Case Study Chemical Pollution
Transcription
Case Study Chemical Pollution
RISKGOV report RISKGOV Report ‘Hazardous Substances: a Case Study of Environmental Risk Governance in the Baltic Sea Region’ Deliverable number: 5 Reporting Period: January 2010 to December 2010 Names and affiliation of participants Oksana Udovyk, Louise Rabilloud, Michael Gilek, Mikael Karlsson Södertörn University, School of Life Sciences, SE141 89 Huddinge, SWEDEN RISKGOV report Table of Content Summary ............................................................................................................................... 3 Acronym List ........................................................................................................................ 5 Aims and Scope ..................................................................................................................... 7 General Background .............................................................................................................. 8 Materials and Methods .......................................................................................................... 9 1. Working Package 1 – Governance Structures ............................................................... 10 1.1. Actors in the Baltic Sea Region .................................................................................. 11 1.2. Regulatory Framework in the Baltic Sea Region......................................................... 16 1.3. Discussion .................................................................................................................. 22 2. Working Package 2: Assessment – Management Interactions ....................................... 25 2.1. The Organisation and Type of Risk Assessment Activities ...................................... 26 2.2. Generation and Evaluation of Management Options ................................................ 31 2.3. Assessment and Management Approaches for Dealing with Scientific Disagreement and Uncertainty................................................................................................................. 33 2.4. Ecosystem Approach to Management...................................................................... 38 2.5. The Role of Science ................................................................................................ 40 2.6. Discussion .............................................................................................................. 42 3. Working Package 3 – Stakeholder Communication ...................................................... 44 3.1.Risk Framing............................................................................................................... 45 3.2.Institutional Risk Communication and Public Participation ......................................... 47 3.3.Discussion ................................................................................................................... 54 Annex I. List of Interviews .................................................................................................. 67 Annex II. Governmental and non-governmental Organisations and Networks ....................... 68 Annex III. Major Governance Structures and actors .............................................................. 77 Annex IV. Timelines of regulatory framework development ................................................ 78 2 RISKGOV report Summary This report aims to describe and analyse the structures and processes that shape risk governance of hazardous chemicals in the Baltic Sea area and, based on this, discuss conditions and opportunities that could improve chemical risk governance. With this purpose in mind we have analysed the risk governance of hazardous chemicals along three dimensions and Work Packages (WP): governance structures (WP 1), risk assessment-risk management interactions (WP 2) and stakeholder communication (WP 3). The report is an initial outcome of the RISKGOV project, in which risk governance in various areas eventually will be compared in order to gain new insights on environmental risk governance and to extract policy-relevant advise on how to better deal with environmental risks in the Baltic Sea context. The report is based on a study of key documents treating policies and risks, 22 semi-structured in-depth interviews with stakeholders conducted in the period February–October 2010, as well as participatory observations at scientific conferences and stakeholder meetings. WP 1 identifies the most important risk governance structures, and maps actors and regulations. In particular, it is concluded that development at the EU and HELCOM level are of main importance for the management of chemicals in the Baltic Sea region. Thus, actors within the EU and HELCOM, as well as regulations within EU – most notably the Water Framework Directive (WFD), the Marine Strategy Framework Directive (MSFD), and the REACH regulation – and regulations and recommendations dealt with by HELCOM – in particular the Baltic Sea Action Plan (BSAP) – were identified as crucial for further analyses in WP 2 and WP 3. Although we recognise the importance and the substantial improvements that have been made in chemical regulation within the EU and HELCOM, these developments are not sufficient in order to meet key objective at hand, nor do they adequately manage relations with Russia. WP 1 concludes that, although there are numerous of national and international regulations creating a massive web of regulations, existing chemical regulation and informal governance structures are very far from covering all existing chemical risks (especially new chemicals and mixtures of chemicals) and to allow for a sufficient extent of safety. Care must be taken in the development of new regulations to promote synergies and data exchange rather than causing further barriers, overlaps and conflicts that could reduce the efficiency. Innovative policy developments, as well as improved international collaboration, are therefore needed, which will be placed in focus in further studies within the RISKGOV project. WP 2 focuses on an in-depth understanding of the interactions between risk assessment and risk management of chemicals. The main assessment and management activities in the Baltic Sea region are identified and analysed. It is concluded that assessments commonly are based on a rather technocratic separation of assessment and management activities (with often unclear strategies for bringing these activities together in decision-making). Assessments also generally suffer from lack of data, insufficient harmonisation of methodology, as well as unclear strategies for assessing uncertainties and adjusted communication of assessment results. Consequently, assessments would benefit greatly from more harmonised assessment methodologies, not least for chemical mixtures, ecological effects as well as methods for integrating various lines of evidence. Both assessment and management might benefit from increased stakeholder participation. Furthermore, we have analysed risk assessment and management interactions through the prisms of uncertainty and the Ecosystem Approach to Management (EAM). These aspects have become top challenges for the assessment and management of chemical risks as well as for coping with science-policy interactions connected with the governance of chemical risks. We conclude that the enormous knowledge gap (for most chemicals, for the risks of chemical mixtures, for ecosystem-specific risks etc) need to be addressed by combining increased efforts on data and knowledge production with better ways of assessing, communicating and managing uncertainty. Hence, a main question is how much evidence is needed for motivating decision-making on risk reduction. This is a 3 RISKGOV report policy-related issue, not a scientific one. However, science does need to develop and implement improved methodology for assessing and communicating uncertainty to relevant stakeholders. On the management side, the precautionary principle is increasingly stipulated for coping with uncertainty. In spite of that, there is no consensus on the exact implementation of the principle in practice, and regulations such as REACH, the WFD, the MSFD and the BSAP ought to be developed on this point. Risk reduction is needed and motivated even, or even particularly, under uncertainty. Looking at the EAM, the approach is clearly receiving increase attention (e.g. in the BSAP and the MSFD), but only partially in the field of chemical regulation and concrete measures. So far, it is therefore not certain that the EAM will substantially improve risk management in cases of high uncertainty. On the contrary, requirements on implementation of the EAM may stall measures and increase complexity. These initial insights will be further developed in coming RISKGOV publications. WP 3 describes and analyses how risks of hazardous chemicals are framed by key actors and stakeholders in the Baltic Sea region, such as governments, agencies, regionally intergovernmental agencies such as HELCOM, economic actors, academia, and civil society. It is shown that different actors have different ways of framing the risk of chemicals in the Baltic Sea. For example, differences were observed along a gradient spanning from framing chemicals and chemical products as basically useful for society, to framing chemicals as substantial threats to the environment and human health. Most interviewed stakeholders could be placed somewhere in the middle of this gradient between benefit and cost. This is reflected in the dominant opinions expressed on required general management approaches, which do not fundamentally question abundant production of chemicals, but rather suggest a focus on managing chemicals with proven hazardous properties, thus tilting towards a market rather than an environmental starting point. This view on chemical risk management is rather surprising given the major uncertainties and lack of data described in WP 2. In light of this we propose that the management of chemicals might benefit from a shift towards seeing quality of life as based on sufficiency of chemicals rather than on (over)-abundance of them. Many of the interviewed stakeholders (e.g. politicians, journalists and NGO staff) also expressed a surprising lack of interest in the environmental risks of hazardous chemicals in the Baltic Sea region. If concern mostly expressed was health risks of chemicals. It is also clear that besides some NGOs and other stakeholders, quite few have a primary focus on taking initiatives for improving the management of chemicals, something that is a problem given the common political ambitions to increase participation in connection with implementation of the EAM. WP 3 also analyses existing institutional arrangements for and procedures of risk communication at the regional Baltic Sea level. Clearly, communication between the EU and Russia is still in need of improvement, as is two-way communications and cooperation between stakeholders, as well as between actors connected with risk assessment and risk management and the general public. For example, in those (rare) cases when scientific information about chemicals does exist, it is not well communicated among knowledge producers and stakeholders, and current scientific assessment activities seldom relate directly to concerns of stakeholders or the public. In conclusion our initial analysis and conclusions show that risks of chemicals are rather dealt with by traditional risk-based governmental strategies, than by broad environmental governance, based on precaution and the ecosystem approach to management. Furthermore, there are no clear strategies or guidelines on how to cope with uncertainty in assessment and management. As a result, even though there is a growing scientific capacity to develop new chemicals, there is at present no well functioning system for their safe management. We will address these challenges further in future RISKGOV publications. 4 RISKGOV report Acronym List ALARP BSAP As Low As Reasonably Practicable principle Baltic Sea Action Plan of HELCOM BSS Baltic Sea Strategy of EU CBI Confidential Business Information CCB Coalition Clean Baltic CEFIC the European Chemical Industry Council CLRTAP Convention on Long-Range Transboundary Air Pollution COHIBA HELCOM project on control of hazardous substances in the Baltic Sea region COMMPS Combined Monitoring-based and Model-ling-based Priority Setting scheme CSA Chemical Safety Assessment (in REACH) EAM Ecosystem Approach to Management ECHA European Chemical Agency EP European Parliament EU The European Union GHS Globally Harmonized System of Classification and Labelling of Chemicals HELCOM The Helsinki Commission, under the Helsinki Convention ICES The International Council for the Exploration of the Sea ILO International Labour Organization MP Maritime Policy MSFD Marine Strategy Framework Directive NGO Non-Governmental Organizations OSPAR The Convention for the Protection of the marine Environment of the North-East Atlantic PBT Persistent, Bioaccumulative, and Toxic PIC Prior Informed Consent POP Persistent Organic Pollutants 5 RISKGOV report PSSA Particularly Sensitive Sea Areas RBD River Basin District REACH Registration, Evaluation, Authorisation and Restriction of Chemicals SAICM Strategic Approach to International Chemicals Management SSNC The Swedish Society for Nature Conservation TGD Technical Guidance Document of EU for risk assessment of the chemicals UN United Nations UNCED United Nations Conference on Environment and Development WFD Water Framework Directive WHO World Health Organization WWF Worldwide Fund for Nature 6 RISKGOV report Aims and Scope The aim of this case study is to analyse the major regulatory frameworks for hazardous chemicals, chemical policies and norms as well as the forms of decision-making, consultation, interaction and stakeholder involvement and communication in the Baltic Sea connected with chemical risks. We also aims at developing in-depth understanding of the interactions between chemicals risk assessment and risk management, how uncertainties and the ecosystem approach to management (EAM) are understood and handled, as well as how management options are generated and evaluated. Finally, we analyse how chemical risk issues are framed and communicated, as well as the role of communication in chemical risk governance. The study is focused on the regional Baltic Sea level, in contrast with most previous studies, which have often focused on either national or transnational levels, or on identifying rational and optimal management strategies. This regional approach is especially important given the growing recognition of the EAM (which for example entails an international regional watershed perspective on environment), as well as the ongoing partial regionalisation of for example environmental policy within the EU. While focusing on the Baltic Sea region, we recognise the existence of two main regulatory arenas area, namely the EU and Russia, the latter being the only non-EU member country bordering the Baltic Sea. It was decided to exemplify the national level within EU with Sweden, and outside the EU with Russia. These national examples were mainly chosen to illustrate the interactions between national and regional levels, not to develop in-depth comparisons of individual countries. The main focus of the study is on manufactured chemicals, in particular so-called industrial chemicals. This group of chemicals constitutes the major bulk of chemicals used in society. Some pesticides, biocides and pharmaceuticals are mentioned, but particular legal control on them is not covered in detail. The study is structured in three Work Packages (WP): WP 1 (Governance Structures) focuses on the regional governance scale and on central national and international risk management measures. The study begins with a broad description of the most important regulatory actors and bodies, central conventions and regulations, action plans as well as governmental and non-governmental networks, collaborative patterns and other structures and institutions influencing governance at different levels. WP 2 (Assessment-Management Interactions) includes an analysis of the organisation and content of risk assessment activities connected with hazardous chemicals in the Baltic Sea and other relevant levels, such as the EU. The package focuses on assessment and management approaches, and their interactions, for dealing with scientific disagreements and uncertainty. Special attention is given to the issues of generation and evaluation of management options. This package in total thus focuses on double-sided science-policy interactions. WP 3 (Stakeholder Communication) includes an analysis of how chemical risks are framed by key actors and stakeholders in the Baltic Sea area, as well as an analysis of existing institutional arrangements and procedures for chemical risk communication in the region. 7 RISKGOV report General Background Since the mid of the last century the production of chemicals and their application in medicine, agriculture, industry and in many other areas have increased tremendously. While increasing in production and use, chemicals have also become responsible for adverse impacts on human health and the environment (Gebel et al, 2009). Problems connected with chemical pollution have become acute in the Baltic Sea the last decades. Being a relatively young water body, constituting a semi-enclosed shallow sea with a large catchment area, with a very special marine and coastal environment, the Baltic Sea is very sensitive to the impact of pollution (Ducrotoy and Elliott, 2008). In spite of this, the 85 million people living in the fourteen-country catchment area have since a long time extracted resources from the Baltic Sea (Ducrotoy and Elliott, 2008). Municipal waste water, agricultural leakage and other sources have loaded the sea with phosphorus and nitrogen (Savchuk et al., 2008), which together with intensive fishing and changing climate have contributed to ecosystem regime shifts in some sub-basins (Österblom et al, 2010). Presently, the most severe environmental problems include eutrophication, overfishing, biodiversity loss, climate change and oil pollution, as well as the problem in focus of our case study – the contamination by hazardous chemicals (SEPA, 2005). Many toxic and persistent man-made substances, such as PCBs, DDT, polychlorinated camphenes, and polychlorinated terphenyls (PCTs), have found their way into the Baltic Sea (HELCOM, 2010). Many harmful substances have been detected in Baltic Sea biota like chlorinated terpenes, halogenated paraffins, polyaromatic hydrocarbons (PAH) and chlorinated pesticides, such as chlordane and dieldrin (HELCOM, 2010). Human activity is also responsible for the increase of certain natural substances in the Baltic Sea, such as nutrients (phosphorus and nitrogen compounds), heavy metals and hydrocarbons. According to HELCOM (2010), the inputs of some hazardous substances to the Baltic Sea have declined over the past 20 to 30 years. In particular, the discharges of heavy metals have decreased significantly. As a result, we can observe the recovery of populations in Baltic Sea wildlife such as white-tailed eagle and grey seals. However, DDT, PCBs, dioxins and other old contaminants are still found in elevated concentrations in the Baltic ecosystem and the causes and sources of many of these are still not sufficiently known. Looking at most other chemicals, and in particular at new and emerging chemical contaminants, very little information is available on sources, environmental concentrations and environmental risks. In spite of decreasing environmental concentrations of several chemicals, and linked indications of improving health status of some top predators, the latest HELCOM integrated thematic assessment of hazardous substances in the Baltic Sea concludes that almost all assessed open sea and coastal areas have an environmental status implying “Baltic Sea with life disturbed by hazardous substances” (HELCOM, 2010). Moreover, the levels of some substances are so high that for example responsible Swedish authorities recommended women in fertile age, with respect to health risks for their children, to be very restrictive in their consumption of some fatty fish species such as salmon and herring (SNFA, 2008). Thus, there are still challenges connected with the governance of health and environmental risks posed by chemicals. 8 RISKGOV report Materials and Methods In this study, data was collected through in-depth stakeholder interviews and other oral information; together with reviewing documents, reports and publications from different sources. Semi-structured interview with open-ended questions was used for this study. The method of in-depth interviews was chosen before surveys to provide an in-depth knowledge about the issue. While understanding that analysis of in-depth interviews is rather time intensive and often involves a small number of respondents, this type of interviews enables discovery of issues and perspectives that could not be fully covered by other methods such as questionnaires. The respondents consisted of individual actors, persons from related branches of HELCOM, national and EU authorities, scientists, politicians and journalists. A total of 22 interviews were conducted during March – October 2010 (see the interviews list in the Annex I). Participatory observations were also made during relevant conferences, meetings, workshops and discussions. This allowed a deeper exploration of the topic and gave the opportunity to cross-check data that was collected through interviews. Observations were made at the following events: Conference on the theme “Coping with Uncertainty”. Stockholm, Sweden, November, 2009 (arranged by RISKGOV). “Brainstorming” roundtable discussion with key stakeholders on the topic “Scientific Uncertainty, Precaution and the Implementation of the Ecosystem Approach to Management for the Baltic Sea”. Stockholm, Sweden, March, 2010 (arranged by RISKGOV). The 4th Stakeholders’ Day of the European Chemicals Agency. Helsinki, Finland, May, 2010. The International Chemicals Forum. Helsinki, Finland, May, 2010. HELCOM Ministerial seminar “Building marine policy on best available knowledge”. Stockholm, Sweden, August, 2010. The document and literature studies were based on policy documents, peer-reviewed journals, papers and reports as well as publications from regional governmental and nongovernmental bodies. Mainly we focused our studies to EU and HELCOM related policies and regulatory documents; EU: The Water Framework Directive (WFD), the Marine Strategy Framework Directive (MSFD) and the REACH regulation; together with several technical risk assessment documents. HELCOM: The Baltic Sea Action Plan (BSAP) under the Helsinki Convention, several relevant official recommendations, technical documents for monitoring and assessment, current relevant assessment reports. The main method for WP 1 and WP 2 was literature and document analysis, although a few selected interviews with experts and respondents from key bodies also provided a fruitful complement. In the WP 3 framing analysis, “frames” was used as a heuristic instrument for analysing stakeholders’ perspectives and perceptions, keeping in mind that these frames can be explicit or rather implicit. The frame analysis of WP. 3 was based on three main sources: literature and document research including analysis of documents of stakeholder selfrepresentations; qualitative, semi-structured interviews (following an interview guide) with key stakeholders (inter)-governmental organisations, public authorities, scientific institutions/academia, economic actors and NGOs. participatory observation 9 RISKGOV report 1. Working Package 1 – Governance Structures SUMMARY WP 1 identifies the most important risk governance structures, and maps actors and regulations. In particular, it is concluded that development at the EU and HELCOM level are of main importance for the management of chemicals in the Baltic Sea region. Thus, actors within the EU and HELCOM, as well as regulations within EU – most notably the Water Framework Directive (WFD), the Marine Strategy Framework Directive (MSFD), and the REACH regulation – and regulations and recommendations dealt with by HELCOM – in particular the Baltic Sea Action Plan (BSAP) – were identified as crucial for further analyses in WP 2 and WP 3. Although we recognise the importance and the substantial improvements that have been made in chemical regulation within the EU and HELCOM, these developments are not sufficient in order to meet key objective at hand, nor do they adequately manage relations with Russia. WP 1 concludes that, although there are numerous of national and international regulations creating a massive web of regulations, existing chemical regulation and informal governance structures are very far from covering all existing chemical risks (especially new chemicals and mixtures of chemicals) and to allow for a sufficient extent of safety. Care must be taken in the development of new regulations to promote synergies and data exchange rather than causing further barriers, overlaps and conflicts that could reduce the efficiency. Innovative policy developments, as well as improved international collaboration, are therefore needed, which will be placed in focus in further studies within the RISKGOV project. 10 RISKGOV report 1.1. Actors in the Baltic Sea Region “There is a great number of actors involved in the management of chemicals. Sometimes it looks to be so dense and complex, like a spider web”- expert from the academia Governmental Organisations and Networks International Actors The problems associated with chemicals are of concern to the global population. Thus the management of chemicals is addressed in a number of international organisations, including UN organisations, treaties, and programmes. The main UN body directly dealing with chemicals in the environment is the United Nations Environment Programme (UNEP). It delivers policy and technical assistance for the sound management of chemicals. For example, UNEP Chemicals programme builds and strengthens partnerships with governments, organisations (like OECD), and non-governmental organisations. It also works closely with agencies within the UN family (see Annex II) and the secretariats of the Basel, Rotterdam and Stockholm conventions on chemicals and wastes. A good example of this cooperation is an introduction of the Strategic Approach to International Chemicals Management (SAICM)1, as a policy framework to foster the sound management of chemicals (UNEP web, 2010). See more about these organisations in Annex II. The EU Actors Today, EU environment legislation is a result of co-decision between the Council and the European Parliament, on basis of proposals from the Commission. The ministerial Council represents Member States and is commonly the most powerful actor. The power of the European Parliament has increased over time and it is a central actor for not least environmental protection and chemicals policy. The European Commission is responsible for drafting new legislation and in our case, DG Enterprise and DG Environment are the most central actors. DG Enterprise can be seen as an actor supporting chemicals development and trade (Pesendorfer, 2006), while DG Environment puts much attention on chemicals safety concerning environment and human health (Hey, 2000). In fact, not only DG Environment but also the environmental ministers from the Northern European states (including Denmark, Finland, Germany, the Netherlands and Sweden) are often actors supporting environmental protection. They dominated the initial discussions on revising EU chemicals law (Selin, 2007; Andersen and Liefferink, 1999). Other important actors are national economic affairs departments and political leaders of several EU members with large chemical industries (e.g. France, Germany and the UK). They may support the development of chemicals trade and industry even though their environmental ministers may express strong opposition and vice versa (Selin, 2007). Selin (2007) gave the example of the British Prime Minister, the French President and the German Chancellor opposing the “environmentalisation” during the negotiations on a new chemicals legislation (eventually called REACH), stating that that a new REACH policy must not endanger the competitiveness of the European chemical industry. Other important actors in EU chemical policy include the European Chemicals Agency (ECHA), the Scientific Committee on Health and Environmental Risks (SCHER), the Joint Research Centre (JRC) and The European Environmental Agency (EEA). ECHA manages the registration, evaluation, authorisation and restriction processes for chemical substances (ECHA web, 2010). SCHER provides advice to the Commission on issues related to risks of chemicals that may have negative impact on human and environmental health. The Committee 1 See more about SAICAM on http://www.saicm.org. 11 RISKGOV report also addresses questions relating to methodological aspects of the assessment of health and environmental risks of chemicals. JRC provides scientific and technical support for the development, implementation and monitoring of EU policies and thereby often as a reference centre for science and technology for the Union (JRC web, 2010). The EEA is also an important actor in EU environmental reporting and monitoring. By commissioning studies on certain topics, the EEA has the possibility to influence policy evaluation, agenda-setting and policy formulation (EEA web, 2010). Regional Actors Within the Baltic Sea regional actors, the most influential one is HELCOM, set up under the Helsinki Convention (Helsinki Convention, 1992), which has been working to protect the marine environment of the Baltic Sea from all sources of pollution, including hazardous chemicals for more than 30 years. It consists of delegates from all 10 Parties (9 countries bordering the Baltic Sea and European Union). The main decisions are made at the ministerial meetings every year. The work of the Commission is currently carried out by 5 Groups (see Fig. 1.1). HELCOM LAND, which is one of the delegations, mainly deals with chemicals issues. Most of the day-to-day HELCOM activities are highly scientific and technology intensive work. Participants in the various HELCOM sub-groups generally have specialised scientific and technological education and professional experience (HELCOM web, 2010). Figure 1.1 HELCOM structure (HELCOM web, 2010) Several countries that belong to HELCOM are also members of OSPAR. The OSPAR Convention guides international cooperation on the protection of the marine environment of the North-East Atlantic from, for example, chemicals pollution. However in light of recent developments in EU environment policy (e.g. the Water Framework Directive (WFD), the Marine Strategy Framework Directive (MSFD)), OSPAR’s work on the selection and prioritisation of substances has been put on hold and it now focuses to collaborate with the EU (OSPAR web, 2010). Another governmental regional actor is the Council of the Baltic Sea States (CBSS). It is an overall political forum for guidance and coordination for regional inter-governmental cooperation. One of CBSS’ missions is to contribute to a sustainable Baltic Sea region by providing a platform for the members as well as acting as a bridge between stakeholders. However, the role of the CBSS in chemicals management in the Baltic Sea is rather limited (CBSS web, 2010) Sub regional to sub national level It is also possible to identify important actors at a sub-regional level. The special authorities (river basin authorities) for the management of river basins were created with the introduction of the WFD. The rivers can be either transboundary (in this case the authority may be international) or national (in this case the authority is national or sub national) (Nilsson and 12 RISKGOV report Langaas, 2006). There are 13 international and several national river basin districts (RBD) in the Baltic Sea drainage area (see Fig. 1.2). Figure 1.2 RBDs, the 13 international RBDs highlighted (dark blue) (Nilsson and Langaas, 2006) National Actors Although many aspects of chemical policies are regulated at the EU level, individual Member States still do have the authority in many areas, for example concerning implementation, supervision, taxation, and in softer policy options such as assistance to industry (Kern, 2004). Thus, it is worth looking at national examples, here, from Sweden, as an EU member, and Russia. Swedish Actors The main Swedish political actor dealing with chemicals in the Baltic Sea is the government with the Ministry of the Environment. The health of the Baltic Sea is prioritised and the parliament has decided 16 environmental quality objectives and to reach “a Non-Toxic Environment” is one of them. The Swedish Chemicals Agency (Kemi), as the central implementing and supervisory authority under the Ministry of the Environment, has responsibility for the goal of “a NonToxic Environment”. It supervises importers and manufacturers of chemical products and articles and supports the supervision of chemicals by municipalities and county administrative boards. Kemi is also responsible for e.g. implementing and enforcing REACH in Sweden and assists in developing and implementing international conventions (KEMI web, 2010). Another important actor is the Swedish Environmental Protection Agency. It is the national agency for environmental protection and nature conservation as well as outdoor recreation and hunting issues. Among its key task are to present proposals for environmental policy and legislation to the government and to ensure that much of environmental policy (Swedish EPA web, 2010). In 2005 Sweden adopted a new National Marine Policy as part of the work with the Marine Strategy for the European Union. The main goal of this strategy is “a sea in balance, and living coastlines and archipelagos” (Naturvårdsverket, 2006). According to interviewees, new 13 RISKGOV report marine authority that, preliminary will be responsible for the marine environment and its resources, will be developed. This will change the existing actors’ structure for Sweden. Russian Actors The key authority responsible for formulating and implementing the environmental policy including chemicals in Russia is the Ministry of Natural Resources and Ecology (MNRE web, 2011). The Ministry performs state policy formulation as well as normative and legal regulation in relation to the use and protection of natural resources. The Ministry has five agencies under its supervision, where three of them are working with chemicals in water bodies. These are: The Federal Supervisory Natural Resources Management Service (FSNRMS web, 2011), which ensures environmental and economic security of Russia. The main tasks of the agency are the detection, suppression and prevention of crime associated with illegal and unsustainable use of natural resources, with negative impacts on the environment. The Federal Water Resources Agency (FWRA web, 2011) is a federal executive body performing the functions related to rendering State services and federal property management in the sphere of water resources. Federal Environmental, Industrial and Nuclear Supervision Service (RTN web, 2011) is the supervisory body dealing with ecological, technological and nuclear issues. Its functions include the passage of regulatory legal acts, supervision and oversight in the field of environmental protection. There are several regional units of RTN that coordinate the annual storage, disposal and management of hazardous waste; discharges of wastewater, and air emissions. The North-West regional unit of RTN (RTNN web, 2011) covers the area of the Baltic Sea. Non-Governmental Organisations and Networks International level There are several non-governmental organisations and networks dealing with chemicals at an international level. The International Council of Chemical Associations (ICCA) is the largest world-wide organisation, representing 80 percent of global chemicals industry. ICCA is also the main channel of communication between the industry and various international organisations that are concerned with health, environment and trade-related issues (ICCA web, 2010). Environmental measures have for a long time been promoted by international environmental NGOs such as Greenpeace, Friends of the Earth (FoE) and the Worldwide Fund for Nature (WWF). The newly established NGO ChemSec, the International Chemical Secretariat is actively working towards a toxic-free environment (ChemSec web, 2010). These NGOs have staff resources to e.g. employ own policy advisers and communicate frequently with policymakers and the public. None the less, as most actors, green NGOs focus their work mainly quite few hazardous chemicals (Pesendorfer, 2006). A new and science-based actor under development is the International Panel on Chemical Pollution (IPCP). It aims to collect scientific knowledge about chemical pollution problems and provide summaries and interpretations of the available knowledge for decision-makers and the public (IPCP web, 2010). Another central scientific actor is the International Council for the Exploration of the Sea (ICES), which since long coordinates and promotes marine research on e.g. the marine environment, and living marine resources. Besides summarising existing scientific knowledge and aiming to fill knowledge gaps, ICES actively gives sciencebased advice. ICES has, for example, a specific Marine Chemistry Working Group (MCWG) which deals with hazardous chemicals in the marine environment (ICES web, 2010). 14 RISKGOV report EU level The European counterpart to ICCA is the European Chemical Industry Council (CEFIC). Acting as an umbrella organisation, CEFIC has gathered numerous sector groups and affiliated associations. CEFIC represents its member toward various organisations and has established working relations and networks with EU institutions and all important actors (CEFIC web, 2010). There are a number of other organisations representing business. Many of these organisations mainly or exclusively exist to influence politics. An example of this is the Downstream Users of Chemicals Co-ordination group (DUCC), founded in 2001 (DUCC web, 2010). The strongest supporters of a more protective chemicals policy within the EU are environmental non-governmental organisations, among them the European Environmental Bureau (EEB web, 2010), Greenpeace Europe (Greenpeace web, 2010), WWF Europe (WWF web, 2010), Friends of the Earth Europe (FoE web, 2010) and so on,, as well as a large number of other smaller NGOs (Pesendorfer, 2006 and Selin, 2007). Regional level (Baltic Sea level) There are several NGO at the Baltic Sea level. Among them is Coalition Clean Baltic (CCB). It unites 26 member organisations from Finland, Russia, Estonia, Latvia, Lithuania, Poland, Germany, Denmark and Sweden. The main goal of CCB is to promote the protection and improvement of the Baltic Sea environment and natural resources. CCB’s activities concerning hazardous substances focus primarily on point sources (CCB web, 2010). Some activities made by the Baltic Sea Action Group (BSAG web, 2010) operate throughout the entire Baltic Sea area. It is an independent foundation that does concrete work in relation to the Baltic Sea environment and aims to accelerate the implementation of HELCOM’s Baltic Sea Action Plan. Another NGO is the Union of the Baltic Cities (UBC) with a network of 100 member cities from ten Baltic Sea countries. (UBC web, 2010). The scientific development in the Baltic region is promoted by BONUS Baltic Organizations' Network for Funding Science (BONUS EEIG). It is a newly established independent organisation that funds research in the area. Its members are either funding agencies, or organisations managing national funding allocations for the joint calls under the Joint Baltic Sea Research Programme (BONUS web, 2010). It is worth to mention that this report is also supported by BONUS. National level Swedish NGOs In Sweden, environmental organisations have been working with chemical hazards for a long time. The Swedish Society for Nature Conservation (SSNC) founded in 1909, picked up on environmental risks of chemicals, in particular pesticides, already in the 1950s (SSNC web, 2010). Today SSNC works with, for example, campaigns on hazardous substances, such as brominated flame retardants, with the purpose of both achieving national phase-outs and communicating perceived shortcomings of EU chemicals policy (see Eriksson et al. 2010b). The Swedish branch of Greenpeace is also active in the chemicals area and WWF Sweden works on e.g. the Baltic Sea environment (Greenpeace web, 2010 and WWF web, 2010). The NGOs commonly collaborate on policy issues. In particular SSNC also carries out surveys on the content of hazardous chemicals in products, such as toys, textiles, hygiene products, shoes and sunscreens with the purpose of initiating debate and stricter regulation. 15 RISKGOV report Russian NGOs The environmental movement, as any other NGO movements, was not very developed during the USSR time (Shulenina, 2003). It was not until the late 80s as a civil society environmental movement developed. Today, there are several Russian NGOs dealing with environmental protection of the Baltic Sea. Among them there is the Green World (GW web, 2011) which is working on saving the coast of the Gulf of Finland. Another NGO, the Ecology and Business (EB web, 2011) is working to promote the implementation of programmes, projects and decisions of HELCOM, as well as providing information to all interested parties about the activities of the Helsinki Commission. Friends of the Baltic (FB web, 2011) works with environmental problems in the area of St. Petersburg as well as in small towns and villages on the South and North shores of the Gulf of Finland. The Russian branch of Greenpeace and WWF are also active in the chemicals area (Greenpeace web, 2010 and WWF web, 2010). 1.2. Regulatory Framework in the Baltic Sea Region “I see that international cooperation around the Baltic is improving. All existing regulations WFD, MSFD, EU BSS and HELCOM BSAP are good tools for cooperation. The only way we can go forward is by cooperation.” –Respondent from authority International regulatory framework The international community has been engaged in continuous cooperation on hazardous chemicals since the 1960s (Selin, 2009) (see Annex IV). However, mainly domestic regulations regarding chemicals use existed at that time (Perrez, 2006). After the United Nations Conference on Environment and Development in Rio (UNCED), regulatory and policy action relating to chemicals became more international and many international organisations started to cooperate, for example the Programme for the Sound Management of Chemicals (IOMC) between UNEP, ILO, OECD and others. However, rather than addressing all chemical management issues under a single treaty, agreements are quite specific and numerous (Buccini, 2004). Within this growing amount of international initiatives, Selin (2009) distinguishes four main international treaties – the Basel Convention, the Rotterdam Convention, CLRTAP and the Stockholm Convention – which create a framework for “life cycle management” by together covering major elements “from cradle to grave”. A summary, inspired by Selin (2009), is presented in the following table: Table 1.1 Summary of the four main international chemicals treaties Name Description Webpage The Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal 1992 The Rotterdam Convention 2004 Covers hazardous wastes that are explosive, www.basel.int flammable, poisonous, infectious, corrosive, and toxic or ecotoxic. The aim of the convention is to control every step in the chain management of the chemical: from the generation to the disposal. Covers pesticides and industrial chemicals that have been banned or severely restricted for health or environmental reasons by the parties. The objectives are for the parties to share responsibility and efforts on the specified 16 www.pic.int RISKGOV report The Convention on Long-Range Transboundary Air Pollution (CLRTAP) 2003 Stockholm Convention on Persistent Organic Pollutants 2004 hazardous chemicals. This is done by improved exchange of information among countries about imports and exports. Identifies 16 POPs in a POP protocol. Some of the substances are banned, others need to be eliminated and reduced. www.unece.or g Identifies 21 POPs that need to be illuminated to www.pops.int protect human health and the environment. These substances are required to be eliminated, restricted in production or their unintentional releases need to be reduced. However, this web of regulations still does not cover more than a small amount of the chemicals in use in society. Some are of the opinion that the numerous efforts taken by international forum and organisations are not sufficient to solve global chemical problems (Krueger and Selin, 2002). Others, although agreeing on the needs for improved international chemicals regulation, instead argue that an extensive number of international agreements might create a risk for overlaps and conflicts as well as a lower degree of implementation (Bengtsson, 2010). A greater problem than the amount of regulations, though, is the true or perceived conflicts that may arise between objectives and operation of interrelated policies or between chemicals policy and policy in other areas (e.g. competitiveness). To cope with the first, of these challenges by promoting regulatory and management synergies, many actors worked for the establishment of increasingly important SAICM (Strategic Approach to International Chemicals Management). Furthermore, recently an Ad Hoc Joint Working Group (Ad Hoc web, 2011) to enhance cooperation under the Basel, Rotterdam, and Stockholm Conventions was created (Perrez, 2006). Parallel to this, the development of a globally harmonised system for classification and labelling of chemicals (GHS) has been completed (GHS web, 2011). When looking specifically at the Baltic Sea, the countries bordering the sea have ratified different conventions and are members of different organisations (see Table 1.2). This creates a rather complex regulatory system in the Baltic Sea. Table 1.2. Membership of Baltic Sea countries in the EU and HELCOM, and ratification of the OSPAR Convention, the CLRTAP, the Stockholm Convention, the Basel Convention, and the Rotterdam Convention (inspired by Selin, 2009) Sweden Finland Demark Germany Poland Estonia Lithuania Latvia Russia EU + + + + + + + + HELCOM + + + + + + + + + OSPAR + + + + CLRTAP + + + + + + + + Convention ratified, not e.g. the POP protocol Stockholm + + + + + + + + Signed but not yet ratified Basel + + + + + + + + + Rotterdam + + + + + + + + The complexity is also increased by the fact that different hazardous substances have been prioritised differently in different international forum (Selin and VanDeveer, 2004). In general, better coordination of regulations and management across treaties would also make it easier for parties to meet their commitments. HELCOM is the only international forum that 17 RISKGOV report unite all of the countries of the region. This means that it might play an important role in the coordination of countries around the Baltic Sea. However, HELCOM’s limited power (i.e. recommendations are not binding) might be a barrier to efficient management of chemical risks in the Baltic Sea. The EU regulatory framework EU chemical policies have gradually developed since the 1960s (Karlsson, 2010see also Annex IV). Due to a lack of data, high complexity and controversies, a new regulation was developed - REACH (Registration, Evaluation and Authorization of Chemicals) in order to cover most manufactured industrial chemicals. It became one of the largest pieces of the EU legislation and entered into force in June 2007. A major part of REACH is the requirement for manufacturers or importers of substances (in volumes more than 1 tonne per year and manufacturer or importer) to register their substances by providing a chemical dossier to the European Chemicals Agency (ECHA). This is an important part of REACH, which implies that data to promote safe use of chemicals must be provided by the industry (data demands vary from very limited for low volumes, to higher for large volumes and for the most hazardous classes). A majority of the respondents argued that REACH is a positive step forward since comprehensive risk assessments were earlier carried out only for very few of the several thousands of substances in use in Europe. However, some argue that legislations like REACH which aims to protect human health and the environment could end up damaging the European economy (Haverland, 2009). ECHA mentioned in an interview that there is always “an exaggeration from both sides (industry and environment)” (See further discussion in WP 2). The EU’s particular attention on the regional environmental status of the Baltic Sea is stated in the new EU strategy for the Baltic Sea (BSS). It calls for a sustainable development of the region and incorporates both environmental and economic development of the region. One of the key priorities of the strategy is reduction of hazardous substances (EC, 2009). Some interviewees mentioned that the BSS might be an attempt of the EU to improve the implementation of HELCOM recommendations. According to one respondent “the environmental part of BSS is based on the HELCOM action plan and … it hopefully will provide some additional commitments at least for EU member states and... additional national resources for the regional implementation”. However, no new institutions or financial support will be established for BSS implementation. This might create a difficult implementation situation in different countries. The Baltic Sea is partly regulated as a common water body by the WFD2 (EC, 2000) and as a marine area by the MSFD (EC, 2008) and the Maritime Policy (MP) (EC 2007). The WFD requires member states to assess both chemical and ecological status of their water bodies. The ecological assessment is based on the status of the biological, hydro-morphological and physico-chemical (including specific pollutants) quality elements (EC, 2000). The chemical status is assessed by comparing monitored concentrations of various priority chemicals (mainly in water) with defined Environmental Quality Standards (EQS). The WFD sets EQS for 33 priority substances and 8 other pollutants (EC, 2000). By 2015, the WFD demands good chemical as well as ecological status of EU waters (EC, 2000). According to one respondent, if the water quality standards (the concentration of chemicals in the water) are not reached by 2015, these substances can eventually be put on the REACH authorisation list. Several interviewees agreed that the WFD is a step forward in protecting the common aquatic environment. An expert from a Swedish marine research institution noted: “Before WFD the problem was to measure the water status; thanks to the directive we see if the status is good 2 Covers only coastal waters up to 12 nautical miles from the territorial baseline for Good Chemical Status 18 RISKGOV report or not which is crucial to have in the monitoring system”. However, several interviewees criticised the WFD for several methodological assessment problems (see further discussion in WP 2) and lack of economic and social aspects. Moreover, the implementation of the WFD can vary among countries. For instance, a respondent from an authority said “for chemicals we are doing the minimum, but acceptable minimum”. While respondents from Sweden argued that countries should do as much as possible. Moreover, it was acknowledged that many local authorities sometimes do not take the EU directives seriously. “Unserious” attitudes can be explained by the fact that both the WFD and the MSFD are related to an information gathering type of regulation, while “REACH is a regulation that actually can enforce action, for instance banning the chemicals” said a respondent from an authority. The MSFD focuses on marine waters and aims to achieve environmentally healthy marine waters by 2021 (EC, 2008). The goal of the MSFD is in line with the objectives of the WFD. Member states will need to assess the state of their marine environment based on 11 descriptors of good marine environmental status: Descriptor 1: Biological diversity; Descriptor 2: Non-indigenous species; Descriptor 3: Population of commercial fish / shell fish; Descriptor 4: Elements of marine food webs; Descriptor 5: Eutrophication; Descriptor 6: Sea floor integrity; Descriptor 7: Alteration of hydrographical conditions; Descriptor 8: Contaminants; Descriptor 9: Contaminants in fish and seafood for human consumption; Descriptor 10: Marine litter; Descriptor 11: Introduction of energy, including underwater noise. Member states (collaborating by help of HELCOM in the case of the Baltic Sea) have to establish targets, indicators and monitoring programmes (EC, 2008). This may be an advantage as it allows more flexible approaches that can be adopted for regional seas such as the Baltic Sea since it is different in many ecological features. But, on the other hand, it may also result in an over-diversification of approaches in the setting of ‘good environmental status objectives’ between the regional seas (Nõges et al., 2008). At this stage of development, it is not possible to evaluate the outcomes of the MSFD. However, many interviewed experts stressed that the MSFD might be able to improve the management of the Baltic Sea, hoping that the MSFD will more fully incorporate EAM and improve pan-Baltic political and scientific cooperation. The MP and the BSS have a broader approach than the MSFD and the WFD, and seek integration of a multitude of sectoral policies (i.e. chemicals, shipping and fisheries) (Van Hoof and Van Tatenhove, 2009). The MSFD and the WFD have a clear environmental focus, while the MP and BSS are more encompassing and stress the need for economic development as well as sustainability (EC, 2008). In general, the WFD, the MSFD and the MP aim at governing the water-marine environment, while the BSS covers the Baltic Sea region. Despite ambitious aims to adopt more holistic approaches (such as EAM), the BSS and MP were criticized by several respondents for not providing well-developed connections between the environmental and economic parts of the policy. From a chemicals’ perspective the MSFD, the WFD, the BSS and the MP present a change in institutional setting; major policy measures no longer descend from the EU chemicals policy alone (e.g. just REACH), but are increasingly derived from general environmental policy developments (see more in the EAM section of WP 2). Regional regulatory framework Many efforts on reducing hazardous substances have taken place at a regional level; around common seas like the Baltic Sea and river basins. Regional cooperation designed to specifically protect the Baltic Sea has been led by HELCOM (Selin and VanDeveer, 2004) (see Annex IV). The Convention on the Protection of the Marine Environment of the Baltic Sea Area (Helsinki Convention, 1974, 1992) was the first regional international agreement that instituted 19 RISKGOV report measures aiming to control all sources of pollution of the Baltic Sea. This Convention also imposed specific obligations on the contracting parties to counteract the introduction of hazardous substances (Brusendorff, 2007). The first chemicals related recommendations of HELCOM were focused on specific chemicals. Later HELCOM tried to cover more substances and in the 1980’s HELCOM Ministerial Declaration identified 47 substances to be reduced to 50% by 1995 (HELCOM, 1998). In 1998, HELCOM members issued recommendation 19/5 regarding hazardous substances, trying to cover a larger part of the present chemical hazards. It selected 280 hazardous substances that needed to be reduced by 2020. In 2007, HELCOM adopted the BSAP that aims to restore good ecological status of the Baltic marine environment by 2021. This plan used an alternative ecosystem based strategy instead of focusing on only single specific hazards. In terms of chemical risks the BSAP selects 11 hazardous substances or substance groups of priority concern and sets ecosystem-based targets for these. All interviewees acknowledged the importance of regional level initiatives taken by HELCOM, especially work related to identifying hotspots. Several interviewees mentioned that HELCOM activities are very helpful in establishing pan-Baltic cooperation among authorities and at a political level. One respondent mentioned that in several cases, for instance for wastewater treatment, HELCOM has more ambitious, but non-binding, requirements than the EU. Thus, compared to the EU, HELCOM focuses on particular regional actions in the Baltic Sea ecosystem (see further discussion in EAM section in WP 2) and has in some cases even more ambitious rules that might be more relevant to the Baltic Sea (owing to the often argued particular sensitivity of the Baltic Sea environment). The main criticism raised against HELCOM in the interviews relates to the fact that HELCON recommendations are not legally binding. “It is always a battle to translate decisions from HELCOM to the national regulations” noted one politically active respondent. The main “hope” of the interviewees was that with the MSFD, EU BSS the status of HELCOM decisions will be strengthened. National Regulatory Framework Nine countries – Denmark, Estonia, Finland, Germany, Latvia, Lithuania, Poland, Russia and Sweden – border the Baltic Sea. According to Selin and VanDeveer (2004) Nordic countries tend to lead in the development of hazardous substances policy in the Baltic Sea area. These countries have often taken domestic regulatory actions on hazardous substances before they are targeted by the HELCOM or by the EU (Selin and VanDeveer, 2004). However, there are also perceived differences between the Nordic countries. While Swedish interviewees considered EU membership as “lowering national standards”, Finnish respondents considered EU membership as a driving force for actions “I don’t know what can push us forward except of the EU... It is forcing us to do something that I am not sure we would do otherwise”. According to Selin (2004), Estonia, Latvia, Lithuania, Poland and Russia have often taken domestic actions on hazardous substances only after decisions have been taken by HELCOM or EU (HELCOM web, 2010). The Russian Federation, which is the only HELCOM member state that is not an EU member country, tends to deliver reports that are quite vague and have numerous data gaps on substance use, sale, stocks and emissions (Selin and VanDeveer, 2004). In general, Russian implementation of HELCOM obligations and recommendations is more dependent on international assistance than any of the other Baltic Sea states. Thus, continued capacity building in the Russian Federation presents a major challenge for the management of hazardous substances in the Baltic Sea (HELCOM, 2002). Sweden Similar to developments in other countries, the Swedish regulations were in the beginning focused on a limited number of single chemicals (see Annex IV), whereas more general 20 RISKGOV report regulations developed over time, from the 1970s and onwards (Karlsson, 2006a). According to one respondent, Sweden reacted earlier compared to other Baltic Sea countries and even the EU on problems connected with hazardous chemicals. As an example, the Swedish parliament has defined a “Non-toxic environment” goal. Several respondents mentioned that the Swedish membership in EU was a good development; “We can do much more than we could do at the national level” as an authority expert put it. However, EU membership was also mentioned by respondents to “lower the Swedish chemical standards”. According to several respondents, Sweden was and is leading in pushing for proenvironmental actions in the region. For example, one respondent acknowledges Sweden’s pioneering position in developing a national BSAP implementation strategy. Moreover, Sweden has always been arguing that the Baltic Sea is much more sensitive than other marine areas, for example in PSSA discussions (Uggla 2007). As for example mentioned in one interview; “On the EU level they do not agree with the special status of the Baltic, thus the Baltic Sea cannot have a higher risk factor. If we do not win this discussion we cannot continue with standards that we think are scientifically reasonable”. The importance of the environmental protection of the Baltic Sea was stressed also by the Environmental Minister of Sweden during the HELCOM ministerial meeting in 2010. Adding to this, the Government in Sweden launched in 2005 a new National Marine Policy and approved the creation of national marine authority, with the aim of promoting a holistic and cross-sectoral management of the marine environment and marine natural resources. Russia The Soviet government perceived the development of the chemical industry as one of its most important tasks (Aftalion, 2001). While large-scale producing enterprises were growing, the environmental concerns were not that developed (Shulenina, 2003). Environmental issues became an issue of interest for politicians and the mass media only in late 1980s due to Gorbachev’s perestroika and glasnost policies, and not to mention the Chernobyl disaster (Порядин 2001). Today the Russian chemicals legislation is in a process of change (OECD, 2009). “Old rules are not used anymore and the experts that were experienced in Soviet laws are not experts anymore. New rules are changing. In general all stakeholders experience a lack of information” as stated by a Russian scientist. In general, interviewees agreed that the current Russian regulatory system for chemicals is rather complex with many different actors involved. There are many laws and each “belongs to different legislations, regulations and fields of law...The main problem of Russian legislation is that it is not systemized” as mentioned by an Russian industry expert. This complexity was mentioned also by the executive director of ECHA to be the main barrier for increased cooperation between Russia and ECHA “because there is no clear partner authority responsible for the same things as ECHA in Russia”. Concerning regulatory harmonisation, the current Russian system of classification and labelling of chemicals differs from that of the EU and the GHS, except the requirements for safety data sheets (OECD, 2009). There are also significant differences in risk assessment terminology in the EU and in Russia (Fjodorova et al., 2008; Ruut and Simanovska, 2004). The issue of harmonisation of Russian chemical management legislation has become highly discussed in relation to the accessibility of Russian exporters to the EU markets under the new REACH regulation (ChemSec, 2006). Concerning chemicals in the environment, there are officially defined concentration levels of chemicals in different environmental compartments (e.g. water, soil and air). Maximum 21 RISKGOV report permissible concentrations, tentative exposure levels and tentative permissible levels of chemicals in various environmental media sometimes exceed those found in the EU (Fjodorova et al., 2008). Similar to the WFD, the Russian government adopted a Water Code of the Russian Federation, which also introduces EAM (Ganoulis and Nikitina, 2008). Knowing that the WFD and possibly also the MSFD may be hard to implement in regional seas as the Baltic Sea, shared between EU member states and countries outside the EU (Nilsson and Langaas, 2006), it is important to understand possible conflicts and synergies between EU and Russian regulations, such as the Water Code of the Russian Federation. There is no environmental strategy specifically related to the Baltic Sea in Russia. The main concern regarding the Russian chemical policy is, however, the practical implementation of existing national and international regulations. “There is not that much control of the effects of industries to the environment…rules exist but nobody controls them” mentioned a Russian industry expert. A Russian academic expert added “today water quality standards in Russia are very strict; they are therefore difficult to comply with and are often ignored”. An illustrative example is obsolete pesticide handling without environmentally sound technology (Vijgen and Egenhofer, 2009, and ChemSec, 2006) or a study done by Greenpeace showing that national standards for chemicals are not followed in the St. Petersburg area of the Neva River 3. According to Wernstedt (2002) the situation can be improved with development in the environmental monitoring sector, but that is very difficult, given the vastness of the Russian territory. Today each station for water monitoring covers 9000 square kilometres (Wernstedt, 2002). In the same time, the Russian prime minister claimed to be concerned with Baltic Sea environmental problems (Tisdall, 2010). However, very often, actions in the Baltic area are supported by external initiatives, as exemplified by the Nordic Investment Bank’s4 investments in better sewage treatment in Russia. The problem of effective cooperation with Russia for the management of the Baltic Sea was raised by a majority of respondents. The Russian-Baltic relations are marked by gaps in bilateral cooperation. Several interviewees showed scepticism towards Russian implementation of existing environmental norms. This indicates that the current EU-Russia Northern Dimension and the HELCOM arrangements do not sufficiently manage existing disputes (Arnswald, 2000). The main hope of the majority of the interviewees is that in the future (with the BSS and the MSFD), HELCOM will be able to improve current cooperation situation. 1.3. Discussion Chemical policy is complex in its actor constellation, networks and regulations. Management of chemicals in transboundary water bodies is even more complex, as the problem is shared across national borders. Approximately 40% of the global population lives in transboundary water basins, 55% of which are located in Europe, emphasising the need for cooperation and harmonisation of policies (Mylopoulos and Kolokytha, 2008). 3 http://www.greenpeace.org/international/en/news/features/A-toxic-river-runs-through-it/ The BSAP Fund is a fund managed by the Nordic Investment Bank (NIB) and the Nordic Environment Finance Corporation (NEFCO). The fund provides grants for technical assistance to projects that support the implementation of the HELCOM Baltic Sea Action Plan (BSAP). Recipients eligible for financing through the Fund include both public and private entities operating in the agricultural and wastewater treatment sectors, as well as those working to reduce hazardous waste in the Baltic Sea catchment area. Sweden has committed SEK 90 million (EUR 9 million) to the BSAP Fund and Finland EUR 1.6 million (see further at http://www.nib.int/news_publications/publications/brochures_leaflets/technical_assistance_for_cleaner_baltic_sea). 4 22 RISKGOV report The Baltic Sea is a good example of a European transboundary water basin. Nine countries border the sea and five more (Belarus, the Czech Republic, Norway, Slovakia and Ukraine) belong to the watershed. A major problem is that the regulatory frameworks for the marine area do not reach beyond the limits of national jurisdiction. Kern (2004) consequently states that new forms of governance beyond the nation state are crucial for the future development of the Baltic Sea region. This environmentally based fact has been both reinforced and underlined by social developments of various kind, such as (Kern, 2004; Kern and Löffelsend, 2004; Joas, Kern and Sandberg, 2007; Joas, Jahn and Kern, 2008): The end of the Cold War and the transformation processes in the former socialist countries; The 1992 United Nations Conference on Environment and Development (Rio de Janeiro); European integration, the product of two waves of enlargement in 1995 (Sweden, Finland) and in 2004 (Poland, Lithuania, Latvia and Estonia together with six other countries). It is against this background, and following increasing knowledge about the challenges caused by a broad number of substance, possible to observe general trends in transition from regulations addressing specific chemicals at the national level, to international efforts to cover a large number of hazardous chemicals (see timeline Annex IV), and even to applying an ecosystem-based management strategy. Today, there is a tremendous amount of national, regional, EU and international actors and regulations related to the management of hazardous chemicals. However, the web of regulations still does not cover more than a small amount of the chemicals in use. Some argue that the solution lies in developing new regulations, but according to several of our interviewees, a growing “diversity” in actors and regulations is not going to sufficiently improve the implementation of real measures. Maybe a fruitful strategy therefore could focus on developing a new and proactive approach that covers existing and new chemical risks, rather than focusing on the number of the regulations. REACH is an attempt to use such an approach by bringing together so-called existing and new chemicals in a joint regulatory framework, even though the implementation is still very slow. This points at a need for policy innovation in this area. Acknowledging the importance of the international cooperation, a majority of the interviewees still agreed that for the Baltic Sea ecosystem the recent development and ongoing implementation of EU and HELCOM regulations are of main importance. This can be explained by the fact that the EU regulations are legally binding for most of the Baltic Sea countries (i.e. not for Russia) and that all of the countries are members of HELCOM; and almost all interviewees agreed that development of global conventions goes very slow, in particular considering the time it takes to implement them. “That is why there are only few chemicals in the Stockholm Convention” as noted by a respondent linked to a Swedish authority. In the course of the interviews and literature studies it was possible to identify that the WFD, the MSFD, REACH and the BSAP are at the forefront of the development of chemicals management in the Baltic Sea region (although at different stages of implementation and with different legal power). All those regulations generate a lot of information, relevant for the management of the chemicals in the Baltic Sea; thus it is important to generate more understanding on the complementarities, overlaps, and potential conflicts of the WFD, the MSFD and REACH and HELCOM. Some mechanisms of interaction already exist but it is still important to look for additional synergies. Already knowing that the WFD and possibly also the MSFD may be hard to implement in regional seas such as the Baltic Sea shared between EU member states and countries outside the EU, it is also important to widen the search for possible cooperative mechanism in relation to the Russian Federation. 23 RISKGOV report A majority of the respondents agreed that EU rules are the most important in the region, as they are legally binding for most of the countries. Several of respondents expressed concern that the EU membership lowered some of the national standards and might not allow for the development of the specific regional measures. Several concerns were also raised in relation to the sensitivity of the Baltic Sea ecosystem that according to several interviewees might require development of stricter rules for chemicals at the regional (Baltic Sea) level than at the general EU level. It is suggested that HELCOM will have an important leading role in future regional Baltic Sea management of chemicals with the introduction of the new EU Baltic Sea Strategy and the MSFD. 24 RISKGOV report 2. Working Package 2: Assessment – Management Interactions SUMMARY WP 2 focuses on an in-depth understanding of the interactions between risk assessment and risk management of chemicals. The main assessment and management activities in the Baltic Sea region are identified and analysed. It is concluded that assessments commonly are based on a rather technocratic separation of assessment and management activities (with often unclear strategies for bringing these activities together in decision-making). Assessments also generally suffer from lack of data, insufficient harmonisation of methodology, as well as unclear strategies for assessing uncertainties and adjusted communication of assessment results. Consequently, assessments would benefit greatly from more harmonised assessment methodologies, not least for chemical mixtures, ecological effects as well as methods for integrating various lines of evidence. Both assessment and management might benefit from increased stakeholder participation. Furthermore, we have analysed risk assessment and management interactions through the prisms of uncertainty and the Ecosystem Approach to Management (EAM). These aspects have become top challenges for the assessment and management of chemical risks as well as for coping with science-policy interactions connected with the governance of chemical risks. We conclude that the enormous knowledge gap (for most chemicals, for the risks of chemical mixtures, for ecosystem-specific risks etc) need to be addressed by combining increased efforts on data and knowledge production with better ways of assessing, communicating and managing uncertainty. Hence, a main question is how much evidence is needed for motivating decision-making on risk reduction. This is a policy-related issue, not a scientific one. However, science does need to develop and implement improved methodology for assessing and communicating uncertainty to relevant stakeholders. On the management side, the precautionary principle is increasingly stipulated for coping with uncertainty. In spite of that, there is no consensus on the exact implementation of the principle in practice, and regulations such as REACH, the WFD, the MSFD and the BSAP ought to be developed on this point. Risk reduction is needed and motivated even, or even particularly, under uncertainty. Looking at the EAM, the approach is clearly receiving increase attention (e.g. in the BSAP and the MSFD), but only partially in the field of chemical regulation and concrete measures. So far, it is therefore not certain that the EAM will substantially improve risk management in cases of high uncertainty. On the contrary, requirements on implementation of the EAM may stall measures and increase complexity. These initial insights will be further developed in coming RISKGOV publications. 25 RISKGOV report 2.1. The Organisation and Type of Risk Assessment Activities Risk assessment is, using a rather technocratic definition, the assessment of probability and extent of negative effects owing to an agent or activity. Similar approaches to risk assessment have been developed and used by the EU, the US EPA and OECD. Despite the scientific background of risk assessment, many national and international regulatory guidelines have different definitions of the term “risk assessment”. The scope and nature of risk assessments range widely, from general scientific analyses of how air pollutants affect an entire country, to site-specific assessment of particular effluents and chemical contaminants. Thus, risk assessment takes many different forms, depending on scope and purpose, the available data and resources, and other factors (see Table 2.1) (Fairman, Mead and Williams, 1998). Table 2.1 Types of risk assessments for chemicals in the EU and the Baltic Sea Type of risk assessment Assessment of single chemicals and chemical products. Assessment of processes and contamination sources Integrated (ecosystem-based) assessment EU Baltic Sea REACH, Biocides, Pesticides, Pharmaceuticals Assessment and monitoring of priority chemicals EIA directive; IPPC directive HELCOM hotspots Whole Effluent Assessment (COHIBA) WFD, MSFD HELCOM chemical assessments etc HELCOM integrated assessment Risk assessment is also performed for different reasons: (1) In the design and implementation of regulation, for instance in determining “acceptable” risk levels which may form the basis of environmental standards (e.g. as in the WFD); (2) To provide a basis for site-specific decisions (e.g. in land-use planning); (3) Prioritisation of environmental risks, for instance in the determination of which chemicals to regulate first (e.g. HELCOM BSAP, WFD and authorisation list of REACH); (4) For comparison of risks, for instance to enable comparisons to be made between the resources being allocated to the control of different types of risk, or to allow risk substitution decisions to be made (e.g. REACH substitution). As will be detailed in the following, , many organisations are now actively involved in performing and using risk assessment at the international, EU and national levels. International risk assessment At the international level, chemicals risk assessments are performed by several organisations; for example by scientist networks (e.g. IPCP), the Global International Waters Assessment group5, by a special expert group of ICES- Marine Chemistry Working Group (MCWG) among others. The OECD and its member countries are also working on assessing chemicals, especially in terms of cooperative testing and assessment chemicals produced at high volumes. The World Health Organization (WHO), through its International Programme on Chemical Safety (IPCS) and partners, UNEP and the International Labour Organisation (ILO), also conduct risk assessments of chemicals. Today, measures are taken to harmonise different approaches to risk assessment and to minimise duplication mainly between programmes from the EU, the OECD and IPCS. The development and international harmonisation of risk assessment methodologies are recognised to be a great challenge. 5 http://www.iwlearn.net/iw-projects/Fsp_112799467513/reports/baltic-sea-17-giwa-regional-assessment 26 RISKGOV report EU risk assessment The EU’s risk assessment programme is a part of the legal scheme to reduce the risks of used hazardous chemicals for human health and the environment and it fits into the international OECD programme on the cooperative testing and assessment of chemicals. Thus, OECD guidelines for risk assessment are widely used in different EU assessments, as an important part of harmonisation of different chemicals assessments. However, according to an interviewed EU expert “there is much novel research that is difficult to include in the assessment because it is not following the guidelines according to OECD”. For a long time in EU, with the exception of a few groups of chemicals, such as pharmaceuticals, pesticides and food additives, chemicals manufacturers had the right to continue to produce and market chemicals without investigating risks or finding alternatives. The EU started to require data for new chemicals put on the market after 1981. Later it applied for some of the existing substances. Those actions were coordinated by the European Chemicals Bureau (ECB) and risk assessments were performed by the competent authorities in member states (EEA, UNEP 1998). The EU Technical Guidance Document (TGD), based on recommendations from OECD, was developed to provide guidelines for the risk assessment of chemicals in EU. In Sweden, risk assessments were mainly performed by Kemi, in Finland by the Finnish Environmental Institute, in Denmark by the Danish Environmental Protection Authority, in Germany by the German Environmental Agency (UBA), the German Occupational Safety Agency (BauA) and the German Institute for Risk Assessment (BfR) and in Poland by the Polish Bureau for Chemical Products6. With the introduction of REACH, the situation has slightly changed and industries are more responsible for performing assessments for manufactured chemicals (see next section). REACH Risk Assessment The TGD guidelines are also used in REACH to guide the industry to perform the assessment of chemicals, called chemical safety assessment (CSA). A manufacturer or importer of a substance in quantities of 10 tonnes or more per year needs to prepare a chemical safety assessment (CSA) and document this chemical safety report (CSR) as part of the chemical registration dossier. In addition to risk assessment done by industry, the Commission, ECHA or EU member states may also propose chemicals for a 'Candidate List' of Substances of Very High Concern (SVHCs) based on the risk assessment and decided by ECHA. Once substances are identified for this list, ECHA may recommend it for authorization, which the Commission can confirm.. However, authorizations may be granted if the applicant can demonstrate that the risk from the use of the substance is adequately controlled. If the risks are not adequately controlled, an authorization may still be granted if it is proven that the socio-economic benefits outweigh the risks and that there, for some types of substances, are no suitable alternative substances or technologies. REACH also gives opportunities to restrict substances more generally, based on risk assessments and interpretations of these in the same manner as before REACH (Karlsson, 2010). In this way REACH aims at protecting human health and the environment. REACH was mentioned by several respondents to be a very important step in improving available information for chemicals in use (see further discussion in WP 1). Yet, REACH is highly controversial, and its adoption may appear surprising given the level of controversy that surrounded it (Selin, 2007). One question that was and still is discussed concerns that testing requirements depend on production volumes – the higher the production volume, the more extensive test batteries should be performed. This will not create comprehensive information for the chemicals produced in the volume less than 1 tonne, though, thus leaving the majority of chemicals outside the risk assessment (Karlsson, 2010; Hansson and Rudén, 2010). 6 See further http://www.kemi.se, http://www.ymparisto.fi, http://www.mst.dk, www.umweltbundesamt.de, www.baua.de, www.bfr.bund.de and www.chemikalia.mz.gov.pl respectively. 27 RISKGOV report Another important feature, also mentioned by the interviewees, is the low requirements in REACH for data on chemicals in specific articles such as toys. Adding to this, REACH also supports new non-animal testing assessment methodologies. On the one hand this is an important alternative approach, knowing that for testing of all chemicals in use; millions of test organisms will be required (Hansson and Ruden, 2010). On the other hand however, these alternative modelling and laboratory methods may, given the lack of ecotoxicological data, even increase existing uncertainty. One further remaining drawback is that the classification and labelling system does not distinguish between a substance that has been tested with negative outcome and a substance for which no data is available (Hansson and Ruden, 2010). This means that incentives for generating additional information are low. Something that could be counteracted by introducing a specific label for untested or insufficiently tested substances (Hansson and Ruden, 2010). During the interviews, several respondents also criticised the credibility and scientific validity of the dossiers produced by the industry. The issue of trust to the industry was raised several times. ECHA will obviously not be able to check all of the dossiers; as one respondent noted “At the end of the year we will get around 30000 dossiers for the high volume substances. It will be impossible to check and verify all of them. So we have to trust the industry”. At the same time REACH is also criticised by the industry for exposing confidential business related information about produced chemicals, and for providing too complex guidelines. According to a respondent from industry, a major problem for business actors is that many ECHA publications and guidelines are “written in a language not easily understood by the industry”. Consequently, REACH poses implementation challenges and there are reasons to suspect that not all dossiers and risk assessments are prepared fully in line with the requirements. While German industries are actively sending the dossiers, the industries from for instance Romania, Poland, and Spain are lagging behind. According to ECHA, the best it can do so far is “only to motivate them to submit the dossiers; other strong actions are not decided yet”. With time however, failure to meet data delivery demands will lead to loss of market opportunities Furthermore, according to a Russian industry representative, non-European industries lack support and sufficient guidance from ECHA when performing risk assessments. This might affect the quality of risk assessments of chemicals as well as of chemicals in articles imported from outside the EU. The perhaps main challenge in REACH is the slow process of performing all the required risk assessments (both for chemicals dossiers and for identification of the chemicals to the candidate list for authorisation). There are, for example, currently only 38 substances on the candidate list. “It is bureaucracy. It takes so much time to decide on chemicals to be authorised. But it is a normal procedure in the democratic society. Everyone who wants to say something needs to be heard” said one of the respondents. Several experts said that the solution is to focus on inherent properties of the substance instead of performing standard risk assessment for each substance. Risk assessment connected to the WFD The WFD requests that EU waters achieve a good chemical (GCS) and ecological status (GES) by 2015. Chemicals risk assessments under the WFD may concern determination of substances to be controlled and can be related to monitoring results. In the former case, a list of priority substances was selected among substances which present a significant risk to the aquatic environment. Substances were prioritised for action on the basis of their risk and were identified by: a) risk assessments carried out under previous regulation or b) targeted riskbased assessment focusing solely on aquatic ecotoxicity and human toxicity (via the aquatic environment). As a result of these risk assessments, 41 priority substances (33 new and 8 which were regulated under previous legislation) were identified and Environmental Quality Standards (EQS) were developed for these 41 chemicals. From the 33 priority substances, 13 were 28 RISKGOV report considered “priority hazardous substances” due to their persistence, bioaccumulation and toxicity. The Commission shall propose controls for eliminating discharges, emissions and losses of such priority substances within 20 years after the adoption of such proposals. Chemical risk assessments related to priority substances in the WFD are primarily performed through monitoring concentrations, mainly in water, and comparing these with EQS (EC, 2000). Environmental targets referring to concentrations in biota have been established only for mercury, hexachlorobenzene, and hexachlorobutadiene (EC, 2009). In addition to EU-wide selected priority substances, the WFD also requires to identify “specific pollutants”, that are part of good ecological status of the water. While for priority substances EU level thresholds exist, Member States shall set quality standards for river basin specific pollutants and shall take action to meet those quality standards by 2015 as part of ecological status (EC, 2001). According to an interviewed WFD expert, identification of these specific pollutants is a very complicated process due to the high uncertainty and ambiguity. As a result, it was said to be omitted by many river basin authorities. In addition, some methods were criticised by several respondents. For example, measurements of chemicals in water were mentioned by several interviewees to be irrelevant, as chemicals are concentrated mainly in sediments and biological objects. Several respondents were also of the opinion that not enough socio-economic input is required. Further, participation in relation to chemical risk assessment was generally seen as problematic among interviewed experts. For example as one expert put it “the information is really technical and it is really hard for common people to understand what we are doing”. The same expert added “sometimes we feel that we have a bad status in a water body due to agriculture or forestry problems, and of course the farmers think it is not their problem”. In total, respondents generally saw present risk assessments as (purely) scientific exercises, whereas interpretation and evaluation of these assessments were seen as more problematic and therefore as something requiring dialogue with stakeholders. Risk Assessment connected to the MSFD The chemical status of EU marine waters (including the Baltic Sea) is covered by the MSFD. When focusing particularly on the Baltic Sea area, the territory covered by the MSFD and the BSAP is overlapping (the Baltic Sea). There is still no information on how chemical risk assessment will be performed in relation to the MSFD; but an obvious question appears about possible overlaps (or maybe synergies) between assessments done for the MSFD and the BSAP. This question was raised, among others, by the German Environmental Minister during the Ministerial seminar of HELCOM, 25 August 2010. HELCOM Chemical Risk Assessment The main assessment activities linked to HELCOM are done in the Monitoring and Assessment Group (HELCOM MONAS). Risks are identified through analysis of the HELCOM monitoring results. These results are also supported by data from scientific reports and/or by modelling. The integrated HELCOM thematic assessment of hazardous substances in the Baltic Sea 2010 is the latest thematic assessment (HELCOM, 2010). It is based on monitoring data (1999– 2007) on various chemicals, compared with threshold levels to establish the chemical status of the water (5 classes are used – high, good, moderate, poor and bad see fig. 2.1.). 29 RISKGOV report Figure 2.1. HELCOM Integrated classification of the ‘status of hazardous substances’ in the Baltic Sea. Source: (HELCOM 2010) A complicating factor for this assessment is that there are no generally agreed HELCOM thresholds levels. This means that various countries had the option of carrying out the coastal assessments using any threshold, “values they wished, whether national or internationally agreed” (HELCOM, 2010). Some countries used country defined target, some OSPAR, EU, U.S. EPA or NOAA targets, even though they are not specific to the Baltic Sea. Thus, there is an obvious need to develop more harmonised criteria for the Baltic Sea or at the least to introduce a common methodology to derive site- or country-specific thresholds. In the interviews several problematic issues were also raised in connection with the HELCOM assessment. For example, heterogeneity in methods and data sources, number and quality of indicators, and the quality of derived threshold levels. These issues are all being addressed by HELCOM but implementation of, for example, a harmonised methodology has proved to be slow and problematic. Since the MSFD in the Baltic Sea region will be given coordinated help by HELCOM, it is evident that HELCOMs capacity to improve assessments further will be important for the implementation of the MSFD. HELCOM risk assessments can however, be seen as a step forward since the measurements are done in several matrices (biota, sediments, water, as well as biological effects), while WFD-related assessments mainly focus on water. HELCOM assessment also covers the entire Baltic Sea area; while WFD-related assessments cover national waters up to the outer limit of territorial waters. 30 RISKGOV report 2.2.Generation and Evaluation of Management Options “Water that we drink, food that we eat, air that we breath, mother’s milk and human blood contain hazardous chemicals, something must have gone wrong and we need to think how to fix it” - Russian scientist Reduction of environmental risks can involve many techniques. For chemicals they are discussed in the draft European Technical Guidance Document (CEC/ECB, 1996): (1) Substitution. Can the chemicals be substituted by another, less risky chemical? (2) Information. Providing information about safe use and disposal of chemicals. (3) Education and information may also allow the public and users to choose lower risk options and force the manufacturers into the production of less risky agents. (4) Limit the availability of the agent by bans or limits on the production or importation of the agent. Such a risk reduction technique may have more or less severe political or economic implications and can often be controversial (Fairman, Mead and Williams, 1998). There are also other ways to reduce risks such as ALARA principle (as low as reasonably achievable principle); safety standards, use restrictions, contaminated land policies, environmental liability legislation, civil action, and other strategies (Van Leeuwen and Vermeire, 2007). A majority of the interviewees agreed that measures from all stakeholders (consumers, industry, agriculture and government) are needed. When looking at a more technical part of management, the impact of chemicals can be reduced by measures at different points in their environmental lifecycles, from pre-market screening to remediation of contaminated areas. A proactive approach is pre-market screening but lack of knowledge about toxicity, persistence and other basic properties, as well as the slow progress in conducting risk assessments, impede such possibilities and many measures and reactive approaches are often applied. According to EEA and UNEP (1998), the slow process of conducting risk assessment for all the substances and the high level of uncertainty have led to an increased focus on exposure reduction rather than on more toxicity testing. This approach has been used by the BSAP, the WFD and the MSFD. Their main objective is to reduce overall chemical loads, starting with priority substances for which there is already toxicity data. Prioritisation Prioritisation is an important factor for management actions and deserves attention. It is apparent that prioritisation is a key point of interaction between assessment and management (even though we acknowledge that it is possible to identify other interactions such as risk evaluation etc). HELCOM prioritisation Recommendation 19/5 issues by HELCOM in 1998, lists 280 hazardous as potential substances of concern. HELCOM selected 42 of these for immediate priority action. In order to prioritise measures further, HELCOM and OSPAR used the DYNAMEC selection and prioritisation mechanism, resulting in identification of eleven priority substances, or substance groups, in the BSAP. Interestingly, it appears as though criteria for prioritisation were rather unfocused in this process. Or as one interviewee put it “there were no clear criteria. It was experience, experts’ judgments combined with available data”. The EU Prioritisation WFD priority substances The WFD required the European Commission to establish a priority list of substances based on their risks to the aquatic environment and to human health via the aquatic environment. For these priority substances the European Commission had to propose community-wide environmental quality standards (EcoQs). The first list was established in 2001. A Combined 31 RISKGOV report Monitoring-based and Modelling-based Priority Setting scheme (COMMPS) was used to select the substances (EC, 1999). In this process, expert groups first recommended a list of priority chemicals, which subsequently was made available for commenting by interested parties. REACH priority (authorisation) substances REACH includes a special prioritisation procedure for authorisation. So-called “substances of very high concern” (SVHCs) are defined in article 57 and may, after proposal by e.g. Member States, be placed on ECHA’s “Candidate list” and may eventually be included in Annex VII of the REACH Regulation. Once included in Annex VII, they can not (after a transition period) be placed on the market or be used, unless the company is granted an authorisation. There is no tonnage threshold for a substance to be subject to authorisation and the selection is based on specifically developed guidelines. Since October 2008, ECHA has published a list of SVHCs7 but until January 2011, only 46 chemicals were listed and several respondents (especially from NGOs) considered the figure too low. In the official list of hazardous substances with a harmonised classification and labelling at EU level, more than 900 substances automatically meet the criteria for being identified as SVHC (Romano at el, 2010). This suggests that the chemicals prioritisation is a subjective practice. Alternative prioritisation In additions to these main priority lists of chemicals, several lists of hazardous chemicals have been developed by governmental agencies or non-governmental organisations, with different purposes. The common denominator is, however, that they include substances that are considered to be of special concern because of their negative effects on human health or environment. Examples of priority lists are: (1) United States Environmental Protection Agency (US-EPA): Extremely Hazardous Substance List8 (2) Finnish Environment Institute: Proposal for a Selection of National Priority Substances9 (3) KEMI-PRIO: PRIO database10 (4) SIN List11 that include 356 substances and substance groups (5) Trade Union Priority List for REACH Authorization12 that includes 334 substances These lists are well-known examples and illustrate the lack of agreement on which and how many chemicals that need to be prioritised and further regulated. NGOs and trade union lists include more chemicals compared to the lists of EU or the BSAP (Romano et al. 2010). For example, from the trade unions point of view, the lack of information on toxicity, production volumes, uses and exposures of chemicals should not be used as an excuse for delaying the inclusion of substances in the REACH Candidate List. Several interviewees also criticised the reactive prioritisation approach in general. For instance, some argued that cutting down the HELCOM list from 280 to 11 priority substances did not eliminate the risks posed by the other 238. Similarly it can be argues that there are most likely chemicals not on the priority list that constitute significant environmental risks. 7 See further on http://www.echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp. 8 http://www.epa.gov/EPA-WATER/1994/October/Day-12/pr-14.html 9 http://www.ymparisto.fi/download.asp?contentid=15659&lan=en 10 http://www.kemi.se/templates/PRIOEngframes____4144.aspx 11 http://www.sinlist.org/ 12 http://www.etuc.org/IMG/pdf/TUListREACH.pdf 32 RISKGOV report Also, risk connected with emerging chemicals usually fall outside the priority list approach, although there are some ongoing chemical screening activities in the Baltic Sea area (Sharpe, 2001). Socio-economic implications There are several possible reasons for why there are more chemicals on the NGOs priority lists compared to the governmental lists. The Finnish Environmental Minister mentioned during the HELCOM ministerial meeting in Stockholm in 2010 that decision-makers need very simplified and prioritised information. Keeping in mind the limited resources available, a list of several hundred substances might, with that view, provide less useful information than a highly prioritised list. The respondents agreed that the final decisions about how to manage chemicals risk in particular are affected by various economic and social factors. For example, a Swedish expert said: “Because politicians have to listen to all and not only scientists. They count money and decide where to spend them and there are a lot of different problem (not only environmental)”. Obviously, most decisions, including those about which chemicals to prioritise, involve trade-offs between costs and benefits. Regrettably, it is difficult to evaluate costs and benefits of chemicals, especially in monetary values (EEA and UNEP, 1998), and it is not common to include such factors when assessing the risk of hazardous chemicals. However, there are several arguments on how such cost-benefit and cost-effectiveness evaluations in risk assessments could improve policy decisions (EEA and UNEP, 1998). Values and social and economic aspects can also influence the agenda of scientists. There is a widespread discussion about the aimed separation of science and policy in e.g. environmental decision-making, which is an attempt to exclude subjective perceptions of facts (Hunt and Shackley, 1999). Interviewees from EU expert groups claimed that their conclusions are purely based on science, excluding biases. On the other hand, decision-making purely based on scientific assessments was criticised by other respondent in light of the common lack of data and substantial scientific uncertainty. It was also argued that sometimes scientists have to do subjective judgments “because it is a question of weighing what is more important; volume or toxicity in particular cases”. Eriksson et al. (2010a) have, among others, described how members of e.g. EU expert committees are affected by their values and affiliations, giving advice not seldom far from being objective or neutral. Hence, it seems clear that there are valid arguments for recognising and explicitly incorporating more socio-economic aspects, and stakeholder involvement, in chemical risk assessments. For example, stakeholders (including community groups, environmental organisations, industry, and consumers) are often disengaged from the processing of risk-assessment at a time when risk assessments are increasingly intertwined with societal concerns. Disconnections between the available scientific data and the information needs of decision-makers often hinder the use of risk assessment as a decisionmaking tool (Abt et al., 2010). With respect to the WFD, several interviewees agreed that more inclusion of economic and societal perspectives could have led to the development of more feasible targets and proposed actions. 2.3.Assessment and Management Approaches for Dealing with Scientific Disagreement and Uncertainty Scientific disagreement All interviewees agreed that chemicals may have a negative impact on human health and the environment. However, there were disagreements about the extent of harm and the importance of the problem. According to a respondent from academia, many scientists believe that chemicals are not a serious issue.. As said, there is also disagreement regarding which 33 RISKGOV report particular chemicals are toxic and how many chemicals that need to be regulated. One expert mentioned the disagreement about the ways to cope with uncertainty (about type one and two error)13. A major reason for these diverging opinions is not surprisingly a basic lack of scientific data. One science expert mentioned that there are only few stations for monitoring and that large areas therefore are not covered. One monitoring expert added that they do have programmes to measure the presence of chemicals, but not to measure the associated ecological consequences. Several respondents also mentioned that the narrow specialisation of scientists in various fields (e.g. specific parts of ecology, toxicology and chemistry) can affect the way they deal with chemicals which can be a reason for disagreements. Uncertainty A huge number of chemicals are used in modern societies (the estimated number is in range from 30.000 to over 10.000). Adding to this complexity various hazardous metabolites and derivatives can also be formed (e.g. DDE/DDD from DDT). Toxicological and ecotoxicological data are missing for the vast majority of chemical substances (Allanou et al., 1999). In particular, there is a general lack of knowledge on long-term effects, risks of contaminant cocktails and ecosystem-specific behaviour and effects of chemicals. The HELCOM thematic assessment of hazardous chemicals in the Baltic Sea concluded that there is a substantial lack of data on concentrations of chemicals, as well as on their potential biological effects (HELCOM, 2010). Thus, one of the major difficulties concerning the establishment of risk assessments is the extremely low availability of data and that the data available is often uncertain (Fairman, Mead and Williams, 1998). This lack of knowledge and data was mentioned by several interviewees. An expert from an authority also said that “Sometimes I suspect that chemicals that we don’t measure or mixtures of different chemicals are responsible for the damage to the ecosystem”. Uncertainty was mentioned in several interviews to be a problem both in risk assessment and risk management. Three categories of uncertainty have be identified: uncertainty in effect, uncertainty in cause, and uncertainty in the relationship between a hypothesised cause and effect (Rogers, 2003). This categorisation is relevant for chemicals risks. There is uncertainty in effect, which means that even if there is knowledge that a particular chemical can cause harm, there is not enough knowledge about the probability of that potential harm. The uncertainty in cause is related to the lack of knowledge about particular causes of the harm (e.g. it can be one particular chemical or a mix of chemicals or other reasons). Several interviewees mentioned this type of uncertainty, related to observed problems in the biota of the Baltic. For example according to a scientist “There is less fat in herring and seals in the Baltic Sea. There must be a reason behind it. What is that reason? What are the reasons for the birds’ disease? What are the reasons for the M7414 disease that affects salmons?” Similarly an expert working with environmental assessment said: “we can say it is bad (status of water) but we can’t say why”. According to Rogers (2003) the type of uncertainty connected with cause-effects relations is of particular concern to the regulator. Furthermore, uncertainties linked to “known unknowns” pose severe challenges for risk assessment as well as risk management. One example of this type of uncertainty mentioned in the interviews was: “source of uncertainty…We don’t have any knowledge on the inputs from Russia. Thus, we cannot say that we have a problem”. Addressing Uncertainty in Risk Assessment 13 Errors may be of Type I (i.e. false positive, meaning that a specific chemical is judged to be hazardous even though it is not) or Type II (i.e. false negative, meaning that a specific chemical is not judged to be hazardous even though it is). 14 M74 syndrome is a thiamine responsive disease of salmon (Salmo salar) in the Baltic Sea and neighboring waters which leads to the death of nearly all fry of certain females. 34 RISKGOV report To characterise uncertainty is a key component of the risk assessment process. This should concern all available knowledge about the type and extent of uncertainties in order to properly inform risk-management decisions. Uncertainty in a risk assessment depends on the quantity, quality, relevance of data, reliability and relevance of models and methods used to fill data gaps. Much has been written about how to categorise different types of uncertainty (Finkel, 1990; Dakins et al., 1994; Krupnick et al., 2006). There are also several useful guidelines on the mechanics of uncertainty analysis (Abt et al., 2010). For example, the US EPA’s practices in addressing uncertainty include: (1) use of default values; (2) Quantitative Uncertainty Analysis (QUA); (3) use of experts’ judgment. The choice of method of expressing uncertainty is important and will most likely affect decision-making. Below we will give example on addressing uncertainty in risk assessment. HELCOM One of the main methods to deal with uncertainty in HELCOM assessments is to propose generation of additional data. Another way is to do a confidence assessment. The latest HELCOM chemicals assessment included great heterogeneity in the data sources (HELCOM 2010). This report includes a short section analysing the confidence given to the estimated integrated status classifications. However, the HELCOM report does not present a comprehensive description and assessment of uncertainties in a specific section of the report. EU REACH While doing the CSA (see previous chapter), the risk characterisation has to include an explanation of uncertainty. “Uncertainty needs to be assessed in order to decide on the robustness of the risk estimate. The uncertainty analysis is further detailed in Chapter R.19”15. According to Verdonck et al, (2007), the TGD of REACH addresses uncertainty in a quite detailed manner. Guidance is given on how to differentiate (e.g. through an uncertainty matrix or checklists), to assess (e.g. through scenarios or probabilistic assessment), and to deal with the uncertainty (e.g., for risk refinement or to search for alternative solutions) (Verdonck et al., 2007). However, fundamental uncertainty remains because of the design of the regulation. For example, the REACH regulation does not require industry to provide data for chemicals produced in a volume of less than 1 tonne. Thus, uncertainty remains for chemicals produced in volumes less than 1 tonne. Moreover, one respondent said that ECHA will not be able to check more than a small part of received risk assessments. This might be another type of uncertainty, as it will not be possible to be certain on the results. Hansson and Ruden (2010) also stress that REACH does not take into account already existing scientific uncertainty. The classification and labelling system does not distinguish between a substance that has been tested with negative outcome and a substance that has not been tested. Thus, substances which lack data do not have their own label, which means that in those cases the substance will remain unclassified (Hansson and Ruden, 2010). The lack of data about chemicals in specific articles is another problem hardly managed by REACH, as the regulation does not always require comprehensive information about content of chemicals in products. According to Hansson and Ruden (2010), the content of chemical in different products should be taken more seriously into account in order to decrease uncertainty. WFD The WFD calls for numerous decisions under uncertainty; it captures for example the lack of knowledge about the present and future conditions of the water bodies, about the causal 15 http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_r19_en.pdf?vers=20_08_08 35 RISKGOV report relationships regarding the nature of pollution, mixture of chemicals and the effects of interrelationship between different risks. Overall it can be argued that the WFD only alludes to the problem of uncertainty (Newig, 2005). It was for example mentioned by a respondent involved in WFD implementation that “…It is easy to discuss effect of different problems like chemicals but in nature it is probably a mix of problems that affect the water status...”. According to the same expert there is not enough data to make concluding statements; “we make the conclusions based on monitoring results from one station only”. Several experts mentioned the problem of giving water a particular status. If a water body, due to uncertainties, is wrongly classified (e.g. moderate instead of good status) it may lead to important consequences, e.g. costly restoration measures or the prohibition of further establishments in the area. More data, specifically biological in nature, are needed to perform the classification in accordance with WFD regulations. It will not be possible to collect all the missing data, at least not within the timeframe of this first planning cycle (Hedelin and Lindh, 2008). According to Sigel et al. (2009), uncertainty is not handled systematically neither in the guidance documents of the WFD nor in the daily work of the experts. Interviews results also indicate that local assessment experts act on basis of their practical experience in dealing with similar situations and therefore use more or less ad-hoc solutions. Expert judgments are thus very often used and experts also often decide on how to deal with uncertainty. The problem of assessing the status of the water was often mentioned in the interviews. Some interviewees thought that it is up to the officials to decide “It is better to be on the safe side and give the bad status” stated a respondent from an authority. Other interviewees were however of the opinion that officials never should act as arbiters. To handle the ‘specific pollutants’ within the WFD is the most complicated task since it is “covered with uncertainty”. This is because specific pollutants need to be identified at the local level and, as mentioned by an interviewed WFD expert, there is a lack of localised information (e.g. the amount of chemicals released or the ecological status of the waterbody). Because of this inherent uncertainty there are different ways of dealing with specific pollutants. The most widespread reaction is, according to the interviewed WFD expert, to abstain from identifying specific pollutants. Addressing Uncertainty in Management Newig et al. (2005) identifies two types of uncertainties in decision-making, normative and informational. Normative uncertainty refers to uncertainty related to the choice of appropriate policy measures, while informational uncertainty relates to the lack of knowledge, i.e. remaining uncertainty following a risk assessment. Thus even a complete review of all available scientific data will not always provide clear, definitive answers to the risk management questions that regulators must address. Four main uncertainties remain in the assessment: (1) lack of information; (2) measurement of uncertainty; (3) observation conditions; (4) inadequacies of models. Because of this, many risk assessments are inconclusive and the challenge for the decision-maker is to decide what to do with these uncertain results (Van Leeuwen and Vermeire, 2007). There are several approaches but according to Newig et al. (2005), it is important to define the type of the uncertainty in question since as normative and informational uncertainty can be managed in different ways. An attempt to briefly exemplify and discuss the most important methods is presented below. Informational uncertainty can be reduced by additional or improved testing. Simulation models and scenario building can help e.g. to extrapolate and thus also reduce informational uncertainty. Scientific dialogue with various expert as well as discussions with stakeholders is mentioned by several respondents. For example, informational uncertainty can potentially be reduced by including other knowledge sources such as local knowledge on environmental status (Newig et al., 2005). 36 RISKGOV report To rely on judgment of experts has historically been considered to be an important way to deal with normative uncertainty. This is particularly visible in EU’s WFD, where decisions are made by the authorities, on a case-by-case basis, according to the WFD expert. Specifically including appraisal of societal concerns and values can also be a way to address this source of uncertainty (Renn, 2008). ALARP (As Low As Reasonably Practicable) is a management principle commonly applied to reduce risk to. Cadmium (Cd) can be a good example of this approach. At high doses, there is little uncertainty about hazard-harm relationships for Cd – it is toxic. However, there is uncertainty about low dose effects. Since there is a significant uncertainty about the low dose effects, an approach based on ALARP can be appropriate. There are also substantial difficulties in deciding on what is reasonable and practicable. An increasingly common way to cope with both informational and normative uncertainty is to apply a precautionary approach. The precautionary principle, in one of its’ most widely cited formulations, states: “where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation” (UN, 1992). For example, it is included in the Stockholm Convention by requiring Parties through regulatory and assessment schemes to prevent production and use of new pesticides or new industrial chemicals that exhibit POP properties, considering that “lack of full scientific certainty shall not prevent a proposal for global action on a chemical”16. A majority of the respondents from NGOs agreed that a precautionary approach is the only correct way to deal with uncertainty in management; however it was mentioned not to be completely applied in practice. As an example, both precautionary and other management strategies can be seen for the endocrine disrupter atrazine. Atrazine is a herbicide that has been found to have low toxicity and is probably not, as far as can be proved today, a human carcinogen. However, endocrine effects of atrazine have been detected in some studies (US-EPA, 2002). The controversy about endocrine disrupters exists because the hazard-harm relationships are still uncertain; thus, there are different ways to manage atrazine because of this uncertainty. For example the EU regulations ban atrazine, based on Also for prove environmental reason and precautionary arguments; while atrazine is still in use in USA (Sass and Colangelo, 2006). When looking at EU regulations, REACH states that the precautionary principle should be applied, even though that is hardly reflected in the substantive provisions, and REACH partially places the burden of proof with operators (see e.g. Karlsson 2010). However, in REACH some of the hazardous substances may be granted a permit through an authorisation process. A producer needs to show that each substance in question is “adequately controlled” or beneficial from a socio-economic point of view. However, any socio-economic analysis of chemicals meets the problem of how to weigh the regulatory, often obvious, costs in the short run, against the, commonly imprecise, health and environmental benefits in the long run. The authorisation concept in REACH has, therefore, been argued not to be fully compatible with the precautionary principle (Karlsson, 2010). In general several of our respondents recognised the precautionary principle to be very important. However, they all agreed that it is not always applied in practice. Another way to deal with normative uncertainty in management is to apply the participatory approach. According to Newig et al. (2005) it is the most appropriate way to handle normative uncertainty, as it includes different societal values and goals that contribute to developing the final decision. In the WFD, for example, participation is an important instrument for the making decisions on measures to be applied in the river basin. According to the interviewed 16 The text outlines the right of States to refuse a hazardous substance which may pose a threat to human health and/or the environment, even where there is a lack of full scientific certainty. For these reasons, the Stockholm Convention is seen as an example of international adherence to the precautionary principle. 37 RISKGOV report WFD expert, local WFD authorities make substantial efforts to involve the general public in discussions on possible measures. In these discussions, participation generates opportunity to gain insight into social system, provide information about acceptability of alternative actions, thus promoting better informed and, supposedly, more easily to implement decisions (Newig et al., 2005). Participation may also play a concrete role to reduce or manage uncertainty but it can on the other hand be rather time consuming. It is important to mention that the participatory process itself might create new uncertainties, i.e. uncertainties that would not have arisen without letting interested parties participate (Newig et al., 2005). This was exemplified by an authority respondent: “When the science is not conclusive, for pesticides and biocides the decisions are made in the working group by all member states. It is like a negotiation process between the experts. The stakeholders and NGOs can give their inputs. When science is not sure then everyone can discuss”. There are several other ways to deal with uncertainty in management, for example (EEA, 2001): (1) Broaden the sources and forms of knowledge (2) Take public concerns or a precautionary approach into consideration (3) Promote multi-disciplinarity by including relevant social issues alongside physical, chemical, biological and medical aspects (4) Identify and reduce interdisciplinary obstacles to learning (5) Provide ongoing scientific monitoring (6) Scrutinise claimed justifications and benefits alongside the risks Most of the recommendations above relate to the problem of improving the knowledge-base. This will not eradicate all uncertainty or ignorance but it could increase the chances of anticipating costly impacts and achieve a better balance between the pros and cons of the solutions (Soneryd and Andersson, 2008). 2.4.Ecosystem Approach to Management The EAM originates from the recognition that ecosystems are complex and that a multidimensional perspective is needed to manage them adequately. The ecosystem approach was codified in the 1992 Convention on Biological Diversity (CBD). Later it was defined in 12 principles (see table 2.2). Table 2.2 The 12 principles of EAM. Source: (CBD web, 2010) 1 2 3 4 5 6 7 8 9 10 11 12 Objectives of management are a matter of societal choice. Management should be decentralised Managers should consider effects on adjacent systems Manage ecosystem in an economic context Conservation of structure and functioning a priority Manage ecosystems within the limits of their functioning. Appropriate spatial and temporal scales. Management objectives should be set for the long term. Management must recognise that change is inevitable Balance between conservation and use Consider all forms of relevant information Involve all relevant sectors and disciplines One key dimension of the EAM is the holistic systems perspective under which all relevant and interlinked systems and parameters should be taken into account, across all sectors, disciplines and over time. Many interviewees expressed an understanding that failure to reach the objectives for hazardous substances will harm the achievement of a favourable status of biodiversity. At the same time management achievements related to eutrophication and maritime activities will have an impact on reaching the goal of a Baltic Sea undisturbed by 38 RISKGOV report hazardous substances. One NGO respondent stated that since the Baltic Sea is already heavily polluted, additional stressors, such as algae blooms and overfishing, can act together to increase the environmental risks; all stressors therefore need to be kept low. All respondents agreed that different risks are related and to look at how various societal sectors and risks interact is an important part of EAM. For hazardous substances, EAM thus implies that combined effects of different chemical substances should be considered (e.g. so-called ‘cocktail effects’) and that hazardous chemicals and e.g. eutrophicating substances could be relevant to address jointly since lower nutrients levels might, for example, cause release of chemicals from bottom sediments. In general, a majority of the interviewees recognised EAM to be important and a relevant approach to manage the Baltic Sea. Only one interviewee (respondent from academia) hesitated, saying that EAM is an approach which is too general and might bring more uncertainty to the management of the sea. However, it is important to mention that the understanding of the EAM concept varied among the respondents; spanning from understanding it a purely theoretical concept to a practically applicable management tool. When looking at the development over time of chemical regulations (see Annex IV) there is a general trend from single-chemical regulations to broader regulations attempting to implement EAM (such as the BSAP and the MSFD). At a regional level, HELCOM has the leading role in promoting the EAM principle. The HELCOM Ministerial Meeting in Bremen 2003 decided to fully implement the EAM by 2010, using EcoQs as central tools (HELCOM, 2006). At the EU level several environmental directives stipulate strategies, recommendations, and agreements that require a shift from local-based regulations to more ecosystem-based, holistic environmental management (Apitz et al., 2006). The most relevant for the Baltic Sea are the WFD and the MSFD. In general, the launch of the WFD was parallel to the development of the EAM (UNESCO web 2000). What is in line with EAM in the WFD is management of the water bodies according to natural but not political boundaries. The WFD also widens the scope of water ecosystem management since the water status is assessed not only based on chemical measurements but also on ecological ones (e.g. phytoplankton and fish). The MSFD also goes toward adaptation of EAM by developing 11 different indicators for describing good ecosystem status. Chemical status is only one of these indicators. Particular targets for all of the indicators will be defined, often at the regional levels, by the Member States, for the Baltic Sea supposedly coordinated within HELCOM . Although the outcomes of the MSFD process are unknown, the procedure does allow for a more flexible approach than the WFD and enables consideration of ecosystem-specific sensitivity (Nõges et al., 2008). Many experts interviewed for this study, also stressed that the MSFD might be able to improve the management of the Baltic Sea and fully incorporate the EAM. It is clear that the EAM is an important principal aspect of water management in the EU and HELCOM. However, particularly for chemicals, not much has been changed in current regulatory practice. Both the BSAP and the WFD define lists of single substances that need to be controlled. The majority of the respondents agreed that this approach is too far from implementing the EAM, as it does not incorporate either cocktail effects of chemicals mixtures or an understanding of interactions among risks. “One chemical might not do that much damage for the ecosystem as the mix of chemicals”, noted one respondent from an authority. It was also said that “you cannot point at one chemical. The cause of the problem is very complex. To solve the problem you have to look at the whole ecosystem”. Moreover, existing regulations are based on rather simplified assessments (explained in previous chapters). For example in the WFD, the measurements of the chemicals are conducted in water, when the concentration of the chemicals can be detected in sediments or biota at several times the level found in the water (Hinsby et al., 2008). A recent comprehensive review of the risk assessment of chemicals also concluded that at the present level of understanding, it is usually not possible to predict adverse effects of chemicals on ecosystems “We are only able to assess risks in a very general and simplified manner” (Van Leeuwen and Vermeire, 2007). 39 RISKGOV report An important question is then whether the EcoQs concept that expresses good quality status of the ecosystem is an appropriate way to approach EAM. Some interviewees argued that EcoQs are science-based. It seems to be a rather technocratic approach in which science defines measurable standards to which a phenomenon has to comply (Heslenfeld and Enserink, 2008). EcoQs emphasises ecological targets and put less attention to socio-economic aspects of EAM (principle 1, 4, 10, 11, 12 are not fully included). They focus on good environmental status of the marine/water environment, rather than on balancing multiple objectives of ecological, economical and societal development (Van Hoof and Van Tatenhove, 2009). However, almost all human activities have a direct and indirect impact on ecosystems and often need to be managed in an ecosystem context in an integrated manner. The EU Marine and Maritime Research Strategy also reflects emphasis on an “integrated approach to cope with ecosystem complexity” (Van Hoof and Van Tatenhove, 2009). Furthermore, the Maritime Policy (MP), or the newly adopted EU strategy for the Baltic Sea, may be seen as integrative and participatory policy arrangement, as they seek to bring together actors from a wide variety of sectors (shipping, oil and gas extraction, fisheries and conservation) and also raise the issue of balancing ecological and economic objectives. Thus, it is possible to conclude that from the 12 principles of EAM, only some are currently incorporated in the assessment and management of hazardous chemicals. Results of our interviews indicate that a lack of implementation lies to some extent in the understanding of the EAM concept and its practical implementation. For example, even though agreeing on the importance of EAM, none of the interviewees had a clear vision about the practical implementation of EAM. “It is like the precautionary principle. It is the way it should be done but it is not always the case” mentioned one of the politically active respondents. Some NGO respondents argued that marine protected areas and biodiversity protection (mainly by stopping overfishing) are the good ways to practically implement EAM. Some interviewees also mentioned development of appropriate EcoQ, while others considered designation of areas in the Baltic Sea as PSSA (particular sensitive sea area) as the main EAM implementation tool. Today the Baltic Sea PSSA is approved by IMO (since November 2005), excluding Russian waters. However, several of the interviewed experts mentioned the importance for the Baltic Sea to be PSSA in the framework of EU, as this might have a greater effect on chemical target levels. Several barriers for the implementation of EAM were also mentioned. Particularly lack of appropriate tools and methods, neglect of socio-economic aspects as well as existing sectoral barriers were highlighted. Or as a respondent from an authority put it “We don’t have any structure that is dealing specifically with the EAM. We cannot accept that some issues are left to the fisheries and other to chemicals regulating bodies. It is one ecosystem. It is easy to say but very difficult to achieve if you have already existing bodies responsible for these things, sectoral division. At least we need more cooperation between authorities”. 2.5.The Role of Science The interactions between experts and policy-makers have emerged as an important discourse in many scientific publications (Soneryd and Andersson, 2008; Maasen and Weingart, 2005; Backstrand, 2003 and Brint, 1990) as well as in most of our interviews. This probably relates to an increased importance of risk assessments in policy development concerning environmental and health issues (Cohen, 1997; Haverland, 2009, Kurth and Glasmacher, 2008). The European Union, as a political system, has a number of characteristics that promotes an increased importance of science (Haverland, 2009). A major source of the EU legitimacy lies in the quality of policy, guided by criteria such as “rationality” and “effectiveness”. Expertise is required for this purpose (Radaelli, 1999). Because the European Commission itself has relatively limited resources, it is dependent on external experts. At the stage of strategy determination and policy preparation, numerous expert committees support the Commission. 40 RISKGOV report In the preparation and contextualisation of policy implementation, the Commission also works together with experts in the so-called “Comitology” (Steunenberg, Koboldt and Schmidtchen, 1996). Comitology in the European Union refers to the committee system, which oversees the delegated acts implemented by the European Commission17. The WFD and the MSFD were developed using comitology procedure. The comitology procedure is thus an example of a governance process resulting in a rather high importance of science in EU decisions. The “common implementation structure” is the main instrument for the decision making process for the MSFD. The coordination group involves member states, neighbouring countries and relevant stakeholders. The work is then divided among different working groups; one of them is “good environmental status”. ICES and JRC gathered the expert group to deal with the 11 descriptors for good environmental status. They worked for one year and made a report and presented the state of the art and suggested indicators and criteria to use. The results were presented to the coordinating group with suggestions on how to define indicators for good environmental status. “Of course this became a discussion, back and forth between experts and the coordinating group” a respondent with insight into the process explained. Thus, expert influence was clearly visible in development of the MSFD.. A similar approach was also used in the WFD. Thus, both the WFD and the MSFD have rather technocratic approaches in which science defines a measurable standard to be reached (van Hoof, 2009). A different role of science can be seen in the REACH. With REACH a crucial shift of risk assessment responsibility in some parts of REACH has taken place, from experts in authorities to the industry. However, according to Bodar et al. (2002) authority experts still have an important role in the new risk management system. These experts are still needed in order to “check the industry assessment, to develop new methodologies, non-animal testing, guidelines, new tools, interpretation of how the assessment needs to be done”. Furthermore, public experts play a key role for e.g. authorisations and restrictions in REACH, i.e. for the most protective among all provisions. In general, respondents agreed about the need of science to understand chemical risks for the ecosystem and human health. At the regional Baltic Sea level, science was mentioned to be very important for the work of HELCOM, “We are definitely based on science firstly” mentioned an expert from HELCOM. HELCOM has built a long-term established cooperation with scientific experts, monitoring experts and expert groups that provide advice to policy makers. There are also differences between various Baltic countries concerning the role of science in policy making. Some countries tend to rely mainly on expert advice in their regulations, usually in the form of expert committees. Others have set up extensive negotiation procedures, in which a wide range of groups participate, even in rather technical discussions (Soneryd and Andersson, 2008). In some countries, regulation is based on a precautionary approach, which requires that risks should be minimised, even if the causes and mechanisms are unknown. As an example, in Sweden the precautionary principle is recognised to be very important (although a few respondents argued that even in Sweden there is an overemphasis on strong scientific evidence), which differs compared to e.g. Poland (Eriksson et al. 2010b). In summary, science plays an important role in the management of the chemicals both at EU and HELCOM levels. The influence of experts can be explained by the fact that scientific results sometimes are so complex that not many (for example the general public) can evaluate the whole process that underpins the outcome (Soneryd and Andersson, 2008). However, there is seldom sufficient knowledge for well-informed scientifically based decision-making 17 However, there are differences depending on the statutes in question, for e.g. REACH authorization, a committee of Member States representatives decides on the outcome. 41 RISKGOV report and consequently, risk managers might overestimate the reliability of risk assessment outcomes (Verdonck et al., 2007). 2.6. Discussion The results of WP 2 show that despite advances in the field, risk assessment and management still face a number of substantial challenges, including: Speeding up the processes of risk assessments Lack of data, which leads to uncertainty in risk assessments; Establishing risk assessments for many unevaluated chemicals and mixtures of chemicals Developing policies for decision-making under uncertainty The complexity is presented both in the science and policy dimensions. Socio-economic ambiguity, as well as regulatory and ecosystem complexity are just some of the challenges for risk management. There are several different chemical risks assessments approaches used internationally, on EU and HELCOM, national and local levels. REACH, the WFD, the MSFD and HELCOM chemicals risk assessments are the most relevant for the Baltic Sea region. While REACH assessments partially are proactive (as new chemicals will be assessed before being placed on the market), other assessments (WFD, MSFD, HELCOM) are rather reactive since they focus on chemicals that are already present in the environment. Proactive and reactive assessments differ in terms of methodology and data availability. There are many problems in the environmental risk assessments which need to be resolved, examples are: (1) (2) (3) To harmonise the methodologies among different assessments and improve synergies and feedbacks. To develop appropriate assessment and monitoring strategies for: a. determining the effects at population and community level b. selecting appropriate end-points and indicator species c. selecting appropriate field and laboratory tests d. incorporating assessment of resilience and ecosystem recovery e. assessing cocktail effects of chemical mixtures Involve decision-makers and stakeholders early in the planning and scoping of the risk assessments. For chemical management, there are many possible approaches for improvement and for complementing the presently dominating reactive risk reduction approach, in order to reduce overall chemical loads. However, priority substances in focus differ among regulations, showing that there is no general agreement on prioritisation mechanisms and which chemicals thus need to be controlled firstly. From this point of view, REACH includes a step towards a more proactive approach, but many REACH procedures are slow and not based on precautionary management of uncertainty, which stalls appropriate measures. Finally, the lack of clear management strategies for dealing with chemical mixtures is a major challenge that needs to be addressed. Concerning scientific disagreements several respondents mentioned that disagreements are mainly based on different backgrounds, training and knowledge. Thus, a possible way to reduce scientific disagreement would be to develop closer interdisciplinary cooperation. Substantial uncertainty is present in both chemical risk assessment and management. A general accepted and systematically applied approach for assessing and handling these uncertainties is lacking. According to Ruden and Gilek (2010) the approach used for coping with uncertainty relies on case-by-case expert judgments and that results therefore might vary depending on experts training and experience. Thus, a strategy to deal with uncertainty in risk assessment is to improve guidelines and requirements on uncertainty assessment in 42 RISKGOV report assessment methodologies (Fairman, Mead and Williams, 1998). This might improve coping with uncertainty also in risk management. We argue that strategies for assessing and communicating uncertainty need to be improved by developing common guidelines. These common guidelines should identify what level of detail to use in characterising uncertainty to support risk-management decisions and public involvement in the process. Methods for addressing major types of uncertainty already exist, and the guideline should therefore primarily focus on developing a better understanding of when and which analyses to apply in specific cases. The majority of the respondents recognised the EAM as important and relevant for the Baltic Sea environment, even though the concept was understood and interpreted differently by different experts, including its meaning in practise. According to respondents, EAM is not fully integrated in current regulations, neither concerning assessment nor management. This is particularly relevant for chemicals, as there are no adequate methods for assessing chemicals effect on the ecosystem (including chemicals cocktail effects and interactions among risks), nor for managing chemicals on such a basis. In risk assessments a better understanding of ecosystem complexity and of complex human and ecosystem interactions are this needed, as are improved management approaches for balancing social, economic and ecological objectives. In the Baltic Sea perspective, the question of ecosystem-specific risk and sensitivity has a great importance for implementing the EAM. In chemical policy, risk assessment (as an objective scientific exercise) is commonly separated from risk management (considered to be purely normative). The EAM spans over the two parts, thereby underlining that assessment indeed is a part of management, and that management without appropriate assessment would be quite ineffective. In general, a high level of uncertainty and recurring calls for implementation of the EAM affects the traditional system of science-policy interactions. If scientific certainty cannot be provided, what should then guide the final scientific conclusions and political decisions? The results of WP 2 show that at the EU and HELCOM level, science plays a very important role in the chemical decision-making. Risk assessments usually follow a rather technocratic model both in EU and HELCOM, despite the development of the new models of risk governance (Renn, 2008). Risk management procedures also rely heavily on science, although there are trends to increase public participation and to apply a precautionary approach to both risk assessment and risk management. However the role of the various actors in the risk governance still seems not to be well defined. Many respondents expressed an interest in guidelines better defining the relationship between the scientists, decision makers and stakeholders, for example in the framework of the WFD. “We need to clarify our roles” as mentioned by an interviewed expert from an authority. 43 RISKGOV report 3. Working Package 3 – Stakeholder Communication SUMMARY WP 3 describes and analyses how risks of hazardous chemicals are framed by key actors and stakeholders in the Baltic Sea region, such as governments, agencies, regionally intergovernmental agencies such as HELCOM, economic actors, academia, and civil society. It is shown that different actors have different ways of framing the risk of chemicals in the Baltic Sea. For example, differences were observed along a gradient spanning from framing chemicals and chemical products as basically useful for society, to framing chemicals as substantial threats to the environment and human health. Most interviewed stakeholders could be placed somewhere in the middle of this gradient between benefit and cost. This is reflected in the dominant opinions expressed on required general management approaches, which do not fundamentally question abundant production of chemicals, but rather suggest a focus on managing chemicals with proven hazardous properties, thus tilting towards a market rather than an environmental starting point. This view on chemical risk management is rather surprising given the major uncertainties and lack of data described in WP 2. In light of this we propose that the management of chemicals might benefit from a shift towards seeing quality of life as based on sufficiency of chemicals rather than on (over)-abundance of them. Many of the interviewed stakeholders (e.g. politicians, journalists and NGO staff) also expressed a surprising lack of interest in the environmental risks of hazardous chemicals in the Baltic Sea region. If concern mostly expressed was health risks of chemicals. It is also clear that besides some NGOs and other stakeholders, quite few have a primary focus on taking initiatives for improving the management of chemicals, something that is a problem given the common political ambitions to increase participation in connection with implementation of the EAM. WP 3 also analyses existing institutional arrangements for and procedures of risk communication at the regional Baltic Sea level. Clearly, communication between the EU and Russia is still in need of improvement, as is two-way communications and cooperation between stakeholders, as well as between actors connected with risk assessment and risk management and the general public. For example, in those (rare) cases when scientific information about chemicals does exist, it is not well communicated among knowledge producers and stakeholders, and current scientific assessment activities seldom relate directly to concerns of stakeholders or the public. 44 RISKGOV report 3.1.Risk Framing Jasanoff (2003) states that the quality of solutions to problems depends on the way they are framed. If a problem is framed too narrowly, too broadly, or wrongly, the solution will suffer from the same defects. Today, chemicals are framed to be important (e.g. pharmaceuticals) but are also a threat to human life. In the first case where chemicals are framed to be important, the term chemical is a product or a function (e.g. soft plastic or medicine). Users of chemicals do not want the chemical “products” as such, but just the “services” that their chemical properties bring (EEA and UNEP, 1998). For example, one interviewed Russian expert mentioned products like shampoos and creams are marketed to be the products that “make things cleaner; however in practice they pollute human bodies and the environmental with hazards”. Similar marketing strategies were previously used for hazardous chemicals such as Bisphenol A (as soft plastic for baby bottles) or DDT (as a safe pesticide) (see Fig. 1) Today the danger of using DDT or plastics containing Bisphenol A is recognized. Figure 3.1. DDT Advertisement, Time Magazine 30 June 1947 The use or banning of chemicals is still “a dilemma for us living on this planet. On the one hand we need and use chemicals to solve our problems, but we also create more problems in this way. We don’t even think how much we will pay in the future in terms of health and environment” stated an expert from the academia. This shift in focus from chemicals to products can affect the relationship between chemicals and environment because the chemical itself shifts from being the source of pollution to be a source of “good service” (EEA and UNEP, 1998). According to several NGO respondents, NGOs inform the society about the chemical content of the products and their hazards and risks. In this way they are trying to “deconstruct” a frame of “important for life” products. Today, abundant production and use of chemicals is not questioned in general; it is only chemicals with proven hazardous properties that are the main concern. However, the respondents all agreed that the presence of chemicals in the environment (e.g. Baltic Sea, air, human body and mother milk) is a problem. Still, there were different views among different stakeholders on the extent and type of the problem. In EU regulatory documents, it is possible to define three main regulatory frames of chemicals risks as 1) health threats where consumer protection, safety of food among others are mentioned. 2) environmental risks where REACH, the WFD and the MSFD are mentioned and 3) health and safety at work which brings up EU legislation on protection of workers from the risks of chemicals at work18. The EU legislation therefore tends to separate chemical risks to the environment from human health risks19. This affects assessment and management 18 19 http://ec.europa.eu/health-eu/my_environment/chemical_risks/index_en.htm It should be mentioned, though, that REACH covers both health and environmental risks. 45 RISKGOV report strategies (described in WP 2). For example, assessment of environmental and health risk are usually separated, which might not be the most appropriate way to assess the risks according to an interviewed expert from academia (see more in WP 2). The HELCOM regulatory documents (e.g. Helsinki Convention and the BSAP) frame chemicals as a threat to both environmental and human health. Economic and social consequences of environmental degradation caused by chemicals are not included. The respondents also had different ways of framing the issue. Several interviewees were mainly concerned with potential effects on human health, for example risks related to increased rates of cancers, physical birth defects and mental retardation. Some also framed the issue to the chemical content that can be found in fat fish. The respondents often stated that “the fish is unhealthy to eat”. The Swedish National Food Administration similarly recommends children, pregnant women and women who are planning a family, to avoid eating fatty fish species from the Baltic Sea more than twice a year (SNFA, 2008). A respondent from a NGO commented that “we are already accepting in the society the fact that you cannot eat fish from the Baltic, I think that this is outrageous”. Other respondents were concerned with the health of Baltic Sea top predators (e.g. seals), while still others mentioned general loss of biodiversity. Some had a more holistic approach and were concerned about the health of the Baltic Sea ecosystem (that includes humans) in general. Moreover, many chemical-testing policies focus on testing particular chemicals (not mixture) and thus frame problems related to particular hazardous chemicals (see more in WP 2). The same was observed during our interviews; respondents were concerned about particular hazardous properties of particular chemicals (e.g. DDT, dioxin and PCB). However, several respondents also mentioned chemical mixtures and cocktail effects as an important issue. One of the respondent stated that ”this is a big concern, especially when taking into account that our knowledge about combinations of chemicals is very limited and the number of chemicals is constantly increasing”. In this case the chemical pollution was framed as a very complex and uncertain problem, which given the state of knowledge is seen as hard (if not impossible) to manage. Several respondents were also of the opinion that it is almost impossible to predict the seriousness of the problems that we are facing. Some respondents also had different views concerning the causes of the problems and what measures can be taken in order to reduce them. The mentioned causes of the problem were seen in individuals and industry as well as in general human activity. One of the NGO respondents was of the opinion that the solution to the problem of hazardous chemicals is termination of chemicals production in general. However, none of the other respondents supported this idea. They discussed different methods to reduce emissions of chemicals; starting from individual action, better regulations and better application of the regulations, industry actions to the joint efforts of all of these. Everyone agreed that it is hard to pick only one solution that will solve the problem. All interviewees agreed that chemical pollution is not the main environmental or health concern in the Baltic Sea area. An expert from a Swedish authority expressed the view that “for me the main risk in the Baltic Sea is the increased transport of oil”. Several NGOs also admitted that the issue of chemicals in the Baltic Sea might not be the top-issue on their agenda. An expert from a Finnish authority agreed “we will see the effect of the chemicals risk only over time”. So far, according to several respondents, eutrophication receives more attention in the media. The reason for this was because eutrophication is a problem that can be visualised, which is usually not the case for chemicals; consequently media may more rarely writes about chemicals. According to several respondents, chemicals risks are mentioned in media in relation to contaminated fish and the gas pipeline (Nord Stream) in the Baltic Sea. Adding to this, some interviewees mentioned that the issue of chemical pollution is not on the top of media’s agenda, as there is a general lack of interest in environmental problems. They argued that this is quite natural due to the economic crisis and the predominant interest on 46 RISKGOV report climate change related topics. Similar comments were given by Russian experts. However, compared to respondents from EU member countries, environmental issues receive less attention in Russia – “we need to wait for a disaster” in order for environmental issues to be raised in Russian media, commented a Russian respondent. Moreover, environmental problems in the Baltic Sea are considered to be “less important” compared to those in the lake Baikal. Thus, it is possible to observe a lack of strong attention to the chemical risks in the whole Baltic Sea area. Several interviewees agreed that if the issues are not discussed often by the public they will probably not be discussed by the media and vice versa, which will definitely affect the political discussions and the possibilities for management actions and research funding. 3.2.Institutional Risk Communication and Public Participation Communication about the risks of chemicals is a critical element for a sustainable chemicals policy. It enables and empowers those affecting or affected by chemical production, use and disposal, to make informed decisions that minimise risk (Denison and Scientist, 2005). For a long time, risk communication focused on educating and persuading the public (Fischhoff, 1995), but this understanding has gradually been replaced by communicative risk governance, in which exchanges of views take place between policy makers, experts, stakeholders and the general public (Renn, 2008). The various structural units of the EU and HELCOM serve as communication platforms in the Baltic Sea region. For example, Swedish and Finnish environmental and chemicals authorities communicate results of monitoring and assessment to the responsible bodies of the EU or HELCOM, and simultaneously find results there, of monitoring or assessment done in other countries. Communication within other international structures like ICES or OSPAR was mentioned by some of the respondents to also be important, even tough less important than the EU and HELCOM. Many interviewees mentioned the growing importance of the EU for risk communication in the region, but EU was also seen as a barrier for direct communication; an interviewed researcher for example said that “many decisions are not made in Sweden but at the EU level. Even if you convince the Swedish politicians, you cannot convince the whole Europe. You have one representative from Sweden and even if he agrees with you, you are not sure if he will convince the others”. The media does hardly cover the chemicals issues at EU level, according to some interviewees. Stakeholders in the Baltic Sea countries are therefore not always aware of major issues concerning chemicals, and have then obvious problems in influencing decision-making. According to an interviewed EU expert this is due to the low activity in the field of the EU and national media, which in turn reflects a low interest among the public. The public definitely has an impact on media’s coverage, which might result in a vicious cycle. Within the EU, there are attempts to improve regional management and risk communication. One attempt was made with the introduction of the WFD even though the introduction of new structures (e.g. river basin commissions) has been criticised for creating regulatory complications (Nilsson and Langaas, 2006; Mylopoulos and Kolokytha; 2008). In contrast, the MSFD will not necessarily lead to creation of new regulatory bodies, but promotes using existing ones (HELCOM, for the Baltic Sea) to coordinate action. HELCOM can in that case become a more important communication platform in the region. According to several interviewees, the BSS is also an attempt of the EU to strengthen the power of HELCOM in the region. Obviously, these EU measures do not reach to Russia. As an interviewed authority expert said; ”Russia and Norway are not parts of the EU. But we are trying to involve them in our activities” and added “We have not found any contacts in Russia yet, it really takes time”. The problem of communication between EU and Russia was raised several times during the 47 RISKGOV report interviews with politicians, authorities and scientists. From the Russian side, several interviewees agreed on the problem, and one Russian journalist said that “The main problem is that Russia has little communication with the EU and vice versa. We know little about each other”. The language problem was also mentioned by an interviewed Russian journalist, “everything that is in English is kind of “silent” for Russia”. A Russian industry expert also claimed that Russian companies have little or no information about REACH. This might be a problem, since chemicals can still be imported to EU in products. The executive director of ECHA also discussed this issue during t he 4th Stakeholders’ Day of the European Chemicals Agency, May, 2010. He mentioned that there are several cooperation projects between ECHA, Canada and USA, but not with Russia. He explained that this is because there is no single agency to cooperate with in Russia, “There is no structure similar to ECHA in Russia. It is hard to know how and with whom to cooperate.” The EU and HELCOM were mentioned to be good platforms of communication for politicians and authorities but not for independent single scientist or laboratories. For example, during interviews with scientists it was mentioned that research about the same substance sometimes is done in several countries, which was seen as misuse of funding. If different methods are used to analyse chemicals then different results will not be comparable. An example of this can be seen in HELCOM’s latest chemicals risk assessment report, where different thresholds levels for chemicals were used by different countries (HELCOM, 2010). Several voices were also raised for improving information on what research is ongoing. A respondent from an authority explained that the main communication in for example Sweden is based on personal contacts, “It is important to know the right people and have a network of contacts. If you send a letter to the agency, you will never know where it will end up”. However, this mechanism might not be easy to apply for the whole Baltic Sea region and several interviewees mentioned that an improved Baltic Sea regional research network is needed. Participation and communication with general public Participation and communication with the general public is recognised to be an extremely important element of risk governance (Renn, 2009). The concept of the public’s “right-toknow” (RTK) in the context of chemical information has received increasing attention in chemicals policy. The spread of Pollutant Release and Transfer Registers (PRTRs)20 is one example of the legally-binding implementation of RTK. Aarhus Convention requires the parties to this convention to set up PRTRs as a tool to provide the information to the general public (AC web, 2011). With the worldwide spread and implementation of PRTR programmes, a number of meetings and activities are taking place to share information and advance the development of these programmes. Another example is the EU’s “Seveso” Directive on Hazardous Installations where the public are informed by employers. Furthermore, the Chemicals Product Register in Denmark, Finland, France, Norway and Sweden helps to promote an understanding of which chemicals are found in consumer products (EC, 1996). There are numerous attempts of international actors to communicate to the public through new media techniques. As for example: The "Safe Planet Campaign" of the United Nations The documentary "The Disappearing Male" (CBC Documentaries) The film "Underkastelsen" by Stefan Jarl (original in Swedish, English title: "Submission: The defence of the unborn") The book and film "La Grande Invasion" by Stéphane Horel 20 http://www.prtr.net/ 48 RISKGOV report At the Baltic Sea level, the communication is lead by HELCOM, EU and several regional branches of international NGOs like Greenpeace, FoE and WWF as well as national NGOs and industry. HELCOM According to HELCOM rules, any intergovernmental organisation or non-governmental international organisation (with specialised technical, scientific or equivalent expertise pertinent to objectives of the Convention) can be represented as an observer at the meetings of the Commission, given that some basic criteria are met. These are examples of NGOStakeholders involved: Alliance of Maritime Regional Interests in Europe (AMRIE), Baltic Farmers’ Forum on Environment (BFFE), Baltic Ports Organisation (BPO), Baltic and International Maritime Council (BIMCO), Birdlife International; European Chemical Industry Council (CEFIC), Coalition Clean Baltic (CCB), Union of the Baltic Cities (UBC) and World Wide Fund for Nature (WWF). A respondent stated that the work of HELCOM is mainly driven by science: “We have established a growing and long term corporation with scientific experts, monitoring system, expert groups which provide advices to policy makers. For example we have a monitoring assessment group, which consists of scientists. They provide assessment so that policy makers can judge what should be done”. The stakeholders are invited to the meetings as observers but they are not directly involved in the work of for instance the risk assessment expert group. A similar approach (i.e. that assessments and monitoring are not fully open for the public) is used in some of the EU programmes and in national programmes. For example, an interviewed expert from academia commented the process of selecting chemicals to be monitored “it is a closed council that decides on the monitoring of the chemicals”. At the same time, it is important to mention that substantial efforts have been made by HELCOM to adjust the reporting of assessment results to different audiences. For example, illustrated Atlas “comprehensive Atlas of the Baltic Sea”, TV-series “the Baltic – Sea of Surprises”, radio series "The Baltic - A Sea of Change" are all available at the HELCOM interactive webpage. However, several of the interviewed experts and stakeholders thought that more and better examples of such adjusted information and communication are required. For example, the Minister of the Environmental Protection of Finland clearly stated during the HELCOM seminar 2010 that “more simplified information is needed”. European Union A majority of EU documents regarding the environment, health, risk and safety issues include calls for public participation in the management (De Marchi, 2003). For example, the Decision on conclusion of the Aarhus Convention by the EC (EC, 2005) and later Regulation on the application of the provisions of the Aarhus Convention (EC, 2006) strongly support public access to environmental and participation. Further, the sixth environment action programme (EC, 2002a) is a current example that recognises and strongly encourages public participation. Another important document that stresses the importance of public participation is the European Commission White Paper on European Governance (EC, 2001a). In this document, governance is described as “rules, processes and behaviour that affect the way in which powers are exercised at European level, particularly as regards openness, participation, accountability, effectiveness and coherence” (EC, 2001a). Similar ideas are described in the European Commission Science and Society Action Plan, where the recommendations are to take into account different types of knowledge (EC, 2002b). The WFD is one of the first European regulations that explicitly demand a high degree of involvement of non-state actors in the implementation (Newig et al., 2005). According to the WFD, member states shall encourage the active involvement of all interested parties in the implementation of the directive; more detailed and stringent rules are given for public information and consultation in the production of the river basin management plans. The interviewed expert working with local implementation of the WFD agreed that participation is 49 RISKGOV report indeed important in practice. However, this is mainly the case for the implementation part, and not so much for the assessment and monitoring parts of the WFD. “The information is really technical and it is really hard for common people to understand what we are doing. Sometimes we feel that we have a bad status in a water body due to agriculture or forestry problems, and of course the farmers think it is not their problem”. The same expert added that they use scientific methods and cannot involve local knowledge, since even if local knowledge is good it is not scientifically based. The final conclusion made about the status of the water after assessment can definitely affect the selection of appropriate actions. Thus, lack of public participation at the first assessment stage might affect management outcomes in the WFD. In general, several interviewees mentioned that a socio-economic dimension was not being fully incorporated in the WFD. “People just want to be secured. They don’t want to get involved in the chemicals assessments”, said a Russian scientist. The MSFD calls for an increased participation among stakeholders in marine governance. The mechanism through which this will be implemented is yet to be determined (De Santo, 2010). The chapter on “Updating, Reports and Public Information” of the MSFD sets requirements for providing access to environmental information and public consultation. In particular, Member States must regularly review their individual and regional marine strategies, report on the implementation of these instruments, and ensure that this information is publicly available. By seeking integration and participation, cutting across sectors, the Maritime Policy (MP) can be seen as an integrative and participatory policy arrangement. It seeks to bring together actors from a wide variety of sectors, hence also with an agenda covering a wide range of issues. It brings on board new actors or at least brings them together in a new configuration. The MP is thus an inclusive approach, embracing and incorporating, for example, both the common fishery policy and the MSFD. Integration raises the question of inclusion of increasingly heterogeneous stakes and stakeholders (shipping, oil and gas extraction, fisheries, and conservation) and also raises the issue of balancing ecological and economic objectives. The recently published “Marine and Maritime Research Strategy” (EC, 2008) reinforces this emphasis on an “integrated approach to cope with complexity”. Looking at the participatory management in REACH, it enables civil society organisations to participate in discussion of the chemicals to be authorised (see more information in WP 2). According to an interviewed expert from ECHA, dossiers submitted by member states are published on the ECHA web page, whereafter “We invite each interested party to comment them for a period of 45 days. If we do not receive comments of these documents it will automatically be taken to the candidate list of substances annex 14 (candidate substances to authorization”). For the latest proposal of eight new substances, 460 comments from all over Europe were received. 57% of the comments come from the industry. “The Industry is usually the biggest part; then member states and then NGOs” noted the same expert from ECHA. Another expert from ECHA mentioned that, with growing recognition of the participatory approach, the REACH authorisation process is comparatively slow since “in the democratic society, everyone who wants to say something needs to be heard”. However, REACH has also been criticised by environmental NGOs because of several aspects; it does not provide sufficient public involvement and enough access to data (see e.g EEB position on REACH21. On the other hand, one of the most comprehensive reviews of the inclusiveness in the REACH framework concluded that there is certainly some cause for satisfaction (Heyvaert, 2008). Other concerns are availability of information on a chemical once it enters a product, and procedures for requesting information are too cumbersome. At 21 See the position statement on REACH of the European Environmental Bureau, available at www.eeb.org/activities/chemicals/20031210-EEB-position-on-REACH.pdf, and the Copenhagen Chemicals Charter, www.eeb.org/activities/chemicals/Copenhagen%20Chemicals%20Charter2310.pdf. 50 RISKGOV report the same time article 33.2 of REACH states the importance of communicating information about candidate list substances in products. Industry Traditionally, the flow of information on chemicals is limited among industries. Producers and downstream users have little incentive to share information. This is explained by the confidential business information (CBI) rules (Denison and Scientist, 2005). However, it is critical to other actors in the value chain to have that information for a wide range of purposes - including meeting regulatory obligations or supplier/customer requirements, disclosure and labelling, and assessing risk (OECD, 2004). REACH improves the flow of information between the actors in the supply chain. Specific risk information must be included into the registration chemical dossier at ECHA (see more in WP 2). This is a controversial regulation since on one hand it aims to improve the public data availability for the safety improvement (that also goes inline of the EU governance strategy) and on the other, industry is concerned about misuse of the business related information. There are also several limitations to what information must be delivered in the registration chemical dossiers. During the 4 th ECHA stakeholders’ meeting, the main concern of industry was the confidentiality of the information provided. ECHA acknowledges the problem, but as mentioned by the Executive Director of ECHA “all will be able to profit from increased information in the future”. While there can be legitimate reasons for certain information to be confidential business information (CBI), the public needs to be provided “with explanation” for making conceal any data. According to interviews with NGOs, any data relevant to assessing the hazard, exposure or risk posed by a chemical should not be qualified as CBI. Still, many voluntary initiatives have been taken by the industry itself. For example some of the companies in the Netherlands have succeeded in strongly reducing their emissions of volatile organic compounds (EEA and UNEP, 1998). Many measures, including information sharing, are taken by industry in the frame of corporate social responsibility (EEA and UNEP, 1998). Labelling is another way to make information available to the public. Many efforts today are done in order to harmonise the labelling requirements across countries, for them to be accessible for all consumers (Pratt, 2002). The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) has been developed under the auspices of the United Nations ECE. The GHS (which can also be applied to consumer products and pesticides) includes: (a) harmonised criteria for classifying substances and mixtures according to their health, environmental and physical hazards; and (b) harmonised hazard communication elements, including requirements for labelling and safety data sheets. Much effort has been done by labour organisations to improve the amount and quality of the information available to public, mainly to workers (Tietenberg and Wheeler, 2001). The organisations have generally supported REACH legislative efforts, arguing that many companies consistently fail to provide enough information for the workers (Cole, Elliott and Lindley, 2009; Selin and VanDeveer, 2006). Non- Governmental Organisations Some authors argue that NGOs are stakeholders that play an important role in risk communication of chemicals (Lahr and Kooistra, 2009). Environmental NGOs have earlier been shown to have a crucial role when raising awareness to the general public concerning environmental issues (Anderson and Chiavari, 2009). All NGO respondents considered that raising awareness on environmental issues is a very crucial part of their work. They may also want to start dialogues among politicians, 51 RISKGOV report authorities, industries, NGOs and the public in order for actions to be taken. One respondent explained that they collaborate with specialists around the world to get the latest information on substances and that this information is subsequently used to raise general public awareness. Others have their own research laboratories that provide scientific information. One NGO commented on the importance of raising awareness among the public “once you succeed in raising an issue…, it starts to get its “own life” so our work is not that necessary anymore”. Compared to the general public, NGOs often have access to political negotiations, which is why awareness rising is such a crucial task in order to prepare the ground for politicians to make decisions; “politicians are sensitive of the pressure since they want to get votes so we definitely need the support of the public”. However, NGOs try to affect not only final political decision but also individuals; as one respondent from an NGO said “one can think that a person can’t do much about for instance the dioxin level in the Baltic Sea, but reductions of chemicals are much easier to accept if there is an awareness and knowledge about the issue”. Some respondents from NGOs mentioned that they also work to inform the private sector in order to reduce the production of products containing hazardous chemicals. Thus, NGOs are trying to affect all involved stakeholders that have an impact on the issue. However, although research has proved that NGOs are powerful in raising awareness among the general public about chemical risks in the Baltic Sea, some scholars claim that NGOs have been less influential then industry and have had limited opportunities to engage politicians and the industry (Heyvaert, 2008; Selin, 2007). Websites were mentioned to be a major communication tool for the interviewed NGOs. Some of them also organise conferences and meetings where specialists and other actors are invited in order to discuss hazardous substances. One NGO mentioned that it has communication channels in order to target teachers. Those channels are used to develop specific material for education, as “they are the key players for the coming generations”. Another responded from an NGO stated that it is more important to focus on having an impact on politicians; thus they are working with specific articles, papers, open letters and meetings directed to politicians. While some NGOs, e.g. Greenpeace, have strong campaigns on chemicals found in electronic products to prevent e-waste to be sent to developing countries, others (e.g. SSNC) show a great interest and focus on chemicals found in other products (toys, clothes, shoes etc) (Greenpeace web, 2010; SSNC web, 2010). To summarise, different NGOs use different communication strategies and target groups in order to promote improvement in chemicals management. These differences often take the form of division of labour (i.e. different NGOs focus on different issues) as well as reflect the different main focuses of the NGOs. Some of the respondents recognised the importance of joint efforts of Baltic NGOs in order to solve chemicals pollution issues. The Coalition Clean Baltic (CCB) is a good example of a NGO network, working with environmental problems of the Baltic Sea. The main goal of CCB is to “promote the protection and improvement of the Baltic Sea environment and natural resources” by lobbying, raising awareness, supporting member organisations and initiating projects in the field (CCB web, 2010). Communication between Science and Policy The role of science in policy making can be seen in different ways (see WP 2). However, the majority of the interviewees were of the opinion that scientific findings need to be communicated to the involved stakeholders. The communication issues in the frame of science-policy interactions were raised several times in the course of the interviews. At a first glance, the science-policy interface may seem to be straightforward: at the interface, relevant scientific findings are passed on to policy-makers in national governments or international institutions. However, researchers provide information which might be: (1) lost; (2) not delivered; (3) not in time; (4) not understood; (5) not accepted; (6) not used; (7) not used in appropriate way and (8) politicised (Scheringer, 2008) 52 RISKGOV report An interviewed EU expert pointed out the need to “bridge the gap between science and policy” and the importance of informing politicians. At the same time an expert from academia was of the opinion that it is important for decision-makers to provide clear research requests. Several respondents from academia mentioned that they are not aware of what kind of information that politicians need. One respondent was of the opinion that politicians need one clear message in order to avoid confusion and to actually initiate actions: “politicians need only one message; otherwise they don’t know what to do… They have little time to read the background. They have to listen to scientists and if one says it is bad and another says it is good… they would not do anything”. Information is also delivered in heavy and demanding documents which are difficult for politicians to read. Thus, the information needs to be simplified and not overloaded with uncertainty according to several respondents. The Environmental Minister of Finland asked scientists to “simplify and prioritise” during the HELCOM ministerial meeting in Stockholm, 2010. Some scientists expressed a clear understanding of this requirement for simplification and said they do try to present syntheses, which explain the findings in a simple way. However, an authority expert said “the problem is that scientists cannot go further from what they definitely know. The easiest thing is to say that this is uncertain”. Thus, the same expert suggested that scientists should provide discussions about uncertainty and possible recommendations. However, several respondents from academia stated that they are not providing recommendations. One respondent from a research institution added “Often, we only give pure facts. “What to do” questions are more tricky...we just lay out the facts, saying that this is the problem that should be addressed. But exactly in what way, it is not our competence to say... because there is no easy answer”. In general, there are significant differences in the way scientists and policy makers deal with chemicals risks. Studies show that experts often tend to see risk as synonymous with probability of harm or expected mortality (Slovic, 1999). Politicians have an interest not only in tackling problems, but also in gaining as many votes as possible in the next election in order to remain in power (Haverland, 2009). Policies are therefore for them also a mechanism of pleasing voters and existing or potential coalition partners. The risk issue is in this respect more related to social, economic and environmental goals than just “probability of harm or expected mortality”. Thus, this affects the way both politicians and experts conceptualise risks. If the risk is defined in a purely scientific way, the management options may differ from those provided if the risk is defined in a more socially oriented way (Slovic, 1999). There are also methodological differences. For example, scientific research aims to find answers and go very deep inside the specific research problem, while politicians typically need a broad overview of a certain topic and a focused selection of the knowledge that is most relevant to the decisions to be made (Scheringer, 2008). Those are just some of the examples of the differences that may create barriers in science-policy communication. Moreover, EU membership is one additional potential barrier for science and policy to communicate. A Swedish scientist explained that a majority of the decisions are not made in Sweden but on EU level, thus the issue of how to communicate science to the EU politicians was recognised to be a problem (at least for scientist active at the national level). Taking into account that research within the EU is largely focused to one institution, The Joint Research Centre (JRC), the importance of national or regional (Baltic Sea level) research results is enormous. In general, there is a dissimilarity of objectives and needs of scientists and policymakers, and improved communication at the science-policy interface is generally identified as a key objective. This need of improved communication was recognised both during interviews and in the studied literature and documents. One respondent from an authority was of the opinion that communication among authorities and scientists in Sweden very much is based on 53 RISKGOV report personal contacts, which cannot easily be applied across the entire Baltic Sea region. Thus, the need for “translators” of scientific information to decision makers was mentioned in some interviews. Scheringer (2008) proposes to establish an institutional framework to improve the science-policy interaction (Fig. 3.2). For a sound management of chemicals an increased access of information is required for the planning, implementation, evaluation, and coordination of chemicals management activities. Interlinked institutions can be responsible for this. Some of the respondents mentioned HELCOM to be a good example of such an interlinked institution. Indeed, HELCOM has, as said above, taken substantial efforts with other organisations to adapt results to various audiences (such as decision-makers). However, the work of HELCOM is to a large extent scientifically based and several interviewed experts and stakeholders consider that more and better examples of such adjusted information and communication are required from HELCOM. For example, during the HELCOM ministerial seminar 2010 the main message was “More simplified information is needed”. Another example, but at an international level, is the IPCP. 3.3.Discussion Chemicals can be framed in many ways. They could be framed as a product, which is important for life (e.g. pharmaceuticals), but at the same time they could be framed as a problem. NGOs are taking the leading role in improving the understanding of the issues of chemicals i society and aim to inform people to promote environmentally adapted behaviour. However, it is possible to identify several ways of framing the problems; from single threats to human health to a very uncertain and growing problem. Chemical pollution can also be framed as a not important environmental problem. Obviously, some of the frames are quite narrow, while others are rather broad. The way these issues are framed might affect decisions on how to design management. Thus, it is important to improve the general knowledge about existing hazards in the environment in order to counteract “wrong” frames (Jasanoff, 2003). For example, the existing “useful chemicals products” framing in chemical management has potentially contributed to a focus on proven hazardous properties, or even on proven risks, of chemicals. It might be beneficial to think about possible shifts in chemicals management from abundance of chemicals produced to sufficiency of chemicals. Improved communication is also important in order to make the process of risk management more transparent, and to ensure a better implementation of risk management decisions (Renn, 2008). At the Baltic Sea region, EU structures and HELCOM were mentioned to be the main communication platforms. However, there is room for improving science-to-science communication, as well as the general involvement of the stakeholders at all stages of the management of chemicals. Communication efforts have been done by the industries, both voluntary and in the legal frame. However, industries have weak incentives to share information, considering competition and referring to the confidential business information (CBI) rules. The REACH regulation is aiming to slightly change this and will likely improve the information provided by the industry. However, this initiative has been confronted by several industries. Science-policy communication was recognised to be one among many complex challenges for improving chemical risk communication. In many cases, a lack of communication or a lack of clear coordination mechanisms have led to unused or unknown research results, and a lack of communication of the research needs of decision makers to the scientific community (Quevauviller et al., 2005). There are many potential barriers for a straightforward science policy communication. An interlinked organisation that helps to transfer information from 54 RISKGOV report science to policy and vice versa could therefore be important. Several examples of this kind of organisations exist, however there is room for improvement. A few respondents also mentioned the importance of an interaction between science and the public. The interviewed experts dealing with scientific risk assessment did not see the importance of listening to the general public or involving the public in risk assessments, referring to securing the objectivity of science. We disagree on this traditional role of scientists in the tower of knowledge, surrounded by an ignorant public, and consider that laymen can give important contributions to the building of scientific knowledge, as long as scientists are prepared to be active in dialogues outside their safety nets. The role of communicating information from scientists to the general public was considered to be realised by NGOs and partly by the media. Several NGOs agreed that they are communicating science to the public. Even though it is possible to assume that NGOs are the link between science and the public, more effective two-ways or three-ways communication is needed. While some organisations have developed in order to improve the interaction between science and policy, we consider that there is also a need to develop interlinked organisations to improve communication between science and the general public. There is a general lack of information about chemicals in the society. Only a few chemicals are assessed but not even the minimal existing information is delivered properly and widely. Furthermore, it seems clear that communication and collaboration between Russia and the EU is rather difficult in the studied field. The language barrier, Russia’s lack of information about REACH and difficulties for the EU to know with whom to collaborate, are examples of issues encountered. One worrying problem noted during our studies is the limited attention that chemical problems receive in media and among many politicians, which might contribute to a lack of interest among the general public to participate in chemicals risk governance. 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List of Interviews Nr 1 Actor Scientist EU expert Scientist Authority Authority Country Sweden Organisation EU expert group and academia Date March 2010 Sweden Sweden Sweden Marine Research Organisation National Chemicals Authority National Environmental Authority March 2010 April 2010 April 2010 Sweden EU EU Sweden Finland EU National Chemicals Authority ECHA ECHA National Environmental Authority National Environmental Authority EU Expert and Academia May 2010 May 2010 Sweden Belgium Russia Russia 15 16 Authority Authority Authority Authority Authority Scientist EU expert Politician Industry Science Science, Industry Media Authority Russia Regional Green Party CEFIC Academia Scientific Expert in the Industry Organisation Newspaper HELCOM 17 Authority Regional HELCOM 18 Authority 19 NGO Regional, Nordic Sweden Authority for Local Implementation of WFD Environmental NGO 20 NGO Nordic Environmental NGO 21 EU Commission NGO EU DG Environment Regional Environmental NGO 2 3 4 5 6 7 8 9 10 11 12 13 14 22 67 May 2010 May 2010 September 2010 May 2010 May 2010 June 2010 May 2010 May 2010 August 2010 August 2010 October 2010 October 2010 October 2010 October 2010 October 2010 RISKGOV report Annex II. Governmental and non-governmental Organisations and Networks GOVERNMENTAL ORGANISATIONS AND NETWORKS International Non-Governmental Actors Organisation Description Webpage UNEP United Nations Environment Programme UNEP deals with chemical issues through its Chemical www.unep.org programme that reflects global priorities identified by governments. The organisation works directly with countries to build national capacity for the clean production, use and disposal of chemicals, and promotes and disseminates state-of-the-art information on chemical safety. UNEP Chemicals, as a non-regulatory division of UNEP, has several global and regional chemicals assessment and policy initiatives, including: The UNEP Mercury Program; regionally Based Assessment of Persistent Toxic Substances (PTS) program; the UNEP Pollution Release and Transfer Register. WHO The World Health Organization WHO is the UN organization that is involved in the www.who.int/ip health aspects of chemicals. The organisation is the cs executing agency of the International Program on Chemical Safety (IPCS) which is a joint program with ILO and UNEP. It is implementing activities related to chemical safety and WHO’s main roles “are to establish the scientific basis for safe use of chemicals and to strengthen national capabilities and capacities for chemical safety”. ILO International Labour Organization ILO is mainly working with chemicals issues related to www.ilo.org the safety of workers. Together with UNEP and WHO, ILO is implementing International Program on Chemical Safety (IPCS) which is related to chemical safety. They have produced together with the EU and other bodies the International Chemical Safety Cards (ICSCs) which is information about chemical compounds to be used by workers handling these chemicals. ILO presents a “Chemicals Convention” (from 1990) which provides a coherent policy on safety in the use of chemicals at work, which includes the production, the handling, the storage, and the transport of chemicals as well as the disposal and treatment of waste chemicals, the release of chemicals resulting from work activities, and the maintenance, repair and cleaning of equipment and containers of chemicals. In addition, it allocates specific 68 RISKGOV report responsibilities to suppliers and exporting states. UNECE United Nations Economic Commission for Europe UNECE is one of five regional commissions of the www.unece.org United Nations. Its major aim is to promote panEuropean economic integration. It provides analysis, policy advice and assistance to governments; it gives focus to the United Nations global mandates in the economic field, in cooperation with other global players and key stakeholders, notably the business community. The UNECE also sets out norms, standards and conventions to facilitate international cooperation within and outside the region. OECD Organisation for Economic Cooperation and Development OECD is committed to democracy and market economy www.oecd.org from around the world in order to support sustainable economic growth; boost employment, raise living standards, maintain financial stability, assist other countries' economic development and contribute to growth in world trade. Economic development and trade might also mean chemicals development and trade. The OECD has a number of programmes relating to chemicals policy, including work on alternative methods, chemical test guidelines and hazard assessment of selected substances. It is very important to mention that OECD assists member countries in developing and harmonising methods for assessing chemicals risk. European Commission European Union Actors DG Enterprise works to improve the business http://ec.europa. environment and to support the development of a strong eu/enterprise/ and sustainable industrial base able to compete globally, as well as improving the framework conditions and access to finance for research and innovation. It is a central actor within the European Commission that supports chemicals development and trade. It is responsible for internal markets, competitiveness and sustainable development topics in chemicals policy. DG Environment ensures that member states correctly http://ec.europa. apply the EU environmental law. Its objective is to eu/dgs/environm protect, preserve and improve the environment for ent/ present and future generations. It suggests policies that aim at protecting the environment in the EU and that preserve the quality of life of EU citizens. DG Environment gives a lot of attention on chemicals safety concerning environment and health. 69 RISKGOV report European Parliament The European Parliament is the only directly-elected www.europarl.e body of the European Union. The 736 Members of the uropa.eu European Parliament are there to represent the citizen. The parliament plays an active role in legislation, including on environmental protection and chemicals. ECHA European Chemicals Agency Another central actor in chemicals policy is the www.echa.europ European Chemicals Agency. The agency manages the a.eu registration, evaluation, authorization and restriction processes for chemical substances to ensure consistency across the European Union. In its decision-making the agency takes the best available scientific and technical data and socio-economic information into account. It also provides information on chemicals and technical and scientific advice. SCHER Scientific Committee on Health and Environmental Risks SCHER provides opinions in health and environmental risks related to pollutants in the environmental which may have a negative impact on health and the environment. The committee also provides opinions in life cycle environmental assessment. It shall also address health and safety issues related to the toxicity and ecotoxicity of biocides. In addition, the committee addresses questions relating to methodological aspects of the assessment of health and environmental risks of chemicals (including mixtures) for providing sound and consistent advice in its areas of competence and to contribute to relevant issues in close cooperation with other European agencies. EEA The European Environment Agency EEA is an agency of the EU and play important role in www.eea.europa environmental reporting and monitoring. By .eu commissioning studies on certain topics, the EEA has the possibility to influence policy evaluation, agenda-setting and policy formulation. In recent years, the EEA has published extensive data on chemicals in the EU, several reports and studies on chemicals policy in general and on specific substances in particular. In short, EEA is part of the ‘green’ coalition contributing to the scientific and political discourse, but with limited influence over decision-making. JRC Join research centre JRC provides additional scientific and technical support ec.europa.eu/dgs in focusing on; the continuing role of the European /jrc/index.cfm Chemicals Bureau in the assessment of chemicals until the European Chemicals Agency is ready. They give support to the implementation of current and new European chemicals policy and also give support in developing chemical risk assessment. 70 http://ec.europa. eu/health/scienti fic_committees/ environmental_r isks/index_en.ht m RISKGOV report HELCOM Helsinki Commission Regional Actors The most influential regional actor is HELCOM, the www.helcom.fi responsible body under the Helsinki Convention, which is a regional cooperation designed to protect the Baltic Sea from pollution (including hazardous chemicals) since over 30 years. HELCOM has developed to become an important centre of both regional scientific and policymaking activities. HELCOM consists of delegates from the 10 member countries. All HELCOM decisions are taken by consensus under the principle of one Party, one vote. HELCOM meets at least annually, occasionally at the ministerial level which generally attracts regional media attention and result in announcements of common goals in the form of Ministerial Declarations (see more information about the HELCOM Ministerial meeting at Annex 1), they also give recommendations which are not legally binding but member states are expected to fully incorporate them into domestic law, regulation and procedures. National Actors Sweden The Ministry of the Environment works to ensure www.sweden.go The sustainable development. Priority areas for the v.se/sb/d/2066 Government Government's environmental policy are measures to and the Ministry of the tackle climate change and to preserve biological diversity, as well as efforts to ensure a non-toxic Environment environment and to safeguard the Baltic and the Skagerrak and Kattegat as living seas. Kemi is a central supervisory authority under the www.kemi.se KEMI The Swedish Ministry of the Environment, responsible for the efforts Chemicals to attain a non-toxic environment. Agency EPA Environmental Protection Agency EPA presents proposals for environmental policy and www.naturvards legislation to the Swedish Government and ensures that verket.se environmental policy decisions are implemented. One of the EPA’ responsibilities is to reduce the environmental impact associated with the use and distribution of chemicals and chemical products, as well as the discharge of unintentionally produced or extracted compounds. Russia 71 RISKGOV report MNR The Ministry of Natural Resources of the Russian Federation www.mnr.gov.r MNR of Russia is a federal executive body performing u the functions related to state policy formulation and normative and legal regulation in the sphere of the study, renewal, and conservation of natural resources. The Ministry has 5 agencies under its supervision. 3 of them are working with the chemicals in the water bodies. The Federal Supervisory Natural Resources Management Service The Federal Supervisory Natural Resources www.rpn.gov.ru Management Service ensures environmental and economic security of Russia, compliance management, continuous, sustainable, environmentally sound wildlife management, protection of all components of the environment from degradation and destruction. The main tasks of state control and supervision are the detection, suppression and prevention of crime associated with illegal and unsustainable use of natural resources, with negative impacts on the environment. The Federal Water Resources Agency The Federal Water Resources Agency is a federal www.voda.mnr. executive body performing the functions related to gov.ru rendering state services and federal property management in the sphere of water resources. RTN Federal Environmental Industrial and Nuclear Supervision Service under the Russian Government RTN is the supervisory body of Russia on ecological, www.gosnadzor. technological and nuclear issues. Its functions include ru the passage of regulatory legal acts, supervision and oversight in the field of environmental protection. There are several RTN’s regional units that facilite annually store or dispose of more than 10 000 tonnes of hazardous waste; discharge over 15 million m3 of wastewater, and produce more than 500 tonnes of air emissions. The North-West regional unit of RTN covers the area of the Baltic Sea. NON-GOVERNMENTAL ORGANISATIONS AND NETWORKS ICCA The International Council of Chemical Associations Greenpeace International Level ICCA is a world-wide organisation, representing 80 www.iccapercent of global manufacturing operations. ICCA is also chem.org the main channel of communication between the industry and various international organisations that are concerned with health, environment and trade-related issues. Greenpeace is an independent global campaigning www.greenpeac organisation that acts to change attitudes and behaviour, e.org to protect and conserve the environment and to promote 72 RISKGOV report peace. The organisation is present in 40 countries and has earlier led a campaign to show the widespread in the environment of hazardous chemicals; in household products, electronic goods and children's clothes, and detectable in house dust, rain water, food and, ultimately, our own bodies. To spur innovative solutions, Greenpeace has in recent years approached brand product manufacturers and asked them to commit to substitute harmful chemicals in their products with safer alternatives. Friends of the Earth is an NGO that seeks to influence www.foe.co.uk/ the government to make changes to policies in favour of people and planet. It informs about the importance of safer chemicals, the health threats and how to make the future safer. FoE is challenging industry, retailers and the EU to support REACH. Read more here: http://www.foeeurope.org/safer_chemicals/safer_future.h tm WWF is an independent foundation where its mission is www.wwf.org WWF World Wide to stop the degradation of the planet's natural Fund for Nature environment and to build a future in which humans live in harmony with nature. They aim for conserving the world's biological diversity, ensuring that the use of renewable natural resources is sustainable, as well as promoting the reduction of pollution and wasteful consumption. Friends of the Earth IPCP International Panel on Chemical Pollution The IPCP represents an international network of www.ipcp.ch scientists working on various aspects of chemical pollution. Its goal is to collect scientific knowledge about chemical pollution problems and to provide summaries and interpretations of the available knowledge for decision makers and the public. ICES The International Council for the Exploration of the Sea ICES coordinates and promotes marine research on www.ices.dk oceanography, marine environment, marine ecosystem, and on living marine resources in the North Atlantic. Members of the ICES community now include all coastal states bordering the North Atlantic and the Baltic Sea, with affiliate members in the Mediterranean Sea and southern hemisphere. It is a network of more than 1600 scientists from 200 institutes. Scientists are gathering information about the marine ecosystem. Besides filling gaps in existing knowledge, this information is developed into unbiased advice. ICES has a specific marine chemistry working group (MCWG) that deals with hazardous chemicals in the marine environment. 73 RISKGOV report ChemSec The International Chemical Secretariat CEFIC The European Chemical Industry Council ChemSec is a non-profit organisation dedicated to work www.chemsec.o towards a toxic free environment. ChemSec was founded rg in 2002 by four Swedish environmental organisations; SSNC, WWF, Nature and Youth, and Friends of the Earth. ChemSec strives to bridge the gap between decision-makers, industry, NGOs and scientists; and offer expertise and guidance on chemical management policies in order to get progressive chemical legislation. It also works together with companies to reduce their use of hazardous chemicals and to get their support for progressive chemicals legislation. Primarily it is focused on promoting and monitoring EU chemicals legislation, but also follows global chemicals issues, for example SAICM. EU Level CEFIC is representing the European chemical industry www.cefic.org and consists of 25 national federations of chemicals producers, 30 corporate members and approximately 700 business members. Acting as an umbrella organisation, CEFIC has also recognised about 100 sector groups and affiliated associations such as Eurochlor and European Brominated Flame Retardant Industry Panel (EBFRIP). DUCC Downstream Users of Chemicals Coordination group DUCC is an organisation founded in 2001 with the www.duccplatfo specific purpose of influencing the development of rm.org REACH. It comprises seven organisations representing about 3,700 companies that use chemicals, such as paint and ink producers, perfume producers, chemicals distributors and producers of detergents. EEB European Environmental Bureau EEB is Europe's largest federation of environmental www.eeb.org organisations with more than 140 member organisations who gain their membership from the general public. They are guided by the voices of 15 million European citizens, and act as the ears and voice of its members towards the EU decision makers. The organisation works on a large number of environmental issues, including chemicals, and the policy officers use experts, scientists, members and politicians to work toward development and protection of environmental policies. BEUC European Consumers Organisation BEUC informs about dangerous chemical substances www.beuc.org which can be found in everyday products, the organisation aims at raise awareness with decision makers of the risks posed by chemical substances on health and the environment, as well as minimise the exposure of consumers and the environment to 74 RISKGOV report dangerous chemicals in particular from consumer products. BSAG Baltic Sea Action Group CCB Coalition Clean Baltic Regional Level (Baltic Sea) BSAG operates throughout the entire Baltic Sea area and www.en.bsag.fi is an independent foundation that does concrete work on behalf of the Baltic Sea. Behind the operations of BSAG is the Foundation for a Living Baltic Sea. The foundation is an independent actor with a vast network of professionals for help and guidance. BSAG aims to accelerate the implementation of the Baltic Sea Action Plan by HELCOM. Operations are carried out with comprehensive co-operation between the private and public sectors throughout the entire Baltic Sea area. CCB is a politically independent, non-profit association. www.ccb.se It unites 26 member organisations from Finland, Russia, Estonia, Latvia, Lithuania, Poland, Germany, Denmark, and Sweden. Together the member organizations of CCB have over half a million members in all countries around the Baltic Sea. The main goal of CCB is to promote the protection and improvement of the Baltic Sea environment and natural resources. Baltic 21 is an initiative and process to develop and implement a regional agenda 21 for the Baltic Sea region in order to attain sustainable development in the region. An agenda for the Baltic Sea Region Baltic 21 is a joint, long-term effort by the 11 countries of the Council of the Baltic Sea States (CBSS). BONUS is a newly established independent organisation BONUS Baltic that is established as the European Economic Interest Organizations' Grouping, so that it can be a contractor with the Network for European Commission and other possible parties. Its Funding Science members are either funding agencies directly, or EEIG organisations managing national funding allocations for the joint calls under the Joint Baltic Sea Research Programme. Baltic 21 UBC Union of the Baltic Cities www.baltic21.or g www.bonusport al.org UBC is a network of 100 member cities from ten Baltic www.ubc.net Sea countries, aiming to develop co-operation and exchange between the UBC-members, to contribute to democratic, economic, social, cultural and environmentally sustainable development of the Baltic Sea region and to follow closely the developments of the EU and prepare its Eastern member cities to smooth transition to the prospective EU membership. 75 RISKGOV report National Level Sweden SSNC is an organisation active since 1909 that picked up SSNC Swedish Society on pesticides already in the 1950s and has since then for Nature worked on the negative impact chemicals have on Conservation environment and human (among the other environmental issues). The organization was founded in 1971. The primary Swedish focus for its work is to preserve biodiversity and to branch of ensure the sustainable use of natural resources. Baltic sea WWF (Världsnaturfon and Marine environment are among the priorities of the den WWF) conservation work in Sweden. The Swedish branch of Greenpeace is actively involved Swedish in the environmental work. It is working with chemicals branch of issues in the frame of the Greenpeace international action Greenpeace “Eliminate toxic chemicals”. Green World St. Petersburg Public Organization "Ecology and Business” FB Friends of the Baltic www.naturskyd dsforeningen.se http://www.wwf .se www.greenpeac e.org/sweden Russia Green world (GW) is the single non-governmental, non- www.greenworl profit environmental organisation that covers the area of d.org.ru 80 km to the west from St. Petersburg on the south coast of the Gulf of Finland, Baltic Sea. One of their aims is to save marine ecosystem of the Baltic Sea; the unique nature reserves of the south coast of the Gulf of Finland. The main task of the St. Petersburg Public www.helcom.ru Organization "Ecology and Business" is to promote the implementation of programmes, projects and decisions of HELCOM, as well as provide information to all interested parties about the activities of the Helsinki Commission. FB is an environmental NGO. More than 300 residents www.baltfriends of the Gulf of Finland coasts (Russian part) are involved .ru to the FB projects and programmes. The NGO works in St. Petersburg, small towns and villages on the South and North shores of the Gulf of Finland. 76 RISKGOV report Annex III. Major Governance Structures and actors Case Component Regulatory framework International Global International Regional EU National Institutional Structures (Legislative bases and decision and decision-making procedures) International Global International Regional EU National 77 Chemicals CLRTAP, Stockholm, Basel and Rotterdam Conventions HELCOM Baltic Sea Action Plan, HELCOM Ministerial Declaration, HELCOM recommendations, Helsinki Conventions MSFD, Maritime Policy, WFD, REACH and BSS National laws and regulations Treaties, International law, unanimous (mostly) Unanimous consent (mostly) Qualified Majority Voting (QMV), Unanimous consent; Co-decision National law RISKGOV report Annex IV. Timelines of regulatory framework development Before • 1960s - 1970s industrialized countries domestic regulations • 1974 HELCOM Convention • 1985 International Code of Conduct for the Distribution and Use of Pesticides • 1987 London Guidelines for the Exchange of Information on Chemicals in International Trade • 1992 UNCED UNCED Post-UNCED • 1992 HELCOM Convention • 1989 Basel Convention; • 1998 Rotterdam Convention; • 1998 CLRTAP; • 2001 Stockholm Convention. • 2003 Globally Harmonised System (GHS) • 2006 Strategic Approach to International Chemicals Management (SAICM) 1. The timelines and the international regulatory framework development Specific chemicals • First directive on dangrous substances, 1967 • Directive on restrictions, 1976 • Directive on preparations, 1988 • Separate laws on pesticides, biocides, waste, integrated pollution prevention and controll, pharmaceuticals, and cosmetic and hygienic products, etc • EU REACH regulation, 2006 - one system for all industrial substances, with great exceptions for e.g. lower volumes, but for all forms of hazard All hazards Ecosystem approach • WFD, 2000 • MSFD, 2005 2. Timelines and the EU regulatory framework development RISKGOV report Specific chemicals All hazards • 1974 Convention • 1980s Recomendations for DDT, PCBs and PCTs; mercury, cadmium, and lead • 1988 Ministerial Declaration • 1992 Convention • 1998 Recommendation 19/5 • The new Baltic Sea Action Plan (BSAP) Ecosystem approach 3. The timelines for HELCOM regulatory framework development Specific chemicals All hazards Ecosystem approach • Law of 1734 - those selling venomous substances must have adequate knowledge. • Ordinance on Arsenic, 1876 - group classification of substances • Ordinance on toxic substances, 1906 - classification and restrictions for some substances and products. • Notification on occupational health, 1949 - substitution requirements • Pesticide regulations, 1962 - various regulations • Environmental Protection Act, 1969 - covered all pollution from point sources, e.g. industries, precaution • Act on products hazardous to health and the environment, 1973 - preventive measures and precaution • Act of chemical product, 1985 - prevention and precaution, substitution; Chemicals Agency set up • Environmental Code, 1998 - covering all pollution and activities, including chemicals • advocates it within the EU and internatonally, and considers it important in e.g. the Baltic Sea Action Plan (BSAP) and in relevant EU directives etc. 4. The timelines for the Swedish regulatory framework development RISKGOV report USSR Russia • 1972 Stockholm • 1974 HELCOM • 1986 Chernobyl • 1991 the Law "On Environmental Protection" • 1992 HELCOM2 • 1992 Rio • 2002 "Federal Law of Russia on Environmental Protection " • 2003 State policy in the field of chemical and biological safety to 2010 • 2008 Water strategy of Russia for the period up to 2020 5. The timelines for the Russian regulatory framework development