Inquiry Report | Attachment 1 | Attachment 2 | Attachment 3, 4,5
ATTACHMENT 6
GENERAL ISSUES RAISED IN PUBLIC COMMENTS
The majority of submissions received in response to the Section 14 Gazette Notice, expressed general views against the use of gene technology and asserted that food produced using this technology is unsafe for human. A number of general issues were raised in these submissions and are addressed below.
The safety of genetically modified foods for human consumption
A majority of submitters raised the issue of public health and safety in relation to food produced using gene technology. In particular, it was stated that there has been inadequate testing of genetically modified foods, that there is limited knowledge concerning the risks associated with the technology and that there may be potential long term risks associated with the consumption of such foods.
Evaluation
It is a reasonable expectation of the community that foods offered for sale are safe and wholesome. In this context, safe means that there is a reasonable certainty of no harm. As with other aspects of human activity, the absolute safety of food consumption cannot be guaranteed. Conventionally produced foods, while having a long history of safe use, are associated with human disease and carry a level of risk which must be balanced against the health benefits of a nutritious and varied diet.
Because the use of gene technology in food production is relatively new, and a long history of safe use of these foods has yet to be established, it is appropriate that a cautious approach is taken to the introduction of these foods onto the market. The purpose of the pre market assessment of a food produced using gene technology under Standard A18 is to establish that the new food is at least as safe as existing foods. The comprehensive nature of the scientific safety assessment, undertaken on a case-by-case basis, for each new modification is reflective of this cautious approach.
The safety assessment focuses on the new gene product(s), including intentional and unintentional effects of the genetic modification, its properties including potential allergenicity, toxicity, compositional differences in the food and it s history of use as a food or food product.
Foods produced using gene technology are assessed in part by a comparison with commonly consumed foods that are already regarded as safe. This concept has been adopted by both the World Health Organisation (WHO)/Food and Agriculture Organisation (FAO) and the Organisation for Economic Cooperation and Development (OECD). The Authority has developed detailed procedures for the safety assessment of foods produced using gene technology that are consistent with international protocols developed by these bodies.
The need for long-term feeding studies
A number of submissions were concerned about the lack of long-term toxicity studies on genetically modified foods.
Evaluation
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, and human exposure is generally low. It is therefore relatively straightforward to feed such compounds to 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 studies on foods is the need to maintain the nutritional value and balance of the diet. A diet that is poorly balanced will compromise the interpretation of any feeding study, since the effects observed will confound and usually override any small adverse effect which may be related to a component or components of the food. 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.
If there is a need to examine the safety of a newly-expressed protein in a genetically-modified food, it is more appropriate to examine the safety of this protein alone in an animal study rather than when it is part of a whole food. For newly-expressed proteins in genetically-modified foods, the acute toxicity is normally examined in experimental animals. In some case, studies up to 14 days have also been performed. These can provide additional re-assurance that the proteins will have no adverse effects in humans when consumed as part of a food. Such experiments can provide more meaningful information than experiments on the whole food. Additional re-assurance regarding the safety of newly-expressed protein can be obtained by examining the digestibility of the new protein inin vitroassays using conditions which simulate the human gastric system.
Substantial equivalence
A number of submitters expressed concern regarding the use of the concept of substantial equivalence as part of the assessment process. Some rejected the premise of substantial equivalence on the grounds that differences at the DNA level make foods substantially different.
Evaluation
Substantial equivalence embodies the concept that, as part of the safety assessment of a genetically modified food, a comparison can be made in relation to the characteristics and properties between the new food and traditionally-produced food. This can include physical characteristics and compositional factors, as well as an examination of the levels of naturally occurring allergens, toxins and anti-nutrients.
This allows the safety assessment to focus on any significant differences between the genetically modified food and its conventionally produced counterpart. Genotypic differences (i.e. differences at the DNA level) are not normally considered in a determination of substantial equivalence, if that difference does not significantly change the characteristics for composition of the new food relative to the conventional food.
The concept of substantial equivalence 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 genetically modified 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. Each food needs to be evaluated on an individual basis with regard to the significance of any changes in relation to its composition or to its properties.
The concept of substantial equivalence was first espoused by a 1991 Joint Consultation of the Food and Agricultural Organisation (FAO) and the World Health Organisation (WHO) 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.
The concept has been internationally recognised and embraced as a valuable tool in the safety assessment of foods produced using gene technology. The OECD also advocates an approach to safety assessment based on substantial equivalence as being the most practical to address the safety of foods and food components derived through modern biotechnology.
The nutritional value of food produced using gene technology
A small number of submitters expressed concern that the genetic alteration of food decreases its nutritional value.
Evaluation
The assessment of food produced using gene technology by ANZFA entails an exhaustive evaluation of analytical data on any intentional or unintentional compositional changes to the food. This assessment encompasses the major constituents of the food (fat, protein, carbohydrate, fibre, ash and moisture) as well as the key nutrients (amino acids, vitamins, fatty acids). There is no evidence to suggest that genetic modificationper sereduces the nutritional value of food.
In the future, genetic modification may be used intentionally to improve the nutritional value of food. In this regard, GM foods may be able to assist in addressing the general nutritional needs of the community and also specific dietary needs of sub-populations.
Potential toxins and allergens
Some submitters expressed concerns about the risks of the introduction of new toxins or allergens.
Evaluation
This issue is considered in detail as part of the safety assessment conducted on each new genetic modification applied to a food or commodity crop. New toxins or allergens may be introduced into food by either gene technology or by traditional breeding techniques, or by altered production processes. It is also possible to use these techniques to develop foods specifically where such compounds are significantly reduced or eliminated. One advantage of gene technology, in comparison with these other methods, is that any transferred genes are well characterised and defined, thus the possibility of developing a food with a new toxic or allergenic compound is likely to be reduced.
Antibiotic resistance
Some submitters raised concerns about increased antibiotic resistance resulting from the use of gene technology. Some felt that it would be reassuring if independent biomedical advice were available to reassure the public that the use of antibiotic resistance markers does not pose a risk to the future use of antibiotics in the management of human disease.
Evaluation
The human health considerations in relation to the potential for the development of antibiotic resistance depend on the nature of the novel genes and must be assessed on a case-by case basis. This issue arises because of the use of antibiotic resistance marker genes in the generation of genetically modified plants. In some circumstances, antibiotic resistance genes are linked to the gene of interest, to enable the initial selection of the engineered cells in the laboratory. Those cells that contain the antibiotic resistance marker gene, and hence the gene of interest, will be able to grow in the presence of the antibiotic. Those cells that failed the transformation process are eliminated during the selection procedure.
Concern has arisen that ingestion of food containing copies of antibiotic resistance genes could facilitate the transfer of the gene to bacteria inhabiting the gut of animals and humans. It is argued that these genes may then be transferred to disease causing bacteria and that this would compromise the therapeutic use of these antibiotics.
In 1993, the World Health Organisation Food Safety Unit considered this issue at a Workshop on the health aspects of marker genes in genetically modified plants. It was concluded at that Workshop that the potential for such gene transfers is effectively zero, given the complexity of the steps required. Since this time, several separate expert panels (Report to the Nordic Council, Copenhagen 1996; Advisory Committee on Novel Foods and Processes, UK 1994, 1996; The Royal Society, UK 1998) and numerous scientific papers published in peer reviewed journals have also considered the available evidence on this issue. It is generally agreed that the presence and subsequent transfer of an intact functional gene from transgenic food to micro-organisms in the human intestine is an extremely unlikely event. Furthermore, if this were to occur, bacteria would not normally retain the resistance genes unless there was an environment for positive selection. The majority of these genes provide for resistance to antibiotics whose use is confined to the laboratory and are not considered to be of major therapeutic use in humans.
Antibiotic resistant bacteria are naturally occurring, ubiquitous and normally inhabit the gut of animals and humans. There is a general consensus that the transfer of antibiotic resistance genes is much more likely to arise from this source and from associated medical practices, rather than from ingested genetically modified food. Even so, at the recent OECD Conference (GM Food Safety: Facts, Uncertainties, and Assessment) held in Edinburgh on 28 February 1 March 2000, there was general consensus that the continued use of antibiotic marker genes in GM food crops is unnecessary given the existence of adequate alternatives, and should be phased out.
Transfer of novel genes
Some submitters have expressed concern that the transfer of any novel gene may be a health concern.
Evaluation
It is extremely unlikely that novel genetic material will transfer from GM foods to bacteria in the human digestive tract because of the number of complex and unlikely steps that would need to take place consecutively. It is equally unlikely that novel genetic material will transfer from GM foods to human cells via the digestive tract. In considering the potential impact on human health, it is important to note that humans have always consumed large amounts of DNA as a normal component of food and there is no evidence that this consumption has had any adverse effect on human health. Furthermore, current scientific knowledge has not revealed any DNA sequences from ingested foods that have been incorporated into human DNA. Novel DNA sequences in GM foods comprise only a minute fraction of the total DNA in the food (generally less than 0.01%) and are therefore unlikely to pose any special additional risks compared with the large amount of DNA naturally present in all foods.
Viral recombination
Some submitters expressed concern about the long term effects of transferring viral sequences to plants.
Evaluation
This is an issue that is commonly raised because some of the genes that are transferred to plants use a plant virus promoter. Promoters are controlling DNA sequences which act like a switch and enable the transferred genes to be expressed (i.e. to give rise to a protein product) in a plant cell. The routine use of these viral promoters is often confused with research which has shown that plant virus genes, which have been transferred into plants to render them virus resistant, may recombine with related plant viruses that subsequently infect the plant, creating new viral variants. This research demonstrates that there may be a greater risk to the environment if viral genes are transferred to plants because it may lead to the generation of new plant virus variants capable of infecting a broader range of plants. This is a matter that will be addressed by the Genetic Manipulation Advisory Committee (GMAC) on a case by case basis when it assesses such plants.
However, the presence of plant viruses, plant virus genes or plant virus segments in food is not considered to pose any greater risk to human health as plant viruses are ubiquitous in nature and are commonly found in food eaten by animals and humans. Plant viruses are also biologically incapable of naturally infecting human or animal cells.
Labelling of foods produced using gene technology
A majority of submissions focussed on this issue. Specifically, the submissions called for the labelling of all foods produced using gene technology, regardless of whether they are substantially equivalent to conventional foods. The submitters based their demands for full labelling on the presumption that all foods produced using gene technology are unsafe and on consumer right to know arguments. It was stated that full labelling was the only means of identification of foods produced using gene technology available to consumers.
Evaluation
The existing Standard A18 already makes provision for mandatory labelling of genetically modified foods that are substantially different from their conventional counterparts. However, ANZFA is committed to implementing the in-principle decision of ANZFSC Health Ministers of August 1999 to require labelling of all genetically modified foods, including those that are substantially equivalent in composition to the unmodified form. In conjunction with a task force of officials from State and Territory Health Departments and the New Zealand Ministry of Health, ANZFA developed draft revision to Standard A18 in October 1999 that requires labelling of other categories of genetically modified foods. At the Ministers request this draft was circulated for public review and a cost-benefit analysis of full labelling was commissioned. The task force considered both public comments and the cost-benefit analysis in finalising their recommendations to Ministers, which were delivered in May 2000. Ministers are to meet to resolve the issue in July 2000 following whole-of-government consideration of the issue. It is therefore expected that, following a decision and legal amendments to the standard, labelling requirements will be implemented that will apply to all current and subsequent applications.
The need for post marketing surveillance of genetically modified foods
A number of submitters have commented on the need for post-market surveillance of genetically modified food consumption.
Evaluation
Surveillance of potential adverse or beneficial effects of GM foods is seen by many as a logical follow-up to the initial scientific risk assessment. Nevertheless, it is recognised that there are limitations to the application of epidemiology studies, particularly in relation to food components. A key requirement for post-market surveillance systems is that a clear hypothesis be identified for testing. Establishing a system for the surveillance of potential health effects of exposure to novel foods requires monitoring of the consumption patterns of novel foods in the population, and health effects in both exposed and non-exposed individuals/populations, so that risk estimates can be derived. For any such monitoring system to be useful, there needs to be a range of exposures, otherwise, any variation in health outcome would be unexplainable by that exposure. Variations in exposure could be apparent over time (temporal trends), space (geographical trends) or both.
Availability of robust data on consumption of the foods in question is vital in order to establish a surveillance system. The other side of the equation is the need for access to data on population health outcomes. Such a system could also be used to identify potential positive health outcomes, such as improved nutritional status or lower cholesterol levels. The availability of linked basic data (e.g. date of birth, sex, geographical location), and the ability to correlate with demographic data, could potentially offer the means of establishing links with food consumption.
The possibility of setting up a post-market health surveillance system for novel foods, including GM foods, has been examined by the UK s Advisory Committee on Novel Foods and Processes (ACNFP). Recognising the many difficulties involved in developing such a system, an initial feasibility study to look at the available data and its usefulness has been proposed. Work is currently being commissioned; when completed in 18 months, it will be subject to peer review. If such a feasibility study suggests that post-market surveillance is practical, methods and details concerning data collection will be determined in the UK, but common strategies might be able to be harmonised internationally in order to minimise the use of resources while maximising the reliability of the final results. This is an area that ANZFA will be monitoring closely, along with international regulatory bodies such as the OECD Taskforce for the Safety of Novel Foods and Feeds.
Public consultation and information about gene technology
A number of submitters were concerned that the public has not been properly consulted or informed by government or ANZFA on the introduction of foods produced using gene technology. Some submitters urged to undertake wider consultation with all affected parties including growers, the food industry and consumers before these food commodities are introduced, and to ensure that adequate consultation is undertaken as part of its assessment process.
Evaluation
The issue of gene technology and its use in food has been under consideration in Australia since 1992. The Agreement between the Governments of Australia and New Zealand for a joint food standard setting system, however, did not occur until 1995, and the New Zealand community therefore had not been consulted on this matter by the Authority until after that time. Consequently, the proposed standard (the current Standard A18) underwent only one round of public comment in New Zealand at which time significant objections were raised by the New Zealand community to the use of gene technology in food production. Many New Zealand consumers, both in these submissions, and in previous submissions to the Authority, have expressed the view that there has been insufficient consultation and a consistent lack of information about gene technology.
Although Standard A18 came into force in May 1999, the public have a continuous and ongoing opportunity to provide comment in relation to applications under the standard. ANZFA s statutory process for all applications to amend theFood StandardsCodenormally involves two rounds of public comment. Furthermore, all the documentation (except for commercial in confidence information) relating to these applications is available in the public domain, including the safety assessment reports. There is ample evidence that the provision of such information by ANZFA has already significantly stimulated public debate on this matter.
In addition, other government departments including the Environmental Risk Management Authority (ERMA), are potential sources of information about gene technology available to consumers in New Zealand. ERMA is a statutory authority set up by the New Zealand Government to administer theHazardous Substances and New Organisms (HSNO) Act 1996, and has responsibility for assessing the risks to the environment from genetically modified organisms. This body has been assessing applications for the approval of genetically modified organisms since July 1998 and this has involved a number of public meetings.
In response to the concerns raised in public submissions with regard to gene technology and GM foods, ANZFA is in the process of preparing a public discussion paper on the safety assessment process for GM foods. This will be widely available and may assist in addressing some of the concerns raised by the public. Other government and industry bodies are also addressing the broader concerns in relation to gene technology.
Maori beliefs and values
Some New Zealand submitters stated that Maori people find genetic engineering in conflict with their beliefs and values and that, out of respect to Maori, no genetically modified foods should be allowed into New Zealand until a wider discussion, both within Maori and non Maori, is held.
Evaluation
This issue was also raised during consideration of the proposal for the establishment of Standard A18. At that time, it was stated that the likely implications for Maori regarding genetically modified organisms surround the issues of the rights of Maori to the genetic material from flora and fauna indigenous to New Zealand and the release into the environment of genetically modified organisms. TheHSNO Act 1996requires that these matters be considered by ERMA.
Environmental concerns and the broader regulatory framework
A number of submitters have raised concerns that genetically modified crops may pose a risk to the environment.
Evaluation
These issues are considered in the assessment processes of GMAC in Australia and the Environmental Risk Management Authority (ERMA) in New Zealand. The Authority does not have the mandate to assess matters relating to environmental risks resulting from the release of food produced using gene technology into the environment. However, links exist between ANZFA and other regulatory agencies in both Australia and New Zealand, and a large degree of information sharing occurs. ANZFA would not recommend the approval of a food produced using gene technology if the genetically modified organism from which it was derived did not have the appropriate clearance for general release from either GMAC (or its successor) or ERMA, as appropriate.
The regulatory system in Australia will comprise the existing regulators with a legal remit to cover some aspects of GM products (such as imports, food, agricultural and veterinary chemicals):
· the Australia New Zealand Food Authority (ANZFA)
· the Therapeutic Goods Administration (TGA)
· the National Registration Authority for Agricultural and Veterinary Chemicals (NRA)
· the National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
· the Australian Quarantine and Inspection Service (AQIS).
Similarly, various other departments and agencies play their role in the regulatory process in New Zealand:
· the Ministry of Agriculture and Fisheries (MAF)
· the Ministry of Health (MoH)
· the Ministry of Research, Science and Technology (MoRST)
In Australia a new Office of the Gene Technology Regulator (OGTR) will complement the existing arrangements. OGTR will supersede the existing arrangements under the Genetic Manipulation Advisory Committee (GMAC), which advises on research and environmental release of GMOs. OGTR will regulate all GMOs and any gap products (i.e. products for which no other regulator has responsibility).
All GM food is assessed and regulated by the Australia New Zealand Food Authority (ANZFA) under the direction of Commonwealth, State and Territories Health Ministers and the New Zealand Health Minister, sitting as Australia New Zealand Food Standards Council (ANZFSC).
There will be an interface between ANZFA and OGTR. Consequential amendments proposed to the ANZFA Act arising from the draft Gene Technology Bill 2000 will establish a statutory interface between OGTR and ANZFA. This will involve amendments to the ANZFA Act requiring the Authority to advise OGTR of recommendations to ANZFSC regarding the standard for foods produced using gene technology (currently Standard A 18).
Maximum residue levels of agriculture/veterinary chemicals
A number of submitters have raised concerns that residues of agricultural and veterinary chemicals in genetically modified (e.g. herbicide tolerant) crops may pose a health risk.
Residues of these chemicals can only legally be present if the chemical has been registered for use in Australia and/or New Zealand, and it has been demonstrated that the residue at specified levels does not lead to adverse health impacts. The concentration of a chemical residue that may be present in a food is regulated through maximum residue limits (MRLs). The MRL is the highest residue concentration that is legally permitted in the food. Food products have to meet the MRL, whether or not they are derived from genetically modified organisms. The MRL does not indicate the chemical residue level that is always present in a food, but it does indicate the highest residue level that could result from the registered conditions of use.
It is important to note that MRLs are not direct public health and safety limits but rather, are primarily indicators of appropriate chemical usage. MRLs are always set at levels lower than, and normally very much lower than, the health and safety limits. The MRL is determined following a comprehensive evaluation of scientific studies on chemistry, metabolism, analytical methods and residue levels. In Australia, the National Registration Authority (NRA) applies to ANZFA to amend the MRLs in the Food Standards Code and the application is considered by ANZFA through its legislated decision making processes. In New Zealand MRLs are set by the Ministry of Health , generally following a request from, and in collaboration with, the Ministry of Agriculture and Forestry. Only following demonstration that the use of agricultural and veterinary chemicals will not result in unsafe residues will the MRL enter into food law through its inclusion in either the Food Standards Code in Australia, or the Food Regulations (1984) in New Zealand.