1. Implementation of science-based application of SPS measures
risk analysis for
application of SPS measures
in Australia
Implementation of science-based risk analysis for application of SPS measures in Australia
Australia has been actively involved in the development and implementation of international standards through the Interim Commission for Phytosanitary Management and the expert standards committee that preceded the current interim standards committee
Actively integrated principles of SPS and IPPC into policy development
Australia is widely recognised for its conservative quarantine policies
Scientific analysis provides a means of assessing import access requests more effectively and in a shorter time frame
Implementation of the international standards and the SPS agreement have not fundamentally changed what has been done in the past. Application of phytosanitary measures has always been on the basis of risk and risk management. However, there is an increased obligation for transparency and documentation of under SPS and IPPC International standard that has seen a change in the way Australia has documented its analysis of import requests
While there are benefits to increased transparency (may have been touched on by other speakers) there are also costs. You may like to expand on these later if time permits.
The requirement for transparency and scientific rigour that is open to challenge under the SPS Agreement is technically demanding on both Australia and the exporting country. This is becoming more widely appreciated.
The presentation will trace the Australian risk analysis process using a case study to highlight issues that arose and that have lead to the ongoing evolution of risk analysis processes.

2. The Risk Analysis Process
Transparency and consultation
The AQIS Import Risk Analysis Process Handbook
available on-line at
Technical analysis
International Standard for Phytosanitary
Measures No. 2
The Risk Analysis Process
Australia’s risk analysis process combines technical risk analysis with a stakeholder consultation process that seeks technical feedback on the risk analysis.
The technical process is adapted from and is consistent with, the International Standard for Phytosanitary Measures Number 2:Guidelines for Pest Risk Analysis.
The consultative process has been adopted by the Australian Government as policy in the AQIS Import Risk Analysis Process.
A number of convergent factors arose during the latter half of the 1990s that led to the full implementation of a transparent science-based risk analysis system in Australia
- The SPS Agreement was finalised in 1994
- ISPM No 2 was endorsed by IPPC members in November This led to the development of templates within AQIS to facilitate consistency in risk analysis in a manner consistent with the ISPM
- A review into Australian quarantine was completed in 1997 with recommendation to government for more transparency in quarantine policy making
- The Import Risk Analysis Process was developed and codified in the AQIS IRA Process Handbook (available on the AQIS web site)
The IRA process has been used for a number of animal, plant, fish importation requests over the last 3 years
The process is continuing to evolve with lessons learned and policies determined with each risk analysis undertaken.

3. The AQIS Import Risk Analysis (IRA)
The AQIS Import Risk Analysis (IRA) Process
The IRA handbook outlines a number of steps that must be followed in completing a risk analysis:
Process initiation
- a formal request is received from the proposing country or from interested parties within Australia. To initiate the IRA process the request must be accompanied by technical information needed to begin the scientific analysis. This is generally a comprehensive pest and disease list but may also include pest management information. A list of required information is provided at Annex 3 of the IRA handbook
- the request is acknowledged
Priority considered
- Stakeholders are advised of receipt of a request. Comment is sought on the proposed priority of the access request. The final decision on priority is made by AQIS. Stakeholder comments are but one of a number of factors considered. A primary consideration is resource availability.
Analysis pathway determined
- AQIS has established two pathways for risk analysis. The first (routine) is managed by AQIS, the second (non-routine) is managed by an independent risk analysis panel. The latter pathway is used where the analysis is technically complex - for example global risk analyses for a commodity, multiple commodities from multiple countries.
- The scientific analysis for both pathways is the same but there is an issues paper released to stakeholders in the non-routine process that defines the scope of the analysis.
Draft IRA released to stakeholders for a 60 day period in which technical input is sought from industry, other countries and the science community/external experts
Comments received that are technically valid are incorporated into the final IRA that is circulated for a 30 day period prior for any appeals against deficiencies in the IRA process that may include omission of significant bodies of technical evidence.
The Director of Plant and Animal Quarantine makes a determination on the adoption of the policy developed in accordance with the Australian Quarantine Act. Policy is implemented
The AQIS Import Risk Analysis (IRA)
Process

4. Technical analysis (ISPM No. 2)
Technical analysis (following) ISPM No. 2
Initiating the risk analysis process
- The ISPM identifies the circumstances that may lead to the initiation of a risk analysis. These generally refer to a change in conditions that may lead to importation of a new commodity or a new pest following a change in a nation’s pest status.
- In initiating the risk analysis the commodity and importation pathway is identified and the pests that are likely to follow the pathway are listed. If there are no potential quarantine pests the risk analysis stops and the importation is allowed.
Pest risk assessment.
- Each pest potentially associated with the pathway has its quarantine status determined against the IPPC definition of a quarantine pest which is … a pest of potential economic importance to the area endangered thereby and not yet present there, or present but not widely distributed and being officially controlled…
- Actual information about the distribution, biology and economic importance for each pest is assessed and expert judgement applied to assess the establishment, spread and economic importance potential to the area that could be endangered. The potential for introduction is determined.
- Information to assist in the pest status assessment is sought from the exporting country, international literature, visits, joint research programs etc.
Pest risk management
- Phytosanitary risk management measures may need to be applied where the introduction potential and economic consequences of the introduction of the new pest are high enough to justify additional measures to mitigate the risk
- Measures are identified that are proportional to the risk identified in the pest risk assessment and are applied to the minimum area necessary for effective protection of the endangered area. Their efficacy and impact in reducing risk to an acceptable level is evaluated and documented. The efficacy of measures is required to be monitored and reviewed if necessary.

5. A Case Study - Importation of Ya Pear from Hebei Province,
People’s Republic of China
… In 1991 China requested access to Australia for Ya pear…
Case study: The Importation of Ya pear from Hebei (he-bay) Province in the People’s Republic of China
AQIS received an application from China in April 1991 for access to Australia for fresh Ya pear fruit from two designated export areas within the Province of Hebei.
The Ya pear is an Asian pear type that looks like a yellow-skinned European variety. It is sweet and juicy without the gritty texture of European varieties
Hebei Province surrounds the Chinese capital Beijing with the Province capital, also called Hebei (and pictured on the map), lying about 100 km to the west of Beijing.
Subequent to the original application Chinese authorities requested access for Ya pear from adjacent export areas within Hebei and the neighbouring Shandong Province (to south east of Hebei)
The case study will trace the technical analysis against the steps in ISPM No. 2 leading to the identification of the pests of quarantine concern to Australia for which additional measures were required. It will also identify issues that were raised by stakeholders, including the Chinese Government, during the IRA process and which were subsequently addressed.

6. Risk assessment
pests were found to be associated with fruit in proposed export areas
- Quarantine status of these pests was determined from information provided by China, supplemented by Australian literature investigation and field visits
- Introduction potential, economic impact was assessed
pests determined to be of quarantine concern to Australia
Risk assessment
Initiation
- The importation pathway was defined as fresh Ya pear fruit from specific areas of China for export to Australia in refrigerated containers.
List of pests
- Pest and disease lists were provided by China to initiate the assessment in These were shown from supplementary searches of international scientific literature to be incomplete and a more comprehensive list was provided in A total of 120 pests were finally established as being associated with Ya pear in the proposed export areas.
- Australian scientists visited production areas and packing facilities in Hebei Province in 1994 to validate the pest status of the areas and to study crop management practices.
- Further technical information on the quarantine pests and their prevalence in the proposed export areas was provided by Chinese quarantine authorities during bilateral technical talks in 1996.
18 pests of Ya pear in Hebei were determined to be of quarantine concern to Australia.
- A pest risk assessment determined that these pests were either closely associated with pear fruit in the designated export areas and were likely to enter and become established in Australia if measures were not applied to prevent this, or
- their status in the proposed export areas was not well documented and evidence of absence was required to verify freedom from serious pests.
The risk assessment determined that most of the 18 pests had a wide host range and would cause signficant damage under Australian conditions if the pest became established. European pears and apples are widely grown commercially in all states in the south of Australia with production in excess of 300,000 tonnes per annum.
The entry pathway recognised that following clearance of the Australian border, there were no domestic constraints on the movement of the fruit (except into Western Australia where all pome fruits are prohibited entry by legislation pending a risk analysis by state authorities to review the legislation. WA maintains area freedom for black spot disease and Codling moth in accordance with the international standard for pest free areas (ISPM No.4))
The risk assessment considered factors such as pest biology, host range, pest distribution, entry potential, establishment potential, spread potential and economic impact in determining that only 18 of the 120 pests commonly associated with Ya pear were of quarantine concern to Australia.

7. Oriental fruit fly (Bactrocera spp.) - Trapping program to detect
Risk management
Oriental fruit fly (Bactrocera spp.) - Trapping program to detect
seasonal incursions
Brown rot (Monilinia fructigena) - Orchard freedom by survey plus
petal testing
Japanese pear rust (Gymnosporangium asiaticum ) - Host
removal to 2 km radius or chemical control and bagging of fruit
Pear scab (Venturia nashicola) - Early season petal test, orchard
survey fruit bagging, orchard hygiene and inspection and
certification
Risk management
Of the 18 quarantine pests, analysis determined that 11 could be managed through routine phytosanitary procedures including orchard control measures and inspection and certification practices.
Components to the management system include;
- orchard registration (for trace back purposes in the event that a quarantine pest is found),
- pest surveillance and management programs,
- placement of bags over developing fruit,
- post harvest grading and inspection, and
- phytosanitary certification of absence of quarantine pests.
Seven of the quarantine pests required additional specific management strategies due to their biological properties including their host range, potential impact and difficulty of detection.
Components additional to routine procedures include:
- monitoring and detection surveys
- area or orchard freedom status verified by surveillance
- testing for latent diseases (diseases that may occur without the expression of symptoms at harvest. Disease may develop as fruit ages or is removed from storage conditions)
The overhead lists specific measures for particular pests (examples and explanation given below, some are expanded upon in the next section addressing issues raised by stakeholders in response to the draft). Some measures may contribute towards managing a number of pests.
Oriental fruit fly (Bactrocera spp.) - Trapping program was required to verify that seasonal incursion had not occurred. There are insufficient domestic quarantine measures in place to prevent incursion of tropical fruit flies into pear production areas.

8. Brown rot (Monilinia fructigena) - Orchard freedom by survey plus petal testing. Petal testing is required to verify that the orchard is free from the disease when the host is most susceptible. Infected petals may result in fruit infected with latent disease that would not express until in Australia. The fungus produces masses of spores that would be impossible to contain if diseased fruit was found in imported consignments.
Japanese pear rust (Gymnosporangium asiaticum ) - Host removal to 2 km radius or chemical control and bagging of fruit. This fungus affects both pears and its alternative host the Juniper. Both hosts are required to complete the fungal life cycle and both are widespread in Australia. By preventing disease on alternate hosts and by bagging fruit, infection levels on imported fruit are kept very low.
Pear scab (Venturia nashicola) - Early season petal test, orchard survey fruit bagging, orchard hygiene and inspection and certification. This disease causes significant damage to fruit in infected orchards. As this disease is widespread in production areas in China, the measures require that orchard infection rates are low (as verified by the petal test) and that opportunities for fruit infection during the growing season are minimised. Orchard freedom is unachievable in practice, hence the requirement for effective orchard management. Fruit is required to be visibly free of disease symptoms at export inspection.

9. Final importation conditions
Orchards and packing facilities registered by Chinese quarantine authorities
Pest management measures applied
Measures to verify status of quarantine pests in place
Joint inspection and phytosanitary certification
Review of conditions after the first season of export
Final importation conditions (for Ya pears)
Fruit are to be sourced from orchards in designated export areas registered by the national Chinese quarantine authority (now known as China Inspection and Quarantine (CIQ). The regulatory section of CIQ is the State Administration for Entry-Exit Inspection and Quarantine of the People’s Republic of China (SAIQ) - formerly CAPQ)
Packed in registered packing houses within the export areas
Orchards tested for brown rot, black spot and pear scab with results to be provided to AQIS before trade is allowed for the year
Export orchards are to be subject to field sanitation and pest control measures for all quarantine pests
The required surveys to support pest free areas must be conducted by CIQ
Fruit must have bags placed over developing fruit to prevent entry of pests. Fruit with intact bags only are permitted for export to Australia
Joint inspection of harvested fruit fly Australian and Chinese quarantine inspectors
Inspection of export orchards by an Australian inspector to ensure that quarantine pests are adequately controlled.
An Australian plant pathologist will visit export areas in China in the first year of trade to survey for pests and audit annual disease survey data. AQIS reserves the right for an officer to visit China to conduct field surveys and undertake audits in subsequent years.
Fruit must be packed in new boxes and cartons. No packing material of plant origin is allowed.
Fruit must be free from leaves, stems and other material designated as trash
A phytosanitary certificate is signed by the AQIS pre-clearance officer with an additional declaration stating that the fruit was “produced and inspected under the ya pear arrangement between SAIQ and AQIS.”
AQIS reserves the right to examine certification and seals on arrival in Australia. Fruit that does not comply with AQIS requirements will be re-exported or destroyed.
The requirements must be reviewed at the end of the first season of export.

10. Issues raised in response to the Draft IRA
Status of fire blight in China
Orchard monitoring for fruit diseases
Latent fruit diseases
Pest occurrence/status
Fruit fly area freedom
Post harvest treatments
Issues raised in response to the Draft IRA
Feedback on the Draft IRA
- The IRA process allows for technical comment from stakeholders on the draft IRA. AQIS circulated the draft IRA for Ya pear to 70 stakeholders and received 23 written comments. This included 10 responses from industry groups representing Australian pome fruit growers, seven from Australian state departments of agriculture, two from Federal Government agencies and three from Australian research organisations. A response was also provided by the Chinese quarantine agency (SAIQ)
- Comments were consolidated into 50 issues that were addressed by AQIS in the final IRA.
The major issues raised by stakeholders include:
The reported presence in China of the serious apple and pear disease, fire blight
- International literature reported a number of outbreaks of this disease in particular regions of China through the 1920s and 30s and again in the 1950s. Chinese Quarantine authorities maintained that fire blight does not occur in China and that measures are in place to prevent its entry. Subsequent surveys of the proposed export areas by Chinese authorities and an Australian expert indicated that fire blight did not occur in the region for export to Australia.
Monitoring of orchards for brown rot, black spot and pear scab
- What is the efficacy of testing and the biological basis for the testing methodology and detection thresholds? Australian scientists assessed the technical information available in determining that petal tests were justified because of the lack of knowledge of the disease (because it is not present in Australia) or the potential for it to occur on mature fruit at harvest. These measures will be reviewed at the end of the first year of trade. If they are judged to be excessively restrictive on the basis of experience gained during orchard inspections and pre-export certification inspections these measures may be modified to an appropriate level. All IRAs carry a requirement for a review at the end of the first year of trade to evaluate the measures applied.
The occurrence of spores of the Japanese pear rust on fruit
- Chinese authorities were concerned at the measures required for pear rust and disputed the likely presence of spores on the fruit at harvest. AQIS requires that export orchards be free from this disease. There are reports that the disease can cause latent infection (infection that does not express symptoms and is therefore hidden) so there is potential for disease to escape detection during pre-export inspection. The validity of this measure will be subject reviewed at the end of the first export season.

11. Concerns over latent infections of fruit
- AQIS in the first year of trade required testing of samples of fruit under conditions that would allow diseases to show symptoms. This requirement has been reviewed and will not be required for subsequent years. AQIS scientists determined that due to a lack of scientific information to validate the risk posed by latent infection more stringent measures would be applied until the information was available.
Determination of pest status
- General feedback from stakeholders on the status of pests based on the information assessed by AQIS. Additional information was provided by China and by Australian stakeholders that allowed pest status to be reviewed on the basis of scientific evidence.
Area freedom status of the export area with regard to fruit flies
- Oriental fruit fly is recorded from southern China. It does not occur in the proposed export areas because harsh winters ensure that any seasonal incursions are eradicated (the tropical fruit flies cannot survive the sub-zero temperatures that occur through winter). AQIS was concerned that due to a lack of documented domestic quarantine arrangements seasonal incursions of the fruit fly could occur.
- AQIS required that fruit fly traps be placed in the export areas to demonstrate freedom from this pest. The trapping requirements are consistent with those implemented in Australia in support of area freedom from fruit flies. Australia recently eradicated an exotic tropical fruit fly from northern areas (papaya fruit fly) at a cost of more than $34 million. The potential impact of further incursions justify these measures.
Why were post harvest pest disinfestation treatments not considered
- Asian pears do not tolerate methyl bromide fumigation and deteriorate with a heat treatment. Cold treatments were unlikely to be effective against pests of a temperate host.
- It was considered that the system developed by AQIS, that incorporates current Chinese production practices, provides adequate protection against the introduction of the quarantine pests of concern to Australia with fruit imports.

12. Trade outcome No consignments rejected as a result of pests
78 containers of fruit (approximately 1700 tonne)
imported from late 1999 to early 2000
No consignments rejected as a result of pests
associated with the imported fruit
Trade outcome
Imports of Ya pear fruit from approved areas under the defined measures commenced in October 1999.
All fruit was pre-cleared by an AQIS inspector in China and was stored for subsequent shipment to Australia over a 5 month period.
78 containers of fruit (approximately 1700 tonne) were imported from late 1999 to early 2000
No consignments rejected as a result of pests associated with the imported fruit
(Not sure if you want to comment that fruit was initially retailed at $2.99 per kilo but that end of season prices dropped to $0.99 per kilo. Fruit quality became worse through the season.)

13. Science in support of Australian exports
ISPM No: 4 - Pest Free Areas
Similar to the OIE concept of regionalisation
Technical submission to support fruit fly free
status of south eastern Australia
Major trading partners accept produce from
fruit fly free area without treatment
Area freedom worth more than $70 million to
Australia p.a
Science in support of Australian exports
The use of scientific data and technical justification has been used to support Australian exports.
The best examples are the establishment and maintenance of areas of mainland Australia that are free from fruit flies.
ISPM No: 4 - Pest Free Areas was used as a guideline to the establishment, verification, maintenance and documentation of the fruit fly freedom of areas of inland New South Wales, Victoria and South Australia in southern Australia. The same principle has been applied to support fruit fly freedom for the island state of Tasmania.
The concept of pest free areas is practically synonymous with the OIE concept of regionalisation.
A technical submission to support fruit fly free status of south eastern Australia was prepared for trading partners. This provided the information needed to allow the potential importing country conduct a risk analysis and expedite pest free area recognition. (The information provided is outlined in the next slide).
Major trading partners accept produce from fruit fly free area without specific disinfestation treatment, although treatments are there as a contingency in the event that fruit flies are detected.
Area freedom status in southern Australia is worth more than $70 million to the region in exports per annum.

14. Technical data provided to verify:
The nature and status of the PFA
The systems that establish freedom
Phytosanitary measures that maintain freedom
Ongoing checks to verify freedom is
maintained
Ongoing documentation, audit and review of
the area
Technical data provided to verify:
The nature and status of the PFA
The systems that establish freedom
Phytosanitary measures that maintain freedom
Ongoing checks to verify freedom is maintained
Ongoing documentation, audit and review of the area
(We can provide a summary of a submission as background information if you think you will need this)

15. Differences between terrestrial animal and plant risk analysis:
There are more plant species in commercial
production world wide
Plants have more damaging pests
There is less quantitative data available for
scientific risk analysis
Pests have broader host ranges
Differences between terrestrial animal and plant risk analysis
There are more plant species in commercial production world wide
Plants have more damaging pests
There is less quantitative data available for scientific risk analysis
Pests have broader host ranges
(proceed with next slide)
The consequences of incursion are insidious (rarely cause widespread mortality)
Fewer international standards
Less experience in application of standards
Fewer plant health experts
Significant ongoing challenges
(I thought that these two slides are self explanatory, but could elaborate if necessary.)

16. The consequences of incursion are insidious
(rarely cause widespread mortality)
Fewer international standards
Less experience in application of standards
Fewer plant health experts
Significant ongoing challenges