quarta-feira, 14 de dezembro de 2011

Brazil´s new post release monitoring system for GMOs

On the 10th of November 2011 the Brazilian National Biosafety Committee (CTNBio) approved a new monitoring system for marketed GMOs which breaks paradigms and innovates in many aspects in relation to other established or proposed systems. What is new in this proposal? The flowchart in Figure 1 summarizes the steps leading to the monitoring plan or to its exemption and the various decisions and actions within the plan.

Figure 1: Flowchart of actions and decisions needed for the approval and implementation of a monitoring plan after commercial release, or to its exemption, as in the proposal approved at the plenary session at CTNBio on November 10, 2011. The process begins after the risk assessment and the decision for commercial release, as its contents depend on the risks highlighted by CTNBio. If the exemption requested is granted, the process ends. Otherwise, the monitoring plan usually will start as a general surveillance and will continue until the term is reached, unless damages associated with GMOs are observed during the period; in this case a case-specific monitoring plan is enabled. Other decision steps and actions are depicted in the figure.

Innovation begins with the understanding that in certain cases the applicant me be exempted of monitoring. This is a controversial issue and will not be possible to establish a consensus in the short term, but there are already some cases in which the exemption is consensually acknowledged: for GMOs that are not released alive into the environment (grown in fermentation tanks, etc.) or for those who do not proliferate in the environment (such as transgenic mosquitoes that die after a few days and whose progeny also dies). Over time, other cases of exemption could be considered by CTNBio. It is important to bear in mind that the Brazilian law does not require post release monitoring of GMOs and that the decision to require monitoring is much more a matter of meeting the demand from certain social sectors than an explicit need for risk management, since all GMOs released today by CTNBio were considered as safe as their non-transgenic parental organisms. According to the flowchart, monitoring will be generally directed to the detection of damage associated with risks unanticipated in the risk assessment prior to commercial release. The know-how in Brazil and worldwide with the cultivation and use of various GMOs continues to build up and will certainly lay down a solid foundation of risk management that will decide whether it is productive to monitor a new GM or if the information available will allow the exemption of this procedure.

The exemption option is thus a positive innovation because it is aligned with the best science, fits the previous risk assessment and avoids the expenditure of time, resources and personnel tracking products whose biosafety is already attested by a robust history of safe use or by other criteria, or which cannot be monitored by technical issues. A mandatory monitoring indicates excessive caution, which ends up creating major barriers to the domestic entrepreneur without bringing any additional safety to humans, livestock or the environment.

Another innovation is the introduction of the general surveillance (GS) as the main monitoring system. This mechanism is similar to the European proposal, which has been first suggested almost a decade ago, although not actually adopted; however, the real innovation lays on the way it operates: while the European proposal is based on monitoring numerical variables extracted from environmental observations, based on baselines previously established for multiple protection targets, the Brazilian system uses direct alerts of damage, without the aid of baseline values.

The two ways of assessing environmental damage are very different indeed. In the European system deviations of baseline values ​​ suggest damage, but the magnitude of the deviation that can trigger the system is very difficult to establish and is a matter of considerable scientific dispute, as well as the actual construction of baselines​​. The whole system is extremely costly for the State, which is entitled to produce the data in Europe. According to the Brazilian proposal, early damage warnings generated by the monitoring network must be first assessed by the company (which conducts monitoring and pays its cost) and a technical report must then be submitted to CTNBio, for each alert. If a scientific plausible link between the damage and the monitored GMO is found, a containment experiment is conducted to prove the hypothesis (with previous approval and consequent follow up by CTNBio). If there is corroboration of causality, mitigation measures should be adopted and the case-specific monitoring (CSM) is therefore triggered. Alternatively, CSM can be triggered from the very start of the monitoring if non-negligible risks are identified in the risk assessment prior to commercial release. This approach is more objective than the European one and, additionally, more economical. The pertinent decisions and actions underlying GS and CSM are summarized in Figure 2 below (part of the flowchart in Figure 1).

Figure 2: Excerpt taken from the general flow chart showing how a damage alert (real adverse effect) generated during GS can trigger experiments and ultimately the CSM. An alert requires the finding of an adverse effect (damage); if it truly exists, the alert generates a technical report that CTNBio, together with the company, must analyze to find an eventual causation link between the GMO and the harm. If there is scientific basis for causation, specific experiments should be performed, whose results will determine the subsequent actions.

The strength of the Brazilian form of monitoring is the possibility of building up an information network with the effective participation of many actors from the areas where the monitoring will be conducted. Although the European proposal also describes a network, it is much more restricted because it is responsible for creating baselines and demand high qualification of its members, something complex and unrealistic in Brazil and in many other countries, especially among government agencies responsible for technical training on agricultural practices, seed sellers, producers' associations and other forms of social organization. The network information may have great penetration and must be open to the entry of alerts from different sources. The quality of the network is evaluated by the consistency of the alerts and network members generating frequent  inconsistent damage alerts may be excluded. On the other hand, the network is not open to the public, as it has to be approved by CTNBio. Thus, a well-built network represents an invaluable source of information, without the need to establish expensive baselines and with minor chances of frequent false damage reports.

In conclusion, the new monitoring system incorporates important steps to fine tune the actions included in the monitoring plan to the risk assessment made prior to commercial release. Its costs will be certainly  compatible with its possible results. It is also flexible and can be adjusted to the Brazilian reality over the next year due to the increase of the Brazilian and World experience in the area. It also meets the demands of the Brazilian society for transparency, rational use of resources, opportunity for national companies and food and environmental biosafety, without using an excessive precautionary approach that excessively burdens the companies with unnecessary costs, inevitably passed on to the final consumer.

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