146.  In 1993 the House of Lords' Select Committee on Science and Technology reported on the regulation of biotechnology[191] in general. Their report concluded that regulation should be kept to a minimum:

"the benefits of biotechnology are already well proven; biotechnology and products of biotechnology are with us to stay; and these products will yield enormous future benefits to mankind. What is more, United Kingdom scientists and industry are good at it. We think that in all areas where biotechnology has applications, people should be able to exploit its economic benefits, subject only to such regulation as may be necessary to meet identifiable disbenefits, especially to preserve safety."[192]

147.  The Science and Technology Committee's report was written when virtually no genetically modified organisms had been intentionally released into the environment and there had been no application to release on a commercial scale. To date only a small number of products have been approved for commercial release within the European Community (see Appendix 4[193]), compared with a great many in the United States[194], but the commercial exploitation of genetically modified maize, soya and cotton in the United States and Canada[195] has meant that world production is now significant[196]. More than 60 per cent. of processed foods sold in supermarkets contain soya, most of which comes from North America and may therefore contain a significant proportion of the genetically modified produce. We agree that regulation should be kept to the necessary minimum, but the release into the environment and food use of GMOs require strict regulation.

UNITED KINGDOM REGULATORY COMMITTEES

—MEMBERSHIP

148.  While ACRE (see paragraph 32) received compliments from our witnesses[197], its membership was criticised by Iceland (p 62) and Greenpeace (Q 103) as being dominated by those connected to, knowledgeable about or favourable towards the technology and some have called for membership to be broadened to include consumer representatives. ACRE's role is to assess the safety of complex products based on complex data. As a result, the membership of such a regulatory committee must be dependent on scientists. Some of those competent to assess the data are inevitably going to have a degree of connection to the agro-chemical/seeds sector[198]. We do not question ACRE's integrity, but it and its members must be seen to be acting independently. We were informed that when an application is submitted to which a member is commercially connected, that member leaves the room while it is discussed and plays no part in the decision-making (the same is true of ACNFP (Mr Rooker, Q 624)). The membership of such a committee should however be balanced in its expertise and we value Mr Meacher's commitment to broaden it in ACRE's case[199] (Q 607), particularly given the wider environmental remit we recommend in the next paragraph. The consumer representation on and contribution to ACNFP is much valued by all involved[200]. We believe the same would work in ACRE's case and that its membership should thus include a consumer representative. In the interests of openness, it is also right that there should be a rotation in the membership of such committees. It is desirable however that a body of knowledge should be built up. That which ACRE has acquired may be lost when ten of the current 13 members retire in April 1999 as expected (Mr Meacher, Q 613). We would very much regret such a lack of continuity and would urge the Government to review the situation as a matter of urgency. This position should be avoided in future.

—ROLE

149.  Several witnesses criticised the narrowness of particularly ACRE's remit, whereby it is unable to take all of the pertinent issues into account (Greenpeace, Q 103; Green Alliance Q 195; SNCAs, p 322; CA, p 53, Mr Meacher, Q 607). The remit of ACRE should be adjusted so that it considers, for example, indirect and cumulative environmental effects when judging individual applications (see paragraphs 89-95).

150.  The actual role of ACRE and ACNFP can also be questioned. In the United States, the government conducts the risk assessment. Some countries outside the EC have adopted this approach, whereby the same officials make decisions on the information needed to support the assessment and on the assessment itself. The United Kingdom (and EC) system has introduced the concept of scientific audit. The advisory committee assesses whether the information supplied by the applicant is adequate and whether the assessment is accurate. The committees often request further information and research before reaching a decision. We consider that the United Kingdom's audit approach is valuable and not inferior to the alternative of assessment by government officials. Accordingly we support the status quo.

—STRATEGY

151.  A distinction can be drawn between the scientific assessment of individual applications for release (performed by ACRE) and a strategic examination of the issues relating to genetic modification. There have been increasing calls for a new committee of some sort. Professor James called for an ability to take a broad view, especially as the number of individual applications for releases increases (Q 671, also Professor Bainbridge, QQ 681, 692) - otherwise we will be in danger of losing sight of the wood for the trees. Mr Meacher announced to us that he is considering calls to establish an "environmental stakeholders' forum" (Q608) and the Royal Society have recently called for an "over-arching" committee[201]. Both are aimed at what Mr Rooker referred to as "joined up government" (Q 606). To this end we can but welcome the establishment of the cabinet committee[202] under the Minister for the Cabinet Office (Dr Cunningham). We consider however that a new committee is still required because a more detailed and continuous approach is necessary. Which of the two options to choose, forum or over-arching, depends on the remit necessary to achieve the strategic end.

152.  We believe that a new committee is needed to examine more general issues which arise from the use of genetic modification in agriculture and to co-ordinate and plan policy as a "seamless whole" (FDF, Q 544), as opposed to the assessment of individual applications which should continue to be performed by ACRE. Such a committee is needed to address predominantly environmental[203] questions raised by the current advisory committees which either fall outside their remit, or which require an integrated response from Government, for example the regulation and monitoring of herbicide tolerant crops. The remit should include the impact on agriculture in general of the integrated management of novel crop plants and their cumulative effect, changes to agricultural practice and changes in pest control and herbicide use (see paragraphs 94-95 and 105-106). The committee would need to ensure that appropriate research was conducted and acted upon. The committee should have issues referred to it by Ministers or ACRE but should also act on its own initiative. It should seek advice from the other advisory (and regulatory) committees and vice versa. It should establish the principles by which the development and application of the technology should proceed. Its membership should be wide-ranging (including cross-membership with other committees) and we believe that the committee would be effective with consumer representatives involved. These issues are not solely the preserve of scientists, as has been demonstrated by successful consumer involvement in the food regulatory committees (Professor James QQ 648-9; Professor Bainbridge, Q 688).

153.  The remit we envisage necessitates a committee similar to that proposed by the Royal Society rather than a stakeholders' forum. It would appear that the latter would be but a forum for debate whereas we wish to see a more integrated approach to policy. For example, it is good that Mr Rooker has commissioned an analysis and comparison of herbicide tolerant crops (see paragraph 68), but this sort of research and analysis should not be dependent on occasional Ministerial attention but be able to be commissioned and acted upon by the new committee. The committee should engage in broad consultation with interested groups.

FILLING GAPS IN THE SYSTEM

154.  It is distressing to find that regulations have been and are still running to keep up with the technology. This is confusing for those involved and a reason for consumer disquiet. We still lack a Community labelling policy (United Biscuits, p 400). The revision of Directive 90/220/EEC offers an opportunity to try to create more durable legislation. Gaps not already identified include:

—ANIMALS

155.  GM animals will primarily be used in containment and, unless they escape, as such do not pose release problems. The possibility of accidental release, escape and cross border transfer is not yet covered by Community legislation.

—FISH

156.  Fish are being modified for rapid growth and cold tolerance[204] and further modifications are in development. Once released, it would be impossible to recapture a fish or to control its breeding (unless sterile). Fish do not respect national boundaries and we would be very concerned if sea or river releases were to take place here or abroad. We strongly recommend that there be an international agreement prohibiting such actions. Any trials or commercialisation must be in containment and not released into the sea or freshwater network.

—RELEASE - WHOSE DECISION?

157.  In certain cases, particularly for animals, there is no need to notify a competent authority of the environmental risk assessment if the user decides that an application of the technology is contained. We consider that the decision as to whether or not a use of a GMO is a release should be subject to review by the competent authority.

—IMPORTED FOOD

158.  The EC's current control regime for GMOs has given rise to some difficulty between United States manufacturers and the EC regulatory authorities[205]. The process could be assisted if, where there is no intention to use an imported product other than in food or feed (i.e. not for growing), the risk management procedures were to focus mainly on the properties which affect human or animal health and safety. The permit should specify the procedures needed to ensure that the product cannot be grown and reproduced. If the product can be grown (as with soya beans but not with soya oil), an assessment of the risk to the environment would have to be performed and risk management would need to be implemented to avoid release. It is important to note that consents to market GM foods are valid throughout the EC and the Commission should take steps to ensure that these consents are permitted to operate in every Member State.

EC EFFICIENCY

159.  The safety and public concern considerations outlined above justify that effort should be put into the regulation of GMOs. The process must however be conducted effectively and efficiently and subject to review in the light of experience.

—POLITICISATION AND OPT-OUTS

160.  As Europe has a single market it is right that the approval procedure for commercial releases should be European. The procedure involves all 15 Member States and results in a Community-wide permit to grow and market a crop. The regulatory process is meant to be exclusively scientific, but the domestic pressures of Member States have intruded and caused delay. This might be assisted if a degree of opt-out for growing was available[206]. We acknowledge that domestic pressures, ecological and agricultural conditions vary across the Community and consider that Member States should have the right to opt-out of growing certain GM crops for domestic or environmental reasons (i.e., after approval, a Member State could disallow commercial release within its territory). We acknowledge that this will hinder the single market in seeds (HMG officials, Q 483), but consider this preferable to the Community being forced to proceed at the pace of the most reluctant. The products of such crops, food or other, should however be available throughout the Community and the market will determine their acceptability and so success or failure.

—ALTERATION OF THE RELEASE PROCEDURES

161.  We note and share the concern expressed by DETR (Q 437) at the removal of the current simplified procedures for trial releases. The introduction of two levels of release, the first of which is considered relatively without risk, does not adequately replace the current procedure. If the status quo is not to be maintained then the new provisions need clarification to prevent discrepancies of interpretation between Member States. We do not consider attractive the proposal whereby research and development releases in several Member States would be processed initially at Commission level before being passed to each Member State for decision. The new procedure would be less efficient than the current system which requires a separate application to the Competent Authority in each Member State. We do, however, support the proposal for simplified permits for repeat experiments. We support the Commission's forward planning whereby a simplified procedure for marketing applications is established.

—COMITOLOGY

162.  The current comitology procedure appears to allow applications to succeed when most Member States are opposed. We therefore support the proposal to move from the IIIa to the tighter IIIb procedure (see paragraphs 59-60). Under this procedure, a simple majority of Member States may prevent a product being marketed, an option not available under the IIIa procedure. This should not allow products on to the market when a majority of Member States have been opposed (as has seemed to happen under IIIa).

—COMMUNITY SCIENTIFIC ADVICE

163.  The proposed revision of the Directive formalises a requirement for the Commission to consult its scientific committees[207] when a dispute has arisen between Member States. Professor James, a senior member of the scientific steering committee and Dr Chesson, a member of the GMO committee, described a convoluted process for appointing members to the committees, ostensibly with regard to expertise but inevitably with careful reference to geographic distribution. Of more concern was the use of inappropriate expertise: Professor James found himself responsible for a cosmetics committee (Q 654). Community science is more frequently criticised for its operation than for the quality of its advice, and this assessment was confirmed by Professor James and Dr Chesson (Q 658). Though the position had improved now that Directorate-General XXIV was responsible for all the committees, too much pressure was put on academics giving their time voluntarily (QQ 656, 661, 668). There was not sufficient scientifically literate administrative support at Community level. The support was estimated to be between a quarter and a tenth of the level a similar committee in a Member State would receive (Q 655). These two factors had led to the resignation of some British academics. Some Member State governments provided up to ten staff for their nationals on these committees to assist with the workload (Q 656). Professor James commented that the "pressure of the last year has been too intense to get really very well balanced, beautiful judgments that are explicit and clear in all aspects." (Q 658). In addition, the committees were often asked by the Commission to comment on an issue without sufficient background information (Q 660). The committees' time was wasted when essentially political issues were referred to them (Q 659). Perhaps more seriously, the interlocking of the committees and sub-committees was too muddled, with the result that issues could fall between committees (Q 655).

164.  We consider that consultation of the scientific committees will be useful for resolving inter-Member State disputes. The appointment, membership and operation of the committees must be open to scrutiny. The current method of appointment is inadequate. Appointment must be on the basis of scientific expertise and should not necessarily reflect geographic considerations or the voting strengths of Member States. The structure of the committees could also be streamlined to increase their relevance to the regulation of GM releases. The committees require improved resources in Brussels. It is not appropriate for Member States to support their nationals as the members of the committees are independent academics not representatives of Member States (Q 657). The committees need relevant, precise questions put to them by the Commission at the earliest possible stage with the fullest information available. While it is necessary for the committees to be able to take a broad view when examining an issue, they should only be required to comment on the specific disputes between Member States and should not be required to re-assess dossiers from scratch, especially as each dossier will already have been examined in detail by the lead Member State's scientific committees and also by every other Member State (Professor James, Q 667).

165.  Professor James and Dr Chesson approved of stopping the clock[208] (see paragraphs 63 and 167) for the committees' consultation, primarily as a vast amount of information had to be assimilated by academics giving voluntarily of their time. They admitted however that this might not be necessary if the consultation was more efficient (QQ 662-3). We consider that the efficiency of the committees' working should be improved before resorting to stopping the clock. If this proves impossible, consideration will need to be given as to whether it would be preferable to make the committees permanent or to stop the clock.

—TIME LIMITS

166.  The delay inherent in the European regulatory system (the stages of which are described in paragraphs 61-63) attracted repeated criticism, including Mr Meacher, who referred to "unjustifiably long delays at a number of stages" (Q 621). Professor Beringer commented that it was the "regulatory environment in Europe which is a major stumbling block". He described a "very weak, ineffectual and (I would even use the word) incompetent system in Brussels which is allowing various delaying tactics to be introduced" (Q 20). Monsanto noted that the approximate average time from the initial submission to the lead Member State to publication of the approval in the Official Journal is 18-19 months, whereas in the United States it is 7 months (pp 137-8)[209]. This is a major problem which must adversely affect Europe's competitiveness. The unnecessary delay in approving products has created a vacuum in which ignorance has been exploited and the consumer is both denied choice and the opportunity to build up experience.

167.  The industry's call was not so much for a speedy system but for a predictable system (Zeneca, p 21). Research and commercialisation programmes are not conducted on a whim and demand accurate funding and planning. The United States argued that consultation of the Community scientific committee should not have been arbitrarily introduced into the working of the current system, whatever its merits (p 155) and Dr von Schomberg and the DETR noted inconsistency in the application of risk assessments between Member States (p 404; Q 439). We thus welcome the introduction of strict time limits and the definition of risk assessment which should help end discrepancies between Member States. There are however two flaws. The first is too ready a willingness to stop the clock. We recommend that the clock should only be stopped when further information is requested from the applicant. Additionally, the Commission has failed to set itself a time limit for approving or rejecting a release following the (in)decision of the Council. Almost all of the applications that have so far been considered have been delayed by the Commission, and of the four applications submitted in 1995 only two had received consent by June this year (DETR, pp 187-8). This stage should be automatic or subject to a token period of a week. So should the subsequent issuing of a permit by the lead Member State, following EC approval.

168.  It will be a considerable period of time before the revision of the deliberate release Directive is adopted, especially as the European Parliament is involved under the co-decision procedure. We thus urge the Commission to reform its internal workings so that the present system is subject to less delay. Member States should agree voluntary time-limits where they are currently not set under the existing Directive.

169.  Monsanto complained that the two-year national plant variety registration system[210] placed an unnecessary additional hurdle at the end of an already protracted process. The committee recognises their frustration, particularly where trials have been performed which meet the same criteria, and consider that the results of such trials should be acceptable for plant variety registration.

—SEVEN YEAR CONSENTS

170.  The draft Directive proposes that marketing consents be issued for seven year periods and only renewed for seven years at a time. While supported by some, such as Iceland (p 355), this proposal has drawn much criticism (Professor Beringer Q 443; DETR Q 443) and we find no merit in it. There is merit in imposing valid conditions on individual applications for consent and in placing a time limit on a product for which there is a particular concern (see paragraphs 100-101). It is also important that permits may be withdrawn at any time if there is evidence of harm to the environment or to health. If monitoring is conducted properly, if a report on any unexpected events or harm to the environment is required and if the permit can be revoked at any time should evidence of harm arise then the specification of a time limit is pointless. The same proposal implies that permission will only be given for a specific product as opposed to a class of products. This could cause severe difficulties to plant breeders who would want to create a number of varieties in order to maintain agricultural biodiversity, decrease susceptibility to disease and to ensure that it is the best varieties that have modified characteristics.