Select Committee on European Communities Minutes of Evidence


Memorandum by the Ministry of Agriculture, Fisheries and Food, the Department of Health, Scottish Office, Welsh Office and Northern Ireland Office

INTRODUCTION

  1. The Government aims to protect public health in relation to food by promoting and enforcing high standards of food safety as a matter of paramount importance at all stages in the production, processing and supply of food. It is committed to openness and transparency in the way it works and consults fully with all interested groups affected by its activities. The Government recognises the many potential benefits that genetic modification offers to agriculture and ultimately to consumers. Examples include a reduction in the quantities of herbicides through the development of herbicide tolerant plants, the production of insect resistant or disease resistant crops and the production of medicinal products using animals. Consumers stand to gain from foods that are more nutritious, tastier, more plentiful and cheaper. Therefore, provided that all GM foods have been thoroughly assessed for safety, the Government believes that consumers should be allowed to choose whether to purchase them or not. For this to be possible all foods containing GM materials must be clearly labelled. The recently agreed EC Regulation on the labelling of GM soya and maize will help to make sure this requirement is met. The only GM foods currently on the market are a vegetarian cheese made using the enzyme chymosin obtained from a GM organism, a GM tomato paste, and foods containing ingredients from GM soya and maize. Oils produced from GM oil seed rape is likely to be the next product on the market. The Government will continue to ensure that GM products are regulated in an appropriate manner and that the regulatory framework is kept under regular review.

GMO LEGISLATION

  2. There is a comprehensive UK regulatory framework, based on EU legislation, covering all stages of work with genetically modified organisms (GMOs) designed to protect human health and the environment. This consists of the EC Contained Use Directive (90/219) dealing with all aspects of the development of GM Micro Organisms prior to their release into the environment, the EC Deliberate Release Directive (90/220) which lays down environmental safety controls for releases and marketing for GMOs and the Novel Foods and Novel Food Ingredients Regulation (258/97) which covers all aspects of the use of GM technology for the production of foods. In Great Britain, the competent authorities for the first two Directives are the Health and Safety Executive and the Department of the Environment, Transport and the Regions who will deal with their respective Directives in their memoranda. The Novel Foods and Novel Food Ingredients Regulation and associated controls are described in more detail in the following paragraphs.

GENETICALLY MODIFIED FOODS

The EC Novel Foods Regulation 258/97

  3. The EC Novel Foods Regulation (258/97) came into force on 15 May 1997, following extensive consultation between Member States. The then UK Government also conducted a series of consultations with industry and consumer groups at various stages of the Regulation's development. The Regulation established an EU wide pre-market approval system for all novel foods, that is foods which have not hitherto been used for human consumption to a significant degree in the EU before, including foods containing or produced from genetically modified organisms (GMOs). Where an application is for a food or food ingredient that contains or consists of a GMO, the application will also need to include an environmental risk assessment in line with the requirements of Directive 90/220/EEC. The Regulation also lays down general labelling requirements (see paragraph 9).

  4. The Novel Foods Regulation is enforced in the UK by The Novel Foods and Novel Food Ingredients Regulations 1997, which lay down offences and penalties. These also designate the Minister of Agriculture, Fisheries and Food and the Secretary of State for Health, acting jointly, as the competent food assessment authority in the UK. The Novel Foods and Novel Food Ingredients (Fees) Regulations 1997 make provisions for charges to be set for assessment of novel foods and novel food ingredients applications. DETR and the Advisory Committee on Releases into the Environment (ACRE) will be consulted on the environmental risk assessment, under arrangements set out in a Memorandum of Understanding.

Safety Assessment of Novel Foods

  5. In the UK we have considerable experience of assessing the safety of novel foods, including those produced using genetic modification, stretching back over some 10 years. These assessments are carried out by the Advisory Committee on Novel Foods and Processes (ACNFP), a body of independent experts whose expertise is acknowledged world-wide. The safety assessment is based on the concept of substantial equivalence which involves a comparison of a GM food with its conventional equivalent and a detailed examination of any differences. Where there is no equivalent, all aspects of the novel food are examined in detail. This approach has been endorsed by the World Health Organisation and is widely used by regulatory authorities around the world. Applications currently under consideration by the Committee are for processed products from two GM cotton seeds (cotton seed oil) (one developed to be insect protected and the other to be herbicide tolerant), one GM maize (developed to be both insect protected and herbicide tolerant) and one GM potato (developed to be insect protected).

  6. The ACNFP includes amongst its members an ethicist and a consumer representative. More general issues, including labelling, are referred as necessary to the Food Advisory Committee (FAC). This Committee has a broader membership than the ACNFP consisting of those with backgrounds in food, enforcement, advertising standards, consumer affairs, manufacturing and retailing, and academia and is therefore well equipped to deal with any matters requiring a wider perspective.

  7. The ACNFP has for some time published the agendas and a note of the outcome of each of its meetings as well as detailed reports of its assessments and an annual report (copy of 1996 report attached). [not printed]. More recently however it has begun to publish the minutes of its meetings. It has also been agreed that papers discussed at the meetings will be made available on request and a Newsletter will be published. It has also decided to hold open meetings on topics of wider interest so as to provide as much opportunity as possible for people to learn about, and contribute to, the issues that it is dealing with. In this way, it is hoping to encourage interested parties, including members of the public, to make more of an input into its deliberations.

  8. One such meeting of a subgroup of the ACNFP was recently held to examine the possibility of setting up post-market surveillance arrangements for monitoring any long term affects of novel foods on public health as an additional safeguard. This was also attended by industry, pressure groups and consumer observers. The meeting proved extremely useful and a number of ideas emerged which are in the process of being followed up.

Labelling of GM Foods

  9. The Government is determined that all foods which contain GM ingredients should be clearly labelled so that consumers know what they are buying. The Novel Foods Regulation requires specific labelling when a food is judged, on the basis of a scientific assessment, not to be equivalent to an existing food. Food will also require labelling if there are any health or ethical concerns or if it contains a GMO. The EC has recently adopted a Regulation laying down detailed rules for the labelling of GM soya and maize, which will come into force in September. This requires all foods containing ingredients produced from Monsanto's GM soya and Novartis' GM maize to be labelled except when neither protein nor DNA resulting from genetic modification is present. This is likely to set a precedent for the way all future GM foods will need to be labelled. The Regulation incorporates a number of requirements put forward by the UK during its Presidency of the EU.

Segregation

  10. A number of organisations have called for GM material, such as soya beans, which are produced outside Europe, to be segregated from conventionally produced products. However, the Government cannot insist on this as a condition of import as GM soya has been cleared on safety grounds by all member states and such a requirement would therefore contravene the rules of the World Trade Organisation. In recognising these constraints, the Government has nevertheless been considering what can be done to help companies who wish to obtain supplies of non-GM soya to be able to do so. With the co-operation of the Canadian and US authorities, a list of suppliers and distributors of non-GM soya has recently been published by MAFF and placed on the Internet.

R&D

  11. MAFF has a sizeable (>£1 million in financial year 1998-99) and expanding programme of research on the safety of Novel Foods and Releases of GMOs into the Environment. The objective of this programme is to provide information needed to safeguard the consumer and the environment from any risks associated with the consumption of novel foods and the release of food related GMOs. Research projects to date have fallen into the broad areas of analysis, labelling and risk evaluation and have covered the genetic stability of crop and model plant species after transformation, gene transfer and the implications for safety of novel gene expression. Projects include work on:

    —  Methods to detect of GMOs in processed and unprocessed foods.

    —  Development of databases on genes that have been introduced by genetic modification of crops intended for food use.

    —  Development of methods to predict the allergenic potential of genetically modified foods and novel protein products.

    —  Investigation of the transfer of genetic material to gut microflora from ingested GM micro-organisms.

    —  Investigation of Agrobacterium as a vehicle of gene escape.

    —  Investigation of the stability of expression and inheritance of transgenes.

    —  Investigation of the effect of background genotype on transgene expression.

    —  Increasing the public's understanding of biotechnology.

GENETICALLY MODIFIED CROPS

Herbicide Tolerant and Pest Resistant Crops

  12. In July 1997, MAFF issued a consultation paper called "Weed Control on the Farm: Management of Genetically Modified Herbicide Tolerant Crops" and invited comments from interested parties. Virtually everyone who responded agreed that GMHT crops must be properly managed. The comments—which are available for reading in MAFF's Main Library—fell mainly into three categories; support for an industry code of practice; support for a moratorium until MAFF-funded research on possible risks to the agricultural environment from the release of GMHT crops was complete; or demands for an outright ban on GM crops. The Government is currently finalising its views and expects to make an announcement soon. It has however received advice that there are no legal powers which would allow the Government to impose a moratorium or a ban on the use of these crops.

R&D

  13. In 1990 MAFF started a programme of research to look at the possible risks to the agricultural environment from the release of genetically modified organisms. Over £3.5 million has been committed to the programme and, to date, results have not indicated any risks to the agricultural environment from the release of GMOs. In 1997, new research on the release of herbicide tolerant crops was commissioned. The research, with a total budget of over £500,000, is due to be completed in 2000. Projects include work on:

    —  Studies of the local and regional scale movement of an oil seed rape transgene.

    —  The role of bees in pollen transport between sites.

    —  Consequence analysis of the impact on agriculture and the environment of the release of herbicide tolerant oil seed rape.

    —  Impact of changes in patterns of herbicide usage on the environment and biodiversity.

    —  Risk assessment of transgene movement.

    —  Frequency and impact of transgene movement by pollen to weed species.

National Listing and plant breeders' rights

  14. The Seeds (National Lists of Varieties) Regulations 1982 as amended implement EC Directive EC 70/457 and EC 70/458 and provide that varieties of the main agricultural and horticultural species must be on the UK National list or the EC Common Catalogue before their seed can be marketed. Varieties are grown in official tests and trials, normally for two years, to establish that they are Distinct, Uniform and Stable (DUS) and have value for cultivation and use (VCU), before they are Nationally Listed. This system underpins the quality of new agricultural crops being introduced into the UK.

  15. If a plant variety is genetically modified the quite separate stringent controls under part VI of the Environmental Protection Act 1990 and Regulations made under it, which implement Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, also apply. Under these controls, MAFF cannot undertake official tests and trials unless a consent to release or market has been issued by the Secretary of State or by another Member State's competent authority. Moreover, GM plant varieties will not be added to the National List until all the necessary safety and environmental clearances to permit marketing are in place.

  16. At present, there are no GM varieties on the UK National List, though MAFF has received applications for addition of GM varieties of sugar beet (five varieties), maize (one variety) and oilseed rape (14 varieties). These are at varying stages in National List tests and trials and the point at which they might be available commercially varies from application to application. The earliest point at which seed of GM varieties (two spring oilseed rapes) could be available for commercial planting is spring 1999.

  17. MAFF is also responsible for the administration of UK plant breeders' rights. These are an intellectual property right, akin to patents, but designed specifically to protect plant varieties. Varieties entered for plant breeders' rights are also tested for Distinctness, Uniformity and Stability. MAFF is currently considering 22 applications for plant breeders' rights in respect of gm oilseed rape varieties (nine of these are combined National List/plant breeders' rights applications and 13 are for plant breeders' rights only).

Pesticide approvals

  18. Herbicides are controlled, under British and EC law, as pesticides. Under the pesticides approvals process, no pesticide may be advertised, sold, supplied, stored or used unless Ministers have approved that pesticide and consented to that activity. Applicants for pesticide approval must show that their products are effective, humane and pose no unacceptable risks to human beings, non-target species or the wider environment. Various statutory conditions are attached to pesticide approvals to protect human and environmental safety. These include the crop on which the pesticide may be used, maximum dose rates and the maximum number of applications that can be made. In seeking any extension of authorisation of a pesticide to include herbicide tolerant crops necessary safety and efficacy data would have to be supplied by the applicant. The normal considerations of human and environmental safety would determine whether such an application would be granted. At present there are no approvals for the use of herbicides on GM herbicide tolerant or pest resistant crops.

GENETICALLY MODIFIED FARM ANIMALS

Cloning

  19. Research on cloning (nuclear transfer) requires a licence from the Home Office under the Animals (Scientific Procedures) Act 1986. Regulations to control the commercial cloning of animals could be made under the Animal Health and Welfare Act 1984. Cloning was considered acceptable by the 1995 "Committee to Consider the Ethical Implications of Emerging Technologies in the Breeding of Farm Animals" (the Banner Committee). The Farm Animal Welfare Council has been asked to consider the possible implications of cloning for the welfare of farmed livestock, and whether any further moral or ethical issues need to be addressed. Human cloning is the concern of the UK Human Embryology and Fertilisation Authority and the Human Genetics Advisory Commission.

Other Genetic Modification Involving Farm Animals

  20. MAFF's policy on genetic modification of farm animals is guided by the recommendation of the Banner Committee report. The report recognised that existing regulations mean that genetically modified animals are likely to be more thoroughly protected than those produced by conventional means.

  21. Genetic modification of animals is a regulated procedure under the Animals (Scientific Procedures) Act 1986 and requires a licence from the Home Office. The Genetically Modified Organisms (Contained Use) Regulations 1992 and the Genetically Modified Organisms (Deliberate Release) Regulations 1992, both as amended, cover the storage, use, release for research purposes, marketing, transportation and destruction of genetically modified animals.

R&D

  22. MAFF has been the major supporter of work on cloning and has funded research at the Roslin Institute on cloning since 1991 at a cost of over £2 million to date. An additional £1.3 million has been spent on research into the problem of oversized offspring—a syndrome known to occur following in vitro fertilisation. MAFF funded the work because of its potential to contribute towards the genetic improvement of livestock. Following the scientific breakthrough leading to Dolly the cloned sheep, MAFF is now focussing research on improving the efficiency of cloning. Current spend on this by MAFF is £120,000 per year.

  23. In the UK there is a view that the benefits to medicine of producing pharmaceuticals in milk, or of xenografts, may justify genetic modification of animals. In addition, much useful information on human (and some animal) diseases is obtained by creating transgenic animal models of diseases. MAFF is considering one such project on scrapie. However, with present knowledge, many people feel that research to improve livestock performance through genetic modification is not justified. MAFF does not fund such research.

ANIMAL FEEDINGSTUFFS

  24. The European Commission is expected to propose shortly a new Directive covering novel feed materials. This will provide an opportunity for a specific assessment of the implications of feeding GM material to animals. Currently in the UK the ACNFP considers the impact of such feeding on food for the ultimate consumer. A new Advisory Committee of Animal Feedingstuffs will consider GM feed materials when it is set up later this year, liaising closely with the ACNFP.

CONSUMER EDUCATION

  25. An important consideration for consumers when deciding whether to purchase GM foods is an awareness of what the technology involves. MAFF has always recognised the importance of providing information about this and first produced a Foodsense booklet on genetic modification and food in 1995. Last year we commissioned and part funded a mobile exhibition on food biotechnology organised by the Science Museum. We are currently considering a number of further initiatives for disseminating information about the technology which we hope to put in place later this year. In the meantime we are actively supporting a public consultation on biotechnolgy which was announced by the Minister for Science and Technology last November. This is an important mechanism for identifying public concerns about the technology.

4 June 1998



 
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