Biosafety biosafetyeurope recommends the relevant ec authoritys 1. Biosafety protects people from germs biosecurity protects germs from. Biosafety has similarly been defined as the avoidance of risk to human health and safety, and to the conservation of the environment, as a result of the use for research and commerce of infectious or genetically modified organisms zaid, 2001. United nations environment programme unep, established in 1972, is the voice for the environment within the united nations system. Biosafety training includes information about the infectious agents that are stored and used by the entity, including health considerations posed by the risk groups 3 agents, routes of exposure, symptoms, medical surveillance, ppe usage, incident response, postincident response, postexposure medical surveillance, postexposure reporting and. Biosafety protocol stevens institute of technology. The university of wisconsinmadison, as an institution receiving research funds from the national institutes of health nih, is subject to the nih guidelines for research involving recombinant or synthetic nucleic acid molecules.
This is the third, revised edition of the booklet biosafety in the laboratory. This plan conforms to regulations set forth by the code of federal regulations, title 29 labor, chapter xviii office of safety and health administration, part 1910, subpart i, sections. Principles and concepts of biosafety environmental. While it is generally recognised that biotechnology has potential benefits for the protection of the environment and for improving human health, by the same token questions have been raised. This specialized agency of the united nations published the first edition of its laboratory biosafety manual in 1983.
Biosafety in microbiological and biomedical laboratories. Biosafety resources office of environment, health and safety. While it is generally recognised that biotechnology has potential benefits for the protection of the environment and for improving human health, by. Human, animal and plant materials may harbor biohazardous organisms or agents and such materials must be handled accordingly. Challenges and practices in building and implementing. Biosafety orientation training this 15 minute online module in reporter biosafety orientation rescompliibc is intended to be a general overview of biosafety at nc state. There are four recommended vertebrate animal biosafety levels. Indiana university is actively committed to preserving the health and safety of its students, staff, and faculty, and to protecting the environment and the community. Principles of biosafety the term containment describes safe methods, or properly managing infectious agents in the laboratory environment where they are being handled or maintained.
We develop biosafety programs that minimize the risks of exposure and ensure compliance with the guidelines for biosafety from the centers for disease control and prevention cdc and the national institutes of health nih as well as a variety of local, state and federal biosafetyrelated regulations. Biosafety, in medicine and health care settings, specifically refers to proper handling of organs or tissues from biological origin, or genetic therapy products, viruses with respect to the environment, to ensure the safety of health care workers, researchers, lab staff, patients, and the general public. The goal of the biological safety program is to ensure the safe and proper use of biohazardous materials, such as bacteria, viruses and fungi. Bsl ii is appropriate when work is done with any human derived blood, body fluids, tissues, or primary human. Per the cdcnih biosafety microbiological laboratories appendix hworking with human, nhp and other mammalian cells and tissues. It is through their absolute commitment to quality, technical accuracy, and dedication to the professional. Director, office of health and safety centers for disease control and prevention atlanta, ga 30333 adapted from the cdcnih 3rd edition of biosafety in microbiological and biomedical laboratories introduction.
The meeting stressed the immediate need for international action to achieve adequate safety in biotechnology that should be directed to ensure safety for human health and the conservation and sustainable use of biological diversity. Biotechnology can generate significant benefits, but there are concerns that it may have adverse impacts on biodiversity and human health. An approved bua assures that an appraisal has been made of the potential impacts associated with the intended use of an organism. Biosafety, biotechnology and gmos legislations in libya. 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. Ofice of environment, health safety 3 return to table of contents introduction to cleb the committee for laboratory and environmental biosafety cleb serves as uc berkeleys institutional biosafety committee ibc.
The goals of the biosafety program are to protect personnel from exposure to infectious agents, to prevent environmental contamination, to provide an environment for high quality research while maintaining a safe work place, and to comply with applicable federal, state and local requirements. Recent international initiatives have put integrated risk management approaches which combine. For a list of materials that require bua submission prior to their acquisition andor use, refer to page 4 of the nc state university laboratory biosafety manual federal, state, local, and university requirements and policies change over time. Additionally, the office of biological safety obs adheres to standardized practices as described in the biosafety in microbiological and biomedical laboratories. Storing human foods or drinks anywhere in the laboratory working areas is. We develop biosafety programs that minimize the risks of exposure and ensure compliance with the guidelines for biosafety from the centers for disease control and prevention cdc and the national institutes of health nih as well as a variety. Organizations and agencies included the american association for laboratory animal science aalas, american biological safety association absa, american clinical laboratory association, american society of microbiology, association of public health laboratories, eagleson institute, emory university, frontline foundation. Principles and concepts of biosafety environmental health. The objective of containment is to confine biohazards and to reduce the potential. To discuss about various aspects of biosafety regulations, ipr and bioethic concerns arising. Law 152003 protection and improvement of the environment the law comprises 11 chapters and 79 articles. The goal of this module is to help participants to understand what materials andor research might trigger institutional biosafety committee ibc approval and how to handle materials andor research. Only a few alterations have been made, especially in the text concerning decontamination and inactivation. Biosafety applications are required for research, including.
The recommendations below describe practices, safety equipment and facilities for experiments with animals infected with agents that cause, or may cause, human infection. Provision of basic training in biosafety is considered a best practice and is usually provided by the biosafety officer or occupational health specialist to visitors, students and workers in biological laboratories. Biosafety for human health and the environment in the context of the potential use of genetically modified mosquitoes gmms a tool for biosafety training based on courses in africa, asia and latin america, 20082011 for research on diseases of poverty unicef undp world bank who training manual. The levels are designated in ascending order, by degree of protection provided to personnel, the environment. Biosafety level ii applicable to facilities in which work is done with indigenous moderaterisk agents present in the community and associated with human disease of varying severity.
Laboratory biosafety manual the laboratory biosafety manual provides a guide to common practices and requirements related to working with biological materials at nc state university in teaching, research, and diagnostic laboratories. Human xenografts in animals absl2 training oh 227 pdf biosafety cabinets video, ut eid required disinfection practices for tissue culture. Human and other primate cells should be handled using bsl2. Jun 27, 2014 biosafety has similarly been defined as the avoidance of risk to human health and safety, and to the conservation of the environment, as a result of the use for research and commerce of infectious or genetically modified organisms zaid, 2001. The world health organization who has long recognized that safety and, in particular, biological safety are important international issues. Printed and spiral bound copies of the manual are available for pickup upon request, please call 650 7230448 for more information. Benefits and controversies article pdf available in african journal of biotechnology 1058. Biosafety in microbiological and biomedical laboratories u.
Concerns over their possible environmental and health implications stimulated regulatory mechanisms. One important biosafety element suggested for all 4 biosafety levels is biosafety training. A framework for implementing national biosafety systems emerged, which consists of the following five. The manual encourages countries to prepare specific. Bsl ii is appropriate when work is done with any human derived blood, body fluids, tissues, or primary human cell. Biosafety and gmo legislations in general, there are about 18 enforced laws and 15 decisions dealing with matters of human and environmental biosafety in libya only one such legislation briefly addresses gmos issues. Pdf biosafety recommendations on the handling of animal.
In the laboratory dna is mostly used in the form of plasmids, digested dna, or primers. Modern biotechnology can bring many benefits, but there are concerns that it could also have adverse impacts on biodiversity and human health. Biosafety, in medicine and health care settings, specifically refers to proper handling of organs or tissues from biological origin, or genetic therapy products, viruses with respect to the environment, to ensure the safety of health care workers, researchers, lab. The uw biosafety manual provides students, staff, and faculty at uw with information that is necessary to protect them and the surrounding community from possible hazards associated with the use of biohazardous agents and recombinant or synthetic dnarna recdna molecules. Animal biosafety level 2 builds upon the practices, procedures, containment equipment, and facility requirements of absl1. Cleb is comprised of subject matter experts, an animal health expert, and an occupational physician, as well as community members. Biosafety practices are used in the proper handling of biohazardous organisms. Biosafety manual and any recommendations made by iu ibc or iuehs biosafety preempts recommendations that follow from the bmbl for biosafety level 2. To merge or at least harmo nize the directives 200054 ec and 9881ec as the same control measures, based on risk assessment, can be applied to both biological agents and gmms. The committee for laboratory and environmental biosafety cleb serves as uc berkeleys institutional biosafety committee ibc. The purpose of containment is to reduce or eliminate the exposure to potentially hazardous agents of laboratory workers, other persons, and the outside environment.
Biosafety resource book food and agriculture organization of the. The intent of the biosafety program at queens university, and the purpose of the queens biosafety manual, is to guide personnel in how to work safely with biological material that can be hazardous to people andor animals. The universitys compliance initiatives for this regulation are covered under the exposure control plan maintained by the health and safety office. Research ethic and complianceinstitutional biosafety committee ibc. Provision of basic training in biosafety is considered a best practice and is usually provided by the biosafety officer or occupational health specialist to. The university of wisconsinmadison, as an institution receiving research funds from the national institutes of health nih, is subject to the nih guidelines for research involving recombinant dna molecules. Leon igras, chief safety officer executive director environmental health and safety david gillum, chief of staff cdc responsible officialinstitutional biosafety officer environmental health and safety chantelle miller, assistant director oked research operations. Biosafety program faqs and resources environmental. It is recognized that use of potentially pathogenic microorganisms, other biological materials, and organisms containing recombinant or synthetic nucleic acid molecules is.
Unep acts as a catalyst, advocate, educator and facilitator to. Institutional biosafety committee and was last approved on december 19, 2017. Cleb is comprised of subject matter experts, an animal health expert, an occupational physician, as well as community members. This is done by providing training on the proper use of such materials, ensuring that proper personal protective equipment ppe, safety devices and work practices are used, and that work with biohazards is done in appropriately. Definition of biosafety health and medical information.
The need for biosafety regulation in developing countries. Laboratory biosafety manual world health organization. We support governments to manage the potential adverse effects and benefits of modern biotechnology, with a focus on protecting biological diversity and human health. The essential elements of the four biosafety levels for activities involving infectious microorganisms and laboratory animals are summarized in table 1 of this section and discussed in section 2.
Recombinant dna technology involves combining genetic material from different sources thereby. Safety plan a safety plan is required for areas listed on the bua. In general, the biosafety level recommended for working with biohazardous material in vivo and in vitro are comparable. Biosafety defines the containment conditions under which infectious agents can be safely manipulated. Biosafety introduction to the queens biosafety program and manual. But on the other hand, working with dna is not always without risk. The application of knowledge, techniques and equipment to prevent personal, laboratory and environmental exposure to potentially infectious agents or biohazards. The benefits of undertaking a biosafety risk assessment are. Bsl2 is suitable for work involving agents that pose moderate hazards to personnel and the environment. This document describes the biosafety protocol for stevens institute of technology. In this booklet you will find all the information that was already present in the earlier editions. Pdf a conceptual framework for implementing biosafety. Safeguarding the health and safety of lab personnel. Biohazardous organisms are microorganisms with an infectious potential for man, animals and plants in the environment.
When applied to biological agents human, animal, zoonotic or plant pathogens the risk may be increased or reduced, depending on the nature of the experimental work, containment available and a variety of factors as outlined below. Additionally, the office of biological safety obs adheres to standardized practices as described in the biosafety in microbiological and biomedical. At the same time, modern biotechnology is recognized as having a great potential for the promotion of human wellbeing, particularly in meeting critical needs for food, agriculture and health care. Absl2 is suitable for work involving laboratory animals infected with agents associated with human disease and pose moderate hazards to personnel and the environment.
Biosafety for human health and the environment in the. Principles of good microbiological practice fact sheet pdf principles of biosafety fact sheet pdf. Institutional biosafety committee ibc environment, health. A list of the members of the expert panel appears on page 23. The intent of the biosafety program at queens university, and the purpose of the queens biosafety manual, is to guide personnel in how to work safely with biological material that can be. Pdf the need for biosafety regulation in developing. All infectious agents or substances requiring handling at biosafety level 2 must be registered with the ibc. Who laboratory biosafety manual having served for global biosafety community hereinafter, who manual for more than 20 30 years, since it was first published in 1983, the laboratory biosafety manual has provided practical guidance on biosafety techniques for use in laboratories at all levels. The institutional biosafety committee meeting will be held on 05062020 from 1. The cartagena protocol on biosafety, a supplement to the convention on biological diversity, aims to ensure the safe handling, transport and use of organisms that have been modified using modern biotechnology.