Whatever can go wrong, will go wrong. Murphy’s Law

What is Pathogen Risk Analysis? A standardized, systematic & defensible method of assessing the risk associated with the movement (importation) of a commodity A mechanism for an importing country to separate the important (unacceptable) risks from the unimportant (acceptable) risks. (i.e. a coping mechanism) For aquatic animal movements, it is:

What is Import Risk Analysis? Import risk analysis (IRA) is an internationally accepted, standard method for deciding whether trade in a particular commodity poses a significant risk to human, animal or plant health, and, if so, what measures (if any) can be applied to reduce that risk to an acceptable level.

Import Risk Analysis Framework

Historical Aspects Risk analysis for aquatic animals is a relatively new concept First formal RAs conducted by Australia & New Zealand on salmonid imports between General principles for RA set out in OIE’s Aquatic Animal Health Code To date, only about 19 formal risk analyses have been conducted for aquatic animal commodities.

Formal Risk Analyses Finfishes (11) Salmonids – 2 (non-viable) Salmonids & nonsalmonids – 1 (non-viable) Tilapia – 1 (non-viable) Pangasius catfish– 1 (non-viable) Yellowtail kingfish – 1 (live) Menhaden – 1 (non-viable) Freshwater finfishes – 1 (non-viable) Pilchards VHSV – 1 (non-viable) Ornamentals – 2 (live)

Formal Risk Analyses Molluscs (2) Marine bivalves - 1 (non-viable) Pacific oyster - 1 (live) Crustaceans (5) Penaeid shrimp – 2 (1 non-viable, 1 live) Freshwater prawns- 2 (1 non-viable, 1 live) Freshwater crayfish -1 (non-viable) Other invertebrates (fish food) (1, non-viable)

Formal Risk Analyses Live AnimalsNon-viable Product Fish 38 Molluscs 11 Crustaceans 2 3 Other -1 Totals 613

Formal Risk Analyses Australia and New Zealand are responsible for most of the formal risk analyses conducted. In one case, a regional agency (Secretariat of the Pacific Community) supported two risk analyses to provide model risk analyses for use by its member countries. Most risk analyses involve movements of a single commodity – however, a few attempts have been made to analyze commodity categories (e.g. ornamentals, marine finfish).

Formal Risk Analyses Two-thirds of the risk analyses have focused on movement of non-viable product rather than live animals. Few attempts have been made to adapt quantitative risk analysis methods to analyzing disease risks for aquatic animals. A formal risk analysis can take several years to complete.

Summary of 9 Pathogen Risk Analyses Risk Analysis (Date)Type of Movement No. Genera / spp. Considered Salmonids for human consumption (1997) International22 species Live Ornamental finfish to Australia (1999) International605 genera Juvenile kingfish (Seriola sp.) from Australia to New Zealand for seacage culture (2003) International1 species Blue shrimp (Litopenaeus stylirostris) from Brunei to Fiji (2004) International1 species Postlarval giant river prawn (Macrobrachium rosenbergii) from Fiji to Cook Islands for land-based culture (2004) International1 species

Summary of 9 Pathogen Risk Analyses (Continued) Risk Assessment (date)Type of Movement No. genera / spp. considered Ornamental fish and marine invertebrates from all countries to New Zealand (2005) International394 genera and species Adult Macrobrachium from Hawaii to New Zealand as broodstock (2006) International1 species Menhaden (Brevoortia sp.) from USA to Australia for lobster bait (2007) International1 species Pacific oysters from Tasmania to NSW for on-growing (2007) Domestic1 species

Major Risk Factors, In Practical Terms: Risk = Commodity x Source x Destination x Volume Live Adult Wild Direct ReleaseBillions Processed SPF Immediate One Product ConsumptionAnimal Higher Lower

Simplified Hypothetical Process for a Pathogen Risk Analysis Getting Started 1. A Risk Analysis Project Team (RAPT) is established within the Competent Authority 2. RAPT defines the Scope of the risk analysis 3. RAPT establishes a Working Group (RAWG) for the specific risk analysis 4. Risk Communication begins: stakeholders are identified & informed.

The Pathogen Risk Analysis Team The Competent Authority should have a permanent PRAT to screen import applications. A standardized screening process and criteria (checklist) should be established. Preliminary Screening by Team Head sorts the applications into: 1. Those that can be immediately approved Example - established trade 2. Those that can be immediately rejected Example – known pest species 3. Those that require more information from proponent before approval or referral to the Team 4. Those that may generate a risk analysis - referred to full Team Meeting

The Pathogen Risk Analysis Team Full PRAT meets regularly Considers and makes decisions on applications that may generate a risk analysis May seek expert comment Possible decisions: Approve/reject proposal without RA More information/clarification needed from proponent Commission a risk analysis

If the Decision is to Conduct a Risk Analysis, the PRAT: Defines the scope of the risk analysis Develops and controls the budget Ensures adequate independent scientific review Ensures implementation of outcomes via: Legislation Liaison with those agencies responsible for implementation: legislation enforcement monitoring risk management

How Risk Analyses are Initiated A Risk Analysis is likely if: an exotic species is being imported a new source is being proposed for existing trade the world disease situation for a species changes dramatically

How Risk Analyses are Initiated By an importer who applies to bring in a commodity. By an exporter or exporting country that wants access to a market. Proactively, by the Lead Agency, due to concern or as a precautionary exercise.

The Proposal to Import Contains essential information needed to decide if a risk analysis is needed. Commodity Description Minimum information to complete a “Commodity Description” includes: scientific name life cycle stage source destination number of animals to be shipped proposed date of shipment

The Proposal to Import For First Time Movements, the CA may require such additional information as: purpose of importation justification (why local species/stocks are not suitable) health status (stock history, diagnostics testing) description of any sanitary measures to be applied (e.g. treatment, vaccination, quarantine)

The Proposal to Import For “First Time Movements”, the CA may require such additional information as: life history information interaction with native species receiving environment and contiguous watershed monitoring plan management plan contingency plan business data references

The Proposal to Import Government needs to provide importer with standardized forms and guidelines for providing the needed information. Without a full and accurate commodity description it is difficult to do a good risk analysis.

The Risk Analysis Working Group Is established to conduct a specific risk analysis & disbanded when the analysis is completed. Usually consists of both generalists and experts Example: request to introduce an exotic mollusc General pathogen risk analyst (chair) Molluscan pathologist Socio–economist Marine ecologist May be “in-house” or (more usually) a combination of staff of the Competent Authority and External Members May use consultants in all or part

The Risk Analysis Working Group Conducts the risk analysis Participates in stakeholder meetings (technical side) Addresses reviewer and stakeholder comments & criticisms and revises the risk analysis, as needed.

Scoping a Risk Analysis for Giant River Prawn Field visit to Fiji Discussions with SPC staff Visit supplying hatchery, veterinary services & other stakeholders

Scoping the Risk Analysis Field visit to Rarotonga, Cook Islands visit proponent, proposed receiving site in Cook Islands, veterinary services & other stakeholders

Scoping the Risk Analysis Develop a commodity description Understand pertinent aspects of local ecology, environment, trade, biosecurity (expertise, infrastructure, capacity, ALOP), social values etc. Based on the information gathered develop an approach to the risk analysis.

Commodity description for the proposed introduction of giant river prawn, Macrobrachium rosenbergii, from Fiji to Rarotonga, Cook Islands. Species to be introduced: Macrobrachium rosenbergii (De Man) (giant river prawn) Life cycle stage to be imported: Postlarvae (PL) Proposed date of importation: within the current year (2004) Proposed number of shipments: One shipment; if the initial culture trial is successful, other shipments of similar volume may be required at intervals of approximately six months until such time as a reliable broodstock can be established. Volume: 5,000 PL

Commodity description for the proposed introduction of giant river prawn, Macrobrachiumrosenbergii, from Fiji to Rarotonga, Cook Islands. Importer: Mr. Tap Pryor, Papa Tap’s Products, P.O. Box 16, Titikaveka, Rarotonga, Cook Islands, Tel.: (682)20051, Proposed exporter: Department of Fisheries, Ministry of Fisheries and Forestry, Government of Fiji Proposed source: Culture ponds at the Ministry of Fisheries and Forestry Aquaculture Center, Naduruloulou, Fiji Proposed destination: Culture ponds at Papa Tap’s Products, Rarotonga, Cook Islands

The Scope: Initial Findings Lack of information on stock history & health status & on national disease status for both importing & exporting countries necessitated that all potential pathogens reported from river prawn on a world-wide basis be considered. A qualitative approach would be used. Since all pathogens would be “hypothetical”, detailed pathways analyses would not be included.

Some Factors Influencing Risk High uncertainty was the major feature: Disease status of Exporting Country (Fiji): Unknown Disease status of Importing Country (Cook Islands): Unknown Disease status supplying hatchery: Unknown Disease status of proposed stock: Unknown

Initial Findings The Precautionary Principle was obviously going to come into play. We would be focusing on ways to reduce uncertainty.

Conducting Pathogen Risk Analysis Special Issues and Problems The aquatic environment Makes observations of health status difficult Presents special problems when holding animals for sampling & quarantine Makes control and eradication of pathogens often difficult or impossible.

Conducting Pathogen Risk Analysis Special Issues and Problems The volume of trade Makes it often impossible to test all animals Makes it difficult to quarantine all animals Sampling must often be based on statistical calculations (e.g. 95% confidence of detection, assuming 2% prevalence of infection and a test that is 100% accurate)

Special Issues and Problems The poor “State of the Art” Health status of species/stock/production facility is often poorly known/documented. National health status of importing and exporting countries usually poorly known. Importance of stock history, diagnostics testing, quarantine and contingency planning in reducing risks.

Special Issues and Problems The “State of the Art” Issues related to diagnostics testing Frequent new and emerging diseases Carrier state and cryptic pathogens common Lack of recognition & appropriate diagnostics tests Issue of specificity & sensitivity of tests Limited expertise available in most countries Over reliance on molecular methods Detects DNA, not viable pathogens Frequent problems with contamination of samples

Special Issues and Problems Dealing with Uncertainty A Precautionary Approach requires that both importing & exporting nations act responsibly & conservatively to avoid the introduction of potential “pest” species & the spread of serious pathogens In PRA, a Precautionary Approach includes: Use of “cautious interim measures” (temporary restrictions, conditions and bans). Targeted research on key areas where critical information is lacking. Application of Risk Management measures

Key Points Poorly planned or ill-conceived introductions & transfers of aquatic animals have caused huge economic, social & biological losses. The changes caused by introductions and transfers are sometimes irreversible. Almost all movements of aquatic animal commodities involve an element of ecological, pathogen or genetic risk. It is usually possible to reduce risk to an acceptable level.

Key Points Risk analysis can be used to aid decision making and examine ways to reduce risk. In view of the current world trade situation, a national policy of “zero risk” is not realistic.