Australia-Canada bilateral arrangement

Upon signature in August 2002, the Cooperative Arrangement between NICNAS and Canada on sharing information on new industrial chemicals was finalised. The Arrangement is for two years in the first instance.

The objective of the Arrangement is to obtain financial and other benefits for governments and for notifying companies in both countries and, ultimately, for formal recognition of the Canadian new chemicals assessment scheme as an approved foreign scheme within the Industrial Chemicals (Notification and Assessment) Act 1989.

NICNAS key achievements 2001-02

Assessment

• new chemicals assessment outputs kept pace with inputs
• number of existing chemicals assessments exceeded targets
• all timeframe targets met or exceeded
• development of electronic template for notification and assessment
• introduction of "Other Assessments" category for rapid priority assessment
• improved chemical safety through increased uptake of risk management recommendations
• use of overseas reports in PEC assessments exceeded target by 25% and $25,000 saved by new chemical notifiers through special initiative rebates
• 276 cosmetic chemicals and 12 non-cosmetic chemicals assessed without cost to industry, saving $748,800 to $2,822,400
• 36 free pre-notification consultations provided to industry
• bilateral agreement between Australia and Canada
• peer review of 63 OECD chemical assessments and 8 IPCS chemicals

Compliance

• 85 compliance investigations completed within target timeframe
• eightfold increase from 2000-01 in industry self-reporting potential breaches
• 2682 AICS searches, an increase of 53% on last year
• development of new search capacity for AICS CD-ROM

Communication

• increase in website visitors from 6555 hits per day to nearly 10,000
• 152 media inquiries leading to better informed articles on chemical safety
• publication of targeted information for the public and workers
• publication of list of chemicals imported into Australia in high volumes
• performance targets for service met, with high client satisfaction
• development of new data management system for tracking business information

NICNAS transfer to DoHA

The transfer of NICNAS to the Department of Health and Ageing, as part of the machinery of government changes announced in November 2001, became effective on 3 July 2002.

The move to Health provides an opportunity to build further cooperative linkages to the medicine and gene technology regulators, as well as taking advantage of major synergies to be gained from bringing public health regulation of chemicals together.

Second TGA-authored assessment monograph published by the OECD

A second scientific monograph authored by the Chemicals Review and International Harmonisation Section of the TGA has been published by the Organisation for Economic Cooperation and Development. The Guidance Notes for Analysis and Evaluation of Chronic Toxicity and Carcinogenicity Studies, now available on the OECD website <http://www.oecd.org>), is intended to assist reviewers in different countries to prepare chemical assessment reports to a consistent level of detail, using a standardised format and methods of scientific interpretation. Although originally prepared for toxicology evaluation of pesticides, the Guidance Notes are also applicable to the assessment of pharmaceuticals, industrial chemicals and biocides.

The project was undertaken on behalf of the OECD Working Group on Pesticides, which was established during the early-1990s to improve international harmonisation of pesticide control procedures. One of the principle obstacles to this objective was that there were significant differences in the assessment procedures used by the various national regulatory agencies, which were impeding the exchange of evaluation reports and contributing to discrepancies in decision-making. In 1994, the USA and Canada suggested that this could be overcome by the development of detailed guidance documents. Australia joined the project in 1995 and took the lead in the preparation of the Guidance Notes for Analysis and Evaluation of Repeat-Dose Toxicity Studies. This first TGA-authored monograph was published in 2001.

Work on the latest monograph, Guidance Notes for Analysis and Evaluation of Chronic Toxicity and Carcinogenicity Studies, began in January 1999. The lead author was Mark Jenner, with input from Les Davies and the other scientific staff. The initial drafting process involved research on the technical policies of the more influential overseas regulatory agencies, which was then combined with the practical knowledge available within the Chemicals Unit of the TGA. Work proceeded rapidly because of the significant steps made towards the harmonisation of assessment approaches over the last five years, as well as the experience gained from preparing the first monograph. After only six months, the initial draft of the Guidance Notes for Analysis and Evaluation of Chronic Toxicity and Carcinogenicity Studies was ready for circulation to other member nations. The first draft was received positively and scientists from participating agencies offered much helpful advice and additional material, which was incorporated into the two further drafts that followed.

Now that the Guidance Notes are finally entering worldwide use, it is hoped they will become a valuable training aid and will increase the efficiency and consistency of chemicals regulation, as well as contributing to the reduction of international trade barriers to chemical products and food containing pesticide residues.