International practice

The following section discusses how the precautionary principle is currently being applied in the United States, the European Union, the United Kingdom and Australia. It examines:

• the extent to which the precautionary principle is being applied in the context of an integrated risk management framework based on good regulatory practice (refer Appendix One)
• whether guiding principles have been developed and, if so, how they are being applied.

An outline is also provided of the Precautionary Principle Project Guidelines based on a major international project (refer Appendix Two).

United States

Precautionary principle being implemented within a risk management framework.

Although the United States government denied the existence of the precautionary principle, the United States view is that precaution can be implemented only within a framework of risk management[11], otherwise significant costs and distortions would result (Graham, 2004).

According to United States guidelines, decision-making that incorporates precaution must be based on an assessment of the costs and benefits and targeted towards government objectives; ie, decisions must be:

• transparent and accountable
• based on scientific evidence
• subject to review and flexible enough to deal with new information.

US guidelines demonstrate many features of good regulatory practice.

The United States guidelines demonstrate many of the features of good regulatory practice. Although the guidelines do not mention reversal of the burden of proof, some United States regulations impose a requirement on proponents of new products, technologies or processes to prove why approval to market or use the product or technology or process should be granted. The standard of proof is generally “reasonable certainty” (Peterson, 2006).

There has been a slow but steady improvement in the conceptual foundations of risk regulation in the United States, which occurred progressively through four sequences (Majone, OECD, 2006):

• Prohibitions – bans presented the earliest and least sophisticated approach. For example, the initial ban on the use of saccharin led to proposals to rank additives in three risk categories: those so serious as to warrant prohibition; those so trivial as to warrant no regulatory action; and those whose acceptability should depend on an assessment of benefits and the availability of alternatives.
• Least-feasible risk – human exposure to health risks should be reduced to the lowest possible level. This is effectively a second-best rule, given a risk-free environment is unattainable. But this fails to balance marginal costs and benefits, alternatives and probabilities. Balancing marginal costs and benefits is problematic when the issue concerns the likelihood of thresholds and step changes.
• Significant risk doctrine – this places a higher analytical burden on regulators than the least-feasible risk approach, or the precautionary principle. Not all potential risks are treated equally; only those activities or substances shown to pose a significant risk will be regulated, focusing limited regulatory resources on the most important risks.
• Balancing costs and benefits – since 1981, there has been a requirement for a full cost-benefit test administered by the Office of Budget and Management:

• Regulatory action is not to be taken unless the potential benefits to society outweigh the potential costs.
• Among alternative approaches to any given regulatory objective, the alternative involving the least net cost to society has to be chosen.
• Agencies are required to set regulatory policies with the aim of maximising net benefits, taking into account the condition of the particular industries affected by regulations, the conditions of the national economy, and other regulatory measures contemplated for the future.

In addition, strong powers of ex-post determination of “liability” for harm from the release of hazardous substances were provided by the CERCLA[12] (Superfund) Act 1980. This strengthened the incentives for private precautionary action.

A unique example of policy learning

According to Majone (OECD, 2006):

“the progress from early reliance on outright bans or simple feasibility tests to the applications of key principles of decision theory not only to agency rule making but also to the enabling legislation, is an outstanding, and in many respects unique, example of policy learning. This was also linked to the development of a proper regulatory impact analysis management system.”

This has been greatly facilitated by the interaction among different partly cooperating, partly competing, institutions.

Majone claims that: “compared to these developments, risk regulation in many other OECD countries is still at rather an early stage”. This view is not necessarily shared by other countries within the OECD.

European Union

The EC places the precautionary principle within the existing risk management framework.

The European Commission’s Communication (2000) places the precautionary principle within the existing framework of risk analysis. The aim of the Communication is to establish guidelines for applying the principle and to “avoid unwarranted recourse to the precautionary principle, as a disguised form of protectionism”. Decisions must be based on scientific risk assessments and satisfy the following criteria[13]:

• Scientific evidence of risk – all effort should be made to evaluate the available scientific information.
• Proportionality – measures based on the precautionary principle must not be disproportionate to the desired level of protection and must not aim at zero risk. Decision-makers must consider less restrictive alternatives that make it possible to achieve an equivalent level of protection.
• Non-discriminatory and consistency – comparable situations should not be treated differently and different situations should not be treated in the same way.
• Examination of cost and benefits – the overall costs, including non-economic considerations, to the European Union of the action and lack of action must be compared. In weighing the costs and benefits, the protection of health takes precedence over economic considerations. An economic cost-benefit analysis should be undertaken where possible.
• Examination of scientific developments – precautionary measures should be maintained as long as the scientific data are inadequate, imprecise and inconclusive, and as long as the risk is considered too high to be imposed on society.
• Assignment of responsibility for producing scientific evidence – while there can often be a reversal of the burden of proof, where the proponent of an activity must provide “reasonable evidence” of safety, such an obligation cannot be entertained as a general principle. In some cases, there will be benefit in research funded by the public.

Member states have considerable discretion made possible by the ambiguity of the precautionary principle.

Within the European Union, Majone (OECD, 2006) claims that even while governments claim to support the Rio Declaration, interpretations may vary. A general inference from the European Court of Justice is that member states have considerable discretion in deciding to err on the side of caution. However, they must provide evidence of specific concrete risk and not merely potential risks based on a general precautionary approach. In the famous dispute about the hormones in beef, the European Union was sanctioned for introducing a public health and consumer measure that was not sufficiently supported by scientific evidence or risk analysis. There have also been other instances where the European Union's use of the precautionary principle has been viewed by its trading partners as a thinly disguised form of protectionism. This has been made possible by the ambiguity of the principle.

Differences between the EU and the US depend on the context of the risk.

While there is still much debate as to whether the approach adopted in the European Union is more precautionary than the United States, the differences in precaution appear to depend more on the context of the risk than on broad differences in national regulatory regimes (Harding and Fisher, 1999; Wiener, 2002).

United Kingdom

UK guidelines are similar to the EC guidelines.

The United Kingdom guidelines have much in common with the European Commission’s guidelines. A summary is provided by Peterson (2006):

• Action in response to the precautionary principle should accord with the principles of good regulation; that is, be proportionate, consistent, targeted, transparent and accountable.
• Costs and benefits should be compared, including: action and inaction, and social and environmental costs.
• Decision-making should be based on the standard procedure of risk assessment and management:
  • using the best scientific advice; and
  • where necessary, making assumptions about consequences and likelihoods to establish credible scenarios when accounting for uncertainties.
• Decisions must be reviewed when more information comes available.

The United Kingdom guidelines demonstrate many of the features of good regulatory practice. As a general rule, the United Kingdom approach shifts the burden of proof to the proponent of an activity, but there is flexibility in the extent to which this occurs and it is determined on a case-by-case basis. This limit on the reversal of burden of proof may reduce potential negative impacts.

ACRE Report highlights inconsistencies in regulatory assessment of environmental impact of GM and non-GM crops.

A recent report released by the Advisory Committee on Releases to the Environment (ACRE, 2006) could have a significant impact on the approach to risk assessment in the United Kingdom. The report highlights inconsistencies in the regulatory assessment of the environmental impact of GM crops in comparison with other agricultural crops and practices. While a risk assessment for GM plants is required as part of a rigorous approval process, non-GM crops and other changes to agricultural management do not require similar risk assessments. Quantitative field studies have shown that environmental impacts of changes in agricultural management can be at least as significant as those associated with GM crops.

A broader and more balanced approach is required, with implications for all new farming techniques.

The ACRE report claims that a broader and more balanced regulatory approach is required. In addition to using sustainability as a marker for introducing novel crops and practices (whether GM or non-GM), an evidence-based approach should be introduced to examine any environmental risks and benefits. The implication is that all new farming techniques in the United Kingdom should be assessed for their environmental impact before they are introduced.

Australia[14]

Official overarching guidelines have not been adopted, but a risk analysis framework and guidelines have  been developed for GMOs.

In Australia, the precautionary approach is one of the guiding principles of ecologically sustainable development[15] and is included in the Inter-Government Agreement on the Environment, which provides an overarching framework for environmental natural resource management. It is also a key component of the Environment Protection and Biodiversity Conservation Act 1999. Although the principle has been incorporated in many laws and policies, official implementation guidelines have not been adopted (Peterson, 2006). However, a risk analysis framework and some guidelines have been developed in a particular policy area for genetically modified organisms (OGTR, 2005). This could be applicable to the Hazardous Substances and New Organisms regime in New Zealand.

Precautionary Principle Project Guidelines

Precautionary Principle Project Guidelines are based on international consultation.

The Precautionary Principle Project was a major international project, which released guidelines following a process of broad consultation with a range of parties[16]. The guidelines are outlined in Appendix Two. They were developed for biodiversity conservation and natural resource management, although they could also be relevant to decision-making across other policy regimes (Cooney and Dickson, 2005).

Several of the project guidelines relate to the steps leading up to the invocation of the principle, starting with explicit incorporation of the principle into legislation and policy. However, the Project guidelines provide less detail than the other guidelines about the methods to be employed in assessing and comparing precautionary options.