Select Committee on Science and Technology First Report


CHAPTER TWO: THE SCIENTIFIC ADVISORY SYSTEM FOR GENETICALLY MODIFIED FOOD

The Advisory and Regulatory Systems concerning GM Food and Crops

36. The Government's first priority in respect of food regulation is to "protect public health in relation to food by promoting and enforcing high standards of safety at all stages of its production, processing and supply".[63] Research and cultivation of GM crops and their use in food is "tightly" regulated and operates at both UK and EU levels.[64] Both EU and UK regulation is based on the precautionary principle. In practice this means that strong evidence is required that a genetically modified organism (GMO) presents a very low risk before consent is given for its use.

37. The current regulatory regime relating to GM crops and food had its origins in the 1970s when researchers were the first to call for, and achieve, a voluntary moratorium. From 1978 any work involving genetic modification had to be notified to the Genetic Manipulation Advisory Group and the Health and Safety Executive (HSE). The Genetic Manipulation Advisory Group was replaced in 1984 by the Advisory Committee on Genetic Modification (ACGM) which is still the body responsible for advising the HSE on the contained (i.e. laboratory) use of GMOs. Responsibility for regulation and the provision of advice on other aspects of genetic modification has since been passed to other authorities, chiefly the Advisory Committee on Releases to the Environment (ACRE) and the Advisory Committee on Novel Foods and Processes (ACNFP) although there is a number of other expert bodies within the scientific advisory system which the Government may call upon. MAFF told us that "in all the Government has access to some 60 experts when seeking advice on the safety of GM Foods".[65]

REGULATION OF RELEASES OF GMOS TO THE ENVIRONMENT

38. Releases to the environment are regulated in the UK under the Genetically Modified Organisms (Deliberate Release) Regulations 1992, which implemented EU Directive 90/220. The competent authority in the UK is the Department of the Environment, Transport and the Regions (DETR), advised by ACRE which was established under the Environmental Protection Act 1990. That Act also introduced a structured regime of notification and risk assessment which was designed to prevent or minimise "any damage to the environment which may arise from the escape or release" of GMOs.[66] Any release into the environment of a GMO, from growing a single plant in a pot to large-scale commercial planting of a crop, must be notified to, and in many cases authorised by, the Secretary of State for the Environment, Transport and the Regions.[67] Applications for releases must be accompanied by comprehensive information including an environmental risk assessment, details of the nature of the organism, the origins and types of gene sequences to be transferred and the transfer technique.[68] Applications to market GMOs follow a similar procedure but must also be approved at EU level. For successful applicants these procedures result in a European Union-wide permit to grow commercially or market their product.


The EU and UK Regulatory System

Stage

UK regulation

EC Directive/Action

Laboratory Research

HSE advised by ACGM

Directive 90/219

Experimental Release (growing plants outdoors, field trials and cultivation)

DETR advised by ACRE

Directive 90/220

Details of all releases circulated to all EU States


Marketing

(I)consent to market GM food in the EU;

(II)consent to market GM seed;

(III)labelling


MAFF/Department of Health advised by ACNFP and other committees

(I)Marketing consents sent to all EU States

(II)Directive 90/220 plus various seeds Directives

(III)Novel Food Regulation 1997

Source: Parliamentary Office of Science and Technology, POST Note 115, May 1998.

REGULATION OF GM FOOD

39. Until 1997 the UK operated its own approval system for all food derived from GM crops or containing GM ingredients. In May 1997 the EU Novel Foods and Novel Food Ingredients Regulations, which set community-wide standards for safety assessments of novel foods, came into effect. The competent authority in the UK is currently the Ministry of Agriculture, Fisheries and Food (MAFF) although the Food Standards Agency will take on this responsibility if the necessary legislation comes into force.[69] MAFF is advised by ACNFP. Under the EU Regulations companies wishing to market new GM food products must apply to the Member State in whose territory they first intend to market their product so that a safety assessment can be carried out. Applicants are required to provide detailed information about the genes and organisms involved, the processes used for genetic modification, the nature of the food product and any processing involved.[70] The Member State then has 90 days to reach a conclusion after which a report is circulated to all other Member States. Member States can raise objections within 60 days. If objections have a scientific or technical basis and cannot be easily resolved, the EU Scientific Committee for Food makes an assessment which forms the basis for a final decision taken jointly by all Member States on the basis of qualified majority voting.[71] Once a GM food has gained marketing consent in one Member State, it may then be sold throughout the EU.

40. Both ACRE and ACNFP may seek guidance from other scientific advisory committees as necessary. Typically these might include the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment, the Committee on Medical Aspects of Food and Nutritional Policy, the Advisory Committee on the Microbiological Safety of Food and the Advisory Committee on Pesticides. In addition they may also draw on the expertise of the Food Advisory Committee on such matters as that of labelling.

THE EU-UK RELATIONSHIP

41. Decisions regarding the commercial release of GMOs are made at EU level through qualified majority voting. Once a consent has been granted for a GM crop, no individual Member State can ban its use, even if the assessment work on environmental impact has been done elsewhere. English Nature believes that "given the difference between wildlife habitats and distribution across Europe, and differences in farming practices, ... it would be better to allow subsidiarity in marketing approvals".[72] We believe that subsidiarity in this area would prove unnecessary in the majority of cases and would increase the workload of advisory committees significantly without any tangible benefit. The House of Lords European Communities Committee suggested that "Member States should have the right to opt-out of growing certain GM crops for domestic or environmental reasons".[73] The Government has rejected this proposal, stating that it sees "no reason for Member States to impose additional restrictions" and that the current provisions of Directive 90/220 are, in this regard, satisfactory to ensure the protection of the environment.[74] This is at odds with Mr Meacher's evidence to the House of Lords Committee that the Government was seeking to ensure that the scope of the Directive and environmental risk assessments were broad enough to cover direct and indirect effects of GMOs.[75] Even if that were to be achieved, it would not necessarily address concerns about differences in habitat and farming practices. Professor Beringer told us "normally if you have European marketing approval it applies everywhere ... If there is sufficient concern that it needs to be limited, then it probably should not be grown".[76] We recommend that the Government seeks to ensure that EU regulations permit local discretion in relation to specific farming practices and habitats in any particular region.

INTERNATIONAL AND TRADE CONSIDERATIONS

42. The application of the precautionary principle results in a regulatory system for GM crops and food that is distinctly different from that used in the USA. US regulation covers a narrower range of GMOs and is based on assessment of damage rather than of safety. This may have significance if different safety standards become a barrier to trade. There are provisions in existing trade agreements for decisions based on the precautionary principle but these have not been tested. Any disputes would be referred to the World Trade Organisation and in turn to the Codex Alimentarius Commission, a joint Food and Agriculture Organisation and World Health Organisation body. Codex sets international food standards and is the final arbiter where trade disputes depend on health issues. Codex is untested in the area of GM food but has previously shown itself ready to rule against the EU — as it did on the issue of hormones in beef. Codex operates through a series of committees with extensive industrial involvement but little participation on the part of consumers.[77] Codex is only permitted to consider 'valid' scientific reasons before products can be prevented from entering the market in a member country, which raises the questions of what is a valid reason, and who should judge? We recommend that the Government seeks to establish international agreement on what constitutes a 'valid' scientific reason; and that the definition of validity is based on the precautionary principle. We further recommend that the Government should press for Codex to find a means of reconciling the US, EU and UK approaches to GMO regulation.

The Quality and Integrity of Scientific Advice

THE EXPERTISE AND MEMBERSHIP OF ADVISORY COMMITTEE MEMBERS

43. The quality of scientific advice to Ministers rests largely upon the expertise of the committee members. Some witnesses argued that both ACRE and ACNFP had insufficient expertise in key areas. For instance, Friends of the Earth claimed that ACRE needed more expertise in soil science, pollen movement and farming practice.[78] Dr Katherine Venables, a member of ACRE and a former member of ACNFP, argued for a wider range of medical expertise, such as toxicologists and public health specialists, to be included.[79]

44. Other witnesses pointed to the eminence of the scientists currently serving on advisory committees and the respect that these committees command internationally. MAFF believes that ACNFP members "are all eminent, practising scientists or medical experts with international reputations".[80] DETR states that "ACRE's views are widely respected, both domestically and internationally".[81] The Royal Society of Edinburgh told us "the thoroughness and quality of scientific advice available on this issue is good".[82] The Minister for the Environment, the Rt Hon Michael Meacher MP, was emphatic that the advice his department received from ACRE was of "unquestionably high quality".[83] While expertise in all the main relevant scientific disciplines should be represented on scientific advisory committees, we do not consider that it would be practical, or indeed possible, to constitute committees to include world-class scientific expertise on every aspect of science that might ever come before ACRE or ACNFP.

45. The Green Alliance, among others, argued that ACRE's recently extended remit (see paras 63-4), which now includes examining the cumulative and indirect effects of GMOs in the environment and changes in agricultural practice, will necessitate a change in the expertise represented on the committee.[84] Professor Beringer agreed.[85] The Minister has acknowledged this and has already stated his intention to take the opportunity presented by the retirement of some members of ACRE to review the expertise needed.[86] We welcome this commitment.

46. Under the rules devised by the Committee on Standards in Public Life, ten of ACRE's 13 members, including its chairman, will come to the end of their term of office this year and will not be eligible for reappointment. We are concerned that such a large proportion of ACRE's membership should change at the same time. We regret the break in continuity that such a change will inevitably cause. We note that the Commissioner for Public Appointments has recommended that when a number of simultaneous appointments are made to one body, Departments should recognise the future difficulties of losing a large number of members at any one time and should stagger the duration of appointments.[87] We agree. We recommend that the Government avoids circumstances where large changes in the membership of scientific advisory committees are required at the same time.

REPRESENTATION ON ADVISORY COMMITTEES

47. Some witnesses from the food manufacturing and retail industries argued that they should have greater representation on scientific advisory committees concerned with food issues.[88] For instance, the Food and Drink Federation suggested that "much expertise resides within the food industry itself. There is no reason why this should not be exploited within the Advisory Committee structure".[89] Somerfield Stores argued that "the food chain are involved in the consequences" of judgements made by the scientific advisory system and that it needed "therefore to have an input into the decision making process" .[90] We are not persuaded by these arguments. We recognise that a good deal of expertise in this area resides in industry, particularly in the biotechnology sector. Ministers must, however, secure appropriate expertise on advisory committees rather than attempt to give representation to any particular groups. We recommend that the Government rejects calls to include, as a matter of course, representatives of any particular interest on scientific advisory committees concerned with genetic modification technology.

48. Both Mr Meacher and Mr Rooker drew a distinction between those scientists serving on advisory committees with research connections to the biotechnology industry and those directly employed by biotechnology companies. Mr Meacher suggested that, because the presence of biotechnology industry employees on ACRE had in the past brought into question the integrity of its scientific advice, he proposed "to avoid having people directly employed by industry" on the Committee in future.[91] Mr Rooker disagreed. Although none of the current membership of ACNFP is directly employed in the food industry, he told us that "it is not ruled out for the future".[92] A considerable amount of expertise on genetic modification resides with the companies that are actively developing the technology.[93] We recommend that the Government rejects proposals to bar employees of biotechnology or food companies from serving on scientific advisory committees. It is vital that appointments to scientific advisory committees should continue to be made by selecting people with the most suitable and relevant expertise.

COMMITTEE MEMBERS' INTERESTS

49. Both ACRE and ACNFP have provisions to ensure that members declare interests and have procedures for dealing with any conflicts of interest which may arise. The procedures for handling conflicts of interest in ACRE are set out in the 1998 ACRE Annual Report: "Members are required to inform the Committee and the Committee decides whether the linkage requires the member to be absent from the discussions. The decisions of the Committee and its reasons for including or excluding the individual are minuted".[94] ACNFP follows a similar practice.[95]

50. These rules have not prevented accusations of partiality. A number of witnesses pointed to apparent conflicts of interest among ACRE and ACNFP members. Iceland plc, among others, told us that the composition of ACRE was biassed towards the biotechnology industry and added that considering "the composition of the ACNFP and ACRE, it is not surprising that such a self interest could arise".[96] Friends of the Earth claimed that "8 out of 13 members [of ACRE] have clear links with the biotechnology industry" and that the chairwoman of ACNFP appeared to be "an additional spokesperson" for the biotechnology industry.[97] Other witnesses, such as Novartis and the Food and Drink Federation, discounted such accusations.[98] Mr Meacher told us "I have no reason to believe that the existing two members [who work in the industry] have not acted perfectly properly" and that "Contrary to views that half of the membership are employed by the biotech industry, that is absolutely not true".[99] Indeed, only 2 of ACRE's 13 members are directly employed in the biotechnology industry. We condemn the unjust attacks that have been made directly or indirectly against public-spirited scientists who have served the community well on both ACRE and ACNFP. We endorse Mr Meacher's view that the current members of ACRE who are employed by the biotechnology industry have acted properly and with integrity as have members of ACNFP.[100]

51. We have consistently supported, indeed advocated, Government efforts to encourage scientists in universities and Government research laboratories to commercialise their research and work more closely with industry. Such efforts to exploit the outputs of the research base are aimed at increasing the UK's industrial competitiveness, economy and quality of life. These policies will inevitably mean that few researchers can be said to be free of industrial associations, if indeed it were ever possible to make such a claim. As the Sheffield Institute on Biotechnology Law and Ethics told us, "it is difficult to see how any committee performing a risk assessment or auditing one already done could consist of other than experts in the field, who perforce cannot be totally independent".[101] Industry and Government, rightly, will always seek to work with the best scientists available. We reject any suggestion that scientists' integrity is automatically compromised by association with industry. If scientists from academia or the public sector with research connections to the biotechnology industry were to be barred from the Government's scientific advisory system relating to GM crops and food the Government would be deprived of some of the best scientific expertise available. We agree with Mr Rooker that this would be "totally inappropriate".[102]

52. Even accusations of partiality, however unfounded, can damage public confidence in the advisory committees.[103] Scientific advisory committees need a means of handling interests that will protect their members from unjustified claims of partiality and help to restore public confidence. Advisory committees must earn rather than assume public confidence or trust. Government must support its advisers by making clear the checks and balances which exist within the system to prevent partiality and to expose it if it were to occur and by responding robustly to false accusations. This support must be well informed. DETR claim that the high quality of the advice from ACRE is demonstrated "by the fact that there have been no incidents of damage to the environment in any of the cases for which ACRE has advised on the conditions to be attached to a consent" when only small scale trials have so far been carried out shows that this is not always the case.[104] The scientists involved deserve better support than this. Professor Beringer acknowledged that the existing requirements were not stringent enough, telling us that, for the last two years, the members of ACRE have argued that they "feel that the rules on declaring interests are far too weak. The number of shares [in a company that] you need to hold are far too high for most academics even to be able to think of entering their interests".[105] We agree with the Institution of Professionals, Managers and Specialists (IPMS) which argued that "serious thought ... needs to be given by Government to establish clear guidelines on disclosure of interest [for members of advisory committees] backed by active policies of annual disclosure, clear and transparent procedures for review of disclosures and clear criteria for decisions on whether interests are material".[106]

LAY MEMBERS ON ADVISORY COMMITTEES

53. ACRE membership includes an environmentalist and meetings are also attended by an assessor from English Nature. ACNFP membership includes a consumer expert and an ethicist. Many witnesses commented on the roles of these 'lay members' on scientific advisory committees. Professor Derek Burke, a former chairman of ACNFP, told us that in his experience, the consumer representative on ACNFP brought a "change in the way that the scientists approached issues " and could "witness to the robustness and independence of the Committee".[107] Both Mr Meacher and Mr Rooker felt that the role that lay members played on scientific advisory committees was important, arguing that lay representation served to increase public confidence and transparency and to challenge scientific members to explain themselves in ways which can be widely understood;[108] or as the Consumers' Association put it, to ensure that "risks are communicated in a way that consumers can understand and act upon".[109] We recognise that lay members add value to committee deliberations by bringing alterative perspectives. The Chief Scientific Adviser to the Government has explicitly set out the need "to involve at least some experts from other, not necessarily scientific, disciplines, to ensure that the evidence is subjected to a sufficiently questioning review from a wide ranging set of viewpoints".[110] We agree. We recommend that such individuals should make up a fifth of the membership of advisory committees.

54. We are, however, concerned about the way in which the role of lay members is defined and acknowledged. Like Mr Rooker we consider that titles such as 'consumer representative' or 'ethicist' which are sometimes applied to lay members are unhelpful.[111] Moreover, such titles may serve to give false impressions that consumer and ethical interests should be addressed by scientific advisory committees or that they have been adequately addressed. Nor can we sanction the use of the term public interest member which might give the erroneous impression that other members are not appointed to serve the public interest. We recommend the use of the term lay member to refer to experts from other disciplines serving on scientific advisory committees.

TRANSPARENCY

55. The Chief Scientific Adviser, in The Use of Scientific Advice in Policy Making, argues that wherever possible departments should "ensure that data relating to the issue are made available as early as possible to the scientific community to enable a wide range of research groups to tackle the issue. Scientific advance thrives on openness and competition of ideas"[112]. Openness is certainly important in maintaining a high standard of scientific debate and decision making; however, as a number of witnesses argued, it is also an important factor in maintaining a system which commands the confidence of the public.[113] Despite recent reforms on the part of the Government to increase the transparency of both ACRE and ACNFP there remain some criticisms of a lack of openness and demands for closer scrutiny. Sainsbury's, for instance, told us of a perception that advisory committees are "unnecessarily shrouded in mystery".[114] The Biotechnology and Biological Sciences Research Council (BBSRC) and the Royal Commission on Environmental Pollution both argued that the results of committee deliberations and the advice they deliver should be placed in the public domain as a matter of routine.[115]

56. ACNFP's agendas and minutes are placed on the Internet and discussion papers are available on request. Assessment reports and annual reports are published and "companies submitting approval requests are strongly encouraged to deposit as much of the supporting data as possible in the British Library".[116] MAFF is also considering publishing supporting data and assessment reports on the Internet, "the intention being to invite comments before the Committee offered its advice".[117] ACNFP has also experimented with public meetings when discussing generic issues but not when considering applications. Indeed, Professor Bainbridge was firmly of the opinion that it was not feasible to have open meetings when the committee was considering applications.[118] Similarly, ACRE now places all its minutes on the Internet along with technical reports and other material, including a newsletter, and the advice it delivers to Ministers is placed on the public register.[119] The BBSRC pointed to ACRE as a "good model" in terms of transparency, although we note that ACRE has not held open meetings.[120] While we acknowledge the arguments made by some witnesses that there would be practical difficulties for committees to operate if all meetings were to be held in public, unnecessary denial of access to meetings only serves to invite accusations that committees are secretive because they are not doing their jobs properly. We recommend that Government continues to drive for further openness by publishing ACNFP and ACRE papers and data (in full and summary form) and negotiating similar treatment of material from similar committees in other EU states. Such information should be published on the Internet for speed and accessibility as well as by conventional means. Summaries should be provided in plain English. We further recommend that, unless applicants can demonstrate that disclosure would cause commercial harm, all future meetings of ACRE and ACNFP should be held in public.

  

COMMERCIAL CONFIDENTIALITY

57. Some witnesses raised concerns about increasing the ACRE's and ACNFP's openness on the grounds that the commercial confidentiality of applicants could be compromised.[121] We also note the Consumers' Association view that "commercial confidentiality can be used as an excuse to prevent the disclosure of information".[122] Nevertheless, we recognise the genuine necessity to maintain commercial confidentiality in certain circumstances. Although much of the research behind applications will already have been patented well before an application is made, details of procedure and process can also be commercially valuable. Total disclosure requirements, which would reduce the incentive for companies to invest, would be inappropriate. We believe that there should be a presumption in favour of public disclosure unless applicants can demonstrate that disclosure would cause commercial harm.


63  Ev. p. 137 Back

64  GM Plants for Food Use, p. 3. Back

65  Ev. p. 138. Back

66  Environmental Protection Act 1990, Section 106(1). Back

67  Or to the Secretaries of State for Scotland and Wales as appropriate. Separate, but similar, provisions apply in Northern lreland. Back

68  Ev. p. 135; POST, GM Foods, p. 23. Back

69  Ev. p. 136. Back

70  For details, see "Commission Recommendation of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97 of the European Parliament and of the Council", Official Journal of the European Communities, L253, 16 September 1997. Back

71  The Scientific Committee for Food consists of up to 19 scientific experts appointed by the European Commission. Back

72  Ev. pp. 64-5. Back

73  Second Report from the House of Lords Select Committee on the European Communities, Session 1998-99, on EC Regulation of Genetic Modification in Agriculture, HL II-I, para 60. Back

74  Government Response to the House of Lords Select Committee on the European Communities, Second Report, Session 1998-99, on EC Regulation of Genetic Modification in AgricultureBack

75  Q. 470. Back

76  QQ. 576-7. Back

77  Ev. p. 36. Back

78  See Ev. p. 210. Back

79  Ev. p. 236. Back

80  Ev. p. 137. Back

81  Ev. p. 136. Back

82  Ev. p. 253. See also Ev. p. 34; Ev. p. 222. Back

83  Q. 713. Back

84  Ev. p. 179. Back

85  Q. 529. Back

86  Q. 754. Back

87  The Commissioner for Public Appointments' Guidance on Appointments to Public Bodies, July 1998, para. 3.68. Back

88  Ev. pp. 171, 2, and 198. Back

89  Ev. p. 198. Back

90  Ev. P. 171. Back

91  Q. 746. Back

92  Ev. Q. 746. Back

93  Ev. p. 184. Back

94  Advisory Committee on Releases to the Environment Annual Report No 5: 1998, DETR, published March 1999 Back

95  Q. 500. Back

96  Ev. p. 1. See also for example Ev. p. 211; Ev. p. 242. Back

97  Ev. p. 211. See also Ev. p. 171; Ev. p. 242; Ev. p. 213. Back

98  Ev. p. 184; Ev. p. 198. Back

99  Q. 746. Back

100  Q. 746. Back

101  Ev. p. 182. See also Ev. p. 184; Ev. p. 191. Back

102  Q. 747. Back

103  Ev. p. 102. See also: Ev. p. 199; Ev. p. 225. Back

104  Ev. p. 136. Back

105  Q. 532. Back

106  Ev. p. 252. Back

107  Ev. p. 222. Back

108  QQ. 754-5. Back

109  Ev. p. 218. Back

110  The Use of Scientific Advice, para 6.iv. Back

111  Q. 730. Back

112  The Use of Scientific Advice, para 6.v. Back

113  Ev. p. 171; Ev. p.191; Ev. p. 195; Ev. p. 192; Ev. p. 253; Ev. p. 124. Back

114  Ev. p. 124. Back

115  Ev. p. 191; Ev. p. 195. Back

116  Ev. p. 138. See also Ev. p. 100. Back

117  Ev. p. 141. Back

118  Ev. p. 100. Back

119  Q. 731. Back

120  BBSRC submission to Government Consultation, February 1999. Back

121  Ev. p. 263; Ev. p. 100. Back

122  Ev. p. 216. Back


 
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