Strengthening the Biological Weapons Convention
Briefing Paper No 7: Article X : Further Building Blocks
Executive Summary
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Attention is being given by the Ad Hoc Group (AHG) to measures to implement Article X of the Convention in accordance with its mandate. As progress is being made on the development of the rolling text for the Protocol to strengthen the Convention, it is timely to consider how the implementation of Article X might contribute to the strengthening of the effectiveness of the Convention. Briefing Paper No 6 considered some of the developments that have occurred nationally, regionally and internationally in respect of the use of bacteriological (biological) agents and toxins for peaceful purposes. It noted that there is increasing awareness world-wide because of public health and environmental concerns of the need to control the handling, use, storage and transfer of such biological agents. That Paper examined some of the current controls and regulations for biological agents and the international initiatives that are ongoing to strengthen biosafety around the world. These were seen as building blocks which might be considered from a point of view of strengthening the BTWC as well as contributing to the implementation of Article X.
This Paper is complementary to Briefing Paper No 6 as it considers the national regulations in the UK, the EEC and in the United States as well as some other countries in respect of micro-organisms and biosafety with the aim of providing some further building blocks to be considered in the strengthening of the BTWC and the implementation of Article X of the Convention. The challenging goal is to identify how these other national, regional and international activities can be utilised to contribute to the strengthening of the BTWC.
UNITED KINGDOM REGULATIONS
There have been tight controls for a number of years in the United Kingdom on the control of human, animal and plant pathogens which have stemmed from concerns about both the health and safety of workers exposed to such pathogens and also the dangers to human health and to the animal and plant environment that could arise should such pathogens be released into the environment. Information about such activities have to be provided to the Government inspectorates responsible for implementation of the national regulations and controls. These national controls have in recent years been harmonized with those for elsewhere in Europe through the Directives of the European Community. The UK Regulations for human, animal and plant pathogens are considered in turn.
EUROPEAN COMMUNITY DIRECTIVES
The European Community Directives aim to harmonise the various controls that have generally previously operated nationally in member states. As the European Community expands in size the number of States covered by these Directives will be increased. Within the European Community there is widespread harmonization of the regulations controlling human, animal and plant pathogens. Many of these are aimed at protecting human health and the environment. Information is required to be provided generally for prior approval to the appropriate authorities in the Member States and, to a varying extent, this may be shared with other Member States.
UNITED STATES OF AMERICA
There are extensive US regulations for human, animal and plant pathogens. In this Paper attention is given primarily to controls of pathogens that "have the potential to pose a severe
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threat to public health and safety." Information is provided on the United States code relating to the regulation of biological products and to the new rules effective 15 April 1997 for the shipping and handling of select agents capable of causing substantial harm to public health. The handling and transfer of select agents having the potential of posing a serious threat to public health and safety -- which unsurprisingly closely reflect those regarded traditionally as biological warfare agents -- are tightly controlled.
ORGANIZATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT
The OECD has recognized the importance of encouraging its Member countries to harmonize their regulations for biotechnology with particular emphasis on guidelines for the safety of work with recombinant DNA.
UNITED NATIONS INDUSTRIAL DEVELOPMENT ORGANIZATION
A useful source of information is the Biosafety Information Network and Advisory Service (BINAS) which monitors international developments in regulatory issues in biotechnology as a service of UNIDO. Information from the BINAS website regarding the regulations in China, India, Egypt, Malaysia, Nigeria, the Russian Federation and South Africa is outlined. Although these differ in detail, there is a general move towards categorization of activities involving genetically modified organisms according to the evaluated risks and for those with higher potential risks, requiring prior application and approval which may frequently involve inspection by national authorities.
CONCLUSIONS
This Paper is complementary to Briefing Paper No. 6 which demonstrated the immense ongoing international activity in all regions of the world to improve biosafety in biotechnology and to build capacity. The regulations described in both Briefing Papers are all driven by an international awareness of the potential dangers to the environment and to public health that may result from the release of micro-organisms into the environment. The requirements are generally for notifications to be made to national authorities which provides relevant information to enable the national authority to consider whether to approve the proposed activity. Inspection provisions are made in many countries to confirm compliance with the regulations or to investigate possible breaches.
There is an international framework of regulations and controls for living modified organisms which are frequently based on the controls for unmodified organisms. The resulting improved transparency and enhanced confidence that pathogenic organisms are being used safely for permitted purposes can contribute to improving international confidence that States are in compliance with the BTWC. It is apparent that in many countries, information is already being collected and submitted to national authorities about activities and facilities handling, using or transferring dangerous pathogens with inspections being carried out to confirm that the regulations are being complied with. The relevance of all of this to the negotiations to develop a Protocol to strengthen the BTWC will be evident in that in many countries for public health and environmental safety reasons national authorities are already establishing regulations, collecting relevant information about facilities and activities and inspecting these facilities and activities. The BTWC Protocol is likewise likely to contain declarations and inspections of facilities and activities together with national implementation measures, as well as measures to improve implementation of Articles III and X of the Convention. There is potential for a two way synergy between the strengthening of the BTWC and the strengthening of national procedures for the handling, use and transfer of harmful pathogens for public health and environmental safety. In regard to the strengthening of the implication of Article X of the BTWC, there appears to be scope for measures to facilitate the harmonization of national, regional and international safety rules for pathogens involving both the collection of data and the inspection of facilities thereby enhancing both national public confidence as well as regional and international security.
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The Biological and Toxin Weapons Convention Database forms part of the Project on Strengthening the Biological and Toxin Weapons Convention and Preventing Biological Warfare, which is based in the Department of Peace Studies, University of Bradford, UK.
Updated 21 August 98.