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What’s the Alternative? Rethinking Risk Assessment of Future Foods

Commentary18th August 2021

If the hype is to be believed, the appetite for alternative proteins is insatiable. A total of $3.1 billion dollars was invested in 2020 with investors ranging from Singapore’s sovereign wealth fund, Temasek, to rapper Jay-Z feeding the frenzy. With the population, meat consumption and negative effects of climate change all projected to grow in the next few decades, it makes sense. Our food system needs an overhaul and alternative proteins present a sustainable way forward. So, what’s the problem? 

According to investors and start-ups, two common barriers are often cited: lagging regulatory environment followed closely by consumer hesitation over novel products. On the one hand, we are embracing the virtues that alternative proteins promise while, on the other, we are questioning their safety. Of course, when introducing any new food products, it’s important for regulators to proceed with caution and ensure a proper risk analysis is carried out. But existing food regulatory frameworks are often glacially paced in comparison to innovation and, significantly, they tend to focus on health risks alone. In several countries, steps to streamline the regulatory process have been made. But faster assessments of the potential health risks of these new products is not enough. Policymakers must also assess the benefits of these products, not only to the health of the individual but to the environment and society as a whole. Only by so doing can we truly account for the value these tech innovations bring to the table

Risk Driven Regulatory Decisions

The current assessment of new foods entering the market is primarily focused on health-related risks to the individual consumer. Potential hazards are identified, exposure determined and the level of risk characterised. Management of any identified risks then falls to policy, with a view to balancing them against other factors, whether social or economic, when making a decision about the product. Whereas the risk assessment takes place at the individual level, the management of such risks is typically at the population level. 

In most cases, risk assessment approaches use conservative, worst-case scenarios in order to try and remove any chance of risk. This is understandable. However, driving towards zero risk is a challenge when we consider that our exposure to individual food products, added ingredients, and unintentionally added contaminants is a factor of our total diet and where it is sourced, not anyone product nor ingredient. Furthermore, when we consider the population diet, we need to consider how specific risks are accepted by the population as a whole and how management of them can influence other risks as well as benefits across the entire food supply. Products can simultaneously have risks and benefits and mitigation strategies for single hazards can lead to confusing dietary recommendations for others. For instance, docosahexaenoic acid (DHA) is an omega-3 fatty acid essential for the brain development of babies. It’s naturally found in many species of oily fish. However, many of these species also contain high levels of heavy metals such as mercury. While some pregnant women may have access to DHA supplements, many others, especially in low-income countries, do not. A review of guidance on fish consumption during pregnancy found a huge variety of guidelines around the world, with the majority focusing on the negative aspects of consuming fish rather than the positive effects. As a result, rather than feeling empowered to make informed choices, there is evidence that women felt confused and consequently avoided fish altogether, which comes with the potential of even more negative impacts on child development. In the case of alternative proteins, any potential or even perceived health risk may drag out the regulatory process even though the benefits (health or otherwise) may outweigh these risks.In the absence of information about products like novel proteins, how far must we go to prove risks are low enough?

A Better Paradigm: Risk Benefit Analysis

This is where risk-benefit analysis (RBA) comes into play. RBA mirrors the risk-analysis paradigm, but with the additional assessment of benefits. This is already used in other areas of regulation, such as drug approval and genetically modified (GM) foods in the EU. In the case of the latter, a GM product cannot be brought to the EU market unless it can be shown to impart benefits above non-modified products. Some researchers are beginning to use this framework to investigate the impact of alternative proteins but regulations are not there yet.

Both qualitative and quantitative frameworks are used in RBA to help assess risks and benefits. While qualitative assessments are important for transparency and capturing uncertainty, quantitative metrics are useful if one outcome is not clearly more beneficial than another, and especially if there are many sources of data that need to be compared.

Since the need to promote healthy, safe and sustainable diets is recognised as a public-health priority, one quantitative metric that can be used is the DALY or disability adjusted life years. This measures the loss of the equivalent of one year of full health or is a sum of the years of life lost due to premature mortality and years lived with a disability. In the case above, using DALYs could help give stakeholders a more precise guideline on the effect of increasing or decreasing fish consumption. Although DALYs are often associated with disease or adverse events, their application could be more broadly applied and used to characterise the impact of dietary changes, environmental effects such as climate change or socioeconomic factors such as povertyall of which can have clear consequences on population health

Getting Over the RBA Hurdles

There are still challenges in using the RBA framework. First, the level of evidence needed to identify positive or negative effects is inconsistent: the evidence needed to accept risks tends to be smaller than the evidence required to accept benefits, which means that risks may be overstated.

Second, the application of RBA methods in nutrition and safety is relatively new and involves various disciplines with different semantics, definitions, study designs and more. If risks and benefits are to be pulled from a number of fields, there may be differing definitions of risks and benefits, leading to confusion. This is especially the case when we are talking about societal versus individual risks. Similarly, RBA currently integrates nutrition, toxicology, microbiology and epidemiology for a comprehensive health-impact assessment. While it has the potential to also integrate environmental impacts, finding a way to harmonise differing data or choosing one indicator from a field like greenhouse gas emissions for sustainabilityis even more difficult. The risk is loss of nuance. From a logistical point of view, in most countries, the regulatory body monitoring food is separate from the regulatory body looking at environmental impact, so an additional challenge for policymakers will be to bring these two together. 

Even with quantitative measures like DALYs, weighing the different factors is complex. If the world made a transition from meat to meat substitutes, how do we measure the impact it would have on the global food system, environment, health and other areas given that the food system is complex with many feedbacks and non‐linear effects? Would these benefits outweigh concerns around health? A thorough review by Santo et al 2020 examines many of the pros and cons that have been associated with plant-based meat substitutes and cell-based meats from both a public-health and food-systems perspective. Although this commentary, and others like it, highlight the pros and cons of alternative proteins to both the individual and society as a whole, the discussion remains subjective and we lack appropriate measures to weigh the different factors. Taking the contaminated fish example above, fish are particularly heterogeneous from a nutritional point of view so how do we balance this against the nutritional quality of plant-based meat analogues (PBMAs)?

A Promising View: Extending RBA

Given the existing limitations, is there a way to update or extend RBA to cover other factors such as sustainability? Some researchers are already trying: one recent Dutch study looked at the impact of substituting meat and dairy with plant-derived products on health and the environment, while another looked at creating guidelines for fish consumption to maximise sustainability and nutrition. The National Food Institute at the Technical University of Denmark (DTU Food) is also currently creating tools and case studies to address these gaps.

One particularly forward-looking team has proposed the use of Liveability Units (LU) as a currency that integrates food, health and sustainability. As their paper suggests that future costs will be less related to monetisation and more to do with resource management, they propose creating a new architecture for an open-source food system based on blockchain technology and matrix barcodes, allowing communities to make informed transactions. Clearly there is promising work being done but much more research needed.

When does the greater societal need outweigh the level of risk to the individual? Is combating climate change a greater concern than introducing a new allergenic protein onto the market? In an ideal world, should we strive for both or accept and manage one more than the other?

There are no easy answers but if our current regulatory framework does not at least raise these questions, then policymakers need to push for a different one. As a society, we are increasingly aware that the health of humans, animals and the environment are complex and linked, and there is a growing movement for more systems-level, integrated approaches such as One Health. Such an approach requires more resources, research and standardised ways to measure the true costs and benefits to our food and health systems

We’re at a critical juncture in which we have the opportunity to move towards a more sustainable future, but only if we are willing to take the radical steps necessary.

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