Select Committee on Science and Technology First Report


CHAPTER THREE: THE APPROVAL PROCESS

Sources of Scientific and Technical Data

58. Applications for approving GMOs for food use or for environmental release are supported by the applicant's own data and risk analyses. Some witnesses argued that "committees rely far too heavily on the biotech industry's own data and risk assessments, many of which have not been independently reviewed".[123] Other witnesses rejected such criticisms. Professor Bainbridge pointed out that the majority of members on scientific advisory committees were well experienced in the assessment of scientific data and peer review.[124] Indeed it is the advisory committees themselves that are performing the independent review. Moreover, ACRE and ACNFP do not rely solely on the information supplied by the applicants but also draw on other sources and almost always demand the production of data from applicants in addition to that submitted with the original application. And as Professor Bainbridge also reminded us it is very important to realise that the science we are looking at is science that has been subject to the normal processes of science, that is, peer review.[125] Novartis argues that the risk assessments produced for the regulators are very expensive and require specialist expertise so it is appropriate that the regulators act as examiners for the assessments rather than attempt to undertake the evaluations themselves.[126] We do not believe that it would be either appropriate or practical for ACRE and ACNFP to do anything other than use an applicant's own data in their assessments. We agree with Novartis that "regulation by review of companies' risk assessments works well in pharmaceutical and pesticide regulation" and this is accepted by the public.[127] Where inadequate information is provided, it is acceptable that further research is commissioned and paid for by the applicant.

COMMISSIONING RESEARCH

59. Some witnesses suggested that scientific advisory committees should be able to commission underpinning research where there are areas of uncertainty that need resolving.[128] ACNFP already has the ability to recommend areas for MAFF research, as ACRE does for DETR research.[129] While we accept that it is important that both ACRE and ACNFP should be able to call for research to be undertaken, we caution against giving them their own specific research budgets. Budget allocation would put a huge administrative responsibility on the committees and their secretariats but the strategic research needs of scientific advisory committees must be considered. We recommend that when ACNFP moves under the management of the Food Standards Agency, an appropriate part of MAFF's research budget be transferred to the Agency. Formal links should be established between DETR, the Foods Standards Agency, the Foresight programme and Research Councils so that ACNFP's and ACRE's longer-term basic research requirements can be considered. We recommend that the Minister for Science plays a strong role in ensuring proper coordination between the various research funding agencies and Departmental research programmes in this area.

Substantial Equivalence

60. Part of the procedure for assessing novel foods rests on establishing 'substantial equivalence' — a methodology developed by the WHO and the OECD and used internationally as a basis for performing risk assessments on novel foods.[130] If a novel food is judged to be substantially equivalent to a conventional counterpart, then it can be considered to be as safe as the conventional counterpart. Establishing substantial equivalence is a complex process involving measurements of the constituents of the GM food and comparing them with a conventional counterpart. If a GM food is found to be substantially equivalent to its conventional counterpart, it will normally be approved. Where a food is deemed not to be substantially equivalent, a more detailed analysis is required.[131]

61. MAFF told us that using this methodology overcomes the "practical difficulties that are associated with trying to test novel foods using traditional animal studies where the nutritional balance of the animals' diet can often be adversely affected"[132]. However substantial equivalence has its critics. The Consumers' Association argued that the approach used to establish substantial equivalence "fails to acknowledge the potential for unintended and unpredictable side effects".[133] Professor James of the Rowett Research Institute pointed out that establishing substantial equivalence "depends on correctly specifying and measuring those elements of concern" which may not always be possible.[134] He also argued that, while there were few doubts that the principle of substantial equivalence was an effective tool for current assessment, "given the extremely large number of GMOs currently under trial, we consider that there is a need to develop new screening strategies which take account of current scientific knowledge and a need ... to have greater assurances on the safety of GMOs".[135] Professor Bainbridge pointed out that ACNFP, rather than the applicant, had discretion over whether to proceed on the basis of substantial equivalence or to conduct a far more detailed analysis.[136] We are not convinced that present GM food safety assessment protocols are flawed. Nevertheless any robust and sustainable scientific advisory system must be prepared to challenge some of its basic tools, especially when doubt is cast on the validity of those assumptions by others. Therefore we recommend that the Government works with its European partners to investigate new approaches to the safety assessment of novel foods and commission appropriate research.

The Case by Case Approach

62. ACRE and ACNFP consider each application submitted to them on its individual merits. This approach has led some witnesses to suggest that there is a lack of analysis of the overall, cumulative impact of genetic modification on agriculture, the environment and of the general effects of GMOs in the long term. Professor Burke told us that "the case by case approach has proved inadequate as the number of approvals have grown ... the cumulative implications of successive decisions have not been considered".[137] The British Medical Association told us that the "case by case approach to GMO regulation ignores the cumulative effects of releases".[138] Both the Royal Society and the Royal Commission on Environmental Pollution have also drawn attention to its weaknesses.[139]

ACRE'S BIODIVERSITY REMIT

63. Until last year, ACRE's role primarily involved assessing the direct impact of releasing a GMO into the environment on a number of selected species and the possibility of escaping genes. Indirect effects, such as the impact of the introduction of a GM variety on the overall volume of chemicals used during the growing season did not form part of ACRE's assessments. ACRE's remit has since been widened to include consideration of the effects on biodiversity of GM crops, especially when grown commercially.[140] This change has been widely welcomed.[141] ACRE has established a working group to explore the scope of the issues and we welcome the fact that English Nature and the RSPB have been participating in this process. We welcome the Government's decision to extend ACRE's remit to include consideration of the cumulative impact of GM crops on biodiversity.

64. The introduction and management of GM crops must also be considered in the context of wider concerns regarding the environmental impacts of today's intensive agriculture. These indirect effects are currently not within the scope of risk assessments as required under the Deliberate Release to the Environment of Genetically Modified Organisms Directive 90/220, and consequently ACRE's extended remit may not be matched community wide. Amendments to this directive are currently under negotiation.[142] Mr Meacher told the House of Lords European Communities Committee that "the UK is seeking to make sure that the scope of the Directive and of the environmental risk assessment is well defined and broad enough to cover indirect as well as direct effects of GMOs".[143] We welcome this. We believe that Directive 90/220 should be amended so that the cumulative effects of GMOs and their management on the environment and on biodiversity are assessed as part of all approvals for deliberate release.

The Need for More Research

ON ENVIRONMENTAL IMPLICATIONS

65. The need for research to underpin Government policy and decision making on GMOs goes further than the need to meet the specific requirements of advisory committees. Several witnesses commented on the limited amount of scientific results on which to base assessments of the environmental hazards presented by releasing GMOs. The Consumers' Association told us that there is lack of independent research into "the long-term implications of the introduction of GM crops and foods".[144] English Nature supplied us with an extensive list of the research projects they believe need to undertaken, a number of which they identified as being of high priority.[145] Mr Meacher argued that the Government already had a broad portfolio of research projects in this area and that the budget for such research had been increased from about £900,000 in the current year to around £1.2 million over the next two to three years.[146] We welcome the increase in publicly-funded research into the environmental impacts of GMOs. However, the Government's research programme should also take into account the concerns of organisations such as English Nature.[147] It is disappointing that this is not yet occurring and Mr Meacher has undertaken to address this point.

A MORATORIUM ON COMMERCIAL PLANTING?

66. There have been calls for a moratorium on the planting of commercial crops although English Nature told us that "we have not pressed specifically for any kind of particular moratorium but what we have said is we need to go more slowly and need much more evidence on some areas ... we are saying that there should be no commercial planting until there is enough evidence to make a better assessment than we can make at the moment".[148] They also told us that they thought this would be around 2003. Other witnesses, such as the RSPB and the Farmers' Union of Wales, supported English Nature's stance, while others have variously called for a three or five year moratorium on commercial planting.[149]

67. Professor Beringer told us that "the field releases that have been done have been so small—about half the size of this room ...that you can make almost no meaningful ecological response from them".[150] The Government has announced three farm-scale trials of GM crops to investigate environmental impacts which will run for the next four years but it has rejected calls for a moratorium on commercial planting.[151] Mr Meacher assured us that commercial planting of GM crops would not be permitted until the Government was satisfied that it had enough information to make a sound judgement, but suggested that it was not possible to predict with any degree of accuracy when this might be.[152] Yet in February this year the Government stated that "limited and monitored commercial planting of GM crops may start in the UK next year" provided that all regulatory hurdles had been cleared.[153] We do not know what advice the Government might have received that led them to this conclusion. We accept it is difficult to determine precisely when farm-scale trials might result in adequate information, or whether further trials may be required, to allow the Government to make well-informed decisions on the commercial planting of GM crops. We also accept that the only way in which the Government can gather such data is to perform further farm-scale trials in accordance with EU Directive 90/220. It is precisely because of the uncertainty over the length of time that will be required to obtain sufficient data from the farm-scale trials that we believe that calls for a fixed term moratorium are inappropriate. We are, however, convinced that it is impossible for the farm-scale trials to have provided adequate information after only one year. In practice it seems that there is already a de facto moratorium on commercial planting in place. GM crops may not be released into the environment without the necessary consent from the Government and no such consents have yet been issued for commercial growing. Government must make it absolutely clear that commercial growing will not be permitted without adequate information from farm-scale trials.

ON THE IMPLICATIONS OF CONSUMPTION OF FOOD FROM GM CROPS

68. Some witnesses raised similar concerns regarding the paucity of knowledge of the long-term impact of eating GM food. For instance, the Royal Society of Edinburgh stated that "while the thoroughness and quality of scientific advice on this issue is good, GM foods come almost entirely into a category where scientific evidence is ... partial and constantly under review".[154] The Health Promotion Agency for Northern Ireland, pointing out that the technology which allows the genetic modification of food ingredients was relatively young, argued that "the potential long-term effects on human health ... should be examined".[155] No foods in the human diet can be said with certainty to be risk-free — there are many conventional foods available which have well-documented health risks. Nevertheless, it is foolhardy to introduce any new technology, in any sphere, without adequate follow up assessment of its impact. Professor Bainbridge, who told us that such monitoring had been discussed by ACNFP, pointed out that there was a danger that such monitoring could create the false impression that the Government had doubts over the safety of the GM products it was allowing into the human food chain.[156] This may represent a presentational problem for the Government but it is not a reason to avoid conducting necessary evaluation. The Medical Research Council (MRC) told us "the most effective means of establishing the long-term effect of particular GM foods on human health will be the randomised controlled trial" and that researchers were beginning to develop practical methodologies.[157] We recommend that the Government supports efforts to find valid ways of monitoring any long-term impact on health of consuming GM foods.


123  See for example Ev. p. 211. Back

124  Q. 453. Back

125  Q. 453. Back

126  Ev. p. 184. Back

127  Ev. p. 185. Back

128  Ev. p. 21; Ev. p. 35. Back

129  Ev. p. 139.  Back

130  Ev. p. 138. Back

131  Ev. p. 138. Back

132  Ev. p. 138. Back

133  Ev. p. 216. See also Ev. p. 212; Ev. p. 219; Ev. p. 241. Back

134  Ev. p. 39. Back

135  Ev. p. 39. Back

136  Q. 478. Back

137  Ev. p. 223. See also Ev. p. 55; Ev. p. 180; Ev. p. 183; Ev. p. 212; Ev. p. 216. Back

138  Ev. p. 238. Back

139  The Royal Society, The Regulation of Biotechnology, February 1999; Ev. p. 195. Back

140  DETR, The Commercial Use of Genetically Modified Crops in the UK: the Potential Wider Impact on Farmland Wildlife. See also ACRE 1998 Annual Report, March 1999, p. 5. Back

141  See Ev. p. 64; Ev. p. 179; Ev. p. 261; Ev. p. 221. Back

142  Q. 579. Back

143  HL Paper 11-II, Q. 603. Back

144  Ev. p. 216. Back

145  Ev. pp. 70-1. Back

146  Q. 737. Back

147  Q. 738. Back

148  QQ. 335-41. Back

149  Ev. p. 261; Ev. p. 194. See also Ev. p. 210. Back

150  Q. 549. Back

151  WA., 15 April 1999, column 301-302. Back

152  Q. 775 Back

153  Letter from the Government, dated 18 February 1999. Back

154  Ev. p. 253. Back

155  Ev. p. 189. Back

156  Ev. p. 87. Back

157  Ev. p. 209. Back


 
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