“Old” Biotechnology to “New” Biotechnology: Continuum or Disjunction?

Since the advent of recombinant DNA techniques and hybridoma technology gave rise more than a decade ago to “new” biotechnology, there has been much discussion of whether the products newly available should be regarded as refinements, or extensions, of previous ones, or as resulting from a technological disjunction. This conundrum is important because of its intimate connection to the question whether existing methods of risk analysis or risk assessment are applicable to or adequate for new processes and products. This is a pivotal issue, because the purpose of such risk assessment is to provide scientists, government regulators and others a measure of the safety attendant to the testing or use of a product, and to provide guidance as to the management of the risk that may be present.