Biosafety Policy Research Articles

Role of Training and Experience in Biosafety Practices Among Nurses Working in Level 2 or 3 Patient Containment.

This study was conducted to assess the difference in biosafety behaviors among nurses working in a levels 2 and 3 hospital unit in Morocco and the need for additional biosafety training before working in a high-containment facility. A prospective cross-sectional and observational study was conducted among new and experienced nurses in the Center of Virology and Tropical Infectious Diseases of the Military Teaching Hospital Mohammed V of Rabat, Morocco, between December 1, 2017 and February 28, 2018 (3 months). We compared behaviors in biosafety practices (donning gloves, handwashing, etc) between the 2 groups, and data were collected by observing workers directly or via camera. A total of 31 nurses, 14 newly graduated nurses (45.2%) and 17 experienced and trained (54.8%) nurses, were observed during 89 entries into high-containment hospital rooms. Among the behaviors observed, only donning an inner pair of gloves was observed consistently between the 2 groups. Experienced and trained nurses washed their hands (100%) and observed the antiseptic contact time (71%), whereas recently graduated nurses ignored these activities significantly (79% and 32%, respectively). During handling of the patient, the trained and experienced nurses were significantly better than the new ones in the practices of biosafety and personal protection. Gaps in biosafety were observed more frequently among newly graduated workers, especially donning outer gloves before patient contact, nurses touching their faces, and the act of wearing jewelry while working. Safety training should begin early in the training curriculum with theoretical and practical courses. It must be introduced into the general biosafety policy as part of a safety and standard working culture. It is recommended that personnel be required to pass a proficiency exam in critical biosafety tasks before working with high-risk patients.

Biosafety and Bioethics Are the Ground of Modern Biotechnologies Development

This article summarizes different points of view in the context of scientific discussion on biosafety and the legal regulation of biotechnology use by states. The legal regulation of biotechnology, as a rapidly developing branch of science, concerns, first and foremost, activities related to the development, use and transfer of technologies for the use of living organisms. The main purpose of this study is to verificate the need to develop a mechanism that, according to the authors, will be able to implement the state biosafety policy based on the development of certain standards by international organizations and that will serve as a platform for the formation of international biomedical law, through integration principles of bioethics into biomedical relations. Object. The object of research is the norms of international law in the sphere of international legal regulation of the use of modern biotechnology through the lens of bioethics. Material and methods. The methodological basis of the research is comparative legal, dialectical, historical legal, comparative, and other research methods. Results. As a result of the analysis of scientific sources and approaches to solving this problem, evidence of the need for a comprehensive study of the existing scientific array to highlight bioethics has been obtained, and therefore biosafety, as an independent scientific direction in the context of modern legal biotechnology research and as part of the national security of the state. Scientific novelty. The scientific novelty of this study consists in conducting comprehensive comparative analysis of the process of formation of legal norms for the protection of human rights. These norms are contained in existing international agreements on the development of biotechnology, from the point of bioethics as a component of state biosafety. Thus, the practical sphere of implementation of the results of this study is a modern international lawmaking process that must adequately reflect the most important aspects of the application of modern biotechnology by the states of the international community. These important aspects must form the basis of the international biomedical law and the Code of Bioethics. Moreover, the authors make no claims a comprehensive analysis of the problem posed in their work, since many important aspects need further study.

Biosafety and Biosecurity Challenges Facing Veterinary Diagnostic Laboratories in Lower-Middle Income Countries in Southeast Asia: A Case Study of Thailand.

Introduction:Global concerns over emerging and transboundary infectious zoonotic diseases have increased disease diagnostic demands, especially in the veterinary sector. In developing or newly developed countries where the sector often works under limited capacity, biosafety and biosecurity are unlikely to be high-priority issues. A recent development program supported by the Biological Threat Reduction Program of the Defense Threat Reduction Agency funded by the US government aimed to increase biosafety and biosecurity measures of government veterinary diagnostic and research laboratories in Thailand.Objective:The purpose of this article is to identify biosafety and biosecurity challenges, opportunities, and recommendations.Methods:Eleven government laboratory centers were assessed against the Biosafety in Microbiological and Biomedical Laboratories (BMBL) biosafety level 2 (BSL-2) requirements checklist. The BMBL assessment outcomes were then combined with the outcomes of discussion sessions, and the results of pre- and post-test questionnaires conducted during biosafety assessment workshops and self-evaluation reports using the Food and Agriculture Organization Biosafety Laboratory Mapping Tool of each laboratory center were reviewed and summarized.Results:Despite established national policies on laboratory biosafety and biosecurity, major challenges included (1) harmonization and enforcement of these policies, especially at the regional level, and (2) engagement of personnel in implementations of biosafety and biosecurity measures.Conclusion:Consistent biosafety policy and allocated resources together with regular training are required to develop sustainable biosafety and biosecurity at the national level. Collaboration between regional countries, international organizations, and donors is essential for improving biosafety and biosecurity on a global scale through setting regional priorities, enacting regulatory standards, and providing technical and financial support.

Gender Differences in the Management of Hazardous Biological Material in Medical Teaching Laboratories

Hazardous waste of medical or research laboratory origin is a potential source of contamination to the environment. Untreated waste could contribute to the prevalence of various antibiotic-resistant human opportunistic pathogens. Efficient and proper handling and disposal of biological and clinical waste increases the biosafety of these facilities and reduce any potential threat to the environment. The aim of this study was to determine any gender difference in the management of hazardous biological materials among workers in medical teaching laboratories. The study included 75 participants, 56% of whom were females and 44% were males. A questionnaire including 4 sections was distributed among the participants. The results of the study found no gender difference in the participant's knowledge of the international biohazard and safety symbols and compliance with the recommended hazardous waste disposal procedures. In contrast, incident reporting was significantly higher among males (p < 0.05). Extensive training programs and regular review of biosafety policy in teaching medical laboratories are required.

Biosafety of RNA silencing and genome editing technologies in crop plants: Malaysian and Australian research perspectives

Research in agricultural biotechnology can produce novel solutions to address the ever growing demand for food, feed, renewable materials and renewable energy using increasingly limited resources. Yet research is expensive with long timelines before implementation can disseminate the benefits to society, so there is a need to maximise co-operation and communication between scientists, stakeholders and their governments, to optimise research, its development and the implementation of research outcomes, into mainstream applications. Recognising the impacts of regulations on biosafety, biosecurity and intellectual property policy on strategies for research, senior and early career researchers from two research intensive universities in Malaysia and Australia, held a workshop to identify and to deliberate over two key areas of technology that offer much promise for agriculture, namely RNA silencing and genome editing. A major focus of the workshop was the regulation of new breeding technologies, and how the regulations need to take into account these new technologies. Themes discussed were the need for harmonisation of international legal frameworks and careful use of terminology, standards and guidelines; and the need for good communication and consensus within and between groups of stakeholders and law-makers. This mini-review highlights the deliberations and recommendations from the workshop.

DUAL-USE TECHNOLOGIES OF CONCERN IN CONTEXT OF BIOSAFETY (review)

One of the main prerequisites for creation and dissemination of bioethics in the world was the concept of dual use in medical and biological sciences, which is defined as the direction of unintentional creation of biological threats in research or implementation of new biotechnologies. To determine the range of dual-use research that could potentially generate products, technologies, or knowledge whose misuse could harm large numbers of people or the environment and that are biosafety-relevant, the international term Dual Use Research of Concern (DURC) is used. Actualization of the debate on the dilemma of dual use in biomedical sciences is due to, on the one hand, the international community's attempt to minimize the potential for destructive use of biomedical research, on the other hand, the active search for effective ways to raise awareness of their social and moral responsibility for implementation of the results of scientific developments in the field of life. This article considers the definition of terms that define the field of DURC in the context of biosafety, which in recent decades have undergone a number of semantic changes. The article also outlines the modern general concept of DURC, defines the categories by which DURC is defined, and outlines the scope of policy on the implementation of control over DURC. Informing the scientific community engaged in biomedical research about the problem issues of DURC biotechnology is a key component of biosafety. Modern biotechnology and related biosafety issues should be applied to society needs, but without compromising human and environmental safety. Systematic consideration of all these disputable questions of the dual-use dilemma with the involvement of all stakeholders will allow to form a rational biosafety policy for biotechnology.

Biomedical Education: A Summary Report of the Biorisk Management Curriculum Development Workshop

<p style="text-align: justify;">Dear Editor,&nbsp; <p style="text-align: justify;">The safety in general and biological safety (biosafety) in particular is an important international issue. Member states of the United Nations (UN) have developed their national biosafety policies to address biosafety (and biosecurity) issues in line with the international agenda. The Biorisk Management (BRM) is a relatively new domain in biomedical sciences and biotechnology. It provides the strategic framework for action for the laboratory biosafety and biosecurity (along with bioethics).^1-2 In fact, BRM is very vital for the global safety and security. Therefore, the BRM curriculum should be developed and incorporated into biomedical sciences and biotechnology education programmes of every country to prepare next generations to meet the biosafety, biosecurity and bioethics challenges.<strong> Read more . . .&nbsp;</strong>

Knowledge of Biosafety Among Workers in Private and Public Clinical and Research Laboratories in Morocco.

This study was conducted to assess the biosafety knowledge among laboratory staff working in Morocco. A cross-sectional study was conducted among all laboratory staff in public and private clinical diagnostic and research laboratories between December 5, 2018, and January 5, 2018. Data were collected using a self-administered questionnaire distributed via Google Form. A total of 235 participants completed the study questionnaire with an estimated response rate of 19%. Overall, 79% of respondents had a high or intermediate level of knowledge. Only 17.4% had participated in prior formal biosafety training courses. The level of knowledge did not differ significantly with gender or activity sector, but it increased with work experience. Knowledge was generally intermediate for signage and principles of biosafety levels (42.1%), low for distinction between technical operations that could pose a risk by generating aerosols (30.2%), and high for wearing personal protective equipment and its components (92.8%). There was a very high level of knowledge on proper waste sorting (100%). These findings underline the need for establishing a biosafety policy and strengthening biosafety training programs in laboratories in Morocco.

Is regulation preventing the development of therapeutics that may prevent future coronavirus pandemics?

Is regulation preventing the development of therapeutics that may prevent future coronavirus pandemics?

Tuberculosis infection among primary health care workers.

ABSTRACTObjective:To estimate the prevalence of and determine the risk factors associated with latent Mycobacterium tuberculosis infection (LTBI) among primary health care workers in the city of Vitória, Brazil. Methods:This was a cross-sectional study with data collected through a survey regarding socio-demographic, occupational, clinical, and exposure characteristics, as well as knowledge about tuberculosis, conducted between 2011 and 2012. All participants underwent a tuberculin skin test (TST), and TSTs were read at 72 h by a trained professional. Results:A total of 218 primary health care workers participated in the study. The prevalence of TST positivity at the ≥ 10-mm and ≥ 5-mm cut-off points was, respectively, 39.4% (95% CI: 32.9-45.9) and 54.1% (95% CI: 47.4-60.7). Regarding occupational categories, community health agents had the highest proportion of TST positivity, regardless of the cut-off point (≥ 10 mm: 47.5%; and ≥ 5 mm: 60.5%). Regarding factors associated with TST results, “having had a previous TST” showed a statistically significant association with TST positivity at the ≥ 10-mm and ≥ 5-mm cut-off points (OR = 2.5 [95% CI: 1.17-5.30] and OR = 2.18 [95% CI: 1.23-3.87], respectively). Conclusions:The prevalence of LTBI was found to be high among the primary health care workers in this sample. Therefore, we recommend the establishment of a periodic screening program for LTBI and implementation of effective biosafety policies for the prevention of this infection among primary health care workers.

Customization of Artificial MicroRNA Design.

RNAi approaches, including microRNA (miRNA) regulatory pathway, offer great tools for functional characterization of unknown genes. Moreover, the applications of artificial microRNA (amiRNA) in the field of plant transgenesis have also been advanced to engineer pathogen-resistant or trait-improved transgenic plants. Until now, despite the high potency of amiRNA approach, no commercial plant cultivar expressing amiRNAs with improved traits has been released yet. Beside the issues of biosafety policies, the specificity and efficacy of amiRNAs are of major concerns. Sufficient cares should be taken for the specificity and efficacy of amiRNAs due to their potential off-target effects and other issues relating to in vivo expression of pre-amiRNAs. For these reasons, the proper design of amiRNAs with the lowest off-target possibility is very important for successful applications of the approach in plant. Therefore, there are many studies with the aim to improve the amiRNA design and amiRNA expressing backbones for obtaining better specificity and efficacy. However, the requirement for an efficient reference for the design is still needed. In the present chapter, we attempt to summarize and discuss all the major concerns relating to amiRNA design with the hope to provide a significant guideline for this approach.

Inclusion and Implementation of Socio-Economic Considerations in GMO Regulations: Needs and Recommendations

Socio-economic considerations are included in the regulatory frameworks on genetically modified organisms (GMOs) of many countries. This is a reflection of an increasing interest in and recognition of the necessity to consider a broader range of issues when conducting a GMO risk assessment. At the same time, there are discussions about how socio-economic considerations can be identified and how their assessment can be carried out. To provide an understanding of the advances achieved so far, we describe the state of the art of existing biosafety institutional frameworks, legislation and policies with provisions on socio-economic considerations. We analyse the scope of the socio-economic considerations that have been included, the methodological options taken and the role of participatory processes and stakeholders involvement in the GMO-related decision-making. Since many of the countries that have legislation for assessing socio-economic considerations lack implementation experience, we provide an analysis of how implementation has evolved in Norway with the intention to illustrate that the inclusion of socio-economic considerations might be based on a learning process. Norway was the first country to include broader issues in its GMO assessment process, and is at present one of the countries with the most experience on implementation of these issues. Finally, we emphasise that there is a great need for training on how to perform assessments of socio-economic considerations, as well as reflection on possible ways for inclusion of participatory processes.

Biosafety Test for Plant Growth-Promoting Bacteria: Proposed Environmental and Human Safety Index (EHSI) Protocol.

Plant growth-promoting bacteria (PGPB) colonize plants and enhance their growth by different mechanisms. Some of these microorganisms may represent a potential threat to human, animal or plant health; however, their use might be approved in parts of Europe if they have been recommended as plant growth enhancers. The current regulatory framework has resulted in a fragmented, contradictory system, and there is an urgent need to establish harmonized protocols for the predictability, efficiency, consistency and especially the safety of PGPB for human and animal health and for the environment. In response to current efforts to update biosafety policies and provide alternative methods to replace the use of vertebrate animals, we propose a panel of tests and an evaluation system to reliably determine the biosafety of bacterial strains used as PGPB. Based on the results of different tests, we propose a scoring system to evaluate the safety of candidates for PGPB within the limitations of the assays used.

Experimental assessment of gene flow between transgenic squash and a wild relative in the center of origin of cucurbits

The introgression of modified genetic sequences (transgenes) into wild populations hinges on the generation of viable and fertile hybrids from crosses between transgenic cultivars and their wild relatives. We assessed the risk of escape of a gene construct that confers resistance to three viruses (ZYMV, WMV, CMV) from a transgenic zucchini (Cucurbita pepo) to Cucurbita argyrosperma ssp. sororia, a wild relative at the center of origin of the genus in Mexico. We experimentally generated first and second generation hybrids, as well as backcross progeny (BC), and evaluated their performance. The virus‐resistance transgene was successfully inherited into both hybrid generations and also to BC progeny from the crosses of hybrids with the wild relative. The transgene generally followed Mendelian inheritance as a dominant trait. Both hybrid generations and the BC progeny had lower reproductive output compared to the wild parent. Given that the hybrid and BC progeny were viable and fertile, the escape and persistence of the transgene is possible via wild populations of C. argyrosperma ssp. sororia. This information is essential for biosafety policy in Mexico—center of origin and diversification of several crops—where the liberation of genetically modified plants is currently under approval, and risk assessment is necessary.

Progress and Challenges for Implementation of the Common Market for Eastern and Southern Africa Policy on Biotechnology and Biosafety.

In 2001, the Meeting of the COMESA Ministers of Agriculture raised concerns that proliferation of genetically modified organisms (GMOs) could impact significantly on trade and food security in the region. This triggered studies on a regional approach to biotechnology and biosafety policy in Eastern and Southern Africa. The studies and stakeholder consultations revealed that farm incomes would increase if they switched from conventional varieties of cotton and maize to genetically modified (GM) counterparts. Commercial risks associated with exports to GM sensitive destinations, e.g., EU were negligible. Intra-regional trade would be affected since exports of GM sensitive commodities, such as maize, cotton, and soya bean, mainly go to other African countries. These findings justified the need to consider a regional approach to biosafety and led to the drafting of a regional policy in 2009. The draft policies were discussed in regional and national workshops between 2010 and 2012 for wider ownership. The workshops involved key stakeholders including ministries of agriculture, trade, environment, national biosafety focal points, biosafety competent authorities, academia, seed traders, millers, the media, food relief agencies, the industry, civil society, competent authorities, and political opinion leaders. The COMESA Council of Ministers in February 2014 adopted the COMESA policy on biotechnology and biosafety that takes into account the sovereign right of each member state. Key provisions of the policy include recognition of the benefits and risks associated with GMOs; establishment of a regional-level biosafety risk-assessment system; national-level final decision, and capacity building assistance to member states. The policies are the first regional effort in Africa to develop a coordinated mechanism for handling biosafety issues related to GMO use. A regional approach to biotechnology and biosafety is expected to foster inter-country cooperation through the sharing of knowledge, expertise, experiences, and resources.

Synthetic circuit designs for earth terraformation.

BackgroundMounting evidence indicates that our planet might experience runaway effects associated to rising temperatures and ecosystem overexploitation, leading to catastrophic shifts on short time scales. Remediation scenarios capable of counterbalancing these effects involve geoengineering, sustainable practices and carbon sequestration, among others. None of these scenarios seems powerful enough to achieve the desired restoration of safe boundaries.Presentation of the hypothesisWe hypothesize that synthetic organisms with the appropriate engineering design could be used to safely prevent declines in some stressed ecosystems and help improving carbon sequestration. Such schemes would include engineering mutualistic dependencies preventing undesired evolutionary processes. We hypothesize that some particular design principles introduce unescapable constraints to the engineered organisms that act as effective firewalls.Testing the hypothesisTesting this designed organisms can be achieved by using controlled bioreactor models, with single and heterogeneous populations, and accurate computational models including different scales (from genetic constructs and metabolic pathways to population dynamics).Implications of the hypothesisOur hypothesis heads towards a future anthropogenic action that should effectively act as Terraforming processes. It also implies a major challenge in the existing biosafety policies, since we suggest release of modified organisms as potentially necessary strategy for success.ReviewersThis article was reviewed by This article was reviewed by Eugene V. Koonin, Tom Ellis (nominated by Purificación Lopez-Garcia) and Eörs Szathmary.

A Survey of Biosafety Practices of Clinical Laboratory Personnel in Four Selected Clinical Laboratories

Objective: Biosafety is an important element of quality management systems in laboratory practice as it is a measuring tool for compliance with accreditation and certification standards. Our aim was to assess the practices of laboratory personnel towards biosafety measures in their respective laboratories. Methods: The study design was a quantitative and qualitative cross sectional prospective one obtained with the use of a structured questionnaire. Data analysis was done with Epi Info version 3.4.1 and was presented using frequency tables with chi square calculated for different variables with the significant p value set at ≤ 0.05. Results: There were 63 respondents in the study. Private laboratories fared better in an assessment of their biosafety practices. Comparative variables identified as unsafe biosafety practices between public and private laboratories were non availability of Hepatitis B virus antibody testing, p value 0.01, odds ratio 5.4, consuming food in the laboratory, p value 0.00, odds ratio 0.2., non-use of N95 masks p value 0.04, O.R 3.9 and biosafety cabinet use p value 0.05, O.R 2.8. Discussion: Biosafety practices in Nigeria need to be streamlined in accordance with good laboratory practices in order to forestall workplace accidents and promote a safe environment for testing of clinical human samples. Conclusion: The absence of appropriate biosafety policies and practices is one of the challenges facing health care workers in sub Saharan Africa. There is the need for biosafety to be placed in the front burner of issues in laboratory practice in our respective facilities.

Comparative Strategic Behavior of Advocacy Coalitions and Policy Brokers: The Case of Kenya’s Biosafety Regulatory Policy

This paper sheds some light on the behavior and effect of advocacy coalitions and policy brokers in a quest to manage collective action problems in Kenya’s biosafety policy process between 1990 and 2011. The analysis demonstrates that formation of coordination structures was one way of solving collective action problems while the resulting coordination patterns were instrumental in characterizing the competing coalitions. An important finding of this study is that strategic actions of these structures were linked to the “devil shift” situation and conflict escalation. This necessitated the intervention of an administrative government agency that negotiated a win–win policy compromise as a policy broker. The dynamic activities of the coalitions and the broker were linked to useful policy learning. The examination of insights drawn from this case study enriches our understanding of the under-researched behavior of coalitions and the policy broker elements of the Advocacy Coalition Framework (ACF).

Robust biosafety policy needed to protect Indian lab workers

Robust biosafety policy needed to protect Indian lab workers

GM crops, the environment and sustainable food production

Today, over 7.1 billion people rely on the earth's resources for sustenance, and nearly a billion people are malnourished, their minds and bodies unable to develop properly. Globally, population is expected to rise to more than 9 billion by 2050. Given the combined pressures of human population growth, the rapidly growing desire for increased levels of consumption, and the continued use of inappropriate technologies, it is not surprising that humans are driving organisms to extinction at an unprecedented rate. Many aspects of the sustainable functioning of the natural world are breaking down in the face of human-induced pressures including our individual and collective levels of consumption and our widespread and stubborn use of destructive technologies. Clearly, agriculture must undergo a redesign and be better and more effectively managed so as to contribute as well as possible to feeding people, while at the same time we strive to lessen the tragic loss of biodiversity and damage to all of its productive systems that the world is experiencing. For GM crops to be part of the solution, biosafety assessments should not be overly politically-driven or a burdensome impedance to delivering this technology broadly. Biosafety scientists and policy makers need to recognize the undeniable truth that inappropriate actions resulting in indecision also have negative consequences. It is no longer acceptable to delay the use of any strategy that is safe and will help us achieve the ability to feed the world's people.