Regulatory government agencies execute their legislative mandates through a series of “traditional practices”, formal policy, and structured processes. Collectively, these largely define how an Agency really operates, and are important points to which all stakeholders react. Examples of such include: data requirements and data review processes; “bright-line” for risk determinations, and the methods for calculating risk; process and policies for inspections, reporting requirements, public access to violation records; function of multi-stakeholder committees in process and policy.

This presentation will be a reflection of how industry has responded to these elements, as observed by industry, regulatory officials, and advocate representatives in the US, noting that this perspective is quite different in other countries.