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INDUSTRIAL CHEMICALS (NOTIFICATION AND ASSESSMENT) AMENDMENT REGULATIONS 2008 (NO. 2) (SLI NO 236 OF 2008)

EXPLANATORY STATEMENT

 

Select Legislative Instrument 2008 No. 236

 

Industrial Chemicals (Notification and Assessment) Act 1989

 

Industrial Chemicals (Notification and Assessment) Amendment Regulations 2008 (No. 2)

 

The Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) establishes a system of notification and assessment of industrial chemicals to protect health, safety and the environment, and to provide for registration of certain persons proposing to introduce industrial chemicals.

 

Section 111 of the Act provides in part, that the Governor‑General may make regulations, not inconsistent with the Act, prescribing matters required or permitted by the Act to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

 

The purpose of the Regulations is to amend the Industrial Chemicals (Notification and Assessment) Regulations 1990 (the Principal Regulations) to give effect to the low regulatory concern chemical (LRCC) reform package.

The main purpose of the LRCC reforms is to provide incentives to industry to introduce safer chemicals while incorporating safeguards to ensure the protection of the Australian people and the environment. The LRCC reform process commenced in November 2002 when the then Parliamentary Secretary to the Minister for Health and Ageing, Trish Worth announced the establishment of the LRCC Taskforce. This was part of the Government's response to the Chemicals and Plastics Action Agenda. The first legislative outcome of the work the Taskforce undertook was the 2004 amendments to the Act, some of which commenced on 13 July 2004. The reforms included additional exemptions and assessment options for low hazard and low risk chemicals (for example, special permits and self-assessment). Additional reporting and record-keeping measures were introduced as safeguards.

 

A number of the LRCC reforms were able to be implemented quickly and amendments were made to the Act in 2004 to set the legislative framework for the reforms. However, some of the reforms required further consultation; the purpose of the Regulations is to implement the final components of the LRCC reforms.

 

In particular, the Regulations :

 

·               enable an increase in volume for low hazardous chemicals introduced under the Low Volume Chemical Permit system. The Regulations describe the criteria which must be met in order for chemicals to be considered low hazardous and therefore able to be introduced at higher volumes but still under the Low Volume Chemical Permit System;

 

·               enable introduction of highly controlled low risk chemicals under the Controlled Use Permit system. Again, it is achieved through amendments to the Principal Regulations to describe the criteria which must be met in order for chemicals to be considered low risk;

 

·               extend the Early Introduction Permit (EIP) system to low hazardous and low risk chemicals. The EIP was introduced in June 1997 to enable the early introduction of new chemicals that are not hazardous chemicals or dangerous goods, before their assessment was completed. In July 2004, the permit was extended to include certain low hazardous and low risk chemicals which did not meet the previous criteria but could meet the yet to be developed new criteria for low hazardous and low risk. Prior to this amendment an EIP could only be granted for non-hazardous chemicals or polymers of low concern. The Regulations provide that chemicals meeting the low hazardous criteria or the low risk criteria also be eligible for an EIP; and

 

·               enable lower fees to be applied in relation to modular assessment of chemicals for which another assessment is available (for example, where a chemical has been assessed by another assessment authority or is a chemical which is similar in structure to another chemical but differing in some slight structural detail, of a previously assessed chemical – an analogue).

 

There is also a number of minor technical amendments to the Principal Regulations.

 

Details of the Regulations are set out in the Attachment.

 

An LRCC Taskforce was established in November 2002 comprising members from Commonwealth and State government, industry and the community. The Task Force and NICNAS consulted widely with a broad range of stakeholders including: the chemicals and plastics industry and its industry bodies; government and non-government organisations; and worker and community representatives. Two background papers were placed on the NICNAS website to provide information to interested parties. A quick response electronic questionnaire was developed to provide an opportunity for those wishing to engage in the reform process but unable to participate in detailed consultation due to time or other constraints.

 

Focus group consultations were conducted in Sydney, Melbourne and Brisbane with industry and the community. A detailed draft options paper was provided to assist in the decision-making process to all the participants of the focus groups. The LRCC Task Force and NICNAS engaged with over 90 individuals of whom 30 per cent were from the community or government agencies to seek additional feedback on the reform options prior to the release of the Public Discussion Paper in May 2003. This was in addition to the LRCC Task Force members and its various technical working groups.

 

Consultation provided an opportunity for all stakeholders to:

 

The LRCC Task Force also took advice provided by NICNAS’s Technical Advisory Group on confidentiality and access to information as a result of industry and community consultations on the current NICNAS guidelines on procedures for establishing a case for confidential listing on the Australian Inventory of Chemical Substances.

 

In general, the industry submissions were highly supportive of the reform options presented in the Public Discussion Paper because of the perceived benefits they would bring to industry through a more efficient and effective regulatory system. Only one submission indicated that the proposed reform options were conservative, but nevertheless provided a good basis upon which to commence a reform program. There was overwhelming support for the reform process itself, in particular the open and consultative way the LRCC Task Force members and NICNAS conducted the review and engaged industry, government and the community from the beginning of the reform process. Industry saw the LRCC reform processes as part of NICNAS’s continuous improvement process of which regulation reform was one component.

For these current amendments, NICNAS conducted further consultation with industry, the community and relevant government representatives through technical working groups which focused on the concepts of low hazard and low risk and then through publicly released discussion papers. Twelve written submissions were received from industry and government. Following consideration of all submissions, the LLRC Implementation of Outstanding Reforms Final Report and Recommendations was published on the NICNAS website on the 28 September 2007.

 

The Act specifies no conditions that need to be satisfied before the power to make the Regulations may be exercised.

 

The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

The Regulations commence on the day after they are registered on the Federal Register of Legislative Instruments.

 

 


ATTACHMENT

 

Details of the Industrial Chemicals (Notification and Assessment) Amendment Regulations 2008 (No. 2)

 

Regulation 1 – Name of Regulations

 

This regulation provides that the title of the Regulations is the Industrial Chemicals (Notification and Assessment) Amendment Regulations 2008 (No. 2).

 

Regulation 2 – Commencement

 

This regulation provides for the Regulations to commence on the day after they are registered.

 

Regulation 3 – Amendment of Industrial Chemicals (Notification and Assessment) Regulations 1990

 

This regulation provides that the Principal Regulations is amended as set out in

Schedule 1.

 

Schedule 1 – Amendments

 

Item [1]

 

This item amends the definition of ‘Library’ in regulation 2 so that it means the library within the National Industrial Chemical Notification and Assessment Scheme, located at 334–336 Illawarra Road Marrickville NSW 2204.

 

Item [2]

This item removes outdated references to 1999 documents and replaces them with updated references.

 

The publications referred to are available on the website of the Australian Safety and Compensation Council at http://www.ascc.gov.au.

 

Item [3]

Item 3 of the regulations replace the words “less than 100 kilograms” in subregulations 6AB (5A) and (7) with the words “not greater than 100 kilograms”. This is to cover an inconsistency in terminology and fill a gap in the operation of subsection 21(1) in the Act and subregulations 6AB(5A) and (7). The effect of this inconsistency is that amounts of precisely 100 kilograms are subject to the exemption from subsection 21(1), but are not subject to the extra reporting requirements in subregulations 6AB(5A) and (7).

 


Item [4]

This item addresses one of the objectives of the LRCC reforms which is to provide increased flexibility in the options for the introduction of low hazardous chemicals by increasing the volume allowed to be introduced under the Low Volume Chemical Permit system from 100 kg to 1000 kg in certain circumstances.

 

In considering an application for a low volume permit, regulation 6BA provides that for subparagraph 21U(2)(b)(ii) of the Act, guidelines setting out matters the Director of NICNAS must have regard to in deciding whether the intended use of the chemical poses an unreasonable risk to occupational health and safety, public health or the environment are set out in Schedule 1AA (refer item [15]).

 

The increased volume is permitted under section 21Q of the Act. The 2004 amendments to the Act introduced the low volume chemicals permit system (Division 1B of Part 3). Under that division, the introduction of volumes above 100 kg is only allowed where prescribed guidelines have been met. In all other cases, where the guidelines prescribed for introducing volumes up to 1000kg are not met, the quantity permitted under a low volume permit will remain at a maximum of 100kg.

 

The circumstances under which an increased volume (up to 1000 kg) is allowable under the permit are set out in the low hazard criteria in proposed Schedule 1AA. Under those circumstances the chemical may satisfy the condition of no unreasonable risk, however under subparagraph 21U(2)(b)(ii) of the Act, the Director must also take into account the inherent nature of the chemical and any other matters the Director considers relevant.

 

Item [5]

Regulation 6B currently sets out the prescribed information for applications for controlled use permits. However, the provision only applies in relation to an application for a permit by an applicant who intends to export a chemical, that is, applications for export-only controlled use permits.

 

This item amends regulation 6B with the effect that it applies to all applications for controlled use permits and not only applications for export-only controlled use permits.

 

Item [6]

Most of the types of information detailed in regulation 6B are equally relevant to any type of application. However, paragraph 6B(i) requires an applicant for a controlled use permit to supply details of the country to which the chemical is to be exported. This is obviously only relevant to applicants who intend to export the chemical.

 

This item amends the paragraph so that it only applies to applications for a controlled use permit by an applicant who intends to export the chemical.

 

Item [7]

One of the objectives of the LRCC reforms is to enable introduction of highly controlled low risk chemicals under the Controlled Use Permit system.

 

Regulation 6C provides that guidelines for granting an application for a Controlled Use Permit are set out in Schedule 1AB (for subparagraph 22F(1)(b)(ii) of the Act). Item [15] inserts Schedule 1AB.

 

The new low risk guidelines (in Schedule 1AB) does not apply for chemicals introduced for export only. The export only option under the Controlled Use Permit in the Act has been operating since 2006 and was the result of separate consultation with stakeholders. No change is being made to the current procedure in respect of chemicals introduced for export only.

 

Item [8]

One of the other objectives of the LRCC reforms is to encourage early introduction of safer chemicals. This item proposes to insert a new regulation 7B - Chemicals to which early introduction permit can apply.

 

In consultation with stakeholders, it was agreed that other low hazard, low risk chemicals could be introduced, subject to safeguards, prior to completion of the assessment. The 2004 amendments extended the existing section 30A to include chemicals or classes of chemicals prescribed by the regulations as chemicals for which an EIP can be granted. Prior to this amendment an EIP could only be granted for non-hazardous chemicals or polymers of low concern; this item prescribes low hazardous and low risk chemicals as additional classes of chemicals eligible for an EIP. Applicants under both the non self-assessed assessment certificate system (section 23) and the self-assessed certificate system (section 23A) will have access to an early introduction permit. Inherent in the criteria are safeguards ensuring that only chemicals meeting the restrictions are eligible for an early introduction permit. The Director has a discretion under subsection 30A(3) to grant the permit.

 

The purpose of regulation 7B is to set out the criteria for chemicals for which a person may apply for a permit to introduce the chemical before the assessment report is completed. They:

 

·               meet the criteria set out in items 2 or 3 of Schedule 1AA or item 2 of Schedule 1AB. The criteria set out health and environmental end points that must be met in order for a chemical to be considered low hazardous or low risk and hence eligible for an application for an early introduction permit. The environmental criteria set limits on the environmental toxicity of the chemical. The risk phrases (for example R36) used in the Schedules are explained in the ASCC Approved Criteria for Classifying Hazardous Substances. They convey a general description of the physicochemical, environmental and health hazards of a substance and are based on results of toxicological and physicochemical studies on the chemical. The individual risk phrases provide an indication of the type of effect (for example, acute toxicity, sensitiser) and in some cases a measure of the effect (for example, harmful, toxic, very toxic). The risk phrases originated in the EU and have been adopted in Australia; and

 

·               meet the requirement that the introduction of the chemical is consistent with the reasonable protection of occupational health and safety, public health and the environment, taking into account the following matters:

-         the nature of the use of the chemical. For example, cosmetic, industrial paint, or a more specific use such as a component of an automotive spray paint;

-         the extent of the use of the chemical. For example, the chemical will be used at one particular site in Australia, or the chemical will be in a domestic product widely distributed across Australia;

-         the effect of the chemical on occupational health and safety and public health;

-         the structure and activity of the chemical;

-         whether, in Australia or overseas, the chemical is the subject of: investigations initiated by a person because of concerns about a possible adverse effect on occupational health and safety, public health or the environment; or action taken by a person to control the use of, or access to, the chemical.

 

Item [9]

This item replaces existing regulation 8A with a new regulation – Regulation 8A – Prescribed authority (Act, s 38(5)(a)).

 

The regulation 8A updates the current list of prescribed authorities.

 

Item [10]

This item replaces existing regulation 8C with a new regulation – Regulation 8C – Prescribed authority (Act, s 40G (1)(a)(i)).

 

Section 40G of the Act provides that in certain circumstances, the Director must publish modifications to an original assessment report by giving a copy of the original assessment report, incorporating the modifications to certain prescribed authorities of the Commonwealth, the States and the Territories. Regulation 8C updates the current list of prescribed authorities.

 

Both Items 9 and 10 update the current lists by removing references to the Commonwealth Department of Environment and Heritage, the Commonwealth Department of Health and Ageing and Worksafe Western Australia on the basis that these agencies either no longer wish to be given copies of the assessment reports or the name of the agency has changed. In the case of the Department of Health and Ageing, since the Principal Regulations were made, NICNAS has become part of the Department and it is therefore no longer necessary to prescribe the Department of Health and Ageing as an authority to be given assessment reports. The only agency that now wishes to receive the reports is the Commonwealth Department of Environment, Water, Heritage and the Arts (previously named the Commonwealth Department of Environment and Heritage). The assessment report contains both publicly available information and exempt information, that is, confidential business information which is not published by NICNAS. The Department of Environment, Water, Heritage and the Arts (DEWHA) conducts the environmental hazard and risk assessment for NICNAS and requires the assessment report for the proper implementation of environmental recommendations in the report.

 

Item [11]

This item replaces existing regulation 9B with a new regulation – Regulation 9B – Prescribed authority (Act, s 60F(7)(a)).

 

Subregulation 60F(7) provides that the Director must publish the final assessment report by giving a copy of it to any prescribed authorities of the Commonwealth, States or Territories.

 

Existing regulation 9B is replaced by the new regulation that updates the current list of prescribed authorities by removing references to agencies that no longer wish to be given copies and by amending an outdated name of an organisation.

 

For items [9], [10] and [11], it is important to note that any other authority of the Commonwealth, States or Territories can still access the full public report through the publicly available Chemical Gazette and the NICNAS website.

 

Items [12] and [13]

Paragraph 106(1)(a) of the Act provides that if an industrial chemical is the subject of a prescribed international agreement to which Australia is a party, the regulations may prohibit the introduction or export of the chemical, either absolutely or subject to such conditions or restrictions as are prescribed.

 

Item [12] amends subregulation 11B(1) so that both the Rotterdam Convention and the Stockholm Convention are prescribed international agreements for the purposes of paragraph 106(1)(a) of the Act. The Stockholm Convention came into force on

17 May 2004, with Australia ratifying the Convention on 20 May 2004 and becoming a Party on 18 August 2004.

 

The Convention aims to protect human health and the environment from the effects of persistent organic pollutants (POPs) with a range of control measures to reduce and, where feasible, eliminate POPs releases, including emissions of unintentionally produced POPs such as dioxins. The Convention recognises that there are other chemicals that could pose similar hazardous threats to human health and the environment, therefore other chemicals may be added in the future. It is possibile that other chemicals that may be added come within the remit of NICNAS hence the amendment is to allow NICNAS to be prepared to act quickly if necessary should a relevant chemical be added to the convention.

 

Item [13] amends subregulation 11B(2) to define ‘Stockholm Convention’ as the Stockholm Convention on Persistent Organic Pollutants, done at Stockholm on

23 May 2001, as amended by any amendment of the Convention that has entered into force in Australia.

 

Item [14]

One of the key planks of the LRCC reforms was the introduction of the modular assessment concept, based on the assumption that part of the assessment (a module) had already been done, either by NICNAS or another authority, and therefore did not need to be repeated. Based on cost-recovery principles, a fee reduction is appropriate for that part of the assessment already done.

 

Consistent with this policy, this item amends regulation 15 so that the Director may remit a percentage of the fee paid for an application under section 23 of the Act if satisfied that the chemical being assessed has been assessed previously by another specified regulatory authority, or is the same or similar or that its intended use is the same or similar, to a chemical that has been assessed by NICNAS. Where multiple applications are made, at the same time, for similar chemicals that have the same or a similar use, the full fee will be charged for the first application, then a part, or the whole of a fee paid for the other applications under section 23, may be remitted.

 

Another aspect of the LRCC reforms was to encourage the introduction of less hazardous chemicals. Consistent with this, the regulation allows the Director to remit fees paid for an early introduction permit in respect of an application for a polymer of low concern or a non-hazardous chemical.

 

This item also replaces existing subregulation 15(6) which is now redundant.

 

Item [15]

This item inserts two new Schedules:

·              Schedule 1AA which is relevant to regulation 6BA (low volume permit guidelines) and regulation 7B (chemicals in relation to which an application for an early introduction permit may be made); and

 

·              Schedule 1AB which is relevant to regulation 6C (guidelines for controlled use permits) and regulation 7B (chemicals in relation to which an application for an early introduction permit may be made).

 

An application for an early introduction permit can be made if a chemical meets the criteria in either Schedule 1AA or 1AB. Such chemicals must also meet the requirement that the introduction is consistent with the reasonable protection of occupational health and safety, public health and the environment.

 

Schedule 1AA serves two purposes:

·               for regulation 6BA – it sets out guidelines containing matters that the Director must consider for an application for a low volume permit, if the total quantity of the chemical to be introduced is not more than 1,000kg; and

·               for regulation 7B – it sets out criteria for a chemical or class of chemicals, other than a polymer of low concern or a non-hazardous chemical, for which an application may be made for an early introduction permit.

 

The guidelines set out different matters/criteria for:

·               all chemicals (including polymers other than those with number average molecular weight that is 1,000 or greater); and

·               polymers with number average molecular weight that is 1,000 or greater.

 

Schedule 1AB also serves two purposes, being:

·               for regulation 6C - it set out guidelines containing matters that the Director must consider for an application for a controlled use permit, if the applicant does not intend to export all of the chemical; and

·               for regulation 7B - it set out criteria for a chemical or class of chemicals, other than a polymer of low concern or a non-hazardous chemical, for which an application may be made for an early introduction permit.

 


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