Chemical risk governance: Exploring stakeholder participation in Canada, the USA, and the EU

Abstract

Hazardous chemicals are one of the greatest environmental challenges facing our planet, testing governments in the face of economic and social development. Chemical risks are often complex systemic risks, which require particular governance processes, stakeholder participation mechanisms, and communication procedures to manage. In this article we explore how such processes, mechanisms, and procedures could offer more effective pathways for international chemical risk assessment and management. Combining document analysis with 69 key informant interviews and four focus groups with experts from across government, non-governmental organizations (NGOs) and industry in Canada, the USA and Europe (n = 24), the results highlight the importance of increasing stakeholder participation and risk communication in existing chemical risk assessment and management frameworks. Similarities and differences between the three jurisdictions are discussed with a view to inform future risk governance strategies. The contemporary insights are of relevance to decision-makers seeking to improve the effectiveness of chemical risk governance in practice.

Supplementary Information

The online version contains supplementary material available at 10.1007/s13280-021-01671-2.

Introduction

The production and use of chemicals have grown exponentially over the last 50 years (UNEP 2019). Manufactured chemicals today play a key role in the provision of most goods and services that support our lifestyles and economies. The problem is that some of these chemicals have hazardous properties, which means that they have the potential to cause significant adverse effects on human health and the environment (UNEP 2019). These adverse effects are increasingly imposed on human populations and ecosystems worldwide due to the transboundary movements of chemicals through air, water, living organisms, and international trade (Honkonen and Khan 2017). Prominent examples of chemical toxicity include lead, asbestos, dichlorodiphenyltrichloroethane (DDT), polychlorinated biphenyls (PCBs), ozone destroying chlorofluorocarbons (CFC), and dioxins (Landrigan et al. 2018). New synthetic chemicals threaten to repeat this toxic legacy, with the number of chemicals being introduced far exceeding the regulatory capacity of governments (Landrigan et al. 2018; UNEP 2019). As global chemical output is expected to increase substantially over the coming decades (UNEP 2019), effective chemicals management is essential. Accordingly, various international and national legislations and regulations have been introduced to establish more control over hazardous chemicals.

Despite notable improvements and advances in chemical assessment, management and policy internationally, it remains widely recognized that existing regulatory approaches and frameworks have not enabled adequate and timely action on most hazardous chemicals (Allen 2013; Chiapella et al. 2019; UNEP 2019). Current knowledge on the adverse effects of chemicals is limited due to missing or incomplete toxicological and eco-toxicological data for thousands of manufactured chemicals (Basu et al. 2019). Furthermore, there is significant uncertainty regarding exposures to chemical mixtures and how they accumulate, disperse, transform and affect living organisms and the environment at different concentrations (EEA 2019; Drakvik et al. 2020). Even when information does exist, hazardous chemicals pose an ambiguous problem to society due to the multitude of actors with different roles and responsibilities that frame the associated risks differently, due to diverging values, perceptions and interests (Gilek et al. 2011; Karlsson et al. 2011; Pain et al. 2020).

Hazardous chemicals can therefore be seen as an archetypical example of a ‘systemic risk’ (Kaufman and Scott 2003; OECD 2003; IRGC 2005). Other terminology used to describe similar concepts include ‘wicked problems’ (Rittel and Webber 1973), ‘intractable policy controversies’ (Schön and Rein 1994) and ‘trans-scientific questions’ (Weinberg 1972). For consistency we will use the term ‘systemic risk’, first coined by the Organisation for Economic Co-operation and Development (OECD) in 2003, and later defined by the International Risk Governance Council (IRGC) in 2005 as complex risks to human health and the environment that are set within wider societal, financial, economic and political contexts with increased interdependencies, both across risks and between their various backgrounds (OECD 2003; IRGC 2005). Systemic risks, which are associated with high levels of complexity, uncertainty and ambiguity (IRGC 2005), stand in contrast to ‘simple risks’ which are measurable, characterized by easily identifiable cause-and-effect relationships, and have little ambiguity. Conventional assessment, management and policy approaches, which are geared toward simple risks, tend to focus on an individual risk in isolation of other factors, rely on single agencies for implementation, and often do not effectively engage the full range of relevant stakeholders, which renders them generally ineffective in addressing systemic risks (Kreuter et al. 2004; Batie 2008; Van Asselt and Renn 2011). By ‘stakeholders’ we mean socially organized groups that are, or will be, affected by hazardous chemicals and/or by the risk management options taken to reduce or eliminate those risks (IRGC 2005). Many existing strategies for addressing chemical risks have been geared toward addressing simple risks, which can ultimately exacerbate the problem by ignoring the systemic nature of the challenge (Van Asselt and Renn 2011; Allen 2013).

As such, there appears to be an urgent need for improvement in the assessment, management, and governance of risks arising from the production, use and disposal of chemicals (UNEP 2019; EC 2020; Strategic Approach to International Chemicals Management 2020). In recent years, more integrative, systems-oriented approaches have emerged as plausible platforms for handling systemic risks (National Research Council 1983; Fischhoff 1995; Stern and Fineberg 1996). This includes an interdisciplinary body of scholarship, often referred to as ‘risk governance,’ that helps to identify the concepts, processes and multi-actor networks needed to understand and manage systemic risks (Gunningham et al. 1998; IRGC 2005; Van Asselt and Renn 2011). The concept is part of wider developments in decision-making that reflect a trend away from approaches that rely solely on direct government intervention and toward broader and more systemic forms of governance (Petts 2004; Hagendijk and Irwin 2006; Chilvers 2007). In the IRGC Risk Governance Framework (Fig. 1), the traditional elements of risk handling—risk assessment, management, and communication—are complemented with additional aspects that aim to account for the inclusion of the societal context, such as the structure and interplay of the stakeholders involved, as well as risk perceptions and concerns (IRGC 2005, 2017).

Fig. 1.

The International Risk Governance Council—Risk Governance Framework (IRGC 2017). The figure shows the four different phases of the risk handling chain with the cross-cutting aspects ‘communication, stakeholder engagement, and the societal context’ as central elements throughout the process

Given the problems surrounding chemical risk governance and the systemic nature of these issues, our objective is to better understand how stakeholders are involved in, and how they perceive their involvement in, chemical risk assessment and management processes in Canada, the USA, and the EU with a view to informing future risk governance strategies. We selected these three regulatory contexts due to their highly integrated economies, democratic government systems, and the leading roles that their regulatory agencies play in advancing international efforts to ensure the sound management of chemicals. Our research responds to recent calls for more attention to be paid to the governance of chemical risks (Mondou et al. 2020, 2021), and arguments advocating for broader stakeholder involvement in chemical assessment, chemical regulation, and chemical policy (Allen 2013; Chiapella et al. 2019; Drakvik et al. 2020).

Materials and methods

We followed an exploratory research design involving both secondary data collection and primary data collection activities in Canada, the USA and the EU. All protocols related to the research involving human subjects were reviewed and approved by the McGill University Research Ethics Board (REB File # 468-0417) prior to starting data collection.

Document analysis

Our research began with a comprehensive examination of the literature, including academic publications, legal/policy documents, and NGO submissions and reports relevant to chemical risk governance in each of the three jurisdictions of interest. We employed a descriptive qualitative analysis approach which consisted of “three concurrent flows of activity: data reduction, data display, and conclusion drawing / verification” (Miles and Huberman 1984). Adopting a restricted approach to content analysis allowed us to focus on stakeholder participation and risk communication policy issues in each jurisdiction and therefore identify which text to include as data (Bose 1995).

Interviews and focus groups

To complement the secondary data analysis, we collected primary data using semi-structured key informant interviews and focus groups discussions. ‘Semi-structured’ means that the broad topic of the interviews is decided beforehand, through a list of questions that can be flexibly altered or reordered during the interview, giving both the researcher and the interviewees the freedom and flexibility to digress to gain richer information (Wengraf 2001; Miller and Brewer 2003). Semi-structured interviews were selected because they provide general comparability between interviews while maintaining the natural flow of the interview, thus providing flexibility to explore unexpected answers in depth and allowing interviewees to respond on their own terms (Wengraf 2001; Miller and Brewer 2003). Supplementing the interviews, focus groups were conducted because they allowed us to obtain the views of multiple people with different roles and responsibilities from the same regulatory agency together at the same time. Our interview and focus group questions covered perceptions of the broader social, political, and technological processes and practices affecting chemical risk assessment, management, policy and regulation (i.e., chemical risk governance), as well as the specific issue of stakeholder participation. The initial list of interview questions is presented in Supplementary Information.

Sampling strategy

We sought to obtain authoritative perspectives on various chemical risk governance processes from diverse stakeholder groups in order to obtain ‘descriptive representation’ (Klinke and Renn 2014). Potential participants were first identified based on their professional roles, responsibilities, and work location, using our network of contacts and through an online search of publicly available information. We sought participants from intergovernmental organizations, national government agencies, private industry, non-governmental organizations (NGOs), trade associations and academic institutions in North America or the European Union (EU). In total, 69 semi-structured interviews were conducted (see Table 1), along with four focus group discussions with a total of 24 participants, between July 2017 and August 2021. Our sample included a large proportion of senior bureaucrats and government scientists because of their inside understanding of, responsibility for, and experience with risk assessment and management processes in each jurisdiction. The Supplementary Information provides further information on the job roles and responsibilities of each of the interviewees and focus groups respondents.

Table 1.

Breakdown of interviewees into the four main stakeholder groups

	Canada	USA	EU
Government	20	9	6
Industry	3	7	2
Academia	9	3	4
NGO	3	1	2

The Supplementary Information includes more information on job roles and responsibilities of interviewees and focus group participants

Data collection and analysis

The interviews were conducted face to face and through online videoconferencing platforms and lasted approximately 40 to 80 min. The focus groups were conducted through online videoconferencing platforms and lasted approximately 90 to 120 min. All interviews and focus groups were recorded and transcribed for subsequent qualitative data analysis in NVivo. Coding involved assigning summative attributes to different portions of the transcribed interview data in order to identify categories and themes (Saldaña 2013). After multiple rounds of recursively refining the coding structure, data saturation was reached since no new categories or themes emerged (Guest et al. 2006; Mason 2010).

Limitations

While every effort has been made to include as much variation in the study participants as possible, a smaller, larger or different group of interviewees would likely have produced a slightly different dataset. We particularly would have preferred to include more NGO participants in the study but found it difficult to recruit participants from this group. Nevertheless, the fact that we reached theoretical saturation during our data coding suggests we have a robust basis for interpretation. In order to further increase the reliability of the data, NGO views were supplemented through a content analysis of published reports and policy submissions by these groups. Using in-depth interviews, focus groups, academic literature, and policy documents ensured data triangulation which enhances reliability and trustworthiness (Wilson 2014). Interviewer and confirmation biases were minimized through careful pre-testing of the interview questions, and manually coding and analyzing the interview transcriptions. Finally, we disseminated our preliminary findings during a project workshop in 2020 which allowed for general informant feedback and member-checking (Yin 2003). The qualitative exploratory nature of the study does not allow us to generalize the results to populations beyond the participants. Instead, we demonstrate reliability and rigor through the transparency and replicability of the research design, which aimed to generate substantive theory that can deepen understandings in different contexts (Olwig 2012).

Results

In this section we present the major themes that emerged from our analyses. We begin with a brief introduction of the main chemical management regulations operating in each of the three jurisdictions based on our secondary data analysis.

CMP (Canada), TSCA (USA) and REACH (EU)

The Canadian Environmental Protection Act (CEPA 1988/1999) is the primary piece of legislation regulating toxic substances in Canada (Government of Canada and Minister of Justice 1999). Given the number of chemicals in commerce and the rapid increase of new chemicals on the market, the approach of the first version of the law was that new chemicals would require pre-market testing. However, the compromise of this approach was that the 23,000 chemicals already in use in Canada were not subject to immediate assessment and were placed on the Act’s Domestic Substances List (DSL). The 1999 revision of the CEPA required the federal government to undertake a review of the substances on the DSL to categorize them as low, medium and high priority for action based on their persistence, bio-accumulativeness and toxic properties. This legislated review was completed, as required, in September 2006, and served to identify the substances that should be subject to further hazard and risk assessments and, by extension, possible management controls. It was at this time that the government introduced its new Chemicals Management Plan (CMP) (Government of Canada and Minister of Justice 1999; Government of Canada 2016a). The main goal of the CMP is to strengthen the existing substances regime to significantly reduce risks to human health and the environment. The CMP also aims to integrate chemical management activities across relevant federal legislation, coordinate and align with international programs, strengthen industry’s role in proactively managing chemical risks, improve risk communication, and establish government accountability (Scott 2009; Government of Canada 2016a).

The Toxic Substances Control Act (TSCA or TOSCA) 1976, regulates the chemical substances and mixtures that present an unreasonable risk of injury to health or the environment in the USA (US Congress 1976). It is administered by the United States Environmental Protection Agency (EPA). TSCA required that chemical manufacturers submit information about the production, use, exposure and environmental fate of new chemicals. Approximately 62 000 existing chemicals that were already on the market before the law passed were ‘grandfathered’ in and never subjected to assessments. The effectiveness of the Act was limited by complex and cumbersome administrative burdens, limited federal authority and capacity, data limitations, procedural complexity and corporate lawsuits (Krimsky 2017). As a result, TSCA was amended for the first time in June 2016 by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) (US Congress 2006). Among other changes, the revision gave the federal government more authority, and required that existing chemicals be evaluated and assessed against a new risk-based safety standard, unreasonable risks be eliminated, and companies substantiate their claims of confidential business information before withholding data (US Congress 2016; Krimsky 2017).

In 2007, the EU enacted legislation called ‘Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)’ to deal with the protection of human health and the environment from hazardous chemicals (Van Der Wielen 2007; EP and EC 2016). Its technical, administrative and scientific aspects are managed by the European Chemicals Agency (ECHA). The REACH legislation was drafted as a response to criticisms of the former legislative framework for new and existing chemical substances combined with proposals for renewing it by Member State authorities, industry, NGOs and EU bodies. REACH aims to streamline and improve chemical regulation and to fill substantial information gaps with regards to the risks posed by synthetic chemicals to human health and the environment. To comply with the regulation, companies that manufacture or import more than one tonne of a substance per year must identify and manage the risks linked to the substance; demonstrate to ECHA how the substance can be safely used; and communicate risk management measures to users. The REACH regulation has been described as one of the strictest and most complex laws to date (Lahl and Hawxwell 2006; Vaughan 2015).

The Canadian, US and EU governments have each responded to the lack of data concerning the safety of existing chemicals, the capacity challenge posed by assessing new chemicals in a timely manner, and public concerns over the health and environmental impacts of synthetic chemicals by implementing a rigorous chemicals management regime. As a result, the structures of laws governing chemicals in the three jurisdictions have many similarities. At the same time, the different histories and political cultures of each jurisdiction has led to significant differences, which have become more pronounced as each jurisdiction has made adjustments. Comparing the regulations (see Tables 2 and 3), yields five main observations: First, REACH requires more data to be generated and uses the same strategy for existing and new chemicals, as opposed to TSCA and CMP. Second, the US and Canadian systems place the burden of data generation on the regulatory agency as opposed to REACH which puts it on the industry. Third, REACH is more precautionary than TSCA and CMP. Fourth, REACH is more transparent and open regarding information disclosure and stakeholder participation. CMP policy and regulatory discussions are also transparent and open, although individual risk assessment processes are less so, while TSCA appears to be the most ‘closed’ system, while also being the least strict in their requirements of industry. Fifth, the US system does retain a culture of litigation that is more punitive of industrial errors than EU and Canadian law (Botos et al. 2019).

Table 2.

Comparison of REACH, TSCA (with LCSA), and CMP on a variety of key dimensions relating to chemical risk assessment and management

Themes	Data development	Prioritization for risk evaluation	Existing chemicals	New chemicals	Restrictions on chemical use	State pre-emption
REACH	REACH requires companies to develop a minimum safety-related-data-set with regards to chemicals’ effects on human health and the environment	All existing and new chemicals require data development and a simple risk assessment before the prioritization for in-depth risk assessment is considered	Chemical Safety Assessment are prepared by industry, on a priority basis, on all existing chemicals through hazard assessment, exposure assessment, and risk characterization	Notification and Chemical Safety Assessment are prepared by Industry on all new chemicals through hazard assessment, exposure assessment, and risk characterization	Authorization part of REACH is designed to stimulate industry to substitute Substances of Very High Concern (SVHC). Restriction focus is on the worrisome uses of chemicals	REACH is an EU regulation and becomes immediately enforceable as a law in all EU member states REACH completely pre-empts EU member state law regarding chemicals
TSCA	No minimum safety-related-data-set. EPA can issue orders (or a rule-making) requiring more information if chemicals present an unreasonable risk or if more information is needed to make a safety determination	Risk-based screening process (with limited data) to classify active existing substances into two groups with a scoring system: high priority or low priority	Risk-based safety assessment for high-priority substances are conducted (35 substances should be evaluated in the next 3.5 years)	Notification by industry. EPA prepares a screening level risk assessment and are required to make an affirmative finding before new chemicals can proceed to the marketplace	The restriction and ban of chemicals are part of the safety determination. EPA is no longer required to adopt the least burdensome approach at risk reduction	TSCA does not completely pre-empt state law regarding chemicals. U.S. states may continue to take regulatory actions on chemicals to better protect their residents in situations where EPA has not taken an official stance and is not in regulatory deliberations
CMP	No minimum safety-related-data-set. All stakeholders can submit data	Risk-based screening process (with limited data) to classify active existing substances into two groups: high priority or low priority	Risk-based safety assessment for chemicals are conducted on a priority-basis set in the screening process, working from high to low	Notification and test data by industry. Screening level risk assessment (SLRA) prepared by government to determine whether the chemical may pose harm to human health or the environment	If the risk or safety assessment determines that a chemical is toxic, persistent, or bio-accumulative, it must be recommended for the Toxic Substances List and will then be considered for elimination	CMP is a regulation by the Government of Canada which is enforceable in all provinces and completely pre-empts Canadian province law regarding chemicals

The data for this table is based on official legal documents and sources (US Congress 1976; EP and EC 2016; Government of Canada 2016a; US Congress 2016; Government of Canada 2017), as well as various existing analyses in the literature (Denison 2007; U.S. GAO 2007, 2009; ECHA 2010; Abelkop and Graham 2014; Botos et al. 2019), none of which completely captured the current situation with regards to the three regulatory frameworks and the updated regulations/acts. Because we want to keep the table short and clear, the above statements only depict what we deem the most important aspects of each dimension, and thus reflect somewhat of a simplification

Table 3.

Comparison of REACH, TSCA (with LCSA), and CMP on a variety of key dimensions relating to the institutional context

Themes	Precaution	Burden of proof	Political cultures	Information disclosure	Risk communication (who/what)	Stakeholder participation
REACH	Strong precautionary principle. Chemical is unsafe until it is proven safe through risk characterization	Burden of proof on chemical companies to ensure that chemicals do not pose risks or that measures are identified for handling them safely	The EU relies predominantly on regulation to protect the public	REACH has provisions to protect confidential business information but also requires public disclosure of certain information. It also places restrictions on the kinds of information chemical companies can claim as confidential	ECHA is required to provide guidance to Member States for the communication of information on the risks and safe use of chemical substances. Member States inform stakeholders and the public. Different strategies for different types of risks exist	ECHA recommends different strategies for one-way communication, public commenting periods, and more active participation, in which the public can help define how risks are managed and communicated. Implementation differs between Member States
TSCA	Weak precautionary principle. Chemical is safe until proven unsafe	Burden of proof on EPA (and the public) to demonstrate that a chemical poses a risk to human health or the environment before it can be regulated	Power is more strongly titled toward industry. Primary risk management system is litigation against chemical companies which could induce industry to implement voluntary bans or safety measures	TSCA has provisions to protect and share confidential business information. However, other than health and safety studies, it generally allows companies to claim most information as confidential and requires EPA to protect that information from unauthorized disclosure	Certain information about TSCA, the decisions of risk evaluations, and the safe use of substances of concern are posted on the EPA website	Public commenting periods on TSCA regulations and amendments. Public commenting periods on chemical risk evaluations for existing chemicals
CMP	CEPA refers to the precautionary principle but chemicals are safe until proven unsafe	It is the government’s burden to demonstrate that a risk exists. Industry can face data-submission requirements for chemicals that are identified as a high priority for risk assessment	In general terms, the Canadian regulations and the CMP are based on the more cooperative and less adversarial political culture of Canada	CMP has provisions to protect and share confidential business information. Assessments of existing chemicals are made publicly available. Assessments of new chemicals are not made public. The government can share confidential Information with other governments or institutions with certain agreements	Efforts are made to inform stakeholders and the public about the CMP. Certain information about the decisions of risk evaluations, and the safe use of substances of concern are posted on the Canada Gazette website	Wide stakeholder participation on CMP implementation and development through a stakeholder advisory council and a science committee. Participation in chemical assessment and management is limited to public commenting periods on existing chemicals

The data for this table is based on official legal documents and sources (US Congress 1976; EP and EC 2016; Government of Canada 2016a; US Congress 2016; Government of Canada 2017), as well as various existing analyses in the literature, (Denison 2007; U.S. GAO 2007, 2009; ECHA 2010; Abelkop and Graham 2014; Botos et al. 2019), none of which completely captured the current situation with regards to the three regulatory frameworks and the updated regulations/acts. Because we want to keep the table short and clear, the above statements only depict what we deem the most important aspects of each dimension, and thus reflect somewhat of a simplification

Stakeholder participation and risk communication

Our findings based on the primary data suggest that stakeholder participation and risk communication in chemical risk assessment and management are important elements of the process in Europe and North America. Despite differences in the three regulatory frameworks, respondents from each jurisdiction generally indicated that, over the last 20 years, there has been a trend toward greater stakeholder participation, communication, transparency and disclosure within chemical risk assessment and management processes. Interview respondents argued that this trend was likely to continue due to the heightened awareness of public concern about chemical risks, eroding trust in governmental and private sector actors, numerous societal controversies over chemical risks, and past mistakes in risk communication. Moreover, respondents recognized that stakeholder participation could add new perspectives, strengthen the process with new information, and build acceptability, trust and confidence in the decisions. As one respondent from industry in the USA stated:

I think having more stakeholders involved is generally a good thing. […] It doesn't necessarily mean the people running the study or running the program can do everything about everyone's concerns. But I think getting that – making people aware of it and listening I think can improve your overall product at the end and also improve acceptance when you're done as well”. (Industry professional, USA).

However, despite recognizing the importance, and the desire for, broader stakeholder participation and risk communication in chemical risk assessment and management, respondents in all jurisdictions also reported that participation is generally limited. The processes appear to be prescribed, with engagement and communication opportunities often being limited to public commenting periods or the posting of a decision. Some of the main barriers identified include a perceived lack of clarity as to whether and how stakeholder feedback is incorporated into final documentation and decisions, the lack of time and resources for both government and external stakeholders, problems communicating and understanding complex technical information, issues related to the transparency and disclosure of information due to confidential business information and—perhaps as a result of these barriers—a lack of trust and confidence in the process. The main barriers to, and potential benefits from, stakeholder participation and risk communication in chemical risk assessment and management, as put forward by the respondents of our study, are summarized in Table 4.

Table 4.

Main barriers and main benefits of increased stakeholder participation and risk communication in chemical risk assessment and management, as put forward by the respondents of our study

Main barriers	Main benefits
A lack of communication about how stakeholder comments were addressed (or not) in preparing final documentation	More well-rounded, overarching perspective as each stakeholder group contributes a certain expertise or a particular societal viewpoint to the process
A lack of time and resources for stakeholders to investigate the necessary documentation and provide an informed response	Potential to strengthen the process with information that might not have otherwise come to light. The more data points that are included in the process, the more robust that the decision is going to be
The tension between maintaining confidential business information while ensuring transparency and disclosure of information to the public	Helps to indicate which parts of the assessment are more acceptable and which parts could lead to societal controversy
Difficulties understanding and communicating technical information associated with risk assessments and the science that underpins them	The more acceptability that can be found with a broad base of stakeholders, the more likely it is that decisions will be accepted by society
The formal processes, timelines, and institutional structures in place for chemical risk assessment and management, which are very prescriptive and not inducive to stakeholder participation	To create trust and confidence in the process, decisions should be open and transparent with an opportunity for a variety of stakeholders to weigh in

Regulators across the three jurisdictions indicated that efforts were ongoing to improve stakeholder participation and risk communication in chemical risk assessment and management, and to expand and diversify the list of groups engaged in chemical risk governance processes, but also admitted that more work is needed. Furthermore, various respondents noted that there have been efforts to help fund, coordinate, and support some external stakeholders’ engagement to overcome the known barriers surrounding the lack of time, resources and technical expertise. Nonetheless, it was recognized that even with additional funding and support, most of the external stakeholder groups will not be able to match the resources of the chemical industry and in that way, it is not, and may never be, a level playing field. However, making sure that opportunities for engagement are in place was generally seen as a suitable way to at least ensure that non-chemical industry actors are more involved in the process. As one respondent in the government of Canada noted:

In the past, typically our conversations were with informed stakeholders, if you will, or those that have the technical whereabouts or even the larger advocacy groups. But in the end, a lot of people have pointed us to the fact that we're missing important subgroups of the population in the conversation when we're risk managing […] So we're constantly pointed towards asking, who is it that we're talking to, and are we getting the right people?. (Government regulator, Canada).

Lastly, respondents in all jurisdictions indicated that stakeholders were able to ask questions or request meetings with regulators outside the formal risk assessment and management processes. NGO respondents also reported using various forms of media to raise important issues, to influence public opinion and to generate political will for certain decisions. Given procedurally defined opportunities as well as these additional ones to engage, some might argue that governmental agencies and existing processes and regulations are not necessarily the most limiting factor, but that it is the public and their representatives who determine how much participation takes place, and how effective it might be. And while this appears to be true to a certain extent, limitations regarding the disclosure of confidential business information, the relatively short timelines combined with the lack of resources and the highly technical nature of chemical risk assessment and management, still make it very difficult.

Chemical policy and regulation

Beyond risk assessment and management processes for specific chemicals, all jurisdictions also have broader stakeholder participation and risk communication processes for chemical policy and regulation. Notably, the development and passage of the CMP, TSCA and REACH legislation and amendments generated substantial public debate and hundreds of submissions from all types of stakeholders, leading to extensive discussions on the best way to design and enact the various regulations, showing the extent of stakeholder involvement in these regulatory discussions.

Another popular mechanism in all three jurisdictions are the scientific and technical committees that provide independent scientific advice and recommendations on technical considerations relating to risk assessments, methodologies, and pollution prevention measures and approaches for chemicals. To help with the implementation of REACH, ECHA established the Committee for Socio-Economic Analysis (SEAC) and the Committee for Risk Assessment (RAC) (ECHA 2021a, b). TSCA and CMP have similar mechanisms with the Science Advisory Committee on Chemicals (SACC) (US EPA 2021) and the CMP Science Committee respectively (Government of Canada 2013). These committees are generally comprised of a diverse group of science experts from academia, industry and government who have various areas of expertise relevant to implementation and oversight of the regulations. In Europe, other types of stakeholders such as NGOs can attend as observers in these committee discussions and are allowed to bring experts with them. Respondents stated that they could participate in these discussions and influence the outcomes if they were spending a lot of resources and the topic under consideration was a highly contested one (such as PFAS currently). Respondents further stated that all information discussed in these committees are under confidentiality agreements and not available to those that did not attend. As one NGO respondent in the EU commented:

I believe that we would all profit if the discussions of the technical committees were streamlined. That anybody could follow them from anywhere. These discussions and also the meetings where member states discuss the design, the final policy decisions. All this should be completely open to the public so you could follow the discussions and see the reasoning. I think that this complete transparency would end in better opinions. (NGO professional, EU)

In Canada and the USA these scientific committees do not appear to have the option to allow other stakeholders to attend. However, the CMP does have another committee called the Stakeholder Advisory Council (Government of Canada 2016b), which is a multi-stakeholder group that contributes to the implementation of the CMP. Its purpose is to provide stakeholders with the opportunity to offer advice and input on the implementation of the CMP, and to foster dialogue on issues pertaining to the CMP between stakeholders and government, and among different stakeholder groups (Government of Canada 2016b). The Council consists of indigenous groups, consumer groups, environmental NGOs, health NGOs, industry, and government representatives. It was often stated by our participants from all sectors to be an excellent mechanism to discuss important issues from a wide range of perspectives.

Finally, the scientific and technical committees are one of the only mechanisms that ensure the participation of academics in the process. Their presence in formal risk assessment and management processes was viewed positively by interview respondents who, nonetheless, often lamented that the involvement of the scientific community in chemical governance processes in general was limited in all jurisdictions. While the advice provided in these technical committees is useful, participants reported a preference to see more engagement of the scientific community in other processes given their considerable scientific, economic and social expertise that is often beyond the reach of other stakeholders.

Discussion

Despite the different regulatory frameworks in the three jurisdictions, stakeholder perceptions of the participation mechanisms did not differ greatly among our sample of expert participants. Although REACH appears to be a stricter regulation for industry, with more transparency and disclosure of information required than CMP and TSCA, in practice there have been complaints about the lack of information provided by applicants in authorisation dossiers, as well as concerns about withheld data and lack of transparency (Cohen 2011; Schaible and Buonsante 2012; Loonen et al. 2019). Even the shifted burden of proof and the precautionary principle upon which the regulation is based have been criticized as not working as they were designed in NGO submissions (Denison 2007; Schaible and Buonsante 2012; Loonen et al. 2019). Although interview results indicated that issues surrounding confidential business information are slowly improving, more work and political commitment is needed to ensure that REACH accomplishes its ambitious goals. In comparison, TSCA and CMP appear to be less strict on industry, so it is perhaps less surprising that interview respondents noted that participation, communication, and transparency is limited in those jurisdictions. NGO respondents in the USA further stated that there is little trust from the environmental community that the TSCA regulations are working in the public interest. That said, when it comes to broader chemical policy and regulation discussions, the CMP Stakeholder Advisory Council is probably one of the most comprehensive stakeholder participation and communication mechanisms that was seen to work quite well by all our respondents from Canada who were part of the committee. The technical committees under REACH that allow other stakeholders to attend as observers and bring experts with them also appears to work quite well, although it could potentially benefit from additional transparency measures, based on the perceptions of our participants. Other jurisdictions could consider experimenting with similar mechanisms.

While our respondents could see the benefits of broader stakeholder participation and communication in chemical risk assessment and management, they also mentioned barriers as to why this is not realized in practice. In all three jurisdictions, chemical risk assessment and management is heavily driven by scientific considerations, with limited formal attention given to contextual factors such as risk perceptions and social concerns. Accordingly, concerns related to stakeholders’ perceived inability to influence decisions and lack of communication appear common, which suggests that stakeholder issues are not fully understood in the risk governance process. As a result, we argue that each of CMP, TSCA and REACH could benefit from experimenting with seemingly under-utilized elements of the risk governance approach to enhance chemical risk governance. For example, including a ‘pre-assessment’ and a’concern assessment’ (see Fig. 1) could be particularly useful to the process. A ‘pre-assessment’ is generally done early to discover the relevance and interests of the stakeholders involved, the various dimensions of risks, the issues that are associated with the framing of risks, as well as the broader social, institutional, political and economic context (IRGC 2017). A ‘concern assessment' is done at the same time as the hazard and risk assessments and includes economic and social scientific assessments of the related concerns as well as the social and economic implications of risk (IRGC 2017). These two assessments aim to enhance the inclusion of socio-economic dimensions in the process, preventing decision-makers from neglecting key risks or concerns, and better understanding what kind of feedback the stakeholders are looking for to enhance the overall chemical risk governance process. A similar finding has also been discussed in a recent paper about the European REACH regulation conducted by researchers at the Dutch National Institute for Public Health and the Environment (RIVM) (Devilee et al. 2016).

Empirical work on risk governance and stakeholder participation has long been identified as a need by researchers (Rowe and Frewer 2004; Boholm et al. 2012; van der Vegt 2018), particularly in the context of chemical assessment, regulation and policy (Allen 2013; Chiapella et al. 2019; Drakvik et al. 2020). This paper provides an empirical contribution to these discussions and provides contemporary insights of relevance to decision-makers seeking to improve the effectiveness of the assessment, management and governance of chemicals in practice. Given that this was an exploratory study, further empirical work on chemical risk governance and stakeholder participation in different regulatory settings is needed. In particular, there is a need for more applied social scientists working in multidisciplinary teams to facilitate and evaluate policy experimentation with alternative risk governance processes, stakeholder participation mechanisms, and risk communication procedures in order to advance chemical risk governance objectives internationally.

Supplementary Information

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Biographies

R.G. van der Vegt

is a Postdoctoral Researcher at McGill University. His main research interest is to discover how complex multi-actor networks and processes dealing with collective decisions on demanding public risks to human health and the environment can be improved. He is also interested in the broader fields of innovation, sustainability and public policy.

Steven Maguire

is Professor of Strategy, Innovation and Entrepreneurship at the University of Sydney Business School, and Adjunct Professor of Chemistry at McGill University. His main research interest includes technological and institutional change driven by the emergence of new risks to human health and the environment. He is also interested in the broader fields of risk, innovation and chemicals management.

Doug Crump

is a molecular toxicologist at the National Wildlife Research Centre at Environment and Climate Change Canada. His research interests include avian ecotoxicology, the development of new approach methods to determine effects of priority environmental pollutants on birds, and the application of toxicogenomics approaches in priority ecosystems (e.g. Great Lakes, Arctic, Oilsands).

Markus Hecker

is Professor at the School of Environment and Sustainability, and Member of the Toxicology Centre, at the University of Saskatchewan. His research interests include the investigation of biological effects of environmental stressors; environmental risk assessment; aquatic ecology/fish biology; and the development and application of bioanalytical techniques to assess environmental pollution.

Niladri Basu

is Professor and Canada Research Chair in Environmental Health Sciences at McGill University. His research objective is to design, validate, and apply innovative and sustainable approaches to address the most pressing societal concerns over toxic chemicals in our environment. He is also interested in the broader fields of environmental science and public health.

Gordon M. Hickey

is Professor and William Dawson Scholar at McGill University. His research seeks to advance the sustainable governance of complex natural resource management systems at a range of scales. He is also interested in the broader fields of innovation, sustainability and public policy.

Author contributions

Conceptualization, RGVDV, GMH, and SM; Investigation, RGVDV; Formal Analysis, RGVDV; Writing – Original Draft, RGVDV; Writing – Review & Editing, RGVDV, GMH, SM, DC, MH, and NB; Funding Acquisition, GMH, SM, DC, MH, and NB; Supervision, GMH, and SM.