If the officer determines: (a) that the chemical is not a chemical of a kind referred to in subsection 23A(1); or (b) that there is a possibility of an unreasonable risk of one or more of the adverse effects referred to in section 32 occurring; then the officer must refuse the application for a self‑assessed assessment certificate. Notification of refusal of application (2) If the officer refuses the application, he or she must give to the applicant a written notice of the decision, as soon as practicable, that sets out: (a) the findings on material questions of fact; and (b) the evidence or other material on which those findings were based; and (c) the reasons for the decision. Person may make a new application under section 23 (3) After a person's application for a self‑assessed assessment certificate has been refused then the person may make a new application in respect of the chemical under section 23. Person must pay additional application fee (4) If the person makes such an application under section 23 in respect of a chemical, then the person must pay any difference between the amount prescribed under section 110 for applications under section 23 and the amount already paid for the application previously made under section 23A in respect of the chemical. 114 Section 36 Repeal the section, substitute: 36 Notice to applicant on completing report Notice after completing non‑self‑assessed assessment report (1) As soon as is reasonably practicable after completing: (a) an assessment report (other than an assessment report referred to in section 33B (self‑assessment)) about a chemical; and (b) the full public report about the chemical; and (c) the summary report about the chemical; the Director must give the applicant for the assessment certificate: (d) a copy of the reports; and (e) a notice setting out the terms of sections 37 and 38. Notice after completing self‑assessed assessment report (2) As soon as is reasonably practicable after completing: (a) an assessment report referred to in section 33B (self‑assessment) about a chemical; and (b) the full public report about the chemical; and (c) the summary report about the chemical; the Director must give the applicant for the assessment certificate: (d) a copy of the reports; and (e) a notice setting out the terms of section 38. Note: The Director must also give the applicant the self‑assessed assessment certificate (see subsection 39(1A)). 115 Subsection 37(1) Omit "section 36", substitute "subsection 36(1)". 116 Paragraph 38(3)(a) Omit "section 37", substitute "section 25 or 37". 117 Before subsection 39(1) Insert: (1A) If an applicant is given a notice under subsection 36(2) (self‑assessment), the Director must give the applicant a certificate at the same time containing such information as is prescribed by the regulations. Note: A person who holds a self‑assessed assessment certificate must comply with the obligations in Division 3B of this Part. 118 Subsection 39(1) Omit "Within", substitute "Otherwise, within". 119 At the end of section 39 Add: (3) If the Director gives an applicant a certificate in respect of a chemical, the Director must also notify the applicant in writing that the applicant may apply to have the chemical included in the non‑confidential section of the Inventory under section 13B. 120 After subsection 40A(1) Insert: (1A) However, an importer or manufacturer may not apply for extension of a self‑assessed assessment certificate. 121 Subsections 40A(3) and (4) Omit "synthetic". 122 Subsection 40A(4) Omit "prescribed", substitute "approved". 123 At the end of section 40H Add: (4) However, if the importation or manufacture of the chemical is subject to a condition of use included in the Inventory under section 13, then the certificate only ceases to be in force to the extent that it relates to that condition of use. 124 After Division 3A of Part 3 Insert: Division 3B—Obligations relating to certain permits and self‑assessed assessment certificates 40K Record keeping requirements (1) A person who is issued: (a) a low volume permit; or (b) a controlled use permit; or (c) a self‑assessed assessment certificate; must keep records to support any statement made in or in connection with the application for the permit or certificate, or any application for a renewal of the permit. (2) The records must be kept for 5 years from the date the permit or certificate is issued. (3) A person commits an offence if: (a) the person is required to keep records under subsection (1) or (2); and (b) the person fails to do so. Penalty: 120 penalty units. 40L Director may obtain information and documents Making of request (1) If the Director believes on reasonable grounds that a person who is issued: (a) a low volume permit; or (b) a controlled use permit; or (c) a self‑assessed assessment certificate; has particular information or a particular document that is relevant to any statement made in or in connection with the application for the permit or certificate, or any application for a renewal of the permit, the Director may request the person to give the information, or produce the document, to the Director. Form of request (2) A request given to a person under subsection (1) must: (a) be made in writing; and (b) state what information the person must give, or what document the person must produce, to the Director; and (c) specify the day on or before which the person must give the information or produce the document (which must be a day at least 14 days after the day on which the Director makes the request); and (d) specify how the person is to give the information, or produce the document, to the Director; and (e) contain a statement to the effect that a failure to comply with the request is an offence. Offence (3) A person commits an offence if: (a) the person is required to give information or produce a document under subsection (1); and (b) the person fails to give the information or produce the document. Penalty: 60 penalty units. 40M Self‑incrimination (1) An individual is not excused from giving information or producing a document under section 40L on the ground that the information or the production of the document might tend to incriminate the individual or expose the individual to a penalty. (2) However: (a) the information given or the document produced; or (b) giving the information or producing the document; or (c) any information, document or thing obtained as a direct or indirect consequence of giving the information or producing the document; is not admissible in evidence against the individual in criminal proceedings other than: (d) proceedings for an offence against subsection 40L(3); or (e) proceedings for an offence against section 137.1 or 137.2 of the Criminal Code that relates to this Act. 40N Annual reports (1) A person who is issued: (a) a commercial evaluation permit; or (b) a low volume permit; or (c) a controlled use permit; or (d) a self‑assessed assessment certificate; in respect of an industrial chemical must provide a report to the Director each registration year. (2) The report must state the following: (a) the name of the chemical in respect of which the permit or certificate is issued; and (b) the volume of the chemical that was introduced during the year; and (c) any adverse effect of the chemical on occupational health and safety, public health or the environment of which the person has become aware during the year. (3) The report must be provided before or on 28 September of the following registration year. (4) A person commits an offence if: (a) the person is required to provide an annual report in accordance with this section; and (b) the person fails to do so. Penalty: 10 penalty units. Note: If a person does not provide the report in accordance with this section before or on 28 September, the obligation to do so continues after that date, with daily offences being committed until the obligation is complied with (see section 4K of the Crimes Act 1914). (5) Subsection 4K(2) of the Crimes Act 1914 ceases to apply in relation to an offence against subsection (4) of this section at the end of the 12th day after 28 September (being 10 October). Note: Because of this subsection, 120 penalty units is the maximum penalty that can be imposed for offences against subsection (4). 125 Paragraph 41(3)(d) After "manufacturer applies", insert "under section 23". 126 Subsection 44(1) After "an application" (first occurring), insert "under section 23". 127 Section 47 Repeal the section, substitute: 47 Application of Division This Division does not apply in relation to new industrial chemicals other than those covered by a commercial evaluation permit or those referred to in: (a) paragraph 21(3)(b) or (e); or (b) subsection 21(4); or (c) paragraph 21(6)(a) or (b). 128 Paragraph 64(1)(a) Repeal the paragraph, substitute: (a) either or both of the following recommends the secondary notification of the chemical in particular circumstances: (i) an assessment report about a chemical; (ii) particulars included in respect of a chemical in the Inventory; and 129 Paragraph 64(2)(d) Omit "adverse health effects or adverse environmental effects", substitute "an adverse effect of the chemical on occupational health and safety, public health or the environment". 130 Paragraph 64(2)(e) Omit "the adverse health effects or adverse environmental effects of the chemical", substitute "an adverse effect of the chemical on occupational health and safety, public health or the environment". 131 After subsection 64(2) Insert: (2A) To avoid doubt, the reference in subsection (2) to an industrial chemical that has been assessed under this Act includes a reference to: (a) a chemical that has been assessed under section 33A (self‑assessmen