Part 4. Other Questions
What is gene technology?
Gene technology involves the use of a technique called recombinant DNA technology to modify the genetic properties of an animal, plant or microorganism. Recombinant DNA technology involves identifying and isolating specific genes, making copies of them, redesigning them by recombining them with other isolated DNA and then introducing them into another organism. These manipulated genes are called recombinant DNA.
What is the purpose of genetic modification?
Genetic modification is used is to alter the characteristics of, or introduce new characteristics to plants, animals or microorganisms (e.g. introduce disease resistance, alter metabolic pathways), which may in some circumstances also alter the properties of derived food products (e.g. change food composition). Changes to an organism’s characteristics can also be done using traditional cross-breeding but may take considerably longer to achieve. In addition to being quicker, techniques of genetic modification also enable desirable characteristics to be transferred between distantly related organisms, i.e. organisms that wouldn’t normally inter-breed, thereby enabling a greater diversity of characteristics to be introduced.
What about food from GM animals?
Food from GM animals is regulated under Standard 1.5.2 - Food produced using Gene Technology. Ths standard requires all GM foods to undergo a pre-market safety assessment before they can be approved for sale. Approve GM foods are listed in a schedule to the standard.
FSANZ has been monitoreing international developments with regard to GM animals for a number of years. FSANZ also participated in the development of the Codex Guideline (CAC\GL 46) for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals which was finalised in 2008.
A number of researchers in Australia and New Zealand are actively involved in the development of GM animals, however most of the work is occuring in other countries. At the present time there are no animals approved for food use in Australia and New Zealand, nor has FSANZ received any applications. Further information on the development of GM animals is available here.
Is animal cloning a form of genetic modification?
Animal cloning is a different technology to genetic modification and does not involve the introduction of any new genetic material into an animal. It involves making a genetically identical copy of an animal using techniques of asexual reproduction. One of the most common techniques used is called Somatic Cell Nuclear Transfer (SCNT). A genetic copy of an animal is produced by replacing the nucleus of an unfertilised egg with the nucleus of a body (somatic) cell from the animal to be cloned. The egg with the transferred nucleus can then be stimulated to form an embryo, which is then transferred to a surrogate female animal where it develops until birth.
Further information on animal cloning can be obtained here
Is it correct that GM peas have been developed that were later found to be allergenic?
In 2005, the Commonwealth Scientific and Industrial Research Organisation (CSIRO) discontinued the development of a particular type of GM pea after the publication of a paper reporting an immune response in mice that had been fed the peas under laboratory conditions. The GM peas were still in the research and development phase and had not been approved for human consumption, nor had FSANZ received an application from CSIRO for their approval for food use. While an immune response in mice fed the GM peas was reported, this is not necessarily predictive of an allergic reaction in humans and, in the absence of further studies and investigation, the relevance of these findings to humans is unclear.
The GM peas had been genetically modified to be protected against pea weevils. This was achieved by introducing an insecticidal protein (alpha-amylase inhibitor) derived from bean plants. Some early laboratory studies to characterise the transferred alpha-amylase inhibitor protein revealed that a modified form of the alpha-amylase inhibitor protein had unexpectedly been produced in the GM peas. CSIRO commissioned further studies to determine if this modified form of the protein also had altered immunogenicity.
However, as the modified form of the alpha-amylase inhibitor protein has not been subjected to the standard assessment for potential allergenicity, it is not possible to make any conclusions about its potential to be a food allergen in humans. Furthermore, the animal model used by the study authors has not been validated to predict human immune or allergic responses and the authors of the study made no such predictions. It is therefore not clear what relevance (if any) the findings have in relation to human food allergy.
While the significance of the mouse study for human allergenicity is not clear, CSIRO decided to end the research program. This type of situation is not unique to the development of GM foods - the development of conventionally bred, non-GM plants have also been terminated when unexpected or adverse effects have been detected.
Further details on the GM peas can be obtained from: www.foodstandards.gov.au/newsroom/factsheets/factsheets2005/geneticallymodifiedf3097.cfm
Is it true that FSANZ has approved a GM corn that was later found to be unsafe when fed to rats?
In 2003, FSANZ approved food derived from an insect-protected corn, called MON863. The approval was granted following a comprehensive safety assessment, which did not identify any public health or safety concerns.
Since that approval was given, FSANZ learned of a feeding study in rats that had been undertaken with MON863, and which had been provided to authorities in Europe as part of a data package for regulatory approval. This study was claimed by certain groups to show evidence of adverse effects in rats following the consumption of MON863 corn.
The study was assessed by the European Food Safety Authority (EFSA) as part of its overall assessment, where they concluded that food derived from MON863 is unlikely to have an adverse effect on human and animal health. FSANZ also examined the new study and could not find any evidence of adverse effects from the consumption of MON863 corn. FSANZ therefore reaffirmed its conclusion that food from MON863 corn is as safe and wholesome as food derived from non-GM corn.
In 2007, a study was published which reported a new statistical analysis of the rat feeding study performed with MON 863 corn, and which claimed to have uncovered adverse effects in rats fed MON863 corn by using different types of statistical testing of the measured parameters in the study. Based on this statistical re-analysis, the authors concluded that MON863 corn caused adverse effects on growth, blood and urine chemistry and organ weights, which collectively indicated liver, kidney and possibly other organ toxicities, with different sensitivities between males and females.
In response to this publication, FSANZ completed a detailed evaluation of the statistical re-analysis, concluding that the use of alternative statistical tests did not identify any new safety concerns. Similar conclusions were reached by other regulatory agencies around the world who also re-evaluated the data (e.g. EFSA, Health Canada, New Zealand Food Safety Authority).
Further details on MON863 corn and the rat feeding study, including detailed FSANZ evaluation reports, can be obtained from www.foodstandards.gov.au/newsroom/factsheets/factsheets2007/updatefsanzreaffirms3622.cfm
Why does FSANZ give food approval to GM crops intended for animal feed?
Many animal feeds are derived from the same GM commodities (e.g. corn) that are used for human consumption, therefore it is difficult to keep the food and feed chains completely separate.
The current approach taken by FSANZ is therefore to avoid what are known as “split use” approvals. A “split use” approval is where a GM plant receives approval for use as animal feed but not for human food. The approach to not allow “split use” is also practiced in the United States and Canada, which are sources of imported GM foods and food ingredients into Australia and New Zealand. The practice of not allowing “split-use” approvals arose following an incident in the United States where traces of a GM corn (known as StarLink™ corn), which had been approved for animal feed only, were found in human food products. The incident caused widespread consumer concern and significant disruption to trade and highlighted that adventitious contamination can occur despite well developed identity preservation and segregation systems being in place. To prevent similar incidents occurring in the future it is now common practice for GM plants intended primarily for feed use to also undergo food safety assessment and approval for human food use. This minimises the risk of unassessed and unapproved products entering the food supply as a result of inadvertent co-mingling of grain/seeds during transport and storage, and also ensures that their use as feed will not pose indirect risks to humans.
Examples of GM crops that have been developed primarily for animal feed but which have also been granted approval as human foods in Australia and New Zealand include high lysine corn, and herbicide-tolerant lucerne.
GM Pollen in honey – is it safe?
Yes. Honey naturally contains very low levels of pollen. There are several ways in which pollen can get into honey, including the activity of bees returning to the hive or when apiarists extract honey from the comb. In certain areas, bees may collect pollen from a GM crop such as RoundUp Ready® canola.
GM crops must be tested for safety both from an environmental and human health perspective, before they are permitted to be grown. Currently, only GM cotton and canola are approved for commercial cultivation in Australia, including RoundUp Ready® canola which is tolerant to the herbicide glyphosate. It is important to note that the novel genetic material and protein in pollen from approved varieties of GM canola and cotton have been comprehensively assessed by FSANZ as safe. This should reassure consumers about the safety of honey containing very small amounts of GM pollen.
Does GM pollen require labelling?
As pollen is not added intentionally, it does not meet the definitions of an ‘ingredient’ or ‘component’ in honey (as defined in the Food Standards Code) and would fall outside the labelling requirements for GM foods. Irrespective of whether GM pollen can be considered as food, the levels found in honey are generally well below 1%. Pollen is also likely to have come from a mixture of plant sources, which means that the levels of any GM pollen would be even lower. Where bee pollen is sold specifically as a product for human consumption, then it must be labelled ‘genetically modified’ if any of the pollen was harvested from GM plants.