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:
Regulatory hurdles slow down the adoption of IB.
GM's framing obscures the role of IB in the CE transition.
Complexity of sustainability assessments and the unavailability of standardized assessment
frameworks.
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.
