biosafety

• Biosafety levels


  The technical means of mitigating the risk of accidental infection from or release of agents in the laboratory setting as well as the community and environment it is situated in
• Biosafety levels


  • Combination of engineered controls, administrative controls, and practices
  • Emphasis is on the equipment and the facility controls, with little attention given to risk assessment
• Biosafety officers


  Adopted the administrative role of ensuring that the proper equipment and facility controls are in place based on the specified biosafety level of the laboratory
• Arnold Wedum, director of Industrial Health and Safety at the US Army Biological Research Laboratories, recognized as one of the pioneers of biosafety


  1944
• Wedum and microbiologist Morton Reitman analyzed multiple epidemiological studies of laboratory – based outbreaks


  1966
• US government enacted the Select Agent Regulations to monitor the transfer of a select list of biological agents from one facility to another


  1996
• Terrorist attacks and the anthrax (disease caused by Bacillus Anthracis) attacks, also known as Amerithrax


  2001
• Revision of the Select Agent Regulations to address the creation of two tier of select agents

  2012
• Tier 1 agents


  Materials that pose the greatest risk of deliberate misuse
• Tier 1 Select Agents

  • Bacillus anthracis (Anthrax)
  • Yersinia pestis (Plague)
  • Francisella tularensis (Tularemia)
  • Clostridium botulinum (Botulism)
  • Variola major (Smallpox)
  • Ebola and Marburg viruses (Viral hemorrhagic fevers)
• Comite Europeen de Normalisation (CEN) published CEN Workshop Agreement 15793 (CWA 15793) which focuses on laboratory biorisk management

  2008
• WHO published its 3rd edition of the Laboratory Biosafety Manual


  1983
• WHO Laboratory Biosafety Manual

  • Covers the different levels of containment laboratories (Biosafety levels 1 – 4), different types of biological safety cabinets, good microbiological techniques, and how to disinfect and sterilize equipment
  • Covers the packaging required by international transport regulations and other types of safety procedures for chemical, electrical, ionizing radiation, and fire hazards
  • Emphasizes the continuous monitoring and improvement directed by a biosafety officer and the biosafety committee
• There is no mechanism to ensure that the WHO biosafety guidance is being adhered to, or that people working in laboratories are sufficiently trained
• The Cartagena Protocol on Biosafety (CPB) made effective, providing an international regulatory framework to ensure "an adequate level of protection in the field of safe transfer, handling, and use of living modified organisms (LMOs) resulting from modern biotechnology"


  2003
• The new National Committee on Biosafety of the Philippines (NCBP) established under E.O. 430 series of 1990

  1990
• The Office of the President promulgated E.O. 514 establishing the National Biosafety Framework (NBF)


  2006
• The NBF is a combination of policy, legal, administrative, and technical instruments developed to attain the objective of the Cartagena Protocol on Biosafety which the Philippines signed on May 24, 2000
• The Department of Agriculture (DA) issued Administrative Order No. 8 to set in place polices on the importation and release of plants and plant products derived from modern biotechnology
• The Department of Health (DOH), together with NCBP, formulated guidelines in the assessment of the impacts on health posed by modern biotechnology and its applications
• American Biological Safety Association (ABSA)

  A regional professional society for biosafety and biosecurity founded in 1984, promotes biosafety as a scientific discipline and provides guidance to its members on the regulatory regime present in North America
• Asia – Pacific Biosafety Association (A-PBA)


  A group founded in 2005 that acts as a professional society for biosafety professionals in the Asia – Pacific region, with members from Singapore, Brunei, China, Indonesia, Malaysia, Thailand, the Philippines, and Myanmar
• European Biological Safety Association (EBSA)


  A non-profit organization founded in June 1996, that aims to provide a forum for discussions and debates on issues of concern and to represent those working in the field of biosafety, focuses on encouraging and communicating among its members information and issues on biosafety and biosecurity as well as emerging legislation and standards
• Philippine Biosafety and Biosecurity Association (PhBBA)


  Created by a multi-disciplinary team with members coming from government, academe, and industry, aims to promote biosafety and biosecurity in the Philippines
• Biosafety


  The containment principles, technologies, and practices that are implemented to prevent unintentional exposure to pathogens and toxins, or their accidental release
• Biosecurity


  The protection, control, and accountability for valuable biological materials within laboratories, in order to prevent their unauthorized access, loss, theft, misuse, diversion, or intentional release
• Biosafety focuses on


  • Laboratory procedures and practices necessary to prevent exposure to and acquisition of infections
  • Protects people from germs
• Biosecurity focuses on

  • Maintenance of secure procedures and practices in handling biological materials and sensitive information
  • Protects germs from people
• Biosafety and Biosecurity Associations

  • American Biological Safety Association (ABSA)
  • Asia - Pacific Biosafety Association (A-PBA)
  • European Biological Safety Association (EBSA)
  • Philippine Biosafety and Biosecurity Association (PhBBA)
  • Biological Risk Association Philippines (BRAP)
• American Biological Safety Association (ABSA)

  • Founded in 1984
  • Promotes biosafety as a scientific discipline
  • Provides guidance to its members on the regulatory regime present in North America
• Asia - Pacific Biosafety Association (A-PBA)


  • Founded in 2005
  • Acts as a professional society for biosafety professionals in the Asia - Pacific region
  • Members are from Singapore, Brunei, China, Indonesia, Malaysia, Thailand, the Philippines, and Myanmar
• European Biological Safety Association (EBSA)

  • Non-profit organization founded in June 1996
  • Aims to provide a forum for discussions and debates on issues of concern and to represent those working in the field of biosafety
  • Focuses on encouraging and communicating among its members information and issues on biosafety and biosecurity as well as emerging legislation and standards
• Philippine Biosafety and Biosecurity Association (PhBBA)


  • Created by a multi-disciplinary team with members coming from the health and education sectors as well as individuals from the executive, legislative, and judicial branches of the government
  • Also included are members of the steering committee and technical working groups of the National Laboratory Biosafety and Biosecurity Action Plan Task Force
  • A long term goal is to assist the DA and DOH in their efforts to create a national policy and implement plan for laboratory biosafety and biosecurity
• Biological Risk Association Philippines (BRAP)


  • A non-government and non-profit association
  • Works to serve the emergent concerns of biological risk management in various professional fields such as in the health, agriculture, and technology sectors throughout the country
• Risk Groups of Microorganisms

  • Risk Group 1 - No or low individual and community risk
  • Risk Group 2 - Moderate individual risk, low community risk
  • Risk Group 3 - High individual risk, low community risk
  • Risk Group 4 - High individual and community risk
• Risk Group 1


  • Includes microorganisms that are unlikely to cause human or animal disease
  • These microorganisms bring about low individual and community risk
• Risk Group 2


  • Includes microorganisms that are unlikely to be a significant risk to laboratory workers and the community, livestock, or the environment
  • Laboratory exposure may cause infection; however, effective treatment and preventive measures are available while the risk of spread is limited
  • This risk group bring about moderate individual risk, and limited community risk
• Risk Group 3

  • Includes microorganisms that are known to cause serious diseases to humans or animals and may present a significant risk to laboratory workers
  • It could present a limited to moderate risk if these microorganisms spread in the community or the environment, but there are usually effective preventive measures or treatment available
  • They bring about high individual risk and limited to moderate community risk
• Risk Group 4


  • Includes microorganisms that are known to produce life-threatening diseases to humans or animals
  • It represents a significant risk to laboratory workers and may be a readily transmissible from one individual to another while effective treatment and preventive measures are not usually available
  • In effect, they bring about high individual and community risk
• Biosafety Levels


  • Biosafety Level 1 (BSL-1)
  • Biosafety Level 2 (BSL-2)
  • Biosafety Level 3 (BSL-3)
  • Biosafety Level 4 (BSL-4)