Biosecurity and Disease security (or Biosafety) are key elements when working in laboratory. This presentation focuses on the basics of the above mentioned topics for educational as well as practical purposes.
2. WHAT IS BIOSECURITY AND DISEASE SECURITY?
▸ BIOSECURITY: It includes all the procedures used to prevent the
introduction and spread of diseases.
‣ Disease security or Biosafety: Principles and practices employed to
protect laboratory personnel and the environment from exposure or
infection while working with living organisms, biological materials, or
agents.
THE RELATIONSHIP BETWEEN BIOSAFETY AND BIOSECURITY
Biosafety and biosecurity are both different approaches to ensure
containment, and they both share an end goal of minimising the risk of
accidental or intentional exposures and releases of pathogens or toxins.
They also share a number of elements such as inventory control, access
restriction, accountability and compliance with biosecurity procedures,
incident reporting, evaluation and revision, and education and training.
3. ‣ Objective: To protect biological agents against the theft or diversion
of high-consequence microbial agents, which could be used by
someone who maliciously intends to conduct bioterrorism or pursue
biological weapons proliferation.
‣ Components of biosecurity :
‣ Physical security/protection
‣ Personnel security/reliability
‣ Material Control & Accountability (MC&A) / Pathogen
accountability
‣ Transportation security
‣ Information security
4. LABORATORY BIO SECURITY
‣ Physical security: heat sensors, smoke detectors
‣ Personal security: lab coats, safety glasses
‣ Material control and accountability: individual ethics and
healthy work place environment
‣ Transport security: thermo-assisted drying and
decontamination for PRR virus
‣ Information security: firewalls etc.
‣ Bio safety levels: laminar air flow, autoclaving etc.
5. MEASURES TAKEN
‣ The global disease detection program (GDD) pursues a
multi lateral approach to strengthen both global
capacity and nation capacity to prevent ,detect and
respond to infectious diseases threats whether naturally
occurring deliberate or accidental.
‣ It is associated with WHO, IHR, OIE, etc. to establish
global health security frameworks.
7. BIOSECURITY PRINCIPLES:
‣ Biosecurity Responsibility: The Biosecurity Coordinator is responsible
for the development, implementation, maintenance and ongoing
effectiveness of the biosecurity program.
‣ Training: The biosecurity program should include training materials
that cover both farm site-specific procedures as well as premises-wide
and/or company-wide procedures as appropriate.
‣ Personnel: The biosecurity program and/or the site-specific
biosecurity plan should include provisions specifically addressing
procedures and biosecurity PPE for site-dedicated personnel.
‣ Equipment and Vehicles: The biosecurity plan should include
provisions for procedures for cleaning, disinfection, or restriction of
sharing of equipment where applicable. Vehicle access and traffic
patterns should be defined in the site-specific biosecurity plan.
8. • Mortality Disposal: Mortality should be collected daily,
stored and disposed in a manner that does not attract wild
birds, rodents, insects, and other animals and minimises
the potential for cross-contamination from other facilities
or between premises.
• Manure and Litter Management: Manure and spent litter
should be removed, stored and disposed of in a manner to
prevent exposure of susceptible poultry to disease agents.
• Replacement Poultry: Replacement poultry should be
sourced from health-monitored flocks which are in
compliance with NPIP guidelines. They should be
transported in equipment and vehicles that are regularly
cleaned, disinfected and inspected.
9. ‣ Risk Assessment: A risk assessment will determine the degree of
correlation between an agent’s risk group classification and
biosafety level. (Risk assessment can evaluate the threat posed by
any laboratory activity.)
‣ Factors to consider when evaluating risk include the following:
‣ Pathogenicity: The more severe the potentially acquired disease,
the higher the risk.
‣ Route of transmission-Agents that can be transmitted by the
aerosol route have been known to cause the most laboratory-
acquired infections.
‣ Agent Stability-The greater the potential for an agent to survive in
the environment, the higher the risk. Consider factors such as
desiccation, exposure to sunlight or ultraviolet light, or exposure
to chemical disinfections when looking at the stability of an agent.
10. ‣ Infectious dose: An infectious dose can vary from one
to hundreds of thousands of organisms or infectious
units.
‣ Concentration: In most instances, the risk increases as
the concentration of microorganisms increases.
‣ Origin: This may refer to the geographic location
(domestic or foreign), host (infected or uninfected
human or animal), or nature of the source (potential
zoonotic or associated with a disease outbreak).
11. VACCINE SAFETY STUDIES
PRE-LICENSURE VACCINE SAFETY STUDIES:
‣ Laboratory trials
‣ Animal trials
‣ Human trials
PRE-LICENSURE HUMAN STUDIES:
‣ Common reactions are identified
‣ Vaccines are tested in thousands of persons before being licensed and
allowed on the market
‣ It is done in 3 phases:
• Phase 1: Test the safety and immunogenicity of a vaccine candidate in a few
low-risk individuals (usually healthy adults) to determine tolerability.
12. • Phase 2: Monitor safety, potential side effects, immune response, and determine
optimum dosage and schedule.
• Phase 3: Address clinical efficacy in disease prevention and provide further safety
information from more heterogeneous populations and longer times of observation.
‣ Submission: The vaccine application is submitted to regulatory authorities for
approval to market.
PRE-LICENSURE VACCINE SAFETY STUDIES:
‣ Identify rare reactions
‣ Monitor increases in known adverse health events
‣ Identify risk factors for reactions
‣ Identify vaccine lots with unusual rates or types of event
‣ Identify signals
13. CASE STUDY: RAJNEESH RELIGIOUS CULT ATTACKS
‣ In 1984, Salmonella typhimurium was used to spread typhoid fever.
‣ This contaminated restaurant, salad bars hoping to incapacitate the
population so their candidates would win the county elections.
‣ CDC suggested that the event was naturally occurring outbreak
which was later proven wrong.
‣ He was charged with 35 counts of deliberate violations of
immigration laws. He received a ten-year suspended sentence and a
fine of US$400,000, and was deported and barred from reentering
the United States for a period of five years.He was never prosecuted
for crimes related to the Salmonella attack.
