Full Draft Assessment Report available [ pdf ]
EXECUTIVE SUMMARY
Background
ANZFA received an application from Rhone-Poulenc Rural Australia Ltd ( now trading as Aventis Cropscience Pty Ltd after its merger with AgrEvo ) on 29 April 1999 for the approval of food derived from bromoxynil-tolerant canola(Brassica napus).This canola is tolerant to applications of the herbicide bromoxynil, and is known commercially as Navigator TM canola. This report describes the scientific assessment of the application.
Issues addressed during assessment
Food from bromoxynil-tolerant canola has been evaluated according to the safety assessment guidelines prepared by ANZFA. The assessment considered the following issues: (1) the nature of the genetic modification; (2) general safety issues such as novel protein expression and the potential for transfer of antibiotic resistance genes to microorganisms in the human digestive tract; (3) toxicological issues; and (4) nutritional issues.
Nature of the genetic modification
A single gene,oxy, was stably transferred to the bromoxynil-tolerant canola line Westar-Oxy-235 using theAgrobacterium-mediated transformation system. The oxy gene is derived from the soil bacterium Klebsiella pneumoniae subspecies ozaenae and encodes the enzyme nitrilase. When produced in canola, the bacterial nitrilase allows the normally bromoxynil-sensitive plants to effectively metabolise the herbicide to a non-toxic compound, thus enabling the plants to survive and grow in the presence of the herbicide. No antibiotic resistances genes were transferred to the bromoxynil-tolerant canola.
General safety issues
Canola is a genetic variation of rapeseed developed by plant breeders specifically for its nutritional qualities, particularly its low levels of saturated fat and naturally occurring toxins. Oil is the only food product of the canola plant that is being evaluated for human consumption as part of this application. Canola oil is routinely used in food and has an established history of safe use.
While nitrilase is readily detected in leaf tissue from bromoxynil-tolerant canola, it is only present in seeds at very low levels and no nitrilase protein could be detected in refined oil.
Toxicological issues
Canola contains two naturally occurring toxins - erucic acid and glucosinolates. The levels of these substances in bromoxynil-tolerant canola were found to be well below the respective mandatory and industry limits. There were no major differences between transgenic and control lines, indicating that the genetic modification process has not altered the levels of these compounds.
The potential toxicity and allergenicity of nitrilase was considered in the assessment. Nitrilase does not have any significant similarity to known protein toxins or allergens and is rapidly digested in conditions that mimic human digestion. The absence of toxicity of nitrilase has also been confirmed through acute toxicity testing in mice. Nitrilase, also cannot be detected in refined canola oil, therefore exposure to the protein, through consumption of refined oil from bromoxynil-tolerant canola, would be effectively zero. There is thus no evidence to indicate that there is any potential for nitrilase to be either toxic or allergenic to humans.
The potential toxicity of DBHA, the by-product of bromoxynil detoxification by nitrilase, was also considered. The evidence indicates that DBHA shows no potential to be toxic to humans at the predicted exposure levels.
Nutritional issues
Detailed compositional analyses did not reveal any consistent differences in key constituents between modified canola plants and control plants, or the oils produced from them. Treatment with bromoxynil also did not affect the levels of any of the key constituents measured. The results confirmed that the levels of key constituents in bromoxynil-tolerant canola are no different to those of non-modified canola varieties. An animal feeding study also confirmed that there is no difference between bromoxynil-tolerant and control varieties of canola in their ability to support typical growth and well being.
Conclusion
On the basis of the data submitted with the present application, refined oil derived from bromoxynil-tolerant canola line Westar-Oxy-235 is considered to be as safe and wholesome as refined oil derived from conventional canola varieties.
The amended Standard for foods produced using gene technology (Standard A18 in Volume 1 of the Food Standards Code, Standard 1.5.2 in Volume 2 of the Food Standards Code) came into effect on 7 December 2001. Under the revised standard, food products made using oil from bromoxynil-tolerant canola will require labelling if it can be shown that novel DNA and/or protein is present in the final food.
Forty-five public submissions were received in relation to this application, of which only four were supportive. Those opposing the application did so primarily on the basis that they perceive GM food to be unsafe. The food safety concerns raised in submissions have been addressed by the safety assessment carried out by ANZFA.
Conclusions
On the basis of the data submitted with the application and evidence obtained from the scientific literature it is concluded that:
- The introduced gene in bromoxynil-tolerant canola line Westar-Oxy-235 is not considered to produce any increased public health and safety risk;
- On the basis of the data submitted in the present application, oil from bromoxynil-tolerant canola line Westar-Oxy-235 is as safe and wholesome as oil derived from conventional canola varieties;
- On 7 December 2001, food products containing oil from bromoxynil-tolerant canola will require labelling if it can be shown that novel DNA and/or protein is present in the final food.
- The proposed amendment to the Food Standards Codeis consistent with the section 10 objectives of the Australia New Zealand Food Authority Act1991 and the conclusions of the regulatory impact assessment.
Recommendation
On the basis of the available evidence, ANZFA considers that oil from bromoxynil-tolerant canola line Westar-Oxy-235 is as safe for human consumption as oil from other commercial canola varieties and is therefore proposing an amendment to the Food Standards Code to give approval to the sale of such food in Australia and New Zealand.
ANZFA now seeks public comment on the proposed amendment in accordance with the procedures described in Section 17 of the Australia New Zealand Food Authority Act 1991.
FOOD STANDARDS SETTING IN AUSTRALIA AND NEW ZEALAND
The Governments of Australia and New Zealand entered an Agreement in December 1995 establishing a system for the development of joint food standards. On 24 November 2000, Health Ministers in the Australia New Zealand Food Standards Council (ANZFSC) agreed to adopt the new Australian New Zealand Food Standards Code. The new code was gazetted on 20 December 2000 in both Australia and New Zealand as an alternate to existing food regulations until December 2002 when it will become the sole food code for both countries. It aims to reduce the prescription of existing food regulations in both countries and lead to greater industry innovation, competition and trade.
Until the jointAustralia New Zealand Food Standards Codeis finalised the following arrangements for the two countries apply:
- Food imported into New Zealand other than from Australiamust comply with either Volume 1 (known as AustralianFood Standards Code)or Volume 2 (known as the jointAustralia New Zealand Food Standards Code)of the AustralianFood Standards Code, as gazetted in New Zealand, or the New ZealandFood Regulations 1984,but not a combination thereof. However, in all cases maximum residue limits for agricultural and veterinary chemicals must comply solely with those limits specified in the New Zealand(Maximum Residue Limits of Agricultural Compounds) Mandatory Food Standard 1999.
- Food imported into Australia other than from New Zealandmust comply solely with Volume 1 (known as AustralianFood Standards Code)or Volume 2 (known as the jointAustralia New Zealand Food Standards Code)of the AustralianFood Standards Code, but not a combination of the two.
- Food imported into New Zealand from Australiamust comply with either Volume 1 (known as AustralianFood Standards Code)or Volume 2 (known asAustralia New Zealand Food Standards Code)of the AustralianFood Standards Codeas gazetted in New Zealand,but not a combination thereof. Certain foods listed in Standard T1 in Volume 1 may be manufactured in Australia to equivalent provisions in the New ZealandFood Regulations 1984.
- Food imported into Australia from New Zealandmust comply with Volume 1 (known as AustralianFood Standards Code)or Volume 2 (known asAustralia New Zealand Food Standards Code)of the AustralianFood Standards Code, but not a combination of the two. However, under the provisions of the Trans-Tasman Mutual Recognition Arrangement, food mayalsobe imported into Australia from New Zealand provided it complies with the New ZealandFood Regulations 1984.
- Food manufactured in Australia and sold in Australia must comply with Volume 1 (known as AustralianFood Standards Code)or Volume 2 (known asAustralia New Zealand Food Standards Code)of the AustralianFood Standards Codebut not a combination of the two. Certain foods listed in Standard T1 in Volume 1 may be manufactured in Australia to equivalent provisions in the New ZealandFood Regulations 1984.
In addition to the above, all food sold in New Zealand must comply with the New ZealandFair Trading Act 1986and all food sold in Australia must comply with the AustralianTrade Practices Act 1974,and the respective Australian State and TerritoryFair Trading Acts.
Any person or organisation may apply to ANZFA to have the Food Standards Code amended. In addition, ANZFA may develop proposals to amend the Australian Food Standards Code or to develop joint Australia New Zealand food standards. ANZFA can provide advice on the requirements for applications to amend the Food Standards Code.
Full Draft Assessment Report available [ pdf ]