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Journal of Applied Aquaculture, 27:185–219, 2015
Copyright © Taylor & Francis Group, LLC
ISSN: 1045-4438 print/1545-0805 online
DOI: 10.1080/10454438.2015.1084164
A Standar dized Approach for Meeting National
and International Aquaculture Biosecurity
Requirements for Preventing, Controlling, and
Eradicating Infectious Diseases
DUŠAN PALI
´
C
1
, A. DAVID SCARFE
2
, and CHRISTOPHER I. WALSTER
3
1
Faculty of Veterinary Medicine, Ludwig-Maximilians University, Munich, Germany
2
OVA-CAP Veterinary & Consulting Services/Aquatic Veterinary Associates LLC, Bartlett,
Illinois, USA
3
The Island Veterinary Associates, Stafford, United Kingdom
Developing effective, practical, and economically viable
approaches to prevent, control, and potentially eradicate infec-
tious and contagious diseases in aquaculture operations has
eluded those involved in farmed aquatic animals for some time.
However, an approach for meeting these objectives using sound
scientific veterinary principles outlined in the World Organization
for Animal Health (OIE) and elsewhere offers a solution that
should meet the needs of producers and governmental regulatory
agencies. Developed over a number of years with input from a
wide variety of collaborators from around the world, the approach
focuses on applying several important core OIE processes targeted
at determining and maintaining disease freedom on any epi-
demiological unit (EpiUnit)—from an individual farm to a whole
country. These include: identifying and assessing the risk and
prioritizing hazardous diseases important to a clearly defined
EpiUnit; identifying and correcting critical points where these
diseases might enter or leave the EpiUnit; developing contingency
plans should a disease be discovered in the EpiUnit through disease
surveillance and monitoring; periodic auditing of the EpiUnit
biosecurity programs and records; and, as necessary, certifying the
Address correspondence to Dušan Pali
´
c, Chair for Fish Diseases and Fisheries Biology,
Faculty of Veterinary Medicine, Ludwig-Maximilians-University Munich, Kaulbachstrasse 37,
80539 Munich, Germany. E-mail: d.palic@lmu.de
Color versions of one or more of the figures in the article can be found online at www.
tandfonline.com/wjaa.
185
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186 D. Pali´cetal.
absence of these diseases in the EpiUnit with governmental agency
oversight and endorsement.
KEYWORDS Biosecurity, epidemiological unit, OIE standards
and regulations, practical and economical, disease prevention,
control and eradication
INTRODUCTION
Facing progressively increasing risks and impacts of disease on aquaculture
productions in all countries, for a number of years a large number
of individuals representing different stakeholders have discussed and
debated what should be incorporated into biosecurity programs (FAO 2000;
APEC/FAO/NACA/SEMARNAP 2001;FAO/NACA 2001; Lee and O’Bryen
2003; Scarfe, Lee, and O’Bryen 2006; and others). Numerous industry, profes-
sional, government, and international entities have devoted significant time
and effort to incorporate some form of biosecurity in best management prac-
tices, some of which have also been incorporated into regulations intended
to prevent disease outbreaks and protect domestic and international trade
(Hastein et al. 2008; European Council 2006). Therefore, most now recognize
that in order to be effective and useful for all stakeholders (from producers
to governmental regulators), biosecurity processes and procedures must:
1. Be practical and economic;
2. Focus only on infectious and contagious diseases;
3. Include procedures that address disease prevention, control, and eradica-
tion in definable epidemiological units;
4. Be based on well-established, sound scientific-justifiable veterinary proce-
dures;
5. Incorporate internationally accepted standards outlined in the World
Organisation for Animal Health (OIE) Aquatic Animal Health Code and
Manual; and,
6. Involve public-private partnerships and collaboration among produc-
ers, aquatic veterinarians, paraveterinary professionals, and gover nmental
regulators.
Many regulatory approaches suggested to date require the integration
of several complex processes and procedures, many of which are difficult
to fully understand and implement. Here we propose and outline a stan-
dardized approach for implementation of a biosecurity program focusing on
any given epidemiological unit (EpiUnit)—from an individual farm or zone,
region, or country—and for any farmed species, that we believe will be
profitable to producers as well as satisfy national and international regula-
tory requirements. When appropriately implemented on a specific EpiUnit,
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Standardized Approach for Meeting Aquaculture Biosecurity Requirements 187
periodic audits to ensure biosecurity tailored to the specific EpiUnit can
confirm and result in certifying freedom from targeted diseases, thereby
providing assurance needed for animals traded or moved—that they are
not infected with a pathogen or pathogens that will result in important or
devastating diseases.
It is often said that “an ounce of prevention is worth a pound of
cure.” Biosecurity programs that focus on preventing diseases and rec-
ognizing disease freedom have enormous implications and impacts on
aquaculture and other livestock development and the value of traded
commodities—something that is clearly illustrated in studies commissioned
under the auspices of the OIE, World Bank, European Commission, and oth-
ers (Alleweldt et al. 2007, 2009; Caspari et al. 2007). Simply, farms or even
countries that cannot demonstrate freedom from diseases of concern will
have difficulty in having others accept their aquaculture products in trade, or
if they do trade these products they are likely to have a reduced economic
value. Furthermore, those that develop and implement effective biosecurity
programs through voluntary or regulatory compliance will not only profit
from increased production, they will have the preferred status of being able
to trade products of greater economic value.
Focusing on the principles noted, several invited speakers at two
International Aquaculture Biosecurity Conferences in Norway (Scarfe et al.
2009, 2011), joined forces to form an informal International Aquatic
Veterinary Biosecurity Consortium (IAVBC
1
) to outline specific activities
that evolved into the first integrated approach for developing, implement-
ing, auditing, and certifying effective and practical aquaculture biosecurity
programs (Figure 1). To test the viability and appeal of this approach
with aquaculture producers, aquatic veterinarians, and government officials,
workshops with table-top and/or on-farm exercises were held in several
venues in Chile (Cameron et al. 2010), Norway (Scarfe et al. 2009, 2011), and
South Africa (Pali
´
cetal.2011). With the IAVBC Secretariat now located in a
new Centre of Excellence for Aquatic Veterinary Education and Biosecurity
at Ludwig-Maximilians University in Munich, Germany, formal collaboration
of the institutions has been established and invitations opened to others who
have expressed interest.
Here we summarize the most important components and seek to outline
what may be a useful process for a standardized approach for the prevention,
control, and eradication of any infectious and contagious disease in any
farmed species and on any type of aquaculture facility.
INTERNATIONAL AND NATIONAL APPROACHES TO BIOSECURITY
With the globalization of the aquatic animal trade and its increase in vol-
ume, diversity, and economic and social importance, the potential for disease
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188 D. Pali´cetal.
FIGURE 1 Steps for developing, implementing, auditing, and certifying an effective
biosecurity program intended to prevent, control, and possibly eradicate disease in any
epidemiological unit (a tank/pond, farm, state/province, zone, region, or country).
spread becomes significant. A number of aquatic animal disease epidemics
have substantially impacted regional, national, and in some cases interna-
tional industries and trade (Lafferty et al. 2015). The most recent example is
the emergence and rapid spread of early mortality syndrome (EMS, or accu-
rately, acute necrotizing hepatopancreatitis—NHP) in shrimp (De Schryver
et al. 2014), which severely impacted global shrimp production and caused
significant price increases for this commodity worldwide (Reed and Royales
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Standardized Approach for Meeting Aquaculture Biosecurity Requirements 189
2014). In the past two decades, high economic losses have also been seen
during infectious salmon anaemia (ISA) outbreaks in Norway, Canada, the
United States, and Chile salmon farms (Lafferty et al. 2015). In fisheries-
dependent communities in the Zambezi River area in South-Eastern Africa,
epizootic ulcerative syndrome (EUS) has decimated fish populations and
endangered the livelihood of thousands of people (Kamilya and Baruah
2014). Numerous other examples of severe impacts from disease outbreaks
could be cited.
The development and implementation of biosecurity programs are
therefore essential steps to reducing disease transmission risks, by decreasing
the chances of pathogen introduction and potential losses due to disease or
death. Furthermore, biosecurity strategies can also aim to prevent the estab-
lishment of pathogens in the wild, where they could have serious impacts
on wild aquatic animal populations and act as a reservoir of infection for
farmed animal populations (Oidtmann et al. 2011). A consistent approach
for the prevention, control, and eradication of infectious and contagious dis-
ease in aquaculture operations is therefore an imperative, if aquaculture is
to remain sustainable.
A number of international and national approaches have been address-
ing the complex issue of biosecurity. The development of global biosecurity
strategies has a foundation in the Sanitary and Phytosanitary Measures
Agreement of the World Trade Organization (WTO 1995: SPS agreement).
The SPS is the highest-level inter national agreement that has set the rules
on food safety, as well as animal and plant health standards. Relevant to
aquatic animals, the SPS agreement applies to any direct or indirect sani-
tary (human or animal health) measures that can impact inter national trade,
including laws and regulations, diagnostic and surveillance procedures, and
product labeling (Scarfe 2003). The main goal of the agreement is to prevent
unjustified trade protectionism of one country against another. Therefore,
WTO member countries are encouraged by the SPS agreement to use exist-
ing international standards, guidelines, and recommendations applicable to
their respective situation, because if they do, it is less likely that they will be
subjected to a WTO complaint and arbitration process.
Within the SPS agreement, the OIE has been recognized as the inter-
national body to provide international guidelines in the field of animal
diseases (Figure 2). The OIE has recommended development and imple-
mentation of general biosecurity procedures in the Aquatic Animal Health
Code (OIE 2015a) and in the Manual of Diagnostic Tests for Aquatic Animals
(OIE 2015b). However, the clear description of the process to achieve the
biosecurity level that is in accordance with the SPS agreement has been miss-
ing, and the interpretation of the recommendation has been left to regional
(e.g., the European Union) or national governments.
Consequently, some regions and countries have progressed further
in setting up aquatic biosecurity standards than others. One example of
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190 D. Pali´cetal.
FIGURE 2 Different levels of aquatic biosecurity framework. The schematic presentation of
relationships between international agreements (SPS agreement), WTO, OIE, FAO, and trans-
lation of the agreements and OIE recommendations to supranational (e.g., European Union),
national, and local legislation, regulations and sublegislative acts affecting aquatic biosecurity.
Modified from Oidtmann et al. (2011).
an approach to follow the OIE recommendations and support the SPS
agreement includes the European Council 2006/88/EC Directive (European
Council 2006) that covers animal health requirements for aquaculture ani-
mals and products thereof and the prevention and control of certain diseases
in aquatic animals. Related to biosecurity, the 2006/88/EC Directive pro-
vides a broad framework on aquatic animal disease diagnostics and includes
surveillance, contingency plans, audits, and certification. It also emphasizes
that “more attention should be paid to preventing disease occurrence than
to controlling the disease once it has occurred” (European Council 2006).
An illustration of how the SPS agreement and OIE standards can be translated
into legislation and regulations at regional and national levels is covered else-
where (Oidtmann et al. 2011). Briefly, European Union (EU) member states
are required to harmonize their national legislations with the EU Directives,
but the actual development and implementation of biosecurity plans con-
tinue to be the responsibility of competent authorities at the national level,
as well as producers at the business level.
One of the first comprehensive government strategies to bring aquatic
biosecurity into the regulatory process has been the Australian AQUAPLAN
that currently is in its third phase of implementation for 2014–2019 (DAFF
2014b). Within this framework, the gover nment has worked closely with
veterinarians and aquaculture producers to define practical and effective
actions to enhance biosecurity at the border and within the country, par-
ticularly for inland aquaculture facilities. The initial AQUAPLAN was soon
complemented with an AQUAVETPLAN (DAFF 2015a) that provides a series
of manuals to help stakeholders implement specific activities that will
protect aquaculture assets, as well as achieve compliance with the new
set of regulatory actions that were formalized in Australian Biosecurity
Compliance Strategy (DAFF 2012). While very effective, the outcome report
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Standardized Approach for Meeting Aquaculture Biosecurity Requirements 191
for the 2005–2010 AQUAPLAN (DAFF 2014a) suggested a significant need
for strengthening enterprise biosecurity levels and awareness, as a gap exists
between regulations and practical and economically viable biosecurity pro-
grams. As an additional examples, the United States and Canada initiated
a National Aquatic Animal Health Plan/Program around 2004, which has
undergone significant revisions since then (NAAHTF 2008;CFIA2012;DFO
2014;APHIS2015). Both approaches are focused on and offer general guide-
lines on disease management, diagnostics, surveillance, disinfection, and
quarantine to minimizing consequences of an outbreak; they leave much
of the actual implementation to the producer. In many cases the interpreta-
tion of how requirements might be promulgated in regulations has been left
to the states/provinces or local regulatory agencies. Unfortunately, in many
cases, both producers and regulatory agency personnel have difficulty in
interpreting many biosecurity requirements or the role of veterinary services
to comply with OIE recommendations and the SPS agreement, which often
leads to incomplete or ineffectual programs, economical losses to producers,
and trade disputes (Rigod 2013).
Significant progress in international and national regulations dealing
with aquatic biosecurity has been made since the adoption of the SPS agree-
ment in 1995. The OIE has been proactive in providing recommendations
to member countries regarding needs for establishment of national aquatic
biosecurity frameworks (OIE 2015i). Multiple countries as well as the EU
community have advanced their legislation to incorporate those recommen-
dations. Unfortunately, the diversity of approaches in translating the OIE
recommendations and promulgating legislation and regulations has slowed
down the development and implementation of biosecurity plans at the pro-
ducer level, perhaps due to the inherent lack of details needed to explain
the complexity of international law (Rigod 2013). The result appears to be
inconsistent information about how to set up and implement a biosecurity
plan that would be compliant with national and international regulations
and at the same time follow the latest veterinary/disease information and
production techniques (Håstein et al. 2008). We therefore offer a standard-
ized approach for an effective and practical biosecurity program we believe
is needed to help the aquaculture industry become sustainable and expand
to be able to contribute to feeding the growing human population.
KEY COMPONENTS OF EFFECTIVE BIOSECURITY PROGRAMS
Essential Elements of the IAVBC Approach for Aquaculture
Biosecurity Programs
At the core of a biosecurity program is an epidemiologic unit
2
(EpiUnit),
containing a well-defined geographical population of animals (OIE 2015k).
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192 D. Pali´cetal.
If all the biosecurity steps or processes outlined in Figure 1 and described
subsequently are implemented consistent with the standards in the OIE Code
(OIE 2015a) and Manual (OIE 2015b), they will achieve the desired outcome
of any biosecurity program—namely the prevention, control, and eradication
of an infectious and contagious disease. An epidemiologic unit might be an
establishment (farm), a compartment (different locations that are all man-
aged as an integrated operation, usually under one ownership or a common
biosecurity plan), a zone (typically a geographical area within a country),
or a region that may overlap one or more geopolitical or biogeographical
areas. Within an EpiUnit, disease transmission between individuals is rela-
tively easy, and to some degree, the population of animals within an EpiUnit
is separated from other populations and affords some level of protection
in preventing disease spread into the EpiUnit. This close association within
an EpiUnit also allows managers to implement practical and effective mea-
sures to control and eradicate a disease within the EpiUnit, particularly if
it is small, such as a single farm or establishment. If disease freedom is
achieved on adjacent farms using similar biosecurity procedures, these can
then be incorporated into a larger EpiUnit, or compartment. Progressively
those EpiUnits that adopt similar biosecurity plans and achieve similar dis-
ease status (typically freedom) can be amalgamated into larger geopolitical or
biogeographical areas to include zones, a whole country, or larger regions.
A second important principle is that all procedures implemented for a
selected EpiUnit must be thought out ahead of time and well documented.
This requires both an a priori definition and evaluation of the EpiUnit and
a written biosecurity plan that addresses all steps and processes specific for
the EpiUnit under consideration and full documentation of all procedures
to be implemented on it. Along with periodic on-site evaluation of opera-
tions and animals on the EpiUnit, the written plan and the documentation of
implemented procedures become the focus for auditing and certification.
Because every farm considered an EpiUnit is unique, the third important
principle is that each biosecurity plan developed should be tailored for each
operation or farm in question. However, development of an individually tai-
lored biosecurity plan should consider elements that are in common with
other adjacent operations (e.g., similar disease hazards), as well as require-
ments from larger EpiUnits (e.g., compartment, zone, state/province, etc.)
if the same end points (e.g., disease freedom) are to be attained, particu-
larly if they are under the jurisdiction of the same governmental authority.
Simply, applying relevant requirements from larger EpiUnits into an individ-
ual biosecurity plan will allow for easier progressive incorporation of smaller
EpiUnits (e.g., farms) into a larger EpiUnit such as a zone or state/province.
To be effective and justifiable, the processes and procedures in a
biosecurity plan need to involve several complex processes that are gen-
erally difficult for many to fully understand but need to be implemented on
the EpiUnit. These include: hazard and risk analysis (hazard identification
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Standardized Approach for Meeting Aquaculture Biosecurity Requirements 193
and prioritization, risk assessment/evaluation, risk management/mitigation,
and risk communication), analysis and remediation of critical control points
(including evaluation and mitigation plans for correcting practices where
disease could enter or leave the EpiUnit), application of epidemiological
principles (including necessary diagnostics, surveillance, monitoring, and
determining the status or freedom of diseases in the EpiUnit), emergency
preparedness (contingency protocols for disease control and eradication
in the event of a disease outbreak in the EpiUnit), and auditing of pro-
cedures and records and certification (providing assurance of compliance
to processes/procedures in the biosecurity plans, disease freedom, and
compliance with regulations, as appropriate).
Optimal Collaboration in Developing a Biosecurity Plan or Program
Intensive culture of aquatic animals is becoming an increasingly important
part of the food supply for the growing world population (FAO 2014).
The rapid growth of the aquaculture industry in many parts of the world
reflects the increase in global market demand for high-quality protein for
human consumption (Thilsted 2013). The principles outlined earlier have
been addressed in numerous different contexts. However, a collaborative
effort of personnel with intimate knowledge of the EpiUnit and what is
required in a biosecurity plan that would meet local regulatory requirements
would optimally keep the focus on the primary end points: the develop-
ment and implementation of effective, justifiable, practical, and economical
biosecurity plans and programs. Inevitably this will require the efforts and
cooperation of experienced and knowledgeable veterinarians or paraveteri-
nary health professionals, aquaculture producers, and government officials
working as a collaborative team, particularly if it is to meet regulatory
requirements. Development and implementation of a biosecurity program
for larger EpiUnits that encompass more than a single far m should consider
the integration of broader stakeholder needs and priorities; optimally the
following should be considered:
1. Identifying all appropriate stakeholders, but in particular government offi-
cials (local/state/national), producers (similar operation types), producer
service providers (veterinarians, paraveterinary fish health biologists), and
industry service providers (shipping agents, feed suppliers, wholesalers,
insurance agents, etc.) who might be involved;
2. Building relationships to understand the producer and governmental goals
for specific types of aquaculture operations and specific targeted end
points (e.g., determining specific hazardous disease of concern, certifying
disease freedom, etc.);
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194 D. Pali´cetal.
3. Identifying and prioritizing specific diseases that are hazards to an oper-
ation and how an assessment of the actual risks and impacts from an
outbreak of each disease might be performed;
4. Identifying and prioritizing critical control points for disease entry/exit on
the EpiUnit;
5. Developing a schedule of disease diagnostic sampling, submission, and
clinical inspection for surveillance and monitoring purposes;
6. Optimizing record keeping, auditing, and issuing (or revoking) veterinary
aquaculture biosecurity certificates of inspection (V-ABC); and
7. Ensuring compliance with the local, state, and national regulations and
requirements or international trade agreements/rules and seeking official
government endorsement of a V-ABC.
The optimal implementation of any effective biosecurity program will
therefore require utilizing an integrated approach of experienced and cre-
dentialed teams of individuals with a full understanding of epidemiology,
pathobiology, and clinical and laboratory diagnostic disease assay interpre-
tation; as well as biosecurity, disease transmission routes, risk analysis, and
assessment of critical control points. In addition, it will be important for all
parties to understand auditing and certification and the associated profes-
sional ethics and liability, a producer’s operation and business goals, and
government and trade regulations and r equirements.
Since the process of building a biosecurity plan or program begins with
determination of an epidemiological unit, for practical purposes, an essen-
tial preparation step is to set the limits of application of the biosecurity
plan/program to the EpiUnit of concern with defined borders (e.g., farm
property) and content (e.g., fish, buildings, etc.). It is therefore necessary that
initial information on the type of production, physical and human resources,
current disease status with perceived risks, and expected goals is provided
to the person or team given the task of developing the biosecurity program
for the particular EpiUnit. An appropriate approach is to provide this infor-
mation in a preassessment questionnaire. One such document was modified
from the Center for Food Security and Public Health for cattle biological risk
management assessment protocol (Moore et al. 2010) and proved to be use-
ful in aquaculture biosecurity training workshops (Scarfe et al. 2011;Pali
´
c
et al. 2011). It is of importance to note that, even though each biosecurity
program should be specifically developed for the conditions and circum-
stances applicable to the EpiUnit in question (whether it is a pond, a farm,
a watershed, or a country, etc.); the process that we describe here is equally
applicable to any EpiUnit as well as any disease or their combination.
As noted previously, the complexity of the tasks necessary to complete
all components of the practical and effective biosecurity program requires the
integration of efforts from at least three key stakeholders: a producer (usually
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Standardized Approach for Meeting Aquaculture Biosecurity Requirements 195
farm manager, educated in the area of biological sciences with working
knowledge of the aquaculture operation), a government representative (pro-
viding regulatory input), and a practicing aquatic veterinarian. Depending
on the size of the EpiUnit and desired level of biosecurity certification (V-
ABC—Steps I through V, Figure 1), it is also possible that stakeholders with
more expert knowledge or with different backgrounds (e.g., trading partner
or a customer) can be involved in the biosecurity program development. For
simplicity, it is easiest to consider the most effective approach for developing
a biosecurity plan on a farm to be a collaborative effort of the producer or
operation manager and the operation’s attending veterinarian, with a gov-
ernment regulatory official who might provide information and comments
from the regulatory perspective.
For the purposes of clearly describing the key components of a
biosecurity plan or program, we will frequently use examples of a finfish
farm during a series of steps to illustrate the development, implementation,
auditing, and certifying of a biosecurity plan or program that is intended to
prevent, control, and possibly eradicate disease in any EpiUnit. These exam-
ples are based on case studies used during table-top and on-farm exercises
during the IAVBC aquatic biosecurity workshops (Pali
´
cetal.2011). For sim-
plicity, for each component of the biosecurity plan outlined in Figure 1 we
will begin with questions that a producer may ask, followed by description
of a more formal biosecurity process, and conclude with the documentation
of processes and results that need to be included in written [farm] records
and useful for later reviews, audits, and certification.
I
DENTIFYING AND PRIORITIZING DISEASE HAZARDS: “WHAT DISEASES ARE
SERIOUS POTENTIAL HAZARDS FOR MY FARM (EPIUNIT)?”
The producer/manager of any aquaculture operation is likely familiar with
the diseases that cause (or have caused in the past) problems on the farm.
However, it is possible that not all of those diseases may be considered a
“serious potential hazard.” It would therefore be expedient for the producer
to work with the attending veterinarian to obtain information from (most
commonly) regulatory authority of the region/country about the current epi-
demiological situation of important or reportable diseases that could be of
concern to his client’s operation (Arthur et al. 2009). The veterinarian and
the producer should discuss all infectious diseases that might be present in
the EpiUnit (e.g., a fish farm), as well as those that might pose the potential
of being introduced through, for example, introduction of fish obtained from
other facilities or diseases that are present or need to be reported to a gov-
ernmental authority (e.g., European Council 2006;CFIA2014;USDA-APHIS
2014;DAFF2015b), most of which are reportable by OIE (OIE 2015c). Once
a list of diseases that would be hazardous to the EpiUnit is identified, their
respective risks and impacts will need to be determined.
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196 D. Pali´cetal.
DETERMINING THE L EVEL OF RISK AND IMPACTS OF DISEASE: “IS MY FARM AT
RISK? IF SO, HOW MUCH RISK AND WHAT IS THE IMPACT OF DISEASE ON MY
OPERATION?”
A number of different approaches can be used to perform qualitative or
quantitative risk assessments (Rodgers, 2004; Bernoth et al. 2008; Arthur
et al. 2009). In most cases semiquantitative approaches are adequate for
developing a farm-based biosecurity plan; comprehensive quantitative risk
assessments can be very complex and can take a very long time. In the OIE
Aquatic Animal Health Code and the EU Directive 2006/88, disease risks
are classified based on several criteria (OIE 2015e; European Council 2006).
In short, each can be evaluated and ranked according to its potential to
cause production loss and possible spread to other areas or animals in the
wild but also on the availability of reliable diagnostic tests used to definitively
identify any disease in question (OIE 2015b). However, it is also important
to note that not all diseases of concern for every farm or EpiUnit fulfill the
requirements for being listed as reportable diseases with OIE. Furthermore,
each country or local area might regulate diseases and require control mea-
sures, depending on the epidemiology and the impact of a disease on their
local production impact or trade situation. Therefore, each EpiUnit (country,
region, farm, etc.) has to be evaluated based on its own specific situation
and the need to identify which diseases pose specific hazards and have the
highest probability of occurring. Such identification and probability estima-
tion may be done by risk profiling, a risk-assessment approach outlined by
Blaikie et al. (2003). However, a number of other publications offer useful
guidance for assessing disease-associated risks in aquaculture (MacDiarmid
1997; Zepeda 2002; Sumner et al. 2004; Arthur et al. 2004; Peeler et al. 2013).
Using a relatively simple semiquantitative approach, the risk of each
disease to a farm can be defined through estimating the probability of it
occurring and the consequences of the occurrence (i.e., risk = probability
× consequences). This approach can provide objective information on the
risk associated with a specific hazard (an infectious disease, in this case).
Using available information (disease reports and epidemiological informa-
tion available) and expertise, including associated variability and uncertainty,
the risk-assessment process will provide insight on various steps needed
to prevent the hazardous diseases being introduced or released from the
farm or EpiUnit. It should also be recognized that a full quantitative risk
assessment is a very complex and time-consuming process, and frequently
it is impossible to complete due to the lack of reliable information to be
included in the analysis. A simplified approach of risk profiling, based on
qualitative/semiquantitative estimates from the experts that provide relative
values (“weights”) for each of the questions or concerns regarding specific
disease and corresponding EpiUnit, including the likelihood of disease occur-
rence (probability) and impact (consequences), are usually adequate (Blaikie
et al. 2003).
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Standardized Approach for Meeting Aquaculture Biosecurity Requirements 197
During this step of developing a biosecurity program, the relative
“weight” for each identified disease needs to be determined based on the
experience of the producer and veterinarian, with possible input from the
government. For example, information in Table 1 may be useful as a tool
to complete this step but also to document the disease hazard identification
and prioritization process. As an example to illustrate the process, consider
that fish on a particular farm frequently show signs of white spot disease (an
infection with a protozoan I. multifiliis) and experience some mortalities.
It is unlikely that this disease will be a disease that has to be reported to
a governmental authority or is subject to eradication program that requires
mandatory depopulation as a disease control measure. In this case, while the
relative risk of infection may be high (present on the farm), the relative con-
sequences of this disease may be low to medium (decreased growth or low
mortalities). In contrast, the occurrence of a viral haemorrhagic septicaemia
(VHS; a reportable disease in most countries) is likely to trigger government
action, including possible quarantine or depopulation, and a report to OIE
identifying that the disease is present. The risk for VHS outbreak in the
EpiUnit may be lower than a white spot, but the potential consequences are
much higher. Therefore, priority should be to include VHS in the biosecurity
plan rather than white spot disease (Table 1). Once the disease hazards are
prioritized, the next step is to evaluate critical points on the farm or in the
farm’s management where these diseases may enter or leave the EpiUnit and
decide how to prevent this.
E
VALUATING A N D PROTECTING DISEASE INTRODUCTION CRITICAL CONTROL
POINTS: “WHERE CAN THESE HAZARDOUS DISEASES GET IN OR OUT (IF PRESENT)?”
All disease entering and leaving an EpiUnit will be transmitted through
vectors (animate carriers such people and animals) or fomites (inanimate
objects such as water, feed, vehicles, etc.), which should be the primary
focus for attention. A well-planned biosecurity approach will provide the
context for selecting effective mitigation measures to prevent the introduc-
tion and spread of the diseases of concern into, within, and from a facility.
This evaluation should be consistent with risk-assessment methodologies and
requires a working understanding of the production systems used in the
EpiUnit or farm, its physical layout and the process flow of the operation,
the biology of the species being farmed, and the pathobiology and epidemi-
ology of the pathogens or diseases of concern (Karreman 2015). A detailed
sequence of the production process (operations) should be included in the
biosecurity plan as a diagram, flow chart, list, or table (Table 2)andcan
be used to determine critical points to control the entry or escape of a
disease.
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TABLE 1 Worksheet to identify and list the infectious and contagious diseases that producer and veterinarian believe may be hazardous to a
finfish EpiUnit (farm). The disease hazard prioritization is based on the assessment of likelihood that specific disease will affect the EpiUnit and
relative impact that it may have on the operation. WS: White spot disease (Ichthyophthirius multifiliis); VHS: viral haemorrhagic septicaemia.
Disease
Is this disease
present in this
EpiUnit/?(Y/N)
Likelihood this
disease will be
introduced on this
EpiUnit/farm? (Rank:
0 = none/low; 5 =
v. high)
What would be the
impact of this disease
on production?
(Rank: 0 = no
impact;
5 = devastating)
Describe the impacts
(e.g., decreases
production, high
mortality,
government
depopulation, etc.)
For each disease:
Likelihood (L) ×
Impact (I)
Rank:
(WS vs. VHS)
WS Y 5 1 Decrease production,
low mortality
52
VHS Y 3 5 High mortality,
possible
depopulation
15 1
198
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Standardized Approach for Meeting Aquaculture Biosecurity Requirements 199
TABLE 2 An example of a flow diagram outlining sequential stages of production required for
determination of critical control points (CCP) for disease entry or exit from the facility. In this
example the first stage of a trout-rearing operation starts with bringing the eyed trout eggs into
the farm premises (e.g., via truck transport service) and continuing with egg disinfection and
placement in hatching trays. The stage sequence is based on individual operation setup and
determination by the owner/manager and veterinarian. In this example, after several stages
(e.g., hatching, feeding start, grading, moving to larger tanks, etc.), the last stage would be
collection and shipping the juvenile trout (fingerlings) from the farm to grow-out facilities.
Stage 1 Bringing the eyed trout eggs to the production facility.
⇓
Stage 2 Egg disinfection and placement in hatching trays.
⇓
Stages 3–X Hatching eggs, transfer to rearing tanks, feeding start, grading, transfer to
larger tanks, change feed type/size, second grading and vaccination ...
⇓
Final Stage Shipping the juvenile trout from the farm to the grow-out facilities.
Functionally, a critical control point (CCP) is a point in a procedure or
operational step that can be controlled to eliminate the hazard or minimize
the likelihood of its occurrence, and critical limits (maximum and minimum)
can be set as a monitoring system to establish and ensure the control of
CCPs (Karreman 2015). A simple example of a CCP is an entrance gate.
The production process may require the passage of people, equipment, or
animals that may be contaminated with pathogens and introduce a disease
to the EpiUnit to be monitored at the entrance to the operation. A gate
controlling access to the operation and a sign-in sheet to record gate traffic
(including visitors) are simple mitigating actions that can be incorporated in
a biosecurity plan.
Collaborative efforts of the producer/manager and veterinarian are
essential in determining critical control points for disease entry or its
escape in the production process. A veterinarian is commonly aware of
major routes for disease or pathogen introduction or escape such as water,
vectors (animate/living beings such as fish, pests, people), and fomites
(inanimate/dead objects such as equipment, boots, trucks, dust). Combining
this with the producer’s firsthand knowledge of the process steps inevitably
produces the best evaluation of CCPs and the most practical mitigation activ-
ities. Based on the prioritized disease hazards and risks list produced during
previous steps in Table 1, and on the diagram of process stages (Table 2),
the producer and veterinarian evaluate each point in the production flow
for CCPs. Optimally, by carefully defining and identifying CCPs and possible
correction measures for each disease and incorporating them as a part of the
written biosecurity plan (e.g., Table 3) will prove to be an important step
toward strengthening any weak points where diseases may enter or leave an
operation.
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TABLE 3 Determination of critical control points (CCP) and corrective actions (if needed) should be documented in a biosecurity plan. In this
example, a CCP is identified by the farmer/manager and veterinarian for possible entry/exit of the parasite (I. multifiliis) causing white spot disease
(and possibly some inadvertent bacterial contaminants), which might be the entry and exit of a transport truck with residual mud or substrate
potentially contaminated with the parasite. A truck entrance gate is therefore a CCP, and a control measure may be 3 min of high-pressure washing
and driving through a shallow disinfection tank to remove bacteria from the wheels. It is therefore important to have written documentation
that this was done, how it was done, when it was done, and who performed these actions. In this example, additional protective actions to
supplement existing washing/disinfection measures might be to avoid pooling of potentially contaminated water on the driveway by installing a
gravel (drainable) parking surface that is exposed to direct sunlight.
Critical Control Point Plan Monitoring Form
Critical
Control
Point (CCP)
Disease
hazard(s)
Limits for each
control
measure What How When Who
Corrective
action(s)
(if needed)
Supporting
documentation
(if any)
Truck entry
through
the farm
gate
White spot
disease
(I. multifiliis)
3 min high-
pressure
wash; drive
through
disinfect
Wash excess
mud and
other
substrate
from the
truck exterior
Pressure hose
and driving
through
disinfection
barrier
At entrance
and exit
Gate keeper;
vehicle
driver
Prepare gravel
drainable
parking
surface for
truck
washing stop
Record of truck
entrance and
wash
procedure;
Record of
disinfectant
concentration
check.
Facility: Trout Farm Ltd. Hatchery Activity 1: Truck entry/exit procedure change to washing on
gravel surface and including disinfection concentration
check at the barrier.
Address: Fish Road 1234, Some Town Activity 2: Record each wash procedure at the log book and
sign the activity log.
Signature: \Person signature\ Date:
I verify the above CCP mitigating actions were performed.
200
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Standardized Approach for Meeting Aquaculture Biosecurity Requirements 201
MITIGATING AND MANAGING RISKS AND STRENGTHENING CRITICAL
CONTROL POINTS: “WHAT CAN BE DONE TO PREVENT DISEASE ENTRY OR ESCAPE?”
As an example, consider how the risk of introducing disease can be mitigated
when trout fingerlings are moved from a hatchery to a grow-out facility using
trucks. In our example, possible vectors (animate object) might include fish
and workers on a farm or a truck driver, while fomites (inanimate objects)
would be tanks, the truck itself, and water in which the fingerlings are trans-
ported. Consider that the fingerlings come from a facility with a history of
white spot disease (Ichthyophthirius multifiliis) but not viral haemorrhagic
septicaemia (VHS). The shipment may be accompanied by a certificate of
veterinary inspection that documents that the fish were examined for clin-
ical signs of white spot, but no diagnostic samples were taken during a
veterinary health exam of the shipped fish lot to confirm presence/absence
of the parasite. However, they were sampled, tested, and found to be free
of VHS and several other diseases. The operational procedure to mitigate
possible introduction of white spot disease may require that the truck with
fingerlings has to drive into the facility’s quarantine section, where the fish
are unloaded, acclimated, and placed in quarantine tanks for 14 days or
more (14 days is usually sufficient for clinical signs of most diseases to
develop).
In this example, the veterinarian and producer might agree that there
are two critical points for disease entering or leaving the facility: (1) where
the truck enters the farm, and (2) movement of the fish from transport tanks
to quarantine tanks. This might be because trucks are contaminated with
mud, earth, or water that could contain the infectious agents for white spot
or other diseases, or the fish may have a subclinical infection that was not
detected during the clinical examination or by diagnostic tests currently avail-
able. Good measures for reducing the risk at the truck entrance (a critical
point) could involve a power wash station on a concrete driveway, where
the exterior of a truck can be mechanically cleaned before entering the farm
that has nonpaved roads. The waste washing water could be drained into a
gravel-covered vehicle parking area with direct sunlight exposure to inacti-
vate possible pathogens, thereby preventing possible diseases from entering
the farm’s water source. Documenting the washing of all trucks and record-
ing other important data (when it was done and the driver’s name and
contact information, etc.) therefore becomes part of the written records of
the biosecurity plan. If it was concluded that quarantine is a necessary critical
control point, disinfection of equipment entering or leaving the quarantine
facilities may be another mitigating action that needs to be incorporated
into the biosecurity plan. The records of these corrective actions for each
CCP would then become part of the biosecurity plan documentation (e.g.,
Table 3) and maintained for future reference.
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202 D. Pali´cetal.
CONTINGENCY PLANS IN THE EVENT OF DISEASE OUTBREAK: “WHAT SHOULD I
DO IF DISEASE GETS IN?”
Having a plan of action before a disease gets in that includes specific strate-
gies and actions in the event of an outbreak can position the EpiUnit to more
easily eradicate it. Preventing any and all diseases from entering any EpiUnit
is not always realistic, as controlling all critical points where a disease may
enter or leave is seldom perfect. Furthermore, the biosecurity plan may have
not yet have incorporated mitigating activities for a new or emerging dis-
ease that has not been recognized as a hazard. Contingency plans prepare
for this possibility. When built into a biosecurity plan, a process for regularly
(e.g., daily) monitoring animal mortality and morbidity is needed, and abnor-
mal numbers of fish that die or show significant morbidity should “trigger”
the need for initiating actions to isolate the animals and rule in or rule out
the possibility of an infectious and contagious disease. Contingency plans
clearly prepare and help governments, businesses, or individuals to recover
from serious incidents as rapidly as possible and with minimum cost and
disruption (OIE 2015f;DAFF2014b).
Aquaculture business and government contingency plans need to
include communicating details of an outbreak to ensure stakeholder sup-
port and understanding. All potentially affected parties need to be kept
informed of the reasons for any disease status changes and any proposed
plan for controlling, confining, and possibly eradicating the disease in the
EpiUnit. Targeted timelines for implementation and completion of actions
and the overall effectiveness of the contingency plan should be consid-
ered. Inevitably input and consultation from the most influential stakeholders
should be incorporated into the building of any contingency plan, as with-
out acceptance from these people any plan will, at best, encounter limited
support or success.
Requirements for contingency planning in aquaculture are well
described in the OIE Aquatic Animal Health Code, the European Council
Directive 2006/88/EC, and elsewhere (OIE 2015g; European Council 2006).
When implemented at a governmental level, contingency plans typically
address:
●
Legal powers needed to implement contingency plans, including quaran-
tine and eradication of infected populations;
●
Access to emergency funds to compensate producers for the depopulation
of privately owned animal by gover nmental agencies;
●
A central decision-making unit with a clear chain of command to ensure
rapid and effective decision making for dealing with disease outbreaks;
●
Adequate resources for implementing all activities, including the personnel
and equipment necessary for implementing the contingency plan; and
●
Adequate diagnostic laboratory facilities to receive samples from the field.
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Standardized Approach for Meeting Aquaculture Biosecurity Requirements 203
Within limits, similar procedures need to be considered by a farm or
aquaculture operation.
The most practical approach for ensuring an optimal response to a dis-
ease outbreak on an EpiUnit is to develop an operations manual that is part
of the written biosecurity plan and contains a detailed, comprehensive, and
practical description of all the actions, procedures, instructions, and control
measures to be employed. These may include strategies to isolate and quar-
antine infected populations or parts of an EpiUnit, treat infected animals,
or implement emergency vaccinations. Training of staff to recognize clinical
signs is imperative before any outbreak occurs. After an outbreak, an epi-
demiological investigation to discover the source of the disease and how and
why it entered the EpiUnit is necessary. It is also important to ensure that,
if depopulation is necessary, animals are killed or slaughtered in accordance
with recommended sanitary and humane guidelines and that veterinary and
environmental safety issues are properly coordinated. If premises are depop-
ulated, attention must be given to mass disposal of aquatic animal carcasses
without endangering animal or human health or increasing the possibility of
spreading the disease.
Contingency plans should therefore be designed to detect and control
the outbreak of a disease within an EpiUnit and outline the “who” and “how”
of immediate actions, particularly for: (1) communication, (2) containment,
(3) disposal procedures, and (4) reestablishing disease freedom. For contin-
gency plans to be an effective part of a biosecurity program that strives for
disease freedom, all steps in the contingency plans and respective actions
during contingency must be documented and verified in the EpiUnit or farm.
It is also important to identify the roles of all personnel that may be involved
with implementing contingency plans. These include:
●
Producers—Producers have the responsibility to instigate a proper dis-
ease investigation whenever unexpected mortality or morbidity is found
to occur and based on a preestablished relationship with their health ser-
vice provider (private or government veterinarian). For most producers it
means that they should have regular involvement of such professionals
and should notify them immediately when changes are seen or suspected,
even if between regular consultations or farm visits.
●
Veterinarians—When the attending veterinarian (or anyone reporting to
them) suspects the presence of a disease (particularly those identified
in the biosecurity planning stages), the veterinarian must follow up with
an inspection of the premises, obtain and submit samples to the appro-
priate diagnostic laboratory to confirm a clinical diagnosis, and, when
appropriate, notify the governmental authority immediately.
●
Diagnostic laboratories—After completing diagnostic assays on samples
submitted by the veterinarian or producer, the diagnostic laboratory should
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204 D. Pali´cetal.
provide a written report of the assay results to the attending veterinarian,
the farm owner or manager, and (if required for a reportable disease) to
the governmental authority listed in the contingency plan. Most diagnos-
tic laboratories will have defined reporting protocols that always include
the submitting veterinarian, their client, and in the case of nationally or
internationally reportable diseases, the regulatory authorities.
●
Regulatory authorities—Depending on what regulations are in place for
reporting diseases, these may be regional (state or provincial) or fed-
eral. Standardized, official forms are often used to ensure collection of
correct information. When reporting to regulatory authorities, the informa-
tion often helps identify the index case (the location and date of where
the disease was first discovered) that assists an epidemiological inves-
tigation and to trace-back and trace-forward any movement of infected
animals.
The suspicion of an important disease typically triggers a sequence of
activities that producers, veterinarians, diagnostic laboratories, and regulatory
officials optimally should collaborate on, including:
1. Disease agent confirmation using appropriate sampling of populations
possibly infected followed by diagnostic tests;
2. Communication/notification to other producers, industry associations, and
regional and federal authorities, if necessary;
3. The use of epidemiologists to assist with specific plans for developing
surveillance zones and risk assessments; and
4. Plans for diagnostic sampling within these zones and possible contain-
ment; biosecurity measures and large-scale disposal plans; and the control
of animal, personnel, and vehicle movement in these zones, if the disease
has spread outside of the EpiUnit.
In the event of a disease outbreak, controlling movement of animals,
people, and vehicles should always be a part of the contingency plan for
any farm for which a biosecurity plan is developed. However, these may vary
depending upon whether the farm utilizes semiopen culture systems (e.g.,
marine cages, riverside culture) in which effluent release is not preventable,
or semiclosed and closed culture systems (e.g., land-based tanks with the
ability to isolate and quarantine parts of the EpiUnit, such as recirculating
systems) in which effluents can be contained, at least for a reasonable time
period.
For each situation, the contingency plan should determine the area
where disease surveillance is concentrated and control measures are being
implemented. These include the following:
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Standardized Approach for Meeting Aquaculture Biosecurity Requirements 205
1. The Infected Zone in which infected case(s) have been confirmed and
typically require isolation and quarantining; possible depopulation and
premises disinfection; no movement of animals out of the EpiUnit except
directly to a slaughter plant for processing; and restricted movement of
personnel, equipment, and vehicles;
2. The Buffer Zone, which includes the area between the infected zone and
an area known to be disease free. Diagnostic testing is usually imple-
mented to detect additional disease cases that may have spread outside the
infected zone, animal movement in or out of this zone may be restricted,
and preventative vaccination programs may be implemented.
3. The Disease-Free Zone, that area beyond the buffer zone where a rigorous
disease surveillance program (and any contributing historical information)
has shown the area to be free of the specific diseases in the infected
and/or buffer zones.
Depopulation of infected and potentially infected fish is done to reduce
the source of the pathogen. However, the removal and disposal of infected
carcasses and contaminated material represents one of the greatest threats
to the spread of disease (OIE 2015f). Animal welfare and human and
infrastructure capacity to depopulate and remove infected animals with no
(or minimal) release of biological contamination must be anticipated and
addressed. Processing plants must be able to decontaminate effluent. Care is
needed to ensure that vessels or vehicles that may have to move between
different infection status areas are adequately disinfected, and wharf and
vehicle logistics must ensure that any new areas are not contaminated (e.g.,
mortalities must be transported across a different wharf than one used for
smolt transfer). All decisions must incorporate knowledge of how specific
pathogens can be transmitted from one area to another (OIE 2015g, 2015f).
D
IAGNOSTICS AND DETERMINING THE PRESENCE OF DISEASE: “ARE ANY OF
THESE DISEASES ON A FARM?”
Clinical evaluation and disease testing are necessary to determine the pres-
ence or absence of a particular disease within the EpiUnit (Oidtmann et al.
2013). This is usually done by a veterinarian and is based on the disease
hazard and prioritization list produced in the earlier stages of the process.
Clinical evaluation of a situation on EpiUnit is based on a site visit, clinical
exam and necropsy, as well as a review of existing (if any) records (water
quality, animal movement, etc.) and history (anamnestic data, earlier veteri-
nary records, diagnostic reports, etc.) received from the producer/manager.
Veterinarians will also collect the samples for disease diagnostics during
necropsy examination and send them to a laboratory for evaluation. It is
important that samples are collected and shipped properly by the authorized
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206 D. Pali´cetal.
individual (either a veterinarian or a person directly supervised by veterinar-
ian). The choice of disease diagnostic tests is also of importance, since they
may need to conform to the regulations—this should be reviewed with a
government official prior to sampling (OIE 2015d, 2015i). Veterinary, labora-
tory, and farm records of the clinical evaluations and disease testing have to
be included in the biosecurity plan to document presence or absence of a
selected disease at any given time.
The circumstances that determine diagnostic testing needs of a facility
are complex, and the principle reasons for carrying out diagnostic testing
may, for example, be to establish a baseline of disease presence or absence
on the farm through disease surveillance, or to monitor animal morbidity and
mortality, or screen new animals entering the farm or EpiUnit. The following
examples of decisions that a biosecurity program development team has to
make in the process of determining needs for disease diagnostics may be
helpful in focusing on priorities and in filling in the information required in
the diagnostic testing record log.
As a first decision, the producer and veterinarian need to consider what
testing is required by the biosecurity plan: “Should we rely on official ser-
vices, or use our suppliers’ own testing, or do we have to provide third-party
(external testing) evidence?” For example, in many countries, some form of
government assistance is offered to fish farmers as part of the broader disease
surveillance following national or regional programs and usually focusing on
reportable diseases. The decision needs to be made if these programs are in
accordance with the set goals of the biosecurity plan and if there is additional
testing that needs to be done. In other circumstances, the testing provided by
the supplier of the fish to the EpiUnit/Farm may be considered adequate for
monitoring purposes and certifying the disease status, especially if there is
no other potential disease entry routes except fish deliveries. But if an export
trade partner or government requires independent testing to confirm disease
status of the EpiUnit, an external testing service, usually involving private
veterinary practitioners and accredited laboratories, may need to be engaged
to assure compliance with contractual or other regulatory obligations.
The decision on which laboratory or laboratories to use for testing
is also closely related to the goals set in the biosecurity plan, as well as
desired level of certification, contractual obligations, or regulatory require-
ments. If government-assisted health services are involved in surveillance
programs and offer assistance in diagnostic testing, usually it is part of the
program that diagnostic samples are sent to government-accredited (offi-
cial) laboratories. However, depending on the diagnostic test that is needed,
other laboratories, either private/university or even in-house facilities, may
be used, and the choice may be based on accessibility, cost, and turnover
time before results are reported. During the preparation of this section of
the biosecurity plan, it is recommended to include contact information about
the diagnostic laboratories where samples should be sent. The attending
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Standardized Approach for Meeting Aquaculture Biosecurity Requirements 207
veterinarian would in most cases have the contact information for diagnostic
laboratory services, or www.aquavetmed.info can be searched for this infor-
mation. The OIE also maintains the list of reference laboratories for aquatic
animal diseases to be included, in case a biosecurity plan is prepared at the
government or regional level (such as zone or compartment) (OIE 2015b).
To be able to determine disease presence or absence on the farm, the
decision needs to be made about what diagnostic tests are available but
also suitable and appropriate for achieving the goals of the biosecurity plan.
Considerations about the tests should include: sensitivity and specificity of
the test, whether lethal or nonlethal sampling is performed to collect test
samples, how easy it is to collect samples, and what the costs of the testing
procedures and the test itself are. The OIE Manual provides a list of avail-
able and validated tests for specific disease diagnostics (OIE 2015b), but the
expert assistance of a veterinary epidemiologist may be needed in order to
select the appropriate test as well as to determine the number of animals
tested and sampling frequency. Detailed analysis of sampling approaches
such as standard versus risk-based sampling, decision making based on
scenario trees, and probability/risk of introducing disease from a supplier
must be performed to establish optimal testing procedures for disease status
determination and surveillance.
M
AINTAINING BIOSECURITY—SURVEILLANCE,MONITORING, AND FARM
RECORDS: “HOW DO ICONTINUE TO MONITOR DISEASE ABSENCE/PRESENCE?”
The essential step in the process of establishing a biosecure facility is ongoing
disease surveillance and monitoring (OIE 2015d) to determine what diseases
are present or absent in any EpiUnit. While there are subtle differences in
the initial determination of disease presence or absence (usually thought
of as surveillance) and monitoring of the disease status of an EpiUnit, both
require periodic sampling for diseases (Salman 2003). Numerous publications
address the appropriate ways to sample and determine disease absence or
presence in aquaculture and other animal populations (e.g., Corsin et al.
2009; Subasinghe et al. 2004; Ziller et al. 2002) that can be applied to
most EpiUnits. Depending on the goals of the producer, the physical lay-
out of the facility, the process flow for operations, and the epidemiology
of the pathogen(s) of concern, a surveillance program should be discussed
and determined by a veterinarian, in concert with producer and regulatory
requirements. The surveillance can be continuous (e.g., twice per year, every
year), especially during initial years of establishing the biosecurity program
on the EpiUnit. Or, in the case of a continued record of disease absence and
consistent application of the biosecurity program with some special restric-
tions (e.g., no new fish introduction), the EpiUnit may reach the degree of
biosecurity where surveillance would not be deemed necessary as long as
the biosecurity situation remains the same (Morgan 2015). However, if there
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208 D. Pali´cetal.
is a change in biosecurity status, as when a new broodstock fish population
is introduced to a previously closed operation from a facility that has a lower
degree of biosecurity or is located in a zone where certain disease is present,
the surveillance program may have to be reinstalled (Oidtmann et al. 2013).
M
AINTAINING BIOSECURITY—SURVEILLANCE,MONITORING, AND FARM
RECORDS: “WHAT INFORMATION SHOULD IKEEP, AND IN WHAT FORM?”
A record is evidence of an event (or decision) that occurred in the past and
may provide insight into what might happen in the future. It can be visual
(a picture), sound (recorded), physical (buildings), or written. On the whole,
for the purposes of a biosecurity plan, the requirement is for some form
of a written record, but visual records may provide better evidence (i.e., a
time- and date-stamped photo) of a procedure and are a requirement when
developing the plan (i.e., a plan or photo of the facility). Records need to
be kept updated and accurate. While the visual record may contain more
information than multiple pages of written records, the advantage of writ-
ten records (or descriptions) is that any information can be written down.
However, there are several issues that arise with records, and more specif-
ically with written records: Because records are evidence of past activities,
there may be difficulty in interpreting them correctly unless there is sufficient
associated metadata. Another issue is that a single record provides no reas-
surance of what might happen in the future or that the event was carried out
consistently. The greater the number of records of an event, and the longer
the period of time the records cover, the more useful the information they
contain becomes. Further, it can happen that records may have been altered
or incorrectly recorded or destroyed; backups should be kept. Also, there
is an opportunity cost in keeping records that may be too cumbersome for
some operations.
By keeping appropriate records, minimizing additional workload, and
ensuring that duplication is avoided (where possible, using records required
for other purposes such as farm management or quality-assurance schemes),
compliance is improved, and the benefits of the biosecurity plan can be
demonstrated. How is diagnostic testing and veterinary and farm record
keeping designed to be useful and to achieve this? Most important are the
initial considerations:
●
Agree on the aims and objectives of the biosecurity plan, as this will dictate
what records are required and their nature. It may be better to initially seek
a lower biosecurity level, as detailed in Figure 1, if the aims and objectives
are considered greater than the available resources allow. The aims and
objectives, along with why the decision was made, should be recorded by
all parties.
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Standardized Approach for Meeting Aquaculture Biosecurity Requirements 209
●
Are the farm records suitable for the aims and objectives of the biosecurity
plan? It can be presumed that the veterinary records will be fit for the
purpose, as this is a professional obligation of the veterinarian; although
this may not be automatically assumed. There is little guidance available
on what constitutes good farm records (or for that matter, good veterinary
records) (Krone et al. 2014). It would seem that it is up to the individuals
concerned to decide what the appropriate records are. Notes should be
kept of why decisions were made.
●
Are the records (both farm and veterinary) recorded in a format that
allows easy distribution among interested parties? This is essential for
communication.
With careful consideration, diagnostic testing and veterinary and farm
records can be integrated with current farm practices and requirements to
maximize the benefit of a biosecurity plan with any additional workload
being reduced to the minimum.
V
ETERINARY AUDITING,CERTIFICATION, AND GOVERNMENT AGENCY
ENDORSEMENT: “HOW DO I GET THIRD-PARTY RECOGNITION OF DISEASE FREEDOM?”
The primary objectives of implementing a biosecurity plan or program is
to establish and maintain a high level of assurance that a selected epi-
demiological unit (tank/pond, farm, zone, country, etc.) is not diseased
or infected with specific infectious and contagious pathogens. Certifying an
operation or other epidemiological unit as specific pathogen free (SPF) offers
a number of obvious benefits and advantages (OIE 2015h). For commercial
aquaculture, advantages include greater animal production, increased eco-
nomic value of saleable products, and a distinct trade advantage. Similarly,
the release of SPF-certified animals for habitat or resource replenishment will
also positively impact aquatic ecosystems.
While regulatory complexity and repeated diagnostic testing leading to
assurance of disease freedom for every shipment is many times seen as a
barrier to compliance, a simple standing zoo-sanitary certificate (perhaps
titled a “Certificate of Biosecurity Assurance,” similar to “Health Certificates”
or a “Certificates of Veterinary Inspection,”—Starling et al. 2007) might be
issued to those audited operations that implement and maintain biosecurity
procedures over time. This decrease in regulatory burden for both pro-
ducers and governmental agencies is likely to encourage and stimulate an
increase in aquaculture production and have a positive impact on pro-
ducer and national economies, as they strive to feed a growing global
population.
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210 D. Pali´cetal.
DISCUSSION AND OTHER CONSIDERATIONS
In addition to developing a biosecurity plan that is efficient and ef fective,
implementing it needs to be evaluated economically (Lafferty et al. 2015;
Peeler and Otte 2014), since there are opportunity costs (the cost incurred
in deciding on one action that prevents the opportunity to take another
action). This cost can be financial or social, but the decision is usually based
on the expected benefit (both financial and social). However, there are clear
economic benefits from being declared free from many important diseases,
over and above increased productivity and the need for expensive proce-
dures such as diagnostic tests that tend to be expensive each time animals
are moved out of a farm or other EpiUnit, or government-enforced embar-
gos against importing animals from areas not implementing or documenting
effective biosecurity.
From initial considerations described previously, a well-developed writ-
ten biosecurity plan will incorporate optimal approaches for each of the steps
tailored to the needs and conditions in a specific EpiUnit and, by necessity,
will require good record keeping. Diagnostic testing as part of the records
assists in determining the benefits. A biosecurity plan may simply be in the
head of the farmer, or a one-page document detailing a few suggested pro-
cedures, or follow the minimum requirement of an Aquaculture Production
Business (APB) in the European Union. While these might be effective, it
can be questioned whether they provide any clear value and will therefore
be carried out or complied with. Even a legal requirement may not provide
sufficient incentive (Peeler and Otte 2014).
In any biosecurity plan, there is a requirement to know what infectious
diseases are present in the EpiUnit, which will require diagnostic testing.
As there is often apparently limited available data on the cost of disease
at the farm level (although reviewing papers dealing with other aspects of
a particular disease will often provide much of the required information),
any initial cost benefit analysis (more correctly termed a partial cost benefit)
that should focus on the marginal or additional benefit may well be based
on “educated guesswork.” Where the initial baseline of disease presence is
known, then the impact of disease control measures can be quantified at a
later date and the cost benefit analysis refined. Morris stated in 1995 that,
“Evidence from a wide variety of studies over the last 30 years has shown
that because of the substantial effects of diseases on productivity and the
relatively low cost of control measures, the net economic benefit obtained
from controlling animal diseases is very high, commonly in the range 200%
to 1,500% return on invested funds” (Morris 1995). If this is correct, then
one wonders at the slow uptake of biosecurity measures. Part of this may be
due to a failure to demonstrate to farmers easily assimilated evidence of the
benefits.
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Standardized Approach for Meeting Aquaculture Biosecurity Requirements 211
Diagnostic testing is also used as part of a surveillance program, which
may be seen as an additional cost. However, it can also be used to provide
additional management data, effectively providing added value, as in the
example that blood sampling and measuring liver enzyme levels appeared
to provide good monitoring for the presence of pancreas disease (Braceland
et al. 2015). Not only could this detect the likely presence of pancreas disease
and the spread throughout the epidemiological unit, but additionally it pro-
vided the farmer with information on which to base management decisions
during an outbreak and also during what might be called the recuperation
phase.
Developing, implementing, auditing, and certifying any comprehensive
biosecurity program may be complex and therefore comes at a cost. The
benefits and costs, along with developing practical approaches for imple-
menting and applying biosecurity principles, and the need for necessary
education, training, credentialing, and certification programs for all involved,
will need to be carefully assessed. This will be particularly important for the
large number of resource-limited, small-scale producers who are involved
with a considerable share of the world’s aquaculture production.
Implementing, auditing, and certifying biosecurity programs may be
driven by industry and/or governmental needs, but inevitably the most palat-
able, feasible, and practical will be those that involve government-industry
partnerships and cost sharing. Several voluntary, industry-driven biosecurity
or certification programs are evolving that may have some application to
animal health and biosecurity (OIE 2015i). Some examples include the U.S.
Marine Shrimp Farming SPF Program, World Wildlife Fund-led Aquaculture
Dialogues, Global Partnership for Good Agricultural Practice (GLOBALGAP),
and Global Aquaculture Alliance’s Best Aquaculture Practices (BAP) certi-
fication standards. Currently, no voluntary biosecurity certification schemes
have fully integrated the veterinary biosecurity principles, approaches, and
infrastructure required to effectively meet biosecurity objectives. Several
national programs with industry-government involvement are in progress
in, for example, Europe, North America, and Australia. Increasingly disease-
free and biosecurity program requirements are being addressed in legislation
and regulations (e.g., 2006/88/EC) and government-endorsed international
standards (e.g., OIE Code) for use in live animal trade and commerce (OIE
2015a; European Council 2006).
Implementation of biosecurity plans or programs to meet the primary
objectives will require input, documentation, and vigilance of many indi-
viduals, including the personnel overseeing animal and facility care and
maintenance, veterinary and diagnostic service providers, and competent
government officials. Education and training programs will be needed for
producers and private and government sector service providers to ensure that
all involved have a full understanding of all biosecurity principles, includ-
ing hazard identification and prioritization; risk assessment/evaluation, risk
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212 D. Pali´cetal.
management/mitigation, and risk communication; analysis and remediation
of critical control points where disease could enter or leave the epidemio-
logical unit; epidemiological principles, diagnostics, surveillance, monitoring,
and determining the status of or freedom from diseases; emergency pre-
paredness and contingency protocols for disease control and eradication;
and record keeping, auditing, and the use of certificates that address dec-
larations related to biosecurity procedures not typically found in existing
model certificates used for documenting animal health. The complexity and
time involved in implementing these requirements and achieving and main-
taining freedom from disease (SPF) may require a biosecurity certification
system that progressively recognizes increasing levels of biosecurity. As has
been done elsewhere, web-based, train-the-trainer, and on-farm workshops
will be effective tools for disseminating this information (Scarfe et al. 2009,
2011;Pali
´
cetal.2011).
The auditing of biosecurity procedures and records and certifying dis-
ease freedom for any specific pathogen need to be undertaken by a credible,
knowledgeable, and experienced independent third party, as these respon-
sibilities are accompanied by legal and professional liability. Traditionally
these responsibilities are assigned to veterinarians, but in some countries
that have a reduced veterinary workforce, veterinary paraprofessionals (e.g.,
fisheries officers) are sometimes utilized. In some countries, many regulatory
activities involving disease diagnosis, surveillance, monitoring, and verifica-
tion of disease presence and absence are performed by private practitioners
who are approved by the national veterinary authority. Examples include
the National Veterinary Accreditation Program (NVAP) in the United States
(USDA-APHIS 2011) and similar programs in Australia, Canada, New Zealand,
and elsewhere, in which these responsibilities are delegate to “Accredited
Veterinarians.” Within the European Union, similar programs are being del-
egated to “Official Veterinarians” in accord with the European Directive
97/78/EC (European Council 1998) and subsequent amendments. Currently
only the United States and Canada have incorporated training modules deal-
ing with aquatic veterinary procedures in their NVAP requirements. Other
countries are anticipated to follow, given the r ecent OIE recommendation for
implementation of a Performance of Veterinary Services (PVS) and Aquatic
Animal Health Services tool (OIE 2013).
Validation, verification (auditing), and certification that effective
biosecurity plans or programs have been developed are also the basis for
issuing Certificates of Veterinary Inspection, often referred to as “health
certificates” (Starling et al. 2007). These certificates are very effective risk-
communication tools to document that the epidemiological unit has been
evaluated, that appropriate disease-risk mitigating procedures (prevention
and control) are in place, and to validate that animals have been exam-
ined and tested to verify the absence (or prevalence) of disease. When
endorsed by the government agency with regulatory authority over aquatic
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Standardized Approach for Meeting Aquaculture Biosecurity Requirements 213
animal health (competent authority), biosecurity certificates provide the
official credibility that the primary biosecurity objectives have been met.
Having a sufficient experienced and credentialed workforce to provide
these services to support aquaculture is imperative, particularly if done with
government oversight or involvement and if used for international trade pur-
poses (DeHaven and Scarfe 2012). Evaluating this workforce capacity using
the OIE PVS Tool may be warranted in some countries, and a system for
competent authorities to accredit this workforce as competent officials to
perform aquatic regulatory functions (similar to existing national veterinary
accreditation systems in many countries) would substantially expand national
capacities to support aquaculture industry growth and trade (OIE 2013).
NOTES
1. The organizations that collaborated under the auspices of the IAVBC include four founding mem-
bers: (1) Center for Food Security and Public Health (CFSPH, also home of IICAB, an OIE Collaborating
Centre for Veterinary Biologicals in North America), Iowa State University; (2) Centre for Aquatic Health
Sciences (CAHS), University of Prince Edward Island, Atlantic Veterinary College, Canada; (3) Norwegian
Veterinary Institute (NVI, together with CAHS manage the OIE Collaborating Centre for Epidemiology and
Risk Assessment for Aquatic Animal Diseases—ERAAAD); and (4) Ludwig-Maximilians-University Munich
Centre of Excellence in Aquatic Veterinary Medicine, Biosecurity and Education (LMU AVC). Other orga-
nizations that provided significant input include the American Veterinary Medical Association, AusVet
Veterinary Services (Australia), and the World Aquatic Veterinary Medical Association.
2. The OIE Aquatic Code defines an epidemiologic unit as “a group of animals that share approxi-
mately the same risk of exposure to a pathogenic agent with a defined location. This may be because they
share a common aquatic environment (e.g., fish in a pond, caged fish in a lake) or because management
practices make it likely that a pathogenic agent in one group of animals would quickly spread to other
animals (e.g., all the ponds on a farm, all the ponds in a village system).”
ACKNOWLEDGMENTS
The principles presented here are the result of collaboration of a very large
number of individuals. In particular we thank the IAVBC colleagues who
have contributed significantly to developing the concept presented here,
in particular: James A. Roth, Roar Gudding, Atle Lillehaug, Larry Hammell,
Edgar Brun, Angus Cameron, and Lori Gustafson. Members of the OIE
Aquatic Animal Health Commission (Barry Hill) and FAO Fisheries and
Aquaculture (Rohana Subasinghe) provided constructive criticism and sug-
gestions for improvement of the presented concepts on multiple occasions.
Numerous other stakeholders, speakers, and attendees of the 2009 and
2011 International Aquaculture Biosecurity Conferences and other venues
where these concepts have been presented have been instrumental in
helping refine the concepts presented herein, for which we are deeply
indebted.
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214 D. Pali´cetal.
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