THE COUNCIL,
HAVING REGARD to Article 5 b) of the Convention on the Organisation for Economic Co-operation and Development (OECD) of 14 December 1960;
HAVING REGARD to the report “Recombinant DNA Safety Considerations – Safety Considerations for Industrial, Agricultural and Environmental Applications of Organisms derived by Recombinant DNA Techniques” (hereafter ‘the report’) which was released in 1986 at the same time as the adoption of this Recommendation;
HAVING REGARD to the ongoing OECD work on the programmes for harmonisation of regulatory oversight in biotechnology and the safety of novel foods and feeds, the related publications, database and reports, including: “Safety Considerations for Biotechnology” [DSTI/STP(91)14]; “Safety Considerations for Biotechnology: Scale-Up of Crop Plants” [ DSTI/STP/BS(92)2/REV5 ]; “Safety Evaluation of Foods Derived by Modern Biotechnology – Concepts and Principles” [ COM/ENV/DSTI/EPOC/BT(92)83 ]; Safety Considerations for Biotechnology: Scale-Up of Microorganisms as Biofertilizers” [OECD, 1995];
RECOGNISING that sharing knowledge and experiences on biosafety and novel food and feed safety in OECD has resulted in significant benefits for Members and non-Members;
HAVING REGARD to the standards developed by other international organisations related to the safety of agricultural and environmental applications of recombinant deoxyribonucleic acid (DNA) organisms;
CONSIDERING that recombinant DNA techniques have opened up new and promising possibilities in a wide range of applications;
RECOGNISING the contributions of these techniques to date and that these contributions are expected to continue to increase in the future;
CONSIDERING that a common understanding of the potential safety issues raised by applications of recombinant DNA organisms provides the basis for international consensus, the protection of human and animal health and the environment, the promotion of international commerce and the reduction of national barriers to trade in the field of biotechnology;
CONSIDERING that the vast majority of large-scale industrial applications of recombinant DNA organisms continues to use organisms which may warrant only minimal containment consistent with good industrial large-scale practice (GILSP);
CONSIDERING that the technology of physical containment is well known to industry and has successfully been used to contain organisms for decades;
RECOGNISING that, when higher-risk organisms containing recombinant DNA are being researched or evaluated, additional criteria for risk/safety assessment may be identified and that these organisms can also be handled and evaluated safely under appropriate physical and/or biological containment;
RECOGNISING that environmental risk/safety assessment of agricultural and environmental applications of recombinant DNA organisms should be approached with reference to, and in accordance with, the decades of experience gained from the extensive use of traditionally bred organisms and recombinant DNA organisms in agriculture and the environment generally, as well as information held in the existing scientific literature and databases, and risk/safety assessments of recombinant DNA organisms;
RECOGNISING that with step-by-step assessment during the research and development process potential risks should be minimised by appropriate measures;
RECOGNISING that experience now exists from the assessment of potential risk of recombinant DNA organisms in industrial, agricultural and environmental applications informed by the step-by-step and case-by-case approaches proposed in the report;
CONSIDERING the significant accumulation of scientific knowledge of, and ongoing advances in, recombinant DNA techniques and applications of recombinant DNA organisms;
CONSIDERING the development of genomic techniques other than recombinant DNA techniques;
RECOGNISING that the accumulated experience of risk/safety assessment of traditionally bred and recombinant DNA organisms for industrial, agricultural and environmental applications may also have relevance to risk/safety assessments of organisms derived by new biotechnology techniques other than recombinant DNA techniques for the same types of applications.
On the proposal of the Chemicals and Biotechnology Committee, in consultation with the Committee for Scientific and Technological Policy:
I. AGREES that this Recommendation applies to risk/safety considerations related to industrial, agricultural, and environmental applications of organisms derived by recombinant DNA techniques.
II. RECOMMENDS that Members and non-Members having adhered to this Recommendation (hereafter the “Adherents”) establish, or update based on experience, and implement domestic regulatory frameworks concerning risk/safety considerations for applications of recombinant DNA organisms. To that effect, Adherents should:
General applications
1. Share, as freely as possible, with a view to facilitating harmonisation in approaches to evaluating and managing applications of recombinant DNA organisms, information on: principles or guidelines for risk/safety assessment under domestic regulations; risk/safety assessments; developments in risk analysis; authorisations and practical experience in risk management;
2. Examine their existing oversight and review mechanisms to ensure that adequate review and control of applications of recombinant DNA organisms can be achieved while avoiding any undue burdens that may hamper innovation and technological developments and their use in this field;
3. Recognise, when working towards international harmonization, that any approach to implementing guidelines should be proportionate to ensure safety while not impeding future developments in recombinant DNA techniques, organisms and their applications;
4. Examine at both national and international levels further developments in science and technology, to facilitate data exchange and minimise trade barriers between countries, taking due account of the ongoing work on standards within the relevant international organisations and bodies/entities;
5. Make special efforts to inform the public about the various aspects of recombinant DNA techniques, organisms and their applications, including domestic regulatory frameworks and risk/safety assessments of industrial, agricultural and environmental applications of recombinant DNA organisms;
6. Monitor the development of recombinant DNA techniques for applications in industry, agriculture and the environment, while recognising that for certain industrial applications, and for agricultural and environmental applications of recombinant DNA organisms, some Adherents have a notification scheme;
7. Ensure that assessment and review procedures protect intellectual property and confidentiality interests, recognising the need for innovation while still ensuring that all necessary information to assess safety is made available.
Industrial applications
8. Ensure, in large-scale industrial applications of recombinant DNA organisms, that organisms which are intrinsically of low risk are used wherever possible and that any appropriate containment measures are applied, including the conditions of Good Industrial Large-Scale Practice (GILSP) described in the report;
9. Encourage, in large-scale industrial applications requiring physical containment, to continue to improve techniques for monitoring and preventing non-intentional release of recombinant DNA organisms.
Agricultural and environmental applications
10. Use the considerable existing scientific data, information and experience on the effects of living organisms (including recombinant DNA organisms) on human and animal health, and the environment to guide future risk/safety assessments;
11. Ensure that, on a case-by-case basis, recombinant DNA organisms are evaluated for potential risks, prior to applications in agriculture and the environment, by means of an independent review. Case-by-case means an individual review of a proposed application of a recombinant DNA organism against assessment criteria which are relevant to the particular proposal, while recognising certain classes of proposals may be excluded from review according to Adherents’ domestic regulatory frameworks;
12. Ensure that the development of recombinant DNA organisms for agricultural or environmental applications continues to be conducted in a stepwise fashion, moving, where appropriate, from the laboratory to the confined experimental facility, to limited field testing, to large-scale field testing and finally, general release;
13. Encourage further research to support the risk/safety assessment and monitoring of applications of recombinant DNA organisms.
III. INVITES the Secretary-General and the Adherents to disseminate this Recommendation.
IV. INVITES non-Adherents to take account of and adhere to this Recommendation.
V. INSTRUCTS the Chemicals and Biotechnology Committee to:
a) Review the experience of Adherents in implementing this Recommendation;
b) Report to the Council on the implementation, dissemination and continued relevance of this Recommendation no later than five years following its revision and at least every ten years thereafter.