Select Committee on European Communities Second Report - Written Evidence


Memorandum by the Organisation for Economic Co-operation and Development

  1. For the purpose of this evidence, it is necessary to define precisely what are "genetically modified" or "biotechnology" products, since both of these terms (and in particular "biotechnology") can be used somewhat indiscriminately to describe products developed by a variety of traditional and novel techniques. For the purpose of this evidence, the described work on safety and regulation of biotechnology products is relevant to agricultural products developed using the techniques of recombinant DNA technology.

  2. The Member countries decided in 1980 that biotechnology issues should be a part of the OECD work programme. In 1982, "Biotechnology: International Trends and Perspectives" was published. Authored by Professors Alan Bull (University of Canterbury), Geoffrey Holt (The Polytechnic of Central London) and Malcolm Lilly (University College London) this report drew upon the expertise of 14 experts from Europe, Japan and the United States. The report focused primarily on biotechnology (in this case recombinant DNA and other techniques) and micro-organisms, and resulted in a number of recommendations with respect to research and development, training, industry-university links, economic impacts, and patents, and specifically recommended that there was a necessity to study and implement new and pragmatic safety measures.

  3. In response to this recommendation, and as requested by the OECD Committee for Scientific and Technological Policy, an Ad hoc group of almost 80 national experts (The Group of National Experts on Safety in Biotechnology) made up from 22 of the OECD Member countries, including five from the United Kingdom and seven from the Commission of the European Communities, published "Recombinant DNA Safety Considerations: Safety Considerations for Industrial, Agricultural and Environmental Applications of Organisms Derived by Recombinant DNA Techniques". This 1986 report is commonly referred to as "The Blue Book".

  4. In the Blue Book, the group of national experts makes a clear distinction between traditional biotechnologies, such as the use of micro-organisms for wine production and the selection and breeding of agricultural crop plant varieties, and the new techniques using recombinant DNA (more commonly called "genetic engineering"). In the Blue Book, which made the fundamental point that any risks raised by recombinant DNA organisms are expected to be of the same nature as those associated with conventional organisms, are specific recommendations, the first step in the harmonisation process of safety principles and practices among the Member countries of the Organisation. In the early 1980s, consideration focused primarily on recombinant DNA safety in laboratory and industrial fermentation systems, and the 1986 Blue Book made corresponding recommendations on safety criteria for "Good Industrial Large Scale Practices". With respect to agricultural and environmental applications of recombinant DNA the Blue Book made the following recommendations:

    —  use the existing considerable data on the environmental and human health effects of living organisms to guide risk assessments;

    —  ensure that recombinant DNA organisms are evaluated for potential risk prior to applications in agriculture and the environment by means of an independent review of potential risks on a case-by-case basis;

    —  conduct the development of recombinant DNA organisms for agricultural or environmental applications in a stepwise fashion, moving where appropriate, from the laboratory to the growth chamber and greenhouses, to limited field testing and finally, to large-scale field testing;

    —  encourage further research to improve the prediction, evaluation and monitoring of the outcome of applications or recombinant DNA organisms.

  5. In the Blue Book, the Group of National Experts chose not to consider ethical issues, but rather, paid specific attention to the identification of scientific criteria relevant to the safety assessment and safe use of recombinant DNA products. The publication of the Blue Book was timely as many countries were setting up the regulatory structures considered necessary for notification and assessment of biotechnology products, prior to their proposed introduction into the environment for testing or for commercial use.

  6. The OECD Council adopted the "Blue Book" recommendations in 1986, thus expressing a high degree of commitment by Member countries to adopt the common scientific framework set out in report.

  7. In 1992 the Group of National Experts published "Safety Considerations for Biotechnology", which elaborated upon the principles set down in the "Blue Book", emphasising Good Industrial Large-Scale Practice for the use of genetically engineered micro-organisms, but more importantly for agricultural purposes, the design of small-scale field research with genetically modified plants and micro-organisms. This was followed in 1993 (77 experts including seven from the United Kingdom) with "Safety Considerations for Biotechnology: Scale-up of Crop Plants", and in 1994 (130 experts including 11 from the United Kingdom) "Safety Considerations for Biotechnology: Scale-up of Micro-organisms as Biofertilizers".

  8. These two publications, apart from reaffirming the basic "Blue Book" safety principles in a "Preamble", developed further the principles of safety assessment and environmental safe use of genetically engineered plants and micro-organisms. In particular, the crop plant document, using the concept of "familiarity", explained how existing data on crop plant species development, the novel attribute engineered into the plant, the environment of proposed introduction, and information on crop plant species/environment interactions are all relevant in the case-by-case safety assessment of genetically engineered crop plants.

  9. The basic principles having been set out by the Group of National Experts, biotechnology work at the OECD then split into two areas: that of basic and applied research and intellectual property rights, which came under the purview of the Working Party on Biotechnology reporting to the OECD Committee for Scientific and Technology Policy; and plant and micro-organism biosafety which is conducted by the Expert Group on Harmonisation of Regulatory Oversight in Biotechnology, formed in 1994 and which is under the purview of the Joint Meeting of the Chemicals Group and Management Committee, also makes its work available to the OECD Environmental Policy Committee.

  10. The first task of the Expert Group on Harmonisation was to survey Member countries on their biotechnology regulatory processes, on the information requirements detailed under those regulations, and on agricultural products that were commercialised. Details of these can be found in Monographs 99, 100 and 107 published in 1995: "Commercialisation of Agricultural Products Derived through Modern Biotechnology: Survey Results"; "Analysis of Information Elements Used in the Assessment of Certain Products of Biotechnology"; and; "Report of the OECD Workshop on the Commercialisation of Agricultural Products Derived through Modern Biotechnology" [these publications are enclosed] [not printed].

  11. The survey showed that, among the Member countries, the regulation of biotechnology products was the responsibility of a variety of different government agencies, and that their authorities were achieved through new legislation, existing legislation that had been modified or through published guidelines. Nonetheless, Member countries were adhering to the basic safety principles published in the "Blue Book" thus bearing out the commitment made by OECD Council, in 1986, when it adopted the common scientific framework for biotechnology safety. The analysis of information elements required for safety assessment was particularly interesting, as it showed a very great similarity among the Member countries. These surveys show that, at the technical level, there is already considerable harmonisation of biosafety assessment principles among the Member countries.

  12. Given the common approach to regulation of biotechnology products among the Member countries, the Expert Group on Harmonisation (which includes delegates from the UK) then developed a work plan that would provide more detailed science on the specific biology of plants and micro-organisms, the specific novel traits being engineered into these, and issues of risk resulting from specific types of modification. These "Consensus Documents" which reiterate the common "Preamble", present scientific data that is mutually recognised by the Member countries, and which is intended to assist in regulatory decision making. In fact, these Consensus Documents may be considered as case-by-case technical descriptions of the components of "familiarity", described in the 1993 "Safety Considerations for Biotechnology: Scale-up of Crop Plants".

  13. To date four Consensus Documents have been made available for general distribution: "Consensus Document on General Information Concerning the Biosafety of Crop Plants Made Virus Resistant through Coat Protein Gene-Mediated Protection"; "Consensus Document on Information Used in the Assessment of Environmental Applications Involving Pseudomonas"; "Consensus Document on the Biology of Brassica napus L. (Oilseed rape)"; and, "Consensus Document on the Biology of Solanum tuberosum subsp. tuberosum (Potato)". [These publications are enclosed.] [not printed.] The Expert Group has a number of plant and micro-organisms biology consensus documents, as well as specific and general novel trait documents, under development and anticipates their publication for general use on a regular basis.

  14. As an outreach activity, the Expert Group makes all of its work available on its Internet site "BioTrack Online" [see enclosed information] [not printed]. This includes links to the regulatory agencies in the Member countries, information on field tests and commercialisation of biotechnology products, and published consensus documents. This information, which is available to all interested persons, provides transparency to the biotechnology regulatory processes in the Member countries and assists in enabling greater regulatory harmonisation. Also, through its outreach programme, and with the assistance of the United Nations Environment Programme and the United Nations Industry Programme, scientific information from non-member countries that are centres of origin and diversity of crop plant species is available for inclusion in the crop plant species biologies.

  15. With respect to point 1(c) in your letter, the OECD member countries have also worked on the safety of novel foods, though not specifically on the issue of whether or how they should be labelled. "Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles" was published in 1993.

  16. This food safety work was undertaken by the Group of National Experts (59 participants including two from the UK and three from the Commission of the European Communities) and is directly related to the 1986 "Blue Book" and the 1992 "Safety Considerations for Biotechnology". The Group of National Experts, recognising benefits to health, nutrition and food preservation resulting from the application of modern biotechnology to food production and processing, elaborated on the scientific principles necessary to assure that the safety of new foods and food components will be at least substantially equivalent to that of widely accepted conventional counterparts. The working group developing the document considered the application of the concept of "substantial equivalence" to be the most practical way to address the issue of food safety. This concept is based on a comparison of a novel food with a traditional food counterpart that has a safe history of use. The publication presents examples of novel food safety assessment through a series of micro-organism, plant, and animal case studies.

  17. In 1994, the OECD held a workshop, "Food Safety Evaluation", with collaborative support from the World Health Organisation, in Oxford, UK (52 delegates including 10 from the UK and two from the Commission of the European Communities). This workshop further explored strategies that could be used in establishing the safety of biotechnology derived foods when no conventional counterpart exists for comparison.

  18. In 1997 another OECD workshop "The Toxicological and Nutritional Testing of Novel Foods" [report in Press], was held in Aussois, France (in attendance were 64 delegates including three from the Commission of European Communities and seven from the UK). The workshop affirmed the conclusions and recommendations of previous consultations of OECD and of the FAO/WHO regarding the utility of the concept of "substantial equivalence" in establishing the safety of foods and food components derived from genetically modified organisms, and noted that the concept had broader application establishing the safety of novel foods. The 1996 FAO/WHO consultation referred to had concluded, in line with earlier FAO, WHO and OECD recommendations, that the food safety considerations regarding organisms produced by recombinant DNA technology are basically of the same nature as those that might arise from other ways of altering the genome of an organism, such as conventional breeding. That consultation also agreed that the comparative approach embodied in the OECD concept of "substantial equivalence" is the basic tool in the assessment used to establish the safety of foods derived from genetically modified plants.

  19. As part of an OECD study on regulatory reform, "Uses of Food labelling Regulations, the OECD Report on Regulatory Reform: Volume I", was published in 1997. This study provides an overview of labelling regulations in the context of the food industry as a whole. Where appropriate, particular reference is made to the potential value of labelling regulations in ensuring food safety. I would draw your attention in particular to section V.3.: "Process Attributes: Use of Biotechnology and Environmental Impacts." This publication is submitted for your consideration [not printed].

  20. Finally, "Biotechnology for Clean Industrial Products and Processes" [in Press], while not directly addressing agricultural biotechnology, states in a chapter on "National and International Policies" that:

    —  International agreements often serve as a basis for national policies and legislation on clean industrial products and processes.

    —  Government policy is a major driving force for clean technologies but can have positive or negative effects, so that both of these require careful consideration.

    —  While many countries consider biotechnology as a critical enabling technology, they have not identified it as a preferred tool for achieving cleaner products and processes; and,

    —  Policies that affect the marketplace can be most effective in driving change.

Consequently "Government policy, as reflected in regulation, legislation and guidance is recognised as a major driving force behind cleaner technologies, and in many cases and countries, the single most decisive factor in their development and diffusion." The report was developed by an Ad hoc task force responsible to the Committee for Scientific and Technological Policy.



 
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