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Thursday, 24 June 2010
Page: 4304

Senator LUDWIG (Special Minister of State and Cabinet Secretary) (11:55 AM) —I table a revised explanatory memorandum and I move:

That this bill be now read a second time.

I seek leave to have the second reading speech incorporated in Hansard.

Leave granted.

The speech read as follows—

The Agricultural and Veterinary Chemicals Code Amendment Bill 2010 is an important step forward in the Government’s plans to reform the way we regulate agricultural and veterinary—or agvet—chemicals.

The overriding priorities are always the protection of human health and the environment.

But the Government remains committed to delivering greater efficiencies without jeopardising those priorities.

A more efficient system for regulating chemicals will benefit farmers and the environment and encourage more innovation in chemical companies.

The Agricultural and Veterinary Chemicals Code Amendment Bill 2010 consists of five measures which amend the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994.

The bill gives effect to reforms agreed by the Council of Australian Governments, or COAG, and delivers on an early harvest reform identified in conjunction with the Productivity Commission research report in 2008.

It also brings forward measures identified through the Better Regulation Ministerial Partnership between the Minister for Agriculture, Fisheries and Forestry and the Minister for Finance and Deregulation, announced in March this year.

These measures will simplify the administration of agvet chemicals, allowing the industry regulator, the Australian Pesticides and Veterinary Medicines Authority, or APVMA, to better focus on its priority of protecting human health and the environment.

The measures will also help producers of agvet chemicals to deliver new and improved products to the market sooner.

Firstly, the bill will allow for applicants to notify the APVMA of a limited range of defined, low risk, minor changes to their products.

The current legislation requires the APVMA to undertake a comprehensive assessment for all technical changes to chemical product approvals and registrations, no matter how minor.

This creates unnecessary delays for industry and the APVMA when making inconsequential changes, such as to the colour of a product or the size of the container.

It also distracts the APVMA from its work assessing higher risk changes.

Items which could be varied by notification, without unnecessary regulatory burden, will be set out in a legislative instrument.

The variations must result in no material change to active product chemistry, no risk to the quality, stability or safety of the product and no risk to the environment or trade.

Applicants will be allowed to make changes through a simplified application process, effectively allowing them to notify the APVMA of the change.

This could see quality products made available to the market sooner.

It will improve the timeliness of minor, low risk changes to agvet chemicals and chemical label approvals and registrations while maintaining full assessment for all other changes.

Secondly, the bill deals with a cumbersome requirement that registrants notify the APVMA in writing of an ‘approved person’ and that the APVMA verifies that each person it corresponds with is an approved person.

The amendments would remove the requirement for industry to advise the APVMA in writing of an ‘approved person’.

The proposed measures would cut red tape while maintaining safeguards, including that an approved person is liable for non-resident registrants, where applicable.

Thirdly, the bill seeks to limit APVMA’s role in regulating labels to matters related to the safe and effective use of the chemical.

The APVMA must currently assess and approve all aspects of labels, even details of colour and presentation.

This is an unnecessary burden and can delay product registration.

The bill will limit the APVMA’s role to assessing whether labels have ‘adequate instructions’ for the safe handling and effective use of a product.

The APVMA will not expect registrants to seek approval to change a label if the changes don’t detract from the particulars which must be displayed.

Registrants will be able to make changes such as changing their logo or adding marketing information.

They will still be responsible for all other label aspects such as warranty and contact information.

Further, the bill seeks to include trade issues as a consideration when determining whether product labels remain adequate.

The APVMA is currently required to consider trade risk when determining whether to grant or refuse an application, but not when approving a label.

Initial instructions on the product label ensure that proper use of the product will not adversely affect Australia’s exports.

However, over time issues may arise that require changes to the label to update the instructions.

If the APVMA currently needs to update label instructions to address a trade-only issue, it has no choice but to reconsider the entire product registration.

The Bill seeks to address this problem by enabling the APVMA to take prompt action to update the label instructions directly.

This may be necessary where an importing country reduces its maximum residue limit or establishes a zero tolerance.

It reduces risk of our exporters unwittingly breaching importing country requirements.

Finally, the bill will clarify what constitutes confidential commercial information when applying for certain types of permits for chemical use.

Currently, all matters about a permit application are confidential commercial information, including the fact that an application has even been made.

Clearly some permit applications to use agricultural and veterinary chemicals will include some commercially valuable information.

However, not all information needs to be protected in the same inflexible way.

Under the present legislation, the APVMA must first obtain the applicant’s approval before seeking information from a product registrant, or others, to inform its expert assessment of permit applications.

This bill would allow the APVMA to seek certain information about a minor use or emergency use permit application without compromising the commercial parties involved.

Regulations will specify the types of information the APVMA can release as it assesses an application.

Details of research permits—which are commonly used by agricultural and veterinary chemical manufacturers during product development—would be protected.

And other information—for example, product formulation details—will remain confidential commercial information.

As I outlined earlier, the key priorities for the government remain protecting human health and the environment.

Nothing else is more important. But we will continue to look for ways to improve the efficiency of chemicals and pesticides regulation in Australia, without jeopardising these priorities.

This bill gives effect to reform agreed on by COAG. It is a down payment on a broader set of reforms to the Australian Pesticides and Veterinary Medicines Authority and the national regulation of agriculture and veterinary chemicals.

We are working with industry and state and territory governments to develop a single national regulatory framework for agricultural and veterinary chemicals.

This forms part of COAG’s initiative to achieve a seamless national economy and is an important reform agenda.

As part of the Better Regulation Ministerial Partnerships initiative, the government is also looking at measures to improve the efficiency and effectiveness of the APVMA.

We are aware that the authority has a very difficult and important role, particularly in protecting human health and the environment.

However, it is clear from industry and other stakeholder feedback that reform is needed.

This bill marks an important milestone in the broader reform process. It will allow the government to begin to remove red tape affecting the work of the APVMA. The bill will benefit not only those who use agricultural and veterinary chemicals, but also the wider community, our food security and our export markets.