Leaking From The Lab

7. REVISION OF THE EU DIRECTIVE 90/219/EEC

Because the Directive sets out minimum standards, Member States may introduce tighter regulations


By removing the requirement for physical barriers, biological barriers alone are sufficient to satisfy the definition of ‘contained’

In December 1995, following heavy industry campaigning, the European Commission decided to revise the 1990 Contained Use Directive. Industry had argued that the Directive needed to be streamlined and authorisation made easier, claiming that the safety requirements put European companies at a competitive disadvantage compared to their main competitors.

A revised Directive has now been agreed (98/81/EC amending Directive 90/219/EEC on the contained use of genetically modified organisms) and has to be implemented by Member States by 5th June 2000. Because the Directive sets out minimum standards, Member States may introduce tighter regulations. UK regulations will have to be amended and the HSE has just begun a consultation process on how this should happen.

7.1 The Revised Directive

The main changes to the Directive and their implications are described below.

7.1.1 Scope of the Directive
The new EU Directive continues to cover only GM micro-organisms (including animals and plant cells in culture). Naked DNA and plasmids are still not included.

7.1.2 The Definition of Contained Use
Currently, the definition of contained use stipulates that ‘physical barriers, or a combination of physical together with chemical and or biological barriers’ should be used to ‘limit their [GMMs] contact with the general population and the environment’. The new Directive defines contained use as:

“…any activity in which micro-organisms are genetically modified …and for which specific containment measures are used to limit their contact with the general population and the environment” (Article 2 (c)).

By removing the requirement for physical barriers, with or without chemical and biological control measures, biological barriers alone - such as the inhibition of sporolation, the use of non-mobilisable plasmids and disabled strains such as E.coli K12 - are sufficient to satisfy the definition of ‘contained’.
This change constitutes a weakening of the present system as it could allow the discharge of GMMs into the environment which previously would have had some form of physical containment and inactivation before discharge.

7.1.3 Classification System
Under the present system, GMMs are classified into two groups depending on the perceived risk of the organism and on two levels depending on the scale of the operation. In the revised Directive, this is replaced by a system based on four classes of containment regardless of the scale. Class 1 organisms will be deemed to carry the least risk and Class 4 the highest risk.
The specifications for containment are much more precise. There are now specific criteria for each type of work - for instance, in laboratories, in glasshouses and growth rooms, in animal units and ‘for other activities’ (really commercial use). There is now a distinction between waste treatment for ‘effluent from hand washing-sinks and showers or similar’ and ‘GMMs in contaminated material and waste including those in process effluent before final discharge’. There is no requirement for waste from Class 1 organisms to be inactivated before discharge. This is optional and dependent on the risk assessment.



In an effort to speed up the whole process for users of GMMs, the revised Directive is reducing the period of time that is allowed to the competent authority to assess applications to use GMMs


7.1.4 Exclusions
The possibility of excluding certain GMMs from the Contained Use regulations is probably the biggest change to the Directive. Yet the criteria for deciding which will be excluded will not be announced until the legislation is due to be implemented.

7.1.5 Notification Procedures
In an effort to speed up the whole process for users of GMMs, the revised Directive is reducing the period of time that is allowed to the competent authority to assess applications to use GMMs. Generally, the notification periods have now been decreased to include, in some instances, immediate starts (Class 1, all but first time users). For other Classes, the time limit for the HSE to decide whether or not to authorise is reduced from 90 to 45 days. This could result in less rigorous scrutiny of proposals as advisory committees may not meet frequently enough to consider them.

7.1.6 Information Available to the Public
In both the new Directive and in current legislation, it is up to the notifier and the competent authority to decide what information is commercially sensitive and therefore confidential. However, notifiers must still provide the following information - the general characteristics of the GMM, the name and address of the notifier and location of use, and an evaluation of the foreseeable effects, particularly any pathogenic and/or environmental effects.
The new Directive removes the requirement to state the purpose of the contained use and the methods and plans for monitoring, but notifiers must state the class of contained use and the measures of containment. Emergency plans, in theory, should be ‘…supplied in an appropriate manner and without them having to request it, to bodies and authorities liable to be affected by the accident. The information shall also be made publicly available’.

7.1.7 Liability Clause




There is extensive provision for commercial confidentiality to be claimed to avoid public disclosure

Notifiers or users of GMMs continue to be responsible for the classification of GMMs

Although the European Parliament wanted to include a clause which would have established liability for damage arising from the use of a GMM, the Commission rejected this amendment on the grounds that it wanted to deal with liability and liability insurance ‘in a horizontal manner’ across all EU legislation instead of piecemeal in individual directives. However, this issue was raised when the Directive was first drafted 10 years ago and was rejected on the same grounds. There is still no legislation to deal with liability ‘in a horizontal manner’.

7.2 The UK’s Proposals for Changes to Regulations

The new Directive presents a real opportunity for the UK Government to improve the current regulatory framework for GMMs. Because the revised Contained Use Directive only sets minimum standards, the UK is free to impose stricter regulations to protect human health and the environment.

The main features of the UK’s proposals are that⁶³:

• 
  Interim arrangements mean that some information on all centres using GMMs will be included in the public register. This goes a small way to addressing the disturbing lack of information currently available.
  
• 
  GMMs will be placed in a class (1-4) which will determine the containment level depending on a risk assessment. This removes the division between large and small scale use (i.e. Group I and II) and is easier to understand.
  
• 
  Plasmids and naked DNA are not included in the scope of the Regulations so need not be considered in risk assessments.
  
• 
  Inactivation of waste (from all classes) before release is required, although live GMMs could still be released as inactivation does not mean that all organisms will be killed.
  
• 
  It is accepted that limiting (not preventing) contact of GMMs with the environment is sufficient because “…absolute prevention of contact at the lower levels of containment (i.e. levels 1 and 2) is neither possible nor necessary on safety grounds” (p 19).
  
• 
  There will be improvements to the format of information on the public register but no dates of starting or finishing projects will be included.
  
• 
  There is extensive provision for commercial confidentiality to be claimed to avoid public disclosure. The details that must be included are the name and address of the notifier, the location of the activity, the general characteristics of the organism (only a general description such as bacteria, yeast, or virus may be required), the class of activity, containment measures, waste treatment and the risk assessment. Details of the genetic modification and much other information - including monitoring plans - can be claimed to be confidential.
  
• 
  The requirement for annual returns is removed so even less information will be collected about the ongoing use of GMMs.
  
• 
  Notifiers or users of GMMs continue to be responsible for the classification of GMMs.
  

Only notification of the first use of a Class 1 organism is required. Subsequent uses can take place without notification.

The use of Class 2 organisms has to be notified. However, no consent is required after the first use is approved.

The use of Class 3 and 4 organisms can only take place with explicit consent.

Risk assessments of Class 1 GMMs remain in the hands of the user with no obligation to notify the HSE, making scrutiny difficult. If a GMM is erroneously placed in Class 1 when it is actually of higher risk and should be in higher containment, it may be released to the environment.

In the risk assessment, no consideration is given to the justification for undertaking a particular genetic modification. This leaves workers and the environment unjustifiably vulnerable should accidents occur following irresponsible experimentation.

No system of independent monitoring is introduced. Such a system is allowed for in the current Irish regulations and should have been included. Inactivation of waste does not kill all organisms and independent scrutiny and setting of legal limits should be required.

Users may apply for dispensations from treating waste before disposal of low risk organisms.

Allowance is made for certain GMOs and GM techniques to be exempt from the regulations. The HSE estimate that this could involve as many as 400-500 new projects annually.

The use of GM animals and plants is included but only if the genetic modification results in an increased likelihood of damage to human health. Therefore, the only requirement for environmental risk assessment of the contained use of GM crops and plants remains under regulations from the Environmental Protection Act of 1990, which require the user to undertake a risk assessment and keep records but not to inform any authority, gain approval or be scrutinised.

Only notification of the first use of a Class 1 organism is required. Subsequent uses can take place without notification

No system of independent monitoring is introduced
The main benefits identified from the new regulations “…are expected to take the form of cost savings to centres using GMOs”

The main benefits identified from the new regulations “…are expected to take the form of cost savings to centres using GMOs” Error: Reference source not found. However, there will be few benefits for human health and the environment because, overall, the regulations have been weakened. There is the possibility that large scale releases of GMMs could begin with no framework for imposing standards or monitoring.