Keeping Up With Changing Regulatory Approaches
Read Time: 4 minutes
Are we the only ones who feel as if the US and EU approach to chemical regulation is inching towards adopting similar approaches in regulating substances? Listening recently to speakers at events from various regulatory authorities in the US and knowing the priorities for change under the EUs Chemicals Strategy for Sustainability, we are shocked by many indicators that show authorities are taking an increasingly similar blend of a hazard/risk approach.
Let’s attempt to understand why this would be a significant change, but to do so, we need to understand the underlying approaches taken by different regulatory frameworks.
Generally, the approach of the US EPA is risk-based, while the approach of the EU is more hazard-based. Of course, things are not quite so straightforward. In actuality, each framework must use a mixture of approaches.
For example, EU REACH uses a blend of hazard and risk-based approaches. REACH first relies on a precautionary approach by taking into account the classification of chemicals according to their hazardous properties. For this, it uses the international Classifications of Substances under the CLP/GHS (hazard-based) and the data provided to ECHA by companies on the hazard properties of a substance and its potential risks as part of a substance registration. Risk assessments play an especially important role for substances that are classified as hazardous. Many have their uses restricted to limit risk, and there must be a compelling case to justify the use of a very hazardous substance.
Risk-based approaches, such as the regulatory frameworks in the US (TSCA, FIFRA) and elements of the EU approach, must always balance the hazards of a substance with the risks to human health and the environment in using it (exposure) by attempting to assess and manage the risks associated with using a substance. To understand those risks, we estimate there to be a few uncertainties. The argument goes, even if a substance is hazardous, the risk of using it might be low because humans and the environment will be exposed to safe levels of it. However, there is always a level of uncertainty about calculating exposure, and a risk-based approach is known to be complex and costly. Adding to this, there will always be some biases or blindspots that creep into any risk-based model. For example:
Which exposure scenarios/populations do we choose to base our decisions on?
Should we look at exposure in pregnant women or exposure in children?
To add to the difficulty, a substance deemed safe today, may not always be considered so. New toxicological endpoints (endocrine disruptors, neurotoxins, mobility) and more complete exposure scenarios might redirect our understanding of a substance so we can more accurately identify those that are more toxic or better understand why they are toxic. Similarly, new data on the degradation of substances in the environment and their hazards help increase our understanding of particular species at risk. Increased data from studies also help us understand what happens with repeated exposure or why and how a substance is toxic. Likewise, we may not have previously calculated the risks of exposure to the same substance as products are endlessly recycled and re-combined into new products as part of the shift to a zero-waste approach. Tracking a substance through the supply chain is difficult and becomes more so when waste is recycled.
Societal approaches to, understanding of, and risk tolerance also shift. For example, there is less tolerance for human and environmental risks now than in the past. The World Values Survey series (conducted every five years) is an effective tool to witness the changing attitudes towards the environment. In the latest survey wave, roughly 78% of people globally stated that they were concerned about human-caused damage to the environment. The Yale Climate Opinion Maps of 2021 (Marlon et al., Feb. 2022) found that 72% of Americans believe that governments should regulate to protect the environment (in this case, pollution emissions).
Similarly, the European Investment Bank Climate Survey of 2021/2022 found that a clear majority of people favour stricter measures that impose changes on people’s behaviour to tackle climate change (70% in the EU, 60% in the USA). The shift represents a change in acceptance of government legislating both companies and individual behaviour to mitigate risks to human health and the environment.
Regulators are influenced by policy, what other governments and regions are doing (federal vs regional, e.g.), public opinion and media, business needs, the latest scientific research, and even lawsuits. With these in mind, some of the shifts we see include:
Increased testing orders in the USA, which moves responsibility for proof of safety to manufacturers
Grouping of classes of substances such as PFAS or phthalates:
In the US: this represents a shift from a risk-based to a condition-of-use approach
In the EU: we see a shift from assessing substances individually to this approach favoured by the Commission and ECHA (under the CSS)
Other groups of substances will surely follow.
An increase in the legislation of substances outside scope of chemical regulations - in particular, polymers. In the EU, these will be grouped according to their hazard properties. With circa 200 000 polymers on the market in the EU, this change could have a significant impact on the industry.
As far back as 2018, the OECD published a document recognising that the current assessment of individual chemicals under regulatory frameworks does not reflect the reality of multiple exposures to a combination of chemicals or chemical cocktails. They made several recommendations and specifically highlighted the need to:
Document uncertainty and
Harmonise or standardise methodologies and approaches in this area.
These recommendations are beginning to filter down to the regulations–one of the priorities of the EU CSS will be on ‘the cocktail effect’.
Get in touch with our team today for more insight into changing regulatory approaches. You can also visit our website to learn more about our EU and US-based regulatory services.
