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Health Committee

{report number} {Year}

Report on Inquiry into GM crops

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SP Paper 743

1 (2003)

 

The Committee reports to the Parliament as follows-

INTRODUCTION

Background

1. Petition PE 470 from Mr Anthony Jackson on behalf of Munlochy Vigil calls for the Scottish Parliament to take the necessary steps to (a) immediately end the GM Farm Scale Evaluations and (b) debate the future handling of the genetically modified ("GM") crops issue in Scotland.

2. The petition was referred by the Public Petitions Committee to the Transport and the Environment Committee. At its 15 May meeting, that Committee agreed to conclude its consideration of Petition PE 470, but to refer the public health aspects of the petition to this Committee.

3. On 19 June 2002, this Committee considered the petition and agreed to appoint a reporter, Nicola Sturgeon MSP. Her remit was to collate evidence and arguments for and against the proposition that allowing GM crop trials to go ahead at certain specified sites in Scotland would have a negative impact on public health, and to report back to the Committee on a proposed course of action.

4. The reporter's report was considered by the Committee on 11 September 2002. The Committee agreed to commence an inquiry into the health impact of GM crop trials.

Remit

5. The remit for the inquiry was agreed as-

To consider whether the Scottish Executive's decision to approve the testing of genetically modified crops at a number of specified sites in Scotland will have negative consequences on public health.

6. It was agreed that the following four questions posed in the reporter's report would be encompassed within the remit-

1) Should the Executive prevent GM crops trials from continuing on the grounds that it is against the precautionary principle to allow them to continue?

2) Is the risk assessment procedure for GM crops currently in place sufficiently robust from a public health perspective?

3) Are the guidelines to prevent conventional crops being cross-contaminated by GM crops adequate?

4) Should it be incumbent on the Scottish Executive to monitor the health of people living around GM farm scale evaluation sites?

GM crop testing in Scotland

7. So far, GM crop trials have been authorised by the Scottish Executive to take place at Munlochy, Ross and Cromarty; Daviot, Udny, Tilliecorthy and Rothienorman, Aberdeenshire; Newport-on-Tay, Fife; Invergowrie, Perth and Kinross; and Bilston and Woodhouselea, Midlothian. The current round of trials has been taking place since 2001.

8. It is the Minister for Rural Development and the Environment, acting on behalf of the Scottish Ministers who has authorised the current trials. The Minister only decides whether to authorise a GM crop trial having taken evidence from ACRE, the Advisory Committee on Releases in the Environment.

9. All the trials authorised thus far in Scotland are of oil seed rape (OSR), which can be harvested and made into cooking oil. The GM oil seed rape currently being grown in Scotland will not (says the Executive) be used to make cooking oil and will not enter the human food chain. The purpose of the trials is to compare the effectiveness of a particular type of herbicide on GM and non-GM OSR.

Legal basis to the trials

10. The release into the environment of genetically modified organisms is an activity controlled by European law. The original Directive 90/220/EEC was repealed by Directive 20001/18/EC during the course of the Committee's inquiry. New Regulations had to be made to implement the new Directive: the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 which were approved by the Scottish Parliament on 4 December 2002 and came into force on 5 December 2002. These regulations amend the Environmental Protection Act 1990 as well as introducing new stand-alone provisions.

11. The law following the introduction of EU Directive 2001/18/EC can be summarised as follows:

· In Scotland, the competent authority responsible for complying with the requirements of the Directive is the Scottish Ministers.

· the Scottish Ministers must, in accordance with the precautionary principle, ensure that they take all appropriate measures to avoid adverse effects on human health and on the environment which might arise from the deliberate release of GMOs into the environment;

· they must ensure that no trial release takes place unless all the steps of the procedure foreseen in the Directive are complied with;

· the procedure requires notification and risk-assessment before consent can be granted;

· there are several circumstances where the Scottish Ministers should not grant consent. These include: where the technical dossier supplied is incomplete; where the environmental risk assessment is inappropriate; or where refusal is necessary to avoid adverse effects on human health which may arise from the release.

12. The releases that have so far been authorised in Scotland, and which the Committee considered in the course of this inquiry, took place under the original Directive. Two of the main differences between the previous and current legal regimes are

· under the previous law, public consultation before authorising a release was not mandatory, whereas it now is, and

· the previous directive made no express reference to the precautionary principle, whereas the new directive does. (However Article 174 of the European Community Treaty provides that Community policy on the environment shall be based on the precautionary principle and on the principles that preventive action should be taken. Furthermore Article 6 EC requires that environmental protection requirements must be integrated into the definition and implementation of all Community policies and activities. Accordingly whenever Member States implement legislation made under the Treaty, they must take these principles into account).

13. There are also a number of differences of detail between the previous and current legal regimes

14. In the light of the adoption of Directive 2001/18/EC and of the coming into force of the implementing Regulations, the Committee seeks comment from the Executive on the following aspects of the regime, in relation to the protection of public health-

· In what way do the Directive and the implementing Regulations strengthen the protection of public health against risks to public health arising from the deliberate release of GMOs into the environment?

· Could the Executive explain how the new Regulations take the precautionary principle into account when the purpose of the consent procedure (as stated under the Environmental Protection Act 1990 as amended by the Regulations) does not include any reference to the principle? This is despite adherence to precautionary principle clearly being one of the objectives of Directive 2001/18/EC.

· Could the Executive explain what effect it anticipates the requirement to engage in public consultation and the duty to take into account and give due weight to representations will have on the protection of public health?

· Could the Executive also clarify what role the Health and Safety Executive, the Food Standards Agency and the Advisory Committee on Release into the Environment will have under the new legal regime to ensure the protection of public health?

Evidence taken

15. The Committee took evidence in public, on 13 November 2002, 20 November 2002 and 27 November 2002. The Committee heard evidence from the following witnesses-

· Anthony Jackson and Linda Martin, Munlochy GM Vigil

· Dr Charles Saunders, British Medical Association

· Professor Alan Gray, Professor Janet Bainbridge, and Dr Steven Hill, Advisory Committee on Releases to the Environment (ACRE)

· Professor Tony Trewavas, and Professor Chris Lamb, Royal Society of Edinburgh

· Ross Finnie MSP, Minister for Environment and Rural Development, and Derek Bearhop, Scottish Executive Environment and Rural Affairs Department

· Dr Vyvyan Howard, Liverpool University

· Dr Paul Rylott, Bayer CropScience

· Dr Geoffrey Squire, and Dr David Robinson, Scottish Crop Research Institute (SCRI)

· Mrs Mary Mulligan MSP, Deputy Minister for Health and Community Care, Dr Mac Armstrong, Chief Medical Officer, and Martin Donaghy, Scottish Executive Public Health Department

· Lydia Wilkie, and Elspeth McDonald, Food Standards Agency

16. We are grateful to all our witnesses for taking the time to give evidence and also for submitting written evidence for the Committee's consideration. This written evidence is set out in the Annex B to this report.

17. The Committee also issued a call for evidence on 4 October 2002 inviting anyone with an interest to submit written evidence. Fifty organisations and individuals responded. The list of respondents is also set out in Annex B. In addition, 26 individuals and bodies submitted evidence in response to an earlier call for evidence on behalf of the Committee reporter. Anyone wishing to obtain a copy of any of this written evidence should contact the clerks to the Committee.

18. The Committee has attempted to analyse the issues raised from the perspective of an informed layperson. Certainly, the process of taking evidence and considering written submissions has broadened our knowledge of this technical and complex matter. However, the Committee fully accepts that it is not qualified to deliberate definitively on the complex scientific questions that GM crops trials raise or to adjudicate on competing interpretations of scientific evidence.

FOCUS OF THE INQUIRY

19. The four main questions posed by the Committee (see Remit above) formed the focus of this inquiry.

Question (1) - Should the Scottish Executive prevent GM crops trials from continuing on the grounds that it is against the `precautionary principle' to allow them to continue?

Defining and applying the principle

20. One of the fundamental problems encountered by the Committee in deliberating on this question is that each of our witnesses enunciated the precautionary principle slightly differently. It was agreed that there were differing definitions and interpretations.1

21. One of the most widely cited definitions appears in the 1992 UN Rio Declaration on Environment and Development, of which the UK is a signatory. This states-

Where there are threats of serious or irreversible damage, lack of scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.

22. Although the precautionary principle was originally framed in the context of preventing environmental harm, it is now widely accepted as applying broadly where there is threat of harm to human, animal or plant health, as well as in situations where there is a threat to environmental damage. The principle is not a justification in itself for doing or not doing something: it is a methodological tool to assist decision-makers in weighing up costs and benefits through risk assessment.

23. There appeared to be general agreement amongst witnesses that at the root of the concept is the idea that one should proceed with caution when contemplating an intervention where the consequences are not known. The aim of the Munlochy petitioners was clearly to invoke the precautionary principle as a justification for discontinuing an environmental intervention (in this case GM trials). However, the inherent ambiguity of the concept is perhaps demonstrated in the following extract, which invokes the principle as a justification for action rather than inaction-

The purpose of the precautionary principle is to create an impetus to take a decision notwithstanding the uncertainty about the nature and extent of the risk, i.e. to avoid `paralysis by analysis' by removing excuses for inaction on the grounds of scientific uncertainty. (HSE Interdepartmental Liaison Group on Risk Assessment.)

24. It seems to the Committee that the precautionary principle is itself an ambiguous concept and is used to justify both sides of an argument for or against allowing a particular course of action.

25. It will also be appreciated that it is impossible to consider the precautionary principle without parallel consideration of the risks (evidential and theoretical) that GM crop testing may pose. This is considered later in this report, when considering the second of the four main questions the Committee has posed in this inquiry.

The Executive and ACRE's position

26. The Executive argues in the first instance that it would be in breach of European law if it were to introduce a blanket ban on the authorisation of any GM crop trials at all on the basis of one interpretation of the precautionary principle.

27. In written evidence, the Chief Medical Officer (CMO), Dr Mac Armstrong stated-

In this context, the precautionary principle is that if a preliminary scientific assessment shows there are reasonable grounds for concern that potentially dangerous effects will occur on...human...health then a release will not proceed.

28. He maintained that the Executive was adhering to the precautionary principle: it had "underpinned the work of ACRE and is at the root of the purpose, design and safety of the Farm Scale Evaluation (FSE) programme". 2 This view was shared by ACRE.

29. The view that the Executive and ACRE had been taking an appropriately precautionary approach was shared by the Royal Society of Edinburgh and the SCRI. Professor Trevawas of the Royal Society made criticisms of what he saw as an over-zealous application of the precautionary principle by opponents of GM testing-

There are situations in which we must accept that we do not know with certainty everything about something, yet life must continue. We try to assess the likelihood of a real risk against what is, in this case, the likelihood of a very low risk. We must try to balance out the benefits and risks accordingly, in this case as in all cases that we deal with. (HC 3424)

We must recognise how we arrived at society's current mindset, which, in a sense, is that there is no gain without risk. We have always taken risks in the past in developing new technologies and we have all benefited from it. When penicillin was developed, there was a risk that, if it was injected into people or used for treatment, it would kill them. The risk was taken and penicillin proved to be extremely beneficial. (HC 3428)

30. The Scottish Crop Research Institute (SCRI) characterised the Executive's handling of BM crops as being in line with the precautionary principle, through a "step-by-step approach": each step being an increment of relaxation of constraint after no evidence of harm has been obtained in the previous step. The same GM OSR crop in the FSE programme has previously been subject to laboratory and small scale trials to reach this point in the evaluation of GM crops. The SCRI said that the precautionary principle should not be used as an excuse for paralysis and that it would never be possible to eliminate all risk. (HC 3491)

Precautionary Principle v Precautionary Approach

31. Witnesses generally agreed that the precautionary principle represented a methodological tool: a way of thinking about whether and how to implement GM crop trials. Some witnesses referred in addition to the precautionary approach: the application of that principle in a practical situation. The view of ACRE, the Royal Society and the SCRI was that the Executive's approach was an appropriately precautionary approach, in line with the precautionary principle.

32. However, Dr Saunders of the BMA had a different interpretation. For him, applying the precautionary principle meant doing nothing until the facts were more fully established. Adopting a precautionary approach as the Executive were doing was not applying the precautionary principle-

Put at its simplest, the precautionary principle means that if we cannot cope with the consequences of doing something and we do not have enough information to be sure of those consequences, we should not do it. My understanding of the precautionary approach is that we release things in tiny quantities and see what happens, and continue doing that until something happens or does not happen. The BMA's concern with that approach is that we may well find that something has happened far too late for us to do anything about it. (HC 3415)

33. Anthony Jackson and Linda Martin from Munlochy GM Vigil also considered that the Executive's approach was inconsistent with the precautionary principle. Their argument was that there was no evidence that GM crops did not cause harm. `No evidence of harm', they told the Committee, `is not the same as evidence of no harm'. (HC 3382).

34. The Committee acknowledges the difficulty in defining the application of the precautionary principle. In addition, it appears to the Committee that the question of how the precautionary principle should be applied for GM crop testing can be looked at in two ways.

· One argument runs that the current testing regime is robust (discussion to follow) and that it has thus far uncovered no even partially persuasive evidence that GM crops are a threat to human health. Therefore it is in accordance with the precautionary principle to authorise GM crop testing. An over-restrictive application of the principle would be a recipe for stagnation.

· The opposing argument is that no evidence of harm is not the same as evidence of no harm, that genetic modification of plant life is a leap in the dark that may have dramatic and unanticipated consequences, and that the precautionary principle requires that there is a moratorium on GM crop testing in the environment.

35. Whilst it is impossible to reconcile these two positions, in order to satisfy even the former, less restrictive, interpretation of the precautionary principle, as put forward by the Scottish Executive, we would have to be satisfied that the current risk assessment procedure was sufficiently robust to adequately assess all potential hazards to human health. As will be apparent later in this report, we are not so satisfied. Therefore, we believe that allowing GM crop trials to continue does contravene the precautionary principle, even as that principle is interpreted by the Scottish Executive.

Question (2) - Is the risk assessment procedure for GM crops currently in place sufficiently robust from a public health perspective?

36. The precautionary principle aside, the main cause for concern is the risk assessment that underpins all applications for GM crop licenses, and therefore the decision whether or not GM crops may be grown in the open environment in FSE programmes.

Substantial equivalence

37. At the heart of this debate, is the question of whether there is anything innate in the concept of GM crops that suggests they could be a danger to human health. It might appear that the point of risk assessment should be to establish this in the first place. However there was a fundamental dispute as to whether the process of genetic modification was innately risky, and this carried over into disputes as to whether the risk assessment regime was adequate.

38. One side of the argument was put by the Royal Society. They argued that the purpose of genetically modifying plant species was to insert a particular gene into a species. The purpose of conventional cross-breeding was the same. However, the process was different. Genetic modification allowed this to be done by what Professor Lamb of the Society described as a "cut-and-paste" approach. Conventional cross-breeding involved trying to reach the same result through "scrambling and sorting"-

Over 10 to 15 back-crossings, the breeder tries to sieve out the desired genes and to remove the undesired genes, leaving one or two genes that have been transferred. The aim is to achieve the same end product that the GM approach would achieve by cutting and pasting genes. (HC 3423)

39. Professor Lamb continued-

the relative risk to which [people living near GM crop trials] are exposed is no greater, and may even be less, than that which would come from being next to a field of conventionally bred crops. (HC 3423)

40. Another view was espoused, particularly by Dr Vyvyan Howard, a toxicologist and pathologist at Liverpool University. This was that the process of genetic modification might change the plant in unanticipated ways-

Our understanding of how a genome is destabilised when a new piece of genetic information from another species is fired randomly into it is in its infancy.

People are now trying to be much more selective about the way in which they put genes in. When they do that, many of the problems that have been associated with gene instability and unpredictable effects will diminish. My feeling is that there is still a lot more homework to do. We have to expect the unexpected. (HC 3461)

41. This dispute spilled over into an argument about the appropriateness of applying the principle of substantial equivalence in carrying out risk assessments of GM crops, as ACRE currently does. This is a principle the point of which is to reduce the degree of scrutiny that requires to be carried out on a genetically modified plant, on the grounds that an already tested plant with similar chemical properties has already been tested and its properties are known. Tests only need to be carried out in respect of the properties of the GM plant that are different from the non-GM plant, most obviously in respect of the gene that genetic modification has inserted.

42. Some witnesses made powerful criticisms of substantial equivalence, and concerns were expressed that the principle ignores the effect GMOs may have on both the chemical composition of food and on human biology. Dr Howard described it as-

a scam. People say that a potato has vaguely the same amount of protein and starch and stuff as all other potatoes, and therefore that it is substantially equivalent, but that is not a test of anything biological. We have to examine and test, which costs money, but I do not think that we can afford to play fast and loose with this technology. We need to take great care. (HC 3461)

43. In written evidence, Dr Howard also said-

The substantial equivalence which prevents GM from being seen as any different from non-GM reflects a gross test of chemical properties. It is not a biological test of toxicology, which should be done, preferably on the most vulnerable state of human life. (quoted in the reporter's report 11 Sept 2002)

44. According to the petitioners, the concept of substantial equivalence has been branded `pseudo-scientific' and `scientifically unjustifiable' by the Royal Society of Canada (HC 3419), while Dr Howard stated that "the underlying assumption with this test is that the processes of genetic engineering and traditional plant breeding are identical, which is contended by, among others, the United States Food and Drug Administration".3

45. ACRE told the Committee that while they did apply the concept of substantial equivalence, this was only a starting point. For instance, all GM novel foods were fully tested.4 Professor Bainbridge of ACRE told the Committee-

The only time when we would use substantial equivalence is if we were considering a pure oil-a pressed, purified oil-perhaps a soya oil, which was derived from GM soya. Before we would go down the substantial equivalence route of our decision tree, we would be sure that there was no DNA of any type or protein in the soya oil. We would ensure that we were looking at 100 per cent pure oil. We would treat that as substantially equivalent to soya oil from a non-GM derivative. The assertion that the substantial equivalence route is a backdoor route or a shortcut is fallacious.

46. Elspeth MacDonald of the Food Standards Agency Scotland told the Committee that "substantial equivalence looks at the differences; it does not just look at the similarities".

Role of ACRE

47. The Scottish Executive executes its responsibility on the advice provided to it by the Advisory Committee on Releases to the Environment (ACRE), which reviews all scientific and risk assessment documentation before making recommendations to Ministers. This information is provided to ACRE by the organisation applying for a licence. The remit of ACRE, within the regulatory framework, is "to provide to the Ministers on request scientific advice on GMOs, including advice to the Health and Safety Commission and Executive in respect of the human health aspects of releases into the environment".

48. Both the Executive and ACRE insist that the risk assessment procedure is robust and exhaustive and that no farm trial is authorised without the most rigorous preliminary investigation. In response to the BMA's evidence that there should be a moratorium of farm trials, the Minister for Rural Development and the Environment replied-

One can have views and opinions based on anecdotal evidence-and I will read the BMA's submission with considerable interest-but I would be interested to establish at what point in the regulatory process the BMA has adduced evidence that undermines or seriously questions that process ...

We are dealing with a process that is laid down by regulation. I hope that ACRE will have made clear in its evidence to the committee the criteria that it applies when determining risk, and that it commented on the processes that it goes through in order to assess that risk. I am open for someone to present evidence that demonstrates that the process and criteria that ACRE uses to gauge harm when it gives advice on the risks are in some way flawed. (HC 3449)

49. ACRE provided the Committee with lengthy written evidence setting out the evidential procedures that they follow before authorising farm trials. Professor Alan Gray explained-

I want to underline, particularly in view of the evidence that I heard earlier, that the committee which I chair is an independent committee and not a Government one. Therefore, ACRE sits in the middle on GMOs. We work within a strict regulatory framework. We must look for risks and identify hazards and harms. We must also assess whether people and the environment are exposed to those harms and, if so, we must assess the degree of exposure and whether that constitutes a risk in any sense. (HC 3431)

50. Professor Gray went on to tell the Committee that he was aware of no evidence to show that GMOs impact on human health, although he appeared to be in doubt as to whether there had ever been specific research on the effects of GMOs on consumers.

51. The CMO for Scotland was satisfied that the full environmental and human health implications of GMOs must, and have been, considered ahead of their wider proliferation for cultivation and there are insufficient grounds to believe that these trials pose a significant health risk to local populations.

52. Dr Howard, expressed a number of concerns about the procedure followed by ACRE. He expressed concerns about the subtlety of the procedure in complex scenarios-

Risk assessment was first devised by engineers to assess the structure of buildings, an area in which the problems are finite. However, the principle is now being applied to very complex systems, such as ecosystems, which contain many unknowns. When there are unknowns, people tend to replace data with models. At one extreme, it is possible to have risk assessments that are based totally on models, with no data. (HC, 3455)

53. He went on to state that hazards have to be identified, which can be difficult. Once identified, hazard assessment is required. This requires hard science, which requires experimentation. Thirdly, for food, exposure assessment is needed-

We need to ask who is eating what and how much of it. It is only when all those are in place that-fourthly-a risk assessment may be attempted. Without the first three steps, however, it is very difficult. (HC, 3455)

54. The BMA also expressed serious concerns about whether current procedures are adequate-

I do not believe that there have been sufficiently robust and thorough investigations into the potential adverse effects of these materials. ... The testing and surveillance process for new pharmaceutical products is extremely thorough and detailed. I cannot off-hand think of an adequate analogy, but that process is several orders of magnitude more thorough than the one for GMOs and GMOs used in foodstuffs. If the same sort of surveillance applied for GMOs, that would probably answer a lot of people's concerns. (HC 3407)

55. The Committee, having considered the evidence above, shares the concerns of Dr Howard about the robustness of risk assessment procedures in relation to public health. At present risk assessment procedures would appear to be flawed in the following way-

· They do not appear to follow a standard format.

· They seek to prove the safety of the GMO rather than test and genuinely assess potential hazards.

· They do not identify areas of uncertainty;

· They are overly reliant on modelling and `model assumptions' rather than hard scientific assessment; and

· There is no set period of time for which risks must be assessed, and subsequently reassessed.

Toxicological and human testing

56. A number of witnesses have expressed the view that toxicological tests, such as those that are required for pharmaceutical products, should be required for GMOs-

Comprehensive health and environmental impact assessments should be applied to all GM crop site applications and be open to public scrutiny. Evidence of safety submitted by biotechnology companies should be openly presented and subject to critical peer review. (BMA interim statement, May 1999)

57. There has also been some evidence calling for human testing (BMA - Dr Saunders), though this carries with it certain ethical reservations. Professor Trewavas, Royal Society of Edinburgh, acknowledged this point-

If you test novel food on human beings and find that there are deleterious effects, you would be under severe constraints and would probably be subject to litigations over what had been done...No GM crop that I know of has ever been released for agricultural use unless it has undergone the most vigorous and detailed scrutiny of its safety, using animals as the recipients of treatment. (HC 3416)

58. The Committee is convinced of the need for additional toxicological tests.

Comparison with pharmaceutical testing

59. Some witnesses were concerned that the risk assessment for GM crops was less stringent than equivalent tests would be for a new pharmaceutical product. One of the main differences is that while GM crops are tested on animals, there were no human feeding trials. Nor were there any systematic trials on humans' environmental exposure to GM crops, although both the SCRI and Bayer told us that staff had been working in close contact with GM OSR for months, with no out-of-the-ordinary effects on their health being recorded.

60. Dr Howard advocated undertaking large-scale voluntary human feeding trials with GM foods similar to clinical trails with pharmaceuticals. He pointed out that "it costs about $400 million to produce a new pharmaceutical which people would take voluntarily...with food there is no choice". (HC, 3458 and 3456)

61. The Committee, after considering the evidence, would wish to see pharmaceutical-style testing being applied to GM crops.

Testing on pollen and allergenicity

62. The Committee heard evidence that there has been insufficient testing on whether GM pollen from OSR has negative health impacts-

One would expect some research to have been done into genetically modified pollen, because it is believed that oil-seed rape pollen is a cause of asthma and other respiratory problems. The head of the pollen research unit at University College Worcester, Dr Jean Emberlin, planned to give evidence to an air pollutants conference about the effects of GM pollen. She trawled through all the reports that she could find, but no testing has been done anywhere on the possible effects of GM pollen. (Petitioners, HC 3386)

63. Professor Trewavas, Royal Society of Edinburgh, assured the Committee that-

The crops that we have at present do not express their protein product in pollen, which means that there can be no difference between the allergic response in people who live near a trial site and in those who do not. The allergy symptoms will be the same because the composition of the pollen is identical. (HC 3419)

64. However, the Royal Society do consider that-

The possibility that pollen or dust might cause different allergic responses should be considered for GM crops that are produced in future.

65. The SCRI and Bayer Crop science told the Committee that they were not aware that any of their employees, who were regularly exposed to GM pollen, had suffered any reactions that would be untypical of non-GM OSR. Clearly, this is evidence of a fairly anecdotal nature.

66. The Committee believes more research should be commissioned into the effect, allergic or otherwise, of genetically modified OSR pollen.

Risk of GM crops entering food chain

67. The GM OSR currently being grown in Scotland are not intended to enter the food chain. However the Committee heard of concerns that it may inadvertently enter the food chain, and indeed that it has already done so. Organic honey grown near GM OSR trial sites at Newport in Fife has been shown to have been contaminated with GM pollen. This point was conceded by the CMO and ACRE in evidence to the Committee. Their evidence was essentially that GM levels in honey would be so low that even if there was any health risk arising from GM crops (which they maintained had not been established in any testing) the danger would be negligible.

68. The Committee also considered written evidence from Karin Kremer which stated-

As we live in Munlochy, we frequently have witnessed the GM crop trials on top of a hill and drainage that is insufficient, cascades of brown, earthy water running down the hill, from the crop trial, down to the main Tore-Cromarty Road and beyond, down to Munlochy Bay and where the potentially polluted water runs into the Moray Firth to be consumed by fish, to be consumed by us. I cannot imagine that this has no long-term implications on humans. (HC 3473)

69. The Committee has concerns about the possibility of GM crops entering the food chain inadvertently.

70. The Committee recommends that all GM crops being considered for trials should be tested as if they were entering the food chain even if they were not intended to be so used.

Membership and independence of ACRE

71. The petitioners said that there were "two sets of scientists" on GM crops, meaning those who had doubts about GM crops and those who did not. Only those without such doubts were on ACRE.

72. However this was disputed by ACRE who said they were an independent body with 13 members, including scientists from a variety of disciplines. Their membership did not include any public health officials other than a virologist, but Professor Gray told the Committee that ACRE's work was observed by the Health and Safety Executive and the Department of Health.

73. Professor Howard argued that the assumptions which can be drawn from risk assessments can be manipulated, especially where there are strong commercial and political influences.

74. It is a point of fact that the majority of the bodies seeking to test GM crops are profit-making companies whose main interest in testing the effectiveness of the new technology is presumably finding out whether it presents any financial opportunities.

75. The Munlochy petitioners argue "one of the initial problems with ACRE was that some of its members were connected with biotechnology companies when the first consents went through". Since the removal of those members, however, "ACRE never went back over the consents that those people had passed to check them". The petitioners said they were concerned that since the decision to allow the programme of GM crops trials, there has been no further evaluation of that decision. (HC 3390)

76. ACRE told the Committee that they were an independent body and the fact that a number of ACRE members had links with commercial companies such as Syngenta did not compromise ACRE's independence in any way-

In a modern, post-Thatcherite Britain, most good scientists receive funding from industry. That is the way that we have been taught to work. I have received funding from SEPA and Scottish National Heritage. Scientists receive funding from people and organisations with interests in the environment. My work involves genetics and conservation. It is certain that scientists are able to separate their interests when making decisions. I vigorously defend the probity and professionalism of the scientists who serve on ACRE. (Professor Gray, HC 3434)

Accessibility of information

77. There was some dispute as to whether or not the information on which ACRE based their assessments was sufficiently publicly available. The petitioners expressed concerns about access to the scientific evaluations that have been made, especially those related to the effect on human health.

78. Professor Gray of ACRE took issue with this-

All the information on feeding trials is available in the public domain in a massive 1,500-page dossier that details the various tests. Moreover, information on the insertion of a gene that codes with the same enzyme and confers herbicide tolerance in maize is also publicly available. ACRE has even held a public meeting at which people with contrary interpretations and different evidence have discussed the results of the feeding trials. In that case, the information is in the public domain. (HC 3483)

79. However Professor Gray went on to concede that commercially sensitive material would be withheld. The Deputy Minister for Health also conceded that companies could withhold commercially sensitive information. However, in response to a request for further clarification from the Committee, the CMO confirmed that the Health Department would be able to compel a company to provide any data it considered necessary to make an assessment, although it might keep that information private. (HC 3483)

80. The Committee is concerned about the transparency of the decision making process and would wish to see all material considered by ACRE in the public domain. Furthermore the Committee seeks clarification from the Executive as to when it is acceptable to withhold commercially sensitive information.

Question (3) - Are the guidelines to prevent conventional crops being cross-contaminated by GM crops adequate?

81. Some concerns expressed by witnesses relate to the potential contamination of non-GM crops. This may happen in a variety of ways; by accident, by inadequate (or breaches of) separation distances, or through cross-pollination by insects (e.g. bees).

82. The Supply Chain Initiative on Modified Agricultural Crops (SCIMAC) is a cross industry group that has helped to produce voluntary controls and guidelines for the regulation of farmers that grow and handle GM seeds. These guidelines are set to follow best practice and to minimise environmental damage and cross contamination.5

83. However, evidence from the petitioners argued that guidelines set by SCIMAC may have been breached.

84. SCIMAC guidelines recommend leaving a three-week gap between harvesting a GM crop and planting a conventional crop in the same soil. Guidelines further state that following the sowing of a GM crop, seed drills should be cleaned thoroughly before leaving the field to prevent the introduction of herbicide tolerant seed into other areas of the farm. The Committee understands that concerns have been raised in the context of at least one Scottish field trial that the farmer may not have cleaned the drills before driving the tractor off the field. We have also heard of concerns that the farmer did not leave the recommended three-week gap between harvesting the GM crop and planting the conventional crop.

85. While we appreciate that the purpose of these trials is not the commercial cultivation of crops for entry into the food or feed chain, it is clear that there are real concerns that GM seed may already have done so. This may introduce GM oil seed rape into the food chain without testing.

86. The Committee seeks clarification from the Executive as to whether the SCIMAC guidelines are binding on those responsible for producing the crop, and if so, what monitoring system and penalties are in place to ensure adherence to them.

87. In addition to this accidental GM contamination, there are considerable reservations expressed about the effect of GM OSR pollen in the open environment and that the separation distances between GM crops and conventional crops on Farm Scale Evaluations are inadequate to prevent cross contamination.

88. In their written evidence, the Scottish Crop Research Institute state that in the case of Oilseed Rape, it is "difficult, if not impossible, to prevent crossing between fields of an open pollinated crop".

89. However, they go on to say that the level of contamination is small and "declines very steeply from the edge of one field into a nearby field. After several tens of metres, cross pollination occurs at a low frequency (1 in 1000, or 1 in 10,000 or possibly higher for crop varieties that have less than full male fertility)".

90. Present measures appear to accept this inevitability of contamination, and are designed to reduce cross-pollination to levels that are `acceptably low' (SCRI). Professor Trevawas of the Royal Society suggested that the "only way of dealing with that ... is accepting some levels of contamination as effectively GM free". (HC 3429) In the light of this evidence there appears to be substantial backing for more research into this area, from the BMA for example, who state-

The regulatory committee-approved standard separation distance between GM and non-GM crops should be reviewed in the light of new research on the risks of cross-pollination.

91. The Committee seeks assurances from the Executive that measures are in place to monitor the contamination of nearby non-GM crops, and other organisms, that may potentially allow GM seed or pollen into the food chain without the appropriate testing or licence. The Committee is particularly concerned that even pro-trial organisations seem to accept the inevitability of GM contamination.

Question (4) - Should it be incumbent on the Scottish Executive to monitor the health of the people living around GM Farm Scale Evaluation sites?

92. While opponents of GM crops trials start from a position that such crops should not be grown in the open air, there is widespread concern that there is no localised human health testing around FSE sites, and that no causal link can be established without the necessary health data from the local population.

93. Anthony Jackson elaborated on this point-

For example, if there is a rise in the incidence of asthma in Munlochy, no one will ever be able to put that down to the two field scale evaluations that were done next to the village because there is no baseline data and therefore no idea where the effect might have come from. If there is to be GM crop testing, human health testing should be part of it. (HC 3389)

94. The Chief Medical Officer responded to this criticism by confirming that-

We have contacted all departments of public health in areas where farm-scale evaluations are being carried out and I can tell the committee that they report no unusual patterns of disease or of unexpected illness in their populations. (HC 3466)

95. Further clarification was sought from the Chief Medical Officer as to what information had been sought from local public health departments, but at the time of this report being completed this information had not been received.

96. In specifically countering the need for more testing of local populations, the CMO said "it is not the case that we are not looking for anything" (HC 3470). He further elaborated, however, that-

There are certain key principles of health monitoring that have been well articulated by the World Health Organisation. The monitoring programme has to be specific, which means that we have to have an accurate definition of what we are monitoring and it has to be measurable. Further, the system has to be action-oriented, which means that the data that we collect must help to guide some action, as well as being realistic and timely. (HC 3466)

97. Martin Donaghy of the Scottish Executive's Public Health Division went on to explain-

If we wanted to institute a programme, we would need something specific to look for, as the CMO said, otherwise we could not do a count. Genetic modification is a technological process. Part of the regulatory framework includes ACRE's going through the specifics of which gene had been modified. If there was any concern that a specific gene could lead of relation to a potential health hazard, a trial should not go ahead. If we scanned the literature and found a potential health hazard, we could institute a programme as we do for other problems and new illnesses, but we have seen no evidence or indications at all of such hazards that would lead us to institute such a programme. (HC 3467)

The problem with that is in working out what we should look for, because the effects might be subtle. Many hundreds, if not thousands, of tests could be carried out to find out whether the trials have an effect on people. The ethical point is that a trial should not proceed if we believe that there will be an effect on human health. The evidence, however, shows that there is nothing specific to look for. To go back to our preliminary statement, we depend on our on-going health monitoring of the population. (HC 3471)

98. The Committee is not satisfied that the Executive has pursued the appropriate monitoring procedures. The arguments being applied to counter the argument that GM crops may be hazardous to health - that no empirical evidence of harm has so far emerged - are similar to those applied in the past concerning other public concerns, such as a possible link between cancer and electricity pylons. As the CMO himself conceded,6 medical experts are now far less certain that the link between electricity pylons and ill-health can be wholly dismissed. The lesson to be learned from this and from similar matters is that any major scientific intervention into the environment must be scrupulously monitored to measure any impact on human health. The Executive should be doing more to examine the effects on human health in relation to the local populations around FSE GM sites.

OTHER CONSIDERATIONS

Antibiotic marker genes

99. The Committee has heard additional concerns about the production of plants using genes that confer resistance to antibiotics that are used in human and veterinary medicine. Antibiotic resistance genes are used as "markers" in genetic engineering to identify when an organism has been successfully genetically modified.

100. Information obtained by the Committee reporter indicated that as of August 2002, up to 2.8% of the Aventis GM Oilseed Rape seed used in the Scottish trials contained an antibiotic resistant gene.

101. The recommendation from ACRE is that these marker genes should not be included in the cultivation of GM crops.There is concern that antibiotic resistant gene sequences could be spread to bacteria in the intestines of animals or humans and compromise the effectiveness of antibiotic treatment.

102. Research carried out by the Food Standards Agency and published earlier this year confirmed that it is possible for GM DNA to be transferred to bacteria in the human intestine. This is known as horizontal transfer of GM DNA. Those concerned about horizontal transfer of GM DNA argue that it could also result in new viruses and disease causing bacteria.

103. Dr Rylott of Bayer CropScience stated that "the crop that is currently being grown in Scotland does not contain [the antibiotic marker] gene." (HC 3500). Dr Rylott in any case disputed evidence that marker genes could cause horizontal transfer. He said he believed that the genes were safe. (HC 3501)

104. The Committee is of the view that antibiotic marker genes should be phased out and welcomes the introduction of Directive 2001/18/EC. The Committee also wish the Executive to confirm that these markers have not been included in GM crops sown in Scotland.

Consultation

105. The Committee agreed to undertake this inquiry in response to concerns raised in petition PE470 from the local population of Munlochy, and questioned the Deputy Minister on the consultation process that preceded the implementation of the FSE GM crop trials.

106. The Committee is concerned that the fears of the local population were not properly addressed by the Scottish Executive, or any other Government agency involved in these trials. The deputy health minister conceded this point-

We need to continue to speak to people. I am very aware of people's fears on the subject. Given the food scares that we have had in recent years, people need to have confidence that we are taking all possible precautionary measures to ensure that health is not at risk. People also need to have confidence that we will continue our monitoring during the trial process and that we will respond quickly to any indication that there might be a risk to health. We need to make information available to people to ensure that they know what we are doing. (HC 3477)

We need to ensure that people know that the trials are not being conducted without the kind of robust risk assessment that is necessary in such trials, just as we would if we were developing new medicines for example. I am happy to speak to my colleagues on the matter. (HC 3478)

107. The Committee accepts the Executive's acknowledgement of mistakes that have been made in the consultation procedures to date, and seeks reassurance that the Executive will adhere to the new Directive 2001/18/EC in relation to consultation. Directive 2001/18/EC (Article 9) states that public consultation must be carried out. The Committee wishes the Executive to provide more information on how it intends to put into place this new obligation.

SUMMARY OF CONCLUSIONS

Legal basis of the trials

108. In the light of the adoption of Directive 2001/18/EC and of the coming into force of the implementing Regulations, the Committee seeks comment from the Executive on the following aspects of the regime, in relation to the protection of public health-

· In what way do the Directive and the implementing Regulations strengthen the protection of public health against risks to public health arising from the deliberate release of GMOs into the environment?

· Could the Executive explain how the new Regulations take the precautionary principle into account when the purpose of the consent procedure (as stated under the Environmental Protection Act 1990 as amended by the Regulations) does not include any reference to the principle? This is despite adherence to precautionary principle clearly being one of the objectives of Directive 2001/18/EC.

· Could the Executive explain what effect it anticipates the requirement to engage in public consultation and the duty to take into account and give due weight to representations will have on the protection of public health?

· Could the Executive also clarify what role the Health and Safety Executive, the Food Standards Agency and the Advisory Committee on Release into the Environment will have under the new legal regime to ensure the protection of public health?

Precautionary Principle v Precautionary Approach

109. In order to satisfy the interpretation of the precautionary principle as put forward by the Scottish Executive, we would have to be satisfied that the current risk assessment procedure was sufficiently robust to adequately assess all potential hazards to human health. We are not so satisfied. Therefore, we believe that allowing GM crop trials to continue does contravene the precautionary principle, even as that principle is interpreted by the Scottish Executive

Risk Assessment

110. The Committee, having considered the evidence has concerns about the robustness of risk assessment procedures in relation to public health. At present risk assessment procedures would appear to be flawed in the following way-

· They do not appear to follow a standard format.

· They seek to prove the safety of the GMO rather than test and genuinely assess potential hazards.

· They do not identify areas of uncertainty;

· They are overly reliant on modelling and `model assumptions' rather than hard scientific assessment; and

· There is no set period of time for which risks must be assessed, and subsequently reassessed.

111. The Committee is convinced of the need for additional toxicological tests and, after considering the evidence, would also wish to see pharmaceutical-style testing being applied to GM crops.

112. The Committee believes more research should be commissioned into the effect, allergic or otherwise, of genetically modified pollen and recommends all GM crops considered for trials should be tested as if they were entering the food chain even if they were not intended to be so used.

Accessibility of information

113. The Committee is concerned about the transparency of the decision making process and would wish to see all material considered by ACRE in the public domain. Furthermore the Committee seeks clarification from the Executive as to when it is acceptable to withhold commercially sensitive information.

Guidelines for GM crop cultivation

114. While we appreciate that the purpose of these trials is not the commercial cultivation of crops for entry into the food or feed chain, it is clear that there are real concerns that GM seed may already have done so. This may introduce GM oil seed rape into the food chain without testing.

115. The Committee seeks clarification from the Executive as to whether the SCIMAC guidelines are binding on those responsible for producing the crop, and if so, what monitoring system and penalties are in place to ensure adherence to them.

116. The Committee seeks assurances from the Executive that measures are in place to monitor the contamination of nearby non-GM crops, and other organisms, that may potentially allow GM seed or pollen into the food chain without the appropriate testing or licence. The Committee is particularly concerned that even pro-trial organisations seem to accept the inevitability of GM contamination.

Monitoring procedures

117. The Committee is not satisfied that the Executive has pursued the appropriate monitoring procedures. The arguments being applied to counter the argument that GM crops may be hazardous to health - that no empirical evidence of harm has so far emerged - are similar to those applied in the past concerning other public concerns, where evidence of hazards to public health has subsequently emerged. Any major scientific intervention into the environment must be scrupulously monitored to measure any impact on human health. The Executive should be doing more to examine the effects on human health in relation to the local populations around FSE GM sites.

Antibiotic marker genes

118. The Committee is of the view that antibiotic marker genes should be phased out and welcomes the introduction of Directive 2001/18/EC. The Committee also wish the Executive to confirm that these markers have not been included in GM crops sown in Scotland.

Consultation

119. The Committee accepts the Executive's acknowledgement of mistakes that have been made in the consultation procedures to date, and seeks reassurance that the Executive will adhere to the new Directive 2001/18/EC in relation to consultation. Directive 2001/18/EC (Article 9) states that public consultation must be carried out. The Committee wishes the Executive to provide more information on how it intends to put into place this new obligation.


Report Footnotes

1 Professor Trevawas told the Committee that he had seen about 50 different definitions; Dr Rylott, by contrast, said that there were two versions of the precautionary principle.

2 Submission from the Chief Medical Officer for Scotland, paragraph 5

3 Dr V Howard, p10

4 NB: as stated earlier, the OSR currently being trialed is not intended to enter the food chain.

5 www.foodfuture.org.uk/gmcrops/regulation3.htm

6 HC 3468

 

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