TY - JOUR T1 - Oncolytic Viruses: An Inventory of Shedding Data from Clinical Trials and Elements for the Environmental Risk Assessment. JF - Vaccines (Basel) Y1 - 2023 A1 - Sheela Onnockx ED - Aline Baldo ED - Katia Pauwels KW - biosafety KW - cancer KW - Clinical trials KW - environmental risk assessment KW - oncolytic virus KW - shedding AB -

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.

VL - 11 CP - 9 M3 - 10.3390/vaccines11091448 ER - TY - JOUR T1 - Environmental Risk Assessment of Recombinant Viral Vector Vaccines against SARS-Cov-2 JF - Vaccines Y1 - 2021 A1 - Aline Baldo A1 - Amaya Leunda A1 - Nicolas Willemarck A1 - Katia Pauwels VL - 9 CP - 5 M3 - 10.3390/vaccines9050453 ER - TY - BOOK T1 - GMO Regulatory Aspects of Novel Investigational Vaccine Candidates T2 - Vaccines - the History and Future’ Y1 - 2019 A1 - Amaya Leunda A1 - Katia Pauwels KW - environmental risk assessment KW - European directives KW - GMO KW - novel vaccine candidates KW - regulatory challenges AB -

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.

JF - Vaccines - the History and Future’ ER - TY - JOUR T1 - 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 JF - Council for Agricultural Science and Technology (CAST) Y1 - 2018 A1 - AJ Bogdanove A1 - DM Donovan A1 - E Elorriaga A1 - J Kuzma A1 - Katia Pauwels A1 - S Strauss A1 - D Voytas AB -

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.

VL - 60 CP - 60 ER - TY - RPRT T1 - Annual polio report for the European Regional Certification Commission for the year 2015. National Certification Committee Belgium Y1 - 2016 A1 - E Mendes A1 - Katia Pauwels A1 - Martine Sabbe KW - national KW - polio KW - public health AB -

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.

PB - WIV-ISP CY - Brussels ER - TY - RPRT T1 - Annual polio report for the European Regional Certification Commission for the year 2014. National Certification Committee Belgium. Y1 - 2015 A1 - E Mendes A1 - Katia Pauwels A1 - Martine Sabbe KW - Activity KW - Belgium KW - Certification KW - European KW - general KW - health KW - national KW - ON KW - programme KW - public KW - public health KW - Public-health KW - regional KW - report KW - status KW - Surveillance AB -

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.

PB - Public Health and Surveillance, WIV-ISP CY - Brussels U1 -

5198

ER - TY - BOOK T1 - Biosafety Recommendations on the Handling of Animal Cell Cultures T2 - Animal Cell Culture Y1 - 2015 A1 - Philippe Herman A1 - Katia Pauwels ED - Al-Rubeai,Mohamed KW - a KW - Activity KW - Agent KW - an KW - Animal KW - aspects KW - assessment KW - at KW - Back KW - biosafety KW - Cell KW - cell culture KW - cells KW - compliance KW - conditions KW - Contained use KW - containment KW - contaminant KW - contaminants KW - culture KW - Development KW - Diagnosis KW - Engineering KW - environment KW - EVALUATION KW - genetically KW - Genetically modified KW - Genetically modified organisms KW - hazard KW - health KW - Human KW - human health KW - Infectious KW - IS KW - IT KW - management KW - measure KW - measures KW - microorganism KW - microorganisms KW - ON KW - ORIGIN KW - pathogenic KW - Pathogenic organisms KW - probability KW - recommendation KW - Recommendations KW - Research KW - risk KW - Risk Assessment KW - risk management KW - risks KW - SBB KW - Tissue KW - Type KW - use AB -

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.

JF - Animal Cell Culture PB - Springer International Publishing CY - Switzerland VL - 9 SN - 978-3-319-10319-8 CP - 22 U1 - 5197 ER - TY - Generic T1 - GAP III - The WHO poliovirus containment policy : Implications and implementation in Belgium Y1 - 2015 A1 - Katia Pauwels ED - Hoge Gezondheidsraad KW - Belgium KW - containment KW - implementation KW - implication KW - IMPLICATIONS KW - POLICIES KW - POLICY KW - Poliovirus KW - WHO JF - Werkgroep vaccinatie CP - Hogegezondheidsraad U1 - 5200 U2 - 19/03/2015 ER - TY - JOUR T1 - Next-generation sequencing as a tool for the molecular characterisation and risk assessment of genetically modified plants: Added value or not? JF - Trends Food Sci. Technol. Y1 - 2015 A1 - Katia Pauwels A1 - Sigrid C.J. De Keersmaecker A1 - Adinda De Schrijver A1 - P. du Jardin A1 - Nancy Roosens A1 - Philippe Herman KW - Genetically modified organism (GMO) KW - Genetically modified plants (GMP) KW - Next-generation sequencing (NGS) KW - Risk assessment Molecular characterisation AB -

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.

VL - 45 SN - 0924-2244 CP - 2 U1 - 5215 M3 - 10.1016/j.tifs.2015.07.009 ER - TY - RPRT T1 - Opinion on Synthetic Biology II - Risk assessment methodologies and safety aspects Y1 - 2015 A1 - T. Vermeire A1 - Epstein,M. A1 - Hartemann,P. A1 - Proykova,A. A1 - E. Rodriguez Farre A1 - L. Martinez Martinez A1 - Fernandes,T. A1 - Chaudhry,K. A1 - Chandra Rastogi,S. A1 - Breitling,R. A1 - Bridges,J. A1 - Delebecque,C. A1 - Gardner,T. A1 - Katia Pauwels A1 - Philp,J. A1 - Schmidt,M. A1 - Takano,E. ED - SCENIHR KW - a KW - additional KW - an KW - Animal KW - application KW - Area KW - Areas KW - AS KW - assessment KW - at KW - Biology KW - Canada KW - Combination KW - Countries KW - criteria KW - definition KW - Design KW - Development KW - Engineering KW - environment KW - environmental KW - environmental risk assessment KW - EU KW - European KW - European Commission KW - European Union KW - Follow KW - Genetic KW - genetic engineering KW - genetic modification KW - genetically KW - Genetically modified KW - Genetically modified organism KW - Genetically modified organisms KW - GM KW - GMO KW - GMOs KW - Guidelines KW - health KW - Human KW - i KW - identification KW - implication KW - IMPLICATIONS KW - IS KW - List KW - living KW - method KW - methodology KW - methods KW - need KW - ON KW - past KW - Practice KW - PRACTICES KW - PROCESSES KW - PRODUCTS KW - public KW - public health KW - Public-health KW - questions KW - Regulatory KW - Research KW - risk KW - Risk Assessment KW - risks KW - SAFETY KW - Science KW - specific KW - summary KW - Synthetic KW - Synthetic Biology KW - System KW - Type KW - work AB - 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). PB - European Union CY - Luxembourg SN - ISSN 1831-4783; ISBN 978-92-79-43916-2 U1 - 39050 ER - TY - JOUR T1 - Engineering nucleases for gene targeting: safety and regulatory considerations. JF - N Biotechnol Y1 - 2014 A1 - Katia Pauwels A1 - Podevin, Nancy A1 - Didier Breyer A1 - Carroll, Dana A1 - Philippe Herman KW - Deoxyribonucleases KW - Gene Targeting KW - Genetic Therapy KW - Humans KW - SAFETY AB -

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.

VL - 31 CP - 1 U1 - http://www.ncbi.nlm.nih.gov/pubmed/23851284?dopt=Abstract M3 - 10.1016/j.nbt.2013.07.001 ER - TY - RPRT T1 - Opinion on Synthetic Biology - I. Definition Y1 - 2014 A1 - T. Vermeire A1 - Epstein,M. A1 - Hartemann,P. A1 - Proykova,A. A1 - E. Rodriguez Farre A1 - L. Martinez Martinez A1 - Fernandes,T. A1 - Chaudhry,K. A1 - Chandra Rastogi,S. A1 - Breitling,R. A1 - Bridges,J. A1 - Delebecque,C. A1 - Gardner,T. A1 - Katia Pauwels A1 - Philp,J. A1 - Schmidt,M. A1 - Takano,E. ED - SCENIHR KW - a KW - additional KW - an KW - application KW - Area KW - Areas KW - AS KW - aspects KW - assessment KW - at KW - Biology KW - Canada KW - Combination KW - concept KW - concepts KW - Countries KW - criteria KW - definition KW - Design KW - Development KW - Engineering KW - environment KW - EU KW - European KW - European Union KW - Field KW - Follow KW - Genetic KW - genetic modification KW - GM KW - GMO KW - Guidelines KW - health KW - i KW - IS KW - IT KW - List KW - living KW - method KW - methodology KW - methods KW - need KW - ON KW - past KW - present KW - PROCESSES KW - PRODUCTS KW - public KW - public health KW - Public-health KW - Regulatory KW - Research KW - risk KW - Risk Assessment KW - risks KW - SAFETY KW - Science KW - specific KW - summary KW - Synthetic KW - Synthetic Biology KW - System KW - technology KW - Type KW - USA KW - work AB - 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. PB - European Union CY - Luxembours SN - ISSN 1831-4783; ISBN 978-92-79-30136-0 U1 - 39049 M3 - 10.2772/76553 ER - TY - JOUR T1 - Biosafety risk assessment and management of laboratory-derived influenza A (H5N1) viruses transmissible in ferrets JF - Applied Biosafety Y1 - 2013 A1 - Aline Baldo A1 - Amaya Leunda A1 - Chuong Dai Do Thi A1 - Didier Breyer A1 - Katia Pauwels A1 - Sarah Welby A1 - Van Vaerenbergh, Bernadette A1 - Philippe Herman KW - biosafety KW - Highly pathogenic avian influenza A (H5N1) virus KW - Risk Assessment AB - 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. VL - 18 CP - 1 M3 - http://journals.sagepub.com/doi/pdf/10.1177/153567601301800102 ER - TY - JOUR T1 - Environmental risk assessment of clinical trials involving modified vaccinia virus Ankara (MVA)-based vectors. JF - Curr Gene Ther Y1 - 2013 A1 - Goossens, Martine A1 - Katia Pauwels A1 - Nicolas Willemarck A1 - Didier Breyer KW - Animals KW - Clinical Trials as Topic KW - Genetic Therapy KW - Genetic Vectors KW - Hazardous Substances KW - Humans KW - Risk Assessment KW - Vaccination KW - vaccinia virus KW - Viral Vaccines AB -

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.

VL - 13 CP - 6 U1 - http://www.ncbi.nlm.nih.gov/pubmed/24397528?dopt=Abstract M3 - https://doi.org/10.2174/156652321306140103221941 ER - TY - JOUR T1 - Event report: SynBio Workshop (Paris 2012) - Risk assessment challenges of Synthetic Biology JF - J.Verbr.Lebensm. Y1 - 2013 A1 - Katia Pauwels A1 - Ruth Mampuys A1 - Catherine Golstein A1 - Didier Breyer A1 - Philippe Herman A1 - M. Kaspari A1 - J-C. Pagès A1 - Herbert Pfister A1 - Frank Wilk KW - 2012 KW - an KW - AS KW - assessment KW - Belgian KW - biological safety KW - Biology KW - biosafety KW - Biotechnology KW - challenge KW - Countries KW - Development KW - Discussion KW - Emerging risks KW - Europe KW - European KW - European Commission KW - European countries KW - Field KW - food KW - Food Safety KW - genetic modification KW - GMOs KW - health KW - identify KW - INFORMATION KW - Institute KW - International KW - journal KW - Monitoring KW - national KW - Netherlands KW - New techniques KW - ON KW - public KW - public health KW - Public-health KW - questions KW - Regulatory KW - report KW - Research KW - REVIEW KW - risk KW - Risk Assessment KW - SAFETY KW - SBB KW - Synthetic KW - Synthetic Biology KW - The Netherlands AB - 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. VL - 8 SN - 1661-5751 U1 - 4220 ER - TY - JOUR T1 - General considerations on the biosafety of virus-derived vectors used in gene therapy and vaccination. JF - Curr Gene Ther Y1 - 2013 A1 - Aline Baldo A1 - van den Akker, Eric A1 - Bergmans, Hans E A1 - Lim, Filip A1 - Katia Pauwels KW - Animals KW - Clinical Trials as Topic KW - Genetic Therapy KW - Genetic Vectors KW - Hazardous Substances KW - Humans KW - Organisms, Genetically Modified KW - Risk Assessment KW - Vaccination KW - Viruses AB -

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.

VL - 13 CP - 6 U1 - https://www.ncbi.nlm.nih.gov/pubmed/24195604?dopt=Abstract M3 - 10.2174/15665232113136660005 ER - TY - Generic T1 - Organisation of expertise for the risk evaluation of biosafety dossiers in Belgium Y1 - 2013 A1 - Katia Pauwels ED - WIV-ISP KW - a KW - Agriculture KW - Belgium KW - biosafety KW - EVALUATION KW - expertise KW - organisation KW - risk U1 - 38848 ER - TY - JOUR T1 - Are 'Omics' contributing to the identification of unintended effects in genetically modified crops?2743 JF - Biosafety Y1 - 2012 A1 - Katia Pauwels KW - crops KW - effect KW - effects KW - epub KW - genetically KW - Genetically modified KW - Genetically modified crop KW - genetically modified crops KW - identification KW - omics KW - SBB KW - unintended effects KW - website AB - Not available VL - 1 CP - 1 U1 - 38845 ER - TY - JOUR T1 - Biosafety aspects of modified vaccinia virus Ankara (MVA)-based vectors used for gene therapy or vaccination. JF - Vaccine Y1 - 2012 A1 - Verheust, Céline A1 - Goossens, Martine A1 - Katia Pauwels A1 - Didier Breyer KW - Animals KW - Clinical Trials as Topic KW - Gene Transfer Techniques KW - Genetic Therapy KW - Genetic Vectors KW - Humans KW - Mammals KW - Neoplasms KW - Poxviridae Infections KW - Practice Guidelines as Topic KW - Vaccination KW - vaccinia virus KW - Viral Vaccines AB -

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.

VL - 30 CP - 16 U1 - http://www.ncbi.nlm.nih.gov/pubmed/22342706?dopt=Abstract M3 - 10.1016/j.vaccine.2012.02.016 ER - TY - RPRT T1 - Synthetic Biology. Latest developments, biosafety considerations and regulatory challenges Y1 - 2012 A1 - Katia Pauwels A1 - Nicolas Willemarck A1 - Didier Breyer A1 - Philippe Herman KW - ALL KW - an KW - application KW - applications KW - AS KW - at KW - Biology KW - biosafety KW - challenge KW - Change KW - Development KW - Discussion KW - evidence KW - Field KW - food KW - general KW - INFORMATION KW - IS KW - ON KW - Paper KW - Regulatory KW - REVIEW KW - SAFETY KW - SBB KW - Synthetic KW - Synthetic Biology KW - Technique KW - website AB - 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. PB - WIV-ISP CY - Brussels, Belgium SN - D/2012/2505/46 U1 - 3787 ER - TY - Generic T1 - De Europese regelgeving inzake GGO's in het licht van nieuwe technieken van genetische modificatie2769 Y1 - 2010 A1 - Katia Pauwels A1 - Didier Breyer A1 - Philippe Herman KW - de KW - GGO KW - New techniques KW - SBB KW - website AB - Not available JF - ILVO Nieuwsgolf VL - Sept 2010 U1 - 38843 ER - TY - Generic T1 - Methodology of the biological risk classification of animal pathogens in Belgium Y1 - 2010 A1 - Bernadette Van Vaerenbergh A1 - F. Koenen A1 - Katia Pauwels A1 - Quanten,K. A1 - Boyen,F. A1 - Declercq,K. A1 - Desmecht,D. A1 - Thiry,J. A1 - Philippe Herman KW - Animal KW - AS KW - Belgium KW - biological risks KW - classification KW - criteria KW - demand KW - Diagnosis KW - disease KW - Diseases KW - ECONOMIC KW - effect KW - effects KW - epidemic KW - Evolution KW - health KW - Human KW - Infectious diseases KW - International KW - Laboratories KW - List KW - methodology KW - microorganism KW - microorganisms KW - movement KW - ON KW - pandemic KW - Paper KW - past KW - pathogen KW - pathogenic KW - plant KW - Plants KW - production KW - report KW - Research KW - revision KW - risk KW - risks KW - SBB KW - Spread KW - System KW - transboundary movement KW - treatment KW - use KW - world AB - 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). PB - WIV-ISP CY - Brussels VL - 2008-2009 SN - D/2010/2505/52 U1 - 2774 ER - TY - JOUR T1 - Methodology of the biological risk classification of animal pathogens in Belgium. JF - Rev Sci Tech Y1 - 2010 A1 - Van Vaerenbergh, B A1 - F. Koenen A1 - Katia Pauwels A1 - Quanten, K A1 - Boyen, F A1 - Declercq, K A1 - Desmecht, D A1 - Thiry, J A1 - Philippe Herman KW - Animal Diseases KW - Animals KW - bacteria KW - Belgium KW - Communicable Diseases KW - Fungi KW - Humans KW - Parasites KW - Risk Assessment KW - Viruses AB -

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).

VL - 29 CP - 3 U1 - http://www.ncbi.nlm.nih.gov/pubmed/21309451?dopt=Abstract ER - TY - RPRT T1 - Methodology of the biological risk classification of animal pathogens in Belgium Y1 - 2010 A1 - Bernadette Van Vaerenbergh A1 - F. Koenen A1 - Katia Pauwels A1 - Quanten,K. A1 - Boyen,F. A1 - Declercq,K. A1 - Desmecht,D. A1 - Thiry,J. A1 - Philippe Herman KW - a KW - Agent KW - Agents KW - Animal KW - AS KW - aspects KW - Attention KW - Belgian KW - Belgium KW - biological risks KW - cause KW - classification KW - criteria KW - definition KW - demand KW - Diagnosis KW - disease KW - Diseases KW - ECONOMIC KW - effect KW - effects KW - epidemic KW - Epidemics KW - Evolution KW - Group KW - health KW - Human KW - Infectious KW - Infectious diseases KW - International KW - IT KW - KNOWLEDGE KW - Laboratories KW - List KW - methodology KW - microorganism KW - microorganisms KW - movement KW - ON KW - organisation KW - pandemic KW - Pandemics KW - Paper KW - past KW - pathogen KW - pathogenic KW - plant KW - Plants KW - production KW - prophylaxis KW - Research KW - revision KW - risk KW - risks KW - SBB KW - severity KW - Spread KW - System KW - Systems KW - transboundary movement KW - treatment KW - use KW - website KW - world KW - World Health AB - 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). PB - Scientific Institute of Public Health CY - Brussels VL - WIV-ISP Scientific Report 2008-2009 U1 - 39034 ER - TY - Generic T1 - New techniques of genetic modification and the GMO definition Y1 - 2010 A1 - Didier Breyer A1 - Katia Pauwels A1 - Philippe Herman KW - a KW - AS KW - at KW - biosafety KW - Biotechnology KW - challenge KW - Context KW - definition KW - European KW - European Union KW - Genetic KW - genetic modification KW - genetically KW - Genetically modified KW - Genetically modified organism KW - Genetically modified organisms KW - GMM KW - GMO KW - GMO regulation KW - i KW - IS KW - IT KW - KNOWLEDGE KW - legislation KW - LEVEL KW - List KW - mating KW - microorganism KW - microorganisms KW - New techniques KW - ON KW - Order KW - PRODUCTS KW - regulation KW - Regulatory KW - result KW - SBB KW - series KW - Technique KW - use KW - website KW - work KW - Yield AB - 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. PB - WIV-ISP CY - Brussels VL - WIV-ISP Scientific Report 2008-2009 U1 - 38526 ER - TY - RPRT T1 - Sampling feasibility study of pathogenic organisms genetically modified or not in contained use activities Y1 - 2010 A1 - Amaya Leunda A1 - Katia Pauwels A1 - Bernadette Van Vaerenbergh A1 - Philippe Herman KW - a KW - Activity KW - AS KW - aspects KW - biological risks KW - conditions KW - Contained use KW - danger KW - environment KW - Feasibility Studies KW - genetically KW - Genetically modified KW - Harm KW - health KW - Human KW - human health KW - i KW - IS KW - ON KW - Order KW - pathogenic KW - Pathogenic organisms KW - present KW - probability KW - public KW - public health KW - Public-health KW - report KW - result KW - results KW - risk KW - risks KW - sampling KW - SBB KW - situation KW - study KW - use KW - website AB - 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. PB - Scientific Institute of Public Health CY - Brussels VL - D/2010/2505/19 U1 - 2770 ER - TY - RPRT T1 - Biological risk assessment sheets : Practical examples of risk assessment and biosafety recommendations for the contained use of genetically modified (micro-)organisms Y1 - 2009 A1 - Katia Pauwels A1 - Bernadette Van Vaerenbergh A1 - Verheust,C. A1 - Philippe Herman KW - a KW - adverse effects KW - ALL KW - an KW - AS KW - assessment KW - biological risks KW - biosafety KW - classification KW - Contained use KW - effect KW - effects KW - environment KW - genetically KW - Genetically modified KW - Genetically modified organism KW - Genetically modified organisms KW - GMO KW - GMOs KW - health KW - Human KW - human health KW - IS KW - List KW - means KW - measure KW - measures KW - ON KW - pathogenic KW - Pathogenic organisms KW - recommendation KW - Recommendations KW - risk KW - Risk Assessment KW - risks KW - SBB KW - summary KW - use KW - website AB - 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. PB - Scientific Institute of Public Health CY - Brussels VL - D/2009/2505/48 U1 - 38841 ER - TY - JOUR T1 - Genetic modification through oligonucleotide-mediated mutagenesis. A GMO regulatory challenge? JF - Environ Biosafety Res Y1 - 2009 A1 - Didier Breyer A1 - Philippe Herman A1 - Brandenburger, Annick A1 - Gheysen, Godelieve A1 - Remaut, Erik A1 - Soumillion, Patrice A1 - Van Doorsselaere, Jan A1 - Custers, René A1 - Katia Pauwels A1 - Myriam Sneyers A1 - Reheul, Dirk KW - Animals KW - Animals, Genetically Modified KW - European Union KW - genetic engineering KW - Government Regulation KW - International Cooperation KW - mutagenesis KW - Plants, Genetically Modified AB -

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.

VL - 8 CP - 2 U1 - http://www.ncbi.nlm.nih.gov/pubmed/19833073?dopt=Abstract M3 - 10.1051/ebr/2009007 ER - TY - RPRT T1 - Inrichtingen met een hoog inperkingsniveau in België. Rapport: Periode 1995-2008 Y1 - 2009 A1 - Chuong Dai Do Thi A1 - Bernadette Van Vaerenbergh A1 - Philippe Herman A1 - Katia Pauwels A1 - Fanny Coppens A1 - Amaya Leunda A1 - Verheust,C. KW - België KW - de KW - GGM KW - L3 KW - pathogen KW - risicoklasse 3 KW - SBB AB - 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 PB - WIV-ISP CY - Brussels SN - D/2009/2505/40 U1 - 2793 ER - TY - RPRT T1 - Les installations de haut niveau de confinement en Belgique. Rapport: Période 1995 - 2008 Y1 - 2009 A1 - Chuong Dai Do Thi A1 - Bernadette Van Vaerenbergh A1 - Philippe Herman A1 - Katia Pauwels A1 - Fanny Coppens A1 - Amaya Leunda A1 - Verheust,C. KW - Belgique KW - classe de risque 3 KW - Confinement KW - de KW - L3 KW - LE KW - MGM KW - objectives KW - pathogène KW - SBB KW - utilisation AB - 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 PB - WIV-ISP CY - Brussels SN - D/2009/2505/40 U1 - 2792 ER - TY - Generic T1 - Should novel organisms developed using oligonucleotide-mediated mutagenesis be excluded from the EU Regulation Y1 - 2009 A1 - Didier Breyer A1 - Philippe Herman A1 - Brandenburger,A. A1 - Gheysen,G. A1 - Remaut,E. A1 - Soumillion,P. A1 - J. Van Doorsselaere A1 - Custers,R. A1 - Katia Pauwels A1 - Myriam Sneyers A1 - Reheul,D. KW - EU KW - mutagenesis KW - New techniques KW - Paper KW - regulation KW - Regulatory KW - SAFETY KW - SBB KW - Technique KW - use KW - website AB -

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.

JF - ISB news report PB - ISBN CY - Brussels VL - November 2009 U1 - 38519 ER - TY - JOUR T1 - State-of-the-art lentiviral vectors for research use: risk assessment and biosafety recommendations. JF - Curr Gene Ther Y1 - 2009 A1 - Katia Pauwels A1 - Gijsbers, Rik A1 - Toelen, Jaan A1 - Schambach, Axel A1 - Willard-Gallo, Karen A1 - Verheust, Céline A1 - Debyser, Zeger A1 - Philippe Herman KW - Animals KW - Genetic Vectors KW - Guidelines as Topic KW - Humans KW - Lentivirus KW - Risk Assessment AB -

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.

VL - 9 CP - 6 U1 - http://www.ncbi.nlm.nih.gov/pubmed/20021330?dopt=Abstract ER - TY - RPRT T1 - Emploi d'appareils de protection respiratoire durant l'utilisation confinée d'organismes génétiquement modifiés et/ou pathogènes Y1 - 2008 A1 - Katia Pauwels A1 - Fanny Coppens A1 - Verheust,C. A1 - Bernadette Van Vaerenbergh A1 - Chuong Dai Do Thi A1 - Philippe Herman KW - a KW - aspects KW - ce KW - CONTACT KW - danger KW - de KW - Decision KW - EN KW - LE KW - mask KW - objectives KW - ON KW - PAR KW - pathogen KW - pathogène KW - protection KW - réglementation KW - risques KW - santé KW - santé publique KW - SBB KW - Technique KW - Type KW - website AB - 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. PB - Scientific Institute of Public Health CY - Brussels VL - D/2008/2505/01 U1 - 38839 ER - TY - Generic T1 - Animal cell cultures: Risk Assessment and biosafety recommendations Y1 - 2007 A1 - Katia Pauwels A1 - Bernadette Van Vaerenbergh A1 - Chuong Dai Do Thi A1 - Berghmans,L. A1 - Geneviève Waeterloos A1 - Van Bockstaele,D. A1 - Dorsch-Hasler,K. A1 - Myriam Sneyers KW - Activity KW - an KW - Animal KW - AS KW - assessment KW - at KW - biosafety KW - Case KW - cell culture KW - cells KW - compliance KW - containment KW - environment KW - EVALUATION KW - general KW - genetic modification KW - hazard KW - health KW - Human KW - human health KW - IS KW - LEVEL KW - measure KW - measures KW - ON KW - ORIGIN KW - pathogen KW - pathogenic KW - recommendation KW - Recommendations KW - Reduction KW - Research KW - result KW - risk KW - Risk Assessment KW - risks KW - SBB KW - Type KW - use KW - work AB - 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. JF - Appl.Biosaf. VL - 12 CP - 1 U1 - 1899 ER - TY - RPRT T1 - Gebruik van ademhalingsbeschermingsmiddelen bij het ingeperkt gebruik van genetisch gemodificeerde organismen en/of pathogenen Y1 - 2007 A1 - Katia Pauwels A1 - Fanny Coppens A1 - Verheust,C. A1 - Bernadette Van Vaerenbergh A1 - Chuong Dai Do Thi A1 - Philippe Herman KW - AAN KW - Aerosols KW - blootstelling KW - de KW - gebruik KW - gezondheid KW - IS KW - mask KW - pathogen KW - risico KW - SBB KW - Type KW - website AB - 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. PB - Scientific Institute of Public Health CY - Brussels VL - 2007/2505/64 U1 - 38838 ER - TY - RPRT T1 - Biosafety recommendations for the contained use of Mycobacterium tuberculosis complex isolates in industrialized countries Y1 - 2006 A1 - Philippe Herman A1 - M. Fauville A1 - Didier Breyer A1 - Bernadette Van Vaerenbergh A1 - Katia Pauwels A1 - Chuong Dai Do Thi A1 - Myriam Sneyers A1 - Wanlin,M. A1 - Snacken,R. A1 - William Moens KW - a KW - Activity KW - Aerosols KW - Airborne KW - an KW - analysi KW - analysis KW - AS KW - Belgium KW - biosafety KW - BSL-3 KW - classification KW - Clinical KW - containment KW - Countries KW - culture KW - developed countries KW - Diagnosis KW - disease KW - Diseases KW - Dna KW - Group KW - Human KW - identification KW - incidence KW - INFECTION KW - Infectious KW - Infectious diseases KW - International KW - IS KW - IT KW - Laboratories KW - Less KW - LEVEL KW - M KW - M tuberculosis KW - Mycobacterium KW - Mycobacterium tuberculosis KW - ON KW - pathogen KW - People KW - Practice KW - PRACTICES KW - recommendation KW - Recommendations KW - Research KW - risk KW - Rna KW - SAFETY KW - SBB KW - Secondary KW - specific KW - Test KW - tests KW - time KW - Times KW - Transmission KW - Tuberculosis KW - use KW - website KW - work AB - 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. PB - Scientific Institute of Public Health CY - Brussels VL - D/2006/2505/22 U1 - 38754 ER - TY - RPRT T1 - Bioveiligheidsaanbevelingen aangaande behandelings- en inactiveringsmethoden voor biologisch besmet afval Y1 - 2006 A1 - Berghmans,L. A1 - Katia Pauwels A1 - Bernadette Van Vaerenbergh A1 - Chuong Dai Do Thi A1 - Philippe Herman KW - België KW - de KW - EN KW - gebruik KW - GGO KW - IS KW - List KW - MEN KW - SBB KW - vlaamse KW - Waste KW - website AB - 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. PB - Scientific Institute of Public Health CY - Brussels VL - D/2006/2505/28 U1 - 38514 ER - TY - RPRT T1 - Enceintes de sécurité microbiologique Y1 - 2006 A1 - Philippe Herman A1 - Katia Pauwels KW - ce KW - de KW - EN KW - ET KW - LE KW - microbiologie KW - OGM KW - pathogène KW - SBB KW - Type KW - website AB - 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. PB - Scientific Institute of Public Health CY - Brussels VL - D/2006/2505/20 U1 - 38756 ER - TY - RPRT T1 - Microbiologische veiligheidswerkkasten Y1 - 2006 A1 - Philippe Herman A1 - Katia Pauwels KW - AAN KW - de KW - EN KW - IS KW - SBB KW - Type KW - website AB - 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. PB - Scientific Institute of Public Health CY - Brussels VL - D/2006/2505/20 U1 - 38755 ER - TY - RPRT T1 - Negatieve luchtdruk bij L3 laboratoria Y1 - 2006 A1 - Katia Pauwels A1 - Bernadette Van Vaerenbergh A1 - Chuong Dai Do Thi A1 - Berghmans,L. A1 - Philippe Herman KW - L3 KW - negative pressure KW - SBB KW - website PB - Scientific Institute of Public Health CY - Brussels VL - D/2006/2505/15 U1 - 38836 ER - TY - RPRT T1 - Pression de l'air négative dans les laboratoires L3 Y1 - 2006 A1 - Katia Pauwels A1 - Bernadette Van Vaerenbergh A1 - Chuong Dai Do Thi A1 - Berghmans,L. A1 - Philippe Herman KW - de KW - L3 KW - LE KW - negative pressure KW - SBB KW - website PB - Scientific Institute of Public Health CY - Brussels VL - D/2006/2505/15 U1 - 38835 ER - TY - RPRT T1 - Recommandations de biosécurité relatives au traitement et aux méthodes d'inactivation des déchets biologiques contaminés Y1 - 2006 A1 - Berghmans,L. A1 - Katia Pauwels A1 - Bernadette Van Vaerenbergh A1 - Chuong Dai Do Thi A1 - Philippe Herman KW - a KW - Belgique KW - biosécurité KW - ce KW - classification KW - culture KW - de KW - EN KW - ET KW - Europe KW - inactivation KW - LE KW - OGM KW - PAR KW - pathogène KW - questions KW - recommandations KW - relatives KW - santé KW - santé publique KW - SBB KW - situation KW - traitement KW - Type KW - VALIDATION KW - Waste KW - website AB - 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: " PB - Scientific Institute of Public Health CY - Brussels VL - D/2006/2505/33 U1 - 38513 ER - TY - RPRT T1 - Opinion on Synthetic Biology III: Risks to the environment and biodiversity related to synthetic biology and research priorities in the field of synthetic biology Y1 - 0 A1 - T. Vermeire A1 - Epstein,M. A1 - Hartemann,P. A1 - Proykova,A. A1 - Rodriguez Farre A1 - Martinez Fernandez A1 - K Chaundhry A1 - S Chandra Rastogi A1 - Breitling,R. A1 - Bridges,J. A1 - Delebecque,C. A1 - Gardner,T. A1 - Katia Pauwels A1 - J Philip A1 - M Schmidt A1 - E Takano ER -