Vasconcelos Gioia et al. One Health Outlook (2021) 3:14 One Health Outlook https://doi.org/10.1186/s42522-021-00045-8

REVIEW Open Access Informing resilience building: FAO’s Surveillance Evaluation Tool (SET) Biothreat Detection Module will help assess national capacities to detect agro- and agro-crime Gisela Vasconcelos Gioia1* , Gaël Lamielle1, Ryan Aguanno1, Ihab ElMasry1, Béatrice Mouillé1, Cristian De Battisti1, Angélique Angot1, Fanny Ewann2, Adrien Sivignon2, Daniel Donachie3, Orr Rozov1, Étienne Bonbon1, Frédéric Poudevigne1, Sophie VonDobschuetz1, Ludovic Plée1, Wantanee Kalpravidh1 and Keith Sumption1

Abstract Attacks using animal pathogens can have devastating socioeconomic, public health and national security consequences. The livestock sector has some inherent vulnerabilities which put it at risk to the deliberate or accidental spread of disease. The growing concern of countries about the risks of agro-terrorism and agro-crime has led to efforts to prepare against potential attacks. One recent international effort is the launch of a joint OIE, FAO and INTERPOL project in 2019 to build resilience against agro-terrorism and agro-crime targeting animal health with the financial support of the Threat Reduction Programme of Global Affairs . Given the importance of strong animal health surveillance systems for the early and effective response to agro-terrorism and agro-crime, the project will use the FAO Surveillance Evaluation Tool (SET) and its new Biothreat Detection Module to evaluate beneficiary countries’ capacities to detect criminal or terrorist animal health events. This paper presents the development of the new SET Biothreat Detection Module and how it will be used to evaluate surveillanceforagro-terrorismandagro-crimeanimaldiseasethreats.Themodulewillbepilotedinearly2021and, once finalized, will be used by beneficiary countries of the joint OIE-FAO-INTERPOL project. Results from evaluations using SET and its Biothreat Detection Module are expected to provide a baseline from which countries can build targeted capacity for animal disease surveillance including early detection and investigation of potential terrorist or criminal events involving zoonotic and non-zoonotic animal pathogens. Keywords: Agro-terrorism, Agro-crime, Surveillance, Biothreat, Needs assessment, Pathogens

* Correspondence: [email protected] The views expressed in this publication are those of the authors and do not necessarily reflect those of the World Organisation for Animal Health (OIE), the Food and Agriculture Organization of the United Nations (FAO) and the International Criminal Police Organization (INTERPOL). 1Food and Agriculture Organization of the United Nations (FAO), Rome, Full list of author information is available at the end of the article

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Introduction harming humans [6]. On the other hand, 80% of agents Before the United Nations Biological Weapons Conven- with potential bioterrorist use are zoonotic [13]. tion (BWC) came into effect in 1975 [1], the study and In terms of vulnerabilities, many factors make animals use of animal pathogens as biological weapons was not more vulnerable to compared to humans exceptional. Countries such as the , former and crops. Firstly, current intensive farming practices USSR, Canada, , and the can facilitate and accelerate the spread of diseases [9, 14, pursued bioweapons programs at various points that in- 15]. Secondly, insufficient biosecurity or disease surveil- cluded research on many animal pathogens which cause lance in animals in some countries, facilitate the intro- diseases such as , African swine fever (ASF), bru- duction and favor greater spread of diseases before they cellosis, Foot-and-mouth disease (FMD), , New are detected and control measures applied [9, 16]. Castle disease and Rinderpest [2, 3]. Today, most coun- Thirdly, there is usually a limited number of veterinar- tries have joined the Convention which requires all ians, veterinary paraprofessionals (VPP), community ani- States Parties to never develop, produce, stockpile, ac- mal health workers (CAHWS) and other animal health quire or retain weapons using biological agents or professionals, especially in the field, capable of detecting [1]. However, especially after the in exotic or eradicated diseases that have similar clinical the United States, concerns have grown regarding the signs and symptoms than endemic disease. This may development and use of biological weapons by non-state also delay detection and implementation of appropriate actors. This led to the development of the United Na- control measures [9, 14, 15]. Moreover, many animals tions Security Council Resolution 1540 in 2004, which will likely be naïve or unvaccinated to exotic or eradi- requires all Member States to adopt laws and effective cated diseases which would potentially facilitate the measures to prevent the proliferation of nuclear, chem- spread and severity of the disease [15]. Fourthly, animals’ ical or biological weapons and their means of delivery by congregation and movement within and between coun- non-state actors, in particular for terrorist purposes [4]. tries are greater than those of crops, notably through Although rare, reports exist throughout history of transhumance or for commercial purposes. The move- non-state actors using or threatening to use biological ment of animals and animal products have greatly in- agents against animals [2, 3, 5, 6]. These acts, when im- creased in the past years due to trade but also to the plemented to coerce politico-social objectives, are classi- globalization of livestock value chains. Today, the differ- fied as agro-terrorism, a sub-set of bioterrorism ent production phases such as reproduction, fattening specifically targeting livestock and crop production [3, and slaughter are rarely done at the same location [14, 7]. When motivated by financial or personal gain, these 15]. The increasing and prosperous illegal trade of exotic deliberate acts are considered as agro-crimes [8]. The pets and wildlife has also been pointed out as a major serious economic, social, public health and security im- gateway for infectious diseases [11]. Finally, advance- pacts of a major animal disease outbreak, the inherent ments in the areas of molecular biology, genomics, bio- vulnerabilities of the livestock sector and of the exotic informatics and genetic engineering have opened a wide pet and wildlife trade, and the perceived advantages of range of positive and dangerous possibilities such as the biological weapons compared to other weapons makes development of genetically-modified disease-causing or- agro-terrorism appealing to ill-intended non-state actors ganisms [16]. [3, 9–11]. As potential biological weapons, animal patho- In view of such risks, several authors and reports have gens can be easier to obtain, handle and be released with called for the development of international and national cap- less expertise and technology compared to other uncon- acities for the prevention, detection and response to agro- ventional weapons [9, 10]. Many biological agents are terrorism and agro-crime [6, 9, 10, 13, 15]. In response, the environmentally resistant and are not included in vac- international community has promoted resilience against cine programs, making them attractive candidates as agro-terrorism and agro-crime with the development of bioweapons. The acquisition and production costs can strategies and activities on biological threat reduction [13, also be considerably lower. According to Gyles (2010), 17–19]. One recent effort is the creation of a consortium be- producing biological weapons may cost approximately tween the World Organisation for Animal Health (OIE), the 10 million USD while nuclear weapons require approxi- Food and Agriculture Organization of the United Nations mately 1 billion USD to develop. In addition, non- (FAO) and the International Criminal Police Organization zoonotic pathogens would be safer for a terrorist to ma- (INTERPOL) to enhance prevention and response to agro- nipulate but can still cause serious harm to a country’s terrorism and agro-crime affecting animals. The consortium economy and food security. For instance, ASF could be signed a joint project in October 2018 on “Building resilience introduced in a country or farm via contaminated items against agro-terrorism and agro-crime” with the financial [12]. Attacks on animals may also be perceived as less support of the Weapons Threat Reduction Programme ethically and morally discomforting compared to (WTRP) of Global Affairs Canada [20]. Vasconcelos Gioia et al. One Health Outlook (2021) 3:14 Page 3 of 13

The aim of the project is the sustainable increase of veterinary laboratories involved in the handling and test- global resilience against animal health emergencies aris- ing of samples from potential terrorist or criminal in- ing from agro-terrorism and agro-crime by improving duced animal disease outbreaks. The FAO GEMP will coordination between the animal health and law en- also include an additional module to evaluate capacities forcement sector. The project focuses on the three prior- and provide training to beneficiary countries on emer- ity regions of the Middle East, North Africa, and South gency management of agro-terrorism and agro-crime East Asia where previous work of the three organizations events. Lastly, the new Biothreat Detection Module de- identified gaps in various aspects of emergency manage- veloped for the FAO SET is the focus of this paper. ment that may make them vulnerable to emergencies Although countries may take several actions to prevent resulting from agro-crime and agro-terrorism [21]. The agro-terrorism or agro-crime, emphasis should be placed first phase of the project focuses on evaluating the on early detection to counter such occurrences [27]. current capacity of target regions and seeking to find in- Therefore, effective preparedness and response frame- novative and sustainable solutions to emergency man- works are needed. This requires well-functioning surveil- agement. Using this evidence, a second phase of lance systems which allow the early detection and trainings, including the development of fit-for-purpose response to an outbreak or event, the tracing of cases for guidance, tools, and workshops, will be implemented disease containment and perpetrator identification, and followed by a third phase that will use regional simula- the confirmation of the end of an outbreak [27]. In tion exercises and a large international simulation exer- addition, animals may act as sentinels for bioterrorism cise to challenge and test the lessons learned and the attacks with zoonotic pathogens [13]. Thus, to inform efficiency of international cooperation. capacity building efforts and biothreat reduction policies, Lastly, through a continuous coordination and com- the joint OIE-FAO-INTERPOL project will evaluate munication phase, project outputs will be shared and beneficiary countries’ capacities to detect deliberate ani- used to produce communications and advocacy material mal health events using FAO’s Surveillance Evaluation to encourage collaboration between veterinary and law Tool (SET) and its new Biothreat Detection Module enforcement sectors. The project will culminate with a along with other tools of the consortium. In this paper, global conference on animal health and welfare emer- we present the newly developed SET Biothreat Detection gency management to review and share lessons learned Module and how it will evaluate the capacity of coun- and knowledge acquired and rally support from the tries to conduct effective surveillance for agro-terrorism international community for an all-hazards and multi- and agro-crime. sectoral approach to emergency management [20]. To evaluate needs and capacities of beneficiary coun- tries, the project will use the OIE Tool for the Evaluation Main text of the Performance of Veterinary Services (PVS) and The FAO Surveillance Evaluation Tool (SET) three FAO tools, namely the Laboratory Mapping Tool SET was developed in 2017 by FAO upon request from (LMT), the Good Emergency Management Practices beneficiary countries in Africa under the Global Health (GEMP) and the Surveillance Evaluation Tool (SET). Security Agenda (GHSA). The tool’s objective is to pro- Relevant results of past Joint External Evaluations (JEE) vide countries with detailed guidance and recommenda- lead by the World Health Organization (WHO) and of tions to improve their national animal disease surveillance recent reports regarding biological security needs, trends systems. SET was adapted from the OASIS tool (“Outil and priorities by the United Nations Interregional Crime d’Analyse des Systèmes de Surveillance”), developed by and Justice Research Institute (UNICRI) will also be the French Agency for Food, Environmental and Occupa- used when available [22]. Additional questions or mod- tional Health & Safety (ANSES) [28], and has been used in ules regarding agro-terrorism and agro-crime preven- 18 countries in Africa and Asia to date [24]. Reports of tion, detection or response are currently being past SET evaluations whose publication were authorized developed for the OIE PVS and the three FAO tools by the respective national Chief Veterinary Officers (LMT, GEMP and SET). The outcomes of PVS evalua- (CVO) are available at the FAO webpage for SET [24]. tions will provide a wider perspective on the current SET is an Excel-based tool with 90 indicators divided performance of veterinary services and resilience against into seven areas and 19 categories specific to animal dis- agro-terrorism and agro-crime targeting animals, ease surveillance (Table 1). The evaluated country re- whereas the FAO SET, LMT and GEMP tools will re- ceives a score from 4 to 1 based on their current spectively provide a more detailed evaluation of national capacity in each indicator. An example of a SET indica- animal disease surveillance, diagnostic and emergency tor is provided in Table 2. Once all 90 indicators are preparedness capacities [23–26]. The LMT Biothreat scored, the tool automatically generates graphics depict- Module will be used to evaluate the capacity of ing the system’s strengths and weaknesses (Fig. 1). Vasconcelos Gioia et al. One Health Outlook (2021) 3:14 Page 4 of 13

Table 1 Overview of SET areas, categories and indicators Area Category Number of Summary of topics covered by indicators indicators Institutional Central institutional 7 Existence of an operational management structure; Existence of steering and technical/ organization organization scientific committees; Existence of formal description of the system’s organization and operations; Vertical coordination and supervision of field level units; and Adequacy of central level resources. Field institutional 8 Formalization, coverage and representativeness of field units; Vertical and horizontal organization coordination between field units; Supervision of field units; and Adequacy of resources. Intersectoral 4 Coordination with private, public health and environmental sectors. collaborations Laboratory Operational aspects 2 Effective integration of laboratories in the surveillance system; and Adequacy of resources. Technical aspects 8 Quality assurance mechanisms including tests, laboratory reagent control and inter- laboratory proficiency testing; Work standardization between laboratories; Field laboratory support; and Relevance, sensitivity and specificity of tests. Analytical aspects 3 Laboratory data management; and Timeliness and quality of laboratory reports. Surveillance Objectives and 4 Quality and formalization of surveillance objectives; and Relevance of priority diseases activities context of surveillance Surveillance data 14 Existence and quality of surveillance plans; Existence and quality of data collection tools; collection Existence and quality of case definitions; Completeness and timeliness of disease reports; Appropriate sample collection; and Timeliness of results delivery. Surveillance 9 Existence and quality of surveillance protocols; Existence and quality of active surveillance procedures activities; Existence of wildlife surveillance; and Existence of vector surveillance. Animal health 2 Availability of animal health investigation teams; and Quality and timeliness of investigations investigations. Risk assessment 2 Implementation and usefulness of animal health risk assessments. Workforce Workforce 5 Planning, Terms of Reference (ToRs) and qualification of epidemiology staff; and Existence management of sufficient manpower for surveillance. Training 4 Existence and overall quality of initial and refresher surveillance staff trainings; and Adequacy of resources for trainings. Data Information system 2 Adequacy and quality of the data management system for the needs of the system. management Data processing and 5 Existence of protocols, quality and timeliness of data entry, validation and analysis; exploiting Existence of sufficient trained staff for data entry, management and analysis; and Adequacy of resources for data management and analysis. Communication Internal 4 Existence, timeliness and completeness of surveillance reports; Existence and timeliness of communication feedback to field actors; and Existence of horizontal and vertical communication mechanisms within the surveillance system. External 3 Existence and timeliness of newsletters; Existence and implementation of an external communication communication policy; and Adequacy of resources for communication. Evaluation Internal evaluation 2 Existence, quality, timeliness and use of performance indicators for the continuous improvement of the surveillance system. External evaluation 2 Existence and use of external evaluations for improvement of the surveillance system.

Table 2 SET indicator number 34 # Indicator Score 4 Score 3 Score 2 Score 1 34 Level of detail, Objectives are well detailed and completely Objectives could benefit Objectives require Objectives are accuracy, and formalized, rendering it possible to estimate from the addition of some significant additional not formalized, formalization of disease prevalence or assess the probability of minor details and details and detailed, or objectives detection in conformance with the nature and formalization. formalization. relevant. purpose of the system. Each indicator in SET is scored from 4 to 1. Score 4 represents full capacity, Score 3 represents moderate capacity, Score 2 represents low capacity and Score 1 represents very low capacity. Above is the indicator 34 of SET under the area of surveillance activities and the category of surveillance objectives Vasconcelos Gioia et al. One Health Outlook (2021) 3:14 Page 5 of 13

Fig. 1 Example of graphical output of the FAO Surveillance Evaluation Tool (SET) using figurative results of a fictive country. The spider graph shows results by SET category of a fictive country who has conducted two SET evaluations. Each of the 19 SET categories form an individual axis whose value varies from 0 to 100%. The green line shows results for the first SET evaluation and the red line shows results for the second SET evaluation conducted 3–5 years after the initial evaluation. The closer either line is positioned to the outer border of the graph, the higher the capacity of the country in the respective category and vice-versa. The graphic shows the progress the country has made after implementing the recommendations of the first SET evaluation, particularly the development and implementation of a communication and inter-sectoral collaboration plan

Scoring is based on information obtained from inter- achievable, locally relevant and have realistic timelines. views with stakeholders from central, sub-national and At the end of the mission, the results and recommenda- field levels of the surveillance system as well as a thor- tions are presented to decision-makers for feedback and ough review of relevant documentation (e.g. surveillance a report is drafted. The report, which includes a detailed plans, protocols, legislation, etc.). This is done during action plan to improve the country’s animal disease sur- the first week of a 12-day mission in the target country. veillance system, is usually finalized around 60 days after Stakeholders vary among countries but generally include the mission and posted online once cleared by the coun- the veterinary service’s epidemiology unit, field veterin- try’s Chief Veterinary Officer (CVO) [24] (Fig. 2). ary officers, veterinary laboratories, VPPs and CAHWS, multi-sectoral partners (e.g. Ministry of Health, Ministry The SET Biothreat Detection Module of Environment/Wildlife, One Health platforms), the pri- Given the importance of strong surveillance systems in vate sector, border inspection posts, slaughterhouses, the preparedness and response to agro-terrorism and markets and more. These stakeholders are identified in agro-crime, the OIE-FAO-INTERPOL consortium de- close collaboration with veterinary services focal points cided to use SET to obtain a detailed understanding of during the preparatory phase of the mission, which usu- the beneficiary countries’ animal disease surveillance sys- ally begins 1 month before the mission itself. It is also tems. However, the surveillance of potential deliberate during the preparatory phase that the evaluation teams, animal disease outbreaks, particularly the investigation which include SET experts and focal points from na- of these events, require additional coordination and tional veterinary services, are formed. activities beyond that of routine surveillance, such as fo- During the second week of the mission, evaluators rensic investigation, forensic sampling and testing, score all 90 indicators, analyze the graphical outputs, proper chain-of-custody processing, among others [7]. and conduct an in-depth analysis of the strengths, weak- Therefore, a specific Biothreat Detection Module was nesses, opportunities and threats (SWOT) of the coun- developed to be used within SET to assess the capacity try’s animal disease surveillance system. The SWOT of countries to detect unusual animal health events that analysis results are then used to guide the development are indicative of agro-terrorism or agro-crime. The Bio- of recommendations that are specific, measurable, threat Detection Module consists of a list of indicators Vasconcelos Gioia et al. One Health Outlook (2021) 3:14 Page 6 of 13

Fig. 2 Overview of a SET mission. After at least 1 month of preparation, the in-country SET mission is conducted for 10–12 days. After a launching meeting with key decision-makers, the first week of the mission is dedicated to interviews with all relevant stakeholders. The second week of the mission is dedicated to scoring all 90 indicators of SET and 32 indicators of the SET Biothreat Detection Module (if used), and the development of recommendations and a first draft of the action plan for improvement of the country’s animal disease surveillance system. The second week ends with a closing meeting presenting the main results and recommendations to key decision-makers. The SET report is drafted, finalized and cleared for publication by the country’s Chief veterinary officer approximately 60 days after the in-country mission that can be used by interested countries in addition to of agro-terrorism and agro-crime against animal health. the core SET indicators during an evaluation mission. These stakeholders may include law enforcement au- The Module was developed by animal health and law thorities, customs, military forces, bioterrorism or agro- enforcement experts from FAO, OIE and INTERPOL with terrorism focal points in veterinary services and other a background in epidemiological surveillance, animal inter-sectoral partners, laboratories handling and testing health emergencies, veterinary diagnostics and biothreat samples from suspected deliberate animal health events, reduction. An initial draft was developed between March among others. Additional relevant documents may in- and May 2020 based on an extensive literature review of clude legislation and strategies to counter agro-terrorism more than 50 documents including international and na- or agro-crime, joint criminal and epidemiologic investi- tional strategies and guidelines, workshop reports, peer- gation guidelines, memoranda of understanding between reviewed articles, legislation, international conventions veterinary services and law enforcement, lists of patho- and more. The draft was then reviewed by 14 biothreat re- gens and toxins of concern for agro-terrorism and agro- duction experts with different technical and geographic crime, among others. backgrounds (Table 3) between July and September 2020. Once all 32 indicators are scored, the module will The module is currently expected to be piloted and final- automatically generate a spider graph of the country’s ized in early 2021. strengths and weaknesses in the detection of biological The module includes 32 indicators divided into 7 cat- threats (Fig. 3). This graphical output may then be used egories related to the surveillance of potential deliberate to develop recommendations to improve national sur- animal disease outbreaks, including their investigation veillance of agro-terrorism and agro-crime events. Simi- (Table 4). Similar to SET, the indicators are scored from lar to SET, recommendations will be developed using 1 to 4 based on the country’s capacity. Scoring will be the SMART approach (Specific, Measurable, Achievable, based on interviews of relevant stakeholders and on the Relevant and Time-bound). For this, the recommenda- review of relevant documents related to the surveillance tions will be prioritized into short, medium and long- acneo Gioia Vasconcelos ta.OeHat Outlook Health One al. et

Table 3 List of external reviewers of the SET Biothreat Detection Module and their technical and geographic background Background Technical Geographic Gender

Reviewer Biothreat Surveillance Investigation Emergency Laboratory Wildlife Public Law Military North Middle Southeast Sub- Europe North Latin (2021)3:14 reduction health enforcement Africa East Asia Saharan America America Africa Alessandro Ripani X X Male Armin Elbers X X X Male Fee Zimmermann X X X X Female Gary Flory X X X Male Gary A. XX X Male Vroegindewey Jacqueline Roberta X X X Female Soares Salgado Julie R. Sinclair X X Female Júlio Gouveia- XX X X Male Carvalho Mirza Qakhon X X X Male Hatoqay Rickard Knutsson X X X X Male Sean Shadomy X X X X X Male Stephen Papagiotas X X X Male Zalini Yunis X X X X Female ae7o 13 of 7 Page Vasconcelos Gioia et al. One Health Outlook (2021) 3:14 Page 8 of 13

Table 4 Overview of SET Biothreat Detection Module categories and indicators Category Number of Summary of topics covered by indicators indicators Institutional 5 Existence of agro-terrorism and agro-crime committee; Existence of formal documents on the organization organization and operation of agro-terrorism and agro-crime surveillance; Existence of focal points and mechanisms for national and international collaboration between animal health, law enforcement and other relevant sectors; and Adequacy of resources for surveillance of agro-terrorism and agro-crime. Laboratory 6 Mechanisms in place to meet laboratory epidemiologic and forensic needs; Existence of guidelines for sampling in joint epidemiologic and criminal investigations; Adequacy of resources and existence of laboratory information management system (LIMS) in laboratories involved in joint investigations; and Capacity of the country to differ endemic, foreign, emerging and potentially manipulated pathogens. Surveillance 11 Existence and quality of a list of pathogens of concern for agro-terrorism and agro-crime; Knowledge of epi- activities demiological situation of pathogens of concern; Existence of awareness campaigns on exotic and eradicated diseases; Existence and implementation of triggers and mechanisms for secure information sharing between veterinary services and law enforcement; Cross-border animal disease surveillance capacity; and Existence and quality of guidelines on joint epidemiological and criminal investigations. Risk assessment 2 Implementation, quality and use of threat/risk assessments to guide agro-terrorism and agro-crime surveil- lance activities. Workforce 5 Existence of staff planning, roster of investigators, background checks and trainings on detection, reporting and joint epidemiological and criminal investigations of potential agro-terrorism or agro-crime animal health events. Data 1 Existence and implementation of mechanisms to secure surveillance data and sensitive information from management theft, loss or misuse. Evaluation 2 Implementation and use of joint simulation exercises and after action reviews for improvement of agro- terrorism and agro-crime surveillance.

term and detailed in an action plan for improvement of animal health agro-terrorism and agro-crime surveillance. The 7 categories of the SET Biothreat Detection Module are Institutional Organization, Laboratory, Surveillance, Risk Assessment, Workforce, Data Management and Evaluation. The following sections describe the require- ments for effective surveillance of suspected deliberate animal disease outbreaks and how national capacities to implement these activities are evaluated under each cat- egory of the SET Biothreat Detection Module.

Institutional organization category of the SET Biothreat Detection Module The timely exchange of information between animal health and law enforcement agencies is critical to con- tain the spread of disease and apprehend the perpetra- tors in a deliberate outbreak. However, several factors may delay the exchange of information including hesi- tancy to share information due to its sensitivity, legal barriers, and lack of awareness and guidance on how to collaborate. Lack of clear guidance on: leadership for re- Fig. 3 Example of graphical output of the FAO SET Biothreat sponse activities when a terrorist or criminal event tar- Detection Module using figurative results of a fictive country. The geting animals is suspected or confirmed, the role and spider graph shows results by SET Biothreat Detection Module category of a fictive country. Each of the 7 SET Biothreat Detection responsibilities of each entity involved, the appropriate Module categories form an individual axis whose value varies from 0 communication lines to be followed as well as outreach to 100%. The blue line shows the results for the SET Biothreat to the public may cause an overlap of efforts, waste of Detection Module from 0 to 100%. The closer the line is positioned resources, and delayed detection of the outbreak source to the outer border of the graph, the higher the capacity of the and of identification of the perpetrators leading to an country in the respective category and vice-versa overall inefficient response [15, 29, 30]. Vasconcelos Gioia et al. One Health Outlook (2021) 3:14 Page 9 of 13

Thus, the institutional organization category of the laboratory capacity to meet surge demands in case of a SET Biothreat Detection Module evaluates the factors nationwide emergency [32]. that would create an enabling environment for intersec- Moreover, for laboratory results to be accepted as evi- toral collaboration and efficient detection of potential dence in court, laboratories and field agents must comply deliberate animal disease outbreaks. This includes the with specific chain of custody procedures [31]. These existence of committees to discuss, develop and review practices ensure the integrity of evidence, demonstrate strategies and plans related to agro-terrorism and agro- that evidence has been handled properly at all times and crime surveillance based on national needs and threats. that no misconduct or tampering took place, and include It also includes the existence of a formal framework that a chronological documentation [32]. Thus, chain of cus- outlines the organization and operation of surveillance tody must be maintained and documented from the col- activities for the detection of potential deliberate animal lection, packaging, handling, and transport of samples, to health events, the existence of focal points and mecha- their arrival, analysis, storage and disposal, to the drafting nisms for national and international inter-sectoral col- and reporting of laboratory results in court [31–33]. laboration particularly between animal health and law The existence of national mechanisms to meet epide- enforcement agencies, and the existence of sufficient miologic and forensic laboratory needs during a poten- resources. tially deliberate animal disease outbreak and the availability of guidelines on proper sample collection, Laboratory category of the SET Biothreat Detection transport, handling and preservation for diagnostic and Module criminal investigation purposes are evaluated in the la- Initially, veterinary services and law enforcement have boratory category of the SET Biothreat Detection Mod- the common aim of identifying the causative agent and ule. The module also addresses the availability of source of a potentially deliberate outbreak using similar sufficient resources in relevant laboratories and the per- methods. However, the end goal of law enforcement is centage of laboratories with information systems. These to determine who committed the criminal offence and information systems are important for evidence tracing, bring them to prosecution. To this end, law enforcement chain of custody maintenance and for timely sharing of agencies use biological and other conventional evidence laboratory results [33]. Finally, the laboratory category to build a case for attribution to a specific source and verifies the capacity of the country to differentiate for- identify perpetrators, partners in crime and victims. Ex- eign, emerging or manipulated pathogens from those ploitation of criminal evidence may require forensic that are already circulating in the country. This would methods that delve deeper into the characterization of require knowledge on the epidemiological situation of the pathogen and specific processing methods. These animal diseases in the country as well as access to tech- methods must be standardized, validated and meet stan- nologies and expertise for pathogen characterization dards for its results to be accepted as evidence in court such as genetic sequencing [14, 33]. While SET and its [31]. Yet, not all forensic laboratories have the necessary Biothreat Detection Module focus on the general cap- equipment for processing and testing animal pathogens acity of laboratory networks, once developed the LMT and biological toxins while not all veterinary or public Biothreat Module will provide valuable details on the health laboratories can perform the necessary forensic specific capacities of veterinary laboratories which can analysis of conventional evidence (fingerprints, DNA, complement SET results with a more complete picture etc.). Therefore, mechanisms need to be in place to meet of national diagnostic capacities. the needs of both the animal health and law enforce- ment sectors in a joint investigation [30, 32]. This may Surveillance category of the SET Biothreat Detection be done by establishing a network of laboratories across Module the animal health, law enforcement and other sectors, Any animal disease surveillance system relies on farmers, such as public health laboratories, that have the neces- private veterinarians, VPP, laboratories, CAHWs and sary expertise and meet the required standards to con- other data sources to report disease events. The add- duct the appropriate diagnostic and forensic analysis. itional challenge for the detection of deliberate animal These networks were established along the XXI century health events is that many classic bioterrorism or agro- in a few countries [15, 30, 33]. Nevertheless, countries terrorism pathogens are rare, non-endemic or eradi- should at a minimum be aware of national and inter- cated. Therefore, the detection should also rely on the national laboratory capabilities across animal health, capacity of animal health professionals to recognize public health and forensic sectors. Based on this, na- eradicated or exotic diseases of high risk for agro- tional plans can be developed, and collaboration agree- terrorism or agro-crime [9, 14, 15, 30]. In light of this, ments established. It is worth noting that these plans the SET Biothreat Detection Module includes an indica- should also include mechanisms for increasing tor verifying the existence of awareness building Vasconcelos Gioia et al. One Health Outlook (2021) 3:14 Page 10 of 13

programs to inform these data sources on relevant exotic Moreover, disease surveillance at entry points of a and eradicated diseases based on the country’s risk country, such as airports, ports, border posts, bus sta- situation. tions and postal services, are crucial for preventing the Early response to deliberate outbreaks also requires accidental or deliberate entry of diseases in a country law enforcement and animal health authorities to share [13]. Therefore, the surveillance category of the SET Bio- information and collaborate. Sharing of information even threat Detection Module evaluates the existence of strat- before confirming suspicions of a deliberate outbreak egies and plans for cross-border surveillance and the can be crucial in the identification of the source, control capacity of points of entry to conduct surveillance. of the spread of disease and apprehension of the perpet- Once a suspected deliberate animal disease outbreak is rator. However, information sharing and collaboration considered a credible threat, it is usually advisable to between sectors for all outbreaks would be overly bur- conduct a joint epidemiologic and criminal investigation densome and unnecessary [15, 29, 30]. To address this between animal health and law enforcement authorities challenge, a few countries and authors have proposed [29, 30, 32]. Depending on the outbreak, other sectors the development of a list of triggers that should prompt may be included such as public health authorities when animal health and law enforcement authorities to collab- the outbreak involves a zoonotic disease or environmen- orate [29, 30, 32, 34, 35]. Among the possible triggers tal authorities when it involves wildlife. Although it is suggested by authors is the detection of a disease with recommended for authorities to agree on actions on a an unusual geographic, host or seasonal distribution or case-by-case basis, general guidelines can provide an ini- with an unusual presentation. For this to be noted, ani- tial understanding on how to proceed including where, mal health authorities must be aware of the epidemio- how and who to include in the investigation, how to logic distribution of the diseases circulating in the conduct interviews, how to communicate with farmers, country and the region. This includes information on the public and all those along the relevant livestock the temporal, geographic and host distribution of patho- value chain, and key principles in outbreak investigations gens and toxins as well as their characteristics such as and criminal investigations (e.g. sample collection, bio- antigenic variants and genetic sequencing [29, 30, 32]. safety and biosecurity procedures, chain of custody pro- However, countries may not have enough resources to cedures, etc.) [29, 30, 32]. Therefore, the existence of regularly collect data on all animal pathogens and toxins. joint criminal and epidemiologic investigation guidelines A commonly used method to prioritize efforts is to focus for animal health events is also assessed by the module. on a list of pathogens and toxins of concern for agro- terrorism and agro-crime based on the country’s context Risk assessment category and threat landscape that is regularly reviewed and up- In this category, the module verifies whether the country dated. Examples include the List of Select Agents and regularly conducts joint risk assessments for potential Toxins of the United States Department of Agriculture agro-terrorism and agro-crime threats involving all rele- (USDA) and the Group Common Control List vant stakeholders. The module also verifies whether all of Human and Animal Pathogens and Toxins [36, 37]. the minimum components of a risk assessment are done, The existence of such a list of pathogens and toxins of and if the results are used in risk management to inform concern, the country’s knowledge on the epidemiological strategies, plans, lists of pathogens and toxins of concern situation of these pathogens and toxins of concern, and and other relevant documents in the detection of agro- the existence of a list of triggers for information sharing terrorism and agro-crime. These assessments are im- are also evaluated under the surveillance category of the portant in prioritizing efforts in the detection of agro- SET Biothreat Detection Module. terrorism and agro-crime [32]. The module also verifies the existence of guidelines or protocols for information sharing between law enforce- Workforce category of the SET Biothreat Detection ment and veterinary services. This is important to allow Module for the safe exchange of information and to overcome po- One of the factors affecting the surveillance of agro- tential barriers to the exchange such as legal restrictions terrorism and agro-crime is the availability of staff with [32]. Moreover, when triggers are met, it is advisable for the necessary training and expertise [27, 32]. In the law enforcement and animal health authorities to quickly workforce category, the SET Biothreat Detection Module verify the suspicion in order to avoid unnecessary use of verifies the existence of staff planning and of a roster of resources in response to a hoax or false alarm [29, 30]. investigators for the surveillance and investigation of The module also assesses the existence and implementa- suspected or confirmed deliberate outbreaks. The mod- tion of protocols to verify the credibility of a possible ule also evaluates the existence of trainings for relevant agro-crime or agro-terrorism threat as well as the report- staff of the animal health, law enforcement and other ing timeliness between sectors of unusual events. relevant entities on the detection, reporting and Vasconcelos Gioia et al. One Health Outlook (2021) 3:14 Page 11 of 13

investigation of potential or confirmed deliberate animal have shown that most countries are not prepared for disease outbreaks. This category also addresses the exist- such threats [2, 7, 22]. This is also mentioned by the UN ence of mechanisms to avoid information concealment, Secretary General who stated “the weaknesses and lack the sharing of false information or the misuse of infor- of preparedness exposed by this [COVID-19] pandemic mation by animal health, law enforcement or other staff. provide a window onto how a bioterrorist attack might unfold – and may increase its risks. Non-state groups Data management category of the SET Biothreat could gain access to virulent strains that could pose Detection Module similar devastation to societies around the globe [38].” The loss, theft or misuse of information could jeopardize The SET Biothreat Detection Module was initially devel- criminal investigations and place the country at risk. Ill- oped to evaluate national agro-terrorism and agro-crime intended actors could use the information for several ne- surveillance capacities and needs to inform subsequent farious ends [29, 30, 32]. As such, the category of data capacity development efforts in beneficiary countries management was created to include an indicator to as- under the joint FAO, OIE and INTERPOL “Building resili- sess the existence of mechanism to prevent the theft, ence against agro-crime and agro-terrorism” project. Once loss or misuse of surveillance data and information. piloted and finalized, the module could also be used with SET by other interested countries to obtain a baseline of Evaluation category of the SET Biothreat Detection country capacity for animal disease surveillance including Module early detection and investigation of potential terrorist or In general, simulation exercises are done to test, evalu- criminal events involving zoonotic and non-zoonotic ani- ate, and refine plans and protocols. Joint simulation ex- mal diseases. FAO is currently planning the organization ercises and trainings between animal health, law of trainings on the use of SET and its Biothreat Detection enforcement and other relevant entities on important Module precisely to expand the network of evaluators surveillance and joint investigation plans and protocols throughout the world that may lead national missions. also build relationships between the sectors and allow The end result of SET missions is an action plan with staff to gain familiarity and expertise with the principles detailed short, medium and long-term recommendations and methods of the detection of deliberate animal dis- to improve national animal disease surveillance systems. ease outbreaks [29, 30, 32]. The evaluation category of The SET Biothreat Detection Module will have the same the SET Biothreat Detection Module assesses whether final output to guide governments on how to improve countries regularly conduct simulation exercises with all the early detection of potential agro-terrorism and agro- relevant staff of law enforcement, animal health and crime events. Moreover, evaluations using SET and its other pertinent sectors as well as after action reviews new Biothreat Detection Module can be repeated every (AAR) following an actual event or exercises. The mod- 3–5 years or upon request from countries to show pro- ule also verifies if these joint exercises and AARs lead to gress following implementation of recommendations. corrective measures to improve the detection of agro- The expectation is that such evaluations will thus sup- terrorism and agro-crime. port ongoing and future efforts to build resilience against agro-terrorism and agro-crime worldwide. Conclusion Acknowledgments Recent epidemics, especially the current COVID-19 pan- We thank all experts who dedicated their time to review the SET Biothreat demic, show us how their impacts may span far beyond Detection Module and shared their expertise with authors to ensure the the physical health of people and animals by also affect- development of a quality tool, namely Alessandro Ripani, Armin Elbers, Fee Zimmermann, Gary Flory, Gary Vroegindewey, Jacqueline Soares, Julie ing livelihoods, economies and food security. The UN Sinclair, Julio Gouveia-Carvalho, Mirza Qakhon Hatoqay, Rickard Knutsson, Secretary General’s remarks to the Security Council on Sean Shadomy, Stephen Papagiotas and Zalini Yunis. We also thank in ad- the COVID-19 pandemic notes that the pandemic also vance our FAO, OIE and INTERPOL field colleagues and the national animal health and law enforcement counterparts of the beneficiary countries and re- poses serious threats to public security and peace by gions who will support us in the piloting and implementating the SET Bio- eroding trust in public institutions, creating stressors threat Detection Module. We would like to give special thanks to colleagues that can lead to conflicts in fragile societies, postponing in the FAO Near East and North Africa region without whom the piloting of the module would not be possible. Last but not least, we are extremely democratic elections or referenda, creating uncertainties grateful to the Government and people of Canada for their generous finan- that may escalate violence, hindering international, re- cial support that has made all activities under the OIE-FAO-INTERPOL project gional and national conflict resolution efforts, and by against agro-terrorism and agro-crime possible. creating a potential window of opportunity for terrorists Authors’ contributions while the attention of governments is focused on the GVG conducted the literature review and coordinated the drafting and pandemic [38]. Yet, despite the potentially devastating review of the SET Biothreat Detection Module. GVG, GL, IE, RA, SvD, OR, EB, FP, CDB, BM, AA, DD, EF and AS developed the SET Biothreat Detection impacts of accidental or deliberate events using animal Module. LP is the Global coordinator of the FAO Emergency Management pathogens, surveys to date and the current pandemic Center for Animal Health which is the lead unit for the implementation of all Vasconcelos Gioia et al. One Health Outlook (2021) 3:14 Page 12 of 13

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