Transitioning to a Circular Economy Safely and Sustainably: A Qualitative Exploration of System Barriers and Drivers for Industrial Biotechnology in the EU

Abstract

Innovations in industrial biotechnology promise great potential for contributing to the circular economy as they can reduce our dependence on fossil-based raw materials. However, their environmental impacts and sustainability benefits can differ greatly. Therefore, it is important to consider the values of safety and sustainability when designing innovative applications for the circular economy transition.

Transitions like the one from a linear to a circular economy are shaped by the dynamics between political, societal, economic, and technological developments. Insights from actors working with industrial biotechnology innovation or policies are useful to explore the barriers and drivers of legislation, culture, and the market in a circular economy transition.

Results indicate that sustainability legislation, genetically modified organism (GMO) legislation, governmental policies, and societal resistance hinder early research and development and appear to delay sustainable industrial biotechnology applications from entering the European market. But the tide might be changing. As market and societal actors are learning how to navigate the tensions between safety and sustainability, they more openly underscore the sustainability benefits of using genetically modified microorganisms over potential risks to environmental and human safety. European policy and legislation are beginning to recognize the need for integrated policies that align safety, sustainability, and circularity needs.

Keywords

Industrial biotechnology - Netherlands - Circular economy - Transitions - European Union - SSbD

Significance

This article explores industrial biotechnology’s potential to contribute to a safe and sustainable circular economy transition. Transitions are shaped by the dynamics between political, cultural, market, and technological developments. Historically, tensions have existed between safety and sustainability for industrial biotechnology ingredients. Societal and market actors seem to be navigating the intricate tensions between safety and sustainability, but policy and legislation are lagging behind. These tensions hinder industrial biotechnology innovation and contribute to maintaining the prevailing, mostly linear economic system.

1

Introduction

The 2030 Sustainable Development Goals of the United Nations (UN), the Paris agreement, and the European Union (EU) Green Deal objectives, along with Dutch climate policy aim for climate neutrality and an entirely circular economy by 2050 [1] [2] [3] [4] [5]. These international, EU, and national policies entail that economies transition away from today’s largely linear ways of production and consumption. In linear economies, crude oil is the main source of both energy and industrial chemicals (e.g., benzene, toluene, ethylene, etc.) used in consumer products such as plastics, synthetic fibers, dyes, detergents, drugs, and more [6], [7].

In a circular economy, microorganisms can digest biodegradable materials and convert them into ingredients that replace fossil fuels in consumer products [8] [9] [10]. The manufacturing of chemicals, materials, ingredients for food and beverages, and drugs from microorganism’s digestion of biobased raw materials is referred to as Industrial biotechnology (IB) and is considered an enabler of the “biochemical feedstock” flow of the biological cycle of a circular economy [11].

Chemicals and fuels made by IB are already replacing fossil resources in consumer products such as detergents, plastics, food flavorings, fragrances, and fabrics [12] [13] [14] and innovations in genetic engineering improve the speed and efficiency of these processes [15]. For example, gene editing techniques have become available that allow precise and rapid gene alterations, the most notable being CRISPR-Cas9 [16].

In the EU, the use of gene editing techniques currently falls under stringent GMO legislations that aim to protect human, animal, and environmental health. For most industrial biotech applications, genetically modified microorganisms (hereafter: GMMs) are confined to fermentation tanks and regulated by Directive 2009/41/EC [17]. Legislation requires risk assessments that focus on keeping the GMMs contained. The legally required level of containment (e.g., the containment regime) is based on the severity of potential environmental impact. In the Netherlands, EU Directive 2009/41/EC is translated into the Dutch GMO Decree [18] and GMO Order [19], which require a notification or permit for applications of GMMs and a trained and approved on-site biosafety officer to be employed by the company or organization using GMMs [20].[1]

GMO legislation in the EU navigates and influences the complex economic, policy [16], [21], [22] and societal [23] [24] [25] [26] debates around the safety of GMOs [27]. Although IB innovations appear to be shielded from much of this debate (e.g., Jasanoff) [28], studies like the one by Asveld and Stemerding [29] describe how IB innovations entered into the discourse and faced societal and subsequently market resistance to adoption.

Although ideally, IB helps secure resource availability in ways that avoid environmental harm, these goals cannot always be realized simultaneously. For example, it is well known that current commercial production of biobased products can release carbon dioxide into the atmosphere [30], and often uses sugar as a raw material requiring substantial land use for cultivation, negatively impacting biodiversity [31], [32]. Furthermore, the ecological impact of unintendedly releasing GMMs into the environment cannot be predicted [33] and differs from case to case [34]. Therefore, when designing technologies for CE or formulating criteria to evaluate the circularity of technology, it is important to simultaneously consider the values of safety (for human health and the environment), and greater environmental and planetary sustainability, as Rockström et al. describe [35].

Policy attention is directed toward exploring what is required for designing innovations that are both safe and sustainable from within a range of different institutions at various levels of policymaking [36]. Focusing on chemicals and materials generally, the European Commission has for instance established a framework to help define criteria for innovations that are ‘safe and sustainable by design’ (henceforth: SSbD) [37], and various Dutch governmental bodies are working towards SSbD policies to enable, support or accelerate the circular transition in IB and chemistry, consistent with the European Green Deal timelines [38] [39] [40]. However, it proves challenging to define precise (technically operationalized) assessment criteria that reproducibly and transparently assess safety and sustainability, highlight potential trade-offs between these values, and guide how to navigate such trade-offs, whether in fossil-based chemistry or IB [41].

This is but one reason why the transition to a CE materialized in safe and sustainable IB innovations is still very much a work-in-progress. Developing a safe and sustainable IB sector that contributes to the CE constitutes a complex sustainability transition. From the system transitions literature, we know that transitions entail both developments in the spheres of knowledge, technology, and regulations touched upon thus far, but also synchronous developments in the spheres of economy, behavior, and culture [42] [43] [44]. Indeed, transitions are shaped by the dynamics between political, societal, economic, and technological developments. Thus, effective governance of such transitions requires a mature understanding of societal perceptions [26], [45], policies and governance [46], economics and sustainability [12], technological developments [47], and how all these interact. Therefore, a systems perspective incorporating all these factors is necessary to understand whether and how IB might eventually contribute to the CE transition [48] [49] [50].

Consistent with this, the present article seeks to contribute to the transition towards a safe and sustainable circular economy, by investigating how safe and sustainable IB innovations crucial to the biological cycle of the CE can land in the EU, in a way that is also economically viable and fits within regulatory frameworks and policies. We investigate key stakeholders’ perceptions of the mutually influencing and co-productive cultural, political, and economic forces [51] relevant to attempts in IB to contribute to safe and sustainable innovations for a circular economy, specifically with an eye to the Dutch–European context. This constitutes a particularly pertinent context, as here significant investments are done at the policy level to strengthen the forward-looking capacities of IB innovation with specific attention for safety [52] [53] [54]. Thus, the research question this exploratory study focuses on: In the context of Dutch and EU policy goals to transition towards a safe and sustainable circular economy, what cultural, political and economic forces help or hinder safe and sustainable IB innovations? To answer this question, we investigated how multiple stakeholder groups relevant to safe and sustainable biotechnological innovations – that can support the transition to a CE – perceive the cultural, political, and economic barriers and drivers relevant to this transition, using semi-structured qualitative interviews.

1.1

Using the Multi-Level Perspective (MLP) to study the transition to a safe, sustainable, and circular IB

The MLP, developed by Rip and Kemp [56] and refined by Geels [57] provides a systems perspective that inspired and guided our research question and was instrumental in delineating our study population and structuring our data gathering and analysis [55]. The elements of the MLP most pertinent to the challenges IB faces and articulated in the research question are culture, market, and policy elements, as shown in [Figure 1]:

• The cultural element concerns the engrained societal perceptions (societal groups and media) of safety and sustainability that influence business and policy decisions on whether and which IB products are developed and enter the market.

• The market (economic) element concerns the dominant economic logic existing within the regime and influencing policy decisions. This can steer IB development towards or away from safety and sustainability and incorporates considerations around product quality, prices, competition, and relationships between buyers of IB products and their values, goals, and beliefs.

• The policy (political) element entails the policies and legislation within which IB innovations are developed. This in turn is influenced by cultural norms and market conditions and expectations. Relevant IB legislation includes Dutch and European legislation relevant to sustainability, biotechnological safety, and market acceptability of IB products or processes. See OECD, 2018 for a comprehensive overview [59].

Figure 1 The Multi-Level Perspective (MLP) regime must be reconfigured to increase the opportunities for industrial biotechnology (IB) innovations to contribute to a safe and sustainable circular economy. Culture and the market are beginning to recognize the many ways that IB can significantly contribute to a safe and sustainable CE transition, but policy alignment is lagging behind.

Under the premise that (IB) innovations are a necessary component of the biological cycle of the circular economy [50] and can reduce fossil resource extraction, insight into these dynamics will help to inform policy and research agendas that enable safe and sustainable IB innovations to enter the circular economy.

2

Results

The following main themes emerged from our data analysis and are described in the sections below: how our respondents make sense of safety, sustainability, and circularity in IB, what they perceive as the most important policies and regulations concerning all three that do or could help or hinder IB innovation, and what they perceive to be the economic and societal influences that help or hinder IB innovation supporting safety, sustainability, and circularity.

2.1

Participants

Of the 30 potential interviewees invited to participate, 11 agreed (36%). As [Table 1] shows, participants represent the following stakeholder groups: Academia [2],[2] IB Industry [5],[3] Policy [3],[4] and NGO [1].[5]

Table 1 An overview of interview participants, their expertise, and identifiers.

ID	Organization type	Job title of representative
1A	Academia	Professor synthetic biology
2A	Academia	Professor synthetic biology
6I	Microenterprise	Co-founder & Business developer IB
9I	Small and medium enterprise (SME)	Project director scale-up IB
7I	Large company	Sustainable process designer IB
5I	Multinational Enterprise (MNE)	Regulatory expert biotech
11I	Multinational Enterprise (MNE)	Bioplastics expert
3P	Dutch ministry	Biotech policy expert & Biotech safety expert
4P	Lobbyist	Biotech lobbyist
8P	Dutch ministry	Circular policy expert
10C	NGO	Circularity expert

Supporting documents were supplied by four participants. The documents consisted of policy papers, EU legislation, expected EC regulatory modifications, peer-reviewed articles, methods of conducting Life Cycle Assessments (LCAs), economic models for circularity, and organizational presentations on sustainability assessments. These supporting documents as well as additional (grey) literature were used to triangulate information provided by participants.

2.2

Perceptions of sustainability and safety of circular IB

Below we describe participants’ divergent and common understandings of sustainability and its relation to safety.

2.2.1

Perceptions of sustainability and circularity

All the IB innovators we spoke to are willing to work towards more sustainable and circular IB (1A, 2A, 5I, 6I, 9I), and describe radical innovations they are developing with the hope of entering the market to contribute to this goal. They consider IB “circular by nature” because it is part of the biological cycle of the circular economy (5I) 6I, and sustainable because it aims to reduce the use of fossil resources (1A, 6I, 9I). However, many expressed confusion (1A, 2A, 8P) or frustration (5I, 8P, 6I) when asked about their efforts to improve the sustainability or circularity of IB. As 7I expressed themselves:

What is circularity for biotechnology? That would definitely be useful… There are more than 600 definitions of circularity. Let's start with a definition. Then I can translate that definition to [an action plan]. -7I

The lack of consistency in definitions referred to here variously emerged and is seen to problematize promoting sustainability and circularity in practice – as without generally accepted definitions, who can say what does or does not promote sustainability and circularity?

2.2.2

Perceptions of safety

Safety of the environment and humans is important to all stakeholders, especially Dutch participants, who mentioned concepts of safety that exceed regulatory requirements, for example, safe by design (1A, 4P, 6I, 7I). However, stakeholders disagree with the amount of attention given to the safety of IB by policy and legislation, particularly when new genomic techniques (NGTs) are used. They noted that microorganisms exchange genes frequently in nature (1A, 2A), NGTs simply accelerate the process (1A). Therefore, IB products identical to their fossil-based counterparts should not be subject to additional legislation because they were made by a GMM (1A, 2A, 7I, 5I, 9I, 3P, 4P).

2.2.3

Potentially conflicting values: sustainability versus safety

One common theme that emerged amongst almost all participants: IB products made with genetically altered microorganisms are more sustainable, because genetic alterations (regulated or not) improve the materials efficiency of microorganisms,[6] and can confer the ability to convert alternative feedstocks (such as waste instead of sugar crops) to products (1A, 2A, 9I, 5I, 8P, 4P).

However, societal values of safety intertwine with genetic modification (GM) safety policy and legislation and are considered barriers to the market entry of more sustainable IB innovations (7I, 5I, 11I, 4P). As scale-up director 9I described, the market culture for food ingredients demands the use of non-GM microorganisms but using GMMs is the only way to improve materials efficiency, and ‘people’ (the merged market and political elements of the regime and society that influences) need convincing of this truth.

I believe that it's nonsense to think that you will be able to [… develop sustainable IB] and to really be successful working only with wildtype [non-GM] strains. [sic] I think there's still a lot of work to be done to convince people that this is the way to go. [sic] A lot of companies produce [sic] with inferior strains, just because public perception would not really like to have something that is GMO derived in a food product for example. Public perception plays a big role in this. Companies are afraid of social media and people making bad advertisements and then losing money. -9I

Like other participants, they were also adamant that by averting the use of NGTs, IB will not become economically or environmentally sustainable enough to enter the current market (1A, 2A, 9I, 5I, 6I, 8P, 3P, 4P).

Which leads to the observation that societal resistance to GM seems to have brought about alternative nomenclature and framing of the term GM.

2.3

What GM is taken to mean, and what that implies?

Both in GM legislation as well as in colloquial language, the terms genetic modification (GM), genetically modified microorganism (GMM), or genetically modified organism (GMO) are used to denote when new genomic techniques (NGTs) are used to engineer (micro)organisms. To be able to grasp how participants make sense of such crucial concepts to IB innovation, we invited them to discuss matters in their own language. Therefore, in the interviews, we avoided using legal discourse, including around the concept of GM. What we found, though, is that in varying ways how participants make sense of GM differentially obscures or foregrounds trade-offs between the values of safety and sustainability.

The use of divergent language can help participants to avoid addressing potentially contentious discourse which in turn masks the role of sustainable IB in the circular economy. As we found, several participants consistently refrained from using the terms GM, GMM, GMO, or NGT. Reasonable explanations for this would be the terms’ associations with safety concerns, or the marketing and technical-legal complications they entail. Those participants instead used terms that avoid distinguishing between IB using ‘wild-type’ microorganisms and IB using GM microorganisms, for example, “smart technologies” (6I), “biobased” (8P), “biotechnology” (5I, 7I, 10C), “microbial cell factories” (2A, 6I). When interviewers probed for clarification, some participants eventually used the term GM, (4P, 8P, 9I). Others kept avoiding mentioning GM but still described conflicts between safety and sustainability. As 7I recounted while clearly manifesting frustration:

[It is not sufficient to use renewables as feedstocks, we must make IB] as efficiently as possible... “Safe” is about all the processing steps, and about the product in the end. We are not matching [our efforts to the needs of sustainability transitions] to having new products [enter the market]. -7I

Yet another participant, CE expert 8P, was entirely unaware of the role microorganisms play in IB applications, for example, making bioplastics. Consequently, they were also unaware of the conflicts between the safety and sustainability of GM IB.

2.4

Regulatory barriers for the design and market entry of (safe and sustainable) IB innovations

Although interview questions were designed to allow participants to bring up any barriers or facilitators participants considered important, legislation was clearly the dominant theme when discussing innovation barriers. Simultaneously, we also found that accounts of GM safety legislation were consistently intertwined with ones about societal values of safety. Therefore, we here discuss these themes together, as factors perceived to hinder both the design – and market entry – of safe and sustainable IB.

2.4.1

The Contained Use Directive is perceived to compromise safer and more sustainable IB innovation

While all participants agree IB processes should be subject to safety legislation that ensures environmental and human safety, multiple argue that the legislative and societal attention given to IB processes using microorganisms altered using NGTs defy their purpose and result in unfair restrictions that even discourage the design of safe(r) microorganisms that will improve the sustainability of IB processes and products (5I, I.11, 9I, 4P, 2A).

According to participants, the Contained Use Directive encourages innovators to use unregulated genome modification techniques like directed evolution, in which microorganisms’ DNA is randomly altered in iterative rounds of mutagenesis. While not regulated for safety like NGTs are, and hence incurring much lower (regulatory) costs then NGTs, this can create unpredictable phenotypes and potentially toxic products (6I, 9I, 5I, 1A, 2A, 3P). Interviewees consider this unfair because they consider NGTs much safer than un-regulated techniques given the high precision gene editing enabled by NGTs. Concretely, the use of NGTs allows one to computationally design microorganisms and check for potentially dangerous DNA combinations or toxic (by)products before altering a living microorganism’s DNA (2A, 6I).

We know exactly the tools we are using. We can make sure the by-products of the process are not toxic. [sic] We’re also not accidentally producing any toxic compounds, and if we do, we already know a priori, so we can develop systems that prevent or neutralize it beforehand. -6I

Project scale-up director 9I even argued NGTs can be used to design safer IB production processes. They provided as example that the company Evonik used NGTs to improve the safety of an IB production process for a biobased and biodegradable specialty chemical. Evonik discovered a microorganism that excreted rhamnolipid surfactant (i.e., cleaning ingredient) that was more sustainable and more effective than similar products on the market. However, the microorganism was an opportunistic pathogen, and hence using the wild type was unsafe. Evonik thus transferred the biochemical pathway that synthesized the surfactant from the opportunistic pathogenic microorganism to a non-pathogenic microorganism (9I).[7]

In one (in)famous case a sustainable palm oil replacement for cleaning products was withdrawn from the market because of societal perceptions of the dangers of NGTs – see Asveld and Stemerding, 2016. According to 9I, Evonik used NGTs to make IB more sustainable than its petrochemical counterpart, and safer than its non-NGT equivalent, shows that using GM is both safe and sustainable.

Evonik made a really important statement. They used another strain which is not opportunistic pathogenic, and they engineered it – they made a GMM! They're now building a multi-thousand-ton scale facility to produce them [the surfactant], which is putting a really important statement out there. [Evonik is saying] “we're doing this, it's a good product. GM is not in the product anymore so stop whining. This is green. This is good”. -9I

They made the point that despite significant hindrances caused by both societal resistance (stop whining, this is green, this is good) and legislative restrictions (GM is not in the product anymore) innovators are pushing safer and more sustainable IB products made using NGTs onto the market.

2.4.2

Product specific transparency legislation hinders the EU market introduction of food and feed ingredients

Participants also directed attention to EU legislation for assessing the safety of all products before they can enter the market, whether made from IB or not (e.g., food ingredients, cosmetic ingredients, or plastic ingredients).[8] They consider product-specific legislation necessary and often voluntarily go beyond regulatory requirements to ensure that IB products are safe for human use and consumption (1A, 2A, 3P, 4P, 6I, 9I, 5I). As 5I explains:

We have an internal dossier for each of our products. [sic] We want to be sure that we know everything about that product, and it's safe. Safety is a prerequisite to even thinking about going on the market. -5I

However, when we asked how IB could be made safer, participants responded with frustration and sadness (9I, 7I, 5I, 2A). They even questioned the very concept of safety and wondered where standards should be set (1A), what it means to be ‘safe enough’ (1A, 2A, 9I), and detailed examples where more sustainable GM microorganisms or fermentation processes were developed, but the combination of process (Contained Use Directive 2009/41/EC) and product safety legislation, especially for food ingredients, hindered the ability and speed at which they could bring the product to market (7I, 5I). They emphasized that the encumbrance of safety legislation for what they consider optimally sustainable IB products is inconsistent with ambitious sustainability and circularity targets.

5I also brought up the recently implemented additional Transparency Regulation (2019/1381/EU) for IB food and feed products. In addition to risk assessment and contained use requirements for IB processes that fall under 2009/41/EC, food and feed enzymes, additives, and flavorings extracted from GMMs must comply with transparency legislation that requires them to disclose the DNA sequences of the microorganisms and media formulations used in the IB (fermentation) process – since June 20, 2021 (11I).[9]

By requiring companies to publicly disclose DNA sequences, the Transparency Regulation limits the ways innovators can protect their innovations, for example, their intellectual property (IP), which 5I argues will hinder the market intro of food and feed IB ingredients in the EU.

I don’t know if management will ever approve a product for the market in Europe anymore. [sic] You can only bring it to the market in Europe if you have brought it all over the place in the world before, and you have nothing to lose. -5I

Furthermore, participants noted that food and feed ingredients, like flavorings or vitamins, are interesting applications for IB (6I, 11I, 8P, 10C), specifically because they tend to score high on sustainability assessments (7I, 5I).

Therefore, by indirectly requiring companies to disclose the intellectual property of food and feed ingredients, the Transparency Regulation adds an additional hurdle to companies who make food and feed ingredients from microorganisms that are already regulated under the Contained Use Directive. As 5I explained, this additional regulatory hurdle will likely prevent sustainable IB products from contributing to Green Deal goals:

You will have way less innovative products in Europe, [sic], and it doesn’t fit together with the Green Deal. -5I

Thus, combined with contained use and product-specific legislation, the Transparency Regulation is perceived to significantly hinder the ability of some of the most sustainable IB products to enter the EU market to contribute to the EU and Dutch CE transition.

2.4.3

Logistic and reguatory hurdles frustrate efforts to use sustainable and circular feedstock for IB

Niche innovators are consistently motivated to make a real impact in sustainability and circularity but receive mixed messages on what they should aim for (6I, 9I, 2A). Policy advisors encourage the use of waste as a feedstock (instead of sugars), but access to waste is difficult (9I, 7I) – for practical as well as regulatory reasons. Waste collection is the responsibility of local and regional governments, and is regulated by regional, EU, and international laws. As 7I explains:

[for an upcoming pilot project], we will start from waste biomass and convert it into biosurfactants, but also lactic acid. Several local organizations have the mandate to give out certificates to start working with waste biomass streams, but there are also international rules that apply so it's quite complicated. In the project, one of the tasks we foresee – with a consultant – is to map all the different levels of regulation and certificates that we need to think about when we go full-scale. -7I

Economically speaking, certain IB products are only competitive and hence realizable at a large scale. So before committing to designing GM that uses waste as a feedstock, and/or developing the IB process, companies must determine whether, given logistic and regulatory complications, they can access enough waste to produce a given IB product at a commercial scale.

2.5

Lack of a uniform definition of sustainability frustrates efforts to develop sustainable and circular IB

The market continues to demand microorganisms that use feedstocks that can also be consumed as food, like beet or corn sugars (9I, 2A), and policy and legislation are concerned about land use changes, biodiversity, and water eutrophication (7I, 8P). Society is perceived as failing to properly understand sustainability (10C) and legislation has not yet defined the criteria for measuring whether or not IB products are sustainable (9I, 7I, 5I).[10]

These issues seem rooted in divergent conceptions of sustainability and circularity as reported earlier and result in a lack of market incentive to pay a premium for IB (2A, 4P, 6I, 8P, 9I). Below, we describe the different ways participants expect sustainability to be assessed, relevant sustainability legislation, and the implications of both on IB’s ability to contribute to the circular economy transition.

2.5.1

Divergent sustainability assessment methods used by stakeholders

Many participants assess IB products’ sustainability and environmental impact via LCAs which consider products’ impacts throughout their ‘lifetime’ (2A, 7I, 9I, 5I, 11I, 4P, 8P, 10C). The lifetime of an IB product can encompass anything from its first stages (e.g., raw materials or feedstocks fed to the microbes) to its last stages (e.g., disposal/ recycling/ reuse of a plastic bottle), including everything in between (e.g., manufacturing of a plastic polymer) – see [Figure 2] for reference. However, participant’s understandings of the ‘lifetime’ of an intermediate IB product differ, and there is no consensus on which impact criteria should be used in LCAs (e.g., whether or not they should consider water eutrophication at different stages, or land use changes associated with raw materials feedstocks for microorganisms, et cetera).

Figure 2 Life cycle assessment (LCA). The lifetime of an IB ingredient can be assessed from the first stages (e.g., raw materials or feedstocks) to its last stages (e.g., disposal/recycling/ reuse of a plastic bottle). The methods and criteria used by participants vary widely.

At the moment, 7I assesses their products with cradle to gate LCAs. They make a polymer that can be used in a wide range of consumer goods, including foods, plastics, and clothing. They sell the polymer (poly lactic acid [PLA]) to their customers and often are not privy to whether their customers will use it in a plastic bottle, clothing, or food. As 7I explains, they therefore cannot follow the life cycle of their polymer all the way to the various (consumer) products their clients make:

Poly lactic acid can be used for everything. We cannot do an LCA cradle to grave for everything. It doesn't make any sense. So, we do the cradle to gate LCA, then, when we have a customer, we give them the data of the cradle to gate that we have, and we leave it within their hands to use it. -7I

7I has collaborated with companies who buy their PLA to do more comprehensive cradle to grave assessments and found that for consumer products like coffee capsules or tea bags, biobased PLA is a sustainable alternative to fossil-based plastics because the former can be composted and biodegraded with the spent coffee and tea (7I, 8P).

In contrast, Policy, NGOs, and MNEs assess sustainability more broadly. CE expert 8P evaluates bioplastics from cradle to grave to recyclability. According to them, innovative bioplastic polymers often cannot be recycled in existing waste streams, so even when the polymer itself is produced more sustainably than fossil-based plastics, they do not necessarily consider them more sustainable (8P, 10C).

We're focusing on a circular economy, and plastic recycling is going to be a very big part of that. There are several new types of biobased plastic that don't go with the current recycling system. They have to go into the trash, and they're burnt, and that doesn't align with our policy goals. -8P

Going beyond 8P’s observation that PLA is not necessarily optimally sustainable, 10C argues that we should limit the use of PLA polymer in plastics because sustainability assessments show that biobased plastic polymers like Polyethylene Furanoate (PEF) can replace a larger proportion of fossil-based polymers in a plastic bottle and therefore are more sustainable.

Furthermore, MNE representatives (5I, 11I) follow the life cycle of an IB ingredient from raw material to consumer product (grave) and beyond, but they do not consider recycling in their cradle to grave LCAs for plastic bags (5I, 11I). As multinational plastics expert 11I explained, plastic bags, when used to transport and preserve tomatoes are more sustainable than paper bags, because they extend the life of tomatoes and hence contribute to preventing food waste. They can also be re-used to line a trash bin, which for example, limits pollution runoff from soapy water cleaning of the bin.

The above shows how complex it is to operationalize the concept of sustainability, and that, in practice, it is done in vastly different ways, which leads to widely differing assessments of products’ sustainability impacts.

2.5.2

LCAs as sustainability assessment methods pose challenges to IB innovation

As discussed above, differing understandings of sustainability can result in different scopes and criteria in sustainability assessments, therefore, the use of LCAs by policy, legislation, NGOs, and can have implications on the direction of IB innovation. Participants argue that this can lead to strategically conducted LCAs that are based on the agenda of whoever conducts them (10C, 2A, 8P, 10C, 9I). They also argue that LCAs are too complex and expensive to undertake – small companies tend not to have the €500,000 doing a comprehensive LCA costs, or the expertise to do one (5I, 10C, 8P, IE7, 9I). As scale-up director 9I explains:

If you want to register a new compound, it's extremely expensive. It’s a lot of administration you have to do. You cannot do that yourself, so you need to pay consultants to help you, which also costs money. And for a startup, with no money or little money: Yeah, it's really a struggle, so we always say if there would be some incentives, like what governments have done for, for example, biofuels [that would be good]. 9I

Furthermore, representative data does not exist yet to conduct LCAs for products still in development (8P, 9I, 7I, 5I), and according to 10C, radically sustainable IB innovations might be overlooked because of this. If unreliable assessments show that an early-stage IB polymer is less sustainable than a fossil-based equivalent, or if IB plastic bottles cannot be recycled with today’s recycling infrastructure companies might not pursue their development (10C, 7I, 9I). As 10C explains:

Our challenges now is: if there are future materials that are way better than what we have now, how can we give them a place in the market, knowing that it probably will complicate in the short term, but it could be promising for long term. -10C

Finally, Academia (1A) and small company (6I) are entirely unaware of the existence of LCAs which makes it difficult for them to assess whether they are developing products that the regime will consider sustainable.

2.5.3

Divergent sustainability understandings not resolved by (taxonomy) legislation

The analysis above reveals that differing understandings of sustainability and inadequate oversight and governance of LCAs result in sustainability assessments that are rarely comparable and hence unreliable indicators of sustainability. According to participants, this causes confusion when designing innovations for a sustainable and circular economy.

For example, participants openly questioned which sustainability improvements they should focus on. It is not clear whether, for instance, one would do better to design microorganisms that use waste as a feedstock (A2) or focus on developing IB polymers that can be recycled in existing waste streams (10C and 8P) or pursue the discovery and design of novel biobased and biodegradable polymers (6I). In the same vein, CE expert 7I wondered whether the Taxonomy Regulation (2020/852), which aims to improve the quality and comparability of sustainability disclosure legislation for market investments, would define LCA scope and criteria that consider their products more sustainable than fossil-based equivalents (5I, 7I):

We expect the Taxonomy Regulation will help us, because we are already quite prepared. We already have a number of LCAs from our products. We believe that for biobased industry, we need to have a lower footprint compared to the fossil based. And we believe we can achieve that. [But] for example, circularity that we are (now) discussing is not yet finalized. What are the requirements for circularity? We don’t even know if that’s applicable or not. -7I

We thus see that while businesses require a uniform standard against which to measure their products’ impacts, thus far regulation does not deliver on this need. And as long as this remains the case and better performance in terms of sustainability and circularity relative to conventional fossil-based industry cannot be proven and monetarized, market entry for safe, sustainable, and circular IB products will remain challenging.

2.6

Opportunities for IB in the safe and sustainable circular transition

Companies and academics are motivated to design IB innovations that, looked at over their entire life cycles, are radically sustainable relative to conventional industrial products. However, the market is discouraging them from doing so (2A, 7I, 9I, 1A). Supporting this, interviewees referred to verbal discouragement to radically innovate (1A, 2A, 9I, 6I), market hesitance to invest in IB innovations (2A, 6I, 9I), and an unwillingness to pay (significantly) more for IB ingredients (5I, 7I, 9I, 2A, 4P). Although there seems to be some momentum on the side of society (3P) to increasingly adopt (more efficient) GM IB, especially by market actors (1A, 2A, 5I, 6I), the unwillingness to pay a premium for IB remains. As participant 2A explains:

If you're selling [IB product] into a value chain and you're making something that's kind of in a business area, and if the guy you're selling it to can also get the same product say from a chemical synthesis, they're often not interested in taking the risk. [sic] I talked to a lot of food companies, and they are very conservative, especially about technologies like genetic engineering. Companies, who, two or three years ago wouldn't even listen to me talking about GMO – had no interest when I started telling them about interesting genetic engineering we are doing now. Now it's changed, there is a change coming, and they're kind of realizing, it looks like this might be the future. -2A

Our results thus far suggest that, in addition to higher costs of IB ingredients (in general), the unwillingness to invest in IB is rooted in a divergent understanding of sustainability, a lack of confidence in the reliability and comparability of sustainability assessment methods, and legislation and society that discourages the use of NGTs.

For IB to fulfill its promise to contribute significantly to the sustainable and safe transition to a CE, the momentum of acceptance of GM by society, including market actors, must find traction also with policy and legislative actors whom, according to many of our respondents, are lagging behind in ways that are counterproductive in light of European and Dutch sustainability goals. Public communication (9I, 3P, 4P, 5I) and knowledge integration amongst all stakeholder groups (2A, 9I) are presumed to help align crucial regime actors in their support of more efficient GM IB.

Legislation is said to be needed to create the space to develop (GM) IB that enables a focus on sustainability that can help pull safe and sustainable IB onto the market. This can be done by operationalizing and incentivizing (radical) sustainability (1A, 2A), enabling equitable pricing of fossil and biobased products (8P), continuing to encourage subsidies for sustainable innovations (2A, 9I, 8P, 4P), and equal taxing of carbon emissions along the entire lifecycle (4P, 6I, 9I, 8P, 7I, 10C).

Summarizing the results, we see a picture emerge from the perceptions of this study’s participants that suggest that, in their own unique yet interrelated ways, sustainability (taxonomy) legislation, GMO legislation, (food) product safety legislation, transparency legislation, access to (waste) feedstock and societal resistance have all discouraged stakeholders from developing and launching products onto the market that have the potential to contribute to sustainability and CE goals (5I, 7I, 1A). If regime actors manage to agree on a shared and formalized conception of sustainability and of how this should be assessed, recognizing that NGTs do not inherently make IB riskier (which many of our interviewees claim), the market and IB innovators are likely to, respectively, encourage and resume radical innovations. In turn, this will encourage IB products that are more sustainable and more profitable than (fossil based) alternatives to enter the market and contribute to the safe and sustainable circular economy (1A, 2A, 6I, 9I, 4P, 8P).

3

Conclusions and Discussion

This exploratory study has shed light on the perceptions that quadruple helix stakeholders have of possible (cultural, economic, and political) barriers and facilitators for IB to contribute to a safe, sustainable, and circular economy [60], [67]). It adds to the existing body of IB safety literature by describing why sustainability and CE policies and legislation thus far have failed to sufficiently encourage radically sustainable IB research and innovation, or to pull more sustainable – and more costly – IB products to the market, and provides a rich and in-depth account of the many complex ways in which different elements in the IB innovation system are intertwined. This research is meant to contribute to several debates and find topics deserving of further research and/or attention by policy makers, entrepreneurs, and researchers. Engaging in follow-up research using complementary methods and larger and more representative mixed methods or qualitative datasets to corroborate stakeholders’ views as Marris [68], [69] and Legge [80] have done, would surely be worthwhile. In this final section, we will place our findings and analyses in the context both of relevant literature and contemporary policy debates at the Dutch and European levels and suggest what direction such follow-up research could take.

Not long ago, the front-runner in terms of environmental sustainability Ecover backtracked on its intention to replace the palm oil-based production of detergents with a GMM-based alternative. Fears for consumers voting with their feet [70] instigated by a campaign by environmental NGOs, made them decide this [29]. What our research suggests, however, is that societal perception is slowly recognizing the benefits of GM IB, consistent with what Foote [71] and Asin-Garcia [72] found for GMOs. It would be worthwhile to further investigate the dynamics and explanatory factors for this, for instance using the framework proposed for analyzing public perceptions of biotechnology by de Witt, Osseweijer, and Pierce [73].

In sync with changing public perceptions, larger companies are quietly becoming more transparent about their use of GM IB to meet sustainability goals – see news articles [74], [75] and communications from DSM and Unilever [76], [77]. This is consistent with our findings that suggest that even IB sectors most resistant to change (like the food sector) are beginning to openly embrace GM. As far as resistance through societal perceptions is concerned, then, market opportunities for IB with NGTs tentatively appear to be improving. Very recently, the European Commission has even proposed eight targeted actions to boost biotechnology and biomanufacturing in the EU [78].

Central to any effective policy supporting the transition to a CE is promoting the reduction of usage of fossil fuels-based raw and intermediate materials and substituting these with recycled or biobased materials. Interestingly, IB can also fulfill multiple roles in the carbon cycle, and hence potentially in the CE, by using waste as a feedstock for IB processes. Industrial-scale biotech processes already exist that capture CO2 from flue gasses emitted by power stations or steel or cement factories, and use that to feed (GM) microorganisms that metabolize the carbons into anything from PLA to enzymes, ethanol or biobased wood glues [79] [80] [81]. Companies are also increasingly transitioning to green chemistry and biobased materials [8], but with development cycles of 10–15 years [82], the pace at which biobased materials are replacing fossil-based materials does not align with the urgency of the sustainability transition. Based on our results, and consistent with existing literature, the following four are possible explanations of why the transition is so slow:

1. Regulatory hurdles slow down the adoption of IB.

2. GM's framing obscures the role of IB in the CE transition.

3. Complexity of sustainability assessments and the unavailability of standardized assessment frameworks.

4. The competition is not fair.

3.1

Regulatory hurdles slow down the adoption of IB

As society and the market slowly and quietly adopt GM, scientific literature [72], entrepreneurial organizations [83], and the European Commission's “study on new genomic techniques” [84] confirm our finding that the existing regulatory framework negatively impacts research and innovation. Technologies and their applications cannot unambiguously be categorized as GMO or non-GMO [16], [34], [85]. Therefore, as the EC report states, “it may not be justified to apply different levels of regulatory oversight to similar products with similar levels of risk”, and the ‘precautionary approach’ to regulating NGTs does not “promote sustainability and contribute to the objectives of the European Green Deal”’ [84]

To solve these issues around NGTs, the European Commission has recently published a proposal for a new regulation [86] that should both address the issue of disproportionate risk assessment requirements for NGTs, as well as concerns around the technical limits of detecting certain types of NGTs [16], [85]. Although the proposed EU Regulation only addresses plants produced with NGTs, industry has already called for additional policy actions for microorganisms following the proposed new Regulation for NGT plants [87].

Not only for the use of GMO’s, but also for the use of biomass waste streams as feedstock regulatory hurdles exist, making access to relevant biomass waste streams difficult. By indirectly requiring companies to disclose intellectual property, the Transparency Regulation adds an additional hurdle for companies producing IB food and feed products.

In line with our findings, the recent EC communication on boosting biotechnology and biomanufacturing in the EU has recognized many of these hurdles and has responded by launching a study analyzing how the legislation that applies to biotechnology and biomanufacturing could be further streamlined across EU policies, exploring targeted simplifications to the regulatory framework, including for faster approval and bringing to the market of IB products [78].

3.2

GM's framing obscures the role of IB in the CE transition

Literature shows that legislation and policies can sometimes encourage companies to adopt sustainable and circular solutions [88], [89]. However, companies continue to fall short of their net-zero goals [90] despite policy initiatives that finance sustainable development.[11] The Netherlands Environmental Assessment Agency (PBL) confirms that EU member states are not on track to achieve CE goals, in their integral circular economy assessment from 2023, they conclude that existing policies are not sufficient to address environmental damage [91], [92].

Interestingly, grey literature shows that the role of IB is largely absent from Dutch CE transition policies for plastics [93] and innovation subsidies [94], [95]. A recent report by The Netherlands Commission on Genetic Modification (COGEM) confirmed that this is a government-wide phenomenon [96]. Our results (Section 4.3) suggest that the continued reframing of the term GM limits the recognition of the role of (GM) IB in the CE transition, which in turn, may contribute to its absence from Dutch policy documents.

3.3

Complexity of sustainability assessments and the unavailability of standardized assessment frameworks

Assessing the exact sustainability impacts of different choices can be hard and intractable as long as uniform operationalizations of relevant dimensions are not in place. Our results suggest that accurate and reliable sustainability assessments are urgent to align IB developers and civil society towards common understandings of sustainability. This alignment will help to avoid arguments that the production consumer biocommodities and biofuels competes with food production, see for example, Rathmann [97]. Indeed, according to the OECD (2022) report on regulatory developments in sustainable reporting, supporting companies and governments to implement robust processes that monitor and validate the credibility of sustainability initiatives will encourage market investments in sustainable IB innovations [98].

In line with our findings, the EC communication on boosting biotechnology and biomanufacturing in the EU has recognized the importance of uniform standards, and the need to further develop methodologies that ensure a fair comparison between fossil- and bio-based products, This will include updating the recommended assessment methods for IB products in 2025 [78].

3.4

The competition is not fair

With current carbon emission prices in the ETS and given the continued subsidization, the industry receives for the use of fossil fuels in the Netherlands, for instance through its regressive energy tax, it is hard to build a business case for safe and sustainable IB for a CE [99]. If IB is to economically compete with fossil-based, it will require either cheap sugars [13] or designing microorganisms with the ability to convert waste more efficiently to IB chemicals for consumer products [100], and regulatory adjustments and associated investments into infrastructure to enable access to waste [101].

Policies like the White House’s Executive Order on Advancing Biotechnology and Biomanufacturing in the United States [102] and the EC communication on boosting biotechnology and biomanufacturing in the EU [78] are beginning to acknowledge the importance of biotechnology in the circular economy transition. However, despite several previously mentioned funding schemes and policy programs that support various aspects of sustainability and CE transitions in the Netherlands, Dutch policies only vaguely recognize the (economic) value of IB [103].

In summary, the coherent regime elements of culture, and the market, influence science, technology, and IB companies in the transition to a safe and sustainable circular economy as shown in [Figure 3]. Ichim [104] and Woźniak [105] confirm our findings that in some European countries, cultural perception of GM is slowly manifesting a clearer recognition of IB sustainability advantages. This suggests that Dutch and EU policies – currently tailored more towards precaution than towards innovation [54], [106] – are failing to accommodate these shifts in societal prioritization. Together with a clear policy push towards sustainability and circularity in the EU and Dutch context, and recent EC communication on boosting biotechnology and biomanufacturing in the EU [78], the changing cultural perceptions would arguably increase market opportunities for IB to realize it’s potential more fully in a safe and sustainable circular economy. Furthermore, sustainability policy, including the EU Taxonomy and SSbD policies, have the potential to help remove barriers to market introduction of safe, sustainable, and circular IB innovations – but might as well complicate things further, if they mean the same processes or products are being assessed under multiple and divergent frameworks [98]. In conclusion, tensions between the values of safety and sustainability manifest between policy actors working on CE, and legislation surrounding waste management, IB, climate and sustainability, and GM. Without proper alignments to enable safe and sustainable innovation, market access to circular and environmentally friendly products will continue to be delayed in the EU, which is bound to extend environmental damage.

Figure 3 The MLP regime must be reconfigured to increase the opportunities for IB innovations to contribute to a safe and sustainable circular economy. Culture and the market are beginning to recognize the many ways that IB can significantly contribute to a safe and sustainable CE transition, but policy alignment is lagging behind.

4

Experimental Section

Inspired by the MLP, this research explores the interplay between cultural, market, and policy forces and how they influence the capacity of IB innovations to integrate into the safe and sustainable circular economy transition. The MLP was used to formulate our research question, guide the selection of interviewees, design interview questions, and analyze data. Since this is a qualitative and exploratory study that aims at clearing the ground for future research, it does not aspire to exhaustively analyze all there is to say about the societal, policy, and economic forces and mechanisms at play at the different levels the MLP distinguishes. Although extensive triangulation with, for example, quantitative, sociological, or financial research methodologies was outside the scope of this research, grey and academic literature was used to qualitatively engage with themes that emerged from the interviews and to check for consistency with literature, some of which was provided by the interviewees.

4.1

Participants selection

Desk research, informal interviews, and snowballing were used to map quadruple helix stakeholders [60] such that we could purposefully select participants from private and public interests in the regime and niche [61] that meet the following criteria [62]: develop, manufacture, or are involved in policies and regulations for IB intermediate ingredients such as chemicals, plastics, fuels, enzymes, flavorings, and textiles; ambition to contribute to safe or sustainable or circular IB or IB rules and regulations; operate in the Netherlands or another European country.

Using this set of criteria, 30 individuals representing different types of stakeholders were identified and sent an email introduction with a request to participate in an interview that explores barriers and drivers to transitioning to a safe, sustainable, and circular IB.

4.2

Interview structure

Between March 2021 and June 2021, semi-structured interviews of approximately 1 h were conducted via teleconferencing by two authors: one with an academic background in biotechnology (author 2) and one with both business experience and academic knowledge of IB innovation (author 1). The interview guide (see Appendix D) incorporated the prior findings of collaborating authors 3 and 4, was designed to allow broader discussions than structured interviews, and encourageed reflection and conversations that focused on each participant’s unique area of expertise [63], [64]. The open questions were aimed to extrapolate the MLP elements of policy, market, culture and society, and technology and infrastructure that participants perceive to help or hinder safe and sustainable IB development. The interview guide was piloted and accordingly revised before use.

Verbal and written consent was obtained to audio-record and subsequently transcribe all but one interview. All participants were offered anonymity and confidentiality, and to reduce bias in reporting, notes taken during the interview and a summary of the take-home messages were sent to all participants for a member check [63].

4.3

Data analysis

Following qualitative analysis methods [65], [66], authors 1 and 2 transcribed the interviews and familiarized themselves with the data, then separately coded safety, sustainability, barriers, and facilitators across the entire dataset. Bottom-up codes were also derived by both authors and divided into the themes of legislation, societal values/culture, and market with the help of Atlas TI. Authors 1 and 2 discussed the findings and restructured and redefined the main themes on multiple occasions. Subsequently, author 3 (environmental policy advisor) and author 4 (expert in sustainability policy and social studies of science, technology, and innovation) joined the other two authors several times to discuss and re-analyze the themes in relation to their relevance to the research question, after which author 1 partially re-analyzed and re-coded the transcripts.

Contributors’ Statement

Conception and design: D. Flaherty, P.A.M. Hogervorst, P. Klaassen Data collection: D. Flaherty, I. Hoefnagel Analysis and interpretation of the data: D. Flaherty, I. Hoefnagel, P.A.M. Hogervorst, P. Klaassen Drafting the manuscript: D. Flaherty, I. Hoefnagel, P.A.M. Hogervorst, P. Klaassen Critical revision of the manuscript: D. Flaherty, I. Hoefnagel, P.A.M. Hogervorst, P. Klaassen

Conflict of Interest

The authors declare that they have no conflict of interest.

Acknowledgment

This study was supported by the Dutch National Institute for Public Health and the Environment (RIVM) Strategic Programme (SPR) under the DIRECT project, in collaboration with the Athena Institute, Vrije Universiteit Amsterdam.

¹ Additional legislation includes traceability and labelling of GMOs and the traceability of food and feed products produced from GMOs (Regulation (EC) No. 1830/2003), and legislation on transboundary movements of GMOs (Regulation (EC) No. 1946/2003).

² Academia includes biotech or synthetic biology experts at universities or research institutes.

³ Industry classified according to company size, SME: 2–250 employees, Large company: >250 employees + operations in one country, MNE: >500 employees + operations in multiple countries.

⁴ Policy includes ministries, governmental agencies or privately funded agencies who gather and disseminate information to develop, support or implement the interests of corporate clients.

⁵ NGO is a non-profit organization which gathers and disseminates information to support citizen interests often in humanitarianism or social sciences missions which has a high degree of public trust.

⁶ Wehrs et al. (2019) confirms this [107].

⁷ Bettenhausen C. confirms 9I’s account [108].

⁸ Scientific Committee on Health and Environmental Risks SCHER [109] confirms this. See also product-specific safety regulations for cosmetics ingredients EHS 1223/2009/EC, surfactants in soap 648/2004/EC, food and feed additives 1831/2003/EC, plastic toys 2009/48/EC.

⁹ Commission Implementing Regulation 234/2011 [110] confirm 5I’s account that IB food and feed ingredients are subject to Transparency Regulation.

¹⁰ Directive (EU) 2018/2001 on biofuels is the exception confirming the rule.

¹¹ Programs like Horizon Europe [111], Just Transition Mechanism [58], the Recovery and Resilience Facility [112], the Dutch government funds MIA VAMIL [113], and WBSO [114] provide financing or subsidies for sustainable development in the EU and Netherlands.

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Publication History

Received: 30 October 2024

Accepted after revision: 06 February 2025

Accepted Manuscript online:
17 February 2025

Article published online:
21 March 2025