Inoculation development for production of recombinant microbial products: Risk analysis

Risk analysis:The foundation of any safety program is the use of control measures appropriate for the risk posed by activities and the agents in use. The process of analyzing and determining the risk associated with use of rDNA microorganisms is known as risk analysis. It consists of risk assessment, risk management and risk communication.

Risks can be classified into four categories, namely,

  • Marginal – minimal adverse health effects, minimal or no damage to the environment or disruption to biological communities.
  • Minor – adverse health effects that are reversible, damage to the environment or disruption to biological communities that is reversible and limited in time and space or numbers affected.
  • Intermediate – adverse health effects that are reversible, damage to the environment or disruption to biological communities that is widespread but reversible or of limited severity.
  • Major – adverse health effects those are severe, widespread and irreversible and extensive damage to the environment or extensive biological and physical disruption of whole ecosystems, communities or an entire species that persists over time or is not readily reversible.

The likelihood of the risk can also be assessed with the help of following categories:

  • Highly unlikely
  • Unlikely
  • Likely, and
  • Highly likely

Risks are evaluated on parameters describe below:

  • Assessment of effect on human health – expected toxic or allergenic effects of the organism and/or its metabolic products, pathogenicity, capacity for colonization, diseases caused and route of entry, infective dose, possibility of survival outside human host, biological stability, antibiotic-resistance patterns, availability of appropriate therapies and prophylactic measures.
  • Information on recipient organism: taxonomy, identification, source, culture, nature and stability of genetic modification, history of prior genetic modification, information on natural occurrence, information on possible spread of recipient organism and its progeny in the absence of confinement, host range (if relevant), history of safe use (if any), ability to form survival structures, information on the potential of organism to establish itself in the accessible environment.
  • Information on process of genetic modification: the nature, function and source of the inserted donor nucleic acid, including regulatory or other elements affecting the function of the DNA and of the vector, rate and levels of expression of the introduced genetic material, any possible dual usage that may compromise health and safety of people and environment, characterization of the site of modification of the recipient genome and sequence confirmation of the introduces genetic elements for the accuracy of modification and for intended function.
  • Assessment of effect on environment: routes by which the recombinant microorganism could be released (including waste disposal, equipment failure and as well as human spread), potential to infect or colonize animals and plants, anticipated result of interaction of recombinant microorganisms and other organisms in case of unintentional release into the environment, the local environment surrounding the containment facility as well as the wider environment, expected survivability, multiplication and extent of dissemination of the microorganism in identified ecosystems.