29 NOVEMBER 2000
10/01
FULL ASSESSMENT REPORT
APPLICATION A412
OBJECTIVE OF THE APPLICATION
The Australia New Zealand Food Authority has before it applicationA412(received on 27 April 2000), from the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) to amend the AustralianFood Standards Codeto establish a maximum residue limit (MRL) of 20 mg/kg for ethylene oxide (EtO) in herbs and spices.
SECTION 37 CONSIDERATION
It is proposed that this application be considered as a matter of urgency, under section 37 of theAustralia New Zealand Food Authority Act 1991in order to avoid compromising the objective set out in subsection 10(1)(a) of the Act, namely the protection of public health and safety.
BACKGROUND
The need to use ethylene oxide on herbs and spices
Selected herbs and spices imported into Australia are treated with ethylene oxide (EtO) to control microbial contamination. Currently, three spices, namely paprika, pepper and cinnamon are routinely tested by AQIS forSalmonella. If the spices fail to meet the required standard, the importer must re-export or decontaminate the shipment most chose to decontaminate the shipment with ethylene oxide. AQIS then test the spices for ethylene oxide residues according to the provisions of the Food Standards Code.
Ethylene oxide is volatile and dissipates quickly during the first few days after treatment. Cooking further reduces the level of EtO. Residues of EtO, itself, therefore, would be expected to be low and the data available in Australia and New Zealand supports this position. EtO, however, is also reactive and is readily forms the less toxic metabolites ethylene chlorohydrin and ethylene bromohydrin upon reaction with available chlorine and bromide, and higher levels of these residues are readily found in herbs and spices.
There seems to be no effective alternative to the use of EtO at this time in Australia. While irradiation is an effective alternative, there is currently no application before ANZFA to approve the use of irradiation on herbs and spices. Representatives from Steritech Pty Ltd will be visiting ANZFA very soon to discuss such an application.
AQIS sought advice from ANZFA recently about the status of EtO in relation to the Food Standards Code and was informed that there was no MRL for EtO and that therefore no residues of EtO were permitted in foods imported into or produced in Australia.
As a result, key herb and spice industry bodies have indicated that they are not prepared to continue importing herbs and spices or to continue supplying them from their current stocks for fear of prosecution and public criticism for breaching the Food Standards Code. Some food manufacturers are now anticipating serious problems of supply for herbs and spices and have indicated an intention to cease manufacture in the near future.
Legality of the use of ethylene oxide on domestic and imported foods
Registration for use through the National Registration Authority (NRA)
Until very recently, there was no registered agricultural use of ethylene oxide in Australia. The then NFA wrote to the NRA on 21 June 1993 seeking clarification of the status of EtO under the Agricultural and Veterinary Chemicals Act 1988. In a reply dated 9 July 1993, the NRA confirmed EtO is an agricultural chemical but at that time registration was still the responsibility of individual State and Territories and that national registration would not be in place until early 1994. The NRA suggested in their letter that EtO might be approved for use in individual States under permit to accommodate quarantine uses.
Recently, an import company applied to the NRA for an emergency use permit for ethylene oxide on herbs and spices (Application No. 3589). This permit was granted on 20 April 2000 until 30 September 2001. The NRA has subsequently made an application to ANZFA to have a maximum residue limit of 20 ppm for ethylene oxide in herbs and spices. The residue definition is ethylene oxide and does not include any metabolites.
Food Standard
There is currently no MRL for ethylene oxide in Standard A14 - Maximum Residue Limits - in the currentFood Standards Code. It is therefore not lawful for residues to be present in food. The current wording in the Standard is: If an MRL for an agricultural or veterinary chemical in a food is not listed in this Standard, there must be no detectable residue of that agricultural chemical in that food.
Prior to 1996, the thenFood Standards Codedid not give direction on chemicals that were not included in the Schedule to Standard A14. In effect, this permitted the risk associated with residues of chemicals not listed in Standard A14 to be managed within the general provisions of StateFood Actsrelating to food being suitable for human consumption. Amendment 30 (June 1996) to A14 inserted a clause that stated that if the chemical was not in the schedule to A14, there was no MRL and residues were defaulted to zero.
In this context, the advice given to AQIS in 1993 (see below) was correct, but this position is no longer valid, and an MRL for EtO residues is necessary for continued use.
Previous ANZFA consideration of EtO
The issue of EtO was raised with the then NFA Board in March 1993 as a result of a New Zealand initiative to review the use of EtO on herbs and spices with a view to phasing out the use of EtO. It was noted by the Board at the time that EtO was used in Australia on imported herbs and spices and that this use may be inconsistent with the Food Acts. However, it was also noted that the use of EtO was necessary to reduce the microbial contamination of some herbs and spices and that the alternative to EtO use, namely, irradiation, was not available. NFA agreed to review the continued use of EtO in co-operation with the NZ Department of Health and the Spice industry.
At this time, NFA staff also has discussions with the Spice Association of Australasia and with AQIS. It was recognized that there was little data on the extent and level of residues of EtO on herbs and spices.
To address this matter, AQIS was directed to place EtO 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 is 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 re-enforced 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 EtO. While some data has been provided, only limited information was obtained from the ASTA.
The issue of establishing an MRL for EtO has not been pursued because:
(i) it was always assumed that the approval of irradiation would make the use of EtO obsolete;
(ii) the lack of adequate residue data on herbs and spices would make registration by the NRA unlikely:
(iii) residues of EtO were considered by State and Territory Health Authorities to be an issue of less public health concern than the potential for health problems caused by the microbial contamination.
Safety of EtO and its residues
Ethylene oxide is regarded as a highly toxic chemical. It has been shown to cause cancer in experimental animals and has strong mutagenic activity in both bacterial and mammalian assays. It is currently in Schedule 7 of the Uniform Schedule of Drugs and Poisons and thus requires special precautions in manufacture, handling, storage and use. There is a significant potential risk to workers handling this chemical.
EtO reacts with available chlorine and bromide to form detectable residues of ethylene chlorohydrin and ethylene bromohydrin in treated food. The residues of EtO itself decrease rapidly (usually
Consideration of EtO in New Zealand
In New Zealand, until recently, EtO has been permitted for use on herbs and spices under a food notice that permits residues of EtO of 50 ppm. There has been on-going concern regarding the use of EtO in New Zealand since 1993. Following consideration of a recent report entitledCancer Risk Assessment of Ethylene Oxide Residues in new Zealand Spicesprepared by the New Zealand Institute of Environmental and Scientific Research (ESR), the New Zealand Ministry of Health recommended an MRL of 20 ppm EtO residues in spices. This regulation came in force on 23 April 2000. This MRL does not include ethylene chlorohydrin.
WORLD TRADE ORGANIZATION (WTO) NOTIFICATION
Australia and New Zealand are members of the WTO and are bound as parties to WTO agreements. In Australia, an agreement developed by the Council of Australian Governments (COAG) requires States and Territories to be bound as parties to those WTO agreements to which the Commonwealth is a signatory. Under the agreement between the Governments of Australia and New Zealand on Uniform Food Standards, ANZFA is required to ensure that food standards are consistent with the obligations of both countries as members of the WTO.
In certain circumstances Australia and New Zealand have an obligation to notify the WTO of changes to food standards to enable other member countries of the WTO to make comment. Notification is required in the case of any new or changed standards which may have a significant trade effect and which depart from the relevant international standard (or where no international standard exists).
Matters relating to public health and safety are notified as a Sanitary or Phytosanitary (SPS) notification, and other matters as a Technical Barrier to Trade (TBT) notification.
As the preferred regulatory option involves the development of a new food standard and one for which there is no international regulation, a World Trade Organization (WTO) notification would be required on the basis of constituting a Technical Barrier to Trade (TBT).
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. The Australia New Zealand Food Authority is now developing a jointAustralia New Zealand Food Standards Codewhich will provide compositional and labelling standards for food in both Australia and New Zealand.
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 the AustralianFood Standards Code, as gazetted in New Zealand, or the New ZealandFood Regulations 1984,but not a combination of both. However, in all cases maximum residue limits for agricultural and veterinary chemicals must comply solely with those limits specified in the New ZealandFood Regulations 1984.
· Food imported into New Zealand from Australiamust comply with either the AustralianFood Standards Codeor the New ZealandFood Regulations 1984,but not a combination of both. 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 New Zealand from Australiamust comply with either the AustralianFood Standards Codeor the New ZealandFood Regulations 1984,but not a combination of both.
· Food imported into Australia from New Zealandmust comply with the AustralianFood Standards Code. However, under the provisions of the Trans-Tasman Mutual Recognition Arrangement, food may be imported into Australia from New Zealand if it complies with the New ZealandFood Regulations 1984orDietary Supplements Regulations 1985.
· Food manufactured in Australia and sold in Australiamust comply solely with the AustralianFood Standards Code, except for exemptions granted in Standard T1.
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 theFood Standards Code amended. In addition, ANZFA may develop proposals to amend the AustralianFood Standards Codeor to develop joint Australia New Zealand food standards. ANZFA can provide advice on the requirements for applications to amend the Food Standards Code.
INVITATION FOR PUBLIC SUBMISSIONS
The Authority has completed a full assessment of the application and amended the AustralianFood Standards CodeANZFA, pursuant to section 37 of theAustralia New Zealand Food Authority Act 1991,to avoid compromising the objective set out in subsection 10(1)(a) of the Act, namely the protection of public health and safety. The Authority is now conducting an inquiry as required under theAustralia New Zealand Food Authority Act 1991.
Written submissions containing technical or other relevant information which will assist the Authority in undertaking a full assessment on matters relevant to the application, including consideration of its regulatory impact, are invited from interested individuals and organisations. Technical information presented should be in sufficient detail to allow independent scientific assessment.
Submissions providing more general comment and opinion are also invited. The Authority's policy on the management of submissions is available from the Standards Liaison Officer upon request.
The processes of the Authority are open to public scrutiny, and any submissions received will ordinarily be placed on the public register of the Authority and made available for inspection. If you wish any confidential information contained in a submission to remain confidential to the Authority, you should clearly identify the sensitive information and provide justification for treating it in confidence. TheAustralia New Zealand Food Authority Act 1991requires the Authority to treat in confidence trade secrets relating to food and any other information relating to food, the commercial value of which would be or could reasonably be expected to be, destroyed or diminished by disclosure.
All correspondence and submissions on this matter should be addressed to the
Project Manager - Application A412at one of the following addresses:
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Australia New Zealand Food Authority |
Australia New Zealand Food Authority |
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PO Box 7186 |
PO Box 10559 |
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Canberra Mail Centre ACT 2610 |
The Terrace WELLINGTON 6036 |
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AUSTRALIA |
NEW ZEALAND |
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Tel (02) 6271 2222 Fax (02) 6271 2278 |
Fax (04) 473 9942 Fax (04) 473 9855 |
Submissions should be received by the Authority by10 January 2001.
General queries on this matter and other Authority business can be directed to the Standards Liaison Officer at the above address or by Email on (slo@ANZFA.GOV.AU). Submissions should not be sent by Email as the Authority cannot guarantee receipt.
Requests for more general information on the Authority can be directed to the Information Officer at the above address or by Email (info@ANZFA.GOV.AU).
PUBLIC CONSULTATION
Under section 37, ANZFA is required as soon as practicable to hold an inquiry into the standard as adopted.
SCIENTIFIC ASSESSMENT
The basis for the recommended MRL is a report entitledCancer Risk Assessment Of Ethylene Oxide Residues In New Zealand Spicesprepared by the New Zealand Institute Of Environmental And Scientific Research (ESR) and commissioned by the New Zealand Ministry of Health (see Attachment 3).
The report provides an estimate for the potential cancer risk associated with the presence of EtO residues and its breakdown products in dry spices in New Zealand.
The report concludes that:
1. On the basis of the current monitoring data and the risk assessment undertaken, there is negligible cancer risk to consumers from EtO residues in spices.
2. There are no known significant cancer risks associated with consumption of ethylene chlorohydrin and ethylene bromohydrin at the levels found in spices. It is acknowledged, however, that the toxicological database on these compounds is limited.
3. An MRL of 20 ppm for EtO in spices is sufficient to take account of residues found in retail spices. This is consistent with the policy of maintaining residues as low as practically achievable.
CONCLUSIONS
On the basis of the data available, an MRL of 20 ppm for ethylene oxide in herbs and spices is justified and does not pose any additional public health and safety risk.
ATTACHMENTS
1. Draft variation to the AustralianFood Standards Code
2. Statement of Reasons
3. Report prepared by the New Zealand Institute of Environmental and Scientific Research (ESR) entitled:Cancer Risk Assessment Of Ethylene Oxide Residues In New Zealand Spices
Attachment 1
DRAFT VARIATION TO THE AUSTRALIAN FOOD STANDARDS code
A412 - MAXIMUM RESIDUE LIMIT FOR ETHYLENE OXIDE IN HERBS AND SPICES
Explanatory Note: This is a new MRL for an agricultural chemical not previously listed in Standard A14.
To commence:On gazettal
Standard A14is varied by inserting in column 1of Schedule 1 the chemical (shown in bold type) and inserting in column 1 and 2 respectively of Schedule1 the food and maximum residue limit for that food, listed below-
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Chemical Food |
MRL |
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Ethylene oxide |
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Herbs |
20 |
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Spices |
20 |
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The MRLs for ethylene oxide cease to have effect on 30 September 2001 |
Attachment 2
STATEMENT OF REASONS DRAFT
APPLICATION A412
MAXIMUM RESIDUE LIMIT FOR ETHYLENE OXIDE IN HERBS AND SPICES
The Australia New Zealand Food Authority has before it applicationA412(received on 27 April 2000), from the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) to amend the AustralianFood Standards Codeto establish a maximum residue limit (MRL) of 20 mg/kg for ethylene oxide (EtO) in herbs and spices.
ANZFA has completed a full assessment of the application, prepared draft variations to the AustralianFood Standards Code.
ANZFA has decided, pursuant to section 37 of theAustralia New Zealand Food Authority Act 1991,to progress 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.
The Australia New Zealand Food Authority recommends the adoption of the draft variation to Standard A14 for the following reasons:
· The MRL for EtO has been recommended by the NRA after the granting of an Emergency Use Permit for fumigant use of EtO on herbs and spices on 20 April 2000.
· The use of EtO of herbs and spices is required to reduce microbial contamination. The alternative decontamination method, namely irradiation, is not yet available for herbs and spices.
· The MRL of 20 mg/kg is set at a level consistent with good agricultural practice.
· On the basis of the report entitledCancer Risk Assessment of Ethylene Oxide Residues in New Zealand Spicesprepared by the New Zealand Institute of Environmental and Scientific Research (ESR), there is negligible cancer risk to consumers from EtO residues in spices.
· The MRL will expire on 30 September 2001, which is the date of expiration of the Emergency Use Permit.
· The MRL for EtO is predicated on A timely industry application to vary Standard A17 Irradiated Food to permit irradiation of herbs and spices.
The commencement date of the draft variation is to be from the date of gazettal.
Attachment 3
Cancer Risk Assessment of Ethylene Oxide Residues in New Zealand Spices
A Report Produced for the New Zealand Ministry of Health
December 1999
Jefferson Fowles, Ph.D.
Institute of Environmental and Scientific Research
PO Box 50-348
Porirua
New Zealand
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Jim Mitchell |
Peter Cressey |
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Peer Reviewer |
Manager- Food |
GroupClient Report
FW9980
Cancer Risk Assessment of Ethylene Oxide Residues in New Zealand Spices
Prepared as part of a Ministry of Health contract for scientific services
by
Jefferson Fowles, Ph.D.
December 1999
DISCLAIMER
This report or document ('the Report') is given by the Institute of Environmental science and Research Limited ('ESR') solely for the benefit of the Ministry of Health, Public Health Service Providers and other Third Party Beneficiaries as defined in the Contract between ESR and the Ministry of Health, and is strictly subject to the conditions laid out in that Contract.
Neither ESR nor any of its employees makes any warranty, express or implied, or assumes any legal liability or responsibility for use of the Report or its contents by any other person or organisation.
ACKNOWLEDGEMENTS
The following people lent valuable assistance and advice on this project:
Jim Mitchell (ESR)
Jim Wilson (Project Manager, Ministry of Health)
Rob Smith (Food Standards, Ministry of Health)
Marion Riordan (Team Leader-Food Standards, Ministry of Health)
Tom McDonald, Ph.D (California Environmental Protection Agency)
Peter Abbott, Ph.D (Australia New Zealand Food Authority)
Executive Summary
This report provides an estimate for the potential cancer risk associated with the presence of ethylene oxide (ETO) residues and its breakdown products in dry spices in New Zealand. The cancer risks were calculated using reported analytical measurements of ETO, ethylene chlorohydrin (ECH) and ethylene bromohydrin (EBH) in retail samples of various spices in New Zealand. Spice consumption estimates were derived using New Zealand Customs annual importation data for black pepper, cinnamon/cassia, paprika, nutmeg, and chilli powder as a conservative measure of per capita intake of these spices. These spices were chosen as they are often not cooked before being consumed. Using this information, a conservative upper-end intake of ETO is estimated to be 3.4 x 10-6 mg/kg/d. This estimate would be expected to decrease as the proportion of these spices that are cooked increases. An oral cancer potency factor of 0.55 (mg/kg/d)-1 for ETO was derived using the linearised multistage model from a chronic oral cancer study on ETO in rats. A published potency factor of 0.29 (mg/kg/d)-1 based on an inhalation study was also used. The use of these potency factors with estimated ETO intakes gave upper-end lifetime cancer risk estimates for a consumer beginning at 1 x 10-6 (1 in a million). High intake estimates for spices in NZ were not found, but the 97.5% intake for spice consumption in the U.S. is reported to be about 6.3-fold higher than the estimated average NZ spice consumption. This could mean that the worst-case estimate of lifetime cancer risk from ETO in spices is about 1 x 10-5 (10 in a million), but would be much lower for the average consumer. Cancer risks to ETO fumigators are not addressed in this report.
The estimated upper-end of the range of consumption of ECH and EBH from the monitoring results is 7.4 x 10-4 and 5.8 x 10-5 mg/kg/d, respectively. Exposure to these compounds is considerably higher (200-300 fold on average) than to ETO itself. It is apparent that ECH and EBH occur in significant quantities in spices and persist long after fumigation. However, the contribution to any potential cancer risk from EBH and ECH is unknown due to a lack of adequate toxicity data on these compounds. The evidence for carcinogenicity andin vivomutagenicity of ECH is conflicting or negative. For EBH, one animal study showed a significant increase in stomach tumours following oral exposure. However, even if this result were sufficient evidence of carcinogenicity in animals, the potency factor from the study is 3.0 x 10-2 (mg/kg/d)-1, which would yield a cancer risk less than that posed by ETO given the current monitoring results.
The spices currently surveyed were all compliant with the current regulatory limit (MRL) for ETO in the NZ Food Notice of 1999 of 50 ppm. Only two samples of cinnamon out of 22 sampled were detectable at the limit of detection of 2 ppm. The highest value encountered was 15 ppm in one sample. The exposures and cancer risks to average consumers from ETO are extremely small and are unlikely to be significant even using the conservative assumptions in this report. On the other hand, it appears that if an MRL for ETO is to be retained, it may be unnecessary to keep the MRL at the current 50 ppm level as it is evident that the MRL could be reduced without any impact to the spice industry. Additionally, ETO is a known human carcinogen, and any exposures, no matter how slight, should be reduced in the food supply by using Good Manufacturing Practices. These points support a reduction in the MRL for ETO.
As with ETO, it does not appear that the breakdown products, ECH and EBH, pose significant cancer risks, given the current toxicological data. However, it should be emphasised that there are large data gaps, including the absence of a 2-year cancer bioassay by the oral route of exposure for ECH, and further studies should also be done on EBH to ascertain the nature and degree of hazards posed by these chemicals at chronic low level exposures.
Recommendations
It is recommended the New Zealand Ministry of Health:
1. Acknowledge that the current monitoring and risk assessment has indicated that there is negligible cancer risk to both upper-end and worst-case scenario consumers associated with ETO residues in spices.
2. Acknowledge that there are no known significant cancer risks associated with consumption of ECH or EBH at the levels found in retail spices. Neither compound is a known carcinogen. However there is a significant degree of scientific uncertainty in this advice as some key toxicological studies have not been done for these compounds.
3. Consider lowering the current temporary MRL for ETO in spices from 50 ppm to 20 ppm, as it appears this level is unnecessarily high, and because ETO residues should be kept at current levels or lower if practically achievable.
4. Maintain a watching brief on chronic oral toxicity studies or international toxicological assessments on ECH and EBH, particularly those relating to mutagenicity or carcinogenicity.
1 Background
Ethylene oxide (ETO) is considered by the International Agency for Research on Cancer (IARC) to be a human carcinogen (IARC, 1994). As a fumigant, ETO gas is currently used as a way to disinfect spices potentially contaminated with pathogenic bacteria, such as salmonella, in New Zealand, the United States, and Canada. However, i