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Oct. 21 — Australia is proposing major reforms to its system for assessing and approving chemicals, with industry broadly supportive and environmental and consumer groups much more critical.
In its fourth consultation paper issued Oct. 4, the Department of Health said the number of industrial chemicals that must undergo assessment before entering the Australian market would decrease by more than 70 percent under the proposed reforms.
About 9,000 new chemicals are introduced to Australia annually and, if the reforms are implemented, the number requiring pre-market assessment is expected to fall from about 300 to 100, the department said.
The reforms would make Australia more competitive and maintain the current level of protection for residents and the environment, the Department of Health’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) said in the consultation paper. While the government previously outlined the risk-based approach, this is the first of the consultation papers to provide an overview of the legislation that would implement the reforms. .
According to the proposal, the reforms would take effect in mid-2018.
The reforms would establish three pathways for chemicals to enter the Australian market, depending on whether they are very low risk (exempted chemicals), low risk (reported chemicals), or either medium or high-risk (assessed chemicals). New chemicals that can be introduced without assessment still must meet notification obligations.
Very low-risk chemicals would be exempted from notification and assessment requirements. Low-risk chemicals could be introduced to market providing they were notified to the chemicals regulator, NICNAS, but they wouldn’t require assessment.
Medium- and high-risk substances generally would require pre-market assessment, although medium-risk ones could follow the notification-only path if they have been assessed by specified international chemical agencies.
In addition, hazard and exposure criteria would be addressed in the regulations, not the primary legislation.
The consultation papers are open for comment until Nov. 4.
The department acknowledged that views on the proposed reforms to NICNAS “have been polarized.” Differences have emerged over both the broad thrust of the reforms and technical aspects of the hazard and exposure criteria.
“The proposed reforms go some way to ensuring Australian users of industrial chemicals have access to the latest and most innovative chemical solutions, on the same day as their overseas competitors,” Bernard Lee, policy and regulation director of Plastics & Chemicals Industries Association (PACIA) in Melbourne , told Bloomberg BNA in an Oct. 17 e-mail.
Lee said PACIA welcomed the reduction in the volume of chemicals requiring pre-market assessment and the prospect that low-risk polymers would for the first time be able to enter the market without assessment or notification.
He said it was “disappointing,” however, that although the reforms would accept international assessments from specified overseas regulators, the U.S. Environmental Protection Agency initially would be excluded because it does not publish public reports of its assessments .
Meanwhile, community and health groups are much more cautious about the reforms, largely because many new chemicals will be allowed to enter the Australian market without any obligation to notify NICNAS and a higher proportion will not require assessment.
Paul Grogan, director of advocacy with the Cancer Council Australia in Sydney , told Bloomberg BNA by phone Oct. 17 that “rigor and safety are priority one.”
The council has yet to finalize its position on the latest paper but previously said the government provided no justification for the proposed reforms nor any evidence that they would improve population health outcomes.
Meanwhile, the Public Health Association of Australia (PHAA) took issue with a proposal that would allow up to 100 kilograms of nanomaterials to be introduced for research purposes without either assessment or notification.
“It is not appropriate for such large quantities of these materials to be introduced, even for [research and development], without the knowledge of NICNAS, given the limited understanding of the risks they may pose to people and the environment,” its submission said.
Consultation paper 4 and submissions to consultation paper 3 are available at http://src.bna.com/jvD.
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