Risk analysis

Question 1

Risk analysis - aim, major steps (4)

Answer 1

Principal aim of import risk analysis is to provide importing countries with an objective and defensible method of assessing the disease risks associated with the importation of animals/products/genetic material etc.

Steps:

1. Hazard identification (I)
2. Risk assessment (A-EECR)
3. Risk management (M)
4. Risk communication (C)

Question 2

Hazard identification - definition, considerations (3)

Answer 2

Involves identifying pathogens (and pests) that could be introduced with the importation of the commodity

Considerations:

1. Species being imported
2. Current disease status of exporting country (OIE) vs importing country (including strain differences)
3. Whether disease is notifiable or subject to control or eradication in the importing country

Question 3

Risk assessment - definition, steps (4)

Answer 3

Assessment of the likelihood of an event occurring and the consequences of that event occurring e.g. likelihood and biological/economic consequences of entry, establishment and spread of disease. At each step, the risk question should be carefully framed and risk pathways elaborated (e.g. using scenario trees) to identify any data needs.

Steps (completed in step-wise fashion):

1. Entry (release) assessment [risk of introduction] - biological pathways necessary and probability of entry via each pathway. Considers biological factors (signalment of animals, vaccine status), country factors (incidence, veterinary services in exporting country), commodity factors (quantity, ease of contamination, effect of processing/ storage/transport)
2. Exposure assessment [risk of exposure to domestic herd/humans] - biological pathways necessary and probability of exposure via each pathway. Considers biological factors (agent), country factors (presence of vectors, cultural practices, geography) and commodity factors (quantity, intended use, disposal)
3. Consequence assessment - potential consequences of given exposure and probability of them occurring. Considers: direct consequences (animal disease and production losses, public health) and indirect consequences (surveillance/control costs, compensation costs, potential trade losses, environmental consequences)
4. Risk estimation - integrates results from entry/exposure/consequence assessment to produce overall measure

Question 4

Risk management - definition, steps (4)

Answer 4

Process of deciding and implementing measures to achieve Members’ ALOP while also minimizing negative effects on trade.

Steps:

1. Risk evaluation - compare risk estimated from risk assessment with Member’s ALOP
2. Option evaluation - identify, evaluate efficacy and feasibility of and select measures associated with importation in order to bring it into line with Member’s ALOP. According to SPS Agreement, international standards of OIE are the preferred choice of sanitary measures.
3. Implementation
4. Monitoring and review

Question 5

Risk communication - process (2), stakeholders, features

Answer 5

Process in which:

1. information on hazards and risks are gathered from stakeholders; and
2. results of risk analysis are communicated back to stakeholders.

Stakeholders include authorities in exporting country, domestic and foreign industry groups, domestic producers and consumer groups. Should be open, interactive, iterative and transparent.

Question 6

Qualitative risk analysis - strengths (3), weaknesses (3)

Answer 6

OIE definition: assessment where the outputs on the likelihood of the outcome or the magnitude of the consequences are expressed in qualitative terms such as ‘high’, ‘medium’, ‘low’ or ‘negligible’.

Often first step in risk assessment, used when numerical data is not available or when the risks perceived do not justify the time and effort required for a quantitative risk assessment.

Strengths:

• No not require evidence (data)
• Cheaper
• Faster

Weaknesses:

• Less accurate (subjective)
• Difficult to prioritize risks
• Difficult to monitor risk management objectively

Question 7

Quantitative risk analysis - strengths (3), weaknesses (3)

Answer 7

OIE definition: assessment where the outputs of the risk assessment are expressed numerically.

Monte Carlo simulation is most commonly used (e.g. @Risk software).

Strengths:

• More accurate (objective)
• Risk management can be tracked objectively
• Easier to prioritize risks

Weaknesses:

• Require evidence (data)
• Expensive
• Time-consuming

Question 8

Import risk analysis (IRA) - Biosecurity Australia background (3)

Answer 8

IRAs are undertaken by Biosecurity Australia when:

1. Relevant risk management measures have not been established; or
2. Likelihood and/or consequence of entry, establishment and spread could differ from those previously assessed.

Basic steps of import risk analysis (IRA):

1. Identify pests/diseases of quarantine concern that may be carried by the good (hazard identification);
2. Assess the the likelihood that that an identified pest/disease would enter, establish or spread and probable extent of the harm that would result (risk assessment).
3. If assessed level of quarantine risk exceeds Australia’s Appropriate Level of Protection (ALOP), then Biosecurity Australia will consider whether there are any risk management measures that will reduce quarantine risk to achieve the ALOP. Risk management measures recommended in the risk analysis will often become conditions imposed on import permits. If there are no risk management measures that reduce the risk to that level, trade will not be allowed.

Question 9

Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) - key principles (3), other principles (6)

Answer 9

Under the SPS Agreement, Members have the right to adopt SPS measures to achieve their self-determined ALOP provided the the measures:

1. Are applied only to the extent necessary to protect life or health
2. Are based on scientific principles and not maintained whithout sufficient scientific evidence (except emergency/provisional measures
3. Do not unjustifiably discriminate between national and foreign or among foreign sources of supply (i.e. must avoid disguised restrictionism)

Members can show that their measures are based on science by using:

1. International standards and guidelines (Codex Alimentarius Commission for food; OIE/Terrestrial Animal Health Code for animal diseases; International Plant Protection Convention for plants); or
2. Scientific risk assessment procedures

Other principles:

1. Equivalence - Members will accept SPS measures of other Members as being equivalent if the exporting Member can demonstrate that it achieves the same level of protection as expected by the importing Member
2. Consistency - Members must avoid unjustifiable differences in the level of health protection they require in different situations, if such differences result in discrimination or a disguised restriction on international trade;
3. Regionalization - Members must recognize disease free areas. It is the exporting Member’s burden to prove the disease-free status that it claims for the region, and the exporting Member is obligated to grant access to the importing Member for investigation of the claim
4. Provisional measures - provisional measures can be taken when there is insufficient scientific evidence to permit a final decision on the safety of a product or process. In such cases, measures can be adopted on the basis of the available pertinent information about the health risk(s) of a product or process.
5. Control, inspection and approval - Should not themselves serve as barriers. Any such procedures should not be less favourable for imported products than they are for domestic goods, and should be no more than what is necessary to ensure compliance.
6. Transparency - Members will ensure that relevant SPS regulations are published and available Deals more with disease/additives/contaminants - things that directly impact health.

In other words, Members may introduce SPS measures which result in a higher level of protection than achieved by international standards however, these measures must be based on scientific risk assessment, consistently applied across Members, and not more trade restrictive than necessary.

Question 10

Appropriate Level of Protection (ALOP) - definition

Answer 10

Level of protection deemed appropriate by Member establishing an SPS measure to protect human, animal and/or plant life within its territory. Note that OIE refers instead to “acceptable level of risk” [figure]. There is some contention regarding the similarity/dissimilarity of these terms.

Question 11

Risk analysis - example in animal importation (rhino from Africa)

Answer 11

1. Hazard identification: identify diseases of rhino. Short list might involve consultation with OIE List A/B diseases, consideration of other disease in exporting region, scientific literature (including serology, strain differences). Dismiss diseases which are endemic/not under control in Australia (e.g. anthrax), diseases which are not present in exporting country/zone. Leads to short list which requires further assessment of risks. Might include diseases like FMD, African horse sickness, Rift Valley fever, bovine tuberculosis and heartwater.
2. Risk assessment: (1) Entry assessment: considers things like susceptibility of rhino to disease, likeilihood of exposure prior to export, pre-export procedures (quarantine, testing, contact with other animals), natural history of infection (transient vs prolonged viremia); (2) exposure assessment: considers things like presence of competent vectors (RVF, heart water), likelihood of rhino being released (negligible) or coming into contact with other animals; (3) consequence assessment: considers impact of infectoin were pathogen to enter and spread (trade restrictions, losses related to production/control, distruction to industry activities)
3. Risk managment: if risk is non-negligible or consequences severe then risk management activities are needed and may include serological or other testing during pre-export quarantine, vaccination, sourcing of animals from free areas during non-transmission season (RVF), treatment with ectoparaciticides (ticks - heart water)