L6& 7 Basic Concepts on Laboratory Biosafety and Biosecurity

• Biohazard - an agent of biological origin that has the capacity to produce deleterious effect on humans, e.g ; microorganisms, toxins, and allergens
• Laboratory Acquired Infections (LAI) - infections acquired in a laboratory setting
• North America and Western Europe - where the biosafety and biosecurity traces its history
• US Biological Weapons Program - origins of biosafety
• 1943 - US biological weapons program started
• Franklin Roosevelt - ordered the start of US biological weapons program
• The US Bioloigical Weapons Program was eventually terminated by US President Richard Nixon in 1969
• Camp Detrick - biological research and development
• Biosafety - inherent component of biological weapons development
• Newell A. Johnson - designed modifications for biosafety at Camp Detrick
• American Biological Safety Association (ABSA)

  • formed during 1984
  • members are from North America
  • biosafety - scientific discpline
• Arnold Wedum

  • invented the ventilated cabinets (biological safety cabinet)
  • director of Industrial Health and Safety at the US Army Bilogical Research Laboratories in 1944
  • pioneer of biosafety
• 1909 - pharmaceutical company developed ventilated cabinets to prevent infection from mycobacterium tuberculosis
• World Health Assembly consolidated the remaining small pox virus stocks into two locations ;

  • Center for Disease Control and Prevention (CDC)
  • State Research Center for Virology and Biotechnology Vector (SRCVB VECTOR)
• 1974 - the CDC published the Classification of Etiological Agents on the Basis of Hazard
• 1976 - the National Institute of Health (NIH) published the NIH Guideline for Research for Involving Recombinant DNA Molecules
• 1983 - World Health Organization (WHO) published the first edition of Laboratory Biosafety Manual (LBM)
• 1984 - CDC & NIH jointly-published the first edition of the Biosafety in Microbiological and Biomedical Laboratories
• Biosafety Levels are ;

  • technical means of mitigating the risk of accidental infection
  • combination of engineered controls, administrative controls, and practices
  • equipment and facility control
• Biosafety Officers - administrative role of ensuring that the propers equipment and facility controls are in place based on the specified biosafety level of the laboratory
• 1966 - Arnold Wedum and Morton Reitman are colleagues at Camp Detrick. They analyzed multiple-epidemiological studies of laboratory-based outbreaks
• 1996 - US government enacted the Select Agent Regulations
• Revision of the Select Agent Regulations in 2012 - sought to adress the creation of two tiers of select agents
• Tier 1 Agents

  • greatest risk for misuse
  • mass casualties
  • adverse effects to the economy and critical infrastracture
  • public panic
• Tier 1 Select Agents

  • Bacillus Antracis (anthrax)
  • Yersinia Pestis (plague)
  • Francisella Tularensis (tularemia)
  • Clostridium Botulinum (botulism)
  • Variola Major (small pox)
  • Ebola and Marburg Viruses (viral hemorrhagic fevers)
• Singapore - Biological Agents and Toxins Act
• South Korea - Act on Prevention of Infectious Diseases in 2005
• Japan - Infectious Disease Control Law
• 2008 - Danish Parliament passed a law to regulate biological agents
• Biosafety Guidelines - protect human health as well as the environment for pathogens

  Guidelines include ;

  • laboratory practices and procedures
  • facility design
  • safety equipment requirements
• February 2008 - Comité Européen de Normalisation published the CEN Workshop Agreement 15793 (CWA 15793) focuses on laboratory biorisk management
• Comité Européen de Normalisation

  • 24 member countries
  • maintain a biorisk management system among diverse organizations
  • updated in 2011
  • expired in 2014
• 1983 - WHO published the 3rd Edition of the Laboratory Biosafety Manual, it includes information on the Biosafety Levels 1 - 4
• The Cartagena Protocol on Biosafety (CBP)

  • 168 member countries
  • ensure adequate level of protection in the field of safe transfer, handling, and use of living modified organisms (LMOS)
• National Committee on Biosafety of the Philippines

  • established under E.O 430 series of 1990
• March 17, 2006, the OP promulgated EO 514 establishing the National Biosafety Framework (NBF) to attain the objective of the CBO which the Philippines signed on May 24, 2000
• Department of Agriculture (DA) issued Administrative Order No. 8 on policies about modern biotechnology in plants
• Asia Pacific Biosafety Association (A-PBA)

  • founded in 2005
  • members are from asia-pacific region
• European Biological Safety Association (EBSA)

  • founded in June 1996
  • non-profit organization
  • provide a forum for discussions and debates on issues concerning biosafety
• Philippine Biosafety and Biosecurity Association (PHBBA)

  • technical working group of the National Laboratory Biosafety and Biosecurity (NLBB) Action Plan Task For e as per DPO No. 2006-2500 dated September 15, 2006