( For Australia only )
13 March 2002
Initial / Draft Assessment Report
Full Report [ pdf 294 kb ]
3. BACKGROUND TO THE APPLICATION
3.1 The Use of Agricultural and Veterinary Chemicals
In Australia, the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) is responsible for registering agricultural and veterinary chemical products, granting permits for use of chemical products and regulating the sale of agricultural and veterinary chemical products. Following the sale of these products, the use of the chemicals is then regulated by State and Territory 'control of use' legislation.
3.2 Maximum Residue Limits
The MRL is the highest concentration of a chemical residue that is legally permitted or accepted in a food. The MRL does not indicate the amount of chemical that is always present in a treated food but it does indicate the highest residue that could possibly result from the registered conditions of use. The concentration is expressed in milligrams per kilogram (mg/kg) of the food.
3.3 Previous Consideration of Ethylene Oxide MRL
PACSC Consideration
In 1983 and 1985, the National Health and Medical Research Council (NHMRC) Pesticides and Agricultural Chemicals Standing Committee (PACSC) considered requests for Maximum Residue Limits for ethylene oxide in a range of foods. The Committee agreed that no MRL could be set for ethylene oxide because of its extremely toxic nature.
NFA Consideration
The issue of ethylene oxide was raised with the then National Food Authority (NFA) in March 1993 as a result of a New Zealand initiative to review the use of ethylene oxide on herbs and spices with a view to phasing out the use of ethylene oxide. It was noted by the NFA at the time that ethylene oxide was used in Australia on imported herbs and spices and that this use may be inconsistent with Commonwealth, State and Territory food legislation. However, it was also considered at that time that ethylene oxide was necessary to reduce the microbial contamination of some herbs and spices and that one of the alternatives to ethylene oxide use, namely, irradiation, was not available. The NFA agreed to review the continued use of ethylene oxide in cooperation with the New Zealand Ministry of Health and the spice industry.
At this time, NFA staff also had discussions with the Spice Association of Australasia and with Australian Quarantine and Inspection Service (AQIS). It was recognised that there were little data on the extent and level of residues of ethylene oxide on herbs and spices. To address this matter, AQIS was directed to place ethylene oxide on the Imported Food Inspection Program' s active surveillance list to obtain more data. In cases where residues were detected, AQIS was to use an action level of 50ppm that was consistent with the tolerance used in the USA for ground spices. This action level was to apply only for 6 months from 10 June 1993. This position was formally advised in a letter from the NFA Chairperson to AQIS in June 1993 advising that an action of 50 ppm for herbs and spices under the Imported Food Program was to apply.
Following discussions with NFA staff, the Spice Association agreed to provide:
(i) the results of residue trials on both local and imported products;
(ii) toxicity data on residues of ethylene oxide from the American Spice Traders Association (ASTA); and
(iii) other information on alternatives to the use of ethylene oxide.
While some data were provided, only limited information was obtained from the Spice Association. The issue of establishing an MRL for ethylene oxide was not pursued by the NFA in the expectation that alternative treatments would make the use of ethylene oxide obsolete.
ANZFA Consideration
In January 2000 AQIS sought advice from ANZFA about the status of ethylene oxide in relation to the Food Standards Code and was informed that there was no MRL for ethylene oxide and that therefore no detectable residues of ethylene oxide (or its breakdown products) were permitted in foods imported into or produced in Australia.
Subsequently, the NRA received an application for an emergency use permit for ethylene oxide treatment of herbs and spices (Application No. 3589). They granted this permit on 20 April 2000. Prior to this date, ethylene oxide on herbs and spices was not registered for use in Australia.
ANZFA received Application A412 on 27 April 2000 from NRA seeking to amend the Food Standards Code to establish a maximum residue limit (MRL) of 20 mg/kg for ethylene oxide in herbs and spices.
ANZFA, pursuant to section 37 of the Australia New Zealand Food Authority Act 1991,progressed this application as a matter of urgency in order to avoid compromising the objective set out in subsection 10(1)(a) of the Act, namely the protection of public health and safety. Accordingly, ANZFA completed a Full Assessment of the application, prepared draft variations to the Food Standards Code, and proposed recommendations to be considered by the Australia New Zealand Food Standards Council (ANZFSC).
On 28 July 2000, ANZFSC agreed to the recommendations to amend Standard A14 - Maximum Residue Limits, and agreed also that the date of implementation of the amendment would coincide with the date of gazettal of the variation to the standard. The variation commenced on the 17 August 2000, the date of gazettal, with an expiry date of 30 September 2001. This expiry date was set to allow the phasing out of ethylene oxide and its replacement by alternative methods of decontamination.
3.4 Treatment of herbs and spices
Selected herbs and spices (particularly paprika, pepper and cinnamon) imported into Australia can be contaminated with Salmonella and may require treatment prior to sale and use. AQIS test for Salmonella in imported herbs and spices and, if found, require decontamination or re-export of the shipment. Until the recent expiry of the NRA permit for the use of ethylene oxide (31 July 2001 - see below), treatment with ethylene oxide was the standard method to control microbial contamination of herbs and spices.
In addition, some segments of the food industry routinely sterilised herbs and spices with ethylene oxide as part of their production processes.
3.5 Consideration of Ethylene Oxide in New Zealand
New Zealand food legislation, until recently, permitted herbs and spices to contain residues of ethylene oxide of 50 ppm. There has been on-going concern regarding ethylene oxide in New Zealand since 1993. Following consideration of a recent report entitled Cancer Risk Assessment of Ethylene Oxide Residues in New Zealand Spices prepared by the New Zealand Institute of Environmental and Scientific Research (ESR), the New Zealand Ministry of Health recommended an MRL of 20 ppm for ethylene oxide residues in spices. This regulation came in force on 23 April 2000. This MRL only applies to residues of ethylene oxide and does not include residues associated with its major breakdown products ethylene chlorohydrin and ethylene bromohydrin.
The agreement between the Commonwealth of Australia and the Government of New Zealand, 1995 to establish a system for the development of joint food standards (the Treaty) excluded MRLs for agricultural and veterinary chemicals in food from the joint Australia New Zealand food standards setting system. Australia and New Zealand separately develop MRLs for agricultural and veterinary chemicals in food.
Following the commencement of the Trans Tasman Mutual Recognition Arrangement (TTMRA) between Australia and New Zealand on 1 May 1998:
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food produced in Australia that complies with volume 1 (Standard A14) or Volume 2 (Standard 1.4.2) of the Food Standards Code can be legally sold in New Zealand; and
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food produced in New Zealand that complies with the New Zealand ( Maximum Residue Limits of Agricultural Compounds ) Mandatory Food Standard, 1999 can be legally sold in Australia.
3.6 Ethylene Oxide as a Processing Aid
Based upon the previous application from the NRA to include an MRL for ethylene oxide in herbs and spices, ethylene oxide has been regarded as an agricultural chemical and regulated as such in the Food Standards Code. However, the residues of ethylene oxide resulting from use of ethylene oxide to treat herbs and spices to reduce microbial contamination could be regulated in the Food Standards Code as an agricultural chemical or as a processing aid. It would also allow for the further treatment of herbs and spices with ethylene oxide and limited further usage of ethylene oxide may be necessary for a short period in order to protect public health and safety. Therefore, the applicant' s request for an extension of the expiry date for the MRL is equivalent to a request for a limit for ethylene oxide residues resulting from its use as a processing aid. This approach would overcome any confusion as to whether the use of ethylene oxide is as an agricultural chemical or a processing aid.
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