Make Sure Legislation And Regulations Are Fit For Purpose

Make Sure Legislation And Regulations Are Fit For Purpose

Author: Vera Koester, Graeme Barden

Graeme Barden, Executive Director of the Australian Industrial Chemicals Introduction Scheme (AICIS), discusses how regulation has changed in recent years, emphasizing the importance of collaboration between different stakeholders and the unique situation in Australia, but also learning from global practices.


The Australian Industrial Chemicals Introduction Scheme (AICIS) is a statutory scheme that regulates the introduction (manufacture or import) of industrial chemicals into Australia. It replaced the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) on July 1, 2020, following the commencement of the Industrial Chemicals Act 2019.

AICIS registers industrial chemical introducers, who categorize chemical introductions into six categories. Lower-risk introduction don’t need assessment, while higher-risk ones require pre-market assessment and authorization. Introducers must register annually, categorize chemical introductions, and submit declarations. AICIS has limits on the use of new animal test data generated since 1 July 2020 for chemicals used in cosmetics.


What fascinates you most about chemistry regulations?

I’ve always been personally attracted to work that involves scientific endeavors and, in this case, using science to protect humans and the environment.

Regulations have evolved. It used to be very draconian: you must meet these very prescribed rules, and if you do, here is your approval. Otherwise, you can’t do anything. I think we’ve seen the evolution of regulation, certainly in Australia, that our governments over the last 10 to 15 years have encouraged regulators to actively engage with the stakeholders, both community and industry. So, we are better informed as we are developing our regulations these days to understand the expectations that society has for regulations but also getting a better sense of the impact the regulation could have and trying to find the line.


What do you mean by find the line?

Regulation by its nature is burdensome. It needs to be to achieve its objective. But there is a line at which that burden should stop growing, so that industry, once it’s managing risks per regulation, can move on and do the things that it’s trying to achieve. Remembering that much of the purpose of the chemical sector is to provide benefits to people, to improve their quality of life, to contribute to their health, to a healthy built environment, and those kinds of things. We don’t want to get in the way of those benefits, so long as risks that might be attached to chemical introduction and use are identified and referred to risk managers.


So how do you keep the balance or find this line?

Engagement. We’ve really been turning our minds recently to how we can better engage with the community and with our industry.

We’ve had various fora that help us engage with those stakeholders. We’ve set up a group called the Stakeholder Engagement Committee; it’s not strictly a formal advisory committee, it’s not a decision-making group, but it’s a way in which we can get industry and community groups that have an interest in health and environmental outcomes in the same room with us. We can share with them how we’re approaching the regulatory strategies that we’re bringing to the table and hear from them what they think the regulatory priorities should be. Then, once it is decided that there may be value in exploring regulation change, we enter into wider engagement and consultation mechanisms.

In fact, we’ve made some changes to our regulations that went into effect in Aril that arose from the industry telling us about practical issues that were attached to the regulation. It’s not that they disagreed with the need for the regulation, it’s just that the mechanism that was called for by the regulation was impractical. We proposed changes aimed at addressing industry concerns while ensuring that the principles of the legislation were still upheld, and then tested these changes with industry stakeholders. After a series of discussions, we consulted the minister responsible for the regulations, who has the authority to implement the final changes.


How difficult is it to prevent industry from looking out for its own interests and preferring not to adopt more sustainable practices even though they are feasible but might be less convenient at the moment?

We tend to deal with industry associations at this stage, and we ask those associations to engage with their members to provide practical examples of the issues they’re talking about. And we do broad public consultation so that all parties, industry companies, but also members of the public and other public interest groups, can engage and give us feedback. And then we take that feedback into account. In the case I mentioned, we heard some good counterarguments, and modified some proposals. On balance, we felt that the changes made were the right changes to make.

We see this as a critical part of our stewardship. Our job as a regulator is no longer just to open up page one of the legislation and go; we always have to make sure that the legislation and the regulations are fit for purpose.


Compared to other international legislation, for example in Europe, what would you say are the main differences?

We’re a very risk-based regulation, relying on risk characterization to guide recommendations for public health, workplace, and environment regulators. The one exception to that is the workplace classification under the Globally Harmonized System (GHS) classification [Editor’s Note: UN-developed system for hazard communication of chemical risks that can be adopted by countries]. It’s by nature hazard-based. We provide classifications, but do not enforce workplace regulations. These classifications are then incorporated by workplace regulators into their own regulations. We do, however, provide risk mitigation recommendations to industry users, such as specific personal protective equipment.

We might start what we call an evaluation of an existing chemical based on its hazard profile using a digital tool created by my team that compiles 107 curated data sets from global regulators and other sources. This tool ranks chemicals by risk. It’s predominantly influenced by hazard due to information availability, but exposure information forms a part of it. Then my staff steps in and prioritizes them for evaluation based on practical considerations and the Australian market context.

We don’t just look at the highest-risk chemicals; we also consider grouping chemicals together. This grouping could be because they’re lower risk, but it could also be because we believe these chemicals are actually not being used in Australia. So, we’ve spent a small amount of our resources to give some assurance to a larger proportion of chemicals that don’t warrant immediate attention. We can then spend the substantial majority of our resources on those higher risk chemicals.


Can you give an example of where Australia is very different from other countries?

We have a unique environment and the way it works, and I don’t just mean the icons like koalas and kangaroos. I mean, for example, the way our river systems work is quite different from what may be the case in other continents. They can flood terribly but then run at really low speeds with variable predictability. So for us, exposure assessment is really quite critical to the extent that data availability allows.

Exposure data are generally limited, but particularly on the environmental side, we have a number of models that help us figure out, for example, how much of a shampoo chemical is going to be degraded through water treatment processes and where, if it gets into a river, will it then get into estuarine systems and then into oceanic water. And when it does those things, is it going to bind to sediments and thus not be bioavailable.

That’s the sort of area where I think it’s critical that we do our own exposure assessment in a place like Australia. It’s why we may take the hazard assessments from Canada and the US under certain specific circumstances, but not their exposure assessments.


Do you think AI will change regulation for example internationally?

The OECD Chemicals and Biotechnology Committee has a range of working parties underneath it that produce things like guidelines that we can all take into our own national settings. These groups have made the transition from traditional approaches to new methodologies. I think there is a future step to be taken in terms of how AIs are used. I’ve said ‘AIs’ in the plural intentionally because there are different AIs out there.

I’m not particularly interested at this point in generative AIs stepping in and doing risk assessments on behalf of humans and making decisions for them, but I am very interested in machine-learning concepts where you can throw massive, disaggregated data sets at these machines and they find patterns that we might not see when we do our chemical-by-chemical assessments. I think that’s the great near-term opportunity for AI, but I think there needs to be a global conversation about how we use them and how we bring the community along as we engage with these kinds of technologies.


What is changing in terms of data management?

Having IUCLID [Editor’s Note: a software tool for managing and sharing chemical data to support regulatory processes] gives us the opportunity to explore the data we collect through our assessment activities in ways we’ve never been able to before. It’s a new area of interest for us, though. We haven’t taken any great steps there yet, but it’s an area that I want to explore both to understand possible trends in toxicology that we may not be seeing through the range of chemicals that come to us, but also to start to understand: are there shifts in the way industry is behaving in terms of the chemistry that they’re developing? are we seeing new trends in the characteristics of the molecules that they’re innovating? and what does that mean for the nature of our regulatory processes, and do we need to make adjustments based on that?


Is it possible to use data from academia for regulatory purposes?

Academic data are not designed for regulatory use. I have staff who always say to me, yes, this new study is interesting, but it doesn’t provide any conclusions, statistical or otherwise, that we can bring to the regulatory process that we have. Having said that, we are open to the idea of somehow getting academic data into formats that might be usable by regulators.

And back to the AI discussion: the power of machines to be able to read the however many hundreds of chemical publications that come out every day and do the sifting and wave the red flags I think is another opportunity for us. It’s not to say, here’s a number of articles from academia, therefore you need to act now on a chemical in a strict regulatory sense, but it could be adding to that tool that I described to you with the 107 data sets. All those researchers are building a weight of evidence that can certainly inform prioritization as opposed to a strict regulatory decision.


How do you keep up with what is going on?

For me, engagement is kind of the be all and end all. I’m informed by the engagements we have with our community and our industry stakeholders.

Talking, listening, reading. Organizationally, we monitor a range of global publications and share information across our organization. It helps all of us understand the context of our regulation in a global setting, it gives us an informal warning that there might be regulatory activity going on in another country that should either inform our prioritization or help us think about how we’re going to communicate the current state of regulation in Australia as it might compare to another country, particularly where a country is making a more hazard-based decision than we would or are able to.

We also have some specific bilateral arrangements with regulators in other countries through which we have conversations about their priorities and whether the measures that are relevant to their country have applicability to the Australian context.

I value fora like the Helsinki Chemicals Forum and the OECD Chemicals and Biotechnology Committee. I want AICIS to be able to take advantage of the good things that others are doing around the world, and if that gives us an opportunity to contribute to international harmonization, then that’s fantastic.


Thank you for the interview.


Graeme Barden has been the Executive Director of the Australian Industrial Chemicals Introduction Scheme (AICIS) since July 2021, following senior roles in the Australian Government Department of Health and Aged Care, including in chemical safety, health protection, and aged care.

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