ACNFP response To Friends of the Earth report - The Great Food Gamble

2001: The report sets out the reasons why the Friends of the Earth is opposed to the introduction of GMOs and why they believe the current regulatory system for the safety assessment for GM foods, is inadequate. The ACNFP felt they should respond since the report questions fundamental aspects of the safety assessment of GM foods, which is currently carried out by the ACNFP.
  1. The ACNFP has seen the report issued for Friends of the Earth, entitled " The Great Food Gamble". The ACNFP and Friends of the Earth have a common goal seeking to protect the health and safety of consumers and we agree with many of the points raised in the report. However, we do not agree with the interpretation of some of the data presented. These particular issues are discussed in more detail below.
  2. The Advisory Committee on Novel Foods and Processes (ACNFP) is the independent body, appointed by the Food Standards Agency (FSA), to carry out the assessment of novel foods in the UK. Committee Members are appointed to ensure that a wide range of relevant scientific expertise and knowledge is represented on the Committee. There are also two lay Members: a consumer representative and an ethicist. Members do not represent any organisations or commercial interests and Members have to declare any interests they have in the food or biotechnology industry. Appointments are made under the Nolan rules, which set out procedures to be adopted when appointing members to public bodies.

Chapter 2: The Challenge of GM crops
The issues raised in this chapter by the Friends of the Earth report included:

  • Concerns over the survival of Agrobacterium tumefaciens in GM plants and that genetic modification is a random, haphazard process.
  • The use of the CaMV 35s promoter.
  • Possibility of unexpected effects, and their detection.
  • The use of Antibiotic Resistance Markers (ARMs)

Concerns over the survival of Agrobacterium tumefaciens in GM plants and genetic modification is a random, haphazard process

  1. The report suggests that genetic modification of crops is a random, haphazard process and therefore raises concerns over its safety. The question arises as to whether it is more or less hazardous than conventional breeding. It can be argued that the production of GM crops is more precise due to:
    • the greater definition of inserted material, in terms of the DNA sequence and knowledge of insertion site, and that;
    • GM plants receiving much greater levels of testing than conventionally produced varieties.

The important point is that the focus should be on the products per se and their risk rather than on the technology used to produce them.

  1. The use of the CaMV 35s promoter
    The safety of the cauliflower mosaic virus (CaMV) 35s promoter and Agrobacterium is considered as part of the safety assessment of individual products, where such technology has been used in the genetic modification process. Agrobacterium tumefaciens is widespread in nature and for centuries has naturally infected and transformed plants. Throughout this time, plant material from these infected, genetically transformed plants have been eaten: no ill effects have been reported. Similarly, the cauliflower mosaic virus is found worldwide in temperate regions and is common in commercial crops of cabbage, Brussels sprouts, and cauliflower. Although some have questioned the safety of the CaMV 35s promoter, this hypothesis is not supported by the majority of research in this area which has been published in peer-reviewed journals.
  2. The cauliflower mosaic virus promoter is termed constitutive, which means it is expressed in a non-tissue specific fashion throughout the plant. However, there can be variation in tissue expression between independently transformed plants carrying this promoter. This variation is generally believed to derive from position effects, where the expression of a transgene can be influenced by the adjacent endogenous plant genetic material. Genes associated with this promoter will follow the same pattern of expression. The risk assessment takes into consideration both the pattern of expression and level of the novel proteins.
  3. Possibility of unexpected effects, and their detection
    When conferring a specific-target trait (intended effect) to a plant by the insertion of defined DNA sequences, additional traits could, in some cases, be acquired or existing traits could be lost or modified (unintended effects). Unintended effects may be deleterious, beneficial, or neutral with respect to the health of the plant or the safety of foods derived form the plant. The assessment for safety of a GM food must address both intentional and unintentional effects that may occur as a result of the particular genetic modification.
  4. The issue of unintended effects is considered in both the draft Codex guidelines1 and the 2000 FAO/WHO joint report2 for the safety of GM foods. Unintended effects resulting from genetic modification include alterations to the physical properties (phenotype) of an organism, such as changes in growth or environmental tolerances. Such effects are readily apparent in the commercial development phase following the initial transformation and, where necessary, is eliminated by appropriate selection procedures (such as   consecutive back-crossing ) . GM plants are further reviewed in the two year plant variety national listing tests that new conventionally produced varieties undergo to establish that their traits are distinctive, uniform and stable. Any varieties that do not satisfy these requirements cannot be grown commercially. The safety implications of any other unintended effects, such as alterations in the levels of key nutrients or natural toxicants, where appropriate are, assessed by evaluation of nutritional toxicological and compositional data.
  5. Present approaches to assess possible unintended effects are based, in part, on the analysis of specific components (targeted approach). The 2000 FAO/WHO expert consultation was satisfied with the approval used to assess the safety of GM foods that have been approved for commercial use. However, as pointed out in this report, '...some aspects of the steps in the safety assessment process could be refined to keep abreast of developments in genetic modification technology. New methodologies, such as profiling techniques, offer the means of providing a more detailed analytical comparison (ibid.).' This will be especially important for more complex genetic modifications perhaps involving multiple traits. However, these methods are not yet fully developed and validated and will have certain limitations.
  6. The Food Standards Agency funds an on-going research programme that addresses the safety of GM foods. It has recently launched a major three-year programme, to examine the use of a variety of existing and emerging techniques, to further refine the current safety assessment procedures for GM foods for the next generation of GM plants.
  7. The use of Antibiotic Resistance Markers (ARMs)
    It is recognised that there are concerns associated with the use of antibiotic resistance markers (ARMs) in genetically modified food crops. The ACNFP has published two reports3 addressing a number of these issues. The Committee concluded that researchers should be encouraged to develop and use alternatives to ARMS or improve methods to excise those used. The Committee's conclusions were endorsed in the 1999 Chief Medical Officer's report on the Health Implications of Genetically Modified Foods.
  8. The recent codex draft guidelines on safety of GM foods, encourages the use of alternatives to ARMs and the phasing out of markers for resistance to clinically used antibiotics in widely used foods. Furthermore, Article 4 (2) of the new Directive 2001/18/EC4, which replaces 90/220/EEC on the deliberate release into the environment of genetically modified organisms, lays down the requirement to ensure that particular consideration is given to GMOs which contain genes expressing resistance to antibiotics in use for medical or veterinary treatment. It stipulates that the use of antibiotic resistance markers in GMOs, to be placed on the market, which may have adverse effects on human health and the environment, should be phased out by the 31 December 2004.

Chapter 3: Substantial Equivalence
The issues raised in this chapter by the Friends of the Earth report included:

  • The use of the concept of substantial equivalence.
  • Confusion with defining and interpreting substantial equivalence.
  • Recognises limitations of conventional toxicology studies.
  1. The use of the concept of substantial equivalence
    The Royal Society of Canada (RSC) published a report in January 2001, 'Elements of Precaution: Recommendations for Regulation of Food Biotechnology in Canada'. This was widely interpreted as the RSC criticising the concept of substantial equivalence. However, on a deeper examination of the report, it can be seen that the RSC supports the use of substantial equivalence on the basis that it is used to structure the safety assessment and that rigorous scientific analysis is used to determine whether the modified organism poses no more risk to health or the environment than its conventional counterpart.
  2. The FAO/WHO expert consultation considered the concept of substantial equivalence as part of its review on the current safety assessment procedure for GM foods in May 2000 and recognised 'that there were presently no alternative strategies that would provide a better assurance of safety for genetically modified foods than the appropriate use of the concept of substantial equivalence' and that 'substantial equivalence should be seen as a key step in the safety assessment process'. The ACNFP fully supports that view.
  3. The Food Standards Agency Board, at its meeting in June 2000, reviewed the safety of GM foods. The Board was satisfied that the current safety assessment procedures for GM foods, using the concept of substantial equivalence, are sufficiently robust and rigorous to ensure that approved GM foods are as safe as their non-GM counterparts.
  4. Confusion with defining and interpreting substantial equivalence
    The application of the substantial equivalence concept is not a safety assessment in itself: it does not characterise the hazard, rather it is used to structure the safety assessment of a genetically modified food relative to its conventional counterpart, whereby the identification of the similarities and differences between the genetically modified food and a comparator with a history of safe food use guides the safety assessment process. It is important to stress that safety is not determined solely on the basis of a consideration of compositional changes.
  5. A further misunderstanding may arise with regards the use of the term 'substantial equivalence' in relation to notifications made under article 5 of the EC Novel Foods Regulation. This is a simplified procedure under which a company can notify the European Commission that they intend to place a highly refined food ingredient on the market. Such notification are supported by a scientific opinion from a Member State that the ingredient is substantially equivalent to existing foods or food ingredients as regard their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein. The ACNFP have considered which types of food ingredients derived from GMOs they would, in the future, provide opinions to support notifications under article 5 of the Novel Food Regulation. They recommended that such opinions should only be provided for highly refined and processed products derived from GM sources that do not contain any novel genetic material. Any new product containing novel DNA or Protein has to go through the full assessment procedure. Other Member States and the Commission endorsed this approach.
  6. Recognises limitations of conventional toxicology studies
    The FAO/WHO expert consultation 2000 report, notes that the practical problems of obtaining meaningful information from animal-based toxicology studies on the safety of whole foods have been well recognised for many years (see OECD 19965). Foods are complex mixtures of compounds, which have a wide variation in their composition and nutritional value. They can only be fed to animals at low multiples of the amounts that might be present in the human diet. Identifying potential adverse effects and relating these to the food and not other factors can therefore be extremely difficult for a number of reasons. In practice, very few foods consumed today have been subject to studies on animals. However, they are generally accepted as safe to eat.
  7. The report concludes that the utility of such animal-based tests has to be considered on a case-by-case basis and that, in specific cases, animal testing may be useful. The ACNFP considers each GM food individually and will consider the need for animal test data in consideration of the overall toxicological profile of the GM food in question. Full details are outlined in an ACNFP paper on the toxicological issues relevant to the safety assessment of novel foods. This information is available on the FSA web site or from the ACNFP Secretariat.

Chapter 4: Establishing the safety of GM foods
The issues raised in this chapter by the Friends of the Earth report included:

  • Allergenicity
  • Lack of published data
  1. Allergenicity
    As explained above the assessment for safety of a GM food must address both intentional and unintentional effects (see response to chapter 2) that may occur as a result of the genetic modification process involved.
  2. Predicting the potential allergenicity of novel proteins is an important part of the safety assessment of any novel foods. There is a range of assessments which can be used to determine whether a protein is likely to be allergenic or not. The 2001 FAO/WHO report6 concluded that a stepwise, case-by-case approach should be applied to the evaluation of the allergenicity of food derived from biotechnology. This approach focuses on the source of the gene, the sequence homology of the newly introduced protein to known allergens, the immunochemical binding of the newly introduced protein with IgE from the blood serum of individuals with known allergies to the transferred genetic material, and the physicochemical properties of the newly introduced protein (molecular weight, sequence homology, heat and processing stability), effect of pH and/or gastric juices (digestive stability), and prevalence in foods. The FSA funds an on-going research programme that addresses the problems associated with detecting potential allergens.
  3. The 2000 FAO/WHO report states that the ability to change nutrient levels in crop plants through plant breeding, including the use of recombinant DNA techniques, has the potential to result in broad changes in at least two ways: (1) the intended modification in plant constituents could change the overall nutrient profile of the plant product and this change could affect nutritional status of the individual, (2) in addition, unexpected alterations in nutrients could also affect nutrient profiles of the product and nutritional status of people. Although the genetically modified plant components may be assessed as safe individually, it will be important to determine if the overall nutrient profile of a GM food has been changed and if dietary intake patterns are altered by the introduction of foods from GM plants. The introduction of a significant nutritional change in a food may require post-market assessment to determine whether the overall diet has been altered and to what degree, before an assessment of the impact on nutritional status can be made.
  4. Where additional assurance of safety is sought, analytical methods traditionally applied in the evaluation of food constituents such as total protein, fat, ash, fibre and micronutrients may need to be augmented with additional analyses to identify unexpected effects and altered nutrient profiles and bioavailability which may impact on dietary intake and health.
  5. Lack of published data
    In line with the FSA's policy of openness and transparency the ACNFP makes public all non-confidential information submitted to it as part of an application to market a novel, including GM, food in the UK. The data are made available electronically at the beginning of the evaluation process on the ACNFP web page at:This offers anyone the opportunity to evaluate the supporting data in the dossier and to submit comments that the ACNFP can take into account as part of its deliberations. The Committee's draft conclusions are also offered for comment before being finalised. This means that the public has the opportunity to contribute to the safety assessment process. Prior to December 1999 when the openness policy was adopted all application dossiers were made available in the British Library. All ACNFP reports have been made public and Annual reports have been published for over 10 years.
  6. The Government set up the Agriculture and Environment Biotechnology Commission to advise Government on the ethical and social implications arising from biotechnology developments and their public acceptability and this forum allows for a wider public debate. In addition, all FSA board meetings are held in public and minutes and papers are on the FSA website.

Chapter 5: The US's GM guinea pigs
The main issue raised in this chapter by the Friends of the Earth report:

  • The lack of labelling of GM foods in the US means that any adverse health effects cannot be linked to GM food exposure.
  1. Whilst the ACNFP cannot comment on the US legislative position regarding labelling, the Committee is aware that U.S. Food and Drug Administration (FDA) commissioned the U. S. Center for Disease Control7 to investigate reports of human illnesses potentially associated with the Cry9C protein in StarLink corn. The report concluded that although the participants in the research may have experienced allergic reactions, it was impossible to confirm, on this basis of this study, that any reported illness was associated with the consumption of corn products containing the Cry9c protein. The ACNFP attaches considerable importance to evaluating the allergic potential of genetically modified foods before they entered the human food chain.
  2. The Chief Medical Officer and Chief Scientific Advisor recommended that some system of population health surveillance, in relation to consumption of GM and other novel foods, be established in their report (Health implications of Genetically Modified Foods, 1999). The ACNFP has considered the question of post market monitoring of GM foods and held a number of open meetings to consider how such monitoring might be conducted. Observers from various organisations, including Greenpeace and Consumers Association attended these ACNFP meetings. A feasibility study on post market monitoring is underway.
  3. Conclusion
    The ACNFP agrees with many of the points raised in the report issued by Friends of the Earth. However, there are some areas where the ACNFP disagrees with the interpretation of the data presented and has set out the basis of its position. The Committee shares the goal of Friends of the Earth of seeking to protect the health and safety of consumers. The Committee is satisfied that current safety assessment procedures allow for a robust and rigorous evaluation of the safety of GM foods. The Committee acknowledges that in order to meet the safety assessment challenges that will be posed by the future GM developments, further research will be needed to refine and further develop the techniques used. The Committee is aware that the Food Standards Agency is funding work in this area and welcomes this initiative.

1. Codex Ad Hoc Intergovernmental Task Force on foods derived from biotechnology (At Step 5 of the Elaboration Procedure), guidelines for the conduct of food safety assessment of foods derived from recombinant DNA plants

2 the 2000 FAO/WHO joint report - Safety aspects of genetically modified foods of plant origin

3 1994 Report on the Use of Antibiotic Resistance Markers in Genetically Modified Food Organisms and in 1996 (The Use of Antibiotic Resistance Markers in Genetically Modified Plants for Human Food - Clarification of Principles for Decision-Making)

4 Official journal of the European Communities (OJ) L106/1 17.4.2001

5 OECD (1996): Food Safety Evaluation. Report Workshop held in Oxford UK, Sept. 12-15, 1994. ISBN 92-64-14867-1

6 2001 FAO/WHO report: 'Evaluation of Allergenicity of GM Foods'. Regarding the approach to use for the prediction of allergenicity of GM foods

7 the U. S. Center for Disease Control "Investigation of Human Health Effects Associated with Potential Exposure to Genetically Modified Corn" 2000