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SCOTTISH EXECUTIVE RESPONSE TO THE HEALTH AND COMMUNITY CARE COMMITTEE’S REPORT ON GENETICALLY MODIFIED CROP TRIALS AND HEALTH

DescriptionRESPONSE TO HCCC REPORT ON GM CROP TRIALS
ISBN
Official Print Publication Date
Website Publication DateMarch 11, 2003

SCOTTISH EXECUTIVE RESPONSE TO THE HEALTH AND COMMUNITY CARE COMMITTEE'S REPORT ON GENETICALLY MODIFIED CROP TRIALS AND HEALTH

(1 ST REPORT 2003)

CONTENTS

Executive Summary

Introduction

Questions about Directive 2001/18/EC

The Committee's Conclusions

Conclusion

Annex A - ACRE response to HCCC

Annex B - CMO evidence to HCCC

The Scottish Executive

March 2003

SCOTTISH EXECUTIVE RESPONSE TO THE HEALTH AND COMMUNITY CARE COMMITTEE'S REPORT ON GENETICALLY MODIFIED CROP TRIALS AND HEALTH

(1 ST REPORT 2003)

Executive Summary

General approach

1. The Executive considers that the Health and Community Care Committee (HCCC) Report on the Inquiry into genetically modified (GM) crops is fundamentally flawed. The Executive is required to reach a view on new applications for the release of genetically modified organisms (GMOs) on a case-by-case basis using the criteria laid down in Directive 2001/18/EC. Such assessments involve particular consideration of the possible risks to human health and the environment. The Executive's view is informed by advice from a number of independent expert groups and by specific scientific concerns arising from public consultation. The Executive authorised the farm-scale evaluation trials only after a wide and rigorous range of safety assessments had been completed to the satisfaction of our expert advisers. No substantive evidence has emerged which might call into question the safety of any of the crop trials and the Executive remains of the view that the farm-scale evaluations are well founded and well regulated.

2. The Committee acknowledges "that it is not qualified to deliberate definitively on the complex scientific questions that GM crops raise or to adjudicate on competing interpretations of scientific evidence" yet goes on to do precisely that by challenging internationally established scientific practice and methodology. The Committee argues that the basis for risk assessments is unsound and not in accordance with the precautionary principle. The Committee also questions the competence of the Advisory Committee on Releases to the Environment (ACRE) to assess the health implications of an application for deliberate release.

3. In preparing its report the Committee seems not to have had regard to oral and written evidence, as well as substantial volumes of peer reviewed research, which confirm, as far as is scientifically possible, that current GM crops pose no greater risk to human health or the environment than comparable non-GM varieties. In reaching its findings, the Committee has placed heavy reliance on evidence presented by those with little relevant or current knowledge of GM technology. They have largely ignored the evidence of the Executive's scientific advisers.

4. The views of the Committee members are clearly at odds with those of the Executive's scientific advisers, but it would be irresponsible of the Executive to ignore the advice of the expert bodies whose role is precisely to provide such advice. In particular the Executive supports ACRE's case by case approach in considering the risks associated with the release of GMOs. This approach enables factors such as the variety of GMO involved and the proposed location and scale of the release to be taken into account. The Health Committee has ignored the volume of evidence recording confidence in ACRE's approach to risk assessment and the quality of scientific advice it offers Ministers.

Specific Concerns

5. The Executive's response to the specific concerns raised by the Committee is summarised below.

- The Executive is satisfied that the precautionary principle is being applied in a robust, consistent and appropriate manner.

- The Directive and implementing regulations prescribe a structured approach to the analysis of risk in line with the precautionary principle.

- The Scottish Executive is entirely satisfied with ACRE's approach to risk assessment and the quality of advice it offers the Scottish Ministers.

- There is no evidence to indicate that the GM crops grown in Scotland pose any greater risk to human health or the environment than non-GM varieties. If the Scottish Ministers were not satisfied that this was the case, consent for a release would not be given.

- The Executive is not convinced that pharmaceutical-style testing is better suited to GM crop trials and will continue to apply the underlying principles and basic procedures for the approval of GMOs in Directive 2001/18/EC.

- The Executive considers that it would be impracticable to undertake comprehensive food and feed testing on all GM lines that were intended for small-scale research and development releases - most of which will never be marketed due to commercial or agronomic reasons.

- In reaching decisions on applications for deliberate release the Executive, as well as its expert advisory committees and the HSE and FSA, has access to all information relating to that application, including that deemed for the purposes of the Environmental Protection Act to be "commercial in confidence".

- Any consent which is granted involves limiting terms and conditions. Some of the Supply Chain Initiative on Modified Agricultural Crops (SCIMAC) guidelines - which are not themselves legally binding - are mirrored in the limitations and conditions of individual consents and as such have legal force.

- The Executive notes the concerns of the Health and Community Care Committee but remains satisfied that the environmental risk assessment includes consideration of the safety implications of any exposure to pollen from GM crops through ingestion or inhalation from the air, or from the pollen landing on other crops.

- The Executive agrees that any major scientific intervention into the environment must be scrupulously monitored and is satisfied that appropriate and proportionate health and environmental monitoring arrangements are in place.

- The Executive agrees with the HCCC that antibiotic resistance marker genes (ARMs) should be phased out. The revised Directive and the implementing regulations make this a legal requirement.

- In line with the Directive the Executive has introduced mandatory public consultation before decisions are taken on applications for consent to release GMOs. For the farm-scale evaluation programme the Executive put additional steps in place that went beyond the statutory requirements at the time.

- The Executive acknowledges there are some generic lessons arising from the HCCC inquiry relating to the importance of communication of science and risk. The Executive will continue to develop policies and practices which seek to engage and inform stakeholders more fully.

While the Executive acknowledges that the HCCC conducted this inquiry in response to public concern, the Report serves to increase the level of anxiety which has existed. The Committee has not given sufficient attention to the evidence it has heard on the science of GM crops, genetics more generally and the precautions which Government and its advisers have recommended and put in place. A Report which should have explained a matter of concern to the public has served to obscure the facts and heighten concern

SCOTTISH EXECUTIVE RESPONSE TO THE HEALTH AND COMMUNITY CARE COMMITTEE'S REPORT ON GENETICALLY MODIFIED CROP TRIALS AND HEALTH (1 ST REPORT 2003)

Introduction

  1. This paper sets out the Scottish Executive's considered response to the Health and Community Care Committee's 1 st report of 2003 on genetically modified (GM) crop trials and health, organised in three sections:
  • A detailed response to specific questions about Directive 2001/18/EC posed by HCCC in paragraph 14 of the report;
  • Specific comments on some the conclusions reached by HCCC (as set out in paragraphs 109 to 119 of their report); and
  • Additional material describing the ways in which the Executive is already taking forward some of the generic lessons arising from the HCCC inquiry relating to the importance of scientific and risk communication.

In addition, Annex A to this paper contains a response from the Advisory Committee on Releases to the Environment (ACRE). Annex B contains the Chief Medical Officer's original submission to HCCC, for ease of reference and completeness.

  1. It is worth reiterating two specific points; firstly that these Farm Scale Evaluations (FSE) are not food safety trials, and the material harvested is not used in the food or feed chains; secondly although technically granted under 90/220/EEC the consents covering these trials were assessed using the strengthened criteria of the revised Directive. The FSE programme involves a three-year long series of crop trials, established to allow the evaluation of environmental impacts of the cultivation of certain herbicide tolerant GM crops at field scale in the UK. GM oilseed rape (OSR) is the only crop being grown in the Scottish FSEs, for agronomic reasons.
  2. Scottish Ministers are advised on the regulation of the 'deliberate release' of genetically modified organisms (GMOs) into the environment in Scotland by ACRE. Expert advice is also obtained prior to every release from the Health & Safety Executive (HSE) and the Food Standards Agency (FSA).
  3. This paper has been prepared in conjunction with ACRE, the FSA, and the HSE. ACRE's substantive response to the HCCC report is set out in full in Annex A.
  4. The Scottish Executive notes that in paragraph 18 of the report "the Committee fully accepts that it is not qualified to deliberate definitively on the complex scientific questions that GM crop trials raise or to adjudicate on competing interpretations of scientific evidence".
  5. Questions about Directive 2001/18/EC

  6. HCCC asked four specific questions about Directive 2001/18/EC. These are addressed in turn in the following paragraphs.
  7. In what way do the Directive and implementing Regulations strengthen the protection of public health against risks to the public health arising from the deliberate release of GMOs into the environment?

  8. Directive 2001/18/EC represents EU legislation designed to protect human health and the environment across the EU from any adverse effects that may be caused by the deliberate release into the environment of GMOs. It does this by setting out a system by which GMOs have to be approved on safety grounds before they are allowed to be released into the environment anywhere in the EU. It also requires that the national legislation and administrative provisions of all 15 Member States are brought into line with the Directive to ensure that the same safety standards are met across the EU.
  9. In essence the main aspects of the deliberate release process under Directive 2001/18/EC require that:
  10. (i) any GMO must be authorised before it can be released into the environment. Each application for consent to release GMOs is judged on its own merits in terms of the potential risks it poses to human health or the environment.

    (ii) applications are scrutinised by independent scientific experts to see whether they meet the safety standards of Directive 2001/18/EC, and a public consultation is held.

    (iii) a decision is taken by Competent Authorities based on expert advice and scientific evidence from public representations, and a consent is either granted or refused. If consent is granted, conditions will be attached to it specifying how the GMO may be used (and how it may not be used).

    (iv) any GMO that is released into the environment will be monitored to confirm that the assumptions made in the original risk assessment remain valid, and any unanticipated adverse effects are identified and acted on. If new risks come to light the Directive enables regulators to further constrain or revoke consent.

  11. The underlying principles and basic procedures for the approval of GMO releases in Directive 2001/18/EC remain firmly based on a scientific assessment of environmental risk, and the generally precautionary approach still follows the "step by step" principle. This involves evaluating each release on its own merits in terms of risks to human health and the environment and only increasing the scale of the release when those risks have been further evaluated and found to justify the next step. In recognition of public interest in the protection of human health and the environment the consents covering the farm scale evaluations, although granted under 90/220/EEC, were assessed against the strengthened risk assessment criteria of the revised Directive.
  12. Environmental risk assessment (ERA) is defined in the Directive as 'the evaluation of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose'. One of the general obligations under the Directive requires Member States and, where appropriate, the Commission to ensure that potential adverse effects on human health and the environment, which may occur are accurately assessed on a case-by-case basis taking into account the environmental impact according to the nature of the organism introduced and the receiving environment. ERA is carried out in accordance with Annex II to the Directive and is crucial to the processing of applications to release GMOs under the new regime underpinning decisions.
  13. The requirement to phase out GMOs containing antibiotic resistance marker genes (ARMs) that may have an adverse effect on human health and the environment is a precautionary element introduced by the new Directive. It places an emphasis on the need for a special level of scrutiny in assessing GMOs that contain ARMs to minimise the chances of negative impacts on human health and the environment arising from their use. There is no published scientific evidence that demonstrates transfer of ARMs from plant material to bacteria in the environment. However, there could be consequences for the therapeutic use of antibiotics in human and animals should such a transfer occur. In the case of some antibiotics (e.g. kanamycin - one of the main markers used in plants) no such risks arise because they are not used for medical or veterinary treatment, but in other cases the risk cannot be ignored.
  14. The concept of risk assessment is explained in more detail below.
  15. Could the Executive explain how the new Regulations take the precautionary principle into account when the purpose of consent procedure (as stated under the Environmental Protection Act 1990 as amended by the Regulations) does not include any reference to the principle? This despite adherence to the precautionary principle clearly being one of the objectives of the Directive 2001/18/EC.

  16. The European Commission communication on the use of the precautionary principle in the EU and internationally (European Commission 2000) stated:

"Where action is deemed necessary, measures based on the precautionary principle should be, inter alia:

  • proportional to the chosen level of protection,
  • non-discriminatory in their application,
  • consistent with similar measures already taken,
  • based on an examination of the potential benefits and costs of action or lack of action(including, where appropriate and feasible, an economic cost/benefit analysis),
  • subject to review, in the light of new scientific data, and
  • capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment."
  1. As such, the precautionary principle is an integral part of Commission policy in relation to the release of GMOs. The Directive and the implementing regulations are based on the precautionary principle as applied by the Commission across the EU. The preamble to the Directive, at paragraph 8, expressly narrates that the precautionary principle was taken into account in the drafting of the Directive and must be taken into account when implementing it. The definition of the precautionary principle continues to give rise to much debate, and to mixed and sometimes contradictory views. The Commission considers that the EU has the right to establish the level of protection - particularly of the environment, human, animal and plant health - that is deemed appropriate. In practice this means where preliminary objective evaluation indicates reasonable grounds of concern, consent will not be given.
  2. The precautionary principle should be considered within a structured approach to the analysis of risk which comprises three elements: risk assessment, risk management, risk communication. The precautionary principle is particularly relevant to the management of risk.
  3. The Directive and implementing regulations enshrine the principle of prior approval before GMOs can be released into the environment. The implementation of the precautionary approach starts with a scientific evaluation, as complete as possible, which identifies at each stage the degree of scientific uncertainty. If, following the scientific assessment there are reasonable concerns relating to human health, the regulator (in this case the Scottish Ministers) should not authorise the release of the GMO.
  4. Implementation of the Directive in Scotland is made up of three main elements. These are:
  • the Directive itself - this provides the legal foundation for implementing legislation in all 15 Member States. It also provides for aspects of the regulatory regime that take place solely at EU level, for instance collective decision making by the European Commission and all Member States on granting and refusal of marketing consents.
  • Part VI of the Environmental Protection Act 1990 (EPA, as amended) that gives the Scottish Ministers powers and responsibilities to control the deliberate release of GMOs in Scotland.
  • the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (SSI 2002 no 541) - secondary legislation that supplements the EPA (the EPA sets the broad requirement that a person wanting to release a GMO in Scotland must apply to the Scottish Ministers for a consent to do so - the Regulations set out the detail of how this must be done).
  1. Taken together, the Directive, the EPA and the Regulations mark out the legislative rules and administrative procedures covered by the new regulatory framework as applied in Scotland.
  2. The scope of risk assessments has been clarified and extended by Directive 2001/18/EC, requiring the identification and evaluation of potential damage to human health and the environment arising from the proposed release of a GMO whether it be direct or indirect, immediate or delayed. The extension of risk assessments to cover indirect and long-term risks is one of the major new precautionary steps introduced by Directive 2001/18/EC, and will require wider effects of GMOs on human health and biodiversity to be taken into account.
  3. Under the Directive notifications for the release or placing on the market of GMOs must include an ERA and the conclusions on the potential environmental impact of the release or the placing on the market of those GMOs in accordance with Annex II to that Directive. The Commission has provided detailed guidance, developed in accordance with the precautionary principle, on the objective, elements, general principles and methodology of the environmental risk assessment referred to in Annex II of Directive 2001/18/EC. In summary an ERA must:
  • compare the GMO with the non-modified organism. The Commission guidance suggests that this can best be achieved by providing baseline information on the receiving environment, including its organisms and their interactions and their known variations, thereby enabling any (harmful) characteristics of the GMO to be identified. The baseline is seen as a point of reference against which future changes can be compared.
  • be carried out in a scientifically sound and transparent manner based on available scientific and technical data. The general principles underlying the Directive and the implementing regulations require that an evaluation of potential adverse effects should be based on scientific and technical data and on common methodology for the identification, gathering and interpretation of relevant data. An ERA has to take into account scientific uncertainty at various levels and may not always result in definitive answers to all questions considered because of lack of data. For potential long-term effects, the availability of data may be very low. In these cases in particular appropriate risk management (safeguards) has to be considered in accordance with the precautionary principle in order to prevent adverse effects on human health and the environment.
  • be undertaken according to the case-by-case principle because of the broad range of individual characteristics of different organisms (GMO by GMO), different 'receiving' environments (site by site and region by region) and the intended use of the GMO. ERA and monitoring are closely linked.
  • enable the analysis of the 'cumulative long-term effects' relevant to the release and the placing on the market of the GMO to be carried out. In particular the accumulated effects of consents on human health and the environment.
  1. The ERA provides the basis for the monitoring plan. The objective of a monitoring plan is to confirm that any assumption regarding the occurrence and impact of potential adverse effects of the GMO or its use in the ERA are correct. Secondly to identify the occurrence of adverse effects of the GMO or its use on human health or the environment which were not anticipated in the ERA. The requirements for the monitoring plans for deliberate release and placing on the market of GMOs are different. The Part C monitoring, including general surveillance, may also play an important role in providing data for long term, potentially adverse effects of GMOs. Monitoring results may confirm the ERA or may lead to re-evaluation of the ERA. An ERA should not be viewed as static. It should be regularly reviewed and updated or perhaps changed to take account of relevant new data. Any reviews should consider the effectiveness, efficiency and accuracy of the ERA and risk management taking account of data from research, other deliberate releases and monitoring data. Following any such reviews, the ERA and risk management should be adapted or upgraded as appropriate.
  2. It is therefore clear that the precautionary principle was taken into account in drafting the Directive and has been taken into account in drafting the implementing Regulations. The precautionary principle is built into the regulation of GM crops, which are only released on a case-by-case basis after detailed scientific risk assessments.
  3. Could the Executive explain what it anticipates the requirement to engage in public consultation and the duty to take into account and give weight to representations will have on the protection of public health?

  4. Directive 90/220 contained optional provisions for consultation with members of the public on releases of GMOs under Part B (research and development) but these consultation provisions were not transposed into the Environmental Protection Act 1990. Instead , in 1993, the UK introduced a statutory system for notifying certain interested organisations about proposed releases, of advertising proposed releases in local newspapers, and of public registers containing specified detailed information, including risk assessment information, proposed locations, and advice given by ACRE. A policy of openness was adopted in relation to the programme of farm scale evaluations in line with the provisions of the new Directive. This approach has, in practice, given members of the public and those with a particular interest an opportunity to express an opinion on proposed releases, and for their views to be heard. Directive 2001/18/EC provides a basis for improvement by introducing a mandatory requirement for Member States to consult the public on proposed research and development releases in their territories.
  5. In Scotland, the implementing regulations provide a system under which public comment is invited on applications for Part B consents. On receipt of a Part B application the Scottish Ministers must invite the public and others to make representations to them on any risks of damage being caused to human health or the environment by the proposed release before granting (or not) consent for release. There is no statutory requirement to hold public meetings / hearings as part of this process. Whenever an applicant is required to submit a document, under the regulatory framework it must be submitted in both paper and electronic form. This is intended to speed up the placing of information on the public register and website and make it more widely accessible to the public. The period of each consultation has been set at a mandatory minimum of 48 days. The Scottish Ministers also have the option to extend this period if they spend a significant amount of time waiting for additional information to be supplied by the applicant. Such time does not count towards the period in which the application must be processed.
  6. The Committee sought clarification of the "weight" given to representations relating to the protection of public health. It is important to acknowledge that only representations from the public relating to possible risks to human health and the environment raised by a proposed release can be taken into account in the decision-making process.
  7. Ministers are required to operate within European law. Decisions taken in the absence of sound scientific evidence could be subject to legal challenge and would be unenforceable. Scottish Ministers would not approve trials if expert advisers had health concerns in relation to new or current research and development trials.
  8. The requirement to advertise proposed releases in newspapers to be selected by the Scottish Ministers is intended to increase the number of people alerted to the fact that a consultation is in progress. The Scottish Ministers will approve such advertisements in advance. The requirement on the applicant to inform local authorities and community councils for the area of the proposed release will encourage debate at local level.
  9. Decisions on the commercial release of GMO products (including imports) on the EU single market are taken collectively by the European Commission and all 15 Member States. Before any collective decision is taken on whether or not to allow a GMO to be used commercially in the EU, the Commission must hold two separate periods of 30 days public consultation. The UK will take steps to advertise the Commission's consultations and public views will help inform the UK position.
  10. As far as decision making on individual product applications is concerned the new Directive and implementing regulations remain firmly based on a scientific assessment of risk on a case-by-case basis. However, the Directive does make provision for socio-economic and ethical issues (i.e. arising from public consultations and elsewhere) to be considered on a more general basis. Member States and the Commission are required to meet regularly and exchange information on the experience acquired with regard to the implementation of the Directive and the prevention of risks related to the release and the placing on the market of GMOs. Every three years the Commission is required to Report on the operation of Part B and Part C consents taking account of the diversity of European ecosystems and the need to complement the regulatory framework in this field. The Report is also required to address the feasibility of various options to improve further the consistency and efficiency of this framework including consideration of the socio-economic and ethical implications of deliberate releases and placing on the market of GMOs. Additional Commission guidance will be of a generic nature and may include proposals with a view to amending the Directive.
  11. Could the Executive clarify what role the Health and Safety Executive, the Food Standards Agency and the Advisory Committee on Releases into the environment will have under the new legal regime to ensure the protection of public health?

  12. The response to this question has been prepared in consultation with the Health and Safety Executive, the Food Standards Agency and the Advisory Committee on Releases to the Environment. All agree that there has been no change to their role as a result of the implementation of Directive 2001/18/EC. These expert bodies continue to provide advice to the Scottish Ministers, as they do to the authorities in other parts of the UK, on the risks to human health and the environment posed by the release of GMOs.
  13. References are made throughout the implementing regulations requiring the Scottish Ministers to have the agreement of the Health and Safety Executive (HSE) before taking certain decisions on the applications to release GMOs. The HSE is involved on the basis that all potential releases need to be assessed specifically for their potential effect on the health and safety of the workers that handle the GMOs in question. This reflects HSE's responsibility for, and expertise, in human health and safety issues, particularly in relation to the potential effect on the human health and safety of the workers that handle the GMOs in question which is the primary responsibility of the HSE.
  14. The role of the FSA is currently determined by provisions of the Environmental Protection Act 1990 (as amended). Specific reference to this requirement is not made in the regulations because provision is included in the Environmental Protection Act. The Act requires that the FSA be consulted before any regulations are made under Part VI of the Act, and that the FSA is consulted before any consent under the Act is granted or varied. By virtue of section 126(3) of the Act, functions of the Scottish Ministers under section 110 of the Act must be exercised jointly with the FSA in relation to matters where the FSA is concerned (i.e. matters connected with food safety and other interests of consumers in relation to food). Section 110 gives powers to prohibit certain persons from releasing, marketing, importing, acquiring or keeping GMOs if it is believed they risk damaging the environment.
  15. ACRE is a statutory body, appointed under Section 124 of the Environmental Protection Act 1990, to advise the Scottish Ministers on the risks posed by GMOs. When an application for a proposed research trial is made to the Scottish Ministers, it is referred to ACRE. ACRE scrutinises the environmental risk assessment that must be supplied with the application (and more information is demanded from the applicant if necessary). Central to all decision making processes under the Directive is a rigorous science-based assessment of associated risks. This is carried out on a case-by-case basis by ACRE, which then advises the Scottish Ministers whether the release of specific GMOs pose risks to human health or the environment. Risk assessments are continually up-dated in the light of new scientific information. If this raises concern or unresolved doubt about the safety of a GMO, ACRE can advise that consent for release be revoked. ACRE also advises on any conditions or limitations which should be attached to consents, including post-release monitoring and provision to make amendments to consents.
  16. ACRE performs a similar role in advising Ministers on proposed commercial GMO releases where their advice informs the UK's position in collective decision making in the EU. The Executive remains fully confident in the advice provided by ACRE to Scottish Ministers and endorses the essential role played by the committee in the regulatory process.
  17. The Committee's Conclusions

  18. HCCC's conclusions are summarised in paragraphs 108 to 119 of the report. These are addressed in turn in following paragraphs.

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

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.
  1. The Executive remains satisfied that the precautionary principle is being applied in a robust, consistent and appropriate manner, notwithstanding the views of HCCC. The Directive and implementing regulations prescribe a structured approach to the analysis of risk in line with the precautionary principle.
  2. The first HCCC conclusion rests wholly on the second, the committee's view that the risk assessment procedure is flawed and does not therefore adequately assess potential hazards to human health. However, as outlined above in the response to specific questions about Directive 2001/18/EC, the "flaws" identified by HCCC do not stand scrutiny:
  • The format of the application dossier is laid down in statute on a point by point basis. For consents issued under Directive 90/220/EEC the information required for inclusion in the application dossier was detailed in regulation. In addition ACRE issued guidance on the format of the risk assessment. Under 2001/18/EC the logical progression of identified characteristics / potential hazards and the associated assessment of risk has been strengthened. The Directive and the regulations specify what should be included in the risk assessment and how to address it. Risk assessments are now required to identify and evaluate potential damage to human health and the environment arising from the proposed release of a GMO, including indirect or delayed effects;
  • The content of application dossiers submitted by applicants varies on a case by case basis depending on the type of GMO involved, the nature of the modification, the scale and purpose of the proposed release. However, the information required for every application is the same and must be submitted in the format laid down in statute;
  • Prior to advising on whether consent to release a GMO into the environment be granted ACRE and other scientific experts such as the FSA and the HSE, consider the whole application dossier submitted by the applicant, of which the ERA is only one part.
  • An ERA has to take into account scientific uncertainty at various levels, and be carried out in a scientifically sound and transparent manner based on available scientific and technical data;
  • Such risk assessments are regularly reviewed taking account of data from research, other deliberate releases and monitoring data; setting a more arbitrary timeframe for review would undermine the evidence-based approach which is an essential feature of the legislation designed to protect human health and the environment.
  • When applications for marketing are considered, post-market monitoring plans must be included which test whether the assumptions of the ERA are correct. They must also include measures for long term observation and detection of unexpected developments.

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.

  1. The regulatory framework for the deliberate release of GMOs in Europe, involving a step-by-step principle as required by Directive 2001/18 is described in paragraph 9. This approach evaluates each release on its own merits in terms of risks to human health and the environment, and only increasing the scale of the release when those risks have been further evaluated and found to justify the next step. This proportionate and precautionary approach formed the basis of Directive 90/220/EEC and similarly forms the basis of Directive 2001/18/EC.
  2. Only when regulators are satisfied that a GMO does not pose any additional risks to human health or the environment based on knowledge built up at each stage of the process, will an application for a Part C consent for marketing be considered. A Part C application to market a GMO for food use would also require a detailed food safety assessment under the EC Novel Foods Regulation 258/97. In the UK the FSA is the competent authority for approving GM foods and takes advice on this from the Advisory Committee on Novel Foods and Processes (ACNFP). The ACNFP is an independent committee that is comprised of a range of relevant scientific experts, complemented by three lay members - two consumer representatives and an ethicist. The safety assessment for a GM food would be structured around the concept of substantial equivalence, which is described in some detail below. There are some well-recognised limitations of conventional toxicity studies in assessing novel, including GM, foods, and these are also described.
  3. Very few foods consumed today have been tested in toxicological studies yet they are generally accepted as being safe to eat. The approach used to assess the safety of new foods is to compare them to existing foods that are already part of the diet that they will replace.
  4. Where appropriate, toxicity studies, including the use of animals, are used as part of the safety assessment of chemicals such as medicines, pesticides and food additives. These materials are usually well-defined chemicals that do not have any nutritive value. They can be fed to animals at a range of doses, including some many times higher than the likely human exposure levels, to determine any adverse health effects, thus allowing safe levels to be set for human exposure.
  5. Foods however, are complex mixtures of compounds that can vary considerably in their composition and nutritive value. There are practical limits on the amounts that can be fed to animals, particularly for bulky foods. In addition, it is difficult to feed increasing amounts of test foods to animals without affecting the nutritive value of their overall diets and thus causing secondary health effects. Therefore before conducting any toxicity studies on novel foods in animals, it is important to assess on a case-by-case basis whether any meaningful information could be obtained from such a study.
  6. Substantial equivalence has been used to compare different varieties of crops developed through conventional plant breeding but it is also particularly useful in the safety assessment of novel foods, e.g. comparing GM foods and food ingredients with their traditional counterparts. The concept of substantial equivalence is not a safety assessment in itself; it is a way of structuring the comparison of a new food with its conventional counterpart to identify any differences, which then become the focus of the safety assessment.
  7. The problem was addressed by the Food and Agriculture Organisation of the United Nations (FAO) and the World Health Organisation (WHO) in 1990 when the principle of comparing a new food with an existing food was identified. The Organisation for Economic Co-operation and Development (OECD) expanded on this principle in 1991 and formulated the concept of substantial equivalence.
  8. The ACNFP used this concept to devise a structured scheme for the assessment of novel foods and processes in 1991. This approach was refined by the ACNFP in 1994 and was subsequently used in the development of EC guidelines for the assessment of novel foods.
  9. The comparative approach recognises that the goal of the safety assessment of a new food is not to establish absolute safety but to determine whether the new food is as safe as its traditional counterpart. The concept of substantial equivalence is used to identify similarities and differences between the novel food and an existing counterpart with a history of safe food use with respect to aspects such as composition, nutritional value and metabolism. To aid this comparative analysis OECD produces reference documents which provide important information on certain crops, such as ranges for normal levels of variation observed for particular components of conventionally bred crops.
  10. The safety assessment then focuses on the health implications of any differences that are identified. For GM foods, this includes evaluating details of the genetic modification event, including a history of the host organism that is being modified and the organisms from which the inserted genetic information is derived, as well as a detailed genetic characterisation of the modified organism; the composition (proteins, fats, carbohydrates, vitamins and minerals) of the food, any effects of the novel proteins produced, including potential toxicity and allergenicity; possible unintended secondary effects; and potential intakes and dietary impact.
  11. An FAO/WHO expert consultation in May 2000 concluded that there were presently no alternative strategies that would provide a better assurance of safety for GM foods than the appropriate use of the concept of substantial equivalence. The FAO/WHO report considered that the application of the concept of substantial equivalence contributes to a robust safety assessment framework. Whilst the current regulatory framework is considered to be robust, this is kept under review to ensure that the best scientific knowledge prevails.
  12. In the UK, the ACNFP, an independent scientific Committee, advises on the safety of novel foods. All applications to market novel foods are reviewed by equivalent authorities in other member states before approval is given. The FSA is satisfied that the current safety assessment procedures for GM foods are sufficiently robust and rigorous to ensure that approved GM foods are as safe as their non-GM counterparts, and pose no additional risk to consumers. The FSA also funds an extensive research programme to underpin the safety assessment on GM foods.
  13. Taking that into account the Committee's pharmaceutical analogy is not compelling. HCCC may wish to note that the control of medicines in the UK is primarily through the system of licensing laid down in EC legislation, in the Medicines Act (1968) and in relevant subordinate legislation. This legislation covers, among other things, the systems by which licences to manufacture, market, distribute, sell and supply medicinal products are granted by Ministers or, in the new centralised licensing system, by the relevant Community institutions.
  14. The UK Medicines Control Agency (MCA) operates a system of licensing before the marketing of medicines. Medicines, which meet the standards of safety, quality and efficacy, are granted a marketing authorisation (previously a product licence), which is normally necessary before they can be prescribed or sold. This authorisation covers all the main activities associated with the marketing of a medicinal product. The MCA carries out pre-marketing assessment of the medicine's safety, quality and efficacy, examining all the research and test results in detail, before a decision is made on whether the product should be granted a marketing authorisation.
  15. Before a product is marketed, experience of its safety and efficacy is limited to its use in clinical trials. The conditions under which patients are studied pre-marketing do not necessarily reflect the way the medicine will be used in hospital or in general practice once it is marketed. Consequently, there is a continued need for vigilance to detect adverse effects that become apparent after marketing and when the medicine is more widely used among a greater variety of patients.
  16. 'Pharmacovigilance' is the process of:

(a) monitoring medicines as used in everyday practice to identify previously unrecognised or changes in the patterns of their adverse effects;

(b) assessing the risks and taking account of the benefits of medicines in order to determine what action, if any, is necessary to improve their safe use;

(c) providing information to users to optimise safe and effective use of medicines; and

(d) monitoring the impact of any action taken.

    1. 'Pharmacovigilance' uses many different sources of information including spontaneous adverse drug reaction (ADR) reporting schemes, clinical and epidemiological studies, the world literature, morbidity and mortality databases.
    2. The Executive is not convinced that such an approach is better suited to GM crop trials, and will continue to apply the underlying principles and basic procedures for the approval of GMO releases in Directive 2001/18/EC. These involve evaluating each release on its own merits in terms of risks to human health and the environment and only increasing the scale of the release when those risks have been further evaluated and found to justify the next step.
    3. 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.

    4. Viewed in the context of the European Commission communication on the use of the precautionary principle, it is clear that this recommendation has no merit. As previously confirmed, the EC communication stated:

    "Where action is deemed necessary, measures based on the precautionary principle should be, inter alia:

    • proportional to the chosen level of protection,
    • non-discriminatory in their application,
    • consistent with similar measures already taken,
    • based on an examination of the potential benefits and costs of action or lack of action

    (including, where appropriate and feasible, an economic cost/benefit analysis),

    • subject to review, in the light of new scientific data, and
    • capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment."
    1. GM lines that are released into the environment have to meet human and environmental safety assessments before approval is granted. Information that is required to support the risk assessments has to be proportionate to the scale and nature of the release. It would be impracticable to undertake comprehensive food and feed testing on all GM lines that were intended for small-scale research and development releases; most of which will never be marketed. Plant breeding is a long process involving numerous selection steps during the development of a new variety. Many lines and varieties are rejected until one shows sufficient promise in meeting the breeder's objectives and is likely to fulfil variety testing criteria for marketing.
    2. As indicated in paragraph 19 above, the scope of risk assessments has been clarified and extended by Directive 2001/18/EC. They are required to identify and evaluate potential damage to human health and the environment arising from the proposed release of a GMO whether it be direct or indirect, immediate or delayed.
    3. The regulations for deliberate release of GM crops require that the regulators are satisfied that there are no additional risks to the environment or human health than would be associated with the cultivation of the crop's non-GM counterpart. If the regulators were not satisfied that this was the case, consent for a release would not be given.
    4. All GM crops intended for deliberate release in the EC must be thoroughly assessed for human and environmental safety before they can be grown. With regard to pollen, the safety assessment includes consideration of the safety implications of any exposure to pollen through ingestion or inhalation from the air, or from it landing on other crops. Any safety concerns arising from, for example, the possible inclusion of small amounts of pollen from GM crops in honey are therefore addressed in detail before the field trials take place. Research carried out on the presence of pollen from GM crops in honey concluded that consumers would ingest no more than 5 nanograms of transgenic protein from a 500 g jar of honey - this is one part in a hundred thousand million, equivalent to one crystal of sugar in 28,000 1 kg bags. In 1999, the ACNFP endorsed its earlier advice issued in 1991, that the presence of very small quantities of GM pollen in honey does not present a safety risk to consumers.
    5. The Chief Scientist Office (CSO), the part of the Scottish Executive Health Department responsible for encouraging and promoting research to both improve the health of the people of Scotland and the services provided by NHS Scotland, will continue to fund well-designed research proposals through its response-mode grant funding scheme. This is widely publicised and well known to the research community in Scotland.
    6. 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.

    7. Section 123 of the Environmental Protection Act 1990 requires Scottish Ministers to treat some information contained in applications as 'commercial in confidence' - for instance information that may be of interest to an applicant's competitors. However, specified information cannot be treated as confidential including the location and intended uses of the GMO, the environmental risk assessment, the methods and plans for monitoring the GMO, and any emergency measures. This applies to both Part B and Part C applications.
    8. It is important to recognise that the Scottish Ministers, their expert committees and the HSE and FSA have complete access to information relating to an application for deliberate release including that deemed for the purposes of the Environmental Protection Act to be 'commercial in confidence'. Without complete and open access to information these expert bodies would be unable to assess properly the risk to human health or the environment. In such circumstances an application for release would be refused.
    9. The UK has a good record of openness on matters to do with GMO deliberate release, including a well-established system of public registers of information. However, the new Directive considerably enhances the public information principles and procedures that all Member States must respect. It is the intention that information claimed to be 'commercial in confidence' will be limited as far as possible - that is, confidential information should be identified precisely and kept to the minimum amount necessary to afford protection.
    10. 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.

      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.

    11. Efforts are made to minimise the potential for GM material from the trial crops entering the food and feed chain, including destruction of the GM crop and the use of separation distances between GM and non-GM crops. Research on gene flow between the FSE GM crops and nearby crops, is being undertaken on a number of FSE trial sites and will help to inform future consideration of co-existence measures. Despite existing precautions some limited contamination of other crops/foodstuffs from the GM crop may occur, however, this is not considered to pose a risk to human health as all GM crops intended for deliberate release are thoroughly assessed for human and environmental safety before they can be grown.
    12. Processed oils are the only products from oil seed rape that are used for human consumption. The processing used to produce highly-refined oils, such as those from oil seed rape, removes DNA so that it cannot be found in the final product. Whilst the varieties of oilseed rape being grown in the farm-scale trials in Scotland do not yet have full Part C marketing consent, oils derived from these varieties have food safety clearance across the EU. With regard to pollen, the risk assessment includes consideration of the safety implications of any exposure to pollen through ingestion or inhalation from the air, or from it landing on other crops. Any safety concerns arising from, for example, the possible inclusion of small amounts of pollen from GM crops in honey are therefore addressed in detail before the field trials take place.
    13. The Committee highlighted particular concerns regarding the potential for contamination arising from cross-pollination and contamination of honey.
    14. Oilseed rape can only breed with a few closely-related species and cross-pollination can only occur when the pollen lands on a compatible related species, while the flowers of that species are fertile and the pollen itself is still alive (OSR pollen has a limited period of viability). Pollen from the GM crop will mostly pollinate flowers that are less than a couple of metres away. Separation distances between the GM crops and related crops are used to minimise the potential for cross-pollination. These separation distances are based on those used successfully in conventional farming, where farmers are equally concerned to prevent breeding between different crops and varieties. Separation distances are about enabling different systems of agriculture to co-exist and do not reflect any doubts about safety.
    15. Sugars which make up honey are not themselves genetically modified and are the same whether the bee has been feeding from GM or non-GM plants, or indeed from a non-food crop or wild plants. The part of a GM plant that does contain genes and which might inadvertently get into honey in minute quantities, is pollen. Paragraph 60 above describes that the possible inclusion of small quantities of pollen from GM crops in honey has been examined in detail by the ACNFP. In 1999, the ACNFP endorsed its earlier advice issued in 1991, that the presence of very small quantities of GM pollen in honey does not present a safety risk to consumers. Whilst every effort is made to minimise contamination from GM crops it must be emphasised that this is not due to concerns about the safety of GM material itself or pollen from GM crops contaminating other crops. The advice of the Executive's advisory bodies is clear that contamination arising from pollen from GM crops does not represent a threat to human health or the environment.
    16. The Executive is disappointed that HCCC has chosen to categorise evidence and organisations as either for or against GM crop trials.
    17. 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.

    18. While the Executive recognises that this HCCC concern is based on hearsay, there is merit in describing the status of the SCIMAC guidelines.
    19. All deliberate environmental releases of GMOs are governed by the limitations and conditions of the particular consent issued under Section 111 of the Environmental Protection Act (EPA) 1990. Compliance with these conditions is monitored by inspectors appointed under Section 114 of the EPA. In Scotland, inspectors from the Scottish Agricultural Science Agency (SASA) carry out this function on behalf of the Scottish Ministers. In the event of the limitations and conditions being breached the Scottish Ministers can withdraw consent and refer the consent holder to the Procurator Fiscal to consider prosecution.
    20. SCIMAC - the Supply Chain Initiative on Modified Agricultural Crops - is a body which brings together the farm supply chain and industry to support the responsible and effective introduction of GM crops in the UK. SCIMAC has developed a set of on-farm guidelines to promote responsible environmental practice for growing herbicide tolerant crops (both GM and non-GM) in the UK. Some of these guidelines are mirrored by the limitations and conditions laid down in the consents in which case they are legally binding. However, others simply involve good practice and have no weight in statute. SCIMAC has indicated that the growing of GM crops as part of the farm-scale trials will be undertaken in accordance with these guidelines. Compliance with the guidelines is subject to independent third part audit undertaken on behalf of SCIMAC. In the event of a breach of the guidelines, SCIMAC may take their own sanctions including the withdrawal of access to GM technology.
    21. 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.

    22. The Executive agrees that any major scientific intervention into the environment must be scrupulously monitored. However, it is important to recognise that the crop being grown as part of the FSE programme is not new. It has been grown under closely monitored research conditions in the UK for over a decade and grown commercially in North America and other parts of the world for a number of years. The Executive is satisfied that appropriate and proportionate health and environmental monitoring arrangements are in place around FSE GM sites, consistent with evidence already presented to HCCC. There are insufficient grounds to suggest that farm trials in Scotland pose any health risks for local populations different to those risks posed by the growing of non-GM crops
    23. Managing Incidents Presenting Actual or Potential Risks to Public Health (January 2003) states that:

    "An essential part of the control of outbreaks and incidents is the recognition of a change in the distribution of illness or of the occurrence of an illness of major public health significance. To this end surveillance, i.e. the collection and collation, analysis and dissemination of information is a vital tool. NHS Boards should ensure that surveillance systems are in operation locally and in particular that these include the notification of clinical illness and laboratory reporting of microbiological isolates. Such systems should feature the early reporting by telephone or electronic means of cases of significant illnesses, which may or may not be statutorily notifiable.

    NHS Boards should have in place systems, which enable them to analyse and interpret information collected through surveillance and identify:

    • an excess in the incidence of a communicable disease, or of an illness which may be due to an environmental hazard, over that expected for a specific time, person or place;
    • the clustering of cases of communicable disease, or of an illness which may be due to an environmental hazard in person, place or time;
    • the occurrence of a single case of a serious infection with significant public health implications;
    • a clustering of cases of severe illness which have an unusual clinical presentation;
    • a clustering of unexplained illnesses;
    • the occurrence of an event which has led or has the potential to lead to a community or significant proportion of the population, being exposed to a hazardous agent."

    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.

    1. The Directive requires the phasing out of ARMs that may have an adverse effect on human health and the environment (see paragraph 11 above). This however, does not override the Scottish Ministers' primary responsibility to ensure that all appropriate measures are taken to avoid adverse effects of GMOs on human health and the environment. If, prior to the phase-out dates, the Scottish Ministers considered that a GMO containing an ARM posed an unacceptable risk they would move either that the application was rejected, or that the consent was varied.
    2. Antibiotic resistance genes have been used in GM potatoes and some, but not all, GM varieties of oilseed rape released in Scotland. Trials in Scotland have contained genes that confer resistance to either kanamycin and neomycin, or in some releases of potato, hygromycin. However, it is important to note that the use of these genes have been within the conditions of their consents and were approved by the Scottish Ministers on the advice of ACRE prior to release. They did not raise any safety concerns.
    3. It was reported in August 2002 that some GM oilseed rape used in the Farmscale Evaluation Trials contained a small quantity of seeds (2.8%) that were resistant to the antibiotics kanamycin and neomycin. ACRE reviewed this unexpected adventitious presence and concluded it did not pose any additional risks to human health or the environment.
    4. The consent conditions for all these releases are such that material from the FSE trials will not be harvested for use in the food or feed chains.
    5. Paragraph 102 of the HCCC report makes reference to research commissioned by the FSA. The FSA funded a range of projects to investigate the potential for gene transfer from transgenes and ARMs from GM crops to gut bacteria. The work referred to in the report focussed on two areas, a simulated human gut and the use of human volunteers. The studies with human volunteers showed small amounts of transgenic soya survived passage through the small intestine, but did not survive passage through the entire gastrointestinal tract. The researchers concluded that gene transfer was unlikely to occur in the human gastrointestinal tract. The projects funded in this area demonstrated that the risk of antibiotic resistance spreading through the use of ARMs is considerably less than originally thought. A number of similar studies carried out in animals have reached the same conclusion.
    6. The implications from the research on gene transfer were discussed publicly at an open meeting of the ACNFP in November 2002. Members of the Committee explained that the results were reassuring, noting that there are numerous reports that genes can flow at a low frequency from bacterial to eukaryote genomes. There was no reason why the presence of a GM construct would increase the frequency and the research demonstrated this. A number of possible effects of genetic transfer have been postulated. ACNFP were of the opinion that this was extremely unlikely to occur.
    7. The view put forward by ACRE and supported by work commissioned by the FSA, that antibiotic resistance markers used in GM crops are extremely unlikely to be transferred to bacteria in the gastrointestinal tract, is endorsed by the Chief Medical Officer for Scotland in the submission to the HCCC.
    8. Both ACRE and ACNFP consider alternatives to antibiotic resistance marker genes should be sought and their use will in future be unnecessary as genetic modification techniques develop. Recently the Head of the Royal Society, Lord Robert May, noted that antibiotic resistant genes made a "theoretical but negligible contribution" to the problem of antibiotic resistance. However, to guard against this remote possibility their use is discouraged. They will have been phased out for marketing by 2004 and for use in small-scale releases by 2008.
    9. 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.

    10. The statement in the Committee's report that "The Executive's acknowledgements of mistakes that have been made in the consultation procedures to date" is not based on an accurate or reasonable interpretation of the evidence presented. Rather the Executive acknowledged the importance of - and an ongoing commitment to - developing policies and practices which seek to engage stakeholders fully. This is confirmed by the following extract from the HCCC official report for Wednesday 27 November 2002:
    11. Margaret Jamieson:The reason why petition PE470 was submitted to the Parliament is that the fears of the local population were never channelled appropriately. Local people felt that they had no option other than to come to the Parliament with their concerns. It is clear to me from the evidence that no Government agency has undertaken any dialogue with local people and yet the Executive has a corporate responsibility to do so. It should not come down to whether the health department, the Food Standards Agency or someone else does it, as the Government has a corporate responsibility to ensure that officials engage with the local population. Local people do not want to hear the views of this or that professor being quoted; they want to hear what measures the Executive is going to put in place to protect them and how the Executive is going to report on those measures. That is the one thing that is missing from the exercise.

      Mrs Mulligan : I totally agree that it is essential for us to ensure that people are given confidence that we are not using them as guinea pigs. We also 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 do if we were developing new medicines, for example. We have to ensure that we protect people who may feel that they are vulnerable in some way. We have to ensure that information is made available to people so that they can see what is happening and what the risks might be.

      Margaret Jamieson : Will you undertake to speak to the other Scottish Executive departments to ensure that consultation starts on a regular basis with the community, albeit that it will be a bit late?

      Mrs Mulligan : I am happy to speak to my colleagues on the matter. It has always been a principle that we should make available to people as much information as possible so that they are given confidence in what is happening

    12. The Agriculture and Environment Biotechnology Commission (AEBC) commended the Scottish Executive's approach to consultation in their report entitled, "Crops on Trial". AEBC acknowledged that the Executive had put additional steps in place that went beyond the statutory requirements at the time to assist public awareness and understanding of the issues and to ensure that as much notification as possible about proposed trials was given to enable anyone with an interest to obtain factual information. However, this did not amount to 'consultation' in the commonly understood sense of the term. The revised consultation procedures under Directive 2001/18/EC are outlined at paragraphs 23 - 29 above.
    13. Conclusion

    14. Some generic lessons arising from this HCCC inquiry confirm one of the key themes from the Phillips' Report, The BSE Inquiry, which highlighted the ongoing need for government to have an effective, transparent and consistent approach to decision making about scientific issues and risk communication. The Executive will continue to develop and review policies and practices which seek to engage stakeholders more fully.
    15. The Scottish Executive Health Department is, for example, currently considering the responses to a recent consultation about improving health protection in Scotland. The consultation document (November 2002) confirms that risk assessment, management and communication are distinct but inter-related elements of health protection measures. The consultation aims to determine whether there is a need for these to be strengthened by: developing guidance on good practice in risk assessment in health protection agencies, particularly those working within the NHS; further ensuring that all policies developed to protect the public are formally founded on a rigorous approach to risk assessment; promoting partnership working on health protection; improving education on hygiene; developing indicators to assess the performance of NHS agencies with health protection responsibilities and the impact of risk reduction measures on health; developing guidance on risk communication for NHS agencies involved in health protection to be used in establishing communication plans and procedures; commissioning research into understanding how certain risks become amplified and how the public can develop better means of comparing and contrasting risks which affect their personal life (risk literacy).
    16. That said, the Executive remains clear that the available scientific evidence supports the view that the FSE programme is well-founded, well-regulated, and designed to increase our knowledge about GM crops, while taking proportionate measures to protect the public against potential adverse effects. In contrast, as this response makes clear, the HCCC report is not supported by evidence and, as such, reflects the Committee's acknowledged inability "to deliberate definitively on the complex scientific questions that GM crop trials raise or to adjudicate on competing interpretations of scientific evidence". While the Executive acknowledges that the HCCC conducted this inquiry in response to public concern, the Report serves to increase the level of anxiety which has existed. The Committee has not given sufficient attention to the evidence it has heard on the science of GM crops, genetics more generally and the precautions which Government and its advisers have recommended and put in place. A Report which should have explained a matter of concern to the public has served to obscure the facts and heighten concern.
    17. ANNEX A

      ACRE RESPONSE

      The committee's report on its inquiry into GM crops raises several concerns about risk assessment and the quality of the advice given by ACRE.

      First, the committee believe that allowing the GM crop trials to continue contravenes the precautionary principle (and by implication ACRE do not adopt this principle, or at least do not take a precautionary approach). This view is not well-founded. Indeed the definition provided under paragraph 27 "if a preliminary scientific assessment shows there are reasonable grounds for concern that potentially dangerous effects will occur ... then a release will not proceed" is exactly the context within which ACRE works, and has always worked. ACRE, as you know, reviews with great rigour the scientific and technical evidence presented by each applicant and only advise Ministers to issue consent when we are satisfied that no reasonable grounds for concern remain. There are many examples of ACRE's precautionary approach - indeed the example given at the inquiry was ACRE advice that consent should not be given to release two crops containing a particular antibiotic resistance marker gene, even though the evidence for harm is extremely low. Other witnesses (from RSE) indicated that ACRE's approach is precautionary.

      Secondly, it was suggested (para 55) that there are a number of flaws in the current risk assessment procedures. ACRE totally rejects all but one of these assertions. Risk Assessment does follow a standard format, dealing with each of the '41 questions' in turn, identifying potential hazards and assessing the probability of exposure to those hazards (and hence the risks). Where potential hazards are identified the applicant is required to provide evidence that either there is not a hazard or, more usually, that there will be no exposure to that hazard, therefore a low risk. ACRE does identify areas of uncertainty and frequently goes back time and again to the applicant until those uncertainties are removed. Where some residual uncertainty in the science remains, the experience of the scientific community is used to assess whether this constitutes a level of uncertainty which may pose a risk to human health and the environment. The belief that ACRE relies on 'modelling and model assumptions' rather than hard scientific assessment is extraordinarily wide of the mark. Finally one must concede that, in the context of a particular deliberate release, there is (apart from the period during which the original risk assessment took place) no set period for assessing and reassessing risks. The permission to release depends on reporting back to the Regulatory Authorities on any events or data that materially affects the risk assessment in this way. ACRE keeps all releases under review and we have revisited several of the releases to date when new evidence has come to light.

      The committee expressed concerns about allergies, and in the context of the current trials, the possible allergic effects of genetically modified oilseed rape pollen (para 66). In evidence ACRE assured the committee that the appropriate assessments of (a) the likelihood that the proteins were expressed in pollen and (b) the possible allergic effects of such proteins, were made at the time of the risk assessment (the genes did not come from an organism which causes allergies and the protein has no homology with any allergenic proteins in the appropriate database).

      ACRE was especially concerned to see in paragraph 75 that the committee repeated the assertion that the current ACRE has not revisited the consents issued by the original (pre-1999) ACRE, which is not correct, and by use of the words 'removal' of the members of that earlier committee perpetuated the insinuation that they were dismissed because of 'connections with biotechnology companies'. Eleven of the thirteen members of that committee no longer serve on ACRE because they had reached their limits of public service under the Peach-Nolan rules. Whilst the committee did not pronounce on their views about the independence of ACRE, they did seek clarification on the rules governing the availability of 'Commercial in Confidence' information. ACRE sees everything and are very strict about allowing applicants to claim commercial in confidence status for any of their evidence (obvious exceptions include cases where applications have been made for patents.

      ANNEX B

      SUBMISSION TO THE SCOTTISH PARLIAMENT HEALTH AND COMMUNITY CARE COMMITTEE - INQUIRY INTO THE HEALTH IMPACT OF GM CROP TRIALS BY THE CHIEF MEDICAL OFFICER FOR SCOTLAND

    18. With the Deputy Minister for Health and Community Care, I am scheduled to give evidence to the Health and Community Care Committee on 27 th November 2002, as part of the inquiry into the health impact of genetically modified crop trials in the Farm Scale Evaluation (FSE) programme. I therefore thought Committee members might find it helpful to have a brief note outlining my response to the four key questions identified by the Committee in order to structure its deliberations.
    19. As Chief Medical Officer for Scotland, I am the senior medical adviser to the Scottish Executive on all matters affecting health and healthcare in Scotland. In this function I liase closely with my counterparts in the other parts of the UK. In May 1999 the CMO (England), Professor Sir Liam Donaldson and Sir Robert May (Chief Scientific Adviser) reviewed the health implications of genetically modified food. They concluded that there is no current evidence to suggest that GM technologies used to produce food are inherently harmful and that many of the concerns related to foods resulting from genetic modification are equally applicable to foods produced by conventional means. I endorse those conclusions and since that publication, I have found no further evidence to persuade me otherwise. I will expand on this below.
    20. First, however, I should stress that the trials in the FSE programme are not food safety trials, and the material harvested is not used in the food or feed chains. The FSE programme involves a three-year long series of crop trials, established to allow the evaluation of environmental impacts of the cultivation of certain herbicide tolerant GM crops at field scale in the UK. Across the UK, GM maize, beet and oilseed rape are being grown in the FSE programme. GM oilseed rape (OSR) is the only crop being grown in the Scottish FSEs, for agronomic reasons.
    21. Second, the 'deliberate release' of genetically modified organisms (GMOs) into the environment in Scotland is regulated by The Scottish Executive Environment and Rural Affairs Department (SEERAD). Scottish Ministers are advised on this by an independent expert committee called the Advisory Committee on Releases to the Environment (ACRE). Representatives of ACRE have given evidence to the Health and Community Care Committee. Expert advice is also obtained prior to every release from the Health & Safety Executive and the Food Standards Agency.
    22. Should the Scottish Executive prevent GM crop trials from continuing on the grounds that it is against the precautionary principle to allow them to continue?

    23. No. The precautionary principle has underpinned the work of ACRE and is at the root of the purpose, design and safety of the FSE programme.
    24. 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 valued and protected aspects of the environment, human, animal or plant health then a release will not proceed until sufficient knowledge has been gained to be able to make a decision based on risk assessment.
    25. The application of this principle guides risk assessments carried out by ACRE in this area. If there is evidence of any potential harm to human health, then they will recommend to Ministers that the proposed trial should not be permitted. However, as the written evidence submitted by the Royal Society of Edinburgh, Scotland's learned society, rightly acknowledges, "a number of National Academies of Science, the European Commission, Government watchdog Commissions and Agencies, have concluded that GM crops pose no additional threats or risks to humans compared with conventional crops".
    26. The RSE also referenced the European Commission communication on the use of the precautionary principle in the EU and internationally (European Commission 2000) which stated:

    "Where action is deemed necessary, measures based on the precautionary principle should be, inter alia:

    • proportional to the chosen level of protection,
    • non-discriminatory in their application,
    • consistent with similar measures already taken,
    • based on an examination of the potential benefits and costs of action or lack of action

    (including, where appropriate and feasible, an economic cost/benefit analysis),

    • subject to review, in the light of new scientific data, and
    • capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment."
    1. Although not central to either the regulation of GM crops or the purpose of the FSE programme, the potential benefits of GM plants should be recognised:
    • A 1994 BMA report stated that "the techniques of genetic modification have the potential through application in agriculture, medicine and technology to increase the well-being of people and to promote the health of the population by disease prevention"; and
    • The 2002 Royal Society "Update" on GM plants for food use and human health concluded that " we recognise the potential and current impact of plant biotechnology on the quality of food and its importance in the development of new crops. We support continuation of research on GM plants as valuable in itself and as the only way to assess the true potential of GM plants."

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

    1. Yes. I have confidence in the risk control provisions of the current regulatory regime via ACRE whose terms of reference include "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 to the environment." As a result of the Phillips Report we have recently been working with the UK Government to enhance the remits, memberships, and procedures of scientific advisory committees.
    2. The full environmental and human health implications of GMOs must be considered ahead of their wider proliferation for cultivation. However, as indicated earlier, we can be confident that the risk control provisions currently in place for those crops involved in the FSE programme are proportionate, and that, based on research evidence, there are insufficient grounds to believe that these trials pose a significant health risk to local populations.
    3. Are the guidelines to prevent conventional crops being cross-contaminated by GM crops adequate?

    4. This question relates to crop-management, not to health.
    5. Should it be incumbent on the Scottish Executive to monitor the health of people living around GM farm scale evaluation sites?

    6. As CMO, I am acutely aware of the need to maintain vigilance with regard to new and emerging hazards to health and ensure that our systems to monitor ill health can detect any consequences from these promptly. I and my colleagues in the Health Department work with a range of partners in continuously developing these systems. However currently there are insufficient grounds to suggest that farm trials in Scotland pose any health risks for local populations different to those risks posed by the growing of non-GM crops.
    7. However, we maintain a watching brief in this area and should emerging scientific evidence support a change to this position, we will reconsider the need to implement an appropriate, effective and evidence-based health surveillance programme.
    8. Other Issues

    9. There are perhaps three principal human health concerns within the GMO debate.
    10. These are that:
    11. (i) the proteins and other compounds produced by the modified genes might be toxic;

      (ii) the proteins and other compounds produced by the modified genes might be allergenic;

      (iii) the current practice of 'marking' modified organisms with genes conferring antibiotic resistance (to test subsequently for the success of modification by exposing them to antibiotics) might lead to these genes being transferred to pathogenic micro-organisms

    12. In relation to the first of these, the main concern is clearly for food which is a matter for the Food Standards Agency. (Before GM foods are approved for sale in the EU they must be rigorously assessed for safety in accordance with the requirements of the EC Novel Foods Regulation (258/97)
      www.europa.eu.int/eur-lex/en/lif/dat/1997/en_397R0258.html <http://www.europa.eu.int/eur-lex/en/lif/dat/1997/en_397R0258.html>. In the UK, the relevant assessment of novel, including GM, foods is carried out by an independent scientific body appointed by the FSA called the Advisory Committee on Novel Foods and Processes (ACNFP).) However, as indicated earlier, GM plants grown in all trials in Scotland are destroyed and do not enter the food or feed chain.
    13. Some residual concern might relate to the possibility that very low levels of cross-pollination might occur from the GM crop to conventional oilseed rape crops, leading to the altered genetic material entering the food chain. This issue is included in ACRE's evaluations. The oil from the GM varieties of oilseed rape grown in the FSE have food safety clearance across the EU The FSA has commented previously that "The oil, which is indistinguishable from oil obtained from non-modified oilseed rape, does not require labelling since neither DNA or protein will be present in the refined oil".
    14. Further, the recent Society of Toxicology Position Paper adopted on September 25th, 2002 The Safety of Genetically Modified Foods Produced Through Biotechnology http://www.toxicology.org/information/GovernmentMedia/GM_Food.html concludes that ' The available scientific evidence indicates that the potential adverse health effects arising from biotechnology-derived foods are not different in nature from those created by conventional breeding practices for plant, animal, or microbial enhancement, and are already familiar to toxicologists."
    15. Also, the World Health Organisation (WHO) (http://www.who.int/fsf/GMfood/q&a.pdf) states that "GM foods currently available on the international market have passed risk assessments and are not likely to present risks for human health. In addition, no effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved."
    16. In relation to potential allergenicity of GM foods (again a matter for the FSA) the WHO http://www.who.int/fsf/GMfood/. states that: " As a matter of principle, the transfer of genes from commonly allergenic foods is discouraged unless it can be demonstrated that the protein product of the transferred gene is not allergenic. While traditionally developed foods are not generally tested for allergenicity, protocols for tests for GM foods have been evaluated by the Food and Agriculture Organization of the United Nations (FAO) and WHO. No allergic effects have been found relative to GM foods currently on the market." Assessing potential allergenicity is an important component in the safety assessment of all novel, including GM foods, and the independent scientific Advisory Committee on Novel Foods and Processes that advises the FSA, has specialist expertise in allergenicity.
    17. The issue of allergenicity might be considered to go beyond food and might also be a concern for inhalation of pollen from GM plants. In this respect, there is no current evidence of different or enhanced allergic reactions to pollen from GM crops for example in workers who are likely to be exposed to higher airborne concentrations than the general public.
    18. In relation to gene transfer, the WHO has stated that "Gene transfer from GM foods to cells of the body or to bacteria in the gastrointestinal tract would cause concern if the transferred genetic material adversely affects human health. This would be particularly relevant if antibiotic resistance genes, used in creating GMOs, were to be transferred. Although the probability of transfer is low, the use of technology without antibiotic resistance genes has been encouraged by a recent FAO/WHO expert panel." I endorse the view that the use of antibiotic resistance markers in the genetic modification process should be discontinued. I note that steps are currently being taken for this to occur and would hope that rapid progress is made.
    19. The FSA has funded several research projects in this area which have recently been completed. Results from these studies have been published in peer reviewed papers in the Journal of Antimicrobial Chemotherapy, Journal of Applied and Environmental Microbiology, FEMS letters and the British Journal of Nutrition. The research projects concluded that it is extremely unlikely that genes from GM food can end up in bacteria in the gut of people who eat them. The implications of the findings from these research projects were discussed publicly earlier this month, at the open meeting of the ACNFP.
    20. In response to these concerns, Article 4 of the Directive 2001/18/EC, which improves the framework for controlling the deliberate release into the environment of GMOs in the European Union (EU), sets target dates for the phasing out of antibiotic resistance markers in GMOs which might have adverse effects on human health or the environment. Further, in relation to the shorter term, the recent Society of Toxicology Position Paper states that: " Even if the occasional transfer of resistance from plant to bacterium did occur, the practical impact would be negligible. However, since any increase in antibiotic resistance is recognized as undesirable, and the technology is now available to omit the use of such marker genes, future genetically-modified organisms are unlikely to contain them." Antibiotic resistant marker genes are not present in the GM crops grown in the FSE programme.
    21. ACRE takes all these factors into consideration in their consideration of applications for the release of GM crops in field trials.
    22. Conclusion

    23. The available evidence supports the view that the FSE programme is well-founded, well-regulated, and designed to increase our knowledge about GM crops, while taking proportionate measures to protect the public against potential adverse effects.