Calls for sustainability criteria for genome edited organisms are welcome and long overdue, but cannot be used as a substitute for risk assessment
Gather a group of people concerned about food and farming together in a room and all of them will agree that our food system needs to be more sustainable. However, ask them to say what a sustainable food system is and what farming and production methods it entails, and there will likely be very little agreement.
For years discussions around sustainability, however passionate, have been mostly rooted in broad themes and cliches. But as pressure mounts to deregulate and integrate technologies such as genetic engineering into agriculture – even into organic and regenerative agriculture – it has also become a policy and legal discussion.
Many countries across the world, including the UK and the EU, are currently considering whether newer genome edited organisms should be more lightly regulated than other types of GMOs. One proposal is to expand or move away entirely from risk assessments and instead introduce a ‘sustainability criteria’ as part of the process for deciding which gene edited organisms should be permitted.
The recent EU public consultation on so-called “new genomic techniques” (NGTs), for instance, included questions about adding a sustainability criteria into forthcoming legislation – a proposal that split respondents. In the UK, the Labour Party has submitted a proposed amendment to the Genetic Technology Bill to “require that a precision bred organism has been developed to provide a public benefit”.
In theory, a sustainability criterion could, it is proposed, harness the most promising aspects of genome editing by prioritising traits such as drought and disease resistance and, more controversially for some, by increasing the availability and diversity of organic seed to promote more sustainable farming systems.
However, there is no agreed definition on what constitutes sustainability, in the EU, UK or elsewhere in the world. So far, agricultural GM markets have been dominated by herbicide resistant and insecticide traits, which promote industrial agriculture by locking farmers into a system where seeds and chemicals are designed to work together and which prioritises yield over all other considerations, including biodiversity loss. Newer gene edited crops are following this same trajectory, even though it has proven to entrench industrial agriculture and, as a result, be unsustainable.
Instead, the assessment of genetic technologies needs to ensure that they promote genuine system change, rather than simply perpetuating existing unsustainable industrial food and farming systems. This means moving beyond stagnant risk/safety paradigms.
Not many practical models exist, but there are at least four reasonable examples of how sustainability is already used in food, farming and chemical policy decisions in Europe. Examining these gives a glimpse into what a sustainability assessment must involve in order to promote the kind of change which would benefit society and the natural world:
- GMO risk assessment in Norway Norway adds an additional layer of assessment on top of classical risk assessment, which takes into account the ethical and social considerations of the technology. Applicants to the Biotech Advisory Board have to show not only that their products are safe, but also that they bring an additional value to society, the economy and the environment. Using this criteria has meant there have, thus far, been no GM crop approvals in Norway
- Sustainability criteria in seed marketing legislation The only seeds which can be marketed in the EU are from varieties which have been registered with the European Common Catalogue. Part of this assessment is ‘Value for Cultivation and Use’ (VCU), the criteria for which is set individually by Member States. On top of the productivity criteria, physiological criteria (e.g., time of flowering) and technological use value (e.g., protein content) used across the bloc, France has introduced an environmental criterion. This looks at factors such as pest or disease resistance, cold resistance and dependence on inputs. In the UK, VCU is also a criterion for adding an agricultural crop to the National List.
- Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) This 1997 legislation includes socio-economic criteria, but is limited to an analysis of whether restrictions on the use of a product would have detrimental effects. The new Chemicals Strategy for Sustainability was adopted by the European Commission (EC) in 2020 and includes an ‘essential use’ criteria which allows for the use of the most hazardous chemicals only if their use is necessary for the health, safety or critical for the functioning of society.
- Debates on ‘Sustainable Food Systems’ (SFS) Law In the EU, a proposal has been put forward for a legislative framework for sustainable food systems. The idea, which is a work in progress, is to integrate sustainability into all food-related policies by adopting criteria for sustainability across the food chain.
These are rare examples of attempts to include some kind of sustainability considerations into existing or proposed legislation. From these it’s possible to draw some conclusions and recommendations for how sustainability can be effectively integrated into law.
Sustainability is not a substitute for safety
Calls for sustainability labelling and sustainability criteria are, in some cases, being used as a proxy for safety. After all, if a product is sustainable how can it be unsafe? But sustainability and safety are not the same thing. They are not assessed in the same way and cannot be used interchangeably.
Risk assessment links a potential source of hazard with likely consequences and identifies probabilities of occurrence. Risk assessment includes different steps: hazard identification and estimation, exposure assessment, risk estimation, characterisation, and evaluation. Although it could, theoretically, provide space for ethical and other non-scientific concerns, it does not automatically include.
Sustainability assessments are in essence more encompassing, and go beyond the notion of risk, looking at the broad environmental, economic, and social context of the process or product that is assessed. Sustainability assessments go beyond a technical/scientific evaluation and should take into account uncertainty.
Counterintuitively, the systems in place for chemical approval (REACH) and proposals for the SFS law may mean that sustainability criteria override risk assessment, thereby allowing more risky substances into the environment.
For example, the new Chemicals Strategy for Sustainability is likely to classify pesticide products as ‘essential’, thereby meaning they may not undergo a full risk assessment before being authorised.
Additionally, the EU sees the SFS law largely as a food safety issue. As a result, it proposes “sustainability analysis” and “sustainability labelling” schemes, which could mean overriding current food safety rules, risk assessments and stringent labelling schemes, by putting emphasis on the potential (proven or otherwise) of products to provide environmental benefits.
Although there are still uncertainties as to what this new SFS law will look like, it is not likely to include a thorough assessment of the risks of a product’s use. This means that while the inclusion of sustainability criteria may give the impression of going above and beyond risk, in reality this would only be the case if the regulatory system is designed to include safety as part of its assessment.
A well-designed process will put sustainability criteria on an equal footing to safety criteria, as in Norway’s GMO authorisation framework. According to the Norwegian Gene Technology Act, the planned release of genetically engineered organisms needs to represent a “benefit to the community” and “enable sustainable development”.
These considerations are assessed alongside traditional human, animal and environmental risk, and applications can be rejected on any of these criteria.
A wholistic view of sustainability is needed
There is no agreed upon definition of sustainability, therefore the success of legislation which includes sustainability criteria for assessment depends largely on the definitions used.
If too narrow a concept of sustainability is used, the system could authorise products which perpetuate existing unsustainable food and farming systems.
For example, the VCU assessment for the authorisation of seed varieties does not look into the process used to develop the plant variety and does not take into account low-input versus high-input conditions. This means the varieties are seldom if ever compared to varieties developed for organic conditions, or more local/regional varieties that could provide viable – and already available – alternatives to new proposed varieties.
With its emphasis on productivity, and on very specific criteria that are only relevant for industrial use (like protein content), VCU testing, even ‘sustainability’ or ‘environmental’ VCU, does not include a truly comprehensive socio-economic analysis of the impacts of a plant variety’s use.
While risk assessments can focus solely on a given product or a process used to obtain it, sustainability assessments need to integrate a more joined-up approach to the social, cultural and economic context in which the product will be used. It cannot be limited to a list of criteria focussed on productivity gains or single technological improvements in an otherwise unsustainable production system (as is currently the case in VCU testing).
Access to a variety of data sources is crucial
For authorities to be able to make full assessments about the positive and negative impacts of a new product or organism, they must have access to as much information as possible about its impact.
This is an inherent difficulty with gene edited organisms, as by definition they are newer forms of genetic engineering and very little information exists as to their full impact. This can lead to an over-reliance on data from the biotech companies, where the metrics and incentives are commercial.
This is also the case with proposed EU reforms to the seed variety testing legislation, where the tests may be carried out “under official supervision”, i.e., in the companies’ own facilities, with little to no independent oversight.
For both risk and socio-economic assessments to be as impartial as possible, an independent or government-run laboratory would be a far better option than the developer’s own lab – though many developers would baulk at this.
It is also important that a wide variety of stakeholders are able to participate in the assessment processes.
Once again, Norway provides an excellent example of best practice here with its Biotechnology Advisory Board, an independent body with 15 members assigned by the government.
Currently, the Board is mostly composed of university professors from very different scientific backgrounds (law, political science, ethics, theology), public research institutes, politicians, and two representatives of the private sector.
Any authority in charge of assessing risk and sustainability of food products must adopt a similar transdisciplinary approach including representations from different scientific disciplines and backgrounds.
Additionally, the process must be able to accept third party submissions, for example from civil society groups. This way a range of data points and opinions can be integrated into assessment and decision-making processes and a holistic view of sustainability can be developed.
Deregulation is incompatible with sustainability
Having explored the methodologies and mindsets for developing a holistic view of sustainability, it seems clear that the deregulation agendas being considered in both the UK and EU are incompatible with sustainability.
At its core, sustainability involves understanding the biophysical limits of our earth’s system which must be respected to avoid collapse of fundamental biological systems on which we depend. Increasingly, economists are saying that in order to respect these biological limits, there must be limits to economic growth.
This view is diametrically opposed to the biotechnology industry’s view that there should be no limits on the development of agricultural biotechnologies. As we note In the report from our roundtable, The Boundaries of Plant Breeding “…while the biotechnology industry – at least publicly – acknowledges no limits to the development and application of its products, limits and boundaries are, nevertheless, core concepts of sustainability that all agricultural technologies need to be measured against“.
Deregulation is all about the removal of boundaries. The UK’s forthcoming legislation, for example, plans to allow developers to release gene edited crops into fields and onto the market in England with no formal authorisation process. They will be able to make their own assessments on whether their product is safe (or sustainable) and whether it meets the requirements for deregulation with little or no oversight from government. This seems out of step with both the mood and the needs of the times.
Changing our direction of travel
A future in which there is no room for governmental oversight as to the limits and boundaries which lie at the heart of sustainability Is unlikely to be legislatively sustainable.
A system that allows commercial companies to pursue, without limits, their own goals is, likewise, not compatible with the environmentally sustainable future we need.
Regulatory oversight to ensure that technological innovations and directions of travel are compatible with a widely-accepted, joined-up definition of sustainability is absolutely essential and introducing sustainability criteria to decide which technologies should be accepted could be a very useful regulatory tool.
Designed well, it has the potential to help change the food and farming system to one which better serves people, non-human animals and the planet.
Of the four examples reviewed here, only one – Norway’s approach to GMO authorisation – genuinely promotes sustainability and legislators could learn much from this system where risk and sustainability are given equal weighting, where a wholistic view to social, cultural and economic factors are taken, and where there is a transdisciplinary and inclusive approach to the authority and process responsible for making the assessment.