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Australasian Biotechnology, Vol. 10 No. 5, 2000, pp. 29-32 BIOTECHNOLOGY REGULATORY NEWS Code Number: au00053
NEW ZEALAND REGULATORY BODIES AND THEIR FUNCTIONS The Hazardous Substances and New Organisms Act (HSNO)http://http://rangi.knowledge-basket.co.nz/gpacts/public/text/%201999/an/035.html http://http://rangi.knowledge-basket.co.nz/gpacts/public/text/%201996/an/030.html The HSNO Act, a comprehensive piece of legislation, was passed by the New Zealand Parliament in 1996. The HSNO Act was brought in to protect the environment, people and communities from the adverse effects of hazardous substances and new organisms. It is already in force for new organisms. The commencement of the hazardous substances part of the Act was delayed until the completion of the necessary technical regulations. Other laws continue to apply alongside HSNO and in some situations additional approvals may be required. These other Acts include the Agricultural Chemicals and Veterinary Medicines Act, the Biosecurity Act, the Medicines Act, the Food Act and the Resource Management Act. ERMA NZ implements the Act (see below). The Environmental Risk Management Authority The Environmental Risk Management Authority (ERMA) is a quasi-judicial body with up to eight members appointed by the Minister for the Environment. It is supported by the Chief Executive and staff of ERMA New Zealand. ERMA considers applications to import or develop new organisms, or to import or manufacture hazardous substances. ERMA New Zealand’s functions include:
ERMA New Zealand’s aim is to meet the purpose of the HSNO Act in a way which allows New Zealanders to benefit from the use of new organisms and hazardous substances. ERMA does this by:
While implementing the HSNO Act, ERMA NZ has noted concerns about the costs of complying with the Act. Following discussions with industry groups, ERMA NZ has put forward a number of proposals that provide greater flexibility so that environmental and public health goals can be achieved at the least cost. These proposals are intended to reduce the costs of approvals and reduce barriers to innovation. The Independent Biotechnology Advisory Council (IBAC) The Independent Biotechnology Advisory Council (IBAC) was established by the Minister of Research, Science and Technology in May 1999 to meet the need for advice and informed public debate about biotechnology. It is independent, advisory and apolitical. IBAC comprises ten people with diverse personal and professional backgrounds. IBAC was established to
The Australia New Zealand Food Authority (ANZFA) is a partnership between the Commonwealth, State, Territory and New Zealand governments. It is responsible for developing, varying and reviewing standards for food available in Australia and New Zealand and for a range of related functions including coordinating national food surveillance and recall systems, conducting research, assessing policies about imported food and developing codes of practice with industry. In 1998 the Australia New Zealand Food Authority (ANZFA) completed its assessment of a Proposal (P97) to establish a standard to regulate food produced using gene technology, otherwise known as genetically modified foods (GMF). ANZFA then recommended to the Australia New Zealand Food Standards Council (ANZFSC) that it adopt the standard into the Food Standards Code. ANZFSC accepted the Authority’s recommendation at its meeting on 30 July 1998. Food Standard A18 - foods produced using gene technology - regulates the sale of genetically modified foods in Australia and New Zealand and was incorporated into the Food Standards Code on 13 May 1999. The standard has two provisions; 1. a mandatory safety assessment requirement, and 2. a mandatory labelling requirement. The standard came into effect nine months after the date of gazettal, on the 13 May 1999. The standard makes it illegal to sell any food produced using gene technology unless an application is made to ANZFA and approval subsequently given by ANZFSC. The approval process is open, consultative and based on a scientific risk assessment undertaken by ANZFA. Public comment on each application will be invited during its assessment process. The standard contains a provision for labelling in circumstances where the nature of the food has been significantly changed with respect to its nutritional quality, composition, allergenicity, or end use. There is broad community and regulatory acceptance, both domestically and internationally, that mandatory labelling in these circumstances is warranted. Royal Commission of Inquiry (genetic modification) The Ministry of the Environment has advised the Government on setting up a Royal Commission of Inquiry into genetic modification. The Royal Commission will have wide terms of reference (which are expected to be announced soon) and will encourage all those with an interest in the issue of genetic modification to contribute. The Royal Commission will be a three member panel, which has yet to be appointed, including an experienced judge. The Australian and New Zealand Food Standards Council The Australian and New Zealand Food Standards Council has approved a new standard for labelling genetically modified food. (See following article). NZ LIFESCIENCES NETWORK BACKGROUND The New Zealand Life Sciences Network brings together national organisations involved or interested in responsible research and the application of biotechnology. The Network actively participates in the public policy process and advocates increasing the community’s awareness and understanding of the value that biotechnology programs and initiatives contribute to our national well-being. Importantly, the Network assists its members to:
- Contributed by Sue Muggleston LABELLING GENETICALLY MODIFIED FOODS On 28 July 2000, the Australia New Zealand Food Standards Council (ANZFSC) agreed to new labelling rules for genetically modified (GM) foods. ANZFSC comprises the Health Ministers from the Commonwealth, New Zealand and the States and Territories of Australia. What are the new labelling rules for GM foods? The new food standard will require the labelling of food and food ingredients where novel DNA and/or novel protein is present in the final food. It also requires labelling of food and ingredients where the food has altered characteristics. Exempt from these requirements are:
The new standard allows any one ingredient in a food to contain up to 1 per cent of genetically modified material where its presence is in the ingredient is unintended. What are highly refined foods, processing aids and additives? In general, highly refined ingredients - such as sugars and oils - have been subjected to heating and other processes which remove genetic material and protein in the food. Processing aids are usually pure substances used in processing of raw materials, foods or ingredients, to fulfil a technological purpose during processing. They are normally not present or active in the final food. An example is the use of the enzyme chymosin to curdle milk in the preliminary steps of cheese manufacture. Chymosin is usually neutralised during later stages of cheese manufacture. Food additives are generally pure substances added to foods, usually in very small quantities, to improve taste, appearance, texture, storage life and other qualities. An example is the addition of ascorbic acid (Vitamin C) as an antioxidant in fruit juices. When will the new labelling rules come into effect? A draft standard based on the ANZFSC decisions is being considered by all Ministers. Subject to their final endorsement, it is hoped to gazette it to give it legal status in September 2000. To give food manufacturers and importers time to ascertain the status of their products and revise their labels, the new standard will take effect twelve months from gazettal - that is, in September 2001. However, consumers will notice the introduction of labels on food containing GM ingredients progressively during that twelve-month period. Some manufacturers may decide to introduce negative labelling in that period, indicating that food ingredients have been obtained from non-GM sources. What will the labels look like? Genetically modified ingredients within a food will be identified in the ingredients panel of the label. For example, a loaf of bread containing GM soy flour and GM maize would identify these ingredients with the words ‘genetically modified’ in the ingredient list. Single-ingredient GM foods, such as a packet of GM soy beans, will require the words ‘genetically modified’ to appear against the name of the food on the front of the packet. How many processed foods on supermarket shelves will be affected by the new labelling regime? This is very hard to estimate. Ingredients made from genetically modified commodities - such as canola, potato, corn, sugar beet, soy and cotton - are used throughout the food industry and can also occur in imported foods. Some manufacturers may choose to replace GM ingredients with non-GM counterparts. The extent to which this will happen cannot be anticipated. How do Australia’s and New Zealand’s labelling requirements for GM foods compare with overseas? Australia and New Zealand now have one of the most rigorous and progressive labelling requirements for GM foods in the world. They are slightly more stringent than those of the European Union, previously the benchmark for GM labelling legislation. The new standard will not require labelling for GM foods sold by restaurants and take-away businesses. In such situations consumers have the right to ask the proprietor what is in the food being purchased and whether it is from a GM source. Japan has a threshold of 5 per cent GM content, above which labelling is required. The United States and Canada do not require the labelling of GM foods which have the same properties and characteristics of the conventionally produced counterparts. How can I avoid GM foods? The ANZFSC Ministers made it clear that the labelling of GM foods was not a safety issue, rather an initiative to give consumers the information necessary to make informed choices. However, some people may have ethical, environmental, religious or other reasons to avoid GM foods. The new labelling requirements will help such people make buying decisions. Consumers can also look for the “GM free” labels which some manufacturers may place on their foods. And, of course, consumers should contact food manufacturers directly if they have any queries about the GM content of foods in the supermarket. “GM free” means just that - no GM ingredient, additive or processing aid has been used in the food. The exemptions from positive labelling do not permit a GM-free label to be carried on the food. While restaurants and take-away businesses are exempt from the new labelling rules, proprietors should know the nature of their ingredients and consumers have the right to ask what is in the food being purchased and whether it is from a GM source. Will foods with GM labelling cost more? Industry will incur costs in complying with the new labelling laws as they will be required to obtain documentation from their suppliers and/or test the GM nature of their ingredients and to change the labels appropriately. While industry may be able to absorb a part of these costs, some costs may be passed onto consumers. In addition, consumers searching for GM-free foods may have to pay a premium to cover the costs by manufacturers of testing their ingredients and complying with the new labelling rules. What about the long-term safety effects of GM foods? GM foods are required to undergo a safety assessment by the Australia New Zealand Food Authority (ANZFA) before they are permitted to be sold in Australia and New Zealand. The assessments rigorously examine the allergenicity, toxicity and nutritional value of GM foods to determine whether they are different from conventionally produced food. To date, all GM foods submitted for assessment have been found to have all the benefits of the conventionally produced foods and no additional risks. Companies wishing to market GM foods and ingredients are required to provide scientific information to ANZFA, obtained from audited laboratories, to enable the safety assessment of the GM commodity to take place. This is standard regulatory practice around the world and is similar to that required by the Therapeutic Goods Administration in Australia for the approval of new drugs for release. Some people have expressed concerns about the long-term effects of genetically modified foods. They have asked why ANZFA does not carry out long-term human trials. Unlike drugs, food is not a single chemical substance ingested at a concentration known to have a clinical effect in the human body. Food breaks down in the digestive system, making it difficult to follow the effects of different components on human health. There is no credible scientific evidence indicating that GM foods have had an adverse effect on health anywhere in the world, even though they have been in the food supply for more than a decade. The GM component in a normal varied diet is very small and analyses of long-term effects need to be carefully structured to determine impacts. A government agency in the United Kingdom has recently announced that it intends to conduct a feasibility study based on long-term monitoring of the health of people in a survey involving possibly millions of individuals. The exercise is being conducted in association with a major supermarket chain. ANZFA is monitoring these developments closely. FOOD HEALTH CLAIMS PROPOSALS RELEASED The Australia New Zealand Food Authority (ANZFA) today announced that its review into the current prohibition of health claims on food in Australia and New Zealand has entered a critical public consultation stage. At present, the food regulations do not allow claims on labels that make a direct link between eating a food or nutrient and a reduced risk of disease. For example, food producers can say ‘fruit and vegetables are good for you’ but cannot say ‘fruit and vegetables may help prevent the risk of cancer’. A full assessment report has just been issued for public comment which discusses the issues involved in the health claims debate and four options available to ANZFA:
ANZFA’s Managing Director, Ian Lindenmayer, said ANZFA’s favoured option is to allow claim-by-claim exemptions to the prohibition, supported by a rigorous, science-based examination of the claims by an Expert Panel. “ANZFA has recently evaluated its health claims pilot which permits the promotion of the B-vitamin folate in food as being important to protect against birth deformities due to neural tube defects such as spina bifida,” Mr Lindenmayer said. “This pilot has been in operation for eighteen months and the consultants’ reports will be released next week. “However, I can say that the management framework established for the folate pilot demonstrated that it is possible to successfully manage a health claim system in Australia and New Zealand. It also showed a significant increase in the awareness of women of child-bearing age of the importance of folate in their diet. “As far as we know, no other country has conducted a pilot scheme for a health claim system, making the folate health claim pilot a world-first for Australia and New Zealand.” In the United States, twelve health claims for food labels have been approved, including claims for calcium and osteoporosis, sodium and hypertension, fruit and vegetables and cancer, and heart disease and soy protein. The Review of Health and Related Claims can be obtained directly from ANZFA or on the ANZFA website at www.anzfa.gov.au. ONE POTATO, TWO POTATO, THREE POTATO ANZFA releases three more safety reports on GM foods The Australia New Zealand Food Authority (ANZFA) has released safety assessment reports for three genetically modified varieties of potato for public comment. This brings to ten the number of GM foods on which full safety assessments have been completed by the Food Authority. Reports will be released in the next two months on the remaining eight foods as their assessments are completed. Of the ten commodities whose assessments have been released, Bt cotton and Roundup Ready soy have been approved for sale in Australia and New Zealand by the Australia New Zealand Food Standards Council. Chief Scientist of ANZFA, Dr Marion Healy, said the genetic modifications to the three foods are intended to assist crop production. The foods are:
“When the regulations governing GM foods came into effect in May 1999, GM foods already on supermarket shelves were allowed to remain under certain conditions, including a requirement that food manufacturers provide a package of scientific information to enable ANZFA to make safety assessments”, Dr Healy said. “The other important criteria were that the food must already have been cleared for human consumption in another country and that there must be no scientific basis for concern about its safety. “Other than foods covered by these transition arrangements, no GM food will be permitted to be sold in Australia and New Zealand unless it has passed the ANZFA safety assessment. “GM foods which pass this assessment have all the benefits of the conventionally produced food with no additional risks,” Dr Healy said. Dr Healy said ANZFA scientists pay particular attention to the toxicity, allergenicity and nutritional value of the GM foods and they have to be satisfied that the genetic modification will not lead to adverse health outcomes. To date, ANZFA has found no evidence that GM foods are less safe than their conventionally produced counterparts a finding supported by food agencies around the world. “The safety assessment reports for these three GM foods have been posted on the ANZFA website at www.anzfa.gov.au and copies can also be obtained directly from ANZFA”, Dr Healy said. The Interim Office of the Gene Technology Regulator has considerably expanded its release of information in recent months. The August 2000 draft of the Gene Technology Regulations 2000 and of the accompanying Explanatory Guide were released on 29 August. The following Information Bulletins have also been released: No.2 Monitoring compliance with GMAC recommendations for the conduct of field trials. No.3 Audit of Monsanto Australia Ltd - Processes for the conduct of field trials in accordance with GMAC recommendations. No.4 How outcomes of the first consensus conference or gene technology in the food chain are being addressed. No.5 Audit of Aventis Cropscience Pty Ltd - Conduct of field trials in accordance with GMAC recommendations. No.6 Questions and answers on the Commercial release of Roundup Ready®, and Roundup Ready®/Ingard® Cotton. A detailed, 88-page, I0GTR Quarterly Report for the quarter ending 30 June 2000 has also been released. Copies of these documents are available from IOGTR, or can be accessed via their website: www.health.gov.au/tga/genetech.htm Copyright 2000 - Australasian Biotechnology |
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