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

HAZARDIDENTIFICATION

RISKASSESSM ENT

RISKM ANAGEM ENT

R I S K C O M M U N I C A T I O N

Historical AspectsRisk analysis for aquatic animals is a relatively

new conceptFirst formal RAs conducted by Australia & New

Zealand on salmonid imports between 1994-1997.

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 AnalysesMolluscs (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

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 AnalysesRisk Analysis (Date) Type of

MovementNo. Genera /

spp. Considered

Salmonids for human consumption (1997)

International 22 species

Live Ornamental finfish to Australia (1999)

International 605 genera

Juvenile kingfish (Seriola sp.) from Australia to New Zealand for seacage culture (2003)

International 1 species

Blue shrimp (Litopenaeus stylirostris) from Brunei to Fiji (2004)

International 1 species

Postlarval giant river prawn (Macrobrachium rosenbergii) from Fiji to Cook Islands for land-based culture (2004)

International 1 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)

International 394 genera and species

Adult Macrobrachium from Hawaii to New Zealand as broodstock (2006)

International 1 species

Menhaden (Brevoortia sp.) from USA to Australia for lobster bait (2007)

International 1 species

Pacific oysters from Tasmania to NSW for on-growing (2007)

Domestic 1 species

Major Risk Factors, In Practical Terms:Risk = Commodity x Source x Destination x Volume Live Adult Wild Direct Release Billions

Processed SPF Immediate One Product Consumption Animal

HigherHigher

LowerLower

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 analysis3. RAPT establishes a Working Group (RAWG)

for the specific risk analysis4. Risk Communication begins: stakeholders

are identified & informed.

The Pathogen Risk Analysis TeamThe 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 species3. 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 TeamFull PRAT meets regularly

Considers and makes decisions on applications that may generate a risk analysis

May seek expert commentPossible decisions:

Approve/reject proposal without RA More information/clarification needed from

proponent Commission a risk analysis

If the Decision is to Conduct aRisk Analysis, the PRAT:

Defines the scope of the risk analysisDevelops and controls the budgetEnsures adequate independent scientific

reviewEnsures implementation of outcomes via:

LegislationLiaison 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 importeda new source is being proposed for existing

tradethe 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.Minimum information to complete a “Commodity Commodity

DescriptionDescription” includes:scientific name life cycle stagesourcedestinationnumber of animals to be shippedproposed 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 ImportFor “First Time Movements”, the CA may require such additional information as:

life history information interaction with native speciesreceiving environment and contiguous watershedmonitoring planmanagement plancontingency planbusiness datareferences

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 GroupIs 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 analysisParticipates 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 PrawnField visit to Fiji

Discussions with SPC staff Visit supplying hatchery,

veterinary services & other stakeholders

Scoping the Risk AnalysisField visit to Rarotonga, Cook Islands

visit proponent, proposed receiving site in Cook Islands, veterinary services & other stakeholders

Scoping the Risk Analysis

Develop a commodity descriptionUnderstand 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, E-mail: pryor@tangaroaci.co.ck

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 RiskHigh uncertainty was the major feature:

Disease status of Exporting Country (Fiji): Unknown

Disease status of Importing Country (Cook Islands): Unknown

Disease status supplying hatchery: UnknownDisease 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 environmentMakes observations of health status difficultPresents special problems when holding

animals for sampling & quarantineMakes control and eradication of pathogens

often difficult or impossible.

Conducting Pathogen Risk Analysis Special Issues and Problems

The volume of tradeMakes it often impossible to test all animals Makes it difficult to quarantine all animalsSampling 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 ProblemsThe “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 ProblemsDealing 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 PointsPoorly 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.