The authors and editor of this revised second edition continue the nowestablished who tradition of. Agriculture and food system issues impact of biotechnology on the organization, structure and behaviour of agricultural industry coexistence of conventional organic and biotechnology oriented agriculture the capacity of the food system to segregate geneticallymodified commodity and product of specific markets. 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. The maximum containment laboratory biosafety level 4. Biosafety and biosecurity 1 introduction purpose and scope of the fasttrack action committee in 2015, the biological defense research and development subcommittee bdrd of the national. Every party has a regulatory framework in place and functioning to implement it. In july 2010, the federal experts security adviso ry panel fesap was established by. It outlines the best practices for handling biosafety level 1 and biosafety level 2 materials at the life lab. Laboratory biosafety manual world health organization. National biosafety framework or nbf is a combination of policy, legal, administrative and technical instruments that are developed to ensure an adequate level of protection in the field of the safe transfer, handling and. Biosafety and biosecurity are defined by the world health organization who. Human, animal and plant materials may harbor biohazardous organisms or agents and such materials must be handled accordingly.
Use the biosafety training guide to determine what training requirements apply and how to satisfy those requirements. This guide is intended for use as a supplement to the nih. Need for a standalone national policy on biosafety 23 2. The revised african model law on biosafety and the african. The purpose of containment is to reduce or eliminate the exposure to potentially hazardous agents of laboratory workers, other persons, and the outside environment. The new publication will combine the laboratory biosafety manual, 2nd ed. The world health organization who, the world organisation for animal health oie, and the food and agriculture organization fao are also players in strengthening an international culture of biosafety, biosecurity, and responsible conduct in. Additionally, labspecific biosafety training is needed for all new lab members. Enhancing biosafety and biosecurity in the nations public. Pharm pharmaceutics year 2nd, semester 3 amity university. These regulatory frameworks focus primarily on risks to human health and. Biosafety, biotechnology and gmos legislations in libya. It creates awareness about the value of ipr in our lives and fosters a better understanding of the rights associated with ipr such as, patent, trademarks, industrial designs, geographical indications and so on.
This move has been spearheaded by the science and technology secretariat of the new. Biological safety training vanderbilt environmental. Interim clinical laboratory guideline for biological safety. Aug 25, 2008 biosafety deals with prevention of large scale loss of biological integrity focusing both on ecology and human health. Biosafety in microbiological and biomedical laboratories provides specific descriptions of combinations of microbiological practices, laboratory facilities, and safety equipment, and recommends their use in four biosafety levels of operation with infectious agents. Biosafety deals with prevention of large scale loss of biological integrity focusing both on ecology and human health. The biosafety import, export and transit regulations, 20111.
It is related to several fields such as ecology, agriculture, medicine, chemistry and ecobiology. Scopes and objectives of the proposed national policy on biosafety 24 2. The south korean government passed the bioethics and biosafety act, known henceforth as the bioethics act,in 2003 and it took effect in 2005. 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 survey was distributed via email with a unique survey link and a copy of the survey.
Lncbb has worked closely with biotechnology research center and environmental general authority ega in formulating the national biosafety framework. The bioethics and biosafety of gene transfer springerlink. Barbeito, 1997, a history of the american biological safety association part iii. This is the third, revised edition of the booklet biosafety in the laboratory. Introduction to biosafety learning objectives biosafety. Each laboratory is required to have a labspecific biosafety manual and cannot be borrowed or copied from another lab. Hepatitis tuberculosis typhoid venezuelan equine encephalitis brucellosis tularemia 2.
A phis veterinary services vs announces the launch of the efile vs permitting assistant vspa biosafety manual in pdf. Training needs will vary based upon what a person works with in the lab. The report is divided into five chapters and several annexes. In the case of agricultural biotechnology and biosafety, the debate has focused on.
This course is designed to be a primary component of the introductory training for the sciences and is intended. Chapter 2 deals with the need for a biosafety protocol and includes both arguments for and against such a protocol. Biosafety practices are used in the proper handling of biohazardous organisms. Biological safety training vanderbilt environmental health. Amity institute of pharmacy 1 slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising.
National biosafety framework produced within the unepgef project gf2716014319 development of the national biosafety framework in the kyrgyz republic bishkek, 2005. Sentinel laboratories perform inhouse testing that includes gram stains and at least one of the following. Investigators pi, laboratory workers, the university biosafety officer bso, the institutional biosafety committee ibc, and certain administrative officials. Ensuring institutional compliance with biosafety, biocontainment, and laboratory biosecurity regulations and guidelines.
Experiments described in a protocol of this nature may be. The international cartagena protocol on biosafety deals primarily with the agricultural definition but many advocacy groups seek to expand it to include postgenetic threats. Public interest report fall 2011 6 there are four basic biosafety levels as determined by cdc and nih which describe the microbiological techniques, lab practices, safety equipment and lab facilities necessary to protect workers and the environment. Only a few alterations have been made, especially in the text concerning decontamination and inactivation.
These regulatory frameworks focus primarily on risks to human health and the environment, and the concepts of substantial equivalence and familiarity seem to be the two universally adopted principles on which risk assessments are based. The various biosafety levels appropriate for these works are biosafety levels 3 and 4, animal facilityvivarium absl3 and absl4, and biosafety level 3 agricultural facilities bsl3ag. In this booklet you will find all the information that was already present in the earlier editions. Biosafety testing is normally designed to ensure the detection of both known and unknown adventitious agents, but the results of the risk assessment can be used to put in place a biosafety testing. Ipr, biosafety and bioethics deepa goel, shomini parashar. A biosafety level bsl is based on the potential hazard of the agent and the functions of the lab. This biosafety practices document is an extension to the biological safety manual and exposure control plan. The biosafety levels described in the nih guidelines for research involving rdna molecules are based on and consistent with the biosafety levels presented here. Agrobacterium radiobacter, aspergillus niger, bacillus thuringiensis.
Principles of biosafety fact sheet biosafety is a practice. Ipr, biosafety and bioethics provides a broad coverage of three areas of patentingintellectual property rights ipr, biosafety and bioethics. Biosafety and biosecurity have dominated the policy discourse and the two have been inexorably intertwined. The vice president for research has established a webpage that will be accessible from the tamu. High containment refers to the highest level of biosafety. Appropriate biosafety regulations are one of the prerequisites for a successful transfer of biotechnology to and, among developing countries. Governments need to accept and embrace some of these new trends and new technologies. New trends illustrate a greater appreciation of a strong need for a cooperative partnership. Biological safety manual environment, health and safety. They include personal protective equipment like gloves, coats, respirators, etc.
Every party to the cartagena protocol on biosafety is. Lncbb has worked closely with biotechnology research center and environmental general authority ega in formulating the national biosafety framework, nbf. At least since 2001 and the amerithrax anthrax letters, the usa has had a significant focus on biosecurity and the related subject of biosafety. National biosafety framework or nbf is a combination of policy, legal, administrative and technical instruments that are developed to ensure an adequate level. At this time, a biosafety training checklistrecord is available and strongly recommended for all short term lab members i. Molecular detection of pre symptomatic genetic diseases and its importance in healthcare. Primary barriers, which include all the physical safety devices that prevent direct contact between the agent and the worker. The cartagena protocol on biosafety is widely implemented. South koreas bioethics and biosafety act 2005 the embryo. National biosafety authority biosafety regulations. This course is designed to be a primary component of the.
Contents unit1 an overview of the legal and socioeconomic impacts of 1 biotechnology biosafety regulations national and international level biosafety regulations 2 trials onfield 2 upscaling of field trials 2 developing countries 3 coordination and capacity establishment 3 screena newsletter on biosafety 4 risks versus benefits 4 hazardous materials used in biotechnologyhandling. Two other concepts in safety are primary and secondary barriers. Biosafety in agriculture, chemistry, medicine, exobiology and beyond will likely require the application of the precautionary principle, and a new definition focused on the biological nature of the threatened organism rather than the nature of the threat. It is concerned with the ethical questions that arise in the. Development of biosafety practices 1951, 1965, 1976 sulkin and pike surveys for labassociated infections more than 5,000 labs cumulative total of 3,921 cases cited most commonly reported. Develop standard operating procedures sops to ensure the safe use of biohazardous agents. May 22, 2015 6 bioethics and biosafety in biotechnology b instructions for hazardous waste disposal proper disposal of chemical wastes is required by central and state governmental laws. Bioethics is the philosophical study of the ethical controversies brought about by advances in biology and medicine. Bioethics and biosafety in biotechnology biojuncture. All parties have available adequate capacity as well as increased resources and technology transfer to implement it, and that. Biosecurity and biosafety systems in the philippines and new. Because they indicate the breadth of the approach taken to biosafety under the convention, the texts of these articles are included in annex 1. Published by aph publishing corporation 2007 isbn 10.
Biosecurity and biosafety systems in the philippines and. South koreas ministry of health and welfare proposed the law to the south korean national assembly to allow the progress of biotechnology and life sciences research in south korea while protecting human research subjects with practices such as. Biological safety, or biosafety, is the application of knowledge, techniques and equipment to prevent personal, laboratory and environmental exposure to. Biohazardous organisms are microorganisms with an infectious potential for man. From the early stages of genetic engineering legal frameworks were set up to ensure the safe development of this technology. Prenatal diagnosis genetic manipulations and their ethical issues. Good biosafety and biocontainment practices can help in effective laboratory biosecurity.