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Wednesday, 15 May 2013
Page: 3246


Mr SIDEBOTTOM (BraddonParliamentary Secretary for Agriculture, Fisheries and Forestry) (13:03): by leave—I thank members, and the shadow minister opposite, for their contribution to this very important legislation and debate today. Whilst I have the opportunity, I would also like to thank all those staff in the department for the tremendous amount of work over years that they have put into this very important piece of legislation, as well as staff in the minister's office, my own staff and, of course, stakeholders who have participated in this process.

The Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 improves the regulatory system for agricultural and veterinary chemicals in Australia. The bill also meets a 2010 election commitment.

Essentially, this bill is about continuing to secure the safety of farmers, those who work on farms and those communities that are involved heavily with farming and agriculture. It is there to give assurances of health and safety to consumers of products from our farms and also to improve and secure the security and protection of our environment. These are worthy ideals indeed. It is an improvement and it seeks to do more to improve the system we already have. I hope the member for Kennedy will listen carefully to what I have to say, taking into account, notwithstanding his contribution, some of his criticisms.

The bill improves the current high level of protection for human health and the environment and provides a greater certainty to the community that agricultural and veterinary chemicals approved for use in Australia are safe. Other measures improve the efficiency and effectiveness of the work of the national regulator, the Australian Pesticides and Veterinary Medicines Authority, or APVMA , which I will in this speech refer to as the 'authority'.

At its core the authority is an evidence based risk manager. Its job is to scientifically evaluate and review agricultural and veterinary medicines—or 'agvet' chemicals as we commonly call them. Its job is to monitor and promote compliance. The authority regulates approximately 10,000 agricultural chemicals and veterinary medicines, products vital for food and fibre production in the community. In other words, it is an essential service.

Stakeholders are keen to see changes to the way we regulate agvet chemicals. Environment and community groups, the chemical industry and farmer groups have made significant contributions to these reforms, including the re-registration scheme and risk framework. Some members opposite have tried to make the claim that the government has not consulted industry, including farmers, about these reforms. Nothing could be further from the truth.

Stakeholders have been extensively consulted during the development of the reforms proposed in this bill, and the government has listened to these. The minister, his office and the Department of Agriculture, Fisheries and Forestry have put substantial energy into stakeholder engagement on this bill. It is important that I reinforce this. There has been dialogue between the government, the Public Service and the agricultural chemicals and veterinary medicines industry. We have heard from stakeholder groups in more than 190 submissions. Nearly 200 people attended workshops and public meetings. We published two separate drafts of the legislation and listened to stakeholders about these drafts before introducing the bill to parliament. So it is a nonsense to suggest we have not consulted or not consulted widely.

Australia's agriculture, fisheries, forestry and food industries have been involved. The government has discussed this bill with primary producer organisations in every state. Community and environment groups and the general public have had their say and been heard, as they have a right to. The states and territories have been consulted. We will continue to engage with and listen to stakeholders as we implement these important reforms. I would like to thank on behalf of the government all those groups that contributed with submissions, participated in workshops and who were involved in the committee processes.

It is clear that not all stakeholders are happy with the current system and want to see improvement; but it is not true that none of these stakeholders are happy with this bill. As with any new piece of legislation, there will always be a variety of views. Given the different priorities stakeholders have for the system, it is not surprising that some views are not aligned. This bill seeks to balance the conflicting interests of different stakeholder groups and make sensible compromises where those interests do not align. I am pleased that both the House and Senate committees in their recent inquiry reports into the bill have recommended that the bill be passed.

The member for Calare, during the previous debate on the bill, made claims to the effect that there was no need for these reforms. The member pointed to ANAO findings from a 2006 audit. But we must remember that the ANAO did not find the agvet chemical regulatory system to be all 'fine and okay'. The Productivity Commission also looked at the APVMA. The ANAO and the Productivity Commission, in their reports, picked up on a number of areas where issues were evident, flowing from: overly complex and prescriptive legislation that is difficult to understand and administer; legislation that could better ensure stakeholder confidence about the safety of chemicals; and a one-size-fits-all approach that does not enable—I say again: does not enable—the APVMA, or the authority, to allocate regulatory resources to the most efficient management of the aggregate risks of agvet chemicals. This legislation simply sets out to fix those issues, so noted by the Productivity Commission.

Let us look at the area of improving efficiency. Schedule 1 of the bill encourages the development of more modern and safer chemicals by providing for a more transparent, flexible and streamlined regulatory process. Amendments will allow the APVMA to use the most up-to-date international research more effectively and provide improvements to intellectual property protection for those who invest in the development of the new chemicals. The reformed system will provide the regulatory settings necessary to enable the authority to do its job better. It will be able to deliver more predictable outcomes, particularly for low-risk products—and I emphasise this—in a more timely manner, contrary to the claims of those opposite. The reformed system will also result in improved health and environmental protection for the broader community.

The bill also improves the way the authority works. These amendments will result in a more straightforward assessment process that is easier to understand and is more cost-effective to administer. These processes will have high levels of transparency and predictability for those seeking approval for agricultural and veterinary chemicals to enter the market. This will make the process of getting a new agricultural or veterinary chemical approved easier to understand. Thus it will remove unnecessary regulatory burden from the industry. The bill will not only make it easier to prepare good-quality applications; it will make it a requirement and, in so doing, the authority will be able to focus its resources on good-quality applications and will be working more effectively. This will be to everyone's benefit.

What about re-registration? We have heard a few industry representatives and those opposite on this debate raised some concerns about having a re-approval and re-registration scheme. This scheme is set out in schedule 2 of the bill. The scheme is about better protecting human, animal and environmental health, as I mentioned earlier, and providing greater certainty to the community that the agricultural chemicals and veterinary medicines used in our nation are safe. This is of the utmost importance. The regulator receives around 3,000 applications a year for new registrations, approvals, permits and variations. Very few applications are made for genuinely new and innovative products. The market is dominated by generics. The authority estimates that more than 9,000 of the products currently available contain actives grandfathered into the national registration scheme when it commenced under Labor in 1993. That is—and this is a very important point to remember—more than 90 per cent of products available today contain chemistry that has not been reviewed against contemporary standards. There is currently no systematic approach to considering whether it is appropriate for a chemical currently on the market to stay on the market. This is unacceptable. It is clear that the community expects a rigorous scientific approach to agvet chemical assessments.

Mr Hartsuyker interjecting

Mr SIDEBOTTOM: If you just sit there quietly and listen you will find out. You are a respectful type, I must say—I have travelled with you and you do not snore.

The DEPUTY SPEAKER ( Ms O'Neill ): Through the chair, if you will, Minister.

Mr SIDEBOTTOM: But it also expects that these assessments will occur on a regular basis so they remain up to date.

This government is concerned for the health and safety of those people most exposed to dangerous chemicals. We want to improve farmer safety as well as improving the health and safety of all people exposed to agvet chemicals. We also want our trading partners to be assured about the agricultural products we export. The reregistration scheme proposed brings Australia into line with other comparable international regulators but is not a copy necessarily of the overseas approach. The scheme in schedule 2 complements the Australian chemicals market so it delivers the desired outcomes without unnecessarily resulting in the withdrawal of safe and useful chemicals. So let us be clear about this: companies will not have to generate new data to make an application for reregistration. Opposition members have continually repeated this fundamentally wrong view about what is involved with a reregistration application.

The scheme design imposes the most minimal requirements on industry. Holders of approvals or registrations would only need to provide information that they should already have access to. They will make a simple application electronically; the authority then does all the work from here. There is no blanket requirement for a chemical company to generate a whole new set of data to support reregistration, contrary to statements made by those opposite. The bill specifically provides that the authority cannot—and I reinforce that, cannot—require information from an applicant that the applicant cannot reasonably be expected to have. The government accepts that a long history of safe use counts in favour of keeping a tried and true chemical on the market. After looking at the simple application, where there are no reasonable grounds to believe a chemical is not safe the chemical will be reregistered without further obligations on the chemical company. The chemical company may choose not to reregister a chemical rather than have its safety examined. It is their choice. That is a commercial decision. The government does not promote particular products over others.

The opposition also does not understand how chemicals will come into the reregistration scheme. The safety of a chemical is determined mainly by the hazard of the active constituent. Whether or not a product passes reregistration will be determined almost entirely on whether the active constituent in the product is still safe to be used. The APVMA will consider all products with the same active constituent together. It will not be looking at individual products, as mentioned by those opposite, so much as it will look at the chemistry behind the product. There are only 780 different active constituents. The authority will not have to, as the member for Paterson earlier incorrectly claimed, assess applications for more than 9,000 products in one year. All reregistration applications will not happen all at once, as the member for Paterson said earlier in a gross exaggeration—but why am I not surprised by that?

Applications will be made progressively over the next 15 years, with the order of those applications determined by the risk of the chemical. This was made clear in draft regulations published last year. Products will remain on the market during this time and will continue to be on the market until a decision is made. If the decision is that a more detailed review is required, this will be scheduled and unless there is an immediate safety issue the product will remain on the market until a full scientific review of the issues identified in reregistration can be considered. The reregistration process cannot be manipulated by pressure groups to force chemicals off the market. (Extension of time granted)

Finally, on compliance, in 2011-12 the authority closed 198 cases of alleged noncompliance, completed eight investigations, completed 18 recall actions, conducted 96 compliance monitoring visits and oversaw 60 audits of veterinary manufacturers. Schedule 3 of the bill improves the authority's ability to do this job. It provides the authority with more enforcement options to allow it to respond to the risk posed by non-compliant behaviour in an appropriately proportional manner. This will improve the authority's ability to make regulatory decisions that protect public health and safety and the environment with confidence.

It is of great concern that the member for Dawson should think that improving the authority's ability to deal will those few malfeasant companies that try to avoid the law should mean that the system is harder to navigate. Industry is supportive of strong compliance powers as they benefit law-abiding makers and users of agvet chemicals. The authority is developing education and communication information to assist industry with the adjustment to the new law. This includes publishing a risk compendium. The compendium has already progressively been published by the authority's websites.

I understand that the opposition will make amendments seeking the removal of the reapplication and reregistration scheme and delaying implementation, as the member earlier mentioned. I will have more to say about these amendments and the importance of and the need for these reforms at the appropriate time. Thanks for your patience.

Question agreed to.

Bill read a second time.

Message from the Governor-General recommending appropriation announced.