- Email: [email protected]
Regulation of genetically modified foods in Australia and New Zealand
Food Control 14 (2003) 409–416 www.elsevier.com/locate/foodcont
Regulation of genetically modified foods in Australia and New Zealand Paul Brent
*,1,
Dennis Bittisnich, Simon Brooke-Taylor 1, Nora Galway, Lynda Graf, Marion Healy, Lisa Kelly Food Standards Australia New Zealand, P.O. Box 7186, Canberra, BC ACT 2610, Australia
Abstract Food standards in Australia and New Zealand build on the level of food safety that is generally accepted by the community. An explicitly cautious approach is applied in cases where there is no established history of safe human consumption, as is the case for foods produced using gene technology. Novel foods, including genetically modified (GM) foods, undergo a mandatory pre-market safety assessment and approval process. The approach used in Australia and New Zealand to assess the safety of foods produced using gene technology draws on concepts and principles that have been developed internationally. Crown Copyright 2003 Published by Elsevier Science Ltd. All rights reserved. Keywords: Genetically modified foods; Safety assessment; Labelling; Gene technology; Substantial equivalence
1. Introduction Modern biotechnology, particularly the use of recombinant-DNA techniques, has allowed the isolation, cloning and incorporation of genes conferring novel or altered traits into plants, as well as other organisms. These techniques involve taking copies of genes from the cells of a plant, animal or microbe and inserting them into another cell to give a desired characteristic. The resulting plants or animals are often termed genetically modified (GM), and thus food derived from these organisms is referred to simply as GM food. The use of modern biotechnology, especially for the production of food, continues to be the subject of considerable debate. While many consider the use of the technology to have the potential to increase productivity, provide innovative mechanisms to control devastating pests and diseases, and to produce foods with targeted health and nutritional benefits (McLaren, 1998; Peacock, 2000), others have suggested the production of GM foods might pose unknown risks in both the short and long term (Halloran & Hansen, 1998) and also
raises major ethical and social questions for sections of the community (Kellow, 1999; Nestle, 1998). Since food and feed products of modern biotechnology are now being commercialised and marketed in many countries, appropriate approaches are required to the effective regulation of these products. Governments worldwide have been developing regulatory frameworks to protect both the environment and human health from potential adverse effects that may arise from production of GM organisms (GMOs) and foods derived from them. This paper describes the development of the regulatory framework for GM foods in Australia and New Zealand, outlines the essential elements of a procedure to assess the safety of GM foods and their labelling, and identifies some of the major issues and challenges facing regulatory authorities both now and in the future. 2. Key features of the GM food standard GM foods entering the Australian and New Zealand food supplies must comply with Standard 1.5.2––Food Produced Using Gene Technology. The Standard was adopted in July 1998 as a joint standard with New Zealand and came into legal effect on 13 May 1999. 2
*
Corresponding author. Tel.: +61-2-62712279; fax: +61-262712278. E-mail address: [email protected] (P. Brent). 1 Present address: Brooke–Taylor and Co Pty Ltd, Suite 34, 4 Goulburn Street, Sydney, NSW 2000, Australia.
2
The Standard was originally adopted as Standard A18, but since the development of the newly adopted joint Australia New Zealand Food Standards Code, it is now known as Standard 1.5.2.
0956-7135/03/$ - see front matter Crown Copyright 2003 Published by Elsevier Science Ltd. All rights reserved. doi:10.1016/S0956-7135(03)00037-9
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The Standard defines a Ôfood produced using gene technologyÕ as a food, which has been derived or developed from an organism, which has been modified by gene technology. ÔGene technologyÕ is limited to recombinant DNA techniques that alter the heritable genetic material of living cells or organisms. Standard 1.5.2 is divided into two sections. The first section (Division 1) imposes a pre-market approval system for GM foods in Australia and New Zealand whereby the sale and use of food produced using gene technology is prohibited unless it has been specifically permitted. Companies wishing to market a GM food in Australia and New Zealand must apply to Food Standards Australia New Zealand (FSANZ) 3 to have the Standard amended to include their particular GM food as an approved food produced using gene technology. Approval of a specific food produced using gene technology is contingent on the outcome of a pre-market safety assessment undertaken by FSANZ. The Standard also recognises that some foods derived using the process of gene technology were already in the food supply when the Standard came into effect. Transitional arrangements were put in place to permit these foods to remain in the marketplace while the foods underwent a safety assessment. Division 2 of the Standard specifies labelling and other information requirements for foods produced using gene technology. Unlike the pre-market assessment and approval aspects of the standard, the labelling provisions also apply to food additives and processing aids that have been produced using gene technology. Labelling is required if novel DNA or protein is present in the final food (see Section 7). It is important to note that the labelling provisions of Standard 1.5.2 are intended to provide information to consumers, not to act as health warnings because unsafe foods, GM or otherwise, are not permitted for sale in Australia or New Zealand. GM foods approved under Standard 1.5.2 must be determined to be as safe as their traditional counterparts.
3. Key principles in the safety assessment of GM foods The safety of the Australian and New Zealand food supply is regulated through a risk-based, evidence-based approach that includes cautious and conservative elements. Under the FSANZ regulatory framework in Australia and New Zealand, an explicitly cautious approach is applied to foods where there is no established history of safe human consumption (see ANZFA, 2000a; Healy, Brooke-Taylor, & Liehne, in press).
3
Formerly the Australia New Zealand Food Authority (ANZFA).
To date GM foods have been derived from foods with a long established history of safe human consumption. Moreover, the use of gene technology to modify these foods is a recent innovation. As such, GM foods are subjected to case-by-case assessment of safety with the benchmark for an acceptable level of safety being that conferred by the conventionally produced counterpart. The pre-market assessment and approval process thus aims to ensure that GM food is as safe as conventionally produced food. FSANZ uses an open and transparent assessment process. All data submitted in support of an application (except a small amount of commercial-in-confidence data) are available to the public. The assessment and decision-making processes are fully documented with the documentation available to all who are interested. To this extent, the transparency of FSANZÕs process is probably unique in the world. FSANZ also undertakes two rounds of public consultation during its assessment of applications. This ensures that the public (including consumers, non-government organisations, scientists, public health professionals and any other interested parties) may comment on, and contribute relevant information to, the safety assessments before they are finalised. The FSANZ safety assessment process for GM foods is based on internationally recognised concepts and principles that have been developed through the expert consultation processes of the OECD, the WHO/FAO and Codex Alimentarius Commission (ANZFA, 2000a, 2001a). FSANZ undertakes the safety assessment of GM food according to five key principles: • Safety assessments use scientific, risk-based methods. Scientific data for safety assessments are obtained from a variety of sources (primarily from the applicant but also from the scientific literature, general technical information, independent scientists, other regulatory agencies and international bodies, and the general community) and assessed using internationally recognised scientific, risk-based methods. • Safety assessments are conducted on a case-by-case basis. The safety of GM foods cannot be assessed as a single class because the safety concerns depend on the type of food and the nature of the genetic modification. Safety assessments are done on the fractions or components of individual GM varieties that are used as food or in food preparation. If the food derived from a GM plant or animal has been assessed as safe, they may be used as ingredients in other foods. For example, food components derived from GM soybeans such as soy oil, soy flour and lecithin may be used in foods such as breads, pastries and snack foods if the GM soybeans have been assessed as safe. The various breads, pastries and snack foods containing the GM soybean are not assessed individually.
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• New genetic material, new proteins and other characteristics of the GM food are considered. The safety of new components (new genetic material (DNA) and proteins which are coded by the DNA) in the GM food is considered separately and completely. Other characteristics of the food, such as the levels of nutrients and naturally occurring allergens, toxins and anti-nutrients, are also considered in detail because they could be indirectly affected by the genetic modification. • Both the intended and unintended effects of genetic modification are considered. The intended effect (direct effect) of the introduction of the new gene is the production of the new protein that confers the desired trait. The direct consequences of the genetic modification, for example the potential toxicity/allergenicity of any novel protein, potential for horizontal DNA transfer of an antibiotic resistance gene or the nutritional consequences of any intended compositional change, are thoroughly assessed as part of the safety assessment process. Unintended (indirect) effects, such as changed composition, e.g. significant changes to fatty acid profile, new toxin or allergen, significantly changed vitamins and minerals etc, need to also be considered in detail. These may vary depending on the nature of the genetic modification. • Where appropriate, comparisons are made to conventionally produced foods. Conventionally produced foods with a history of safe use are compared to the GM variety. The comparison is used to identify differences in levels of naturally occurring allergens, toxins, nutrients and anti-nutrients, or the ability to support typical growth and well being. Any significant differences between the GM variety and the conventional variety are assessed for their potential adverse health effects.
ters requiring assessment in the new food. Information is therefore required on the gene transfer method, the origin and function of any novel genetic material, and a molecular characterisation of the inserted genetic material, including around the junction region of the inserted DNA with the surrounding plant DNA. Data demonstrating that the novel genetic material has been stably integrated in the host genome and the phenotype is stably maintained over several generations is also required.
4. Issues considered in the safety assessment of GM foods
4.3. Toxicological and allergenicity issues
To support their application for approval of a GM food, the applicant must provide a large amount of scientific information to enable a thorough safety assessment to be conducted. All scientific data obtained from the applicant must be generated according to international standards of Good Laboratory Practice (where appropriate) in laboratories, which are independently audited. These data are supplemented with information obtained from a variety of sources. The safety assessment process considers all available information, focussing particularly on the following.
Toxicological concerns include the levels of naturally occurring toxins as well as the level and potential toxicity of any novel proteins. The levels of naturally occurring allergenic proteins as well as the potential allergenicity of any novel proteins are also considered. In an evaluation of the potential toxicity of the novel protein, consideration is given to the similarity of the novel protein to any known toxins. The results of any animal toxicity tests and the likely human exposure to the novel protein are also considered. Two aspects of potential allergenicity are considered. First, the assessment considers the likely transfer of an allergen during the genetic modification, which may cause foods previously considered non-allergenic to become allergenic. Second, the assessment considers if the expression of a novel protein in a food is likely to lead to
4.1. Nature and stability of the genetic modification A full description and molecular characterisation of the genetic modification identifies the relevant parame-
4.2. General safety issues The general safety issues are divided into three areas––history of use, nature and level of expression of any novel protein and the potential for transfer of novel genetic material to get microorganisms. The history and extent of use of the conventional unmodified food is an indication of its wholesomeness and safety and thus it can be used as a benchmark for comparison with the modified food variety. Factors considered include the levels of nutrients, anti-nutrients, natural toxicants and ability to support typical growth and well being. The nature of the novel proteins present in the GM food are analysed to determine their expression levels and patterns and to determine whether the expressed protein has been modified in any unexpected way. The impact on human health from potential transfer of novel genetic material, including antibiotic resistance genes, to cells, including microorganisms, in the human digestive tract is also considered. FSANZ considers the overall risk of gene transfer affecting the therapeutic use of antibiotics in humans to be so low as to be effectively zero. This position is supported by several recent reviews on GM food safety (Kuiper, Kleter, Noteborn, & Kok, 2001; Society of Toxicology, 2002; The Royal Society, 2002).
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the development of a new allergy in certain individuals. The first aspect can be addressed for known allergens, using human sera or human skin tests, to test for its presence in the modified food. However there are no reliable tests or animal models, which predict the allergenic potential of novel proteins. Instead, potential allergenicity can only be indicated through a Ôweight of evidenceÕ approach where a range of predictor tests on the novel protein are examined to determine whether it has any of the characteristics common to known allergens. If the novel protein does not possess these characteristics, it can usually be concluded that the novel protein is unlikely to be allergenic. 4.4. Nutritional issues In assessing the safety of a GM food, a key factor is the need to establish that the food is nutritionally adequate and will support typical growth and well being. In most cases, this can be achieved through an understanding of the genetic modification and its consequences together with an extensive compositional analysis of the food. Where, on the basis of available data, there is still concern or doubt in this regard, FSANZ considers that carefully designed feeding studies in animals may provide further reassurance that the food is nutritionally adequate. Such studies may be necessary where the compositional analysis indicates significant differences in a number of important components or nutrients or where there is concern that the bioavailability of key nutrients may be compromised by the nature of the genetic changes to the food.
5. Major issues raised during development of safety assessments 5.1. The need for long-term animal toxicity studies It is useful when examining the need for long-term animal toxicity studies to compare the type of tests available for medicines and chemicals with those possible for whole foods (for example, WHO, 2000). Animal studies are a major element in the safety assessment of many compounds, including pesticides, pharmaceuticals, industrial chemicals and food additives. In most cases, the test substance is well characterised, of known purity and of no nutritional value. Human exposure to such substances is generally low. It is therefore relatively straightforward to feed such compounds to laboratory animals at a range of doses (some several orders of magnitude above expected human exposure levels) in order to identify any potential adverse effects. Establishing a dose–response relationship is a pivotal step in toxicological testing. By determining the level of exposure at which no adverse effects occur, a safe level of
exposure for humans can be established which includes appropriate safety factors. By contrast, foods are complex mixtures of compounds characterised by wide variations in composition and nutritional value. Due to their bulk, they can usually be fed to animals only at low multiples of the amounts that might be present in the human diet. Therefore, in most cases, it is not possible to conduct dose–response experiments for foods in the same way that these experiments are conducted for chemicals. In addition, a key factor to be considered in conducting animal feeding studies is the need to maintain the nutritional value and balance of the diet. A diet that consists entirely of a single food is poorly balanced and will compromise the interpretation of the study, since the effects observed would confound and usually override any other small adverse effect, which may be related to a component or components of the food being tested. Identifying any potentially adverse effects and relating these to an individual component or characteristic of a food can, therefore, be extremely difficult. Another consideration in determining the need for animal studies is whether it is appropriate from an ethical standpoint to subject experimental animals to such a study if it is unlikely to produce meaningful information. It is therefore more appropriate to examine the safety of newly expressed protein as a purified substance in an animal study rather than as part of a whole food. The acute toxicity of newly expressed proteins in GM foods is normally examined in experimental animals. It is generally accepted that when proteins are toxic, they are known to act via acute mechanisms and at very low dose levels (Sjoblad, McClintock, & Engler, 1992). These studies can provide additional reassurance that the proteins will have no adverse effects in humans when consumed as part of a food. While animal experiments using a single new protein can provide more meaningful information than experiments on the whole food, additional reassurance regarding the safety of newly expressed protein can be obtained by examining the digestibility of the new protein in laboratory conducted in in vitro assays using conditions which simulate the human gastric system. 5.2. The comparative approach The comparative approach, previously referred to as substantial equivalence, requires GM foods to be compared to their conventionally produced counterparts, usually commonly consumed foods already regarded as safe (WHO, 1995, 2000). The comparison is usually made at the level of the composition of the food. This allows the safety assessment to focus on any significant differences between the GM food and its conventionally produced counterpart. Phenotypic differences are not normally considered in the comparison,
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if that difference does not significantly change the characteristics for composition of the new food relative to the conventional food. This is partly because differences in phenotype can occur with every breeding event and often arise also as a result of certain environmental factors. The comparative approach allows for an evaluation of the important constituents of a new food in a systematic manner while recognizing that there is general acceptance that normally consumed food produced by conventional methods is regarded by the community as safe. It is important to note that, although a GM food may be found to be different in composition to the traditional food, this in itself does not necessarily mean that the food is unsafe or nutritionally inadequate. The health and safety impact of any changes in the composition or properties of the GM food are evaluated. The comparative approach was first espoused by a 1991 Joint FAO/WHO Consultation where it was noted that the comparison of a final product with one having an acceptable standard of safety provides an important element of safety assessment (WHO, 1991). Since this time, the concept has been integrated into safety assessment procedures used by regulatory authorities worldwide. It has thus been in use for approximately 10 years and has been an integral part of the safety assessment of some 40 products. Although the approach has attracted criticism, it remains the most appropriate mechanism for assessing the nutritional and food safety implications of foods produced using gene technology (WHO, 2000). It is generally agreed also that continual review of the concept, in response to the criticism, provides a useful stimulus to ensure that safety assessment procedures are kept at the forefront of scientific knowledge (New Zealand Royal Commission, 2001; Royal Society of Canada, 2001; The Royal Society, 2002; WHO, 2000). 5.3. Post-market surveillance The need for post-market monitoring and surveillance systems to be established for assessing the longterm health impacts of GM foods has often been raised by a number of stakeholders. There are currently no official mechanisms within Australia and New Zealand for monitoring the long-term impacts of GM foods. In Australia and New Zealand, as in most other countries, the responsibility for post-market surveillance is covered by an ongoing duty of care on the part of the developer. The developer is expected to monitor for existing and emerging risks that may be associated with its product and notify regulatory authorities whenever new information is uncovered. In any discussion of post-market surveillance in relation to the evaluation of GM foods and products, it should be noted that one important consideration is that GM food products should not be placed on the market
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if any question associated with negative health effects is left unanswered during the pre-market safety assessment. A robust, science-based assessment, such as used by FSANZ and others, should minimise the need for post market surveillance. Furthermore, the labelling requirements introduced in December 2001 in Australia and New Zealand will help to ensure a much better knowledge of whether particular foods contain GM ingredients and, if so, which ingredients. From that time, it might be possible to link data on the health of individuals with information on their consumption of GM foods of differing types. The United KingdomÕs Food Standards Agency began an 18 month feasibility study to determine whether long-term monitoring of novel foods is possible (Baynton, 1999). The rationale is that it may be possible to link any detected variation at district level in food purchasing and consumption to health outcomes at district level. The results of the study might lead to recommendations with respect to the future surveillance of novel foods.
6. Current status of regulatory approvals for GM foods in Australia and New Zealand At the time of writing this paper, FSANZ had received 23 applications for the assessment and approval of GM foods derived from soybeans, corn, canola, potato, sugarbeet and cotton (see Table 1). All but one of the introduced genetic traits are designed to improve agronomic characteristics, such as pest and disease resistance or tolerance to herbicides. The other modification relates to changes in the oleic acid content of a soybean, which improves the cooking characteristics of the oil and may also provide potential health benefits to consumers. To date, FSANZ has completed and released full safety assessments on 20 of these GM foods for public comment, all of which have subsequently been approved for sale in Australia and New Zealand. Three other applications are still being assessed at earlier stages of the process. Two of the applications were withdrawn as commercialisation of the products had been discontinued.
7. Labelling of GM foods When Standard 1.5.2 was first adopted in 1998, it contained mandatory labelling provisions for those GM foods that had been specifically changed with respect to composition or end use. Subsequently broader labelling requirements were considered in view of growing public concern over GM foods. This resulted in a series of stakeholder consultations as well as the commissioning of a study to investigate the costs to industry and
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Table 1 Applications for GM foods assessed by FSANZ Crop
Product
Status
Soybean
Glyphosate-tolerant soybean line 40-3-2 High oleic soybean lines G94-1, G94-19 and G168 Glufosinate-ammonium tolerant soybean lines A2704-12
Approved Approved
Canola
Glufosinate-ammonium tolerant canola topas 19/2 and T45 and glufosinateammonium tolerant and pollination controlled lines Ms1, Ms8, Rf1, Rf2, RF3 Glyphosate-tolerant canola line GT73 Bromoxynil-tolerant canola Westar-oxy-235
Approved Approved Approved
Corn
Insect-protected corn line MON 810 Glufosinate-ammonium tolerant corn line T25 Glyphosate-tolerant corn line GA21 Glyphosate-tolerant corn line NK603 Insect-protected and glufosinate-ammonium tolerant DBT418 corn Insect-protected Bt-176 corn Insect-protected and glufosinate-ammonium tolerant Bt-11 corn Insect-protected and glufosinate-ammonium corn line 1507 Glufosinate-ammonium tolerant DLL25 corn Insect-protected MON 863 corn
Approved Approved Approved Approved Approved Approved Approved Assessment in progress Withdrawn
Potato
Insect-protected potato lines BT-06, ATBT04-06, ATBT04-31, ATBT04-36, and SPBT02-05 Insect- and potato leafroll virus-protected potato lines RBMT21-129, RBMT21-350 and RBMT22-82 Insect- and potato virus Y-protected potato lines RBMT15-101, SEMT15-02 and SEMT15-15
Approved
Sugarbeet
Glyphosate-tolerant sugarbeet line GTSB77
Approved
Cotton
Insect-protected cotton lines 531, 757 and 1076 Glyphosate-tolerant cotton line 1445 Insect-protected cotton line 1849 Bromoxynil-tolerant cotton transformation events 10211 and 10222 Insect-protected cotton event 15895
Approved Approved Withdrawn Approved Approved
enforcement agencies of broader labelling requirements (ANZFA, 2000b). In November 2000 mandatory labelling requirements for GM foods were adopted. These requirements came into effect in Australia and New Zealand on 7 December 2001, although provisions were made for retailers to continue to sell unlabelled GM foods already in stock before this date for a further 12 months. Labelling is now required where • novel DNA and/or protein is present in the final food; and/or • the food has altered characteristics when compared with its conventional counterparts. Exemptions from these labelling requirements apply to • highly refined food where the effect of the refining process is to remove novel DNA and/or protein; • processing aids and food additives except those where novel DNA and/or protein is present in the final food; • flavours which are present in a concentration less than or equal to 0.1% in the final food; and • food prepared at the point of sale. An ingredient is permitted to contain up to 1% of unintended presence of GM material in non-GM food
Approved Approved
without requiring labelling. It is expected that compliance with the new requirements will most typically be demonstrated through the use of verifiable documentation rather than analytical testing (ANZFA, 2001b). Such a process generally relies on food businesses being diligent in determining the accuracy of the documentation. In assessing compliance with the standard, enforcement agencies would review the documentation as a first step. Analytical testing would only be required where the GM status of a food could not be determined through documentation The decision to require mandatory labelling of GM foods represented a balance between what consumers desired, cost effective regulation for industry and what was enforceable. Reaction to the GM labelling standard has been mixed. Industry has indicated that compliance with the standard might be costly and that costs arising from the requirement to label will have to be passed on to consumers. Consumers, whilst expressing reservations about the fact that not all GM foods will be labelled (‘‘process labelling’’), seem to have accepted that labelling will facilitate their desire for making informed choices about the food they eat. The new labelling requirements will be reviewed three years from the date of their adoption, i.e., towards the end of 2003.
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8. International harmonisation and information sharing International harmonisation and capacity building in the safety assessment of GM foods is seen as integral by FSANZ to the future development and regulation of this technology. A key component of this is the sharing of information about GM food safety assessments that should be a priority for all regulatory agencies involved in the regulation of GM food and for international standard setting bodies such as Codex. Better use of existing information and mechanisms for information exchange are vital as a first step toward the broader objective of international mutual recognition of assessments on GM foods and adoption of broad regulatory principles of operation such as transparency and public consultation and participation. There are currently no internationally agreed regulatory requirements for food derived from biotechnology, either in relation to assessing the potential human health impacts of the foods or for providing information about the method of production of the food. However, the data requirements for safety assessments on GM foods are very similar in various countries around the world. Most regulatory agencies around the world have adopted elements of the earlier principles developed by the WHO/ FAO and OECD (FAO, 1996; OECD, 1993; OECD, 1996; WHO, 1991; WHO, 1995) as the basis of their guidelines in individual countries. Australia and New Zealand recognise the Codex Alimentarius Commission (Codex) as the appropriate body for setting international food standards, including those that apply to GM foods. The Codex Ad Hoc Taskforce on Foods Derived from Biotechnology has expedited the development of guidance on assessing the safety of GM foods. The Taskforce recently finalised its recommendations on guidelines for the safety assessment of foods derived from plants developed using biotechnology (now at Step 8 (final) of the Codex procedure). FSANZ (and previously as ANZFA) has undertaken a number of activities in relation to international harmonisation, capacity building and information sharing. FSANZ and Health Canada signed a Memorandum of Understanding in 1991 establishing an agreement for the exchange of information relating to the safety assessment and regulation of GM foods. This agreement will enhance evaluation activities related to food biotechnology and bring mutual benefits to both organisations. Recently, FSANZ collaborated with Health Canada in the presentation of workshops on the safety assessment of GM foods. These workshops have been targeted to meet the needs of Asia-Pacific Economic Co-Operation (APEC) member countries and the Association of South East Asian Nations (ASEAN) countries and have been designed to allow participants (‘‘train the trainers’’) to be in a position to develop regulatory frameworks in their own countries. Such work is increasingly being rec-
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ognised by international organisations (OECD, WHO) as essential to international harmonisation in this area.
9. Future directions and the implications for GM foods As with any new enabling technology, gene technology may bring both potential benefits and raise concerns. The next generation of GM foods is likely to raise more complex and challenging issues for food regulators and may blur the boundary between foods and therapeutics. Products may include nutraceuticals, edible vaccines and biopharmaceuticals produced in both plants and animals. An early progenitor of such ‘‘second generation’’ products is ‘‘Golden rice’’, which was engineered to enhance its content of carotene, a precursor of vitamin A (Ye et al., 2000). This food was developed with the aim of combating vitamin A deficiency, which is a significant problem in many developing countries. Future directions in the development of gene technology are likely to have significant impacts on the community and present many challenges for regulatory authorities. Some of the issues, which will need consideration include: • continuing high levels of consumer and community interest in the development of the technology in relation to GM foods and potential health impacts; • the development of genetically modified animals, including fish, and GM microorganisms and how these will be assessed for their safety; • an increasing number of GM foods with new properties which may provide benefits to consumers in taste, shelf-life, nutrition etc; • the development of GM foods with therapeutic effects. These will create challenges for food and therapeutic goods regulatory authorities in coordinating regulatory action; • development of internationally agreed protocols and arrangements for the regulation of GM foods; • monitoring and evaluation of potential and unforeseen health effects of both the current and future range of GM foods available commercially; • harmonisation of regulatory activity/safety assessment requirements and ‘‘work sharing’’; • capability and capacity building in the regulatory system; and • the need for post-market monitoring and surveillance system for long-term health impacts.
10. Conclusions Interest in GM products has intensified as applications of gene technology have accelerated, particularly in agriculture and medicine. While gene technology offers the potential for significant benefits, including
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enhanced agricultural production, improved healthcare, and new possibilities for chemical and manufacturing industries, it has also raised concerns and generated considerable debate. Much of this debate focuses on agriculture and food, and on consumersÕ Ôright to knowÕ and make an informed choice in selecting food products. The debate also raises consumer concerns about potential health effects, ethical issues and potential environmental impacts. Further elements of the debate include the competitiveness of some Australian and New Zealand industries, international trade, intellectual property rights, the potential for concentration of ownership in food production, and opportunities for, and corresponding responsibilities of, those producing the GM foods. These issues are receiving prominence both in Australia and New Zealand and globally, for example by international bodies such as Codex Alimentarius, FAO/ WHO, OECD, the World Trade Organization and the United Nations. Australian and New Zealand government policies in relation to GM foods and their implementation, and how industry and the community respond to these developments, have significant implications for the economies of Australia and New Zealand, their social fabric and the environment. The framework established for the regulation of GM foods in Australia and New Zealand is arguably one of the most scientifically robust, consultative and transparent in the world today (CBAC, 2000). Even though the regulatory system has a number of strengths, many believe there are opportunities for improving efficiency, effectiveness and public understanding of the system. Discussion of the procedures and criteria for the approval of GM foods is well advanced. Further communication between regulatory authorities, scientists from various disciplines and consumer organisations will guarantee sound risk assessment procedures for these products and thereby safeguard a varied, safe and wholesome food supply. Valuable experience gained by FSANZ is being used to incorporate better strategies for developing an even more rigorous and comprehensive regulatory system for ensuring the safety of GM foods in Australia and New Zealand. This experience is also being applied to foods produced using other novel production techniques (e.g., irradiation) to novel foods or foods containing novel ingredients.
References ANZFA (2000a). GM foods and the consumer: ANZFAÕs safety assessment process for genetically modified food. ANZFA occasional paper series no. 1. Canberra: Australia New Zealand Food Authority. ANZFA (2000b). Report on the costs of labelling genetically modified foods. Canberra: Australia New Zealand Food Authority.
ANZFA (2001a). Information for applicants: amending standard A18/ standard 1.5.2––food produced using gene technology, September 2001. Canberra: Australia New Zealand Food Authority. ANZFA (2001b). Labelling genetically modified food. User guide to standard A18/1.5.2––food produced using gene technology. Canberra: Australia New Zealand Food Authority. Baynton, C. (1999). Surveillance and post-market monitoring of potential health effects of novel foods. Feasibility study. London: United Kingdom Food Standards Agency. CBAC (2000). International comparison of regulatory frameworks for food products of biotechnology (pp. 1–65), Canada: Canadian Biotechnology Advisory Committee. FAO (1996). Biotechnology and food safety. Report of a Joint FAO/ WHO consultation. FAO food and nutrition paper 61. Rome: Food and Agriculture Organisation of the United Nations. Halloran, J., & Hansen, M. (1998). Why we need labelling of genetically engineered food. Consumers International. Healy, M., Brooke-Taylor, S., & Liehne, P. (in press). Reform of food regulation in Australia and New Zealand. Food Control. Kellow, A. (1999). Risk assessment and decision-making for genetically modified foods. Melbourne: IPA Biotechnology Backgrounder, Institute of Public Affairs. Kuiper, H. A., Kleter, G. A., Noteborn, H. P. J., & Kok, E. J. (2001). Assessment of food safety issues related to genetically modified foods. The Plant Journal, 27(6), 503–528. McLaren, J. S. (1998). The success of transgenic crops in the USA. Pesticide Outlook (December), 36–41. Nestle, M. (1998). Food biotechnology: labelling will benefit industry as well as consumers. Nutrition Today, 6–12. New Zealand Royal Commission (2001). Report of the Royal Commission on genetic modification. Available: www.gmocommission.govt.nz. OECD (1993). Safety evaluation of foods derived by modern biotechnology, concepts and principles. Paris: Organisation for Economic Cooperation and Development. OECD (1996). Food safety evaluation. Report of a Workshop held in Oxford, UK, 12–15 September, 1994. Paris: Organisation for Economic Cooperation and Development. Peacock, W. J. (2000). The role of gene technology in food agribusiness systems. Food Australia, 52, 367–371. Royal Society of Canada (2001). Elements of precaution: recommendations for the regulation of food biotechnology in Canada. An expert panel report on the future of food biotechnology. Ontario: Royal Society of Canada. Sjoblad, R. D., McClintock, J. T., & Engler, R. (1992). Toxicological considerations for protein components of biological pesticide products. Regulatory Toxicology and Pharmacology, 15, 3–9. Society of Toxicology (2002).The safety of foods produced through biotechnology. Position paper, pp. 1–12. The Royal Society (2002). Genetically modified plants for food use in human health––an update. Policy Document 4/02. London: The Royal Society. WHO (1991). Strategies for assessing the safety of foods produced by biotechnology. Report of a Joint FAO/WHO Consultation. Geneva: World Health Organisation. WHO (1995). Application of the principles of substantial equivalence to the safety evaluation of foods or food components from plants derived by modern biotechnology. Report of a WHO workshop. Geneva: World Health Organisation. WHO (2000). Safety aspects of genetically modified food of plant origin. Report of a joint FAO/WHO expert consultation on food derived from biotechnology. Geneva: World Health Organisation. Ye, X., Al-Babili, S., Kloti, A., Zhang, J., Lucca, P., Beyer, P., & Potrykus, I. (2000). Engineering the provitamin A (b-carotene) biosynthetic pathway into (carotenoid-free) rice endosperm. Science, 287, 303–305.
Regulation of genetically modified foods in Australia and New Zealand Paul Brent
*,1,
Dennis Bittisnich, Simon Brooke-Taylor 1, Nora Galway, Lynda Graf, Marion Healy, Lisa Kelly Food Standards Australia New Zealand, P.O. Box 7186, Canberra, BC ACT 2610, Australia
Abstract Food standards in Australia and New Zealand build on the level of food safety that is generally accepted by the community. An explicitly cautious approach is applied in cases where there is no established history of safe human consumption, as is the case for foods produced using gene technology. Novel foods, including genetically modified (GM) foods, undergo a mandatory pre-market safety assessment and approval process. The approach used in Australia and New Zealand to assess the safety of foods produced using gene technology draws on concepts and principles that have been developed internationally. Crown Copyright 2003 Published by Elsevier Science Ltd. All rights reserved. Keywords: Genetically modified foods; Safety assessment; Labelling; Gene technology; Substantial equivalence
1. Introduction Modern biotechnology, particularly the use of recombinant-DNA techniques, has allowed the isolation, cloning and incorporation of genes conferring novel or altered traits into plants, as well as other organisms. These techniques involve taking copies of genes from the cells of a plant, animal or microbe and inserting them into another cell to give a desired characteristic. The resulting plants or animals are often termed genetically modified (GM), and thus food derived from these organisms is referred to simply as GM food. The use of modern biotechnology, especially for the production of food, continues to be the subject of considerable debate. While many consider the use of the technology to have the potential to increase productivity, provide innovative mechanisms to control devastating pests and diseases, and to produce foods with targeted health and nutritional benefits (McLaren, 1998; Peacock, 2000), others have suggested the production of GM foods might pose unknown risks in both the short and long term (Halloran & Hansen, 1998) and also
raises major ethical and social questions for sections of the community (Kellow, 1999; Nestle, 1998). Since food and feed products of modern biotechnology are now being commercialised and marketed in many countries, appropriate approaches are required to the effective regulation of these products. Governments worldwide have been developing regulatory frameworks to protect both the environment and human health from potential adverse effects that may arise from production of GM organisms (GMOs) and foods derived from them. This paper describes the development of the regulatory framework for GM foods in Australia and New Zealand, outlines the essential elements of a procedure to assess the safety of GM foods and their labelling, and identifies some of the major issues and challenges facing regulatory authorities both now and in the future. 2. Key features of the GM food standard GM foods entering the Australian and New Zealand food supplies must comply with Standard 1.5.2––Food Produced Using Gene Technology. The Standard was adopted in July 1998 as a joint standard with New Zealand and came into legal effect on 13 May 1999. 2
*
Corresponding author. Tel.: +61-2-62712279; fax: +61-262712278. E-mail address: [email protected] (P. Brent). 1 Present address: Brooke–Taylor and Co Pty Ltd, Suite 34, 4 Goulburn Street, Sydney, NSW 2000, Australia.
2
The Standard was originally adopted as Standard A18, but since the development of the newly adopted joint Australia New Zealand Food Standards Code, it is now known as Standard 1.5.2.
0956-7135/03/$ - see front matter Crown Copyright 2003 Published by Elsevier Science Ltd. All rights reserved. doi:10.1016/S0956-7135(03)00037-9
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The Standard defines a Ôfood produced using gene technologyÕ as a food, which has been derived or developed from an organism, which has been modified by gene technology. ÔGene technologyÕ is limited to recombinant DNA techniques that alter the heritable genetic material of living cells or organisms. Standard 1.5.2 is divided into two sections. The first section (Division 1) imposes a pre-market approval system for GM foods in Australia and New Zealand whereby the sale and use of food produced using gene technology is prohibited unless it has been specifically permitted. Companies wishing to market a GM food in Australia and New Zealand must apply to Food Standards Australia New Zealand (FSANZ) 3 to have the Standard amended to include their particular GM food as an approved food produced using gene technology. Approval of a specific food produced using gene technology is contingent on the outcome of a pre-market safety assessment undertaken by FSANZ. The Standard also recognises that some foods derived using the process of gene technology were already in the food supply when the Standard came into effect. Transitional arrangements were put in place to permit these foods to remain in the marketplace while the foods underwent a safety assessment. Division 2 of the Standard specifies labelling and other information requirements for foods produced using gene technology. Unlike the pre-market assessment and approval aspects of the standard, the labelling provisions also apply to food additives and processing aids that have been produced using gene technology. Labelling is required if novel DNA or protein is present in the final food (see Section 7). It is important to note that the labelling provisions of Standard 1.5.2 are intended to provide information to consumers, not to act as health warnings because unsafe foods, GM or otherwise, are not permitted for sale in Australia or New Zealand. GM foods approved under Standard 1.5.2 must be determined to be as safe as their traditional counterparts.
3. Key principles in the safety assessment of GM foods The safety of the Australian and New Zealand food supply is regulated through a risk-based, evidence-based approach that includes cautious and conservative elements. Under the FSANZ regulatory framework in Australia and New Zealand, an explicitly cautious approach is applied to foods where there is no established history of safe human consumption (see ANZFA, 2000a; Healy, Brooke-Taylor, & Liehne, in press).
3
Formerly the Australia New Zealand Food Authority (ANZFA).
To date GM foods have been derived from foods with a long established history of safe human consumption. Moreover, the use of gene technology to modify these foods is a recent innovation. As such, GM foods are subjected to case-by-case assessment of safety with the benchmark for an acceptable level of safety being that conferred by the conventionally produced counterpart. The pre-market assessment and approval process thus aims to ensure that GM food is as safe as conventionally produced food. FSANZ uses an open and transparent assessment process. All data submitted in support of an application (except a small amount of commercial-in-confidence data) are available to the public. The assessment and decision-making processes are fully documented with the documentation available to all who are interested. To this extent, the transparency of FSANZÕs process is probably unique in the world. FSANZ also undertakes two rounds of public consultation during its assessment of applications. This ensures that the public (including consumers, non-government organisations, scientists, public health professionals and any other interested parties) may comment on, and contribute relevant information to, the safety assessments before they are finalised. The FSANZ safety assessment process for GM foods is based on internationally recognised concepts and principles that have been developed through the expert consultation processes of the OECD, the WHO/FAO and Codex Alimentarius Commission (ANZFA, 2000a, 2001a). FSANZ undertakes the safety assessment of GM food according to five key principles: • Safety assessments use scientific, risk-based methods. Scientific data for safety assessments are obtained from a variety of sources (primarily from the applicant but also from the scientific literature, general technical information, independent scientists, other regulatory agencies and international bodies, and the general community) and assessed using internationally recognised scientific, risk-based methods. • Safety assessments are conducted on a case-by-case basis. The safety of GM foods cannot be assessed as a single class because the safety concerns depend on the type of food and the nature of the genetic modification. Safety assessments are done on the fractions or components of individual GM varieties that are used as food or in food preparation. If the food derived from a GM plant or animal has been assessed as safe, they may be used as ingredients in other foods. For example, food components derived from GM soybeans such as soy oil, soy flour and lecithin may be used in foods such as breads, pastries and snack foods if the GM soybeans have been assessed as safe. The various breads, pastries and snack foods containing the GM soybean are not assessed individually.
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• New genetic material, new proteins and other characteristics of the GM food are considered. The safety of new components (new genetic material (DNA) and proteins which are coded by the DNA) in the GM food is considered separately and completely. Other characteristics of the food, such as the levels of nutrients and naturally occurring allergens, toxins and anti-nutrients, are also considered in detail because they could be indirectly affected by the genetic modification. • Both the intended and unintended effects of genetic modification are considered. The intended effect (direct effect) of the introduction of the new gene is the production of the new protein that confers the desired trait. The direct consequences of the genetic modification, for example the potential toxicity/allergenicity of any novel protein, potential for horizontal DNA transfer of an antibiotic resistance gene or the nutritional consequences of any intended compositional change, are thoroughly assessed as part of the safety assessment process. Unintended (indirect) effects, such as changed composition, e.g. significant changes to fatty acid profile, new toxin or allergen, significantly changed vitamins and minerals etc, need to also be considered in detail. These may vary depending on the nature of the genetic modification. • Where appropriate, comparisons are made to conventionally produced foods. Conventionally produced foods with a history of safe use are compared to the GM variety. The comparison is used to identify differences in levels of naturally occurring allergens, toxins, nutrients and anti-nutrients, or the ability to support typical growth and well being. Any significant differences between the GM variety and the conventional variety are assessed for their potential adverse health effects.
ters requiring assessment in the new food. Information is therefore required on the gene transfer method, the origin and function of any novel genetic material, and a molecular characterisation of the inserted genetic material, including around the junction region of the inserted DNA with the surrounding plant DNA. Data demonstrating that the novel genetic material has been stably integrated in the host genome and the phenotype is stably maintained over several generations is also required.
4. Issues considered in the safety assessment of GM foods
4.3. Toxicological and allergenicity issues
To support their application for approval of a GM food, the applicant must provide a large amount of scientific information to enable a thorough safety assessment to be conducted. All scientific data obtained from the applicant must be generated according to international standards of Good Laboratory Practice (where appropriate) in laboratories, which are independently audited. These data are supplemented with information obtained from a variety of sources. The safety assessment process considers all available information, focussing particularly on the following.
Toxicological concerns include the levels of naturally occurring toxins as well as the level and potential toxicity of any novel proteins. The levels of naturally occurring allergenic proteins as well as the potential allergenicity of any novel proteins are also considered. In an evaluation of the potential toxicity of the novel protein, consideration is given to the similarity of the novel protein to any known toxins. The results of any animal toxicity tests and the likely human exposure to the novel protein are also considered. Two aspects of potential allergenicity are considered. First, the assessment considers the likely transfer of an allergen during the genetic modification, which may cause foods previously considered non-allergenic to become allergenic. Second, the assessment considers if the expression of a novel protein in a food is likely to lead to
4.1. Nature and stability of the genetic modification A full description and molecular characterisation of the genetic modification identifies the relevant parame-
4.2. General safety issues The general safety issues are divided into three areas––history of use, nature and level of expression of any novel protein and the potential for transfer of novel genetic material to get microorganisms. The history and extent of use of the conventional unmodified food is an indication of its wholesomeness and safety and thus it can be used as a benchmark for comparison with the modified food variety. Factors considered include the levels of nutrients, anti-nutrients, natural toxicants and ability to support typical growth and well being. The nature of the novel proteins present in the GM food are analysed to determine their expression levels and patterns and to determine whether the expressed protein has been modified in any unexpected way. The impact on human health from potential transfer of novel genetic material, including antibiotic resistance genes, to cells, including microorganisms, in the human digestive tract is also considered. FSANZ considers the overall risk of gene transfer affecting the therapeutic use of antibiotics in humans to be so low as to be effectively zero. This position is supported by several recent reviews on GM food safety (Kuiper, Kleter, Noteborn, & Kok, 2001; Society of Toxicology, 2002; The Royal Society, 2002).
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the development of a new allergy in certain individuals. The first aspect can be addressed for known allergens, using human sera or human skin tests, to test for its presence in the modified food. However there are no reliable tests or animal models, which predict the allergenic potential of novel proteins. Instead, potential allergenicity can only be indicated through a Ôweight of evidenceÕ approach where a range of predictor tests on the novel protein are examined to determine whether it has any of the characteristics common to known allergens. If the novel protein does not possess these characteristics, it can usually be concluded that the novel protein is unlikely to be allergenic. 4.4. Nutritional issues In assessing the safety of a GM food, a key factor is the need to establish that the food is nutritionally adequate and will support typical growth and well being. In most cases, this can be achieved through an understanding of the genetic modification and its consequences together with an extensive compositional analysis of the food. Where, on the basis of available data, there is still concern or doubt in this regard, FSANZ considers that carefully designed feeding studies in animals may provide further reassurance that the food is nutritionally adequate. Such studies may be necessary where the compositional analysis indicates significant differences in a number of important components or nutrients or where there is concern that the bioavailability of key nutrients may be compromised by the nature of the genetic changes to the food.
5. Major issues raised during development of safety assessments 5.1. The need for long-term animal toxicity studies It is useful when examining the need for long-term animal toxicity studies to compare the type of tests available for medicines and chemicals with those possible for whole foods (for example, WHO, 2000). Animal studies are a major element in the safety assessment of many compounds, including pesticides, pharmaceuticals, industrial chemicals and food additives. In most cases, the test substance is well characterised, of known purity and of no nutritional value. Human exposure to such substances is generally low. It is therefore relatively straightforward to feed such compounds to laboratory animals at a range of doses (some several orders of magnitude above expected human exposure levels) in order to identify any potential adverse effects. Establishing a dose–response relationship is a pivotal step in toxicological testing. By determining the level of exposure at which no adverse effects occur, a safe level of
exposure for humans can be established which includes appropriate safety factors. By contrast, foods are complex mixtures of compounds characterised by wide variations in composition and nutritional value. Due to their bulk, they can usually be fed to animals only at low multiples of the amounts that might be present in the human diet. Therefore, in most cases, it is not possible to conduct dose–response experiments for foods in the same way that these experiments are conducted for chemicals. In addition, a key factor to be considered in conducting animal feeding studies is the need to maintain the nutritional value and balance of the diet. A diet that consists entirely of a single food is poorly balanced and will compromise the interpretation of the study, since the effects observed would confound and usually override any other small adverse effect, which may be related to a component or components of the food being tested. Identifying any potentially adverse effects and relating these to an individual component or characteristic of a food can, therefore, be extremely difficult. Another consideration in determining the need for animal studies is whether it is appropriate from an ethical standpoint to subject experimental animals to such a study if it is unlikely to produce meaningful information. It is therefore more appropriate to examine the safety of newly expressed protein as a purified substance in an animal study rather than as part of a whole food. The acute toxicity of newly expressed proteins in GM foods is normally examined in experimental animals. It is generally accepted that when proteins are toxic, they are known to act via acute mechanisms and at very low dose levels (Sjoblad, McClintock, & Engler, 1992). These studies can provide additional reassurance that the proteins will have no adverse effects in humans when consumed as part of a food. While animal experiments using a single new protein can provide more meaningful information than experiments on the whole food, additional reassurance regarding the safety of newly expressed protein can be obtained by examining the digestibility of the new protein in laboratory conducted in in vitro assays using conditions which simulate the human gastric system. 5.2. The comparative approach The comparative approach, previously referred to as substantial equivalence, requires GM foods to be compared to their conventionally produced counterparts, usually commonly consumed foods already regarded as safe (WHO, 1995, 2000). The comparison is usually made at the level of the composition of the food. This allows the safety assessment to focus on any significant differences between the GM food and its conventionally produced counterpart. Phenotypic differences are not normally considered in the comparison,
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if that difference does not significantly change the characteristics for composition of the new food relative to the conventional food. This is partly because differences in phenotype can occur with every breeding event and often arise also as a result of certain environmental factors. The comparative approach allows for an evaluation of the important constituents of a new food in a systematic manner while recognizing that there is general acceptance that normally consumed food produced by conventional methods is regarded by the community as safe. It is important to note that, although a GM food may be found to be different in composition to the traditional food, this in itself does not necessarily mean that the food is unsafe or nutritionally inadequate. The health and safety impact of any changes in the composition or properties of the GM food are evaluated. The comparative approach was first espoused by a 1991 Joint FAO/WHO Consultation where it was noted that the comparison of a final product with one having an acceptable standard of safety provides an important element of safety assessment (WHO, 1991). Since this time, the concept has been integrated into safety assessment procedures used by regulatory authorities worldwide. It has thus been in use for approximately 10 years and has been an integral part of the safety assessment of some 40 products. Although the approach has attracted criticism, it remains the most appropriate mechanism for assessing the nutritional and food safety implications of foods produced using gene technology (WHO, 2000). It is generally agreed also that continual review of the concept, in response to the criticism, provides a useful stimulus to ensure that safety assessment procedures are kept at the forefront of scientific knowledge (New Zealand Royal Commission, 2001; Royal Society of Canada, 2001; The Royal Society, 2002; WHO, 2000). 5.3. Post-market surveillance The need for post-market monitoring and surveillance systems to be established for assessing the longterm health impacts of GM foods has often been raised by a number of stakeholders. There are currently no official mechanisms within Australia and New Zealand for monitoring the long-term impacts of GM foods. In Australia and New Zealand, as in most other countries, the responsibility for post-market surveillance is covered by an ongoing duty of care on the part of the developer. The developer is expected to monitor for existing and emerging risks that may be associated with its product and notify regulatory authorities whenever new information is uncovered. In any discussion of post-market surveillance in relation to the evaluation of GM foods and products, it should be noted that one important consideration is that GM food products should not be placed on the market
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if any question associated with negative health effects is left unanswered during the pre-market safety assessment. A robust, science-based assessment, such as used by FSANZ and others, should minimise the need for post market surveillance. Furthermore, the labelling requirements introduced in December 2001 in Australia and New Zealand will help to ensure a much better knowledge of whether particular foods contain GM ingredients and, if so, which ingredients. From that time, it might be possible to link data on the health of individuals with information on their consumption of GM foods of differing types. The United KingdomÕs Food Standards Agency began an 18 month feasibility study to determine whether long-term monitoring of novel foods is possible (Baynton, 1999). The rationale is that it may be possible to link any detected variation at district level in food purchasing and consumption to health outcomes at district level. The results of the study might lead to recommendations with respect to the future surveillance of novel foods.
6. Current status of regulatory approvals for GM foods in Australia and New Zealand At the time of writing this paper, FSANZ had received 23 applications for the assessment and approval of GM foods derived from soybeans, corn, canola, potato, sugarbeet and cotton (see Table 1). All but one of the introduced genetic traits are designed to improve agronomic characteristics, such as pest and disease resistance or tolerance to herbicides. The other modification relates to changes in the oleic acid content of a soybean, which improves the cooking characteristics of the oil and may also provide potential health benefits to consumers. To date, FSANZ has completed and released full safety assessments on 20 of these GM foods for public comment, all of which have subsequently been approved for sale in Australia and New Zealand. Three other applications are still being assessed at earlier stages of the process. Two of the applications were withdrawn as commercialisation of the products had been discontinued.
7. Labelling of GM foods When Standard 1.5.2 was first adopted in 1998, it contained mandatory labelling provisions for those GM foods that had been specifically changed with respect to composition or end use. Subsequently broader labelling requirements were considered in view of growing public concern over GM foods. This resulted in a series of stakeholder consultations as well as the commissioning of a study to investigate the costs to industry and
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Table 1 Applications for GM foods assessed by FSANZ Crop
Product
Status
Soybean
Glyphosate-tolerant soybean line 40-3-2 High oleic soybean lines G94-1, G94-19 and G168 Glufosinate-ammonium tolerant soybean lines A2704-12
Approved Approved
Canola
Glufosinate-ammonium tolerant canola topas 19/2 and T45 and glufosinateammonium tolerant and pollination controlled lines Ms1, Ms8, Rf1, Rf2, RF3 Glyphosate-tolerant canola line GT73 Bromoxynil-tolerant canola Westar-oxy-235
Approved Approved Approved
Corn
Insect-protected corn line MON 810 Glufosinate-ammonium tolerant corn line T25 Glyphosate-tolerant corn line GA21 Glyphosate-tolerant corn line NK603 Insect-protected and glufosinate-ammonium tolerant DBT418 corn Insect-protected Bt-176 corn Insect-protected and glufosinate-ammonium tolerant Bt-11 corn Insect-protected and glufosinate-ammonium corn line 1507 Glufosinate-ammonium tolerant DLL25 corn Insect-protected MON 863 corn
Approved Approved Approved Approved Approved Approved Approved Assessment in progress Withdrawn
Potato
Insect-protected potato lines BT-06, ATBT04-06, ATBT04-31, ATBT04-36, and SPBT02-05 Insect- and potato leafroll virus-protected potato lines RBMT21-129, RBMT21-350 and RBMT22-82 Insect- and potato virus Y-protected potato lines RBMT15-101, SEMT15-02 and SEMT15-15
Approved
Sugarbeet
Glyphosate-tolerant sugarbeet line GTSB77
Approved
Cotton
Insect-protected cotton lines 531, 757 and 1076 Glyphosate-tolerant cotton line 1445 Insect-protected cotton line 1849 Bromoxynil-tolerant cotton transformation events 10211 and 10222 Insect-protected cotton event 15895
Approved Approved Withdrawn Approved Approved
enforcement agencies of broader labelling requirements (ANZFA, 2000b). In November 2000 mandatory labelling requirements for GM foods were adopted. These requirements came into effect in Australia and New Zealand on 7 December 2001, although provisions were made for retailers to continue to sell unlabelled GM foods already in stock before this date for a further 12 months. Labelling is now required where • novel DNA and/or protein is present in the final food; and/or • the food has altered characteristics when compared with its conventional counterparts. Exemptions from these labelling requirements apply to • highly refined food where the effect of the refining process is to remove novel DNA and/or protein; • processing aids and food additives except those where novel DNA and/or protein is present in the final food; • flavours which are present in a concentration less than or equal to 0.1% in the final food; and • food prepared at the point of sale. An ingredient is permitted to contain up to 1% of unintended presence of GM material in non-GM food
Approved Approved
without requiring labelling. It is expected that compliance with the new requirements will most typically be demonstrated through the use of verifiable documentation rather than analytical testing (ANZFA, 2001b). Such a process generally relies on food businesses being diligent in determining the accuracy of the documentation. In assessing compliance with the standard, enforcement agencies would review the documentation as a first step. Analytical testing would only be required where the GM status of a food could not be determined through documentation The decision to require mandatory labelling of GM foods represented a balance between what consumers desired, cost effective regulation for industry and what was enforceable. Reaction to the GM labelling standard has been mixed. Industry has indicated that compliance with the standard might be costly and that costs arising from the requirement to label will have to be passed on to consumers. Consumers, whilst expressing reservations about the fact that not all GM foods will be labelled (‘‘process labelling’’), seem to have accepted that labelling will facilitate their desire for making informed choices about the food they eat. The new labelling requirements will be reviewed three years from the date of their adoption, i.e., towards the end of 2003.
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8. International harmonisation and information sharing International harmonisation and capacity building in the safety assessment of GM foods is seen as integral by FSANZ to the future development and regulation of this technology. A key component of this is the sharing of information about GM food safety assessments that should be a priority for all regulatory agencies involved in the regulation of GM food and for international standard setting bodies such as Codex. Better use of existing information and mechanisms for information exchange are vital as a first step toward the broader objective of international mutual recognition of assessments on GM foods and adoption of broad regulatory principles of operation such as transparency and public consultation and participation. There are currently no internationally agreed regulatory requirements for food derived from biotechnology, either in relation to assessing the potential human health impacts of the foods or for providing information about the method of production of the food. However, the data requirements for safety assessments on GM foods are very similar in various countries around the world. Most regulatory agencies around the world have adopted elements of the earlier principles developed by the WHO/ FAO and OECD (FAO, 1996; OECD, 1993; OECD, 1996; WHO, 1991; WHO, 1995) as the basis of their guidelines in individual countries. Australia and New Zealand recognise the Codex Alimentarius Commission (Codex) as the appropriate body for setting international food standards, including those that apply to GM foods. The Codex Ad Hoc Taskforce on Foods Derived from Biotechnology has expedited the development of guidance on assessing the safety of GM foods. The Taskforce recently finalised its recommendations on guidelines for the safety assessment of foods derived from plants developed using biotechnology (now at Step 8 (final) of the Codex procedure). FSANZ (and previously as ANZFA) has undertaken a number of activities in relation to international harmonisation, capacity building and information sharing. FSANZ and Health Canada signed a Memorandum of Understanding in 1991 establishing an agreement for the exchange of information relating to the safety assessment and regulation of GM foods. This agreement will enhance evaluation activities related to food biotechnology and bring mutual benefits to both organisations. Recently, FSANZ collaborated with Health Canada in the presentation of workshops on the safety assessment of GM foods. These workshops have been targeted to meet the needs of Asia-Pacific Economic Co-Operation (APEC) member countries and the Association of South East Asian Nations (ASEAN) countries and have been designed to allow participants (‘‘train the trainers’’) to be in a position to develop regulatory frameworks in their own countries. Such work is increasingly being rec-
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ognised by international organisations (OECD, WHO) as essential to international harmonisation in this area.
9. Future directions and the implications for GM foods As with any new enabling technology, gene technology may bring both potential benefits and raise concerns. The next generation of GM foods is likely to raise more complex and challenging issues for food regulators and may blur the boundary between foods and therapeutics. Products may include nutraceuticals, edible vaccines and biopharmaceuticals produced in both plants and animals. An early progenitor of such ‘‘second generation’’ products is ‘‘Golden rice’’, which was engineered to enhance its content of carotene, a precursor of vitamin A (Ye et al., 2000). This food was developed with the aim of combating vitamin A deficiency, which is a significant problem in many developing countries. Future directions in the development of gene technology are likely to have significant impacts on the community and present many challenges for regulatory authorities. Some of the issues, which will need consideration include: • continuing high levels of consumer and community interest in the development of the technology in relation to GM foods and potential health impacts; • the development of genetically modified animals, including fish, and GM microorganisms and how these will be assessed for their safety; • an increasing number of GM foods with new properties which may provide benefits to consumers in taste, shelf-life, nutrition etc; • the development of GM foods with therapeutic effects. These will create challenges for food and therapeutic goods regulatory authorities in coordinating regulatory action; • development of internationally agreed protocols and arrangements for the regulation of GM foods; • monitoring and evaluation of potential and unforeseen health effects of both the current and future range of GM foods available commercially; • harmonisation of regulatory activity/safety assessment requirements and ‘‘work sharing’’; • capability and capacity building in the regulatory system; and • the need for post-market monitoring and surveillance system for long-term health impacts.
10. Conclusions Interest in GM products has intensified as applications of gene technology have accelerated, particularly in agriculture and medicine. While gene technology offers the potential for significant benefits, including
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enhanced agricultural production, improved healthcare, and new possibilities for chemical and manufacturing industries, it has also raised concerns and generated considerable debate. Much of this debate focuses on agriculture and food, and on consumersÕ Ôright to knowÕ and make an informed choice in selecting food products. The debate also raises consumer concerns about potential health effects, ethical issues and potential environmental impacts. Further elements of the debate include the competitiveness of some Australian and New Zealand industries, international trade, intellectual property rights, the potential for concentration of ownership in food production, and opportunities for, and corresponding responsibilities of, those producing the GM foods. These issues are receiving prominence both in Australia and New Zealand and globally, for example by international bodies such as Codex Alimentarius, FAO/ WHO, OECD, the World Trade Organization and the United Nations. Australian and New Zealand government policies in relation to GM foods and their implementation, and how industry and the community respond to these developments, have significant implications for the economies of Australia and New Zealand, their social fabric and the environment. The framework established for the regulation of GM foods in Australia and New Zealand is arguably one of the most scientifically robust, consultative and transparent in the world today (CBAC, 2000). Even though the regulatory system has a number of strengths, many believe there are opportunities for improving efficiency, effectiveness and public understanding of the system. Discussion of the procedures and criteria for the approval of GM foods is well advanced. Further communication between regulatory authorities, scientists from various disciplines and consumer organisations will guarantee sound risk assessment procedures for these products and thereby safeguard a varied, safe and wholesome food supply. Valuable experience gained by FSANZ is being used to incorporate better strategies for developing an even more rigorous and comprehensive regulatory system for ensuring the safety of GM foods in Australia and New Zealand. This experience is also being applied to foods produced using other novel production techniques (e.g., irradiation) to novel foods or foods containing novel ingredients.
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