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The Six Step Review Process for PECs

 

Step 1: Nomination

Any person or organisation with a concern about the public health, occupational health and safety, or environmental effects of an industrial chemical may nominate it for assessment.

Nominators may include members of the public, workers, unions, industry groups, public interest groups, and State, Territory and Commonwealth government agencies

The chemicals nominated can be chemicals used on their own, or chemicals that form part of a product (an ingredient) or industrial process.

The Director of NICNAS periodically makes a public call for nominations, through notices in the Chemical Gazette, relevant industry journals, and national newspapers. Nominations should be made on the appropriate form, available from NICNAS.

The Director will also accept nominations for assessment at any time, not only when there is a public nomination phase.

Step 2: Screening and Information Gathering

Once nominated, chemicals are screened to determine if they are eligible for inclusion in the program.

A chemical may not be accepted into the program if it is not an industrial chemical under the definitions of the legislation.

Each nominated chemical is then assessed against a set of criteria covering issues in public health, occupational health and safety, and the environment.

By consulting a number of standard sources of chemical information, a decision is made on whether the concerns relating to health and environment are sufficient to merit further consideration.

The chemicals are then ranked on the basis of perceived severity of the threat posed to human health or the environment.

Additionally, in the ranking of chemicals these factors may be considered:

  • Whether is has been recently reviewed by another government agency within Australia;

  • Whether it is under review in another country, and NICNAS is awaiting the outcome of such a study; and

  • Chemicals that are ranked with a high priority may not only include those which rank high in all areas of concern, but could also cover those which may have a very strong concern in one key area (e.g. carcinogenicity).

The outcome of the screening and ranking process is a candidate list of chemicals.

The Director of NICNAS may decide that more information is needed in relation to particular chemicals on the candidate list. To seek this information, the Director may publish a notice in the Chemical Gazette under provision of section 48 of the Act (known as a ‘section 48 notice’).

A section 48 notice is directed to persons who have imported or manufactured the chemical(s) in the 12 months prior to the publication of the notice, and/or to anyone the Director believes has relevant information concerning the chemical(s).

The notice can require the provision of various types of information, such as amounts imported or manufactured, known uses of the chemical in Australia, information on health effects or environmental effects, or information on occupational exposure.

A summary of the information obtained from a section 48 notice is prepared within 90 days of the date the last information was received. The summary is published in the Chemical Gazette, or a notice giving details of how to obtain a copy is published.

Step 3: Declaration

The Director uses the information that is obtained through the screening and ranking process, together with any information gained from a section 48 notice, to help decide whether to recommend to the Minister for Health and Ageing, that a chemical be declared as a PEC.

The Minister for Health and Ageing may decide, on the basis of a recommendation from the Director of NICNAS, to declare a chemical to be a PEC. A notice of declaration is published in the Chemical Gazette. It provides details of the type of assessment to be undertaken and what information is required to be supplied to NICNAS by applicants (see below).

Step 4: Assessment

Once a chemical has been declared a PEC, all importers and manufacturers are required to make an application for assessment within 28 days of the declaration. The application must be accompanied by the information referred to in the declaration notice.

A 'weight of evidence' approach is adopted in the assessment of each chemical, taking into account all available information including published literature, unpublished data, public information, international assessments and the data submitted in response to notices placed in the Chemical Gazette.

Full assessments will usually include information on chemical and physical properties, uses, exposure, kinetics and metabolism, effects on experimental animals and in vitro test systems, and human health effects. It will usually include a hazard assessment and classification, a section on risk characterisation, risk management, and recommendations. Full assessments include an occupational, consumer and/or environmental risk assessment.

Preliminary assessments are less detailed, tailored to the particular aspects that are the focus of the assessment. Preliminary assessments do not include a risk assessment.

Both preliminary and full assessments can apply to the chemical generally, or can focus on particular uses of the chemical, or on its manufacture, handling, storage or uses in a specified geographical area or in specified circumstances.

Sometimes related or similar chemicals are assessed as a group. This flexibility in assessment ensures that NICNAS resources are targeted effectively to priority areas of concern.

As the assessment proceeds, NICNAS may request more information from introducers of the chemical or other specified people through placement of a notice in the Chemical Gazette under the provisions of section 58 of the Act (a 'section 58 notice').

Step 5: Public Comment

NICNAS is committed to industry and public involvement, and sees consultation with these groups as an essential part of the assessment process.

When the draft report of the assessment is prepared, a copy of the draft report is given to applicants with a notice asking the applicants to notify of any errors in the report. Any errors must be corrected by the Director within 56 days of sending the draft report to applicants.

Corrected draft reports are sent to applicants and anyone who has provided information for the report in response to a section 58 notice (notifiers). At the same time, a notice is published in the Chemical Gazette describing how copies of the report can be obtained.

Requests for variation to the report may be made by any interested party on Form 4a within 28 days of publication of the notice. A copy of the decision made by the Director in relation to requests for variation is sent to each applicant and the person who made the request.

There are provisions for appeal to the Administrative Appeals Tribunal (AAT) if a person does not agree with a decision made by the Director regarding a request for variation to the draft report. A report cannot be finalised or published until any such appeal is finalised.

Step 6: Outcomes

National
Through the assessment reports, information on any risks to human health and the environment, and recommendations on ways to control and reduce any risks is made available to companies introducing chemicals, to people within the workplace, to other Government agencies, and the public.

Recommendations from PEC assessment reports can have an important bearing on regulatory action that may be implemented within Australia in the context of protecting the health of workers and the public, and protecting the environment. For instance, they may impact on national occupational exposure standards, hazard classification, health surveillance guidelines, labelling requirements, and the development of codes of practice.

International
The quality of the assessments produced by NICNAS is accepted as being high on an international level.

As a member of the OECD, Australia participates in the OECD’s High Production Volume Existing Chemicals Program. Assessments produced as part of Australia’s Existing Chemicals Program are used in this international forum, forming a part of Australia’s contribution to the worldwide assessment of existing chemicals. See Australia’s contribution to international assessments.

Participation in international assessment programs also assists in the review and development of Australian Assessment methodologies.

 

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