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INDUSTRIAL CHEMICALS (NOTIFICATION AND ASSESSMENT) AMENDMENT REGULATIONS 2002 (NO. 1) 2002 NO. 58

STATUTORY RULES 2002 No. 58

Issued by the authority of the Parliamentary Secretary to the Minister for Health and Ageing

Industrial Chemicals (Notification and Assessment) Act 1989

Industrial Chemicals (Notification and Assessment) Amendment Regulations 2002 (No. 1)

The object of the Industrial Chemicals (Notification and Assessment) Act 1989 (the ICNA Act) is to provide for 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, to provide information and make recommendations about industrial chemicals to Commonwealth, State and Territory bodies, to give effect to Australia's obligations under international agreements and to collect statistics in relation to these chemicals.

Section 111 of the Act provides that the Governor-General may make regulations not inconsistent with this 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 broaden the number of industrial chemicals which can be used in Australia which are considered polymers of low hazard and low risk to human health and the environment, and to make a number of consequential technical/remedial adjustments to the Regulation.

The Regulations:

•       Amend regulation 2 of the principal Regulations in relation to the definition of the words 'Act' and 'cationic' (Items 1 and 2 of Schedule 1 refer);

•       Substitute existing regulation 4A with regulations 4A-4I and insert new Schedule 3 to revise the criteria relating to the definition of PLCs. This amendment has the effect of increasing the number of low risk industrial chemicals to be included within the definition of PLCs. The revised criteria aligns the definition of PLCs to the United States Environmental Protection Agency (US EPA) criteria (Items 3 and 11 refer);

•       Update the names of Commonwealth prescribed authorities which are the Department of the Environment and Heritage and the Department of Health and Ageing for the purposes of paragraph 38(5)(a), subparagraph 40G(1)(a)(i) and paragraph 60F(7)(a) of the Act (Item 4 of Schedule 1 refers);

•       Amend Regulation 11B to reflect the new name of the voluntary Prior Informed Consent (PIC) procedure and its derivation (Items 5 and 6 of Schedule 1 refer);

•       Omit Regulations 12A and 12C relating to fees for the assessment of priority existing chemicals and when it is payable (Item 7 of Schedule 1 refers);

•       Omit Regulation 16 relating to the waiver of fees payable in relation to 1,4 dioxane (Item 8 of Schedule 1 refers);

•       Amend Regulation 17 to allow for review by the AAT of decisions made under subregulation 15(6) and regulation 16A (Item 9 of Schedule 1 refers);

•       Insert a new prescribed form to accompany an application for an assessment certificate for a synthetic polymer of low concern for the purposes of section 24A of the Act (Item 10 of Schedule 1 refers); and

•       Provide a list of prescribed reactants for the purposes of section 5 of the Act (Items 1 and 2 of Schedule 2 refer).

Details of the Regulations are set out in the Attachment.

The Regulations, except for Schedule 2, commenced on the date of gazettal. Schedule 2 is dependent on the commencement of item 5 of the Safety, Rehabilitation and Compensation and Other Legislation Amendment Act 2001 (SRCOLA Act), which happens to be 1 April 2002. Item 5 of the SRCOLA Act relates to prescribed reactants for the purposes of section 5 of the ICNA Act which is listed in Schedule 2.

The Minute recommends that Regulations be made in the form proposed.

Authority:       Section 111 of the Industrial Chemicals (Notification and Assessment) Act 1989

ATTACHMENT

Details of the Industrial Chemicals (Notification and Assessment) Amendment Regulations 2002 (No. 1)

Regulation 1 states that the title of these Regulations will be the Industrial Chemicals (Notification and Assessment) Amendment Regulations 2002 (No. 1).

Regulation 2 provides for the commencement of regulations 1, 2, 3 and Schedule 1 on gazettal and that Schedule 2 commences on the commencement of item 5 of Schedule 1 of the Safety, Rehabilitation and Compensation and Other Legislation Amendment Act 2001(the SRCOLA Act).

Regulation 3 provides that Schedules 1 and 2 amend the Industrial Chemicals (Notification and Assessment) Regulations 1990.

SCHEDULE 1- AMENDMENTS COMMENCING ON GAZETTAL

Item 1

Inserts the definition of the terms, 'Act' and 'cationic'. The definition of the 'Act' is merely a substitute for the previous definition of 'the Act', and is a formality change. 'Cationic' is a scientific term that appears in Regulations 4C and 4E.

Item 2

Item 2 omits the definition of the "the Act" in Regulation 2 as a consequence of item 1.

Item 3

Item 3 inserts regulations 4A to 4I, revising the criteria relating to the definition of PLCs. Its effect is to widen the number of chemicals included in this special category. There is a special notification category for PLCs that includes a lower assessment fee and reduced notification requirements. The broad definition of synthetic polymer of low concern is provided in section 5 of the Act.

The new criteria are based on the current criteria of the United States Environmental Protection Agency (US EPA). The amendment of the criteria for PLCs will mean that some polymers currently notified under the limited notification category (subsection 23(7) of the Act) will become eligible for notification as PLCs due to the broadening of the criteria. As the fees for PLCs are considerably less than for limited notifications, the amendment is expected to be an incentive to industry to introduce more new chemicals. A significant increase in the number of PLC applications will be associated with a reduction in the number of the more expensive limited notifications. This will lighten the burden on industry without significantly impacting on health, safety or the environment.

Regulation 4A defines, for the purposes of paragraph (a) of the definition of synthetic polymer of low concern (in section 5 of the Act), the number average molecular weight (NAMW) for those synthetic polymers with a NAMW greater than 1,000, but less than 10,000. It also places a restriction (limit) on the number of reactive functional groups listed in Schedule 3, in the polymer.

Regulation 4B defines, for the purposes of paragraph (a) of the definition of synthetic polymer of low concern (in section 5 of the Act), the NAMW for those synthetic polymers with a NAMW 10,000 or greater.

Regulation 4C defines, for the purposes of paragraph (b) of the definition of synthetic polymer of low concern, when a synthetic polymer is considered to have a low charge density.

Regulation 4D defines, for the purposes of paragraph (c) of the definition of synthetic polymer of low concern, the low residual monomer content required for a synthetic polymer.

Regulation 4E defines for the purposes of paragraph (d) of the definition of synthetic polymer of low concern, when a synthetic polymer does not dissociate readily.

Regulation 4F defines, for the purposes of paragraph (e) of the definition of synthetic polymer of low concern, that every synthetic polymer is taken to have low water solubility. Note that every synthetic polymer will be deemed to have low water solubility, as this characteristic is no longer considered necessary for determining whether a polymer is of low concern. However, the characteristic remains a data requirement for the purposes of the risk assessment of the PLC.

Regulation 4G defines, for the purposes of paragraph (f) of the definition of synthetic polymer of low concern, that a synthetic polymer may have any particle size in solid form. Note that the definition allows any particle size, as this characteristic is no longer considered necessary for determining whether a polymer is of low concern. However, the characteristic remains a data requirement for the purposes of the risk assessment of the PLC.

Regulation 4H defines, for the purposes of paragraph (g) of the definition of synthetic polymer of low concern, when a synthetic polymer is regarded as stable.

Regulation 4I prescribes, for the purposes of paragraph (h) of the definition of synthetic polymer of low concern, the other characteristics required for a synthetic polymer to be a PLC, namely, elemental composition and water absorbing potential.

Item 4

Item 4 updates the name of prescribed Commonwealth authorities in paragraphs 8A(a), 8C(a) and 9B(a).

Item 5

Item 5 omits the words 'Prior Informed Consent (PIC) Scheme' from subregulation 11B(1) and insert instead the words 'interim PIC procedure'. This amendment is related to item 6.

Item 6

Item 6 substitutes a new subregulation 11B(2). The regulations provide a new definition of PIC and its derivation. Currently the PIC Scheme is named as a prescribed international arrangement, for the purposes of section 106 of the Act, under regulation 11B. The international PIC procedure is a means for formally obtaining and disseminating the decisions of importing countries as to whether they wish to receive future shipments of a certain chemical, and for ensuring compliance with these decisions by exporting countries.

The voluntary scheme will continue internationally, with some changes to procedures as the 'interim PIC procedure'. The interim PIC procedure was adopted by the resolution of the diplomatic conference on the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (the Convention). This procedure will be in place until the Convention enters into force. This regulation is intended to reflect the new name of the voluntary procedure and its derivation.

Item 7

Item 7 omits Regulation 12A and 12C. Regulation 12A provides for fees for an application under section 55(1) of the Act for the assessment of priority existing chemicals. Regulation 12C provides that the fee under section 55(1) or (2) of the Act is payable at the time the application is lodged. The collection of fees under section 55(1) of the Act has now been subsumed under Part 3A of the Act since 1997.

Item 8

Item 8 omits regulation 16 as this regulation is now redundant. The assessment of 1,4-dioxane has been completed and the chemical is no longer a priority existing chemical.

Item 9

Item 9 amends subregulation 17(1) to allow the AAT review of decisions made under subregulation 15(6) and regulation 16A, which relate to the remission of a fee paid in relation to a secondary notification under section 65 of the Act subject to certain conditions, and in relation to a waiver of a fee payable by a person under paragraph 110(1)(s) of the Act in relation to a notification of a listed industrial chemical, respectively.

Item 10

Item 10 amends Schedule 1 of the Regulations to substitute a new form 1A. This Form is to be followed when making a statement under s24A regarding a PLC. The new form incorporates changes to the criteria for PLCs in item 3.

Item 11

Item 11 inserts a new Schedule 3. The Schedule contains a table of reactive functional groups. This table contains information for determining which synthetic polymers meet the requirements of regulation 4A.

SCHEDULE 2- AMENDMENTS COMMENCING ON THE COMMENCEMENT OF ITEM 5 OF THE SRCOLA ACT

Item 1

Item 1 inserts a new regulation 4AB which provides that the definition of a 'prescribed reactant' for the purposes of section 5 of the Act is any substance listed in Schedule 4 to the Regulations.

Item 2

Item 2 inserts a new Schedule 4 to the Regulations. Schedule 4 lists substances which are prescribed reactants for the purposes of the definition of prescribed reactants under section 5 of the Act.

The chemicals on the list are of low health and environmental concern. It is considered that potentially greater amounts of low molecular weight polymers produced using these prescribed reactants do not pose an undue risk to health or the environment. The list of reactants is based on a similar list by the United States Protection Authority in assessing synthetic polymers as to whether they present an unreasonable risk of injury to human health or the environment. Schedule 4 consists of a table with two identifiers for each reactant: its chemical name and its Chemical Abstract Service Registry (CAS) number.

REGULATION IMPACT STATEMENT

To add a new regulation to the Industrial Chemicals (Notification and Assessment) Act 1989 to revise the criteria relating to the definition of synthetic polymers of low concern.

Synthetic polymers of low concern (PLC's) have a low hazard rating due to their physical and chemical properties, for example, high molecular weight and low reactivity. Polymers, which satisfy the criteria for a PLC, are more likely to be of low risk to human health and the environment. Polymers of low molecular weight which contain reactive chemical groups are more hazardous than polymers regarded as of low concern.

1.       Identify the Problem

At the moment, certain synthetic polymers of low concern are ineligible for notification as polymers of low concern and thereby attract a higher fee when assessed by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), regardless of the fact that they have a similar risk/hazard status.

Under current arrangements, assessment fees for polymers of low concern are $3,300 while fees for limited notification category (which may include other low hazard synthetic polymers) are $9,800. These fees are currently prescribed under paragraphs 13(2)(c) and 13(2)(b) of the Regulations.

2.       Objective of the Regulation

To broaden the criteria for polymers of low concern to include certain synthetic polymers of low concern and thereby lower the fees charged to client requiring assessments for these chemicals and reduce notification requirements.

3.       Identify regulatory and non-regulatory options

Option One

Establish new criteria for synthetic polymers of low concern to align more closely with existing US criteria for polymers of low concern.

Option Two

Status quo

4.       Assess the costs and benefits of the options

Option One

Business

Benefit to Business-Lower fees for approximately 20 chemicals per annum. The data requirements for a Polymer of Low Concern (PLC) are substantially less than for a Limited Notification. This leads to a reduction in the cost of generating data for the notification and compiling the notification package. This should lead to an increase in new chemicals assessed which is estimated at 30 per annum once the new regulation is enacted.

Cost to Business-Fees 66% lower than before. Approximately half of the PLCs under the new criteria would have been classified under the Limited Notification category under the old criteria. Possibly traditional introducers of polymers may lose some market share to more efficacious synthetic polymers of low concern.

Government

Benefit to Government-The more streamlined assessment process applying to synthetic polymers of low concern will result in shorter assessment time, with consequent cost savings that can be applied to other priorities.

Cost to Government-None identified.

Consumer

Benefits to Consumer-With simpler assessment methodology and lower costs, business is more likely to introduce new chemicals that are more effective and possibly less polluting or damaging to occupational health and safety, public health and the environment.

Costs to Consumer-No increase in costs to consumer.

Option 2

Business

Benefits to Business-No benefit, as current process is more costly (except where polymers are already regarded as of low concern). Retention of the current arrangement could provide possible benefit to traditional producers of polymers as there will be no competition with polymers that are identified as of low concern. (NB, The trend towards less hazardous polymers (and products) would not be expected to be associated with any loss of market share. The effect would be minimal at best.)

Cost to Business-Higher fees than for introducers of polymers of low concern which don't meet old criteria than for introducers of polymers of low concern which meet old criteria.

Government

Benefit to Government-No benefit to Government. Chemical assessment is more lengthy even though the risk/hazard is not higher than for polymers of low concern.

Cost to Government-Greater time expended on assessing low hazard polymers under the old notification category.

Consumer

Benefit to Consumer- Possibly more data available for synthetic polymers of low concern which don't meet old criteria, however benefits are expected to be minimal.

Cost to Consumer-Possibly less choice in chemical products as industry may be reluctant to introduce new chemicals if the fees were higher. Under the new PLC criteria, there is more incentive for industry to introduce low hazard synthetic polymers, therefore, there is a greater likelihood of lower hazard (safer) polymers entering the public domain.

5.       Public Consultation

Following extensive industry consultation in 1997-98, a Polymer Focus Group consisting of expert industry representatives, government representatives (Environment Australia) and specialist academics in the polymer field (CSIRO) was established to assist NICNAS in the scientific aspects of the development of the new criteria. Two Position Papers outlining the proposed changes was then prepared for public comment in 1998 and 1999. The response to the public comment was published in the Chemical Gazette in July 1999.

6.       Conclusion and recommended option

As industry, government and consumers all gain from lower fees and a possible greater choice of assessed chemicals available to the Australian market, it is recommended to add a new regulation to be made under the Industrial Chemicals (Notification and Assessment) Act 1989 to establish a new criteria for synthetic polymers of low concern.

7.       Strategy to implement and review

Change will be effective from the date of regulation. The regulation will be reviewed by NICNAS 12 months after its implementation. Affected parties will be notified of the change by a notice in the Chemical Gazette and NICNAS websites and via publicity by industry organisations.