Senate debates
Wednesday, 1 December 2021
Bills
Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019; Second Reading
10:38 am
Sam McMahon (NT, Country Liberal Party) Share this | Link to this | Hansard source
As I was saying last night when I opened my contribution on the Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019, the importance of agricultural and veterinary chemicals and their regulation can't be overemphasised. How has this come before us? It's not something we thought up yesterday; it has been a long process. It was part of the 2015 Agricultural competitiveness white paper. The government committed to streamline access to agvet chemicals and better manage the risks they pose whilst at the same time retaining protection for the health, welfare and safety of humans, animals, plants and the environment. The Morrison-Joyce government recognises the need to better balance regulatory effort with risk and improve veterinary surgeons', farmers' and other users' access to newer and better agricultural and veterinary chemicals, including many medications. This government also recognises the need to ensure that our regulatory agencies have effective governance arrangements, with clear accountability and transparency.
The department consulted on potential agvet chemical reforms between 2015 and 2018. Stakeholder feedback indicated widespread interest in reform and support for a more efficient and effective regulatory system. I can personally report that people in industry that I have been speaking to recently—as you're well aware, I'm very close to this industry, being a veterinary surgeon—have talked about how they have seen improvements in the way that the APVMA works, in the way that it approves medications and chemicals and in the time that it takes to get approvals through. That was a big thing that industry has had for many, many years. This is quite a small agency and it's often dealing with hundreds of applications at any one time. Industry has been concerned for many years about the time taken to get things approved. I am very pleased to report that under the previous ag minister, Senator McKenzie, and under the current ag minister, Mr Littleproud, there have been incremental improvements. Industry is still looking for more improvements to be made, but they are quite impressed with the steps that have been taken to improve these areas.
The APVMA is probably an agency that a lot of people haven't really heard of and don't really pay a lot of attention to, but, as I've stated, it is a vital agency. It approves and regulates all of the chemicals that are used in agriculture. It's absolutely vital for our agricultural industries. We have a very strong agricultural industry in Australia. We have a proud history of our agriculture and the food and fibre that we produce. For all of this to be efficient, effective and safe relies on the efficient regulation of the chemicals that are used in it.
Although many Australians would not have heard of this agency, the vast majority of Australians have animals, or have at some stage owned animals. They've owned either farm animals or companion animals, pets or performance animals, such as racing horses and greyhounds, or horses that are used in competition. The veterinary side of it is very vital for production animals. Veterinarians and the medications that we have access to are vital for animal health and welfare in our production systems. These range from intensive production systems, such as chicken and pigs, to quite extensive systems, such as beef cattle. The treatment, the maintenance of not only the health but, as I said, the welfare is absolutely vital. It's vital we get the medications that are used in doing that approved in a timely manner. It's vital that they are regulated in a way that, as I said, is safe, efficient and effective.
We also have companion pets. Most people in Australia will be well aware of pet cats, dogs and birds, and these days reptiles, fish. Veterinary medications that are regulated by this agency are absolutely vital for all of these companion animals. Modern veterinary medicine is increasingly coming into line with human medicine, and people are increasingly demanding improved treatments and outcomes for their pets. In fact, these days it is quite common for pets to undergo chemotherapy for cancer, to have complex surgeries—including complex orthopaedic surgeries and complex soft-tissue surgeries—and to take medications for many emerging and existing diseases and conditions. The regulation and approval of these medications is vital to pets and their owners.
We're a very small country, in terms of population and in terms of our pets and our veterinary industry, compared to countries such as the US and the UK, so we don't have a lot of medications that are developed in this country. We rely heavily on both human medications and medications that are developed overseas. These have to be approved in Australia to be used, and that is where this agency comes in. It is absolutely critical in getting timely approval for these medications and in making sure that the testing and regulation that have been done overseas are appropriate for Australian conditions and for Australian pets and production systems.
This bill will improve the APVMA's governance, reduce the regulatory burden on industry, support the APVMA's operations, strengthen the integrity of the regulation system and enhance the way the regulation operates. I've already spoken about how this agency operates and the fact that it's important to increase efficiency and the time in which various medications and chemicals are approved. One example of this is minor use permits. These are permits that are granted by the agency for chemicals and medications that generally don't have widespread use or are needed in a very urgent situation. They're generally used in small amounts, with small production systems, and there may not have been the time or it may not have been worthwhile to the company to go through the full registration process, which is quite expensive and quite onerous.
An example of where these are used in veterinary medicine is autogenous vaccines, where you have an outbreak of a disease on a particular property. We're trying to get away from the widespread use of antimicrobials, and that's where these vaccines are important. There will be a veterinary investigation on a property where a disease is occurring. Identified bacteria—the cause of the disease outbreak—will be found and a vaccine will be developed for the specific bacteria on that specific property. You're not going to go through a whole regulation process to get a vaccine to market for use on one or two individual properties. That's where the minor use permits come in.
One of the issues that has come about is that, while the APVMA has five months in which to approve one of these minor use permits, the agency can go back to the proponent with a question about the information that's contained in the permit application and that then triggers another five months. So you can have almost a year between a disease being identified on a property and a permit being issued for the vaccine to combat that disease. Anyone would acknowledge that that's not desirable. We need to speed this process up. We still need to maintain safety and efficacy, but we need to speed this process up. That is where this will come into effect, so that we're continually improving the governance of the APVMA and we're continually improving its efficiency and effectiveness.
As someone who is intimately involved in the agricultural and veterinary industries, I thank the ministers involved. As I said, Minister McKenzie has been instrumental in this, and I thank her for the work that she's done on it. Industry certainly strongly welcomes and recommends this bill and the improvements in effectiveness and efficiency that it will bring about.
10:50 am
Tim Ayres (NSW, Australian Labor Party) Share this | Link to this | Hansard source
I did listen with interest to Senator McMahon's contribution to this debate, which is rooted very much in her own expertise in this area. It does cause me to reflect that it is a pity, in my view—I'm not sure what Senator McMahon's views is—that she won't be back here in the next term, because bringing that perspective is very important. I'm sure there are a lot of things about which I don't agree with Senator McMahon, but she does genuinely bring perspective and expertise from that sector with her. I think it is a bit of a symbol of the decline of the modern National Party that instead of continuing to put people from the agriculture sector into parliament—somebody who brings that particular set of expertise with them—they've decided, in this case in the Northern Territory, to put a Sky After Dark right-wing operator into the parliament. I just wanted to say that at the outset of this discussion.
Senator McMahon is right. Yes, these issues about the regulation of agricultural and veterinary chemicals are important for the future of our agriculture sector, but they do have an impact, too, for people who operate in the veterinary industry, in terms of people's companion animals and also in terms of the greyhound-racing and horse-racing industries. They are critical questions.
The chemicals that are regulated and the process for utilising the chemicals that are regulated are important also from an animal welfare and environmental perspective. They are often powerful and dangerous chemicals that require an effective regulatory system. Just like chemicals that are used for human health, the applications of these chemicals should be properly enforced in a proper compliance regime.
Of course, human health and animal health aren't interchangeable. I've noticed that the coalition backbench isn't immune from having members on it who think that products that are used for horse health, for example, might have applications for human health. There have been some characters who inhabit the government's backbench who've been urging Australians—who should be paying attention to real scientific research, not to people in their cellars doing their own research—to buy horse paste and use it on themselves, instead of getting themselves properly vaccinated. Those people ought to stop. They ought to pay attention to the science, and they ought to actually act in the national interest.
More broadly in agriculture, we've seen falling public investment in agricultural research and falling public investment in research. I take Senator McMahon's point: Australia is small, in population terms, compared with the rest of the world. But our agriculture industry is large compared with the rest of the world, so our investment in public research—whether in veterinary medicine or pesticides or on broader questions of genomic research, plant development, animal husbandry and on-farm activity—ought to be punching above its weight in global terms. But it's not. At both the Commonwealth and state levels, public investment in these areas has continued to decline.
We have big challenges, as a country, in agriculture—in terms of water availability, future animal and plant diseases, and insulating Australian agriculture. We have been a step ahead in developments in animal and plant disease and in productivity, but we are absolutely behind the eight ball in terms of the Commonwealth's engagement with Australian agriculture in the effort to lift Australian agriculture up the value chain so that we're not just exporting raw commodities overseas but also creating good jobs in country towns—food processing jobs in particular: meatworks in our north, making just-in-time food products for the South-East Asian market. We are falling well and truly behind in those areas.
It's all very well for the National Farmers Federation and the government—and, indeed, the Labor Party—to say they support the National Farmers Federation's objective of $100 billion in agriculture exports by 2030. But it's not enough. On-farm productivity in Australia has continued to rise every year since the 1970s except for drought years. Australian farmers—the 86,000 farming operations—have been doing their bit in lifting productivity. The real lift in national productivity will be in shifting Australian agriculture up the value chain, not just operating on the basis of incremental improvements in on-farm productivity and then being a function of volume and price. We should be leading the world in these areas.
Returning to just this agency, the Australian Pesticides and Veterinary Medicines Authority controls the assessment and registration of all these chemicals as well as the supply activities right up to the point of retail sale. The bill really proposes to just create an additional governance arrangement. That governance arrangement was the result of the Independent Review of the Pesticides and Veterinary Medicines Regulatory System in Australia. They are correct that the APVMA is one of the few corporate Commonwealth entities without a board. The other Commonwealth regulatory entities that have direct responsibilities for human life and health—Food Standards Australia, the Australian Maritime Safety Authority and the Civil Aviation Safety Authority—all have boards, and the APVMA does haven't a board. Gosh, it needed one. Somebody needed to stand up in the public interest when the then Deputy Prime Minister—and again Deputy Prime Minister—Mr Joyce announced the transfer of the APVMA's offices to Armidale without any process. But, on the basis that this has been proposed and it's consistent with what's happening more broadly, Labor will be supporting the bill.
It is worth noting that critical stakeholder groups have expressed some concerns with the design of the bill. They say it will have no independent power over the authority, there's no clear policy rationale for it to exist and, as always, the costs will be borne by farmers themselves through higher prices. It's not often you can construct a governance system that alienates all of the stakeholders in the sector, but, of course, this is the modern National Party. Senator Canavan says, correctly, that they don't represent farmers anymore.
There's an utter hypocrisy in this legislation. We'll support it. There needs to be some governance over this authority. A few years ago, the Deputy Prime Minister filmed himself yelling at the sky about how he doesn't want government in his life. It was quite an odd video. If you haven't seen it, you should watch it. In the other chamber, he mocked the concept of achieving public policy outcomes through legislation or even regulation, which is an odd thing for a bloke who sits in the parliament to say.
It is notable that the Deputy Prime Minister wanted to get a whole lot more government in the lives of the citizens of Armidale by moving the APVMA there. It's hard to accept the claim he made at the time that this was all about creating jobs in regional Australia. At that time, the government was embarked upon a course of deleting thousands of public sector jobs. Thousands of public servant jobs were deleted all across regional Australia at the same time, and the New England government cuts to agricultural research devastated scores of jobs in the Deputy Prime Minister's own electorate. Two hundred jobs were gone from the local university, the University of New England.
The relocation was opposed by the department. Almost all of the serious stakeholders opposed it. Even Ernst & Young, when commissioned to provide a report, argued there would be little or no benefit. It wasn't legislated. There was no cabinet process. There was no consultation. It was utterly bungled. The APVMA and Minister Joyce forgot to hire an office space. Public servants, for months, were reduced to going and sitting in McDonald's to use the wi-fi. Eighty-five per cent of the staff refused to move. It's been plagued with financial difficulty ever since. It's cost at least $26 million. There's no way of calculating the real financial cost of this utter bungle. It's hard not to think that having some board, even with the deficiencies of this regulatory system, would have provided some assistance at protecting this capability from Mr Joyce's pre-emptive and senseless approach to this move.
The other thing that gives me pause for thought, in this, is it allows yet another government board that the government can make appointments to. We've seen what happens with the National Party and Mr Joyce, in particular, and their approach to government appointments. Recently, the mayor of Tamworth, who's retiring, sat down with the Prime Minister as he outlined in the Northern Daily Leader, which is a fantastic newspaper based in Tamworth, that he was worried about what he'd be doing to occupy his mind in his retirement. So he spoke to his old mate, Mr Joyce, and Mr Joyce appointed him as the chair of Infrastructure Australia. It entirely swept aside any idea of merit, any idea of what's in the national interest. He just appointed his mate who needed a retirement job. It's a 'men's shed for mates' approach in the National Party these days. I hope, but I don't trust, that the Morrison government and Mr Joyce can make fair-dinkum appointments to this board—appointments that are actually in the national interest—by appointing people like Senator McMahon who've actually got a little bit of expertise in this area rather than appointing former staffers, retiring councillors, political fixers, branch stackers and National Party mates to all of these boards, because that's all this government has been capable of doing when it comes to public appointments.
As I say, there's a deep complacency in the National Party about the future of Australian agriculture. Much more work needs to be done. We'll support this legislation, but what Australian agriculture needs is a government that actually stands up for it and actually does a little bit of work.
11:05 am
Peter Whish-Wilson (Tasmania, Australian Greens) Share this | Link to this | Hansard source
[by video link] I want to start by pointing out, for those who might be watching this debate today or reading the Hansard, that it is curious that this legislation, the Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019, in one form or another has been kicking around this chamber and the House, and through a number of reviews, for nearly seven years. For background: the regulation of chemical products in Australia, or the regulatory framework for managing pesticides and veterinary medicines in Australia, is collectively referred to as the National Registration Scheme for Agricultural and Veterinary Chemicals, or the NRS, and this is a partnership between the Commonwealth and the states and territories. The assessment and registration of agricultural and veterinary or agvet chemicals, as well as the control of supply activities up to the point of retail sale, is undertaken by the APVMA, and control of the use of agvet chemicals after sale is the responsibility of individual states and territories. The Agvet Code is contained in a schedule under the code act, and, under the NRS, the Agvet Code operates together with the code of each participating jurisdiction to constitute a single national code applying through Australia.
Now, going back to 2008, this regulatory framework has had a number of reviews and those reviews, which I haven't got time to go into in any detail, essentially led to legislation in 2013—eight years ago—and that was called the 2013 amendment act. I remember the debate, when that bill came before the parliament back in 2013. The act, it was said, would encourage the development of newer and safer chemicals by providing more flexible and streamlined regulatory processes with higher levels of transparency and predictability for business seeking approval for agvet chemicals to enter the market. It was claimed that the reforms should result in a more straightforward assessment process that would be easy to understand and more cost-effective to administer, and, particularly for products of low regulatory concern, the reform system as established by those amendments should be faster, deliver more predictable outcomes and result in improved health and environmental protection for the broader community. Now, despite the lengthy consultation which led to the 2013 amendment act, as it said in the Bills Digest, it was not without its critics as it was unclear whether the relevant amendments would lead to greater efficiencies, which they were intended to create. Of greatest concern were the following: the potential for increased cost for registrants and applicants; and increased complexity in the regulatory system, which might result in the loss of existing agricultural chemical products and discourage the introduction of newer modern chemistry and biological products and the potential loss from the Australian market of useful products that were safe and effective to use, due to the need to obtain reapproval or reregistration of these products.
This sounds like good, wholesome policy content, but you need to look at the politics of this. This bill, after a very long consultation process and nearly seven years of reviews, was dissented from by the coalition senators at the time that it went to committee. They also voted against this bill when it came to the Senate. That led to a 2013 federal election promise to review and overturn the 2013 amendment act. That gave birth to the coalition's 2014 amending act after that election promise.
The coalition government got elected in 2013, and clearly they were doing the bidding of the chemical industry, who wanted to make it even easier to register products. It's taken another seven years for this legislation to get before us today. I'm not sure what the basis is of the government's lethargy in relation to this bill. I also note that this legislation has been on the papers in the Senate now for many months and is continually put to the back of government bills. Nevertheless, in the final hours of the 2021 parliamentary year, we now have this bill before us. There are a lot of concerns that a number of stakeholders have with this bill, and the Greens have made it very clear in its earlier iteration—my colleague Senator Janet Rice had the agricultural portfolio for the Greens back in 2019—that we don't support making it easier for large chemical companies to register products. We believe this is counterproductive both for farmers and for community trust in the Agvet Code and legislative framework we have in this country.
Let's be honest: this bill serves two purposes but one master. The first purpose is supposedly to improve the effectiveness and efficiency of regulation. The second purpose re-establishes a board for the APVMA. Both purposes serve the need of the pesticide industry, and it's been raised by a number of stakeholders such as the National Toxics Network and Public Health Association of Australia, including in the Senate inquiry into this bill, that these dangers are a recipe for further deregulation, which we're seeing in this bill. This puts consumers at risk and undermines trust in the framework. We believe it puts at risk public health, smaller farms, biodiversity and the science of the process.
The bill seeks to introduce a streamlined process for approvals. The streamlined process, part of the codified doublespeak of privatisation and neoliberalism, removes a whole subset of chemicals from the regulatory scheme. Big industry need is prioritised at the expense of scientific and environmental safeguards. I would like to point out that I have used these chemicals myself as a vineyard owner and a small business operator. Over many years I tried to move my vineyard to biodynamic farming from the use of, in my early years, the use of things such as glycophosphate, Roundup and various pesticides and insecticides that are covered in this bill. I've done my training to get certified to use agricultural chemicals. I did many hours of training to try to understand these bills. My father was a farmer and often used agricultural chemicals. Many of my friends who I went to school with were farmers who have used these chemicals. Interestingly, at my 30-year school reunion, which I think shows my age, this issue was discussed—how many friends I went to school with who had lost their fathers to cancer, working on farms over many years. There was a real concern about what caused that high level of cancer and whether it was exposure to using crop chemicals, pesticides and herbicides. I think this is a real issue for farmers that have to use these chemicals every day. They have to have a system and a framework that they have trust in.
This bill would permit the APVMA applying a disqualifying criteria to any application for new chemicals. This criteria in this bill is poorly explained and opens up decision-making to arbitrary judgement rather than defined scientific and public health analysis. Furthermore, even if disqualified through this mechanism, an applicant could still apply for approval and registration under other provisions of the Agvet Code.
The bill proposes extending the rejection period for protected information. This is essentially copyright for chemicals. Extending the protection period means that large corporations can monopolise chemicals, preventing farmers from accessing generic cheaper goods. Given the financial pressures many farmers face, this also risks the prospect of more imported counterfeit products entering the market. These concerns are all in the bill's digest and have been raised by very respected stakeholders in this debate.
Part 4 of the bill makes changes that restrict mandatory reporting for total chemical product quantities. In effect, this means data on active constituents is lost. There are already limits on available data on chemicals in Australia, particularly on the relationship between cause and effect on public health and on their effectiveness. Further restrictions of data mean more risk of chemicals entering the market that are lacking in detailed information. The bill establishes a new board of the APVMA, and this has been one of the most controversial aspects of this legislation, ostensibly to support the chief executive in governance of the APVMA. What the government are glossing over, however, is the fact that an advisory board already exists under the administration act but they've failed to appoint positions on this board for a number of years. In fact, the last appointments expired in 2015. Why is this the case? This is a very good question for the minister to answer.
The current advisory board gives plenty of scope for appointments to be made on the basis of experience in the regulation of chemical products, toxicology, consumer interests, public health and work health and safety. It beggars belief that the government has consistently, and one can only assume deliberately, failed to fulfil a board designed to support all functions of the regulatory framework run by the APVMA. I believe the board is a transparent attempt to stock the APVMA with industry figures. I understand Labor, in their contribution yesterday, speaking to this bill said that they've expressed concerns, as they have in their response to the latest piece of legislation.
The bills digest, quoting the Rural and Regional Affairs and Transport Committee report, said:
The majority view of the Committee was that the Bill should be passed.[45] However, Australian Labor Party (ALP) Senators expressed their 'deep concerns about the policy rationale for the implementation of a Governance Board' because, amongst other things:
The APVMA Governance Board will not have the power to independently set the APVMA's strategic direction, drive its operational performance, set an appropriate risk management framework and ensure greater accountability. Under the proposed legislation the Minister will continue to have the power to direct the APVMA and will be provided with the power to direct the board in the performance of its functions. Therefore, it appears the Governance Board will just be another layer of regulation which will add additional cost to Australian farmers.
My concern goes beyond the fact that this will just be another additional cost to farmers. It will be over whether the board is actually truly independent of the chemicals industry and figures within this industry or advocacy groups lobbying for lower regulation and increased or more rapid approvals of their products.
I would like to point out, as a kind of backdrop or frame to this debate, that groups of experts, such as the National Toxics Network, have made it clear that Australia already has a very lax system of control of agricultural chemicals. This would put us further out of step with the EU, the US and Canada, which are increasingly looking at new research and information into key chemicals that we use on our farms and chemicals I openly admitted that I used when I first started my vineyard, such as Roundup or glyphosate. I have here before me new reports out of the EU in recent weeks around the validity of the science, especially around human safety, that has gone into the registration of these products. There have been concerns raised in recent months about a product called fipronil, which I also used to control European wasps on my vineyard, that can have negative effects, especially on bee populations. These chemicals are being reviewed all around the world yet, in this bill before us today, we are going to be passing legislation that makes it even easier for chemicals such as these, especially if they're considered to be consumer chemicals, to be registered, which, I believe, is totally unacceptable. In fact, I believe that many farmers, especially small farmers—and my state is absolutely full of smaller farmers who are trying to grow high-value niche products that rely on a clean, green and clever brand—think that any deregulation of agricultural chemicals is going to put their industry and its reputation further at risk.
I think we need to be very clear here that this bill is not what's needed for the Australian agricultural industry, and the Greens will oppose it. After neglecting the APVMA and its authoritative scientific advice for so many years, the government is instead seeking to elevate industry voices to progress their own agenda. I would ask that people do read the submissions that were made to the rural and regional affairs committee most recently on this bill, and note the concerns of experts in relation to protecting health, safety and the environment.
I will just finish by saying that the Greens will oppose this bill, as we did in 2019.
11:20 am
Bridget McKenzie (Victoria, National Party, Minister for Emergency Management and National Recovery and Resilience) Share this | Link to this | Hansard source
It gives me great pleasure to provide this second reading debate speech on behalf of the agriculture minister, David Littleproud, with respect to the Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019.
Australians need access to safe and effective agricultural chemicals and veterinary medicines. They protect our crops, livestock and domestic pets; they safeguard our environment from invasive weeds and pests; and they meet consumer needs for things such as household insecticides. Agvet chemicals, as these products are commonly known, have brought long-term benefits to Australian agriculture by supporting increased productivity, better-quality produce and more competitive industries. It's important that the regulation of agvet chemicals continues to be streamlined to maximise the benefits for Australia. It's also imperative to ensure that the strong safeguards built into the regulation of agvet chemicals are not compromised.
Through a cooperative scheme with the states and territories, the Australian Pesticides and Veterinary Medicines Authority, the APVMA, is the national regulator of agvet chemicals up to and including the point of supply. The APVMA has an important role to ensure that agvet chemicals supplied in Australia are safe for people, animals, plants and the environment and don't adversely impact our trade market access. The APVMA needs to be both efficient and effective in its regulation of agvet chemicals, and I thank the senators who have made contributions today to that effect. The bill supports these objectives by streamlining regulatory processes, while strengthening vital protections for the health and safety of humans, animals and the environment.
Given its vital role, the APVMA also requires robust governance arrangements that reflect modern practices to ensure the accountability and performance of the regulator. The bill supports this critical outcome by establishing the APVMA board and ceasing the advisory board. Legislation underpinning the APVMA and agvet chemical regulation was developed in the 1990s, and we have announced a comprehensive review of the whole legislative framework from first principles. In the meantime, however, the chemical industry has made it clear that there are simple and non-controversial changes that could be done right now to improve the efficiency of the agvet chemical regulatory framework, reducing costs and increasing the speed with which farmers can get access to safe and effective chemicals.
The bill therefore includes measures to improve the administrative efficiency of the APVMA and promote quicker access to chemical products. This has been one of the key issues that industry, stakeholders and primary producers have raised with us as a government time and time again, and it's our government which is dealing with this. The measures in the bill reduce the regulatory burden for applications by increasing the APVMA's flexibility when dealing with minor errors in applications and for information that can be taken into account during an application. The bill will also enable the APVMA to choose, where appropriate, to use computerised decision-making as part of the process, thereby increasing efficiency whilst maintaining appropriate checks and balances. Computerised decision-making might be used, for example, in decisions involving an administrative check of an application.
The bill also makes changes to enable the use of new, simpler processes for assessments based on risk. Specifically, the bill provides for new prescribed approval and registration processes that will be quicker and less costly than those which are currently available, whilst ensuring that the chemicals assessed are safe and effective. These new processes will apply for those active constituents, chemical products and labels that require minimal or no assessment of technical information, and will retain the requirement that the product meet the relevant statutory criteria, including in relation to the safety of humans, plants, animals and the environment. This measure has the potential to free up the time of the APVMA assessors so they can focus on more complex assessments.
The bill removes the need for industry to undertake two unrelated reporting activities: one for levies based on chemical product sales and a second, more complex reporting activity on active constituent quantities. It simplifies and aligns these reporting processes based on the quantity and value of product sales. This significantly reduces reporting costs for industry without compromising the availability of information for our international reporting obligations and policy development needs. The chemical industry has been seeking changes to these burdensome reporting requirements for some time, and the bill delivers on those changes.
The bill also provides for incentives for registration holders to include on product labels certain uses of chemical products that they do not ordinarily register. Similar to the approaches applied internationally, the incentives in the bill operate by extending data protection periods on information for up to five years if certain priority users are included on the labels. These extensions would be prescribed in the regulations. Based on the experience of these incentives overseas, this will encourage more priority uses on labels, including minor uses where the costs of adding the use are not justified by the additional commercial returns to chemical manufacturers. This will significantly benefit Australian farmers. Don't believe Senator Ayres's rhetoric.
Other measures in the bill enable the holder of an approval or registration to vary the approval or registration while it is suspended. This will ensure that the issue identified that led to the suspension of the approval or registration can be appropriately rectified at the holder's request. The bill also makes changes to strengthen the integrity of the regulatory framework. To perform its role, the regulator of the APVMA has to rely on information provided to it by applicants. The bill provides the APVMA with a broader suite of sanctions that will allow it to proportionally respond to any false or misleading information it receives. This includes both administrative sanctions and civil pecuniary penalties. Industry understands the importance of increasing the range of compliance options available to the APVMA. The bill further bolsters the integrity of the system by harmonising the need to inform the APVMA of new information, including information that shows a substance may no longer meet the safety criteria across all holders and applicants. The bill also includes measures to improve risk communication about chemical products. This increases the integrity and transparency of voluntary recalls of agvet chemicals and modernises the legislation so the reporting obligations are very clear for persons recalling these chemicals.
Importantly, the bill introduces a five-person skill-based governance board for the APVMA. This board will provide the APVMA with additional skills and experience to deliver an increasingly accountable, efficient and effective organisation. Currently, all responsibility for the APVMA strategic leadership, governance and day-to-day operation rests with the chief executive officer. The CEO is therefore responsible for setting, implementing and monitoring the APVMA's policies without any other direct support. This is an unreasonable and unsustainable management burden on the CEO that is not effective or efficient for the APVMA's successful long-term operation and ongoing improvement. The board will be accountable as an authority under the Public Governance, Performance and Accountability Act. It will ensure the proper, efficient and effective performance of the APVMA's functions and determine the policies, objectives and strategies that the APVMA will follow. In addition, the board will play an important role in implementing the outcomes of the government's comprehensive review of the whole agvet legislative framework from first principles.
The board, appointed by the Minister for Agriculture, David Littleproud, will consist of a chair, the APVMA CEO and three other members selected on the basis of their skills. Board members will be appointed on a part-time basis. The CEO is included as an ex officio board member to support informed and collective decision-making and ensure the policies are effectively integrated into day-to-day operations. The APVMA will continue to deliver independent and evidence-based decisions. The board will oversee how the APVMA does its job by establishing and monitoring the framework under which it operates. Day-to-day administration and decision-making such as registering individual chemical products and undertaking compliance and enforcement activities will remain the responsibility of the APVMA's CEO. The APVMA is one of the few corporate Commonwealth entities that doesn't have a governance board to ensure corporate compliance and management accountability. All other Commonwealth regulatory entities with direct responsibility for protecting human life and/or health have governance boards. So this is a great reform.
The board model chosen by the government is comparable with other corporate Commonwealth entities and with private sector companies. Its proposed size, composition, role, functions, duties and powers conform to Commonwealth policies, as well as modern best practice guidance on corporate governance. Board members will be required to have appropriate qualifications, skills or experience in financial management, law, risk management, public sector governance, science and/or public health. The board will be able to establish committees to assist it perform its functions and exercise its powers. These committees will provide a mechanism to seek input from and engage directly with industry stakeholders and other experts as required.
The bill provides transparency around ministerial directions to the board. Any written directions made to the board by the minister will be notifiable instruments with the particulars and effects of these directions reported to the APVMA's annual report. The bill additionally requires a review of the operation of the board after four years to ensure it is actually being effective and efficient.
The bill also ceases the existing APVMA advisory board. The advisory board had no legislative power to direct a particular course of action and has not been operational since 2015. There are further measures in the bill clarifying meanings or addressing deficiencies or inconsistencies in relation to the regulation of agvet chemicals, which is great to see. These are largely minor issues; however, when considered together they improve the overall operational efficiency of the APVMA. The measures in the bill represent a considered approach to improving agvet legislation and have been developed through a program of engagement with all stakeholders. The board measures have been developed through a process of detailed, targeted consultation with stakeholders directly affected by the APVMA's governance. Other measures in the bill have also been consulted on publicly, and this has confirmed that these measures will deliver benefits to the industry, the regulator and the broader community.
The bill will improve the effectiveness and efficiency of the national system for regulating agvet chemicals while strengthening its integrity and positioning the APVMA to become a modern and sustainable regulator. It will ensure that safe and effective agvet chemicals continue to be available to our community now and into the future. A more efficient regulator will deliver flow-on benefits to the APVMA's clients, including improved client services and reduced regulatory burden, which will reduce the cost of doing business.
On behalf of the minister, I would like to thank all those involved. As has been noted in comments today by both sides of the chamber, this has been a long process and we believe we've got the settings right. The APVMA is a great example of our government's commitment to decentralised government services to the regions, closer to the communities that they serve. History has borne out that, whilst controversial at the time, moving the APVMA to Armidale has been a benefit not just to the agency but also to the broader community and hasn't actually resulted in some of the perceived challenges by those who opposed it. I would like to thank previous Minister Joyce and the current minister, Minister Littleproud, for ensuring that this fantastic bill gets the support of the Senate to hopefully pass today with amendment.
Sue Lines (WA, Deputy-President) Share this | Link to this | Hansard source
The question is that this bill be now read a second time.