%0 Journal Article %J Vaccines (Basel) %D 2023 %T Oncolytic Viruses: An Inventory of Shedding Data from Clinical Trials and Elements for the Environmental Risk Assessment. %A Sheela Onnockx %E Aline Baldo %E Katia Pauwels %K biosafety %K cancer %K Clinical trials %K environmental risk assessment %K oncolytic virus %K shedding %X

Attenuated and/or genetically modified oncolytic viruses (OV) gain increasing interest as a promising approach for cancer therapy. Beside the assessment of subject safety, quality and efficacy aspects of medicinal products for human use, genetically modified viruses are also governed by EU regulatory frameworks requiring an environmental risk assessment (ERA). An important element to be assessed as part of the ERA is the incidence of exposure to OV of individuals, other than the trial subjects, and the environment. The evidence-based evaluation of shedding data is considered to be decisive in that context, as it may impact the OV capacity to be transmitted. This is particularly true for OV still able to (conditionally) replicate as opposed to replication-defective viral vectors commonly used in gene therapy or vaccination. To our knowledge, this article presents the most extensive and up-to-date review of shedding data reported with OV employed in clinics. Besides the identification of a topical need for improving the collection of shedding data, this article aims at providing an aid to the design of an appropriate shedding study, thereby relying on and further complementing principles described in existing guidelines issued by European and international institutions.

%B Vaccines (Basel) %V 11 %8 2023 Sep 01 %G eng %N 9 %R 10.3390/vaccines11091448 %0 Journal Article %J Vaccines %D 2021 %T Environmental Risk Assessment of Recombinant Viral Vector Vaccines against SARS-Cov-2 %A Aline Baldo %A Amaya Leunda %A Nicolas Willemarck %A Katia Pauwels %B Vaccines %V 9 %8 Jan-05-2021 %G eng %N 5 %R 10.3390/vaccines9050453 %0 Book %B Vaccines - the History and Future’ %D 2019 %T GMO Regulatory Aspects of Novel Investigational Vaccine Candidates %A Amaya Leunda %A Katia Pauwels %K environmental risk assessment %K European directives %K GMO %K novel vaccine candidates %K regulatory challenges %X

Recent scientific and technical developments create novel opportunities for
vaccine development. Regulatory compliance has to be ensured from preclinical
research to market authorization, whereby different legal frameworks that go
beyond quality, efficacy or patient safety aspects need to be taken into account.
As academia and start-ups are often focused on gathering scientific evidence,
the regulatory maze is often regarded by applicants as challenging in the overall
pathway to clinical translation. This is particularly true for applications concerning
vaccine candidates containing or consisting of genetically modified organisms
(GMOs). Active communication between applicants and competent authorities or
advisory bodies early in the development stages facilitates a correct implementation
of the regulatory frameworks and is of utmost importance to identify challenges
or hurdles in order to avoid unnecessary delay in scientific review. Based on the
state-of-play in Belgium, this chapter discusses examples of regulatory journeys of
applications with genetically modified viral vectors and novel vaccine candidates
that have been reviewed by GMO national competent authorities in Belgium and in
Europe. They highlight the need of having a comprehensive view of global perspectives
early in the development to facilitate the translation of research to clinical
development or even market authorization.

%B Vaccines - the History and Future’ %G eng %0 Journal Article %J Council for Agricultural Science and Technology (CAST) %D 2018 %T Genome Editing in Agriculture: Methods, Applications, and Governance—A paper in the series on The Need for Agricultural Innovation to Sustainably Feed the World by 2050 %A AJ Bogdanove %A DM Donovan %A E Elorriaga %A J Kuzma %A Katia Pauwels %A S Strauss %A D Voytas %X

Genome editing is the process of making precise, targeted sequence changes in the deoxyribonucleic acid of living cells and organisms. Recent advances have made genome editing widely applicable, offering the opportunity to rapidly advance basic and applied biology. In the face of the mounting food, fiber, feed, and fuel needs and the decreasing availability of land and water caused by global population growth, as well as the challenges climate change poses to agriculture, genome editing for crop and livestock improvement is garnering increasing attention. This issue paper describes how genome editing is performed, the types of “edits” that can be made, how the process relates to traditional breeding and conventional genetic engineering, and the potential limitations of the approach. The paper also presents an overview of the current landscape of governance of genome editing, including existing regulations, international agreements, and standards and codes of conduct, as well as a discussion of factors that affect governance, including comparison with other approaches to genetic modification, environmental and animal welfare impacts of specific applications, values of producers and consumers, and economic impacts, among others. Recognizing both that genome editing for crop and livestock improvement has the potential to substantially contribute to human welfare and sustainability and that successful deployment of genome editing in agriculture will benefit from science-informed, value-attentive regulation that promotes both innovation and transparency (alongside strategies to improve food distribution, decrease socioeconomic disparities, mitigate barriers to trade, and moderate political and market dependencies), the paper aims to provide a conceptual and knowledge-based foundation for regulatory agencies, policy- and lawmakers, private and public research institutions, industry, and the general public.

%B Council for Agricultural Science and Technology (CAST) %V 60 %8 2018 %G eng %N 60 %0 Report %D 2016 %T Annual polio report for the European Regional Certification Commission for the year 2015. National Certification Committee Belgium %A E Mendes %A Katia Pauwels %A Martine Sabbe %K national %K polio %K public health %X

Abstract

This annual polio report consists of three sections: 1) the National Certification Committee statement, 2) the update on general programme activities, and 3) the update on the status of the National plan of action to sustain polio-free status.

%I WIV-ISP %C Brussels %P 49 %8 01/04/2016 %G eng %M D/2016/2505/08 %0 Report %D 2015 %T Annual polio report for the European Regional Certification Commission for the year 2014. National Certification Committee Belgium. %A E Mendes %A Katia Pauwels %A Martine Sabbe %K Activity %K Belgium %K Certification %K European %K general %K health %K national %K ON %K programme %K public %K public health %K Public-health %K regional %K report %K status %K Surveillance %X

This annual polio report consists of three sections: 1) the National Certification Committee statement, 2) the update on general programme activities, and 3) the update on the status of the National plan of action to sustain polio-free status.

%I Public Health and Surveillance, WIV-ISP %C Brussels %P 39 %8 1/4/2015 %G eng %M D/2015/2505/39 %1

5198

%& 1 %0 Book %B Animal Cell Culture %D 2015 %T Biosafety Recommendations on the Handling of Animal Cell Cultures %A Philippe Herman %A Katia Pauwels %E Al-Rubeai,Mohamed %K a %K Activity %K Agent %K an %K Animal %K aspects %K assessment %K at %K Back %K biosafety %K Cell %K cell culture %K cells %K compliance %K conditions %K Contained use %K containment %K contaminant %K contaminants %K culture %K Development %K Diagnosis %K Engineering %K environment %K EVALUATION %K genetically %K Genetically modified %K Genetically modified organisms %K hazard %K health %K Human %K human health %K Infectious %K IS %K IT %K management %K measure %K measures %K microorganism %K microorganisms %K ON %K ORIGIN %K pathogenic %K Pathogenic organisms %K probability %K recommendation %K Recommendations %K Research %K risk %K Risk Assessment %K risk management %K risks %K SBB %K Tissue %K Type %K use %X

The first steps in tissue culture are dating back to the beginning of the nineteenth century when biosafety measures did not yet exist. Later on, animal cell culture became essential for scientific research, diagnosis and biotechnological activities. Along with this development, biosafety concerns have emerged pointing to the risks for human health and in a lesser extent for the environment associated to the handling of animal cell cultures. The management of these risks requires a thorough risk assessment of both the cell cultures and the type of manipulation prior the start of any activity. It involves a case-by-case evaluation of both the intrinsic properties of the cell culture genetically modified or not and the probability that it may inadvertently or intentionally become infected with pathogenic micro-organisms. The latter hazard is predominant when adventitious contaminants are pathogenic or have a better capacity to persist in unfavourable conditions. Consequently, most of the containment measures primarily aim at protecting cells from adventitious contamination. Cell cultures known to harbour an infectious etiologic agent should be manipulated in compliance with containment measures recommended for the etiologic agent itself. The manipulation of cell cultures from human or primate origin necessitates the use of a type II biosafety cabinet. The scope of this chapter is to highlight aspects relevant for the risk assessment and to summarize the main biosafety recommendations and the recent technological advances allowing a mitigation of the risk for the handling of animal cell cultures.

%B Animal Cell Culture %7 27 %I Springer International Publishing %C Switzerland %V 9 %P 27 %8 1/1/2015 %@ 978-3-319-10319-8 %G eng %N 22 %9 Cell Engineering %1 5197 %& 689 %0 Generic %D 2015 %T GAP III - The WHO poliovirus containment policy : Implications and implementation in Belgium %A Katia Pauwels %E Hoge Gezondheidsraad %K Belgium %K containment %K implementation %K implication %K IMPLICATIONS %K POLICIES %K POLICY %K Poliovirus %K WHO %B Werkgroep vaccinatie %8 19/3/2015 %G eng %N Hogegezondheidsraad %1 5200 %2 19/03/2015 %0 Journal Article %J Trends Food Sci. Technol. %D 2015 %T Next-generation sequencing as a tool for the molecular characterisation and risk assessment of genetically modified plants: Added value or not? %A Katia Pauwels %A Sigrid C.J. De Keersmaecker %A Adinda De Schrijver %A P. du Jardin %A Nancy Roosens %A Philippe Herman %K Genetically modified organism (GMO) %K Genetically modified plants (GMP) %K Next-generation sequencing (NGS) %K Risk assessment Molecular characterisation %X

BackgroundLegislations and international organizations provide a framework to ensure proper risk assessment of Genetically Modified Organisms (GMO). With regard to the deliberate release of GMO as food or feed, applications for Genetically Modified Plants (GMP) typically contain data for the molecular characterisation at the nucleic acid level based on Southern blot and polymerase chain reaction analysis in combination with Sanger sequencing. Along with the diverse range of applications of next-generation sequencing (NGS) in genomic research, some recent research projects and product developers explored the use of NGS as an alternative tool for meeting the data requirements for the molecular characterisation of GMPs in view of their risk assessment.Scope and approachBy means of a literature survey and information collected through the organisation of an international workshop, we investigated whether NGS can replace and/or complement the currently used techniques for molecular characterisation of GMP taking into account the possibilities and current bottlenecks of NGS technologies and recent developments in molecular breeding.Key findings and conclusionsWe conclude that although NGS might present clear advantages for product developers, NGS currently does not always offer a significant added value with respect to the risk assessment of GMPs. However, the approaches used so far may soon be further challenged by the fast evolution in NGS technologies and also by the recent developments in molecular breeding of plants. We postulate that setting up a common workflow for the generation of relevant and interpretable data by NGS would facilitate a scientifically sound assessment of GMPs.

%B Trends Food Sci. Technol. %V 45 %P 319 - 326 %@ 0924-2244 %G eng %N 2 %1 5215 %& 319 %R 10.1016/j.tifs.2015.07.009 %0 Report %D 2015 %T Opinion on Synthetic Biology II - Risk assessment methodologies and safety aspects %A T. Vermeire %A Epstein,M. %A Hartemann,P. %A Proykova,A. %A E. Rodriguez Farre %A L. Martinez Martinez %A Fernandes,T. %A Chaudhry,K. %A Chandra Rastogi,S. %A Breitling,R. %A Bridges,J. %A Delebecque,C. %A Gardner,T. %A Katia Pauwels %A Philp,J. %A Schmidt,M. %A Takano,E. %E SCENIHR %K a %K additional %K an %K Animal %K application %K Area %K Areas %K AS %K assessment %K at %K Biology %K Canada %K Combination %K Countries %K criteria %K definition %K Design %K Development %K Engineering %K environment %K environmental %K environmental risk assessment %K EU %K European %K European Commission %K European Union %K Follow %K Genetic %K genetic engineering %K genetic modification %K genetically %K Genetically modified %K Genetically modified organism %K Genetically modified organisms %K GM %K GMO %K GMOs %K Guidelines %K health %K Human %K i %K identification %K implication %K IMPLICATIONS %K IS %K List %K living %K method %K methodology %K methods %K need %K ON %K past %K Practice %K PRACTICES %K PROCESSES %K PRODUCTS %K public %K public health %K Public-health %K questions %K Regulatory %K Research %K risk %K Risk Assessment %K risks %K SAFETY %K Science %K specific %K summary %K Synthetic %K Synthetic Biology %K System %K Type %K work %X This Opinion is the first of a set of three Opinions addressing a mandate on Synthetic Biology (SynBio) from DG SANCO, DG RTD, DG Enterprise and DG Environment requested to the three Scientific Committees (SCs). %I European Union %C Luxembourg %P 65 %8 4/5/2015 %@ ISSN 1831-4783; ISBN 978-92-79-43916-2 %G eng %1 39050 %& 1 %0 Journal Article %J N Biotechnol %D 2014 %T Engineering nucleases for gene targeting: safety and regulatory considerations. %A Katia Pauwels %A Podevin, Nancy %A Didier Breyer %A Carroll, Dana %A Philippe Herman %K Deoxyribonucleases %K Gene Targeting %K Genetic Therapy %K Humans %K SAFETY %X

Nuclease-based gene targeting (NBGT) represents a significant breakthrough in targeted genome editing since it is applicable from single-celled protozoa to human, including several species of economic importance. Along with the fast progress in NBGT and the increasing availability of customized nucleases, more data are available about off-target effects associated with the use of this approach. We discuss how NBGT may offer a new perspective for genetic modification, we address some aspects crucial for a safety improvement of the corresponding techniques and we also briefly relate the use of NBGT applications and products to the regulatory oversight.

%B N Biotechnol %V 31 %P 18-27 %8 2014 Jan 25 %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/23851284?dopt=Abstract %& 18 %R 10.1016/j.nbt.2013.07.001 %0 Report %D 2014 %T Opinion on Synthetic Biology - I. Definition %A T. Vermeire %A Epstein,M. %A Hartemann,P. %A Proykova,A. %A E. Rodriguez Farre %A L. Martinez Martinez %A Fernandes,T. %A Chaudhry,K. %A Chandra Rastogi,S. %A Breitling,R. %A Bridges,J. %A Delebecque,C. %A Gardner,T. %A Katia Pauwels %A Philp,J. %A Schmidt,M. %A Takano,E. %E SCENIHR %K a %K additional %K an %K application %K Area %K Areas %K AS %K aspects %K assessment %K at %K Biology %K Canada %K Combination %K concept %K concepts %K Countries %K criteria %K definition %K Design %K Development %K Engineering %K environment %K EU %K European %K European Union %K Field %K Follow %K Genetic %K genetic modification %K GM %K GMO %K Guidelines %K health %K i %K IS %K IT %K List %K living %K method %K methodology %K methods %K need %K ON %K past %K present %K PROCESSES %K PRODUCTS %K public %K public health %K Public-health %K Regulatory %K Research %K risk %K Risk Assessment %K risks %K SAFETY %K Science %K specific %K summary %K Synthetic %K Synthetic Biology %K System %K technology %K Type %K USA %K work %X This Opinion is the first of a set of three Opinions addressing a mandate on Synthetic Biology (SynBio) from DG SANCO, DG RTD, DG Enterprise and DG Environment requested to the three Scientific Committees (SCs). This first Opinion concentrates on the elements of an operational definition for SynBio. The two Opinions that follow focus on the methodology to determine what, if any, risks SynBio may potentially pose to public health and what type of further research in this field is required.This first Opinion lays the foundation for the two other Opinions with an overview of the main scientific concepts, developments, tools and research areas in SynBio. Additionally, a summary of relevant regulatory aspects in the European Union (EU), in other countries such as the USA, Canada, South America, China, and at the United Nations is included.Current definitions of SynBio generally emphasise modularisation and engineering concepts as the main drivers for faster and easier GMO design, manufacture and exploitation. However, the operational definition offered by the Scientific Committees here addresses the need for a definition that enables risk assessment and is sufficiently broad to include new developments in the field. Therefore, for the purpose of these Opinions, this is the operational definition derived from a working understanding of SynBio as a collection of conceptual and technological advances:SynBio is the application of science, technology and engineering to facilitate and accelerate the design, manufacture and/or modification of genetic materials in living organisms.It is difficult to accurately define the relationship between genetic modification and SynBio on the basis of quantifiable and currently measurable inclusion and exclusion criteria. Thus, in addition to the definition, a list of specific criteria was considered reflecting that SynBio covers any organism, system, material, product, or application resulting from introduction, assembly, or alteration of the genetic material in a living organism. Although these criteria are helpful guiding principles that specify whether or not a certain process, tool or product belongs to SynBio, none are quantifiable or measurable. Additional criteria including the complexity of the genetic modification, the speed by which modification was achieved, the number of independent modifications, or the degree of computational design methods used, alone or in combination, are also unable to unambiguously differentiate SynBio processes or products from GM.This definition has the advantage that it does not exclude the relevant and large body of risk assessment and safety guidelines developed over the past 40 years for GM work and extensions of that work, if needed, to account for recent technological advances in SynBio. Additionally, the present definition also enables the rapidly advancing nature of GM technologies and adds an important nuance that supports the need for on-going updates of risk assessment methods, which will be addressed in Opinion II. %I European Union %C Luxembours %P 67 %8 25/9/2014 %@ ISSN 1831-4783; ISBN 978-92-79-30136-0 %G eng %1 39049 %& 1 %R 10.2772/76553 %0 Journal Article %J Applied Biosafety %D 2013 %T Biosafety risk assessment and management of laboratory-derived influenza A (H5N1) viruses transmissible in ferrets %A Aline Baldo %A Amaya Leunda %A Chuong Dai Do Thi %A Didier Breyer %A Katia Pauwels %A Sarah Welby %A Van Vaerenbergh, Bernadette %A Philippe Herman %K biosafety %K Highly pathogenic avian influenza A (H5N1) virus %K Risk Assessment %X Highly pathogenic avian influenza (HPAI) A (H5N1) viruses occasionally infect humans, but currently do not transmit efficiently among them. However, the risk for human pandemic influenza is a major concern should these viruses acquire the capacity for human-to-human transmission and retain their current virulence. Recently, two research teams have succeeded in modifying HPAI A (H5N1) viruses in such a way that they could be efficiently transmitted by respiratory route between ferrets, the experimental model for studying influenza virus transmission. In this article, the authors discuss the risk assessment of these mutant HPAI A (H5N1) viruses in the context of the European Union regulatory framework and recommend that laboratory-derived HPAI A (H5N1) viruses transmissible in ferrets should be handled in biosafety level 3 (BSL-3) facilities with some additional biosafety measures. %B Applied Biosafety %V 18 %8 3/2013 %G eng %N 1 %& 6 %R http://journals.sagepub.com/doi/pdf/10.1177/153567601301800102 %0 Journal Article %J Curr Gene Ther %D 2013 %T Environmental risk assessment of clinical trials involving modified vaccinia virus Ankara (MVA)-based vectors. %A Goossens, Martine %A Katia Pauwels %A Nicolas Willemarck %A Didier Breyer %K Animals %K Clinical Trials as Topic %K Genetic Therapy %K Genetic Vectors %K Hazardous Substances %K Humans %K Risk Assessment %K Vaccination %K vaccinia virus %K Viral Vaccines %X

The modified vaccinia virus Ankara (MVA) strain, which has been developed as a vaccine against smallpox, is since the nineties widely tested in clinical trials as recombinant vector for vaccination or gene therapy applications. Although MVA is renowned for its safety, several biosafety aspects need to be considered when performing the risk assessment of a recombinant MVA (rMVA). This paper presents the biosafety issues and the main lessons learned from the evaluation of the clinical trials with rMVA performed in Belgium. Factors such as the specific characteristics of the rMVA, the inserted foreign sequences/transgene, its ability for reconversion, recombination and dissemination in the population and the environment are the main points of attention. Measures to prevent or manage identified risks are also discussed.

%B Curr Gene Ther %V 13 %P 413-20 %8 2013 Dec %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/24397528?dopt=Abstract %R https://doi.org/10.2174/156652321306140103221941 %0 Journal Article %J J.Verbr.Lebensm. %D 2013 %T Event report: SynBio Workshop (Paris 2012) - Risk assessment challenges of Synthetic Biology %A Katia Pauwels %A Ruth Mampuys %A Catherine Golstein %A Didier Breyer %A Philippe Herman %A M. Kaspari %A J-C. Pagès %A Herbert Pfister %A Frank Wilk %K 2012 %K an %K AS %K assessment %K Belgian %K biological safety %K Biology %K biosafety %K Biotechnology %K challenge %K Countries %K Development %K Discussion %K Emerging risks %K Europe %K European %K European Commission %K European countries %K Field %K food %K Food Safety %K genetic modification %K GMOs %K health %K identify %K INFORMATION %K Institute %K International %K journal %K Monitoring %K national %K Netherlands %K New techniques %K ON %K public %K public health %K Public-health %K questions %K Regulatory %K report %K Research %K REVIEW %K risk %K Risk Assessment %K SAFETY %K SBB %K Synthetic %K Synthetic Biology %K The Netherlands %X In Europe and beyond, several advisory bodies have been monitoring the developments in the field of Synthetic Biology. Reports have been sent to national governments for information on the developments and possible regulatory and risk assessment questions raised by this field. To put the issues in a broader perspective, four national biosafety advisory bodies (the French High Council for Biotechnology, the German Central Committee on Biological Safety, the Netherlands Commission on Genetic Modification and the Belgian Scientific Institute of Public Health (Biosafety and Biotechnology Unit)) decided to join forces and organize an international scientific workshop to review some of the latest scientific insights and look into possible challenges in the risk assessment of Synthetic Biology. The SynBio Workshop (Paris 2012) - Risk assessment challenges of Synthetic Biology took place on the 12th of December 2012 and gathered scientists from biosafety advisory bodies from fifteen European countries, from the European Food Safety Authority as well as representatives of the European Commission, together with research scientists selected for their excellence in the field. The workshop was divided into two sessions: the first session gave an overview of four major fields in Synthetic Biology. The second session was set up for discussion with a scientific panel and the audience to identify and address relevant questions for risk assessment raised by recent and future developments of Synthetic Biology. An overview of the workshop and the discussion points put forward during the day are discussed in this document. %B J.Verbr.Lebensm. %V 8 %P 215 - 226 %8 0/0/2013 %@ 1661-5751 %G eng %1 4220 %& 215 %0 Journal Article %J Curr Gene Ther %D 2013 %T General considerations on the biosafety of virus-derived vectors used in gene therapy and vaccination. %A Aline Baldo %A van den Akker, Eric %A Bergmans, Hans E %A Lim, Filip %A Katia Pauwels %K Animals %K Clinical Trials as Topic %K Genetic Therapy %K Genetic Vectors %K Hazardous Substances %K Humans %K Organisms, Genetically Modified %K Risk Assessment %K Vaccination %K Viruses %X

This introductory paper gathers general considerations on the biosafety of virus-derived vectors that are used in human gene therapy and/or vaccination. The importance to assess the potential risks for human health and the environment related to the use of genetically modified organisms (GMO) in this case genetically modified viral vectors is highlighted by several examples. This environmental risk assessment is one of the requirements within the European regulatory framework covering the conduct of clinical trials using GMO. Risk assessment methodologies for the environmental risk assessment of genetically modified virus-derived vectors have been developed.

%B Curr Gene Ther %V 13 %P 385-94 %8 2013 Dec %G eng %N 6 %1 https://www.ncbi.nlm.nih.gov/pubmed/24195604?dopt=Abstract %& 385 %R 10.2174/15665232113136660005 %0 Government Document %D 2013 %T Organisation of expertise for the risk evaluation of biosafety dossiers in Belgium %A Katia Pauwels %E WIV-ISP %K a %K Agriculture %K Belgium %K biosafety %K EVALUATION %K expertise %K organisation %K risk %8 14/5/2013 %G eng %1 38848 %0 Journal Article %J Biosafety %D 2012 %T Are 'Omics' contributing to the identification of unintended effects in genetically modified crops?2743 %A Katia Pauwels %K crops %K effect %K effects %K epub %K genetically %K Genetically modified %K Genetically modified crop %K genetically modified crops %K identification %K omics %K SBB %K unintended effects %K website %X Not available %B Biosafety %V 1 %8 15/2/2012 %G eng %N 1 %1 38845 %0 Journal Article %J Vaccine %D 2012 %T Biosafety aspects of modified vaccinia virus Ankara (MVA)-based vectors used for gene therapy or vaccination. %A Verheust, Céline %A Goossens, Martine %A Katia Pauwels %A Didier Breyer %K Animals %K Clinical Trials as Topic %K Gene Transfer Techniques %K Genetic Therapy %K Genetic Vectors %K Humans %K Mammals %K Neoplasms %K Poxviridae Infections %K Practice Guidelines as Topic %K Vaccination %K vaccinia virus %K Viral Vaccines %X

The modified vaccinia virus Ankara (MVA) strain is a highly attenuated strain of vaccinia virus that has been demonstrated to be safe for humans. MVA is widely considered as the vaccinia virus strain of choice for clinical investigation because of its high safety profile. It also represents an excellent candidate for use as vector system in recombinant vaccine development for gene delivery or vaccination against infectious diseases or tumours, even in immunocompromised individuals. The use of MVA and recombinant MVA vectors must comply with various regulatory requirements, particularly relating to the assessment of potential risks for human health and the environment. The purpose of the present paper is to highlight some biological characteristics of MVA and MVA-based recombinant vectors and to discuss these from a biosafety point of view in the context of the European regulatory framework for genetically modified organisms with emphasis on the assessment of potential risks associated with environmental release.

%B Vaccine %V 30 %P 2623-32 %8 2012 Mar 30 %G eng %N 16 %1 http://www.ncbi.nlm.nih.gov/pubmed/22342706?dopt=Abstract %R 10.1016/j.vaccine.2012.02.016 %0 Report %D 2012 %T Synthetic Biology. Latest developments, biosafety considerations and regulatory challenges %A Katia Pauwels %A Nicolas Willemarck %A Didier Breyer %A Philippe Herman %K ALL %K an %K application %K applications %K AS %K at %K Biology %K biosafety %K challenge %K Change %K Development %K Discussion %K evidence %K Field %K food %K general %K INFORMATION %K IS %K ON %K Paper %K Regulatory %K REVIEW %K SAFETY %K SBB %K Synthetic %K Synthetic Biology %K Technique %K website %X This document is a background paper aiming at providing general information and considerations about techniques, applications and safety aspects of Synthetic Biology (SB). It is not a position paper. It should be considered as food for thought to sustain and stimulate further discussion on this topic amongst interested stakeholders. It is important to note that SB is a rapidly evolving field encompassing many different topics. It is therefore worth mentioning that this document does not aim at providing an exhaustive overview of all SB applications and is based on currently available scientific evidence. Its descriptive and analytic parts could be subject to review and change if new important information becomes available. %I WIV-ISP %C Brussels, Belgium %P 43 %8 0/0/2012 %@ D/2012/2505/46 %G eng %1 3787 %& 1 %0 Government Document %D 2010 %T De Europese regelgeving inzake GGO's in het licht van nieuwe technieken van genetische modificatie2769 %A Katia Pauwels %A Didier Breyer %A Philippe Herman %K de %K GGO %K New techniques %K SBB %K website %X Not available %B ILVO Nieuwsgolf %V Sept 2010 %8 0/0/2010 %G eng %1 38843 %0 Report %D 2010 %T Methodology of the biological risk classification of animal pathogens in Belgium %A Bernadette Van Vaerenbergh %A F. Koenen %A Katia Pauwels %A Quanten,K. %A Boyen,F. %A Declercq,K. %A Desmecht,D. %A Thiry,J. %A Philippe Herman %K a %K Agent %K Agents %K Animal %K AS %K aspects %K Attention %K Belgian %K Belgium %K biological risks %K cause %K classification %K criteria %K definition %K demand %K Diagnosis %K disease %K Diseases %K ECONOMIC %K effect %K effects %K epidemic %K Epidemics %K Evolution %K Group %K health %K Human %K Infectious %K Infectious diseases %K International %K IT %K KNOWLEDGE %K Laboratories %K List %K methodology %K microorganism %K microorganisms %K movement %K ON %K organisation %K pandemic %K Pandemics %K Paper %K past %K pathogen %K pathogenic %K plant %K Plants %K production %K prophylaxis %K Research %K revision %K risk %K risks %K SBB %K severity %K Spread %K System %K Systems %K transboundary movement %K treatment %K use %K website %K world %K World Health %X Pathogenic micro-organisms receive much attention due to their potentially harmful effects on human, animal or plant health.Over the past few decades, this attention has grown due to the emergence of new (and known) infectious diseases inducing local epidemics as well as worldwide pandemics.Along with the research and diagnosis of those etiological agents, (bio)safety concerns have highlighted the biological risks associated with their deliberate use in laboratories, animal facilities and production plants, and their transboundary movements (import and export). This has led to their categorisation into risk groups and the elaboration of classification lists.Current international classification systems rely on criteria defined by the World Health Organisation, which cover the severity of the disease the micro-organism might cause, its ability to spread and the availability of prophylaxis or efficient treatment. Animal pathogens are classified according to the definitions of the World Organisation for Animal Health, which also consider economic aspects of disease.Evolution of scientific knowledge will demand regular updating of classification lists. This paper describes the Belgian risk classification system and the methodology that was used for its peer-reviewed revision (with a focus on animal pathogens). %I Scientific Institute of Public Health %C Brussels %V WIV-ISP Scientific Report 2008-2009 %P 5 %8 0/0/2010 %G eng %1 39034 %& 135 %0 Conference Proceedings %D 2010 %T Methodology of the biological risk classification of animal pathogens in Belgium %A Bernadette Van Vaerenbergh %A F. Koenen %A Katia Pauwels %A Quanten,K. %A Boyen,F. %A Declercq,K. %A Desmecht,D. %A Thiry,J. %A Philippe Herman %K Animal %K AS %K Belgium %K biological risks %K classification %K criteria %K demand %K Diagnosis %K disease %K Diseases %K ECONOMIC %K effect %K effects %K epidemic %K Evolution %K health %K Human %K Infectious diseases %K International %K Laboratories %K List %K methodology %K microorganism %K microorganisms %K movement %K ON %K pandemic %K Paper %K past %K pathogen %K pathogenic %K plant %K Plants %K production %K report %K Research %K revision %K risk %K risks %K SBB %K Spread %K System %K transboundary movement %K treatment %K use %K world %X Pathogenic micro-organisms receive muchattention due to their potentially harmfuleffects on human, animal or plant health.Over the past few decades, this attentionhas grown due to the emergence of new(and known) infectious diseases inducinglocal epidemics as well as worldwide pandemics.Along with the research and diagnosisof those etiological agents, (bio)safetyconcerns have highlighted the biologicalrisks associated with their deliberate usein laboratories, animal facilities and productionplants, and their transboundarymovements (import and export). This hasled to their categorisation into risk groupsand the elaboration of classification lists.Current international classification systemsrely on criteria defined by the WorldHealth Organisation, which cover the severityof the disease the micro-organismmight cause, its ability to spread and theavailability of prophylaxis or efficient treatment(1). Animal pathogens are classifiedaccording to the definitions of the WorldOrganisation for Animal Health, which alsoconsider economic aspects of disease (2).Evolution of scientific knowledge will demandregular updating of classificationlists. This paper describes the Belgian riskclassification system and the methodologythat was used for its peer-reviewed revision(with a focus on animal pathogens). %I WIV-ISP %C Brussels %V 2008-2009 %P 135 - 140 %8 0/0/2010 %@ D/2010/2505/52 %G eng %1 2774 %& 135 %0 Journal Article %J Rev Sci Tech %D 2010 %T Methodology of the biological risk classification of animal pathogens in Belgium. %A Van Vaerenbergh, B %A F. Koenen %A Katia Pauwels %A Quanten, K %A Boyen, F %A Declercq, K %A Desmecht, D %A Thiry, J %A Philippe Herman %K Animal Diseases %K Animals %K bacteria %K Belgium %K Communicable Diseases %K Fungi %K Humans %K Parasites %K Risk Assessment %K Viruses %X

Since many micro-organisms are a biological hazard, they have been categorised into risk groups by many countries and organisations and classification lists have been developed. Current classification systems rely on criteria defined by the World Health Organization, which cover the severity of the disease the micro-organism might cause, its ability to spread and the availability of prophylaxis or efficient treatment. Animal pathogens are classified according to the definitions of the World Organisation for Animal Health, which also consider economic aspects of disease. In Europe, classification is often directly linked to containment measures. The Belgian classification system, however, only considers the inherent characteristics of the micro-organism, not its use, making the risk classification independent of containment measures. A common classification list for human and animal pathogens has been developed in Belgium using as comprehensive an approach as possible. The evolution of scientific knowledge will demand regular updating of classification lists. This paper describes the Belgian risk classification system and the methodology that was used for its peer-reviewed revision (with a focus on animal pathogens).

%B Rev Sci Tech %V 29 %P 513-22 %8 2010 Dec %G eng %N 3 %1 http://www.ncbi.nlm.nih.gov/pubmed/21309451?dopt=Abstract %0 Conference Proceedings %D 2010 %T New techniques of genetic modification and the GMO definition %A Didier Breyer %A Katia Pauwels %A Philippe Herman %K a %K AS %K at %K biosafety %K Biotechnology %K challenge %K Context %K definition %K European %K European Union %K Genetic %K genetic modification %K genetically %K Genetically modified %K Genetically modified organism %K Genetically modified organisms %K GMM %K GMO %K GMO regulation %K i %K IS %K IT %K KNOWLEDGE %K legislation %K LEVEL %K List %K mating %K microorganism %K microorganisms %K New techniques %K ON %K Order %K PRODUCTS %K regulation %K Regulatory %K result %K SBB %K series %K Technique %K use %K website %K work %K Yield %X In the European Union, genetically modified organisms (GMO) and genetically modified micro-organisms (GMM) are defined respectively according to Directives 2001/18/EC on deliberate release of GMO and 2009/41/EC on the contained use of GMM (2). In accordance with the legislation, a GMO/GMM is defined as "an organism/micro-organism ... in which the genetic material has been altered in a way that does not occur naturally by mating and/or naturalrecombination". This definition must be read together with a series of annexes that list techniques (i) that result in genetic modification, (ii) that are not considered to result in genetic modification, or (iii) that result in genetic modification but yield organisms that are excluded from the scopeof the Directives.A novel organism will therefore fall under the scope of the GMO regulation only if it has been developed with the use of defined techniques. With the advance of scientific knowledge, techniques which are applied in genetic modification of organisms have emerged that may challenge the current regulatory definition of a GMO because it is not always clear whether the products obtained through these techniques are subject to the prevailing European GMOlegislation or not.Several initiatives have been taken at the European level in order to evaluate some of these new techniques in the context of the existing legislative framework. The Division of Biosafety and Biotechnology (SBB ) is actively contributing to this work. %I WIV-ISP %C Brussels %V WIV-ISP Scientific Report 2008-2009 %P 144 - 146 %8 0/0/2010 %G eng %1 38526 %& 144 %0 Report %D 2010 %T Sampling feasibility study of pathogenic organisms genetically modified or not in contained use activities %A Amaya Leunda %A Katia Pauwels %A Bernadette Van Vaerenbergh %A Philippe Herman %K a %K Activity %K AS %K aspects %K biological risks %K conditions %K Contained use %K danger %K environment %K Feasibility Studies %K genetically %K Genetically modified %K Harm %K health %K Human %K human health %K i %K IS %K ON %K Order %K pathogenic %K Pathogenic organisms %K present %K probability %K public %K public health %K Public-health %K report %K result %K results %K risk %K risks %K sampling %K SBB %K situation %K study %K use %K website %X The aim of this study is to discern situations where sampling may be feasible and relevant. Both will be determined by the probability of subsisting biological risks arising from a contained use activity. Notwithstanding biological risks may harm the environment, this study will primarily focus on the feasibility of sampling in situations where subsisting biological risks may present a danger for public health. Therefore this report serves as a guideline for inspectors to i) evaluate the potential biological risks for human health ii) consider technical and practical aspects in order to perform sampling in the best conditions and iii) highlight issues encountered during the interpretation of sampling results. %I Scientific Institute of Public Health %C Brussels %V D/2010/2505/19 %P 59 %8 0/0/2010 %G eng %1 2770 %& 1 %0 Report %D 2009 %T Biological risk assessment sheets : Practical examples of risk assessment and biosafety recommendations for the contained use of genetically modified (micro-)organisms %A Katia Pauwels %A Bernadette Van Vaerenbergh %A Verheust,C. %A Philippe Herman %K a %K adverse effects %K ALL %K an %K AS %K assessment %K biological risks %K biosafety %K classification %K Contained use %K effect %K effects %K environment %K genetically %K Genetically modified %K Genetically modified organism %K Genetically modified organisms %K GMO %K GMOs %K health %K Human %K human health %K IS %K List %K means %K measure %K measures %K ON %K pathogenic %K Pathogenic organisms %K recommendation %K Recommendations %K risk %K Risk Assessment %K risks %K SBB %K summary %K use %K website %X To ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment that might arise from the contained use of genetically modified and/or pathogenic organisms, an risk assessment is carried out as regards to the biological risks. While classification list of pathogenic, non genetically modified, organisms provide a tool to assess the biological risks associated to the contained use of those organisms, the risk assessment of GMO appear to be more complex. This document provides a practical means for performing risk assessment of contained uses dealing with genetically modified organisms (GMOs), whether they are pathogenic or not. The first part offers a brief summary of the key issues of risk assessment of contained uses. The second part (annexes) consist of examples that have been elaborated to illustrate the risk assessment of contained uses dealing with GMOs. %I Scientific Institute of Public Health %C Brussels %V D/2009/2505/48 %P 22 %8 0/0/2009 %G eng %1 38841 %& 1 %0 Journal Article %J Environ Biosafety Res %D 2009 %T Genetic modification through oligonucleotide-mediated mutagenesis. A GMO regulatory challenge? %A Didier Breyer %A Philippe Herman %A Brandenburger, Annick %A Gheysen, Godelieve %A Remaut, Erik %A Soumillion, Patrice %A Van Doorsselaere, Jan %A Custers, René %A Katia Pauwels %A Myriam Sneyers %A Reheul, Dirk %K Animals %K Animals, Genetically Modified %K European Union %K genetic engineering %K Government Regulation %K International Cooperation %K mutagenesis %K Plants, Genetically Modified %X

In the European Union, the definition of a GMO is technology-based. This means that a novel organism will be regulated under the GMO regulatory framework only if it has been developed with the use of defined techniques. This approach is now challenged with the emergence of new techniques. In this paper, we describe regulatory and safety issues associated with the use of oligonucleotide-mediated mutagenesis to develop novel organisms. We present scientific arguments for not having organisms developed through this technique fall within the scope of the EU regulation on GMOs. We conclude that any political decision on this issue should be taken on the basis of a broad reflection at EU level, while avoiding discrepancies at international level.

%B Environ Biosafety Res %V 8 %P 57-64 %8 2009 Apr-Jun %G eng %N 2 %1 http://www.ncbi.nlm.nih.gov/pubmed/19833073?dopt=Abstract %R 10.1051/ebr/2009007 %0 Report %D 2009 %T Inrichtingen met een hoog inperkingsniveau in België. Rapport: Periode 1995-2008 %A Chuong Dai Do Thi %A Bernadette Van Vaerenbergh %A Philippe Herman %A Katia Pauwels %A Fanny Coppens %A Amaya Leunda %A Verheust,C. %K België %K de %K GGM %K L3 %K pathogen %K risicoklasse 3 %K SBB %X Het doel van dit rapport bestaat erin een stand van zaken van de inrichtingen met een hoog inperkingsniveau in België op te maken. Het gaat om inrichtingen waar het ingeperkte gebruik van genetisch gemodificeerde en/of pathogene (micro-)organismen van risicoklasse 3 plaatsvindt. De gegevens in dit rapport hebben betrekking op de periode 1995-2008 %I WIV-ISP %C Brussels %P 31 %8 0/0/2009 %@ D/2009/2505/40 %G eng %1 2793 %& 1 %0 Report %D 2009 %T Les installations de haut niveau de confinement en Belgique. Rapport: Période 1995 - 2008 %A Chuong Dai Do Thi %A Bernadette Van Vaerenbergh %A Philippe Herman %A Katia Pauwels %A Fanny Coppens %A Amaya Leunda %A Verheust,C. %K Belgique %K classe de risque 3 %K Confinement %K de %K L3 %K LE %K MGM %K objectives %K pathogène %K SBB %K utilisation %X Ce rapport a pour objectif de présenter l'état de la question sur les installations de haut niveau deconfinement en Belgique. Il s'agit des installations où se déroulent des utilisations confinées de (micro)-organismes génétiquement modifiés et/ou pathogènes de classe de risque 3. Les données exposéesdans ce rapport couvrent la période de 1995 à 2008 %I WIV-ISP %C Brussels %P 31 %8 0/0/2009 %@ D/2009/2505/40 %G eng %1 2792 %& 1 %0 Government Document %D 2009 %T Should novel organisms developed using oligonucleotide-mediated mutagenesis be excluded from the EU Regulation %A Didier Breyer %A Philippe Herman %A Brandenburger,A. %A Gheysen,G. %A Remaut,E. %A Soumillion,P. %A J. Van Doorsselaere %A Custers,R. %A Katia Pauwels %A Myriam Sneyers %A Reheul,D. %K EU %K mutagenesis %K New techniques %K Paper %K regulation %K Regulatory %K SAFETY %K SBB %K Technique %K use %K website %X

This paper discusses regulatory and safety issues associated with the use of oligonucleotide-mediated mutagenesis and provides scientific arguments for not having organisms developed through this technique fall within the scope of the EU regulation of GMOs.

%B ISB news report %I ISBN %C Brussels %V November 2009 %P 2 - 12 %8 0/0/2009 %G eng %1 38519 %& 2 %0 Journal Article %J Curr Gene Ther %D 2009 %T State-of-the-art lentiviral vectors for research use: risk assessment and biosafety recommendations. %A Katia Pauwels %A Gijsbers, Rik %A Toelen, Jaan %A Schambach, Axel %A Willard-Gallo, Karen %A Verheust, Céline %A Debyser, Zeger %A Philippe Herman %K Animals %K Genetic Vectors %K Guidelines as Topic %K Humans %K Lentivirus %K Risk Assessment %X

Lentiviral vectors (LV) are competent gene transfer vehicles, as used for both research and gene therapy applications, because of their stable integration in non-dividing and dividing cells and long-term transgene expression. Along with our understanding that LV offer solutions for gene therapy, biosafety concerns have uncovered risks due to insertional mutagenesis, the generation of replication competent lentiviruses (RCL) and vector mobilization. Researchers therefore continue to devote significant efforts in designing LV with improved efficacy and biosafety features. The choice of a particular LV system for experimental studies is often driven by functional considerations, including increased productivity and/or transduction efficiency. The design of safer vectors has also directly benefited researchers allowing them to conduct experimental studies with lower risk. Currently, vectors combine improved safety features (that decrease the risk of recombination and vector mobilization) with increased transduction efficiency. Hence, risks associated with the inadvertent transduction of cells of the investigator gain greater importance in assessing the overall risk of these vectors and become an important biosafety concern. This review outlines the different strategies used to improve LV biosafety by comparing state-of-the-art and emerging LV production systems and highlighting biosafety issues that can arise during their contained use. The few existing national and international biosafety recommendations that specifically address the use of LV in research are discussed and recommendations for most common research activities using LV are proposed.

%B Curr Gene Ther %V 9 %P 459-74 %8 2009 Dec %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/20021330?dopt=Abstract %0 Report %D 2008 %T Emploi d'appareils de protection respiratoire durant l'utilisation confinée d'organismes génétiquement modifiés et/ou pathogènes %A Katia Pauwels %A Fanny Coppens %A Verheust,C. %A Bernadette Van Vaerenbergh %A Chuong Dai Do Thi %A Philippe Herman %K a %K aspects %K ce %K CONTACT %K danger %K de %K Decision %K EN %K LE %K mask %K objectives %K ON %K PAR %K pathogen %K pathogène %K protection %K réglementation %K risques %K santé %K santé publique %K SBB %K Technique %K Type %K website %X Ce document a pour but de donner un aperçu des critères de décision qui mènent au choix d'uneprotection respiratoire en cas d'exposition aux aérosols infectieux durant l'utilisation confinéed'organismes pathogènes et/ou génétiquement modifiés.Il est clair que ce sujet a plusieurs points communs avec la réglementation en matière deprotection du travailleur, qui stipule que les employeurs sont tenus de protéger leurs employéscontre tout danger. Pour ce faire, des équipements de protection individuelle doivent êtreutilisés lorsque les risques ne peuvent être évités ou suffisamment limités par des moyenstechniques de protection collective ou par des mesures, méthodes ou procédés d'organisation dutravail (Cadre 1).On entend par équipement de protection individuelle tout équipement destiné à être porté outenu par le travailleur en vue de le protéger contre un ou plusieurs risques susceptibles demenacer sa sécurité ou sa santé au travail, ainsi que tout complément ou accessoire destiné à cetobjectif.Les masques sont donc principalement des équipements de protection individuelle destinés auxpersonnes rentrant en contact avec de l'air contaminé. Dans certains cas, le port d'un masqueconfère également une protection supplémentaire pour la santé publique et/ou l'environnement.Dans le cadre des arrêtés régionaux (1, 2, 3) relatifs à l'utilisation confinée d'organismesgénétiquement modifiés et/ou pathogènes, ces deux derniers aspects doivent également être prisen compte pour le choix du type de masque. %I Scientific Institute of Public Health %C Brussels %V D/2008/2505/01 %P 27 %8 0/0/2008 %G eng %1 38839 %& 1 %0 Government Document %D 2007 %T Animal cell cultures: Risk Assessment and biosafety recommendations %A Katia Pauwels %A Bernadette Van Vaerenbergh %A Chuong Dai Do Thi %A Berghmans,L. %A Geneviève Waeterloos %A Van Bockstaele,D. %A Dorsch-Hasler,K. %A Myriam Sneyers %K Activity %K an %K Animal %K AS %K assessment %K at %K biosafety %K Case %K cell culture %K cells %K compliance %K containment %K environment %K EVALUATION %K general %K genetic modification %K hazard %K health %K Human %K human health %K IS %K LEVEL %K measure %K measures %K ON %K ORIGIN %K pathogen %K pathogenic %K recommendation %K Recommendations %K Reduction %K Research %K result %K risk %K Risk Assessment %K risks %K SBB %K Type %K use %K work %X During the last three decades, animal cell culturing hasbeen essential for biomedical research and biotechnologicalactivities in general. Along with this increasing importance,biosafety concerns have pointed to the risks of manipulatinganimal cell cultures for human health and the environment. Amaximal reduction of these risks necessitates a thorough riskassessment of the cell cultures used. It involves an evaluationof both the intrinsic properties of the cell culture, includingsubsequent properties acquired as a result of genetic modification,and the possibility that the cell culture may inadvertentlyor deliberately become contaminated with pathogens.The latter is a major hazard associated with the manipulationof animal cell cultures, as adventitious agents may be pathogenicand have a better capacity to survive in unfavorableconditions. Consequently, most of the containment measuresprimarily aim at protecting cells from adventitious contamination.Therefore, a comprehensive evaluation of the risks encounteredduring the handling of cell cultures should includeconsiderations regarding the type of manipulation as well. Asa rule, cell cultures known to harbor an infectious etiologicagent should be manipulated in compliance with containmentmeasures recommended for the etiologic agent. With the exceptionof very well-characterized cell cultures for which theuse of a type II biosafety cabinet depends on the origin of thecells, work with cell cultures from human or primate originshould generally and minimally be performed under containmentlevel 2 using a type II biosafety cabinet. In every case,containment measures should minimize adventitious contaminationof the cell cultures and offer a maximal protection ofhuman health and the environment. %B Appl.Biosaf. %V 12 %P 26 - 38 %8 0/0/2007 %G eng %N 1 %1 1899 %& 26 %0 Report %D 2007 %T Gebruik van ademhalingsbeschermingsmiddelen bij het ingeperkt gebruik van genetisch gemodificeerde organismen en/of pathogenen %A Katia Pauwels %A Fanny Coppens %A Verheust,C. %A Bernadette Van Vaerenbergh %A Chuong Dai Do Thi %A Philippe Herman %K AAN %K Aerosols %K blootstelling %K de %K gebruik %K gezondheid %K IS %K mask %K pathogen %K risico %K SBB %K Type %K website %X Dit document heeft als doel een overzicht te geven van beslissingscriteria die leiden tot de keuzevan type ademhalingsbeschermingsmiddelen bij blootstelling aan infectieuze aerosols tijdenshet ingeperkt gebruik van pathogene en/of genetisch gemodificeerde organismen.Uiteraard heeft dit onderwerp verschillende raakvlakken met de regelgeving inzakebescherming van de werknemer. Werkgevers zijn namelijk wettelijk verplicht hun werknemerstegen gevaren te beschermen, zeker wanneer de risico's onvoldoende door collectievetechnische beschermingsmiddelen of werkprocedures kunnen worden beperkt (Kader 1).Persoonlijke beschermingsmiddelen (PBM) worden dan ook gedefinieerd als iedere uitrustingdie bestemd is om door de gebruiker gedragen of vastgehouden te worden ten einde hem tebeschermen tegen één of meer risico's die zijn veiligheid of gezondheid op het werk kunnenbedreigen, alsmede als alle aanvullingen of accessoires die daartoe kunnen bijdragen.Maskers zijn dus op de eerste plaats bedoeld als persoonlijk beschermingsmiddel voor personendie in aanraking komen met besmette lucht. In sommige gevallen biedt het dragen van eenmasker echter ook een bijkomende bescherming voor de volksgezondheid en/of het leefmilieu. %I Scientific Institute of Public Health %C Brussels %V 2007/2505/64 %P 28 %8 0/0/2007 %G eng %1 38838 %& 1 %0 Report %D 2006 %T Biosafety recommendations for the contained use of Mycobacterium tuberculosis complex isolates in industrialized countries %A Philippe Herman %A M. Fauville %A Didier Breyer %A Bernadette Van Vaerenbergh %A Katia Pauwels %A Chuong Dai Do Thi %A Myriam Sneyers %A Wanlin,M. %A Snacken,R. %A William Moens %K a %K Activity %K Aerosols %K Airborne %K an %K analysi %K analysis %K AS %K Belgium %K biosafety %K BSL-3 %K classification %K Clinical %K containment %K Countries %K culture %K developed countries %K Diagnosis %K disease %K Diseases %K Dna %K Group %K Human %K identification %K incidence %K INFECTION %K Infectious %K Infectious diseases %K International %K IS %K IT %K Laboratories %K Less %K LEVEL %K M %K M tuberculosis %K Mycobacterium %K Mycobacterium tuberculosis %K ON %K pathogen %K People %K Practice %K PRACTICES %K recommendation %K Recommendations %K Research %K risk %K Rna %K SAFETY %K SBB %K Secondary %K specific %K Test %K tests %K time %K Times %K Transmission %K Tuberculosis %K use %K website %K work %X Staff working in microbiological diagnostic and research laboratories is likely to be exposed to infection risk with pathogens. Among human infectious diseases, tuberculosis is one of the most severe, killing 2 millions people worldwide every year. %I Scientific Institute of Public Health %C Brussels %V D/2006/2505/22 %P 17 %8 0/0/2006 %G eng %1 38754 %& 2 %0 Report %D 2006 %T Bioveiligheidsaanbevelingen aangaande behandelings- en inactiveringsmethoden voor biologisch besmet afval %A Berghmans,L. %A Katia Pauwels %A Bernadette Van Vaerenbergh %A Chuong Dai Do Thi %A Philippe Herman %K België %K de %K EN %K gebruik %K GGO %K IS %K List %K MEN %K SBB %K vlaamse %K Waste %K website %X De afvalstoffenproblematiek behoort tot één van de belangrijkste problemen in Europa. De eerste Europese richtlijnen op dit terrein dateren uit de periode 1975-1976. Een belangrijkeontwikkeling was het tot stand komen van een basisrichtlijn (Richtlijn 91/156/EEG) met eenduidelijkere Europese definitie van het begrip 'afvalstof'. Deze luidt als volgt: elke stof of elkvoorwerp waarvan de houder zich ontdoet, voornemens is zich te ontdoen of zich moetontdoen. Deze definitie werd aangevuld met een uniforme Europese classificatie van deafvalstoffen (Europese Afvalcatalogus) (Beschikking 93/3/EG). Sinds 1 januari 2002, zijn debestaande Europese afvalstoffenlijsten, Europese Afvalcatalogus (EAC) en Hazardous wasteList (HWL) vervangen door de Europese Afvalstoffen Lijst (EURAL). De EURALharmoniseert de indeling van afvalstoffen en de aanduiding van gevaarlijke stoffen in deverschillende lidstaten.In België is het afvalstoffenbeleid een regionale aangelegenheid (Decreet 2/07/1981, Decreet27/06/1996, Ordonnantie 7/03/1991). De Vlaamse en Waalse Regering hebben de EuropeseAfvalstoffencatalogus overgenomen.Voor gevaarlijke afvalstoffen is er een specifieke Europese richtlijn (91/689/EEG) die beoogtdat in vergelijking tot de niet-gevaarlijke afvalstoffen, er een striktere controle wordtdoorgevoerd (inzake identificatie en registratie, scheiding, verwijdering, verpakking, opslagen vervoer, optreden in nood- en gevaarsituaties).In dit document beperkt men zich tot afval afkomstig van ingeperkt gebruik met genetischgemodificeerde organismen (GGO) en/of pathogenen. Dit afval valt onder de rubriekgevaarlijk afval. Zoals in de Regionale Besluiten (Besluit 8/11/2001, Besluit 6/02/2004,Besluit 4/07/2002) beschreven staat, moet biologisch afval en/of biologische residu's(besmette kadavers, uitwerpselen*, strooisel*, besmette planten, besmette substraten e.d.),alsook besmet materiaal (glaswerk, kooien e.d.) afkomstig van laboratoria, animalaria en/ofserres en kweekkamers, een gevalideerde inactivering ondergaan volgens een geschiktemethode vóór verwijdering. Deze inactivering is vereist, ongeacht de risicoklasse van hetGGO of het pathogeen en ongeacht het risiconiveau/risicoklasse van het ingeperkt gebruik.Een ongepaste behandeling en/of uiteindelijke verwijdering kunnen leiden tot negatievegevolgen voor de volksgezondheid en het leefmilieu.Dit document geeft een overzicht van de inactivatie- en decontaminatiemethoden, alsookvalideringswijzen. %I Scientific Institute of Public Health %C Brussels %V D/2006/2505/28 %P 33 %8 0/0/2006 %G eng %1 38514 %& 1 %0 Report %D 2006 %T Enceintes de sécurité microbiologique %A Philippe Herman %A Katia Pauwels %K ce %K de %K EN %K ET %K LE %K microbiologie %K OGM %K pathogène %K SBB %K Type %K website %X Une enceinte de sécurité microbiologique (ESM) est un équipement de sécurité courant dans la plupartdes laboratoires de recherche, les laboratoires de microbiologie et l'industrie pharmaceutique.L'objectif de ces pages est de prÈsenter aux responsables de laboratoires, aux Ètudiants et au personnelde laboratoire en général les différents types d'ESM aussi appelées "postes de sécuritémicrobiologique" existants. Leur description, ainsi que des consignes d'utilisation pour ceux quimanipulent des (micro-)organismes génétiquement modifiés (OGM) et/ou pathogènes font l'objet despages référencées ci-dessous. %I Scientific Institute of Public Health %C Brussels %V D/2006/2505/20 %P 15 %8 0/0/2006 %G eng %1 38756 %& 1 %0 Report %D 2006 %T Microbiologische veiligheidswerkkasten %A Philippe Herman %A Katia Pauwels %K AAN %K de %K EN %K IS %K SBB %K Type %K website %X Een microbiologische veiligheidswerkkast (MVK) is bij de meeste onderzoeks- en microbiologischelaboratoria en laboratoria van de farmaceutische industrie een veel voorkomende veiligheidsuitrusting.Het algemeen doel van deze webpagina's is een overzicht te geven van de verschillende bestaandetypes MVK's, ook "microbioveiligheidsposten" genoemd, aan laboratoriumverantwoordelijken,studenten en het laboratoriumpersoneel. De beschrijving van deze alsook de gebruiksvoorschriftenvoor de personen die pathogene en/of genetisch gemodificeerde micro-organismen manipuleren zijnhet onderwerp van de pagina's waarnaar hieronder wordt gerefereerd. %I Scientific Institute of Public Health %C Brussels %V D/2006/2505/20 %P 15 %8 0/0/2006 %G eng %1 38755 %& 1 %0 Report %D 2006 %T Negatieve luchtdruk bij L3 laboratoria %A Katia Pauwels %A Bernadette Van Vaerenbergh %A Chuong Dai Do Thi %A Berghmans,L. %A Philippe Herman %K L3 %K negative pressure %K SBB %K website %I Scientific Institute of Public Health %C Brussels %V D/2006/2505/15 %P 6 %8 0/0/2006 %G eng %1 38836 %& 1 %0 Report %D 2006 %T Pression de l'air négative dans les laboratoires L3 %A Katia Pauwels %A Bernadette Van Vaerenbergh %A Chuong Dai Do Thi %A Berghmans,L. %A Philippe Herman %K de %K L3 %K LE %K negative pressure %K SBB %K website %I Scientific Institute of Public Health %C Brussels %V D/2006/2505/15 %P 6 %8 0/0/2006 %G eng %1 38835 %& 1 %0 Report %D 2006 %T Recommandations de biosécurité relatives au traitement et aux méthodes d'inactivation des déchets biologiques contaminés %A Berghmans,L. %A Katia Pauwels %A Bernadette Van Vaerenbergh %A Chuong Dai Do Thi %A Philippe Herman %K a %K Belgique %K biosécurité %K ce %K classification %K culture %K de %K EN %K ET %K Europe %K inactivation %K LE %K OGM %K PAR %K pathogène %K questions %K recommandations %K relatives %K santé %K santé publique %K SBB %K situation %K traitement %K Type %K VALIDATION %K Waste %K website %X La problématique des déchets constitue une des questions les plus importantes en Europe. Lespremières directives européennes dans le domaine datent de la période 1975-1976. Undéveloppement important a été réalisé dans la directive de base (Directive 91/156/CEE) quicontient une définition plus claire de la notion de 'déchet'. Elle s'énonce comme suit: " %I Scientific Institute of Public Health %C Brussels %V D/2006/2505/33 %P 33 %8 0/0/2006 %G eng %1 38513 %& 1 %0 Report %D 0 %T Opinion on Synthetic Biology III: Risks to the environment and biodiversity related to synthetic biology and research priorities in the field of synthetic biology %A T. Vermeire %A Epstein,M. %A Hartemann,P. %A Proykova,A. %A Rodriguez Farre %A Martinez Fernandez %A K Chaundhry %A S Chandra Rastogi %A Breitling,R. %A Bridges,J. %A Delebecque,C. %A Gardner,T. %A Katia Pauwels %A J Philip %A M Schmidt %A E Takano %G eng