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Precautions for Non-addressing Scientific Data in Agricultural Field!
Scientific data is able to be collected at many sites around the world which can provide an insight into the manner in which the product may interact with its environment when released into a particular environment.
Where data is not available or where a country believes that its environment is different from that in which the organism was tested it may require field testing before an organisms is released or placed on the market.
Where data is knowable further experimentation will provide data that may address concerns and provide answers as to the likely behaviour of the organism in a particular environment. However, because of the inherent variability of biological systems information as to the behaviour may fall into the not-knowable. Category where no amount of information collected can provide more than increased precision in determining the variability.
The precautionary approach is invoked in order to address the absence of data. It is usually taken to refer to Principle 15 of Agenda 21 agreed in Rio de Janeiro in 1992. 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.
There have been many cases of serious environmental degradation that have made governments change their perception of environmental protection. These have also affected the public’s perception of the environment.
Outbreaks of disease in animals and humans due to lack of care (as it is perceived) or to environmental pollution has had a significant effect on an appreciation of both known and potential risks to the environment and to human health and a public acceptance that these potential problems need to be addressed.
The use of precaution cannot be limited to approving an action or process, or prohibiting it, but implies managing various levels of risk and uncertainty, and taking the appropriate measures at each level. A risk may vary significantly depending on the level of activity or the likelihood that an organism may persist and establish itself in the environment. The inter-relationship with other actions or processes or other organisms with which genetic material may be exchanged may also require caution in analysing the potential risk.
This precautionary principle (or approach) has attracted many and various interpretations; for many it means that if the science is unknown and there is a risk of environmental damage, do not proceed. Caution dictates that it implies that where there is doubt over the safety of an action, that action should not be taken until evidence is available that the steps to be taken will not have disastrous consequences for the environment.
The concern in relation to transgenic organisms is due to the possibility that once an organism is in the environment it is virtually impossible to recall and because of its property of replication, it does not decay over time; indeed numbers may increase disastrously.
Others interpret this as an injunction to proceed with caution, considering each release into the environment on a case- by-case basis and probably also proceeding step-by-step, where small field trials precede larger ones and the results are analysed before proceeding to commercial unfettered release .
Recourse to the approach presupposes that potentially dangerous effects deriving from a phenomenon, product or process have been identified, and that scientific evaluation does not allow the risk to be determined with sufficient certainty. Decision making about risks in the context of a precautionary approach is further complicated by the inherent dynamics of science.
Even though scientific information may be inconclusive, decisions will still have to be made to meet society’s expectations that risks be addressed and living standards maintained. Scientists may be concerned that the principle is used to stifle research, innovation and competition.
Where action is deemed necessary, measures based on the precautionary principle should be, inter alia:
1. Proportional to the chosen level of protection,
2. Non-discriminatory in their application,
3. Consistent with similar measures already taken, based on an examination of the potential benefits and costs of action or lack of action (including, where appropriate and feasible, an economic cost/benefit analysis).
4. Subject to review, in the light of new scientific data, and capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment.
The use of precaution requires a number of major considerations to be taken into account. The Canadian Principles provide a starting point for defining policy in relation to precaution.
1. The decision-making process for managing risks always requires sound and rigorous judgment, where Judgment means determining what is a sufficiently sound or credible scientific basis, what follow-up activities may be warranted, and who should produce a credible scientific basis.
2. To reduce significant scientific uncertainty and improve decision making, the precautionary approach usually includes follow-up activities such as research and scientific monitoring.
However, it has to be noted that in many instances the collection of data may increase the precision of determination of variation, rather than provide data which permits the reduction of uncertainty. Monitoring can only provide assurance that expected events occur, and events predicted not to occur are not observed.
Unexpected, unpredictable, indirect and delayed effects on the environment are by their nature difficult if not impossible to monitor. The arguments that have ranged around precaution are serious, for they have directly impacted on the policy decisions of many countries.
In Europe precaution in relation to transgenic organisms is taken to require case-by-case and step-by step approaches to risk. This way of interpreting precaution is built into the Protocol, which also requires a case-by-case process in assessing risk.