Australasian Biotechnology (backfiles) AusBiotech ISSN: 1036-7128 Vol. 8, Num. 1, 1998

Protocol on Biosafety

Corinne Tomkinson

Environment Branch, Department of Foreign Affairs and Trade, Barton, ACT 2600

Code Number:AU98009
Sizes of Files:
      Text: 10K
      Graphics: No associated graphics files

Background

International negotiations are underway on a Protocol on Biosafety, to the Convention on Biological Diversity. The decision to develop a Protocol was made by the Conference of Parties to the Convention at their second meeting in November 1995, consistent with Article 19 (3) of the Convention. The specific mandate states that Parties would develop "in the field of the safe transfer, handling and use of living modified organisms, a protocol on biosafety, specifically focusing on transboundary movement, of any living modified organism resulting from modern biotechnology that may an have adverse effect on the conservation and sustainable use of biological diversity, setting out for consideration, in particular, appropriate procedures for advance informed agreement".

While living modified organisms (LMOs) are still to be defined in the context of the Protocol, they are understood by most industrialized countries to include organisms in which the genetic material has been altered through modern biotechnology, and which are capable of propagation in ways which do not occur in nature. They include a wide range of plants, animals and micro-organisms, including food and pharmaceutical products, with wide application to agricultural production, environmental management and public health. Transboundary movement of LMOs occur for contained scientific research, controlled field trials or general release into the environment for production, processing or consumption.

The first meeting of the Ad Hoc Working Group on Biosafety (BSWG I) in July 1996, established by the Conference of Parties to conduct negotiations, requested governments to submit proposals on issues to be covered under a Protocol. An Australian submission was lodged in December 1996. At BSWG II in May 1997 governments were requested to submit draft legal texts for a Protocol by 1 August 1997. An Australian draft legal text was amongst the 23 texts submitted, which were considered at BSWG III in October 1997. The Chair of the BSWG, Mr Veit Koester of Denmark, is producing a Chairman's text of the draft Protocol based on government submissions and discussions, to be used as a basis for negotiations at BSWG IV in February 1998. Further BSWG meetings are scheduled for July and December 1998, with the aim of reaching agreement on the Protocol by the end of 1998.

Key Issues

The Protocol will provide a legally-binding international agreement to regulate the safe transboundary movement of LMOs. One of the issues to be resolved will be whether the Protocol should also cover the domestic use and handling of LMOs, such as through a harmonization of international biosafety standards. Some countries have called for the Protocol to address the socio-economic consequences of trade in LMOs, in addition to potential environmental and public health effects. Some have also argued for the Protocol to cover the non-living products of LMOs, while others believe that these pose no threat to biodiversity and are outside of the scope of the Protocol . Differences also exist over possible liability and compensation provisions in the Protocol.

The central issue in the Protocol is the establishment of procedures for importing countries to give prior consent for the import of LMOs, through a system known as Advance Informed Agreement (AIA). Issues to be resolved include responsibility for import notification and risk assessment, time frames for decision making, review of import decisions, treatment of LMOs as subsequent imports or in transit, simplified procedures in certain low risk cases, and bilateral and regional arrangements. There are also various views on the appropriate scope of the AIA procedure. Proposals range from universal coverage, to the development of either positive or negative lists of categories of LMOs (based on various criteria such as intended use or degree of risk), to national discretion for the applicability of AIA procedures.

Australian Interests

While the commercialisation of LMOs internationally is still limited, it is expected to become a major growth industry in future. As a country rich in biodiversity, relatively free of disease, and as an importer and exporter of LMOs, Australia has significant long-term economic, trade, health and environmental interests in a Biosafety Protocol. Australia will need to protect these interests by ensuring we are able to maintain appropriate standards of risk assessment and management for imports of LMOs, while ensuring that our exports of LMOs are not inhibited by the erection of non-tariff trade barriers.

Australia currently imports only one type of LMO on a commercial basis (soybean seeds), but many more are likely in the future. We also import LMOs in non-commercial quantities for contained use and field trials. Our quarantine regulations are amongst the most comprehensive in the world, and we already have in place many of the regulatory mechanisms of the type likely to be called for under a Protocol, including procedures for notification, risk assessment and decision making. Australia will need to ensure that the Protocol does not diminish our future capacity to continue to exercise the import controls required by our national circumstances.

Australia has exported only small numbers of LMOs for commercial use so far, but is likely to export more in the future. Future Australian exports of agricultural commodities may include a range of LMOs - including live animals, fruit, vegetables, flowers and grains. As a number of Australia's key trading partners are likely to become Parties to the Protocol, our future trade in LMOs with these Parties will be subject to the provisions of the Protocol, whether we become a Party or not. Consequently, a significant proportion of our agricultural trade in the next century may be governed by the Protocol.

Australia's Policy Approach

The system of Advance Informed Agreement is expected to include a process for notification, risk assessment and decision making by importing Parties for the transboundary movement of LMOs. Australia will be promoting a system designed to facilitate informed decision making, based on scientific principles and evidence, through an exchange of information between exporters and importers of LMOs. Our approach is based on the need to strike a balance between our interests as an importer and exporter of LMOs, and to cater for our future needs as well as our immediate concerns. It also takes account of the uncertain nature of future developments in biotechnology, agricultural production, environmental risks, public health and consumer demand.

As an exporter, we will wish to avoid non-tariff trade barriers, discriminatory trade practices or other trade distorting measures. To address this, Australia will be proposing that import decisions be based on scientifically sound risk assessments, that bilateral and regional arrangements and simplified procedures be available to facilitate trade in particular cases, and that procedures for export notification, risk assessment, and import decisions minimise onerous regulations, be transparent and consistent with World Trade Organisation rules.

As an importer, Australia must ensure that it is able to continue to protect its public health and animal and plant life through our existing quarantine controls. In doing so, we do not wish to impose our own systems of regulation on other Parties with differing circumstances and requirements, nor have other systems imposed on us. Any moves towards the international harmonization of biosafety standards through the Protocol will therefore require careful consideration. Australia will also be seeking to avoid the creation of any impediments to the development of, or our access to, environmentally sound biotechnology.

Australia's approach to the negotiations has been developed through an intensive process of Commonwealth inter-agency consultations, under the Chairmanship of the Department of Foreign Affairs and Trade. This process includes the Departments of Prime Minister and Cabinet; Primary Industries and Energy; Environment; Industry, Science and Tourism; Health and Family Services; Attorney General's; Australian Customs Service; Treasury; Finance; and the Australian New Zealand Food Authority.

Consultations are also held between Commonwealth Departments and States/Territories, industry and non-government organizations, as a key element in the development of our whole-of-government position. These consultations are held in Canberra at regular intervals, usually prior to BSWG meetings. Australian Government reports of BSWG meetings are circulated to all stakeholders who have expressed an interest. Additional information may also be obtained from the official Convention Secretariat report of BSWG III, which is available on the World Wide Web (www.biodiv.org/biosafe/bswg3/ 3-6-e/2.html). Unofficial reports of the meetings can be found in the Earth Negotiations Bulletin published by the International Institute for Sustainable Development, on the World Wide Web (www.mbnet.mb.ca/linkages/biodiv.ht ml).

Copyright 1998 Australian Biotechnology Association Ltd.