FEDERAL “RELATED SCIENCE ACTIVITIES” (RSA) AND MULTI-LEVEL REGULATION  INTRODUCTION AND CENTRAL PURPOSES  RSA AND LEVELS OF SCIENCE-BASED REGULATION  CASE STUDY AGENCIES -VETERINARY DRUGS DIRECTORATE (Health Canada) -NEW SUBSTANCES BRANCH (Environment Canada)  CONCLUSIONS

RSA AND LEVELS OF SCIENCE- BASED REGULATION  RSA DEFINITIONS, RELATIONSHIPS AND BOUNDARIES  RSA IN FEDERAL S&T AND INNOVATION POLICY  RSA IN THE SMART REGULATION AGENDA

MAPPING RSA IN MULTI-LEVEL REGULATION  REGULATION AND ITS SERVICE RELATIONSHIPS: THE TRIAD OF - CLIENTS/CUSTOMERS - SERVICE PROVIDERS - SERVICE MEDIUMS TANGIBLE GOODS CODIFIED KNOWLEDGE INDIVIDUALS  REGULATION AS RULES AND COMPLIANCE  MAPPING RSA IN - PRE-MARKET PRODUCT OR OTHER APPROVALS - MONITORING (GENERAL AND POST-MARKET)

Table 1: Core RSA Relations in Multi-level Regulation a) RSA for Regulation and Product Approvals –direct assessment by RSA staff of products for approval/use in markets. –direct assessments/actions on compliance and enforcement –drafting of guidelines and guideline documents for use by client groups, and users of products in the general public and by employees of other levels of government –continuous exchange of RSA knowledge with international and foreign regulators.

b) RSA for General and Post-Market Monitoring –general and continuous surveys and monitoring –specific or targeted monitoring and reporting (e.g. pharmacovigilence) –not regulatory in the first instance but can tie into or lead to other regulations by other governments or self- regulation by stakeholders; –can produce guidelines and actions which citizens perceive as regulatory in some overall sense of the state as protector of health and safety –involves numerous exchanges of RSA knowledge amongst staff in other core federal, provincial and international agencies as well as professional knowledge groups.

THE CASE STUDY AGENCIES AND MULTI- LEVEL REGULATION  RSA IN HEALTH CANADA AND ENVIRONMENT CANADA  CORE MANDATES -VETERINARY DRUGS DIRECTORATE -NEW SUBSTANCES BRANCH  CORE DECISION AND RISK ASSESSMENT AND MANAGEMENT CYCLES AND VOLUMES  RSA PARTNERSHIPS AND DEPENDENCIES  RSA PERSONNEL BACKGROUNDS AND COMPETENCES

CONCLUSIONS  RSA NEEDS TO MORE CLEARLY UNDERSTOOD AS CRUCIAL TO REGULATION AND MULTI-LEVEL REGULATION  RSA HAS BEEN SYSTEMICALLY UNDERPLAYED IN FEDERAL S&T, INNOVATION AND SMART REGULATION POLICY  THE FEDERAL GOVERNMENT IS CONTINUOUSLY INCREASING ITS OWN AND CANADA’S MULTI-LEVEL NEEDS FOR RSA BUT IT IS NOT SUPPORTING IT OR INVESTING IN IT WITH