Import Risk Analysis

Table 1 Risk estimation matrix

Margaret Leggoe.
Biosecurity Australia, Agriculture, Fisheries and Forestry Australia, GPO Box 858, Canberra, ACT, 2601.

Acronyms
AQIS - Australian Quarantine and Inspection Service
IRA - Import Risk Analysis
WTO - World Trade Organization
SPS - Sanitary and Phytosanitary Agreement
SPS measures - measures to protect a country against the introduction of unwanted pests and disease.
ALOP - appropriate level of protection.

Introduction
Although non-domestic animals have been kept in captivity for scientific and education purposes for many years, there is increasing interest in keeping unusual pets by private individuals. If animals, for whatever purpose, must be imported into Australia, Biosecurity Australia must first determine whether the importation is likely to lead to the introduction, establishment and spread of an unwanted disease or pest.

Biosecurity Australia has a structured process to ensure that such an importation is investigated thoroughly, and that all concerned persons have the opportunity to contribute to the process. This is called an Import Risk Analysis (IRA), and is the topic I am going to address. At this point, I must make it perfectly clear that I am not a reptile or amphibian specialist, and if any of you have questions regarding specific diseases of these animals, I would ask that you give me your names and email address, and I shall have them answered by someone qualified to do so. I must also point out that my brief is to present matters of quarantine interest only, and that Environment Australia, and equivalent State Government departments, will be discussing matters relating to the environment.

Policy development and review
Prior to 1998, certain pieces of quarantine legislation prohibited the importation of named species of animals. In 1998, a new Proclamation, replacing a host of smaller Proclamations, removed the prohibition on named species of animals. That is not to say that environmental legislation, under other Acts of Parliament, does not still have such provisions. However, the importation of any live animals (with very limited exemptions) cannot take place without an import permit from the Australian Quarantine and Inspection Service (AQIS).

WTO/SPS
Australia is a member of the World Trade Organization (WTO), and therefore bound by the requirements of the Sanitary and Phytosanitary (SPS) Agreement. This agreement requires that Member Countries, when applying SPS measures only use measures based on scientific principles and/or internationally accepted standards. When a country feels the need to apply a more stringent measure, this must be scientifically justifiable.

Who does what
Biosecurity Australia conducts an Import Risk Analysis (IRA) to determine what diseases and pests might be introduced by the importation of a species of animal. For exotic animals, a whole family is generally dealt in a single IRA. The IRA then determines what quarantine requirements must be met for an importation to safely take place. AQIS issues import permits for individual animals. They may supervise the pre-export quarantine requirements in an overseas country in addition to supervising quarantine on arrival in Australia. Environment Australia issues import permits for non-domestic animals, which the following speaker will address.

Initiation of Import Risk Analysis (IRA)
An Import Risk Analysis is conducted when there is a demonstrated desire to import an animal, and there is no existing protocol for such an importation. This could apply to a species of animal not previously imported, or the importation of a common species of animal from a new country whose animal health status is not well understood. A generic import risk analysis covers the possibility of an animal being imported from any country. An IRA may also be conducted for animals already being imported if new disease information comes to hand, or the animal health status in an exporting country changes.

Stakeholder notification
Stakeholders are contacted on several occasions while an IRA is in progress. At present, the following regime is followed for IRAs.
a) Stakeholders are advised of the proposal to import;
b) Stakeholders are consulted on the approach to the IRA, i.e. whether a risk analysis panel comprising outside specialists is used, or whether it is conducted “in house”, seeking outside advice as the need arises;
c) Stakeholders are advised on the approach adopted;
d) Stakeholders receive a copy of an issues paper and are invited to comment. This is essentially a list of all the disease agents known to be associated with that commodity or animal;
e) Stakeholders receive a copy of the draft IRA report and are invited to comment;
f) Stakeholders are sent a copy of the final IRA report. There is an opportunity to appeal against the process.
g) Stakeholders are advised when the recommended quarantine measures are adopted.
In responding to the drafts received, stakeholders should raise technical issues on receipt of the issues paper and draft IRA report. Appeals against the IRA process itself may be lodged to within 30 days of publication of the IRA final. A new handbook detailing the full process is in preparation, and the latest draft is available through this website: www.affa.gov.au
In the case of reptiles, a notification was sent to stakeholders in 1997 advising the approach would be an in-house IRA. In 1998 advice was sent to stakeholders that crocodiles would be examined as a group first, and other groups within Reptilia would follow. The IRAs for live crocodiles and crocodile meat were completed last year. Snakes are next in line.

How to become a Stakeholder
You may become a stakeholder by filling in the application form and posting it to
Mr Warren Vant,
Biosecurity Australia
GPO Box 858
Canberra, ACT, 2601
The form is available on:
Form and click on “register as a stakeholder”.
Or by contacting me on:
email: margaret.leggoe@aqis.gov.au or by phone on 02 6971 6557.

I would advise that you only tick the areas of special interest to yourself, otherwise you will be deluged with mail. I hope that many of you will register as stakeholders and reply to the notifications and drafts you receive. This will help us to understand the amount of interest there is in reptile importation, and the most popular species and countries of origin involved. It will also improve our understanding of your problems and needs.

Hazard identification
The scientific work of an IRA begins with the hazard identification. The aim is to list all disease agents and parasites that may be present in or on the imported animal, and to decide whether they should be subjected to a detailed analysis. Those that are selected for a detailed analysis, i.e. Risk Assessment, must satisfy these criteria:
a) have the potential to cause harm to humans, animals or the environment;
b) not be endemic in Australia, or if endemic there must be official control programs in place for the agent;
c) it could be carried in or on the live animal for export; and
d) it is, or may be, present in the exporting country.
For example, if a parasite were common in snakes in all countries of the world, including Australia, and had not been associated with ill health in these or other animals, it would not be considered a potential hazard. If a disease agent had been associated with sickness and death in snakes overseas, and it was not known whether the agent was endemic in Australia or was known to be exotic, it would be subjected to a detailed risk assessment.

Risk Assessment
In the risk assessment, we put together all the available information in a structured manner. The information we use is generally sourced from reputable refereed literature, as opposed to unsubstantiated statements and hearsay as can be found so readily on the Internet.
Expert opinion from specialists in their field, both within and outside Australia is also sought. Biosecurity Australia acknowledges that when assessing disease agents of concern for non-domestic animals there are many gaps in available knowledge. Where information falls short of what is required for a full assessment, a conservative approach is adopted.
The types of information that are relevant to a risk assessment are:
a) Nature of the agent, e.g. is it a parasite requiring 2-3 hosts to complete its life cycle; or a virus spread by contact; does it remain viable in the environment; or require intimate contact between one host and the next for transmission?
b) Host range and the potential for other species to become infected (not always predictable).
c) Pathogenesis, i.e. the process by which the agent causes harm to the host. Does it cause chronic disease with lifetime infection, or does it run a short course from which the animal makes a complete recovery?
d) Mode of transmission is important, for example in the case of Leishmaniasis, it appears that no vector for transmission of the agent is present in Australia.
e) The likelihood of introduction of the agent.
f) The likelihood of establishment and spread following introduction of an agent. This would depend on factors such as the likelihood of a native or local animal having contact with the imported animal or to an agent it has introduced. Ticks and insect vectors may also be involved in spread of some agents.
g) The consequences of introduction, establishment and spread. This section evaluates the socio-economic and environmental consequences that could be expected if the disease were to spread to native fauna, domestic animals or man. A range of scenarios are possible, ranging from extreme consequences on a national scale, to insignificant consequences in the case of an agent that was a non-pathogenic commensal.
Having said all of that, we are acutely aware that, in dealing with non-domestic animals, we not looking at blank gaps in information, but rather, snippets of information between the blanks. A conservative approach is usually adopted. For each agent considered a quarantine risk, we apply a matrix to determine whether the proposed import should be allowed without quarantine measures, or only after the application of quarantine measures. Quarantine measures are applied when the unrestricted importation of the animal would not meet Australia’s appropriate level of protection.

Take, for example, a disease agent that has the potential for extreme socio-economic effects, and, in the absence of any quarantine measures, there is a low likelihood of that the agent would enter and be exposed to susceptible animals in Australia. By applying the matrix, it can be seen that the overall risk is high. This importation would not be permitted until quarantine measures had been introduced that would reduce the risk of entry and exposure to a negligible level.

Quarantine measures
Quarantine measures, when applied, must be appropriate for the disease agent in question and the species of animal being imported. Types of measures that may be considered:
- Source animals from a country or institution free from the disease. This is only applicable to disease agents that are subjected to formal reporting in the country of origin, i.e. notifiable diseases. This mainly applies to infectious diseases of farm animals.
- Tests for a disease agent must be reliable. A test developed on one species may be less reliable when used on other species. The disease agent must be detectable at all stages of infection. Otherwise repeated tests are necessary. For example, some blood parasites are only periodically detectable.
- Treat animals for the disease agent. This is a reasonable measure for agents that are eliminated by a particular drug. It is not used for quarantine purposes where the drug produces a clinical improvement in the animal without eliminating the carrier state. - Vaccination is effectively used against some diseases. It is not used if the vaccine masks the detection of carrier animals, or is made from live virus that could itself become virulent. Neither is it used unless it produces a very high rate of protection against the disease.
- Pre- and post-export quarantine periods are designed to detect diseases that have a relatively short incubation period and are likely to be expressed as clinical disease in the host animal. Pre-export quarantine also prevents the exposure of the animal for export to infectious agents close to the time of export. In some instances, sentinel animals, i.e. those more susceptible to the disease, may be placed with the quarantined animals as an aid to the detection of some disease agents.

Only when Biosecurity Australia and is satisfied that that quarantine measures appropriate for the identified agents of concern have been developed, will the IRA be finalised, and importations begin.