How do we regulate novel organisms?


Since the early 1990s, the Australian Government has been doing its best to surf the biotechnology wave, in particular, the economic flow-on from genetically engineered crops, foods, and therapies. This direction has been steadily encouraged by the Department of Foreign Affairs and Trade, with regulation of the GM industry placed under the Commonwealth Department of Health and Ageing. Departments like Environment and Heritage, or Agriculture, have intermittent input. Yet given that human well being is a sub-set of environmental conditions, it’s hard to say why Health has been given priority. Perhaps it reflects the powerful role of pharmaceutical corporations in GM market innovation?

Thanks to Fiona Katauskas

Thanks to Fiona Katauskas

Genetic engineering is currently managed under the Gene Technology Act 2000, whose object is ‘to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs’. What is remarkable about this objective is the admission that GM is risky. Equally remarkable is the assumption that risks can be readily identified and managed. The fact is that the unanticipated consequences of genetic engineering may not even be imaginable at this point in time. Moreover, it is widely conceded that any harm resulting from premature commercialisation of this young science may well be irreversible.

The Gene Technology Act calls for appointment of a Regulator, whose office, the OGTR is expected to assess the safety of experimental studies dealing with novel organisms and applications for product development and release. The Regulator gives accreditation to GM research institutes and licenses commercial dealings. In this, the OGTR works in with State regulatory schemes, and under the aegis of a Federal-State Ministerial Council. However, the latter has met only a couple of times since the Act was put in place.

Consequential Amendments to the Act provide that relevant pre-existing authorities take advice from the Regulator on GM dealings. These are: the National Agricultural and Veterinary Chemicals Register; Food Standards Australia; the National Industrial Chemicals Notification and Assessment Scheme; Therapeutic Goods Administration; National Health and Medical Research Council; Australian Quarantine and Inspection Service; and various State authorities.

Clearly, this dispersed regulatory process will have holes. For example, assessment of the DNA aspect of a product is handled by OGTR and the chemical aspect by the Australian Pesticides and Veterinary Medicines Authority. But the ‘interaction’ of DNA with chemical components is not examined prior to commercial licensing.

Meanwhile, the regulation of imports like US GM corn for chicken feed is somewhat discretionary. In fact, national competition policy, bilateral free trade agreements, and pressures for deregulation from the World Trade Organization, all lean against clear cut regulatory practices.

Before licensing a novel food crop or vaccination, the Regulator is required to take advice from a Minister-appointed Technical committee (GTTAC). Two parallel advisory bodies, a Community committee (GTCCC) and an Ethics committee (GTEC) have no direct influence on licensing. Thus in 2003, while GTCCC was alerting the Regulator to widespread community disquiet over GM Canola, GTTAC scientists advised the Regulator to go ahead with a crop license. And as things stand, the Act contains no provision to appeal the Regulator’s decisions.

In recent months, the OGTR has undergone a performance appraisal by the Australian National Audit Office (ANAO). Public submissions to ANAO have pointed to a number of anomalies. For instance, the Gene Technology Act specifies that the Regulator must ensure the fitness of a person to hold a GM licence. But already, two companies with a record of convictions – Bayer and Monsanto – have had dealing applications approved. In terms of monitoring GMOs out in the environment, the Regulator has not prosecuted a single firm, though some three dozen licence breaches have occurred to date.

The adequacy of risk assessment by the Regulator has also been raised with the ANAO performance audit. Basically, a novel organism may interfere with any or all of five functional levels in nature: evolutionary processes, ecological networks, genetic mechanisms within organisms, protein interactions in cells, or cellular metabolism. Risk assessment by the Gene Technology Regulator does not look at all possible synergistic interactions between biota in the environment, nor at long-term human health impacts. This is not done because technically, it cannot be done.

Essentially, risk assessment, dubbed ‘best practice’, comes down to a scientist’s best guess. This is why the 1998 UK Royal Commission came to the conclusion that in a democratic society: ‘When environmental standards are set … decisions must be informed by an understanding of peoples’ values’. The same reasoning should apply in the health field. The Australian GM regulatory process has not taken these values very seriously. The Community and Ethics committees are marginalised by the science and business focus of the OGTR. Nor does the Regulator take on board the ways in which the safety of a novel release depends on social factors – like cultural attitudes, organisational norms, political climate, and even international trade.

It is possible that staffing levels at the OGTR are simply inadequate to support more thorough assessment, monitoring, prosecution – and therefore full compliance with the Act. It is believed that OGTR functions are sometimes out sourced, possibly to Biotechnology Australia, the Federal Government’s GM promotion wing. But for transparent governance, the public should be informed when OGTR delegates responsibilities; people have a right to know who the backroom consultants are.

It is to be hoped that these concerns will be tackled as the first review of the Gene Technology Act 2000 gets underway. And there are other matters outstanding: the legal liability of GM producers, organic farmer’s rights, patent controls, corporate use of indigenous knowledge, the principle of food sovereignty, and the interests of reproductive women. The question is: how broad will the terms of reference set down by the Ministerial Council be? How balanced and independent will the Review Panel be? Will a diverse cross section of the public be asked for input? Will regional voices be heard? Genetic engineering is a risky business and Australians deserve quality protective legislation.

Office of the Gene Technology Regulator OGTR

Anna Salleh 2003 ‘Pesticide Study Fuels GM Risk Debate’

Geneethics 2003 ‘GE Canola Should Be Banned’

SMH 2003 ‘Monsanto Pays Penalty for Indonesian Bribe’

Silvio Funtowicz and Jerome Ravetz 2004 ‘Post-Normal Science: Environmental Policy Under Conditions of Complexity’

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