March 2001 A Precautionary Approach to Toxic Chemicals “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.” Principle 15, Rio Declaration on Environment and Development “…Contracting Parties shall apply a precautionary approach to environmental protection … whereby appropriate preventative measures are taken when there is reason to believe that wastes or other matter introduced into the environment are likely to cause harm even when there is no conclusive evidence to prove a causal relation between inputs and their effects.” Article 3, 1996 Protocol to the London Convention on the Prevention of Marine Pollution Precaution, Policy, and Decision-Making Precaution governs many aspects of daily life, from the emergency services department that discharges firefighters and ambulances (whether for burnt toast or blazing buildings), to the natural resource agency that bars the import of a predatory fish (that may or may not endanger native species). Precaution responds to the complexity of health and environmental problems and the often-indeterminate nature of cause-and-effect relationships. The principle was first enunciated as an explicit basis of policy in German water protection law during the 1970s. Known as “Vorsorgeprinzip,” or the “foresight” principle, it has since guided a wide range of policies, laws, and treaties addressing such issues as acid rain, biotechnology, fisheries, radioactive waste discharges, toxic chemicals, and climate change. “In order to achieve sustainable development, policies must be based on the precautionary principle. Environmental measures must anticipate, prevent, and attack the causes of environmental degradation. Where there are threats of serious or irreversible damage, lack of full scientific certainty should not be used as a reason for postponing measures to prevent environmental degradation.” Bergen Ministerial Declaration on Sustainable Development in the ECE Region, 1990 The inclusion of the principle in the Rio Declaration at the Earth Summit in June 1992 firmly placed precaution on the global stage. Since that time, the principle has been embraced in numerous international agreements including the 1995 UN Fisheries Agreement, the Framework Convention on Climate Change, and the Montreal Protocol on Substances that Deplete the Ozone Layer. More recently, the January 2000 Cartagena Protocol on Biosafety reaffirmed the appropriateness of taking protective action where there is a “lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects….” The precautionary approach bids us to prevent harm before it occurs. It states that where there is evidence that an activity threatens wildlife, the environment, or human health, protective measures should be taken even in the absence of scientific certainty regarding the nature and extent of the threat. Precaution stresses the importance of prevention, the need for comprehensive and rigorous inquiry, and the humility that comes with acknowledging the enormity and complexity of scientific pursuit. Where we can not pin down the exact nature and extent of health and environmental effects, precaution directs us to consider protective action -- based on the available knowledge and research -- rather than wait years or decades in hopes of a more precise answer. The December 2000 United Nations Environment Programme treaty to eliminate persistent organic pollutants (POPs) includes explicit precautionary references in the preamble, the objective, the section on adding new chemicals to the treaty, and the determination of best available technology. The objective states, “Mindful of the precautionary approach as set forth in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Convention is to protect human health and the environment from persistent organic pollutants.” The section on new chemicals says that a “lack of full scientific certainty shall not prevent the proposal from proceeding” and emphasizes that decisions are to be made “in a precautionary manner.” WWF embraces precaution as an overarching framework that should inform every step of the decision-making process, both for newly developed chemicals and for those already in use. Precaution challenges us to study every option and to consider substituting safe alternatives. Precaution and Risk Assessment Precaution provides an overarching framework for addressing threats from toxic chemicals. Additional tools such as risk assessment can provide useful input in the 2 decision-making process, helping to sort out which threats deserve priority attention. But the precautionary analysis must go well beyond risk assessment. Though a valuable tool in certain contexts, risk assessment has the potential to narrow rather than broaden the analysis. In part this is because risk assessment imparts a false sense of authority and exactitude. Results are often expressed with a high degree of precision, yet the adoption of divergent assumptions and priorities in the appraisal may change the conclusions by several orders of magnitude. Despite risk assessment’s aura of scientific objectivity, political and ideological preferences – often inserted throughout the calculations -- can affect the outcomes radically. The risk management emphasis on quantifying permissible levels of health or environmental damage narrows the analysis further, condoning acceptable harms even where safe alternatives may exist or where benefits are derived only by private interests. The precautionary approach, by contrast, calls for review of the proposed action in light of all the possible options and alternatives. WWF Endorses Precaution 1. Increasingly prominent in local and international policies, laws, and treaties, precaution represents an emerging principle of customary international law in the context of high-stakes, low certainty environmental decision-making. 2. Precaution provides an overarching analytical framework that should guide every step of the decision-making process, from the earliest planning stages to monitoring and evaluation of impacts. 3. The precautionary approach revolves around proactive analytical tools: vigilance in anticipating and preventing harm; assessment of alternatives; substitution; and research and monitoring. 4. Additional tools such as risk assessment can provide input in the decision-making process, but precaution must remain the overarching analytic framework. Adding uncertainty factors to a risk analysis may be wise but does not take the place of a proactive precautionary approach. Toxic Chemicals Context The WWF Global Toxic Chemicals Initiative endorses precaution as an overarching framework for decisionmaking. This approach calls for rigorous scientific inquiry into all relevant options and alternatives. It promotes progress and productivity while protecting wildlife, the environment, and human health. Precaution should guide the review of both newly developed chemicals and those already in use. Serious or irreversible damage may be at stake. Wildlife and people are regularly exposed to large numbers of toxic chemicals, from mercury to dioxins to brominated diphenyl ethers. Chemicals such as these cause a range of adverse health outcomes including cancers, immune and nervous system effects, and impaired growth and reproduction. Not all of the consequences are well understood. For the many chemicals that persist and bioaccumulate, or that are passed along through generations as “hand-medown” poisons, there is no turning back once unleashed in the environment. This is particularly true in the case of POPs and endocrine disrupting chemicals, two classes of especially troublesome chemicals targeted for priority attention by WWF. The precautionary approach is needed to prevent serious or irreversible effects. Some cause-and-effect relationships are not fully established. There is unequivocal evidence on many aspects of chemical toxicity, but some questions remain elusive. These include: the congruence of health effects in animals and humans. To what extent does illness in laboratory mice or rats, for example, suggest similar effects in people? the long-term impacts. What can short-term rodent studies tell us about latent or chronic effects in wildlife or humans? the low-dose effects. If large doses of a substance cause disease, what are the impacts of lesser amounts? An increasing number of chemicals appear to have effects at exposures not previously considered harmful. the interactive effects of exposures to multiple substances. Laboratory studies usually test the effects of single chemicals alone, yet generally we are exposed to mixtures of multiple chemicals. What is their combined effect? the extent of non-cancer endpoints, from endocrine disruption to immune system impairment. What are the other health effects besides cancer? Research remains insufficient. Each of these concerns raises a series of complex questions. For instance it is particularly difficult to predict, based on animal studies, the effects on human brain function from low level exposure to chemicals such as lead or PCBs. And the conditions under which exposures occur may affect outcomes dramatically; the toxicity of polycyclic aromatic hydrocarbons to aquatic species, for instance, may be increased significantly in the presence of ultraviolet light. More generally, it is often not possible to predict the effects of a chemical on all 3 organisms from tests on a few selected species. Scientists did not expect, for example, the harmful effects on molluscs that have resulted from exposure to tributyl tin leaching from the painted hulls of ships. The case of plastics additives exemplifies the need for precaution even where connections between cause and effect are not crystal-clear. Manufacturers add chemical softeners to increase the flexibility of many plastic products such as food packaging, children’s toys, and medical devices. With the recent unexpected discovery of these chemicals in the general population, however, the safety of the additives is increasingly becoming a concern. Di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) and other common softeners have now been implicated as a possible cause of adverse developmental and reproductive effects. Prenatal exposure to these chemicals appears particularly harmful to male offspring -- laboratory animals and possibly humans -- potentially associated with testicular atrophy, reduced sperm count, structural deformities in reproductive organs, or other outcomes. That the mechanism, extent, and implications of possible effects remain under investigation is no reason to postpone removal of these chemicals from baby pacifiers, food wrappers, nail polish, medical equipment, and other products. The lack of scientific certainty shall not be used as a reason for postponing measures to prevent harm. The knowledge that industrial chemicals are persisting in the environment and concentrating in animal and human tissue should be reason enough to look for replacements. Even in the absence of scientific certainty, the threat of birth defects, cancers, and other serious or irreversible damage provides a compelling basis for precautionary action. Polar ecosystems have become a storage reservoir or “sink” for pollutants traveling on wind and water currents from temperate and tropical regions. In the Arctic, for example, Inuit peoples and marine mammals have accumulated dangerously high concentrations of PCBs and other POPs in their body fat. Transferred to offspring during fetal development and nursing, these contaminants may be contributing to reproductive problems and weakened immune systems. Likewise in Norway’s Svalbard region, the heavy concentration of pesticides and industrial chemicals found in polar bears may be affecting immune function and reproductive success. Elevated levels of persistent chemicals – as well as immune system and/or fertility problems – are found also in whales, seals, birds of prey, and other animals that are high in the food web. That the cause-and-effect relationships remain poorly understood is no justification for a failure to act. The Mechanics of Precaution As noted earlier, the precautionary approach can best be understood as an overarching principle that informs each step of the decision-making process. In keeping with the ideals of foresight and careful planning, the principle places great weight on data collection and analysis. The information-gathering process involves multiple sources, including the public, to ensure that all relevant data are considered. The precautionary approach includes the following elements: (a) Vigilance in anticipating and preventing harm. The precautionary approach calls for vigilance in anticipating and preventing harm, acting upon early warning signs even when scientific studies conflict or do not give complete information. The evaluation needs to consider both short- and long-term health and ecological effects. Safety testing has its limits, however. Even where initial tests suggest only minimal hazards, ongoing vigilance is important to recognize undetected dangers. Long-term monitoring can provide information on synergistic outcomes and unpredictable complex interactions. (b) Assessment of alternative materials, products, and processes. To identify the response that best protects wildlife, the environment, and public health, precaution entails a thorough review of all relevant options, from no action to goal-setting to phase out and elimination. Many non-toxic substances and processes exist today; others are within scientific reach. The assessment of alternatives should not be limited to chemical options. Clean production technologies or organic farming, for example, can eliminate the need for many toxic substances. Product or process modifications can actually reduce manufacturing costs, particularly those associated with handling and disposal of hazardous chemicals, while protecting the environment and public health. (c) Substitution. The precautionary approach calls for substituting non-toxic or less-toxic alternatives in place of dangerous chemicals. Sweden pioneered this innovative approach in its Chemical Products Act. The law directs companies to select the least harmful chemical for a specified purpose and to strive to use safer alternatives in place of hazardous chemicals wherever possible. The substitution mechanism drives the development of greener and cleaner 4 production by assuring a market share for safer products. Corporate Responsibility and the Burden of Persuasion Like the Swedish law, the UNEP global POPs treaty directs parties to consider substitution. Specifically, Article D3(c) calls on parties to “Promote the development and where it deems appropriate, require the use of substitute or modified materials, products and processes to prevent the formation and release of chemicals listed in Annex C [on the registry of byproduct POPs]…” Objectivity and transparency are critical components in each stage of scientific review, as are opportunities for public input. Costs associated with the assessment should be borne by the companies that stand to profit from the chemical or technology. The proponent should accept responsibility for generating information on options and alternatives, making those data publicly accessible, and ensuring that harm does not occur. Where damage does result, the proponent bears responsibility for mitigating the harm and providing compensation. Where no safe alternatives can replace a dangerous chemical, precaution calls for an additional review: Who uses the substance? For what purpose? Who benefits? What would be the consequence if the chemical or product were no longer available? Depending on the severity of the threat, the irreversibility of the action, and the determination of public benefit, the evaluation may lead to ultimate elimination, product modification, or a range of interim options such as education campaigns, product labeling, regulatory standards, or research initiatives. For severely hazardous substances and those that bioaccumulate and/or persist in the environment, the evaluation should result in prohibition or severe restriction unless there is a clear societal need for the chemical. For example in the case of carbonless copy paper, which conventionally was made with PCBs, researchers have had difficulty identifying safe alternatives with which to replace these dangerous POPs. The fact that common substitutes such as formaldehyde, xylene, and benzene are themselves toxic should prompt a follow-up question: is carbonless copy paper a product we cannot live without? Toxic chemicals that meet important societal needs but lack safe, effective, and affordable substitutes should be placed on a fast-track for research and development of alternatives. (d) Rigorous scientific research. The precautionary approach calls for rigorous scientific research on chemical hazards, safe substitutes, and clean production methods. It’s not good enough to consider what is available currently – what replacement could be developed is important too. Precaution challenges us to design alternatives that address societal needs without spawning harmful consequences. The approach places great weight on thorough scientific inquiry. A reversal in the burden of persuasion should be utilized to shift the starting point of analysis. Given the potential for harm and the difficulty of remediation once a chemical is “on the loose” in the environment -- and bioaccumulating in the food web -- potentially dangerous substances should not be permitted without prior review. This is particularly true for chemicals that are severely hazardous, bioaccumulative, or persistent. It should be up to the producers and marketers to show that the chemicals are safe or that the societal benefits are so great as to necessitate production and use. Ultimately precaution is important not only for the environment and public health but also for the bottom line. The story of PCBs illustrates well how precaution makes sound economic sense. Chemical company executives were warned about serious health problems from PCBs more than 60 years ago, but those early warnings were not heeded. The chemicals were exported to nearly every country in the world. Today, virtually everyone has PCBs in their bodies. Corporations and communities around the world face a complex multibillion dollar effort to replace old equipment, remediate contaminated sites, and develop PCB destruction technologies. Precaution would have prevented this costly situation. Global Toxic Chemicals Initiative WWF International Avenue du Mont Blanc 1196 Gland Switzerland Tel: +41.22.364.9111; Fax: +41.22.364.5829 www.panda.org/toxics World Wildlife Fund 1250 24th Street, NW Washington, DC 20037 Tel: +1.202.778.9625; Fax: +1.202.530.0743 www.worldwildlife.org/toxics Email: toxics@wwfus.org