GM Canola safety assessments 

SUMMARY

Suggestions that Europe has rejected import of the genetically modified herbicide tolerant oilseed rape GT73 (known in Australia as Roundup Ready canola) are wrong.

• The UK Advisory Committee on Releases to the Environment (ACRE) did not reject the import and processing of the GT73 oilseed rape.  ACRE was satisfied with safety aspects but requested additional information, including more data on DNA sequences, likely places of import/processing, animal feed studies and monitoring measures. 
   
•  Both ACRE and the European Food Safety Agency (EFSA) have evaluated the oilseed rape and found it as safe as other approved imported oilseed rape.
  
  
• However, the relevant European Regulatory Committee was not able to come to a clear decision on 16 June 2004, to approve the use of the oilseed rape for feed and food use. It was therefore referred to the European Council of Ministers for consideration.  
  
  
• The Council of Ministers must act within three months.  If the Council neither adopts nor rejects the Draft Decision, it will return to the European Commission which is then authorised to decide on its own authority.
  
  
• Media releases also suggest that Australian agencies have not considered European reports on the safety of canola, particularly issues relating to changed liver weight in rats.  
  
  
• The suggestion that Australian agencies have failed to consider these issues is not correct.
  
  
• The Gene Technology Regulator and Food Standards Australia New Zealand (FSANZ) both examined the issue of increased liver weight in rats in considerable detail during the evaluation of Roundup Ready canola and concluded that there were no human health and safety concerns in relation to the feeding studies in rats fed on canola meal.
  
  
• It should also be noted that canola meal is not consumed by humans and is used as an animal feed. Only the highly refined oil from GM canola is approved by FSANZ to enter the Australian food supply.
  
  
• The New Zealand Ministry of Health and the New Zealand Institute of Environmental Science and Research, the South Australian Department of Human Services, regulators in Japan, the USA, UK, Canada, and members of FSANZ’s panel of independent experts were also satisfied with this evaluation
  

BACKGROUND

Health and safety findings – feed studies on rats

Comments in media releases relate to a feeding study in which there was a small increase in liver weights in rats fed a diet of GM (glyphosate tolerant) canola meal. Three rat feeding studies were provided by the applicant to regulatory authorities for assessment.

The first study used unprocessed and processed canola meal, and showed no differences of any significance in liver weights between the GM canola and the non-GM parent line, although a minor difference in the group mean body weight for male rats was observed. However, the seed used in this study was found to be mixed with another GM line that was not under assessment, and therefore was not a valid test of the GT73 line being assessed.

The second study used only processed canola meal. This study showed a slight increase in liver weights compared to the control, at the highest dietary intake level (15%), but not at the lower level of intake (5%). However, it was noted that the processing of the canola seed from the GM and non-GM control lines was performed at a different time and place, and consequently there were differences in the extent of processing of the canola meal.

The third study was an assessment of the GM (GT73) canola meal, non-GM control lines from around the world, and rat chow as a negative control. On this occasion, all seed samples from the GM and non-GM lines were processed at the same time, and to the same extent. There were no significant differences in body weight, cumulative weight gain, terminal body weights or food consumption for animals fed GM canola meal compared to the non-GM control canola meal. Most importantly, there were also no significant differences in absolute or relative liver or kidney weights between animals fed the GM canola meal compared to the non-GM canola meal, or the population of canola varieties.

Discussion of the results

FSANZ points out in the safety assessment of foods derived from GM canola (see FSANZ website  www.foodstandards.gov.au) that approval applies only to the oil from glyphosate-tolerant canola. Canola meal is not normally considered to be a human food fraction due to the presence of natural toxicants (e.g. glucosinolates). The feeding studies using canola meal were evaluated to compare levels of major components, and any potential unintended effects.

All rapeseed contains natural toxins (such as glucosinolates in the seed meal, and erucic acid in the oil) which are strictly regulated by canola industry standards to very low levels. Canola oil is a highly processed food in which glucosinolates are not present.  

Although liver weights were increased in rats fed GM canola meal, this difference was considered to be due to variation in the degree of processing of the GM and non-GM canola seed used in the second study, leading to differences in the levels of glucosinolates in the meal fraction. Glucosinolates are well known to cause liver enlargement (Hayes, Principles and Methods of Toxicology, 3^rd Edition). Equally, and perhaps more likely, the slight increases in liver weight were due to chance, as there were no other behavioural or physiological differences detected.

FSANZ scientists, the New Zealand Ministry of Health and the New Zealand Institute of Environmental Science and Research, the South Australian Department of Human Services, regulators in Japan, USA, UK and Canada, and members of FSANZ’s panel of independent experts were satisfied with this evaluation. FSANZ concluded that there were no human health and safety concerns in relation to the feeding studies in rats fed on canola meal.

It should be noted that canola oil itself cannot be fed to rats in sufficient quantities to test for adverse effects because this would cause malnutrition and other physiological imbalances. Thus no meaningful information would result from this testing. Using canola meal in feeding studies provides a test for more compounds than are present in oil and is essentially a worst-case scenario. In feeding studies testing GT73 canola seeds on other animals, no adverse effects were observed.

The Gene Technology Regulator’s Risk Assessment and Risk Management Plan for Roundup Ready canola also considered the issue of liver weight in rats in considerable detail. This assessment is publicly available on the Gene Technology Regulator’s website at www.ogtr.gov.au/rtf/ir/dir020finalrarmp.rtf.

European decision making process

On 23 September 2003 the UK Advisory Committee on Releases to the Environment (ACRE) notified its response to an application for import of genetically modified GT73 herbicide tolerant rapeseed into the European Community and use for processing for food and feed (but not cultivation).  

ACRE advised that the risks posed by GT73 were “no different from that of other oilseed rape imported for processing and animal feed purposes”. ACRE also requested additional information on DNA sequence, likely places of import/processing, animal feed studies and monitoring measures.  

On 11 February 2004 the European Food Safety Authority (EFSA) Scientific Panel on Genetically Modified Organisms concluded that “… GT73 oilseed rape is as safe as conventional oilseed rape and therefore the placing on the market of GT73 oilseed rape for processing and feed use is unlikely to have an adverse effect on human or animal health or, in the context of its proposed use, on the environment'.  The Panel considered the increase in liver weights as an incidental finding, similar to all other regulators that have approved this GM canola.

After a GMO application receives a positive safety assessment from the EFSA, a ‘Draft Decision’ is sent for approval to the appropriate Regulatory Committee (in this case under the Committee covered by Directive 2001/18/EC).  The Committee comprises representatives of Member State. To approve an application, a qualified majority of votes (88 out of 124) in favour of the application is needed. Member States' votes are weighted on the basis of their population and corrected in favour of less-populated countries.

Following a vote in the Regulatory Committee (on 16 June 2004) on the release of genetically modified organisms into the environment, the decision to authorise the import and processing of the genetically modified oilseed rape known as GT73 will pass on to the Council of Ministers. The Committee, which is set up under Directive 2001/18 and representing the Member States, did not reach the qualified majority necessary to support the Commission proposal to authorise the oilseed rape.

The European Commission will now, in the coming weeks, formally adopt the proposal to be sent to the Council of Ministers. The Council can either adopt or reject the proposal with a qualified majority. If no decision is taken after three months, the file returns to the Commission which can then adopt it. If authorised, the oilseed rape, which has been modified for increased tolerance to the herbicide glyphosate, would be clearly labelled as containing GM oilseed rape, in accordance with the new legislation in force since 18 April 2004.

 

28 June 2004