International Frameworks
There are, of course, national frameworks for risk assessment in most countries and there
are regional frameworks (e.g. European Community). One example of an attempt to reach global
agreement on biosafety is the Precautionary Principle.
The precautionary principle entered the international stage in the context of marine pollution
control through the 1987 Ministerial Declaration of the Second Conference on the Protection of
the North Sea. The focus was on toxic substances and the required control measures were left
rather open-ended.
The precautionary principle emerged in German national law as the Vorsorgeprinzip, usually
translated as the "precaution" or "foresight" principle. As enunciated in 1976 by the federal
government in Germany: "Environmental policy is not fully accomplished by warding off
imminent hazards and the elimination of damage which has occurred. Precautionary
environmental policy requires furthermore that natural resources are protected and demands on
them are made with care."
The participants accept the principle of safeguarding the marine ecosystem of the North Sea by
reducing polluting emissions of substances that are persistent, toxic and liable to bioaccumulate
at source, by the use of the best available technology and other appropriate measures. This
applies especially when there is reason to assume that certain damage or harmful effects on the
living resources of the sea are likely to be caused by such substances, even where there is no
scientific evidence to prove a causal link between emissions and effects ("the principle of
precautionary action").
The principle was quickly adopted into numerous multilateral treaties and international
declarations (see Appendix). Treaties articulating the precautionary approach include the 1987
Montreal Protocol on Substances that Deplete the Ozone Layer, the 1992 Convention on
Biological Diversity, the 1992 Climate Change Convention, the 1992 Treaty on European
Union, the 1992 Convention for the Protection of the Marine Environment of the North-East
Atlantic and the 1992 Helsinki Convention, dealing with protection of the marine environment of
the Baltic. Parties to the London Convention 1972, governing the control of ocean dumping,
embraced the precautionary approach in 1991 through a Resolution and upcoming amendments
almost certainly will incorporate the approach. The Montreal Guidelines on land-based sources
of marine pollution are in the process of being revamped and the precautionary approach will
likely be incorporated. International declarations containing the precautionary principle include
the 1990 Bergen Declaration, issued by ministerial representatives from European countries (as
well as Canada), and the 1992 Rio Declaration on Environment and Development.
The International Joint Commission (IJC), composed of U.S. and Canadian representatives, has
also called for a precautionary approach to controlling chemical pollution of the Great Lakes. In
its Seventh Biennial Report on Great Lakes Water Quality, the IJC has called for the virtual
elimination of various persistent toxic substances and the imposition of a reverse onus approach
on chemical producers and users.
Scope
Some international conventions and statements limit the scope of the precautionary principle to
toxic substances control and even more specifically to those toxic substances that are persistent
and liable to bioaccumulate. For example the Final Declaration of the Third North Sea
Conference provides:
[The participants] will continue to apply the precautionary principle, that is to take action to
avoid potentially dangerous impacts of substances that are persistent, toxic and liable to
bioaccumulate even when there is no scientific evidence to prove a causal link between
emissions and effects.
The precautionary principle has also been expanded to cover all government policies with the
potential to degrade the environment. The Bergen Declaration states:
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.
The precautionary principle/approach has recently been extended to cover various resource
extraction activities and ecosystem protection in general. The approach has emerged in the fields
of fisheries management and forestry management. The Biodiversity Convention implicitly
includes the principle in the Preamble:
[W]here there is a threat of significant reduction in loss of biological diversity, lack of full
scientific certainty should not be used as a reason for postponing measures to avoid or minimize
such a threat.
Spectrum of Meanings
The precautionary principle's main thrust is at first glance very simple and straightforward.
Where an activity raises threats of harm to the environment or human health, precautionary
measures should be taken even if certain cause and effect relationships are not established
scientifically. Common-sense phrasings capturing the essence include "an ounce of prevention is
worth a pound of cure"; "a stitch in time saves nine"; and "if in doubt, don't pump it out."On
closer scrutiny, however, the principle is difficult to grasp, providing only "bare bones" and
requiring further fleshing out in national and international legal systems. Debates continue over
what should trigger the principle with words such as "likely harm" or "serious or irreversible
harm" being favoured verbal candidates. Who should "pull the trigger" and make such
determinations is open for discussion, as is the question of required precautionary control
measures.
The UN has promulgated a voluntary code for risk assessment on a regional basis. (link).
Although both the United States and the United Kingdom developed their regulatory systems
following the Moratorium self-imposed by scientists in the 1970's, the regulatory systems moved
apart significantly. In the United States it was decided not to impose new regulatory burdens on
the biotechnology laboratory or industry. Guidelines for the safe use of modified organisms were
introduced, in particular the NIH Guidelines, which imposed a set of safety precautions on those
funded by the NIH for the safe use of modified organisms. Most industries, although not funded
by NIH, followed these guidelines, at least in spirit. In Europe, however, a statutory regulatory
system is in force, which requires an assessment of the risks associated with the use of modified
organisms in containment. The statutory system in Europe also depends on a Directive which
defines the conditions in which biological agents (whether genetically modified or not) may be
used in the workplace.
