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

The Regulation of Foods Produced using Gene Technology in Australia and New Zealand

Lisa Kelly^# and Simon Brooke-Taylor,

Australia New Zealand Food Authority, PO Box 7186, Canberra MC, ACT 2610, Australia
^# to whom correspondence should be addressed

Code Number:AU98008
Sizes of Files:
      Text: 13K
      Graphics: No associated graphics files

Introduction

The system for regulating foods in Australia and New Zealand is in a state of transition as both countries move toward a system of joint standards which will be developed and maintained by the Australia New Zealand Food Authority (ANZFA). ANZFA was created under an Agreement (the Treaty) between the governments of Australia and New Zealand in December 1995 and is now in the process of developing a joint Australia New Zealand Food Standards Code.

In Australia, food standards implemented under State and Territory food legislation are set out in the Australian Food Standards Code and in New Zealand in the New Zealand Food Regulations. Until the joint Australia New Zealand Food Standards Code is completed, transitional arrangements between the two countries apply, such that, with a few exceptions, food sold in New Zealand, or imported into Australia from New Zealand, may comply with either the Australian Food Standards Code or the New Zealand Food Regulations, but not a combination of both.

There is currently no requirement for pre-market approval of foods, including foods produced using gene technology, in Australia or New Zealand.

Background

The issue of foods produced using gene technology, and whether they should be specifically regulated, was first considered in Australia by the then National Food Authority in 1992. It has proved to be a complex and challenging issue for regulators and has been made more so by the formation of the joint Australia New Zealand Food Authority in 1996 which has meant some reconsideration of the issues in the context of both countries. The release of some foods produced using gene technology onto the market, and the imminent release of others, means that a speedy resolution of these issues is imperative to preserve consumer confidence in the food supply while promoting innovation and competitiveness in the food and agricultural sectors.

It is important to understand that deliberations by the Authority on foods produced using gene technology have occurred during a time of proposed reforms to the way in which gene technology is regulated both in Australia and New Zealand. This has influenced the progress in relation to food as the Authority considers that, to be truly effective, regulatory arrangements for food should operate in the context of a broad regulatory framework for gene technology as a whole.

Gene technology has been subject to voluntary oversight in Australia since 1975, most recently through the operations of the Genetic Manipulation Advisory Committee, established in 1987, and in New Zealand, through the operations of various groups, most recently the GMO Interim Assessment Group (IAG), established in 1988.

In New Zealand, a statutory body, the Environmental Risk Management Authority, which will subsume the functions of the IAG, has been established under the Hazardous Substances and New Organisms (HSNO) Act 1996 and is due to commence operations on 1 July 1998. In Australia, progress on the introduction of comprehensive, national regulatory arrangements has been somewhat slower (see paper by Corcoran and McLean). Nevertheless, ANZFA has progressed the development of regulatory arrangements for foods produced using gene technology, commencing with the release, in February 1997, of a draft standard and assessment guidelines for public comment.

The draft standard required a pre-market case-by-case assessment of foods derived from genetically modified crops, animals and microorganisms before they could be sold. The guidelines that accompanied the draft standard detailed how ANZFA proposes to conduct this safety assessment based on internationally accepted protocols (OECD 1993; FAO/WHO 1996) and also proposed a set of comprehensive labelling criteria, consistent with those recently enacted in the European Union (EU).

The period for public comment on the draft standard and assessment guidelines closed in May 1997.

The submissions received were then analysed and relevant issues identified. In addition, ANZFA undertook further consultation with several government departments in both Australia and New Zealand, with responsibilities in agriculture, industry and trade, so that agreement could be reached as to the most appropriate standard. The standard was then finalised and recommended to Commonwealth, State, Territory, and New Zealand Health Ministers in their capacity as the Australia New Zealand Food Standards Council (ANZFSC) in February 1998.

Issues being Addressed in the Finalisation of a Standard for Genetically Modified Foods

The release of the draft standard generated substantial consumer and media interest, particularly in New Zealand, and this interest still continues today. ANZFA received an unprecedented number of detailed submissions in response to the draft standard, a number of which were from overseas government and food industry bodies. ANZFA also received thousands of campaign letters, as well as a petition containing over 7000 signatures, from New Zealand, expressing concerns about the proposed standard. Many of these submissions focussed on only two issues of concern - the safety of the technology, as a whole, for food use and to what extent should labelling be prescribed by the standard.

Safety Issues

In developing and varying food standards the Authority must have regard to a set of five objectives which are specified, in descending priority order, in the Australia New Zealand Food Authority Act 1991 (Figure 1). When finalising the form that the new standard should take, the Authority must, therefore, have regard to the comments received in the context of these five objectives.

Fig 1. ANZFA objectives in setting food standards

In addition to the five objectives in Figure 1, the Authority also has other obligations that must be considered. The Australia New Zealand Treaty to develop a joint standard setting system imposes certain obligations upon ANZFA when developing regulatory measures. These obligations result from the national regulatory policies of both Australia and New Zealand which reflect the fact that Australia and New Zealand are both signatories to World Trade Organization (WTO) Agreements.
The principles underlying these Agreements require regulatory measures to be:

• minimum and effective;
• based on sound scientific principles;
• developed using consistent risk assessment practices;
• performance based (unless prescription is needed to protect public health and safety) and have identifiable outcomes;
• transparent;
• no more restrictive than necessary to achieve a legitimate objective; and
• reviewed periodically.

ANZFA's proposed safety assessment guidelines for foods produced using gene technology appear to be generally well accepted. Food safety assessments are, in general, based on the concept that there should be a reasonable certainty that no harm will result from the intended use of the food. The purpose of a safety assessment of a genetically modified food is to provide this basic level of safety that is expected of a food. It also confirms the genetically modified food to be equivalent to a traditional food with all the benefits and risks normally associated with food. It should be emphasised that where a genetically modified food is deemed by the Authority to be unsafe for human consumption then it will not be permitted for sale.

Certain sections of the community, however, are ethically opposed to the use of this technology, particularly for food production, and are not reassured by the proposed requirement in the standard for pre-market approval of these foods. Instead, these groups have called for a moratorium on their introduction until safety can be guaranteed, or, failing this, for full mandatory labelling of all foods that have been produced using this technology to enable easy identification and the opportunity for selective purchasing.

Labelling Issues

The issue of labelling, and how much mandatory labelling is appropriate, is by far the dominant issue associated with the draft standard. This issue also represents the most challenging from a regulatory point of view because, in addition to having regard to the specific interests of consumers, the interests of industry and international trade for Australia and New Zealand must also be considered.

In the assessment guidelines that were released along with the draft standard, a set of comprehensive labelling criteria, consistent with the EU labelling regulations for novel foods, were proposed. Since that time, the Authority has had the opportunity to observe the effects of the EU labelling regulations which have been in force in the EU for several months.

A problematic situation has arisen because some countries, such as the United States and Canada, have adopted a less stringent position on labelling. These countries have determined that labelling is not required if the modified food is "substantially equivalent" (ie essentially the same in composition) to the non-modified form. Hence, genetically modified commodities, such as soybeans and corn, which are principally imported from the United States and Canada, are not separated from their conventionally bred counterparts. Therefore, EU manufacturers are unable to know for sure if the food is or is not derived from a GMO.

It now seems apparent that if the EU's comprehensive labelling regulations are enforced, this will result in a majority of foods being labelled as "may contain GMO". The Authority does not believe that this would be a desirable outcome for Australia and New Zealand. Accordingly, the recommended standard contains provisions for the mandatory labelling of foods produced using gene technology. However, it is likely that these will be confined to those foods that are no longer substantially equivalent in their characteristics.

Nevertheless, the Authority is concerned to ensure that a comprehensive approach is taken to consumer requests for information which would allow them to make an informed choice and avoid these foods, if that is desired. However, it is important to emphasise that a safety assessment by the Authority should allay any consumer concerns as to the public health and safety aspects of consuming these foods. Therefore, the challenge is to infuse all sections of government, industry and the scientific community with an interest in providing consumers with an information rich environment as these foods become available in the market.

Effective measures to educate and inform consumers need not rely solely on government imposed rules for labelling. Indeed, far greater resources can be harnessed in providing this information if industry, the scientific community and the media work together, possibly through voluntary Codes of Practice, to inform the public of the presence of these foods and the exciting opportunities that can be obtained from using gene technology. Such an approach avoids any potential pitfalls that await unwary governments that might attempt to impose mandatory requirements which restrict international trade in food and might invoke a challenge through WTO Agreements by a disadvantaged trading partner.

ANZFA recommended Standard A-18, Foods Produced using Gene Technology to ANZFSC on 23 February 1998. It is now up to Health Ministers to decide whether to accept the new Standard.

References

FAO/WHO (1996) Biotechnology and Food Safety. Report of a Joint FAO/WHO Consultation Rome, Italy, 30 September - 4 October 1996. (World Health Organization, Geneva) 31 pages

OECD (Organization for Economic Cooperation and Development). (1993) Safety evaluation of foods derived by modern biotechnolog39 Concepts and Principles. (OECD, Paris)

Copyright 1998 Australian Biotechnology Association Ltd.