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

Standing Committee on Agriculture and Resource Management Working Group Report on Gene Technology Regulation in Agriculture

John Madden,

Chair of the Working Group and Director, Science and Technology Policy, Commonwealth Department of Primary Industries and Energy, PO Box 858, Canberra, ACT 2601

Code Number:AU98006
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Introduction

Australia has been markedly successful in agriculture innovation and it will be essential to continue this tradition if it is to remain a competitive producer of agricultural commodities of global significance. In addition, the country's natural resource endowments and cost reducing technologies are crucial for international competitiveness. These advantages are less crucial in markets for semiprocessed and consumerready products. Here, more important factors are product characteristics and nonprice factors such as enhanced quality, product differentiation, the regulatory environment, and trade policies.

Gene technology offers great potential to increase agricultural production by introducing beneficial characteristics which are not available through conventional means. It is likely to significantly change production systems and markets by reducing farmers' input costs, increasing the sustainability of agricultural enterprises, and improving safety, quality and variety.

Australia has a relatively strong publiclyfunded research capacity, a small biotechnology industry with growing export potential, and established markets for agricultural commodities and processed agriculturebased goods. If the factors that enhance the competitiveness of gene technology applications are well managed, Australia has the capacity to capture a significant share of emerging global markets for food, fibre and other products based on gene technology. Whilst some of this potential will hinge on access to GMOs developed in other countries, there are some opportunities for locally developed GMOs.

Major agricultural innovations resulting from the genetic manipulation of organisms are expected to include crops and livestock more resistant to diseases and parasites; crops better able to absorb and use fertiliser; crops able to fix their own nitrogen; plants with better photosynthetic efficiency; crops with herbicide resistance; crops with greater resistance to drought, salinity, and frost; crops with higher ratios of edible to nonedible parts, fewer structural weaknesses, and higher yields of economically important components; plants with improved nutritional value; plants with introduced or enhanced medicinal properties; regulation of plant growth to allow the harvest of uniformly ripe fruits and vegetables; faster growing stock and fish; increased meat production with lower fat content; higher milk yields; and the production of pharmaceuticals by animals.

The public and commercial acceptance of gene technology depends on its effective regulation. The establishment of appropriate gene technology regulation will have competitive benefits for Australian agriculture, but there are indications that it is being restricted in its development and uptake of this new technology because of regulatory uncertainty.

Australia has yet to develop a comprehensive, national approach to the regulation and encouragement of this technology (see paper by Corcoran and McLean, page 30). Concerned by the absence of a coordinated, legally binding regulatory system to assess or control the impact of GMOs in many situations, particularly in agriculture, the Standing Committee on Agriculture and Resource Management (SCARM) established a Working Group on Gene Technology Regulation in February 1997. It was chaired by the Commonwealth Department of Primary Industries and Energy (DPIE) and involved representatives from the Commonwealth Department of Industry Science and Tourism, several State and Territory agriculture departments and CSIRO.

Recommended Approach

The Working Group's report discussed both the opportunities and responsibilities associated with GMOs. Because of the risks in releasing some products of the technology, the report found it was prudent to impose regulatory controls on the technology, its products and the substances produced by GMOs.

The Working Group considered that, ideally, there should be a seamless, national, uniform assessment process that would:

• provide a robust, responsive and evolving regime in the face of rapidly evolving technologies;
• provide the necessary assurances to consumers and distributors of GMO products, particularly by protecting against unwanted public health and environmental outcomes;
• provide a clear regulatory pathway for innovation and product development, with timely assessments of research and commercial initiatives, a consistent regulatory approach across government and low compliance and administration costs
• control the importation of GMOs; and
• not inhibit innovation and trade involving gene technology products.

The Working Group found that GMOs had already given rise to new challenges for regulatory bodies. These could lead to bureaucratic delays, confusion and ad hoc decisions, which would be damaging to business and Australia's innovative potential. There was a need to provide clear and efficient structures and procedures for the oversight of GMO development procedures and GMO products. There should be consistent, easily understood triggers for regulation, that are scientifically based.

The regulatory process needed to cover the technology, its products and the substances produced by GMOs, and provide for:

• notification, which may be mandatory for all development, use, release and sale of GMOs and GMO products, and include the provision of specific information;
• clearly articulated regulatory outcomes as part of a transparent and accountable process;
• risk assessment, which should be case by case or class by class, objective, focussed on the scientific questions, impartial, possibly involving peer review, and aim to facilitate the safe application of the technology;
• public involvement in the regulatory process to allow public comment and where necessary informed consent;
• risk determination, that is decisions made by government after consideration of the risk assessment advice and matters such as riskbenefit tradeoffs, efficacy of the product, border controls, trade implications;
• approval to allow certain activities but not others;
• certification, which may be conditional eg specific containment procedures, and include monitoring, involving inspection, or self regulation;
• compliance, which may include penalties where appropriate if conditions are not met; and
• retraction of approval, in the light of experience, additional information or failure to comply with conditions.

Processes would be necessary to allow the assessment of the potential hazards of GMOs in a given situation, the severity of the risk associated with them (ie extent of exposure to the hazard, the nature of the adverse effects), their reversibility, the extent of multiple or sequential effects, and to provide a means to minimise or prevent any impact on the environment and human health.

Proposed Operational Structure

The report proposed the establishment through Commonwealth, State and Territory legislation of a small office termed the Gene Technology Agency (GTA) in a Commonwealth Department. It would incorporate the current functions of the nonstatutory Genetic Manipulation Advisory Committee (GMAC) as one of its advisory committees.

The GTA would be the clearing house for applications for research, field trials, release into the environment, commercial use and for postrelease surveillance. It would direct applicants to the body with the appropriate legislative authority for risk determination and assessment (eg AQIS, NRA and State bodies that follow ANZFA standards) and provide them with advice, where necessary, on how to assess the GMO. Regulatory agencies might wish in turn to contract out the assessment to appropriate bodies (eg Bureau of Resource Sciences, State agriculture departments, universities, or the private sector) but would retain responsibility for making the decision.

If no agency has the legislated scope to cover the GMO or its product, the GTA would conduct the risk determination itself, again with outsourcing possible where this does not compromise the validity of the assessment. Where more than one agency has responsibility for an issue, the GTA would coordinate the decision process so that the applicant would be given a consistent set of rules to follow. The States and Territories would be involved to the extent that agencies like NRA currently involve them in their procedures; and possibly in terms of giving approval for the conduct of field trials. The coverage of GMOs by existing regulatory agencies may need to be extended or modified.

Compulsory notification to GTA was proposed for GMO activities and products that are determined (by relevant Commonwealth and State agencies) to pose some risk in the absence of conditions of use. Initially this would mean all GMO activities and products. The GTA would determine the safety of categories of GMO activities and products, on advice from other regulators, and allocate them as appropriate to a schedule, or exempt them from regulation.

The GTA or other regulatory agency would certify that scheduled GMO activities and products could only be undertaken/released under specific conditions, following risk assessment and determination. GTA would accredit the safety of nonscheduled (exempt) GMO activities and products if requested by an applicant. In all cases, GTA would be available to advise on certification procedures, and prior to release, GTA would be notified of any certified GMO to ensure that the Agency could fulfil its responsibilities as the central clearing agency.

Current Status

The report was considered by the Territory, State, Commonwealth and New Zealand Ministers meeting as the Agriculture and Resource Management Council of Australia and New Zealand (ARMCANZ) in August 1997. The Council agreed that a framework for regulating the products of gene technology was required to provide assurance to the community regarding the use of this technology, but the framework should be only that necessary to achieve effective assurance.

ARMCANZ also agreed in principle to support the proposed minimal regulatory framework involving the establishment of a small Gene Technology Agency which acts as a clearing house for applications for research on, and release of, GMOs in concert where appropriate with other regulatory bodies and will manage or coordinate the notification, application and assessment of GMO activities and products in conjunction with other relevant administrative bodies. The Ministerial Council noted that while this regulatory framework had been developed to meet the needs of agriculture, it had broader application for regulating GMOs for nonagricultural use.

Acknowledgments

The author would like to thank the members of the SCARM Working Group (Mr Brian Stynes, Agriculture WA; Dr Ken Reed, Department of Primary Industries, Queensland; Dr Catherine Hollywell, Department of Natural Resources and Environment, Victoria; Dr Mikael Hirsch, CSIRO; Dr Vic Edge, NSW Agriculture; Dr Howard Dengate, Department of Primary Industries and Fisheries, Northern Territory; Mr Donn Corcoran, Commonwealth Department of Industry, Science and Tourism) for their contributions to the development of the Working Group's report.

The internet address of the SCARM report is:
http://www.dpie.gov.au/dpie/ armcanz/gene/index.html

Copyright 1998 Australian Biotechnology Association Ltd.