|Proposals for revised Genetically Modified Organisms (Contained Use) Regulations|
The Royal Society of Edinburgh (RSE) is pleased to respond to the Health and Safety Commission’s consultation on proposals for revised genetically modified organisms (contained use) regulations. The RSE is Scotland’s premier Learned Society, comprising Fellows elected on the basis of their distinction, from the full range of academic disciplines, and from industry, commerce and the professions. This response has been compiled with the assistance of a number of Fellows with direct experience of genetic modification procedures, or with interests in this area.
Overall, much of the proposed Regulations and Guide is perfectly reasonable. With reference to Devolution and the ability of the Scottish and Welsh Parliaments to draw up their own versions of the Regulations, it should be remembered that genes are no respecters of political boundaries.
Public safety and public opinion will also require the effective policing of the proposed regulations and it will be important that the Inspectorate is sufficiently strong in manpower and other resources to fulfil these obligations. The proposed new fees, however, are substantial and are bound to decrease the amount and pace of scientific experimentation involving genetically modified organisms (GMOs). The impact of the enhanced fees will depend to a considerable extent on the interpretation of ‘connected programmes’ and of the need to supply supplementary information. For example, the use of an additional, not previously specified, plant virus in a particular line of research may become desirable or essential as the results of research unfold, but without changing the level of containment needed. Where this is at level 2, it would seem unreasonable to levy an additional £400 to permit minor research changes of this kind to proceed, because these would not involve any substantial amounts of extra work for officials. We would suggest that such minor changes at level 2 should be notified but should not incur an additional fee. This arrangement would not be appropriate at levels 3 and 4 where comparable changes to work already proposed should still need to be notified, authorised and paid for.
The specific questions raised in the consultation document are addressed below:
QUESTION 1: OVERALL CLARITY OF THE PROPOSED REGULATIONS AND GUIDE
Are you satisfied with the clarity of the proposed Regulations when read in conjunction with the accompanying Guide?
The explanations of the Regulations in the Guide are useful and, in general, clear. They are, however, written in a verbose manner, going through specific Regulations one by one. The Guide would be much more useful and user-friendly if it summarised the rules to be followed, with reference to individual Regulations where relevant, pointing scientists to the part they need to fill in toensure they are within the regulations. This would guide users to the letter of the law, but enable them to go from their own situations to the Regulations with much greater ease. The scientist needs to know how much detail on a research project must be provided, the risk assessment category it comes into, and how to ensure this is displayed in the laboratory and to the people involved in the work. Further, more emphasis should also be placed on training and preparation.
QUESTION 3: RISK ASSESSMENT PROCEDURES FOR ACTIVITIES INVOLVING GMMs (paragraphs 32 to 34)
Are you content with the clarity and comprehensiveness of the risk assessment requirements in the proposed new Regulations?
The specimen proformas given in the Guide are clear and helpful. However, it is unfortunate that the example risk assessments have not been completed since risk assessment is often a very difficult exercise and one for which maximum guidance is required. Further clarification is needed as to whether ‘educational establishment’ covers industrial labs which run courses of instruction, for example, on the use of instruments. The definition of ‘student’ is also somewhat vague.
QUESTION 4: NOTIFICATION PROVISIONS FOR ACTIVITIES INVOLVING GMMs (paragraph 40)
Do you support the new provisions for classification of activities on the basis of containment levels and the linking of notification procedures to such classification?
Part II of the Regulations is clearly set out. However, with regard to Regulation 15(2), it is recommended that (a) and (b) should only apply when the change, or new information, significantly increases the risks, instead of has significant consequences for the risks.
QUESTION 5: NOTIFICATION PERIODS (point 10 of the chart following paragraph 23)
Are you satisfied with the adjustments to current notification periods which would be introduced by the proposed new Regulations?
With regard to the delays required before new activities can begin, subsequent to the acknowledgedreceipt of notification (Regulation 10(4) a(i)), care should be taken to avoid potentially significant delays in acknowledging receipt of applications, which could in turn lead to significant delays in critical research programmes.
Do you support the provisions for notification of connected activities and the proposed approach to charging for them?
The acceptance of connected programmes of work is welcome and should assist forward planning of research activity.
QUESTION 8: CONTAINMENT TABLES FOR ACTIVITIES INVOLVING GMMs (Schedule 8 to the Regulations)
Are you content with the clarity, comprehensiveness and appropriateness of these tables of containment and control measures?
A lot will depend on the level of containment deemed appropriate and it is noted that no examples are supplied in the current draft. For example, for chimaeric plant viruses based on indigenous parents, and for plant virus vectors based on indigenous plant viruses, where the risk to human health is very small and any potential hazard is essentially to the environment, an interpretation could be that the appropriate containment would be at level 2. However, there is no indication in the Regulations that this interpretation would be acceptable.
QUESTION 15: QUALITY OF THE CONSULTATIVE DOCUMENT
In your view how well does the consultative document, ‘Proposals for revised Genetically Modified Organisms (Contained Use) Regulations' represent the different issues involved?
The consultation document represents the issues well enough; however, it is disappointing that the Guide within the consultation document has so many pieces missing.
Further information is available from the Research Officer, Dr Marc Rands August 1999