Leaking From The Lab

8. CONCLUSIONS

No authority has comprehensive information about the large scale, industrial use of GMMs in the UK


Despite the considerable uncertainty surrounding both the health and environmental impact assessments of GMMs, the culture in Government and among regulators appears to be that risk classifications are accurate and correct

The use of GMMs for research and for the commercial production of enzymes and drugs has become commonplace. Ensuring that they are used safely is of prime importance. An effective regulatory system requires:

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  knowledge of what activities are taking place;
  
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  a system of risk evaluation which is robust;
  
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  an effective system of monitoring;
  
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  proper policing and enforcement of regulations;
  
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  transparency and openness to public scrutiny.
  

The present regulatory system has failings in all of these areas. The revision of the regulations provides the opportunity to address these weaknesses but, judging by its proposals, it is an opportunity which the Government is reluctant to take.

8.1 Information about Activities with GMMs

No authority has comprehensive information about the large scale, industrial use of GMMs in the UK. Neither is there comprehensive information about research activities. Centres are registered with the HSE but, once registered, do not have to inform the HSE as long as in the opinion of the user they are only using low risk, Group IA or B GMMs.

This means there is no overall picture of the use of GMMs, where they may be released accidentally or intentionally, what products they are being used to produce or if there is the potential for recombinations between GMMs to take place in mixed waste. Because there are no data about start and finish dates of projects, knowledge of what is happening at any one time is impossible.
The proposed interim arrangements for the new regulations go part way to addressing this lack of information by requiring all centres to re-register and so very basic information will be entered on the database. However, data on actual organisms used, products made, monitoring, etcetera - especially for GMMs categorised as low risk - will not be included, leaving knowledge about the situation to the subjective impressions of regulators.

8.2 Risk Evaluation

The risk assessment system depends upon being able to place a GMM in a containment class with confidence. Despite the considerable uncertainty surrounding both the health and environmental impact assessments of GMMs, the culture in Government and among regulators appears to be that risk classifications are accurate and correct. This rather unscientific sense of security appears to have driven the lack of scrutiny of discharges and examination of the fate of GMMs.

Because the success (in terms of ensuring safety) of the risk assessment process depends fundamentally on the class into which a GMM is categorised, this should not be left to those who may have a vested interest in having the lowest possible containment for reasons of convenience or finance.
The main concerns in relation to human health are that genetic modifications are now being undertaken which could make organisms much more pathogenic and/or enable them to infect a wider range of species. Dramatic changes in pathogenicity can arise through very simple changes which may be unpredictable. On at least one occasion, concern has been expressed that the researchers had an unrealistically optimistic view of the risksError: Reference source not found.


Genetic modifications are now being undertaken which could make organisms much more pathogenic and/or enable them to infect a wider range of species

No experiment with a GMM can be stopped on the grounds that there is no scientific justification for its creation or because it is irresponsible


The absence of any independent monitoring is one of the most strikingly obvious shortcomings of the present situation

In assessing the potential for environmental harm, the situation appears even worse than for human health risks. Only a cursory approach is taken to environmental risk assessment. However, there is evidence that even ‘low risk’ GMMs can persist for days if not weeks in the environment, that safety mechanisms to prevent gene transfer by plasmids are not 100% effective, that gene flow between micro-organisms is ubiquitous in nature and that naked DNA can be taken up and incorporated into micro-organisms. Understanding of microbial ecosystems is extremely poor. Therefore, if a rigorous view of the scale of the uncertainties is taken, glib conclusions that any GMM poses no risk to the environment are not scientifically defensible.

No experiment with a GMM can be stopped on the grounds that there is no scientific justification for its creation or because it is irresponsible. The only conditions which can be imposed relate to the class of confinement. As no containment system can ever be 100% effective, risks may be taken for which there is no broader social benefit in terms of the acquisition of scientific knowledge.
The proposed new regulations leave most of the risk assessment in the hands of the users with little formal scrutiny for the majority of uses. Introducing safeguards on the quality of risk assessments is vital.

8.3 Monitoring

The absence of any independent monitoring is one of the most strikingly obvious shortcomings of the present situation. In contrast to the regulation of chemical discharges from factories, for example, there is no requirement either for the user, the HSE or the Environment Agency to monitor releases.

A circular argument is often used to justify a lack of monitoring. This is based on an assessment that the organism itself is ‘safe’ and, therefore, there is no need to monitor for it and no real concern about safety. However, this means that no data can ever be collected which questions the original assumption that the GMM is safe, even though such assumptions are subject to huge uncertainty and ignorance about the potential impact of GMMs and their transgenes.
Although monitoring is not easy and combinations of methods will be needed, this argues for an investment in their rapid development rather than a failure to monitor at all. The demands of industry for non-GM food ingredients has led to the rapid emergence of sensitive tests for particular DNA sequences. The military in the US, concerned about the use of biological weapons, are also developing sensitive tests for organisms. There is no reason why such tests could not be developed for use in the monitoring of contained use. Until reliable monitoring systems are established, the routine discharges of GMMs should not even be considered.

8.4 Policing and Enforcement

Why should the activities of researchers and companies involved in the use of GMMs be secret?

Serious breaches of the Contained Use regulations have already occurred but these probably represent the tip of the iceberg. Having the equivalent of one person to inspect the activities of about 500 sites is clearly inadequate. Unless there are more resources allocated to inspections, there can be no confidence that safety measures are being observed.

Policing and enforcement should also include setting standards and release limits for GMMs with the default level being zero. It is only by doing this that there will be the impetus to monitor routinely. Not only is this the standard approach to pollution regulation in the UK, it is used in practice in Denmark and has the additional advantage of allowing for prosecution should limits be exceeded.

8.5 Transparency and Openness to Public Scrutiny

Secrecy breeds suspicion. The use of GMMs is shrouded in secrecy and obtaining information is difficult, takes a long time and can be expensive. To obtain a list of projects requiring containment levels 3 and 4, GeneWatch was charged £50 by the HSE and a further £25 to obtain additional information about the Group II research activities of industry. Information initially requested on 4th January 1999 was not provided at the time because several companies withdrew their notifications. However, an application for the data under the Environmental Information Regulations resulted in the information arriving in May 1999 - some four months after the original request.

Nor is it easy to access even the limited data in the public registers since these are located in London and Bootle and no data is available via the Internet.
Allowances for commercial confidentiality dominate the current regulations and remain in the proposed revised regulations. Why should the activities of researchers and companies involved in the use of GMMs be secret? There is a wider public interest in being informed both to allow scrutiny of the nature of what is taking place and to help avoid harm arising.