Biosafety System Research Articles

Global Health Security Risk Assessment in the Biological Threat Reduction Program.

In 2014, the Biological Threat Reduction Program (BTRP) developed a country assessment tool to assess the risk to a country's biosurveillance, biosafety, and biosecurity systems and their vulnerability to naturally occurring, accidental, or nefarious release of weaponizable pathogens. The country assessment tool is a unique method of assessing public health and veterinary systems at the national and subnational levels. The assessment process is led by a multisectoral, multidisciplinary team composed of 8 subject matter experts who conduct a combination of document reviews, individual and focus group interviews, and in-person assessments. The intent of the tool was to standardize the BTRP program planning process and support quantitative metrics to measure partner country capacities and capabilities throughout BTRP engagement. Used in more than 25 countries to establish a baseline of the health security risk landscape, the tool provides a foundation for identifying and prioritizing system-wide risk mitigation and management activities as well as periodic evaluations of the impacts of these activities.

An interim review of lessons from the Novel Coronavirus (SARS-CoV-2) outbreak in China

<p indent="0mm">Since the spread of the novel coronavirus (SARS-CoV-2), China has launched an unprecedented fight against the epidemic. At the beginning of the outbreak, China responded quickly by informing the World Health Organization (WHO) and sharing sequence information internationally soon after the draft genome of the virus was revealed by Chinese researchers. China’s effort in transparency, data sharing and quick response for controlling the outbreak was praised by the international community. Although the outbreak is not over yet, the important consideration for this and future outbreaks has aroused wide public discussion. This article is aimed to identify the lessons we could learn from the outbreak and propose suggestions for future improvement from aspects including improving the public health and disease control and prevention system, improving the emergency response mechanism, promoting technological innovation, and increasing medical supplies and reserves. An enhanced holistic system is in urgent need for disease control and prevention through strengthening the public health and disease control and prevention system, improving the emergency response system, building relevant legal system, and establishing a national biosafety system. Future outbreaks might be inevitable, but we can save more lives and avoid much financial loss by effective countermeasures when public health emergency happens.

A brief history of the development of infectious disease prevention, control, and biosafety programs in China

Safety of human beings has always been threatened by infectious diseases. In the process of fighting them, humans have continuously explored and researched the pathogens, transmission routes, prevention, and curing methods as well as other aspects concerning these diseases; therefore, accumulating a rich experience. Here, biosafety refers to the prevention and control measures taken to reduce risk factors leading to infectious diseases. Since ancient times, China has been aware of biosafety and has taken aggressive measures to reach it. Nowadays, China has established a complete infectious disease prevention, control, and biosafety system which effectively reduces the prevalence of infectious diseases. In this paper, the history on the development of infectious disease prevention, control, and biosafety protocols in China since ancient times is studied. Moreover, specific suggestions for their improvement are proposed.

Erratum

In the journal Bulletin of the Russian State Medical University (July – August 2018/04, p. 5–18), mistakes were made in the article: https://vestnikrgmu.ru/archive/2018/4/1/abstract?lang=en Guschin VA, Manuilov VA, Makarov VV, Tkachuk AP. The proper structure of a biosafety system as a way of reducing the vulnerability of a society, economy or state in the face of a biogenic threat. Bulletin of RSMU. 2018; (4): 5–18. DOI: 10.24075/brsmu.2018.054 The editors ask for the following changes: Printed by: p. 5, "Funding" This work was supported by the Ministry of Health of the Russian Federation as part of the project The National System for Chemical and Biological Security of the Russian Federation (2015-2020) and by the Ministry of Education and Science as part of the project RFMEFI60117X0018. It should be: This work was supported by the Ministry of Education and Science within the framework of the project RFMEFI60117X0018.

Pathogenic microorganism biobanking in China

Pathogenic microbial strains and specimens are crucial national and strategic biological resources. Preservation and management of the pathogenic microbial resources, as an integral component of biosafety, play an important role in the national biosafety system and in the overall framework of national security. Sound preservation and management rely on the effective designation of preservation institutions, strengthened operation and management of preservation institutions, standardized description and data specifications, establishment of preservation information management systems, and promotion of resource-sharing and utilization. Firm protection and efficient sharing and utility of pathogenic microbial resources are expected to make a unique contribution to the sustainable development of the national economy.

Readiness for Environmental Release of Genetically Engineered (GE) Plants in Uganda

Research and development of genetically engineered (GE) crops in Uganda was initiated in 2003 with the launch of a national agricultural biotechnology center at Kawanda in central Uganda. The country has now approved 17 field experiments for GE plants, which were first established in 2006 with the planting of a banana confined field trial that evaluated performance of plants modified to express resistance to black sigatoka disease. Researchers leading the GE experiments have indicated that some of these GE plants are ready for environmental release that is moving beyond confined field testing toward commercialization. The government of Uganda, over the past two decades, has supported processes to put in place an effective national biosafety framework including establishment of a supportive policy environment; creation of a clear institutional framework for handling applications and issuance of permits; building critical capacity for risk analysis; and providing options for public engagement during decision-making. Uganda is ready to make a biosafety decision regarding environmental release of GE plants based on the level of capacity built, progress with priority GE crop research in the country, and the advancement in biosafety systems. Enactment of a national biosafety law that provides for a coordinated framework for implementation by the relevant regulatory agencies will strengthen the system further. In addition, product developers need to submit applications for biosafety approval for environmental release of GE crops so that mechanisms are tested and improved through practice.

The proper structure of a biosafety system as a way of reducing the vulnerability of a society, economy or state in the face of a biogenic threat

Оценка потенциальной уязвимости общества, экономики и государства перед биогенными угрозами сводится прежде всего к поиску слабых звеньев существующей системы обеспечения биологической безопасности государства. К ним можно отнести как отсутствие отдельных элементов и технических средств мониторинга биологических рисков, так и недостаточность имеющихся аналитических средств для принятия своевременных мер по предупреждению биологических угроз или устранению их последствий. В целом действующие на сегодняшний день в России системы мониторинга биологических угроз достаточно хорошо развиты. Однако их отдельные элементы, во-первых, ведомственно разобщены, что не позволяет создать единую систему с общей координацией, а во-вторых, ни один из них по отдельности не дает результатов, соответствующих всем требованиям, предъявляемым к такой информации. Так, в России действуют, как минимум, четыре отдельные государственные системы сбора информации по эпидемической и эпидемиологической ситуации, которые с должной эффективностью решают узкие задачи по инфекционному мониторингу, но, к сожалению, не способны дополнять друг друга из-за отсутствия единого аналитического центра с доступом ко всем данным. На сегодняшний день отсутствие единого мониторингового центра в области биологической безопасности является фактором потенциально высокой уязвимости общества, экономики и государства перед лицом биогенных угроз. Необходима надлежащая организация современной полнофункциональной и эффективной национальной системы мониторинга биологических угроз как основа для функционирования общенациональной службы обеспечения биологической безопасности и одновременно как средство для идентификации и устранения собственных уязвимых элементов такой государственной структуры.

Надлежащая организация системы биобезопасности как средство снижения уязвимости общества, экономики и государства перед биогенными угрозами

To understand how vulnerable are a society, an economy and a state in the face of a biohazard, one should attempt to identify any potential holes in the national biosafety system, such as the lack of important components or technologies for biological monitoring and the inadequacy of existing analytical methods used to prevent or counteract biogenic threats. In Russia, biological monitoring is quite advanced. However, the agencies that ensure proper functioning of its components lack collaboration and do not form a well-coordinated network. Each of such agencies alone cannot provide comprehensive information on the subject. In the Russian Federation, there are at least 4 state-funded programs that collect epidemiological data and are quite efficient in performing the narrow task of monitoring infections. But because there is no central database where epidemiological data can be channeled and subsequently shared, these agencies do not complete each other. This leaves the Russian society, economy and state vulnerable to biogenic threats. We need an adequately organized, modern, fully functional and effective system for monitoring biohazards that will serve as a basis for the national biosafety system and also a tool for the identification and elimination of its weaknesses.

Assessment of National Public Health and Reference Laboratory, Accra, Ghana, within Framework of Global Health Security.

The Second Year of Life project of the Global Health Security Agenda aims to improve immunization systems and strengthen measles and rubella surveillance, including building laboratory capacity. A new laboratory assessment tool was developed by the Centers for Disease Control and Prevention to assess the national laboratory in Ghana to improve molecular surveillance for measles and rubella. Results for the tool showed that the laboratory is well organized, has a good capacity for handling specimens, has a good biosafety system, and is proficient for diagnosis of measles and rubella by serologic analysis. However, there was little knowledge about molecular biology and virology activities (i.e., virus isolation on tissue culture was not available). Recommendations included training of technical personnel for molecular techniques and advocacy for funding for laboratory equipment, reagents, and supplies.

Biosafety in the Context of Labour Protection. Biotechnological and Regulatory Aspects

Вackground. The rapid spread of modern biotechnologies causes public concern about their potential harmful effects on biodiversity, taking into account risks to human health. One of the important aspects of the implementation of the biosafety requirements is the observance of rules of labor protection.Оbjective. The aim of this work is to analyze the current status of biosafety through the implementation of requirements for labor protection in enterprises and research institutions of biotechnological (pharmaceutical) profile.Methods. The analysis and synthesis of information on biotechnological and regulatory aspects of biosafety and occupational safety are conducted.Results. The biological safety principle is to limit the spread or prevent spillage of infectious material from the lab environment, where various manipulations or maintaining in culture of the material are carried out. The main legal documents regulating the sphere of labor protection when working with BO in Ukraine: Law of Ukraine “On ensuring sanitary and epidemic wellbeing of population”, Law of Ukraine “On state Biosafety system while creating, testing, transportation and use of genetically modified organisms”, the State sanitary norms and rules on “Organization of work of laboratories in the material study, which contains pathogenic biological agents of I–IV groups of pathogenicity by molecular-genetic methods”, State sanitary rules on “Safety of work with microorganisms of I–II groups of pathogenicity”.Conclusions. An important element of access for the products of the biotechnology industry of Ukraine to the markets of developed countries is compliance with international recommendations on biosafety, which is not possible without the implementation of relevant international instruments in domestic legislation. The formation of the system approach to biosafety and occupational safety in enterprises and research institutions of biotechnological profile will contribute to the development and implementation of regulations (licensing conditions) for the implementation of the activities with genetically modified organisms.

National biosafety system for regulating agricultural biotechnology in India

Agricultural biotechnology has the potential to improve crop productivity, increase farm incomes, and alleviate food security concerns in India. Adoption of such technologies has resulted in the need for establishing biosafety regulatory systems to reduce and eliminate potential risks arising from agribiotechnology on plant, animal and human life, environment and biodiversity. As a Party to the Convention on Biological Diversity and Cartagena Protocol, India has taken the role of strengthening her biosafety system very seriously. In this paper, we have undertaken a comparative study of the existing national biosafety framework (NBF) in place in India, with the UNEP-GEF Framework implemented across 126 countries. On comparison with the UNEP-GEF Framework, the Indian experience has been admirable, but not without its own challenges. The purpose of this exercise is to identify challenges within the system, in an endeavour to transform the Indian biosafety regulatory system into a predictable, transparent and sustainable system.

Regulatory oversight of human pathogens and toxins in Canada.

From 1994 to 2009, federal oversight of human pathogens and toxins was limited to facilities importing human pathogens and toxins into Canada under the Human Pathogens Importation Regulations (HPIR). This narrow focus of authority restricted the Government of Canada's ability to regulate and monitor a full range of activities, including those involving human pathogens and toxins acquired from domestic sources. In 2009, the Human Pathogens and Toxins Act (the Act) received Royal Assent to establish a national safety and security regime and expand oversight through a national, standardized process to verify safe and secure use of human pathogens and toxins in Canada. The Act and the Human Pathogens and Toxins Regulations (the Regulations), in full force since December 1, 2015, provides legislative and statutory requirements for the comprehensive oversight of the control of human pathogens and toxins in Canada. Expanded regulation and monitoring program activities aim to reduce the risks posed by human pathogens and toxins and strengthen biosafety management systems that serve to protect the health of Canadians.

Alimentos derivados de cultivos genéticamente modificados. ¿Nuevos, seguros para la salud humana, consumidos?

Since 1996, with the approval by the FDA of the first food derived from a genetically modified crop, the tomato SavrFlavr®, which had a delayed maturation, development of genetically modified organisms (GMOs) has grown rapidly, being considered the biotechnology technique with the faster adoption and globally growth. The development of recombinant DNA technology allowed more efficient and safe developments, such as in the pharmaceutical industry for the production of antibiotics, vaccines, hormones, diagnostics, recombinant human insulin; in floriculture, for the development of new varieties; repair of contaminated environments and in agriculture, for introducing traits, in particular for herbicide tolerance and insects resistance. Parallel to these developments,concerns have arisen about the safety and harmlessness of genetically modified crops and foods derived from them, which has led to the development of biosafety systems that seek to establish appropriate measures for research, use, handling, transportation, safe marketing of GMOs. This paper describes the evolution of the development of biosafety systems for GMOs in this country, the current regulatory system, the procedures, and also describes the gradual process of adoption and use of GM crops.

A mobile biosafety microanalysis system for infectious agents.

Biological threats posed by pathogens such as Ebola virus must be quickly diagnosed, while protecting the safety of personnel. Scanning electron microscopy and microanalysis requires minimal specimen preparation and can help to identify hazardous agents or substances. Here we report a compact biosafety system for rapid imaging and elemental analysis of specimens, including powders, viruses and bacteria, which is easily transportable to the site of an incident.

Seroprevalence of Salmonella and Mycoplasma in commercial broilers, backyard chickens, and spent hens in the region of Triângulo Mineiro, State of Minas Gerais, Brazil

Avian salmonellosis and mycoplasmosis are infectious diseases that, in addition of causing lack of flock uniformity, represent a hazard to human health. The objective of the present study was to evaluate the seroprevalence of mycoplasmosis and salmonellosis in commercial broilers, backyard chickens, and spent hens slaughtered at a processing plant with local health inspection in Uberlândia, MG, Brazil. A total of 210 samples were randomly collected at the time of bleeding. Samples were submitted to rapid plate serum agglutination test (RSA) for the classification of Salmonella pullorum, Salmonella gallinarum, Mycoplasma gallisepticum and Mycoplasma synoviae. In order to increase result specificity, mycoplasmosis-positive samples were submitted to hemagglutination inhibition test (HI). No samples presented detectable antibodies against Salmonella pullorum or Salmonella gallinarum in the RSA test. Only Mycoplasma synoviae was detected in 14% of the backyard chickens and 0.74% in commercial broilers, whereas no antibodies were detected in spent hens. The seroprevalence rates found in the present study emphasize the need of keeping chicken flocks free from disease using effective biosafety systems.

GENETICALLY MODIFIED BANANAS: PAST, PRESENT AND FUTURE

Edible bananas comprise several characteristics that make them an ideal target for improvement through genetic engineering: (i) they constitute the N° 1 fresh fruit crop in the world, (ii) they are highly sterile which makes classical breeding extremely difficult but at the same time prevents transgene drift via pollen into the environment, (iii) their cultivation is monoclonal, and (iv) they are susceptible to a wide range of pests and diseases. The latest outbreak of Fusarium wilt disease caused by Fusarium oxysporum f. sp. cubense Race 4 or TR4, which is seriously threatening the international banana trade, strengthens the need for developing resistant bananas. Despite these facts, the number of publications and research groups dealing with genetic engineering of banana remains low compared to other crops. Possible reasons are among others the difficulties in obtaining transformation competent tissues (in case of banana embryogenic cell suspensions or ECS), the duration to obtain fully transformed plants, the cost and effort of maintaining transgenic lines, the lack of a proper and functional legal biosafety system for testing and culturing GMOs in many banana producing countries and the size of individual banana plants rendering large scale testing of transgenes extremely costly. In this review, we discuss the 19 years history of banana genetic modification. An overview of the different transformation methodologies will be given, from the first reports on protoplast electroporation to Agrobacterium-mediated transformation of ECS. Also the applications of this technology for banana improvement (agronomic treats, quality treats, etc.) will be discussed along with examples of confined field trials of genetically modified bananas. Finally, a brief overview of the research topics on banana genetic engineering at the Laboratory of Tropical Crop Improvement (LTCI, KU Leuven, Belgium) is discussed. Topics include selectable marker genes, promoter and gene characterization as well as molecular breeding for fungus and drought resistance.

Revealing the footprint: Supranational organizations and transnational governance of biotechnology in southern Africa

AbstractThis paper analyses the roles of three supranational organizations (SNOs), the African Union (AU), New Partnership for Africa's Development (NEPAD) and Southern African Development Community (SADC), in the development of cross‐national policy, regulatory and administrative systems for managing modern biotechnology, also referred to as biosafety systems, in southern Africa. The desire for convergence of these systems is not an uncontested issue. Therefore in seeking to understand the feasibility of this policy agenda, this paper traces how the three SNOs are contributing towards coalescence of the many contending issues. One of the major arguments presented by the paper is that the policy footprint of the SNOs has varying intensity across the biosafety terrain of the region, leaving one wondering whether this is by design or by accident, and what impact this has on the countries that see the SNOs as rallying points for regional aspirations.

Biosafety systems in Eastern and Central Africa

This review examines the biosafety systems of selected countries in the Eastern and Central Africa. The biosafety systems are meant to safeguard human health, animal health and the environment against any possible risks posed by development and application of modern biotechnology. Though the focus is in the Eastern and Central African region, the study gives an overview of worldwide biosafety frameworks as guided by the Cartagena protocol on biosafety. The Eastern and Central African countries covered in this study are Tanzania, Kenya, Uganda, Rwanda, Burundi, Ethiopia and the Democratic Republic of Congo (DRC). An attempt is made to assess the current status on the countries’ compliance to biosafety international conventions, institutional arrangements and regulatory regimes. A critical look is given to the existing biosafety frameworks, pinpointing their weaknesses and giving suggestions on what could be done to address the shortfalls. The study shows that Kenya is leading the group by having all the requirements in place, followed by Uganda. Tanzania has cleared the legal frameworks hurdles, but it is rather slow in processing applications of genetically modified organisms (GMOs) for containment and confined trials. Ethiopia, Rwanda, Burundi and DRC are still in the process of formulating their biosafety laws. The challenges facing the operationalization of the biosafety systems are financial constraints, insufficient trained human resources, poor facilities, low awareness and insufficient political will by some governments. It is argued that while biosafety frameworks stand to safeguard safe application of modern biotechnology, they should not have too stringent regulations, lest they impede the development of modern biotechnology in the Eastern and Central African region. Key words : Biosafety, Cartagena Protocol, genetically modified organisms, regulatory regimes, institutional framework, liability and redress.

Epidemiological Situation Control at Biohazardous Facility

The analysis of current regulatory requirements and applicable guidelines, as well as scientific papers, confirmed the existence of the subsystem of the control over epidemiological situation at the potentially hazardous biological facility. This subsystem is an element of the facility biosafety support system. Developed is the set of models which contain schemes of epidemiological situation management in case a sick facility officer is detected whose disease is suspected to be caused by the microorganisms of I-II pathogenicity groups.

Socio‐economic Considerations in Biosafety and Biotechnology Decision Making: The Cartagena Protocol and National Biosafety Frameworks

AbstractArticle 26.1 of the Cartagena Protocol on Biosafety left open the possibility for member countries to include in their biosafety regulatory processes the assessment of socio‐economic considerations. Countries may also decide to include such assessments as part of their national legislation or regulations for the approval and deliberate release into the environment of genetically engineered technologies. Countries are debating if and how to implement assessment of socio‐economic considerations. This paper contributes to the ongoing policy dialogue by discussing issues related to socio‐economic assessment including scope, timing, inclusion modalities, methods, decision‐making rules and standards, and the integration of socio‐economic assessments in biosafety and/or biotechnology approval processes. This paper also discusses the implications of such inclusion for technology flows and public and private sector R&amp;D. If inclusion is not done properly, it may negatively impact technology flows especially from the public sector and render an unworkable biosafety system.