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Biotechnology has become a growth industry; recent advances in technology have enabled the industry to develop new products at an increasingly rapid rate. Although many traditional laboratory techniques are employed by manufacturers of biotechnology products, new techniques are also being developed that are more appropriate or more specific to the new technologies. Similarly, although many of the risks and potential liabilities associated with biotechnology laboratories are the same as those associated with the operation of conventional laboratories, bioprocessing presents unique risks and liabilities of its own. The paper provides a brief overview of the traditional bases of legal liability that most likely will be applied to biotechnology producers in the event injury or illness results from biotechnology products or production methods. The paper also discusses allocation of losses resulting from such liability and suggests ways to minimize the legal risks associated with bioprocessing technology. The bases of legal liability discussed include violation of statutes or regulations, negligence, strict liability, products liability, and workers' compensation. In discussing allocation of loss, the paper touches briefly on the need to promote the availability of appropriate insurance coverage. In discussing ways to minimize legal risks, the paper suggests specific courses of action, including compliance with regulatory and statutory requirements and appropriate community standards; voluntary initiation of risk avoidance and risk management programs; careful education of laboratory personnel in the use of appropriate safety procedures; education of consumers as to potential hazards and safe methods of use; documentation of employee participation in educational programs; health monitoring programs for employees; and continual reassessment of safety, compliance, and educational programs. Finally, the paper points out the need for international cooperation on the development of standards of safety and liability in the biotechnology industry.
bioprocessing, international biotechnology, legal aspects of biotechnology regulation, biotechnology insurance, legal issues in biotechnology, legal issues in genetic engineering, liability, recombinant DNA, risk management
Partner, Wood, Lucksinger, & Epstein, Houston, TX
Wood, Lucksinger, & Epstein, Houston, TX