INTERNATIONAL COUNCIL OF CHEMICAL ASSOCIATIONS 15 August 2000 ICCA COMMENTS ON THE APPLICATION OF THE PRECAUTIONARY PRINCIPLE IN REGULATORY DECISION-MAKING BACKGROUND This document sets out principles intended for use by ICCA members as a basis for ongoing international discussions concerning the precautionary principle. The ICCA principles are intended to assure that the precautionary principle is implemented in a consistent and transparent manner. The ICCA principles are based on three fundamental goals: 1. Integrate Responsible Care and the precautionary principle into the industry's international advocacy; 2. Maintain a risk-based, science-justified approach in future government decision making processes; 3. Ensure openness, transparency and industry participation in future activities relating to the development, use and communication of the precautionary principle. THE PRECAUTIONARY PRINCIPLE The precautionary principle articulates an approach to risk management in circumstances of scientific uncertainty, reflecting the need to take prudent action in the face of potentially serious risks without having to await the completion of further scientific research. The most broadly accepted definition of the precautionary principle is Principle #15 of the June, 1992, Declaration of the Rio Conference on Environment and Development: "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 precautionary principle has been incorporated by reference into several international instruments. 1 While the chemical industry firmly believes that risks from its products are effectively managed through Responsible CareÒ and existing domestic and international regulatory systems, that belief is challenged by some who argue that a risk-based system is inconsistent with the precautionary principle. Indeed, industry today faces the prospect of having some chemicals, chemical groups, and entire technologies banned or strictly controlled as a result of government decisions that seem to apply the precautionary principle in a way that disregards important science and allows risk management decisions to be made on the basis of hazard, or intrinsic properties such as persistence or bio-accumulation alone. The principle should offer guidance to lawmakers. However, the principle does not override established law. It is important to recognize that the principle does not replace substantive law as a basis for action. Moreover, whatever the basis for action, decisions applying the principle are subject to legal redress and accountability. The ICCA principles are intended as a response to these pressures and to serve as a common ground for industry's advocacy on the precautionary principle. PRECAUTION IN THE CHEMICAL INDUSTRY The chemical industry as a matter of common practice takes precautionary actions to ensure the safe production, management, and use of their products. Under the Responsible Care initiative, for example, the chemical industry has committed to continuous improvement in health, safety and environmental protection -- a commitment that is grounded in precaution. In addition, the industry's considerable research efforts, assessments of risks, and compilation of test data are an example of how the industry implements the precautionary principle. These efforts are precautionary because they rely on well-accepted tools -- such as conservative assumptions and margins of safety -- to address the problems scientific uncertainties may create. ICCA believes that risks can and should be scientifically assessed. If full scientific certainty is not available, interim management actions may be necessary to address significant risks. THE ICCA PRINCIPLES FIRST PRINCIPLE: Implementation of the precautionary principle should start with an objective risk assessment identifying at each relevant stage the degree of scientific uncertainty. Risk assessments should be based on actual data, where possible. When data is not available, appropriate models and assumptions should be used. 2 ICCA believes that risk assessment is fundamental to the identification and management of health and environmental risks. Risk assessment is entirely consistent with the application of the precautionary principle. Indeed, the precautionary principle cannot be applied without a risk assessment. The precautionary principle applies only when there is a "lack of full scientific certainty" regarding the degree of risk, not where there is an absence of any scientific knowledge. SECOND PRINCIPLE: The risk assessment process that supports application of the precautionary principle should generally include an independent, balanced and transparent scientific peer review process, with the extent to which this is done depending on the importance and novelty of the issue. Peer review and transparency are two fundamental elements of the risk assessment process. Both are important to providing balanced scientific input in situations involving particularly difficult or novel hazards, exposures and/or risks. THIRD PRINCIPLE: The precautionary principle should apply when an objective risk assessment demonstrates that reasonable evidence exists of "threats of serious or irreversible damage to health or the environment". The precautionary principle does not apply to theoretical risks based on vague statements of hazard. It applies to serious or irreversible risks identified pursuant to a risk assessment. FOURTH PRINCIPLE: Where the precautionary principle is applied, risk reduction measures should be targeted as precisely as possible at the specific issue or concern (e.g. specific chemical and specific application), using existing and reasonably obtainable scientific knowledge. FIFTH PRINCIPLE: 3 Measures based on the Precautionary Principle must be proportionate to the risk that is to be limited or eliminated; the degree of uncertainty there is about that risk; and how the measure will address it. The approach outlined in principles 4 and 5 is consistent with how many domestic and international programs are currently administered, namely to encourage taking the least restrictive measures sufficient to achieve necessary progress. SIXTH PRINCIPLE: Measures based on the precautionary principle must include recognition of the costs and benefits and other advantages and disadvantages with an eye to taking measures that are acceptable. Principles 5 and 6 are consistent with the wording of the precautionary principle that "cost-effective measures" be applied. SEVENTH PRINCIPLE: Affected parties should be involved in the decisions to study the various management options that may be envisioned once the results of the risk assessment are available, and the procedure should be as transparent as possible. All stakeholders must be fully involved in decisions relating to the proposed use of the precautionary principle, in order to fully implement the spirit and intent of the Rio Declaration. The results of risk assessments should be communicated in a way that provides useful information, including where appropriate an estimate of the risk(s) and information about the data on which the assessment was conducted. EIGHTH PRINCIPLE: The precautionary principle must not be applied in a manner that unreasonably delays efforts to prioritize future regulatory actions or to implement appropriate risk management decisions. As noted earlier, risk assessments and stakeholder involvement are fundamental to the correct application of the precautionary principle. However, the correct application of the precautionary principle should not 4 result in unreasonable delays in making regulatory decisions or applying appropriate risk management decisions. NINTH PRINCIPLE: Measures based on the Precautionary Principle generally should be provisional in nature, and reviewed as new information becomes available. If the data on which the measures are based are inadequate, imprecise or inconclusive, newly developed information may suggest different risk management measures. In some cases risk management measures will be based on more precise or conclusive data, and may not necessarily be provisional in nature. 5