Frequently Asked Questions on Genetically Modified Foods

(Revised March 2008)

Part 1.   General Questions

How are genetically modified (GM) foods regulated in Australia and New Zealand?

What is GM food?

What is the process for approving GM foods?

How can the public participate in the GM food approval process?

Who considers potential environmental risks associated with GM foods?

Part II.   Safety Assessment of GM Foods

How does FSANZ ensure that GM foods are safe?

            What is the basis of the safety assessment?

            Is company data used during the assessment of a GM food?

Why does FSANZ not do its own independent testing of GM foods?

                        Are there potential long-term risks associated with the consumption of GM foods?

Why doesn’t FSANZ require that GM foods be tested in animals?

Is the composition of GM foods different to the composition of non-GM foods?

            Does genetically modifying a food decrease its nutritional value?

Are there risks associated with the possible introduction of new toxins and allergens in GM foods?

            Is there potential for an increase in antibiotic resistance in humans resulting from the use of antibiotic resistance marker genes in GM foods?

            Is post market monitoring of GM foods undertaken?

Do herbicide-tolerant crops have higher chemical residues?

Part 3.   Labelling of GM Foods

Are GM foods required to be labelled?

            Where can I find this information on the label?

Are some foods excluded from mandatory labelling?

What about food purchased in restaurants?

What about unpackaged food?

Part 4.   Other Questions

What is gene technology?

What is the purpose of genetic modification?

Is animal cloning a form of genetic modification?

Is it correct that GM peas have been developed that were later found to be allergenic?

Is it true that FSANZ has approved a GM corn that was later found to be unsafe when fed to rats?

Why does FSANZ give food approval to GM crops intended for animal feed?

Part 1.   General Questions

How are genetically modified (GM) foods regulated in Australia and New Zealand?

Food Standards Australia New Zealand (FSANZ) has responsibility for regulating the sale and use of GM foods in Australia and New Zealand.   FSANZ is an independent statutory authority responsible for the development and maintenance of food standards and other food-related regulatory measures.   Food produced or imported for sale into Australia and New Zealand must comply with the food standards that are contained in the Australia New Zealand Food Standards Code (the Code).  GM foods are regulated under Standard 1.5.2 – Food Produced using Gene Technology of the Code . This Standard requires that before any GM food may enter the food supply FSANZ must conduct a pre-market assessment to evaluate the safety of the GM food.   This process ensures that approved GM foods are as safe as conventional foods already in the food supply.

What is GM food?

In Standard 1.5.2, GM food is described as “food produced using gene technology” and is defined as “a food which has been derived or developed from an organism which has been modified by gene technology”, where gene technology is defined as “recombinant-DNA techniques that alter the heritable genetic material of living cells or organisms”.   GM food is the common name by which we refer to such foods.   Such foods may also be referred to as genetically engineered or GE foods, and sometimes biotechnology-derived foods.

What is the process for approving GM foods?

Companies or other bodies that have developed GM foods are required to make an application to FSANZ to have their GM food approved before it may be sold in Australia and New Zealand.   As part of that application, companies are required to provide evidence that the GM food is safe for human consumption.   Once an application has been received and accepted, FSANZ will then assess the application, which includes undertaking a full safety assessment of the GM food.   GM foods that are approved are listed in a table contained in Standard 1.5.2.

How can the public participate in the GM food approval process?  

FSANZ has a transparent and consultative regulatory framework for developing food standards in Australia and New Zealand. Before making a change to the Code , comments are sought from interested members of the public (individuals, organisations) through a public consultation process.   Public consultation is mandatory for all food standards matters including applications for GM foods. This system allows members of the public to raise relevant issues that can then be addressed by FSANZ during the assessment process.

As part of the open and transparent system operating at FSANZ, all information and data relating to a GM food is accessible via a public register file.   An exception to this occurs only when certain information is given confidential commercial information status by FSANZ.   Copies of all assessment reports are also available from the FSANZ website.

Who considers potential environmental risks associated with GM foods?

The potential environmental risks associated with the release of GM organisms (GMOs) into the environment are considered by the Office of the Gene Technology Regulator (OGTR) in Australia, and the Environmental Risk Management Authority (ERMA) in New Zealand.   FSANZ does not have the legislative authority to assess matters relating to environmental risks resulting from the release of GMOs into the environment.   However, information is shared between FSANZ and these other regulatory agencies in both Australia and New Zealand through Memoranda of Understanding.

Part II.   Safety Assessment of GM Foods

How does FSANZ ensure that GM foods are safe?

FSANZ has established a rigorous and transparent process for assessing the safety of GM foods.   The safety assessment is undertaken in accordance with internationally established scientific principles and guidelines developed through the work of the Organisation for Economic Cooperation and Development (OECD), Food and Agriculture Organization (FAO) of the United Nations, World Health Organization (WHO) and the Codex Alimentarius Commission.

The safety assessment process used by FSANZ is described in detail in the Guidance Document “Safety Assessment of Genetically Modified Foods”, which is available from the FSANZ website.   FSANZ conducts a thorough safety assessment of all GM foods before they are allowed in the food supply.   This assessment ensures that any approved GM foods are as safe and nutritious as comparable conventional foods already in the Australian and New Zealand food supply.

What is the basis of the safety assessment?

The safety assessment of a GM food is conducted within the established risk assessment framework used by FSANZ.   In the case of GM food, the primary purpose is: (i) to identify new or altered hazards associated with the food as a result of the genetic modification; (ii) to assess whether there is any risk associated with any identified hazards under the intended conditions of use; and (iii) to determine if any new conditions of use are needed to enable safe use of the food.

The safety assessment is characterised by:

• Case-by-case consideration of GM foods;

Case-by-case assessment is necessary because the key issues requiring consideration in a safety assessment will often depend on the type of food being evaluated and the nature of the genetic modification.

• Consideration of both the intended and unintended effects of the genetic modification;

In addition to the intended effect (e.g. a new trait, such as insect protection), there may also be other effects associated with the genetic modification that were unintended (e.g. compositional changes to the food) and which may impact on the health and safety of the population.   Therefore it is important that both the intended and any unintended effects are evaluated.

• Comparisons with conventional foods having an acceptable standard of safety.

Such a comparative approach focuses on: (i) the identification of similarities and differences between the GM food and an appropriate comparator; and (ii) a characterisation of any of the identified differences in order to determine if they may raise potential safety and nutritional issues.  

The goal of the safety assessment is not to establish the absolute safety of the GM food but rather to consider whether the GM food is comparable to the conventional counterpart food, i.e., that the GM food has all the benefits and risks normally associated with the conventional food.  

Is company data used during the assessment of a GM food?

The responsibility for demonstrating the safety of any new food product on the market lies with the developer of that product. This is also the case for new chemicals and drugs.   When an applicant seeks approval for a new GM food, they must provide FSANZ with the evidence that supports the safety of the product.  It is a requirement that this data be generated according to quality assurance guidelines that are based on internationally accepted protocols (i.e. validated methodology and procedures that are consistent with Good Laboratory Practice (GLP)) and stand up to external scrutiny (i.e. independent audits and documentation trails). To achieve this, the applicant submits to FSANZ a comprehensive dossier of quality-assured raw experimental data for each GM food. This enables FSANZ to independently assess the data and reach a conclusion about the safety of the food.

FSANZ also complements the data package provided by the applicant with information from the scientific literature, other applications, other government agencies and the public. 

Why does FSANZ not do its own independent testing of GM foods?

Paper reviews are a standard scientific method of evaluation used by regulators around the world, to evaluate the health and safety of a variety of products including food, drugs and agricultural and veterinary chemicals.   The methods and approach used by FSANZ are wholly consistent with international guidelines developed according to scientific advice provided by the WHO, FAO, and OECD.

Companies involved in the development of GM foods spend millions of dollars rigorously testing their products according to these requirements, which include detailed documentation of testing.   Thorough analysis is conducted of the data and of the protocol used to ensure the validity of results.   If FSANZ determines that the data are not sufficient, additional information and testing may be required.   FSANZ may also supplement the information provided by the Applicant with any published data in Australia and New Zealand or internationally that is relevant to the product in question.

Are there potential long-term risks associated with the consumption of GM foods?

Many of the food safety issues raised by GM foods are equally applicable to foods produced by conventional means.   GM foods are however subjected to a safety assessment before they are permitted in the food supply.  The safety assessment includes extensive analyses of the composition of the food, a full consideration of the safety of any new substances that have been introduced into the food (e.g. proteins), as well as a thorough characterisation of the genetic changes that have been introduced into the organism from which the food is derived.  This ensures that any GM food that is approved is as safe as food already in the food supply, including in the long term.

To date, gene technology has not been shown to introduce any new or altered hazards into the food supply, therefore the potential for long term risks associated with GM foods is considered to be no different to that for conventional foods already in the food supply.   As a consequence, FSANZ does not consider that long term studies are generally needed to ensure the safety of GM foods.

Should developments in the technology result in modifications that potentially introduce new or altered hazards into the food, such foods may require additional considerations to address the potential for long term health effects.   In such cases, long term studies may be a valid approach to include in the assessment of the overall safety of such foods.

Why doesn’t FSANZ require that GM foods be tested in animals?

FSANZ considers that a scientifically-informed comparative assessment of GM foods with their conventional counterparts can generally identify any potential adverse health effects or differences requiring further evaluation. In the majority of circumstances, animal toxicity studies with whole foods are not likely to contribute any further useful information to the safety assessment and are therefore not warranted. As a consequence, FSANZ does not require that animal toxicity studies with whole GM foods be undertaken on a routine basis.

FSANZ acknowledges there may be future GM applications, particularly for foods with intentional modifications to composition, where the results of animal toxicity studies may be informative.   FSANZ therefore continues to assess the need for animal studies on a case-by-case basis, taking into account the nature of the genetic modification and the results of the comparative assessment.   While FSANZ does not routinely require animal toxicity studies to be undertaken, where such studies already exist, Applicants are expected to provide these to FSANZ to evaluate as additional supporting information.

As part of a continual review of FSANZ’s scientific approach to the safety assessment of GM foods, FSANZ convened an expert panel in June 2007 to develop guidance and recommendations on the role animal feeding studies can play in the safety assessment of GM foods.

The expert panel recommended that FSANZ should continue with its case-by-case assessment of GM foods on the basis of best available science. The panel noted that whole-food animal feeding studies may be informative in some limited circumstances, but concurred with FSANZ that any potential adverse health effects can generally be identified by a scientifically informed comparative assessment of the GM food against its conventional counterpart.

The report from the expert panel is available from:  www.foodstandards.gov.au/_srcfiles/Workshop%20Report%20FINAL.pdf

Is the composition of GM foods different to the composition of non-GM foods?

Sometimes the purpose of the genetic modification may be to deliberately introduce a compositional change to the food, e.g. to increase the level of a particular nutrient.   Examples of GM foods with deliberate changes to composition that have been assessed by FSANZ include high oleic acid soybeans and high lysine corn.   In most cases however other characteristics are changed in the organism, without affecting the composition of derived food, e.g. herbicide tolerance.

Compositional analyses are primarily done to determine if any unexpected changes in composition have occurred to the food and to establish its nutritional adequacy.   Compositional analyses are particularly important where there has been a deliberate change to the composition of food.   Analysis of the composition of the food in these circumstances helps to confirm that the new or altered characteristic is being expressed appropriately, and also helps to quantify the magnitude of the change, which may be important for assessing safety.

Sometimes, even when there has been no intent to alter the composition of a food, the analysis will indicate that the composition of the GM food differs slightly from the non-GM control line.  Where this occurs, FSANZ will analyse such differences to determine their biological relevance.  This is done by comparing the values for the altered constituent to those of other commercial varieties and to the range of natural variation (obtained from the published literature). The use of published ranges and historical control data as comparators in safety assessment studies is standard for interpreting biological and analytical variation.  

To date, the significant differences between test and control lines tend to be small and they are usually within the range that would be expected for other commercial varieties. In these cases, FSANZ concludes that the observed difference is not biologically meaningful and certainly does not pose a risk to consumers.  Sometimes, differences can be explained by differences in locations or seasons. Generally, the differences do not occur consistently in all locations and are therefore not considered to indicate a trend.  

Does genetically modifying a food decrease its nutritional value?

There is no evidence to suggest that genetic modification per sereduces the nutritional value of food. To assess this, FSANZ evaluates the major constituents of the food (fat, protein, carbohydrate, fibre, ash and moisture) as well as the key nutrients (amino acids, vitamins, minerals, fatty acids). This approach enables both the intentional effects and any unintentional compositional changes in the food to be assessed.   To date, none of the GM foods assessed by FSANZ have been shown to have any unintentional changes to their nutritional value.

Are there risks associated with the possible introduction of new toxins and allergens in GM foods?

Typically the main outcome of genetic modification is the expression of a new protein or proteins in the organism.   These new proteins may subsequently be present in derived food products.   While a large and diverse range of proteins are ingested as part of the normal human diet without any adverse effects, a small number have the potential to impair health, e.g. because they are allergens or may have toxic or anti-nutritional effects.   As a consequence, one of the main parts of the safety assessment of any GM food is a consideration of the potential toxicity and allergenicity of any new proteins introduced into the food.

Assessment of potential toxicity and allergenicity is done using a weight of evidence approach, which means a variety of evidence, drawn from a number of different studies, is used to reach an overall conclusion.   Further details on the assessment of potential toxicity and allergenicity can be obtained from the following sources:

1. For a detailed technical description of the assessment process, refer to the Guidance Document “Safety Assessment of Genetically Modified Foods”; 
   ww.foodstandards.gov.au/_srcfiles/GM%20FINAL%20Sept%2007L%20_2_.pdf
   
2. For a lay persons description of the assessment process, refer to the bookletGM Foods – Safety Assessment of Genetically Modified Foods, www.foodstandards.gov.au/_srcfiles/GM%20Foods_text_pp_final.pdf

In addition to these considerations, the GM food safety assessment also considers the issue of naturally occurring toxins (e.g. solanine in potatoes) and allergens in the food and whether any changes in the amounts of any pre-existing natural toxins and/or allergens have occurred as a result of the modification.

While the introduction of new toxins and allergens is a recognised risk associated with GM foods, it may also be possible to use gene technology to develop foods specifically where such compounds are significantly reduced or eliminated.   For example, research is underway on certain proteins in peanuts that are known to be the cause of major allergies in susceptible individuals.

Is there potential for an increase in antibiotic resistance in humans resulting from the use of antibiotic resistance marker genes in GM foods? 

Antibiotic resistance marker genes are sometimes used in the development of GM plants to facilitate the selection of cells that have been transformed with the gene of interest.    The antibiotic resistance gene provides a selective advantage to the transformed cell enabling it to grow and divide in the presence of the antibiotic.   Cells that have not been transformed will not survive.

It has been suggested 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 could compromise the therapeutic use of antibiotics.

This is one of the many issues that FSANZ considers during the food safety assessment.  

Although theoretically possible, horizontal DNA transfer of antibiotic resistance genes from food products to gut microorganisms is regarded as a rare possibility because of the many complex and unlikely events that would need to occur consecutively. Furthermore, the transfer of antibiotic resistance genes from GM food to bacteria has not been observed under natural conditions.   As horizontal DNA transfer cannot be completely ruled out, the potential human health impact, should such a transfer occur, is also considered by FSANZ during the safety assessment.

The human health impact will largely depend on the nature of each particular antibiotic resistance gene and must be assessed on a case-by-case basis.   However, the commonly used kanamycin, ampicillin and streptomycin resistance genes, are not considered to pose any significant health concerns and have been safely used for a number of years.  As a precaution, the use of marker genes encoding resistance to antibiotics with significant public health uses (e.g. vancomycin) are avoided.

Not all GM foods contain antibiotic resistance genes. In some cases, these genes are removed after successful transformation.   In other cases alternative selectable marker genes may be used (e.g. herbicide tolerance genes are frequently used for selection purposes in plants).   With time, it is anticipated that the presence of antibiotic resistance genes in GM foods will become less commonplace.   If alternative marker genes are used, they also need to be evaluated for their safety in the same way as for any other novel gene.

Is post market monitoring of GM foods undertaken?

Post-market monitoring is often suggested as a means of demonstrating whether long-term adverse health effects may be associated with the consumption of GM foods.

It has been recognised internationally that the use of pre-market safety assessment already provides assurance that a GM food is comparable to its conventional counterpart in relation to health risks and benefits, therefore the likelihood of identifying long-term effects specifically attributable to GM foods would be very low.   Moreover, the practicality of using post-market monitoring to assess the long-term human health impacts of consuming GM foods has not been established.  

Many chronic health problems have complex causes and it is unlikely that observational epidemiological studies could identify such effects specifically related to GM foods. The same also applies to the identification of potential long-term beneficial health effects.

In general, therefore, FSANZ does not believe post-market monitoring to be a practical, enforceable or effective risk management option. This is particularly the case where passive monitoring or general health surveillance, which does not address a specific hypothesis, is proposed.  

Nevertheless we recognise that post-market monitoring may be appropriate in certain circumstances.   Post-market monitoring may be useful in situations where a GM food has been developed specifically to produce a nutritional effect in the population. In these cases it may be desirable to monitor changes in nutrient intake levels in order to confirm assumptions made during the risk assessment and evaluate their potential effect on the nutritional and health status of the population.

The need for post-market monitoring following approval of a GM food will be considered by FSANZ on a case-by-case basis, taking into account the unique characteristics of the GM food and the feasibility of undertaking such a study.

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 monitoring 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.

Do herbicide-tolerant crops have higher chemical residues?

The use of herbicide tolerant crops is likely to result in a shift either in the type of herbicide that is used during the cultivation of the crop or the pattern of usage but will not necessarily result in higher chemical residues.   Herbicide tolerant crops exist that have been developed using conventional plant breeding therefore the issue of herbicide tolerance is not specific to GM crops.

Residues of any agricultural chemicals, for example herbicides, can only legally be present in food if the residues comply with specific Maximum Residue Limits (MRLs) for agricultural and veterinary chemicals.  The MRLs apply irrespective of whether the food is derived from conventional (non-GM) or GM crops.

Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary chemicals in food.   For New Zealand, MRLs for agricultural compounds are included in the New Zealand (Maximum Residue Limits of Agricultural Compounds) Food Standards, 2007(and subsequent amendments) issued under sections 11C and 11Z of theFood Act 1981.  For Australia, MRLs are listed in Standard 1.4.2 of the Code.

Under the Trans Tasman Mutual Recognition Arrangement (TTMRA) between Australia and New Zealand, which commenced on 1 May 1998, the following applies:

• Food produced or imported into Australia that complies with Standard 1.4.2 of the Code can be legally sold in New Zealand.
• Food produced or imported into New Zealand that complies with the New Zealand (Maximum Residue Limits of Agricultural Compounds) Food Standards, 2007can be legally sold in Australia.

Part 3.   Labelling of GM Foods

Are GM foods required to be labelled?

This is a mandatory requirement under Standard 1.5.2 Food Produced using Gene Technology for GM foods to be labelled.   These requirements came into effect in Australia and New Zealand in December 2001 and are intended to provide information to consumers to facilitate choice, assisting consumers to purchase or avoid GM foods depending on their own views and beliefs.

The standard requires that food (including ingredients, food additives and processing aids) be labelled with the words ‘genetically modified’, if novel DNA and/or novel protein from an approved GM variety is present in the final food.   Therefore the general labelling requirements are based on the presence of novel DNA and/or protein at detectable levels in the food itself rather than on the process used.   There are also additional labelling requirements where GM foods have altered characteristics compared to their conventional counterpart.   For example, if a GM food has an increased level of a particular nutrient (e.g. vitamin), or has to be cooked or prepared in a different way compared to the conventional food, then this also needs to be indicated on the label.   These additional labelling requirements also apply where the GM food raises significant ethical, cultural and religious concerns with respect to genetic modification.

FSANZ determines whether an additional labelling requirement is warranted through the standard development/variation process.   For example, FSANZ has assessed two GM foods that have been found to have altered characteristics.   These were high oleic acid soybeans and high lysine corn.   In the case of high oleic soybeans, the label must include a statement that the food has been genetically modified to contain high levels of oleic acid.   For high lysine corn, the label must include a statement that the food has been genetically modified to contain increased levels of lysine.   The only exception to this is where the protein content has been removed as part of a refining process.

Where can I find this information on the label?

The statement ‘genetically modified’ must be used in conjunction with the name of the food or in association with the specific ingredient in the ingredient list.  

For example, for a single ingredient food such as soy flour, the label would appear as follows:

Soy Flour

Genetically Modified

Or

Soy Flour

From genetically modified soya beans

Or in the case of a food containing multiple ingredients, the ingredient list may look something like the following:

Ingredients: Soy Protein Isolate (genetically modified); Maltodextrin; Vegetable Oil; Food Acid (332); Emulsifier (371); Vegetable Gum (407); Water Added.

Are some foods excluded from mandatory labelling?

A number of exclusions to the mandatory labelling requirements exist.   The types of GM food not subject to the labelling requirements include:

• highly processed food where the processing removes all DNA and/or protein; and
• minor ingredients, including processing aids and food additives (unless they contain novel DNA and/or novel protein).

Examples of highly refined foods include refined vegetable oils or sugars.  However, if these highly processed foods contain altered characteristics, e.g. refined oil with an altered fatty acid profile, then the food is still required to be labelled.

The Standard also allows a food in which an approved GM food is unintentionally present in a quantity of no more than 10g/kg (1%) per ingredient to remain unlabelled.   This exclusion applies in circumstances where the manufacturer has actively sought to avoid GM food (including ingredients or processing aids) but there is an inadvertent presence of GM material.   As long as the presence is unintentional and under the permitted amount of 10g/kg per ingredient, there is no requirement to label the product as containing an approved GM food, ingredient or processing aid.  GM foods that are not approved in the Standard however are not permitted in any food either intentionally or unintentionally.  

What about food purchased in restaurants?

Foods that are intended for immediate consumption that are prepared and sold from food premises and vending vehicles are exempt from mandatory labelling.  Types of food premises captured by this exemption include restaurants; take away outlets, caterers and self-catering institutions.  However the Food Acts in Australian States and Territories have a general provision which prohibits a food business or person from supplying food by way of sale if it is not of the nature or substance demanded by the purchaser.  Therefore if a consumer wants to know whether the ingredients used are from a GM source, the onus is on the vendor to provide information about the product, which is not misleading or untruthful. This is another mechanism which enables the consumer to obtain the information they require to make an informed purchasing decision.

What about unpackaged food?

If the food is unpackaged (e.g. loose vegetables in a grocery store) then the information that otherwise would have been on the package, must be displayed on or in connection with the display of the food.  

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.

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 from:  www.foodstandards.gov.au/newsroom/factsheets/factsheets2008/foodderived from clone3821.cfm

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.