Final Import Risk Analysis Report for Fresh Unshu Mandarin Fruit from Shizuoka Prefecture in Japan

Roles and responsibilities of other government agencies

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Roles and responsibilities of other government agencies

State and territory governments play a vital role in the quarantine continuum. Biosecurity Australia and PIAPH work in partnership with state and territory governments to address regional differences in pest and disease status and risk within Australia, and develop appropriate sanitary and phytosanitary measures to account for those differences. Australia’s partnership approach to quarantine is supported by a formal Memorandum of Understanding that provides for consultation between the Australian Government and the state and territory governments.

Depending on the nature of the good being imported or proposed for importation, Biosecurity Australia may consult other Australian Government authorities or agencies in developing its recommendations and providing advice.

As well as a Director of Animal and Plant Quarantine, the Act provides for a Director of Human Quarantine. The Australian Government Department of Health and Ageing is responsible for human health aspects of quarantine and Australia’s Chief Medical Officer within that Department holds the position of Director of Human Quarantine. Biosecurity Australia may, where appropriate, consult with that Department on relevant matters that may have implications for human health.

The Act also requires the Director of Animal and Plant Quarantine, before making certain decisions, to request advice from the Environment Minister and to take the advice into account when making those decisions. The Australian Government Department of the Environment, Water, Heritage and the Arts (DEWHA) is responsible under the Environment Protection and Biodiversity Conservation Act 1999 for assessing the environmental impact associated with proposals to import live species. Anyone proposing to import such material should contact DEWHA directly for further information.

When undertaking risk analyses, Biosecurity Australia consults with DEWHA about environmental issues and may use or refer to DEWHA’s assessment.

Australian quarantine legislation

The Australian quarantine system is supported by Commonwealth, state and territory quarantine laws. Under the Australian Constitution, the Commonwealth Government does not have exclusive power to make laws in relation to quarantine, and as a result, Commonwealth and state quarantine laws can co-exist.

Commonwealth quarantine laws are contained in the Quarantine Act 1908 and subordinate legislation including the Quarantine Regulations 2000, the Quarantine Proclamation 1998, the Quarantine (Cocos Islands) Proclamation 2004 and the Quarantine (Christmas Island) Proclamation 2004.

The quarantine proclamations identify goods, which cannot be imported, into Australia, the Cocos Islands and or Christmas Island unless the Director of Animal and Plant Quarantine or delegate grants an import permit or unless they comply with other conditions specified in the proclamations. Section 70 of the Quarantine Proclamation 1998, section 34 of the Quarantine (Cocos Islands) Proclamation 2004 and section 34 of the Quarantine (Christmas Island) Proclamation 2004 specify the things a Director of Animal and Plant Quarantine must take into account when deciding whether to grant a permit.

In particular, a Director of Animal and Plant Quarantine (or delegate):

  • must consider the level of quarantine risk if the permit were granted, and

  • must consider whether, if the permit were granted, the imposition of conditions would be necessary to limit the level of quarantine risk to one that is acceptably low, and

  • for a permit to import a seed of a plant that was produced by genetic manipulation – must take into account any risk assessment prepared, and any decision made, in relation to the seed under the Gene Technology Act, and

  • may take into account anything else that he or she knows is relevant.

The level of quarantine risk is defined in section 5D of the Quarantine Act 1908. The definition is as follows:

reference in this Act to a level of quarantine risk is a reference to:

(a) the probability of:

(i) a disease or pest being introduced, established or spread in Australia, the Cocos Islands or Christmas Island; and

(ii) the disease or pest causing harm to human beings, animals, plants, other aspects of the environment, or economic activities; and

  1. the probable extent of the harm.

The Quarantine Regulations 2000 were amended in 2007 to regulate keys steps of the import risk analysis process. The Regulations:

  • define both a standard and an expanded IRA,

  • identify certain steps, which must be included in each type of IRA,

  • specify time limits for certain steps and overall timeframes for the completion of IRAs (up to 24 months for a standard IRA and up to 30 months for an expanded IRA),

  • specify publication requirements,

  • make provision for termination of an IRA, and

  • allow for a partially completed risk analysis to be completed as an IRA under the Regulations.

The Regulations are available at

International agreements and standards

The process set out in the Import Risk Analysis Handbook 2007 is consistent with Australia’s international obligations under the SPS Agreement. It also takes into account relevant international standards on risk assessment developed under the International Plant Protection Convention (IPPC) and by the World Organisation for Animal Health (OIE).

Australia bases its national risk management measures on international standards where they exist and when they achieve Australia’s ALOP. Otherwise, Australia exercises its right under the SPS Agreement to apply science-based sanitary and phytosanitary measures that are not more trade restrictive than required to achieve Australia’s ALOP.

Notification obligations

Under the transparency provisions of the SPS Agreement, WTO Members are required, among other things, to notify other members of proposed sanitary or phytosanitary regulations, or changes to existing regulations, that are not substantially the same as the content of an international standard and that may have a significant effect on trade of other WTO Members.

Risk analysis

Within Australia’s quarantine framework, the Australian Government uses risk analyses to assist it in considering the level of quarantine risk that may be associated with the importation or proposed importation of animals, plants or other goods.

In conducting a risk analysis, Biosecurity Australia:

  • identifies the pests and diseases of quarantine concern that may be carried by the good

  • assesses the likelihood that an identified pest or disease or pest would enter, establish or spread

  • assesses the probable extent of the harm that would result.

If the assessed level of quarantine risk exceeds Australia’s ALOP, Biosecurity Australia will consider whether there are any risk management measures that will reduce quarantine risk to achieve the ALOP. If there are no risk management measures that reduce the risk to that level, trade will not be allowed.

Risk analyses may be carried out by Biosecurity Australia’s specialists, but may also involve relevant experts from state and territory agencies, the Commonwealth Scientific and Industrial Research Organisation (CSIRO), universities and industry to access the technical expertise needed for a particular analysis.

Risk analyses are conducted across a spectrum of scientific complexity and available scientific information. An IRA is a type of risk analysis with key steps regulated under the Quarantine Regulations 2000. Biosecurity Australia’s assessment of risk may also take the form of a non-regulated analysis of existing policy or technical advice to AQIS. Further information on the types of risk analysis is provided in the Import Risk Analysis Handbook 2007.

Appendix D: Distribution of Japanese orange fly in Japan

Japan advised in 2008 that Japanese orange fly (Bactrocera tsuneonis) occurs in the Kumamoto, Oita, Miyazaki and Kagoshima Prefectures on Kyushu Island (Figure D1). It is also distributed on Tanegashima Island, Yakushima, Kuchinoerabujima, Nakanoshima and Amami Islands to the south of Kyushu Island, and in Taiwan, Vietnam and southern China. The species has never been reported in the Shizuoka Prefecture.

Figure D1: Distribution of Bactrocera tsuneonis on Kyushu Island, Japan

Export areas at Fujieda City on Honshu Island

Kyushu Island; the prefectures positive for

B. tsuneonis are highlighted

The USA, as of March 2004, imports fresh unshu mandarin from Japan from Honshu, Shikoku and specified Prefectures on Kyushu Island (i.e. Fukuoka, Kumanmoto, Nagasaki, and Saga, only). The export areas on Kyushu Island are also subject to monitoring for Japanese orange fly as the species is present in specified areas on the island (APHIS 2004; US Electronic Code of Federal Regulations 2008).

Unshu mandarins from Shikoku and specified Prefectures on Kyushu Island (i.e. Fukuoka, Kumanmoto, Nagasaki, and Saga, only) may be imported through authorised ports in the USA,

  • subject to methyl bromide fumigation into any area of the Unites States, except for American Samoa, the Northern Mariana Islands, Puerto Rico, and the US Virgin Islands; or

  • without methyl bromide fumigation into all States other than citrus producing States (i.e. Texas, Arizona, Florida, California, Louisiana, Hawaii) aside from American Samoa, the Northern Mariana Islands, Puerto Rico, and the US Virgin Islands (US Electronic Code of Federal Regulations 2008).

Methyl bromide fumigation is carried out at a rate of 3 lbs./1,000 cu. ft. for 2 hrs at 59ºF or above at normal atmospheric pressure (chamber only) with a load factor of 32% or below (US Electronic Code of Federal Regulations 2008).

Japan has a fruit fly monitoring program in place within and near the production area at Fujieda City. Each fruit fly monitoring site, of which there are 12, consist of one protein trap, one methyl eugenol and one cuelure trap. Japan advised that traps are installed on a 2 km grid. Protein trap lure replacement and trap clearances are on a fortnightly basis. No B. tsuneonis has been reported since monitoring for this fruit fly commenced in 2001. The location of the trapping grid is shown in Figure D2, below.

The coordinates for each of the trap installation sites near Fujieda City are:

Longitude Latitude

    Trap 1: E 138.13497 N 34.56323

    Trap 2: E 138.13463 N 34.55306

    Trap 3: E 138.13488 N 34.54260

    Trap 4: E 138.14568 N 34.54061

    Trap 5 E 138.15035 N 34.55134

    Trap 6 E 138.14371 N 34.56101

    Trap 7 E 138.12387 N 34.57282

    Trap 8 E 138.12387 N 34.57160

    Trap 9 E 138.12187 N 34.56155

    Trap 10 E 138.12184 N 34.55086

    Trap 11 E 138.12593 N 34.55542

    Trap 12 E 138.13545 N 34.55014

Figure D2: Trap installation points for Bactrocera tsuneonis monitoring both within and near the production area at Fujieda City

Appendix E: Distribution of citrus greening and citrus psyllid in Japan

Under Japanese plant protection law, both citrus greening (Candidatus Liberibacter asiaticum) and its vector, the Asian citrus psyllid (Diaphorina citri), are subject to movement restrictions. In 2003 Japan advised that movement of the pest and disease from regions where they occur is prohibited, and the movement of host material is restricted.

Since April 2007, a movement ban for citrus greening host commodities is in place for all areas south of latitude 27º 58N (i.e. all islands south of the Amami Oshima island group and including Kikai Island). In 2007 Japan advised that citrus greening on Kikai Island is currently undergoing eradication (refer to Figure E1). These islands are situated to the south of Kyushu Island and are about 1000 km to the south of the designated unshu mandarin export areas to Australia on Honshu Island.

While citrus greening is confined to the control zone, its vector, the Asian citrus psyllid occurs naturally throughout the chain of islands to the south of Kyushu Island including islands to the north of the citrus greening control zone (Kohno et al. 2002). However, Japan advised that the psyllid does not occur on the islands of Honshu, Kyushu or Hokkaido.

Figure E1: Japan’s transport regulations in relation to citrus greening (as of April 2007)

Appendix F: Monitoring for citrus canker in the Shizuoka Prefecture

The Shizuoka Prefecture is part of the National Pest Outbreak Forecasting Program that undertakes pest and disease forecasting for specified agricultural crops, including unshu mandarins and other mid-season citrus. The National Pest Outbreak Forecasting Program operates under Japan’s Plant Protection Law and Regulations relevant to Plant Quarantine of 1950 (version 1 April 1997). These regulations refer to Japan’s legislation pertaining to inspection, movement of plants and plant material, emergency control of pests and pest forecasting for high risk designated pests (Chapters 3, 4 and 5 of Japan’s Plant Protection Law), which must be adhered to by all Prefectures to keep Japan free of, or to control, these pests.

Chapter 6 of Japan’s Plant Protection Law provides a list of injurious animals and plants for which Prefectural governments have special powers to ensure freedom from (or control of) those pests that are of concern to a particular Prefecture. This list includes citrus canker.

The Prefectural Pest Forecasting Program is based on 30 sentinel inspection points where specified pest and disease levels are regularly monitored. The sentinel inspection points consist of 10 sites each in the eastern (Numatzu City), central (Shizuoka City) and western (Hamamatzu City) districts within the Prefecture. Japan advised that the two closest inspection points in relation to the designated export areas are Shizuoka City and Numatzu City, which of both of which are 25–50 km from the export areas.

The Pest Forecasting Program for citrus canker at the Shizuoka Prefectural level consists of monthly monitoring during the growing season from March to October. Each month a combined, random sample of 100 leaves (old leaves and new leaves) and fruit is collected from one citrus tree at each of the 30 sentinel stations. This sampling is conducted for two categories of citrus: unshu mandarins and other mid-season citrus. The following equation is used for obtaining monthly statistics that report on the absence/presence of citrus canker from unshu mandarin and other mid-season citrus at the Prefecture level:

100 x 7A + 5B + 3C + D10

7 x leaf No

A = 21 and more lesions/leaf (or fruit)

B = 11–20 lesions per/leaf (or fruit)

C = 4–10 lesions/leaf (or fruit)

D = 1–3 lesions/leaf (or fruit)

at the 30 monitoring points.

Forecasting information is issued once per month and covers the status of the pest, the predicted level of an emerging pest, and evidence and proportion of fields (orchards) requiring controls. Forecasting information will include information on how to control the pest (e.g. pesticide dosage and timing). This information is disseminated speedily and appropriately to institutions, organisations and stakeholders that engage in the planning, provision of guidance and publicising of controls, to the national government offices in the affected prefecture and surrounding prefectures.

In addition, MAFF officers monitor unshu mandarin orchards exporting fruit from four designated export areas near Fujieda City to the USA and New Zealand twice through the production cycle. Monitoring is conducted after petal fall and prior to harvest.

MAFF inspectors inspect half of all orchards after petal fall and the other half of the orchards at the pre-harvest inspection, which includes inspection of export orchards and buffer orchards. MAFF assistant inspectors inspect the other half of orchards after petal fall and at pre-harvest. Within each orchard 30% of all unshu trees are inspected at random at both the after petal fall and the pre-harvest inspection.

The pre-harvest inspection for the USA consists of a joint field inspection of MAFF and the Animal and Plant Health Inspection Service (APHIS) personnel. According to information provided by Japan, there has been no detection of citrus canker in the export areas since trade in unshu mandarins commenced to the USA in 1968. New Zealand does not require a joint field inspection.


Term or abbreviation


Additional declaration

A statement that is required by an importing country to be entered on a phytosanitary certificate and which provides specific additional information on a consignment in relation to regulated pests (FAO 2008).

Appropriate level of protection (ALOP)

The level of protection deemed appropriate by the Member establishing a sanitary or phytosanitary measure to protect human, animal or plant life or health within its territory (WTO 1995).


An officially defined country, part of a country or all or parts of several countries FAO 2006.

Area of low pest prevalence

An area, whether all of a country, part of a country, or all parts of several countries, as identified by the competent authorities, in which a specific pest occurs at low levels and which is subject to effective surveillance, control or eradication measures FAO 2006.

Biosecurity Australia

A prescribed agency within the Australian Government Department of Agriculture, Fisheries and Forestry. Biosecurity Australia provides science-based quarantine assessments and policy advice that protects Australia’s favourable pest and disease status and enhances Australia’s access to international animal and plant related markets.


A quantity of plants, plant products and/or other articles being moved from one country to another and covered, when required, by a single phytosanitary certificate (a consignment may be composed of one or more commodities or lots) FAO 2006.

Unshu mandarin fruit covered by one phytosanitary certificate shipped via one port in Japan to a designated port in Australia.

Control (of a pest)

Suppression, containment or eradication of a pest population FAO 2006.

Endangered area

An area where ecological factors favour the establishment of a pest whose presence in the area will result in economically important loss FAO 2006.

Entry (of a pest)

Movement of a pest into an area where it is not yet present, or present but not widely distributed and being officially controlled FAO 2006.


Perpetuation, for the foreseeable future, of a pest within an area after entry FAO 2006.


Living; not dried, deep-frozen or otherwise conserved FAO 2006.

Fruits and vegetables

A commodity class for fresh parts of plants intended for consumption or processing and not for planting FAO 2006.

Host range

Species capable, under natural conditions, of sustaining a specific pest or other organism FAO 2006.

Import Permit

Official document authorising importation of a commodity in accordance with specified phytosanitary import requirements FAO 2006.

Import Risk Analysis

The assessment of the level of risk associated with the importation, or proposed importation, of animal, plants or other goods and, where necessary, the identification of risk management options to limit the level of quarantine risk to one that is acceptably low (Quarantine Act 1908).

Infestation (of a commodity)

Presence in a commodity of a living pest of the plant or plant product concerned. Infestation includes infection FAO 2006.


Official visual examination of plants, plant products or other regulated articles to determine if pests are present and/or to determine compliance with phytosanitary regulations FAO 2006.

Intended use

Declared purpose for which plants, plant products, or other regulated articles are imported, produced, or used FAO 2006.

Interception (of a pest)

The detection of a pest during inspection or testing of an imported consignment FAO 2006.

International Standard for Phytosanitary Measures (ISPM)

An international standard adopted by the Conference of the Food and Agriculture Organization, the Interim Commission on phytosanitary measures or the Commission on phytosanitary measures, established under the IPCC FAO 2006.


The entry of a pest resulting in its establishment FAO 2006.


A number of units of a single commodity, identifiable by its homogeneity of composition, origin etc., forming part of a consignment FAO 2006.

All unshu mandarin fruit packed for export to Australia each day by a registered packing house.

National Plant Protection Organization (NPPO)

Official service established by a government to discharge the functions specified by the International Plant Protection Convention FAO 2006.

Official control

The active enforcement of mandatory phytosanitary regulations and the application of mandatory phytosanitary procedures with the objective of eradication or containment of quarantine pests or for the management of regulated non-quarantine pests FAO 2006.


Any means that allows the entry or spread of a pest FAO 2006.


Any species, strain or biotype of plant, animal, or pathogenic agent injurious to plants or plant products FAO 2006.

Pest categorisation

The process for determining whether a pest has or has not the characteristics of a quarantine pest or those of a regulated non-quarantine pest FAO 2006.

Pest Free Area (PFA)

An area in which a specific pest does not occur as demonstrated by scientific evidence and in which, where appropriate, this condition is being officially maintained FAO 2006.

Pest free place of production

Place of production in which a specific pest does not occur as demonstrated by scientific evidence and in which, where appropriate, this condition is being officially maintained for a defined period FAO 2006.

Pest free production site

A defined portion of a place of production in which a specific pest does not occur as demonstrated by scientific evidence and in which, where appropriate, this conditions is being officially maintained for a defined period and that is managed as a separate unit in the same way as a pest free place of production FAO 2006.

Pest Risk Analysis (PRA)

The process of evaluating biological or other scientific and economic evidence to determine whether an organism is a pest, whether it should be regulated, and the strength of any phytosanitary measures to be taken against it FAO 2006.

Pest risk assessment (for

quarantine pests)

Evaluation of the probability of the introduction and spread of a pest and the magnitude of the associated potential economic consequences (FAO 2008).

Pest risk management (for

quarantine pests)

Evaluation and selection of options to reduce the risk of introduction and spread of a pest FAO 2006.


The measure of the acidity or alkalinity of a solution.


Plant meristem (growth layer) responsible for secondary growth of a corky protective layer.

Phytosanitary Certificate

Certificate patterned after the model certificates of the IPPC FAO 2006.

Phytosanitary measure

Any legislation, regulation or official procedure having the purpose to prevent the introduction and/or spread of quarantine pests, or to limit the economic impact of regulated non-quarantine pests FAO 2006.

Phytosanitary regulation

Official rule to prevent the introduction and/or spread of quarantine pests, or to limit the economic impact of regulated non-quarantine pests, including establishment of procedures for phytosanitary certification FAO 2006.


Feeding on a relatively large number of hosts from different genera.

PRA area

Area in relation to which a Pest Risk Analysis is conducted FAO 2006.

Quarantine pest

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 FAO 2006.

Regulated article

Any plant, plant product, storage place, packing, conveyance, container, soil and any other organism, object or material capable of harbouring or spreading pests, deemed to require phytosanitary measures, particularly where international transportation is involved FAO 2006.

Restricted risk

Risk estimate with phytosanitary measure(s) applied.


Expansion of the geographical distribution of a pest within an area FAO 2006.

SPS Agreement

WTO Agreement on the Application of Sanitary and Phytosanitary Measures (WTO 1995).


Government agencies, individuals, community or industry groups or organizations, whether in Australia or overseas, including the proponent/applicant for a specific proposal, who have an interest in the policy issues.

Systems approach(es)

The integration of different risk management measures, at least two of which act independently, and which cumulatively achieve the appropriate level of protection against regulated pests FAO 2006.

Unrestricted risk

Unrestricted risk estimates apply in the absence of risk mitigation measures.

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