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INDUSTRIAL CHEMICALS (NOTIFICATION AND ASSESSMENT) AMENDMENT BILL 2017

                                  2016-2017



   THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA




                    HOUSE OF REPRESENTATIVES




 INDUSTRIAL CHEMICALS (NOTIFICATION AND ASSESSMENT)
                AMENDMENT BILL 2017




                    EXPLANATORY MEMORANDUM




(Circulated by authority of the Assistant Minister for Health, the Hon Dr David
                                 Gillespie MP)


INDUSTRIAL CHEMICALS (NOTIFICATION AND ASSESSMENT) AMENDMENT BILL 2017 OUTLINE The Industrial Chemicals (Notification and Assessment) Act 1989 (the ICNA Act) establishes a national system of notification and assessment of industrial chemicals and for registration of certain persons manufacturing or importing industrial chemicals into Australia. The Industrial Chemicals (Notification and Assessment) Amendment Bill 2017 (the Amendment Bill) provides for amendments to be made to the ICNA Act. These amendments enable the early introduction of certain aspects of the Australian Government's reforms to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to make regulatory effort more proportionate to risk and to promote safer innovation by encouraging the introduction of lower risk chemicals, while also maintaining Australia's robust health and safety standards. The proposal to implement certain aspects of the reforms in advance of the main reforms (proposed to commence in 2018) was detailed in a number of consultation papers released in 2016, and was also the subject of public consultation forums. The amendments to the ICNA Act described in this Bill:  make changes to the definition of a new synthetic polymer to more closely align with international approaches;  make changes to the notification requirements for new chemicals, such that polymers of low concern would be exempt from notification;  remove the requirement for introducers to provide annual reports to NICNAS for permits and self-assessed assessment certificates;  remove the requirement for introducers to provide a final statement of the value of relevant industrial chemicals actually introduced in a registration year; and  make consequential changes to the ICNA Act related to these changes. Collectively these changes reduce unnecessary regulatory burden (by reducing reporting requirements) and commence the process of reducing regulation for lower risk chemicals (by exempting polymers of low concern from notification requirements). This is consistent with broader changes reflected in the Industrial Chemical Bill 2017 that are proposed to take effect from 1 July 2018. Financial Impact Statement It remains Government policy that the cost of the Commonwealth industrial chemicals scheme is fully recovered from the regulated industry. Therefore, the initiatives implemented through this Bill are cost neutral. 1


Statement of Compatibility with Human Rights Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011 Industrial Chemicals (Notification and Assessment) Amendment Bill 2017 This Bill is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. Overview of the Bill The Industrial Chemicals (Notification and Assessment) Amendment Bill 2017 makes amendments to the Industrial Chemicals (Notification and Assessment) Act 1989 (ICNA Act) to enable the early commencement of certain aspects of the Australian Government's reforms to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) designed to make regulatory effort more proportionate to risk, to promote safer innovation by encouraging the introduction of lower risk chemicals, and to maintain protections for human health and the environment. The amendments also provide for definitional changes to achieve greater international alignment of the regulation of industrial chemicals. The amendments to the ICNA Act described in this Bill:  make changes to the definition of a new synthetic polymer to more closely align with international approaches;  make changes to the notification requirements for new chemicals, such that polymers of low concern would be exempt from notification;  remove the requirement for introducers to provide annual reports to NICNAS for permits and self-assessed assessment certificates;  remove the requirement for introducers to provide a final statement of the value of relevant industrial chemicals actually introduced in a registration year; and  make consequential changes to the ICNA Act related to these changes. Human rights implications This Bill engages the human right to the enjoyment of the highest attainable standard of physical and mental health Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). Right to health Article 12(1) of the ICESCR promotes the right of all individuals to enjoy the highest attainable standard of physical and mental health. This includes the improvement of all aspects of environmental and industrial hygiene (Article 12(2)(b)). While the ICNA Act does not explicitly relate to the right of a person to enjoy the highest attainable standard of physical and mental health, it does deal with subjects relevant to the right to health. Included in the objects of the Act is the provision of a national system of notification and assessment of industrial chemicals for the purposes of aiding in the protection of the Australian people and the environment by identifying 2


risks to occupational health and safety, to public health and to the environment that could be associated with the importation, manufacture or use of industrial chemicals (refer subparagraph 3(a)(i) of the ICNA Act). Many of the amendments described in this Bill focus on reducing unnecessary regulatory burden. For example, the changes include reducing duplicative reporting requirements for permits and self-assessed assessment certificates. These changes do not reduce health protections and nor do they remove the obligation on introducers to report to NICNAS adverse effects of an industrial chemical on work health and safety, public health or the environment of which the introducer of the chemical has become aware. In relation to polymers of low concern (PLCs), this Bill proposes changes to several aspects of the PLC criteria to both clarify the current criteria and to achieve greater international alignment. In addition, the changes proposed in this Bill begin to align the requirements for PLCs with the requirements that are described in the Industrial Chemicals Bill 2017 (under which most PLCs would be exempted introductions and would therefore not require pre-market advice to NICNAS). The regulatory framework proposed in the Industrial Chemicals Bill 2017 is designed to make regulatory effort more proportionate to risk, to promote safer innovation by encouraging the introduction of lower risk chemicals, and to continue to protect the Australian people (both workers and the general public) and the environment from any harmful effects of industrial chemicals. The amendments to the ICNA Act proposed in this Bill are therefore consistent with the right to health, and promote the improvement of all aspects of environmental and industrial hygiene by minimising, so far as is reasonably practicable, the causes of health hazards inherent in a working environment that involves industrial chemicals. Conclusion This Bill is compatible with human rights because it promotes the protection of the human right to health. The Hon Dr David Gillespie MP, the Assistant Minister for Health 3


INDUSTRIAL CHEMICALS (NOTIFICATION AND ASSESSMENT) AMENDMENT BILL 2017 NOTES ON CLAUSES Clause 1 - Short Title Clause 1 provides for the short title of the Act to be the Industrial Chemicals (Notification and Assessment) Amendment Act 2017 (the Amendment Act). Clause 2 - Commencement The effect of clause 2 is to enable sections 1 to 3 of the Amendment Act to commence on the day the Amendment Act receives Royal Assent. Schedule 1 commences on the latest of 1 July 2017, the day the Amendment Act receives Royal Assent, or the same time the Industrial Chemicals Act 2017 and its related charges legislation receive Royal Assent. However, this Schedule does not commence at all if the Industrial Chemicals Act 2017 and its related charges legislation do not receive Royal Assent. Clause 3 - Schedule(s) This clause provides that each Act that is specified in a Schedule to this Bill is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item has effect according to its terms. SCHEDULE 1 - AMENDMENTS Industrial Chemicals (Notification and Assessment) Act 1989 Item 1 - Subsection 5(1) (definition of new synthetic polymer) This item provides for a new definition of the term 'new synthetic polymer'. The existing definition of new synthetic polymer in section 5 of the ICNA Act is repealed and replaced with a new definition, which creates closer alignment with the approach taken in the United States of America and Canada. The key difference in the new definition compared to the existing definition is the change in weight described in both paragraph (a) and paragraph (b) of the definition. The references to "at least" are changed to "greater than", so that a new synthetic polymer is defined to mean: (a) a synthetic polymer that includes a combination of monomers and other reactive components each representing greater than 2% by weight, being a combination not listed in the Inventory; or (b) a synthetic polymer of whose weight greater than 2% is attributable to a monomer or other reactive component that is not listed in the Inventory as a component of a synthetic polymer. 4


Item 2 - Subsection 5(1) (definition of polymer of low concern) This item repeals and replaces paragraph (a) of the existing definition of polymer of low concern in the section 5 of the ICNA Act to achieve greater international harmonisation. The exiting definition of a polymer of low concern has five components expressed in the ICNA Act, with other characteristics prescribed by the regulations made under the ICNA Act. Complementary changes are proposed to be made to those regulations. This item repeals and replaces the definition of a polymer of low concern. The changes made to the definition through this item relate largely to the component of the definition described in paragraph (a). Paragraph (a) of the definition is replaced to state that a polymer of low concern is a polymer that either: (i) has a number average molecular weight, as defined by the regulations, that is greater than or equal to 1,000 and has such other characteristics relating to weight as are prescribed by the regulations; or (ii) is made from a prescribed reactant and has molecules that contain 2 or more carboxylic acid ester linkages, one or more of which links internal monomer units together. The effect of this change is to expand the number of polymers that come within the polymer of low concern definition. This change recognises that while not all polymers can be assumed to be of very low risk, the majority of polymers which are non- hazardous should be dealt with in a more efficient way. By modifying the existing definition of polymer of low concern, greater alignment with the equivalent criteria used in the United States of America and Canadian regulatory schemes is achieved. The changes made to paragraphs (b) to (e) address a technical drafting issue whereby the enabling provisions in the Act now accurately provide for the matters already prescribed in the regulations in respect of the definition of polymer of low concern. Paragraph (f) continues to enable characteristics to be prescribed by the regulations. Item 3 - At the end of subsection 21(6) Section 21 of the ICNA Act establishes that a person must not introduce a new industrial chemical in Australia. It also specifies the circumstances in which such introduction would not be an offence. Subsection 21(6) describes the circumstances in which new industrial chemicals are not prohibited from being introduced. For example, new industrial chemicals that are introduced by a person solely for the purpose of research, development or analysis in a quantity of not more than 100 kilograms in any 12 month period. This item inserts a new circumstance in which the introduction of a new industrial chemical will not be prohibited. The addition of new paragraph 21(6)(d) provides that a new industrial chemical that is a polymer of low concern, and whose introduction 5


meets any requirements prescribed in regulations, is not prohibited from introduction (by subsection 21(1)). The effect of this amendment is to make polymers of low concern exempt from notification requirements under the ICNA Act. As such, it will not be necessary for a permit or certificate to be obtained in respect of a polymer of low concern prior to its introduction. Giving effect to this change from 1 July 2017 is consistent with the broader NICNAS reforms described in the Industrial Chemicals Bill 2017 and proposed for commencement on 1 July 2018. Item 4 - Subsection 21L(1) (note) Subsection 21L(1) of the ICNA Act sets out the conditions of commercial evaluation permits. There is a note under subsection 21L(1) that specifies that a person who holds a commercial evaluation permit must also provide an annual report (as described in section 40N). Item 4 repeals this note as, consistent with changes proposed to section 40N, it will no longer be necessary for annual reports to be provided to the Director of NICNAS. More detail about the changes to the requirement for a person who holds a commercial evaluation permit to provide an annual report is provided at Item 5. Item 5 - Section 40N One of the ways that the NICNAS reforms will reduce the regulatory burden on industry is by removing the requirement for reports to be provided to the Director of NICNAS each registration year. This item repeals section 40N of the ICNA Act, which specifies the circumstances in which annual reports must be provided to the Director of NICNAS, the information that the report must contain, when the report must be provided, the offence for failing to do so and the applicable penalty units. Removing the requirement for annual reporting described in section 40N makes a significant contribution to the reduction in regulatory burden, while still maintaining human health and environmental protections through an increase in risk-based post- market compliance activity. Removing this requirement from 1 July 2017 is consistent with the broader NICNAS reforms described in the Industrial Chemicals Bill 2017 and proposed for commencement on 1 July 2018. Item 6 - Section 80Q and Item 7 - Subsection 80QA(1) Section 80Q of the ICNA Act stipulates that certain registered persons are to provide the Director of NICNAS with final written statements indicating the value of the relevant industrial chemicals actually introduced by the person in that registration year, within 2 months after the end of that registration year. This item repeals section 80Q, which means that final statements of the value of relevant industrial chemicals actually introduced in a year will no longer be required to be submitted by registrants who are at registration levels B and C. It is anticipated 6


that removing this requirement will result in reduced regulatory burden for approximately 2,200 registrants. Section 80QA of the ICNA Act describes the way the Director assesses registration charges for certain registered persons on the basis of a statement provided under subsection 80Q(1). The changes to section 80QA are consequential to the repeal of section 80Q to remove the requirement for final statements. Section 80QA contains seven subsections. Item 7 repeals subsection 80QA(1), and replaces it with four new subsections, namely 80QA(1AA), (1), (1A) and (1B). In essence, the changes provide that for certain people who have paid an amount on account of registration charge:  the Director must issue an assessment of registration charge if the person makes a written request to the Director to do so. This means that although a person will no longer be required to give the Director a final statement in accordance with the existing requirement in section 80Q, a person will be able to request that an assessment of registration charge payable be undertaken by the Director. The Director will make the assessment on the basis of any relevant information that is available to the Director (refer subsection 80QA(1)). For example, if an introducer has paid a registration charge for a tier of introduction value that is higher than that actually introduced, the introducer may seek a re-assessment to obtain a refund of the difference between the tiers;  the Director may, on the basis of any relevant information, issue an assessment of registration charge payable by the person in relation to a registration year. This means that the Director can make an assessment of registration charge payable on his or her own initiative (refer subsection 80QA(1)). For example, if the Executive Director obtains information that demonstrates that an introducer imported chemicals of a higher value than the tier for which the introducer was registered, the Executive Director may initiate an assessment to determine whether the introducer should pay a higher amount;  when an assessment is provided, it must be in writing, and set out the amount of registration charge payable (assuming that a registration charge is applicable), or, if registration charge is not payable by the person for the year, a statement to that effect. If registration charge is payable, but the person is entitled to be repaid some of the charge, the notice will also set out the amount of the charge that should be paid and the amount of the repayment (subsection 80QA(1A)); and In some circumstances, the Director may require additional information from an applicant in order to be able to issue the assessment. If this is the case, the Director may provide a written notice to the person, requiring further information, within a time period specified in the notice (which must not less than 14 days after the notice is given) (refer subsection 80QA(1B)). 7


Item 8 - Paragraph 102(1)(b) Section 102 of the ICNA Act provides for applications for review to be made to the Administrative Appeals Tribunal. Paragraph 102(1)(b) includes decisions made by the Director for the purposes of subsection 80Q(1). As this subsection has been repealed, consequential changes are made to paragraph 102(1)(b) to remove the reference to subsection 80Q(1). Item 9 - Application - polymer of low concern Item 9 provides information about when the change to the definition of polymer of low concern will take effect. In summary, the amended definition of polymer of low concern in subsection 5(1) of the Act (as described in item 2 of this Bill) will apply in relation to industrial chemicals that are introduced on the later of 1 July 2017, the day this Act receives Royal Assent, or the same time the Industrial Chemicals Act 2017 and its related charges legislation receive Royal Assent. Introductions before this time will be subject to the previous definition. Item 10 - Savings - regulations Item 10 provides information about how the regulations will operate in relation to the amended definition of a polymer of low concern. Regulations that were made for the purposes of the definition of polymer of low concern in subsection 5(1) of the Industrial Chemicals (Notification and Assessment) Act 1989 (other than paragraph (a) of that definition), that were in force immediately before the day this item commences, will continue to be in force after that day, and may be dealt with as if the regulations had been made under that definition as amended by this Schedule. The effect of this savings provision is that that regulations made for the purposes of the definition of polymer of low concern continue to have effect without disruption. Item 11 - Application - assessment of registration charge by Director Item 11 provides information about when the change to the Director's assessment of the registration charge (as reflected in the amended section 80QA) will take effect. For assessments issued on or after this item commences, section 80QA as amended by this Bill is applicable. Item 12 - Application - review of decisions Item 12 provides that even though amendments have been made to section 102 of the ICNA Act to remove the reference to subsection 80Q(1), the application of review of decisions continues to apply in relation to decisions made by the Director the day before this item commences as if those amendments had not been made. This means that, subject to the Administrative Appeals Tribunal Act 1975, an application may be made to the Tribunal for review of a decision by the Director before this item commences for the purposes of subsection 80Q(1). 8


 


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