In Response
BIAC comments on the
draft ‘Compendium of international and national food safety
systems and activities’
BIAC welcomes the opportunity to comment on the draft ‘Compendium of international and national food safety systems’, which has been prepared by the Ad Hoc Group on Food Safety and will be an important part of the response of the OECD to the G8 mandate. In addition, we would be pleased to submit comments on the revised drafts and summaries to be prepared when available.
General comment
The reports comprehensively illustrate the existence of extensive national and international guidelines and regulatory frameworks for risk assessment and risk management of foods that can be drawn upon, where applicable for the safety assessment of foods derived from modern biotechnology.
COMPENDIUM OF NATIONAL FOOD SAFETY SYSTEMS
I Synthesis
8. Developing national food safety frameworks: It could be mentioned that an increasing number of Member States favour an agency approach over a Ministerial approach to food safety assessment. A comparison of the establishments of agencies and management of food safety evaluations by Ministries may warrant further analysis in section II of the document (see below).
10. Precaution: It is suggested in this paragraph to add the following text: “It should also be recognised that risk assessments are often designed to compensate for uncertainties, including over-estimations of predicted risks. This built-in conservatism should be acknowledged as management decisions are taken.”
· The current proposed changes in the food safety evaluation system of the European Union could be mentioned in a separate point in the section of ‘Areas of continuing development’.
II Overview of food safety systems in OECD member countries
A. Institutional structure and regulatory framework
· A point in which institutional structures based on the establishment of food safety agencies are compared with management of food safety evaluations by Ministries could be included after point 21.
· Points 66. and 67. on the current EU system for scientific advice and proposed changes are already relevant in this section and could be inserted after point 22.
· Further analysis could be included to the extent that one approach is to manage the safety assessment of foods derived from modern biotechnology within or by amendment of existing legal frameworks for food safety assessment, another approach is to implement new legislation for ‘Novel Foods’.
III Activities of OECD member countries in addressing food safety issues
46. It is proposed to add the italicized words to the third sentence: Key issues are the establishment of minimum thresholds for the quantity of genetically modified material present for the purpose of labelling and the definition of ‘substantial equivalence’.
48. We are not aware that Sweden, Norway, Finland and Germany have banned the sale of food products containing genetically modified material. Several food products containing genetically modified materials including foods that contain genetically modified crops, additives derived from GMOs and genetically modified enzymes are approved and commercially available in these countries. Other countries have permitted commercialisation, it is suggested to delete the last three words “to varying degrees”. This point requires clarification.
49. "… Although there are differences in the exact definition and scope of precaution in this context, it is generally acknowledged to imply that controls aimed at preventing possibly serious or irreversible effects on public health may be justified, even if current scientific evidence does not permit a full risk
analysis." àThis is consistent with the definition used in Article 15 of the Rio Declaration on Environment and Development, which is generally the most widely cited internationally-agreed articulation of the concept."
50. Consistent with the suggested changes for Paragraph 10, in commenting that precautionary approaches are an element of risk management, and not risk assessment, and the following sentence, the following point should be added: “However, as noted in Paragraph 10, risk assessments are often designed to compensate for uncertainties, including over-estimations of predicted risks. This built-in conservatism should be acknowledged as management decisions are taken.”
"…tends to be applied after a preliminary risk assessment based on existing scientific knowledge has been undertaken and has indicated that a comprehensive assessment is not possible at the time when a decision must be taken."
51. Consequently, any safety based regulatory measure is an integral part to a precautionary approach.
COMPENDIUM OF INTERNATIONAL FOOD SAFETY SYSTEMS AND ACTIVITIES
I Synthesis
2. Codex Alimentarius are based on the principle of sound scientific analysis and evidence of risks, with regard, where appropriate, to other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in food trade.
7. Paragraph 7 makes the statement that "criteria for establishing an internationally appropriate level of protection do not currently exist within the Codex system". Establishing and imposing an internationally appropriate level of protection would be in conflict with the SPS agreement described under point 3.
8. "There are currently no specific provisions within any international food safety system for the food safety assessment of products of modern biotechnology, (change) "beyond those that are used to evaluate any new food ingredient or additive."
"The safety of" biotechnology has not been a major issue of discussion in WTO".
"Regulation of modern biotechnology": (This statement is used throughout both documents.) Is it the technology itself or the products produced from the technology that are being regulated? It might be better stated as "regulation of products from modern biotechnology".
10. Addressing socio-economic concerns: A sentence could be added to the effect that socio-economic concerns are addressed in food safety policy, but that there are differing views as to whether socio-economic factors should be taken into account in the decision-making process on individual products, the purpose of which is a science-based risk assessment.
11. Add to end: Currently, there are no special plans to include biotechnology-based foods in expansion of food disease surveillance systems.
12. Capacity building: Programmes by UNIDO and ICGEB on capacity building for biosafety evaluation in the developing world, such as workshops for future regulators from developing countries could be mentioned.
"In many countries of the world, the emergence of a food safety agenda, independent of issues related to biotechnology, has underlined the need for strengthening…"
13. "The potential segmentation of GMO and non-GMO markets, in response to market demand or public regulation, will have a direct impact on the international seed trade, especially because of the technical challenges of differentiation and segregating GMO and non-GMO products in the marketplace."
II International organisations with responsibilities for food safety
A2. WHO
In this section a separate point could be added in which reference could be made to contributions of WHO to assess health aspects of marker genes and to shape the principle of substantial equivalence for the safety assessment of Novel Foods derived from biotechnology:
WHO. 1993. Health Aspects of Marker Genes in Genetically Modified Plants. Report of a WHO Workshop. World Health Organization, Geneva. WHO/FNU/FOS/93.6.
WHO. 1995. Application of the Principles of Substantial Equivalence to the Safety Evaluation of Foods and Food Components from Plants Derived by Modern Biotechnology. Report of a WHO Workshop. World Health Organization, Geneva. WHO/FNU/FOS/95. 1.
B2. Other FAO/WHO joint activities
In this section additionally to mentioning the Expert consultation on Biotechnology and food safety in Rome in 1996 more explicit reference could be made in a separate point to the important contributions of joint FAO/WHO activities towards establishing the principle of substantial equivalence for the safety assessment produced by biotechnology.
WHO, 1991. Strategies for Assessing the Safety of Foods Produced by Biotechnology. Report of a Joint FAO/WHO Consultation. World Health Organization, Geneva.
FAO/WHO. 1996. Biotechnology and food safety. Report of a Joint JAO/WHO Consultation. FAO, Food and Nutrition Paper 61.
III Activities addressing Food Safety Issues
117: "Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the potential adverse effects of a LMO on, inter alia, risks to human health, shall not prevent an importing Party from taking a decision in order to avoid or minimise such potential adverse effects. à It should be noted that in implementing such action, parties are referred specifically to the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, as stated in the Preamble to the protocol.
122. “As long as these obligations are met, governments may take socio-economic concerns into account in their food safety decisions.” It might be more accurate if this statement were replaced with a sentence referring to ongoing work by the Codex Committee Committee on General Principles on defining ‘other legitimate factors’ that can be taken into account in decisions on food safety, as has been done in other parts of the document (see points 48. and 55.).
H. Capacity building
A point could be added on programmes by UNIDO and ICGEB to help capacity building for biosafety evaluation in the developing world, such as workshops for future regulators from developing countries.
April 2000
