Bureaucracy, creation

We do not recommend the creation of a large, centralized bureaucracy at the OSD level but suggest a single point of contact for coordination with FDA for CBW drugs and biologies. 

The Health and Safety at Work etc. Act (HSW Act), 1974, instituted a system of enforced self-regulation which placed primary responsibility for health and safety with industry. It charged companies with risk management responsibilities which ideally involved companies in developing risk management systems and rules to secure compliance and also entailed worker participation (Ch. 6). But, as Dawson et al. (1988 44) warn, the creation of health and safety structures and procedures within a company is an imperfect measure which does not in itself indicate an improvement in health and safety. Indeed their own case studies demonstrated that compliance with the formalities did not necessarily indicate a serious and established concern to improve standards of health and safety (1988 87). There is therefore a need to consider the impact of these structures in terms of the difference they make at an everyday level. As Stone (1975) comments, the key task is to make bureaucracies think like responsible individuals, so the systems and decision-making processes they institute are critical. 

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