Chemical production is increasing and poses risks to ecosystems and human health
European legislation has reduced acute pollution, but chronic, less apparent effects persist
Environmental and societal megatrends are changing exposure patterns
Chemical risks are traditionally underestimated by science
Green and sustainable chemistry requires targeted innovation
A focus on critical parameters is more important than gathering more general data
Monitoring for a wider variety of chemicals can provide earlier warnings
Policy approaches need to be further integrated in support of sustainability objectives
Avoiding upstream use of persistent and hazardous chemicals is key
A less toxic environment requires visionary and inclusive stakeholder approaches
The EEA Scientific Committee, composed of independent scientists, assists the EEA Management Board and the Executive Director in providing advice on scientific matters. Featured image credit eea.europa.eu.
How to find and analyse alternatives in the authorisation process
Analysis by ChemSec and ClientEarth shows the chemicals approval process gives undue influence to companies producing dangerous chemicals and stifles information on safer alternatives, limiting the market for companies that produce them.
The main goal of the authorisation process is to promote the replacement of substances of very high concern (SVHC) with substances or technologies that are safer.
However, during the “stocktaking conference on authorisation” held in November 2017, it emerged that the authorisation process has not delivered its full potential. In particular, authorisations have been granted even when alternatives did exist, contrary to the requirements of REACH and having negative effects on alternative providers.
When an authorisation is granted under Article 60 despite the existence of a suitable alternative, it not only violates REACH, it also rewards the laggards and frustrates the frontrunners.
On the basis of the conference on authorisation, experience as observers in the socio-economic committee (SEAC) and extended exchanges with alternative providers, ChemSec and ClientEarth have identified two of the issues in the way SEAC operates, that prevent the authorisation process to fully deliver.
First, applicants do not always comply with their obligation to provide ECHA with accurate and comprehensive information on alternatives. The way to find existing alternatives has to be re-thought.
Second, SEAC does not use clear and appropriate criteria to assess the feasibility of suitable alternatives. The way that SEAC assesses the feasibility of alternatives needs to be improved.
This publication aims to explain the current challenges and recommend solutions that could be implemented without changing the existing regulatory framework.
Read the full reportHow to find and analyse alternatives in the Authorisation Process on chemsec and press release EU chemicals approval process stifles safer alternatives on clientearth.
Research done by the Pesticide Action Network reveals that in 92% (11 out of 12) of the EU-methods for pesticide risk assessment examined, it was the industry that designed and/or promoted their regulatory use. Industry is writing its own rules. This is a major conflict of interest. The cases concern criteria and methods (risk assessment methodologies) on HOW the rules of the pesticide Regulation 1107/2009 should be used in decision-taking on individual pesticides. In most cases European Food Safety Authority, EFSA, drafted the guidelines on the use of these criteria and methods. Such methods are used to dismiss tumours observed in animal toxicity testing of pesticides, to approve carcinogenic pesticides in our food, to classify polluting pesticide metabolites in our groundwater as irrelevant, to allow the dying of 50% of the insects in every spraying turn, to construct ‘safe’ levels for harmful pesticides without any experimental evidence, among others.
Industry, spearheaded by industry lobby group ILSI (International Life Sciences Institute), developed their desired methods during the past 15 years in a series of invited-only meetings with industry employees and a few university professors that generally shared their views. Next it tried to get its allies in regulatory expert panels that draft opinions on the methods like the panels of EFSA, IPCS/WHO (World Health Organisation/ International Program on Chemical Safety), JMPR (WHO Joint Meeting on Pesticide Residues) and other agencies.
In 75% (9 out of the 12) of the risk assessment methods studied by the Pesticide Action Network, industry-linked experts managed to get a seat in EU and global panels where these methods were produced. Generally there were only a handful of experts present in the panels that decided on far-reaching opinions about the methods. Only rarely were experts present in these meetings that are actively conducting experimental scientific work. In any case, not much science is used for drafting opinions on risk assessment methods in panels. “Expert judgement” is the prevailing practice, which is in fact just the opinions and ‘feelings’ of those that are present in the room. The global scientific societies that bundle the hundreds of thousands of scientists that do scientific research in the world are not involved nor asked to do a peer-review of these methods of risk assessment, which is the standard procedure for scientific work. In none, 0% (0 out of 12) of the methods studied by the Pesticide Action Network, the method was peer-reviewed by independent academic scientists.
Since a solid conflict-of-interest policy was lacking in the beginning of this century in most agencies, many expert panels have been dominated by experts that support the views of industry. In the case of TTC (Threshold of Toxicological Concern; a method to design safe levels for pesticides) up to 77% (10 out of the 13) of the experts in the EFSA-working group were linked to industry and were promoting this method in the past.
Food Authority EFSA is known for having close ties to industry. In 50% (6 out of the 12) of the methods studied by the Pesticide Action Network, EFSA and other agencies had exclusive meetings with industry on the design of the methods, sidelining other stakeholders.
Industry obtained most of its inspiration from the US where citizens are not protected by the precautionary principle and the burden of proof on harmfull effects of pesticides is put largely on the public. An entirely different system therefore from the EU system. Yet, in 67% (8 out of the 12) of the methods studied by the Pesticide Action Network, an US-origin could be seen. Without a doubt the US-type of risk assessment is invading the EU-system through the backdoor.
The 12 methods studied here all are designed to lower the level of protection of the public and to enable the approval of pesticide that can cause harm. On top of this, the methods adopted are even misused in practice. In 92% (11 out of 12) of the methods studied by the Pesticide Action Network misuse was observed in actual decision-making of EU pesticide approval.
A full revision of the EU risk assessment methods is needed, according to the Pesticide Action Network. Fully independent scientists that are actively conducting experimental work as a daily practice should be tasked to do this to protect the public with the newest scientific in sights and knowledge.
Continue readingIndustry writing Its own rules, a research report written by the Pesticide Action Network Europe, January 2018.
Human health and well‑being are intimately linked to environmental quality
Preface
Human health and well-being are intimately linked to environmental quality. This has been recognised for decades amongst policymakers in Europe, and most recently appears as a cornerstone in the European Commission’s proposal for the 7th Environment Action Programme. This report, produced jointly by the European Environment Agency and the European Commission’s Joint Research Centre, outlines a number of environmental issues with a direct influence on people’s health and well-being and is a follow-up and update to the 2005 EEA/JRC report.
In the 8 years that have passed, the political context of environment and health has evolved. As highlighted in EEA’s The European Environment — state and outlook 2010 the policy focus is increasingly shifting from single environmental pollution issues towards systemic challenges regarding the maintenance of ecosystem resilience and the delivery of ecosystem services to human society. Climate change is a good example with its combined impacts on food and water security, heat waves, flooding risks and potential spread of diseases.
Human health and well‑being are intimately linked to environmental quality. This report, produced jointly by the European Environment Agency (EEA) and the European Commission’s Joint Research Centre (JRC), outlines a number of environmental issues with a direct influence on people’s health and well-being.
Where problem detection and measures in the environment and health area have typically been based on dose-effect studies of individual polluting substances and stressors, this new report makes the case for a more integrated take on health issues, acknowledging the complex inter-linkages between resource-use patterns, environmental pressures, multiple exposures and disease burden, as well as the key role that social inequalities play.
It also touches upon emerging issues resulting from long-term environmental and socio-economic trends, such as climate change, lifestyle and consumption changes and the rapid uptake and application of new chemicals and technologies. As such, it complements the recent EEA publication Late lessons from early warnings; science, precaution and innovation, which makes a strong argument for precautionary science in political decision-making, allowing us to strike a better balance between using economic opportunities and avoiding disproportionate risks to the environment and human health and well-being.
Environment and health is not just ‘an aspect’ of environmental policy, it is at the heart of it. In fact, it is central to Europe’s ambition to move towards a Green Economy. With this report, taking stock of the most pertinent environment and health issues, and combining the expertise of our two institutes in environmental reporting and scientific research, we hope to contribute to this goal.
An investment in knowledge pays the best interest ~ Benjamin Franklin ~
Preface
There is something profoundly wrong with the way we are living today. There are corrosive pathologies of inequality all around us — be they access to a safe environment, healthcare, education or clean water. These are reinforced by short-term political actions and a socially divisive language based on the adulation of wealth. A progressive response will require not only greater knowledge about the state of the planet and its resources, but also an awareness that many aspects will remain unknown. We will need a more ethical form of public decision-making based on a language in which our moral instincts and concerns can be better expressed. These are the overall aims of Volume 2 of Late lessons from early warnings.
Volume 1 of Late lessons from early warnings was published at a time when the world was experiencing an economic slowdown, China had joined the World Trade Organization and western Europe was still a 15-member Union. Global grain production had declined for the third time in four years due mainly to droughts in North America and Australia, and the world saw major recalls of contaminated meat, foot and mouth disease and bovine spongiform encephalopathy (mad cow disease). Global temperatures continued to climb and many bird populations were in decline, but the United States of America had rejected the Kyoto Protocol. We were seeing ourselves through the lens of the first human genome sequence, yet we were trying to manage chemicals known to be harmful to humans and ecosystems, through international conventions and treaties such as the Basel Convention to deal with toxic waste dumping in the developing world; the OSPAR/HELCOM Conventions to reduce the discharges, emissions and the loss of hazardous substances into the sea and the Montreal Protocol, to phase out ozone-depleting substances. The destruction of the World Trade Center had just happened.
The 2013 Late lessons from early warnings report is the second of its type produced by the European Environment Agency (EEA) in collaboration with a broad range of external authors and peer reviewers.
Since then, we have witnessed a period of extraordinary hubris. Most visibly, the financial profligacy of the first decade of the century led inexorably to the crises of 2007–2009 whereby the major components of the international financial system were weakened to the extreme by indebtedness, mispriced products, lax monetary policies and mis-engineered protection against risks and uncertainty. The world experienced more not less volatility. Political systems became silted up by vested interests and a determination by citizens to protect assets accumulated in easier times, and beneath it all lay a deeper environmental crisis epitomised by climate change and biodiversity loss.
There was also a collapse of trust, not only in financial institutions but in big companies, as they abandoned staff, pensions and health care schemes. Recent evidence from social psychology has shown that despite rising levels of education and innovation in products and services, people trust only those they know and not strangers. As Stephen Green said in Good value: reflections on money, morality, and an uncertain world in 2009:
‘There has been a massive breakdown of trust: trust in the financial system, trust in bankers, trust in business and business leaders, trust in politicians, trust in the media, trust in the whole process of globalisation — all have been severely damaged, in rich countries and poor countries alike’.
The scientific elites have also been slowly losing public support. This is in part because of the growing number of instances of misplaced certainty about the absence of harm, which has delayed preventive actions to reduce risks to human health, despite evidence to the contrary.
Suddenly, our problems have grown into what Charles W. Churchman in 1967 termed wicked problems — difficult or impossible to solve because of incomplete, contradictory and changing requirements, difficult to recognize, resistant to resolution because of the complexity of their interdependencies and needing to be tackled not by one but via many forms of social power. Solving them requires a new combination of hierarchical power, solidarity and individualism.
What could this mean, for example, for the 100 thousand chemicals currently in commercial use?
To begin with we have more conventions and treaties in place than a decade ago: the 2004 Rotterdam Convention on the Prior Informed Consent (PIC) Procedure covering international trade of 24 pesticides, four severely hazardous pesticide formulations and 11 industrial chemicals; the 2004 Stockholm Convention on Persistent Organic Pollutants to protect human health and the environment from substances which are highly toxic, persistent, bio-accumulative and move long distances in the environment, such as DDT, PCBs, various industrial chemicals, and a set of unintentional chemical by-products such as dioxin. But these conventions only address the top-down hierarchical approach to power.
At the same time Europe has put in place legislation to achieve a global regulatory influence including the EU Cosmetic Directive banning the use of chemicals known or strongly suspected of being carcinogens, reproductive toxins, or mutagens causing cancer, mutation or birth defects; the EU Restriction of Hazardous Substances Directive, which restricts the use of hazardous materials in the manufacture of various types of electronic and electrical equipment including lead, mercury, cadmium, hexavalent chromium, the flame retardents polybrominated biphenyls and polybrominated diphenyl ethers, and which encourages the substitution to safe/or safer alternatives in the electric and electronic equipment industry; the closely linked 2006 EU Waste Electrical and Electronic Equipment Directive for collection, recycling and recovery of electrical goods; the 2006 Strategic Approach to International Chemicals Management (SAICM); and the 2007 EU Registration, Evaluation and Authorisation of Chemicals, widely known as REACH, to assign greater responsibility to industry to manage the risks from chemicals and to provide safety information on substances. The effects of these regulatory tools are described in different chapters, but once again point to the main economic actors rather than communities or individuals.
One thing that has become clearer over the past decade is that certain chemical substances are highly stable in nature and can have long-lasting and wide ranging effects before being broken down into a harmless form. The risk of a stable compound is that it can be bio-accumulated in fatty tissues at concentrations many times higher than in the surrounding environment. Predators, such as polar bears, fish and seals, are known to bio-magnify certain chemicals in even higher concentrations with devastating consequences for both humans and ecosystems. So exposure to toxic chemicals and certain foodstuffs are at risk of causing harm, especially to vulnerable groups such as foetuses in the womb or during childhood when the endocrine system is being actively built. Even with small dose exposures, the consequences can in some instances be devastating with problems ranging from cancer, serious impacts on human development, chronic diseases and learning disabilities. Here the power to act could be more properly set by well-informed individuals and communities.
The relationship between knowledge and power lies at the heart of Volume 2. In many chapters, the implicit links between the sources of scientific knowledge about pollutants, changes in the environment and new technologies, and strong vested interests, both economic and paradigmatic, are exposed. A number of authors also explore in greater depth, the short-sightedness of regulatory science and its role in the identification, evaluation and governance of natural resources, physical and chemical hazards. By creating a better understanding of these normally invisible aspects, it is hoped that this volume will enable communities and people to become more effective stakeholders and participants in the governance of innovation and economic activities in relation to the associated risks to humans and the planet.
Much of what we are able to learn from the histories of past environmental and public health mistakes is also directly applicable to the better regulation and governance of global institutions and financial and economic risks. Robin G. Collingwood argued in his Autobiography (1939), that:
‘History can offer something altogether different from [scientific] rules, namely insight. The true function of insight is to inform people about the present…we study history in order to see more clearly into the situation in which we are called upon to act… the plane on which, ultimately, all problems arise is the plane of ‘real’ life: that to which they are referred for their solution is history.’
In this volume, we go further. Whilst still drawing lessons from such widely accepted tragedies as leaded petrol, mercury poisoning in Japan’s Minamata Bay and older pesticides which sterilised many men who used it, we have ventured into the uncertainties of potential yet contested harm, from genetically modified products; nanotechnologies; chemicals such as Bisphenol A; new pesticides and mobile phones. There is also an examination of the 80 or so potential ‘false positives’ where there had been indications of harm but where it was subsequently claimed that there were in fact no risks to prevent: these cases too can provide information that can help to improve future decision-making about innovation and emerging technologies.
A major part of effective decision-making lies in the way issues are framed. In the case of climate change, the first order question is whether it is worth worrying about at all. US Vice President Al Gore chose to make the question a matter of choice between believers and sceptics. However, problems arose when the public was asked to make a scientific decision when too few people had the qualifications to make any kind of reasoned judgement. They were in fact asked to make a false choice. Instead the question should have been framed around which areas should people and governments make decisions and which should be delegated to experts.
In the end there are few certain and enduring truths in the ecological and biological sciences, nor in the economics, psychologies, sociologies and politics that we use to govern them. One, however, comes from the work of Elinor Ostrom, a late and widely missed colleague, who showed from her work on managing fisheries and ecosystems that complex problems can be solved if communication is transparent and open, visions are shared, trust is high and communities are activated to work from the bottom-up as well as from the top down.
As we navigate the Anthropocene, the epoch named in recognition of our impact on the planet, we will need to encourage more people to become involved in solving the wicked problems of our times. Whether through gathering local information or becoming more aware of the many uncertainties and unpredictabilities in our surroundings, the power structures of knowledge will need to change. And if we are to respond more responsibly to the early warning signals of change, we will need to re-design our style of governance to one which reflects a future defined by the local and specific rather than only the global and the average. We hope that Volume 2 of Late lessons from early warnings with its many lessons and insights can help us all meet such a challenge.
Overview
Introduction
The precautionary principle and false alarms — lessons learned
Lead in petrol ‘makes the mind give way’
Too much to swallow: PCE contamination of mains water
Minamata disease: a challenge for democracy and justice
The impacts of endocrine disrupters on wildlife, people and their environments – The Weybridge+15 (1996–2011) report
The impacts of endocrine disrupters on wildlife, people and their environments – The Weybridge+15 (1996–2011) report.
Rates of endocrine diseases and disorders, such as some reproductive and developmental harm in human populations, have changed in line with the growth of the chemical industry, leading to concerns that these factors may be linked. For example, the current status of semen quality in the few European countries where studies have been systematically conducted, is very poor: fertility in approximately 40 % of men is impaired. There is also evidence of reproductive and developmental harm linked to impairments in endocrine function in a number of wildlife species, particularly in environments that are contaminated by cocktails of chemicals that are in everyday use. Based on the human and wildlife evidence, many scientists are concerned about chemical pollutants being able to interfere with the normal functioning of hormones, so-called endocrine-disrupting chemicals (EDCs), that could play a causative role in these diseases and disorders. If this holds true, then these ‘early warnings’ signal a failure in environmental protection that should be addressed.
