Volume 2
Regulation of the United Kingdom biotechnology industry and global competitiveness / Select Committee on Science and Technology.
- Great Britain. Parliament. House of Lords. Science and Technology Committee.
- Date:
- 1993
Licence: Open Government Licence
Credit: Regulation of the United Kingdom biotechnology industry and global competitiveness / Select Committee on Science and Technology. Source: Wellcome Collection.
12/310 (page 4)
![i 11 March 1993] [Continued a 18. The broader legislation referred to at paragraphs 2 and 3 above, in most activities not involving GMOs, is enforced by HSE’s general factory and agricultural inspectorate. Burdens and competitiveness 19. The questions that have been raised about the burdens and the effects on competitiveness of UK health and safety legislation as applied to biotechnology have mainly been about the law specifically dealing with GMOs. It should be borne in mind however that, as noted at paragraph 4 above, this is a small part of the regulatory framework and applies to a small proportion of biotechnological activity. The substantive safeguards that are needed, those that involve expensive engineering and systems of work, are required in any case by more general legislation such as the Health and Safety at Work Act and the Control of Substances Hazardous to Health Regulations. The additional measures required by the GMO legislation must be seen against this background. Even so, although they will rarely bar an activity by the placing of conditions on the work itself, they do impose some burden. There are administrative costs in the preparation of notification documents and applications for consent, both directly incurred and transferred to the notifier in the fees charged, and the scheduling of work will be affected by the need to go through clearance procedures before a start can be made. Particular competitiveness issues 20. Three particular issues have arisen in early reaction to the Contained Use Regulations which warrant explanation. The first is whether the criteria used to classify organisms for the purposes of the regulations are unnecessarily burdensome by being ambiguous, or worse, wrongly set. The second is the same point but in relation to the criteria used to classify activities. The third is whether some organisations will face high costs by being required to make multiple notifications. They are examined in paragraphs 21-23 below. 21. The criteria used to divide micro-organisms into lower and higher hazard groups (referred to in the regulations as Group I and Group II) are taken from the contained use directive and a supporting CEC decision (91/448) which sets out classification guidelines. Broadly speaking they are intended to distinguish between organisms that are pathogenic to humans, animals or plants and those that are not. They do this by applying multiple tests to the host organism, the genetic material to be inserted into it, and the means of insertion. They are based on criteria developed earlier by OECD and widely accepted as a basis for classifying organisms. Flexibility and qualifications are built in, to allow for the subtleties of hazard assessment in this field, and this does mean that there will be marginal cases needing careful interpretation. Some reasoning and judgment in the use of the criteria is unavoidable because of the scientific complexity of the assessment and, sometimes, uncertainty about the organisms and genetic material involved. There is a trade-off between flexibility and lack of ambiguity, both wanted by practitioners. To a degree difficulties can best be dealt with by refining guidance in the light of experience. But none of this is to say that a consensus will not emerge pointing to an adjustment of the threshold set by the present criteria. 22. The criteria for classifying activities are also taken from the contained use directive, with some elaboration to relate what is meant by “small-scale” to the activity under consideration. There are two conditions which an activity must satisfy to be placed in the less strictly regulated group (Type A), one of purpose and one of scale. The purpose must be teaching, research, development or an non-industrial or non- commercial purpose. Most activities in question are research or development. The “‘commercial” test need not normally be applied, though it is the one that has worried commentators most. The scale must be “‘small’’, but what counts as small depends on the process and facility. It must be possible to contain a spill if primary containment fails. Standard laboratory decontamination must be sufficient and easily undertaken (if, say, a tanker of biocide is needed the scale is by definition not “‘small’’). Different activities may satisfy these tests at widely varying volumes. The contained use directive gives an indicative figure of 10 litres but this is unhelpful in practice. Even so most commentators are relatively happy to subject the scale criterion to common sense reasoning case by case. The shortcoming of the activity criteria, if there is one, is not so much ambiguity as that the test of purpose is not related to risk, though this may underclassify, say, a research activity, as well as overclassifying some industrial production. 23. The third point mentioned at paragraph 20 above is the suggestion that the regulations will unduly burden organisations that carry out large numbers of individual GMO activities by requiring a correspondingly large number of separate notifications and fees. This is a perceived difficulty mainly in academic institutions which may carry out large numbers of experiments using pathogenic organisms. Many of these were notifiable under the 1989 regulations, though not subject to a fee. (Type A activities using Group I organisms are not notifiable separately or in advance). The problem is largely solved by the regulations themselves, which allow a group of activities making up a connected programme of work to be collected in a single notification. It will usually be possible in this way to reduce the number of notifications required. Generally the number of discrete programmes in a given institution will be limited by the number and feasible range of interests of the supervisory academic staff. By their nature, large-scale or industrial activities either involve few discrete processes or are connected by the commercial ends of the company, and do not give rise](https://iiif.wellcomecollection.org/image/b32218825_0002_0012.jp2/full/800%2C/0/default.jpg)
