That protocol, the cartagena protocol on biosafety, was adopted in january 2000. The program includes close cooperation and interaction with committees approving research protocols. Compared to the fiasco of 1999, in 2000, there was a somewhat successful treaty to regulate the international transport and release of genetically modified organisms to protect natural biological diversity. Interim laboratory biosafety guidelines for handling and processing specimens associated with middle east respiratory syndrome coronavirus merscov to date, little is known about pathogenic potential and transmission dynamics of middle east respiratory syndrome coronavirus merscov. Information specific to bsl 1 and bsl 2 will follow. Biosafety manual office of environmental health and safety 5425 woodward, suite 300 detroit, michigan 48202 3.
Pdf a conceptual framework for implementing biosafety. The cartagena protocol on biosafety was adopted by 150 countries in january 2000 to regulate the transboundary movement of genetically modified organisms that might pose a risk to the environment. Pi but is shared with the institutional biosafety committee ibc, biosafety professionals, laboratory staff and other stakeholders which may include lab animal veterinarians and caretakers, farm staff, operations staff, occupational health practitioners, etc. Earth negotiations bulletin report saturday, 29 january, 2000. Biohazardous organisms are microorganisms with an infectious potential for man. With this information, choose suitable methods depending on the features of each. I will use the terms biosafety protocol and the protocol interchangeably throughout this article to refer to the cartagena protocol on biosafety.
For bibliographic and reference purpose this publication should be referred to as. Interim laboratory biosafety guidelines for handling and. Identification of elements of the framework which need updating in light of recent advancements on the subject. The cartagena protocol on biosafety to the convention on biological diversity is an international treaty governing the movements of living modified organisms lmos resulting from modern biotechnology from one country to another. Biosafety protocols and socioeconomic considerations in relevant regulatory laws.
Iqoq protocol installation qualification operation qualification purifier logic series biological safety cabinets labconco no. It was adopted on 29 january 2000 as a supplementary agreement to the convention on biological diversity and entered into force on 11 september 2003. The cartagena protocol on biosafety to the convention on biological diversity is an international agreement on biosafety as a supplement to the convention on biological diversity effective since 2003. The nagoyakuala lumpur supplementary protocol on liability and. The influence of the cartagena protocol on biosafety mit press. Living modified organism advanced informed agreement convention on biological diversity world trade organization. It was named in honor of cartagena, colombia, where negotiations were expected to conclude in february 1999. 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. In this booklet you will find all the information that was already present in the earlier editions. The biosafety program must meet nih, cdc, usda, osha, any other granting agency, as well as federal, state, and local requirements. The uta biosafety manual focuses on biosafety levels bsl 1 and 2 since no work with bsl3 or 4 agents is conducted at uta at the moment. Whenever you change the work described in your rdna andor biosafety protocol, you need to update the protocols to reflect the changes. In part 3, the interaction between the wto and the biosafety protocol and iccat is.
The cartagena protocol on biosafety cpb was concluded in 2000. Human, animal and plant materials may harbor biohazardous organisms or agents and such materials must be handled accordingly. A biosafety risk assessment should consider every activity and procedure in a laboratory that involves infectious disease agents. Biodiversity cartagena protocol on biosafety convention on biological diversity. In accordance with precautionary approach the objective of cpb is to contribute to ensuring adequate level of protection in the field of the safe transfer, handling and use. Pdf the cartagena protocol on biosafety allows the possibility of including. Principles of biosafety fact sheet biosafety is a practice. It was adopted on 29 january 2000 and entered into force on 11 september 2003. Provides protection for the worker and the laboratory environment but not to product being utilized in the cabinet. Facility gef council adopted the gef initial strategy on biosafety in november 2000. 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 protocol derives much of its significance from the fact that it provides the first lineaments of a legal regime addressing some environmental and human impacts of genetic. This is the third, revised edition of the booklet biosafety in the laboratory. The laboratory biosafety manual should be a living, working document that is an important resource for personnel engaged in the activities using biological and or rdna materials. Simon brown daud hassan application of the precautionary. An analysis of results an iisd briefing note1 introduction when, on january 29, 2000, negotiators from over countries checked out of their montreal hotel rooms carrying agreed final text of an international agreement on biosafety, nobody was more surprised than the environmental community. One should not be surprised therefore that an issue combining ambiguity and a. Secretariat of the convention on biological diversity.
The very existence of the protocol is a landmark achievement given the hard line taken in the. The story of the cartagena protocol better known as the biosafety protocol to the convention on bio. Biosafety protocol official documents convention on biological diversity montreal, 20 28 january 2000. Biosafety protocol, in areas of capacity building on various levels, and the proper use of biosafety clearing house, bch mechanism. Pdf the need for biosafety regulation in developing.
The mission of the ehs biosafety group is to assure a safe and healthy environment for individuals working with biohazards and to protect the community and environment by preventing the release. 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. Benefits and controversies article pdf available in african journal of biotechnology 1058. Laboratory biosafety and biosecurity risk assessment. Laboratory facilities are designated as basic biosafety level 1, basic biosafety level 2, containment biosafety level 3, and maximum containment biosafety level 4. The need for biosafety regulation in developing countries. The impact of the cartagena protocol on biosafety regulation. The biosafety protocol seeks to protect biological diversity from the potential risks posed by genetically modified organisms resulting from modern biotechnology. Biosafety manual may 2010 page 2 class i biosafety cabinet an enclosure with an inward airflow through the front opening. Protocol amendments are required with any change in host, vector or modified gene expression, any change in biohazardous materials, agents, or toxins used, and any change in procedures, location of your work, or to update irb, iacuc, or ibc protocol numbers.
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. A biosafety protocol meeting was hosted in montreal, canada january 24, 2000 to january 28, 2000. Institutional biosafety manual, version 102016 page 6 of 53. The institutional biosafety committeeibc reports to the executive vice president for research on matters related to the use of biological hazards and recombinant or synthetic nucleic acid molecules in research, clinical, and educational activities at uthealth. Iqoq protocol purifier logic biological safety cabinets. The biosafety protocol is an international agreement reached in montreal, january 2000 aimed at regulating the transboundary movement of living modified organisms lmos, or living gmos.
Laboratories are assigned a biosafety level numbered 1 through 4 based on their potential. Chapter 26 lim li lin cartagena protocol on biosafety biosafety first 2007 traavik, t. The cartagena protocol on biosafety is an international agreement which aims to ensure the safe handling, transport and use of living modified organisms lmos resulting from modern biotechnology that may have adverse effects on biological diversity, taking also into account risks to human health. The cartagena protocol on biosafety icgeb international centre. The cartagena protocol on biosafety is a legally binding protocol to the convention on biological diversity cbd. This problem is of utmost importance, because the implications of international treaties are profound and farreaching. The biosafety manual is designed in accordance with nih guidelines for research involving recombinant or synthetic nucleic acid molecules and the biosafety in microbiological and biomedical laboratories bmbl, 5th edition to assure laboratory personnel that with proper precautions, equipment, and facilities most biohazardous materials can be handled without undue risk to. Cartagena protocol on biosafety to the convention on biological diversity. The cartagena protocol on biosafety biosafety protocol or protocol, 1 adopted in january 2000 as a supplementary agreement to the 1992 united nations convention on biological diversity cbd, 2 could soon become one of the first binding multilateral international agreements dealing specifically and exclusively with some of the challenges. Bsl ii is appropriate when work is done with any humanderived blood, body fluids, tissues, or primary human cell. Biosafety protocol cbd press release cartagena protocol adopted 29 january 2000 belgian biosafety server updated 3 february, 2000 with full text of protocol. Secretariat of the convention on biological diversity 2000. Its primary focus should be to provide pertinent information to help execute the operations of the lab in a. Biosafety level designations are based on a composite of the design features, construction, containment.
The biosafety protocol allows countries to block importation of genetically modified crops, altered seeds, microbes and animals the countries consider as a threat to the environment. Biosafety protocol stevens institute of technology. Biosafety protocol the cartagena protocol on biosafety. Biosafety encompasses the knowledge, techniques, equipment, and facilities necessary to prevent or minimize an exposure to, or release of, a biohazard. The provisions specified in this biosafety manual are applicable to all persons working in laboratories including. A biosafety risk assessment allows a laboratory to determine the relative level of risks its different activities pose and helps guide risk mitigation decisions so they are targeted to the most important risk. There arecurrently no facilities for this type of research. The office of environmental health and safety restricts routine distribution. Sample laboratory biosafety manual for microbiological. Class ii biosafety cabinet an enclosure with an inward airflow through the front opening. Biosafety practices are used in the proper handling of biohazardous organisms.
This booklet contains the text of the cartagena protocol on biosafety to the convention on biological diversity, which starts on page 2. The cartagena protocol on biosafety to the convention on biological diversity is an international agreement which aims to ensure the safe handling, transport and use of living modified organisms lmos resulting from modern biotechnology that may have adverse effects on biological diversity, taking also into account risks to human health. Chapter title page table of contents 2 emergency phone numbers and resources 34 1 biological safety program 510 2 approval of research projects 1117 3 regulations and guidelines 1823 4 biosafety principles 2431 5 laboratory biosafety practices 3249 6 laboratory training 5053 7 decontamination and sterilization 5458 8 biohazardous spill response 5966. Ibc faqs office of research support and compliance. Be clear about the degree of decontamination that needs to be conducted in the laboratory and then inspect the type, concentration, and location of microorganisms present in the lab. The purpose of containment is to reduce or eliminate the exposure to potentially hazardous agents of laboratory workers, other persons, and the outside environment. This booklet contains the text of the cartagena protocol on biosafety to the convention on biological diversity, which starts.
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