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Biosafety and biotechnology policy developers/makers cannot continue putting forward policies or other legal instruments without putting at least some consideration to the potential implementation feasibility of such requirements. Effective biosafety and biotechnology policy formulation needs to clearly define the implementation process in order to ensure that in the end you will have a functional regulatory and technology development system that has the ability to approve, reject or ask for more information which describes a functional system.

A functional system thus implies defining who, when , how, assessment trigger,  rules and decision making standards, quality controls including peer review /verifiability and other elements of best practice, and even the rationale why you are including socioeconomics, even in the case of a law  that has been passed already.

Important to consider inclusion of the option in any assessment process that allows an initial screening that determines whether a specific application can be excluded (Complete Exclusion or Statements of No Significant Impact), have the possibility of a “lighter” assessment or to consider a more complete study.

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