Global Trends in Chemicals Management

Abstract

International cooperation in chemical safety has existed for more than a 100 years. Over the past half century it has grown considerably, and there are now upwards of one hundred international agreements, programs and initiatives concerning chemical safety. Within a few decades, almost all chemicals of significance will have been assessed for their hazards, and a global system will ensure that chemical substances and preparations are classified and labelled in a uniform way with respect to their hazards. This chapter discusses the challenges and trends in global chemical management with focus on three major issues: (1) the difficulties for both developed and developing countries to live up to the many international agreements, particularly with respect to reducing risks, (2) the difficulties for non-governmental stakeholders to keep abreast of the enormously complex information and to contribute to chemical safety development, and (3) how to best cope with the risks from the many substances that emerge from various sources with volumes doubling within a generation and reaching the environment and man via a multitude of pathways. Addressing these issues requires new policy developments. In this respect, the chapter examines the potential for the global chemical safety framework to adopt some of the regulatory and economic instruments in use in global radiation safety.

1 Drivers for International Cooperation in Chemical Safety

Toxic chemicals were used thousands of years ago in medicine, for suicide, and to poison adversaries in warfare and in struggles for power. Regulatory control of chemicals in most countries began with a focus on specific chemicals known to be toxic in the context of criminal law. Over the past two centuries, as countries have developed, so has legislation to control hazardous chemicals in pharmaceuticals, occupational safety, food quality and clean air and water. This approach has, during the past half century, been broadened to consider most chemicals as potentially hazardous (Lönngren 1992). In the following, several factors that drive global cooperation in chemical safety are discussed.

1.1 Developed Countries Lead Legislation and Its Implementation

Today, extensive chemical safety legislation and reasonably effective implementation exist in two of the blocks of countries that dominate international negotiations: the JUSCANNZ block (Japan, USA, Switzerland Canada, Australia, Norway and New Zealand) and the 27 countries of the European Union (EU). These are referred to here, for the sake of abbreviation, as developed¹ countries, although this is an oversimplification used in order to facilitate description of the trends in chemical safety. There is less extensive legislation in the G77 block of developing countries (Group77 + China: the Group of 77 developing countries plus China, which in reality comprises about 130 developing countries), and its implementation is often inadequate. These countries together with countries with economies in transition are referred to here, for the sake of abbreviation, as developing countries. In general, the legislation in these countries is advancing along the route travelled by the countries of the first two blocks, starting with some of the most hazardous substances. Much of the global work on chemical safety deals with bridging the gap between the countries that have extensive chemical safety legislation and those that do not.

1.2 Developing Countries Suffer the Worst Effects of Chemicals on Health

The health impacts of chemicals are significant, though difficult to quantify. Some estimates are available (WHO 2002) indicating that about 5% of the global burden of disease can be attributed to environmental chemicals exposures. The distribution of effects across the globe is the result of the combined effect of the volume of chemicals use and the effectiveness of chemical safety measures. In the countries of the OECD (Organisation for Economic Co-operation and Development) in ­general the use of chemicals per person is more than tenfold compared to non-OECD countries, but the risks are compensated for by more well developed chemical safety systems. Fig 12.1 illustrates differences in the rate of unintentional ­poisoning across the globe. Unintentional poisonings were in 2002 estimated to kill 355,000 people globally each year (WHO 2005), and two-thirds of these deaths occurred in developing countries. Such poisonings are strongly associated with excessive exposure to, and inappropriate use of, toxic chemicals. In general, chemical safety in developing countries leaves much to be desired. Accidents are abundant, although statistics are often of poor quality. An unfortunate milestone in this regard is provided by the accident in Bhopal, India in 1984 where a chemical factory accidentally released methyl isocyanate into the air, killing thousands of people.

Fig. 12.1

Differences in annual death rates due to unintentional poisonings. Data are for many countries based on scant information. Still, it appears that the highest rates occur in some countries in Western Africa, north-east Asia and south-east Asia. (Reproduced with permission from WHO 2005)

1.3 Chemicals Cross National Borders

There are several reasons why international cooperation is sought for chemical safety. The first international instrument for restricting chemicals use may have been the St. Petersburg Declaration from 1868 dealing with the use of fulminating substances, a type of explosive. The Brussels International Formulary dealing with pharmaceuticals was concluded in 1906. The First Hague Convention on Exercising Control over Opium was signed in 1912. These examples show that similar to the national level, warfare and pharmaceuticals were of early interest with regard to international control. Occupational safety, food quality and clean air and water followed as areas of interest (Lönngren 1992). Reasons for instituting international control of chemicals risks include that hazardous chemicals may be

• Manufactured across the globe, and increasingly in developing countries with less stringent safety measures, by a workforce that is sometimes transnationally recruited

• Intentionally transported across national borders in the form of chemical preparations, manufactured goods and wastes

• Released into the environment and unintentionally transported across international boundaries through air, water and migratory species and endanger living organisms, contaminate food and water and lead to health concerns that have been noted even in pristine Arctic ecosystems

1.4 Production and Use Move Towards Developing Countries

The chemicals industry is very diverse, producing thousands of substances that are used by other industries and that are present in countless consumer products. Approximately 600 million tonnes are produced annually, in addition to some 4,000 million tonnes of petroleum products. An earlier study (OECD 2001) predicted that the industry would continue to expand over the next 20 years, with faster growth rates in non-OECD countries. The demand for chemicals would, over that period, more than double in the non-OECD countries, while it would increase by about half that rate in the OECD countries. Still, come 2020 the OECD countries would account for twothirds of the world demand. These trends have been essentially confirmed by later studies (CEFIC 2008).

Trade across regions would continue to be large, almost 30% of the total production, and even more is traded across national borders. The trends for chemical safety in the OECD study (2001) were predicted to be

• Greater focus on safety over the life cycle of chemicals

• Increasing involvement of all stakeholders, with industry taking more responsibility for generating and assessing health and environmental data and other stakeholders involved in oversight

• Increasing outreach to non-OECD countries to help them build up their chemical safety in order to cope with the rapid expansion of their chemicals industries

1.5 A Multitude of Chemicals May Harm Health and the Environment

Early concerns for risks from chemicals started from very obvious toxic effects on humans. Carcinogenic effects were recognised quite early, and later less immediate effects came in, such as hereditary disease and neurological effects.

Today, exposures are known to be widespread and the chemicals known to be ­predominantly harmful. The number of hazardous chemicals runs into the tens of thousands, albeit many with low production volumes. For instance, in a major ­database (Prevent 2009) more than 21,000 of about 32,000 substances are classified as ­hazardous to health or to the environment. Of all substances, some 2,200 are classified as or suspected to be carcinogens, almost 1,600 as hazardous to reproduction, about 750 as mutagens and some 7,400 as hazardous to the environment. Of 85 million tonnes of chemical preparations in Sweden in 2006, 70 million tonnes were classified as hazardous to health and 27 million tonnes as hazardous to the environment (KemI 2009). The largest globally produced volumes are for petroleum products, and these are typically toxic, carcinogenic and hazardous to the environment.

Much larger material flows are due to mining and other activities, which mobilise more than 50,000 million tonnes per year (OECD 2008). While these mainly give rise to considerations of sustainability and resource efficiency (Fig. 12.2), their contaminants may entail considerable chemical safety concerns. For instance, the coal mining of 7,000 million tonnes annually mobilises associated contaminants of some 40,000 tonnes of lead, 20,000 tonnes of arsenic and 600 tonnes of cadmium, based on estimates of contaminants in internationally traded coal (CSIRO 2009).

Fig. 12.2

Schematic representation of material flows, environmental impact and policy uses. (Reproduced from Measuring material flows and resource productivity Synthesis report, p. 9, © OECD 2008 (OECD 2008) with permission from OECD)

More than 100 substances in urine or blood are subject to a large-scale monitoring program (CDC 2005), and more than 100 phenolic chlorinated or brominated substances have been detected in human blood in Sweden (Hovander et al. 2002). Exposure of newborns has attracted particular attention, and almost 300 chemicals have been detected in the umbilical cord blood in newborn babies (Houlihan et al. 2005) and hundreds of substances in breast milk (Massart et al. 2008).

These exposures may sometimes have long-term effects, not least on children. For instance, reduced birth weights or birth lengths have been associated with environmental levels of bisphenol A (NTP-CERHR 2008), PFOA (Fei et al. 2008), phthalates (Latini et al. 2003) and others (IFCS 2003a), and effects on the central nervous system that may lead to effects on intelligence or behaviour (IFCS 2003a) have been associated with environmental levels of lead, mercury and PCBs.

Effects have also been observed on the environment. Rachel Carson’s Silent Spring in the 1960s drew attention to effects on wildlife. Our Stolen Future (Colborn et al. 1996) created an interest in disruption of the endocrine system by chemicals, even in animals. Many cases of effects on natural animal populations can now be inferred from laboratory experiments, although confirmation in the environment is extremely difficult. For instance, organochlorine concentrations in adult male bottlenose dolphins are approaching the levels associated with adverse effects found in marine mammals (Carballo et al. 2008), and exposures of tadpoles to a mixture of nine pesticides at environmentally occurring levels lead to developmental effects in most frogs, while none were observed when the pesticides were applied one at a time (Hayes et al. 2006).

1.6 Reducing Differences May Help Industry, Trade and Health

The gap in chemical safety management between countries in different stages of development is a driving force in international chemical safety work. Reducing the differences could lead to

• Better production conditions and more level playing fields for industry

• Smoother international trade in chemicals and manufactured goods

• Lower risks to health and the environment in countries exposed to chemicals from far away

These are strong driving forces for special measures designed to assist developing countries in improving their chemical safety measures.

A special driver has recently come from strong European chemicals policies that include substances and waste relating to electronic products (Selin 2009). These have influences on policy makers, producers and advocacy organisations across many countries.

1.7 Chemical Safety Helps Overall Development

Chemical safety is only one aspect of development. Achieving chemical safety may assist in fighting poverty, protecting vulnerable groups and advancing public health and human security. Global agreements on chemical safety have reflected commitments to respect human rights and fundamental freedoms, to understand and respect ecosystem integrity and to address the gap between the current reality and global ambitions.

The overall development effort of the global community is codified in the Millennium Development Goals (United Nations 2008), adopted by the United Nations in 2001. The eight Millennium Development Goals have been adopted by the international community as a framework for the development activities of over 190 countries in ten regions; they have been articulated in more than 20 targets and more than 60 indicators. Donor countries and organisations are also pursuing the Millennium Development Goals in the development of chemical safety.

1.7.1 The Poor Are at Greatest Risk

Among the Millennium Development Goals, Goal 1 is to ‘Eradicate extreme poverty and hunger’. It has a target to ‘Halve, between 1990 and 2015, the proportion of people whose income is less than $1 a day’.

A notion of chemical safety related to Goal 1 has been presented by UNDP (2009):

The poor are at higher risk of exposure to toxic and hazardous chemicals because of their occupations, living locations, and lack of knowledge about chemicals. Sound chemicals management can improve their living environment, and consequently their health, and can help increase their revenue (e.g. proper use of pesticides can boost crop yields and protect the productivity of freshwater and marine fisheries).

A detailed assessment has been made in a report to the World Bank (2002).

A concrete example relates to the environmental levels of e.g. PCB, dioxin, pesticides or mercury, or air contamination including small particles. These have been associated with impaired perception, intelligence and mobility in children, entailing impaired earning ability and enhanced social inequity. Several case studies have indicated a loss of around 5 IQ points in a population due to hazardous chemicals, which might mean about a 10% loss of income or about the same loss of worker productivity (Trasande et al. 2005, IFCS 2003a).

1.7.2 Chemical Safety Has Links to Development Beyond Poverty Aspects

Other links are that sound management of chemicals can:

• Through awareness raising help reduce the occurrence of chemical related accidents.

• Through women’s empowerment help protect women and their families.

• Combined with better nutrition, improve children’s working and living conditions, decrease their sensitivity to chemicals and reduce child mortality.

• Lower women’s risk of contamination, improve maternal health and, thus, the health of future generations.

• Minimise the side effects of malarial medications (prophylactics) and other ­chemical products (for example treated mosquito bed nets) that prevent millions of deaths worldwide; almost a million people still die each year of malaria (WHO 2008).

• Prevent and/or minimise the entry of harmful chemicals into the environment and reduce the need for difficult and costly environmental remediation.

Work on elaborating links between chemical safety and development in a practically useful toolkit is in an advanced stage (UNDP 2009).

1.8 A Broad Range of Stakeholders Are Involved

The value of stakeholder involvement is generally recognised in donor policies and is slowly seeping into national preparations for chemicals management. In almost all countries, industry and academia can contribute significantly. Industry is responsible for making available to stakeholders data and information on health and environmental effects and is often interested in clean production programs. A distinction should be made between the chemicals producing industry and the using industry. The producing industry is often farther away from the end customer and has a stronger interest in defending the chemicals it produces, as witnessed by the very strong lobbying against the European REACH initiative (DiGangi 2003).

The chemicals using companies, such as car and furniture manufacturers, are often much closer to the market than the chemicals producing companies. Movements in the market towards environmental protection are often clearly reflected in the policies of the chemicals using companies. Because of the enormous variety of producing companies, they have great difficulties of influencing global chemical safety work but increasingly put pressure on their chemicals suppliers for better chemical safety.

The strength and competence of environmental, consumer and labour organisations varies, but in developed countries it is generally recognised that their input should be sought and may often be substantial. Environmental organisations have a role to play in information and awareness raising but always have difficulties of funding, particularly for work at the global level. The government of Sweden has systematically funded environmental organisations to raise awareness and to be an independent critical voice. In particular, in the chemical safety sector, a Secretariat has received government funding for participation in international discussion. It operates on behalf of environmental organisations (Chemsec 2009).

1.9 Main Contentions: Protecting Industry vs. Funding for Developing Safety

The production of chemicals has, up to now, been dominated by developed countries, although a change is underway (see Section 12.1.4). Developing countries have had to deal with their own lower volume chemical safety issues but also with exports of waste from developed countries. In international negotiations, it often happens that some chemicals producing countries oppose stricter management (see, for instance, Eckley et al. 2006) and put pressure on developing countries to join them. Developing countries are pressed by their needs for general development and often fear imposition of excessively strict standards by the developed countries. Therefore, a major issue brought up in international negotiations concerns funding for the implementation of safety measures in developing countries. A proposal at the very heart of the controversy concerns a direct tax on the global chemicals industries; this is put in perspective in Section 12.3.3.

2 Global Development of Chemical Safety

The drivers discussed above have resulted in international agreements for efficient management of hazardous chemicals. There are now around one hundred international agreements, programs or initiatives dealing with chemical safety at the international level. They are so many that several programs have been instituted just to coordinate international work.

2.1 Excessively Comprehensive Cooperation?

2.1.1 Almost 100 International Agreements and Programs

An extensive review of international agreements (Buccini 2004) discusses 22 global and 27 regional agreements on chemical safety, as well as 39 international programs and initiatives going beyond direct support for the agreements.

The list is not exhaustive; for instance, it does not contain:

• The 1972 Convention on the Prevention of Marine Pollution by Dumping of Wastes and Other Matter

• The 1998 Convention on Access to Information, Public Participation In Decision-Making And Access To Justice In Environmental Matters

• The 2001 International Convention on Civil Liability for Bunker Oil Pollution Damage

Furthermore, some ten new agreements have been made after the list was compiled (Mitchell 2009). The most significant of these are the global Strategic Approach to International Chemicals Management (SAICM) and the European Union Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), both adopted in 2006.

According to the review by Buccini 2004, most agreements, programs and initiatives­ deal with risk management for hazardous chemicals (a discussion of the ­different types of instruments used is found in Section 12.2.1.3). In addition, ­several deal with monitoring and evaluation and some with problem identification and risk assessment, particularly among the programs and initiatives.

2.1.2 Policy from the Highest International Level

Chemical safety gained significantly increased global visibility with the advent of the chemical safety Chapter 19 of Agenda 21 that emerged from the 1992 Rio meeting of the United Nations Conference on Environment and Development (UNCED). This chapter addressed six substantive areas:

• (a) Assessment of risks

• (b) Harmonisation of classification and labelling

• (c) Information exchange

• (d) Risk reduction

• (e) Strengthening of national capacities

• (f) Prevention of illegal international traffic

In addition, a short subsection deals with the enhancement of cooperation related to several programme areas.

Progress in these areas after 10 years was reviewed at the World Summit on Sustainable Development in Johannesburg. Its Plan of Implementation (WSSD 2002) set the goal that by the year 2020 chemicals should be produced and used in ways that minimise significant adverse impacts on the environment and on human health. This has been the portal goal that has since been at the forefront of global chemical safety efforts, not least SAICM (Section 12.2.4.1).

2.1.3 Policy Instruments: Binding and Voluntary

A broad range of instruments for environmental management has been reviewed by Sterner (2002). These can be characterised as

• Command-and-control regulations

• Provision of information, e.g. classification and labelling, green labelling and emission registers

• Economic incentives, e.g. taxes, fees, permit trading and green procurement

• Construction of institutions for the allocation of rights that are fundamental for any market mechanism, e.g. bodies that make rules for liability and courts

In the choice of policy instruments, efficiency is important, but so are aspects of distribution, information, politics and implementation. Where monitoring and access to technology and credits are particularly difficult, it is crucial to consider policies that avoid antagonism and encourage cooperation and involvement (Sterner 2002).

In line with the latter, instruments at the global level tend in practice to be ­voluntary for the ratifying governments. This has been the case, for instance, with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS, Section 12.2.3.2) and SAICM (Section 12.2.4.1). However, even with the for­mally binding Basel, Rotterdam (Section 12.2.3.3) and Stockholm (Section 12.2.3.4) Conventions, the mechanisms discussed for treatment of parties in non-compliance are softly worded and generally concern arbitration in different forms. The non-compliance mechanisms of the Rotterdam and Stockholm Conventions have still not been agreed to, 10 and 8 years, respectively, after being signed, an indication that many states remain highly protective of their sovereignty. This is a general experience from environmental agreements (Selin 2009).

The international chemical safety agreements deal to a large extent with command-and-control regulations to be established by the ratifying states, even when the agreements themselves are voluntary. For instance, the voluntary GHS has already been transformed into binding regulations in a number of countries, and in some countries emission registers are required by law in line with the Aarhus convention Protocol on Pollutant Release and Transfer Registers (UNECE 2003).

Information instruments have been widely used in global chemical safety. For instance, the generation of hazard information has been a main issue since Agenda 21. The GHS is very much about providing information for staff working in protection and for end users, and part of this involves the information instrument of Safety Data Sheets. The Pollutant Release and Transfer Registers/emission inventories (Section 12.2.3.3) are to large extent information tools that may help citizens dialogue with enterprises on releases.

Economic incentives have not been used much in chemical safety (OECD 2009e). At the national level some countries use fees, and there are a few examples of taxes. The fees for registration of pesticides have worked as deterrents to the marketing of many pesticides. It remains to be seen whether the REACH registration in the European Union will have a similar effect for low production volume substances.

Facilitation of market mechanisms has not been used to any great extent. An ­example is provided in the National Implementation Plan of China for the Stockholm Convention (GEF 2007b), which contains activities to ‘determine the principles and mechanism for responsibility sharing among stakeholders for different types of activities, e.g. non-profitable and profitable activities’. These might include suggestions and recommendations to remove barriers to market oriented operations in response to reducing emissions from combustion and managing wastes.

2.2 International Coordination Is Extensive

With upwards of 100 international agreements, programs and initiatives, there is an obvious risk for overlaps and duplications. Therefore, many mechanisms of international coordination have emerged. They include eight initiatives that are briefly described in the following in approximate order of appearance that mirrors the trends described above.

2.2.1 Organisation for Economic Cooperation and Development (OECD)

OECD brings together 31 countries committed to democracy and the market ­economy; the number is slowly growing. The most important part of OECD chemical safety work has been carried out by the special chemicals groups that have appeared under different names since 1971. At present, the work is presented under Chemical safety. The first important tasks dealt with mercury, cadmium and polychlorinated biphenyls (PCBs), in addition to coordination and information exchange. They were later followed by issues in accreditation and good laboratory practice, chemicals testing and hazard assessment. Today, the work of the OECD covers twelve headings, from accidents and biocides to nanomaterials and pesticides (OECD 2009a).

2.2.2 International Program on Chemical Safety (IPCS)

The IPCS has since 1980 been a joint undertaking by the United Nations Environment Program (UNEP), the International Labour Organisation (ILO) and the World Health Organisation (WHO). The initial work dealt with assessment of hazards and risks from general chemicals, food additives and contaminants, and pesticide residues. From the very onset, the IPCS had technical cooperation with member states, in particular developing countries, as an important objective. Today, the IPCS still produces assessments of hazards and risks from chemicals, including in food, with methodology development being an important element (IPCS 2009). Poisoning Prevention and Management is a major activity, lending support to almost one hundred poison centres around the world. The WHO Chemical Alert and Response Team identifies, alerts, tracks and, when appropriate, coordinates a response to chemical incidents and emergencies on a global basis.

2.2.3 The International Council of Chemical Associations (ICCA)

The ICCA is the world-wide voice of the chemical industry, representing chemical manufacturers and producers all over the world. It is the main channel of communication between the industry and various international organisations that are concerned with health, environment and trade relations (ICCA 2009). The program Responsible Care® has since 1985 committed the worldwide chemical industry to continual improvement in all aspects of health, safety and environmental performance and to open communication about its activities and achievements. Since 1998, ICCA, in co-operation with the OECD and its member countries, has produced harmonised, internationally agreed upon data and initial hazard assessments for high production volume substances representing more than 90% of the global chemicals production. The ICCA also has programs on product stewardship (management of health, safety and environmental aspects of a product throughout its total life cycle, working in cooperation with upstream and downstream users) and on long term research.

2.2.4 Intergovernmental Forum on Chemical Safety (IFCS)

The great need for international coordination in chemical safety was discussed in the beginning of the 1990s as the United Nations Conference on Environment and Development was being prepared. Eventually, the discussions led to the chemicals Chapter 19 of Agenda 21. The IFCS was formed in 1994 to promote the implementation of Chapter 19 as an over-arching mechanism to develop and promote strategies and partnerships among national governments, intergovernmental organisations and non-governmental organisations (IFCS 2009). In 1994, it produced Priorities for Action in global chemical safety, dealing with the six areas of Chapter 19.

In 2002, these priorities were updated and revised. The IFCS also developed indicators of progress towards achieving the Priorities and compiled the outcomes. Before the next revision of the Priorities, a new instrument took over the formulation and follow-up of objectives: the Strategic Approach to International Chemicals Management, SAICM. At the first conference in 2009 to follow up SAICM achievements, participants decided to leave it to the IFCS to decide on its own future, thus rejecting at that time a proposal to make the IFCS a follow-up mechanism for the SAICM process. For lack of funding the operation of the IFCS was in July 2009 suspended for the foreseeable future.

2.2.5 Inter-Organisation Programme for the Sound Management of Chemicals (IOMC)

The IFCS was an organisation independent of the UN system, with unique contributions on the part of developing countries and non-governmental organisations. The governmental organisations saw a need to promote coordination at about the same time as IFCS was formed, and in 1995 formed the IOMC. This has defined itself as the pre-eminent mechanism for initiating, facilitating and coordinating international action to achieve the World Summit on Sustainable Development 2020 goal of sound management of chemicals. There are seven Participating Organisations and two observer organisations of the IOMC; of the latter, the World Bank has decided to become a full member.

The IOMC works by strengthening international cooperation in the field of chemicals, increasing the effectiveness of the programmes of the nine organisations and promoting coordination of policies and activities pursued jointly or separately (compare its resource guide IOMC 2009). The coordinated views, programs and studies are represented by IOMC in the governing bodies of international organisations and other fora.

2.2.6 The International POPs Elimination Network (IPEN)

Public interest non-governmental organisations have generally found it difficult to work at the global level, both for economic and language reasons. The advent of Internet greatly facilitated working in large networks. The first strong global ­activity in the chemical safety field was the IPEN, launched in 1998. It is a global network of more than 600 public interest non-governmental organisations working together for the elimination of persistent organic pollutants (POPs) on an expedited yet socially equitable basis (IPEN 2009).

IPEN focuses on mobilizing resources for NGO activities in developing countries and countries with economies in transition. IPEN has established eight regional hubs working in the regional languages to promote the implementation of IPEN’s international projects. At present, three projects are in operation, dealing with the elimination of POPs, egg sampling for analysis of several POPs substances and awareness raising and engagement for SAICM.

2.2.7 Strategic Approach to International Chemicals Management (SAICM)

The IFCS had managed to promote a rapid global agreement on actions against Persistent Organic Pollutants (POPs) and to establish the framework for the voluntary global harmonisation of classification and labelling. However, the follow-up of the other Priorities for Action indicated that there was little commitment on the part of many countries, even when it came to providing IFCS with progress information. There were calls for stronger instruments with associated financial resources that would permit developing countries to give higher priority to chemical safety. In 2006, SAICM was agreed upon. This was a new international framework that replaced the Priorities for Action of the IFCS and that was supplied with a special fund to facilitate implementation. Work to define processes, including indicators for follow-up, is still in progress. Important steps were taken at the second International Conference on Chemicals Management (ICCM-2) in 2009, including initiating action on electronic waste, which had until then tended to fall through the cracks between the organisations. SAICM is described more in detail in Section 12.2.4.1.

2.2.8 Coordination of Basel, Rotterdam and Stockholm Conventions

With upwards of 100 international initiatives in chemical safety, countries are struggling to keep track of and implement the large number of agreements. They have in SAICM called for significant coordination. The functions of the International Conference on Chemicals Management include promoting the implementation of existing international instruments and programmes and coherence among chemicals management instruments at the international level. Three key international instruments have been reviewed in this regard for ICCM-2, namely, the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal, the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade and the Stockholm Convention on Persistent Organic Pollutants (ICCM 2009). These ­formally independent treaties cover partially different life-cycle issues. Strong coordination of these with SAICM has been proposed, and a special joint Extra Conference of the Parties for the tree conventions was held in February 2010.

2.3 Domination by Developed Countries

From Agenda 21 in 1992 until the adoption of SAICM in 2006, the concerted collaboration on chemical safety globally was structured according to the six substantive areas of Chapter 19 of Agenda 21. Implementation was dominated by work of developed countries as follows.

2.3.1 Assessment of Risks

IFCS in 2003 stated that facilitation of global consistency and global collaboration in data generation and accessibility would have several advantages:

• Improved safe use of chemicals with respect to human health and the environment, including increased transparency

• Minimised use of laboratory animals for testing

• Economy of testing and assessment

• Reduced barriers to trade

These have underpinned international attempts at coordination. A difficulty has been that certain companies bear the burden of producing the data and have a commercial interest in sharing this data only if they are compensated. At the same time, there is a strong public interest in essential health, safety and environmental information being accessible.

Initially, assessments of hazards and risks were made substance by substance according to the most pressing needs. More systematic programs were operated by the IPCS and a few OECD member countries, particularly for pesticides. Several attempts were made to establish registers or websites linking the different sources of information, but they never came into broad use. Over time, balances between interests have been struck to enable coordinated large-scale programs for hazard assessment. Today, there is considerable coordination in the generation and dissemination of data for thousands of general chemicals (OECD 2009b). The process is significantly aided by more than 150 detailed and internationally agreed upon testing methods used by government, industry and independent laboratories to assess the safety of chemical products (OECD 2009c) and by common principles developed mainly under IPCS Section 12.2.2.2) for harmonised approaches for performing and reporting health and environmental risk assessments. Important tools for minimising costs and use of laboratory animals for testing have been developed in the form of computer models for the properties of chemical substances and elaborate testing strategies.

For pesticides, there has been considerable technical work performed to enable coordination. The OECD countries have adopted a vision (OECD 2009d) that by the end of 2014 governments will routinely accept ‘dossiers’ prepared by stakeholders in the OECD format, will routinely exchange ‘monographs’ (containing reviews of the data submitted) and will use OECD ‘monographs’ as a basis for independent risk assessments and regulatory decisions for new and existing pesticides.

2.3.2 Harmonisation of Classification and Labelling

A very important chemical safety measure is informing users about the hazards of chemicals through symbols and phrases on the packaging labels and through additional comprehensive safety information. The skull and crossbones symbol is a well-known early example applied to poisons.

There has been growing pressure to harmonise the hazard information for several reasons

• An increasing use of many different chemicals

• An increasing international trade; and

• An increasing knowledge of many types of hazards to health and the environment

A globally harmonised system of classification and labelling was conceived around 1950 in discussions of the Chemicals Industries Committee of the ILO. Via a tortuous path, it was eventually followed up in 1992 with a decision on an action area of Chapter 19 in Agenda 21. The first operative version of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) was agreed upon 10 years later in 2002. The work had been coordinated and managed under IOMC, with separate technical focal points for completing the work concerning hazard communication and classification of health and environmental hazards as well as physical hazards.

In the Priorities for Action of the IFCS in the year 2000, the target year 2008 was set for implementation of a harmonised system, and this was endorsed by the World Summit on Sustainable Development in 2002. The system adopted in late 2002 was revised in 2005 and 2006 (UNECE 2007). Responsibility rests with the United Nations Economic and Social Council Sub-Committee of Experts on the GHS under the United Nations Economic Commission for Europe (UNECE). The target of full GHS implementation by 2008 has not been reached, but implementation is well underway. Major actors have set deadlines, such as the United States (transportation 2010) and the European Union (2010 for classification of substances and 2015 for mixtures).

The text is about 560 pages long with much technical detail. It describes physical, health and environmental hazards. For each type of hazard (for instance explosivity, carcinogenicity and hazards to the aquatic environment) there is a definition, criteria for classification (for instance as suspected human carcinogen) (Fig. 12.3) and hazard communication instructions with a designated:

Fig. 12.3

Health hazard symbol

• Symbol, for instance the symbol for Health hazard as shown to the right – there are nine symbols

• Signal word, for instance Warning – there are three levels (Warning, Danger, No signal word)

• Hazard statement, for instance Suspected of causing cancer – there are about 70 hazard statements

In addition, there is guidance for those who classify substances or mixtures of substances.

Recent work has involved classification for environmental effects with respect to environmental fate and toxicity to aquatic organisms. Discussions are ongoing concerning toxicity to terrestrial organisms. Classification and labelling are cornerstones of chemical safety, and today tens of thousands of substances are classified as hazardous.

The GHS also prescribes information in 16 headings to be used for describing hazards of chemical products in a Safety Data Sheet (SDS). They deal with inherent properties as well as safety measures for e.g. fire fighting, disposal, transport and accidents. The use of such data sheets was recommended in the Priorities for Action.

Several databases deal with classifications and with safety data sheets, as a simple search on the Internet will reveal. However, there is no internationally coordinated database. An extensive listing of safety data sheet sites is available (MSDSonline 2009). A major challenge is to make all of this information available in the languages of the users.

2.3.3 Information Exchange

Access to information is a fundamental right in a democracy, enabling informed decisions by citizens. It has been given much weight in chemical safety ever since Agenda 21 in 1992. The Priorities for Action 2000 called for national arrangements for exchange of information on chemicals with recognition of the language issue. At that time, gaining access to Internet was also high on the agenda. A program was instituted for that purpose (CIEN 2009) and has provided Internet access, documents, databases, a website building tool and workshops to more than 40 countries in Africa, Central America and Mexico.

IFCS in 2000 also recognised the role of information exchange in relation to toxic chemicals in the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade. It encouraged its implementation. The Convention went into force in 2004. It requires information prior to export of some 30 chemicals that are listed, most of these with very little circulation. Additions of ‘live’ chemicals have been very ­controversial. At the Conference of the Parties in 2008, agreement was reached to add tributyl tin compounds but not concerning chrysotile asbestos and endosulfane. The IFCS in 2000 also recognised the importance of providing all relevant parties with safety information consistent with the safety data sheets.

Many attempts have been made to set up comprehensive registers, databanks or portals with data on chemicals. They have in general failed because of the enormity of the task. There are some 30,000 chemical substances in use in hundreds of thousands of chemical preparations and millions of manufactured products. Information needs to be available in many languages. A compilation within the IFCS (2003b), in need of updating, listed some 25 major databases on hazards, exposures and risks, almost exclusively in English. The IFCS has given particular attention to the development of emission registers, which it has sorted under Risk reduction.

2.4 Risk Reduction

In the best of worlds, risks of an undertaking can be assessed and balanced against the costs and benefits resulting in an agreed risk management option. When it comes to most chemicals, information is neither available nor accessible, and decisions on risk management have to be taken under considerable uncertainty. As guidance in this situation, the Rio Declaration from 1992 contains Principle 15. ‘In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. 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.’ The interpretation of precaution has been the subject of considerable discussion, but chemicals negotiations have in the end relied on Principle 15.

Implementation of risk reduction actions agreed in the Priorities for Action in 2000 is dealt with in Table 12.1. In addition, risk reduction initiatives on other chemicals of major concern were to be put on the future agenda. This was a placeholder for the controversial topics of metals, such as cadmium, lead and mercury, and organic substances, such as polybrominated compounds. It took many years, but in 2009 the Governing Council of UNEP embarked on a plan that was to end in a treaty to strongly reduce mercury use (UNEP 2009a). Several new organic substances are considered under the Stockholm Convention, and the need for global action related to lead and cadmium is currently under discussion.

In the 17 years from UNCED to ICCM-2, progress has been made in many areas. Still, it should be recognised that in more complex cases, risk reduction takes decades. For example, some of the substances called PCBs were initially detected in environmental samples in 1966, first banned in Sweden in 1972 and globally restricted by the Stockholm Convention in 2001, with efforts for sound management of waste required no later than 2028. Clean-up of contaminated sites is a major risk reduction challenge that has so far barely been addressed in international cooperation.

Table 12.1 The risk reduction actions of Priorities for Action in 2000 and corresponding actions taken until 2009

2.5 Strengthening of National Capacities

There has been an increasing urgency in strengthening national capabilities and capacities for management of chemicals in developing countries and countries with economies in transition. When the chemicals part of the Rio Conference was being prepared at a London meeting in 1991, 43 developing countries and 28 others were represented. Fifteen years later when SAICM was adopted, there were more than twice as many developing countries but about the same number of others. This may reflect a strongly increased interest in chemical safety on the part of developing countries.

The Priorities for Action contained the same main elements for strengthening national capacities as the SAICM Global Plan of Action, even though SAICM contained many more details.

2.6 Prevention of Illegal International Traffic

Prevention of illegal international traffic in toxic and dangerous products was made a priority in Chapter 19 of Agenda 21, as it was for waste in Chapter 20; for waste the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal was signed as early as in 1989. For the first years after Agenda 21, the issue was put on hold, since it was felt that chemical safety legislation had to be in place first. The issue was given more weight over the years, and in the SAICM Global Plan of Action it was once again a separate area for action. In 2007, UNEPs Governing Council called in general terms for the implementation of existing international instruments in the area but up to 2010 little concerted action had been taken. This long delay reflects the complexity of the issue and illustrates how over 2 decades it has been so difficult to achieve concrete and specific actions and why the many calls for specific working groups have gone unheeded.

3 Developing Countries Start with the Most Hazardous Chemicals

When the Global plan of action of SAICM was adopted in 2006, many of the priorities from Agenda 21 of interest to developed countries had been met or their targets were well on the way towards being fulfilled.

A new instrument, such as SAICM (2006), was thus neither of major interest to the developed countries nor did most of them see the need for a continuation of the IFCS. Funding for international chemical safety was limited, and there were increasing difficulties funding these undertakings in addition to the basic work of the OECD and the three conventions of Basel, Rotterdam and Stockholm. SAICM, therefore, tended to be focused on the developing countries, and a new funding mechanism was devised for it with focus on developing countries. The funding for the IFCS dwindled, and some developed countries pulled out of IFCS activities. Non-governmental organisations and developing countries felt that they had a better platform in the IFCS than in the more formal SAICM mechanism and advocated its continuation. A new role for the IFCS was to be discussed at the first follow-up conference of SAICM in 2009. This was the setting for the implementation of SAICM from the point of view of the developed countries.

At the same time, the developing countries were struggling to cope with extensive intoxications from pesticides, lead and mercury poisoning, legacies of stockpiled obsolete pesticides and polychlorinated biphenyls and other issues that had to a large extent already been taken care of in the developed countries.

3.1 The SAICM Contents and Implementation

In Dubai in 2006 countries agreed to SAICM, which is distinguished by its:

• Comprehensive scope

• Ambitious ‘2020’ goal for sound chemicals management

• Multi-stakeholder and multi-sectoral character

• Endorsement at the highest political levels

• Emphasis on chemical safety as a sustainability issue

• Provision for resource mobilisation

• Formal endorsement or recognition by the governing bodies of key intergovernmental organisations

SAICM comprises:

• The Dubai Declaration on International Chemicals Management, expressing high-level political commitment to SAICM.

• An Overarching Policy Strategy, which sets out its scope, needs, objectives, financial considerations, underlying principles and approaches, and implementation and review arrangements. Objectives are grouped under five themes, which significantly overlap with the six areas of the Priorities for Action: risk reduction, knowledge and information, governance, capacity-building and technical cooperation, and illegal international traffic.

• A Global Plan of Action that serves as a working tool and guidance document to support implementation of SAICM and other relevant international instruments and initiatives.

A new funding mechanism called the Quick Start Programme was set up. Its objective is to ‘support initial enabling capacity building and implementation activities in developing countries, least developed countries, small island developing States and countries with economies in transition.’

The strategic priorities of the Quick Start Programme are:

• Development or updating of national chemical profiles and the identification of capacity needs for sound chemicals management

• Development and strengthening of national chemicals management institutions, plans, programmes and activities to implement the Strategic Approach, building upon work conducted to implement international chemicals-related agreements and initiatives

• Undertaking analysis, interagency coordination and public participation activities directed at enabling the implementation of the Strategic Approach by integrating – i.e., mainstreaming – the sound management of chemicals in national strategies and thereby informing development assistance cooperation priorities.

These compare well with the elements from the Priorities for action: National ­profiles, national action plans and incorporating chemical safety issues in national development plans. In addition, the Priorities had an element of access to information on capacity building involving the development of an Information Exchange Network on Capacity Building for the Sound Management of Chemicals. This ­element was transferred to the Secretariat of SAICM (SAICM 2010).

The Global Plan of Action also contained a list of 36 work areas with 273 activities dealing with essentially all aspects of chemical safety. An enormous program of this kind can only be partially dealt with, even by very advanced countries, and initially it may have confused more than helped developing countries setting up the first parts of a chemical safety program. Extensive work on indicators might help to focus efforts. However, the proposal decided on at ICCM-2 suffers partly from the same disease, going far beyond the more limited information that was not able to be collected by the IFCS and leaving many difficulties of interpretation if one is to get away from the 30-page draft surveys.

In the following section, only the three more realistic and limited priorities of the Quick Start Programme mentioned above will be discussed.

3.2 National Profiles

A national profile is a document assessing and diagnosing a country’s existing infrastructure for the sound management of chemicals. By 1999, national profiles had been prepared by 61 countries. These were often first drafts, sometimes called micro- or mini-profiles. In the beginning of 2009, the National Profile homepage reported 114 profiles, many of which had been revised at least once (UNITAR and ECB 2009), and an additional 25 countries had Profiles under preparation. Implementation of national profiles was, thus, well established as the starting point for further development of chemical safety.

3.3 National Action Plans

The production of national action plans for chemical safety had a slow start in the 1990s. The poor statistics available indicated that 46 national plans were produced or under preparation by 1999. The drafting was strongly boosted with the start of implementation of the Stockholm Convention after its entry in force in 2004. Through the Global Environment Facility, which is the financial mechanism of the Convention, funding for drawing up national implementation plans was awarded quickly and with little bureaucracy. In the beginning of 2009, 89 countries had submitted such plans and an additional 73 countries had committed themselves to do so according to the Convention. The plans that were submitted were often extensive documents based on National profiles.

The Stockholm Convention plans are likely to be the core of the work on national action plans that began after SAICM was adopted in 2006. Preparatory work has been started in about 60 countries, with funding mainly from the Quick Start Program. The preconditions are, thus, significantly more favourable than those that prevailed after Agenda 21 in 1992.

3.4 Chemical Safety and National Development Priorities

Donors of developmental aid have emphasised the need to link chemical safety to overall development. This is also reflected in the priorities of the SAICM Quick Start Program.

While it may be very important to attend to the links between chemical safety and national development, this is seldom done in a systematic way. National chemical safety planners tend to look at their activity in isolation and not to identify synergies with other areas of chemical safety. For instance, actions such as legislation, national committees or data bases may be proposed separately for PCBs, dioxins, contaminated sites, chemical hazard information and monitoring, while some of these could be combined.

Looking at their most proximate interests in a similar way, national sector planners and politicians tend to look at one sector at a time and miss the fact that chemical safety issues exist over a broad range of sectors, having a combined impact far beyond the impact within any one sector. For instance, implementation of conventions may be viewed separately for each convention, while there may be synergies in some degree of coordination. They may also fail to assess the full picture, with chemicals promoting as well as counteracting national development goals.

SAICM has an emphasis on combining the perspectives of chemical safety and national development. Hopefully, this emphasis in combination together with the funding instrument of the Quick Start Program could help in dealing with this combination. Similarly, and with much more economic clout, the Global Environment Facility (GEF) has modified its focal area strategies to include:

• Strategic Program 1: Integrating Sound Chemicals Management in GEF Projects, and

• Strategic Program 2: Articulating the Chemicals-related Interventions Supported by the GEF Within Countries’ Frameworks for Chemicals Management (GEF 2007a).

One might say that Program 1 reflects the perspectives of the development planners and Program 2 those of the chemical safety planners.

3.5 How To Build Capacity

Chemicals production may in a few decades be dominated by today’s developing countries, and even now these represent a larger number of countries and a greater population than developed countries. Therefore, global chemical safety will over the next decades likely be dominated by capacity building and other actions in developing countries. The three elements discussed above – national profiles, national action plans and alignment with national development priorities – will be cornerstones in this work. If this work is to be successful, a number of other considerations should also be taken into account and applied whenever appropriate (IFCS 2003c). Projects should, for instance:

• Consider long-term coaching and support and make use of twinning arrangements.

• Have an ownership/demand driven approach with clear definition of who the owners of a project and the stakeholders that have an interest in a successful outcome are.

• Build on successful previous or existing bilateral projects (‘A successful project is also the donor’s success’).

• Use clear indicators and validation data to measure progress and success of projects.

• Seek opportunities to link to direct positive economic results and to promote active participation of trade, industry and chemicals consumers.

An internationally agreed guidance document on strategy for capacity building has been prepared by the IOMC (2010).

Capacity building is a slow process that can be significantly aided by reference to the experiences of others. An attempt has been made to establish a tool for systematic accessibility to experiences from capacity building on chemical safety. This tool has been transferred to the Secretariat of the SAICM (SAICM 2010).

4 The Future of Global Chemical Safety

Over the next decades developed countries are likely to continue to accomplish what they have begun in global chemical safety, and developing countries will likely continue trying to catch up. What new developments are waiting beyond the horizon?

There will always be new types of chemicals and new exposure situations, but these are not really a major challenge. They can be exemplified by the ‘emerging issues’ before the ICCM-2: nanotechnology, chemicals in articles, lead in paint and electronic waste. These are not really new issues but have been discussed for a decade or more. It is likely that the global system will be able to deal with similar issues through minor modifications to the established system. As a precedent, when the endocrine disruptors emerged in the beginning of the 1990s, they were dealt with mainly by adding some tests and changing priorities (see for instance USEPA 2009a).

But there are other challenges that will be more difficult to meet. These include:

• Securing commitment over a broad range of stakeholders in ever more complex work with chemical safety

• An increasing number of international instruments for chemical safety

• An increasing number of countries participating in international cooperation

• An increasing risk due to increasing volumes and increasing numbers of substances of concern

4.1 Developed Countries Accomplish What They Started

Over the next decades developed countries will continue to implement what has been accomplished since Rio 1992. For instance:

• The timeline for the European Union extensive program on assessing industrial chemicals is to end by 2019.

• The OECD countries have adopted a vision that by the end of 2014 governments will routinely accept pesticide ‘dossiers’ prepared by stakeholders in the OECD format.

• The Globally Harmonised System for classification and labelling will be implemented in many countries over the next few years.

• In cooperation within OECD, emerging issues, such as nanomaterials, will continue to be addressed.

With the obvious effects being regulated and assessments and approaches harmonised, it is natural that attention be turned even further to ubiquitous environmental contamination with chemicals. The most obvious substances with persistent, toxic and bioaccumulating properties have been addressed in the Stockholm Convention, and there is a working process to review additional substances for ­possible inclusion. Such additions may not come easily, as shown by the example from the Rotterdam Convention with contention around inclusion of additional ‘live’ chemicals, such as chrysotile asbestos and endosulfane. The great attention paid to these types of substances in, for instance, the United States and European Union points towards a continued struggle to control a large number of substances that each may contribute only a small share to the overall risks to health and the environment.

Another set of controversies has been raging around the concept of substitution, that is replacing hazardous chemicals with less hazardous ones. This is an important constituent in chemical safety work, for instance under the name of ‘Green chemistry’. The controversies concern the formalisation of this process. Rather strong requirements for substitution concerning plant protection products and biocides have been included in European Union legislation. Substitution was given a prominent place in the SAICM outcome (Section 12.2.4.1) in 2006. In some countries this has been aided by lists of chemicals of particular concern. A renewed interest and controversy has appeared around the SIN (Substitute It Now) list of 267 substances presented by a Swedish non-governmental organisation (ChemSec 2009).

4.2 Lagging Implementation, Few New Agreements, Calls for Coordination

It is easy to predict that this increasing complexity will not make international cooperation easier. In fact, with upwards of 100 international agreements, programs and initiatives on chemical safety, a lower degree of implementation is likely. For instance, part of the work will have to be done via the foreign ministries. Considering that overall the United States has around 12,000 and Canada around 4,000 international agreements to deal with, the manpower that can be devoted to each of them will not be very great. Participation in international negotiations will be a burden for many smaller countries with limited resources for chemical safety. Also, non-­governmental organisations will find it necessary to set tough priorities for where they interact in the international processes. In particular, this will hold for academia, labour and public interest organisations, with their very limited resources.

There is also bound to come a time when countries will be reluctant to sign further agreements. In Sweden in the 1990s, representatives of the Environment Ministry had instructions to be very restrictive with new international commitments and to make sure that they could be implemented and periodically reported on within the limits of existing resources before anything was agreed upon. Arrangements for coordination of international work, such as those described in Section 12.2.2, are also likely to gain more weight.

4.3 Developing Countries Will Not Keep Up To Speed

With developing countries playing an increasing role in international negotiations on chemical safety, funding issues have become among the most critical elements in the negotiations. As an indication of funding needs, China has made a first assessment that it may need 1.3 billion USD for implementation of the Stockholm Convention over the years 2007–2010, or some 300 million USD annually. With China having one-fifth of the world’s population, a first estimate of global needs would be the fivefold amount, or some 1,500 million USD annually. This can be compared with the expected total allocation of funds for POPs from the Global Environment Facility of about 100 million USD per year for the same period, with approximately the same amount leveraged in co-funding. A similar level can be inferred for all chemical safety assistance over the first years of the new millennium, according to an OECD survey (OECD 2003). The SAICM quick start programme trust fund allocations are expected to be much smaller, around 4 million USD per year for 2006–2011. Contributions for assistance from the other two conventions, Basel and Rotterdam, are even smaller, each being less than 1 million USD per year.

Even though all of these numbers are uncertain estimates, it is obvious that development aid will be on an order of magnitude less than what is needed. The lack of resources was a major issue at ICCM-2, but resolutions were vague, encouraging research and further funding, including requesting GEF to consider further chemicals management. Consequently, it is highly unlikely that the commitments of developing countries under the chemicals agreements will be met at the agreed pace, and it may take ten times longer than anticipated, thus running into centuries rather than decades. It will be a great challenge for international chemical safety to falsify these gloomy predictions. As one option, a tax has been proposed on the global chemicals producing industry (IPEN 2005). A tax of 0.1% was determined to yield 1.5 billion USD annually, a number that would be of the right order of magnitude to meet developing country needs. In the SAICM Overarching Policy Strategy, the text on Financial considerations contained a follow-up of the proposal in the form ‘Where appropriate, assessing and adopting at the national and sub-national levels economic instruments intended to internalise the external costs of chemicals’. It remains to be seen whether this instrument will be used; there are a few previous examples at the national level (OECD 2009e).

Fortunately, general economic growth provides greater resources for some countries. Several former developing countries and countries with economies in transition are now members of the OECD (Korea, Mexico, Turkey, Czech Republic, Slovak Republic, Poland, Hungary and Chile) and the OECD has invited Estonia, Israel and Slovenia to become members and offered enhanced engagement, with a view towards possible membership, to Brazil, China, India, Indonesia and South Africa. Similarly, the European Union now comprises more than half a dozen countries that used to be among countries with economies in transition. In addition, there is a slow migration of countries from recipients to donors of assistance, with the Czech Republic, Hungary and Thailand being examples in relation to chemical safety.

4.4 New Approaches Needed To Meet Increasing Risks

The OECD report (2001) predicted almost a doubling of chemicals production in the 25 years between 1995 and 2020, and a similar rate of increase was confirmed by CEFIC (2008). With lagging implementation and convention fatigue, what can be done to keep pace with this potential increase in risks?

4.4.1 A More Complex Chemical Safety Landscape Takes Time To Master

The obvious and immediate effects of chemical substances were regulated long ago in developed countries, and international cooperation began already in the nineteenth century. As more subtle effects, such as cancer, hereditary effects and effects on the developing organism, became known, the hazards and risks became more difficult to identify and quantify. Environmental pathways were also added to the exposure routes of interest. There was also an increased understanding that many chemicals in manufactured goods will eventually lead to exposures from the use or disposal of the goods. These developments led to a complexity in ­international cooperation, with developed countries worrying about subtle and long-term effects, while developing countries struggled with managing obvious and immediate effects.

The measures taken in developed countries are already quite complex. For instance:

• The European chemicals legislation called REACH encompasses some 850 pages of legal text

• For one single substance, trichloroethylene, 29 different working groups have addressed the issue of its carcinogenicity without reaching any unambiguous answer (Rudén 2001)

• There are several thousands of high production volume substances, and tens of thousands more, with lower production volumes

The complexity and the difficulties in obtaining proof entail that international ­regulation of chemical safety takes time and develops over decades, as shown by the two half-century examples of GHS (Section 12.3.3.2) and PCBs (Section 12.2.3.4). The time scale for risk abatement is, thus, of the same order of magnitude as the time scale for significant risk increase, a few decades.

4.4.2 Controlling Total World Emissions To Be Below Natural Ones?

Efforts to control a substance are often hampered by a lack of knowledge about its harmful effects. One simple policy instrument that obviates the need for knowledge has been adopted as a major principle by some countries and by the organisation ‘The natural step’, but has not been applied in international negotiations. It concerns the warning signal that may come from a significant accumulation of substances above the natural levels. In the long run, the average global accumulation will be governed by the anthropogenic flow in relation to the ­natural one. At present this ratio is, for instance, between 100 and 2,000 for ­copper, lead, nickel and zinc (based on OECD 2008 and Ayres and Simonis 1994). This may be of concern in the long run, if production continues at the ­current level over a period of time longer than the time of residence of these ­substances in the technosphere or biosphere; theoretically one could expect average levels of up to 2,000 times the natural ones. However, this is not likely to occur, since the existing reserves generally have a life expectancy of less than 100 years (OECD 2008), and even if new reserves are found, production rates are likely to decrease due to price increases. Still, a high ratio may be an indication that further studies on health and environmental consequences of long-term use of the substance are justified.

For strongly toxic organic substances, there is little information on natural flows even though many organic substances occur in nature. For instance, a wide range of chlorinated substances is produced in ordinary wood, and forest fires produce similar combustion products as are produced due to the combustion of petroleum products. The complexity of the thousands of substances involved makes it likely that references to natural flows of organic substances will rarely be able to provide perspectives on the degree of concern that would be reasonable in relation to anthropogenic emissions.

4.5 Control at the Source Instead of Cleaning Up Later

There are tens of thousands of substances that are harmful, as mentioned in Section 12.1.5. With widespread environmental exposures comes the risk that many of these will influence the same mechanism for injury to humans or other organisms as may have been the case for the previously mentioned tadpole example. Even though effects of exposures to multiple substances are systematically used to advance studies on the effects of pharmaceuticals on humans (Lehár et al. 2008), the complexities have prevented broader generalisations about deleterious effects on health and the environment. There are, however, some examples of potential rules of thumb. For instance, it has been shown (Silva et al. 2002) that the response of several substances may be best described by adding their amounts weighted by their toxicity equivalency factors.

In contrast to the existence of tens of thousands of harmful substances, major international agreements on chemical safety target only some 40 substances or substance groups, and the rate of addition of substances is of the order of one per year. New approaches will be needed to cope with the total effects of all ­hazardous substances. There is, however, still little policy available for chemicals ­concerning the combined effects of all substances from all sources via all pathways, although some efforts have been made in this direction. For instance, the United States Environmental Protection Agency is developing tools to address aggregate exposures (exposure to a single pollutant via multiple pathways) and cumulative exposures (aggregate exposure from multiple pollutants) (USEPA 2009b) and applying a life stage perspective (USEPA 2006). A case in point concerns phthalates (NRC 2008).

A global policy for all substances from all sources is, in contrast, being implemented for radioactive substances (ICRP 2008). Two characteristics of this policy are source control and the use of economic instruments. To implement a similar policy for chemical substances will require simplifications with respect to the relationships between releases from sources and exposure and between exposure and response. In the following, two potential simplifications are suggested: the intake fraction for exposures and assigned linearity for responses. Thereafter, some potential policy instruments for global use are discussed.

4.5.1 The Intake Fraction Links Release and Exposure

It is, of course, extremely difficult to get an idea of the exposures and effects of tens of thousands of substances arising from hundreds of thousands of different preparations and millions of different articles manufactured using these preparations. The concept of intake fraction, however, promises to yield approximations to exposures. The intake fraction is the fraction of a released substance passing through any human being at any time. This concept has attracted increasing attention as a potential tool for risk assessment for hazardous chemicals. One very interesting feature is the relatively low variability of the intake fraction for substances that are relatively persistent in nature (Jantunen et al. 2008). According to a case study (Bennett et al. 2002), the intake fraction distributions for 308 substances are very similar, whether the release is to the air or to water. The log-normal distributions are relatively narrow, with a standard deviation of about 11 times, meaning that most intake fractions are within a factor of 10 from the geometric mean of about 5 parts per million (ppm). Similar values were found using monitoring data for four radioactive substances with global dispersion (Bengtsson 1985).

4.5.2 Equitable Responsibility for Releases Through Assigned Linearity

In toxicology, there is a long standing tradition that more often than not dose response relationships have thresholds. A linear dose-response relationship would, accordingly, have little value in describing harm; for most exposed individuals, there would be no harm, and protection should aim at keeping exposures below certain thresholds.

In contrast, radiation protection policy (ICRP 2008) benefits from an assumption of linearity as a tool to attribute causation in an equitable way. Linear dose-response relationships could also serve a useful purpose for chemical safety, with the following qualifications:

• They should be used as one facet, probably only to protect against human health effects; other paradigms will be necessary to address other areas of protection, say, of the environment

• They would only be useful in protection against widespread exposures at low levels (obviously higher exposures exceeding certain thresholds, say, at the workplace or in conjunction with accidents would lead to acute symptoms)

• It should be recognised that they are assumptions for attributing potential harm and protective needs among sources – not descriptions of biological consequences

Arguments, within these qualifications, to assume linear dose-response relationships or to assume that increments of exposure cause a proportionate increment of response, include the following:

• Some biological dose-response relationships are nearly linear, e.g. those involving mutations or cancer initiation. The quasi-linear dose-response relationship for proteinuremia following environmental cadmium exposure to human populations may be an example. Reproductive and developmental toxicity, including neurotoxic effects on children, may also provide examples; incremental impairment of IQ in children may be linearly related to increments of low lead exposures (WHO/IPCS 2000). There is, however, a continuing debate concerning the applicability of linear or threshold relationships (Swenberg et al 2009).

• Some exposures may involve additions to considerably high levels previously existing.

• Exposures from other substances may affect the same target mechanism.

• Threshold relationships will tend to be smoothed when applied to a strongly heterogeneous population; the response may depend strongly on e.g. age, gender, genetic constitution and health status.

• If regulation is based on a designated linear dose-response relationship, responsibility will automatically be assigned in relation to the magnitude of exposures. There are no other practically useful options for attribution. It is, for instance, extremely difficult, and in practice impossible, to make a detailed assessment of potential synergistic or antagonistic effects of simultaneous exposures. Fair regulation would require that responsibility be assigned in relation to the exposures, independent of the order in which the exposures occur.

4.5.3 Screening Tools Can Elucidate the Need for Source Control

One simple policy application using intake fraction and presumed linearity would be to screen for potentially troublesome amounts of substances produced globally. This would require assessing the chain emission-intake-risk.

For the emission term, it can be assumed that in a longer time perspective (decades or more) all substances produced will be emitted; this will overestimate the risks, since there will be losses e.g. due to chemical transformations.

For the intake term, the intake fraction can be used. As a default value, an intake fraction of approximately 100 ppm (arithmetic mean) can be assumed; it should be remembered that the variation is large and, for instance, the geometric mean is likely to be around 5 ppm.

For the risk, the Threshold of Toxological Concern of 0.15 µg per day (Kroes et al 2005) can be applied. For comparison, it is about 60 times stricter than the guideline values for known poisons such as benzene and arsenic and 5,000 times stricter than the geometric mean of Acceptable Daily Intakes in a database of 588 substances (Australian Government 2009).

Alternatively, a threshold of concern could be assumed for the risk of serious effects, such as cancer and hereditary disease or serious impairment of the intellectual ability (loss of more than 10 IQ points). One option might be that lifetime exposure entails a lifetime risk of 10 in one million of suffering such a serious effect. This is the level of cancer risk associated with the WHO guidelines for drinking water; for the sake of comparison, it is about 400 times stricter than the risk for cancer and hereditary disease associated with radiation exposures at the dose limit for the public (ICRP 2008).

The total global emission of a substance that is tolerable according to the Threshold of Toxicological Concern is, then, about 400 t per year (assuming 7 billion people each ingesting 0.15 µg per day and an intake fraction of 100 ppm). The corresponding number according to the 10 in a million cancer risk criterion is 200 t per year (using the arithmetic mean cancer risk factor for oral intake in the database IRIS (2009), which is 54 times the value for arsenic, assumed to be 1 case per ingested kilogram by Spadaro and Rabl 2004). Considering the uncertainties in the assumptions of several orders of magnitude, the similarity of the tolerable emissions is fortuitous.

Finally, an emission of 2 million tonnes of lead per year might in equilibrium cause an average loss of 10 IQ points to the world’s population (an emission of 17 kilograms of lead would cause a collective loss of 10 IQ points, according to Spadaro and Rabl 2004). If the probability of the effect were to be 1/10,000, then 20 t would be the tolerable emission.

All of these numbers are the result of a long series of assumptions and, for instance, do not account for the distribution of exposures or individual sensitivities among the population, intake fractions among substances or emission factors per produced volume among substances.

These examples indicate that there should be no concern for emissions on a global scale in relation to chemicals that are produced in production volumes below 10 t per year. Volumes below 10 t per year are subject to the lowest degree of requirements in the new REACH regulation in the European Union. This is certainly necessary for exposure situations in occupational or other use but not when it comes to global dispersion.

Above 10 t per year, relevant to some 10,000 substances in the European Union, a more detailed analysis should be considered to see if restrictions on total global production might be warranted for the case of very sensitive endpoints, such as cancer or influence on the central nervous system.

4.5.4 Paying for Unnecessary Emissions

In considering economic instruments, what are reasonable prices to pay for ­emissions? The economic detriment due to risks can be calculated using a series of assumptions (Spadaro and Rabl 2004). In two examples, the assumed numbers are 10,000 Euros per lost IQ point and 2 million Euros per case of cancer, corresponding­ to 6,000 Euros and 2 Euros per emitted kilogram of lead and carcinogenic ­substances, respectively. Estimates of detriments such as these can be used in two different ways.

Directly, the cost calculations can be a basis for restricting emissions using economic instruments such as emission fees or trading of emission permits. This might, for instance, have important applications for emissions of dioxins and other substances from combustions. The examples above indicate that the costs of a detriment can be substantial in relation to the value of the product, which is usually in the range of 1–10 Euros per kg. Consequently, such economic instruments might be expected to lead to substantial reductions in emissions.

The cost calculations can also be used in a more indirect way, following the example from global radiation protection recommendations (ICRP 2008). According to this philosophy, even small exposures should be kept as low as reasonably achievable. Legislation, then, requires that enterprises wishing to use hazardous emissions should calculate the worldwide detriment caused by them translated to economic terms. Emission reduction should be sought as long as the costs of the reduction activities are less than the costs of the prevented detriment. For instance, a scrubber preventing the emission of 10 kg of lead annually should be installed as long as the annual operating costs are below 10*6,000 = 60,000 Euros.

4.5.5 Policy Developments Overdue

There are already documented effects from environmental exposures on, for instance, children’s health and reproduction in aquatic organisms. With chemicals production and thereby releases doubling over the next generation, the time to take action to prevent the future occurrence of even worse effects from a multitude of substances and sources is well overdue. Tools, such as intake fraction and assumed linearity, and economic instruments need to be further developed and applied. The weak trends in this direction that have been observed during the past decade need to be strengthened in order to achieve the globally agreed goal that by 2020 chemicals be used and produced in ways that lead to the minimisation of significant adverse effects on human health and the environment.