Position Statement on the Application of Precaution in Managing Biosecurity Risks Associated with the Importation of Risk Goods

Scope

This document sets out the position of the Biosecurity Council in applying precaution when managing biosecurity risks associated with the importation of risk goods under the Biosecurity Act 1993. It does not deal with the application of precaution when making other decisions under the Biosecurity Act, or decisions relating to new organisms under the Hazardous Substances and New Organisms Act 1996. The document supports the MAF Biosecurity Authority policy statement on conducting import risk analyses and applying them in the development of import health standards (dated 9 February 2001), which contains a section (2.9) dealing with uncertainty or lack of knowledge that is based on this document. This statement sets out the current position of the Biosecurity Council in applying precaution in the situations included within the scope defined in this paragraph; that position may need to be revised following development of the Biosecurity Strategy.

Background

Precaution is defined as “action taken beforehand to avoid risk or ensure a good result” (Oxford English Dictionary). Similar terms include ‘prudence’ and ‘caution’.

The concept of a ‘precautionary approach’ or ‘precautionary principle’ is an emerging principle of international environmental law, especially since the incorporation of a precautionary approach in the Rio Declaration on Environment and Development. Principle 15 of the Rio Declaration states that “In order to protect the environment, the precautionary approach shall be applied widely 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 use of precaution in biosecurity risk analysis is not fundamentally different from a precautionary approach used in the environmental field because of lack of information. Applying precaution is not new to biosecurity risk management; risk analysis and application of sanitary or phytosanitary measures have long been undertaken from a cautious position in order to protect New Zealand’s flora and fauna. Application of precaution does not remove the need for a scientific risk analysis to be undertaken and progressively refined as further scientific evidence becomes available.

Precaution in New Zealand’s biosecurity system

Precaution is an integral part of New Zealand’s approach to biosecurity protection. Under the Biosecurity Act “risk goods” (broadly speaking anything that might pose a biosecurity risk to New Zealand ) cannot be cleared for entry to New Zealand unless the risks posed by the goods have been assessed and can be effectively managed. Any risk goods that do not meet the biosecurity conditions for import (set out in an import health standard), or which have not been assessed, may not be cleared for entry to New Zealand. Goods that are or contain a new organism also may not be cleared for entry to New Zealand.

Where there is insufficient information to make a decision in the face of significant potential risks, applying precaution may mean that additional risk management measures are included in the import health standard, or that an import health standard is not issued, until adequate information is sought and obtained which adequately reduces uncertainty.

Application of precaution in risk analysis

Risk analysis is a management tool that incorporates scientific methods to enable regulators to gather and assess information in a thorough, consistent, logical and transparent way. Risk analysis is essentially a tool aimed at making predictions based on current knowledge and practice.

The confidence that can be drawn from predictions made in a risk analysis depends on the amount and reliability of the information used. In the real world it is impossible to have a perfect understanding of every situation and the amount of variation that exists. It is likely that all risk analyses will be conducted in situations where there is incomplete scientific evidence, and a balance must be sought between trying to acquire complete knowledge and obtaining reasonable estimates upon which predictions can be based with a reasonable level of confidence.

Part of the risk analysis process is evaluating scientific evidence, and making estimates of risk that take account of (among other things) the comprehensiveness of that evidence. The scientific evidence might, for example, include information on the nature or impact of organisms in other countries, with assumptions made about the applicability of such information to New Zealand conditions.

Deciding at what point scientific evidence is sufficient is a judgement to be made by appropriately-qualified specialists, and will be different for different situations. Biosecurity departments build a level of precaution into such determinations. The key point is deciding when scientific evidence is sufficient to be the basis for risk management measures; science can never prove a complete absence of risk, but it can assist in assessment of risk and providing measures to manage uncertainty.

Scientists do not usually provide a unanimous body of opinion on a subject; there may be divergent scientific views on a subject. All relevant scientific opinion should be considered in a risk analysis and judged on the weight of available scientific evidence. Restrictive regulatory measures will not be imposed simply on the basis of minority scientific opinion about perceived risks.

Risk analyses must document their sources of information with references to scientific literature and, where relevant, expert opinion. Risk analyses should also document the uncertainties and assumptions made and, where possible, the effect of those on the final risk estimate.

Application of precaution in recommending risk management measures

In recommending risk management measures based on the conclusions of a risk analysis, precaution is incorporated by selecting measures known to deal with the variation expected in the situation under study and effectively manage risks to at least the levels desired (i.e. to achieve the level of protection considered appropriate in this situation).

The acceptability of scientific uncertainty in biosecurity risk management diminishes as the severity of potential negative effects increases. The extent of measures needed to compensate for uncertainty must be commensurate with the potential risks. The measures also need to be based on what pertinent scientific information is available, including that from relevant international organisations and the measures applied by other countries.

Where biosecurity risk management measures are adopted in situations where there is not sufficient scientific evidence necessary for a comprehensive analysis of risks, biosecurity departments will take appropriate steps to seek the additional information necessary for a more objective assessment of risk, and review these measures accordingly within a reasonable period of time.

New and emerging pests or diseases

Under New Zealand’s biosecurity risk management system protection against unknown (new or emerging) pests and diseases is achieved in several ways. Sanitary or phytosanitary measures are applied to imported risk goods to deal with risks that are known; in many cases these same measures can be expected to deal also with unknown organisms posing a biosecurity risk.

Biosecurity department risk analysts and other technical specialists will further address the risks posed by new and emerging pests and diseases by ensuring they keep up to date with scientific developments in their fields, and revise risk analyses where necessary to take account of new information.

The precautionary approach and the SPS agreement

The Biosecurity Council considers the approach set out in this paper to be consistent with New Zealand's obligations under the SPS agreement . Although the status of the precautionary principle in areas that affect trade law is not particularly well defined, the relationship between the precautionary principle and the SPS agreement was considered by the WTO Appellate Body in the EC hormones case . The Appellate Body found that the precautionary principle does find reflection in the SPS agreement in article 5.7 and other places, but that it does not override the obligations in articles 5.1 and 5.2 of the SPS agreement (to base biosecurity risk management measures on a scientific assessment of risk). Article 5.5 of that agreement also contains obligations relating to consistency in the levels of protection considered appropriate in different situations, and to avoiding arbitrary or unjustified distinctions in the application of SPS measures in different situations.

John Hellström Chair,
Biosecurity Council

Page last updated: 15 October 2008