Whatever can go wrong, will go wrong.
Murphy’s Law
What is Pathogen
Risk Analysis?
For aquatic animal movements, it is:
 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)
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
HAZARD
IDENTIFICATION
RISK
ASSESSMENT
RIS K COM MUNI CATI ON
RISK
MANAGEMENT
Historical Aspects
 Risk analysis for aquatic animals is a relatively new
concept
 First 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 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 Animals
Non-viable
Product
Fish
Molluscs
Crustaceans
Other
3
1
2
-
8
1
3
1
Totals
6
13
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)
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
Product
SPF
Immediate
Consumption
One
Animal
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.
 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, 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 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.