file no: 98/3538
12 November 1999
|Chief Veterinary Officers, all States and the NT||Office of the Australian CVO|
|Director, Animal Health Branch, NOAPH||Manager, Animal Programs Section, AQIS Operations|
|Chief, CSIRO Division of Animal Health||Food Policy Branch, AQIS|
|National Farmers' Federation||Australian Animal Health Council|
|Australian Livestock Exporters' Council||Quarantine and Animal Health Task Force, NFF|
|National Meat Association of Australia||Australian Veterinary Association|
|Australia New Zealand Food Authority||Australian Dairy Farmers Federation|
|Veterinary Counsellors, Washington, Brussels and Seoul||Australian Dairy Products Federation|
|Agricultural Counsellor, Australian Embassy, Tokyo||Australian Food Council|
|EU Delegation, Canberra||Australian Dairy Industry Council|
|Embassy of Brazil||Australian Dairy Corporation|
|Embassy of Switzerland||Dairy Research and Development Corporation|
|Food and Beverage Importers' Association|
Import Risk Analysis: Importation of Dairy Products for Human Consumption Decision on Revised Conditions
This Animal Quarantine Policy Memorandum provides the final Import Risk Analysis (IRA) and quarantine requirements for the importation of dairy products for human consumption.
Under the IRA procedures the Executive Director of AQIS has considered and agreed to the requirements set out in the conditions attached as part of the final IRA report (Attachment A).
AQIS circulated for public comment AQPM 1998/95 which included the draft IRA. All responses have been considered in finalising the IRA and a number of changes were made in producing the final paper. A summary of comments received and AQIS’s responses is at Attachment B. Apart from the revised assessment of the risk posed by poxviruses, these changes were of a minor nature. Foot and mouth disease (FMD) remains the disease of greatest quarantine concern in relation to imported dairy products.
Section 4.1.4 which outlines the rationale behind the decision not to permit the importation of colostrum except as a human therapeutic has been re inserted in the final IRA, having been inadvertently omitted from the draft IRA paper.
To enable the reader to quickly access amended sections of the IRA, a list of all changes made in producing the final document is at Attachment C.
Amendments to Proclamation 1998 proposed by AQIS were gazetted on 4 May 1999, and are presented under Requirements (5.2), and in Appendix III of the IRA.
This AQPM advises the final conditions endorsed by the Executive Director of AQIS. Stakeholders may appeal against the process followed for this IRA by writing to:
Department of Agriculture, Fisheries and Forestry - Australia
GPO Box 858
CANBERRA ACT 2601
Appeals should be received by close of business on 12 December 1999. If there are no appeals, the attached conditions will be adopted on 19 December 1999. AQIS will issue a further AQPM advising adoption or, alternatively, that an appeal has been received. All enquires should be directed to the officer whose contact details appear below.
Respondents are advised that, subject to the Freedom of Information Act 1982 and the Privacy Act 1982, all submissions received in response to Animal Quarantine Policy Memoranda will be publicly available and may be listed or referred to in any papers or reports prepared on the subject matter of the Memoranda.
The Commonwealth reserves the right to reveal the identity of a respondent unless a request for anonymity accompanies the submission. Where a request for anonymity does not accompany the submission the respondent will be taken to have consented to the disclosure of his or her identity for the purposes of Information Privacy Principle 11 of the Privacy Act.
The contents of a submission will not be treated as confidential unless it is marked ‘confidential’ and the material is capable of being classified as such in accordance with the Freedom of Information Act.
A/g Assistant Director
Animal Quarantine Policy Branch
Contact Officer: Warren Vant
Telephone no: (02) 6272 4436
Facsimile no: (02) 6272 3399
Email: Animal Biosecurity
Concerns that were raised by more than one respondent:
- the basis for approval of countries to export dairy products to Australia, and the process of individual assessment for products from countries not free from FMD
AQIS is developing draft guidelines for Approval of Countries to Export Animals and Animal Products to Australia (the Guidelines). Because these guidelines will be used for a range of animals and animal products, they will be released for consultation as an AQPM. These guidelines allow for countries that already export dairy products to Australia, and have a history of reliable certification, to continue to do so, whilst setting the criteria to be met by countries that wish to export animals or animal products to Australia for the first time. For relatively safe products produced in a country that is not approved, the guidelines cover the process of approval of individual manufacturing plants.
- that the risk assessment was qualitative and not quantitative
AQIS chose the qualitative not the quantitative methodology because the risk assessment was generic, i.e. it examined the risk of introduction of dairy products from any country. The risk of any disease agent being present in the product varied greatly with animal health status of the country of origin. Further, certain data that are essential for the performance of a quantitative analysis were not available.
- assumptions made with regard to the inactivation of Poxviridae by heat treatment
The draft IRA contained a summarised version of data that had been compiled during the literature search. This section has been expanded in the final document, and additional data included. The sections dealing with transmission, likelihood of introduction and establishment have also been expanded.
After reviewing all available information, and consulting with international experts on poxviruses, it has been concluded that there is currently insufficient evidence to support the proposition that short time/high temperature pasteurisation would effectively inactivate poxviruses in milk. Given that poxviruses may be transmitted orally, AQIS has decided that the risk posed by dairy products other than cheese and butter, from countries in which these viruses are present, is not acceptable. Amendments have been made to the health requirements with regard to lumpy skin disease, buffalo pox, sheep pox, goat pox and camel pox to reflect the revised conclusions. These poxvirus requirements were not present in previous health conditions for imported dairy products.
Concerns raised by individual respondents:
- establishment of whether a region is free from FMD and reliability of the official veterinary controls in the exporting country
With regard to freedom from FMD, AQIS will only recognise countries or zones that have been assessed and accepted as free by the OIE. In addition to this, countries wishing to export dairy products to Australia will need to be approved by a process that is dependent on a number of factors such as the standard of veterinary services, animal health status and integrity of the certifying authority. These factors are described in the Guidelines.
- concerns regarding the effect of spray drying on the inactivation of FMD virus
The draft IRA stated that it was “likely that pasteurisation followed by the high heat of the modern spray drying process would inactivate FMDV.” AQIS is aware that there has been insufficient research with this product to be able to confidently predict the inactivation of FMDV in powdered milk. The importation of powdered milk from countries/zones not free from FMD will therefore not be permitted.
- apparent lack of provision for AQIS to inspect individual plants
This has been addressed by including a provision under 5.1 “Eligibility” for AQIS to require inspection of individual manufacturing plants. The approval of individual plants is also addressed in the proposed Guidelines.
- AQIS’s apparent acceptance of double pasteurisation as a means of inactivation of FMDV was seen as inconsistent with the statement that the virus survived in whole milk heated at 72ºC for 5 minutes
Blackwell and Hyde determined infectivity by performing multiple sublingual injections plus an intramuscular injection into cattle. However the quantitative risk analysis conducted by Donaldson took into account the dilution effect of milk from uninfected animals, and reduction of infectivity that occurs with pasteurisation. Notwithstanding, AQIS’s recommendations were conservative and the importation of dairy products from a country or zone not free from FMD (except for cheese in certain circumstances) will remain prohibited.
- that there was insufficient consideration of bovine virus diarrhoea
This was accepted as a valid concern and additional information and references have been provided in the final IRA.
- that there were insufficient safeguards to ensure that Bacillus anthracis organisms would not be present in milk from infected cows
Bacillus anthracis organisms may be shed in the milk of diseased animals, however the peracute nature of the disease would make it unlikely that these animals would be milked. Only countries with reliable certifying authorities will be approved to export dairy products to Australia, and the certification required includes a clause that covers the general health status of donor animals.
- inconsistency between the findings of the IRA and AUSVETPLAN with regard to poxviruses
The IRA has been conducted in liaison with officers responsible for AUSVETPLAN. Under AUSVETPLAN, milk from farms infected with a capripoxvirus is not permitted to leave the premises, and milk from non-affected farms in an infected area must be pasteurised. AUSVETPLAN considers there to be a risk arising from the transportation of milk from infected farms to the dairy factory, and by potentially contaminated milk trucks moving from farm to farm. These risks are not considered relevant for milk that is processed in the exporting country.
In view of the paucity of data on the effect of pasteurisation on the inactivation of poxviruses in milk, milk products other than cheese and butter will not be permitted from countries or zones in which poxviruses are present.
- query over what controls exist to limit the importation of New Zealand milk in the event of a disease outbreak in that country
Although Proclamation 1998 permits the free entry into Australia of New Zealand dairy products for human consumption, Section 55A of the Quarantine Act (1908) provides a quarantine officer with the power to inspect and order into quarantine any goods likely to be infected with a disease affecting animals or plants. AQIS considers that this approach is appropriate with regard to imports from New Zealand.
- query over the controls on the end use of dairy products after release from quarantine
Import permits for dairy products will only be issued for products destined for human consumption, and these consignments may not be downgraded for stockfeed. Nevertheless, AQIS recognises that dairy products purchased in shops by individuals could be fed to animals, and this is reflected in the requirements.
List of changes that appear in the final IRA on dairy products.
This list does not include the correction of typographical and formatting errors.
|1.3, 2||Factors in the establishment of disease||replace 'persist' with 'persist and/or multiply'.|
|2. Table 1||Diseases not listed by the OIE whose agents may be excreted in the milk||Inclusion of camel pox and buffalo pox.|
|2. Table 2||Diseases not listed by the OIE whose agents may be excreted in the milk||Further data on BVD added to table and footnote xiii.|
|3.1||Foot and mouth disease (b) Survivability/ inactivation of the agent in dairy products||New third last paragraph inserted. Additional comment on experimental methods used.|
|3.4||Poxviridae||Enlargement of section with inclusion of more information on the heat lability of poxviruses and the epidemiology of lumpy skin disease, buffalo pox, sheep pox/goat pox and camel pox. Revised conclusions.|
|4.1.4||Colostrum||Section explaining the rationale behind the decision not to permit the importation of colostrum other than as a human therapeutic.|
|4.2.1||Risk management in relation to FMD||Third last paragraph replaced with 'In addition, AQIS will continue to permit the importation of dairy products from countries/zones affected by FMD in the case of samples for scientific analysis; and will ease the restrictions on infant formula to enable travellers accompanied by an infant to bring with them sufficient for the child’s needs. AQIS is also considering a request to permit the importation of powdered, composite, milk based beverages in personal baggage by persons entering Australia'.|
Addition of the words: 'AQIS is developing Guidelines for the approval of countries to export animals and animal products to Australia and this will be used as the basis for this approval.
Furthermore, AQIS may require inspection and approval of individual manufacturing plants prior to issuing an import permit.'
|5.2.1||Defined exemptions||The list of exemptions has been re-written to include the recent amendments to Proclamation 1998 that permit the importation without a permit of butter oil, and the relaxation of the 1Kg restriction on infant food.|
|5.2.2||Note on colostrum||Stating AQIS’s policy on importation of colostrum.|