Precautionary Principle limits

Because of the great importance of drinking water for human health, quality standards for pesticides in water were developed at Community level based on the precautionary principle. Toxicological considerations were not taken into account to derive the general limit for pesticides. 

The first warning against the use of phthalates in toys was the Recommendation adopted by the European Commission on 1 July 1998 concerning toys and childcare articles intended to be placed in the mouth by children under three years of age, made of soft PVC and containing phthalates. The Commission Decision of 7 December 1999 (1999/815/EC) [58] made it possible to prohibit the use of certain phthalates on the basis of the legislation on general product [59]. Since 1999, The Commission Decision 1999/815/EC [58] was extended more than 20 times in the name of the precautionary principle until the adoption of Directive 2005/84/EC [60]. This Directive restricted the use of DEHP, DBP, and BBP in the manufacmre of toys and childcare articles intended for children and DiNP, DiDP, and DnOP are limited only in toys and childcare articles which can be placed in the mouth. The restriction states that the amount of phthalates may not be greater than 0.1% by mass of the plasticized material part of the toys. The member states of the EU applied this directive from 16 January 2007. 

Many corporations dislike the principle for several reasons. The principle puts a constant pressure upon users of chemicals to keep informed and act accordingly, and thus provides limited certainty regarding what is expected of them. The principle may therefore not work well in countries where the legal culture may mean that corporations may have to defend their substitution efforts (or lack thereof) in courts, or where authorities may have to defend why they have not done more to promote substitution if they have established the Substitution Principle in law. Similar problems exist when it comes to the potential use of the Precautionary Principle in the United States, and this in one reason as to why principles are easier to deal with in Civil law countries like Sweden than in the United States. 

Another view explores the limits of the risk assessment-based approach to decision-making and what a precautionary paradigm might look like. The precautionary principle calls for preventive actions when there is reasonable scientific evidence of harm, although the nature and magnitude of that harm may not be fully understood scientifically. While a highly contentious term, proponents of the precautionary approach see this as a means to make better, more health protective decisions in the face of highly uncertain and complex risks. 

Precaution and Environmental Science. When the precautionary principle is discussed in its relationship to science, it is often portrayed as an antiscience or a risk-management principle that is only used after undergoing conventional scientific processes. As discussed earlier, in practice the limitations of science to characterize complex risks show that precaution is not at odds (Kriebel et al., 2001). Further, precaution is not just about additional safety factors or changing risk assessment default assumptions. Research by U.S. EPA scientists has demonstrated that many of the EPA s Reference Doses - or conservative safe exposures - may correspond to risks of greater than 1 in 1000, meaning that safety factors alone may not protect health (Castorina and Woodruff, 2003). 

Conclusions. This section has outlined the problem of uncertainty in preventing risks from chemical exposures and the limitations of current scientific and decision tools based on the concept of risk assessment. It has outlined a new paradigm for decision-making for sustainability embodied in the precautionary principle. This approach has several key aspects ... 

Three basic principles have emerged as common themes in these policies the Polluter Pays Principle clarifies who bears the costs for chemical contamination the Substitution Principle encourages the adoption of the safest chemicals and the Precautionary Principle promotes preventive action even in the face of the uncertainties of risks (see Section 3.3.2 for a more in depth discussion of the Precautionary Principle). Specifically, the new national chemicals policies of Northern European countries have relied on rapid screening tests for determining regulatory actions on chemicals, focused on products and product lifecycles for risk reduction, established lists of undesirable substances, and, in limited cases, employed government authority to phase out the use of the most hazardous substances such as lead, mercury, cadmium, brominated flame retardants and chlorinated paraffins (for a more extensive review, see Tickner and Geiser, 2003, www.chemicalspolicy.org). 

The performance of systematic risk assessments is a task often taken by federal agencies like US EPA, US FDA, EU EFSA or national institutions. The result of a risk assessment is a starting point for the risk manager, e.g., the ministries, to develop adequate measures, like controls, limits or use restrictions. In the structured approach to the risk analysis the precautionary principle can be particularly relevant to the risk management. It shall be applied in those circumstances where scientific evidence is insufficient or imcertain and when there are indications for concern [95]. In order to prevent a disproportionately intensive use measures based on the precautionary principle should be... 

Marchant, G. E. (2003). Erom general policy to legal rule Aspirations and limitations of the precautionary principle. Environ Health Perspect 111, 1799-1803. 

Pesticide safety was another environmental problem that remained in the public eye through the 50s. A special committee of the House of Representatives under Rep. James Delaney of New York, established in 1950, held 46 days of public hearings around the country. The Food and Drug Administration, still supporting the precautionary principle it had backed in 1930s debates over lead arsenate, wanted new pesticides to be allowed on the market only when proven safe. Extended negotiations over new legislation led to the Miller Amendment of 1954, which allowed the FDA to limit the uses of a pesticide on fresh produce but still denied it the power to keep a substance entirely off the market. In its clear rejection of the precautionary principle, the Miller Amendment is seen by historians as a victory for the pesticide manufacturers.7... 

In the European Union, because of the general view that there should be no pesticides in drinking water, a precautionary principle is applied, and standards are set as low as is reasonably achievable. EEC directive 98/83/CE for drinking water therefore set limit values at 0.1 /rg/1 for each individual pesticide and 0.5 /rg/1 for total pesticides. For surface water used to produce drinking water, these values are 2 /rg/1 for each individual substance and 5 /rg/1 for total pesticides. 

Figure 2 illustrates the recommended approach for the decision-making process. Different types of analyses provide input to the managerial review and judgment, where the boimdaries and limitations of the analyses are also reflected. The weight given to the uncertainties are influenced by stakeholder values, priorities, objectives etc, for example related to the use of the precautionary principle. 

The overtopping limits suggested in Tables 14.4-14.7 derive from a generally precautionary principle informed by previous guidance and by observations and measurements made by the CLASH partners and other researchers. Limits for pedestrians in Table 14.4 show a logical sequence, with allowable discharges reducing... 

The EU approach to chemicals control is based on a stepwise process of hazard assessment, risk assessment, and risk management. This process assists a rational prioritization in the allocation of limited resources to achieve a high level of health and environmental protection. Because this process often involves uncertainties due to insufficient or inconclusive scientific evidence, the precautionary principle may need to be applied in cases where there are indeed reasonable grounds for concern that health or the environment may be seriously endangered. The precautionary principle was first recognized in international law in the World Charter for Nature, adopted by the UN General Assembly in 1992. At the Rio Conference on the Environment and Development, Principle 15 states that in order to protect the environment, the precautionary approach shall be widely applied by... 

Marchant, G.E. (2003) From General Policy to Legal Rule Aspirations and Limitations of the Precautionary Principle , Environmental Health Perspectives 111(14) 1799-803. 

---